Prospective Grant of Exclusive License: Field of Use: Treatment of Inflammatory Diseases Using Ghrelin, 66182 [E6-19051]

Download as PDF 66182 Federal Register / Vol. 71, No. 218 / Monday, November 13, 2006 / Notices the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person. In the interest of security, NIH has instituted stringent procedures for entrance onto the NIH campus. All visitor vehicles, including taxicabs, hotel, and airport shuttles will be inspected before being allowed on campus. Visitors will be asked to show one form of identification (for example, a government-issued photo ID, driver’s license, or passport) and to state the purpose of their visit. (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: November 6, 2006. Anna Snouffer, Acting Director, Office of Federal Advisory Committee Policy. [FR Doc. 06–9171 Filed 11–9–06; 8:45 am] BILLING CODE 4140–01–M DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Exclusive License: Field of Use: Treatment of Inflammatory Diseases Using Ghrelin National Institutes of Health, Public Health Service, HHS. ACTION: Notice. cprice-sewell on PROD1PC66 with NOTICES AGENCY: SUMMARY: This is notice, in accordance with 35 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 an exclusive license to practice the invention embodied in: U.S. Provisional Patent application, S/N 60/569,819 filed May 11, 2004, entitled ‘‘Methods for Inhibiting Proinflammatory Cytokine Expression Using Ghrelin,’’ converted to PCT on May 11, 2005 (E–016–2004/0–PCT–02), (Inventors: Vishwa D. Dixit, Dennis D. Taub, Eric Schaffer, and Dzung Nguyen) (NIA), to Sapphire Therapeutics, Inc. (Hereafter Sapphire), having a place of business in Bridgewater of NJ. The patent rights in these inventions have been assigned to the United States of America. DATES: Only written comments and/or application for a license, which are received by the NIH Office of Technology Transfer on or before January 12, 2007 will be considered. ADDRESSES: Requests for a copy of the patent application, inquiries, comments VerDate Aug<31>2005 15:22 Nov 09, 2006 Jkt 211001 and other materials relating to the contemplated license should be directed to: Sally Hu, PhD, M.B.A., Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852–3804; email: hus@od.nih.gov; telephone: (301) 435–5606; facsimile: (301) 402–0220. under the Freedom of Information Act, 5 U.S.C. 552. 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 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. E–016–2004/0–US–01 provides methods for treating inflammation by inhibiting pro-inflammatory cytokine expression using Ghrelin, or a fragment thereof. Inflammation could be caused by a variety of viral, bacterial, fungal, or parasitic infections. The invention also provides methods for treating loss of appetite, and sepsis. Ghrelin, a naturally occurring peptide hormone was shown to be the ligand for growth hormone secretagogue receptor (GHS–R ), and is mainly produced by the epithelial cells in the stomach. Ghrelin exerts many important actions in the body, including stimulation of growth hormone secretion, induction of appetite, and regulation of energy expenditure. Ghrelin directly controls human growth hormone and insulin growth factor expression by human immune cells. The inventors showed that Ghrelin exerts anti-inflammatory effects by inhibiting the secretion of acute and chronic cytokines, including IL–1, IL–6, TNF–a, IFN–g, IL–12, chemokines, and CSF in vitro and in in vivo mouse models of sepsis and inflammation. This invention can be useful for treatment of various inflammatory disorders, including inflammatory bowel disease, Crohn’s disease, rheumatoid arthritis, multiple sclerosis, atherosclerosis, endotoxemia, and graft-versus-host disease. It can also be used as a treatment for loss of appetite and sepsis. The field of use may be limited to the use of Ghrelin as a novel drug to treat a range of inflammatory diseases. Properly filed competing applications for a license filed in response to this notice will be treated as objections to 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 BILLING CODE 4140–01–P SUPPLEMENTARY INFORMATION: PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 Dated: October 30, 2006. Steven M. Ferguson, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. E6–19051 Filed 11–9–06; 8:45 am] DEPARTMENT OF HOMELAND SECURITY Bureau of Customs and Border Protection Notice of Intent To Prepare a Draft Environmental Impact Statement for Department of Homeland Security, Customs and Border Protection, Office of Border Patrol, Laredo Sector, Laredo North and South Station’s Road Improvement and Non-Native Vegetation Removal Project U.S. Customs and Border Protection, Department of Homeland Security. ACTION: Notice of Intent to Prepare a Draft Environmental Impact Statement (DEIS). AGENCY: SUMMARY: The U.S. Army Corps of Engineers on behalf of the U.S. Customs and Border Protection (CBP) will prepare a Draft Environmental Impact Statement pursuant to the National Environmental Policy Act of 1969 (NEPA) for the construction and improvement of existing patrol roads and the removal of non-native (giant cane, Arundo donax) vegetation along 111 miles of the Rio Grande (Proposed Action) in Webb County, Texas. The U.S. Customs and Border Protection is the decision-making agency for this project. This EIS is being prepared in support of the proposal by the Office of Border Patrol’s (OBP) Laredo North and Laredo South Stations for controlling and deterring the influx of illegal immigration and contraband into the United States. Due to the increased violent activity in Nuevo Laredo, Mexico and increase in drug trafficking in Webb County, the Secretary of Homeland Security has mandated this effort as the top priority of the OBP’s Laredo Sector. The Laredo Sector has a need to secure the border by obtaining an unobstructed line of sight to the Rio Grande and a continuous patrol road. These actions are intended to gain and maintain control of the border to further prevent the influx of illegal aliens and drugs into the United States. E:\FR\FM\13NON1.SGM 13NON1

Agencies

[Federal Register Volume 71, Number 218 (Monday, November 13, 2006)]
[Notices]
[Page 66182]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-19051]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Field of Use: Treatment 
of Inflammatory Diseases Using Ghrelin

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 404.7(a)(1)(i), that the National Institutes of Health (NIH), 
Department of Health and Human Services, is contemplating the grant of 
an exclusive license to practice the invention embodied in:
    U.S. Provisional Patent application, S/N 60/569,819 filed May 11, 
2004, entitled ``Methods for Inhibiting Proinflammatory Cytokine 
Expression Using Ghrelin,'' converted to PCT on May 11, 2005 (E-016-
2004/0-PCT-02), (Inventors: Vishwa D. Dixit, Dennis D. Taub, Eric 
Schaffer, and Dzung Nguyen) (NIA), to Sapphire Therapeutics, Inc. 
(Hereafter Sapphire), having a place of business in Bridgewater of NJ. 
The patent rights in these inventions have been assigned to the United 
States of America.

DATES: Only written comments and/or application for a license, which 
are received by the NIH Office of Technology Transfer on or before 
January 12, 2007 will be considered.

ADDRESSES: Requests for a copy of the patent application, inquiries, 
comments and other materials relating to the contemplated license 
should be directed to: Sally Hu, PhD, M.B.A., Office of Technology 
Transfer, National Institutes of Health, 6011 Executive Boulevard, 
Suite 325, Rockville, MD 20852-3804; e-mail: hus@od.nih.gov; telephone: 
(301) 435-5606; facsimile: (301) 402-0220.

SUPPLEMENTARY INFORMATION: 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 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.
    E-016-2004/0-US-01 provides methods for treating inflammation by 
inhibiting pro-inflammatory cytokine expression using Ghrelin, or a 
fragment thereof. Inflammation could be caused by a variety of viral, 
bacterial, fungal, or parasitic infections. The invention also provides 
methods for treating loss of appetite, and sepsis. Ghrelin, a naturally 
occurring peptide hormone was shown to be the ligand for growth hormone 
secretagogue receptor (GHS-R ), and is mainly produced by the 
epithelial cells in the stomach. Ghrelin exerts many important actions 
in the body, including stimulation of growth hormone secretion, 
induction of appetite, and regulation of energy expenditure. Ghrelin 
directly controls human growth hormone and insulin growth factor 
expression by human immune cells. The inventors showed that Ghrelin 
exerts anti-inflammatory effects by inhibiting the secretion of acute 
and chronic cytokines, including IL-1, IL-6, TNF-[alpha], IFN-[gamma], 
IL-12, chemokines, and CSF in vitro and in in vivo mouse models of 
sepsis and inflammation. This invention can be useful for treatment of 
various inflammatory disorders, including inflammatory bowel disease, 
Crohn's disease, rheumatoid arthritis, multiple sclerosis, 
atherosclerosis, endotoxemia, and graft-versus-host disease. It can 
also be used as a treatment for loss of appetite and sepsis.
    The field of use may be limited to the use of Ghrelin as a novel 
drug to treat a range of inflammatory diseases.
    Properly filed competing applications for a license filed in 
response to this notice will be treated as objections to 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: October 30, 2006.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. E6-19051 Filed 11-9-06; 8:45 am]
BILLING CODE 4140-01-P

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