[Federal Register Volume 78, Number 3 (Friday, January 4, 2013)]
[Notices]
[Page 740]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-31743]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive License: The Development of Gene
Expression Signatures of Neoplasm Responsiveness to mTOR and HDAC
Inhibitor Combination Therapy
AGENCY: National Institutes of Health, Public Health Service, HHS.
ACTION: Notice.
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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, Department
of Health and Human Services, is contemplating the grant to Empire
Genomics LLC of an exclusive patent license to practice the inventions
embodied in US Provisional Patent Application 61/558,402 entitled,
``Gene Expression Signatures of Neoplasm Responsiveness to Therapy''
[HHS Ref. E-013-2012/0-US-01], and all continuing applications and
foreign counterparts. The patent rights in this invention 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:
the use of the licensed patent rights limited to an FDA-cleared or
an FDA-approved in vitro diagnostic test kit for human use and
predictive of the therapeutic benefit of combination therapy
comprising an HDAC inhibitor and an mTOR inhibitor in the treatment
of multiple myeloma, breast cancer, melanoma, lymphoma, and prostate
cancer.
DATES: Only written comments or applications for a license, or both,
which are received by the NIH Office of Technology Transfer on or
before January 22, 2013 will be considered.
ADDRESSES: Requests for copies of the patent application, inquiries,
comments, and other materials relating to the contemplated exclusive
license should be directed to: Patrick P. McCue, Ph.D., Licensing and
Patenting Manager, Office of Technology Transfer, National Institutes
of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-
3804; Telephone: (301) 435-5560; Facsimile: (301) 402-0220; Email:
[email protected].
SUPPLEMENTARY INFORMATION: This invention concerns the discovery of
gene expression signatures indicative of tumors that are sensitive to
combination therapy comprising mTOR and HDAC inhibitors. Broadly
applicable to several cancer subtypes, the detection of such signatures
in a tumor could be used to identify a patient as a potential candidate
for mTOR and HDAC inhibitor combination therapy.
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 the NIH
receives, within fifteen (15) days from the date of this published
notice, 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.
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: December 31, 2012.
Richard U. Rodriguez,
Director, Division of Technology Development & Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. 2012-31743 Filed 1-3-13; 8:45 am]
BILLING CODE 4140-01-P