BR112016010103A8 - métodos, kits e dispositivos de suprimento de fármaco osmótico. - Google Patents

métodos, kits e dispositivos de suprimento de fármaco osmótico.

Info

Publication number
BR112016010103A8
BR112016010103A8 BR112016010103A BR112016010103A BR112016010103A8 BR 112016010103 A8 BR112016010103 A8 BR 112016010103A8 BR 112016010103 A BR112016010103 A BR 112016010103A BR 112016010103 A BR112016010103 A BR 112016010103A BR 112016010103 A8 BR112016010103 A8 BR 112016010103A8
Authority
BR
Brazil
Prior art keywords
kits
devices
drug supply
osmotic drug
supply methods
Prior art date
Application number
BR112016010103A
Other languages
English (en)
Portuguese (pt)
Inventor
Lee Heejin
Daniel Karen
Original Assignee
Taris Biomedical Llc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Taris Biomedical Llc filed Critical Taris Biomedical Llc
Publication of BR112016010103A8 publication Critical patent/BR112016010103A8/pt

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M31/00Devices for introducing or retaining media, e.g. remedies, in cavities of the body
    • A61M31/002Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7042Compounds having saccharide radicals and heterocyclic rings
    • A61K31/7052Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides
    • A61K31/706Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom
    • A61K31/7064Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom containing condensed or non-condensed pyrimidines
    • A61K31/7068Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom containing condensed or non-condensed pyrimidines having oxo groups directly attached to the pyrimidine ring, e.g. cytidine, cytidylic acid
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0002Galenical forms characterised by the drug release technique; Application systems commanded by energy
    • A61K9/0004Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0034Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2009Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • A61K9/2018Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/04Macromolecular materials
    • A61L31/06Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/08Materials for coatings
    • A61L31/10Macromolecular materials
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/16Biologically active materials, e.g. therapeutic substances
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00Drugs for disorders of the urinary system
    • A61P13/10Drugs for disorders of the urinary system of the bladder
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P23/00Anaesthetics
    • A61P23/02Local anaesthetics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2096Combination of a vial and a syringe for transferring or mixing their contents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/20Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials
    • A61L2300/23Carbohydrates
    • A61L2300/232Monosaccharides, disaccharides, polysaccharides, lipopolysaccharides
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/402Anaestetics, analgesics, e.g. lidocaine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/416Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/432Inhibitors, antagonists
    • A61L2300/436Inhibitors, antagonists of receptors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/04General characteristics of the apparatus implanted
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2209/00Ancillary equipment
    • A61M2209/04Tools for specific apparatus
    • A61M2209/045Tools for specific apparatus for filling, e.g. for filling reservoirs

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Molecular Biology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Anesthesiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Biomedical Technology (AREA)
  • Urology & Nephrology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Surgery (AREA)
  • Vascular Medicine (AREA)
  • Hematology (AREA)
  • Gynecology & Obstetrics (AREA)
  • Reproductive Health (AREA)
  • Biophysics (AREA)
  • Inorganic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Materials For Medical Uses (AREA)
BR112016010103A 2013-11-05 2014-11-05 métodos, kits e dispositivos de suprimento de fármaco osmótico. BR112016010103A8 (pt)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201361899982P 2013-11-05 2013-11-05
PCT/US2014/064063 WO2015069723A1 (en) 2013-11-05 2014-11-05 Osmotic drug delivery devices, kits, and methods

Publications (1)

Publication Number Publication Date
BR112016010103A8 true BR112016010103A8 (pt) 2018-01-30

Family

ID=51946057

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112016010103A BR112016010103A8 (pt) 2013-11-05 2014-11-05 métodos, kits e dispositivos de suprimento de fármaco osmótico.

Country Status (10)

Country Link
US (1) US20160279399A1 (enExample)
EP (1) EP3065807A1 (enExample)
JP (1) JP2017500171A (enExample)
KR (1) KR20160083061A (enExample)
CN (1) CN105792880A (enExample)
BR (1) BR112016010103A8 (enExample)
CA (1) CA2929554A1 (enExample)
IL (1) IL245445A0 (enExample)
RU (1) RU2016120199A (enExample)
WO (1) WO2015069723A1 (enExample)

Families Citing this family (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10137287B2 (en) 2013-03-05 2018-11-27 Taris Biomedical Llc Drug delivery devices and methods for controlled drug release through device orifice
RS67337B1 (sr) * 2014-03-06 2025-11-28 Taris Biomedical Llc Sistemi za isporuku leka i metode za lečenje karcinoma bešike gemcitabinom
ES2734394T3 (es) 2015-03-30 2019-12-05 Taris Biomedical Llc Dispositivos para la administración local fármacos al tracto urinario superior
US9867974B2 (en) * 2015-06-01 2018-01-16 Wisconsin Alumni Research Foundation Microfluidic device for multiplexed point source administration of compounds
PT3432970T (pt) * 2017-02-01 2021-05-26 Taris Biomedical Llc Dispositivos de administração de fármaco in vivo
BR112020000832A2 (pt) 2017-07-25 2020-07-21 Taris Biomedical Llc métodos para tratar metástase tumoral
CA3076366C (en) 2017-09-22 2023-05-16 Becton, Dickinson And Company 4% trisodium citrate solution for use as a catheter lock solution
IL274343B2 (en) 2017-11-08 2023-10-01 Taris Biomedical Llc Treatment methods and maintenance treatment for bladder cancer using gemcitabine
MX2021001264A (es) 2018-08-01 2021-07-02 Taris Biomedical Llc Métodos para tratar la vejiga hiperactiva con el uso de trospio.
CN109589491B (zh) * 2019-01-29 2024-01-09 上海安翰医疗技术有限公司 自动给药装置
CA3140207C (en) 2019-06-13 2025-05-13 Hollister Incorporated REUSABLE URINARY CATHETER-TYPE PRODUCTS
AU2020304005B2 (en) 2019-06-25 2025-12-04 Hollister Incorporated Reusable urinary catheter products
EP4221657A4 (en) * 2020-09-30 2024-10-09 Modibodi Australia Pty Ltd TEXTILE FRAME
WO2025147449A1 (en) * 2024-01-02 2025-07-10 Manta Pharma Llc Active implantable medical device (aimd) system for drug delivery with fixed dose size

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GB2155889B (en) * 1984-03-21 1988-03-02 Alza Corp Dispenser-capsule
MY125870A (en) * 1997-07-25 2006-08-30 Alza Corp Osmotic delivery system flow modulator apparatus and method
US6436091B1 (en) * 1999-11-16 2002-08-20 Microsolutions, Inc. Methods and implantable devices and systems for long term delivery of a pharmaceutical agent
US8133501B2 (en) * 2002-02-08 2012-03-13 Boston Scientific Scimed, Inc. Implantable or insertable medical devices for controlled drug delivery
CA2520610A1 (en) * 2003-03-31 2004-10-21 Alza Corporation Osmotic pump with means for dissipating internal pressure
US8257963B2 (en) * 2007-06-01 2012-09-04 Depuy Mitek, Inc. Chondrocyte container and method of use
EP1933810B1 (en) 2005-08-11 2012-10-10 Massachusetts Institute of Technology Intravesical drug delivery device and method
TW200927141A (en) * 2007-11-22 2009-07-01 Bayer Schering Pharma Oy Vaginal delivery system
ES2481454T3 (es) 2007-12-11 2014-07-30 Massachusetts Institute Of Technology Dispositivo implantable de administración de fármacos
CN102176931B (zh) * 2008-08-09 2015-03-04 麻省理工学院 治疗男性泌尿生殖组织和外周组织的可植入药物递送设备和方法
AU2010265866B2 (en) 2009-06-26 2012-07-12 Taris Biomedical Llc Solid drug tablets for implantable drug delivery devices
US9017312B2 (en) 2009-09-10 2015-04-28 Taris Biomedical Llc Implantable device for controlled drug delivery
US8721621B2 (en) 2009-09-10 2014-05-13 Taris Biomedical, Inc. Systems and methods for deploying devices to genitourinary sites
AU2010339821B2 (en) 2009-12-17 2015-02-19 Taris Biomedical Llc Implantable device with intravesical tolerability and methods of treatment
EP2848271B1 (en) * 2010-03-09 2016-04-27 Board of Regents of the University of Texas System Electro-osmotic pumps
PT2600800T (pt) 2010-08-05 2020-11-05 Taris Biomedical Llc Dispositivo de administração de drogas por stent ureteral, kit e método
WO2012048104A1 (en) 2010-10-06 2012-04-12 Taris Biomedical, Inc. Implantable drug delivery device with bladden retention feature
JP5945544B2 (ja) * 2010-10-06 2016-07-05 タリス バイオメディカル エルエルシー 時間選択的に生体吸収可能または崩壊可能な薬剤送達システムおよび方法
EP2663300B1 (en) 2011-01-10 2023-03-08 TARIS Biomedical LLC Lidocaine regimen for the use of sustained treatment of bladder pain and irritative voiding
TWI615155B (zh) * 2011-11-01 2018-02-21 拜耳股份有限公司 滲透活性的陰道遞送系統
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Also Published As

Publication number Publication date
RU2016120199A3 (enExample) 2018-06-29
EP3065807A1 (en) 2016-09-14
RU2016120199A (ru) 2017-12-11
WO2015069723A1 (en) 2015-05-14
CA2929554A1 (en) 2015-05-14
KR20160083061A (ko) 2016-07-11
JP2017500171A (ja) 2017-01-05
US20160279399A1 (en) 2016-09-29
CN105792880A (zh) 2016-07-20
IL245445A0 (en) 2016-06-30

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Legal Events

Date Code Title Description
B07D Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]
B08F Application dismissed because of non-payment of annual fees [chapter 8.6 patent gazette]

Free format text: REFERENTE A 5A ANUIDADE.

B08K Patent lapsed as no evidence of payment of the annual fee has been furnished to inpi [chapter 8.11 patent gazette]

Free format text: EM VIRTUDE DO ARQUIVAMENTO PUBLICADO NA RPI 2539 DE 03-09-2019 E CONSIDERANDO AUSENCIA DE MANIFESTACAO DENTRO DOS PRAZOS LEGAIS, INFORMO QUE CABE SER MANTIDO O ARQUIVAMENTO DO PEDIDO DE PATENTE, CONFORME O DISPOSTO NO ARTIGO 12, DA RESOLUCAO 113/2013.