[Federal Register Volume 70, Number 86 (Thursday, May 5, 2005)]
[Notices]
[Pages 23883-23884]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-8967]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of an Exclusive License: Cancer Diagnostic 
Based on Detecting Expression of Human Brother of Regulator of 
Imprinted Sites (``BORIS'') and BORIS Antibodies

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

ACTION: Notice.

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SUMMARY: This notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 
Part 404.7(a)(1)(i), announces that the Department of Health and Human 
Services is contemplating the grant of an exclusive license to practice 
the inventions embodied in U.S. Provisional Patent Application Serial 
No. 60/611,789, entitled ``Method of Detecting Cancer Based On Immune 
Reaction To BORIS'' filed September 21, 2004 (E-241-2004/0-US-01); U.S. 
Provisional Patent Application Serial No. 60/358,889, entitled 
``Brother of The Regulator of Imprinted Sites (BORIS)'' filed February 
22, 2001 (E-227-2001/0-US-01); PCT Application No. PCT/US03/05186, 
entitled ``Brother of The Regulator of Imprinted Sites (BORIS)'' filed 
February 21, 2003 (E-227-2001/0-PCT-02); and U.S. Patent Application 
Serial No. 10/505,377, entitled ``Brother of The Regulator of Imprinted 
Sites (BORIS)'' filed August 19, 2004 (E-227-2001/-0-US-03), to NewLink 
Genetics Corporation, having a place of business in Ames, Iowa.
    The prospective exclusive territory may be United States, Canada, 
Europe and Japan, and the field of use may be limited to manufacture 
and sale of Analyte Specific Reagents or FDA-approved in vitro 
diagnostics for cancer and cancer predisposition.

DATES: Only written comments and/or license applications which are 
received by the National Institutes of Health on or before July 5, 2005 
will be considered.

ADDRESSES: Requests for copies of the patent and/or patent 
applications, inquiries, comments and other materials relating to the 
contemplated exclusive license should be directed to: Mojdeh

[[Page 23884]]

Bahar, J.D., Technology Licensing Specialist, Office of Technology 
Transfer, National Institutes of Health, 6011 Executive Boulevard, 
Suite 325, Rockville, MD 20852-3804. Telephone: (301) 435-2950; 
Facsimile: (301) 402-0220; E-mail: [email protected].

SUPPLEMENTARY INFORMATION: The above-mentioned patent applications 
describe the human protein Brother of Regulator of Imprinted Sites 
(``BORIS''), and a method of detecting cancer by monitoring BORIS 
expression or by detecting anti-BORIS antibodies. Dr. Victor V. 
Lobanenkov and colleagues at the National Institute of Allergy and 
Infectious Diseases discovered BORIS and its potential application as a 
cancer diagnostic. BORIS is a paralog of CCCTC-binding factor 
(``CTCF''), a transcription factor that also functions in chromatin 
insulation. The amino acid sequences of BORIS and CTCF contain eleven 
conserved zinc fingers each of which binds to DNA. BORIS protein can be 
detected in cancer cells, and importantly, it is one of a few cancer-
testis antigens that are immunogenic in humans.
    BORIS resides in 20q13.2, a region that is commonly amplified in 
many human cancers. Normally, BORIS mRNA can be detected in testis, but 
not in other human tissues. However, BORIS mRNA is detectable in over 
one hundred cancer cell lines representing most of the major forms of 
human tumors and is also detectable in primary breast cancer tumor 
samples, but not in controls. BORIS protein is mis-expressed in cancer 
cell lines, and antibodies against BORIS have been detected in serum 
from patients with gliomas, lung, breast, or prostate cancers but not 
in serum from controls.
    The correlation between cancer and BORIS expression indicates that 
detection of aberrantly expressed BORIS and/or anti-BORIS antibodies 
could serve as a method of screening or diagnosing cancer. In patients 
already known to have cancer, expression of BORIS could be monitored to 
measure a patient's response to a particular therapeutic regimen.
    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 establish 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: April 27, 2005.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 05-8967 Filed 5-4-05; 8:45 am]
BILLING CODE 4140-01-P