Prospective Grant of an Exclusive License: Therapeutics for the Treatment of Autoimmune Disease, 3723-3724 [05-1413]

Download as PDF Federal Register / Vol. 70, No. 16 / Wednesday, January 26, 2005 / Notices Place: Beacon Hotel and Corporate Quarters, 1615 Rhode Island Avenue, NW., Washington, DC 20036. Contact Person: John Bishop, PhD, Scientific Review Administrator, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5180, MSC 7844, Bethesda, MD 20892, (301) 435– 1250, bishopj@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Predoctoral Fellowships (F31) Minority/Disability: CVS, DIG, IFCN, MOSS, RUS. Date: February 22, 2005. Time: 8 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: Hyatt Regency Bethesda, One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814. Contact Person: Najma Begum, PhD, Scientific Review Administrator, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 2175, MSC 7818, Bethesda, MD 20892, (301) 435– 1243, begumn@csr.nih.gov. Name of Committee: Oncological Sciences Integrated Review Group; Drug Discovery and Molecular Pharmacology Study Section. Date: February 23–25, 2005. Time: 8 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: Bethesda Marriott, 5151 Pooks Hill Road, Bethesda, MD 20814. Contact Person: Morris I. Kelsey, PhD, Scientific Review Administrator, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 6158, MSC 7804, Bethesda, MD 20892, (301) 435– 1718, kelseymcsr.nih.gov. Name of Committee: Respiratory Sciences Integrated Review Group; Lung Cellular, Molecular, and Immunobiology Study Section. Date: February 23–24, 2005. Time: 8 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: Wyndham City Center Hotel, 1143 New Hampshire Ave., NW., Washington, DC 20037. Contact Person: George M. Barnas, PhD, Scientific Review Administrator, Center for Scientific Review National Institutes of Health, 6701 Rockledge Drive, Room 2180, MSC 7818, Bethesda, MD 20892, (301) 435– 0696, barnasg@csr.nih.gov. Name of Committee: Infectious Diseases and Microbiology Integrated Review Group, Prokaryotic Cell and Molecular Biology Study Section. Date: February 23–24, 2005. Time: 8:30 a.m. to 4 p.m. Agenda: To review and evaluate grant applications. Place: Holiday Inn Select Bethesda, 8120 Wisconsin Avenue, Bethesda, MD 20814. Contact Person: Diane L. Stassi, PhD, Scientific Review Administrator, Center for Scientific Review National Institutes of Health, 6701 Rockledge Drive, Room 3202, MSC 7808, Bethesda, MD 20892, (301) 435– 2514, stassid@csr.nih.gov. Name of Committee: Oncological Sciences Integrated Review Group; Cancer VerDate jul<14>2003 19:33 Jan 25, 2005 Jkt 205001 Immunopathology and Immunotherapy Study Section. Date: February 23–24, 2005. Time: 8:30 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: Bethesda Marriott, 5151 Pooks Hill Road, Bethesda, MD 20814. Contact Person: Marcia Litwack, PhD, Scientific Review Administrator, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 6206, MSC 7804, Bethesda, MD 20892, (301) 435– 1719, litwackm@csr.nih.gov. Name of Committee: Brain Disorders and Clinical Neuroscience Integrated Review Group; Neural Basis of Psychopathology, Addictions and Sleep Disorders Study Section. Date: February 23–25, 2005. Time: 3 p.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: Residence Inn Bethesda, 7335 Wisconsin Avenue, Bethesda, MD 20814. Contact Person: Julius Cinque, MS, Scientific Review Administrator, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5186, MSC 7846, Bethesda, MD 20892, (301) 435– 1252, cinquej@csr.nih.gov. Name of Committee: Health of the Population Integrated Review Group; Epidemiology of Clinical Disorders and Aging Study Section. Date: February 23–25, 2005. Time: 6 p.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: Holiday Inn Select Bethesda, 8120 Wisconsin Avenue, Bethesda, MD 20814. Contact Person: Mary Ann Guadagno, PhD, Scientific Review Administrator, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3170, MSC 7770, Bethesda, MD 20892, (301) 451– 8011, guadagma@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; ZRG1 SBIB H 40P: Shared Resource: Magnetic Resonance and Optical Imaging. Date: February 23–24, 2005. Time: 7 p.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: Holiday Inn Select Bethesda, 8120 Wisconsin Ave., Bethesda, MD 20814. Contact Person: Arthur A. Petrosian, PhD, Scientific Review Administrator, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5112, MSC 7854, Bethesda, MD 20892, (301) 435– 1258, petrosia@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: January 18, 2005. LaVerne Y. Stringfield, Director, Office of Federal Advisory Committee Policy. [FR Doc. 05–1349 Filed 1–25–05; 8:45 am] BILLING CODE 4140–01–U PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 3723 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review: Cancellation of Meeting Notice is hereby given of the cancellation of the Biological Rhythms and Sleep Study Section, February 9, 2005, 9:00 a.m. to February 9, 2005, 5:00 p.m., Hyatt Regency Bethesda, One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814 which was published in the Federal Register on January 18, 2005, 70 FR 2872–2875. The meeting is cancelled due to a lack of quorum. Dated: January 19, 2005. LaVerne Y. Stringfield, Director, Office of Federal Advisory Committee Policy. [FR Doc. 05–1418 Filed 1–25–05; 8:45 am] BILLING CODE 4140–01–M DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of an Exclusive License: Therapeutics for the Treatment of Autoimmune Disease 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 404.7(a)(1)(i), announces that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive license to practice the inventions embodied in U.S. Patent No. 6,083,503, entitled ‘‘Interleukin-2 stimulated T lymphocyte cell death for the treatment of autoimmune diseases, allergic responses, and graft rejection’’ (DHHS Reference E–137–1991/0–US– 03); U.S. Patent No. 5,989,546 entitled ‘‘Interleukin-2 stimulated T lymphocyte cell death for the treatment of allergic responses’’ (DHHS Reference E–137– 1991/0–US–04); U.S. Patent No. 5,935,575, entitled ‘‘Interleukin-4 stimulated T lymphocyte cell death for the treatment of allergic disorders’’ (DHHS Reference E–151–1992/0–US– 11); U.S. Patent Application No. 08/ 431,644 filed May 2, 1995 entitled ‘‘Modified Myelin Basic Protein Molecules’’ (DHHS Reference E–033– 1996/0–US–01); and U.S. Patent Application No. 08/482,114 filed June 7, 1995 entitled ‘‘Modified Proteolipid Protein Molecules’’ (DHHS Reference E– E:\FR\FM\26JAN1.SGM 26JAN1 3724 Federal Register / Vol. 70, No. 16 / Wednesday, January 26, 2005 / Notices 128–1996/1–US–01); to Apogenix Biotechnology AG, having a place of business in Heidelberg, Germany. The patent rights in these inventions have been assigned to the United States of America. The prospective exclusive license territory will be worldwide and the field of use may be limited to therapeutics for the treatment of Multiple Sclerosis. DATES: Only written comments and/or license applications which are received by the National Institutes of Health on or before March 28, 2005, will be considered. Requests for copies of the patent and/or patent applications, inquiries, comments and other materials relating to the contemplated exclusive license should be directed to: Mojdeh Bahar, J.D., Technology Licensing Specialist, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852–3804; Telephone: (301) 435–2950; Facsimile: (301) 402– 0220; E-mail: baharm@od.nih.gov. SUPPLEMENTARY INFORMATION: The technology claimed in the aforementioned patents is a method for the treatment or prevention of autoimmune diseases, allergic or atopic disorders, and graft rejections. The instant method comprises inducing the death by apoptosis of a subpopulation of T lymphocytes that is capable of causing such diseases, while leaving the majority of other T lymphocytes unaffected. Cell death is achieved by cycles comprising challenging via immunization these T cells with antigenic substance at short time intervals, or by immunization followed by administering interleukin-2 (IL–2) when these T cells are expressing high levels of IL–2 receptor so as to cause these T cells to undergo apoptosis upon re-immunization with the antigenic peptide or protein. The technologies in the aforementioned patent applications are directed to compositions and methods for clinical assessment, diagnosis and treatment of Multiple Sclerosis (MS). The compositions are molecules related to the human proteolipid protein (PLP), and the 21.5 kDA fetal isoform of human myelin basic protein (MBP), and include nucleic acids and polypeptides. The nucleic acids are useful in the efficient production of modified PLP polypeptides and modified and unmodified MBP polypeptides and the polypeptides are useful for assaying T cells for responsiveness to MBP and PLP epitopes. They are further useful as therapeutic agents that act by inducing ADDRESSES: VerDate jul<14>2003 19:33 Jan 25, 2005 Jkt 205001 T cell responses, including apoptosis, as a means of treating MS. 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 establish 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: January 19, 2005. Steven M. Ferguson, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. 05–1413 Filed 1–25–05; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HOMELAND SECURITY Coast Guard [USCG–2005–20120] Towing Safety Advisory Committee Coast Guard, DHS. Notice of meetings. AGENCY: ACTION: SUMMARY: The Towing Vessel Inspection Working Group of the Towing Safety Advisory Committee (TSAC) will meet to discuss matters relating to these specific issues of towing safety. The meetings will be open to the public. DATES: The Towing Vessel Inspection Working Group will meet on Wednesday, March 2, 2005 from 1:30 p.m. to 4:30 p.m. and on Thursday, March 3, 2005 from 8:30 a.m. to 2 p.m. The meetings may close early if all business is finished. Written material and requests to make oral presentations should reach the Coast Guard on or before February 18, 2005. Requests to have a copy of your material distributed to each member of the Working Group should reach the Coast Guard on or before February 18, 2005. ADDRESSES: The Working Group will meet in the 4th Floor All-Hands Conference Room (#4202), U.S. Coast Guard Headquarters, 2100 Second Street PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 SW., Washington, DC 20593–0001. Please bring a government-issued ID with photo (e.g., driver’s license). Send written material and requests to make oral presentations to Mr. Gerald Miante, Commandant (G–MSO–1), U.S. Coast Guard Headquarters, 2100 Second Street SW., Washington, DC 20593–0001. This notice and related documents are available on the Internet at https:// dms.dot.gov under the docket number USCG–2005–20120. Mr. Gerald Miante, Assistant Executive Director of TSAC, telephone 202–267– 0214, fax 202–267–4570, or e-mail gmiante@comdt.uscg.mil. FOR FURTHER INFORMATION CONTACT: Notice of these meetings is given under the Federal Advisory Committee Act, 5 U.S.C. App. 2 (Pub. L. 92–463, 86 Stat.770, as amended). SUPPLEMENTARY INFORMATION: Agenda of Working Group Meetings The agenda for the Towing Vessel Inspection Working Group tentatively includes the following items: (1) Identify and discuss the elements that would comprise a safety management system for use in towing vessel inspection program including audit, oversight and enforcement of this safety management system. (2) Identify and discuss equipment standards appropriate for a towing vessel inspection program including use of existing standards and incorporation of new standards. (3) Identify and discuss the use of a risk-based approach incorporating available casualty data and other input to develop and support working group proposals. Procedural The meetings are open to the public. Please note that the meetings may close early if all business is finished. At the Chair’s discretion, members of the public may make oral presentations during the meeting. If you would like to make an oral presentation at the meeting, please notify the Assistant Executive Director (as provided above in for further information contact) no later than February 18, 2005. Written material for distribution at the meeting should reach the Coast Guard no later than February 18, 2005. Information on Services for Individuals with Disabilities For information on facilities or services for individuals with disabilities or to request special assistance at the meeting, contact Mr. Miante at the number listed in FOR FURTHER E:\FR\FM\26JAN1.SGM 26JAN1

Agencies

[Federal Register Volume 70, Number 16 (Wednesday, January 26, 2005)]
[Notices]
[Pages 3723-3724]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-1413]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of an Exclusive License: Therapeutics for the 
Treatment of Autoimmune Disease

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 
404.7(a)(1)(i), announces that the National Institutes of Health, 
Department of Health and Human Services, is contemplating the grant of 
an exclusive license to practice the inventions embodied in U.S. Patent 
No. 6,083,503, entitled ``Interleukin-2 stimulated T lymphocyte cell 
death for the treatment of autoimmune diseases, allergic responses, and 
graft rejection'' (DHHS Reference E-137-1991/0-US-03); U.S. Patent No. 
5,989,546 entitled ``Interleukin-2 stimulated T lymphocyte cell death 
for the treatment of allergic responses'' (DHHS Reference E-137-1991/0-
US-04); U.S. Patent No. 5,935,575, entitled ``Interleukin-4 stimulated 
T lymphocyte cell death for the treatment of allergic disorders'' (DHHS 
Reference E-151-1992/0-US-11); U.S. Patent Application No. 08/431,644 
filed May 2, 1995 entitled ``Modified Myelin Basic Protein Molecules'' 
(DHHS Reference E-033-1996/0-US-01); and U.S. Patent Application No. 
08/482,114 filed June 7, 1995 entitled ``Modified Proteolipid Protein 
Molecules'' (DHHS Reference E-

[[Page 3724]]

128-1996/1-US-01); to Apogenix Biotechnology AG, having a place of 
business in Heidelberg, Germany. The patent rights in these inventions 
have been assigned to the United States of America.
    The prospective exclusive license territory will be worldwide and 
the field of use may be limited to therapeutics for the treatment of 
Multiple Sclerosis.

DATES: Only written comments and/or license applications which are 
received by the National Institutes of Health on or before March 28, 
2005, will be considered.

ADDRESSES: Requests for copies of the patent and/or patent 
applications, inquiries, comments and other materials relating to the 
contemplated exclusive license should be directed to: Mojdeh Bahar, 
J.D., Technology Licensing Specialist, Office of Technology Transfer, 
National Institutes of Health, 6011 Executive Boulevard, Suite 325, 
Rockville, MD 20852-3804; Telephone: (301) 435-2950; Facsimile: (301) 
402-0220; E-mail: baharm@od.nih.gov.

SUPPLEMENTARY INFORMATION: The technology claimed in the aforementioned 
patents is a method for the treatment or prevention of autoimmune 
diseases, allergic or atopic disorders, and graft rejections. The 
instant method comprises inducing the death by apoptosis of a 
subpopulation of T lymphocytes that is capable of causing such 
diseases, while leaving the majority of other T lymphocytes unaffected. 
Cell death is achieved by cycles comprising challenging via 
immunization these T cells with antigenic substance at short time 
intervals, or by immunization followed by administering interleukin-2 
(IL-2) when these T cells are expressing high levels of IL-2 receptor 
so as to cause these T cells to undergo apoptosis upon re-immunization 
with the antigenic peptide or protein.
    The technologies in the aforementioned patent applications are 
directed to compositions and methods for clinical assessment, diagnosis 
and treatment of Multiple Sclerosis (MS). The compositions are 
molecules related to the human proteolipid protein (PLP), and the 21.5 
kDA fetal isoform of human myelin basic protein (MBP), and include 
nucleic acids and polypeptides. The nucleic acids are useful in the 
efficient production of modified PLP polypeptides and modified and 
unmodified MBP polypeptides and the polypeptides are useful for 
assaying T cells for responsiveness to MBP and PLP epitopes. They are 
further useful as therapeutic agents that act by inducing T cell 
responses, including apoptosis, as a means of treating MS.
    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 establish 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: January 19, 2005.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 05-1413 Filed 1-25-05; 8:45 am]
BILLING CODE 4140-01-P

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