[Federal Register Volume 62, Number 182 (Friday, September 19, 1997)]
[Notices]
[Page 49249]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-24882]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Limited Exclusive License: Monoclonal 
Antibodies to Thymidylate Synthase

AGENCY: National Institutes of Health, Public Health Service, HHS.

ACTION: Notice.

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SUMMARY: This 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 of an exclusive 
worldwide license to practice the inventions embodied in the U.S. 
Patent Application SN 07/690,841 filed 04/24/91, entitled ``Monoclonal 
Antibodies to Thymidylate Synthase'' to Oncotech, Inc. of Irvine, CA. 
The patent rights in this invention have been assigned to the United 
States of America.
    The prospective exclusive license field of use may be limited to 
the in vitro diagnosis of elevated Thymidylate Synthase for the 
treatment of cancer in humans.

DATES: Only written comments and/or applications for a license which 
are received by NIH on or before November 18, 1997 will be considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
comments and other materials relating to the contemplated licenses 
should be directed to: Joseph G. Contrera, M.S., J.D., Technology 
Licensing Specialist, Office of Technology Transfer, National 
Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, 
Maryland 20852-3804; Telephone: (301) 496-7056 ext. 244; Facsimile: 
(301) 402-0220. A signed Confidentiality Agreement will be required to 
receive copies of the patent application.

SUPPLEMENTARY INFORMATION: The invention relates to monoclonal antibody 
(MoAb) technology. The technology provides improved sensitivity and 
specificity that is necessary to overcome the problems of traditional 
biochemical assays. The present invention provides for the 
immunological detection and quantitation of thymidylate synthase (TS) 
through a series of hybridoma cell lines that produce MoAbs specific 
for antigenic determinants on TS. TS plays a critical role in DNA 
nucleotide precursor synthesis, and thus, an important therapeutic 
target for the fluoropyrimidine class of antineoplastic agents.
    In sum, this invention allows for the immunological detection and 
quantitation of TS in human cells and enables the immuno-histochemical 
localization of TS in human colon carcinomas.
    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 within sixty 
(60) days from the date of this published notice, 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.
    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 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: September 10, 1997.
Barbara M. McGarey,
Deputy Director, Office of Technology Transfer.
[FR Doc. 97-24882 Filed 9-18-97; 8:45 am]
BILLING CODE 4140-01-M