[Federal Register Volume 81, Number 75 (Tuesday, April 19, 2016)]
[Notices]
[Page 22995]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-08985]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Development of the CB1/
iNOS Series of Compounds as a Therapeutic To Treat System Sclerosis, 
Scleroderma, and Other Skin Fibrotic Diseases in Humans

AGENCY: National Institutes of Diabetes and Digestive and Kidney 
Diseases, Public Health Service, PHS, National Institutes of Health.

ACTION: Notice.

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SUMMARY: This notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 
part 404.7, that the National Institutes of Health, Department of 
Health and Human Services, is contemplating the grant of an exclusive 
patent license to practice the following inventions embodied in the 
following patent applications, entitled ``CB1 receptor mediating 
compounds'':

1. U.S. Provisional Patent Application No.: 61/991,333, HHS Ref. 
No.: E-140-2014/0-US-01, Filed: May 09, 2014
2. PCT Application No.: PCT/US2015/029946, HHS Ref. No.: E-140-2014/
0-PCT-02, Filed: May 08, 2015
3. U.S. Provisional Patent Application No.: 61/725,949, HHS Ref. 
No.: E-282 -2012/0-US-01, Filed: November 13, 2012
4. PCT Application No.: PCT/US2013/069686, HHS Ref. No.: E-282 -
2012/0-PCT-02, Filed: November 12, 2013
5. U.S. Patent Application No.: 14/442,383, HHS Ref. No.: E-282-
2012/0-US-03, Filed: May 12, 2015
6. Canadian Patent Application No.: 2889697, HHS Ref. No.: E-282-
2012/0-CA-04, Filed: April 27, 2015
7. European Patent Application No.: 13802153.0, HHS Ref. No.: E-282-
2012/0-EP-05, Filed: June 01, 2015
8. Indian Patent Application No.: 3733/DELNP/2015, HHS Ref. No.: E-
282-2012/0-IN-06, Filed: May 01, 2015
9. Japanese Patent Application No.: 2015-542015, HHS Ref. No.: E-
282-2012/0-JP-07, Filed: May 11, 2015
10. Chinese Patent Application No.: 201380069389.9, HHS Ref. No.: E-
282-2012/0-CN-08, Filed: July 3, 2015
11. US Provisional Application No.: 62/171,179, HHS Ref. No.: E-282-
2012/1-US-01, Filed: June 04, 2015

to Vital Spark Inc., (``Vital Spark''), a company incorporated under 
the laws of Delaware and having an office in Jerusalem, Israel. The 
patent rights in these inventions have been assigned to the United 
States of America. This license may be worldwide. The field of use may 
be limited to the use of the Licensed Patent Rights to ``develop the 
CB1/iNOS series of compounds as a therapeutic to treat systemic 
sclerosis, scleroderma, and other skin fibrotic diseases.''

DATES: Only written comments and/or applications for a license which 
are received by the Technology Advancement Office, The National 
Institute of Diabetes and Digestive and Kidney Diseases on or before 
May 4, 2016 will be considered.

ADDRESSES: Requests for copies of the patent application, patents, 
inquiries, comments, and other materials relating to the contemplated 
exclusive license should be directed to: Betty Tong, Ph.D., Sr. 
Licensing and Patenting Manager, Technology Advancement Office, The 
National Institute of Diabetes and Digestive and Kidney Diseases, 12A 
South Drive, Bethesda, MD 20892, Email: [email protected]. A signed 
confidentiality non-disclosure agreement will be required to receive 
copies of any patent applications that have not been published by the 
United States Patent and Trademark Office or the World Intellectual 
Property Organization.

SUPPLEMENTARY INFORMATION: This technology, and its corresponding 
patent applications, is directed to methods of treating fibrosis, 
obesity and associated diseases such as type 2 diabetes by 
administering an agent that reduces appetite, body weight, hepatic 
steatosis, and insulin resistance. This technology may be useful as a 
means for treating various fibrotic diseases and metabolic syndromes 
without serious adverse neuropsychiatric side effects.
    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 fifteen 
(15) days from the date of this published notice, the Technology 
Advancement Office 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.
    Properly filed competing applications for a license 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: April 13, 2016.
Anna Amar,
Acting Deputy Director, Technology Advancement Office, National 
Institute of Diabetes and Digestive and Kidney Diseases, National 
Institutes of Health.
[FR Doc. 2016-08985 Filed 4-18-16; 8:45 am]
 BILLING CODE 4140-01-P