81_FR_54739 81 FR 54581 - 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

81 FR 54581 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 81, Issue 158 (August 16, 2016)

Page Range54581-54582
FR Document2016-19418

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:

Federal Register, Volume 81 Issue 158 (Tuesday, August 16, 2016) 
[Federal Register Volume 81, Number 158 (Tuesday, August 16, 2016)]
[Notices]
[Pages 54581-54582]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-19418]


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

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.

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

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

Federal Register / Vol. 81, No. 158 / Tuesday, August 16, 2016 / Notices 54581 clearing/approving forms, processing The total estimated annualized other than their time. CDC will seek a forms, and acknowledging data entered. burden hours for all respondents are three-year approval from OMB. 1,280. There are no costs to respondents ESTIMATED ANNUALIZED BURDEN HOURS Average Number of Number of burden per Total burden Type of respondents Form name responses per respondents response (in hours) CIO (in hours) Initiator/C/I/O ..................................... CDC 0.4601 ..................................... 64 5 1 320 Initiator/C/I/O ..................................... CDC 0.410A ..................................... 64 5 1 320 Initiator/C/I/O ..................................... CDC 0.410B ..................................... 64 5 1 320 Initiator/C/I/O ..................................... Section C of the CDC 0.1475 .......... 64 5 1 320 Totals ......................................... ........................................................... ........................ ........................ ........................ 1,280 Leroy A. Richardson, Bethesda, MD 20892–9823, (240) 669–5069, Reference No. E–157–2011/0–US–01], Chief, Information Collection Review Office, lrust@niaid.nih.gov. status: Expired; Office of Scientific Integrity, Office of the (Catalogue of Federal Domestic Assistance International Patent Application No. Associate Director for Science, Office of the Program Nos. 93.855, Allergy, Immunology, PCT/US2012/32772 filed April 9, 2012 Director, Centers for Disease Control and and Transplantation Research; 93.856, titled ‘‘Small molecule therapeutic Prevention. Microbiology and Infectious Diseases Research, National Institutes of Health, HHS) compounds targeting thioesterase [FR Doc. 2016–19461 Filed 8–15–16; 8:45 am] deficiency disorders and methods of BILLING CODE 4163–18–P Dated: August 10, 2016. using the same’’ [HHS Reference No. E– Natasha M. Copeland, 157–2011/0–PCT–02], status: Converted; Program Analyst, Office of Federal Advisory European Patent Application No. DEPARTMENT OF HEALTH AND Committee Policy. 12716889.6, filed November 7, 2013, HUMAN SERVICES [FR Doc. 2016–19417 Filed 8–15–16; 8:45 am] titled ‘‘Small molecule therapeutic National Institutes of Health BILLING CODE 4140–01–P compounds targeting thioesterase deficiency disorders and methods of National Institute of Allergy and using the same’’ [HHS Reference No. E– Infectious Diseases; Notice of Closed DEPARTMENT OF HEALTH AND 157–2011/0–EP–03], status: Pending; Meeting HUMAN SERVICES and United States Patent Application No. Pursuant to section 10(d) of the National Institutes of Health 14/110,393, filed October 7, 2013, titled Federal Advisory Committee Act, as ‘‘Small molecule therapeutic amended (5 U.S.C. App.), notice is Prospective Grant of Start-Up Exclusive Evaluation Option License compounds targeting thioesterase hereby given of the following meeting. deficiency disorders and methods of The meeting will be closed to the Agreement: Small Molecule Therapeutic Compounds using the same’’ [HHS Reference No. E– public in accordance with the 157–2011/0–US–04], status: Pending. provisions set forth in sections Encompassed Within the Licensed Patent Rights for the Treatment of The patent rights in these inventions 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., have been assigned and/or exclusively as amended. The grant applications and Thioesterase Deficiency Disorder licensed to the government of the the discussions could disclose AGENCY: National Institutes of Health, United States of America. confidential trade secrets or commercial HHS. The territory of the prospective Start- property such as patentable material, Up Exclusive Evaluation Option License and personal information concerning ACTION: Notice. Agreement may be worldwide and the individuals associated with the grant field of use may be limited to: ‘‘Small applications, the disclosure of which SUMMARY: This notice, in accordance with 35 U.S.C. 209 and 37 CFR part 404, molecule therapeutic compounds would constitute a clearly unwarranted encompassed within the Licensed invasion of personal privacy. that the National Institutes of Health, Department of Health and Human Patent Rights for the treatment of Name of Committee: National Institute of Services, is contemplating the grant of a thioesterase deficiency disorders’’ Allergy and Infectious Diseases Special Upon the expiration or termination of Start-Up Exclusive Evaluation Option Emphasis Panel; NIAID Clinical Trial the Start-up Exclusive Evaluation Implementation Cooperative Agreement License Agreement to practice the inventions embodied in the following Option License Agreement, Circumvent (U01). Date: September 22, 2016. Patent Applications to Circumvent will have the exclusive right to execute Time: 10:00 a.m. to 12:00 p.m. Pharmaceuticals Inc. (‘‘Circumvent’’) a Start-Up Exclusive Patent License Agenda: To review and evaluate grant located in Pasadena, California, USA: Agreement which will supersede and asabaliauskas on DSK3SPTVN1PROD with NOTICES applications. replace the Start-up Exclusive Place: National Institutes of Health, Room Intellectual Property Evaluation Option License Agreement, 3F100, 5601 Fishers Lane, Rockville, MD United States Provisional Patent with no greater field of use and territory 20892 (Telephone Conference Call). than granted in the Start-up Exclusive Contact Person: Lynn Rust, Ph.D., Application No. 61/473,692, filed April 8, 2011, titled ‘‘Small molecule Evaluation Option License Agreement. Scientific Review Officer, Scientific Review Program, Division of Extramural Activities, therapeutic compounds targeting DATES: Only written comments and/or Room 3G42A, National Institutes of Health/ thioesterase deficiency disorders and applications for a license which are NIAID, 5601 Fishers Lane, MSC 9823, methods of using the same’’ [HHS received by the NIH Office of VerDate Sep<11>2014 18:36 Aug 15, 2016 Jkt 238001 PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 E:\FR\FM\16AUN1.SGM 16AUN1

54582 Federal Register / Vol. 81, No. 158 / Tuesday, August 16, 2016 / Notices Technology Transfer on or before under the Freedom of Information Act, Name of Committee: National Cancer August 31, 2016 will be considered. 5 U.S.C. 552. Institute Special Emphasis Panel; NCI Barrett’s Esophagus Translational Research ADDRESSES: Requests for copies of the Dated: August 8, 2016. Network Review. patent application, inquiries, comments, Richard U. Rodriguez, Date: October 20, 2016. and other materials relating to the Associate Director, Technology Transfer Time: 8:00 a.m. to 5:00 p.m. contemplated Start-Up Exclusive Center, National Cancer Institute. Agenda: To review and evaluate grant Evaluation Option License Agreement [FR Doc. 2016–19418 Filed 8–15–16; 8:45 am] applications. should be directed to: Surekha Place: Bethesda Marriott Pooks Hill, 5151 BILLING CODE 4140–01–P Pooks Hill Road, Bethesda, MD 20814. Vathyam, Ph.D., Senior Licensing and Contact Person: Wlodek Lopaczynski, MD, Patenting Manager, National Cancer Ph.D., Scientific Review Officer, Research Institute Technology Transfer Center, DEPARTMENT OF HEALTH AND Programs Review Branch, Division of 9609 Medical Center Drive, Rm 1E–530 HUMAN SERVICES Extramural Activities, National Cancer MSC9702, Rockville, MD 20850–9702, Institute, 9609 Medical Center Drive, Room Email: vathyams@mail.nih.gov. National Institutes of Health 7W608, Rockville, MD 20892–9750, 240– 276–6458, lopacw@mail.nih.gov. SUPPLEMENTARY INFORMATION: The National Cancer Institute; Notice of Name of Committee: National Cancer subject technology describes methods of Closed Meetings Institute Special Emphasis Panel; PAR 15– using derivative compositions of 266 Imaging. hydroxylamine, including N-t-butyl Pursuant to section 10(d) of the Date: October 24, 2016. hydroxylamine (NtBuHA), for the Federal Advisory Committee Act, as Time: 11:00 a.m. to 3:00 p.m. treatment of thioesterase deficiencies. amended (5 U.S.C. App.), notice is Agenda: To review and evaluate grant NtBuHA is small molecule derivative of hereby given of the following meetings. applications. hydroxylamine which possesses strong Place: National Cancer Institute Shady The meetings will be closed to the Grove, 9609 Medical Center Drive, Room anti-oxidant properties and an ability to public in accordance with the 6W030, Rockville, MD 20850, (Telephone cleave thioester linkages with high provisions set forth in sections Conference Call). specificity. These capabilities suggest 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Contact Person: Kenneth L. Bielat, Ph.D., that NtBuHA may be useful as a Scientific Review Officer, Research as amended. The grant applications and modulator of intracellular protein Technology and Contract Review Branch, the discussions could disclose palmitoylation dynamics when Division of Extramural Activities, National confidential trade secrets or commercial endogenous mechanisms are Cancer Institute, 9609 Medical Center Drive, property such as patentable material, insufficient to support normal function. Room 7W244, Rockville, MD 20892–9750, and personal information concerning 240–276–6373, bielatk@mail.nih.gov. The compounds disclosed in this individuals associated with the grant invention have potential therapeutic Name of Committee: National Cancer applications, the disclosure of which Institute Special Emphasis Panel; NCI applications for both the management of would constitute a clearly unwarranted diseases driven by excess accumulation Omnibus R03 SEP–3. invasion of personal privacy. Date: November 3, 2016. or malfunction of palmitoylated Time: 8:00 a.m. to 3:30 p.m. proteins. Target disorders may therefore Name of Committee: National Cancer Institute Special Emphasis Panel; Integrating Agenda: To review and evaluate grant include neuronal ceroid lipofuscinoses Biospecimen Science Approaches into applications. (also known as Batten Disease), Clinical Assay Development. Place: Bethesda North Marriott Hotel & amyotrophic lateral sclerosis, and Ras- Date: September 8, 2016. Conference Center, 5701 Marinelli Road, driven cancers. Time: 11:00 a.m. to 2:00 p.m. North Bethesda, MD 20852. The prospective Start-Up Exclusive Agenda: To review and evaluate grant Contact Person: Byeong-Chel C. Lee, Ph.D., applications. Scientific Review Officer, Review Training Evaluation Option License Agreement is Place: National Cancer Institute Shady and Resources Branch, Division of being considered under the small Extramural Activities, National Cancer Grove, 9609 Medical Center Drive, Room business initiative launched on October Institute, 9609 Medical Center Drive, Room 7W030, Rockville, MD 20850, (Telephone 1, 2011 and will comply with the terms Conference Call). 7W238, Rockville, MD 20892–9750, 240– and conditions of 35 U.S.C. 209 and 37 Contact Person: Clifford W. Schweinfest, 276–6260, byeong-chel.lee@nih.gov. CFR part 404.7. The prospective Start- Ph.D., Scientific Review Officer, Special Name of Committee: National Cancer Up Exclusive Evaluation Option License Review Branch, Division of Extramural Institute Special Emphasis Panel; Pancreatic Agreement may be granted unless the Activities, National Cancer Institute, 9609 Cancer Detection Consortium (U01). NIH receives written evidence and Medical Center Drive, Room 7W108, Date: November 9, 2016. argument that establishes that the grant Rockville, MD 20892–9750, 240–276–6343, Time: 9:00 a.m. to 5:00 p.m. of the contemplated Start-Up Exclusive schweinfestcw@mail.nih.gov. Agenda: To review and evaluate grant Name of Committee: National Cancer applications. Evaluation Option License Agreement Institute Special Emphasis Panel; NCI Place: National Cancer Institute Shady would not be consistent with the Grove, 9609 Medical Center Drive, Room Program Project I SEP–1. requirements of 35 U.S.C. 209 and 37 7W032, Rockville, MD 20850, (Telephone Date: September 29–30, 2016. CFR part 404.7 within fifteen (15) days Time: 8:00 a.m. to 6:00 p.m. Conference Call). from the date of this published notice. Agenda: To review and evaluate grant Contact Person: Majed M. Hamawy, Ph.D., Complete applications for a license in applications. Scientific Review Officer, Research Programs an appropriate field of use that are filed Place: Gaithersburg Marriott Review Branch, Division of Extramural asabaliauskas on DSK3SPTVN1PROD with NOTICES Washingtonian Center, 9751 Washingtonian Activities, National Cancer Institute, 9609 in response to this notice will be treated Blvd., Gaithersburg, MD 20878. Medical Center Drive, Room 7W120, as objections to the grant of the Rockville, MD 20892–9750, 240–276–6457, contemplated Start-Up Exclusive Contact Person: Shakeel Ahmad, Ph.D., Scientific Review Officer, Research Programs mh101v@nih.gov. Evaluation Option License Agreement. Review Branch, Division of Extramural Name of Committee: National Cancer Comments and objections submitted to Activities, National Cancer Institute, 9609 Institute Special Emphasis Panel; this notice will not be made available Medical Center Drive, Room 7W122, Biospecimen Science. for public inspection and, to the extent Rockville, MD 20892–9750, 240–276–6349, Date: December 9, 2016. permitted by law, will not be released ahmads@mail.nih.gov. Time: 10:00 a.m. to 3:00 p.m. VerDate Sep<11>2014 18:36 Aug 15, 2016 Jkt 238001 PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 E:\FR\FM\16AUN1.SGM 16AUN1


Document Created: 2016-08-16 03:20:40
Document Modified: 2016-08-16 03:20:40
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesOnly written comments and/or applications for a license which are received by the NIH Office of Technology Transfer on or before August 31, 2016 will be considered.
FR Citation81 FR 54581 
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR