Prospective Grant of Exclusive License: Identification of Non-Invasive Biomarkers of Coordinate Metabolic Reprogramming in Colorectal Tumor, 47468-47469 [2014-19144]
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Federal Register / Vol. 79, No. 156 / Wednesday, August 13, 2014 / Notices
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[FR Doc. 2014–19114 Filed 8–12–14; 8:45 am]
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[FR Doc. 2014–19164 Filed 8–12–14; 8:45 am]
BILLING CODE P
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.
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.
SUMMARY:
Intellectual Property
1. United States Provisional Patent
No. 61/755,891, issued January 23,
2013, entitled ‘‘Identification of Noninvasive 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
E:\FR\FM\13AUN1.SGM
13AUN1
mstockstill on DSK4VPTVN1PROD with NOTICES
Federal Register / Vol. 79, No. 156 / Wednesday, August 13, 2014 / Notices
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: chatterjeesa@od.nih.gov.
SUPPLEMENTARY INFORMATION: The
technology identifies a set of noninvasive 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
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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]
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[FR Doc. 2014–19146 Filed 8–12–14; 8:45 am]
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[Federal Register Volume 79, Number 156 (Wednesday, August 13, 2014)]
[Notices]
[Pages 47468-47469]
From the Federal Register Online via the Government Printing 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: chatterjeesa@od.nih.gov.
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
