Prospective Grant of Exclusive License: The Use of Adenovirus Vectors for the Development of Vaccines Against Human Immunodeficiency Virus and Other Infectious Agents, 7904 [E7-2883]

Download as PDF 7904 Federal Register / Vol. 72, No. 34 / Wednesday, February 21, 2007 / Notices Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3028D, MSC 7770, Bethesda, MD 20892, 301–435– 1251, melnicks@csr.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393–93.396, 93.837–93.844, 93.846–93.878, 93.892, 93.893, National Institutes of Health, HHS) Dated: February 8, 2007. Anna Snouffer, Acting Director, Office of Federal Advisory Committee Policy. [FR Doc. 07–762 Filed 2–20–07; 8:45 am] BILLING CODE 4140–07–M DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Exclusive License: The Use of Adenovirus Vectors for the Development of Vaccines Against Human Immunodeficiency Virus and Other Infectious Agents National Institutes of Health, Public Health Service, HHS. ACTION: Notice. rmajette on PROD1PC67 with NOTICES AGENCY: SUMMARY: This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR Part 404.7(a)(1)(i), that the National Institutes of Health (NIH), Department of Health and Human Services (HHS), is contemplating the grant of an exclusive patent license to practice the inventions embodied in Patent Cooperation Treaty Application No. PCT/US02/27592 filed August 29, 2002 and United States National Stage Application Serial No. 10/487,974 filed February 27, 2004, entitled ‘‘New Adenovirus Type 7 Vectors’’ [HHS Reference No. E–236– 2001/0], and United States Patent Application Serial No. 11/282,319 filed November 17, 2005, entitled ‘‘Improved Replication-Competent Adenovirus Vectors’’ [HHS Reference No. E–203– 2004/0], to PaxVax, Inc., which has offices in Menlo Park, CA. The patent rights in these inventions have been assigned and/or exclusively licensed to the Government of the United States of America. The prospective exclusive license territory may be the United States of America, and the field of use may be limited to the development of vaccines against human immunodeficiency virus, human papillomavirus, influenza, malaria, and tuberculosis. DATES: Only written comments and/or applications for a license which are received by the NIH Office of VerDate Aug<31>2005 15:09 Feb 20, 2007 Jkt 211001 Technology Transfer on or before April 23, 2007 will be considered. ADDRESSES: Requests for copies of the patent application, inquiries, comments, and other materials relating to the contemplated exclusive license should be directed to: Susan Ano, Ph.D., Technology Licensing Specialist, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852–3804; Telephone: (301) 435– 5515; Facsimile: (301) 402–0220; E-mail: anos@mail.nih.gov. SUPPLEMENTARY INFORMATION: The subject application addresses two (2) technologies related to specific techniques for producing adenoviral vectors and application of such vectors for gene transfer, vaccine development and therapeutics. Use of the present technologies in the prevention and/or treatment of disease, especially human immunodeficiency virus (HIV), is the primary focus of the current subject inventions. The first technology (HHS Reference No. E–236–2001/0) describes a cosmid adenoviral serotype 7 (Ad7) vector for use in the prevention and/or treatment of HIV–1. This invention includes methods for producing and administering both replicationcompetent and incompetent Ad7. The cosmid Ad7 vector includes an Ad7 genome that can be modified to express specific nucleic acid sequences for production of a desired protein or epitope such as an HIV–1 gene product. This system may be used to generate proteins or epitopes of infectious agents for stimulation of desired immunogenic responses. The second invention (HHS Reference No. E–203–2004/0) discloses improvements upon replicationcompetent Ad vectors, which serve to produce high level expression of any gene of interest, i.e., a transgene. This system incorporates a novel hybrid gene regulatory unit comprising a CMV promoter and an adenovirus tripartite leader sequence for regulation of transgene expression. Additionally, the present disclosure provides methods of producing and administering the described adenoviral expression vectors, containing the nucleic acid sequence of significant HIV–1 proteins as transgenes for stimulation of an immune response to HIV–1. 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 part 404.7. The prospective exclusive license may be granted within ninety (90) days from the date of this published notice, unless the PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 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 part 404.7. Applications for a license in the field of use filed in response to this notice will be treated as objections to the grant of the contemplated exclusive license. Comments and objections submitted 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 12, 2007. Steven M. Ferguson, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. E7–2883 Filed 2–20–07; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF THE INTERIOR Fish and Wildlife Service Conference of the Parties to the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES); Fourteenth Regular Meeting; Provisional Agenda; Announcement of Public Meeting Fish and Wildlife Service, Interior. ACTION: Notice. AGENCY: SUMMARY: We, the United States, as a Party to the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES), will attend the fourteenth regular meeting of the Conference of the Parties to CITES (CoP14) in The Hague, The Netherlands, June 3–15, 2007. Currently, the United States is developing its negotiating positions on proposed resolutions, decisions, and amendments to the CITES Appendices (species proposals), as well as other agenda items that have been submitted by other Party countries and the CITES Secretariat for consideration at CoP14. With this notice we announce the provisional agenda for CoP14, solicit your comments on the items on the provisional agenda, and announce a public meeting to discuss the items on the provisional agenda. DATES: The public meeting will be held on April 9, 2007, at 1:30 p.m. In developing the U.S. negotiating positions on proposed resolutions, decisions, and species proposals, and other agenda items submitted by other Party countries and the CITES Secretariat for consideration at CoP14, we will consider written information E:\FR\FM\21FEN1.SGM 21FEN1

Agencies

[Federal Register Volume 72, Number 34 (Wednesday, February 21, 2007)]
[Notices]
[Page 7904]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-2883]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: The Use of Adenovirus 
Vectors for the Development of Vaccines Against Human Immunodeficiency 
Virus and Other Infectious Agents

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

ACTION: Notice.

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

SUMMARY: This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 
CFR Part 404.7(a)(1)(i), that the National Institutes of Health (NIH), 
Department of Health and Human Services (HHS), is contemplating the 
grant of an exclusive patent license to practice the inventions 
embodied in Patent Cooperation Treaty Application No. PCT/US02/27592 
filed August 29, 2002 and United States National Stage Application 
Serial No. 10/487,974 filed February 27, 2004, entitled ``New 
Adenovirus Type 7 Vectors'' [HHS Reference No. E-236-2001/0], and 
United States Patent Application Serial No. 11/282,319 filed November 
17, 2005, entitled ``Improved Replication-Competent Adenovirus 
Vectors'' [HHS Reference No. E-203-2004/0], to PaxVax, Inc., which has 
offices in Menlo Park, CA. The patent rights in these inventions have 
been assigned and/or exclusively licensed to the Government of the 
United States of America.
    The prospective exclusive license territory may be the United 
States of America, and the field of use may be limited to the 
development of vaccines against human immunodeficiency virus, human 
papillomavirus, influenza, malaria, and tuberculosis.

DATES: Only written comments and/or applications for a license which 
are received by the NIH Office of Technology Transfer on or before 
April 23, 2007 will be considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
comments, and other materials relating to the contemplated exclusive 
license should be directed to: Susan Ano, Ph.D., Technology Licensing 
Specialist, Office of Technology Transfer, National Institutes of 
Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-3804; 
Telephone: (301) 435-5515; Facsimile: (301) 402-0220; E-mail: 
anos@mail.nih.gov.

SUPPLEMENTARY INFORMATION: The subject application addresses two (2) 
technologies related to specific techniques for producing adenoviral 
vectors and application of such vectors for gene transfer, vaccine 
development and therapeutics. Use of the present technologies in the 
prevention and/or treatment of disease, especially human 
immunodeficiency virus (HIV), is the primary focus of the current 
subject inventions.
    The first technology (HHS Reference No. E-236-2001/0) describes a 
cosmid adenoviral serotype 7 (Ad7) vector for use in the prevention 
and/or treatment of HIV-1. This invention includes methods for 
producing and administering both replication-competent and incompetent 
Ad7. The cosmid Ad7 vector includes an Ad7 genome that can be modified 
to express specific nucleic acid sequences for production of a desired 
protein or epitope such as an HIV-1 gene product. This system may be 
used to generate proteins or epitopes of infectious agents for 
stimulation of desired immunogenic responses.
    The second invention (HHS Reference No. E-203-2004/0) discloses 
improvements upon replication-competent Ad vectors, which serve to 
produce high level expression of any gene of interest, i.e., a 
transgene. This system incorporates a novel hybrid gene regulatory unit 
comprising a CMV promoter and an adenovirus tripartite leader sequence 
for regulation of transgene expression. Additionally, the present 
disclosure provides methods of producing and administering the 
described adenoviral expression vectors, containing the nucleic acid 
sequence of significant HIV-1 proteins as transgenes for stimulation of 
an immune response to HIV-1.
    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 part 
404.7. The prospective exclusive license may be granted within ninety 
(90) days from the date of this published notice, unless the 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 part 404.7.
    Applications for a license in the field of use filed in response to 
this notice will be treated as objections to the grant of the 
contemplated exclusive license. Comments and objections submitted 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 12, 2007.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. E7-2883 Filed 2-20-07; 8:45 am]
BILLING CODE 4140-01-P
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