Prospective Grant of Exclusive Patent License: Production of Attenuated West Nile Virus Vaccines, 25804-25805 [2017-11491]
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Federal Register / Vol. 82, No. 106 / Monday, June 5, 2017 / Notices
Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel; NIDDK P01 Review.
Date: July 18, 2017.
Time: 4:00 p.m.to 6:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, Two
Democracy Plaza, 6707 Democracy
Boulevard, Bethesda, MD 20892 (Telephone
Conference Call).
Contact Person: Xiaodu Guo, MD, Ph.D.,
Scientific Review Officer, Review Branch,
DEA, NIDDK, National Institutes of Health,
Room 7023, 6707 Democracy Boulevard,
Bethesda, MD 20892–5452, (301) 594–4719,
guox@extra.niddk.nih.gov.
Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel; Program Project on
Mucosal Immunology.
Date: July 25, 2017.
Time: 12:00 p.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, Two
Democracy Plaza, 6707 Democracy
Boulevard, Bethesda, MD 20892 (Telephone
Conference Call).
Contact Person: Maria E. Davila-Bloom,
Ph.D., Scientific Review Officer, Review
Branch, DEA, NIDDK, National Institutes of
Health, Room 7017, 6707 Democracy
Boulevard, Bethesda, MD 20892–5452, (301)
594–7637, davila-bloomm@
extra.niddk.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.847, Diabetes,
Endocrinology and Metabolic Research;
93.848, Digestive Diseases and Nutrition
Research; 93.849, Kidney Diseases, Urology
and Hematology Research, National Institutes
of Health, HHS)
Dated: May 30, 2017.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2017–11495 Filed 6–2–17; 8:45 am]
BILLING CODE 4140–01–P
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: NIGMS Initial Review
Group; Training and Workforce Development
Subcommittee—D; To review R25 Bridges to
Baccalaureate and K12 IRACDA Grant
applications.
Date: June 22–23, 2017.
Time: 8:30 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hotel Palomar, 2121 P Street NW.,
Washington, DC 20037.
Contact Person: Rebecca H. Johnson, Ph.D.,
Scientific Review Officer, Office of Scientific
Review, National Institute of General Medical
Sciences, National Institutes of Health,
Natcher Building, Room 3AN18C, Bethesda,
MD 20892, 301–594–2771, johnsonrh@
nigms.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.375, Minority Biomedical
Research Support; 93.821, Cell Biology and
Biophysics Research; 93.859, Pharmacology,
Physiology, and Biological Chemistry
Research; 93.862, Genetics and
Developmental Biology Research; 93.88,
Minority Access to Research Careers; 93.96,
Special Minority Initiatives; 93.859,
Biomedical Research and Research Training,
National Institutes of Health, HHS)
Dated: May 30, 2017.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2017–11498 Filed 6–2–17; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive Patent
License: Production of Attenuated
West Nile Virus Vaccines
National Institutes of Health,
Department of Health and Human
Services.
ACTION: Notice.
AGENCY:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
asabaliauskas on DSKBBXCHB2PROD with NOTICES
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
VerDate Sep<11>2014
17:31 Jun 02, 2017
Jkt 241001
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 Commercialization
Patent License to practice the inventions
embodied in the Patents and Patent
Applications listed in the Summary
Information section of this notice to the
International Medica Foundation
located in Shoreview, Minnesota, U.S.A.
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
SUMMARY:
National Institute of General Medical
Sciences; Notice of Closed Meeting
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
Property Office on or before June 20,
2017 will be considered.
ADDRESSES: Requests for copies of the
patent application, inquiries, and
comments relating to the contemplated
Exclusive Commercialization Patent
License should be directed to: Peter
Soukas, Technology Transfer and Patent
Specialist, Technology Transfer and
Intellectual Property Office, National
Institute of Allergy and Infectious
Diseases, National Institutes of Health,
5601 Fishers Lane, Suite 6D, Rockville,
MD 20852–9804; Email: ps193c@
nih.gov; Telephone: (301) 594–8730;
Facsimile: (240) 627–3117.
SUPPLEMENTARY INFORMATION:
Intellectual Property
E–357–2001/0,1, Pletnev et al.,
‘‘Construction of West Nile Virus and
Dengue Virus Chimeras for use in a Live
Virus Vaccine to Prevent Disease Cause
by West Nile Virus,’’ U.S. Provisional
Patent Application Number 60/347,281,
filed January 10, 2002, PCT Patent
Application Number PCT/US2003/
00594, filed January 9, 2003, U.S. Patent
Application Number 10/871,775 filed
June 18, 2004 (now U.S. Patent Number
8,778,671), U.S. Patent Application
Number 14/305,572, filed June 16, 2014,
European Patent Application Number
03729602.7, filed January 9, 2003,
Israeli Patent Application Number
162949, filed January 9, 2003 (now
Israeli Patent Number 162949),
Canadian Patent Application Number
2472468, filed January 9, 2003 (now
Canadian Patent Number 2472468),
Australian Patent Application Number
2003216046, filed January 9, 2003 (now
Australian Patent Number 2003216046),
Japanese Patent Application Number
2003–559545, filed January 9, 2003
(now Japanese Patent Number 4580650),
Australian Patent Application Number
2008203442 filed July 31, 2008 (now
Australian Patent Number 2008203442),
Israeli Patent Application Number
209342, filed January 9, 2003 (now
Israeli Patent Number 209342),
European Patent Application Number
11000126.0, filed January 9, 2003 (now
European Patent Number 2339011,
validated in Belgium, Great Britain, the
Netherlands, Norway, Germany,
Denmark and France), Australian Patent
Application Number 2011250694, filed
November 10, 2011 (now Australian
Patent Number 2011250694), Australian
Patent Application Number
2013213749, filed August 9, 2013,
European Patent Application Number
15163537.2, filed April 14, 2015, and
Canadian Patent Application Number
2903126, filed August 27, 2015, and
U.S. and foreign patent applications
E:\FR\FM\05JNN1.SGM
05JNN1
asabaliauskas on DSKBBXCHB2PROD with NOTICES
Federal Register / Vol. 82, No. 106 / Monday, June 5, 2017 / Notices
claiming priority to the aforementioned
applications.
E–006–2007/0, Pletnev et al.,
‘‘Synergistic Internal Ribosome Entry
Site/MicroRNA Based Approach for
Attenuation of Flaviviruses and Live
Vaccine Development,’’ U.S. Provisional
Patent Application Number 62/443,214,
filed January 6, 2017, and U.S. and
foreign patent applications claiming
priority to the aforementioned
applications.
The patent 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 live
attenuated West Nile Virus vaccines for
use in humans or animals.
West Nile virus (WNV) is a positivestrand RNA virus of the family
Flaviviridae, part of the Japanese
encephalitis virus serocomplex that
includes important human pathogens
such as Murray Valley encephalitis,
Japanese encephalitis, and St. Louis
encephalitis viruses. WNV has been
present in Africa and Asia for decades
and has usually been associated with
mild illness that includes symptoms of
low-grade fever, headache, rash,
myalgia, and arthralgia. Recently, WNV
has spread rapidly across the Western
hemisphere and is now the major
vector-borne cause of viral encephalitis
in the United States. By 2010, 3 million
adults were estimated to have been
infected with WNV in the United States,
with nearly 13,000 cases of
neuroinvasive disease, almost half of
which occurred in adults greater than 60
years of age. In this age group, WNV
infection can cause hepatitis,
meningitis, and encephalitis, leading to
paralysis, coma, and death. WNV is
considered an emerging infection in the
United States and presents a significant
public health threat. This
epidemiological trend of WNV suggests
that the United States can expect
periodic WNV outbreaks, underscoring
the need for a safe and effective vaccine
to protect at-risk populations, especially
older adults.
WNV is also a significant worldwide
public health threat. Starting in the mid1990s, the frequency, severity, and
geographic range of WNV outbreaks
increased, and outbreaks of WNV
meningitis and encephalitis affecting
primarily adults struck Bucharest,
Romania, in 1996, Volgograd, Russia, in
1999, and Israel, in 2000. WNV crossed
the Atlantic and reached the Western
hemisphere in the summer of 1999
when a cluster of patients with
encephalitis was reported in the
metropolitan area of New York City,
VerDate Sep<11>2014
17:31 Jun 02, 2017
Jkt 241001
New York, in the United States, and
within 3 years the virus had spread to
most of the contiguous U.S. and the
neighboring countries of Canada and
Mexico. In addition, although few
human cases have been reported, WNV
has also been found in Central and
South America through surveillance
studies in field specimens, suggesting a
potential risk for an outbreak in
humans. In the approximately eighty
(80) years since its discovery, the virus
has propagated to a vast region of the
globe and is now considered the most
important causative agent of viral
encephalitis worldwide.
No vaccine exists today to prevent
WNV. The methods and compositions of
this invention provide a means for
prevention of WNV infection by
immunization with live attenuated,
immunogenic viral vaccines against
WNV.
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, 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 filed
in response to this notice will be treated
as objections to the grant of the
contemplated Exclusive
Commercialization 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 24, 2017.
Suzanne Frisbie,
Deputy Director, Technology Transfer and
Intellectual Property Office, National Institute
of Allergy and Infectious Diseases.
[FR Doc. 2017–11491 Filed 6–2–17; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Aging; 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.
PO 00000
Frm 00051
Fmt 4703
Sfmt 4703
25805
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
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute on
Aging Special Emphasis Panel; Microbiome
and Antibiotic Resistance in Elders Study
(MARvELS).
Date: June 19, 2017.
Time: 1:30 p.m. to 5:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute on Aging,
Gateway Building, 2W200, 7201 Wisconsin
Avenue, Bethesda, MD 20892.
Contact Person: Carmen Moten, Ph.D.,
MPH, Scientific Review Officer, National
Institute on Aging, Gateway Building, 7201
Wisconsin Avenue, Suite 2C212, Bethesda,
MD 20892, 301–402–7703, cmoten@
mail.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
Name of Committee: National Institute on
Aging Special Emphasis Panel; A Global
Perspective on Cognition and Dementia.
Date: June 22, 2017.
Time: 1:30 p.m. to 4:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute on Aging,
Gateway Building, 2W200, 7201 Wisconsin
Avenue, Bethesda, MD 20892.
Contact Person: Carmen Moten, Ph.D.,
MPH, Scientific Review Officer, National
Institute on Aging, Gateway Building, 7201
Wisconsin Avenue, Suite 2C212, Bethesda,
MD 20892, 301–402–7703, cmoten@
mail.nih.gov.
Name of Committee: National Institute on
Aging Special Emphasis Panel; Pragmatic
Trials for Dementia Care.
Date: June 23, 2017.
Time: 2:30 p.m. to 4:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute on Aging,
Gateway Building, Suite 2W200, 7200
Wisconsin Avenue, Bethesda, MD
(Telephone Conference Call).
Contact Person: Carmen Moten, MPH,
Ph.D., Scientific Review Officer, National
Institute on Aging, Gateway Building, 7201
Wisconsin Avenue, Suite 2C212, Bethesda,
MD 20892, 301–402–7703.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.866, Aging Research,
National Institutes of Health, HHS)
E:\FR\FM\05JNN1.SGM
05JNN1
Agencies
[Federal Register Volume 82, Number 106 (Monday, June 5, 2017)]
[Notices]
[Pages 25804-25805]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-11491]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive Patent License: Production of
Attenuated West Nile Virus Vaccines
AGENCY: National Institutes of Health, Department of Health and Human
Services.
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
Commercialization Patent License to practice the inventions embodied in
the Patents and Patent Applications listed in the Summary Information
section of this notice to the International Medica Foundation located
in Shoreview, Minnesota, U.S.A.
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 June 20, 2017 will be considered.
ADDRESSES: Requests for copies of the patent application, inquiries,
and comments relating to the contemplated Exclusive Commercialization
Patent License should be directed to: Peter Soukas, Technology Transfer
and Patent Specialist, Technology Transfer and Intellectual Property
Office, National Institute of Allergy and Infectious Diseases, National
Institutes of Health, 5601 Fishers Lane, Suite 6D, Rockville, MD 20852-
9804; Email: ps193c@nih.gov; Telephone: (301) 594-8730; Facsimile:
(240) 627-3117.
SUPPLEMENTARY INFORMATION:
Intellectual Property
E-357-2001/0,1, Pletnev et al., ``Construction of West Nile Virus
and Dengue Virus Chimeras for use in a Live Virus Vaccine to Prevent
Disease Cause by West Nile Virus,'' U.S. Provisional Patent Application
Number 60/347,281, filed January 10, 2002, PCT Patent Application
Number PCT/US2003/00594, filed January 9, 2003, U.S. Patent Application
Number 10/871,775 filed June 18, 2004 (now U.S. Patent Number
8,778,671), U.S. Patent Application Number 14/305,572, filed June 16,
2014, European Patent Application Number 03729602.7, filed January 9,
2003, Israeli Patent Application Number 162949, filed January 9, 2003
(now Israeli Patent Number 162949), Canadian Patent Application Number
2472468, filed January 9, 2003 (now Canadian Patent Number 2472468),
Australian Patent Application Number 2003216046, filed January 9, 2003
(now Australian Patent Number 2003216046), Japanese Patent Application
Number 2003-559545, filed January 9, 2003 (now Japanese Patent Number
4580650), Australian Patent Application Number 2008203442 filed July
31, 2008 (now Australian Patent Number 2008203442), Israeli Patent
Application Number 209342, filed January 9, 2003 (now Israeli Patent
Number 209342), European Patent Application Number 11000126.0, filed
January 9, 2003 (now European Patent Number 2339011, validated in
Belgium, Great Britain, the Netherlands, Norway, Germany, Denmark and
France), Australian Patent Application Number 2011250694, filed
November 10, 2011 (now Australian Patent Number 2011250694), Australian
Patent Application Number 2013213749, filed August 9, 2013, European
Patent Application Number 15163537.2, filed April 14, 2015, and
Canadian Patent Application Number 2903126, filed August 27, 2015, and
U.S. and foreign patent applications
[[Page 25805]]
claiming priority to the aforementioned applications.
E-006-2007/0, Pletnev et al., ``Synergistic Internal Ribosome Entry
Site/MicroRNA Based Approach for Attenuation of Flaviviruses and Live
Vaccine Development,'' U.S. Provisional Patent Application Number 62/
443,214, filed January 6, 2017, and U.S. and foreign patent
applications claiming priority to the aforementioned applications.
The patent 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 live attenuated West Nile Virus
vaccines for use in humans or animals.
West Nile virus (WNV) is a positive-strand RNA virus of the family
Flaviviridae, part of the Japanese encephalitis virus serocomplex that
includes important human pathogens such as Murray Valley encephalitis,
Japanese encephalitis, and St. Louis encephalitis viruses. WNV has been
present in Africa and Asia for decades and has usually been associated
with mild illness that includes symptoms of low-grade fever, headache,
rash, myalgia, and arthralgia. Recently, WNV has spread rapidly across
the Western hemisphere and is now the major vector-borne cause of viral
encephalitis in the United States. By 2010, 3 million adults were
estimated to have been infected with WNV in the United States, with
nearly 13,000 cases of neuroinvasive disease, almost half of which
occurred in adults greater than 60 years of age. In this age group, WNV
infection can cause hepatitis, meningitis, and encephalitis, leading to
paralysis, coma, and death. WNV is considered an emerging infection in
the United States and presents a significant public health threat. This
epidemiological trend of WNV suggests that the United States can expect
periodic WNV outbreaks, underscoring the need for a safe and effective
vaccine to protect at-risk populations, especially older adults.
WNV is also a significant worldwide public health threat. Starting
in the mid-1990s, the frequency, severity, and geographic range of WNV
outbreaks increased, and outbreaks of WNV meningitis and encephalitis
affecting primarily adults struck Bucharest, Romania, in 1996,
Volgograd, Russia, in 1999, and Israel, in 2000. WNV crossed the
Atlantic and reached the Western hemisphere in the summer of 1999 when
a cluster of patients with encephalitis was reported in the
metropolitan area of New York City, New York, in the United States, and
within 3 years the virus had spread to most of the contiguous U.S. and
the neighboring countries of Canada and Mexico. In addition, although
few human cases have been reported, WNV has also been found in Central
and South America through surveillance studies in field specimens,
suggesting a potential risk for an outbreak in humans. In the
approximately eighty (80) years since its discovery, the virus has
propagated to a vast region of the globe and is now considered the most
important causative agent of viral encephalitis worldwide.
No vaccine exists today to prevent WNV. The methods and
compositions of this invention provide a means for prevention of WNV
infection by immunization with live attenuated, immunogenic viral
vaccines against WNV.
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, 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 filed in response to this notice will be treated as objections
to the grant of the contemplated Exclusive Commercialization 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 24, 2017.
Suzanne Frisbie,
Deputy Director, Technology Transfer and Intellectual Property Office,
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2017-11491 Filed 6-2-17; 8:45 am]
BILLING CODE 4140-01-P