Prospective Grant of Exclusive Patent License: Development of RegulatoryT-Cell Therapies for the Treatment of Hemophilia A (HA), 3062-3063 [2020-00721]
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Federal Register / Vol. 85, No. 12 / Friday, January 17, 2020 / Notices
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Average
burden per
response
(in hours)
Total burden
hours
Form name
Application Waiver/Supplemental A Research ....................
Application Waiver/Supplemental B Clinical Care ..............
HHS 426 ........
HHS 426 ........
45
35
1
1
10
10
450
350
Total ..............................................................................
........................
........................
........................
........................
800
Terry Clark,
Office of the Secretary, Asst Paperwork
Reduction Act Reports Clearance Officer.
[FR Doc. 2020–00717 Filed 1–16–20; 8:45 am]
BILLING CODE 4150–38–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Mental Health;
Notice of Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
lotter on DSKBCFDHB2PROD with NOTICES
Number of
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Number of
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Type of respondent
Name of Committee: National Institute of
Mental Health Special Emphasis Panel; Early
Phase Clinical Trials for Psychosocial
Interventions.
Date: February 11, 2020.
Time: 9:00 a.m. to 5:00 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: David I. Sommers, Ph.D.,
Scientific Review Officer, Division of
Extramural Activities, National Institute of
Mental Health, National Institutes of Health,
6001 Executive Blvd., Room 6154, MSC 9606,
Bethesda, MD 20892, 301–443–7861,
dsommers@mail.nih.gov.
Name of Committee: National Institute of
Mental Health Special Emphasis Panel; Early
Phase Clinical Trials—Pharma/Device.
Date: February 20, 2020.
Time: 11:30 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center Building (NSC), 6001
VerDate Sep<11>2014
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Executive Boulevard, Rockville, MD 20852
(Telephone Conference Call).
Contact Person: David I. Sommers, Ph.D.,
Scientific Review Officer, Division of
Extramural Activities, National Institute of
Mental Health, National Institutes of Health,
6001 Executive Blvd., Room 6154, MSC 9606,
Bethesda, MD 20892, 301–443–7861,
dsommers@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.242, Mental Health Research
Grants, National Institutes of Health, HHS)
Technology Transfer and Patent
Specialist, Technology Transfer and
Intellectual Property Office, National
Institute of Allergy and Infectious
Diseases, 5601 Fishers Lane, Suite 6D,
MSC9804, Rockville, MD 20852–9804;
Telephone: (301) 496–2644; Facsimile:
(240) 627–3117; Email: prabhuyo@
niaid.nih.gov.
SUPPLEMENTARY INFORMATION:
Dated: January 13, 2020.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
Intellectual Property
• U.S. Patent 9,481,866—issued
November 1, 2016, entitled ‘‘Methods
of Producing T Cell Populations
Enriched for Stable Regulatory TCells’’ [HHS Reference No. E–279–
2011/0–US–02]
• U.S. Divisional Application No.15/
284,840—filed October 4, 2016,
entitled ‘‘Methods of Producing T Cell
Populations Enriched for Stable
Regulatory T-Cells’. [HHS Reference
No. E–279–2011/0–US–03]
The patent rights in these inventions
have been assigned to the government of
the United States of America.
The prospective exclusive license
territory will be the United States and
the field of use will be limited to:
‘‘Human cell-based therapeutics for the
treatment of Hemophilia A in patients
that have inhibitory Factor VIII
antibodies.’’
The technology is directed to a
method for producing or growing cell
populations that are enriched for stable,
highly suppressive regulatory T cells
(Tregs). Tregs are critical in regulating
immune system processes that maintain
tolerance to self-antigens and prevent
immune mediated diseases. The method
takes a population of cells comprising
stable, regulatory T cells and enriched
for specific CD markers, cultures these
cells in the presence of interleukin-2, an
anti-CD3 antibody, an anti-CD28
antibody, and oligodeoxynucleotides of
specified length having a
phosphorothioate backbone, and yields
the expansion of the initial population
of regulatory T-cells. The expanded
Tregs may then be used for the
treatment of immune-mediated diseases.
This notice is made in accordance
with 35 U.S.C. 209 and 37 CFR part 404.
[FR Doc. 2020–00688 Filed 1–16–20; 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 Regulatory
T-Cell Therapies for the Treatment of
Hemophilia A (HA)
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
The National Institute of
Allergy and Infectious Diseases, an
institute of the National Institutes of
Health, Department of Health and
Human Services, is contemplating the
grant of an Exclusive Patent License to
practice the inventions embodied in the
Patents and Patent Applications listed
in the SUPPLEMENTARY INFORMATION
section of this notice to TeraImmune,
Inc. (‘‘TeraImmune’’) located in
Rockville, Maryland.
DATES: Only written comments and/or
applications for a license which are
received by the National Institute of
Allergy and Infectious Diseases’
Technology Transfer and Intellectual
Property Office on or before February 3,
2020 will be considered.
ADDRESSES: Requests for copies of the
patent application, inquiries, and
comments relating to the contemplated
Exclusive Patent License should be
directed to: Dr. Yogikala Prabhu,
SUMMARY:
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17JAN1
Federal Register / Vol. 85, No. 12 / Friday, January 17, 2020 / Notices
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
Institute of Allergy and Infectious
Diseases 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 exclusive patent
commercialization license. 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 from 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: January 6, 2020.
Wade W. Green,
Acting Deputy Director, Technology Transfer
and Intellectual Property Office, National
Institute of Allergy and Infectious Diseases.
[FR Doc. 2020–00721 Filed 1–16–20; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
lotter on DSKBCFDHB2PROD with NOTICES
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Brain Disorders and
Clinical Neuroscience Integrated Review
Group; Clinical Neuroscience and
Neurodegeneration Study Section.
VerDate Sep<11>2014
18:20 Jan 16, 2020
Jkt 250001
Date: February 10–11, 2020.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892.
Contact Person: Alessandra C. Rovescalli,
Ph.D., Scientific Review Officer, National
Institutes of Health, Center for Scientific
Review, 6701 Rockledge Drive, Rm. 5205
MSC 7846, Bethesda, MD 20892, (301) 435–
1021, rovescaa@mail.nih.gov.
Name of Committee: Healthcare Delivery
and Methodologies Integrated Review Group;
Biomedical Computing and Health
Informatics Study Section.
Date: February 12–13, 2020.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: AC Hotel by Marriott National
Harbor, 156 Waterfront Street, National
Harbor, MD 20745.
Contact Person: Karen Nieves Lugo,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, Bethesda, MD 20892, (301) 594–9088,
karen.nieveslugo@nih.gov.
Name of Committee: Interdisciplinary
Molecular Sciences and Training Integrated
Review Group; Cellular and Molecular
Technologies Study Section.
Date: February 12–13, 2020
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Bahia Resort Hotel, 998 West
Mission Bay Drive, San Diego, CA 92109.
Contact Person: Tatiana V. Cohen, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5213,
Bethesda, MD 20892, 301–455–2364,
tatiana.cohen@nih.gov.
Name of Committee: Population Sciences
and Epidemiology Integrated Review Group;
Biostatistical Methods and Research Design
Study Section.
Date: February 13–14, 2020.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: San Francisco Marriott Fisherman’s
Wharf, 1250 Columbus Ave., San Francisco,
CA 94133.
Contact Person: Chittari V. Shivakumar,
Ph.D., Scientific Review Officer, National
Institutes of Health, Center for Scientific
Review, 6701 Rockledge Drive, Bethesda, MD
20892, 301–408–9098, chittari.shivakumar@
nih.gov.
Name of Committee: Interdisciplinary
Molecular Sciences and Training Integrated
Review Group; Enabling Bioanalytical and
Imaging Technologies Study Section
Date: February 13–14, 2020.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Washington Marriott Georgetown,
1221 22nd Street NW, Washington, DC
20037.
Contact Person: Kenneth Ryan, Ph.D.,
Scientific Review Officer, Center for
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Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3218,
MSC 7717, Bethesda, MD 20892, 301–435–
0229, kenneth.ryan@nih.hhs.gov.
Name of Committee: Endocrinology,
Metabolism, Nutrition and Reproductive
Sciences Integrated Review Group; Clinical
and Integrative Diabetes and Obesity Study
Section.
Date: February 13–14, 2020.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Renaissance Mayflower Hotel, 1127
Connecticut Avenue NW, Washington, DC
20036.
Contact Person: Hui Chen, MD, Scientific
Review Officer, Center for Scientific Review,
National Institutes of Health, 6701 Rockledge
Drive Bethesda, MD 20892, 301–435–1044,
chenhui@csr.nih.gov.
Name of Committee: Endocrinology,
Metabolism, Nutrition and Reproductive
Sciences Integrated Review Group;
Integrative Physiology of Obesity and
Diabetes Study Section
Date: February 13–14, 2020.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Washington Marriott Metro Center,
775 12th Street NW, Washington, DC 20005.
Contact Person: Raul Rojas, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6185,
MSC, Bethesda, MD 20892, (301) 451–6319.
rojasr@mail.nih.gov.
Name of Committee: Vascular and
Hematology Integrated Review Group;
Atherosclerosis and Inflammation of the
Cardiovascular System Study Section.
Date: February 13–14, 2020.
Time: 8:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Catamaran Resort, 3999 Mission
Boulevard, San Diego, CA 92109.
Contact Person: Natalia Komissarova,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5207,
MSC 7846, Bethesda, MD 20892, 301–435–
1206, komissar@mail.nih.gov.
Name of Committee: Cell Biology
Integrated Review Group; Membrane Biology
and Protein Processing Study Section.
Date: February 13–14, 2020.
Time: 8:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Residence Inn Bethesda, 7335
Wisconsin Avenue, Bethesda, MD 20814.
Contact Person: Janet M. Larkin, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5142,
MSC 7840, Bethesda, MD 20892, 301–806–
2765, larkinja@csr.nih.gov
Name of Committee: Molecular, Cellular
and Developmental Neuroscience Integrated
Review Group; Biophysics of Neural Systems
Study Section.
Date: February 13–14, 2020.
Time: 8:00 a.m. to 6:00 p.m.
E:\FR\FM\17JAN1.SGM
17JAN1
]]>Agencies
[Federal Register Volume 85, Number 12 (Friday, January 17, 2020)]
[Notices]
[Pages 3062-3063]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-00721]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive Patent License: Development of
Regulatory T-Cell Therapies for the Treatment of Hemophilia A (HA)
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The National Institute of Allergy and Infectious Diseases, an
institute of the National Institutes of Health, Department of Health
and Human Services, is contemplating the grant of an Exclusive Patent
License to practice the inventions embodied in the Patents and Patent
Applications listed in the Supplementary Information section of this
notice to TeraImmune, Inc. (``TeraImmune'') located in Rockville,
Maryland.
DATES: Only written comments and/or applications for a license which
are received by the National Institute of Allergy and Infectious
Diseases' Technology Transfer and Intellectual Property Office on or
before February 3, 2020 will be considered.
ADDRESSES: Requests for copies of the patent application, inquiries,
and comments relating to the contemplated Exclusive Patent License
should be directed to: Dr. Yogikala Prabhu, Technology Transfer and
Patent Specialist, Technology Transfer and Intellectual Property
Office, National Institute of Allergy and Infectious Diseases, 5601
Fishers Lane, Suite 6D, MSC9804, Rockville, MD 20852-9804; Telephone:
(301) 496-2644; Facsimile: (240) 627-3117; Email:
[email protected].
SUPPLEMENTARY INFORMATION:
Intellectual Property
U.S. Patent 9,481,866--issued November 1, 2016, entitled
``Methods of Producing T Cell Populations Enriched for Stable
Regulatory T-Cells'' [HHS Reference No. E-279-2011/0-US-02]
U.S. Divisional Application No.15/284,840--filed October 4,
2016, entitled ``Methods of Producing T Cell Populations Enriched for
Stable Regulatory T-Cells'. [HHS Reference No. E-279-2011/0-US-03]
The patent rights in these inventions have been assigned to the
government of the United States of America.
The prospective exclusive license territory will be the United
States and the field of use will be limited to: ``Human cell-based
therapeutics for the treatment of Hemophilia A in patients that have
inhibitory Factor VIII antibodies.''
The technology is directed to a method for producing or growing
cell populations that are enriched for stable, highly suppressive
regulatory T cells (Tregs). Tregs are critical in regulating immune
system processes that maintain tolerance to self-antigens and prevent
immune mediated diseases. The method takes a population of cells
comprising stable, regulatory T cells and enriched for specific CD
markers, cultures these cells in the presence of interleukin-2, an
anti-CD3 antibody, an anti-CD28 antibody, and oligodeoxynucleotides of
specified length having a phosphorothioate backbone, and yields the
expansion of the initial population of regulatory T-cells. The expanded
Tregs may then be used for the treatment of immune-mediated diseases.
This notice is made in accordance with 35 U.S.C. 209 and 37 CFR
part 404.
[[Page 3063]]
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 Institute of
Allergy and Infectious Diseases 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 exclusive patent
commercialization license. 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 from 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: January 6, 2020.
Wade W. Green,
Acting Deputy Director, Technology Transfer and Intellectual Property
Office, National Institute of Allergy and Infectious Diseases.
[FR Doc. 2020-00721 Filed 1-16-20; 8:45 am]
BILLING CODE 4140-01-P
