WO2020009920A1

WO2020009920A1 - Foldable box for genetic assessment kit

Info

Publication number: WO2020009920A1
Application number: PCT/US2019/039735
Authority: WO
Inventors: Robin Y. Smith
Original assignee: Orig3N, Inc.
Priority date: 2018-07-06
Filing date: 2019-06-28
Publication date: 2020-01-09

Abstract

Embodiments of the present invention provide convenient foldable boxes for transporting materials related to genetic assessments (e.g., DNA tests). The foldable boxes are lightweight, compact, easily manufactured, and inexpensive. In certain embodiments, the present disclosure is directed to a genetic assessment kit which includes a foldable box, as described herein, a buccal swab, and other materials which support the efficient and collection and transport of a biological sample. For example, the genetic assessment kit may include a plastic bag or other appropriate vessel for storing a buccal swab after it is used to collect a biological sample (e.g., a DNA sample). The genetic assessment kit may also include a pre-addressed envelope so an individual may easily mail his/her biological sample to an appropriate test location.

Description

FOLDABLE BOX FOR GENETIC ASSESSMENT KIT

Cross Reference to Related Applications

[0001] This application claims priority to and benefit of U.S. Provisional Patent Application No. 62/694,788, filed July 6, 2018, the content of which is hereby incorporated by reference in its entirety.

Field

[0002] This invention relates generally to foldable box systems. In particular, in certain embodiments, the invention relates to foldable boxes that are well adapted for use in a genetic assessment kit.

Background

[0003] Genomes hold valuable information that can be used to better understand

characteristics of living things. Much research is being conducted to establish relationships between the human genome and biological characteristics and traits, in particular. For example, single nucleotide polymorphisms (SNPs) are specific sites identified in particular genes that influence biological characteristics and traits depending on the particular polymorphism of an individual. Different polymorphisms of the nucleotides at a specific site influence the relevant characteristic or trait differently. Relationships between the variants of SNPs and their corresponding biological characteristics and traits have been established and many more possible relationships are currently undiscovered and under investigation.

[0004] Personalized genetic profiles, such as LifeProfile offered by Orig3n, Inc. of Boston, Massachusetts, provide SNP -based assessments of various characteristics and traits. These genetic assessments employ buccal swabs (e.g., cheek swabs) which individuals use to collect a biological sample for the assessment. A user contacts the tip of the buccal swab to the interior surface of her/his cheek to collect a biological sample which includes the individual’s DNA. Ideally, this biological sample is collected under clean conditions, appropriately stored, and transported to a test location where the sample is analyzed. After the biological sample is analyzed, individuals may access a genetic profile assessment which includes information about their genetic profile and is accessible for review on their smartphones. Individuals can learn from their genetic profile how their genome impacts their personal health characteristics, fitness characteristics, and dietary characteristics, for example. Any errors which occur during sample collection, storage, and/or transport may result in a less accurate and less reliable assessment.

[0005] There is a need for improved systems and methods for delivering materials related to personalized genetic profiles in an efficient and user-friendly manner.

Summary

[0006] Embodiments of the present invention provide convenient foldable boxes for transporting materials related to genetic assessments (e.g., DNA tests). The foldable boxes are lightweight, compact, easily manufactured, and inexpensive. In certain embodiments, the present disclosure is directed to a genetic assessment kit which includes a foldable box, as described herein, a buccal swab, and other materials which support the efficient and collection and transport of a biological sample. For example, the genetic assessment kit may include a plastic bag or other appropriate vessel for storing a buccal swab after it is used to collect a biological sample (e.g., a DNA sample). The genetic assessment kit may also include a pre-addressed envelope so an individual may easily mail his/her biological sample to an appropriate test location. [0007] Certain embodiments of the foldable boxes described herein are manufactured through simplified processes that require less material than those used to manufacture conventional packaging materials. For example, in certain embodiments, the foldable boxes of the present disclosure are manufactured from a single sheet of a foldable material, and the shape of the sheet is simple to manufacture. In certain embodiments, the foldable boxes of the present disclosure require less material than conventional boxes. In certain embodiments, less adhesive material is required to seal a box according to the present disclosure than is required to seal conventional boxes. For example, in certain embodiments, the foldable box described herein only requires an adhesive material disposed at a single surface of the box. For example, the single adhesive portion 215 shown in FIG. 2 may be adequate to seal the box for transport. Conventional boxes often require tape disposed along multiple surfaces. Without wishing to bound to any particular theory, the boxes described herein may be more likely to be recycled than conventional boxes, because the foldable boxes described herein can be easily transitioned to an unfolded (e.g.,“flattened”) configuration which is more manageable for transport to an appropriate recycling facility. Manual effort and sharp tools (e.g., a knife, scissors, or the like) are often required to flatten conventional boxes for recycling.

[0008] The present disclosure encompasses the recognition that providing clear instructions in an easily recognized and immediately identifiable location (i.e., on the top surface of the sheet of the box) will improve user conformation with proper techniques for collecting and handling biological samples. When correct procedures are followed for collecting, storing, and

transporting the biological sample, the quality and reliability of the genetic assessment improves. For example, instructions may be presented in a clear and easily accessible manner on a top surface of the sheet from which the foldable box is manufactured, such that individuals can easily view the instructions. Individuals are thus more likely to follow these instructions (e.g., and avoid mishandling of their biological samples). For example, the instructions may include additional guidance on what actions not to take (e.g.,“do not touch the tip of the buccal swab with your hands”) in order to improve the outcome of the assessment. Thus, certain embodiments, promote improved conformance with proper use of a DNA test kit and thereby improve the accuracy and reliability of test results.

[0009] Certain embodiments improve the user experience for individuals who are using a genetic assessment kit, as described herein. As described above, in certain embodiments, instructions are presented in a convenient location on the top surface of the sheet from which the box is manufactured, reducing frustration during use of the genetic assessment kit. The individual does not need to search through packaging materials to find instructions related to how the buccal swab is used to collect a biological sample, how to store the biological sample for transport to a testing facility, how to access assessment results once they are available, and the like.

[0010] Certain embodiments improve an individual’s ability to retain useful information for future reference by the individual. For example, when the box is in the unfolded configuration, it may have an appearance which is similar to that of an ordinary sheet of paper, which may be conveniently stored (e.g., in a folder or filing cabinet) for future reference. Instructions printed on an internal surface of conventional box (e.g., on a surface of the conventional box 100 shown in FIG. 1) would not be easy to retain for future use. In certain embodiments, the sheet includes perforations along edges so that an individual may choose to remove flaps from the box and retain a central portion of the sheet, which contains instructions, for future reference.

[0011] In certain embodiments, the flaps of the foldable box are shaped and sized so that a user, upon opening the box may immediately view a recognizable logo and/or other visual information related to the corresponding genetic assessment (e.g., logo 405 of box 400 shown in FIG. 4). This allows for improved brand recognition by individuals opening the box.

[0012] It should be understood that - while the present invention is primarily described with respect to the use of a foldable box for storing, or as part of, a genetic assessment kit - the systems, apparatus, and approaches described in the present disclosure may also be used for other applications and in other industries, for example, where a foldable box may be beneficial. For example, the lightweight, compact, easily manufactured, and inexpensive boxes described herein may be used to store and/or transport other products which would benefit from improved conformance with instructions of use such as other types of health and/or biological tests, medicines, nutritional supplements, vitamins, and the like.

[0013] In one aspect, the invention is directed to a genetic assessment kit comprising: a foldable box forming an enclosure, the foldable box comprising a sheet of a foldable material, wherein the sheet comprises (i) a top surface (e.g., corresponding to an interior surface of the box) and (ii) a plurality of folds, wherein the sheet is shaped and sized, and the plurality of folds are positioned, to provide a folded (e.g., closed) configuration and an unfolded (e.g., open) configuration of the box, wherein, when the foldable box is in the folded configuration, the sheet forms the enclosure; a buccal swab (e.g., cheek swab) housed in the enclosure (e.g., the cheek swab is for collecting a biological sample from an individual using the genetic assessment kit); a sealable plastic bag housed in the enclosure; and an envelope housed in the enclosure.

[0014] In certain embodiments, the sealable plastic bag is for storing the buccal swab and/or preserving the collected biological sample.

[0015] In certain embodiments, the envelope is a pre-addressed envelope for mailing the stored and/or preserved buccal swab to a location for testing. [0016] In certain embodiments, the top surface of the sheet (e.g., corresponding to the interior surface of the box) comprises instructions [e.g., wherein the instructions comprise text and/or illustrations, e.g., wherein the instructions comprise a hyperlink, e.g., as a barcode (e.g., QR code)] [e.g., wherein the instruction comprise one or more steps an individual should not perform (e.g., wherein not performing said one or more steps will improve the accuracy of a genetic assessment)]. In certain embodiments, when the foldable box is in the unfolded (e.g., open) configuration, the instructions are viewable by an individual using the genetic assessment kit.

[0017] In certain embodiments, the foldable box comprises a hinged cover portion, a left hinged flap and a right hinged flap, wherein, when the hinged cover portion is in an open configuration, and the left hinged flap and the right hinged flap are in a folded configuration, an edge of the left hinged flap does not touch or overlap with an edge of the right hinged flap such that at least a portion of one or members selected from the group consisting of the buccal swab, the sealable plastic bag, the envelope, and a logo (e.g., displayed on a paper card housed in the enclosure) is viewable by an individual using the genetic assessment kit (e.g., as described with respect to FIG. 4).

[0018] In certain embodiments, the buccal swab comprises a body portion, a tip portion disposed on an end of the body portion, and a protective sleeve covering the tip portion, wherein the protective sleeve is reversibly attachable (e.g., removable and reattachable) to the body portion of the swab.

[0019] In certain embodiments, the foldable box comprises a hinged lid flap with an adhesive portion disposed thereon, wherein, when the hinged lid flap is in a closed configuration, the adhesive portion is contactable to a portion of a bottom surface of the sheet to hold the box in the folded (e.g., closed) configuration.

[0020] In certain embodiments, the foldable box comprises a hinged bottom flap, wherein the hinged bottom flap has a length in a range from about 2 cm to about 8 cm and a width in a range from about 10 cm to about 25 cm (e.g., wherein the hinged bottom flap has a length of about 18 cm) (e.g., as described with respect to FIG. 3B).

[0021] In certain embodiments, the foldable box is a single, continuous piece of the foldable material.

[0022] In certain embodiments, the foldable material is paper (e.g., cardstock, e.g., kraft paper) or cardboard.

[0023] In another aspect, the invention is directed to a foldable box comprising: a base portion, a top portion hinged to the base portion, wherein the top portion comprises a hinged lid flap with an adhesive material disposed thereon; a left flap hinged to the base portion; a right flap hinged to the base portion; and a bottom flap hinged to the base portion, wherein, when the left flap, right flap, and bottom flap are in a folded configuration, the base portion, left flap, right flap, and bottom flap form a partial enclosure, wherein at least a portion of a surface of an inner surface of the base portion is viewable within the enclosure, and when the top portion, left flap, right flap, and bottom flap are in a folded configuration: (i) the base portion, top portion, left flap, right flap, and bottom flap form an enclosure, and (ii) the bottom portion is married to the lid flap by the adhesive material, thereby maintaining the foldable box in a folded (e.g., closed) configuration.

[0024] In certain embodiments, an interior surface of the box comprises instructions [e.g., wherein the instructions comprise text and/or illustrations, e.g., wherein the instructions comprise a hyperlink, e.g., as a barcode (e.g., QR code)] [e.g., wherein the instruction comprise one or more steps an individual (e.g., an individual using a genetic assessment kit enclosed within the foldable box) should not perform (e.g., wherein not performing said one or more steps will improve the accuracy of a genetic assessment)]. In certain embodiments, when the foldable box is in an unfolded (e.g., open) configuration, the instructions are viewable by the individual.

[0025] In certain embodiments, when the hinged lid flap is in an unfolded (e.g., open) configuration, and the left flap and the right flap are in the folded configuration, an edge of the left flap does not touch or overlap with an edge of the right flap such that a region sufficiently large so as to provide for display of at least a portion of one or members selected from the group consisting of a buccal swab, a sealable plastic bag, an envelope, and a logo (e.g., displayed on a paper card housed in the enclosure) is viewable by an individual (e.g., an individual using a genetic assessment kit enclosed within the foldable box). In certain embodiments, the buccal swab comprises a body portion, a tip portion disposed on an end of the body portion, and a protective sleeve covering the tip portion, wherein the protective sleeve is reversibly attachable to the body portion of the swab.

[0026] In certain embodiments, the bottom flap has a length in a range from about 2 cm to about 8 cm and a width in a range from about 10 cm to about 25 cm (e.g., wherein the bottom flap has a length of about 18 cm) (e.g., as described with respect to FIG. 3B).

[0027] In certain embodiments, the foldable box is a single (e.g., continuous) sheet of a foldable material. In certain embodiments, the foldable material is paper (e.g., cardstock, e.g., kraft paper) or cardboard.

[0028] Features of embodiments described with respect to one aspect of the invention may be applied with respect to another aspect of the invention. Definitions

[0029] In order for the present disclosure to be more readily understood, certain terms are first defined below. Additional definitions for the following terms and other terms are set forth throughout the specification.

[0030] “ Approximately “About: As used herein, the term“approximately” or“about,” as applied to one or more values of interest, refers to a value that is similar to a stated reference value. In certain embodiments, the term“approximately” or“about” refers to a range of values that fall within 25%, 20%, 19%, 18%, 17%, 16%, 15%, 14%, 13%, 12%, 11%, 10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, 1%, or less in either direction (greater than or less than) of the stated reference value unless otherwise stated or otherwise evident from the context (except where such number would exceed 100% of a possible value).

[0031] “Comprising” : A device or method described herein as“comprising” one or more named elements or steps is open-ended, meaning that the named elements or steps are essential, but other elements or steps may be added within the scope of the composition or method. To avoid prolixity, it is also understood that any composition or method described as“comprising” (or which“comprises”) one or more named elements or steps also describes the corresponding, more limited composition or method“consisting essentially of’ (or which“consists essentially of’) the same named elements or steps, meaning that the composition or method includes the named essential elements or steps and may also include additional elements or steps that do not materially affect the basic and novel characteristic(s) of the composition or method. It is also understood that any composition or method described herein as“comprising” or“consisting essentially of’ one or more named elements or steps also describes the corresponding, more limited, and closed-ended composition or method“consisting of’ (or“consists of’) the named elements or steps to the exclusion of any other unnamed element or step. In any composition or method disclosed herein, known or disclosed equivalents of any named essential element or step may be substituted for that element or step.

[0032] “ Substantially As used herein, the term“substantially” refers to the qualitative condition of exhibiting total or near-total extent or degree of a characteristic or property of interest.

[0033] Unless defined otherwise, technical and scientific terms have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs.

Brief Description of the Drawings

[0034] The foregoing and other objects, aspects, features, and advantages of the present disclosure will become more apparent and better understood by referring to the following description taken in conduction with the accompanying drawings, in which:

[0035] FIG. l is a schematic diagram of a prior art box in an unassembled configuration;

[0036] FIG. 2 is an image of a foldable box in an unfolded configuration, according to an illustrative embodiment;

[0037] FIG. 3 A is a diagram of foldable box, according to an illustrative embodiment;

[0038] FIG. 3B is a diagram of foldable box, according to an illustrative embodiment;

[0039] FIG. 4 is an image of a foldable box with the left, right and bottom flaps in a folded configuration, according to an illustrative embodiment;

[0040] FIG. 5A is a front view of a foldable box, according to an illustrative embodiment; [0041] FIG. 5B is a back view of a foldable box, according to an illustrative embodiment;

[0042] FIG. 6 is an image of a genetic assessment kit, according to an illustrative embodiment; and

[0043] FIG. 7 is a method for using a genetic assessment kit, according to an illustrative embodiment.

[0044] The features and advantages of the present disclosure will become more apparent from the detailed description set forth below when taken in conjunction with the drawings, in which like reference characters identify corresponding elements throughout. In the drawings, like reference numbers generally indicate identical, functionally similar, and/or structurally similar elements.

Detailed Description

[0045] It is contemplated that systems, methods, and processes of the claimed invention encompass variations and adaptations developed using information from the embodiments described herein. Adaptation and/or modification of the systems, methods, and processes described herein may be performed, as contemplated by this description.

[0046] Throughout the description, where articles, devices, systems, and architectures are described as having, including, or comprising specific components, or where processes and methods are described as having, including, or comprising specific steps, it is contemplated that, additionally, there are articles, devices, systems, and architectures of the present invention that consist essentially of, or consist of, the recited components, and that there are processes and methods according to the present invention that consist essentially of, or consist of, the recited processing steps. [0047] It should be understood that the order of steps or order for performing certain action is immaterial so long as the invention remains operable. Moreover, two or more steps or actions may be conducted simultaneously.

[0048] Elements of embodiments described with respect to a given aspect of the invention may be used in various embodiments of another aspect of the invention. For example, it is contemplated that features of dependent claims depending from one independent claim can be used in apparatus, articles, systems, and/or methods of any of the other independent claims.

[0049] The Background section is presented for purposes of clarity and is not meant as a description of prior art with respect to any claim. Headers are provided for the convenience of the reader - the presence and/or placement of a header is not intended to limit the scope of the subject matter described herein.

Foldable Box

[0050] FIG. 2 shows a foldable box 200, according to an illustrative embodiment, where the box is in an unfolded configuration. The foldable box 200 comprises a sheet of a foldable material, where the sheet comprises a top surface 205, a bottom surface (not shown), and a plurality of folds 230a-j. The foldable material may, for example, be paper (e.g., card stock, e.g., kraft paper) or cardboard. In certain embodiments, a thickness of the sheet is about 0.5 mm or less. For example, in certain embodiments, the sheet is a 14 point or less card stock. In the illustrative embodiment shown FIG. 2, the foldable box is a single sheet of the foldable material. However, in other embodiments, the foldable box may have additional portions of foldable material attached thereto such that the foldable box comprises two or more sheets of the foldable material.

[0051] The sheet from which box 200 is manufactured is shaped and sized, and the folds are positioned to provide a folded configuration of the box and an unfolded configuration of the box. FIG 2 shows the box 200 in an unfolded configuration in which the top surface 205 of the sheet is viewable by an individual. When the box is in the folded configuration, the top surface of the sheet is substantially enclosed inside the box, as shown in images 500 and 550 of FIG. 5 A and 5B, respectively.

[0052] Referring again to FIG. 2, the top surface of the sheet (e.g., corresponding to an interior surface of the box) may include instructions. The instructions may include, for example, a description of the process used for collecting a biological sample, e.g., using a buccal swab, a description of the process used to store and/or mail the sample for analysis, and a description of the process used to register the buccal swab such that it is associated with the individual from which the biological sample was obtained. Supplementary information may also be displayed on the top surface of the box. For example, this supplementary information may directed an individual to a website (e.g. a web address may be displayed on the surface). In certain embodiments, a scannable (e.g., by a mobile phone device) image or barcode (e.g., a QR code) is displayed on the surface such that a user may more efficiently access an appropriate website or application for viewing supplementary information about a product or registering the product.

[0053] Still referring to FIG. 2, the sheet from which box 200 is manufactured comprises a plurality of flaps, and each flap is defined by a corresponding fold in the sheet. For example, box 200 includes a lid flap 210 defined by fold 230a. Lid flap 210 has an open configuration (as shown in FIG. 2) and a closed configuration (shown in FIG. 5B). Each comer of the lid flap may be square or rounded. In the illustrative embodiment of FIG. 2 and FIG. 5B, the left corner of the lid flap 210 is squared and the right comer is rounded. In certain embodiments, the lid flap has a different shape (e.g., both corners may be squared, e.g., both corners may be rounded, e.g., the lid flap may have a parabolic shape).

[0054] Box 200 may include an adhesive portion for, e.g., marrying two surfaces of the box to maintain the box in a folded (e.g., closed) configuration. An adhesive portion comprises an adhesive material (e.g., tape, e.g., glue). The illustrative embodiment of FIG. 2 shows an adhesive portion 215 disposed on the lid flap 210. When the lid flap 210 is in the closed configuration, the adhesive portion is contactable to a portion of the bottom surface of the sheet, as shown, e.g., in FIG. 5B. In certain embodiments, a removable non-adhesive portion covers the adhesive portion 215. For example, a user may remove the non-adhesive portion to uncover the adhesive portion so the adhesive portion may be used to secure the box 200 in a folded (e.g., closed) configuration (e.g., the configuration shown in FIG. 5A and FIG. 5B). [0055] Referring now to FIG. 3 A, diagram 300 shows lid flap 325 with an adhesive portion 330 disposed thereon. Referring also to diagram 350 of FIG. 3B, the lid flap 325, in certain embodiments, has a length 375 in a range from about 1 cm to about 8 cm (e.g., 2.5 cm). In certain embodiments, the width 380 of the adhesive portion 330 may be in a range from about 5 cm to about 13 cm. In certain embodiments, the width 380 of the adhesive portion 330 may be in a range from about 10% to about 100% of the width 360 of the sheet.

[0056] Referring again to FIG. 2, the box 200 includes a bottom flap 225 defined by fold 230j. The bottom flap 225 may, for example, help to reinforce the box in the folded

configuration. Referring now to FIG. 3 A and FIG. 3B, the bottom flap 335 may have a length 385 in a range from about 2 cm to about 8 cm and a width 360 in a range from about 10 cm to about 25 cm (e.g., 18 cm).

[0057] Referring again to FIG. 2, the box 200 comprises a left flap 220a and a right flap

220b defined by folds 230e and 230g, respectively. In the illustrative embodiment of FIG. 2, the left flap 220a and the right flap 220b have a parabolic shape. In other embodiments (not shown), the left and right flaps may have a different shape (e.g., a triangular shape, e.g., a square shape). In certain embodiments, when the sheet is in the folded configuration (e.g., or in a partially folded configuration), such as that shown in FIG. 4, an edge of the left flap 220a does not touch or overlap with an edge of the right flap 220b. This allows a portion of the contents of the box, e.g., logo 405, to be visible when the flaps are in a closed configuration. This can be helpful for an individual using the box, because she/he may view the items while the items are still conveniently maintained substantially in the same place by the flaps.

[0058] Referring to FIG. 3 A and 3B, the left flap 320a has a length 370a in a range from about 4 cm to about 11 cm (e.g., 7.5 cm). The right flap 320b may have a length 370b in a range from about 4 cm to about 11 cm (e.g., 7.5 cm). In certain embodiments, including the illustrative embodiment of FIG. 2, the left flap and right flap are the same size and shape. In certain embodiments, the left flap and the right flap are not the same size and/or shape. For example, in certain embodiments, the shape and size of the left flap and right flap are modified to ensure that important information can be viewed inside the box when the left and right flaps are in a folded configuration.

[0059] While each of the flaps (i.e., the lid flap, bottom flap, left flap, and right flap) is described herein as being a single flap, it should be understood that each flap may alternatively be a plurality (i.e., two, three, or more) flaps while performing the same, or an equivalent, function. An adhesive material may also be disposed on other portions of a foldable box. For example, referring to FIG. 2, one or more additional or alternative adhesive portions (not shown) may be disposed on the bottom flap 225 to marry said flap to the left flap 220a and/or right flap 220b

[0060] The sheet from which the foldable box is manufactured also includes portions which form the top, bottom, and sides of the box, when the box is in the folded configuration. For example, referring to FIG. 3 A, the foldable box may include a bottom portion 305a, a top portion 305b, and a plurality of side portions 315a-e. When the box is in the folded configuration, the bottom portion 305a and top portion 305b define the bottom and top surfaces of the box, respectively, while the side portions 315a-e define the other sides of the folded box. Bottom portion 305a may be defined by folds 230d and 230i shown in FIG. 2, and top portion 305b may be defined by folds 230b and 230c shown in FIG. 2. Side portion 315a may be defined by folds 230a and 230b shown in FIG. 2. Side portion 315b may be defined by folds 230c and 230d shown in FIG. 2. Side portion 315c may be defined by folds 230i and 230j shown in FIG. 2. Side portion 315d may be defined by folds 230e and 230f shown in FIG. 2, and side portion 315e may be defined by folds 230h and 230g shown in FIG. 2.

[0061] As shown in FIG. 3 A and 3B, the bottom portion 305a and top portion 305b may, for example, each have a length 355 in a range from about 5 cm to about 18 cm (e.g., 12 cm) and a width 360 in a range from about 10 cm to about 25 cm (e.g., 18 cm). Each of the side portions 315a-c may, for example, have a length 365 in a range from about 0.25 cm to about 2.5 cm (e.g.,

1 cm) and a width 360 in a range from about 10 cm to about 25 cm (e.g., 18 cm). Each of the side portions 315d,e may, for example, have a length 355 in a range from about 5 cm to about 18 cm (e.g., 12 cm) and a width 365 in a range from about 0.25 cm to about 2.5 cm (e.g., 1 cm).

Genetic Assessment Kit

[0062] FIG. 6 shows a genetic assessment kit 600, according to an illustrative embodiment of the invention. The kit includes a foldable box 605, as described above (e.g., as described above with respect to FIGs. 2, 3 A, 3B, 4, 5A, and 5B), and a buccal swab 610 for collecting a biological sample from an individual. The top surface of the sheet of the foldable box 605

(shown in FIG. 6) includes instruction for the use, storage, and delivery of the buccal swab. In certain embodiments, the instructions include graphical emphasis (e.g., as bold and/or colored text, e.g., as illustrations) to highlight critical steps related to the use of the genetic assessment kit. Without wishing to be bound to a particular theory, this graphical emphasis of the conveniently placed instructions may improve individuals’ conformance with the intended use of the genetic assessment kit, resulting in more accurate assessments.

[0063] The kit may also include a paper insert card 615, which includes additional information for identifying the product (e.g., a company logo and, optionally, additional information about the associated genetic assessment). The kit may also include a plastic zipper bag 620 or other sealable vessel or container for storing the buccal swab 610 after it is used to collect a biological sample and a pre-addressed envelope 625 for mailing the stored biological sample to a test location.

Use of a Genetic Assessment Kit

[0064] FIG. 7 shows a method 700 for using a genetic assessment kit, according to an illustrative embodiment of the invention. In Step 705, a genetic assessment kit (e.g., as described above with respect to FIGs. 2, 3 A, 3B, 5, 6A, and 6B). In Step 710, the box is unfolded to reveal the contents of the kit, which includes a buccal swab, a plastic bag for storing the buccal swab after its use, and an envelope for mailing the plastic bag containing the used buccal swab. In Step 715, the buccal swab is contacted to the internal surface of a mouth of an individual. In Step 720, the buccal swab is inserted into the plastic zipper bag, which should subsequently be sealed by the individual. In Step 725, the plastic bag containing the swab is inserted into the envelope to be mailed to a test location.

[0065] In certain embodiments, a genetic assessment kit is used via the following steps, not necessarily in the order enumerated below:

[0066] 1. Unfold the foldable box by folding in/up/down the flaps of the box.

[0067] 2. Separate the buccal swab from its sleeve by grasping and pulling both ends. The sleeve should not be discarded, and the tip of the sleeve should not be contacted by the user’s hands. [0068] 3. Rub the tip of the buccal swab firmly on the inside of the cheek of the user approximately 20 times on each side of the mouth. The swab should contact as much of the inside of the cheek as possible.

[0069] 4. Insert the buccal swab back in the sleeve.

[0070] 5. Place the swab and sleeve into the plastic zipper bag and close the seal of the bag.

[0071] 6. Register the user’s buccal swab online using the barcode of the swab.

[0072] 7. Place the plastic bag containing the swab and sleeve in the pre-addressed envelope and mail the envelope.

[0073] 8. View results online and/or download an application (e.g., a mobile phone application) to view the results.

Manufacture of Foldable Box and Genetic Assessment Kit

[0074] In certain embodiments, a genetic assessment kit is manufactured via the following steps, not necessarily in the order enumerated below:

[0075] A. Manufacturing foldable box.

[0076] 1. Receive (a) a sheet of a foldable material.

[0077] 2. Fold the sheet to obtain a plurality of folds in the sheet wherein the sheet is shaped and sized and the folds are positioned such that the sheet has a folded configuration (shaped like) a box and an unfolded configuration (the flat sheet), thereby preparing a foldable box.

[0078] B. Manufacturing genetic assessment kit:

[0079] 3. Receive (a) a buccal swab for collecting a biological sample, (b) a plastic bag for storing the buccal swab, and (c) an envelope for mailing the plastic bag. [0080] 4. Place (a), (b), and (c) in the foldable box prepared in step 2.

[0081] 5. Fold the foldable box into the folded (e.g., closed) configuration. In certain embodiments, the box, when in its folded configuration, is covered with a water-proof material (e.g., plastic, e.g., polyethylene) (e.g., to protect the box during transport).

[0082] While the invention has been particularly shown and described with reference to specific embodiments, it should be understood by those skilled in the art that various changes in form and detail may be made therein without departing from the spirit and scope of the invention as defined by the appended claims.

Claims

What is claimed is:

1. A genetic assessment kit comprising:

a foldable box forming an enclosure, the foldable box comprising a sheet of a foldable material, wherein the sheet comprises (i) a top surface and (ii) a plurality of folds, wherein the sheet is shaped and sized, and the plurality of folds are positioned, to provide a folded configuration and an unfolded configuration of the box, wherein, when the foldable box is in the folded configuration, the sheet forms the enclosure;

a buccal swab housed in the enclosure;

a sealable plastic bag housed in the enclosure; and

an envelope housed in the enclosure.

2. The genetic assessment kit of claim 1, wherein the sealable plastic bag is for storing the buccal swab and/or preserving the collected biological sample.

3. The genetic assessment kit of claims 1 or 2, wherein the envelope is a pre-addressed envelope for mailing the stored and/or preserved buccal swab to a location for testing.

4. The genetic assessment kit of any one of the preceding claims, wherein the top surface of the sheet comprises instructions.

5. The genetic assessment kit of claim 4, wherein, when the foldable box is in the unfolded configuration, the instructions are viewable by an individual using the genetic assessment kit.

6. The genetic assessment kit of any one of the preceding claims, wherein the foldable box comprises a hinged cover portion, a left hinged flap and a right hinged flap, wherein, when the hinged cover portion is in an open configuration, and the left hinged flap and the right hinged flap are in a folded configuration, an edge of the left hinged flap does not touch or overlap with an edge of the right hinged flap such that at least a portion of one or members selected from the group consisting of the buccal swab, the sealable plastic bag, the envelope, and a logo is viewable by an individual using the genetic assessment kit.

7. The genetic assessment kit of any one of the preceding claims, wherein the buccal swab comprises a body portion, a tip portion disposed on an end of the body portion, and a protective sleeve covering the tip portion, wherein the protective sleeve is reversibly attachable to the body portion of the swab.

8. The genetic assessment kit of any one of the preceding claims, wherein the foldable box comprises a hinged lid flap with an adhesive portion disposed thereon, wherein, when the hinged lid flap is in a closed configuration, the adhesive portion is contactable to a portion of a bottom surface of the sheet to hold the box in the folded configuration.

9. The genetic assessment kit of any one of the preceding claims, wherein the foldable box comprises a hinged bottom flap, wherein the hinged bottom flap has a length in a range from about 2 cm to about 8 cm and a width in a range from about 10 cm to about 25 cm.

10. The genetic assessment kit of any one of the preceding claims, wherein the foldable box is a single, continuous piece of the foldable material.

11. The genetic assessment kit of any one of the preceding claims, wherein the foldable material is paper or cardboard.

12. A foldable box comprising:

a base portion,

a top portion hinged to the base portion, wherein the top portion comprises a hinged lid flap with an adhesive material disposed thereon;

a left flap hinged to the base portion;

a right flap hinged to the base portion; and

a bottom flap hinged to the base portion, wherein,

when the left flap, right flap, and bottom flap are in a folded configuration, the base portion, left flap, right flap, and bottom flap form a partial enclosure, wherein at least a portion of a surface of an inner surface of the base portion is viewable within the enclosure, and

when the top portion, left flap, right flap, and bottom flap are in a folded configuration: (i) the base portion, top portion, left flap, right flap, and bottom flap form an enclosure, and (ii) the bottom portion is married to the lid flap by the adhesive material, thereby maintaining the foldable box in a folded configuration.

13. The foldable box of claim 12, wherein an interior surface of the box comprises instructions.

14. The foldable box of claim 13, wherein, when the foldable box is in an unfolded configuration, the instructions are viewable by the individual.

15. The foldable box of any one of claims 12 to 14, wherein, when the hinged lid flap is in an unfolded configuration, and the left flap and the right flap are in the folded configuration, an edge of the left flap does not touch or overlap with an edge of the right flap such that a region sufficiently large so as to provide for display of at least a portion of one or members selected from the group consisting of a buccal swab, a sealable plastic bag, an envelope, and a logo is viewable by an individual.

16. The foldable box of claim 15, wherein the buccal swab comprises a body portion, a tip portion disposed on an end of the body portion, and a protective sleeve covering the tip portion, wherein the protective sleeve is reversibly attachable to the body portion of the swab.

17. The foldable box of any one of claims 12 to 16, wherein the bottom flap has a length in a range from about 2 cm to about 8 cm and a width in a range from about 10 cm to about 25 cm.

18. The foldable box of any one of claims 12 to 17, wherein the foldable box is a single sheet of a foldable material.

19. The foldable box of claim 18, wherein the foldable material is paper or cardboard.