[Federal Register Volume 72, Number 166 (Tuesday, August 28, 2007)]
[Notices]
[Pages 49289-49290]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-16930]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: FDA Cleared Pediatric 
Cancer Diagnostics and Prognostics

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 invention embodied in Patent 
Applications U.S. 10/133,937, filed 04/25/2002, entitled ``Methods for 
Analyzing High Dimensional Data for Classifying, Diagnosing, 
Prognosticating and/or Predicting Diseases and Other Biological 
States''; and U.S. 10/159,563, filed 05/31/2002, entitled ``Selections 
of Genes And Methods of Using The Same For Diagnosis And For Targeting 
The Therapy of Select Cancers''; to Althea Technologies, Inc. having a 
place of business in San Diego, California. The patent rights in this 
invention have been assigned to the United States of America (PHS ref 
E-324-2001/0,1).

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

ADDRESS: Requests for a copy of the patent application, inquiries, 
comments and other materials relating to the contemplated license 
should be directed to: Cristina Thalhammer-Reyero, Ph.D., M.B.A., 
Office of Technology Transfer, National Institutes of Health, 6011 
Executive Boulevard, Suite 325, Rockville, MD 20852-3804; e-mail: 
[email protected]; Telephone: 301-435-4507; Facsimile: 301-402-
0220.

SUPPLEMENTARY INFORMATION: 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 invention relates to a method of using supervised pattern 
recognition methods for classifying, diagnosing, predicting, or 
prognosticating various diseases. The method includes obtaining high 
dimensional experimental data, such as gene expression profiling data, 
filtering the data, reducing the dimensionality of the data through use 
of one or more methods, training artificial neural networks (ANN, a 
supervised pattern recognition method), ranking individual data points 
from the data, choosing multiple data points from the data based on the 
relative ranking, and using the multiple data points to determine if an 
unknown set of experimental data indicates a diseased condition, a 
predilection for a diseased condition, or a prognosis about a diseased 
condition. Further, the invention relates to sets of genes expressed in 
cancer cells that function to characterize each cancer type, and 
methods of using the sets of genes for diagnosis and for targeting the 
therapy of selected cancers. In particular, the methods apply to 
classify cancers which often present diagnostic dilemmas in clinical 
practice, such as the pediatric small round blue cell tumors (SRBCTs), 
including neuroblastoma (NB), rhabdomyosarcoma (RMS), Burkitt's 
lymphoma (BL), and the Ewing family of tumors (EWS). Specifically, the 
invention is an application of ANNs for

[[Page 49290]]

the diagnostic classification of cancers based on gene expression 
profiling data derived from cDNA microarrays. The ANNs were first 
trained to be used as models, and then correctly classified all samples 
tested and identified the genes most relevant to the classification. 
Their study demonstrated the potential applications of these methods 
for tumor diagnosis and for the identification of candidate targets for 
therapy. The uniqueness of this method is taking gene expression data 
generated by microarrays, minimizing the genes from the original 1000s 
to less than 100, identifying which genes are the most relevant to a 
classification, which gives an immediate clue to the actual biological 
processes involved, not just surrogate markers which have no bearing on 
the biology.
    The field of use may be limited to ``FDA Cleared Pediatric Cancer 
Diagnostics and Prognostics''.
    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. E7-16930 Filed 8-27-07; 8:45 am]
BILLING CODE 4140-01-P