[Federal Register Volume 67, Number 31 (Thursday, February 14, 2002)]
[Notices]
[Page 6940]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-3567]


-----------------------------------------------------------------------

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, Influenza virus, Nisseria 
gonorrhea and Vibrio cholerae

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

ACTION: Notice.

-----------------------------------------------------------------------

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. 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''; U.S. Patent Number 5,869,608 issued February 9, 1999, 
entitled ``Nucleotide and Amino Acid Sequences of the Four Variable 
Domains of the Major Outer Membrane Proteins of Chlamydia 
Trachomatis''; U.S. Patent Application Serial Number 09/247,137 filed 
February 9, 1999, entitled ``Nucleotide and Amino Acid Sequences of the 
Four Variable Domains of the Major Outer Membrane Proteins of Chlamydia 
trachomatis''; U.S. Patent Number 4,892,827 issued January 9, 1990, 
entitled ``Recombinant Pseudomonas Exotoxins: Construction of an Active 
Immunotoxin with Low Side Effects''; U.S. Provisional Patent 
Application 60/160,923 filed October 22, 1999, entitled ``Delivery of 
Proteins Across Polar Epithelial Cell Layers''; and U.S. Patent Number 
5,328,984 issued July 12, 1994, entitled ``Recombinant Chimeric 
Proteins Deliverable Across Cellular Membranes into Cytosol of Target 
Cells'' 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 the NIH Office of Technology Transfer on or before 
April 15, 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 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, 
Mycoplasma pneumoniae, Influenza virus, Nisseria gonorrhea and Vibrio 
cholerae. Trinity BioSystems 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 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. U.S. Patent Number 5,869,608 and U.S. Patent Application 
Serial Number 09/247,137 relate to Chlamydia epitopes needed for the 
Chlamydia vaccine. U.S. Provisional Patent Application Number 60/
160,923 provides methods for parenteral administration of a protein by 
transmucosal delivery and without injection. U.S. Patent Number 
4,892,827 describes Pseudomonas exotoxins with a deletion in the Ia 
domain that makes them less toxic. U.S. Patent Number 5,328,984 
contains claims relating to the chimeric Pseudomonas exotoxin protein 
compositions.
    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: February 7, 2002.
Jack Spiegel,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer.
[FR Doc. 02-3567 Filed 2-13-02; 8:45 am]
BILLING CODE 4140-01-P