Prospective Grant of Exclusive License: Method for production of Layered Expression Scans for Tissue and Cell Samples.

AGENCY:

National Institutes of Health, Public Health Service, DHHS.

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 worldwide to practice the invention embodied in: U.S. Patent Application Serial No. 60/145,613 entitled “Method for Production of Layered Expression Scans for Tissue and Cell Samples”, filed July 26, 1999, to 20/20 genomics, LLC. having a place of business in Rockville, Maryland. The United States of America is an assignee to the patent rights of this invention.

The contemplated exclusive license may be limited to the development of instruments for medical diagnostics and research, based on the novel Layered Expression Scans (LES) technique.

DATES:

Only written comments and/or applications for a license which are received by the NIH Office of Technology Transfer on or before September 18, 2000 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: Uri Reichman, Ph.D., Technology Licensing Specialist, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-3804; Telephone: (301) 496-7056, ext. 240; Facsimile: (301) 402-0220; E-mail: reichmau@od.nih.gov. A signed Confidential Disclosure Agreement will be required to receive copies of the patent application.

SUPPLEMENTARY INFORMATION:

LES is a new approach to comprehensive molecular analysis of biological samples that uses a layered array of capture membranes coupled to biological binders (antibodies, receptors, or DNA sequences) to perform multiplex protein, DNA or mRNA analysis. Cell or tissue samples are transferred through a series of individual capture layers, each linked to a separate binder. As the biomolecules in the sample traverse the membrane set, each targeted protein, mRNA or DNA is specifically captured by the layer containing its corresponding binder and then identified and quantified by molecular staining. The two-dimensional relationship of the cell populations of a tissue sample is maintained during the transfer process, thereby producing a molecular profile of each cell type present. The LES technology, when fully developed, will have multiple applications in both clinical and research areas. In particular, it will have applications in diagnostic and prognostic analysis of diseased tissues (i.e., tumors).

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.

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.