Prospective Grant of an Exclusive Patent License: AAV Mediated Exendin-4 Gene Transfer to Salivary Glands To Protect Subjects From Diabetes or Obesity, 20508 [2020-07706]

Download as PDF khammond on DSKJM1Z7X2PROD with NOTICES 20508 Federal Register / Vol. 85, No. 71 / Monday, April 13, 2020 / Notices of the Bayh-Dole Act codified as 35 U.S.C. 200–212. The prospective patent license will be an exclusive in India and may be limited to those fields of use commensurate in scope with the patent rights. It will be sublicensable, and any sublicenses granted by CCSHAU will be subject to the provisions of 37 CFR part 401 and 404. This technology discloses a graphene oxide-polycarbonate nanosieve electrochemical biosensor for the detection of HIV envelope glycoprotein. The nanosieve is comprised of a polycarbonate membrane layered with graphene oxide laminate, which is conjugated to a bispecific tetravalent antibody, ‘‘2Dm2m’’, comprised of CD4 fused to a human domain targeting HIV– 1 coreceptor binding domain that has high affinity to the HIV envelope glycoprotein gp140. The nanosieve is fitted between two Ag/AgCl electrodes to form an electrochemical nanobiosensor capable of detecting HIV virus (see attached figures). Binding of the HIV gp140 to 2Dm2m reduces the ionic current through the nanosieve biosensors, which functions as the marker of HIV presence. The biosensor has the potential to be a low-cost, portable and quick method for HIV viral load detection. This notice is made in accordance with 35 U.S.C. 209 and 37 CFR part 404. The prospective exclusive license will be royalty bearing, and the prospective exclusive license may be granted unless within fifteen (15) days from the date of this published notice, the National Cancer Institute receives written evidence and argument that establishes that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR part 404. In response to this Notice, the public may file comments or objections. Comments and objections, other than those in the form of a license application, will not be treated confidentially, and may be made publicly available. License applications submitted in response to this Notice will be presumed to contain business confidential information and any release of information in these license applications will be made only as required and upon a request under the Freedom of Information Act, 5 U.S.C. 552. Dated: April 2, 2020. Richard U. Rodriguez, Associate Director, Technology Transfer Center, National Cancer Institute. [FR Doc. 2020–07707 Filed 4–10–20; 8:45 am] BILLING CODE 4140–01–P VerDate Sep<11>2014 17:57 Apr 10, 2020 Jkt 250001 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of an Exclusive Patent License: AAV Mediated Exendin-4 Gene Transfer to Salivary Glands To Protect Subjects From Diabetes or Obesity AGENCY: National Institutes of Health, HHS. ACTION: Notice. The National Institute of Diabetes and Digestive and Kidney Disease and National Institute of Dental and Craniofacial Research, institutes of the National Institutes of Health, Department of Health and Human Services, are contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the United States, European and Canadian Applications listed in the Supplementary Information section of this notice to Kriya Therapeutics, Inc., located in Palo Alto, California, USA. DATES: Only written comments and/or applications for a license which are received by the National Institute of Diabetes and Digestive and Kidney Disease’s Technology Advancement Office on or before April 28, 2020 will be considered. ADDRESSES: Requests for copies of the patent applications, inquiries, and comments relating to the contemplated an Exclusive Patent License should be directed to: Vladimir Knezevic, MD, (Senior) Advisor for Commercial Evaluation, Technology Advancement Office, Building 12A, Room 3011, Bethesda, MD 20817–5632 (for business mail), Telephone: (301)–435–5560; Email: vlado.knezevic@nih.gov. SUPPLEMENTARY INFORMATION: SUMMARY: Intellectual Property I. U.S. Pat: 9,511,103 issued 2016–12– 06, entitled ‘‘AAV mediated exendin-4 gene transfer to salivary glands to protect subjects from diabetes or obesity’’ (HHS Reference Number E– 142–2011–0–US–05). II. U.S. Divisional Pat: 10,300,095 issued 2019–05–28, entitled ‘‘AAV mediated exendin-4 gene transfer to salivary glands to protect subjects from diabetes or obesity’’ (HHS Reference Number E–142–2011–0–US–6). III. European Patent National Stage: EP2709653 granted 2017–11–22, entitled ‘‘AAV mediated exendin-4 gene transfer to salivary glands to protect subjects from diabetes or obesity’’ (HHS Reference Number E–142–2011–0EP– PO 00000 Frm 00042 Fmt 4703 Sfmt 9990 04), validated in Great Britain, France and Germany. IV. U.S. Patent Application No. 16/ 396,262 filed 2019–04–26, entitled ‘‘AAV Mediated Exendin-4 Gene Transfer to Salivary Glands to Protect Subjects from Diabetes or Obesity’’ (HHS Reference Number E–142–2011– 0–US–10). V. Canadian Application No. 2,833,623 filed 2012–04–19, entitled ‘‘AAV Mediated Exendin-4 Gene Transfer to Salivary Glands to Protect Subjects from Diabetes or Obesity’’ (HHS Reference Number E–142–2011– 0–CA–03). The patent rights in these inventions have been assigned or exclusively licensed to the Government of the United States of America. The prospective exclusive license territory may be worldwide and in fields of use that may be limited to prevention and treatment of type-2 diabetes and obesity. The above-listed patent portfolio covers inventions directed to gene therapy and specifically, expression vectors and therapeutic methods of using such vectors in the treatment of type-2 diabetes and obesity. This notice is made in accordance with 35 U.S.C. 209 and 37 CFR part 404. The prospective exclusive license will be royalty bearing. The prospective exclusive license may be granted unless within fifteen (15) days from the date of this published notice, the National Institute of Diabetes and Digestive and Kidney Disease receives written evidence and argument that establishes that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR part 404. In response to this Notice, the public may file comments or objections. Comments and objections, other than those in the form of a license application, will not be treated confidentially and may be made publicly available. License applications submitted in response to this notice will be presumed to contain business confidential information and any release of information in these license applications will be made only as required and upon a request under the Freedom of Information Act, 5 U.S.C. 552. Dated: April 1, 2020. Vladimir Knezevic, Senior Advisor for Commercial Evaluation, Technology Advancement Office, National Institute of Diabetes and Digestive and Kidney Disease. [FR Doc. 2020–07706 Filed 4–10–20; 8:45 am] BILLING CODE 4140–01–P E:\FR\FM\13APN1.SGM 13APN1

Agencies

[Federal Register Volume 85, Number 71 (Monday, April 13, 2020)]
[Notices]
[Page 20508]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-07706]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of an Exclusive Patent License: AAV Mediated 
Exendin-4 Gene Transfer to Salivary Glands To Protect Subjects From 
Diabetes or Obesity

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The National Institute of Diabetes and Digestive and Kidney 
Disease and National Institute of Dental and Craniofacial Research, 
institutes of the National Institutes of Health, Department of Health 
and Human Services, are contemplating the grant of an Exclusive Patent 
License to practice the inventions embodied in the United States, 
European and Canadian Applications listed in the Supplementary 
Information section of this notice to Kriya Therapeutics, Inc., located 
in Palo Alto, California, USA.

DATES: Only written comments and/or applications for a license which 
are received by the National Institute of Diabetes and Digestive and 
Kidney Disease's Technology Advancement Office on or before April 28, 
2020 will be considered.

ADDRESSES: Requests for copies of the patent applications, inquiries, 
and comments relating to the contemplated an Exclusive Patent License 
should be directed to: Vladimir Knezevic, MD, (Senior) Advisor for 
Commercial Evaluation, Technology Advancement Office, Building 12A, 
Room 3011, Bethesda, MD 20817-5632 (for business mail), Telephone: 
(301)-435-5560; Email: [email protected].

SUPPLEMENTARY INFORMATION: 

Intellectual Property

    I. U.S. Pat: 9,511,103 issued 2016-12-06, entitled ``AAV mediated 
exendin-4 gene transfer to salivary glands to protect subjects from 
diabetes or obesity'' (HHS Reference Number E-142-2011-0-US-05).
    II. U.S. Divisional Pat: 10,300,095 issued 2019-05-28, entitled 
``AAV mediated exendin-4 gene transfer to salivary glands to protect 
subjects from diabetes or obesity'' (HHS Reference Number E-142-2011-0-
US-6).
    III. European Patent National Stage: EP2709653 granted 2017-11-22, 
entitled ``AAV mediated exendin-4 gene transfer to salivary glands to 
protect subjects from diabetes or obesity'' (HHS Reference Number E-
142-2011-0EP-04), validated in Great Britain, France and Germany.
    IV. U.S. Patent Application No. 16/396,262 filed 2019-04-26, 
entitled ``AAV Mediated Exendin-4 Gene Transfer to Salivary Glands to 
Protect Subjects from Diabetes or Obesity'' (HHS Reference Number E-
142-2011-0-US-10).
    V. Canadian Application No. 2,833,623 filed 2012-04-19, entitled 
``AAV Mediated Exendin-4 Gene Transfer to Salivary Glands to Protect 
Subjects from Diabetes or Obesity'' (HHS Reference Number E-142-2011-0-
CA-03).
    The patent rights in these inventions have been assigned or 
exclusively licensed to the Government of the United States of America.
    The prospective exclusive license territory may be worldwide and in 
fields of use that may be limited to prevention and treatment of type-2 
diabetes and obesity.
    The above-listed patent portfolio covers inventions directed to 
gene therapy and specifically, expression vectors and therapeutic 
methods of using such vectors in the treatment of type-2 diabetes and 
obesity.
    This notice is made in accordance with 35 U.S.C. 209 and 37 CFR 
part 404. The prospective exclusive license will be royalty bearing. 
The prospective exclusive license may be granted unless within fifteen 
(15) days from the date of this published notice, the National 
Institute of Diabetes and Digestive and Kidney Disease receives written 
evidence and argument that establishes that the grant of the license 
would not be consistent with the requirements of 35 U.S.C. 209 and 37 
CFR part 404.
    In response to this Notice, the public may file comments or 
objections. Comments and objections, other than those in the form of a 
license application, will not be treated confidentially and may be made 
publicly available.
    License applications submitted in response to this notice will be 
presumed to contain business confidential information and any release 
of information in these license applications will be made only as 
required and upon a request under the Freedom of Information Act, 5 
U.S.C. 552.

    Dated: April 1, 2020.
Vladimir Knezevic,
Senior Advisor for Commercial Evaluation, Technology Advancement 
Office, National Institute of Diabetes and Digestive and Kidney 
Disease.
[FR Doc. 2020-07706 Filed 4-10-20; 8:45 am]
 BILLING CODE 4140-01-P

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