[Federal Register Volume 77, Number 94 (Tuesday, May 15, 2012)]
[Notices]
[Page 28614]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-11690]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Development of 
Chemopreventive Treatments for Head and Neck Squamous Cell Carcinoma

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 
CFR404.7(a)(1)(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 inventions embodied in PCT 
Patent Application No. PCT/US2009/054478, U.S. Patent Application No. 
13/059,335 and foreign equivalents thereof entitled ``Chemopreventive 
of Head and Neck Squamous Cell Carcinoma'' (HHS Ref. No. E-302-2008/0) 
to Yissum Research Development Company of the Hebrew University of 
Jerusalem, Ltd., which is located in Jerusalem, Israel. The patent 
rights in these inventions have been assigned to the United States of 
America.
    Other than license applications submitted as objections to this 
Notice of Intent to Grant an Exclusive License, no further license 
applications will be considered for the exclusive field of use set 
forth below if the Yissum Research Development Company of the Hebrew 
University of Jerusalem, Ltd. is granted an exclusive license pursuant 
to this Notice of Intent to Grant an Exclusive License. The prospective 
exclusive license territory may be worldwide and the field of use may 
be limited to use of the Licensed Patent Rights for the prevention and 
treatment of head and neck cancers.

DATE: Only written comments and/or applications for a license which are 
received by the NIH Office of Technology Transfer on or before June 14, 
2012 will be considered, in addition to the current non-exclusive 
applications under consideration, for the prospective license territory 
and field of use to be granted under the contemplated exclusive patent 
license.

FOR FURTHER INFORMATION CONTACT: Requests for copies of the patent 
application, inquiries, comments, and other materials relating to the 
contemplated exclusive license should be directed to: Whitney A. 
Hastings, 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) 451-7337; 
Facsimile: (301) 402-0220; Email: [email protected].

SUPPLEMENTARY INFORMATION: In head and neck squamous cell carcinoma 
(HNSCC), a cancer occurring mostly in the mouth, it is frequently 
observed that the Akt/mTOR pathway is abnormally activated. Therefore, 
inhibiting this signaling pathway may help in treating this disease. 
Rapamycin and its analogs are known to inhibit the activity of mTOR so 
in principle they could serve as therapeutics for treating HNSCC.
    This technology describes a method of potentially preventing or 
treating HNSCC through the inhibition of mTOR activity. The proof of 
this principle was demonstrated by rapid regression of mouth tumors in 
mice afflicted with Cowden syndrome with the administration of 
rapamycin. Like HNSCC, development of this disease is linked to over 
activation of the Akt/mTOR pathway. Furthermore, the therapeutic 
potential of rapamycin was demonstrated using mice in experiments that 
model chronic exposure to tobacco, which promotes the development of 
HNSCC. Therefore, inhibitors of mTOR have considerable potential in the 
prevention and treatment of HNSCC.
    The prospective exclusive license and any further license 
applications received as objections to this Notice of Intent to Grant 
an 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 thirty (30) 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 404.7.
    Any additional 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: May 9, 2012.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2012-11690 Filed 5-14-12; 8:45 am]
BILLING CODE 4140-01-P