2011-27308. Prospective Grant of Exclusive License: The Development of a Companion Diagnostic Kit for Predicting Therapeutic Efficacy of Anti-Cancer Agents

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 Part 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the inventions embodied in US Patent Application 61/144,501 entitled “Ratio Based Biomarker of Survival Utilizing PTEN and Phospho-AKT” [HHS Ref. E-025-2009/0-US-01], and all continuing applications and foreign counterparts, to 20/20 GeneSystems, Inc. The patent rights in this invention have been assigned to the Government of the United States of America.

The prospective exclusive license territory may be worldwide, and the field of use may be limited to:

the use of the Licensed Patent Rights limited to an FDA-approved (i) Laboratory Developed Test (LDT) offered as a service or (ii) in vitro diagnostic (IVD) kit distributed in commerce for human use of a protein panel predictive of the therapeutic effect of an anti-cancer agent in the treatment of kidney, lung, and breast cancers that includes at least one of the following proteins (phosphorylated or unphosphorylated): PTEN, Akt, mTOR.

DATES:

Only written comments and/or applications for a license which are received by the NIH Office of Technology Transfer on or before November 21, 2011 will be considered.

ADDRESSES:

Requests for copies of the patent application, inquiries, comments, and other materials relating to the contemplated exclusive license should be directed to: Patrick P. 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: [phone]; Facsimile: [phone]; E-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

This invention concerns methods for the prognosis for a subject with cancer and to evaluate therapeutic regimes through the comparison of normalized expression values of two or more cancer-associated proteins. Several specific cancer-associated proteins are covered by this technology, including PTEN, phosphorylated Akt, phosphorylated mTOR, EGFR, phosphorylated MAPK, HER2, and HER3. Examined individually, these proteins do not provide discrimination of survival. However, examined together as protein ratios, the prognostic function survived multivariate analysis. The approach has been demonstrated for biliary tract, kidney, lung, and stomach cancers.

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 part 404.7. The prospective exclusive 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 404.7 within thirty (30) days from the date of this published notice.

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 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: October 13, 2011.

Richard U. Rodriguez,

Director, Division of Technology Development & Transfer, Office of Technology Transfer, National Institutes of Health.