E9-3809. Prospective Grant of Exclusive License: Methods of Using Deacetylase Inhibitors To Treat Dystrophies and Other Tissue Degeneration Disorders

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), 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. Provisional Patent Application No. 60/335,705, filed October 18, 2001, now abandoned, entitled “Methods of Using Deacetylase Inhibitors as Tools to Promote Cell Differentiation and Regeneration” [HHS Ref. No. E-353-2001/0-US-01]; U.S. Provisional Patent Application No. 60/343,854, filed October 25, 2001, now abandoned, entitled “Methods of Using Deacetylase Inhibitors as Tools to Promote Cell Differentiation And Regeneration” [HHS Ref. No. E-353-2001/1-US-01]; PCT Patent Application No. PCT/US02/33570, filed October 17, 2002, now abandoned, entitled “Methods of Using Deacetylase Inhibitors as Tools to Promote Cell Differentiation and Regeneration” [HHS Ref. No. E-353-2001/2-PCT-01]; U.S. Patent Application No. 10/492,901, filed April 15, 2004, which issued as U.S. Patent No. 7,229,963, on June 12, 2007, entitled “Methods of Using Deacetylase Inhibitors as Tools to Promote Cell Differentiation and Regeneration” [HHS Ref. No. E-353-2001/2-US-02]; and U.S. Patent Application No. 11/800,151, filed May 4, 2007, which published as 2008/0248994, on October 9, 2008, entitled “Methods of Using Deacetylase Inhibitors to Promote Cell Differentiation and Regeneration” [HHS Ref. No. E-353-2001/2-US-03] to ADVANCELL Advanced In Vitro Cell Technologies, S.A. which has an office in Barcelona, Spain. The patent rights in these inventions have been assigned to the United States of America and The Salk Institute for Biological Studies.

The prospective exclusive license territory may be “worldwide”, and the field of use may be limited to “the use of deacetylase inhibitors to treat dystrophies and other disorders involving tissue degeneration.”

DATES:

Only written comments and/or applications for a license which are received by the NIH Office of Technology Transfer on or before April 21, 2009 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: Suryanarayana (Sury) Vepa, PhD, J.D., Licensing and Patenting Manager, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-3804; Telephone: [phone]; Facsimile: [phone]; E-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

This technology relates to methods of enhancing progenitor cell differentiation, including enhancing myogenesis, neurogenesis and hematopoiesis, by contacting a progenitor cell with an effective amount of a deacetylase inhibitor (DI). The progenitor cell can be part of cell culture, such as a cell culture used for in vitro or in vivo analysis of progenitor cell differentiation, or can be part of an organism, such as a human or other mammal. Contacting the progenitor cell with a DI can lead to enhancement of expression of terminal cell-type specific genes in the progenitor cell, such as enhancing expression of muscle-specific genes in myoblasts, and can lead to skeletal muscle hypertrophy. Administering a DI to a subject also can provide some prophylactic or therapeutic effect for inhibiting, preventing, or treating conditions associated with a degeneration or loss of tissue. The DI can be administered to a subject as part of a pharmaceutical composition.

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: February 10, 2009.

Richard U. Rodriguez,

Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health.