01-4093. Prospective Grant of Exclusive License: Method and Apparatus for Constructing Tissue Microarrays

AGENCY:

National Institutes of Health, Public Health Service, DHHS.

ACTION:

None.

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 inventions embodied in: (1) U.S. Patent Application Serial No. 60/075,979 (PCT/US99/04001) entitled “Tumor Tissue Microarrays for Rapid Molecular Profiling”, provisionally filed February 24, 1998 and PCT filed February 24, 1999, and (2) U.S. Patent Application Serial No. 60/170,461 (PCT/US00/34043) entitled “Method and Apparatus for Constructing Tissue Microarrays”, provisionally filed December 13, 1999 and PCT filed December 13, 2000, to Beecher Instruments Company having a place of business in Silver Spring, Maryland. The United States of America is an assignee to the patent rights of these inventions.

The contemplated exclusive license may be limited to the development of instruments for the construction of tissue microarrays for use for medical research and clinical diagnostics.

DATES:

Only written comments and/or applications for a license which are received by the NIH Office of Technology Transfer on or before April 23, 2001 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: [phone], ext. 240; Facsimile: [phone]; E-mail: [e-mail]. A signed Confidential Disclosure Agreement will be required to receive copies of the patent application.

SUPPLEMENTARY INFORMATION:

The advent of the technology of Tissue Microarrays (also called “Tissue Chips”) has made it possible to perform simultaneous molecular profiling of hundreds or even thousands of tissue samples in a high-throughput fashion. Tissue Microarrays include multiplicity of sub-millimeter tissue specimens, fixed and arranged on a single microscope slide. The technology provides means to generate hundreds of identical copies of the slides. These slides then can be used for specific molecular analyses, such as DNA and mRNA in situ hybridization and protein immunostaining. The subject inventions, contemplated for the exclusive license, are directed towards the instruments used for the construction of tissue microarrays, and describe the design and the operations of these instruments. The method-of-use and the different applications of tissue microarrays for medical research and diagnostics are available for licensing by the NIH on a nonexclusive basis under a separate arrangement.

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 established 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.

Dated: February 12, 2001.

Jack Spiegel,

Director, Division of Technology Development and Transfer, Office of Technology Transfer.