[Federal Register Volume 79, Number 131 (Wednesday, July 9, 2014)]
[Notices]
[Page 38922]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-16030]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Start-Up Exclusive Evaluation Option License
Agreement: AAV Mediated Aquaporin-1 Gene Transfer To Treat
Sj[ouml]gren's Syndrome
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
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SUMMARY: This is notice, in accordance with 35 U.S.C. 209 and 37 CFR
part 404, that the National Institutes of Health (NIH), Department of
Health and Human Services (HHS), is contemplating the grant of a Start-
Up Exclusive Evaluation Option License Agreement to Milo, LLC, a
company having its headquarters in Cleveland, Ohio, to practice the
inventions embodied in U.S. Provisional Patent Application No. 61/
695,753, filed 20 April 2011 (HHS Ref. No. E-139-2011/1-US-01]), and
PCT Patent Application No. PCT/US13/57632, filed 30 August 2013 (HHS
Ref. No. E-139-2011/1-PCT-02), entitled ``AAV Mediated Aquaporin-1 Gene
Transfer to Treat Sj[ouml]gren's Syndrome.'' The patent rights in these
inventions have been assigned to or exclusively licensed to the
Government of the United States of America. The territory of the
prospective license may be worldwide and the field of use may be
limited to: ``the use of the Licensed Patent Rights, limited to AAV
mediated aquaporin-1, for the treatment of Sj[ouml]gren's syndrome in
humans.''
Upon the expiration or termination of the Start-Up Exclusive
Evaluation Option License Agreement, Milo will have the exclusive right
to execute a Start-up Exclusive Patent License Agreement which will
supersede and replace the Start-up Exclusive Evaluation Option License
Agreement, with no greater field of use and territory than granted in
the Start-Up Exclusive Evaluation Option License Agreement.
DATES: Only written comments and/or applications for a license which
are received by the NIH Office of Technology Transfer on or before July
24, 2014 will be considered.
ADDRESSES: Requests for copies of the patent application, inquiries,
comments and other materials relating to the contemplated Start-Up
Exclusive Evaluation Option License Agreement should be directed to:
Vince Contreras, Ph.D., Licensing and Patenting Manager, Office of
Technology Transfer, National Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville, MD 20852-3804; Telephone: (301) 435-
4711; Facsimile: (301) 402-0220; Email: [email protected]. A
signed confidentiality nondisclosure agreement will be required to
receive copies of any patent applications that have not been published
or issued by the United States Patent and Trademark Office or the World
Intellectual Property Organization.
SUPPLEMENTARY INFORMATION: The subject technology includes methods of
treating Sj[ouml]gren's syndrome by using recombinant adeno associated
virus (rAAV) serotypes as vectors to deliver a gene that expresses
AQP1. Aquaporin-1 is a pore protein that selectively channels water
molecules across the cell membrane. Using animal models that mimic the
dry mouth symptoms (xerostomia) of Sj[ouml]gren's, it was discovered
that there was restoration of fluid movement upon expression of AQP1.
This potentially represents a long-term treatment for restoring
exocrine gland function in Sj[ouml]gren's patients where salivary gland
activity is significantly reduced.
The prospective Start-Up Exclusive Evaluation Option License
Agreement will be royalty bearing and will comply with the terms and
conditions of 35 U.S.C. 209 and 37 CFR part 404. The prospective Start-
Up Exclusive Evaluation Option License Agreement and a subsequent
Start-Up Exclusive Patent License Agreement may be granted unless the
NIH receives, within fifteen (15) days from the date of this published
notice, 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.
Complete applications for a license in the prospective field of use
that are filed in response to this Notice will be treated as objections
to the grant of the contemplated Start-Up Exclusive Evaluation Option
License Agreement. 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: July 7, 2014.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. 2014-16030 Filed 7-8-14; 8:45 am]
BILLING CODE 4140-01-P