[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