[Federal Register Volume 70, Number 130 (Friday, July 8, 2005)]
[Notices]
[Pages 39525-39526]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-13446]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Heat Induced Gene 
Expression to Treat Cancer

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 part 404.7(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 U.S. 
Provisional Patent Application Serial No. 60/024,213, entitled 
``Spatially And Temporal Control Of Gene Expression Using A Heat Shock 
Protein Promoter In Combination With Local Heat'' filed August 15, 1996 
(E-235-1995/0-US-01), and all related foreign patents/patent 
applications, to New England OncoTherapeutics, Inc., having a place of 
business in Cambridge, Massachusetts. The patent rights in these 
inventions have been assigned to the United States of America.
    The prospective exclusive license territory may be worldwide and 
the field of use may be limited to gene-based therapeutics which 
incorporate focused ultrasound heating technologies to treat cancer.

DATES: Only written comments and/or license applications that are 
received by the National Institutes of Health on or before September 6, 
2005 will be considered.

ADDRESSES: Requests for copies of the patent, inquiries, comments and 
other materials relating to the contemplated exclusive license should 
be directed to: George G. Pipia, Ph.D., Technology Licensing 
Specialist, 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; E-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: The above-mentioned patent application 
describes methods of using heat to

[[Page 39526]]

control expression of specific genes in genetically engineered tissues 
and tumors. Therapeutic genes are put under control of a heat-
responsive promoter, such as a promoter of a heat shock gene, and then 
introduced into cells. Expression of the therapeutic genes is induced 
by heating the cells with focused ultrasound or electromagnetic 
radiation. When guided by MRI, it is possible to heat small areas while 
visualizing and quantitating the level of heating. Thus, the technology 
could be used to target specific tissues or tumors for cancer 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 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: June 28, 2005.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 05-13446 Filed 7-7-05; 8:45 am]
BILLING CODE 4140-01-P