Prospective Grant of Exclusive License: The Development of Gene Expression Signatures of Neoplasm Responsiveness to mTOR and HDAC Inhibitor Combination Therapy, 740 [2012-31743]

Agencies

• DEPARTMENT OF HEALTH AND HUMAN SERVICES
• National Institutes of Health

[Federal Register Volume 78, Number 3 (Friday, January 4, 2013)]
[Notices]
[Page 740]
From the Federal Register Online via the Government Printing 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: 
mccuepat@mail.nih.gov.

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