Prospective Grant of an Exclusive Patent License: Gene Therapy for Ocular Disease, 65169-65170 [2019-25685]
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65169
Federal Register / Vol. 84, No. 228 / Tuesday, November 26, 2019 / Notices
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.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Topics in
Gastroenterology.
Date: December 19, 2019.
Time: 10:00 a.m. to 1:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Telephone Conference
Call).
Contact Person: Rass M Shayiq, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 2182,
MSC 7818, Bethesda, MD 20892, (301) 435–
2359, shayiqr@csr.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: November 20, 2019.
Ronald J. Livingston, Jr.,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2019–25594 Filed 11–25–19; 8:45 am]
BILLING CODE 4140–01–P
National Institutes of Health
Prospective Grant of an Exclusive
Patent License: Gene Therapy for
Ocular Disease
National Institutes of Health,
HHS.
ACTION:
Only written comments and/or
applications for a license which are
received by the National Cancer
Institute’s Technology Transfer Center
(representing the National Eye Institute
and the National Heart, Lung, and Blood
Institute (representing the National
Institute on Deafness and Other
Communication Disorders) on or before
January 10, 2020 will be considered.
DATES:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
patent license to OcQuila Therapeutics
Ltd., a C corporation incorporated under
the laws of the state of Delaware and a
limited company incorporated under
the laws of the United Kingdom, to
practice the inventions covered by the
patent estate listed in the
SUPPLEMENTARY INFORMATION section of
this notice.
Notice.
The National Eye Institute,
the National Institute on Deafness and
Other Communication Disorders, and
the National Heart, Lung, and Blood
Institute, institutes of the National
Institutes of Health, Department of
Health and Human Services, are
contemplating the grant of an exclusive
SUMMARY:
Requests for copies of the
patent application, inquiries, and
comments relating to the contemplated
an exclusive patent license should be
directed to: Michael Shmilovich, Esq.,
Senior Licensing and Patent Manager,
31 Center Drive Room 4A29, MSC2479,
Bethesda, MD 20892–2479, phone
number 301–435–5019, or shmilovm@
mail.nih.gov.
ADDRESSES:
SUPPLEMENTARY INFORMATION:
INTELLECTUAL PROPERTY
NIH ref No.
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E–284–2012–1–US–01
E–284–2012–2–PCT–01
E–284–2012–2–AU–02
E–284–2012–2–CA–03
E–284–2012–2–JP–04
E–284–2012–2–US–05
E–284–2012–2–US–07
E–284–2012–2–EP–06
E–284–2012–2–PCT–08
E–164–2018–0–US–01
E–164–2018–1–US–01
E–164–2018–2–US–01
E–164–2018–3–PCT–01
VerDate Sep<11>2014
16:47 Nov 25, 2019
Title
Patent application No.
Methods And Compositions For
Treating Genetically Linked Diseases Of The Eye.
Methods And Compositions For
Treating Genetically Linked Diseases Of The Eye.
Methods And Compositions For
Treating Genetically Linked Diseases Of The Eye.
AAV8 retinoschisin expression vector
for treating X-linked retinoschisis.
AAV8 retinoschisin expression vector
for treating X-linked retinoschisis.
Methods And Compositions For
Treating Genetically Linked Diseases Of The Eye.
Methods And Compositions For
Treating Genetically Linked Diseases Of The Eye.
Methods And Compositions For
Treating Genetically Linked Diseases Of The Eye.
Methods And Compositions For
Treating Genetically Linked Diseases Of The Eye.
Methods And Compositions For
Treating Genetically Linked Diseases Of The Eye.
Intraocular Delivery Of Gene Therapy
Expression Vectors.
Intraocular Delivery Of Gene Therapy
Expression Vectors.
Intraocular Delivery Of Gene Therapy
Expression Vectors.
Intraocular Delivery Of Gene Therapy
Expression Vectors.
Jkt 250001
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Frm 00057
Issued
patent No.
Filing date
Issue date
61/765,654
February 15, 2013.
61/815,636
April 24, 2013.
PCT/US2014/16389
February 14, 2014.
2014216160
February 14, 2014 .....
2014216160
July 13, 2017.
2900231
February 14, 2014 .....
2900231
July 30, 2019.
2015–558144
February 14, 2014 .....
6449175
December 14, 2018.
14/766,842
February 14, 2014 .....
9,873,893
January 23, 2018.
15/876,821
February 14, 2014 .....
10,350,306
July 16, 2019.
14708176.4
February 14, 2014.
PCT/US2019/14418
January 21, 2019.
62/701,267
July 20, 2018.
62/724,480
August 29, 2018.
62/768,590
November 16, 2019.
PCT/US2019/042365
July 18, 2019.
Fmt 4703
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65170
Federal Register / Vol. 84, No. 228 / Tuesday, November 26, 2019 / Notices
all U.S. and foreign patents and
applications claiming priority to any
member of the above.
The patent rights in these inventions
have been assigned or exclusively
licensed to the Government of the
United States of America.
The prospective exclusive license
territory may be worldwide and in fields
of use that may be limited to human
therapeutics for (1) X-linked juvenile
retinoschisis and (2) schisis cavity
associated ocular disease or injury.
The aforementioned patent estates
cover inventions directed to gene
therapy and specifically, expression
vectors and therapeutic methods of
using such vectors in the treatment of
ocular diseases resulting from failure to
produce or the defective production of
an ocular protein. This invention is also
directed to methods of administering
expression vectors capable of
modulating a target gene or gene
product for the treatment of ocular
disease.
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. The prospective
exclusive license may be granted unless
within thirty ( ) days from the date of
this published notice, the National
Heart, Lung, and Blood Institute
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.
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 in 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: November 21, 2019.
Michael A. Shmilovich,
Senior Licensing and Patenting Manager,
National Heart, Lung, and Blood Institute.
[FR Doc. 2019–25685 Filed 11–25–19; 8:45 am]
BILLING CODE 4140–01–P
VerDate Sep<11>2014
16:47 Nov 25, 2019
Jkt 250001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Agency Information Collection
Activities: Proposed Collection;
Comment Request
In compliance with Section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 concerning
opportunity for public comment on
proposed collections of information, the
Substance Abuse and Mental Health
Services Administration (SAMHSA)
will publish periodic summaries of
proposed projects. To request more
information on the proposed projects or
to obtain a copy of the information
collection plans, call the SAMHSA
Reports Clearance Officer on (240) 276–
1243.
Comments are invited on: (a) Whether
the proposed collections of information
are necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) ways to enhance the
quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Proposed Project: 2020–2023 National
Survey on Drug Use and Health:
Methodological Field Tests (OMB No.
0930–0290)—Extension
The National Survey on Drug Use and
Health (NSDUH) is a survey of the U.S.
civilian, non-institutionalized
population aged 12 years old or older.
The data are used to determine the
prevalence of use of tobacco products,
alcohol, illicit substances, and illicit use
of prescription drugs. The results are
used by SAMHSA, the Office of
National Drug Control Policy (ONDCP),
federal government agencies, and other
organizations and researchers to
establish policy, direct program
activities, and better allocate resources.
Methodological tests will continue to
be designed to examine the feasibility,
quality, and efficiency of new
procedures or revisions to existing
survey protocol. Specifically, the tests
will measure the reliability and validity
of certain questionnaire sections and
items through multiple measurements
on a set of respondents; assess new
methods for gaining cooperation and
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participation of respondents with the
goal of increasing response and
decreasing potential bias in the survey
estimates; and assess the impact of new
sampling techniques and technologies
on respondent behavior and reporting.
Research will involve focus groups,
cognitive laboratory testing, customer
satisfaction surveys, and field tests.
These methodological tests will
continue to examine ways to increase
data quality, lower operating costs, and
gain a better understanding of sources
and effects of nonsampling error on
NSDUH estimates. Particular attention
will be given to minimizing the impact
of design changes so survey data
continue to remain comparable over
time. If these tests provide successful
results, current procedures or data
collection instruments may be revised.
The number of respondents to be
included in each field test will vary,
depending on the nature of the subject
being tested and the target population.
However, the total estimated response
burden is 8,225 hours. The exact
number of subjects and burden hours for
each test are unknown at this time, but
will be clearly outlined in each
individual submission. These estimated
burden hours are distributed over three
years as follows:
TABLE 1—ESTIMATED BURDEN FOR
NSDUH METHODOLOGICAL FIELD
TESTS
Time period
Respondent
burden hours
May 2020 to May 2021 ........
May 2021 to May 2022 ........
May 2022 to May 2023 ........
2,742
2,742
2,741
Total ...............................
8,225
Send comments to Summer King,
SAMHSA Reports Clearance Officer,
5600 Fishers Lane, Room 15E57–B,
Rockville, Maryland 20857, OR email a
copy to summer.king@samhsa.hhs.gov.
Written comments should be received
by January 27, 2020.
Summer King,
Statistician.
[FR Doc. 2019–25647 Filed 11–25–19; 8:45 am]
BILLING CODE 4162–20–P
DEPARTMENT OF HOUSING AND
URBAN DEVELOPMENT
[Docket No. FR–6190–N–01]
Notice of Intent To Close Reno Field
Office
Office of Field Policy and
Management, HUD.
AGENCY:
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]]>Agencies
[Federal Register Volume 84, Number 228 (Tuesday, November 26, 2019)]
[Notices]
[Pages 65169-65170]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-25685]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive Patent License: Gene Therapy
for Ocular Disease
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The National Eye Institute, the National Institute on Deafness
and Other Communication Disorders, and the National Heart, Lung, and
Blood Institute, institutes of the National Institutes of Health,
Department of Health and Human Services, are contemplating the grant of
an exclusive patent license to OcQuila Therapeutics Ltd., a C
corporation incorporated under the laws of the state of Delaware and a
limited company incorporated under the laws of the United Kingdom, to
practice the inventions covered by the patent estate listed in the
Supplementary Information section of this notice.
DATES: Only written comments and/or applications for a license which
are received by the National Cancer Institute's Technology Transfer
Center (representing the National Eye Institute and the National Heart,
Lung, and Blood Institute (representing the National Institute on
Deafness and Other Communication Disorders) on or before January 10,
2020 will be considered.
ADDRESSES: Requests for copies of the patent application, inquiries,
and comments relating to the contemplated an exclusive patent license
should be directed to: Michael Shmilovich, Esq., Senior Licensing and
Patent Manager, 31 Center Drive Room 4A29, MSC2479, Bethesda, MD 20892-
2479, phone number 301-435-5019, or [email protected].
SUPPLEMENTARY INFORMATION:
Intellectual Property
--------------------------------------------------------------------------------------------------------------------------------------------------------
Issued patent
NIH ref No. Title Patent application No. Filing date No. Issue date
--------------------------------------------------------------------------------------------------------------------------------------------------------
E-284-2012-0-US-01 Methods And 61/765,654 February 15, 2013.......
Compositions
For Treating
Genetically
Linked Diseases
Of The Eye.
E-284-2012-1-US-01 Methods And 61/815,636 April 24, 2013..........
Compositions
For Treating
Genetically
Linked Diseases
Of The Eye.
E-284-2012-2-PCT-01 Methods And PCT/US2014/16389 February 14, 2014.......
Compositions
For Treating
Genetically
Linked Diseases
Of The Eye.
E-284-2012-2-AU-02 AAV8 2014216160 February 14, 2014....... 2014216160 July 13, 2017.
retinoschisin
expression
vector for
treating X-
linked
retinoschisis.
E-284-2012-2-CA-03 AAV8 2900231 February 14, 2014....... 2900231 July 30, 2019.
retinoschisin
expression
vector for
treating X-
linked
retinoschisis.
E-284-2012-2-JP-04 Methods And 2015-558144 February 14, 2014....... 6449175 December 14, 2018.
Compositions
For Treating
Genetically
Linked Diseases
Of The Eye.
E-284-2012-2-US-05 Methods And 14/766,842 February 14, 2014....... 9,873,893 January 23, 2018.
Compositions
For Treating
Genetically
Linked Diseases
Of The Eye.
E-284-2012-2-US-07 Methods And 15/876,821 February 14, 2014....... 10,350,306 July 16, 2019.
Compositions
For Treating
Genetically
Linked Diseases
Of The Eye.
E-284-2012-2-EP-06 Methods And 14708176.4 February 14, 2014.......
Compositions
For Treating
Genetically
Linked Diseases
Of The Eye.
E-284-2012-2-PCT-08 Methods And PCT/US2019/14418 January 21, 2019........
Compositions
For Treating
Genetically
Linked Diseases
Of The Eye.
E-164-2018-0-US-01 Intraocular 62/701,267 July 20, 2018...........
Delivery Of
Gene Therapy
Expression
Vectors.
E-164-2018-1-US-01 Intraocular 62/724,480 August 29, 2018.........
Delivery Of
Gene Therapy
Expression
Vectors.
E-164-2018-2-US-01 Intraocular 62/768,590 November 16, 2019.......
Delivery Of
Gene Therapy
Expression
Vectors.
E-164-2018-3-PCT-01 Intraocular PCT/US2019/042365 July 18, 2019...........
Delivery Of
Gene Therapy
Expression
Vectors.
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 65170]]
all U.S. and foreign patents and applications claiming priority to any
member of the above.
The patent rights in these inventions have been assigned or
exclusively licensed to the Government of the United States of America.
The prospective exclusive license territory may be worldwide and in
fields of use that may be limited to human therapeutics for (1) X-
linked juvenile retinoschisis and (2) schisis cavity associated ocular
disease or injury.
The aforementioned patent estates cover inventions directed to gene
therapy and specifically, expression vectors and therapeutic methods of
using such vectors in the treatment of ocular diseases resulting from
failure to produce or the defective production of an ocular protein.
This invention is also directed to methods of administering expression
vectors capable of modulating a target gene or gene product for the
treatment of ocular disease.
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.
The prospective exclusive license may be granted unless within thirty (
) days from the date of this published notice, the National Heart,
Lung, and Blood Institute 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.
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 in 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: November 21, 2019.
Michael A. Shmilovich,
Senior Licensing and Patenting Manager, National Heart, Lung, and Blood
Institute.
[FR Doc. 2019-25685 Filed 11-25-19; 8:45 am]
BILLING CODE 4140-01-P
