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###### Department of Health and Human Services

###### National Institutes of Health

# 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. 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: salatac@OD.NIH.GOV. 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