[Federal Register Volume 65, Number 134 (Wednesday, July 12, 2000)]
[Notices]
[Page 43030]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-17532]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


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.

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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: [email protected]; 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.

    Dated: June 30, 2000.
Jack Spiegel,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer.
[FR Doc. 00-17532 Filed 7-11-00; 8:45 am]
BILLING CODE 4140-01-M