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]
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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
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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
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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: https://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: https://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]
-----------------------------------------------------------------------
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
