Prospective Grant of an Exclusive License: Diagnostics Based on Immune Reactions to Brother of the Regulator of Imprinted Sites (BORIS), 49690-49691 [E8-19454]
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Federal Register / Vol. 73, No. 164 / Friday, August 22, 2008 / Notices
Research; 93.849, Kidney Diseases, Urology
and Hematology Research, National Institutes
of Health, HHS)
Dated: August 15, 2008.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E8–19450 Filed 8–21–08; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
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Type of Meeting: Strategic Planning
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VerDate Aug<31>2005
17:12 Aug 21, 2008
Jkt 214001
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Dated: August 15, 2008.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E8–19455 Filed 8–21–08; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive
License: Diagnostics Based on
Immune Reactions to Brother of the
Regulator of Imprinted Sites (BORIS)
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
Department of Health and Human
Services is contemplating the grant of an
exclusive license to practice the
inventions embodied in PCT
Application No. PCT/US2007/77281,
entitled ‘‘BORIS Isoforms and Methods
of Detecting and Treating Disease’’ filed
August 30, 2007 (E–117–2006/0–PCT–
02); EP Application No. 05799643.1,
entitled ‘‘Method of Detecting Cancer
Based On Immune Reaction To BORIS’’
filed September 21, 2005 (E–241–2004/
0–EP–03); U.S. Application Serial No.
11/575,732, entitled ‘‘Method of
Detecting Cancer Based On Immune
Reaction To BORIS’’ filed March 21,
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
2007 (E–241–2004/0–US–04); U.S.
Patent No. 7,375,206, entitled ‘‘Brother
of The Regulator of Imprinted Sites
(BORIS)’’ issued May 28, 2008 (E–227–
2001/0–US–03); and EP Patent
Application No. 03743179.8, entitled
‘‘Brother of The Regulator of Imprinted
Sites (BORIS)’’ filed September 17, 2004
(E–227–2001/0–EP–04) to Wellstat
Diagnostics, Inc.
The prospective exclusive territory
may be worldwide, and the field of use
may be limited to manufacture and sale
of diagnostics for cancer and cancer
predisposition.
DATES: Only written comments and/or
license applications which are received
by the National Institutes of Health on
or before October 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., 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
above-mentioned patent applications
describe the human protein Brother of
Regulator of Imprinted Sites (‘‘BORIS’’),
and a method of detecting cancer by
monitoring BORIS expression or by
detecting anti-BORIS antibodies. Dr.
Victor V. Lobanenkov and colleagues at
the National Institute of Allergy and
Infectious Diseases discovered BORIS
and its potential application as a cancer
diagnostic. BORIS is a paralog of
CCCTC-binding factor (‘‘CTCF’’), a
transcription factor that also functions
in chromatin insulation. The amino acid
sequences of BORIS and CTCF contain
eleven conserved zinc fingers each of
which binds to DNA. BORIS protein can
be detected in cancer cells, and
importantly, it is one of a few cancertestis antigens that are immunogenic in
humans.
BORIS resides in 20q13.2, a region
that is commonly amplified in many
human cancers. Normally, BORIS
mRNA can be detected in testis, but not
in other human tissues. However,
BORIS mRNA is detectable in over one
hundred cancer cell lines representing
most of the major forms of human
tumors and is also detectable in primary
breast cancer tumor samples, but not in
controls. BORIS protein is misexpressed in cancer cell lines, and
antibodies against BORIS have been
detected in serum from patients with
E:\FR\FM\22AUN1.SGM
22AUN1
Federal Register / Vol. 73, No. 164 / Friday, August 22, 2008 / Notices
gliomas, lung, breast or prostate cancers
but not in serum from controls.
The correlation between cancer and
BORIS expression indicates that
detection of aberrantly expressed BORIS
and/or anti-BORIS antibodies could
serve as a method of screening or
diagnosing cancer. In patients already
known to have cancer, expression of
BORIS could be monitored to measure
a patient’s response to a particular
therapeutic regimen.
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 404.7. 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 Part 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.
which has offices in Vancouver, Canada.
This patent has been assigned to the
Government of the United States of
America. There are no foreign patents or
patent applications associated with this
technology. There are no other U.S.
Patents or Patent Applications
associated with this technology.
The prospective exclusive license
territory may be worldwide, and the
field of use maybe limited to the
development and sale of antibody
conjugated toxins targeting the nicotinic
acetylcholine receptors for therapeutic
treatment of focal muscle spasms, as
claimed in the Licensed Patent Rights.
DATES: Only written comments and/or
applications for a license which are
received by the NIH Office of
Technology Transfer on or before
October 21, 2008 will be considered.
ADDRESSES: Requests for copy of the
patent, inquiries, comments, and other
materials relating to the contemplated
exclusive license should be directed to:
Betty B. Tong, PhD, Technology
Licensing Specialist, Office of
Technology Transfer, National Institutes
of Health, 6011 Executive Boulevard,
Suite 325, Rockville, MD 20852–3804;
Telephone: (301) 594–6565; Facsimile:
(301) 402–0220; E-mail:
tongb@mail.nih.gov.
Dated: August 14, 2008.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. E8–19454 Filed 8–21–08; 8:45 am]
SUPPLEMENTARY INFORMATION:
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive
License: The Development of
Inmunotoxins as Therapeutics for
Focal Muscle Spasms
National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
jlentini on PROD1PC65 with NOTICES
AGENCY:
SUMMARY: This is notice, in accordance
with 35 U.S.C. 209(c)(l) and 37 CFR part
404.7(a)(l)(i), that the National Institutes
of Health, Department of Health and
Human Services, is contemplating the
grant of an exclusive patent license to
practice the invention embodied in
issued U.S. Patent 6,780,413 entitled
‘‘Immunotoxin (MAB–Ricin) for the
Treatment of Focal Movement
Disorders’’ [HHS Ref. E–132–1996/0–
US–04] to Aphrodite Therapeutics, Inc.,
VerDate Aug<31>2005
17:12 Aug 21, 2008
Jkt 214001
The
invention describes immunotoxins and
methods of using the immunotoxins for
the treatment of focal muscle spasms. A
specific immunotoxin covered by this
technology is MAB–Ricin. The
immunotoxins are targeted via an
antibody that is specific to acetylcholine
receptors present in large numbers on
the muscle side of the neuromuscular
junction, allowing the specific
destruction of muscle cells.
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 404.7. 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 establishes that the grant
of the license would not be consistent
with the requirements of 35 U.S.C. 209
and 37 CFR part 404.7.
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.
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
49691
Dated: August 14, 2008.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. E8–19463 Filed 8–21–08; 8:45 am]
BILLING CODE 4140–01–P
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
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E:\FR\FM\22AUN1.SGM
22AUN1
]]>Agencies
[Federal Register Volume 73, Number 164 (Friday, August 22, 2008)]
[Notices]
[Pages 49690-49691]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-19454]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive License: Diagnostics Based on
Immune Reactions to Brother of the Regulator of Imprinted Sites (BORIS)
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 PCT Application No. PCT/US2007/77281,
entitled ``BORIS Isoforms and Methods of Detecting and Treating
Disease'' filed August 30, 2007 (E-117-2006/0-PCT-02); EP Application
No. 05799643.1, entitled ``Method of Detecting Cancer Based On Immune
Reaction To BORIS'' filed September 21, 2005 (E-241-2004/0-EP-03); U.S.
Application Serial No. 11/575,732, entitled ``Method of Detecting
Cancer Based On Immune Reaction To BORIS'' filed March 21, 2007 (E-241-
2004/0-US-04); U.S. Patent No. 7,375,206, entitled ``Brother of The
Regulator of Imprinted Sites (BORIS)'' issued May 28, 2008 (E-227-2001/
0-US-03); and EP Patent Application No. 03743179.8, entitled ``Brother
of The Regulator of Imprinted Sites (BORIS)'' filed September 17, 2004
(E-227-2001/0-EP-04) to Wellstat Diagnostics, Inc.
The prospective exclusive territory may be worldwide, and the field
of use may be limited to manufacture and sale of diagnostics for cancer
and cancer predisposition.
DATES: Only written comments and/or license applications which are
received by the National Institutes of Health on or before October 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., 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 above-mentioned patent applications
describe the human protein Brother of Regulator of Imprinted Sites
(``BORIS''), and a method of detecting cancer by monitoring BORIS
expression or by detecting anti-BORIS antibodies. Dr. Victor V.
Lobanenkov and colleagues at the National Institute of Allergy and
Infectious Diseases discovered BORIS and its potential application as a
cancer diagnostic. BORIS is a paralog of CCCTC-binding factor
(``CTCF''), a transcription factor that also functions in chromatin
insulation. The amino acid sequences of BORIS and CTCF contain eleven
conserved zinc fingers each of which binds to DNA. BORIS protein can be
detected in cancer cells, and importantly, it is one of a few cancer-
testis antigens that are immunogenic in humans.
BORIS resides in 20q13.2, a region that is commonly amplified in
many human cancers. Normally, BORIS mRNA can be detected in testis, but
not in other human tissues. However, BORIS mRNA is detectable in over
one hundred cancer cell lines representing most of the major forms of
human tumors and is also detectable in primary breast cancer tumor
samples, but not in controls. BORIS protein is mis-expressed in cancer
cell lines, and antibodies against BORIS have been detected in serum
from patients with
[[Page 49691]]
gliomas, lung, breast or prostate cancers but not in serum from
controls.
The correlation between cancer and BORIS expression indicates that
detection of aberrantly expressed BORIS and/or anti-BORIS antibodies
could serve as a method of screening or diagnosing cancer. In patients
already known to have cancer, expression of BORIS could be monitored to
measure a patient's response to a particular therapeutic regimen.
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
404.7. 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 Part 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: August 14, 2008.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. E8-19454 Filed 8-21-08; 8:45 am]
BILLING CODE 4140-01-P
