Prospective Grant of Exclusive License: Pressure Mediated Selective Delivery of Therapeutic Substances and Cannula

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: PCT Patent Application Serial Number PCT/US99/11277 (PHS Ref. E-196-98/2) entitled “Pressure Mediated Selective Delivery of Therapeutic Substances and Cannula” filed on May 21, 1999, to InTissue, Inc., having a place of business in Swarthmore, PA. 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 September 11, 2000, will be considered.

ADDRESSES:

Requests for a copy of the patent applications, inquiries, comments and other materials relating to the contemplated license should be directed to: Peter Soukas, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-3804; Email: ps193c@nih.gov; Telephone: (301) 496-7056, ext. 268; Facsimile: (301) 402-0220.

SUPPLEMENTARY INFORMATION:

The patent application describes methods and devices for improved regional, organ, tissue, tissue-compartment, and celltype-specific delivery of therapeutic agents via infusion of those agents into body lumens under controlled pressure and volume conditions. Methods of varying pressure and flow rates for given body targets and depths are also disclosed along with methods of determining the proper protocol for a given target tissue. This application also includes designs for access cannulas, catheters, access ports, and other devices for controlled, targeted delivery of therapeutic agents, including drugs and gene therapy vectors. Local administration of drugs, gene therapy vectors, and other therapeutic agents in accordance with this invention can permit organ, tissue, tissue-compartment, and celltype-specific delivery, thereby maximizing administration to intended tissue targets using therapeutically effective dosages while simultaneously reducing the risk of systemic delivery and toxicity.

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 pressure mediated selective delivery of therapeutic substances to the gastrointestinal (GI) and genitourinary (GU) organs.

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.