02-23335. Prospective Grant of Exclusive License: “Laser Capture Microdissection (LCM) for Cellular Protein Analysis”

AGENCY:

National Institutes of Health, Public Health Service, HHS.

ACTION:

Notice.

SUMMARY:

This is a public 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:

U.S. Patent Application No. 09/913,667, filed August 16, 2001, and PCT Application No. PCT/US00/04023, filed February 16, 2000, “Methods and Devices for Isolation and Analysis of Cellular Protein Content” by Liotta, Petricoin, Simone, and Emmert-Buck (NIH Reference Numbers E-261-98/0, 1, 2)

to EntPharma, Inc., having a place of business in Rockville, Maryland.

The United States of America is the assignee to the patent rights of these inventions.

The contemplated limited term exclusive license may be restricted to the field of providing in-house commercial services for drug design using reverse phase protein microarrays, for non-cancer indications only. The field may further include a co-exclusive commercial license limited to the licensee and a fixed number of co-exclusive licensees, for diagnostic products and services using reverse phase protein microarrays, for non-cancer indications.

DATES:

Only written comments and/or applications for a license that are received by the NIH Office of Technology Transfer on or before November 12, 2002, 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: Dale D. Berkley, Ph.D., J.D. Technology Licensing Specialist, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-3804; Telephone: [phone], ext. 223; Facsimile: [phone]; e-mail: [e-mail]. A signed Confidential Disclosure Agreement will be required to receive copies of the patent application.

SUPPLEMENTARY INFORMATION:

The invention is a method and device for the analysis of cell samples where the samples are pure populations or subpopulations of desired types. Laser Capture Microdissection (LCM) is used in this invention to retrieve cells of interest from a tissue sample, which permits proteomic analysis on cells of different populations. The proteins in the micro-dissected cells are subjected to various analytic processes, such as immunoassays, 1D and 2D electrophoresis characterization, Western blotting, Matrix Assisted Desorption/Ionization/Time of Flight (MALDI/TOF), Liquid Chromatography Quadrapole Ion Trap Electrospray (LCQ-MS), and Surface Enhanced Laser Desorption Ionization Spectroscopy (SELDI). These methods allow for convenient and direct comparison of qualitative and quantitative protein content of diseased cells and normal cells from the same tissue sample.

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.

Dated: September 6, 2002.

Jack Spiegel,

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