[Federal Register Volume 68, Number 132 (Thursday, July 10, 2003)]
[Notices]
[Page 41166]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-17406]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Vaccine For Protection 
Against Shigella sonnei Disease

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 to practice the invention embodied in: United 
States Patent Application 10/346,706 entitled ``Vaccine For Protection 
Against Shigella Sonnei Disease'' filed on January 15, 2003, to Aridis, 
Inc., having a place of business in Portola Valley, California. 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 8, 2003 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: Peter Soukas, Office of Technology Transfer, 
National Institutes of Health, 6011 Executive Boulevard, Suite 325, 
Rockville, MD 20852-3804; Email: [email protected]; Telephone: (301) 435-
4646; Facsimile: (301) 402-0220.

SUPPLEMENTARY INFORMATION: Shigellosis is a global human health 
problem. Transmission usually occurs by contaminated food and water or 
through person-to-person contact. The bacterium is highly infectious by 
the oral route, and ingestion of as few as 10 organisms can cause an 
infection in volunteers. An estimated 200 million people worldwide 
suffer from shigellosis, with more than 650,000 associated deaths 
annually. A recent CDC estimate indicates the occurrence of over 
440,000 annual shigellosis cases in the United States alone, 
approximately eighty percent (80%) of which are caused by Shigella 
sonnei.
    Shigella sonnei is more active in developing countries. Shigella 
infections are typically treated with a course of antibiotics. However, 
due to the emergence of multidrug resistant Shigella strains, a safe 
and effective vaccine is highly desirable. No vaccines against Shigella 
infection currently exist. Immunity to Shigellae is mediated largely by 
immune responses directed against the serotype specific O-
polysaccharide. Claimed in the invention are compositions and methods 
for inducing an immunoprotective response against S. sonnei. 
Specifically claimed is an attenuated bacteria capable of expressing a 
S. sonnei antigen comprised of the S. sonnei form I O-polysaccharide 
expressed from the S. sonnei rfb/rfc gene cluster. The inventors have 
shown that the claimed vaccine compositions exhibited one hundred 
percent (100%) protection against parenteral challenge with virulent S. 
sonnei in mice.
    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 vaccines against S. sonnei.
    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: July 2, 2003.
Steven M. Ferguson,
Acting Director, Division of Technology Development and Transfer, 
Office of Technology Transfer.
[FR Doc. 03-17406 Filed 7-9-03; 8:45 am]
BILLING CODE 4140-01-P