[Federal Register Volume 72, Number 103 (Wednesday, May 30, 2007)]
[Notices]
[Page 30022]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-10352]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Use of Cripto-1 as 
Claimed in the Licensed Patent Rights, for the Development of a FDA 
Approved Diagnostic Kit for Human Cancers

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 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. 
Patent No. 7,078,176; European Patent No. 1370869 and PCT Application 
No. PCT/US02/02225 and foreign equivalents thereof entitled ``Detection 
and quantification of Cripto-1'' (E-290-2000/0), to Biosite, Inc, which 
is located in San Diego, California. 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 the use of the Licensed Patent 
Rights, for the development of a FDA approved diagnostic kit for human 
cancers.

DATES: Only written comments and/or applications for a license which 
are received by the NIH Office of Technology Transfer on or before July 
30, 2007 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: Michelle A. Booden, Ph.D., Technology 
Licensing Specialist, 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; E-
mail: [email protected].

SUPPLEMENTARY INFORMATION: Cripto-1 (CR1) is a member of the epidermal 
growth factor (EGF)-related families of peptides and is involved in the 
development and progression of various human carcinomas. In particular, 
CR1 overexpression has been detected in 50-90% of carcinomas of the 
colon, pancreas, stomach, gallbladder, breast, lung, endometrium and 
cervix. Current methodologies of cancer detection, e.g. 
immunohistochemistry, can be time consuming, inconvenient and 
oftentimes, inaccurate, and therefore, a need exists for more 
efficient, reliable and less time consuming methods of detection. The 
invention relates to such a method of detection. The inventors disclose 
methods for the detection and quantification of CR1 in human milk, 
using an ELISA-based protocol. This test could also be used to more 
effectively detect and perhaps stage cancers. Additionally, should 
particular tumor cells, e.g. breast tumor cells, express a sufficiently 
high level of CR1, it may be possible to use the assay to detect and 
measure CR1 in human serum and/or plasma.
    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, 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.
    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 22, 2007.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. E7-10352 Filed 5-29-07; 8:45 am]
BILLING CODE 4140-01-P