E7-16930. Prospective Grant of Exclusive License: FDA Cleared Pediatric Cancer Diagnostics and Prognostics

AGENCY:

National Institutes of Health, Public Health Service, HHS.

ACTION:

Notice.

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: [e-mail]; Telephone: [phone]; 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 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.