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

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National Institutes of Health, Public Health Service, HHS.




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.


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.


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:

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The above-mentioned patent application describes methods of using heat to Start Printed Page 39526control 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.

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Dated: June 28, 2005.

Steven M. Ferguson,

Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health.

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[FR Doc. 05-13446 Filed 7-7-05; 8:45 am]