[Federal Register Volume 72, Number 166 (Tuesday, August 28, 2007)]
[Notices]
[Page 49290]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-16931]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Method for Determining 
the Redox Status of a Tissue

AGENCY: National Institutes of Health, Public Health Service, HHS.

ACTION: Notice.

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SUMMARY: This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 
CFR 404.7(a)(1)(I), that the National Institutes of Health (NIH), 
Department of Health and Human Services, is contemplating the grant of 
an exclusive license to practice the inventions embodied in: PCT 
Application No. PCT/US2006/031208 (E-258-2005/0-PCT-02) filed August 
10, 2006 claiming priority to U.S. Provisional Application No. 60/
707,518 (E-258-2005/0-US-01), titled ``Method for Determining the Redox 
Status of a Tissue'' (Inventors: Dr James Mitchell et al.) to Mitos 
Pharmaceutical, Inc. (hereafter Mitos), having a place of business in 
Newport Beach, California. The patent rights in these inventions have 
been assigned to the United States of America.

DATES: Only written comments and/or application for a license, which 
are received by the NIH Office of Technology Transfer on or before 
October 29, 2007 will be considered.

ADDRESSES: Requests for a copy of the patent application, inquiries, 
comments and other materials relating to the contemplated license 
should be directed to: Chekesha Clingman, PhD, Office of Technology 
Transfer, National Institutes of Health, 6011 Executive Boulevard, 
Suite 325, Rockville, MD 20852-3804; e-mail: [email protected]; 
Telephone: (301) 435-5018; Facsimile: (301) 402-0220.

SUPPLEMENTARY INFORMATION: The present invention relates to a method of 
determining the redox status of tissues by administering a cell-
permeable nitroxide, such as 4-hydroxy-2,2,6,6-tetramethylpiperidine-1-
oxyl (or Tempol), as a contrast agent and employing magnetic resonance 
imaging (MRI). Also provided by the invention are a method for 
diagnosing a tumor and other pathologies associated with oxidative 
stress and a method for determining a cancer treatment protocol. Tumor 
tissues exhibit viable but hypoxic regions that allow them to reduce 
nitroxide compounds more efficiently than normal tissue. The 
paramagnetic relaxivity of nitroxide compounds makes it possible to use 
standard MRI scanners to determine the redox status of tissue in vivo. 
By determining the redox status of a tumor it is possible to not only 
diagnose a tumor due to its enhanced reduction of intracellular 
nitroxide contrast agent, but also to determine appropriate radiation 
treatment fields spatially to deliver therapeutic doses of radiation, 
and to determine appropriate timing sequences after the administration 
of a nitroxide contrast agent such that the maximum difference between 
normal and tumor tissue with respect to the radioprotective form of the 
nitroxide is present in the normal tissue, thereby limiting collateral 
damage to the normal tissue.
    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 404.7. 
The prospective exclusive license may be granted unless, within 60 days 
from the date of this published Notice, 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 404.7.
    The field of use may be limited to methods for determining the 
redox status of tissues by utilizing nitroxide contrast agents in 
combination with MRI for diagnosis of cancer and other pathologies.
    Properly filed competing applications for a license filed in 
response to this notice will be treated as objections to the 
contemplated license. Comments and objections submitted in response 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 20, 2007.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
 [FR Doc. E7-16931 Filed 8-27-07; 8:45 am]
BILLING CODE 4140-01-P