You are on page 1of 1

49290 Federal Register / Vol. 72, No.

166 / Tuesday, August 28, 2007 / Notices

the diagnostic classification of cancers Redox Status of a Tissue’’ (Inventors: Dr that the grant of the license would not
based on gene expression profiling data James Mitchell et al.) to Mitos be consistent with the requirements of
derived from cDNA microarrays. The Pharmaceutical, Inc. (hereafter Mitos), 35 U.S.C. 209 and 37 CFR 404.7.
ANNs were first trained to be used as having a place of business in Newport The field of use may be limited to
models, and then correctly classified all Beach, California. The patent rights in methods for determining the redox
samples tested and identified the genes these inventions have been assigned to status of tissues by utilizing nitroxide
most relevant to the classification. Their the United States of America. contrast agents in combination with
study demonstrated the potential DATES: Only written comments and/or MRI for diagnosis of cancer and other
applications of these methods for tumor application for a license, which are pathologies.
diagnosis and for the identification of received by the NIH Office of Properly filed competing applications
candidate targets for therapy. The Technology Transfer on or before for a license filed in response to this
uniqueness of this method is taking October 29, 2007 will be considered. notice will be treated as objections to
gene expression data generated by ADDRESSES: Requests for a copy of the the contemplated license. Comments
microarrays, minimizing the genes from patent application, inquiries, comments and objections submitted in response to
the original 1000s to less than 100, and other materials relating to the this notice will not be made available
identifying which genes are the most contemplated license should be directed for public inspection, and, to the extent
relevant to a classification, which gives to: Chekesha Clingman, PhD, Office of permitted by law, will not be released
an immediate clue to the actual Technology Transfer, National Institutes under the Freedom of Information Act,
biological processes involved, not just of Health, 6011 Executive Boulevard, 5 U.S.C. 552.
surrogate markers which have no Suite 325, Rockville, MD 20852–3804; Dated: August 20, 2007.
bearing on the biology. e-mail: clingmac@mail.nih.gov; Steven M. Ferguson,
The field of use may be limited to Telephone: (301) 435–5018; Facsimile: Director, Division of Technology Development
‘‘FDA Cleared Pediatric Cancer (301) 402–0220. and Transfer, Office of Technology Transfer,
Diagnostics and Prognostics’’. SUPPLEMENTARY INFORMATION: The National Institutes of Health.
Properly filed competing applications present invention relates to a method of [FR Doc. E7–16931 Filed 8–27–07; 8:45 am]
for a license filed in response to this determining the redox status of tissues BILLING CODE 4140–01–P
notice will be treated as objections to by administering a cell-permeable
the contemplated license. Comments nitroxide, such as 4-hydroxy-2,2,6,6-
and objections submitted in response to tetramethylpiperidine-1-oxyl (or DEPARTMENT OF HEALTH AND
this notice will not be made available Tempol), as a contrast agent and HUMAN SERVICES
for public inspection, and, to the extent employing magnetic resonance imaging
permitted by law, will not be released (MRI). Also provided by the invention National Institutes of Health
under the Freedom of Information Act, are a method for diagnosing a tumor and
5 U.S.C. 552. Policy for Sharing of Data Obtained in
other pathologies associated with NIH Supported or Conducted Genome-
Dated: August 20, 2007. oxidative stress and a method for Wide Association Studies (GWAS)
Steven M. Ferguson, determining a cancer treatment
Director, Division of Technology Development protocol. Tumor tissues exhibit viable AGENCY: National Institutes of Health,
and Transfer, Office of Technology Transfer, but hypoxic regions that allow them to HHS.
National Institutes of Health. reduce nitroxide compounds more ACTION: Notice.
[FR Doc. E7–16930 Filed 8–27–07; 8:45 am] efficiently than normal tissue. The
BILLING CODE 4140–01–P paramagnetic relaxivity of nitroxide Background
compounds makes it possible to use The NIH is interested in advancing
standard MRI scanners to determine the genome-wide association studies
DEPARTMENT OF HEALTH AND redox status of tissue in vivo. By (GWAS) to identify common genetic
HUMAN SERVICES determining the redox status of a tumor factors that influence health and
it is possible to not only diagnose a disease. For the purposes of this policy,
National Institutes of Health tumor due to its enhanced reduction of a genome-wide association study is
intracellular nitroxide contrast agent, defined as any study of genetic variation
Prospective Grant of Exclusive
but also to determine appropriate across the entire human genome that is
License: Method for Determining the
radiation treatment fields spatially to designed to identify genetic associations
Redox Status of a Tissue
deliver therapeutic doses of radiation, with observable traits (such as blood
AGENCY: National Institutes of Health, and to determine appropriate timing pressure or weight), or the presence or
Public Health Service, HHS. sequences after the administration of a absence of a disease or condition.1
ACTION: Notice. nitroxide contrast agent such that the Whole genome information, when
maximum difference between normal combined with clinical and other
SUMMARY: This is notice, in accordance and tumor tissue with respect to the phenotype data, offers the potential for
with 35 U.S.C. 209(c)(1) and 37 CFR radioprotective form of the nitroxide is increased understanding of basic
404.7(a)(1)(I), that the National present in the normal tissue, thereby biological processes affecting human
Institutes of Health (NIH), Department limiting collateral damage to the normal health, improvement in the prediction
of Health and Human Services, is tissue. of disease and patient care, and
contemplating the grant of an exclusive The prospective exclusive license will
license to practice the inventions be royalty bearing and will comply with 1 To meet the definition of a GWAS, the density
embodied in: PCT Application No. PCT/ the terms and conditions of 35 U.S.C.
pwalker on PROD1PC71 with NOTICES

of genetic markers and the extent of linkage


US2006/031208 (E–258–2005/0–PCT– 209 and 37 CFR 404.7. The prospective disequilibrium should be sufficient to capture (by
02) filed August 10, 2006 claiming exclusive license may be granted unless, the r2 parameter) a large proportion of the common
variation in the genome of the population under
priority to U.S. Provisional Application within 60 days from the date of this study, and the number of samples (in a case-control
No. 60/707,518 (E–258–2005/0–US–01), published Notice, NIH receives written or trio design) should provide sufficient power to
titled ‘‘Method for Determining the evidence and argument that establishes detect variants of modest effect.

VerDate Aug<31>2005 19:52 Aug 27, 2007 Jkt 211001 PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 E:\FR\FM\28AUN1.SGM 28AUN1