[Federal Register Volume 80, Number 55 (Monday, March 23, 2015)]
[Notices]
[Page 15218]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-06487]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: The Development of 
Theranostic Kits for mTOR Analog-based Chemotherapy

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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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 to ProVivoX, Inc., of an 
exclusive evaluation option license to practice the inventions embodied 
in the following US Patent, US Patent Application, and International 
Patent Application (and all foreign counterparts): US Provisional 
Patent Application Serial No. 61/144,501, filed 14 January 2009, 
entitled: ``Ratio-based Biomarker of Survival Utilizing PTEN and 
Phospho-AKT'' [HHS Reference No. E-025-2009/0-US-01]; International 
Application No. PCT/US2010/020944, filed on 13 January 2010, entitled: 
``Ratio-based Biomarkers and Methods of Use Thereof'' [HHS Reference 
No. E-025-2009/0-PCT-02]; US Patent Application Serial No. 13/144,474, 
filed 13 July 2011 [HHS Reference No. E-025-2009/0-US-02]; and Canadian 
Patent Application No. 2,749,601, filed on 13 January 2010 [HHS 
Reference No. E-025-2009/0-CA-05]. The patent rights in this invention 
have been assigned to the Government of the United States of America.
    The prospective exclusive evaluation option license territory may 
be United States and Canada, and the field of use may be limited to:

    a. ``Exclusive use of the Licensed Patent Rights to develop an 
immunohistochemistry (IHC)- or tissue microarray-based test kit for 
use with human tissue samples and approved in the United States and 
Canada as a Class III medical device, such test kit to be 
distributed in commerce for the for the purpose of predicting 
survival, response to therapy, or cancer recurrence in breast cancer 
patients.''
    b. ``Non-exclusive use of the Licensed Patent Rights to develop 
an immunohistochemistry (IHC)- or tissue microarray-based test kit 
for use with human tissue samples and for which the United States 
FDA issues an order, in the form of a letter, which finds Licensee's 
kit to be a medical device substantially equivalent to one or more 
similar legally marketed devices, and states that the Licensee's 
device can be marketed in the U.S. (i.e., 510(k) cleared), such test 
kit to be distributed in commerce for the purpose of predicting 
survival, response to therapy, or cancer recurrence in breast cancer 
patients.''

    Upon the expiration or termination of the exclusive evaluation 
option license, ProVivoX, Inc., will have the exclusive right to 
execute an exclusive commercialization license which will supersede and 
replace the exclusive evaluation option license with no greater field 
of use and territory than granted in the exclusive evaluation option 
license.

DATES: Only written comments or applications for a license (or both) 
which are received by the NIH Office of Technology Transfer on or 
before April 7, 2015 will be considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
comments, and other materials relating to the contemplated exclusive 
evaluation option license should be directed to: Patrick McCue, Ph.D., 
Licensing and Patenting Manager, Office of Technology Transfer, 
National Institutes of Health, 6011 Executive Boulevard, Suite 325, 
Rockville, MD 20852-3804; Telephone: (301) 435-5560; Facsimile: (301) 
402-0220; Email: <a href="/cdn-cgi/l/email-protection#fd909e9e88988d9c89bd909c9491d3939495d39a928b"><span class="__cf_email__" data-cfemail="e28f81819787928396a28f838b8ecc8c8b8acc858d94">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: The technology describes a method of 
identifying cancer patients that may benefit from mTOR analog-based 
chemotherapy or agents directed against the AKT pathway.
    The prospective exclusive evaluation license is being considered 
under the small business initiative launched on 1 October 2011, and 
will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 
part 404. The prospective exclusive evaluation option license, and a 
subsequent exclusive commercialization license, may be granted unless 
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 within fifteen (15) days from the 
date of this published notice.
    Complete 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 evaluation option 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: March 17, 2015.
Richard U. Rodriguez,
Acting Director, Office of Technology Transfer, National Institutes of 
Health.
[FR Doc. 2015-06487 Filed 3-20-15; 8:45 am]
 BILLING CODE 4140-01-P


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