Prospective Grant of Start-Up Exclusive Evaluation Option License Agreement: AAV Mediated Aquaporin-1 Gene Transfer To Treat Sjögren's Syndrome, 38922 [2014-16030]

Download as PDF 38922 Federal Register / Vol. 79, No. 131 / Wednesday, July 9, 2014 / Notices ESTIMATES OF ANNUALIZED BURDEN HOURS—Continued Number of respondents Type of respondents Applicant Survey .............................................................................................. Dated: July 2, 2014. Lawrence A. Tabak, Deputy Director, National Institutes of Health. [FR Doc. 2014–16072 Filed 7–8–14; 8:45 am] BILLING CODE 4140–01–P 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 ¨ Sjogren’s Syndrome AGENCY: National Institutes of Health, HHS. ACTION: Notice. 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 Sjogren’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 Sjogren’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 sroberts on DSK5SPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 20:08 Jul 08, 2014 Jkt 232001 240 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: vince.contreras@nih.gov. 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. The subject technology includes methods of ¨ treating Sjogren’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 Sjogren’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 Sjogren’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 SUPPLEMENTARY INFORMATION: PO 00000 Frm 00073 Fmt 4703 Sfmt 4703 Number of responses per respondent Average burden per response (in hours) 1 Total annual burden hours 20/60 80 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing AGENCY: National Institutes of Health, HHS. ACTION: Notice. The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 209 and 37 CFR Part 404 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing. FOR FURTHER INFORMATION CONTACT: Licensing information and copies of the U.S. patent applications listed below may be obtained by writing to the indicated licensing contact at the Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852–3804; telephone: 301– 496–7057; fax: 301–402–0220. A signed Confidential Disclosure Agreement will SUMMARY: E:\FR\FM\09JYN1.SGM 09JYN1

Agencies

[Federal Register Volume 79, Number 131 (Wednesday, July 9, 2014)]
[Notices]
[Page 38922]
From the Federal Register Online via the Government Printing 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.

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

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: vince.contreras@nih.gov. 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

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