Prospective Grant of Exclusive Patent License: Development and Commercialization of Regulatory T-Cell Therapies for the Treatment of Multiple Sclerosis (MS), 3832 [2022-01330]
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Federal Register / Vol. 87, No. 16 / Tuesday, January 25, 2022 / Notices
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Wenjuan Wang, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institute of
Health, 6701 Rockledge Drive, Room 3154,
Bethesda, MD 20892, (301) 480–8667,
wangw22@mail.nih.gov.
Name of Committee: Digestive, Kidney and
Urological Systems Integrated Review Group;
Pathobiology of Kidney Disease Study
Section.
Date: March 2–3, 2022.
Time: 9:00 a.m. to 8:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Atul Sahai, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 2188,
MSC 7818, Bethesda, MD 20892, 301–435–
1198, sahaia@csr.nih.gov.
Name of Committee: Infectious Diseases
and Immunology B Integrated Review Group;
Host Interactions with Bacterial Pathogens
Study Section.
Date: March 2–3, 2022.
Time: 9:30 a.m. to 8:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892, (Virtual Meeting).
Contact Person: Michelle Marie Arnold,
Ph.D., Scientific Review Officer, Center for
Scientific Review, 6701 Rockledge Drive,
Bethesda, MD 20892, (301) 451–7806,
michelle.arnold@nih.gov.
(Catalogue of Federal Domestic Assistance
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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: January 20, 2022.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2022–01421 Filed 1–24–22; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
khammond on DSKJM1Z7X2PROD with NOTICES
National Institutes of Health
Prospective Grant of Exclusive Patent
License: Development and
Commercialization of Regulatory T-Cell
Therapies for the Treatment of Multiple
Sclerosis (MS)
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
The National Institute of
Allergy and Infectious Diseases, an
SUMMARY:
VerDate Sep<11>2014
17:19 Jan 24, 2022
Jkt 256001
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
Gaithersburg, Maryland, USA.
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 9,
2022 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: prabhuyo@
niaid.nih.gov.
SUPPLEMENTARY INFORMATION:
Intellectual Property
• U.S. Patent 9,481,866, entitled
‘‘Methods of Producing T Cell
Populations Enriched for Stable
Regulatory T-Cells’’ [HHS Reference
No. E–279–2011/0–US–02]
• U.S. Patent 11,060,059, entitled
‘‘Methods of Producing T Cell
Populations Enriched for Stable
Regulatory T-Cells’’ [HHS Reference
No. E–279–2011/0–US–03]
• U.S. Divisional Application No. 17/
371,589—filed July 9, 2021, entitled
‘‘Methods of Producing T Cell
Populations Enriched for Stable
Regulatory T-Cells’’ [HHS Reference
No. E–279–2011/0–US–04]
The patent and patent application
rights in these inventions have been
assigned 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: ‘‘Use of
the Licensed Patent Rights to develop
and commercialize Treg cell therapies
for the treatment of multiple sclerosis
(MS).’’
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
PO 00000
Frm 00079
Fmt 4703
Sfmt 4703
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.
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, unless 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 19, 2022.
Surekha Vathyam,
Deputy Director, Technology Transfer and
Intellectual Property Office, National Institute
of Allergy and Infectious Diseases.
[FR Doc. 2022–01330 Filed 1–24–22; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Human Genome Research
Institute; Notice of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
E:\FR\FM\25JAN1.SGM
25JAN1
]]>Agencies
[Federal Register Volume 87, Number 16 (Tuesday, January 25, 2022)]
[Notices]
[Page 3832]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-01330]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive Patent License: Development and
Commercialization of Regulatory T-Cell Therapies for the Treatment of
Multiple Sclerosis (MS)
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 Gaithersburg,
Maryland, USA.
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 9, 2022 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, entitled ``Methods of Producing T Cell
Populations Enriched for Stable Regulatory T-Cells'' [HHS Reference No.
E-279-2011/0-US-02]
U.S. Patent 11,060,059, entitled ``Methods of Producing T Cell
Populations Enriched for Stable Regulatory T-Cells'' [HHS Reference No.
E-279-2011/0-US-03]
U.S. Divisional Application No. 17/371,589--filed July 9,
2021, entitled ``Methods of Producing T Cell Populations Enriched for
Stable Regulatory T-Cells'' [HHS Reference No. E-279-2011/0-US-04]
The patent and patent application rights in these inventions have
been assigned 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: ``Use of the Licensed Patent Rights
to develop and commercialize Treg cell therapies for the treatment of
multiple sclerosis (MS).''
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. 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, unless 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 19, 2022.
Surekha Vathyam,
Deputy Director, Technology Transfer and Intellectual Property Office,
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2022-01330 Filed 1-24-22; 8:45 am]
BILLING CODE 4140-01-P
