[Federal Register Volume 67, Number 180 (Tuesday, September 17, 2002)]
[Notices]
[Page 58628]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-23547]



[[Page 58628]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Co-Exclusive License: Prophylactic and/or 
Therapeutic Vaccine Against Pseudomonas Aeruginosa

AGENCY: National Institutes of Health, Public Health Service, DHHS.

ACTION: Notice.

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SUMMARY: This is notice in accordance with 15 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 limited field of use co-exclusive worldwide license to practice the 
inventions embodied in: U.S. Provisional Patent Application Serial 
Number 60/257,877, filed December 21, 2000, entitled ``A Chimeric 
Protein Comprising Non-Toxic Pseudomonas Exotoxin A and Type IV Pilin 
Sequences'' to Cytovax Biotechnologies Inc. of Alberta, Canada. The 
United States Government as represented by the Department of Health and 
Human Services is an assignee of these patent rights.

DATES: Only written comments and/or applications for a license which 
are received by NIH on or before November 18, 2002 will be considered.

ADDRESSES: Requests for a copy of these patent applications, inquiries, 
comments, and other materials relating to the contemplated license 
should be directed to: Carol A. Salata, Technology Licensing 
Specialist, Office of Technology Transfer, National Institutes of 
Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-3804; 
Telephone: (301) 496-7735 ext 232; Facsimile: (301) 402-0220; E-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: The prospective co-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. It is anticipated that this license may be 
limited to the field of use as a prophylactic and/or therapeutic 
vaccine against Pseudomonas aeruginosa. Cytovax Biotechnologies Inc. 
will use Pseudomonas exotoxin A to target and deliver pathogen Type IV 
pilin peptide epitopes wherein said pathogen peptide epitopes are 
inserted into or replace a domain of Pseudomonas exotoxin A. This 
prospective co-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 patent Application Serial Number 60/257,877 describes a 
chimeric protein wherein key sequences from a Type IV pilin protein are 
inserted into a non-toxic version of Pseudomonas aeruginosa exotoxin A. 
This invention provides candidate chimeric vaccines that generate 
antibodies that interfere with adherence of Pseudomonas aeruginosa 
exotoxin A to epithelial cells and neutralize the cytotoxicity of 
exotoxin A.

    Note: This is a modification to a previously published 
Prospective Grant of Exclusive License notice to Trinity Biosystems 
LLP (67 FR 6940, February 14, 2002). It is contemplated that both 
Trinity Biosystems Inc. and Cytovax Biotechnologies Inc. will 
receive co-exclusive licenses to the technology mentioned above.

    Applications for a license filed in response to this notice will be 
treated as objections to the grant of 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: September 10, 2002.
Jack Spiegel,
Director, Division of Technology, Development and Transfer, Office of 
Technology Transfer.
[FR Doc. 02-23547 Filed 9-16-02; 8:45 am]
BILLING CODE 4140-01-P