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

Download as PDF 740 Federal Register / Vol. 78, No. 3 / Friday, January 4, 2013 / Notices mstockstill on DSK4VPTVN1PROD with Place: InterContinental Mark Hopkins Hotel, 999 California Street, San Francisco, CA 94108. Contact Person: Julius Cinque, MS, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5186, MSC 7846, Bethesda, MD 20892, (301) 435– 1252, cinquej@csr.nih.gov. Name of Committee: Biobehavioral and Behavioral Processes Integrated Review Group; Biobehavioral Regulation, Learning and Ethology Study Section. Date: February 7–8, 2013. Time: 8:30 a.m. to 2:30 p.m. Agenda: To review and evaluate grant applications. Place: Lorien Hotel & Spa, 1600 King Street, Alexandria, VA 22314. Contact Person: Melissa Gerald, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3172, MSC 7848, Bethesda, MD 20892, (301) 408– 9107, geraldmel@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; PAR–11– 216: Early Phase Clinical Trials in Imaging and Image-Guided Interventions. Date: February 7, 2013. Time: 2:15 p.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Serrano Hotel, 405 Taylor Street, San Francisco, CA 94102. Contact Person: David L Williams, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5110, MSC 7854, Bethesda, MD 20892, (301)435– 1174, williamsdl2@csr.nih.gov. Name of Committee: Surgical Sciences, Biomedical Imaging and Bioengineering Integrated Review Group; Medical Imaging Study Section. Date: February 7–8, 2013. Time: 7:00 p.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Serrano Hotel, 405 Taylor Street, San Francisco, CA 94102. Contact Person: Xiang-Ning Li, MD, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5112, MSC 7854, Bethesda, MD 20892, 301–435– 1744, lixiang@csr.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393–93.396, 93.837–93.844, 93.846–93.878, 93.892, 93.893, National Institutes of Health, HHS) Dated: December 31, 2012. Melanie J. Gray, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2012–31739 Filed 1–3–13; 8:45 am] BILLING CODE 4140–01–P VerDate Mar<15>2010 16:34 Jan 03, 2013 Jkt 229001 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 National Institutes of Health, Public Health Service, HHS. ACTION: Notice. AGENCY: 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: SUMMARY: 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. 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 DATES: PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 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 DEPARTMENT OF HOMELAND SECURITY Coast Guard [Docket No. USCG–USCG–2012–1091] Availability of Draft Environmental Assessment for the Proposed Modification of the Bayonne Bridge Across the Kill Van Kull Between Bayonne, Hudson County, NJ and Staten Island, Richmond County, NY Coast Guard, DHS. Notice of availability and request for comments; notice of public meetings. AGENCY: ACTION: The Coast Guard announces the availability of a Draft Environmental Assessment (Draft EA) and the dates and locations of two public meetings on the Draft EA, which considered the reasonably foreseeable environmental impacts and socio-economic impacts of the proposed modification of the historic Bayonne Bridge across the Kill Van Kull between Bayonne, New Jersey and Staten Island, New York. As a structure over navigable waters of the United States, the proposed bridge modification would require a Coast Guard Bridge Permit Amendment. We SUMMARY: E:\FR\FM\04JAN1.SGM 04JAN1

Agencies

[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.

-----------------------------------------------------------------------

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