Prospective Grant of an Exclusive License: Development and Commercialization of Therapeutic Products for Breast Cancer, 9581-9582 [E8-3165]
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Federal Register / Vol. 73, No. 35 / Thursday, February 21, 2008 / Notices
amended (5 U.S.C. Appendix 2), 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: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; Regulation of Adaptive
Immunity by the Innate Immune System.
Date: March 13, 2008.
Time: 1:30 p.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6700B
Rockledge Drive, MSC 3136, Bethesda, MD
20892 (Telephone Conference Call).
Contact Person: Mercy R. Prabhudas, PhD,
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities,
NIAID/NIH/DHHS, 6700B Rockledge Drive,
MSC 7616, Bethesda, MD 20892–7616, 301–
451–2615, mp457n@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: February 13, 2008.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 08–773 Filed 2–20–08; 8:45 am]
National Institutes of Health
pwalker on PROD1PC71 with NOTICES
National Institute on Aging; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), 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
Jkt 214001
Dated: February 13, 2008.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 08–774 Filed 2–20–08: 8:45 am]
BILLING CODE 4140–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive
License: Development and
Commercialization of Therapeutic
Products for Breast Cancer
National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
16:34 Feb 20, 2008
Name of Committee: National Institute on
Aging Special Emphasis Panel; SWAN.
Date: March 4, 2008.
Time: 2 p.m. to 6 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute on Aging, 7201
Wisconsin Avenue, Suite 2C212, Bethesda,
MD 20814 (Telephone Conference Call).
Contact Person: Alicja L. Markowska, PhD,
DSC, National Institute on Aging, 7201
Wisconsin Avenue, Suite 2C212, Bethesda,
MD 20892, 301–496–9666,
markowsa@nia.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.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.866, Aging Research,
National Institutes of Health, HHS)
AGENCY:
BILLING CODE: 4140–01–M
VerDate Aug<31>2005
would constitute a clearly unwarranted
invasion of personal privacy.
SUMMARY: This notice, in accordance
with 35 U.S.C. 209(c)(1) and 37 CFR
Part 404.7(a)(1)(i), announces that the
Department of Health and Human
Services is contemplating the grant of an
exclusive license to practice the
inventions embodied in U.S. Patent
Application No. 09/693,600 filed
October 20, 2000 entitled ‘‘Method and
Composition for Enhancing Immune
Response’’ [E–037–2001/1–US–01];
Japanese Patent Application No. 2002–
555834 filed October 22, 2001 entitled
‘‘Method and Composition for
Enhancing Immune Response’’ [E–037–
2001/1–JP–03]; and European Patent
Application No. 01989341.1 filed
October 22, 2001 entitled ‘‘Method and
Composition for Enhancing Immune
Response’’ [E–037–2001/1–EP–04]; to
ODC Therapy, Inc.
The prospective exclusive license
territory may be worldwide and the
field of use may be limited to
therapeutic applications for breast
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Sfmt 4703
9581
cancer patients expressing high levels of
serum or plasma IgE.
DATES: Only written comments and/or
license applications which are received
by the National Institutes of Health on
or before April 21, 2008 will be
considered.
ADDRESSES: Requests for copies of the
patent and/or patent applications,
inquiries, comments and other materials
relating to the contemplated exclusive
license should be directed to: Mojdeh
Bahar, J.D., M.A., Technology Licensing
Specialist, Office of Technology
Transfer, National Institutes of Health,
6011 Executive Boulevard, Suite 325,
Rockville, MD. 20852–3804. Telephone:
(301) 435–2950; Facsimile: (301) 402–
0220; E-mail: baharm@od.nih.gov.
SUPPLEMENTARY INFORMATION: The
invention relates to a method of
inhibiting tumor growth which
comprises the administration of an IL–
13 inhibitor. Additionally, the invention
relates to a method and composition for
enhancing an immune response in a
subject by administering to a subject an
inhibitor of IL–13 or an inhibitor of an
NK–T cell. The method can be used to
prevent growth of a tumor in a subject,
e.g., to inhibit tumor recurrence or
metastasis. The method can also be used
to enhance a response to a vaccine in a
subject. IL–13 is an interleukin which
has potent immunomodulatory effects.
It is primarily secreted by TH2
lymphocytes. This invention relates to
the discovery of a role for IL–13 in the
down-regulation of tumor
immunosurveillance. Using a mouse
model in which tumors show a growthregression-recurrence pattern, the
mechanisms for down-regulation of
cytotoxic T lymphocyte-mediated tumor
immunosurveillance was investigated. It
was discovered that interleukin 4
receptor (IL–4R) knockout mice, and
downstream signal transducer and
activator of transcription 6 (STAT6)
knockout mice, but not IL–4 knockout
mice, resisted tumor recurrence. Thus,
IL–13, the only other cytokine that uses
the IL–4R–STAT6 pathway, was
discovered to have a role in the downregulation of tumor
immunosurveillance.
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 sixty (60) days from the date of
this published notice, the NIH receives
written evidence and argument that
establish that the grant of the license
would not be consistent with the
requirements of 35 U.S.C. 209 and 37
CFR 404.7.
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9582
Federal Register / Vol. 73, No. 35 / Thursday, February 21, 2008 / Notices
Applications for a license in the field
of use filed in response to this notice
will be treated as objections to the grant
of the contemplated exclusive license.
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: February 11, 2008.
Steven M. Ferguson,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. E8–3165 Filed 2–20–08; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive
License: Regulatory Approved Clinical
Diagnostics for Anti-HPV16 L1 Serum
Antibody Detection in HPV Vaccine
Recipients
National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
pwalker on PROD1PC71 with NOTICES
AGENCY:
SUMMARY: This is notice, in accordance
with 35 U.S.C. 209(c)(1) and 37 CFR
404.7(a)(1)(i), that the National
Institutes of Health (NIH), Department
of Health and Human Services, is
contemplating the grant of an exclusive
worldwide license to practice the
invention embodied in HHS Ref. No. E–
253–1993/0 and certain foreign rights
under HHS Ref. No. E–166–1992
including U.S. Patent 5,437,951, U.S.
Patent 5,985,610, U.S. Patent 5,871,998,
U.S. Patent 5,716,620, U.S. Patent
5,744,142, U.S. Patent 5,756,284, U.S.
Patent 5,709,996, U.S. Patent
Application 09/316,487, U.S. Patent
Application 10/371,846, International
Patent Application PCT/US93/08342,
European Patent Application
93921353.4, European Patent
Application 040104531.1, European
Patent Application 040783235,
Australian Patent 683220, Australian
Patent Application 2004203609,
Canadian Patent No. 2,143,845, Japanese
Patent Applications 1994–507481,
Japanese Patent Applications 2001–
101791 and continuation and divisional
patents and patent applications thereof,
entitled ‘‘Self-Assembling Recombinant
Papillomavirus HPV16 Capsid
Proteins,’’ to Biotrin International, Ltd.,
a limited liability company formed
under the laws of the European Union
and the Republic of Ireland. The United
VerDate Aug<31>2005
16:34 Feb 20, 2008
Jkt 214001
States of America is the assignee of the
patent rights of the above inventions.
The contemplated exclusive license
may be granted in the field of regulatory
approved clinical diagnostics for serum
anti-HPV16 L1 antibody detection in
HPV vaccine recipients.
DATE: Only written comments and/or
applications for a license received by
the NIH Office of Technology Transfer
on or before April 21, 2008 will be
considered.
ADDRESSES: Requests for a copy of the
patent applications, inquiries,
comments and other materials relating
to the contemplated license should be
directed to: Michael A. Shmilovich,
Esq., Office of Technology Transfer,
National Institutes of Health, 6011
Executive Boulevard, Suite 325,
Rockville, MD 20852–3804; Telephone:
(301) 435–5019; Facsimile: (301) 402–
0220; E-mail: shmilovm@mail.nih.gov.
A signed confidentiality nondisclosure
agreement may be required to receive
copies of the patent applications.
SUPPLEMENTARY INFORMATION: The patent
applications intended for licensure
disclose and/or cover the following:
E–253–1993 and E–166–1992, ‘‘SelfAssembling Recombinant
Papillomavirus Capsid Proteins of
HPV16,’’ Lowy et al.
Recombinant human papillomavirus
16 capsid proteins that are capable of
self-assembly into capsomer structures
and viral capsids that comprise
conformational antigenic epitopes. The
capsomer structures and viral capsids,
consisting of the capsid proteins that are
expression products of a bovine,
monkey or human papillomavirus L1
conformational coding sequence
proteins, can be prepared for use in
ELISA or cell-based immunoassays for
detecting the level of serum antibody in
recipients of a vaccine against HPV16.
The self-assembling capsid proteins can
also be used as elements of diagnostic
immunoassay procedures for
papillomavirus infection.
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 sixty (60) days from the date of
this published notice, 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.
Properly filed competing applications
for a license filed in response to this
notice will be treated as objections to
the contemplated license. Comments
and objections submitted in response to
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Fmt 4703
Sfmt 4703
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: February 14, 2008.
David Sadowski,
Deputy Director, Division of Technology
Development and Transfer, Office of
Technology Transfer, National Institutes of
Health.
[FR Doc. E8–3162 Filed 2–20–08; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF THE INTERIOR
Fish and Wildlife Service
[FWS–R9–MB–2008–N0031]
Wildlife and Sport Fish Restoration
Program
Fish and Wildlife Service,
Interior.
ACTION: Notice of receipt of priority list.
AGENCY:
SUMMARY: We, the U.S. Fish and
Wildlife Service (FWS), announce the
FY 2008 priority list of wildlife and
sport fish conservation projects from the
Association of Fish and Wildlife
Agencies (AFWA). As required by the
Wildlife and Sport Fish Restoration
Programs Improvement Act of 2000,
AFWA submits a list of projects to us
each year to consider for funding under
the Multistate Conservation Grant
program. We then review and award
grants from this list.
ADDRESSES: John C. Stremple, Multistate
Conservation Grants Program
Coordinator, Division of Federal
Assistance, U.S. Fish and Wildlife
Service, 4401 North Fairfax Drive, Mail
Stop MBSP–4020, Arlington, Virginia
22203.
FOR FURTHER INFORMATION CONTACT: John
C. Stremple, (703) 358–2156 (phone) or
John_Stremple@fws.gov (e-mail).
SUPPLEMENTARY INFORMATION: The
Wildlife and Sport Fish Restoration
Programs Improvement Act of 2000
(Improvement Act, Pub. L. 106–408)
amended the Pittman-Robertson
Wildlife Restoration Act (16 U.S.C. 669
et seq.) and the Dingell-Johnson Sport
Fish Restoration Act (16 U.S.C. 777 et
seq.) and established the Multistate
Conservation Grant Program. The
Improvement Act authorizes us to
award grants of up to $3 million
annually from funds available under
each of the Restoration Acts, for a total
of up to $6 million annually. We may
award grants from a list of priority
projects recommended to us by AFWA.
The FWS Director, exercising the
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Agencies
[Federal Register Volume 73, Number 35 (Thursday, February 21, 2008)]
[Notices]
[Pages 9581-9582]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-3165]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive License: Development and
Commercialization of Therapeutic Products for Breast Cancer
AGENCY: National Institutes of Health, Public Health Service, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR
Part 404.7(a)(1)(i), announces that the Department of Health and Human
Services is contemplating the grant of an exclusive license to practice
the inventions embodied in U.S. Patent Application No. 09/693,600 filed
October 20, 2000 entitled ``Method and Composition for Enhancing Immune
Response'' [E-037-2001/1-US-01]; Japanese Patent Application No. 2002-
555834 filed October 22, 2001 entitled ``Method and Composition for
Enhancing Immune Response'' [E-037-2001/1-JP-03]; and European Patent
Application No. 01989341.1 filed October 22, 2001 entitled ``Method and
Composition for Enhancing Immune Response'' [E-037-2001/1-EP-04]; to
ODC Therapy, Inc.
The prospective exclusive license territory may be worldwide and
the field of use may be limited to therapeutic applications for breast
cancer patients expressing high levels of serum or plasma IgE.
DATES: Only written comments and/or license applications which are
received by the National Institutes of Health on or before April 21,
2008 will be considered.
ADDRESSES: Requests for copies of the patent and/or patent
applications, inquiries, comments and other materials relating to the
contemplated exclusive license should be directed to: Mojdeh Bahar,
J.D., M.A., Technology Licensing Specialist, Office of Technology
Transfer, National Institutes of Health, 6011 Executive Boulevard,
Suite 325, Rockville, MD. 20852-3804. Telephone: (301) 435-2950;
Facsimile: (301) 402-0220; E-mail: baharm@od.nih.gov.
SUPPLEMENTARY INFORMATION: The invention relates to a method of
inhibiting tumor growth which comprises the administration of an IL-13
inhibitor. Additionally, the invention relates to a method and
composition for enhancing an immune response in a subject by
administering to a subject an inhibitor of IL-13 or an inhibitor of an
NK-T cell. The method can be used to prevent growth of a tumor in a
subject, e.g., to inhibit tumor recurrence or metastasis. The method
can also be used to enhance a response to a vaccine in a subject. IL-13
is an interleukin which has potent immunomodulatory effects. It is
primarily secreted by TH2 lymphocytes. This invention relates to the
discovery of a role for IL-13 in the down-regulation of tumor
immunosurveillance. Using a mouse model in which tumors show a growth-
regression-recurrence pattern, the mechanisms for down-regulation of
cytotoxic T lymphocyte-mediated tumor immunosurveillance was
investigated. It was discovered that interleukin 4 receptor (IL-4R)
knockout mice, and downstream signal transducer and activator of
transcription 6 (STAT6) knockout mice, but not IL-4 knockout mice,
resisted tumor recurrence. Thus, IL-13, the only other cytokine that
uses the IL-4R-STAT6 pathway, was discovered to have a role in the
down-regulation of tumor immunosurveillance.
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 sixty
(60) days from the date of this published notice, the NIH receives
written evidence and argument that establish that the grant of the
license would not be consistent with the requirements of 35 U.S.C. 209
and 37 CFR 404.7.
[[Page 9582]]
Applications for a license in the field of use filed in response to
this notice will be treated as objections to the grant of the
contemplated exclusive license. 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: February 11, 2008.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. E8-3165 Filed 2-20-08; 8:45 am]
BILLING CODE 4140-01-P