WO2023146988A1

WO2023146988A1 - Antiviral and antibacterial composition and methods, and apparatus related thereto

Info

Publication number: WO2023146988A1
Application number: PCT/US2023/011657
Authority: WO
Inventors: Kamal FARHA; Gerald Hutchinson; Said Farha
Original assignee: Technoswiss Llc
Priority date: 2022-01-26
Filing date: 2023-01-26
Publication date: 2023-08-03

Abstract

An antiviral/antimicrobial composition is provided. The composition is a water-based antiviral/antimicrobial formula that is capable of being applied on porous and nonporous surfaces or sprayed in the air for disinfecting purposes. The composition comprises materials that are water soluble with different functionalities capable of creating a synergistic effect between the materials within the composition.

Description

ANTIVIRAL AND ANTIBACTERIAL COMPOSITION AND METHODS, AND APPARATUS RELATED THERETO

Cross-Reference to Related Applications

[0001] This application claims priority pursuant to co-pending U.S. Provisional Patent

Application Serial No. 63/303,228, filed January 26, 2022, the entire disclosure of which is incorporated herein by reference.

Field of the Invention

[0002] The present invention relates generally to antiviral and antibacterial compositions and methods, and apparatus related thereto. More specifically, the present invention is concerned with a water-based antiviral/antimicrobial composition that is capable of being applied to porous and nonporous surfaces, methods of using an antiviral/antimicrobial composition, and apparatus utilizing/containing an antiviral/antimicrobial composition

(including, but not limited to protective and/or filtration equipment).

Background of the Invention

[0003] Coronaviruses (CoVs) are enveloped positive RNA viruses, belonging to the coronaviridae family and the order Nidovirales. They are capable of adapting to new environments through mutation and recombination and are programmed to alter host range and tissue tropism. Coronaviruses are phylogenetically subdivided into four genera, a, b, g, and d, with type a and b known to be able to infect humans. Coronavirus b can be classified as Severe

Acute Respiratory Syndrome (SARS) and Middle East Respiratory Syndrome (MERS), both considered as zoonotic infections. The coronaviral genome encodes four major structural proteins: the spike (S) protein, the nucleocapsid (N) protein, the membrane (M) protein, and the envelope (E) protein, all of which are required to produce a structurally complete viral particle.

[0004] In general, pandemic viruses such as SARS-COV-2 have highlighted that certain microbial/viral characteristics make it extremely difficult to fully prevent microbial transmission via fomites (inanimate objects which carry infection) and/or aerosols in a high burden environment such as a hospital ward or nursing home. Such highly pathogenic characteristics include high microbial and/or viral load in the upper respiratory tract, the ability of infected persons to transmit the microbe/virus while asymptomatic, the ability of the microbe/virus to travel several meters in the air even if the subject merely exhales or speaks, and the ability of the microbe/virus to remain viable and infectious after hours in the air, and up to days on various surfaces. It seems that this makes this virus so virulent as it can live without a host for extended periods of time. The revealing fact is the difference of life sustainment on different surfaces and discovering what accounts for the variations of time the virus can live on different surfaces.

[0005] With such pathogens, it is inevitable that persons subject to high burden environments for an extended period will be subject to and colonized by the pathogen. For those at risk, health authorities recommend the use of PPE (personal protective equipment) to reduce the risk of pathogenic transmission in aerosolized droplets. PPE requirements typically include either one or a combination of gloves, gowns, face shields, and masks (N95, surgical or community masks). PPE requirements in high burden environments can be extensive as suggested by a recent study at the Hospital Clinico San Carlos in Milan, which suggests that a 24 hour shift in a 12-bed intensive care unit (ICU) is staffed by 12 doctors, 32 nurses, 2 radiology technicians, 2 cleaning personnel and 2 consultants. In a 24 hour shift, these 50 providers would require 100 sets of gloves (to double glove), 50 gowns, 50 face shields and 50 masks.

Extrapolating this Italian model to the whole United States, approximately 830'000 sets of gloves, 415'000 gowns, 415'000 face shields, and 415'000 masks would be required daily.

Clearly, this would put a great burden on the PPE supply chain, and health authorities are advocating for either a) reusing or b) manufacturing PPE from scratch, both raising concerns about the ability of PPE to be protective. [0006] The antimicrobial and antiviral properties of various alcohols have been well known for years, and alcohol-based antiseptic liquid formulations designed to kill microbes on skin and/or surfaces are commonly used in the hospital setting in addition to PPE to protect healthcare workers from microbial and viral exposure. Hands are a common vector for microbial spread, and as outlined by the WHO guidelines on hand hygiene in healthcare: a) the hands offer an attractive environment for microbes / viruses to grow, b) microbial contamination increases linearly with longer duration of patient care in the absence of proper hand cleansing, c) the inanimate environment is commonly colonized by microbes /viruses (e.g., surfaces of phones, computer keyboards, and even PPE). Not only can PPE act as a vector for infection, but during times of increased demand, such as the current global CO VID- 19 pandemic, the supply of unworn PPE can become quite limited. In addition, the virus originates from a moist environment and become airborne. It carries an outer ultra-thin layer of water. Therefore, the virus will survive on surfaces for several days. It has been tested that when the virus lands on surfaces like PPE (N 95 and the like) it can stay infective for an average of 7 days and can be reairborne. Moreover, conventional alcohol-based antiseptic liquid formulations evaporate quickly and likewise quickly loose their effectiveness a short time after being applied to a surface. As such, alcohol-based antiseptics are only effective when applied to surfaces after such surfaces have been exposed to a virus/microbial. Such antiseptics have little if any affect on a virus/microbial that comes into contact with the surface subsequent to disinfecting with an alcohol-based antiseptic.

[0007] Therefore, it would be desirable to provide an antiviral/antimicrobial composition that remain effective in killing viruses, bacteria, and/or other microbials that come into contact with a surface long after the composition has been applied to the surface. Summary of the Invention

[0008] The present inventive concept comprises an antiviral/antimicrobial composition that is capable of being applied to porous and nonporous surfaces that remains effective in killing viruses, bacteria and/or other microbials that come into contact with said surfaces long after the composition has been applied, methods of using an antiviral/antimicrobial composition, and apparatus utilizing/ containing an antiviral/antimicrobial composition (including, but not limited to protective and/or filtration equipment).

[0009] The composition of the inventive concept comprises a water-based formulation that includes a humectant compound capable of retaining water after being applied to surfaces, sprayed, dispersed, and/or dried by air or other means. The humectant has the capability to absorb moisture while residing on dry surfaces. The significance of such retained and absorbed water in the humectant allows the other water-soluble ingredients of the antiviral/anti-bacterial formulation to stay ionically and functionally active on the surface to which the composition is applied. The retained water content of the humectant allows such other ingredients of the formula to be fully dissociated in water while residing on dry surfaces. As such the active components of the formula maintain its functionality and ionic charges and therefore enhance the synergistic effect between these components within the formula.

[0010] In some embodiments of the composition of the inventive concept, one example of a safe and very effective humectant utilized is Glycerin. It will be appreciated that other embodiments of the inventive concept utilize other humectants, including, but not necessarily limited to polyethylene or propylene glycols.

[0011] In some embodiments the humectants retain water when the formulation is dried on a surface to which the formulation has been applied, while at the same time being capable of absorbing additional moisture from the environment. [0012] In some embodiments the anti-viral/anti-bacterial formulation that includes a humectant is capable of attracting biological microorganisms that are covered by a thin film of water. One example is the coronavirus or other encapsulated virus. Because such virus include a film of water, the virus is absorbed into the humectant, even after the composition has dried on a surface, when the virus comes into proximity to the humectant.

[0013] In some embodiments, the humectants like glycerin or others are quasi encapsulating and keep the key functional water soluble components of the inventive composition active together.

[0014] In some embodiments, the formulation includes a safe quaternary ammonium salt that is highly soluble in water and compatible with the humectant. When dissolved in water the quaternary ammonium salt will dissociate and the cationic head will be active to interact with a virus ionic charges while the tail will interact with the viral lipid component.

[0015] In some embodiments, quaternary ammonium salts are cetylpyridium chloride

CPC ,OR BKZ OR Dimethyl benzoyl ammonium saccharinate are commonly used. These salts when dissolved in water dissociate and become antiviral but are inactive when dry.

[0016] In some embodiments, other forms of cationic compounds are capable of being used like cationic starch where it is capable of providing a very strong cationic charges to interact with the virus.

[0017] In some embodiments a safe mild zwitterionic surfactant that will dissociate in water resulting in a cationic active part and anionic active tail to interact with the virus.

[0018] In some embodiments, a supporting surfactant and solubilizing compound is a nonionic triblock copolymer capable of solubilizing and interacting with lipids while in water solution. One example is poloxamers. [0019] In some embodiments another supporting component is adding a film forming component to help in retaining and spreading such components on surfaces. Non-limiting examples are Polyvinyl acetate and methyl cellulose / ethyl cellulose can be added to formulation.

[0020] In some embodiments, for air filters application a safe tackifier is added to help physically capture the air particles while trying to penetrate the air filter membranes. Various embodiments of tackifiers include, but are not necessarily limited to Polybutene, Functional V-

425, Functional V-422, Poly-EM 110, Poly -EM 106, Poly-EM 109, Functional V-802, and

Rheozan BLC.

[0021] In some embodiments, Once the formulation is applied on a surface the composition of the inventive concept maintains effectiveness even when the external water evaporates.

[0022] In some embodiments, a nonionic surfactant, specifically an ethoxylated surfactant /alcohol is capable of being added that has a very low toxicity of at least of level 3 and has a unique interaction with lipids and oils. Such nonionic surfactants are capable of containing a sulfur molecule that enhances its oil/lipid interaction.

[0023] Some embodiments include a nonionic triblock copolymers composed of a central hydrophobic chain of polyoxypropylene flanked by 2 hydrophilic chains of polyoxyethylene that is capable of enhancing lipid solubilization in water.

[0024] In some embodiments the ISO test method 21702 is utilized for testing and data purposes related to the inventive composition.

[0025] Some embodiments of the inventive concept comprise methods of applying a composition of the inventive concept to one or more surfaces, and apparatus. Other embodiments of the inventive concept comprise apparatus that include, utilize, and/or contain a composition of the inventive concept. Various embodiments of methods of applying a composition of the inventive concept and/or apparatus that include, utilize, and/or contain a composition of the inventive concept are similar to, and in various embodiments, identical to, those described in any of: U.S. Provisional Application Ser. No. 63/058,407, filed on Jul 29,

2020, and titled “ANTI-MICROBIAL PROTECTIVE SYSTEM CONSISTING OF PERSONAL

PROTECTIVE EQUIPMENT”; U.S. Provisional Application Ser. No. 63/036,317, filed on Jun

8, 2020, and titled “ANTI-MICROBIAL PROTECTIVE SYSTEM CONSISTING OF A

PERSONAL PROTECTIVE EQUIPMENT”; U.S. Provisional Application Ser. No. 63/014,540, filed on Apr 23, 2020 and titled “ANTI-MICROBIAL PROTECTIVE SYSTEM CONSISTING

OF A PERSONAL PROTECTIVE EQUIPMENT”; or International Patent Application No.

PCT/EP2021/060580, filed on April 23, 2021, titled “ANTIVIRAL AND ANTIBACTERIAL

COMPOSITION”, the entire contents of which are hereby incorporated into this document by reference and made a part of this specification for all purposes, for all that it contains. It will be appreciated that the enhancements disclosed in the instant application are capable of being utilized, and in various embodiments are utilized, alone or in combination with the various embodiments disclosed in the above-incorporated applications.

[0026] The foregoing and other objects are intended to be illustrative of the invention and are not meant in a limiting sense. Many possible embodiments of the invention may be made and will be readily evident upon a study of the following specification and accompanying drawings comprising a part thereof. Various features and subcombinations of invention may be employed without reference to other features and subcombinations. Other objects and advantages of this invention will become apparent from the following description taken in connection with the accompanying drawings, wherein is set forth by way of illustration and example, an embodiment of this invention and various features thereof. Brief Description of the Drawings

[0027] A preferred embodiment of the invention, illustrative of the best mode in which the applicant has contemplated applying the principles, is set forth in the following description and is shown in the drawings and is particularly and distinctly pointed out and set forth in the appended claims.

[0028] Fig. 1 shows test results of two embodiments of compositions of the inventive concept compared to the individual components.

[0029] Fig. 2 shows test results of diluted concentrations of embodiments of compositions of the inventive concept.

[0030] Fig. 3 shows test results for the effectiveness of compositions of the inventive concept over time.

[0031] Fig. 4 shows test results of compositions of the inventive concept applied to a mask.

[0032] Fig. 5 shows test results of compositions of the inventive concept applied to a filter.

[0033] Fig. 6 is a front perspective view of two embodiments of a 3D fan of the inventive concept.

[0034] Exhibit A includes the disclosure of US Provisional Application No. 63/058,407, filed on Jul 29, 2020, and titled “ANTI-MICROBIAL PROTECTIVE SYSTEM CONSISTING

OF PERSONAL PROTECTIVE EQUIPMENT”.

[0035] Exhibit B includes the disclosure of International Patent Application No.

COMPOSITION”. Detailed Description of a Preferred Embodiment

[0036] As required, a detailed embodiment of the present invention is disclosed herein; however, it is to be understood that the disclosed embodiment is merely exemplary of the principles of the invention, which may be embodied in various forms. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the present invention in virtually any appropriately detailed structure.

[0037] The composition of the inventive concept comprises a water-based formulation that includes a humectant compound capable of retaining water after being applied to surfaces, sprayed, dispersed, and/or dried by air or other means. The humectant has the capability to absorb moisture while residing on dry surfaces. The significance of such retained and absorbed water in the humectant allows the other water-soluble ingredients of the antiviral/anti-bacterial formulation to stay ionically and functionally active on the surface to which the composition is applied. The retained water content of the humectant allows such other ingredients of the formula to be fully dissociated in water while residing on dry surfaces. As such the active components of the formula maintain its functionality and ionic charges and therefore enhance the synergistic effect between these components within the formula.

[0038] In some embodiments, the humectant comprises Glycerin. Glycerin has the capability of absorbing 2-3 times its weight of water, and is capable of retaining water within the inventive composition even after the composition is applied to and allowed to dry upon a surface.

After the composition has dried upon a surface, the glycerin (or other humectant, in other embodiments) absorbs moisture, while other active ingredients are dissociated within the water retained by the glycerin. As virus or other microbials come into contact with a surface treated with the inventive composition, the moisture in the air and/or surrounding the microbial are absorbed by the glycerin and the virus is exposed to the active ingredients within the composition.

[0039] Embodiments of compositions of the inventive concept comprise a humectant, an antiviral/antibacterial/antimicrobial agent, and water. In some embodiments the humectant is water soluble. In some embodiments the antiviral/antibacterial/antimicrobial agent is water soluble. In some embodiments, the composition further includes a tackifier. In some embodiments the tackifier is water soluble. The inclusion of a tackifier is particularly beneficial for use on compositions intended to treat porous surfaces. In some embodiments the tackifier is water soluble. In some embodiments the composition includes a zwitterionic material. In some embodiments the zwitterionic material is water soluble.

[0040] Various examples of active ingredients of the composition of the inventive concept include, but are not necessarily limited to BKZ, CPC, cocamidroprpyl betaine, Luviquat

(poly[(3-methyl-l-vinylimidazolium chloride)-co-(l-vinylpyrrolidone)], cationic starch, polyquatemium 7&10, malic acid, L-Arginine, methyl-cellulose, polyvinyl alcohol, polyisobutylene, metal stearate, malic acid, food grade tackifier (polysobutylene), asluminium starch octenylsuccinate, and glycerol.

[0041] As is discussed above, some preferred embodiments of a composition of the inventive concept include glycerin (“G”) as the humectant. Glycerin is water soluble, and capable of absorbing water from the air moisture, even after the composition has dried on a surface. In addition, glycerin allows the inventive composition to retain some water as part of a water based composition, and after the formula is applied and dries on the surface . This allows the key ingredients (e.g. the antiviral/antibacterial/antimicrobial, and if included tackifier, zwitterionic material, or any other compounds included for desired actions) to be active on the dry surface after application and drying. [0042] In some embodiments of a composition of the inventive concept, glycerin (G) is mixed in water with a quaternary ammonium salt (“QAC”), such as CPC or BKZ (or other similar QAC. Such QAC’s act as antiviral and antimicrobial agents, and are water soluble products. The QAC’s dissociate in water solution and become very active. Nevertheless, if these

QAC’s are dissolved in water alone and sprayed on the surface they will be active while wet, but once dried they will not be active. The synergistic effect of the composition inventive concept, in which the composition remain active even after drying on the surface results from the combination of the QAC with the glycerin. The glycerin helps in retaining and providing water for the QAC to be active even after the composition has dried on the surface.

[0043] In some embodiments, the inventive composition includes glycerin (or another humectant), QAC, and additionally includes cocomidopropyl betaine, all mixed in water.

Cocomidopropyl betaine is a zwitterionic surfactant where its ionically charged head interacts with a virus (such as coronavirus) and can disrupt its ionic balance while its fatty tail can interact with the lipid part of the envelope virus.

[0044] In some embodiments of the inventive composition includes glycerin (or another humectant), QAC, and additionally includes a Cationic starch, all mixed in water. The Cationic starch provides a consistent constant positive charge on the surface capable of ionically interacting with a virus (such as coronavirus).

[0045] It will be appreciated to those of ordinary skill in the art that the concentration of ingredients of the composition within water, and the ratios of active ingredients to each other, of the inventive concept will vary by specific ingredients, treated surface (or environment, e.g. if air within a room or location is being traded), and application methodology. The ideal ratio of humectant to other active ingredients, and the concentration of all ingredients to water, in any embodiment of the composition of the inventive concept is such that the humectant is able to “encapsulate” and maintain the other active ingredients of the composition in their active form for a period of time (e.g. longer than several minutes) after the composition has dried upon a given surface, and at the same time absorb moisture. The ratios and concentration will also vary depending upon the desired length of time in which the ingredients are to remain active on the given surface.

[0046] In some preferred embodiments the ratio of humectant to other active ingredients is approximately 4 to 5 parts humectant to 0.5 to 2 parts other active ingredients. In some such embodiments, the humectant and other active ingredients are mixed into water such that the composition is approximately 93-95% water (5-7% humectant plus other active ingredients).

Such embodiments are particularly useful for use in treating nonporous surfaces. In other such embodiments, the humectant and other active ingredients are mixed into water such that the composition is approximately 85-90% water (10-15% humectant + other active ingredients).

Such embodiments with a higher concentration of humectant and other active ingredients is particularly suited for use in treating porous surfaces. The embodiments discussed above allow the composition to remain active while at the same time minimizing “oily” residue (caused by the humectant) on the surfaces to which the composition is applied. These embodiments work well in spray application type uses, as well as other types of applications. In some embodiments, in which the composition is applied to a surface using flow coat or dip coat methods, much higher concentrations of humectant + other active ingredients to water are also utilized.

[0047] Some preferred embodiments of the inventive concept include 93-95% water, 3-5 glycerin, and 1-2% QAC (and/or other active ingredients).

[0048] Some embodiments include 0.1-1% and optimally 0.5-1% CPC. Some embodiments include 2-3% and optimally 1.0-2.5% cocamidropropyl Betaine. Some embodiments optimally include 3.0-50% glycerol. In some embodiments, the ranges above are used on non-porous surface applications. Other porous surface applications include embodiments with any or all of the following: 0.1-1% and 0.1-0.3% optimal CPC; 2-3% and 0.1-

0.2% optimal cocamidropropyl Betaine; open range and 0.1-0.8% optimal glycerol; and 2-3% and 0.0-0.3% optimal tackifier.

[0049] Referring to Figs. 1-5, test results of two embodiments of compositions of the inventive concept are shown. The ABC composition was made by mixing 1% cocomidopropyl,

3% cationic starch, 3% BZK (benzalkonium chloride) or CPC (cetylpyridinium chloride), and

3% glycerin, with 90% water. The GCC composition was made by mixing 1% cocomidopropyl,

3% BZK (benzalkonium chloride) or CPC (cetylpyridinium chloride), and 3% glycerin, with

93% water.

[0050] Referring to Fig. 1, testing of the ABC and GCC compositions was conducted using the testing methodology of ISO 21702. A fluorescent dye is integrated into the membrane of a segregate virus. The measured fluorescent released concentration is the indicator of the virus inactivation level on the surface. Column PC indicates full inactivation while NC indicates no effect. The graph in Fig. 1 indicates that the ISO test was performed on each individual active ingredient, CO (cocomidoprphyl), CP (cetylpyridinium chloride) and CA (cationic starch) separately. ABC & GCC are the full formulation. Fig. exhibits the synergistic effect of the complete formulation. As can be seen, the full formulations, ABC and GCC, both provide nearly full inactivation of the virus, while each of the individual components alone do not.

[0051] Referring to Fig. 2, testing of the ABC and GCC compositions was conducted using the ISO 21702 test method comparing the full formulations, and diluted 10X, 100X,

1000X, and 10,000X. As can be seen in Fig. 2, the formulations of ABC & GCC are fully active even when diluted by 10X and by 100X, and still highly active when diluted lOOOx. This dilution results in formulations of the active ingredients far below the threshold governed by EP A & FDA ON THE INDIVIDUAL INGREDIENTS. As such, Fig. 2 shows that embodiments with much higher percentage of water than the preferred embodiments discussed above are still highly effective. As such the diluted embodiments are viable for use as an airborne spray application to inactivate virus or other microbials in the air.

[0052] Referring to Fig. 3, test results of the ABC and GCC compositions were conducted at intervals of 1 minute, 5 minutes, 15 minutes, and 24 hours after application (and natural drying of the compositions on the surface being tested). Fig. 3 also shows similar testing of the ABC formulation with the addition of a tackifier, and the GCC formulation with the addition of methocel. In the testing, the ABC and GCC formulations inactivate the virus in 60 seconds or less. Typically, the ABC and GCC formulations inactivate the virus in 30-40 seconds or less. This is due to the fact that the humectant makes the active ingredient solution highly concentrated. After the water evaporates/dries from the composition, the remaining ingredients are more concentrated. In addition, the glycerin’s absorption of water attracts the virus which itself includes water on its surface.

[0053] Referring to Fig. 4, the ABC, GCC, ABC+tackifier, and GCC+methocel compositions were tested by spraying the compositions on to the surface of a surgical mask. In

Fig. 4, PP represents the untreated mask. Once each composition dried, a controlled air borne virus was allowed to land on the surface of the treated mask and the untreated mask with all conditions being equal. A negative pressure simulating breathing pressure is applied to both. The results exhibit improved mask efficacy by almost 70 percent in the treated mask. 48 blocked particles of untreated to 82 blocked particles of the treated mask. In addition, the blocked particles on the treated surface were inactivated as a result of the dry sprayed antiviral coating active by the humectant effect. [0054] Referring to Fig. 5, the graph represents an air filter rated as Merv 8 treated in the same way of the surgical mask of Fig. 4. The results exhibit improved filtration efficacy by almost 40 percent from the untreated filter . According to the Merv rating chart of air filters, a

Merv 8 Merv 12 filters will block less than 20 percent of 300 nanosize particles. The treated filters were able to block 30 percent of the 100 nano particles as shown in the graph of Fig. 5.

Fig. 5 shows testing of filtration particles (below 300 nanosize particles) efficacy. Fig. 5 does not show any antiviral testing.

[0055] Sample preparation:

[0056] Preparation of formulations: all formulations were prepared with deionized water, and are composed by an organic acid, a positively charged aminoacid, a cationic substance, and a zwitterionic surfactant. Malic acid (Sigma-Aldrich) was used as organic acid.

L-Arginine (pure grade, Sigma-Aldrich) was used as a pH buffer. As a cationic substance, we tested cationic starch (GPC), luviquat® (pure grade, Sigma-Aldrich), cetylpyridinium chloride

(pure grade, Sigma-Aldrich), benzalkonium chloride (pure grade, Sigma-Aldrich). As zwitterionic surfactant, we employ cocoamidopropyl betaine (cosmetic grade, company))

[0057] -Non-Porous Surfaces: 1ml of the target solution was sprayed into a sterlized

PEET Petri dish with ca. 18 cm2 of surface area. The solution was leaved it overnight inside the fume-hood with continuous extraction to evaporate all the water. After this period, the solution’s components form a thin film, which covers the entire surface. Subsequently the petri-dish is treated with the virus testing mixture.

[0058] -Porous surface: a 6cm diameter disc of the textile/filter was coated with approx.

1 ml of the sprayed target solution. Subsequently, the discs were leaving overnight inside the fume-hood in order to evaporate the water. [0059] -Confocal test sample: a lcm2 of the textile/filter was coated with 10 ml of the target antiviral solution. Next the samples were left inside the fume-hood for 2 hours.

Subsequently 10 ml of the modified virus was added by means of confocal microscopy.

[0060] Antiviral Activity:

[0061] InViS Antiviral liquid characterization; The antiviral analysis for the liquid antiviral solution follows the method described in the work of Furer et al. An InViS solution in antiviral liquid (0.4% v/v) was incubated for 5 minutes at room temperature and protected from light. A vortex mixer was used to ensure homogenization of the samples. A Horiba FluoroMax

SpectraFluo-rometer was used to assess the fluorescence of the samples. The excitation wavelength was 560 nanometers and emission spectra was measured between 580 nm and 650 nm. A solution of InViS in PBS (0.4% v/v) was used as negative control to provide the fluorescence intensity of intact InViS. The detergent octaethylene glycol monododecyl ether

(OEG CAS: 3055-98-9; 2.5% v/v) was added to disrupt the viral envelope and indicate the fluorescent intensity disinte-grated InViS.

[0062] InViS Antiviral coating characterization: To assess the antiviral properties of the coated form of the liquid solutions, a volume of 0.5 mL was spread evenly in disposable petri dishes or filter and incubated at RT for 24 hours. As a guideline for sample preparation the ISO norm 21702, which covers the antiviral characterization of non-porous materials, and the methods described in Furer et al were adopted. A virus inoculum of 0.4 mL for each sample and composed of a 20% v/v InViS stock solution in PBS was applied to the coated petri dishes. The same inoculum was applied to an uncoated petri dish as a negative control. As positive control,

OEG (62.5 mg mL-1) was added to the inoculum, vortexed and applied to an uncoated petri dish.

An inert polymer film (low density polyethylene (LDPE)) film (dimensions 40 mm x 40 mm) was used to cover the inoculum. To maximize the contact surface area between the inoculum and the antiviral coating, the film was gently pressed down to form a sandwich structure while avoiding leakage beyond the edges of the inert film. The samples were stored protected from light at room temperature. After the required incubation time, 20 mL of PBS were added to each petri dish. The dishes subsequently underwent agitation to ensure the homogenization of the newly added PBS and the InViS inoculum. After homogenization, samples of 2 mL were collected from each petri dish and pipetted into transparent cuvettes. Similarly to the the liquid antiviral characterization, the emission fluorescence spectra of the samples was characterized using the Horiba FluoroMax SpectraFluorometer. The excitation wavelength was set to 560 nm and the emission intensity was measured between 580 nm and 650 nm.

[0063] Viral treatment and nucleocapsid detection by ELISA

[0064] The SARS-CoV-2 Delta variant (GISAID number EPI ISL 3342900) isolated, sequenced and grown as previously described (1) was assayed in a 96-well plate, where wells were previously coated with different virucidal compounds in duplicates. A constant quantity of viral stock was added into each well, left for 5 minutes and diluted 1/10 with 225uL of phosphate-buffered saline (PBS) to stop the virucidal activity. The amount of SARS-CoV-2 nucleocapsid protein from these supernatants was measured with SARS-CoV-2 nucleocapsid protein High-sensitivity Quantitative ELISA (ImmunoDiagnostics) according to manufacturer’s instructions protocol, but replacing the assay buffer of the kit with 0.1% bovine serum albumin

(BSA) diluted in PBS. This replacement was done to avoid the detergent that lyses the viral membrane and releases the nucleocapsid content present in the buffer of the ELISA kit, as previously described in (2, 3).

[0065] Various embodiments of compositions of the inventive concept are capable of being utilized in various methods of application and/or in connection with various apparatus, including, but not necessarily limited to: [0066] 1) coating or spraying the surface of a porous layer like a nonwoven structure, a textile or a foam material that is capable of being used as a HVAC Filter element, mask, an air fan cover, or other suitable air filtration element, to provide an active media to interact and inactivate the envelope viruses and/or other microbials that are drawn through the media. In some embodiments of a fan cover, the cover is capable of being applied on industrial size fans capable of air exchange in a closed space, on small individual desk fan or a personal small fan.

Such air coming through the cover of a fan is filtered twice on the incoming or outgoing streams.

In addition in some embodiments, a small personalized fan with a treated cover and positioned on the neck and directed to the nose provides clean air with low viral load.

[0067] A treated porous materials like nonwoven PP, a textile or foam material with higher concentration and more industrial components carrying the same functionality, characteristics and behavior is capable of being positioned with a low Merv rated air filters to provide an antiviral trap to reduce the viral load in the filtered air. In addition such formulation are capable of being applied directly on the air filters.

[0068] Spraying includes water spray applied directly on surface being treated. Pre-spray and allow to air dry. Air spray for an enclosed space (treat surfaces and/or the air).

[0069] In some embodiments, a composition of glycerin and tackifier (802) with lie percentages is applied on a merv 16 filter. Such an embodiment obtains filtration efficacy of about 20 percent of the lOOnano size particles. This is significant:

[0070] a) the industry test only up to 300nano. A merv 14-16 Alteration efficacy of

(300nano) range from 74/for merv 14 to 95 / for merv 16. So a 20/ increase will put it in the 99/ and certainly is a major improvement on the higher particle size.

[0071] b) hepa filters perform at 99/ for the 300nano size. [0072] As such the inventive composition is able to boost a Merv 14-15 to the HEP A level which presents a significant financial benefit and ability to go to market without the need of

EP A approval.

[0073] This efficacy performance is significantly improved when the raw material making the filters are pretreated before making the filter..

[0074] 2) misting and aerosolizing a formulation from the above components to disinfect the air without any alcohol or propellers like butane and propane. In some embodiments, water will be a key component, along with the 4 components of the active ingredients discussed in the

ABC composition. It will be appreciated that various embodiments of the composition will utilize the same ingredients of the ABC (and/or the GCC formulations) at varying concentrations of each ingredient and water.

[0075] 3) an alcohol-free disinfectant formulation for antiviral hand sanitizer capable of being applied as a mist or foamed.

[0076] 4) A apparatus comprised one to four (or more) treated filter elements secured in a metal or wood frame with the bottom closed and a fan secured to the top (3 dimensional shape). One example of such an apparatus is constructed utilizing 20X20X2 or 20X20X4 standard HVAC dimensions increases the projected area of the treated filter by 4X standard commercial systems. Such large capacity treated filters increase air flow and air exchange rate, efficiency and efficacy.

[0077] 5) Impregnating of the composition and/or the active ingredients of the inventive composition into a finished filter apparatus, mask, nasal filter, or other air filtration device, and/or impregnating into a component of such a device. [0078] 6) Creating a multi layered appartus of thin filter material where each is treated with one or more inventive compositions that creates a torturous path and a synergistic effect enhancing the filtration efficacy.

[0079] Referring to Fig. 6, an embodiment of a 3D fan with a cylindrical cross section is shown including one embodiment in which intake air for the fan is drawn in through the 3D fan filter, and another embodiment in which the fan outputs air through the 3D fan filter of the inventive concept. Fig. 6 shows a 3D cylindrical shape, with a fan at the top and closed at the bottom. The walls are made from a supporting structure, tightly covered with a treated air filter membrane. That treatment allows an airborne virus to be captured by the tackifier and inactivated by the antiviral agents of the inventive composition. Glycerin (or other humectant), in being on the surface after the filter treated with the water based formula, will enable the continuous antiviral/antimicrobial effect even after the evaporation and the drying of the surface filter. The key and SURPRISING phenomenon here is the synergistic effect created mainly between glycerin (humectant) and the quantrary ammonium QAC (antiviral/antimicrobial agent).

The glycerin maintains some water after water evaporation from the surface maintaining the

QAC in a dissociated active form. Then glycerin will start absorbing water from the air. In this situation a highly concentrated antiviral solution is created on the surface capable of interacting with the viruses. In addition, since glycerin is hygroscopic it attracts water molecules in the moisture /air. Hence it will also attract the envelope virus that is surrounded by the thin water film.

[0080] The system of Fig. 6 follows the inventive concept similar to a treated cover on the head of fan, but with an expanded filtration surface area. Another feature to the 3D structure is the ability to easily add/integrate a water container or other humidifier source to provide moisture to the air in the room to avoid dryness in the room. [0081] It will be appreciated that various embodiments of a 3D fan filter apparatus are constructed of any cross-sectional shape, including triangular, circular, rectangular, polygonal, etc. that is desired or needed for a particular application. Air flow through the filter is capable of being either positive or negative through the filter depending on fan rotation direction.

[0082] In some embodiments, a filtration apparatus is comprised one to four (or more) treated filter elements secured in a metal or wood frame with the bottom as a water reservoir and a fan secured to the top (square, rectangle shape, or any other suitable shape). One example of said apparatus is constructed utilizing a “base pan” applying controlled volume of water for humidification purposes. Negative pressure and air flow carry humidity of the treated air into atmosphere.

[0083] A methodology for testing a 3D fan of the inventive concept utilizes a modified model virus to determine the efficiency of the filtration methodology technology described above. The virus selected in one embodiment is a deactivated influenza, in which its lipidic membrane is decorated with a biocompatible fluorescence dye, such as rhodamine B.

[0084] A known concentration of modified viruses is pressurized, obtaining a virus airborne solution. Subsequently, the treated filters are bombarded with the virus spray capturing the air passing through the filters into a chamber. This chamber contains a surfactant solution that destroys the viruses’ cellular membranes and consequently releases the fluorescent dye.

Accordingly, the fluorescence correlation before and after the virus spray passes through the membrane determines the number of viruses captured inside the filters.

[0085] In addition, in some embodiments, the viruses captured in the filters are determined by confocal fluorescence microscopy. To this end, the fluorescence of the dye used to mark the viruses is defined in a specific filter area. [0086] Other embodiments include the application of the composition of various embodiments of the inventive concept in the manner and to the apparatus described further in any of: U.S. Provisional Application Ser. No. 63/058,407, filed on Jul 29, 2020, and titled

“ANTI-MICROBIAL PROTECTIVE SYSTEM CONSISTING OF PERSONAL PROTECTIVE

EQUIPMENT”; U.S. Provisional Application Ser. No. 63/036,317, filed on Jun 8, 2020, and titled “ANTI-MICROBIAL PROTECTIVE SYSTEM CONSISTING OF A PERSONAL

PROTECTIVE EQUIPMENT”; U.S. Provisional Application Ser. No. 63/014,540, filed on Apr

23, 2020 and titled “ANTI-MICROBIAL PROTECTIVE SYSTEM CONSISTING OF A

PERSONAL PROTECTIVE EQUIPMENT”; or International Patent Application No.

COMPOSITION”, and further set forth in Exhibits A and B hereto.

[0087] Various other embodiments of the inventive concept include

[0088] Embodiment 1 An anti-viral/anti-bacterial formula wherein applied on non porous or porous surfaces or sprayed in the air for disinfecting purposes comprising materials that are water soluble with different functionalities capable of creating a synergistic effect between them.

[0089] Embodiment 2 The anti-viral/antibacterial formula of embodiment 1 wherein a humectant, quaternary ammonium salts like cetylpyridium chloride CPC,

Benzalkonium chloride ,OR Dimethyl benzoyl ammonium saccharinate . These salts when dissolved in water dissociate and become ionically and biochemically active and act as a very antiviral/ antibacterial agent even when dried on the surface.

[0090] Embodiment 3 The anti-viral/anti-bacterial formula of embodiment 1 wherein a humectant compound capable of retaining water after being applied to surfaces, sprayed, dispersed and dried by air or other means. Said Humectants have the capability to absorb moisture while residing on dry surfaces. Water in the Humectant allows the other water- soluble ingredients of the antiviral/anti-bacterial formulation to stay ionically and functionally active.

[0091] Embodiment 4 The anti-viral/antibacterial formula of embodiment 1 wherein the formulation includes a safe quaternary ammonium salt that is highly soluble in water and compatible with the humectant. When dissolved in water the quaternary ammonium salt will dissociate and the cationic head will be active to interact with the virus ionic charges while the tail will interact with the viral lipid component.

[0092] Embodiment 5 The anti-viral/Anti-bacterial formula of embodiment 1 wherein commonly used quaternary ammonium salts can be cetylpyridium chloride CPC,

Benzalkonium chloride or Dimethyl benzoyl ammonium saccharinate . These salts when dissolved in water they dissociate and become antiviral but are inactive when dry.

[0093] Embodiment 6 The anti-viral/anti-bacterial formula of embodiment 1 wherein, other forms of cationic compounds are capable of being used like cationic starch wherein it is capable of providing a very strong surface cationic charges to interact with the virus.

[0094] Embodiment 7 The anti-viral/anti-bacterial formula of embodiment 1 wherein a safe mild zwitterionic surfactant that will dissociate in water resulting in a cationic active part and anionic active tail to interact with the virus.

[0095] Embodiment 8 The anti-viral/anti-bacterial formula of embodiment 1 wherein, a supporting surfactant and solubilizing compound is a nonionic triblock copolymer capable of solubilizing and interacting with lipids while in water solution. One example is poloxamers. [0096] Embodiment 9 The anti-viral/anti-bacterial formula of embodiment 1 wherein another supporting component is adding a film forming component to help retaining and spreading such components on surfaces. Non-limiting examples are Polyvinyl acetate and methocel / ethocel capable of being added to formulation.

[0097] Embodiment 10 The anti-viral/anti-bacterial formula embodiment 1 wherein application a tackifier is added to air filters to assist in capture airborne particles while trying to penetrate the air filter membranes.

[0098] Embodiment 11 The anti-viral/anti-bacterial formula of embodiment 1 wherein the formulation when applied on a surface, it’s activity is maintained even when the external water has evaporated.

[0099] Embodiment 12 The anti-viral/anti/bacterial formula of embodiment 1 wherein the retained water content of the humectant allows such ingredients of the formula to be fully dissociated in water.

[00100] Embodiment 13 The anti-viral/anti-bacterial formula of embodiment

1 wherein a humectant is retaining water after drying and absorbs moisture from the environment.

[00101] Embodiment 14 The anti-viral/anti-bacterial formula of embodiment

1 wherein the formulation is applied on a surface, it’s activity is maintained even when the external water evaporated.

[00102] Embodiment 15 The anti-viral/anti-bacterial formula embodiment 1 wherein, the humectants like glycerin or others is quasi encapsulating and keep the key functional water-soluble components active together.

[00103] Embodiment 16 The formula of embodiment 1 wherein misting and aerosolizing a formulation from the above components to disinfect the air without any alcohol or propellers like butane and propane. In some embodiments water will be the key components with the 4 components of the active ingredients of the ABC composition.

[00104] Embodiment 17 The formula of embodiment 1 wherein the formula is an alcohol-free disinfectant for antiviral hand sanitizer applied by misting or foam.

[00105] Embodiment 18 The application of embodiment 1 wherein coating or spraying the outer layer of a textile or foam material that is capable of being used as a mask or an air fan cover to provide a media to interact and inactivate the envelope viruses. The fan cover is capable of being applied on industrial size fans capable of air exchange in a closed space or on small individual desk fan. Such air coming through the cover of a fan is filtered twice on the incoming or outgoing streams. In addition, a small, personalized fan with a treated cover and positioned on the neck and directed to the nose will provide clean air with low viral load.

[00106] Embodiment 19 The application of embodiment 1 wherein a treated textile or foam material with higher concentration and more industrial components carrying the same functionality, characteristics and behavior is capable of being positioned with low Merv air filters to provide an antiviral trap to reduce the viral load in the filtered air. The formulation of embodiment 1 is applied directly on the air filters.

[00107] Embodiment 20 The formula of embodiment 1 wherein a nonionic surfactant, specifically an ethoxylated surfactant /alcohol is capable of being added that has a very low toxicity of at least of level 3 and has a unique interaction with lipids and oils. Such nonionic surfactants are capable of containing a sulfur molecule that enhances its oil/lipid interaction.

[00108] Embodiment 21 The formula embodiment 1 wherein a nonionic triblock copolymer composed of a central hydrophobic chain of polyoxypropylene flanked by 2 hydrophilic chains of polyoxyethylene that is capable of enhancing lipid solubilization in water. [00109] Embodiment 22 A filter system of utilizing any of embodiments 1 through 21 wherein multiple treated filters are combined to increase projected filtration area, air flow and air exchanges within a closed room.

[00110] Embodiment 23 An apparatus utilizing any of embodiments 1 through 22 wherein a frame constructed of multiple filters, wood, metal, or other structural members comprise a single unit with a closed bottom and fan attached to the open end. Positive or negative air pressure force air through the treated filters.

[00111] Embodiment 24 An apparatus utilizing any of embodiments 1 through 23 wherein four standard filters are combined wherein tape or other adhesives are applied to create a 3 dimensional structure for the filter system. One example is 20X20X2 form a square combined with a closed bottom and top mounted fan.

[00112] In the foregoing description, certain terms have been used for brevity, clearness and understanding; but no unnecessary limitations are to be implied therefrom beyond the requirements of the prior art, because such terms are used for descriptive purposes and are intended to be broadly construed. Moreover, the description and illustration of the inventions is by way of example, and the scope of the inventions is not limited to the exact details shown or described.

[00113] Although the foregoing detailed description of the present invention has been described by reference to an exemplary embodiment, and the best mode contemplated for carrying out the present invention has been shown and described, it will be understood that certain changes, modification or variations may be made in embodying the above invention, and in the construction thereof, other than those specifically set forth herein, may be achieved by those skilled in the art without departing from the spirit and scope of the invention, and that such changes, modification or variations are to be considered as being within the overall scope of the present invention. Therefore, it is contemplated to cover the present invention and any and all changes, modifications, variations, or equivalents that fall with in the true spirit and scope of the underlying principles disclosed and claimed herein. Consequently, the scope of the present invention is intended to be limited only by the attached claims, all matter contained in the above description and shown in the accompanying drawings shall be interpreted as illustrative and not in a limiting sense.

[00114] Having now described the features, discoveries and principles of the invention, the manner in which the invention is constructed and used, the characteristics of the construction, and advantageous, new and useful results obtained; the new and useful structures, devices, elements, arrangements, parts and combinations, are set forth in the appended claims.

[00115] It is also to be understood that the following claims are intended to cover all of the generic and specific features of the invention herein described, and all statements of the scope of the invention which, as a matter of language, might be said to fall therebetween.

EXHIBITB Antiviral and antibacterial composition The present invention relates to the use of a composition asantiviral and/or antimicrobial agent. Coronaviruses (CoVs) are enveloped positive RNA viruses,belonging ttoo the coronaviridae family and the orderNidovirales. They are capable of adapting to new environmentsthrough mutation and recombination and are programmed to alterhost range aand tissue tropism. Coronvirusess arephylogenetically subdivided into four genera, α, β,γ, y, andδ 5,with type or and β known to be able to infect humans. Coronavirusp can be classified as Severe Acute Respiratory Syndrome (SARS'and Middle East Respiratory Syndrome (MERS), both consideredas zoonotic infections. The coronaviral genome encodes fourmajor structural proteins: spikes )(S) protein, themicleocapsid (N) protein, the membrane (M) protein, and theenvelope (E) protein, all of which are required to produce astructurally complete viral particle. In general, pandemic such as SARS-COV-2 'havehighlighted that certain microbial/viral characteristics makeit extremely difficult to fully prevent microbial transmissionvia fomitess (inanimate objects which carry infection) and/oraerosols in a high burden environment such as a hospital wardor nursing home. Such h characteristicsinclude high microbial and/or viral load in tthhee upperrespiratory tract, the ability of infected persons to transmitthe microbe/virus while asymptomatica , tthhee ability of themicrobe/virus to travel several meters in ths air even if thesubject merely exhales or specks, and the ability of the microbe /virus to remain viable and infectious after hours in the air, and up to days on various surfaces. Tt seems that this makes this virus so virulent as it can live without a host for extended periods of time. The revealing fact is the difference of life sustainment on different surfaces and discovering what accounts for the variations of time the virus can live on different surfaces.

With such pathogens, it is inevitable that persons subject: to high burden environments for an extended period will be subject to and colonized by the pathogen. For those at risk, health authorities recommend the use of PPE (personal protective equipment) to reduce the risk of pathogenic transmission in aerosolized droplets. PEE requirements typically include either one or a combination of gloves, gowns, face shields, and masks (N95, surgical or community masks) . PPE requirements in high burden environments can be extensive as suggested by a recent study at the Hospital Clinico San Carlos in Milan, which suggests that a 24 hour shift in a 12-bed intensive care unit (ICU) is staffed by 12 doctors, 32 nurses, 2 radiology technicians, 2 cleaning personnel and 2 consultants. Tn a 24 hour shift, these 50 providers would require 100 sets of gloves (to double glove) , 50 gowns, 50 face shields and 50 masks. Extrapolating this Italian model to the whole United States, approximately 830' 000 sets of gloves, 415' 000 gowns, 415' 000 face shields, and 415' 000 masks would be required daily. Clearly, this would put a great burden on the PPE supply chain, and health authorities are advocating for either a) reusing or b) manufacturing PPE from scratch, both raising concerns about the ability of PPE to be protective.

The antimicrobial and antiviral properties of various alcohols have been well known for years, and alcohol-based antiseptic liquid formulations designed to kill microbes on skin are commonly used in the hospital setting in addition to PPE to protect healthcare workers from microbial and viral exposure. Hands are a common vector for microbial spread, and as outlined by the WHO guidelines on hand hygiene in healthcare: a) the hands offer an attractive environment for microbes / viruses to grow, b) microbial contamination increases linearly wxth longer duration of patient ccaarree in the absence of proper hand cleansing, c) the inanimate environment is commonly colonized by microbes /viruses (e.g. , surfaces of phones, computer keyboards, and even PPE) .

Not only can PPE act as a vector for infection, but during times of increased demand, such as the current global COVID- 19 pandemic, the supply of unworn PPE can become quite limited. In addition, the virus originates from a moist environment and become airborne. It carries an outer ultra-thin layer of water. Therefore, the virus will survive on surfaces for several days. It has been tested that when the virus lands on surfaces like

PPE (N 95 and the like) it can stay infective for an average of 7 days and can be re-airborne.

The problem of the present invention is therefore to provide an antiviral and antibacterial composition made from safe ingredients to protect mouth and nose from viral infection .

The problem is solved by the composition according to the present invention. Further preferred embodiments are subject of the dependent claims. It was found that the composition according to the present, invention is an extremely powerful antiviral and/or antimicrobial agent, wherein the composition comprises at least

- a positively charged natural or unnatural amino acid, an organic acid

- a cationic polymer, and a zwitterionic surfactant .

It was found that, the unique combination of the ingredients of the composition according to the present invention surprisingly create a synergistic effect to inactivate enveloped vi ruses aanndd bacteria. These ingredients work selectively to inactivate the envelope virus by targeting the protein, the lipid and the amino acids of the viral membrane, spike and envelope . The strong cationic polymer of the composition interferes with the balance of the ionic charges of the virus thus attracting the virus and overwhelming the viral charges . This creates an .imbalance in the equilibrium of vi ral ionic charges . Further, the organic acid and the amino acid interact with the protein of the infective viral RNA and di sable it . Thus, the synergistic action of the ingredients of the composition according to the present invention allows to deactivate viruses and bacteria. The composition according to the present invention creates aann active surface that can inactivate the virus and/or bacterium in minutes. The ingredients of the composition according to the present invention ensure in an aquatic status its dissociation and activities . Thus, the composition according to the present invention can, when applied to a carrier such as a mask, not only capture the virus but at the same time inactivate the virus permanently. In addition, once destroyed, they no longer adhere to the surface treated with the composition according to the present Invention.

The composition according to the present invention can comprise up to 95% by weight of water. However, it can also be provided as a concentrate or even as essentially water-free composition. Since all ingredients can be easily dissolved in water, the composition can be stored as concentrate and then be diluted before use if it is used for example as spray. However, for example, also saliva ccaann be used to dissolve the active ingredients for example if the composition according to the present invention is provided as lozenges.

Since the ingredients according to the present invention are easily dissolved in water what is meant by the term "water- soluble" (thus, the indicated concentrations of all ingredients result in a clear solution at 25°C) the moisture can connect with the water outer surface on the virus which is the key enabler of the capillary transmi ssion of such ingredients into the surrounding water l ayer to effect the viral inactivation .

Preferably, the composition according to the present invention comprises an organic acid which is selected from the group consisting of malic acid, citric acid, lactic acid, acetic acid, glutamic acid, ascorbic acid and benzoic acid or a mixture thereof, preferably malic acid and/or glutamic acid. Said acids are all GRAS compounds (generally regarded as safe compounds) and commonly used in preservatives, dyes, flavours and in food industry. Said organic acids lower the pH of the composition according to the present invention and act as an antiviral or antibacterial agent as a result of interacting with the proteins, the RNA and the lipids of the vi rus or the bacteria. These acid components can be added as powder to the composition according to the present invention. Especially malic acid and glutamic acid are preferred since they have a synergistic effect with the positively charged amino acid which is also contained in the composition according to the present invention. In addition, glutamic acid is known as humectant moisturizer and skin-conditioning agent which is an additional benefit.

Preferably, the composition according to the present invention comprises a positively charged amino acid which is selected from the group consisting of L-arginine, L-lysine, L- histidine, ornithine; 2, 4-diaminobutanoic acid, 2, 3- diaminopropanoic acid, 3- (aminoiminomethyl) amino-alanine, 2- amino- 4- (ami no iminomethyl) aminobutanoic acid, N6- (aminoiminomethyly) lysine, 2 -amino- 7-

(amino iminomethyl ) aminoheptanoic acid, 2, 7 -di aminoheptanoic acid, 2, 8-diaminooxtanoic acid, 2, 9-di aminonona noic acid, 2, 10-diaminodecanoic acid, 4- (aminoiminomethyl ) phenylalanine and 4- (aminoiminomethyl) aminophenylalanine, preferably the natural amino acids L-arginine, L-lysine and L-histi dine. Best results could be obtained with L-arginine. L-arginine is the only amino acid with strong positive charge that remains protonated while binding to protein structure membranes. It binds to viral proteins, creates crowding and is able to suppress protein aggregation, thus making envelope viruses vulnerable to attack. In addition, due to its cationic charges it can interfere with the lipide membrane by causing pore formation in the lipid area, interfere and disrupt the flow of ions in the ion channel and with the phospholipid of the viral capsid.

The composition according to the present invention comprises a cationic polymer. The active cationic charges are provided by either a GRAS (Generally Recognized as Safe) material or industrial synthetic chemical compounds. Preferably the cationic polymer is selected from the group consisting of polyquaternium., fatty amines, polyethylene imine or. a copolymer thereof, cationic starch, metal cation components and mixture thereof . Most preferably, the composition according to the present invention comprises at least one polyquaternium.

Within the context of the present invention, the term polyquaternium (INCI designation) stands for polycationic polymers containing quaternary ammonium centres in the polymer which are typically used in the personal care industry. For example, PQ-1 through -47 of these polymers are listed in the Official Journal of the European Union, CoTnmission Decision dated 09 February 2006, 2006/257/EC . Even more polyquaternium polymers are known, and include in particular the following polyquaternium polymers:

Within the context of the present invention, the term metal cation components stands for colloidal systems comprising a metal ion which is stabilized by a tenside layer such as colloidal silver or colloidal copper. Most preferably, said metal cation components are present together with a further cationic polymer such as polyethyleneimine. For example, a combination of polyethyleneimine and colloidal silver results in a higher antibacterial and/or antiviral log than is these components are used alone.

The cationic polymer can also be cationic starch, Cationic starch made from starch granules reacted with quaternary ammonium yielding a continuous positive charge independent of pH. Many different commercially available cationic starches can be used for the present invention. The example includes CHARGEMASTER cationic starch lines (CHARGEMASTER line of cationic starches available from Grain Processing Corporation of Muscatine, IA) . Chargemaster L340 is especially preferred. Cationic starch is non-toxic and can be produced in food grade, which is of course a big advantage, in particular if the composition according to the present invention is orally applied.

In one embodiment of the invention, the cationic polymer is a linear or branched polyethyl eneimine which can have a high molecular weight (25kDa) or a low molecular weight (1.8 kDa) . Preferably, it is a branched polyethyleneimine comprising repeating units composed of ethylene diamine groups . It can contain primary, secondary and tertiary amino groups. Said branched polyethyleneimide can be at least partly crosslinked, preferably with a crosslinker selected from the group consisting of phthalaldehyde and PEG since these combinations significantly increase or even double the efficacy of the composition according to the present invention on surfaces.

In some embodiments, the hydrophobic polycationic polymer is an N -alkylated polyethylenimine with various alkyl chain lengths, such as N,N-dodecyl,methyl-polyethylenimine or N, N- hexyl,methyl-polyethylenimine. In other embodiments, the polymer is a poly (4-vinyl-N-alkylpyridlne) .

In addition, the composition according to the present invention comprises a zwitterionic surfactant . A zwitterionic surfactant has a positive and a negative charge and thus is less sensitive to pH changes . The zwitterionic surfactant interacts with both the hydrophobic and the hydrophilic sides of the amino acids which compose the proteins of the viral membrane and of the envelope protein, thus resulting in the viral protein disintegration. AA preferred zwitterionic surfactant is cocamiaopropyl betaine. Due to its long hydrocarbon chain, it can interact with the lipids and its polar head can interact with the viral ionic charges.

It could be shown that the effect of zwitterionic surfactants can be enhanced by the addition of non-ionic surfactants such as polysorbates resulting in a better membrane lipid and protein solubility. The presence of the positively charged amino acid and of the organic acid has the effect that they buffer the composition according to the present invention. It has been found that the composition of the present invention has preferably a pH above 5. 5, in particular for the inactivation of SARS-COV-2, since the proteins of the envelope and the spike have an isoelectric point of 5.5.

In one embodiment, the composition according to the present invention comprises L-arginlne as positively charged amino acid and malic acid and/or glutamic acid as organic acid, preferably in a ratio of 1: 10 to 10 : 1. The combination of L- arginine with one or both of said organic acids significantly increase the solubility of proteins by about factor 6 due to increased hydrogen, bonding thus increasing the interaction between said ingredients and the surface of the viral protein.

The composition according to the present invention can include a humectant to provide skin moisturizing, skin softening, skin barrier maintenance, anti-irritation, or other skin health benefits . Seme non-limiting examples of humectants include hydroxyethyl glycerine, urea, agarose, urea, 5-0xo-L-prolin, fructose, glucose, honey, lactose, maltose, polyethylene glycol, sorbitol and mixtures thereof.

Preferably, the composition according to the present invention is free of ethanol . Ethanol attacks and destroys the envelope protein that surrounds some viruses, including coronaviruses . In contrast, hand sanitiser needs to contain at least 60% alcohol in order to kill most viruses. However, such high levels of ethanol dry the skin and in a worse case cause dermatitis, especially in low humidity climates or during the "dry" months cf the year.

In addition, the composition according to the present invention can additionally comprise a cationic surfactant to increase the positive charge. Examples of cationic surfactants are cetyltrimethylammonium chloride, behenyltrimethylammonium chloride, cetylpyridinium chloride, tetramethylammonium chloride, tetraethylammonium chloride, octyltrimethylammonium chloride, dodecyltrimethylammoniuzn chloride, hexadecyltr imethylammonium chloride , cctyldimethyibenzylammonium chloride , decyldimethylbenzyl ammonium chloride, st earyldimethylbenzyl ammonium chloride , di dodecyldimethyl ammonium chloride, dioctadecyldimethylammonium chloride, tallcwtrlmethylammonium chloride, cocotrimefhylammonium chloride, and the corresponding hydroxides thereof .

Especially good results could be obtained with a composition comprising at least a total of 0.02% to 8 % by weight of a positively charged natural or unnatural amino acid, 0.02 to 8 % by weight of an organic acid, 0.02 to 5 % by weight of a cationic polymer, and 0.02% to 3 % by weight cf a zwitterionic surfactant . Preferably such a composition comprises up to 92% by weight of water. Especially preferred is a composition comprising at least 0.02% to 8 % by weight of L-arginine, 0.02 to 5 % by weight of malic acid or glutamic acid or a mixture thereof, 0.02 to 5 % by weight of polyquaternium and 0.02 to 8 % by weight of a cocamidopropyl betaine. Preferably, such a composition comprises up to 92% by weight of water. The composition according ttoo the present invention can inactivate a bread variety of bacteria and viruses, in particular viruses selected from, the group consisting of corona virus, influenza virus, human rhinovirus (HRN) , parainfluenza virus (PIK) , respiratory syncytial virus (RSN) , adenovirus, metapneumevirus, and rhinovirus, and especially SARS-COV-2 or a mutant thereof . The composition of the present invention is especially active against airborne viruses.

The composition according to the present invention can be applied in different formulations such as a spray, a pre-spray gel (spray and dry system) , a water soluble pod, a mist, a strip or a lozenge.

Water soluble pods allow to store the composition according to the present invention as concentrate while the bottle can be reused thereby avoiding shipping and paying for water and saving or. the cost of Individual plasuic bottle and spray systems. In addition, it has a significant sustainability value. Water soluble pods containing the composition of the present invention ccaann be applied alone oorr with other ingredients ssuucchh aass laundry detergents oorr dish washing detergents . The composition of the current invention within the pods are capable of activating fabrics such as hospital bed linins in bulk thereby protecting patents against bacteria and virus . In addition, the composition of the present invention can be used to activate dishes and utensils as well as tools or any object placed within the washing equipment. The composition of the present invention can be applied before during or after the rinse cycle of the washing process or during drying. The composition of the present invention can have fragrances added to enhance comfort and smell of the fabrics .

Wash systems such as sinus wash systems are known to the skilled person. The composition according to the present invention can directly be used as a wash system or it can be added as a concentrate to the usual saline solution.

In one embodiment of the present invention relates a carrier which is coated with a composition according to the present invention or its essentially water-free dried form. The term essentially water-free means a water content of less than 1D%. Spray -drying is a method in which a composition is sprayed by a device for preparing fine particles on the surface of a carrier and subsequent drying by evaporation of moisture. Thus, a carrier which is coated with the composition according to the present invention in its essentially water-free form means that the carrier Is covered with a thin layer comprising the ingredients of the composition according ttoo the present invention, wherein the water has been partly oorr fully evaporated. Interestingly, the composition according to the present invention is active in its dried form. Since the corona virus is an airborne virus, its water layer on the virus particle will reactivate the composition according to the present invention and capture and inactivate the virus .

Carriers coated with the composition according to the present Invention have preferably more than 15 millions, preferably more than 50 millions and most preferably more than "100 millions positively charged ions per square centimetre and adhere the negatively charged viruses and bacteria. On contact with this surface, viral protein capsids or envelopes are disrupted.

The term carrier within the context cf the present invention stands for any surface that could come into contact with the virus or the bacteria. Preferably, said carrier comprises or consists of molded fiber, plastics, non-wovens, foam and open cell foam, rubbers and textiles. Due to the composition according to the present invention, it is possible to create a smart active surface mask that can allow breathing, block penetration and inactivate viruses . Especially, it is no longer necessary to use N95 masks, which can cause difficulties in breathings and are universal with one size fits all creating significant discomfort, skin Irritation and inconvenience during use. Actually, new recent regulations are limiting the continuous use of N95 directly on the face for not more than 75 minutes before removal for a short period to allow breathing fresh air .

Carriers, such as masks made of molded fibers are especially preferred. They are made from recyclable pulp of paper which are locally available. Such carriers can be ergonomically optimi zed with specific size and shape, for example addressing the difference in physiognomy of male and female. Furthermore, Laminating an inner clear plastic film on the inside of the mask will allow for friendly interaction with skin and face while providing excellent protection. in addition, Such clear film can be integrated and positioned inside the mask to offer a see through of the mouth while offering protection and ccaann be protected from viral accumulation by using an. antiviral spray treatment. The nose area can be equipped by appriately treated menbranes to allow continuous fresh air breathing. The capital, costs for molds are very low allowing a production of said carriers also in poor countries . The surface structure of the molded fibers allow a good retention of composition according to the present invention .

The coated surface while dry is still receptive to absorb water, humidity, moisture from the air as well as from breathing through the nose or mouth. The PPE, masks and nasal devices can be pre-treated, and its surface will be immediately active.

The composition according to the present invention can also be used as a surface treatment. The surface treatment will block, capture, and kill enveloped viruses and bacteria providing maximum protection against transfer and infection in wet or dry environments. Such surfaces include doorknobs, elevator buttons, staircase railings, telephone sets, computer keyboards and water taps which all commonly serve as vectors for viral, transmission.

The carrier which can be treated or pre-treated with the composition according to the present invention is preferably a personal protection equipment, and most preferably selected from, the group consisting of air filters, personal protective equipment., N95 surgical mask, community mask, textile mask, foam mask, Bandana mask, molded fiber mask, foam textiles, cotton textiles, cellulose textiles, composites, nasal inserts, foam nasal inserts, nasal filters, nasal screens or nasal filters, air filters, surgical gowns, coverings and wipes . All ingredients of the composition according to the present invention are water-soluble or water-dissolvable. Therefore, the carrier can be washed in the washing machine or by hand, thereby removing the composition according to the present invention. Afterwards, the carrier can be dried, for example air-dried in a clean space before treating it again with the composition according to the present invention. Thus, the composition according to the present invention allows to use reusable personal protective equipment.

The pre-treated carrier with plasma / Corona resulting in active surface ion can be stored in a modified atmospheric packaging, gas barrier plastic, foils and nitrogen rich environments or vacuum type packaging in order to protect the treated surface before use.

If the carrier is a personal protection equipment comprising a filter system, said filter system can comprise activated carbon and an acidic protein fibril membrane. The composition of the present invention enhances the cationic nature of the fibril membrane, and thus increases the efficacy of the filter system. In addition, such a fibril protein-based membrane may additionally be coated or impregnated with poly e thy lenimine (PEI) / branched polyethylenimine (BPEI) , or mixed with colloidal silver and / or colloidal copper ions to further increase the positive charge on the surface of the carrier, which acts like a positive magnet for the negatively charged viruses and bacteria.

The composition according to the present invention can also be applied topically or orally. Due to its safe ingredients, it can be sprayed on the naked skin around the mask as well as on the inside of the mask including the nose, throat mouth and the whole respiratory system. The composition can be applied to the human respiratory system, from nose and mouth to the lungs, via standard delivery techniques of consumer and medical products, including sprays, food-based preparations, lozenges, oral strips, solutions for nasal irrigation systems (nasal wash) and fine mist . Especially preferred, the composition according to the present invention is used in a system for nasal irrigation since it is medically proven that infection through nasal inhalation is 10' 000 times more often than through the mouth. A nasal rinse with the composition according to the present invention can significantly reduce the virus load in this area .

In order to protect the nasal system, an active anti-viral device capable of capturing the virus particles floating in the inhaled air can be used. Such nasal systems are known in the art, ffoorr eexxaammppllee aass ccoossmmeettiicc nnoossee p prrootteeccttoorr,, nasal air filters (US 6, 962, 156; 086, 971, 387; US 6, 981, 501) , nasal tampon or as nose dilators for snoring (for example comprising an existing flexible frame and an exchangeable filter) . Said systems can be partly or fully treated with the composition according to the present invention, and therefore inactivates the virus when inhaled through the nasal system, The manufacturing process for such a system can for example involve the production of the foam by a chemical reaction process and then removing the cell walls within the foam by a thermal or chemical process thereby producing reticulated foam. The reticulated foam consists of a three-dimensional matrix with voids and intricacies within the skeletal structure.

Preferably, the foam is an open cell reticulated polyurethane foam of low density and light weight . Reticulating the fcaia allows for managed cell numbers, its design, shape, and location within the foam structure. Alternatively, a polyether or polyester foam may be used. The porosity of such a foam can range from 10 - 100 pores per inch. Alternatively, the system can be made of molded fibers . Dependent on the selected porosity or the nature of the molded fiber, the structure allows for high breathability and high retention of the composition according tc the present invention. Such nasal systems are extremely cost effective, safe, highly effective, and extremely sustainable. They can be used for example in all indoor activities such as in restaurants, theatres, schools as well as in public transport and airplanes.

In addition, such a nasal system can be pre- treated with cold atmospheric plasma. Cold atmospheric plasma and/or corona is known to the skilled person and allows to increase the cationic charge and the electrostatic charges of the surface A metallic stearate, preferably selected from the group consisting of magnesium stearate, calcium stearate and zinc stearate can be added during the foaming process oorr sprayed pre plasma treatment to help maintain, and extend the ionic charges created. In addition, such substrates can be treated wich a food grade sillcone base material preferably pclydimethyl siloxane PMDS to enhance the ionic density and retension. These treated foam structures have low odour and in some embodiments are made to fit certain medical specifications.

The composition according to the present invention may contain other additives typically used in cosmetic medical applications like gelling agents, film forming agents, coalescing agents such as polyvinyl acetate (PVA) , methocel, carboxymethyl cellulose, preservatives such as benzalkonium chlorides, suspending agents, thickening agents, emollients, and other ingredients without impacting the antiviral potency of the key active ingredients. Such additional ingredients are known to the skilled person.

In a further embodiment of the present Invention, the carrier is additionally treated with cold atmospheric plasma. Cold atmospheric plasma is known to the skilled person and allows to increase the cationic charge of the surface. The presence of a metallic stearate such aass magnesium, stearate, calcium stearate or zinc stearate on the carrier or the carposition according io the present invention can stabilize electrostatic charges and result in intensified and retained anti-viral properties.

Figure 1 shows a schematic diagram of the experimental setup;

Figure 2 shows the antiviral activity of solutions and mixes •inhibiting SARS-CoV-2 entry.

Fi gure 3 shows the antiviral activity of mixes inhibiting SARS-CoV-2 entry.

Figure 4 shows a schematic diagram of the experimental setup.

Examples :

Example 1 : Iso like experiment on coated Petri dishes.

Step 1 Prepare 400 ul of R18 rhodamine labled inactivated virus inoculum solution in PBS for each sample.

Step 2 Apply the inoculum on the sample and sandwich it with LDPE inert film as shown in Figure 1 (ISO 21702) : -A Petri dish 5 is coated with the composition according to the present invention and dried to form, an antiviral surface 3.

-Artificial inactivated enveloped coronavirus sample 2 having the same composition of covid 19 virus but the mRNA genome was removed and replaced with a fluorescent dye is added to the antiviral surface 3.

- Plastic film 1 to cover the petri dish antiviral surface once the viral solution is applied.

Step 3 Incubate the samples for 24 hours at room temperature and in dark environment.

Step 4 Add 10 ml of PBS to each sample to recover the inoculum.

Step 5 Pipette 2 ml of the recover mixture in a transparent cuvette (2 replicates per sample) .

Step 6 Measure emission spectra with fluorometer (excitation wavelength 560nm, emission measure from. 580nm to 650nm) .

Antiviral efficacy of the solution was determined by using the above test procedure.

The interaction and the disintegration of the virus is determined by measuring the fluorescent concentration on the antiviral surface resulting from viral disintegration . the range is defined by the mmaaxx amount of fluorescent dye represented aass (PC? and no dye as (NC) indicating no interaction . The graph below shows that the formulations demonstrated efficacy against the virus .

example 2 : Inhibition of SARS-CoV-2

Cell Cultures: Vero E6 cells (ATCC CRL-1586) were cultured in

Dulbecco' 3 modified Eagle medium, (DMEM) with 10% fetal bovine serum, 100 lU/ml penicillin and 100 pg/ml streptomycin (all from. Invitrogen} . HEK-293T overexpressing the human ACE2 were kindly provided by Integral Molecular Company and maintained in DMEM (Invitrogen) with 10% fetal bovine serum, 100 IU /ml penicillin and ICO pg/ml streptomycin, and 1 pg/ml of puromycin (all from Invitrogen) .

Pseudovirus production: HHIIVV--11 luciferase reporter pseudoviruses expressing SSAARRSS--CCooVV--22 Spike protein were generated using two plasmids. pNL4-3.Luc.R-.E- was obtained from the SIH AIDS repository. SARS-CoV-2. Set Al 9 was generated (Geneart) from the full protein sequence of SARS-CoV-2 spike with a deletion of the last 19 amino acids in C -terminal, human-codon optimized and inserted into pcDNA3.4-TOPO 1. Spike plasmid was transfected with X-tremeGENE HP Transfection Reagent (Merck) into HEK-293T cells, and 24 hours later, cells were transfected with pNL4-3.Luc.R~.E-. Supernatants were harvested 48 hours later, filtered with 0.45 pm (Millex Millipore) and stored at -80°C until use. Viruses were titrated in REK-293T overexpressing human ACE2 to use an equal amount of fusogenic viruses.

Pseudovirus assay. HEK-293T overexpressing the human ACE2 were used to test provided mixes and their vehicles at the indicated dilutions. A constant pseudoviral titer was used to pulse cells in the presence of the samples. After 48h post-inoculation, cells were lysed with the Bright Gio Luciferase Assay system (Proiaega) . Luminescence was measured with an EnSight Multimode Plate Reader (Perkin Elmer) . To detect any associated cytotoxic effect, mix formulations were also tested with media, and were equally cultured on cells but in the absence of pseudovirus. Cytotoxic effects of these products were measured 48h post- inoculation, using the CellTiter-Glo luminescent cell viability assay (Promega) . Sample preparation:

RESULTS

We have tested the capacity of the provided mixes to inhibit SARS-CoV-2 entry into target cells. We employed a luciferasebased assay, using a reporter lentivirus pseudotyped with the spike protein of SARS-CoV-2, which allows the detection of viral fusion with target HEK-293T cells expressing human ACE2 receptor. A constant concentration of the reporter pseudovirus containing the SARS-CoV-2 original Spike protein was mixed with increasing concentrations of the indicated CPC- containing mouth rinses, oorr tthheeiirr ccoorrrreessppoonnddiinngg vveehhiicclleess,, and added to the target cells. To control for any induced cytotoxicity of the mixes, target cells were also cultured with increasing concentrations of the indicated products in the absence of pseudoviruses . All solutions but A at pH 7, C and E were able to Inhibit viral fusion iinn a dose dependent mmaannnneerr at concentrations where no cytotoxic effects were observed (Figure 2) . The combinations of these solutions (mixtures) were very efficacious at inhibiting viral entry at non cytotoxic concentrations. New mixes including active solutions where prepared, and were able to inhibit viral fusion in a dose dependent manner at concentrations where no cytotoxic effects were observed (Figure 3) . These results indicate that solutions and their mixes able to block SARS-CoV-2 viral entry into target cells.

FIGURES

Figure 2 . Antiviral activity of solutions and mixes inhibiting SARS-CoV-2 entry. Viral entry inhibition on target HEK-293T cells expressing ACE2 exposed to a fixed concentration of SARS- CoV-2 in the presence of increasing concentrations of solutions and their mixes. Cytotoxic effect on HEK-293T cells expressing ACE2 cells exposed to increasing concentrations of solutions and mixes in the absence of pseudovirus is also shown (right panels) .

Figure 3. Antiviral activity of mixes inhibiting SARS-CoV-2 entry. Viral entry inhibition oonn target HEK-293T cells expressing ACE2 exposed to a fixed concentration of SARS-CoV- 2 in the presence of increasing concentrations of mixes . Cytotoxic effect oonn HEK-293T cells expressing ACE2 cells exposed to increasing concentrations of mixes in the absence of pseudovirus is also shown (right panels) .

Example 3 : Measurement of the active surface ionic charge density.

The amount of surface charge density can be determined by means of measurement of induced image charges in a sensing electrode. The treated surface repeatedly moves close to and away from a sensing electrode and the induced image charge creates an AC electrical current in the circuitry connected to the sensing electrode. The induced current is measured and is proportional to the surface charge.

The apparatus consists of a sample spinner, contained in a metal box, sensing electrode and Keithley 823 nanovolt amp.l i f i er (Figure 4 )

C and R are capacitance and resistance of the input circuitry of the amplifier. Input capacitance was measured 80pF and input resistance is 50 MOhm .

The sensing electrode is made of 1.3 mm diameter copper wire. When the metal box top is in closed position, the sensing electrode is about 1.5mm. above the sample surface. One half of the sample substrate is treated, and another half is untreated. During the sample spinning treated and untreated surface repeatedly mmoovvee under the sensing electrode. The surface charge is calculated using the following formula :

Q^V*C/A

Where Q is charge per unit area, V is measured voltage on the sensing electrode and A is the area of the sample under the sensing electrode.

Sample preparation:

Paper oorr corrugated substrate ddiisskkss are prepared in approximately 2.5" circular in diameter. Treated samples are attached to 50% of the diameter by use of adhesive or tape. The apparatus detects Ionic charges by sensing the differential of charges on a treated and untreated surface. A disk is prepared wherein half of the disk is treated and the other is not. As the disk is rotated the sensing electrode detects the charge differential.

Sample preparation:

Paper oorr corrugated substrate ddiisskkss aarree prepared in approximately 2.5" circular in diameter. Treated samples are attached to 50% of the diameter by use of adhesive or tape.

The apparatus ddeetteeccttss IIoonniicc charges by sensing the differential of charges on a treated and untreated surface. A disk is prepared wherein half of the disk is treated and the other is not. As the disk is rotated the sensing electrode detects the charge differential. Utilizing the apparatus, and following the identical testing procedure, we tested numerous samples of the "Livinguard" commercial mask. The average Ionic density on the surface, is indicated in the table below.

Examples :

Example 4 :

Two bacterial strains were tested against three different compounds provided. The Gram-negative bacterial strain E. coli K12 was grown in LB media, and the Gram-positive strain

Staphylococcus aureus 113 was cultured in BHI media overnight prior to antimicrobial test . Bacterial density was determined by OD600 mmeeaassuurreemmeennttss and adjusted ttoo approximately 108 bacterial cells per ml with broth media, respectively. Equal volume of compound solutions and bacterial cells were mixed and incubated at 37 ^cC. To determine the killing efficacy, 20 pL of the mixed bacterial suspension was numerated at 1 h, 3 h, 6 h and 30 h after incubation with corresponding compounds, by distributing on an L3 agar plate (for E. coli) and BHI agar plate (for S. aureus) at 10-fold serial dilutions . The plates were further incubated at 37 °C for 24 h and bacteria viability was determined by counting the colony forming units (CFU) .

Testing the formulation samples for antibacterial efficacy shows that the inhibition is effective but in a slow kinetic manner. Bacterial count reduction after a 2 hour incubation was low. However, almost no survived bacteria can be detected after a 24 hour incubation. Reduction time can be improved by increasing the concentration of the components.

Exhibit A

July 29, 2020 PATENT

ANTI-MICROBIAL PROTECTIVE SYSTEM CONSISTING OF PERSONAL

PROTECTIVE EQUIPMENT (PPE) BARRIER, AND CATIONIC POLYMER BASED ANTI-BACTERIAL/ ANTI-VIRAL BLOCK, CAPTURE AND KILL FORMULATIONS, MATERIALS AND IMMUNE BOOSTING PROPERTIES AND METHODS FOR THE MANUFACTURE

ABSTRACT odiments of the inventive concept relate to a modular construction Personal Protection pment including but not limited to masks and nasal protection. The mask and nasal ection of some embodiments is of modular construction encompassing a shell, a canister housing for filter media/membranes and functional media and/or membranes which k, Capture and/or Kill bacteria and virus as well as increases oxygen concentration. In ous embodiments the shell is multi-layer, mono layer and various plastic and molded functional materials. The materials provide improved comfort and seal for its users. e embodiments also include one-way valves when used to inhale and exhale directing le airflow through the media and exhale airflow outside the shell. Many of the odiments apply to numerous types of PPE including but not limited to nasal and mouth, functional properties, formulations and application. An antiseptic formulation is further osed. This formulation is capable of being administered in a number of different ats, including sprays, gels, dissolvable oral films, and fine nebulized mist, and has the city to limit burden of microbial and viral exposure by chemical properties including ive charge and acidic pH as well as other microbicidal mechanisms. The formulation udes a combination of cationic molecules, including polyethyleneimine and GRAS nic starch and metal cation components with well-known efficacy against a variety of robes and enveloped viruses. The formulation, when applied to surfaces or ingested has apacity to attenuate the microbial / viral load to which the subject is exposed by rostatic/Plasma attraction and killing of microbial/viral particles. This collection of ral ingredients, as well as the polyethyleneimine polymer have an extensive body of ence in application to bodily surfaces and antiviral properties against enveloped viruses, uding pandemic influenza and coronavirus. Additionally, the formulation contains ponents with known immune boosting effects to aid the body in defense against obial infection. These components have been demonstrated in prior studies to enhance bility of the innate immune system as well as the cell mediated and humoral responses e adaptive immune system to respond to pathogenic threats.

SUMMARY

For purposes of this summary, certain aspects, advantages, and novel ures of various embodiments are described herein. It is to be understood that not necessarily all such advantages may not necessarily be achieved in accordance with any single embodiment of the inventive concept, and that the following and other objects are intended to be illustrative of the inventive concept and are not meant in a limiting sense. Many possible embodiments of the inventive concept may be made and will be readily evident upon a study of the following specification and accompanying drawings comprising a part thereof. Various fe tures and sub combinations of the inventive concept may be employed without reference to r features and sub combinations. Other objects and advantages of this inventive concept become apparent from the following description taken in connection with the ompanying drawings, wherein is set forth by way of illustration and example, an odiment of this inventive concept and various features thereof. Thus, for example, those ed in the art will recognize that the embodiments may be embodied or carried out in a ner that achieves one advantage or group of advantages as taught herein without essarily achieving other advantages as may be taught or suggested herein. rarching Vision: ract, Capture, Kill, Support” h Level Description: An integrated system or personal kit aimed at limiting the spread mitigating the effect of pandemic viral infections on human hosts terconnected Levels of Support: rotection - improving physical barriers against viral infection through optimization of functionality revention - through principles of chemistry and biology, prevent the ability of viruses to ct and proliferate mmune support - the incorporation of molecules and compounds in the formulation ances the ability of the innate and adaptive immune systems to fight infection Enablers: Smarter Mask/Nasal protection st-effective production from widely available materials, existing manufacturing cesses gonomic design with unique functionalities rface polymers able to be treated to gain capacity to fight viruses ble to be treated with a formulation enabling the attraction and killing of viral particles

- Strongly cationic charge

- Electrostatic/Plasma treatment

- Potent antiviral active ingredients

- Active chemical ingredients proven in consumer applications, sourced from natural materials - Applied with standard surface treatment techniques

B) Anti-Viral Formulation

- GRAS ingredients from natural sources, of pharmaceutical quality

- Formulated to maximize bioavailability of active ingredients

- Capable of being applied to human respiratory system, from nose and mouth to the lungs, via standard delivery techniques of consumer and medical products, including sprays, lozenges, oral strips, fine mist, and others

C) Immune System Support ater soluble ingredients formulated to maximize bioavailability nergistic relationship between active ingredients with respect to immune modulating perties tive ingredients target key biochemical processes necessary for fight against viral ction rong support for active ingredients in the body of medical literature Kit Distribution to Populations in Need mponents can be manufactured at large enough scale to be assembled into a kit and ributed to healthcare settings, nursing homes and other areas of need ts can be made available not only in healthcare settings, but also to the general public to vide protection in times of pandemic to workplaces, public transportation, and other areas re people are in close contact

BACKGROUND d of the Disclosure

[0002) The disclosure generally relates to systems and features on personal ective equipment, anti-bacterial, anti-viral formulations, manufacturing and applications. cription of the Related Art

100031 A surgical mask is an essential component of personal protective equipment E) and includes a shell which covers the nose and mouth, typically wherein the mask seals he face, so that the air within the capsule does not leak around the face so that the incoming well as the outgoing air is filtered or treated thus eliminating or reducing contaminated air m and to the environment. The filter media in which the air flows into the capsule can be grated into the mask material, attached directly thereto or housed within a separate ainer or coated on or within the mask surface as well as the whole personal protective pment setup.

[0004) The antimicrobial / antiviral properties of various alcohols have been well wn for years, and alcohol-based antiseptic liquid formulations designed to kill microbes on are commonly used in the hospital setting in addition to PPE to protect healthcare workers from microbial and viral exposure. Hands are a common vector for microbial spread, and as outlined by the WHO guidelines on hand hygiene in healthcare, a) the hands offer an attractive environment for microbes / viruses to grow b) microbial contamination increases linearly with longer duration of patient care in the absence of proper hand cleansing c) the inanimate environment is commonly colonized by microbes /viruses (e.g. surfaces of phones, computer k boards, and even PPE). Not only can PPE act as a vector for infection, but during times of reased demand, such as the current global COVID- 19 pandemic, the supply of unworn PPE become quite limited. The proposed antiviral coating can be applied to the outer surface of PPE, mask, gown, gloves, shoes, head coverings and others to reduce the risk of viral ad and facilitate the reusability of these garments and equipment. The protective coating also be sprayed on the naked skin around the mask as well as the inside of the mask uding the nose, throat mouth and the whole respiratory system

[0005| With the above in mind, it is critical to develop a mask that enables an ght seal with maximal comfort, with the capacity to exclude viral particles and maximizing gen delivery to the wearer. The protection afforded by the mask, in some embodiments is plemented with a plasma treatment and an antiseptic solution that a) facilitates the ability of PPE b) in cases where PPE fails, is not available, or is not able to be worn, the ect is protected to a certain extent from pathogen burden. Furthermore, in times of demic, the availability of PPE can become limited and the general public may be forced to te PPE from household goods, such as textile products and commercially available air rs. Should this necessity arise, the plasma treatment and antiseptic formulation is capable roviding an additional line of protection when makeshift textile-based masks must be used.

[0006] The first phase of a robust and effective immune response to viral or erial infection is orchestrated by the innate immune system. The innate immune response first line of defense to prevent viral invasion andor replication before a more specific ection is afforded by the action of the adaptive immune system. The innate immune system sists of physical barriers such as skin and mucus, cellular components such as granulocytic s, monocytes, macrophages, dendritic cells, and natural killer cells, as well as soluble iators that include cytokines and cellular receptors. Should the viral infection overwhelm nnate immune system, adaptive immune defenses kick in. The adaptive immune system sists of B cells that produce antibodies and T ceils that are capable of killing virally infected cells. Numerous natural and synthetic products have been identified and developed with the goal of supporting and boosting immune function. Such products commonly modulate the effectiveness of the innate or adaptive immune responses to viral infection and are capable of offering synergy in combination with antiseptic formulations that attack and impair the viability of pathogenic organisms to provide maximal protection to the human host

DESCRIPTION

[0007] The below-mentioned aspects, as well as other features, aspects, and antages of the present technology will be described in connection with various odiments. The embodiments, however, are merely examples and are not intended to be ting.

[0008] In the following description, reference is made to the accompanying wings/figures, which form a part of the present disclosure. The embodiments and claims not meant to be limiting. Other embodiments may be utilized, and other changes may be e, without departing from the spirit or scope of the subject matter presented here. It will eadily understood that the aspects of the present disclosure, as generally described herein, in the embodiments, formulations and claims, can be arranged, substituted, combined, and gned in a wide variety of different configurations and formulations, all of which are icitly contemplated and form part of this disclosure. In addition, such an article, system, mulation or device may be implemented, or such a method may be practiced using other cture or functionality w ithout departing from the spirit and scope of the inventive concept. rations and further modifications of the inventive features illustrated herein, and additional ications of the principles of the inventions herein, which would occur to one skilled in the and having possession of this disclosure, are to be considered within the scope of the ntion. 9] In general, pandemic viruses such as SARS-COV-2 have highlighted that certain robial/ viral characteristics make it extremely difficult to fully prevent microbial smission via fomites (inanimate objects which carry infection) and aerosols in a high den environment such as a hospital ward or nursing home. Such highly pathogenic acteristics include high microbial/viral load in the upper respiratory tract, the ability of cted persons to transmit the microbe/virus while asymptomatic, the ability of the robe/virus to travel several meters in the air even if the subject merely exhales or speaks, the ability of the microbe/virus to remain viable and infectious after hours in the air, and up to days on various surfaces. Since it appears that the virus originated from bats, it would be consistent and logical that frequency and electrostatic/Plasma and electromagnetic forces play a role in the transmission of the virus until it finds a host. The virus has developed characteristics to sustain its existence until it finds a host and this is what makes the new corona virus so virulent is because it can live without a host for extended periods of time. The revealing fact is the difference of life sustainment on different surfaces and discovering what accounts for the variations of time the virus can live on different surfaces. current statements about the length of life the virus sustains on surfaces. "The virus that ses coronavirus disease 2019 (COVID- 19) is stable for several hours to days in aerosols on surfaces, according to a new study from National Institutes of Health, CDC, UCLA Princeton University scientists in The New England Journal of Medicine. The scientists nd that severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was detectable in sols for up to three hours, up to four hours on copper, up to 24 hours on cardboard and o two to three days on plastic and stainless steel" "National Institutes of Health, Tuesday ch .17, 2020, New corona Virus stable on surfaces for hours." e compare the electrostatic nature of the surfaces that the new corona virus sustain a ger life on, and analyze the static nature of these surfaces, the theory that the virus lives ger on surfaces with a negative charge becomes apparent and cannot sustain itself on aces that retain a positive charge such as silk, wool. "Ron Kurtus, Materials that cause c electricity, 4 January 2018" s information may be vital in fighting the spread of the virus making masks and such ty apparel from materials that the virus has the shortest sustained life period outside of a . Knowing this and employing such surfaces and materials in healthcare facilities could enhance the safety of the healthcare workers and providers. The use of materials that can ain the virus outside of a host should be caution against so as not to encourage the spread he virus. The definitive knowledge that the virus responds to the static electric charge of erials could be the end of the pandemic

|00010] With such pathogens, it is inevitable that persons subject to high burden ronments for an extended period will be subject to and colonized by the pathogen. For e at risk, health authorities recommend the use of PPE to reduce the risk of pathogenic smission in aerosolized droplets. PPE requirements typically include either one or a bination of gloves, gowns, face shields, and masks (N95 or surgical masks). PPE uirements in high burden environments can be extensive, as is suggested by a recent study he Hospital Clinico San Carlos in Milan, which suggests that a 24 hr shift in a 12 bed nsive care unit (ICU) is staffed by 12 doctors, 32 nurses, 2 radiology technicians, 2 cleaning onnel and 2 consultants. In a 24 hr shift, these 50 providers would require 100 sets of es (to double glove), 50 gowns, 50 face shields and 50 masks. Extrapolating this Italian del to the whole United States, a country with nearly 100,000 ICU beds, approximately 830,00 sets of gloves, 415,000 gowns, 415,000 face shields, and 415,000 masks would be required daily. Clearly this would put a great burden on the PPE supply chain, and health authorities are advocating for either a) reusing b) manufacturing PPE from scratch, both raising concerns about the ability of PPE to be protective.

[0011] The challenges surrounding PPE availability during the time of a pandemic further compounded by the fact that PPE itself could be a vector of pathogenic transmission. sons from outbreaks including Ebola and SARS revealed that the PPE removal process ies a considerable risk of viral transmission and careful instructions for removal of PPE are part of guidelines from health authorities worldwide. Considering the ability of certain ogens to survive on surfaces, including materials comprising PPE, for an extended period ime much longer than the typical shift in high risk environments, anti-pathogenic or llency to bodily fluids has been examined as a potential to reduce the risk of microbial smission by PPE materials.

[0012] The most popular masks, be it the surgical mask or the N95 mask design e not addressed significant unmet needs of the medical community especially in such high bacterial and viral environments. Within the need of frequent changing/removing of the k and with the possible presence of active viruses accumulated on the surface of the masks, potential for transmission of viruses becomes significantly high. It is known that the virus enter the nasal area become trapped and find their way to the upper respiratory faster and er than through the mouth. An infected individual will spread the virus predominantly by gh, sneeze or simply exhaling. These challenges are addressed by embodiments of the ntive concept by including a more ergonomic design, materials, media, components and ctionality to address the ability of the mask to seal on the face, isolate the nose and mouth, mize negative pressure, filter, block and capture particles below 100 nanometers and ralize germs, microbes, virus and other biohazards with an active antiviral surface. Such ing is capable of being adjusted to different applications, pre-applied/applied on the inside side mask surfaces, the surrounding naked skin on the face, and the respiratory system of nose, mouth, throat and lungs. This coating also is capable of being applied to another PPE.

[0013] Advantageously, the embodiments of this mask incorporate a modular cept in which all components (except filtration media) are re-usable. The sterilizable system prises a shell, a seal around the perimeter of the shell which is easily adaptable to a wide range of face contours, one or more directional air flow valves, a detachable filter media housing, adjustable securing strap and replaceable media and an active antiviral surface.

[0014] Some embodiments of the modular design, materials and ability for sterilization and re-use enhance the economics for manufacture and use of the mask. These ancillary advantages reduce cost by multiple use capability, replacement of media and die rapid lacement of the filtration media.

[0015] Some embodiments include a mask comprising a ridged main shell with a ptacle to receive a container housing for the filler media. Said Shell and media container ome such embodiments are attached by male/female threads or lug configuration to omplish a tight seal.

[0016] In some embodiments, the mask Shell is configured to receive a one-way e allowing a breath to be predominantly evacuated without backflowing through the filter ia.

[0017] In some embodiments, the mask Shell is configured to accept a one-way or diaphragm check valve actuated in conjunction with another one-way valve to prevent kflow pressure evacuation through the filtration media.

[0018] In some embodiments, the mask is configured with the one-way valve built the filter media container.

|0019] In some embodiments, the mask Shell is 3 D printed or fabricated plastic cles.

[0020] In some embodiments, the mask is fabricated from household textile ducts and outfitted with commercially available air filtering materials to enhance the ring capabilities of said textile mask. Viruses, including the novel coronavirus SARS- V-2 can measure 0.1 microns in size. In a study of the capture efficiency of various sehold materials against particles of such size a surgical mask captured almost 90% of les while household textiles such as cotton, linen, and silk captured 70% or less of the icles. Scarves, which have been recommended by public health officials, only capture 50% articles that are as small as viruses. Double layering dish towels and cotton shirts manages apture more particles than a single layer, however, the improvement in capture efficiency odest and breathability is significantly reduced. Clearly, a method to enhance the filtration abilities of household textiles while maintaining breathability is essential. Application of electrostatic, Corona, plasma, Chemical plasma, bi-polar ionization plasma or cationic treatment in concert with anti-microbial. Anti-viral coatings substantially improve performance of all mask and PPE materials.

[0021] In some embodiments, the mask covers the nose, mouth and cheeks from ear to ear.

[0022] In some embodiments, the filter media is encapsulated in a separate ainer which is attached by a threaded or lugged design.

[0023] In some embodiments the filter media is encapsulated in a separate ainer which is attached by a rubber gromet.

[0024] In some embodiments, the filter media receptacle is integrated into the mask l.

[0025] In some embodiments, the closure for the filter media housing is capped by readed or lugged design or snap fit closure.

[0026] In some embodiments, the mask filter media housing is fabricated molded tic or elastomeric skin friendly polymers. Examples are Exxon Vistamax, closed cell foam, moplastic elastomers and thermoplastic rubbers or silicones.

[0027] In some embodiments, the mask filter housing and filter media are one or e various shapes, including: round, square, rectangular or other shape and size to maximize ected area and flow through the media.

[0028] In various embodiments, the filter media is a single layer or multi-layers to vide specific functionality. In some embodiments these filter media also are plasma treated ording to other embodiments of the present invention.

[0029] In some embodiments, the filter Shell does not have any one-way valves.

[0030] In some embodiments, the mask Shell and its modular components are icated molded plastics. Examples are ridged and soft thermoplastic combinations. In some odiments the mask shell and its modular components are infused with copper or silver in bination with other aspects of the present invention.

[0031] In some embodiments, The Shell of the mask is constructed of engineered ded fiber. In some embodiments said molded fiber are infused with copper or silver in combination with other aspects of the present invention. In some embodiments the copper and silver are added to the slurry during the forming process or applied post forming.

[0032] In some embodiments, the Shell is manufactured utilizing molded fiber in already existing high and low volume production lines.

[0033] In some embodiments the PPE is treated with electrostatic/plasma, Corona, t ospheric plasma, bi-polar plasma or chemical Plasma creating a Cationic surface. Examples PPE are treated utilizing the Pillar technologies “Lab Jet” system. It will be appreciated these treatments are capable of being applied to any filtration media or PPE regardless of gn, material, shape or origin in various embodiments of the inventive concept.

[0034] In some embodiments the PPE is constructed from materials which rally generate electrostatic energy. Examples of this material are silk and wool.

[0035] In some embodiments the Cationic surface treated PPE is coated with antirobial and anti-virus products. In various embodiments the coating material is sprayed, ed, soaked or otherwise applied directly or indirectly.

[0036] In some embodiments the PPE surface is Cationic treated prior to being ed with anti-microbial and anti-virus products. Said PPE is capable of being pre or post ma treated.

[0037] In some embodiments, the mask, frame or injection molded surfaces may e copper added or dispensed into the melt during manufacture. Various embodiments of mask including copper comprise plasma, corona or chemical deposition and cationic aces become active anti-microbial, anti-virus.

[0038] In some embodiments, the Cationic surface is preserved through gas barrier -conductive packaging and inert gas environment such as nitrogen. In some embodiments h gas is applied during the package loading process with droplets of liquid nitrogen or under uum.

[0039] In some embodiments the gas barrier packaging is Plastic composition, le and or multi-layer. One example is MAP (modified atmosphere packaging) used in food meat packaging, films of polyethylene, polypropylene, evoh, mxd-6 nylon and other known barrier materials.

[0040] In some embodiments the anti-virus, anti-Microbial liquids of the present ntion is applied to surfaces utilizing static guns or wands which create and project a mist or spray. One example is the Emist Epix 360 disinfectant sprayer. Another example is the Protexus electrostatic sprayer.

[0041] In some embodiments of the current invention, contoured capsules are inserted into the nostrils. Various embodiments of such capsules are manufactured by injection molding, casting or other methods. Examples of materials are silicones, thermoplastics of die lik including but not limited to PP, PE, Vistmax, PU, TPE, TPR and thermosets. In various odiments said capsules are designed to fit small, medium and large nostrils.

[0042] In some embodiments the capsule provides a functional barrier between the ril and the media wherein there is no direct skin contact between the contents of the capsule the nostril.

[0043] In some embodiments the filter is a nasal screen placed at the entrance of nostril. Examples include ‘‘first defense nasal screens” which are known for filtering out icles of various sizes. Applying corona, plasma, cold Plasma, chemical plasma, bi-polar zation plasma and anti-microbial, anti-viral chemistry of the current invention adds the ity for Block, capture and kill wherein it was not previously capable.

[0044] In some embodiments, the media of the nasal insert is open cell foam treated the plasma of the current invention and coated with the anti-viral chemistry of the current ntion.

[0045] In some embodiments, the cellulose is molded fibers.

[0046] In some embodiments, the Mask. Shell is manufactured utilizing molded r including anti-microbial, anti-viral additives directly onio the Shell or into the material he Shell.

[0047] In some embodiments, the mask Shell is manufactured utilizing molded r wherein a soft plastic is formed as an inner liner for comfort.

[0048] In some embodiments, the molded fiber filter media is layered to create air w across a matrix of designated paths.

[0049] In some embodiments, the molded fiber mask Shell includes both microbial, antiviral additives and a receptacle for a separate container housing the treated r media. [0050] In some embodiments the shell has a grill or plurality of holes to allow air flow in both directions. In various embodiments the filtration media is attached to the outside and/or inside of the shell. The holes are less than 2 MM in diameter.

[0051] In some embodiments, the mask Shell is washable and re-usable.

[0052] Jn some embodiments, die mask Shell has a smooth finish that will adhere t the face providing no leakage or outside air penetrating the shell.

[0053] In some embodiments of the mask shell, breathing is provided through a aceable filter media. In some embodiments, such filter media is embedded in a pod like ster which is attached to the shell by screw threads, lugs or snap fit. In some embodiments media is treated and coated with the anti-viral chemistry of the current invention.

[0054] In some embodiments the filter media provides/includes non-stick perties.

[0055] In some embodiments, the filter media electrostatically capture small nano particles. Blocking particles ranging from less than 0.03 nanometers (viruses) to .5 ometers (bacteria).

[0056] In some embodiments, the filter media is a membrane of activated carbon a protein fibril base or acid treated protein fibril material that is capable of capturing eria and viruses.

[0057] In some embodiments, the membrane(s) are capable of being enished/replaced as needed.

[0058] In some embodiments the mask shape and size are 3D printed utilizing tographs of the face or specialized software. Combined with materials and treatments of current invention provide an airtight mask/face seal with anti-bacterial, anti-viral perties.

[0059] In some embodiments of the current invention, the mask is comprised of e elements. The shell is engineered molded fiber including a soft polymeric face seal and ansparent breathable membrane. The membrane provides air flow as well as visibility of mouth and nose for purposes of better communication while speaking. The combination of e in addition to treatments of the current invention provide anti-bacterial and anti-viral ection. [0060] In some embodiments of the current invention the mask covers only the nose. Such mask is a single unit covering the nose and attached to the ears. The cover is treated with the treatments of the current invention inkling electrostatic, corona, cold plasma chemical plasma bi-polar plasma and the like. In some embodiments the nose cover also is coated with the chemistry of the current invention.

[0061] In some embodiments the nose cover is constructed of molded fiber and is gned to have breathing holes on the bottom of the cover. The holes are covered by a filter en or foam or mesh. In some embodiments the covers are treated with electrostatic, mical plasma, cold plasma, bi-polar plasma or treatments of the current invention

[0062] In some embodiments the nose cover is 3D printed with flexible materials.

[0063] In some embodiments the mask is constructed utilizing nano fiber material. ome such embodiments the nano fiber material is treated and coated according to the ent invention and have Block, capture and kill properties.

[0064] In some embodiments, the membrane includes “Zeolite” particles with the ability of selectively providing higher concentration of oxygen during inhalation. In some odiments such membrane is enabled with a mini personal battery-operated pressure system nected to the Mask. The Zeolite adsorbents arc aluminosilicate minerals that have a large roporous surface area, and the cationic charge and quadrupole moment of the zeolite fers nitrogen selectivity. This allows for the adsorption of nitrogen, the primary component mbient air (~80%) and output of a pure oxygen stream (>90%) from inhaled air (~20% gen) under the application of pressure. Decreasing the pressure can release the adsorbed rogen and the zeolite adsorptive surface is capable of being regenerated for further filtration tmospheric air. With time, and cyclic adsorption and desorption of nitrogen, the capacity he zeolite surface can decrease as H2O and CO2 cannot be fully desorbed. As such, in some odiments, a thin layer of aluminum is added before the zeolite layer as a desiccant to rove zeolite capacity. The use of a portable zeolite based pressurized oxygen concentrator been suggested to be feasible to provide oxygen therapy for those with COPD who have r intrinsic respiratory drive, or those who live in Beijing, Los Angeles and other cities with r air quality. In theory, such a system is also highly applicable to healthcare workers who subject to air that could be contaminated with aerosolized droplets, and who must wear ks that seal their nose and mouth to the ambient air. [0065] In some embodiments, all membranes are capable of being configured as needed, designed to fit in the filter media housing and are capable of being easily replaced.

[0066] In some embodiments, the filter media membranes are directly adhered to the Shell.

[0067] In some embodiments, the shell has holes or openings under the filter media mbranes to allow inhalation through the membranes.

[0068] In some embodiments, the mask shell and filter housing are washable and sable.

[0069] In some embodiments, the substrates are pre-sterilized utilizing high nsity UV.

[0070] In some embodiments, the substrates are washed for re-use, sterilized with and recoated by spray, dip or other methods rendering the articles once again ready for ock, Capture and Kill” of microbes and virus.

[0071] In some embodiments, activated carbon filtration membranes are derived m spent coffee grounds

[0072] Some embodiments the filtration media are sprayed with antimicrobial, viral liquids containing the combination of specially charged materials with metal ions of er, copper and or GRAS products.

[ 0073] In some embodiments, the mask shell and filter housing are capable of being sable by applying products such as described in the embodiments of the current invention.

[0074] In some embodiments, the products such as that described in [0052] are be ied to the inside and outside surfaces of cloth masks, which are being recommended by th authorities including the CDC to be worn by the general public to conserve surgical and r medical grade masks for health authorities. Application of the formulation to such cloth ks can provide additional protection to the general population during limes of pandemic.

[0075] In some embodiments, the products such as that described in the odiments are applied to the outside surfaces of PPE as well as penetrating the structure of n cell foams including textiles, foams and other materials of the present invention. Such ments penetrate the surface of the PPE resulting in higher intensity and longevity of the tments. [0076] Highly pathogenic microbes that are able to be transmitted even by asymptomatic patients via aerosolized droplets, across long distances and which are able to survive on surfaces for extended periods of lime, require measures of protection beyond PPE for persons who are exposed to them. In some embodiments, the product as described in [0052] can be applied as is or modified for the use in the nose, mouth and as an aerosolized mist to th lower respiratory tract.

[0077] In some embodiments the filter media is under vacuum or negative pressure ng anti-bacterial, anti-viral treatment to enhance or assist with treatment penetration into media resulting in both surface and interior treatment.

[0078| In some embodiments the filter media is under vacuum or negative pressure ng anti-bacterial, anti-viral treatment to enhance or assist with treatment penetration into media resulting in both surface and interior structure and treatment extending to the inner ace.

[0079] In some embodiments, anti-microbial/antiviral efficacy are enhanced by usion of high Cationic materials like Polyethyleneimine (PEI) family and/or branched PEI EI) in the formulation. PEI has been used widely in the environment, with applications in er purification, mineral extraction, washing agents and packaging materials, but has also n used in personal hygiene products such as shampoos and topical antibacterial products. polycationic nature of PEI, which results from the presence of amine groups allows for attraction of negatively charged membrane components of microbes, and enveloped viruses ing to microbial/viral membrane destruction. Linear PEI (25kDa) at a concentration of % (w/y) has been used widely in antiviral studies with efficacy against viruses such as uenza and human papillomavirus and a good toxicity profile. Furthermore, in vitro studies e revealed that branched, Low Molecular Weight PEI (3kDa) showed strong antiviral vity while maintaining a good toxicity profile, with a selectivity index of 230 against human onavirus in a study by Ishigaki et al. It is anticipated that PEI may be sensitive to oxygen radation. To address this degradation in some embodiments the PEI is encapsulated in other polymers for example PLA or PT A including other known antioxidants. Examples are iron oxide, polybutylene and vitamin C.

[0080] In some embodiments, the polycationic nature of the PEI based formulation has specific efficacy against the infectious process of SARS-COV-2 virus. Structural biology studies have revealed that a key step in the infectious process is the interaction between the i l spike protein and the angiotensin converting enzyme 2 (ACE2) expressed on cells of the respiratory tract. The Valine⁴⁰⁴ (SARS-COV-1) to Lysine⁴¹⁷ (SARS-COV-2) substitution he viral spike protein enables the formation of a salt bridge between Lysine⁴¹⁷ and artate³⁰ on ACE2, enhancing the binding strength and infectivity of SARS-COV-2. ACE2 ghly expressed in the oral cavity, especially on the tongue.

[0081] In some embodiments, a polycationic, acidic solution delivered to the oral ty is expected to impair the electrostatic interaction between the negatively charged artate residue on ACE2 and the positively charged lysine residue on the viral spike protein, ep that is essential in the infective process.

[0082] In some embodiments, the molded fiber, the plastic surfaces of the mask, mbranes and other relevant substrates and surfaces are capable of being created frequently ted with cold plasma or chemical cold plasma to enhance the active cationic nature of the ace allowing for enhanced attraction and antimicrobial/antiviral effect with or without the er or copper ions. Atmospheric cold plasma has been identified as a promising therapy nst various fungi, bacteria, viruses and other micro-organisms, especially those which form films. It is theorized that this anti-microbial effect is due to the generation of biologically tive entities, most importantly, charged species which catalyze peroxidation processes that upt membranes, and target intracellular biochemical processes causing DNA damage most ortantly. The dose and dose rate are critical, with low doses of <1 J/cm suggested as robicidaVviricidal while sparing normal cells, and higher doses causing damage and death ormal cells. Further, the use of cold plasma was suggested to be safe in in vitro testing on nstituted oral epithelial cells, with low cytotoxicity and high viability of treated cells. ing in animal models revealed no adverse toxicities after application of cold plasma to pig and the oral cavity of rabbits.

[0083] In some embodiments, chemical cold plasma, electrostatic, chemical plasma, ona, bi-polar ionization, cationic treatments is applied to masks or other PPE at “stations”, consisting of a closed chamber or housing in which the surface can be treated in a matter of seconds and provide extended functionality of anti-viral protection to the host. Such treatment “stations’* can be located in major public spaces, including transportation centers such as train stations and airports, office buildings, university libraries and other spaces that are highly trafficked.

[0084] In some embodiments, the activity of high cationic materials like PEI nst pathogenic species are enhanced by incorporating Branched polyethyleneimine BPEI onic polymer. BPEI can be N Ndodecyl methyl PEI, N-N Hexyl methyl PEI,N ethylhexdecyl amine PEI and other derivatives of the PEI polymer and cationic starches. i-viral studies with influenza have shown that coating a surface with N,N-dodecylmethyl- conferred a >3.5 log reduction in viral titer.

[0085] In some embodiments, the branched and cationic nature of PEI is capable eading to competitive inhibition with the substrate of the serine protease TMRSS2 required activation of the SARS-COV-2 virus, resulting in decreased catalytic activity

[ 0086] In some embodiments, Branched PEI (BPEI) is capable of being slinked/ semi crosslinked with phthalide base and PEG based crosslinkers to significantly rease its viral inactivating potency. PEGylalion in particular has been shown to be icularly advantageous in applications to the respiratory system as it decreases cytotoxicity, rove mucus penetration by reducing electrostatic interactions with mucin, and make icles less likely to be cleared by alveolar macrophages.

[0087] In some embodiments, the cytotoxicity of the charged cationic polymer nst normal cell membranes is mitigated by the co-formulation with PLGA (poly(lactic-co- olic acid), PU (polyurethane), mannose residues or other previously described methods.

[0088] In some embodiments, the viral inactivating potency of the formulation is matically increased in the presence of colloidal silver or colloidal copper.

[0089] In some embodiments, a formulation combining PEI and silver is capable eing applied to inanimate surfaces in healthcare settings and other public spaces, providing efit over the nano-silver that is used in a significant number of consumer goods, such as ary supplements, toothpaste, and detergents to provide anti-microbial protection. Such o-silver particles have also been delivered in spray applications. The PEl-silver bination, previously described by Lee el al, is a rational formulation to maximize active surface charges and thus antimicrobial activity while circumventing the complex and costly production of nano-silver.

[0090| In some embodiments, the most effective form of silver against enveloped viruses is silver ions in aqueous solution

[0091] Jn some embodiments, the liquid formulation based on high cationic terials like PEI and silver is applied both to skin surfaces, as well as masks or other PPE at tions”, similar to hand sanitizer dispensing stands present in schools, hospitals and other ic spaces. The formulation is stored in a closed housing, and engineered to deliver the e amount of antiseptic solution consistently and accurately to the target area. It is automatic peration, able to sense the insertion of hand or PPE into the aperture to prompt delivery of formulation, and the delivery will terminate after a predefined interval. The formulation exert its antimicrobial effect and dry quickly, providing several hours of protection to the . Such antiseptic treatment “stations” can be established in high traffic public spaces, uding transportation centers such as train stations and airports, office buildings, university aries and others.

[0092] In some embodiments the formula of glycerol, Trypsin (Gadus morhua) .1, nol (as active antimicrobial) water and Menthol is applied to the nasal as a swab, in gel or y formula. One example is “Coldzyme”, a product used to prevent or treat the symptoms ommon cold.

[0093] In some embodiments of the present invention, the formulation of Dicapryl bonate and Stearalkonium Hectorite and propylene Carbonate is a Emulsion stabilizer, film mer, rheology modifier. One example is “Cosmedia Gel CC” by dewolf chemical.

[0094] In some embodiments, the presence of metal cations in the formulation fers an unfavorable environment for the serine protease TMRSS2. TMPRSS2 activity is essary for binding of SARS-COV-2 virus to host cells. Copper has been shown to adversely act protease activity in a number of different studies.

[0095] In some embodiments, a formulation containing a Zwitterion surfactant h or without colloidal silver or copper ions formulation is used as a base wherein branched or natural derived additives are capable of being added to significantly increase the potency he viral kill and inactivation. [0096] In some embodiments, the presence of silver or copper ions with a charged polymer high cationic materials like PEI/ BPEI or other Zwitterion material has a synergistic effect and increases the microbicidal effect to about 9-10 log 10. This is achieved by enhanced disruption of viral membranes by the positively charged material in the formulation.

[0097] Jn various embodiments the combination of Malic acid (anti-viral) and C amidopropylbetaine (surfactant) and hydroxyethyl cellulose as a thickener is applied to al protection as well as mask by spray, gel or swab. The viscosity is adjusted with the roxethyl cellulose. This formulation combined with plasma of the current invention provide g lasting viral protection.

[0098] In some embodiments the active ingredients are malic acid and sodium C- 6 olefin sulfonate. The sodium sulfonate is an anionic surfactant.

[0099| In some embodiments PVP Povidone-Iodine is used as an anti-bacterial, -viral, anti-septic skin friendly component in combination the other treatments of the ent invention.

[ 0100] In some embodiments of the current invention, malic acid and amidopropylbetaine are used without the need for thickeners.

[0101] In some embodiments, the formulation is composed of a cationic polymer, witterions surfactant for example, Cocamidopropylbetaine Betaine and Malic acid.

[0102] In some embodiments the formulation of a cationic polymer, amidopropylbetaine and malic acid without pre or post treatments of the current invention effective Block, catch and kill.

[0103] In some embodiments of the current invention, polyquatemium-37, and aprylyl Carbonate, and Lauryl Glucoside, a high-performance Cationic liquid Dispersion ymer, by example Cosmedia Triple C, combined with Cocamidopropylbetaine and Malic provide effective anti-viral properties.

[00104] The formula of polyquatemium-37, and Dicaprylyl Carbonate, and Lauryl coside, a high-performance Cationic liquid Dispersion Polymer, by example Cosmedia le C, combined with Cocamidopropylbetaine, Malic acid and Metal Stearates provide ctive anti-viral properties prolonged Block, capture and kill ability.

[00105] In some embodiments of the current invention, magnesium stearate is t blended with polypropylene wherein when the material is electrostatically charged, it is ilized, intensified and prolonged. [00106] In some embodiments melt blended metallic stearates, coated, impregnated into plasma treated substrates will stabilize the electrostatic/Plasma and Cationic charges and extend its effectiveness for a longer period of time.

[00107] In some embodiments, metallic stearates of magnesium, calcium and Zinc are Applied on substrates by coating techniques, including coating water-based dispersions or merging etc. In some such embodiments the deposition is in the range of 0.5 -3 percent of the allic stearate on or inside the structure of the substrate. The treated substrate is dried prior to trostatic/plasma treatment.

[00108] In some embodiment, metallic stearates of magnesium, calcium and Zinc e Applied on substrates by coating techniques, including techniques for coating water-based ersions or submerging etc. In some such embodiments the deposition is in the range of 0.5 -3 ent of the metallic stearate on or inside of the structure of the substrate. In some embodiments treated substrate is dried prior to electrostatic/plasma treatment.

[00109] In some embodiments thermoplastic materials used to make weaved nano s are blended with metallic stearates prior to the weaving process & before the electrostatic sma treatment to extend electrostatic duration and intensity.

[00110] In various embodiments a coating of the metallic stearate(s) is applied to en and/or non-woven PRE to increase the efficiency and duration of the electrostatic/Plasma tment.

[00111] In some embodiment metallic stearate is added to thermoplastic products polyesters and polyolefins if targeted for plasma and electrostatic/Plasma treatments

[00112] In some embodiment, magnesium stearate is used in the process of making n cell foam during the foaming process. Also, in various embodiments stearate is injected, regnated, coated or blended to such foam prior plasma treatment.

[0113] In some embodiments, the formulation consists of entirely natural edients, with cationic starch polymer included to provide positive charge necessary to upt the viral infectious process. Cationic polymers with quaternary ammonium functional ups are frequently used in cosmetic and personal care applications. They act as thickening nts and provide smooth feel to skin while also exhibiting functional surface properties, ing them highly applicable to a nasal gel or ointment application. Examples of such mers include cationized hydroxyethylcellulose, hydroxypropyl methylcellulose phthalate ther similar cationized cellulose, starch, protein, lanolin, chiostan or silicone substrate. [0114] In some embodiments, the media of the natural or high cationic materials like PEI formulation is acidic. This is done in some embodiments using citric acid or ascorbic acid or the likes of other organic weak acids as solutions or granules. The optimal pH for the media of the PEI in some embodiments is in the range of 3-4.5.

[0115] In some embodiments, the acidic nature of the natural or PEI based f mulation impairs the activity of the TMPRSS2 serine protease, necessary to cleave the RS-COV-2 viral spike protein, which is regarded as an essential step for viral entry and ction of host cells and subsequent spread. The optimal pH for TMPRSS2 is believed to be he range of 8-9.

[ 0116] In some embodiments, the formulation is made acidic by the addition of orbic acid (vitamin C). Vitamin C will not only provide the optimal pH for the formulation escribed in [0072] and [0073], the immune modulatoiy effects are well documented. min C has been found to enhance such innate immune system functions as neutrophil gocytosis and chemotaxis, macrophage migration, production of interferon, a crucial viral cytokine, and enhances NK cell proliferation. Additionally, Vitamin C has been wn to enhance T cell proliferation, which contributes to cell mediated immunity against ses. Vitamin C has been shown to have direct anti-viral effects, namely the production of rogen peroxide upon oxidation which has direct viricidal effects, while also acting as an oxidant to mitigate damage of normal cells by reactive oxygen species (ROS) formed by ogenic microbes. Vitamin C levels were found to be low in ICU patients, and treatment h high-dose vitamin C led to shorter lime of mechanical ventilation, reduction of mortality to ARDS, a major concern in progressive infection with SARS-COV-2, and decrease in ncidence of multi-organ failure (sepsis). As such, high dose vitamin C administered by IV been used in the treatment of SARS-COV-2 infected patients in China with a favorable ty profile, even when administered in high doses directly into the blood stream.

[0117] In some embodiments, the natural formulation contains a carbohydrate ding protein, or lectin, suggested to have antiviral activity. Such lectins as wheat germ utinin (WGA) are generally recognized as safe (GRAS) as this particular lectin is a ponent of wheat, a dietary staple globally. WGA selectively binds sialic acid moieties, and demic influenza, middle east respiratory virus (MERS), and more recently SARS-COV-2 e been suggested to rely on recognition of sialic acids on host cells. Competition for sialic acid binding between viral glycoproteins and lectins included in the formulation could reduce the number of viral particles able to infect cells.

[0118] In some embodiments, wheat germ agglutinin or other sialic acid binding lectins is incorporated as a crude intermediate product extracted from raw material such as wheat germ

[0119] In some embodiments, wheat germ agglutinin or other sialic acid binding ns is incorporated in their ultra-pure form, purchased from commercial vendors or purified g affinity chromatography

[0120] Cyclodexlrins are a group of natural products formed during bacterial stion of cellulose. These compounds are currently used as additives in vaccines, oclonal antibody formulations and other orally delivered treatments to overcome mulation challenges and improve solubility and bioavailability of active ingredients. A or challenge for many antiviral drugs is their limited solubility. This is an issue for drags h as remdimivir, lopinivir, and oseltamivir, all of which are being explored for their activity nst the novel coronavirus SARS-COV-2. Furthermore, cyclodextrans are capable of being dified to gain viricidal activity and their ability to sequester cholesterol and disrupt lipid s impairs infectivity of enveloped viruses such as influenza and members of the coronavirus ily. As they are currently used in vaccines and administered orally, cyclodextrins have d biocompatibility with skin and mucous membranes. As such, cyclodextrins are a logical AS additive to antiviral formulations for their ability to enhance properties of the mulation such as solubility and bioavailability and for their intrinsic viricidal capabilities.

[0121] In some embodiments, the natural GRAS based or high cationic materials PEI formulation incorporates Octenidine HC1, a cationic biguanide with a known broad ctrum of antibacterial activity, even those exhibiting multi-drug resistance. It is believed Octenidine HC1 exerts its antimicrobial effect from cationic charges which disrupt the erial cell wall. Additionally, research has suggested that Octenidine is an HC1 is an bitor of bacterial proteases, which as mentioned above in [0072] is an essential step in viral ction, including SARS-COV-2 as well. In fact, recent data from a docking study has aled that Octenidine HC1 is among the top 10 compounds of a total of 3118 FDA approved gs investigated in binding affinity to two main SARS-COV-2 proteases. The activity of enidine HC1 against MRS A has supported its use as a wound antiseptic and in the avoidance of surgical site infection (SSI). Octenidine has also been applied intranasally and shown to reduce MRSA colonization. This evidence has led to the use of Octenidine HC1 as an active ingredient in commercial antiseptic products, such as nasal gels.

[ 0122] Licorice is an herb used frequently in Chinese medicine since the year 2000 BC. More recent work has demonstrated that compounds isolated from licorice root, especially Gl cyrrhizin (GL) have anti-viral properties. The anti-viral mechanism of this compound udes targeting of both the viral life cycle - viral adhesion in HTV, HSV and release of viral geny in HCV, and secretion of viral mediators in H5N 1 influenza - and stimulating the mune system by activating T lymphocyte proliferation in the setting of duck hepatitis virus HV) vaccination. Another compound in licorice, 18B-Glycyrrhetinic acid (GA), was shown ave antiviral activity against respiratory syncytial virus by preventing viral attachment, and ulating interferon secretion (1FN), a key cytokine of the innate immune system that alerts activates neighboring cells of a virally infected cell. The mechanism of antiviral activity hese compounds GL and GA, namely preventing viral attachment, inhibiting viral ication, and enhancing the capabilities of the innate immune system, can synergize with r components of the formulation that exert antiviral activity by similar mechanisms. hermore, the fact that these compounds are isolated from licorice root, an herbal plement, lends merit to its GRAS nature and safety of its use in human subjects.

[0123] In some embodiments, the natural GRAS based or high cationic materials PEI formulation as described is impregnated into Polysaccharide or cellulose fibers.

[0124] In some embodiments natural GRAS based or high cationic materials like formulation as described is used as a sizing agent in the molded fiber process.

[0125] In some embodiments the natural GRAS based, or high cationic materials PEI formulation is used as wipes. Such wipes are capable of being used to sterilize aces, tools, flat or irregular surfaces. The wipes are also capable of being used as a filter ia for typical surgical or other mask applications.

[0126] In some embodiments, the natural GRAS based or high cationic materials PE1/BPEI, crosslinked/semi cross linked and mixed with colloidal silver, copper or onic starch ions thereof, such mixture is capable of being coated onto substrates of molded r, plastics, nonwovens, rubbers and textiles. [0127] In some embodiments, the finished product, albeit mask, but also gown, gloves or other articles of PPE is treated with an acidic protein fibril, and the PEI, crosslinked, colloidal silver mix or natural GRAS based formulation.

[0128] In some embodiments, the formulation is liquid, and is capable of being aerosolized through a spray delivery mechanism to be easily applied to any surface including k’s, gowns, gloves, other personal; protective equipment, wipes and the like.

[0129] In some embodiments, a high purity pharmaceutical grade PEI with erent molecular weights and lower toxicity or natural GRAS based formulation with or hout the inclusion of silver and or copper ions solubilized in water is capable of being ulized into a fine mist for introduction into the human respiratory system including the nose uth, throat and lungs.

[0130] In some embodiments, a high purity high cationic materials like PEI with erent molecular weights and lower toxicity, with or with silver and or copper ions or a ral GRAS based formulation is delivered to the oral and nasal cavity in the form of chewing m, strips, gel, or other means to apply through the mouth or nose.

[0131] In some embodiments, the high cationic materials like PEI based or natural AS based formulation are outfitted with anti-inflammatory agents such as dexamethasone ene therapies such as adiponectin for delivery in nebulized form to the lower respiratory t. This is of concern in progressive viral infection such as SARS-COV-2, as 40% of infected ents in one case study developed acute respiratory distress syndrome (ARDS), and of these % died. Central to the pathogenesis of ARDS is the release of inflammatory effector ecules from activated neutrophils and alveolar macrophages, causing a leak in the alveolar mbrane and the accumulation of cellular debris and inflammatory fluid which impairs gas hange, necessitating mechanical ventilation to support respiration. The concern over ilator shortages has been discussed extensively by health authorities and political figures ss the United States and the Globe, and therapeutic solutions to address ARDS are gaining tion.

[0132] The discussion on Vitamin C in [0074] outlined the importance of providing ost to the innate and adaptive immune system of patients suffering from severe infection iring ICU level care. CoQlO is a critical part of oxidative phosphorylation in the ochondria, and acts to transfer electrons between members of the electron transport chain. Depletion of CoQIO levels is common in acute and chronic disease, especially in those who are critically ill The decrease in ATP production leads to an increase in free radical production and damage to the mitochondria. CoQJ 0 levels were found to be decreased in patients with influenza infection, and influenza infection is known to induce oxidative stress and deplete antioxidants such as glutathione, vitamin C and vitamin E. Furthermore, the release of pro- i flammatory cytokines leads to the pathogenesis of conditions such as ARDS, a key ributor of mortality in influenza and coronavirus infection. CoQIO has been shown to nuate the “over-activation” of the immune system seen in influenza infection - as CoQIO been associated with decreased TNF-a and IL-2 secretion. Inclusion of a formulation of QIO with high bioavailability mitigates any oxidative stress induced by severe infection, concurrent replenishment with vitamin C could provide additional antioxidant capacity. itionally, CoQIO supplementation attenuates the deleterious effects of immune activation uman systems such as the respiratory system.

[0133] In some embodiments, the PEI formulation or cationic starch of the natural AS based formulation activates the cationic activity of the coated surface

[0134] In some embodiments, the high cationic materials like PEI formulation or ral GRAS based formulation covers the inner surface of the PPE

[0135] In some embodiments, the PEI or natural GRAS based formulation is able of being applied to cover or surround the mouth or nose.

[0136] In some embodiments, the application to the nose is facilitated by regnating a cotton-based vehicle with the natural GRAS based or PEI based formulation mounting it on a nasal clip such as those used most commonly in the prevention of snoring. ous exemplary embodiments of such a clip are made of plastic, silicone, or other material ndly to mucus membranes, and are capable of acting as a scaffold to deliver the prophylactic ral GRAS based or PEI based formulation.

[0137] In some embodiments, the smart mask and PEI formulation is capable of g combined into a “kit” format, produced at large enough scale and mobilized quickly ugh to be distributed to both healthcare settings but also to the general civilian consumer ng times of pandemic. In such trying times, the supply of resources for both treatment of protection from viral infection can become quite limited. It is imperative in such times to be able to provide such a “kit” solution that is able to be distributed widely and applied easily to reduce the rate of spread of infection and supplement the ability of persons to fight infection.

[0138] In yet another application of the current invention, it has been scientifically proven that the small viral aerosol droplets enter the body predominantly through the nose d ing breathing and to a lesser degree through the mouth. A large body of literature on the hanism of viral transmission exists in pandemic influenza viruses. The current erstanding is that the virus preferentially binds to the a-2,6 glycan receptors in ciliated cells he upper respiratory tract, namely the nasal turbinates, pharynx and larynx, as suggested by pas et al. In a recent study in ferret and human models, Richard et al demonstrate that virus n respiratory droplets and aerosols are also expelled in large part from the nasal respiratory helium. With the understanding that the nasal respiratory epithelium is key to both infection transmission, some embodiments of the present invention combined both a nasal insert a mask in a “kit" to maximally limit infection and expulsion of viral particles through iratory droplets.

Some embodiments of the present invention address the nose and the mouth in the form “Kit" wherein the nasal insert and mask are packaged together.

[0139] In some embodiments of the current invention the nose insert shell is a cal shape wherein the two shell inserts are attached by an extension composed of the same erial of the shell that stretches across the columella. Such connection ensures the inserts do extend too far into the nasal cavity and are easily removed.

[0140] In some embodiments of the current invention, the nasal shell is a conical pe consisting of smooth sides and a grid or plurality of holes in the end. The smooth sides vide isolation between the shell, shell contents and mucus membrane. The gird or plurality oles permit air flow while retaining the media within the shell and preventing any transfer ng breathing.

[0141] It is medically proven through recent studies that infection through nasal lation is 10,000 times more than through the mouth. Therefore, it is prudent to protect the al system with an active anti-viral device capable of capturing the virus particles floating e inhaled air. In some embodiments of the current invention, the nasal shell and inserts are efficiency filters. Examples of high efficiency filter are 3M 2200 series. Such filter media of the present invention include anti-viral- anti-microbial gels, liquids and vapor and the like. In some embodiments the conical shell is impregnated with metal cations known to have antiviral properties such as copper or silver, to further enhance anti-viral properties of the system.

[0142] In some embodiments of the current invention, the nasal shell and inserts are open cell foam. Examples of open cell foams are foams with cells at or less than 2mm in di meter. Such filter media include treatments of the present invention and anti-viral- antirobial gels, liquids and vapor and the like known or determined to have anti-viral perties.

[0143] In some embodiments of the present invention the filter media of the nasal l inserts are electrostatically charged or treated by electrostatic/plasma, bi-polar ionization ma, corona or others of the present invention. Such treated filter media shell inserts will ure virus and microbials. This combination of electrostatically charged media and antis, ant-microbial components of the present invention create a capture and kill nasal cavity l and insert.

[0144] In some embodiments of the present invention, the filter media of the nasal rt are “stacked 1¹” in layers. In various embodiments such layers have discreet properties bining filter, capture, kill, and therapeutic components. Various embodiments of such ked layers are comprised of cotton, textiles, open cell foam, cellulose, 3M 2200 series, r 3M filter media and the like.

It is known that viral concentration can rise in home, office or industrial air ditioning systems. Further to some embodiments of the present invention, these fillers, tments and coatings applied to large-scale air-conditioning system provide Block, Capture Kill properties on a large scale. The treatment and coaling process of the filter media in e embodiments are automated to occur at predetermined times insuring fresh clean air.

Additionally, in some embodiments, filter media, as is used in 3M respirator masks are rporated as one or multiple layers, fashioned to fit into the conical structure, to provide tional fillration capacity of small droplets containing viral particles. Some embodiments hese stacked filler components are porous in nature to enable the user to continue breathing ly.

These stacked filter components do not inhibit the ability of the user to breath freely. [ 0145] In some embodiments of the present invention, the media of the nasal shell insert is prefabricated to specific dimensions and ni some such embodiments are directly applied to the nasal shell wherein there is a component to component tolerance fit. This component to component fit prevents the media from movement within the insert shell during breathing. Various embodiments of said nasal shell inserts are Plasma treated cotton, open cell f m. PU, TPR, TPE, Textiles and the like.

[0146] In some embodiments of the present invention the nasal shell and inserts ain Copper or Silver.

[0147] In some embodiments of the present invention, the nasal insert is a conical pe comprised of slots or holes around the circumference and at the base. Such slots and or s enable the media to be retained in the insert shell while allowing air to pass when thing.

[0148| In some embodiments the nasal insert is a screen attached to the nasal ance. In various embodiments the screen is one or several layers each having specific perties. Examples are layer I collects dust, pollen and larger airborne particles wherein the ond layer includes treatments of the present invention and a third layer includes antierial, anti-viral coatings of the current invention.

|0149] In some embodiments of the present invention, the nasal insert shell vides a functional barrier between the nasal cavity and the filtration/anti-viral, antirobial components. These components are not in direct contact to die nasal cavity as such insert shell performs the functionality of a ‘liner* isolating the active ingredients from ct contact within the nasal cavity.

[0150] In some embodiments of the present invention, the nasal insert shell is ufactured utilizing materials well known such as Silicones, thermoplastics and'or mosets which contain Copper, Silver or the ions. In some embodiments said Copper and-'or er are infused into the raw material prior to molding, or in other various embodiments are yed or misted post manufacturing,

[0151] In some embodiments of the present invention, all or some of the ponents albeit the mask, nasal inserts and the various media are Plasma treated and apsulated in barrier packaging within a nitrogen rich environment or an insert gas. In variousembodimentssuchpackagingareconstructedoffilmorbarriercontainerssuchasfoils,knowgasbarrierplasticsandthelike.Theseconditionsenhanceandextendtheefficacyandshelflifeofthecomponents. [0152] In some embodiments of the current invention, the shell“pre-insert” iscomprisedofacopperorsilver“mesh”whereintheinsertisindirectcontactwiththemesh dshell.Variousembodimentsoftheshellinsertarecomprisedofanycombinationwherein insertinsomeembodiments isasinglecomponentorin otherembodimentsismultiple ponents ofthe presentinvention includingbut not limited to plasmatreated activated on,proteincelluloseandthelike. [0153] Insomeembodimentsofthepresentinvention,theshellinsertsare“fluffy” onthathasbeenplasmatreated. [0154] Insomeembodimentsofthepresentinvention,thenasalshellisfittedwith rts which are chosen forspecific functionality. Functionality, in various embodiments udesbeingforanti-microbial,anti-virusorothermedicinalaspectssuchasantihistamines respiratorytreatmentsadministeredthroughthenasalcavity. [0.155] In some embodiments ofthe present invention, the nasal insert shell is ufacturedinvarioussizestofitwomen,menchildrenorasanexamplesmall,mediumand etocoverawiderangeofnasalcavitydimensions. [0156] In some embodiments, the components of the current invention are viduallypackagedorinotherembodimentsarepackagedasa“kit”.Insomeembodiments componentsorkitsare“privatelabeled”andsoldorprovidedtopeopleatthe“pointof ”. SuchPOUincludesanylocationwhereintherearegatheringsofpeople.Examplesare lanes,trains,buses,sportingeventsandthelike.The“kits”containingthenasalshelland kwiththeanti-virus,anti-microbialcomponentsareakeyenablerforthesegatheringsto urinasafeenvironment. [0157] In another embodimentofthepresentinvention, virus andmicrobes are wntoenterthroughthemouth.Ediblelozengesordissolvingstripsofthepresentinvention prisedofGRAS components(GenerallyRegardedasSafe)areeffectivepreventionfor sandmicrobials. [0158] Inanotherembodimentofthepresentinvention,asviralparticlesarealso wn toinfecthoststhroughreceptors inthepharynx and larynx oftheupperrespiratory tract, edible lozenges or dissolving strips of the present invention comprised of GRAS components (Generally Regarded As Safe) are an effective preventive measure. In some embodiments such lozenges or strips are incorporated into “kits” which also include the nasal insert and mask components. Such a kit is apable of providing maximal protection from viral infection and also expulsion of virus laden droplets or aerosols from an infected host.

[0159] In some embodiments of the current invention, “It is preferable to use an open cell Reticulated polyurethane foam of low density and Light weight. Reticulating the foam allows for managed cell numbers , it’s design, shape and location within the foam structure.

[0160] In some embodiments the foam is a polyether or polyester. In some embodiments the porosity of such foam ranges from 10 - 100 pores per inch ( ppi). Dependent on the ppi selected , the foam structure is capable of allowing for high breathability, and retention of antiviral/ antimicrobial spraying as well as plasma Cationic and electrostatic treatment. Magnesium stearate is sometimes added during the foaming process of open cell to help maintain its structure. Managing The MgST content can enhance and extend the plasma charges. In addition such foam structures have low odor and are capable of being made to fit certain medical specifications. These foams are commercially available and capable of being supplied and fitted for the nasal device application.

[01611 In some embodiments, A formulation consists essentially of a high water soluble onic ingredients , a surfactant preferably zwitterionic surfactant and antiviral/ antimicrobial edients that are water soluble and approved for use in cosmetics ,skin care and topical ications.

[0161] In some embodiments Cationic ingredients are sourced preferably a quaternized olymer specifically a quanterized copolymer of vinylpyrrolidone with er dimethylaminoethyl methacrylate or vinylimidazole with wide ranges of charge densities in eous solution. One example of a family of such products is commercially available under the e name Luviquat from BASF.

[0162] In some embodiments, Cationic material is based on cetrimonium chloride . It is a quaternium -6 product and exist commercially as family of products under trade name of yquart from BASF.

[0163| In some embodiments, one example of cationic material is based on quaternium 37 with Dicaprylyl carbonate and lauryl glucoside commercially available under the e mark as Cosmedia from BASF. The function of these cationic ingredients are to help attracting holding and interfering with the anionic outer envelope of the virus

[0164] In various embodiments, Polyquaternium based ingredients are used separately combination with each other depending on the rheology and the intensity of the cationic ges needed in the aqueous solution and the ultimate application. |01651 in some embodiments, all these ingredients are used in the cosmetics , in skin care applications & topical application.

[0166] In some embodiments, A water soluble surfactant is used in cosmetics, skin care and topical applications. A preferable surfactant that fits this application is a zwitterionic surfactant from the family of Cocamidopropyl betaine. Cocamidopropyl betaine is water soluble ,safe to use with cosmetics ,skin care and topical applications . Its function in this application is to interfere with the Envelope of the viruses and help inactivating it.

[0167] In some embodiments, Two antiviral / antibacterial ingredients are derived from ral resources that are water soluble and used in topical as well as nasal applications : Malic acid cod trypsin. Both acids are water soluble for use in topical as well nasal application. Studies e been done previously and renewed to verify its efficacy. The combinations of these antiviral pounds provide a mechanism to attract and hold the virus while the surfactant interferes with envelop and finally these antiviral compounds completes the viral and bacterial inactivity.

[01671 In some embodiments, nonessential or inactive ingredients are added to improve smell, the foaming capability and a biocidal to protect the water solution. One example is ng a very small amount of silver ions.

[0168] In some embodiments, there are key elements of the current invention. uctural Material Molded fiber Integral elastomer lining Impregnation of material with cationic polymers: PEI/starch Anti-viral agent

Silver Copper ions Replaceable Breathing Filters positioned at proximity of nose /mouth Electrostatically/ catatonically charged Treated nanofiber clear textile is capable of being integrated with the mask body to cover the area of nose and mouth for see through 3D printing/picture for personal ized mask and nose device se devices Flexible conical based plastic inserts in nose Breathable treated membranes inserted in the conical flexible nose device. Also treated membrane on the nose tip from the outside or inside the nose attached to the cone Conical structure to carry acti ve membranes o Cationic o Electrostatic o Anti-viral Material on cotton Open cell foam Nanofiber membrane plasma treated membrane replaceable

Antimicrobial antiviral formulation

• GRAS based formulation based on live cationic materials with active surfactants and anti-viral components

• PEI/cationic starch for spraying outer surfaces including masks and PPE especially molded fiber Cosmedia cationic compounds, malic acid and cocamidopropyl betaine is most optimal Can be used in nose inserts and masks sma electrostatic surface treatment Corona, cold plasma treatment Depositing Electrostatic charges on the PPE surfaces long lasting repelling of virus and micro particles Creating active Cationic charges on surface to capture and lock the viral envelope Need recharging after 48-50 hours of air exposure. Need vacuum packaging for storing Applied in a second Metallic stearates either blended in or surface coated on PPE

BREIF DESCRIPTION OF THE DRAWINGS

[0169) Figure A shows a non-limiting example of the mask of the present ntion. Some features include the modular design utilizing a soft interface for wearer mfort, molded fiber shell, replaceable filter media, detachable filter media housing, aded removeable fi lter housing cap and back flow valves.

[0170] Figure B shows a non-limiting example of the media of the present ntion wherein specific types of media can be combined withi n the capsule.

[0171] Figure C shows a non-limiting example of the molded shell and comfort r. 101721 Figure D shows a non-limiting example of the modular mask with a multi- layer liner.

[0173| Figure E shows a non-limiting example of a coated mask shell.

[01741 Figure F shows a non-limiting example of the mask shell and injection lded filter media capsule.

[01751 Figure G shows a non-limiting example of the mask which incorporates ygen supply.

[01761 Descriptions of unnecessary parte or elements may be omitted for clarity conciseness, and like reference numerals refer to like elements throughout.

[01771 Features of the present disclosure will become more fully apparent from the owing description and claims. It will be understood these embodiments and claims depict y certain embodiments in accordance with the disclosure and, therefore, are not to be sidered limiting of its scope. An article, system, formulation or method according to some he described embodiments can have several aspects, no single one of which necessarily is ly responsible for the desirable attributes of the article, system formulation or hod. Included here for reference are non-limiting tables providing a descriptive summary ome polymers within the present inventive concept known to be capable of inactivating or ucing microorganisms (Figure G 1 through G7).

[0178| Figure H is a non-limiting example of high cationic material like PEL

[0179| Figure 1 1-3 is also a non-limiting example of PEL

[01801 Figure J is a non-limiting example of interactions with various viral eins.

[0181] Figure K is a non-limiting technology platform of the present invention.

[0182| Figure Land M shows the efficacy of do it yourself (D1Y) masks at filtering viral sized particles, with percent of particles filtered on the horizontal axis and material on the vertical axis.

[0183] Figure N and O shows the shell with the connection and the shell insert aining the media of the present invention. WHA TIS CLAIMED IS:

Claim 1

An antiviral, Anti-microbial protective system designed to Block Capture and Kill enveloped viruses. This system is composed of PPE including but not limited to mask, nasal inserts, nasal screens or nasal filters, air filters, surgical gowns, coverings and the like accompanied partially d folly with an electrostatic/Plasma charge treatment and antiviral coating. These coatings treatments are capable of maintaining and renewing the antiviral capability of the PPE and nding its usage time before replacement.

The PPE further comprising: A Mask Shell of modular design, a detachable housing filtration media, one-way valves for inhale and exhale isolation, capture, capture and kill elope virus, bacteria and microbes.

1. The PPE of Claim 1 , wherein the Mask shell and filtration media housing are fabricated from molded plastic. Examples are Polypropylene, Polyethylene, ABS, Thermoplastic elastomers, thermoplastic rubbers, Exxon Vistamax, closed cell foam and the like.

2. The PPE of Claim 1, wherein the mask shell is constructed from engineered Polysaccharides or cellulose molded fiber or the combination thereof

The PPE of claim 1 wherein the mask is constructed of nano synthetic fibers.

3. The PPE of Claim 1, wherein the shell is fabricated with textiles.

4. The PPE of Claim 1, wherein the Mask shell covers the mouth, nose, cheeks, ands and extends ear to ear.

5. The PPE of claim 1 wherein electrostatic/Plasma treatments and chemistry of Block, Capture and Kill are universally applied to all types of PPE.

6. The electrostatic/Plasma treatments and chemistry of the current invention are universally applied to all air filtration systems, large and small for Block, capture and kill properties.

7. The PPE of Claim 1, where in the mask covers the mouth, nose, cheeks, extends ear to ear and attaches to the back of each ear

8. The PPE of claim 1 wherein the mask only covers the nose and extends to attach to the back of the ears or stretched around the back of the head. 9. The PRE of Claim 1 , wherein the inside includes a higii cationic material like PEI based coating conferring cationic activity to the surface of the PRE

10. The PPE of claim 1 wherein the mask is a surgical mask pre-treated with corona, atmospheric or chemical plasma Bi-Polar ionization, cold plasma and coated with antiviral, Anti-microbial liquids of the present invention by spray or misting.

1 1. The PPE of claim 1 wherein the mask is a surgical mask treated with anti-viral, antimicrobial liquids of the present invention and post treated with Corona, atmospheric or chemical plasma, bi-polar ionization.

12. The system of claim 1 wherein the PPE is a surgical mask wherein step 1 the mask is automatically fed into either single file or bulk configuration. Step 2 the mask(s) are delivered to a corona, atmospheric or chemical plasma treater, step 3 the mask(s) are transferred to an area for spray or misting with liquids of the present invention. Step 4 the mask(s) are transferred to a drying station, step 5 the mask(s) are released from the system.

13. The PPE of claim 1 wherein the mask frame is injection molded thermoplastic or silicone composite containing silver or copper powder. Said mask may be corona, atmospheric or chemical plasma treated, sprayed or misled with liquids of the present invention to create an sustainable active anti-virus, anti-microbial surface.

14. The PPE of claim 1 wherein cationic treatments are preserved in MAP (modified atmospheric packaging), gas barrier plastic, and nitrogen rich environments or vacuum type packaging.

15.

16. The PRE of Claim 1, wherein the GRAS based coating covers the inside

17. The PRE of Claim 1, wherein the GRAS based coaling covers and/or surrounds the nose and mouth

18. The PRE of Claim 1 , wherein the Mask shell has a “soft” interface surface between the shell and face.

19. The PRE of Claim 1, wherein the Mask shell has an airtight seal between the face and the mask. Examples of materials that are capable of creating such a seal are thermoplastic elastomers, thermoplastic rubbers, Exxon Vistamax, closed cell foam, Seran film, Silicones’ and the like. 20. The PPE of Claim 1, wherein the components are washable, sterilizable and reusable.

21. The PPE of Claim 1, wherein the mask has a “soft seal” portion between the face and the mask.

22. The PPE of Claim 1, wherein the mask seals upon the face to prevent air leakage.

23. The PPE of Claim 1 , wherein the mask filter media is replaceable and capable of being embedded into the detachable housing.

24. The PPE of Claim 1, wherein the filter housing accommodates multiple membranes each with specific properties.

25. The PPE of Claiml, wherein at least one of the mask filter membranes is a “nonstick” material.

26. The PPE of Claim 1, wherein at least one of the membranes is sprayed with antimicrobial, anti-viral liquids containing the combination of specially electrostatically charged materials with metal ions of silver and copper products.

27. The PPE of claim 1 wherein the mask shell and filter media housing are re-useable by applying materials with metal ions of silver and copper.

28. The PPE of claim .1 wherein the efficacy is increased by applying a branched polyethyleneimine/ BPEI cationic polymer coaling.

29. The PPE of claim 1 wherein the coatings can include N Ndodecyl methyl PEI, N-N Hexyl methyl PEI,N dimethylhexdecyl amine PEI and other derivatives of the PEI polymer

30. The PPE of claim 1 wherein the branched PEI is crosslinked/semi crosslinked with phthaladehyde base and PEG based crosslinkers or PEG to increase its viral inactivating potency.

31. The PPE of claim 1 wherein the PEI/BPEI viral inactivating potency is increased in the presence of colloidal silver and or colloidal copper in Ionic form.

32. The PPE of claim 1 wherein the membrane with high cationic material like PEI is acidic.

33. The Mask of claim 1 wherein at least one of the membranes block particles less than 0.03 microns - the size of viral particles - to particles ranging from 0.03 - 5 microns the size range of bacteria 34. The PPE of claim 1 wherein the PPE is constructed with nano synthetic fibers creating clear see through breathable structure.

35. The PPE of claim 1 wherein at least one of the mask components includes activated carbon entangled/coated with a protein fibril base material be it in the form of a discrete membrane or loose beads material. These materials are capable of being activated by the addition of high cationic material like PEI molecules or by cold plasma, both of which create reactive, cationic species and enhance its antimicrobial/antiviral capabilities against the cell membranes and intracellular biochemical processes of these pathogens. In addition, these fibril proteins of some embodiments contain a concentrated amount of organic acids like citric or ascorbic to further its antiviral efficacy. The mask is capable of being activated by cold plasma at “stations” established in highly trafficked public spaces which offer an enclosed housing for treatment and activation of masks in a quick manner in order to provide convenient but long-term protection to wearers of the PPE.

36. The PPE of claim 1 wherein a combination of Cocamidopropylbetaine and a cationic surface are applied.

37. The Mask of claim 1 wherein al least one of the membranes contains “Zeolite” particles with the capability of selectively providing higher concentration of oxygen during the inhaling process.

38. The Mask of claim 1 wherein a small battery-operated oxygen concentrator either connected to or integrated with the mask is capable of providing the fresh oxygen supply needed. Some embodiments of this system are capable of being carried on the belt or helmet. Some embodiments are apable of being connected to the mask by external tube tightly fitted to the body of the mask. In some embodiments such zeolite portable oxygen concentrator is capable of being worn at the waist and connected to the mask through tubing

39. The Mask of claim 1, wherein a zeolite portable oxygen concentrator is worn at the waist and pure oxygen is delivered through tubing to the mask. Some embodiments of said zeolite portable oxygen concentrator are outfitted with an aluminum layer to act as a desiccant and improve the longevity of the zeolite molecular sieve. 40. The Mask of claim 1 wherein oxygen is conveyed from a canister to an inlet on the mask.

41. The container of claim 1 which is attached to a belt or secured to the wearer of the mask.

42. The Mask of claim 1 wherein the membranes are capable of being used separately or in combination to provide desired filtration properties.

43. The Mask of claim 1 wherein the membranes of the current invention are designed to fit with the detachable housing.

44. The Mask of claim 1 wherein the filler media/membrane housing and shell is threaded for assembly/disassembly. load/reload of membranes of the current invention.

45. The Mask of claim 1 wherein the filter media/membrane housing is a “snap Fit” for assembly/disassembly, load /reload of membranes.

46. The Mask of claim 1 wherein the molded shell includes a series of openings for air to pass through.

47. The Mask of claim 1 wherein the filter membranes of the current invention are mechanically attached or adhered to the outer surface of the shell.

48. The Mask of claim 1 wherein the filter membranes are attached or adhered to the inside surface of the shell.

49. The Mask of claim 1 wherein the filter membrane is a “wipe” attached to the inner or outer surface of the mask.

50. The Mask of claim 1 wherein the “wipe” is inserted into the shell of foe mask.

51. The Mask of claim 1 wherein foe “wipe” is foe mask.

52. The Mask of claim 1 wherein foe wipe is on the outside of the mask.

53. The mask of claim 1 wherein foe shape of foe mask is determined through a photograph of a subject translated through software and 3D printed.

54. The mask of claim 1 wherein the shell is comprised of three elements. The shell is molded fiber including a soft polymeric seal to foe face and a transparent membrane allowing air flow.

55. The mask of claim 1 wherein foe nose and mask are separate components. The nose is covered by one mask and the mouth is covered by another. Said combination provides discreet more effective protection by means of better fit and specific properties of the current invention.

56. The mask of claim 1 wherein only the nose is covered.

57. The mask of claim 1 wherein only the mouth is covered.

58. The kit of claim 1 wherein the there is a treated nose cover, mouth cover and spray bottle of anti-septic, anti-bacterial or anti-viral coating material.

59. The Mask of claim 1 wherein the plasma electrostatically charged membrane captures nano sized particles in the range of 25 nanometers to 150 nanometers.

60. The Mask of claim 1 wherein the filter media/membranes is sprayed with materials that kill enveloped virus containing active ingredients of high cationic materials like PEI based material that in some embodiments are crosslinked and accompanied by colloidal silver, colloidal copper, and the like.

61. The Mask of claim 1 wherein the filter media-membranes is sprayed with materials that kill enveloped virus containing active ingredients of PVP based material

62.

63. The Mask of claim 1 wherein at least one added membrane is infused with copper ions and impregnated with a higii cationic material like PEI based material

64. The Mask, of claim 1 wherein the impregnated copper and high cationic materials like PEI is capable of being reactivated by frequently spraying high cationic materials like PEI on the surface of the membrane

65. The Mask, of claim 1 wherein it is frequently treated with cold /chemical plasma to maintain a workable ionic surface on the outer layer of the mask.

66. The Mask of claim 1 wherein the mask is exposed to electro Plasma for sterilization and re-activation of anti-microbe and Anti-viral properties. m 2 An antimicrobial/ Anti-viral formulation designed to capture and kill pathogenic microbes present on inanimate surfaces, which commonly serve as vectors for viral transmission including personal protective equipment (PPE).

1. The Personal Protection Equipment of claim 1 and 2 wherein the PPE is a mask, gown, gloves or other PPE.

2. The PPE of claim 1 and 2, wherein the PPE is coated with anti-microbial compounds

3. The PPE of claim 1 and 2 wherein the PPE surface is catatonically charged with the PEI sprayed material and sprayed with metal ions of silver and copper products creating an antimicrobial capability.

4. The PPE of claim I and 2, wherein the PPE surface is treated with a solution containing polyethyleneimine in branch or linear forms, either of high molecular weight (25kDa) or low molecular weight (1.8 kDa),

5. The PPE of claim 1 and 2 wherein the PEI/BPEI are N Ndodecyl methyl PEI, N- N Hexyl methyl PEI,N dimethylhexdecyl amine PEI and other derivatives of the PEI polymer.

6. The PPE of claim 1 and 2 wherein the PEI/BPEI is crosslinked/semi crosslinked to increase its viral inactivating properties.

7. The PPE of claim 1 and 2 wherein the PEI/BPEI inactivating potency is increased in the presence of colloidal silver and or colloidal copper in ion form.

8. The PPE of claim 1 and 2 wherein the substrate is coated with branched PEI, crosslinked/ semi crosslinked with phthaladehyde base and PEG based crosslinkers or others to increase potency from 4 to 10 log or higher when colloidal silver is added.

9. The PPE of claim 1 and 2 wherein the PEI, colloidal silver mix is acidic to a pH of 3-4.5 and impregnated into polysaccharide or cellulose fibers coated onto substrates of fibers, plastics or textiles.

10. The PPE of claim 1 and 2 wherein the filter system composed of activated carbon and an acidic protein fibril membrane is coated with a PEI mixture to enhance the cationic nature of the fibril membrane. 11. The PPE of claim 1 and 2 wherein the PPE air filtering membrane including a fibril protein-based membrane is coated or impregnated with PEI/BPEI, crosslinked and mixed with colloidal silver and or colloidal copper ions.

12. The PPE of claim 1 and 2 wherein the mix of claim 11 is coated onto molded fiber, plastics, nonwovens, rubbers and textiles.

13. The PPE of claim 1 and 2 wherein the mix contains Branched PEI, crosslinked with phthaladehyde base and PEG based crosslinkers to increase the potency from 4 to 10 log or higher with the addition of colloidal silver.

14. The PPE of claim 1 and 2 wherein the said antiviral PEI based formulation contains other additives typically used in cosmetic medical applications like foaming, gelling etc., without impacting the antiviral potency of the key active ingredients

15. The PPE of claim 1 and 2 wherein at least 1 filtration membrane is treated with the

PEI matrix m 3 formulation applied to claim 1 and 2 wherein PEI/BPEI, surfactants, zwitterionactants, stabilizers, metal ions in colloidal or other ionic forms are used to enable an anti¬robial, anti-viral formulations that is capable of being applied by standard coating andying or impregnation techniques to the targeted PPE.

1. The PPE of claim 1 , 2 and 3 wherein the PEI formulation is applied as a coating, spraying or impregnation.

2. The PPE of claim 1, 2 and 3 wherein the PEI material is in an acidic media.

3. The PPE of claim 1, 2 and 3 wherein the PEI material is crosslinked or partially crosslinked.

4. The PPE of claim .1, 2 and 3 wherein the base is a PEI/branched polyethyleneimine BPEI cationic polymer or cationic starch.

5. The PPE of claim .1,2 and 3 wherein the formulation contains colloidal silver, colloidal copper in ion form.

6. The PPE of claim 1, 2 and 3 wherein the membranes include fibril proteins.

7. The PPE of claim 1, 2 and 3 wherein the formulation is water based. 8. The PPE of claim 1 , 2 and 3 wherein the formulation is a spray, coating or apable of impregnation.

9. The PPE of claim 1, 2 and 3 wherein the PEI formulation is added it to activated carbon with an acidic protein fibril.

10. The PPE of claim 1, 2 and 3 wherein the Activated carbon originates as spent coffee grounds.

11. The PPE of claim 1, 2 and 3 wherein the membrane is activated carbon or zeolites particles of different particle size and surface area.

12. The PPE of claim 1, 2 and 3 wherein the addition of citric or ascorbic acid to the formulation lowers the ph. And acid components are capable of being added as powder in a separate membrane or sprayed on the outer layer of the mask with a high concentration solution.

13. The PPE of claim 1, 2 and 3 wherein the fbrmulation(s) are capable of being applied by spray, dip or other coating techniques.

14. The PPE of claim 1, 2 and 3 wherein the formulation is water based and is capable of being applied and re-applied.

15. The PPE of claim 1, 2 and 3 wherein the formulation contains Zwitterion surfactants with or without colloidal silver or colloidal copper or PEl’sm 4

The water-based formulation of polyquatemium-37, and Dicapiylylbonate, and Lauryl Glucoside, a high-performance Cationic liquid Dispersion Polymer, bymple Cosmedia Triple C, combined with Cocamidopropylbetaine, and Malic acid. Totalcentration of active ingredients in the range of 10 to 15% and can be considered a GRAS-Viral material. These components are utilized in cosmetics and skin contact.

The formula of claim 4 can containing Metal Stearates, The articles ofm 1 is pre-treated with Magnesium, Calcium and/or Zinc stearates to stabilizetrostatic/Plasma charges and anti-viral properties are intensified and retained. The coating of claim 1 and 4 wherein Metal Stearates, Magnesium, Calcium and Zinc stabilize electrostatic/Plasma charges and anti-viral properties are intensified and retained.

The article of daim 1 and 4 wherein, metal stearates are melt blended with polypropylene wherein when the material is electrostatically charged, it is stabilized, nsified and prolonged.

The article of daiml and 4 wherein melt blended metallic stearates, coated, impregnated plasma treated substrates will stabilize the electrostatic/plasma and Cationic charges and nd its effectiveness for a longer period of time.

The article of claim 1 and 4 wherein, metallic stearates of magnesium, calcium and Zinc are ied on substrates by coating techniques, including coating water-based dispersions or merging etc. In some embodiments the deposition is in the range of 0.5 -3 percent of the allic stearate on or inside the structure of the substrate. The treated substrate is dried prior to trostatic plasma treatment.

The article of claim 1 and 4 wherein, metallic stearates of magnesium, calcium and Zinc are ied as a pre-treatment on substrates by coating techniques, including techniques for coating er-based dispersions, submerging and other techniques including the application of Vacuum to re the penetration of the treatment into the inner structure of the substrate. In some odiments the deposition is in the range of 0.5 -3 percent of the metallic stearate on or inside or ide of the substrate. In some embodiments the treated substrate is dried prior to trostatic/plasma treatment In some embodiments thermoplastic materials used ake weaved nano fibers are blended with metallic stearates prior to the weaving process & re the electrostatic/ plasma treatment to extend electrostatic duration and intensity.

The article of claim 1 and 4 wherein the coating of the metallic stearate(s) is applied to en and/or non-woven PRE to increase the efficiency and duration of the electrostatic/ tment.

The article of claim 1 and 4 wherein metallic stearate(s) is added to thermoplastic polyesters polyolefins as a pre-treatment for plasma and electrostatic treatments. m 5 formulation based on high cationic material like PEI, Cationic starch, high cationic actants and/or silver copper colloidal is capable of being coated on substrates to reduce / tivate viral potency 1. A water-based formulation containing a high cationic material-based polymer with /without silver copper ions is capable of being applied on porous and nonporous surfaces

2. A water-based formulation containing high cationic material-based material with silver / copper ions capable of being applied on medical devices used in for respiratory protection or support in both hospital and non-hospital settings

3. A water-based formulation containing High cationic material like PEI with silver / copper ions capable of being applied on other inanimate surfaces in the healthcare delivery setting, nursing homes, or other high-risk areas for viral transmission

4. A PEI/BPEI based formulation containing appropriate concentration of both PEIs and Silver/copper ions to be modified to stick effectively as a coated film, to substrates and provide continuous antiviral protection for an extended period

5. A PEI/BPEI based formulation of claim 4, containing some combination of silver/copper ions, PEIs, lectins and other antiviral components, capable of being applied to inner and outer surfaces of cloth face coverings recommended by the CDC to be worn by the general public, to offer enhanced protection for the population at large who due to supply chain shortages are forced to wear face coverings that do not offer a complete seal against microbial/viral particles.

6. The application of claim 1 ,2,3,4 and 5 utilizing electrostatic spray or mist by handheld or stationary systems.

7. The transportation, storage and application of claim 5 in bulk packaging or metal drums.

8. The composition of the anti-viral, anti-microbial liquids in concentrate form wherein the concentrate is diluted with water at the point of use or application. m 6 high purity cationic polymer like polyethyleneimine (PEI) or natural GRAS basedmulation delivered as liquid solution containing silver ions, copper ions with the final oidal ion content being within a range of 0 - 2% of the total formulation m ? A high purity medical/pharmaceutical grade polyethyleneimine (PEI) or natural GRAS based formulation delivered as a liquid solution containing surfactants, zwitterion surfactants with the final surfactant content being within a range of 0 - 30% of the total formulation Claim 8

A high purity medical/pharmaceutical grade polyelhyieneimine (PEI) or natural GRAS based f mulation delivered as a liquid solution containing lectins m 9 gh purity medical/pharmaceutical grade polyethyleneimine (PEI) or natural GRAS based mulation delivered as a liquid solution containing dexamethasone, gene therapies, and other tives with anti-inflammatory properties m 10 gh purity medical/pharmaceutical grade polyethyleneimine (PEI) or natural GRAS based mulation delivered as a liquid solution containing vitamin C, a known antioxidant with mune modulatory and viricidal properties m 11 gh purity medical/pharmaceutical grade polyethyleneimine (PEI) or natural GRAS based mulation delivered as a liquid solution containing cyclodextrin to enhance solubility and vailability of active ingredients while providing additional anti-viral capabilities by eting and sequestering lipid components of enveloped viruses. The formulation will ain a range of 0 - 30% w/v cyclodextrin, including B-cycyclodextrin or modified B- odextrin. m 12 gh purity medical/pharmaceutical grade polyethyleneimine (PEI) or natural GRAS based mulation delivered as a liquid solution containing Octenidine HC1 m 13 gh purity medical/pharmaceutical grade polyethyleneimine (PEI) or natural GRAS based mulation delivered as a liquid solution containing derivatives of licorice root - a GRAS bal supplement -incorporated in ultrapure, pure or intermediate formats from purification he bulk licorice root. Such licorice root derived compounds include Glycyrrhizin (GL) and -Glycyrrhetinic acid (GA), both of which have been demonstrated to have an anti-viral hanism of action which includes inhibition of viral attachment and replication while also boosting the function of the innate immune system. The formulation will contain a range of 0 - 10% of licorice root derivatives, including GL, GA, or others. In some embodiments the licorice itself is Plasma treated to add cationic charges

Claim 14

A high purity medicaVpharmaceutical grade polyelhyneimine (PEI) or natural GRAS based f mulation delivered as liquid solution containing highly bioavail able formulations of CoQ 10, y molecule involved in ATP production, in order to protect against microbially induced dative damage to cells in conjunction with vitamin C while also attenuating deleterious cts of immune activation. m 15 gh purity medical/pharmaceutical grade polyethyleneimine (PEI) or natural GRAS based mulation delivered as a liquid solution containing cationized starch polymers to act as kening agents while also providing additional cationic charges with antiviral properties. me embodiments of the formulation contains a range of 0 - 10% cationized starches.

1. The formulation of claim 4,5, 6, 7, 8, 9, 10, 1.1, 12, 13, 14,15 wherein it is capable of being aerosolized into a fine mist for use in the human respiratory system

2. The formulation of claim 4,5, 6, 7, 8, 9, 10, 11, 12, 13, 14,15 wherein the liquid, gel, cream or foam capable of being utilized as topical skin applications.

3. The formulation of claim 4,5, 6, 7, 8, 9, 10, 11, 12, 13, 14,15 wherein the formulation applied in various formats (gel, dissolvable oral strip, lozenges, nebulized fine mist, etc.) to any part of the human respiratory system from the nasopharynx to the distal airways of the lungs

4. The formulation of claim 4,5, 6, 7, 8, 9, 10, 11, 12, 13, 14,15 wherein the PEI material selected preferably from linear formulations of high molecular weight (25kDa) which have demonstrated antiviral efficacy against both enveloped and non-enveloped viruses and good toxicity profile in vivo at concentrations of 0.5% w/v. In some embodiments Branched or low molecular weight PEI is considered as well should toxicity concerns preclude the use of linear high molecular weight PEI, and low molecular weight branched PEI has demonstrated good antiviral activity with low toxicity (SI = 230) against human coronavirus. 5. The formulation of claim 4,5, 6, 7, 8, 9, 10, 11, 12, 13, 14,15 wherein the formula is further functionalized with chemical additives to further enhance the antimicrobial antiviral effects and impair the viral life cycle. Such modifications include addition of medical cations including by not limited to silver and copper, and weak acids

6. The formulation of claim 4,5, 6, 7, 8, 9, 10, 11, 12, 13, 14,15 wherein the formula contains carbohydrate binding proteins, also called lectins. Such lectins will be generally recognized as safe (GRAS) compounds and will target key carbohydrates that are essential for the viral infection process, including but not limited to sialic acid moieties found to be important in the infectious process of influenza, MERS and other viruses. Such lectins could include wheat germ agglutinin (WGA), Griflithsin - a lectin derived from red algae - or others.

7. The formulation of claim 4,5, 6, 7, 8, 9, 10, 11, 12, 13, 14,15 wherein the formula contains carbohydrate binding proteins, or lectins, purified from raw materials and incorporated in ultrapure, pure, or intermediate forms

8. The formulation of claim 4,5, 6, 7, 8, 9, 10, 1.1, .12, .13, 14,15 wherein the formula contains carbohydrate binding proteins, or lectins, purchased commercially in pure or ultrapure forms

9. The formulation of claim 4, 5, 6, 7, 8, 9, 10, 1 1, 12, 13, 14,15 wherein the formula contains cationic biguanide antiseptic Octenidine HC1, an agent which has been shown to exert dual anti-microbial effect by a) membrane disruption due to its strong cationic charge and b) ability to bind and inactivate pathogenic proteases

10. The formulation of claim 4,5, 6, 7, 8, 9, 10, 11, 12, 13, 14,15 wherein the formulation is capable of being micro encapsulated with standard encapsulating materials and techniques to control its release

11. The formula of claim 4,5, 6, 7, 8, 9, 10, 11, 12, 13, 14,15 wherein the formulation is capable of being delivered via medical equipment and devices used in respiratory applications such as respirators, ventilators, nebulizers, pressurized canisters, masks, personal nasal pumps, sprays and mist bottles

12. The formula of claim 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, .14,15 wherein the formulation is incorporated in the form of dissolvable oral strips, lozenges or the like 13. The formula of claim 4,5, 6, 7, 8, 9, 10, 11, 12, 13, 14,15 wherein the formulation is delivered as a gel or cream to be deposited into the nose. In some embodiments this gel or cream is impregnated onto cotton or another vehicle and held in the nose by a scaffold similar to plastic or silicone nasal clips used to prevent snoring.

14. The formula of claim 4,5, 6, 7, 8, 9, 10, 11, 12, 13, 14,15 wherein the formulation is used in nasal sprays, mists or nasal wash systems.

15. The formula of claim 5, 6, 7, 8, 9, 10, 11 , 12, 13, 14,15 wherein the PEI formulation is delivered in chewable, lozenge, oral strip, oral spray, ointment or gel foam applications

16. The formula of claim 4,5, 6, 7, 8, 9, 10, 11, 12, 13, 14,15 wherein the formulation is delivered at “stations” similar to conventional hand sanitizer delivery stations, wherein the user places their hand or PPE in an aperture and the formula is automatically delivered. These “stations” are capable of being placed in in highly trafficked public spaces. m 16 above described components is capable of being incorporated and packaged into a “kit” is capable of being mobilized and widely distributed to both healthcare settings and theeral populace during times of pandemic, when there is great strain on healthcare resources 1 . An antiviral protection “kit”, combining the PPE of claim 1 , 2, 3, and 4 and the formulation of 4,5,6,7,8,9,10,11,12,13,14 and 15 capable of being packaged and distributed to areas or population with high burden or risk of disease transmission to provide protection against transmission and support the ability of hosts to fight against infection.

Claim 17 medically proven through recent studies that infection through nasal inhalation is 10Kes more than through the mouth. Therefore, it is prudent to protect the nasal system withctive anti-viral device capable of capturing the virus particles floating in the inhaled air.air of conical shaped receptacles (shells) connected at the open end intended for insertion and use in the nasal cavity as PPE. The receptacle having holes or slots to allow air flow through the shell. In some embodiments the receptacle has holes or slots to allow airflow through the shell, and as with anti-snoring nasal clips of a similar design, opens nasal passages to facilitate airflow. In some embodiments inserts are installed within the shell, which impart specific properties such as anti-virus, anti-microbial, filtration or medicinal elements. “It is preferable to use an open cell Reticulated polyurethane foam of low density and Light weight. Reticulating the foam allows for managed cell numbers , it’s design, shape and location within the foam structure. In various embodiments it is a polyether or polyester m. The porosity of such foam can range from 10 - 100 pores per inch ( ppi). Dependent on ppi selected , in some embodiments the foam structure allows for high breathability, and ntion of antiviral/ antimicrobial spraying as well as plasma Cationic and electrostatic tment Magnesium stearate is sometimes added during the foaming process of open cell elp maintain its structure. Managing The MgST content can enhance and extend the ma charges. In addition such foam structures have low odor and in some embodiments made to fit certain medical specifications. These foams are commercially available and ble of being supplied and fitted for the nasal device application. * These inserts are rporated in several layers, each with different functionality. The housing is washable and able while the inserts are intended for single service and replaceable. One example of filtration ia is open cell foam.

1 The articl e of claim 16 wherein the shell is injection molded utilizing Silicone, PP, PE, PU, TPR, TPE, Vistamax, closed cell foam, cellulosic, LCP, thermoplastic and thermoset materials and the like.

2 The article of claim 16 wherein the connection between the receptacles fils across the columella providing for easy installation, removal and limit the depth the shell protrudes into the nasal cavity.

3 The article of claim 1 through 16 wherein the “Kit” includes the nasal insert(shell), mask and functional media are packaged together in a gas barrier, nitrogen rich environment to retain efficacy and shelflife.

4 The article of claim 1 through 16 wherein the nose insert shell is a conical shape and the two shell inserts are connected to each other. Such connection ensures the inserts do not extend too far into the nasal cavity and are easily removed.

5 The article of claim 1 through 16 wherein the nasal shell houses inserts with filtration and anti-viral capabilities. Filtration media includes but is not limited to particulate filters as are used in 3M respirator masks and anti-viral- antimicrobial gels, liquids, vapor and the like. 6 The article of claim 1 through 16 wherein the filter media of the nasal shell inserts are electrostatically charged. This combination of electrostatically charged media and anti-viral, ant-microbial components create a nasal insert capable of capture and kill of viral particles. Such electrostatically charged filter media shell inserts capture virus and microbials. This combination of electrostatically charged media and anti-virus, ant-microbial components create a nasal insert capable of capture and kill of viral particles.

7 The article of claim 1 through 16 wherein the filler media of the nasal insert are “stacked” in layers. In some embodiments such layers have discreet properties combining filter, capture, kill, and therapeutic components. In various embodiments such stacked layers are comprised of cotton, textiles, open cell foam, cellulose and the like. These stacked filter components do not inhibit the ability of the user to breath freely. The “kits” containing the tools to prevent both infection and transmission of pandemic viruses includes the nasal system (housing shell and media insert), mask, and anti-viral oral lozenges/strips are a key enabler to limit viral transmission within large gatherings in public space

8 The article of claim 1 through 16 wherein the media of the nasal shell insert is prefabricated to specific dimensions and is capable of being directly applied to the nasal shell wherein there is a component to component tolerance fit. This component to component fit prevents the media from movement within the insert shell during breathing. Various embodiments of said nasal shell inserts are Plasma treated “Flufly Cotton”, open cell foam. PU, TPR, TPE, Textiles, activated carbon and the like.

9 The article of claim 1 through 16 wherein the nasal shell and or inserts contain Copper or Silver.

7 The article of claim 1 through 16 wherein the nasal insert is a conical shape comprised of slots or holes around the circumference and at the base. Such slots and or holes enable the media to be retained in the insert shell while allowing air to pass when breathing. A thin layer of open cell foam in the end of the cone prevents other filter media from escaping the shell. 8 The article of claim 1 through 16 wherein the nasal insert shell provides a functional barrier between the nasal cavity and the functional insert components. These components are not in direct contact to the nasal cavity as such the insert shell performs the functionality of a “liner” preventing “viral slip”, while isolating the active ingredients from direct contact within the nasal cavity and preventing any deleterious effects of contact of the media with the nasal respiratory epithelium.

9 The article of claim 1 through 16 wherein the nasal insert shell is manufactured utilizing materials well known such as Silicones, thermoplastics and or thermosets which contain Copper, Silver or the ions. In various embodiments said Copper and silver are infused into the raw material prior to molding or sprayed or misted on the articles post manufacturing.

10 The article of claim 1 through 16 wherein all or some of the components albeit the mask, nasal inserts and the various media are in some embodiments Plasma treated and encapsulated in barrier packaging within a nitrogen rich environment or an insert gas. Such packaging in various embodiments is constructed of film, pouches or barrier containers such as foils, know gas barrier plastics and the like. These conditions enhance and extend the efficacy and shelf life of the components.

11 The article of claim 1 through 16 wherein the shell “pre-insert” is comprised of a copper or si Iver “mesh”. The insert is in direct contact with die mesh and shell. In various embodiments the shell insert is comprised of any combination wherein the insert in some embodiments is a single component or in other embodiments is multiple components including but not limited to plasma treated activated carbon, protein cellulose and the like.

12 The article of claim 1 through 16 wherein, the shell inserts is “fluffy” cotton that has been plasma treated.

13 The article of claim 1 through 16 wherein the shell inserts are pre-treated with Cocamidopropylbetaine surfactant licorice. 14 The article of claim 1 through 15 wherein the shell inserts are pre-treated with a GRAS formulation based on Cocamidopropylbetaine surfactant and anti-viral components as previously described, including GL, GA, cyclodextrin.

15 The article of claim 1 through 16 wherein the shell inserts contain copper or silver.

16 The article of claim 1 through 16 wherein the nasal shell is fitted with inserts which are chosen for specific functionality. Some embodiments of Functionality including being for anti-microbial, anti-virus or other medicinal aspects such as antihistamines or respiratory treatments administered through the nasal cavity.

17 The article of claim 1 through 16 wherein the nasal insert shell is manufactured in various sizes to fit women, men children or as an example small, medium and large to cover a wide range of nasal cavity dimensions.

18 The article of claim 1 through 16 wherein the components is individually packaged or packaged as a “kit”. The components or kits are capable of being “private labeled” and sold or provided to people at the “point of use”. Such POU includes any location wherein there are gatherings of people. Examples are airplanes, trains, buses, sporting events, schools and the like. In some embodiments the “kits” containing the nasal shell and mask with the anti-virus, anti-microbial and other components are a key enabler for these gatherings to occur in a safe environment.

19 The article of any of the above claims wherein virus and microbes are known to enter through the mouth. Edible lozenges or dissolving strips comprised of GRAS components (Generally Regarded as Safe) are effective prevention for reduction and or elimination of virus and microbials.

22 The article of claim 1 through 16 wherein the nasal shell is a conical shape consisting of smooth sides and a grid or plurality of holes in the end. The smooth sides provide isolation between the shell, shell contents and mucus membrane. The gird or plurality of holes permit air flow while retaining the media within the shell and preventing any transfer during breathing. 23 The article of claim 1 through 16 wherein the nasal shell and inserts are high efficiency filters. Examples of high efficiency filter are 3M 2200 series. All such filters do not contain fiberglass. Such filter media of the present invention include anti-viral- anti-microbial gels, liquids and vapor and the like.

24 The “kits” containing the tools to prevent both infection and transmission of pandemic viruses includes the nasal system (housing shell and media insert), mask, and anti-viral oral lozenges/strips are a key enabler to limit viral transmission within large gatherings in public space

25 Claim 18

The universal air filter and system wherein the media is plasma treated and coated with anti-bacterial, anti-viral materials of the present invention. Examples can the filter media manufactured by 3M and used in-home air- conditioning systems.

26 The apparatus of claim 17 wherein filter media is mounted to a shuttle or rotary system providing fresh treated media at pre-determined intervals to manage viral concentration in confined spaces.

27 Claim 19

The formula of claim 1 through 18 wherein the article is treated and then coatedh a formula including Glycerol, Trypsin (Gadus Morhua)!, Ethanol (as active anti-viral) er and Menthol (<1 %).

The swab of claim 18 wherein the formula of claim 18 is applied to the nasal .

28 Claim 20

The formulation consisting of waler soluble Cationic ingredients , a surfactant erably zwitterionic surfactant and antiviral/ antimicrobial ingredients that are also water ble and approved for use in cosmetics ,skin care and topical applications. onic ingredients of various embodiments are sourced from the following product families: formulation of claim 20 wherein Cationic ingredients, preferably a quatemized copolymer,cifically a quanterized copolymer of vinylpyrrolidone with either dimethylaminoethylhacrylate or vinylimidazole with wide ranges of charge densities in aqueous solution . a key family of such products is commercially available under the trade name Luviquat from BASF. .

The formulation of claim 20 wherein Cationic material is based on cetrimonium chloride. It is a polyquatemium -6 product and exist commercially as family of products under trade name of DeHyquart from BASF

Th formulation of claim 20 wherein cationic material is based on polyquatemium 37 with aprylyl carbonate and lauryl glucoside. An example of commercially available material er the trade mark as Cosmedia from BASF. function of these cationic ingredients are to help attracting and holding and interfering h the virus anionic outer envelope. formulation of claim 20 wherein Polyquatemium based ingredients used separately or in bination with each other depending on the rheology and the intensity of the cationic ges needed in the aqueous solution and the ultimate application. These ingredients are used he cosmetics , in skin care applications & topical application. water soluble surfactant of claim 20 for use in the cosmetics, skin care and topical ications. A preferable surfactant that fits this application is a zwitterionic surfactant from family of Cocamidopropyl betaine. The surfactants are water soluble ,safe to use with metics ,skin care and topical applications . Its function in this application is to interfere with Envelope of the viruses, exposing the RNA and help to inactivate it. formula of claim 20 wherein Two antiviral / antibacterial ingredients are derived from ral resources that are water soluble, used in topical as well as nasal applications. Two mples are Malic acid and cod trypsin. Both acids are water soluble for use in topical as well al application. These antiviral compounds and combinations thereof with the ability to ct and hold the virus while the surfoctant interferes with the envelop will complete the l and bacterial inactivity. formula of claim 20 wherein other nonessential or inactive ingredients are added to rove the smell, the foaming capability and a biocidal to protect the water solution ne mple is adding a very small amount of silver ions. Inventors):

Said Farha 12 Crestview Dr. Pleasantville, NY 10570

Gerald Hutchinson 1600 Royston Ln. Pflugerville, TX 78660

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Claims

CLAIMS What is claimed is:

1. A composition comprising: a water soluble humectant; a water solvable active agent; and water.

2. The composition as claimed in claim 1 wherein said humectant is capable of absorbing 2-

3 ti its weight of water.

3. The composition as claimed in claim 2 wherein said humectant is capable of retaining wa ithin the composition after the composition is applied to a surface and allowed to dry.

4. The composition as claimed in claim 3 wherein said humectant is capable of absorbing mo e and maintaining said active agent active after the composition has dried on the surface.

5. The composition as claimed in claim 4 wherein said humectant is glycerin.

6. The composition as claimed in claim 4 wherein amounts of said humectant, said active age nd said water are determined based upon the specific properties of said humectant, said act gent, said water, the treated surface or environment, and composition application me ology.

The composition as claimed in claim 6 wherein a ratio of humectant to active agent, and the centration of humectant and active agent in said water determined such that the humectant is a o maintain the active agent in active form after the composition has dried upon a given sur

8. The composition as claimed in claim 7 wherein said humectant is able to absorb moisture after the composition has dried.

9. The composition as claimed in claim 8 wherein the ratios of humectant and active agent and concentration in water are determined based upon the desired length of time in which the acti gent is to remain active on the surface.

10. The composition as claimed in claim 1 wherein said active agent comprises an anti robial.

11. The composition as claimed in claim 10 wherein said antimicrobial comprises an anti s or an antibacterial agent.

12. The composition as claimed in claim 11 wherein said active agent comprises a quaternary am um salt.

13. The composition as claimed in claim 1 wherein said active agent includes a zwitterionic sur nt.

14. The composition as claimed in claim 1 where said active agent includes a cationic starch.

15. The composition as claimed in claim 1 wherein said active agent includes a quaternary am um salt, a zwitterionic surfactant, and a cationic starch.

16. The composition as claimed in claim 1 wherein said active agent includes a quaternary am um salt, and a zwitterionic surfactant.

17. The composition as claimed in claim 1 wherein a ratio of said humectant to said active age 4 to 5 parts humectant to 0.5 to 2 parts active agent.

18. The composition as claimed in claim 17 wherein a concentration of said composition includes approximately 93-95% water.

19. The composition as claimed in claim 17 wherein a concentration of said composition includes approximately 85-90% water.

20. The composition as claimed in either of claims 18 or 19 wherein said composition is fur diluted between 10 and 100 times.