[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