[Federal Register Volume 81, Number 158 (Tuesday, August 16, 2016)]
[Notices]
[Pages 54581-54582]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-19418]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Start-Up Exclusive Evaluation Option License 
Agreement: Small Molecule Therapeutic Compounds Encompassed Within the 
Licensed Patent Rights for the Treatment of Thioesterase Deficiency 
Disorder

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: This notice, in accordance with 35 U.S.C. 209 and 37 CFR part 
404, that the National Institutes of Health, Department of Health and 
Human Services, is contemplating the grant of a Start-Up Exclusive 
Evaluation Option License Agreement to practice the inventions embodied 
in the following Patent Applications to Circumvent Pharmaceuticals Inc. 
(``Circumvent'') located in Pasadena, California, USA:

Intellectual Property

    United States Provisional Patent Application No. 61/473,692, filed 
April 8, 2011, titled ``Small molecule therapeutic compounds targeting 
thioesterase deficiency disorders and methods of using the same'' [HHS 
Reference No. E-157-2011/0-US-01], status: Expired;
    International Patent Application No. PCT/US2012/32772 filed April 
9, 2012 titled ``Small molecule therapeutic compounds targeting 
thioesterase deficiency disorders and methods of using the same'' [HHS 
Reference No. E-157-2011/0-PCT-02], status: Converted;
    European Patent Application No. 12716889.6, filed November 7, 2013, 
titled ``Small molecule therapeutic compounds targeting thioesterase 
deficiency disorders and methods of using the same'' [HHS Reference No. 
E-157-2011/0-EP-03], status: Pending; and
    United States Patent Application No. 14/110,393, filed October 7, 
2013, titled ``Small molecule therapeutic compounds targeting 
thioesterase deficiency disorders and methods of using the same'' [HHS 
Reference No. E-157-2011/0-US-04], status: Pending.
    The patent rights in these inventions have been assigned and/or 
exclusively licensed to the government of the United States of America.
    The territory of the prospective Start-Up Exclusive Evaluation 
Option License Agreement may be worldwide and the field of use may be 
limited to: ``Small molecule therapeutic compounds encompassed within 
the Licensed Patent Rights for the treatment of thioesterase deficiency 
disorders''
    Upon the expiration or termination of the Start-up Exclusive 
Evaluation Option License Agreement, Circumvent 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

[[Page 54582]]

Technology Transfer on or before August 31, 2016 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: 
Surekha Vathyam, Ph.D., Senior Licensing and Patenting Manager, 
National Cancer Institute Technology Transfer Center, 9609 Medical 
Center Drive, Rm 1E-530 MSC9702, Rockville, MD 20850-9702, Email: 
[email protected].

SUPPLEMENTARY INFORMATION: The subject technology describes methods of 
using derivative compositions of hydroxylamine, including N-t-butyl 
hydroxylamine (NtBuHA), for the treatment of thioesterase deficiencies. 
NtBuHA is small molecule derivative of hydroxylamine which possesses 
strong anti-oxidant properties and an ability to cleave thioester 
linkages with high specificity. These capabilities suggest that NtBuHA 
may be useful as a modulator of intracellular protein palmitoylation 
dynamics when endogenous mechanisms are insufficient to support normal 
function.
    The compounds disclosed in this invention have potential 
therapeutic applications for both the management of diseases driven by 
excess accumulation or malfunction of palmitoylated proteins. Target 
disorders may therefore include neuronal ceroid lipofuscinoses (also 
known as Batten Disease), amyotrophic lateral sclerosis, and Ras-driven 
cancers.
    The prospective Start-Up Exclusive Evaluation Option License 
Agreement is being considered under the small business initiative 
launched on October 1, 2011 and will comply with the terms and 
conditions of 35 U.S.C. 209 and 37 CFR part 404.7. The prospective 
Start-Up Exclusive Evaluation Option License Agreement may be granted 
unless the NIH receives written evidence and argument that establishes 
that the grant of the contemplated Start-Up Exclusive Evaluation Option 
License Agreement would not be consistent with the requirements of 35 
U.S.C. 209 and 37 CFR part 404.7 within fifteen (15) days from the date 
of this published notice.
    Complete applications for a license in an appropriate 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 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: August 8, 2016.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2016-19418 Filed 8-15-16; 8:45 am]
BILLING CODE 4140-01-P