Prospective Grant of Exclusive Patent License: Development of Adeno-Associated Virus Vectors for the Treatment of Glycogen Storage Disease Type Ia, 32762-32763 [2016-12168]
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Federal Register / Vol. 81, No. 100 / Tuesday, May 24, 2016 / Notices
wild-type G6Pase-alpha and codonoptimized (co) G6Pase-alpha,
respectively. G6Pase-alpha in both
vectors is directed by nucleotides -2864
to -1 of the G6PC gene 5’-flanking
promoter/enhancer region (GPE). The
vectors also contain an intron and
stuffer sequences. The rAAV-GPE-G6PC
vector not only corrects metabolic
abnormalities in murine GSD-Ia (G6pc/- mice) but also prevents long-term risk
of hepatocellular adenoma. The results
also showed that the enhancer elements
upstream the human G6PC minimal
promoter at nucleotides -382 to -1
contained within the rAAV-GPE-G6PC
vector are responsible for the increased
efficacy in treating GSD-Ia mice.
The prospective exclusive license will
be royalty bearing and will comply with
the terms and conditions of 35 U.S.C.
209 and 37 CFR 404.7. The prospective
exclusive license may be granted unless
within fifteen (15) days from the date of
this published notice, the NIH 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 404.7.
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 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: May 17, 2016.
Richard U. Rodriguez,
Associate Director, NCI, National Institutes
of Health.
[FR Doc. 2016–12169 Filed 5–23–16; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
sradovich on DSK3TPTVN1PROD with NOTICES
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), 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,
VerDate Sep<11>2014
17:24 May 23, 2016
Jkt 238001
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: Cardiovascular and
Respiratory Sciences Integrated Review
Group; Cardiac Contractility, Hypertrophy,
and Failure Study Section.
Date: June 13–14, 2016.
Time: 8:00 a.m. to 2:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Embassy Suites Hotel O’Hare—
Rosemont, 5500 North River Road, Rosemont,
IL 60018.
Contact Person: Olga A. Tjurmina, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4030B,
MSC 7814, Bethesda, MD 20892, (301) 451–
1375, ot3d@nih.gov.
Name of Committee: Center for Scientific
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Related Clinical Sciences Overflow.
Date: June 14–15, 2016.
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(Formerly Holiday Inn Select), 8120
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Contact Person: Martha L. Hare, Ph.D., RN,
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Scientific Review, National Institutes of
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harem@mail.nih.gov.
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Conflict: Auditory Neuroscience.
Date: June 14–15, 2016.
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Agenda: To review and evaluate grant
applications.
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Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: John Bishop, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5182,
MSC 7844, Bethesda, MD 20892, (301) 408–
9664, bishopj@csr.nih.gov.
Name of Committee: Cardiovascular and
Respiratory Sciences Integrated Review
Group; Clinical and Integrative
Cardiovascular Sciences Study Section.
Date: June 16–17, 2016.
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Agenda: To review and evaluate grant
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Place: Beacon Hotel and Corporate
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Contact Person: Yuanna Cheng, MD, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
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1195, Chengy5@csr.nih.gov.
Name of Committee: Oncology 1—Basic
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Cancer Genetics Study Section.
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Date: June 22–23, 2016.
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Circle NW., Washington, DC 20005.
Contact Person: Michael L. Bloom, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6187,
MSC 7804, Bethesda, MD 20892, 301–451–
0132, bloomm2@mail.nih.gov.
Name of Committee: Brain Disorders and
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Study Section.
Date: June 22–23, 2016.
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Pavilion, 4300 Military Road NW.,
Washington, DC 20015.
Contact Person: Seetha Bhagavan, Ph.D.,
Scientific Review Officer, Center for
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Health, 6701 Rockledge Drive, Room 5194,
MSC 7846, Bethesda, MD 20892, (301) 237–
9838, bhagavas@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; PAR14–022:
Juvenile Protective Factors and Aging.
Date: June 22, 2016.
Time: 1:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Wallace Ip, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5128,
MSC 7840, Bethesda, MD 20892, 301–435–
1191, ipws@mail.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: May 17, 2016.
Sylvia L. Neal,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2016–12137 Filed 5–23–16; 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 Vectors for the
Treatment of Glycogen Storage
Disease Type Ia
AGENCY:
National Institutes of Health,
HHS.
ACTION:
E:\FR\FM\24MYN1.SGM
Notice.
24MYN1
Federal Register / Vol. 81, No. 100 / Tuesday, May 24, 2016 / Notices
This notice, in accordance
with 35 U.S.C. 209(c)(1) and 37 CFR
part 404.7(a)(1)(i), that the National
Institutes of Health, Department of
Health and Human Services (HHS), is
contemplating the grant of an exclusive
license to practice the inventions
embodied in the following Patent
Applications to Dimension
Therapeutics, Inc. (‘‘Dimension’’)
located in Cambridge, Massachusetts,
USA:
sradovich on DSK3TPTVN1PROD with NOTICES
SUMMARY:
Intellectual Property
United States Provisional Patent
Application No. 62/096,400, filed
December 23, 2014, titled ‘‘AdenoAssociated Virus Vectors Encoding
G6PC and Uses Thereof’’ [HHS
Reference No. E–039–2015/0–US–01];
International Patent Application No.
PCT/US2015/067338 filed December 22,
2015 titled ‘‘Adeno-Associated Virus
Vectors Encoding G6PC and Uses
Thereof’’ [HHS Reference No. E–039–
2015/0–PCT–02]; and all continuation
applications, divisional applications
and foreign counterpart applications
claiming priority to the U.S. provisional
application No. 62/096,400.
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 licensed
territory may be worldwide and the
field of use may be limited to:
‘‘Development and commercialization of
gene therapy using adeno-associated
viral vectors for the treatment of
Glycogen Storage Disease Type Ia.’’
DATES: Only written comments and/or
applications for a license which are
received by the NIH Office of
Technology Transfer on or before June
8, 2016 will be considered.
ADDRESSES: Requests for copies of the
patent application, inquiries, comments,
and other materials relating to the
contemplated exclusive license should
be directed to: Surekha Vathyam, Ph.D.,
Senior Licensing and Patenting
Manager, National Cancer Institute
Technology Transfer Center, 9609
Medical Center Drive, Rm 1E–530
MSC9702, Rockville, MD 20850–9702,
Email: vathyams@mail.nih.gov.
SUPPLEMENTARY INFORMATION: The
subject technology discloses novel
adeno-associated virus (AAV) vectors
expressing human G6Pase-alpha (or
G6PC) for the treatment of glycogen
storage disease, particularly GSD-Ia.
GSD-Ia is an inherited disorder of
metabolism associated with lifethreatening hypoglycemia, hepatic
malignancy, and renal failure caused by
the deficiency of G6Pase-alpha, a key
VerDate Sep<11>2014
17:24 May 23, 2016
Jkt 238001
enzyme in maintaining blood glucose
homeostasis between meals. These new
recombinant AAV vectors that express
human G6Pase-alpha directed by the
tissue-specific human G6PC promoter/
enhancer at nucleotides -2864 to -1
incorporate the following
improvements: (1) One expresses a
variant of G6Pase-alpha with enhanced
enzymatic activity; (2) the other
expresses a codon-optimized variant of
G6Pase-alpha with higher enzyme
expression levels and enhanced
enzymatic activity.
The prospective exclusive license will
be royalty bearing and will comply with
the terms and conditions of 35 U.S.C.
209 and 37 CFR part 404.7. The
prospective exclusive license may be
granted unless within fifteen (15) days
from the date of this published notice,
the NIH 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 404.7.
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 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.
Date: May 19, 2016.
Richard U. Rodriguez,
Associate Director, NCI, National Institutes
of Health.
[FR Doc. 2016–12168 Filed 5–23–16; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood
Institute; Notice of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), 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
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
32763
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Heart, Lung,
and Blood Institute Special Emphasis Panel;
Stem Cell-Derived Blood Products (SBIR).
Date: June 16, 2016.
Time: 1:30 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Room 7180, Bethesda, MD
20892 (Telephone Conference Call).
Contact Person: Tony L. Creazzo, Ph.D.,
Scientific Review Officer, Office of Scientific
Review/DERA, National Heart, Lung, and
Blood Institute, 6701 Rockledge Drive, Room
7180, Bethesda, MD 20892–7924, 301–435–
0725, creazzotl@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.233, National Center for
Sleep Disorders Research; 93.837, Heart and
Vascular Diseases Research; 93.838, Lung
Diseases Research; 93.839, Blood Diseases
and Resources Research, National Institutes
of Health, HHS).
Dated: May 18, 2016.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2016–12140 Filed 5–23–16; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood
Institute; Notice of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), 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.
Name of Committee: Heart, Lung, and
Blood Initial Review Group; Heart, Lung, and
Blood Program Project Review Committee.
Date: June 17, 2016.
Time: 8:00 a.m. to 1:00 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: Jeffrey H. Hurst, Ph.D.,
Scientific Review Officer, Office of Scientific
Review/DERA, National Heart, Lung, and
Blood Institute, National Institutes of Health,
E:\FR\FM\24MYN1.SGM
24MYN1
]]>Agencies
[Federal Register Volume 81, Number 100 (Tuesday, May 24, 2016)]
[Notices]
[Pages 32762-32763]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-12168]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive Patent License: Development of
Adeno-Associated Virus Vectors for the Treatment of Glycogen Storage
Disease Type Ia
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
[[Page 32763]]
SUMMARY: This notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR
part 404.7(a)(1)(i), that the National Institutes of Health, Department
of Health and Human Services (HHS), is contemplating the grant of an
exclusive license to practice the inventions embodied in the following
Patent Applications to Dimension Therapeutics, Inc. (``Dimension'')
located in Cambridge, Massachusetts, USA:
Intellectual Property
United States Provisional Patent Application No. 62/096,400, filed
December 23, 2014, titled ``Adeno-Associated Virus Vectors Encoding
G6PC and Uses Thereof'' [HHS Reference No. E-039-2015/0-US-01];
International Patent Application No. PCT/US2015/067338 filed December
22, 2015 titled ``Adeno-Associated Virus Vectors Encoding G6PC and Uses
Thereof'' [HHS Reference No. E-039-2015/0-PCT-02]; and all continuation
applications, divisional applications and foreign counterpart
applications claiming priority to the U.S. provisional application No.
62/096,400.
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 licensed territory may be worldwide and
the field of use may be limited to: ``Development and commercialization
of gene therapy using adeno-associated viral vectors for the treatment
of Glycogen Storage Disease Type Ia.''
DATES: Only written comments and/or applications for a license which
are received by the NIH Office of Technology Transfer on or before June
8, 2016 will be considered.
ADDRESSES: Requests for copies of the patent application, inquiries,
comments, and other materials relating to the contemplated exclusive
license should be directed to: Surekha Vathyam, Ph.D., Senior Licensing
and Patenting Manager, National Cancer Institute Technology Transfer
Center, 9609 Medical Center Drive, Rm 1E-530 MSC9702, Rockville, MD
20850-9702, Email: vathyams@mail.nih.gov.
SUPPLEMENTARY INFORMATION: The subject technology discloses novel
adeno-associated virus (AAV) vectors expressing human G6Pase-alpha (or
G6PC) for the treatment of glycogen storage disease, particularly GSD-
Ia. GSD-Ia is an inherited disorder of metabolism associated with life-
threatening hypoglycemia, hepatic malignancy, and renal failure caused
by the deficiency of G6Pase-alpha, a key enzyme in maintaining blood
glucose homeostasis between meals. These new recombinant AAV vectors
that express human G6Pase-alpha directed by the tissue-specific human
G6PC promoter/enhancer at nucleotides -2864 to -1 incorporate the
following improvements: (1) One expresses a variant of G6Pase-alpha
with enhanced enzymatic activity; (2) the other expresses a codon-
optimized variant of G6Pase-alpha with higher enzyme expression levels
and enhanced enzymatic activity.
The prospective exclusive license will be royalty bearing and will
comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR part
404.7. The prospective exclusive license may be granted unless within
fifteen (15) days from the date of this published notice, the NIH
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 404.7.
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 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.
Date: May 19, 2016.
Richard U. Rodriguez,
Associate Director, NCI, National Institutes of Health.
[FR Doc. 2016-12168 Filed 5-23-16; 8:45 am]
BILLING CODE 4140-01-P
