04-4798. Prospective Grant of Exclusive License: Zap 70 Protein Expression in Chronic Lymphocytic Leukemia (CLL)

AGENCY:

National Institutes of Health, Public Health Services, DHHS.

ACTION:

Notice.

SUMMARY:

This is a 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, Department of Health and Human Services, is contemplating the grant of an exclusive license to practice the inventions embodied in U.S. Provisional Patent Appl. Serial No. 60/375,966 (DHHS ref. no. E-091-2002/0-US-01) filed April 25, 2002, U.S. Patent Appl. Serial No. 10/309,548 (DHHS ref. no. E-091-2002/0-US-02), and Canadian Patent Application No. 2413475, all entitled “Zap 70 Expression as a Marker for Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (CLL/SLL),” to Cell Signaling Technology, Inc., of Beverly, Massachusetts. The patent rights in these inventions have been assigned to the United States of America.

The prospective exclusive license territory may be worldwide. The field of use may be limited to the use of antibody based products to diagnose chronic lymphocytic leukemia, wherein the antibody based products are regulated.

DATES:

Only written comments and/or license applications which are received by the National Institutes of Health on or before May 3, 2004 will be considered.

ADDRESSES:

Requests for copies of the patent(s)/patent application(s), inquiries, comments and other materials relating to the contemplated exclusive license should be directed to: Catherine M. Joyce, Intellectual Property Management Specialist, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-3804; Telephone [phone]; Facsimile 301-402-0220; E-mail [e-mail].

Technology Brief: The above-referenced patent(s)/patent application(s) relate to the discovery that detection of Zap70 expression can be used to diagnose chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). In particular, Zap70 expression can be used to distinguish between two subpopulations of CLL/SLL patients: (1) Patients who have stable or slowly progressing disease requiring late or no treatment or (2) patients who had progressive clinical course requiring early treatment.

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 sixty (60) days from the date of this published notice, the NIH receives written evidence and argument that establish that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR 404.7.

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: February 26, 2004.

Steven M. Ferguson,

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