Prospective Grant of Exclusive License: AAV-Mediated Aquaporin Gene Transfer To Treat Sjögren's Syndrome, 25683 [2016-09978]
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Federal Register / Vol. 81, No. 83 / Friday, April 29, 2016 / Notices
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Dated: April 25, 2016.
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Deputy Director for Management Operations,
Indian Health Service.
[FR Doc. 2016–10164 Filed 4–28–16; 8:45 am]
BILLING CODE 4165–16–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive
License: AAV-Mediated Aquaporin
¨
Gene Transfer To Treat Sjogren’s
Syndrome
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
This is notice, in accordance
with 35 U.S.C. 209 and 37 CFR part 404,
that the National Institutes of Health,
Department of Health and Human
Services, is contemplating the grant of
an exclusive license to MeiraGTx,
having a principal place of business in
New York, New York, U.S.A. to practice
the inventions embodied in the
following patent applications, entitled
‘‘AAV-mediated aquaporin gene transfer
¨
to treat Sjogren’s syndrome’’:
asabaliauskas on DSK3SPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
18:31 Apr 28, 2016
Jkt 238001
1. U.S. Provisional Patent Application No.
61/695,753 filed August 31, 2012 (HHS Ref.
No. E–139–2011/1–US–01);
2. PCT Application No. PCT/US2013/
057632, filed August 30, 2013 (HHS Ref. No.
E–139–2011/1–PCT–02);
3. Australia Patent Application No.
2013308470, filed February 25, 2015 (HHS
Ref. No. E–139–2011/1–AU–03);
4. Canada Patent Application No. 2882763,
filed February 20, 2015 (HHS Ref. No. E–
139–2011/1–CA–04);
5. European Patent Application No.
13773443.0, filed March 30, 2015 (HHS Ref.
No. E–139–2011/1–EP–05);
6. U.S. Patent Application No. 14/423,774,
filed February 25, 2015 (HHS Ref. No. E–
139–2011/1–US–06).
The patent rights in these inventions
have been assigned to the Government
of the United States of America. The
territory of the prospective license may
be worldwide, and the field of use may
be limited to adeno-associated virus
(AAV) vector mediated gene delivery of
human aquaporin-1 (hAQP1) in
¨
Sjogren’s syndrome patients with
associated xerostomia and/or
xerophthalmia.
DATES: Only written comments and/or
applications for a license that are
received by the National Institute of
Dental and Craniofacial Research, Office
of Technology Transfer and Innovation
Access on or before May 16, 2016 will
be considered.
FOR FURTHER INFORMATION CONTACT:
Requests for a copy of the patent
application(s), inquiries, comments and
other materials relating to the
contemplated license should be directed
to: Sally Hu, Ph.D., M.B.A., Senior
Licensing and Patenting Manager, Office
of Technology Transfer and Innovation
Access, National Institute of Dental and
Craniofacial Research, National
Institutes of Health, BLDG 1 DEM,
RM667, 6701 Democracy Blvd.,
Bethesda, MD 20817; Telephone: (301)
594–2616; Facsimile: (301) 496–1005;
Email: sally.hu@nih.gov. A signed
confidential disclosure agreement may
be required to receive copies of the
patent application assuming it has not
already been published under the
publication rules of either the United
States Patent and Trademark Office or
the World Intellectual Property
Organization.
SUPPLEMENTARY INFORMATION: This
subject technology is directed to the
methods of using AAV vectors to deliver
the hAQP gene into a salivary gland or
a lachrymal gland in patients who suffer
¨
¨
from Sjogren’s syndrome. Sjogren’s
syndrome is a systemic autoimmune
disease in which immune cells attack
and destroy the glands that produce
saliva and tears, resulting in progressive
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
25683
dry mouth and dry eyes. In a mouse
¨
model of Sjogren’s syndrome,
administration of hAQP–1 to salivary
glands can restore salivary secretion and
reduce inflammation in the glands.
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. The
prospective exclusive license may be
granted unless, within fifteen (15) days
from the date of this published notice,
the Office of Technology Transfer and
Innovation Access, National Institute of
Dental and Craniofacial Research
receives written evidence and argument
that establishes that the grant of the
contemplated license would not be
consistent with the requirements of 35
U.S.C. 209 and 37 CFR part 404.
Properly filed competing 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 contemplated license. Comments
and objections submitted in response 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: April 22, 2016.
David W. Bradley,
Director, Office of Technology Transfer and
Innovation Access, National Institute of
Dental and Craniofacial Research, National
Institutes of Health.
[FR Doc. 2016–09978 Filed 4–28–16; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Drug Abuse;
Notice of Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
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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
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would constitute a clearly unwarranted
invasion of personal privacy.
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[Federal Register Volume 81, Number 83 (Friday, April 29, 2016)]
[Notices]
[Page 25683]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-09978]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive License: AAV-Mediated Aquaporin
Gene Transfer To Treat Sj[ouml]gren's Syndrome
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This is notice, in accordance with 35 U.S.C. 209 and 37 CFR
part 404, that the National Institutes of Health, Department of Health
and Human Services, is contemplating the grant of an exclusive license
to MeiraGTx, having a principal place of business in New York, New
York, U.S.A. to practice the inventions embodied in the following
patent applications, entitled ``AAV-mediated aquaporin gene transfer to
treat Sj[ouml]gren's syndrome'':
1. U.S. Provisional Patent Application No. 61/695,753 filed
August 31, 2012 (HHS Ref. No. E-139-2011/1-US-01);
2. PCT Application No. PCT/US2013/057632, filed August 30, 2013
(HHS Ref. No. E-139-2011/1-PCT-02);
3. Australia Patent Application No. 2013308470, filed February
25, 2015 (HHS Ref. No. E-139-2011/1-AU-03);
4. Canada Patent Application No. 2882763, filed February 20,
2015 (HHS Ref. No. E-139-2011/1-CA-04);
5. European Patent Application No. 13773443.0, filed March 30,
2015 (HHS Ref. No. E-139-2011/1-EP-05);
6. U.S. Patent Application No. 14/423,774, filed February 25,
2015 (HHS Ref. No. E-139-2011/1-US-06).
The patent rights in these inventions have been assigned to the
Government of the United States of America. The territory of the
prospective license may be worldwide, and the field of use may be
limited to adeno-associated virus (AAV) vector mediated gene delivery
of human aquaporin-1 (hAQP1) in Sj[ouml]gren's syndrome patients with
associated xerostomia and/or xerophthalmia.
DATES: Only written comments and/or applications for a license that are
received by the National Institute of Dental and Craniofacial Research,
Office of Technology Transfer and Innovation Access on or before May
16, 2016 will be considered.
FOR FURTHER INFORMATION CONTACT: Requests for a copy of the patent
application(s), inquiries, comments and other materials relating to the
contemplated license should be directed to: Sally Hu, Ph.D., M.B.A.,
Senior Licensing and Patenting Manager, Office of Technology Transfer
and Innovation Access, National Institute of Dental and Craniofacial
Research, National Institutes of Health, BLDG 1 DEM, RM667, 6701
Democracy Blvd., Bethesda, MD 20817; Telephone: (301) 594-2616;
Facsimile: (301) 496-1005; Email: sally.hu@nih.gov. A signed
confidential disclosure agreement may be required to receive copies of
the patent application assuming it has not already been published under
the publication rules of either the United States Patent and Trademark
Office or the World Intellectual Property Organization.
SUPPLEMENTARY INFORMATION: This subject technology is directed to the
methods of using AAV vectors to deliver the hAQP gene into a salivary
gland or a lachrymal gland in patients who suffer from Sj[ouml]gren's
syndrome. Sj[ouml]gren's syndrome is a systemic autoimmune disease in
which immune cells attack and destroy the glands that produce saliva
and tears, resulting in progressive dry mouth and dry eyes. In a mouse
model of Sj[ouml]gren's syndrome, administration of hAQP-1 to salivary
glands can restore salivary secretion and reduce inflammation in the
glands.
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. The prospective exclusive license may be granted unless, within
fifteen (15) days from the date of this published notice, the Office of
Technology Transfer and Innovation Access, National Institute of Dental
and Craniofacial Research receives written evidence and argument that
establishes that the grant of the contemplated license would not be
consistent with the requirements of 35 U.S.C. 209 and 37 CFR part 404.
Properly filed competing 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 contemplated license. Comments and
objections submitted in response 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: April 22, 2016.
David W. Bradley,
Director, Office of Technology Transfer and Innovation Access, National
Institute of Dental and Craniofacial Research, National Institutes of
Health.
[FR Doc. 2016-09978 Filed 4-28-16; 8:45 am]
BILLING CODE 4140-01-P
