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

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:salatac@OD.NIH.GOV.

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.

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