[Federal Register Volume 79, Number 156 (Wednesday, August 13, 2014)]
[Notices]
[Pages 47468-47469]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-19144]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Identification of Non-
Invasive Biomarkers of Coordinate Metabolic Reprogramming in Colorectal 
Tumor

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

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 Cary Pharmaceuticals, Inc. 
(``Cary'') located in Great Falls, VA, USA.

Intellectual Property

    1. United States Provisional Patent No. 61/755,891, issued January 
23, 2013, entitled ``Identification of Non-invasive Biomarkers of 
Coordinate Metabolic Reprograming Colorectal Tumor'';
    2. International Patent Application No. PCT/US2014/012758 filed 
January 23, 2014 entitled ``Compositions and Methods for Detecting 
Neoplasia'' [HHS Reference No. E-020-2013/0-PCT-02]
    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 
for the commercial development of an FDA approved diagnostic/prognostic 
kit or a class III diagnostic test for human colorectal adenoma (non-
malignant polyp) and carcinoma.

DATES: Only written comments and/or applications for a license which 
are received by the NIH Office of

[[Page 47469]]

Technology Transfer on or before September 12, 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: Sabarni K. Chatterjee, Ph.D., M.B.A., 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) 435-5587; Facsimile: (301) 
435-4013; Email: [email protected].

SUPPLEMENTARY INFORMATION: The technology identifies a set of non-
invasive metabolic biomarkers in urine samples that are mechanistically 
associated with colorectal carcinogenesis in a mouse model. In 
addition, pathways related to the production of these metabolites are 
also found to be dys-regulated in human colorectal cancer tissues. 
These indicate that changes in urinary metabolites may be helpful in 
screening and diagnosis of colorectal cancers. Furthermore, the 
mechanistic association of these pathways with proliferation suggests 
that these biomarkers may also be helpful in evaluating and monitoring 
therapeutic response, remission and relapse in colorectal cancer 
patients.
    This technology is intended for use as an adjunctive screening test 
for the detection of colorectal tumor or adenoma. A positive result may 
indicate the presence of colorectal cancer or premalignant colorectal 
neoplasia (adenoma). This urine based screen would not replace 
colonoscopy but would assist in the recommendation for additional 
testing or intervention. Compared to colonoscopy, the currently most 
commonly used colorectal cancer screening/diagnostic test, the test 
based on this new technology is non-invasive, cost effective and safer. 
This technology would be intended for patients who are typical 
candidates for colorectal cancer screening, adults of either sex, 50 
years or older, who are at average risk of developing colorectal 
cancer.
    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. 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 Part 404.
    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: August 11, 2014.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2014-19144 Filed 8-12-14; 8:45 am]
BILLING CODE 4140-01-P