[Federal Register Volume 66, Number 12 (Thursday, January 18, 2001)]
[Notices]
[Page 4848]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-1463]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Prophylactic and/or 
Therapeutic Vaccine Against Pseudomonas Aeruginosa, Chlamydia, 
Trachomatis and Mycoplasma Pneumonia

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 exclusive worldwide license to practice the 
inventions embodied in U.S. Serial Number 09/462,682, filed January 10, 
2000 (claiming priority to U.S. Provisional Patent Application Serial 
No. 60/052,375, filed July 11, 1997), entitled ``Pseudomonas exotaxin 
A-Like Chimeric Immunogens'' and U.S. Serial Number 09/462,713 filed 
May 12, 2000 (claiming priority to U.S. Provisional Patent Application 
Serial No. 60/056,924, filed July 11, 1997), entitled ``Pseudomonas 
Exotoxin A-like Chimera Immunogens for eliciting a secretory IgA-
Mediated Immune Response'' to Trinity BioSystems, L.L.C. of Los Altos 
Hills, California, U.S.A. The United States 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 March 19, 2001 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]. A signed Confidential Disclosure Agreement (CDA) 
may be required to receive copies of the patent applications.

SUPPLEMENTARY INFORMATION: The patent applications describe the use of 
Pseudomonas exotoxin A-like chimeric immunogens in which a non-native 
epitope is inserted into a domain. These immunogens are useful to 
elicit humoral, cell-mediated and mucosal immune responses against the 
non-native epitope.
    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.
    It is anticipated that this license may be limited to the field of 
use as a prophylactic and/or therapeutic vaccine against Pseudomonas 
aeruginosa, Chlamydia trachomatis and Mycoplasma pneumoniae. Trinity 
BioSystems will use Pseudomonas exotoxin A to target and deliver 
pathogen peptide epitopes wherein said pathogen peptide epitopes are 
inserted into or replace a domain of Pseudomonas exotoxin A.
    This propsective 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.
    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: January 8, 2001.
Jack Spiegel,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer.
[FR Doc. 01-1463 Filed 1-17-01; 8:45 am]
BILLING CODE 4140-01-M