Prospective Grant of an Exclusive Patent License: Adeno-Associated Virus Polynucleotides, Polypeptides and Virions, 34246 [2021-13826]
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Federal Register / Vol. 86, No. 122 / Tuesday, June 29, 2021 / Notices
Dated: June 23, 2021.
Tyeshia M. Roberson,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2021–13814 Filed 6–28–21; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; 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.
The meeting 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 DSK11XQN23PROD with NOTICES1
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; NIH Support for
Conferences and Scientific Meetings (Parent
R13 Clinical Trial Not Allowed).
Date: July 26–28, 2021.
Time: 7:30 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications and/or proposals.
Place: National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 3F21B,
Rockville, MD 20892 (Virtual Meeting).
Contact Person: Maryam Feili-Hariri,
Ph.D., Scientific Review Officer, Scientific
Review Program, Division of Extramural
Activities, National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 3F21B,
Rockville, MD 20852, (240) 669–5026,
haririmf@niaid.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
Dated: June 23, 2021.
Tyeshia M. Roberson,
Program Analyst,Office of Federal Advisory
Committee Policy.
[FR Doc. 2021–13815 Filed 6–28–21; 8:45 am]
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The patent rights in these inventions
have been assigned to the Government
of the United States of America, Sydney
National Institutes of Health
Children’s Hospital Network, and the
Children’s Medical Research Institute
Prospective Grant of an Exclusive
(CMRI), a co-owner of said rights, for
Patent License: Adeno-Associated
commercial development and
Virus Polynucleotides, Polypeptides
marketing. The prospective patent
and Virions
license will be for the purpose of
consolidating the patent rights to CMRI.
AGENCY: National Institutes of Health,
Consolidation of these co-owned rights
HHS.
is intended to expedite development of
ACTION: Notice.
the invention, consistent with the goals
SUMMARY: The National Heart, Lung, and of the Bayh-Dole Act codified as 35
Blood Institute, an institute of the
U.S.C. 200–212. The prospective patent
National Institutes of Health,
license will be worldwide, exclusive,
Department of Health and Human
may be limited to those fields of use
Services, is contemplating the grant of
commensurate in scope with the patent
an Exclusive, Sublicensable Patent
rights, and will be sublicensable.
The subject technology pertains to a
License to consolidate co-owned rights
‘‘fossilized’’ AAV-derived endogenous
to the inventions and the Patents and
viral element (referred to as mAAV–
Patent Applications listed in the
EVE) within the germline of an ancient
SUPPLEMENTARY INFORMATION section of
lineage of Australian marsupials. This
this notice to The Children’s Medical
novel AAV coat protein sequence of
Research Institute, having a place of
mAAV–EVE may provide the basis for
business in Westmead NSW, Australia.
recombinant AAV vectors with unique
DATES: Only written comments and/or
biological properties.
applications for a license that are
This notice is made in accordance
received by the National Heart, Lung,
with 35 U.S.C. 209 and 37 CFR 404. The
and Blood Institute Office of
prospective Exclusive Patent License
Technology and Development on or
will be royalty bearing and may be
before July 14, 2021 will be considered.
granted unless, within fifteen (15) days
ADDRESSES: Requests for a copy of the
from the date of this published notice,
patent application(s), inquiries, and
the National Heart, Lung, and Blood
comments relating to the contemplated
Institute Office of Technology Transfer
license should be directed to: John R.
and Development receives written
DeVany, Technology Transfer Analyst,
evidence and argument that establishes
NHLBI Office of Technology Transfer
and Development, Telephone: 301–594– that the grant of the license would not
be consistent with the requirements of
2436; email: john.devany@nih.gov.
35 U.S.C. 209 and 37 CFR 404.
SUPPLEMENTARY INFORMATION:
Complete applications for a license
The following and all continuing U.S.
that are timely filed in response to this
and foreign patents/patent applications
notice will be treated as objections to
thereof are the intellectual properties to
this to the grant of the contemplated
be licensed under the prospective
exclusive patent license.
agreement:
In response to this Notice, the public
1. U.S. Provisional Patent Application No.
may file comments or objections.
62/331,188, filed May 3, 2016, entitled
Comments and objections, other than
‘‘Adeno-Associated Virus Polynucleotides
those in the form of a license
and Virions’’ [HHS Ref. No. E–156–2016–0–
application, will not be treated
US–01].
confidentially, and may be made
2. Patent Cooperation Treaty Patent
publicly available. License applications
Application No. PCT/US2017/030808, filed
submitted in response to this Notice
May 3, 2017, entitled ‘‘Adeno-Associated
will be presumed to contain business
Virus Polynucleotides and Virions’’ [HHS
Ref. No. E–156–2016–0–PCT–02].
confidential information and any release
3. Australian National Phase Patent
of information from these license
Application No. 2017261249, filed October
applications will be made only as
30, 2018, entitled ‘‘Adeno-Associated Virus
required and upon a request under the
Polynucleotides and Virions’’ [HHS Ref. No.
Freedom of Information Act, 5 U.S.C.
E–156–2016–0–AU–03].
552.
4. U.S. Patent No. 10,882,886 issued
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
January 5, 2021, entitled ‘‘Adeno-Associated
Virus Polynucleotides and Virions’’ [HHS
Ref. No. E–156–2016–0–US–04].
5. European National Phase Patent
Application No. 17793239.9 filed December
3, 2018, entitled ‘‘Adeno-Associated Virus
Polynucleotides and Virions’’ [HHS Ref. No.
E–156–2016–0–EP–05].
PO 00000
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Dated: June 22, 2021.
Bruce D. Goldstein,
Director, Office of Technology Transfer and
Development, National Heart, Lung, and
Blood Institute.
[FR Doc. 2021–13826 Filed 6–28–21; 8:45 am]
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[Federal Register Volume 86, Number 122 (Tuesday, June 29, 2021)]
[Notices]
[Page 34246]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-13826]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive Patent License: Adeno-
Associated Virus Polynucleotides, Polypeptides and Virions
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The National Heart, Lung, and Blood Institute, an institute of
the National Institutes of Health, Department of Health and Human
Services, is contemplating the grant of an Exclusive, Sublicensable
Patent License to consolidate co-owned rights to the inventions and the
Patents and Patent Applications listed in the SUPPLEMENTARY INFORMATION
section of this notice to The Children's Medical Research Institute,
having a place of business in Westmead NSW, Australia.
DATES: Only written comments and/or applications for a license that are
received by the National Heart, Lung, and Blood Institute Office of
Technology and Development on or before July 14, 2021 will be
considered.
ADDRESSES: Requests for a copy of the patent application(s), inquiries,
and comments relating to the contemplated license should be directed
to: John R. DeVany, Technology Transfer Analyst, NHLBI Office of
Technology Transfer and Development, Telephone: 301-594-2436; email:
[email protected].
SUPPLEMENTARY INFORMATION:
The following and all continuing U.S. and foreign patents/patent
applications thereof are the intellectual properties to be licensed
under the prospective agreement:
1. U.S. Provisional Patent Application No. 62/331,188, filed May
3, 2016, entitled ``Adeno-Associated Virus Polynucleotides and
Virions'' [HHS Ref. No. E-156-2016-0-US-01].
2. Patent Cooperation Treaty Patent Application No. PCT/US2017/
030808, filed May 3, 2017, entitled ``Adeno-Associated Virus
Polynucleotides and Virions'' [HHS Ref. No. E-156-2016-0-PCT-02].
3. Australian National Phase Patent Application No. 2017261249,
filed October 30, 2018, entitled ``Adeno-Associated Virus
Polynucleotides and Virions'' [HHS Ref. No. E-156-2016-0-AU-03].
4. U.S. Patent No. 10,882,886 issued January 5, 2021, entitled
``Adeno-Associated Virus Polynucleotides and Virions'' [HHS Ref. No.
E-156-2016-0-US-04].
5. European National Phase Patent Application No. 17793239.9
filed December 3, 2018, entitled ``Adeno-Associated Virus
Polynucleotides and Virions'' [HHS Ref. No. E-156-2016-0-EP-05].
The patent rights in these inventions have been assigned to the
Government of the United States of America, Sydney Children's Hospital
Network, and the Children's Medical Research Institute (CMRI), a co-
owner of said rights, for commercial development and marketing. The
prospective patent license will be for the purpose of consolidating the
patent rights to CMRI. Consolidation of these co-owned rights is
intended to expedite development of the invention, consistent with the
goals of the Bayh-Dole Act codified as 35 U.S.C. 200-212. The
prospective patent license will be worldwide, exclusive, may be limited
to those fields of use commensurate in scope with the patent rights,
and will be sublicensable.
The subject technology pertains to a ``fossilized'' AAV-derived
endogenous viral element (referred to as mAAV-EVE) within the germline
of an ancient lineage of Australian marsupials. This novel AAV coat
protein sequence of mAAV-EVE may provide the basis for recombinant AAV
vectors with unique biological properties.
This notice is made in accordance with 35 U.S.C. 209 and 37 CFR
404. The prospective Exclusive Patent License will be royalty bearing
and may be granted unless, within fifteen (15) days from the date of
this published notice, the National Heart, Lung, and Blood Institute
Office of Technology Transfer and Development 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 404.
Complete applications for a license that are timely filed in
response to this notice will be treated as objections to this to the
grant of the contemplated exclusive patent 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: June 22, 2021.
Bruce D. Goldstein,
Director, Office of Technology Transfer and Development, National
Heart, Lung, and Blood Institute.
[FR Doc. 2021-13826 Filed 6-28-21; 8:45 am]
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