Prospective Grant of Exclusive License: Mesothelin, a Differentiation Antigen Present on Mesothelium, Mesotheliomas and Ovarian Cancers and Methods and Kits for Targeting, 40385-40386 [05-13804]

Download as PDF [FR Doc. 05–13706 Filed 7–12–05; 8:45 am] BILLING CODE 4160–01–C DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Exclusive License: Mesothelin, a Differentiation Antigen Present on Mesothelium, Mesotheliomas and Ovarian Cancers and Methods and Kits for Targeting National Institutes of Health, Public Health Service, HHS. ACTION: Notice. AGENCY: SUMMARY: This 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, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the inventions embodied in U.S. Patent Application No. 60/010,166, filed January 5, 1996, entitled ‘‘Mesothelin, A Differentiation Antigen Present On Mesothelium, Mesotheliomas And Ovarian Cancers VerDate jul<14>2003 17:40 Jul 12, 2005 Jkt 205001 And Methods And Kits For Targeting’’ [E–002–1996/0–US–01]; United States Patent No. 6,153,430, issued on November 28, 2000, entitled ‘‘Nucleic Acid Encoding Mesothelin, A Differentiation Antigen Present On Mesothelium, Mesotheliomas And Ovarian Cancers’’ [E–002–1996/0–US– 02]; United States Patent Application No. 09/684,599, filed October 5, 2000, entitled ‘‘Mesothelin, A Differentiation Antigen Present On Mesothelium, Mesotheliomas And Ovarian Cancers And Methods And Kits For Targeting’’ (E–002–1996/0–US–03); United States Patent No. 6,083,502, issued on July 4, 2000, entitled ‘‘Mesothelium Antigen And Methods And Kits For Targeting It’’ [E–002–1996/1–US–02]; PCT Application No. PCT/US97/00224, filed January 3, 1997, entitled ‘‘Mesothelium Antigen And Methods And Kits For Targeting It’’ [E–002–1996/1–PCT–01]; Australian Patent No. 703769, filed January 3, 1997, entitled ‘‘Mesothelium Antigen And Methods And Kits For Targeting It’’ [E–002–1996/1–AU–03]; Canadian Patent No. 2241604, filed January 3, 1997, entitled ‘‘Mesothelium Antigen And Methods And Kits For PO 00000 Frm 00079 Fmt 4703 Sfmt 4703 40385 Targeting It’’ [E–002–1996/1–CA–04]; Japanese Patent Application No. 9– 525355, filed January 3, 1997, entitled ‘‘Mesothelium Antigen And Methods And Kits For Targeting It’’ [E–002–1996/ 1–JP–06]; European Patent No. 0871492, filed January 3, 1997, entitled ‘‘Mesothelium Antigen And Methods And Kits For Targeting It’’ [E–002–1996/ 1–EP–05]; Switzerland Patent Application No. 0871492, filed January 3, 1997, entitled ‘‘Mesothelium Antigen And Methods And Kits For Targeting It’’ [E–002–1996/1–CH–07]; German Patent No. 69726404.1, filed January 3, 1997, entitled ‘‘Mesothelium Antigen And Methods And Kits For Targeting It’’ (E– 002–1996/1–DE–08); French Patent Application No. 0871492, filed January 3, 1997, entitled ‘‘Mesothelium Antigen And Methods And Kits For Targeting It’’ [E–002–1996/1–FR–09]; Italian Patent No. 05503/BE/2004, January 3, 1997, entitled ‘‘Mesothelium Antigen And Methods And Kits For Targeting It’’ [E– 002–1996/1-–T–10]; Spanish Patent No. 0871492, filed January 3, 1997, entitled ‘‘Mesothelium Antigen And Methods And Kits For Targeting It’’ [E–002–1996/ 1–ES–11]; United Kingdom Patent No. E:\FR\FM\13JYN1.SGM 13JYN1 EN13JY05.164</GPH> Federal Register / Vol. 70, No. 133 / Wednesday, July 13, 2005 / Notices 40386 Federal Register / Vol. 70, No. 133 / Wednesday, July 13, 2005 / Notices 0871492, filed January 3, 1997, entitled ‘‘Mesothelium Antigen And Methods And Kits For Targeting It’’ [E–002–1996/ 1–GB–12]; United States Patent No. 5,320,956, issued June 14, 1996, entitled ‘‘Monoclonal Antibody’’ [E–195–1990/ 0–US–20]; United States Patent No. 5,525,337, issued June 11, 1996, entitled ‘‘Monoclonal Antibody Binding Cell Surface Antigen For Diagnosing Cancer’’ [E–195–1990/0–US–21]; United States Patent No. 5,817,313, issued October 6, 1998, entitled ‘‘Monoclonal Antibodies And Conjugates Thereof Useful For The Treatment Of Cancer’’ [E–195–1990/0– US–22]; PCT Patent Application No. PCT/US91/07227, filed October 9, 1991, entitled ‘‘Monoclonal Antibody’’ [E– 195–1990/0–PCT–02]; Denmark Patent No. 0554356, filed October 9, 1991, entitled ‘‘Monoclonal Antibody’’ [E– 195–1990/0–DK–03]; United Kingdom Patent No. 0554356, filed October 9, 1991, entitled ‘‘Monoclonal Antibody’’ [E–195–1990/0–GB–04]; Austrian Patent No. 0554356, filed October 9, 1991, entitled ‘‘Monoclonal Antibody’’ [E– 195–1990/0–AT–05]; Belgium Patent No. 0554356, filed October 9, 1991, entitled ‘‘Monoclonal Antibody’’ [E– 195–1990/0–BE–06]; European Patent No. 0554356, filed October 9, 1991, entitled ‘‘Monoclonal Antibody’’ [E– 195–1990/0–EP–09]; French Patent No. 0554356, filed October 9, 1991, entitled ‘‘Monoclonal Antibody’’ [E–195–1990/ 0–FR–11]; German Patent No. 0554356, filed October 9, 1991, entitled ‘‘Monoclonal Antibody’’ [E–195–1990/ 0–DE–08]; Greece Patent No. 0554356, filed October 9, 1991, entitled ‘‘Monoclonal Antibody’’ [E–195–1990/ 0–GR–12]; Netherlands Patent No. 0554356, filed October 9, 1991, entitled ‘‘Monoclonal Antibody’’ [E–195–1990/ 0–NL–15]; Italian Patent No. 0554356, filed October 9, 1991, entitled ‘‘Monoclonal Antibody’’ [E–195–1990/ 0–IT–13]; Luxembourg Patent No. 0554356, filed October 9, 1991, entitled ‘‘Monoclonal Antibody’’ [E–195–1990/ 0–LU–14]; Spanish Patent No. 0554356, filed October 9, 1991, entitled ‘‘Monoclonal Antibody’’ [E–195–1990/ 0-ES–10]; Sweden Patent No. 0554356, filed October 9, 1991, entitled ‘‘Monoclonal Antibody’’ [E–195–1990/ 0–SE–16]; Switzerland Patent No. 0554356, filed October 9, 1991, entitled ‘‘Monoclonal Antibody’’ [E–195–1990/ 0–CH–07]; Australian Patent No. 648363, filed October 9, 1991, entitled ‘‘Monoclonal Antibody’’ [E–195–1990/ 0–AU–17]; Canadian Patent No. 2093928, filed October 9, 1991, entitled ‘‘Monoclonal Antibody’’ [E–195–1990/ 0–CA–18]; and Japanese Patent No. 2660241, filed October 9, 1991, entitled VerDate jul<14>2003 17:40 Jul 12, 2005 Jkt 205001 ‘‘Monoclonal Antibody’’ [E–195–1990/ 0–JP–19] to Morphotek, Inc., which has offices in Exton, Pennsylvania. The patent rights in these inventions have been assigned to the United States of America. The prospective exclusive license territory may be worldwide, and the field of use may be limited to the use of licensee’s MORAb–009 antibody for the treatment of mesothelin-expressing cancer. DATES: Only written comments and/or applications for a license which are received by the NIH Office of Technology Transfer on or before September 12, 2005 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: Jesse S. Kindra, J.D., M.S., Technology Licensing Specialist, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852–3804; Telephone: (301) 435– 5559; Facsimile: (301) 402–0220; E-mail: kindraj@mail.nih.gov. SUPPLEMENTARY INFORMATION: The technology relates to CAK1, or ‘‘mesothelin’’, which is an antigen present on the cell surface in mesothelium and on many mesotheliomas and ovarian cancers. While the role of this differentiation antigen has not yet been determined, it is postulated that it may be implicated in adhesion and in the dissemination of mesotheliomas and of ovarian cancers. CAK1, therefore, is a potential target for monoclonal antibodies to be used in the diagnosis and treatment of these cancers. The gene for CAK1 has been cloned and sequenced, as embodied in the current technology. This technology, therefore, should provide a valuable research tool for use in the development of diagnostics and/or therapeutic agents toward mesotheliomas and ovarian cancers. 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. The prospective exclusive license may be granted unless within sixty (60) days from the date of this published notice, 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 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 PO 00000 Frm 00080 Fmt 4703 Sfmt 4703 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: July 1, 2005. Steven M. Ferguson, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. 05–13804 Filed 7–12–05; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Cancer Institute Special Emphasis Panel, Centers of Cancer Nanotechnology Excellence (CCNEs). Date: July 19–22, 2005. Time: 6 p.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: Holiday Inn Georgetown, 2101 Wisconsin Ave NW., Washington, DC 20007. Contact Person: Michael B. Small, PhD, Scientific Review Administrator, Research Programs Review Branch, Division of Extramural Activities, National Cancer Institute, National Institutes of Health, 6116 Executive Blvd., Room 8127, Bethesda, MD 20892–8328, 301–402–0996, smallm@mail.nih.gov. This notice is published less than 15 days prior to meeting due to scheduling conflicts. (Catalogue of Federal Domestic Assistance Program Nos. 93.392, Cancer Construction; 93.393, Cancer Cause and Prevention Research; 93.394, Cancer Detection and Diagnosis Research; 93.395, Cancer Treatment Research; 93.396, Cancer Biology Research; 93.397, Cancer Centers Support; 93.398, Cancer Research Manpower; 93.399, Cancer Control, National Institutes of Health, HHS) E:\FR\FM\13JYN1.SGM 13JYN1

Agencies

[Federal Register Volume 70, Number 133 (Wednesday, July 13, 2005)]
[Notices]
[Pages 40385-40386]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-13804]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Mesothelin, a 
Differentiation Antigen Present on Mesothelium, Mesotheliomas and 
Ovarian Cancers and Methods and Kits for Targeting

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

ACTION: Notice.

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

SUMMARY: This 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, Department 
of Health and Human Services, is contemplating the grant of an 
exclusive patent license to practice the inventions embodied in U.S. 
Patent Application No. 60/010,166, filed January 5, 1996, entitled 
``Mesothelin, A Differentiation Antigen Present On Mesothelium, 
Mesotheliomas And Ovarian Cancers And Methods And Kits For Targeting'' 
[E-002-1996/0-US-01]; United States Patent No. 6,153,430, issued on 
November 28, 2000, entitled ``Nucleic Acid Encoding Mesothelin, A 
Differentiation Antigen Present On Mesothelium, Mesotheliomas And 
Ovarian Cancers'' [E-002-1996/0-US-02]; United States Patent 
Application No. 09/684,599, filed October 5, 2000, entitled 
``Mesothelin, A Differentiation Antigen Present On Mesothelium, 
Mesotheliomas And Ovarian Cancers And Methods And Kits For Targeting'' 
(E-002-1996/0-US-03); United States Patent No. 6,083,502, issued on 
July 4, 2000, entitled ``Mesothelium Antigen And Methods And Kits For 
Targeting It'' [E-002-1996/1-US-02]; PCT Application No. PCT/US97/
00224, filed January 3, 1997, entitled ``Mesothelium Antigen And 
Methods And Kits For Targeting It'' [E-002-1996/1-PCT-01]; Australian 
Patent No. 703769, filed January 3, 1997, entitled ``Mesothelium 
Antigen And Methods And Kits For Targeting It'' [E-002-1996/1-AU-03]; 
Canadian Patent No. 2241604, filed January 3, 1997, entitled 
``Mesothelium Antigen And Methods And Kits For Targeting It'' [E-002-
1996/1-CA-04]; Japanese Patent Application No. 9-525355, filed January 
3, 1997, entitled ``Mesothelium Antigen And Methods And Kits For 
Targeting It'' [E-002-1996/1-JP-06]; European Patent No. 0871492, filed 
January 3, 1997, entitled ``Mesothelium Antigen And Methods And Kits 
For Targeting It'' [E-002-1996/1-EP-05]; Switzerland Patent Application 
No. 0871492, filed January 3, 1997, entitled ``Mesothelium Antigen And 
Methods And Kits For Targeting It'' [E-002-1996/1-CH-07]; German Patent 
No. 69726404.1, filed January 3, 1997, entitled ``Mesothelium Antigen 
And Methods And Kits For Targeting It'' (E-002-1996/1-DE-08); French 
Patent Application No. 0871492, filed January 3, 1997, entitled 
``Mesothelium Antigen And Methods And Kits For Targeting It'' [E-002-
1996/1-FR-09]; Italian Patent No. 05503/BE/2004, January 3, 1997, 
entitled ``Mesothelium Antigen And Methods And Kits For Targeting It'' 
[E-002-1996/1--T-10]; Spanish Patent No. 0871492, filed January 3, 
1997, entitled ``Mesothelium Antigen And Methods And Kits For Targeting 
It'' [E-002-1996/1-ES-11]; United Kingdom Patent No.

[[Page 40386]]

0871492, filed January 3, 1997, entitled ``Mesothelium Antigen And 
Methods And Kits For Targeting It'' [E-002-1996/1-GB-12]; United States 
Patent No. 5,320,956, issued June 14, 1996, entitled ``Monoclonal 
Antibody'' [E-195-1990/0-US-20]; United States Patent No. 5,525,337, 
issued June 11, 1996, entitled ``Monoclonal Antibody Binding Cell 
Surface Antigen For Diagnosing Cancer'' [E-195-1990/0-US-21]; United 
States Patent No. 5,817,313, issued October 6, 1998, entitled 
``Monoclonal Antibodies And Conjugates Thereof Useful For The Treatment 
Of Cancer'' [E-195-1990/0-US-22]; PCT Patent Application No. PCT/US91/
07227, filed October 9, 1991, entitled ``Monoclonal Antibody'' [E-195-
1990/0-PCT-02]; Denmark Patent No. 0554356, filed October 9, 1991, 
entitled ``Monoclonal Antibody'' [E-195-1990/0-DK-03]; United Kingdom 
Patent No. 0554356, filed October 9, 1991, entitled ``Monoclonal 
Antibody'' [E-195-1990/0-GB-04]; Austrian Patent No. 0554356, filed 
October 9, 1991, entitled ``Monoclonal Antibody'' [E-195-1990/0-AT-05]; 
Belgium Patent No. 0554356, filed October 9, 1991, entitled 
``Monoclonal Antibody'' [E-195-1990/0-BE-06]; European Patent No. 
0554356, filed October 9, 1991, entitled ``Monoclonal Antibody'' [E-
195-1990/0-EP-09]; French Patent No. 0554356, filed October 9, 1991, 
entitled ``Monoclonal Antibody'' [E-195-1990/0-FR-11]; German Patent 
No. 0554356, filed October 9, 1991, entitled ``Monoclonal Antibody'' 
[E-195-1990/0-DE-08]; Greece Patent No. 0554356, filed October 9, 1991, 
entitled ``Monoclonal Antibody'' [E-195-1990/0-GR-12]; Netherlands 
Patent No. 0554356, filed October 9, 1991, entitled ``Monoclonal 
Antibody'' [E-195-1990/0-NL-15]; Italian Patent No. 0554356, filed 
October 9, 1991, entitled ``Monoclonal Antibody'' [E-195-1990/0-IT-13]; 
Luxembourg Patent No. 0554356, filed October 9, 1991, entitled 
``Monoclonal Antibody'' [E-195-1990/0-LU-14]; Spanish Patent No. 
0554356, filed October 9, 1991, entitled ``Monoclonal Antibody'' [E-
195-1990/0-ES-10]; Sweden Patent No. 0554356, filed October 9, 1991, 
entitled ``Monoclonal Antibody'' [E-195-1990/0-SE-16]; Switzerland 
Patent No. 0554356, filed October 9, 1991, entitled ``Monoclonal 
Antibody'' [E-195-1990/0-CH-07]; Australian Patent No. 648363, filed 
October 9, 1991, entitled ``Monoclonal Antibody'' [E-195-1990/0-AU-17]; 
Canadian Patent No. 2093928, filed October 9, 1991, entitled 
``Monoclonal Antibody'' [E-195-1990/0-CA-18]; and Japanese Patent No. 
2660241, filed October 9, 1991, entitled ``Monoclonal Antibody'' [E-
195-1990/0-JP-19] to Morphotek, Inc., which has offices in Exton, 
Pennsylvania. The patent rights in these inventions have been assigned 
to the United States of America.
    The prospective exclusive license territory may be worldwide, and 
the field of use may be limited to the use of licensee's MORAb-009 
antibody for the treatment of mesothelin-expressing cancer.

DATES: Only written comments and/or applications for a license which 
are received by the NIH Office of Technology Transfer on or before 
September 12, 2005 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: Jesse S. Kindra, J.D., M.S., Technology 
Licensing Specialist, Office of Technology Transfer, National 
Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, 
MD 20852-3804; Telephone: (301) 435-5559; Facsimile: (301) 402-0220; E-
mail: kindraj@mail.nih.gov.

SUPPLEMENTARY INFORMATION: The technology relates to CAK1, or 
``mesothelin'', which is an antigen present on the cell surface in 
mesothelium and on many mesotheliomas and ovarian cancers. While the 
role of this differentiation antigen has not yet been determined, it is 
postulated that it may be implicated in adhesion and in the 
dissemination of mesotheliomas and of ovarian cancers. CAK1, therefore, 
is a potential target for monoclonal antibodies to be used in the 
diagnosis and treatment of these cancers. The gene for CAK1 has been 
cloned and sequenced, as embodied in the current technology. This 
technology, therefore, should provide a valuable research tool for use 
in the development of diagnostics and/or therapeutic agents toward 
mesotheliomas and ovarian cancers.
    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. 
The prospective exclusive license may be granted unless within sixty 
(60) days from the date of this published notice, 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 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: July 1, 2005.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 05-13804 Filed 7-12-05; 8:45 am]
BILLING CODE 4140-01-P
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