Rules and Regulations. Notice

Agency: National Institutes of Health, Public Health Service, DHHS
Action: Notice
Citation: FR Doc. 02-22078

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 a an exclusive license to practice the invention embodied in: United States Patent Application 09/835,124 and its foreign equivalents entitled “Virus-Like Particles for the Induction of Autoantibodies” filed on April 13, 2001, with priority back to U.S. S/N 60/105,132, filed October 21, 1998, to Virionics Corporation, having a place of business in Odenton, Maryland. The patent rights in this invention have been assigned to the United States of America.

Dates

Only written comments and/or application for a license which are received by the NIH Office of Technology Transfer on or before October 28, 2002 will be considered.

Supplementary Information

This invention claims compositions and methods for producing antibodies to tolerogens (self-antigens normally exposed to B cells that fail to induce an antibody response.) The compositions of the invention comprise multiple copies of a tolerogen (or at least one B cell epitope of a tolerogen) chimerized to capsomeric structures or capsid proteins in an orderly manner. The disclosed compositions can be utilized as prophylactic or therapeutic vaccines against self antigens or antigens of infectious agents. The invention could potentially replace any treatment utilizing chronic administration of a monoclonal antibody that reacts with a self-antigen. 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. The field of use may be limited to Human Papilloma Virus-Like Particles vaccines against Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Vascular Endothelial Growth Factor (VEGF) and breast cancer (Her2/neu). 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: August 22, 2002. Jack Spiegel, Director, Division of Technology Development and Transfer, Office of Technology Transfer. [FR Doc. 02-22078 Filed 8-28-02; 8:45 am]