Prospective Grant of Exclusive Patent License: Development of Adeno-Associated Virus-Based Vectors for the Treatment of Menkes Disease and Related Copper Transport Disorders, 66047-66048 [2016-23134]

Download as PDF mstockstill on DSK3G9T082PROD with NOTICES Federal Register / Vol. 81, No. 186 / Monday, September 26, 2016 / Notices Review Group; Macromolecular Structure and Function A Study Section. Date: October 25–26, 2016. Time: 8:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: Hyatt Regency Bethesda, One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814. Contact Person: Nitsa Rosenzweig, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4152, MSC 7760, Bethesda, MD 20892, (301) 404– 7419, rosenzweign@csr.nih.gov. Name of Committee: Cell Biology Integrated Review Group; Biology of the Visual System Study Section. Date: October 25–26, 2016. Time: 8:00 a.m. to 3:00 p.m. Agenda: To review and evaluate grant applications. Place: Hilton Washington/Rockville, 1750 Rockville Pike, Rockville, MD 20852. Contact Person: Michael H. Chaitin, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5202, MSC 7850, Bethesda, MD 20892, (301) 435– 0910, chaitinm@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Developing and Adult Neural Circuits. Date: October 25, 2016. Time: 11:00 a.m. to 3:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Jana Drgonova, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5213, Bethesda, MD 20892, jdrgonova@ mail.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Research Resource: Advanced NMR Technology. Date: October 25–27, 2016. Time: 7:00 p.m. to 1:00 p.m. Agenda: To review and evaluate grant applications. Place: Residence Inn Tallahassee Universities at Capitol, 600 W. Gaines St., Tallahassee, FL 32304. Contact Person: Marie-Jose Belanger, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5181, Bethesda, MD 20892, belangerm@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Cancer Immunotherapy. Date: October 25, 2016. Time: 12:00 p.m. to 2:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Syed M. Quadri, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of VerDate Sep<11>2014 19:40 Sep 23, 2016 Jkt 238001 Health, 6701 Rockledge Drive, Room 6210, MSC 7804, Bethesda, MD 20892, 301–435– 1211, quadris@csr.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393–93.396, 93.837–93.844, 93.846–93.878, 93.892, 93.893, National Institutes of Health, HHS) Dated: September 21, 2016. Natasha M. Copeland, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2016–23135 Filed 9–23–16; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Exclusive Patent License: Development of AdenoAssociated Virus-Based Vectors for the Treatment of Menkes Disease and Related Copper Transport Disorders AGENCY: National Institutes of Health, HHS. ACTION: Notice. The Eunice Kennedy Shriver National Institute of Child Health and Human Development, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Commercialization Patent License to practice the inventions embodied in the U.S. Patents and Patent Applications listed in the Supplementary Information section of this notice to Cyprium Therapeutics, Inc. (‘‘Cyprium’’) located in New York, NY, USA. SUMMARY: Only written comments and/or applications for a license which are received by the National Cancer Institute’s Technology Transfer Center on or before October 11, 2016 will be considered. DATES: Requests for copies of the patent application, inquiries, and comments relating to the contemplated Exclusive Commercialization Patent License should be directed to: Surekha Vathyam, Ph.D., Senior Licensing and Patenting Manager, NCI Technology Transfer Center, 9609 Medical Center Drive, RM 1E530 MSC 9702, Bethesda, MD 20892–9702 (for business mail), Rockville, MD 20850–9702; Telephone: (240) 276–5530; Facsimile: (240) 276– 5504; Email: vathyams@mail.nih.gov. ADDRESSES: SUPPLEMENTARY INFORMATION: PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 66047 Intellectual Property United States Provisional Patent Application No. 62/244,594, filed October 21, 2015 and entitled ‘‘Codonoptimized Reduced-size ATP7A cDNA and Uses for Treatment of Copper Transport Disorders’’ [HHS Reference No. E–062–2015/0–US–01]. The patent rights in these inventions have been assigned and/or exclusively licensed to the government of the United States of America. The prospective exclusive license territory may be worldwide and the field of use may be limited to the use of Licensed Patent Rights for the following: ‘‘Development and commercialization of adeno-associated virus-based vectors for the treatment of Menkes Disease and related copper transport disorders.’’ This technology discloses a codonoptimized reduced-size Adenosine Triphosphate 7A (ATP7-alpha or ATP7A) cDNA, vectors, and recombinant adeno-associated viruses (AAVs) and uses thereof for treatment of copper transport disorders. Such uses, include the administration of copper in addition to ATP7A in order to maximize the advantage of the gene therapy. Human P-type ATPase coppertransporting ATPase 1 (ATP7A) transports copper from enterocytes (where it is taken up from dietary copper) into the blood. ATP7A also mediates passage of copper across the blood-cerebrospinal fluid barrier and the blood-brain barrier. In Menkes disease and occipital horn syndrome (OHS), ATP7A activity is reduced or absent and copper export from the enterocytes is impaired. As a result, copper accumulates in intestinal cells and less copper is delivered to the blood, resulting in restricted copper supply to other tissues, particularly the brain. If successfully developed, this invention would be a first of its kind therapy for treating copper transport disorders, such as Menkes disease, OHS, or ATP7A-related distal motor neuropathy, by administering the disclosed nucleic acid, vector, or recombinant virus to a subject with a copper transport disorder. This notice is made in accordance with 35 U.S.C. 209 and 37 CFR part 404. The prospective Exclusive Commercialization Patent License will be royalty bearing and 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 E:\FR\FM\26SEN1.SGM 26SEN1 66048 Federal Register / Vol. 81, No. 186 / Monday, September 26, 2016 / Notices requirements of 35 U.S.C. 209 and 37 CFR part 404. Complete applications for a license in the prospective field of use that are filed in response to this notice will be treated as objections to the grant of the contemplated Exclusive Commercialization Patent License Agreement. Comments and objections submitted to this notice will not be made available for public inspection and, to the extent permitted by law, will not be released under the Freedom of Information Act, 5 U.S.C. 552. Dated: September 21, 2016. Richard U. Rodriguez, Associate Director, Technology Transfer Center, National Cancer Institute. [FR Doc. 2016–23134 Filed 9–23–16; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Start-Up Exclusive Evaluation Patent License: Development of Autologous Tumorreactive T Cells Isolated From Peripheral Blood for the Treatment of Metastatic Follicular Thyroid Cancer and Metastatic Soft Tissue Sarcomas National Institutes of Health. Notice. AGENCY: ACTION: The National Cancer Institute, National Institutes of Health, Department of Health and Human Services, is contemplating the grant of a Start-up Exclusive Evaluation Patent License to MedGene Therapeutics, Inc. (‘‘MedGene’’) located in Bethesda, MD to practice the inventions embodied in the patent applications listed Supplementary Information section of this notice. DATES: Only written comments and/or applications for a license which are received by the NCI Technology Transfer Center on or before October 11, 2016 will be considered. ADDRESSES: Requests for copies of the patent applications, inquiries, and comments relating to the contemplated Start-up Exclusive Evaluation Patent License should be directed to: Andrew Burke, Ph.D., Licensing and Patenting Manager, NCI Technology Transfer Center, 9609 Medical Center Drive, RM 1E530 MSC 9702, Bethesda, MD 20892– 9702 (for business mail), Rockville, MD 20850–9702 Telephone: (240) 276–5530; Facsimile: (240) 276–5504; Email: andy.burke@nih.gov. SUPPLEMENTARY INFORMATION: United States Provisional Patent Application mstockstill on DSK3G9T082PROD with NOTICES SUMMARY: VerDate Sep<11>2014 19:40 Sep 23, 2016 Jkt 238001 No. 61/771,251 filed March 1, 2013, entitled ‘‘Methods of Producing Enriched Populations of Tumor Reactive T Cells from Peripheral Blood’’ [HHS Reference No. E–085–2013/0–US–01]; and PCT Application No. PCT/US2013/ 038813 filed April 30, 2013 entitled ‘‘Methods of Producing Enriched Populations of Tumor Reactive T Cells from Peripheral Blood’’ [HHS Reference No. E–085–2013/0–PCT–02] (and U.S. and foreign patent applications claiming priority to the aforementioned applications). The patent rights in these inventions have been assigned to the government of the United States of America. The prospective Start-up Exclusive Evaluation Patent License territory may be worldwide and the field of use may be limited to the development, manufacture and commercialization of autologous tumor-reactive peripheral blood T cell therapy products as set forth in the Licensed Patent Rights for the treatment of metastatic follicular thyroid cancer and metastatic soft tissue sarcomas in humans. The present invention describes a method of selecting highly tumorreactive T cells from autologous peripheral blood samples based on the expression of two specific T cell surface markers: Programmed cell death protein 1 (PD–1; CD279) and/or T cell Ig- and mucin-domain-containing molecule-3 (TIM–3). Following selection, isolated cells may be expanded and reinfused into the donor patient as part of an adoptive cell transfer therapeutic regimen. The disclosed method may be advantageous over existing approaches which rely on the isolation of T cells from tumor samples since it eliminates the cost and complications associated with tumor resection, as well as provides a T cell product for patients without resectable lesions. This notice is made in accordance with 35 U.S.C. 209 and 37 CFR part 404. The prospective Start-up Exclusive Evaluation Patent License will be royalty bearing and the 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. Complete applications for a license in the prospective field of use that are timely filed in response to this notice will be treated as objections to the grant of the contemplated Start-up Exclusive Evaluation Patent License. Comments and objections submitted to this notice will not be made available for public PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 inspection and, to the extent permitted by law, will not be released under the Freedom of Information Act, 5 U.S.C. 552. Dated: September 20, 2016. Richard U. Rodriguez, Associate Director, Technology Transfer Center, National Cancer Institute. [FR Doc. 2016–23048 Filed 9–23–16; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Neurological Disorders and Stroke Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of an Interagency Pain Research Coordinating Committee (IPRCC) meeting. The meeting will feature invited speakers and discussions of committee business items including a progress report on implementation of the National Pain Strategy, updates on the Federal Pain Research Strategy and new pain initiatives. The meeting will be open to the public and accessible by live webcast and conference call. Name of Committee: Interagency Pain Research Coordinating Committee. Type of meeting: Open Meeting. Date: October 31, 2016. Time: 8:30 a.m. to 5:00 p.m. *Eastern Time*—Approximate end time. Agenda: The meeting will feature invited speakers and discussions of Committee business items including a progress report on implementation of the National Pain Strategy, updates on the Federal Pain Research Strategy and new pain initiatives. Place: National Institutes of Health, Building 31C, 6th Floor, Room 10, 31 Center Drive, Bethesda, MD 20892. Cost: The meeting is free and open to the public. Webcast Live: http://videocast.nih.gov/. Deadlines: Notification of intent to present oral comments: Monday, October 17, 2016, by 5:00 p.m. ET. Submission of written/electronic statement for oral comments: Monday, October 24, 2016, by 5:00 p.m. ET. Submission of written comments: Monday, October 24, 2016, by 5:00 p.m. ET. Access: Medical Center Metro (Red Line). Visitor Information: http://www.nih.gov/ about/visitor/index.htm. Contact Person: Linda L. Porter, Ph.D., Pain Policy Advisor, Office of Pain Policy, Officer of the Director, National Institute of Neurological Disorders and Stroke, NIH, 31 Center Drive, Room 8A31, Bethesda, MD 20892, Phone: (301) 451–4460, Email: Linda.Porter@nih.gov. E:\FR\FM\26SEN1.SGM 26SEN1

Agencies

[Federal Register Volume 81, Number 186 (Monday, September 26, 2016)]
[Notices]
[Pages 66047-66048]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-23134]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive Patent License: Development of 
Adeno-Associated Virus-Based Vectors for the Treatment of Menkes 
Disease and Related Copper Transport Disorders

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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

SUMMARY: The Eunice Kennedy Shriver National Institute of Child Health 
and Human Development, an institute of the National Institutes of 
Health, Department of Health and Human Services, is contemplating the 
grant of an Exclusive Commercialization Patent License to practice the 
inventions embodied in the U.S. Patents and Patent Applications listed 
in the Supplementary Information section of this notice to Cyprium 
Therapeutics, Inc. (``Cyprium'') located in New York, NY, USA.

DATES: Only written comments and/or applications for a license which 
are received by the National Cancer Institute's Technology Transfer 
Center on or before October 11, 2016 will be considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
and comments relating to the contemplated Exclusive Commercialization 
Patent License should be directed to: Surekha Vathyam, Ph.D., Senior 
Licensing and Patenting Manager, NCI Technology Transfer Center, 9609 
Medical Center Drive, RM 1E530 MSC 9702, Bethesda, MD 20892-9702 (for 
business mail), Rockville, MD 20850-9702; Telephone: (240) 276-5530; 
Facsimile: (240) 276-5504; Email: vathyams@mail.nih.gov.

SUPPLEMENTARY INFORMATION:

Intellectual Property

    United States Provisional Patent Application No. 62/244,594, filed 
October 21, 2015 and entitled ``Codon-optimized Reduced-size ATP7A cDNA 
and Uses for Treatment of Copper Transport Disorders'' [HHS Reference 
No. E-062-2015/0-US-01].
    The patent rights in these inventions have been assigned and/or 
exclusively licensed to the government of the United States of America.
    The prospective exclusive license territory may be worldwide and 
the field of use may be limited to the use of Licensed Patent Rights 
for the following: ``Development and commercialization of adeno-
associated virus-based vectors for the treatment of Menkes Disease and 
related copper transport disorders.''
    This technology discloses a codon-optimized reduced-size Adenosine 
Triphosphate 7A (ATP7-alpha or ATP7A) cDNA, vectors, and recombinant 
adeno-associated viruses (AAVs) and uses thereof for treatment of 
copper transport disorders. Such uses, include the administration of 
copper in addition to ATP7A in order to maximize the advantage of the 
gene therapy.
    Human P-type ATPase copper-transporting ATPase 1 (ATP7A) transports 
copper from enterocytes (where it is taken up from dietary copper) into 
the blood. ATP7A also mediates passage of copper across the blood-
cerebrospinal fluid barrier and the blood-brain barrier. In Menkes 
disease and occipital horn syndrome (OHS), ATP7A activity is reduced or 
absent and copper export from the enterocytes is impaired. As a result, 
copper accumulates in intestinal cells and less copper is delivered to 
the blood, resulting in restricted copper supply to other tissues, 
particularly the brain. If successfully developed, this invention would 
be a first of its kind therapy for treating copper transport disorders, 
such as Menkes disease, OHS, or ATP7A-related distal motor neuropathy, 
by administering the disclosed nucleic acid, vector, or recombinant 
virus to a subject with a copper transport disorder.
    This notice is made in accordance with 35 U.S.C. 209 and 37 CFR 
part 404. The prospective Exclusive Commercialization Patent License 
will be royalty bearing and 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

[[Page 66048]]

requirements of 35 U.S.C. 209 and 37 CFR part 404.
    Complete applications for a license in the prospective field of use 
that are filed in response to this notice will be treated as objections 
to the grant of the contemplated Exclusive Commercialization Patent 
License Agreement. Comments and objections submitted to this notice 
will not be made available for public inspection and, to the extent 
permitted by law, will not be released under the Freedom of Information 
Act, 5 U.S.C. 552.

    Dated: September 21, 2016.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2016-23134 Filed 9-23-16; 8:45 am]
 BILLING CODE 4140-01-P