[Federal Register Volume 78, Number 95 (Thursday, May 16, 2013)]
[Notices]
[Pages 28864-28865]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-11609]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Start-Up Exclusive Evaluation Option License
Agreement: In Vitro Diagnostics for Prediction of Therapeutic Efficacy
in Cancer and Other Angiogenesis-Mediated Diseases
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
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SUMMARY: This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37
CFR Part 404.7(a)(1)(i), that the National Institutes of Health,
Department of Health and Human Services, is contemplating the grant of
a Start-Up Exclusive Evaluation Option License Agreement to Advanced
Personalized Diagnostics, LLC, a company having a place of business in
Alexandria, Virginia, to practice the inventions embodied in U.S.
Provisional Patent Application No. 60/976,732, entitled ``Stably
Transfected Multicolored Fluorescent Cells'', filed October 1, 2007
(HHS Ref. No. E-281-2007/0-US-01); U.S. Patent Application No. 12/
060,752, entitled ``Multiplex Assay Method for Mixed Cell
Populations'', filed April 1, 2008, (HHS Ref. No. E-281-2007/0-US-02);
and U.S. Patent Application No. 12/802,666, entitled ``Methods of
Monitoring Angiogenesis and Metastasis in Three Dimensional Co-
Cultures'', filed June 10, 2010 (HHS Ref. No. E-281-2007/1-US-01). The
patent rights in these inventions have been assigned to the Government
of the United States of America. The territory of the prospective
Start-Up Exclusive Evaluation Option License Agreement may be
worldwide, and the field of use may be limited to ``The use of the
Licensed Patent Rights limited to an FDA-approved Class III in vitro
diagnostic device for prediction of therapeutic efficacy in cancer and
other angiogenesis-mediated diseases.''
Upon the expiration or termination of the Start-up Exclusive
Evaluation Option License Agreement, Advanced Personalized Diagnostics,
LLC will have
[[Page 28865]]
the exclusive right to execute a Start-Up Exclusive Patent License
Agreement which will supersede and replace the Start-up Exclusive
Evaluation Option License Agreement, with no greater field of use and
territory than granted in the Start-up Exclusive Evaluation Option
License Agreement.
DATES: Only written comments and/or applications for a license which
are received by the NIH Office of Technology Transfer on or before May
31, 2013 will be considered.
ADDRESSES: Requests for copies of the patent application(s), inquiries,
comments, and other materials relating to the contemplated Start-Up
Exclusive Evaluation Option License Agreement should be directed to:
Tara L. Kirby, Ph.D., Senior Licensing and Patenting Manager, Office of
Technology Transfer, National Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville, MD 20852-3804; Telephone: (301) 435-
4426; Facsimile: (301) 402-0220; Email: [email protected]. A signed
confidentiality nondisclosure agreement will be required to receive
copies of any patent applications that have not been published or
issued by the United States Patent and Trademark Office or the World
Intellectual Property Organization.
SUPPLEMENTARY INFORMATION: This technology relates to a three-
dimensional co-culture system that can be used to assay cellular
activity relating to angiogenesis (formation of new blood vessels) and
metastasis (spread of cancer). The co-culture system is designed to
mimic the in vivo environment of a tumor and consists of fluorescently-
labeled tumor cells, endothelial cells, and other component cell types
(e.g. macrophages, mast cells, fibroblasts, adipocytes, and pericytes).
The co-culture system can be used to identify, monitor, and measure
changes in morphology, migration, proliferation, and apoptosis of cells
involved in angiogenesis and/or metastasis. The co-cultures are
developed in 96-well plates to allow rapid and efficient screening for
angiogenic agents and/or therapeutic agents for cancer. This technology
may be used to develop diagnostic tests for personalized therapies for
cancer and other angiogenesis-mediated diseases.
The prospective Start-Up Exclusive Evaluation Option License
Agreement is being considered under the small business initiative
launched on October 1, 2011 and will comply with the terms and
conditions of 35 U.S.C. 209 and 37 CFR Part 404.7. The prospective
Start-Up Exclusive Evaluation Option License Agreement and a subsequent
Start-Up Exclusive Patent License Agreement may be granted unless the
NIH receives written evidence and argument, within fifteen (15) days
from the date of this published notice, that establishes that the grant
of the contemplated Start-Up Exclusive Evaluation Option License
Agreement would not be consistent with the requirements of 35 U.S.C.
209 and 37 CFR Part 404.7.
Complete applications for a license in the prospective field of use
that are filed in response to this notice will be treated as objections
to the grant of the contemplated Start-Up Exclusive Evaluation Option
License Agreement. 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 10, 2013.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. 2013-11609 Filed 5-15-13; 8:45 am]
BILLING CODE 4140-01-P