[Federal Register Volume 78, Number 235 (Friday, December 6, 2013)]
[Notices]
[Page 73553]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-29099]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Development of Cripto-1 
Point of Care (POC) Tests and Kits for the Detection of Colon and 
Rectal Cancer, Breast Cancer, and Lung Cancer

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: This is notice, in accordance with 35 U.S.C. 209 and 37 CFR 
Part 404, 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 the following U.S. 
Patents and Patent Applications to Beacon Biomedical LLC (``Beacon'') 
located in Scottsdale, AZ, USA.

    Intellectual Property: U.S. Patent No.7,078,176 issued July 18, 
2006 entitled ``Detection and Quantification of Cripto-1'' [HHS Ref. 
No. E-290-2000/0-US-03] and foreign equivalents thereof.

    The patent rights in these inventions have been assigned to the 
government of the United States of America.
    The prospective exclusive license territory may be worldwide and 
the field of use will be limited to the use of Licensed Patent Rights 
to develop FDA approved and/or 510K cleared Point of Care (POC) tests 
and kits for the purpose of disease state recognition, detection, 
diagnosis, monitoring, association and risk-stratification of colon and 
rectal cancer, breast cancer, and lung cancer.

DATES: Only written comments and/or applications for a license which 
are received by the NIH Office of Technology Transfer on or before 
January 6, 2014 will be considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
and comments relating to the contemplated exclusive license should be 
directed to: Eggerton Campbell, Ph.D. Licensing and Patenting Manager, 
Cancer Branch, Office of Technology Transfer, National Institutes of 
Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-3804; 
Telephone: (301) 435-5282; Facsimile: (301) 435-4013; Email: 
[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. This test could be 
used to more effectively screen 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 
disclosed assay to detect and measure CR1 in human serum and/or plasma 
and possibly other physiological fluids.
    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 
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.
    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: December 2, 2013.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2013-29099 Filed 12-5-13; 8:45 am]
BILLING CODE 4140-01-P