Prospective Grant of an Exclusive License: Anti-Cancer Vaccines, 44673-44674 [05-15344]
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Federal Register / Vol. 70, No. 148 / Wednesday, August 3, 2005 / Notices
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: July 19, 2005.
Steven M. Ferguson,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 05–15343 Filed 8–2–05; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive
License: Therapeutics for the
Treatment of Kidney Cancer and
Thyroid Neoplasms
National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
AGENCY:
SUMMARY: This notice, in accordance
with 35 U.S.C. 209(c)(1) and 37 CFR
404.7(a)(1)(i), announces that the
National Institutes of Health,
Department of Health and Human
Services, is contemplating the grant of
an exclusive license to practice the
inventions embodied in
1. E–199–2002/0–US–01, ‘‘Treatment
Method and Therapeutic Agent of
Kidney Cancer’’, by Susan Bates, and
Yoshinori Naoe, Pat. Application No.
60/369,868 (filing date April 5, 2002);
2. E–199–2002/0–PCT–02, ‘‘Treatment
Method and Therapeutic Agent of
Kidney Cancer’’, by Susan Bates, and
Yoshinori Naoe, Pat. Application No.
PCT/US03/03823 (filing date March 27,
2003);
3. E–199–2002/0–US–04,
‘‘Depsipeptide for Therapy of Kidney
Cancer’’, by Susan Bates, and Yoshinori
Naoe, Pat. Application No. 10/508,958
(filing date October 5, 2004);
4. E–199–2002/0–JP–08,
‘‘Depsipeptide for Therapy of Kidney
Cancer’’, by Susan Bates, and Yoshinori
Naoe, Pat. Application No. 20003581847
(filing date October 5, 2004);
5. E–199–2002/0–EP–05,
‘‘Depsipeptide for Therapy of Kidney
Cancer’’, by Susan Bates, and Yoshinori
Naoe, Pat Application No.037155033–
2107 (filing date October 8, 2004);
6. E–286–2000/0–US–01, ‘‘Histone
Deacetylase Inhibitors in Diagnosis and
Treatment of Thyroid Neoplasms’’, by
Tito Fojo and Susan Bates, Pat.
Application No. 60/260,733 (filing date
January 10, 2001);
VerDate jul<14>2003
15:22 Aug 02, 2005
Jkt 205001
7. E–286–2000/0–US–02, ‘‘Histone
Deacetylase Inhibitors in Diagnosis and
Treatment of Thyroid Neoplasms’’, by
Tito Fojo and Susan Bates, Pat.
Application No. PCT/US02/0714 (filing
date January 9, 2001);
8. E–286–2000/0–EP–03, ‘‘Histone
Deacetylase Inhibitors in Diagnosis and
Treatment of Thyroid Neoplasms’’, by
Tito Fojo and Susan Bates, Pat.
Application No. 02718823.4 (filing date
January 9, 2001);
9. E–286–2000/0–AU–04, ‘‘Histone
Deacetylase Inhibitors in Diagnosis and
Treatment of Thyroid Neoplasms’’, by
Tito Fojo and Susan Bates, Pat.
Application No. 2002249938 (filing date
January 9, 2001);
10. E–286–2000/0–CA–04, ‘‘Histone
Deacetylase Inhibitors in Diagnosis and
Treatment of Thyroid Neoplasms’’, by
Tito Fojo and Susan Bates, Pat.
Application No. 2434269 (filing date
January 9, 2001);
11. E–286–2000/0–US–07, ‘‘Histone
Deacetylase Inhibitors in Diagnosis and
Treatment of Thyroid Neoplasms’’, by
Tito Fojo and Susan Bates, Pat.
Application No. 10/250,320 (filing date
June 26, 2003);
12. E–286–2000/0–JP–05, ‘‘Histone
Deacetylase Inhibitors in Diagnosis and
Treatment of Thyroid Neoplasms’’, by
Tito Fojo and Susan Bates, Pat.
Application No. 2002–556736 (filing
date July 10, 2003)
to Gloucester Pharmaceticals, having a
place of business in Cambridge, MA.
The patent rights in these inventions
have been assigned to the United States
of America.
The prospective exclusive license
territory may be worldwide, and the
field of use may be limited to
therapeutics for the treatment of Kidney
Cancer and Thyroid Neoplasms.
DATES: Only written comments and/or
license applications which are received
by the National Institutes of Health on
or before October 3, 2005 will be
considered.
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: John
Stansberrry, Ph.D., Technology
Licensing Specialist, Office of
Technology Transfer, National Institutes
of Health, 6011 Executive Boulevard,
Suite 325, Rockville, MD 20852–3804;
Telephone: (301) 435–5236; Facsimile:
(301) 402–0220; E-mail:
stansbej@mail.nih.gov.
ADDRESSES:
The
inventions describe methods of treating
kidney cancer and thyroid neoplasms
SUPPLEMENTARY INFORMATION:
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44673
with FK228, which is a histone
deacetylase (HDAC) inhibitor. FK228 is
currently in Phase II clinical trials, and
has been shown to inhibit histone
deacetylation, a process instrumental in
the regulation of gene expression.
FK228 modulates cell cycle arrest and
can promote differentiation and
apoptosis. To date, FK228 has been
administered to more than 300 patients
and has shown promising clinical
activity in Phase II trials for patients
with cutaneous T-cell lymphoma
(CTCL). Clinical responses have also
been observed in Phase II studies in
peripheral T-cell lymphoma, renal cell
carcinoma (RCC) and hormone
refractory prostate cancer (HRPC).
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.
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: July 26, 2005.
Steven M. Ferguson,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 05–15345 Filed 8–2–05; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive
License: Anti-Cancer Vaccines
National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
AGENCY:
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
National Institutes of Health,
Department of Health and Human
Services, is contemplating the grant of
an exclusive license to practice the
inventions embodied in U.S. Patent
E:\FR\FM\03AUN1.SGM
03AUN1
44674
Federal Register / Vol. 70, No. 148 / Wednesday, August 3, 2005 / Notices
Application No. 60/498,238, filed
August 26, 2003, entitled ‘‘Anti-cancer
Vaccines’’ (E–179–2004/0–US–01); U.S.
Patent Application No. 10/926,852, filed
August 26, 2004, entitled ‘‘Anti-cancer
Vaccines’’ (E–179–2004/0–US–03); and
PCT Application No. PCT/US04/27790,
filed August 26, 2004, entitled ‘‘Anticancer Vaccines’’ (E–179–2004/0–PCT–
02), to Vaccine Company, having a place
of business in Carmel-by-the-Sea,
California. The patent rights in these
inventions have been assigned to the
United States of America and MD
Anderson Cancer Center (Part of the
University of Texas System).
The prospective exclusive license
territory may be worldwide, and the
field of use may be limited to
development and sale of diagnostic and
pharmaceutical products useful in
diagnosis and treatment of myeloid
neoplasms.
DATES: Only written comments and/or
license applications which are received
by the National Institutes of Health on
or before October 3, 2005 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., 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: This
technology is directed to the use of
tumor-associated HLA-restricted
antigens (peptides from proteinase-3 or
myeloperoxidase) as vaccines for
treating or preventing cancer,
autoimmune diseases and transplant
rejection. The technology is more
specifically directed to the use of
peptides, such as PR1, derived from
proteinase-3 (a myeloid tissue-restricted
protein) as vaccine to elicit PR1-specific
cytotoxic T lymphocytes. The
technology encompasses the use of PR1
and other peptides in the treatment of
acute and chronic myelogenous
leukemia (AML & CML), and
myelodysplastic syndrome. Such
treatment could result in prolonged
remissions or cure in patients who are
otherwise refractive to treatment.
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
VerDate jul<14>2003
15:22 Aug 02, 2005
Jkt 205001
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.
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: July 26, 2005.
Steven M. Ferguson,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 05–15344 Filed 8–2–05; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HOMELAND
SECURITY
Federal Emergency Management
Agency
[FEMA–1597–DR]
North Dakota; Major Disaster and
Related Determinations
Federal Emergency
Management Agency, Emergency
Preparedness and Response Directorate,
Department of Homeland Security.
ACTION: Notice.
AGENCY:
SUMMARY: This is a notice of the
Presidential declaration of a major
disaster for the State of North Dakota
(FEMA–1597–DR), dated July 22, 2005,
and related determinations.
DATES: Effective July 22, 2005.
FOR FURTHER INFORMATION CONTACT:
Magda Ruiz, Recovery Division, Federal
Emergency Management Agency,
Washington, DC 20472, (202) 646–2705.
SUPPLEMENTARY INFORMATION: Notice is
hereby given that, in a letter dated July
22, 2005, the President declared a major
disaster under the authority of the
Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C.
5121–5206 (the Stafford Act), as follows:
I have determined that the damage in
certain areas of the State of North Dakota,
resulting from severe storms, flooding, and
ground saturation beginning on June 1, 2005,
through July 7, 2005, is of sufficient severity
and magnitude to warrant a major disaster
declaration under the Robert T. Stafford
Disaster Relief and Emergency Assistance
Act, 42 U.S.C. 5121–5206 (the Stafford Act).
Therefore, I declare that such a major disaster
exists in the State of North Dakota.
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Fmt 4703
Sfmt 4703
In order to provide Federal assistance, you
are hereby authorized to allocate from funds
available for these purposes such amounts as
you find necessary for Federal disaster
assistance and administrative expenses.
You are authorized to provide Public
Assistance in the designated areas; Hazard
Mitigation throughout the State; and any
other forms of assistance under the Stafford
Act you may deem appropriate. Consistent
with the requirement that Federal assistance
be supplemental, any Federal funds provided
under the Stafford Act for Public Assistance
and Hazard Mitigation will be limited to 75
percent of the total eligible costs. If Other
Needs Assistance under Section 408 of the
Stafford Act is later requested and warranted,
Federal funding under that program will also
be limited to 75 percent of the total eligible
costs.
Further, you are authorized to make
changes to this declaration to the extent
allowable under the Stafford Act.
The Federal Emergency Management
Agency (FEMA) hereby gives notice that
pursuant to the authority vested in the
Under Secretary for Emergency
Preparedness and Response, Department
of Homeland Security, under Executive
Order 12148, as amended, Anthony
Russell, of FEMA is appointed to act as
the Federal Coordinating Officer for this
declared disaster.
I do hereby determine the following
areas of the State of North Dakota to
have been affected adversely by this
declared major disaster:
Benson, Bottineau, Cavalier, Dickey, Grand
Forks, Griggs, Kidder, LaMoure, McHenry,
Nelson, Pierce, Ramsey, Richland, Sargent,
Sioux, Stark, Steele, Traill, Walsh, and Ward
Counties, and the Turtle Mountain Indian
Reservation, and the portion of the Standing
Rock Indian Reservation which lies within
the State of North Dakota for Public
Assistance.
All counties and Indian Reservations in the
State of North Dakota are eligible to apply for
assistance under the Hazard Mitigation Grant
Program.
(The following Catalog of Federal Domestic
Assistance Numbers (CFDA) are to be used
for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora
Brown Fund Program; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services
Program; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management
Assistance; 97.048, Individuals and
Households Housing; 97.049, Individuals and
Households Disaster Housing Operations;
97.050 Individuals and Households ProgramOther Needs, 97.036, Public Assistance
Grants; 97.039, Hazard Mitigation Grant
Program)
Michael D. Brown,
Under Secretary, Emergency Preparedness
and Response, Department of Homeland
Security.
[FR Doc. 05–15237 Filed 8–2–05; 8:45 am]
BILLING CODE 9110–10–P
E:\FR\FM\03AUN1.SGM
03AUN1
Agencies
[Federal Register Volume 70, Number 148 (Wednesday, August 3, 2005)]
[Notices]
[Pages 44673-44674]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-15344]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive License: Anti-Cancer Vaccines
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 National Institutes of Health,
Department of Health and Human Services, is contemplating the grant of
an exclusive license to practice the inventions embodied in U.S. Patent
[[Page 44674]]
Application No. 60/498,238, filed August 26, 2003, entitled ``Anti-
cancer Vaccines'' (E-179-2004/0-US-01); U.S. Patent Application No. 10/
926,852, filed August 26, 2004, entitled ``Anti-cancer Vaccines'' (E-
179-2004/0-US-03); and PCT Application No. PCT/US04/27790, filed August
26, 2004, entitled ``Anti-cancer Vaccines'' (E-179-2004/0-PCT-02), to
Vaccine Company, having a place of business in Carmel-by-the-Sea,
California. The patent rights in these inventions have been assigned to
the United States of America and MD Anderson Cancer Center (Part of the
University of Texas System).
The prospective exclusive license territory may be worldwide, and
the field of use may be limited to development and sale of diagnostic
and pharmaceutical products useful in diagnosis and treatment of
myeloid neoplasms.
DATES: Only written comments and/or license applications which are
received by the National Institutes of Health on or before October 3,
2005 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., 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: This technology is directed to the use of
tumor-associated HLA-restricted antigens (peptides from proteinase-3 or
myeloperoxidase) as vaccines for treating or preventing cancer,
autoimmune diseases and transplant rejection. The technology is more
specifically directed to the use of peptides, such as PR1, derived from
proteinase-3 (a myeloid tissue-restricted protein) as vaccine to elicit
PR1-specific cytotoxic T lymphocytes. The technology encompasses the
use of PR1 and other peptides in the treatment of acute and chronic
myelogenous leukemia (AML & CML), and myelodysplastic syndrome. Such
treatment could result in prolonged remissions or cure in patients who
are otherwise refractive to treatment.
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.
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: July 26, 2005.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. 05-15344 Filed 8-2-05; 8:45 am]
BILLING CODE 4140-01-P