80 FR 79594 - Prospective Grant of an Exclusive Start-Up Option License: Potent and Selective Analogues of Monamine Transporters; Methods of Making; and Uses Thereof
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 80, Issue 245 (December 22, 2015)
National Institutes of Health
Federal Register Volume 80, Issue 245 (December 22, 2015)
| Page Range | 79594-79595 | |
| FR Document | 2015-32141 |
[Federal Register Volume 80, Number 245 (Tuesday, December 22, 2015)] [Notices] [Pages 79594-79595] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-32141] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of an Exclusive Start-Up Option License: Potent and Selective Analogues of Monamine Transporters; Methods of Making; and Uses Thereof AGENCY: National Institutes of Health, Public Health Service, HHS. [[Page 79595]] ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: This is a notice, in accordance with 35 U.S.C. 209 and 37 CFR 404, that the National Institute of Drug Abuse, National Institutes of Health, Department of Health and Human Services is contemplating the grant of an exclusive start-up option license to practice the inventions embodied in the following Patent Applications and all related continuing and foreign patents/patent applications for the technology family to EncepHeal Therapeutics, Inc., located in Winston- Salem, North Carolina. DATES: Only written comments and/or applications for a license which are received by the NCI Technology Transfer Center on or before January 6, 2016 will be considered. ADDRESSES: Requests for copies of the patent application, inquiries, comments, and other materials relating to the contemplated exclusive license should be directed to Martha Lubet, Ph.D., Technology Transfer Specialist, NCI TTC, 9609 Medical Center Drive, Room IE350, and Rockville, MD 20850. Telephone: (240) 276-5508. Facsimile: (240) 276- 5505. Email: [email protected]. SUPPLEMENTARY INFORMATION: This invention concerns analogues of modafinil and methods of using the analogues for the treatment of substance use disorders and sleep disorders. The prospective exclusive start-up option license 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 exclusive start-up option may be granted unless within fifteen (15) days from the date of this published notice, the NCI 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 part 404. Complete applications for a license in the field of use filed in response to this notice will be treated as objections to the grant of the contemplated exclusive start-up option license. 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. Intellectual Property: U.S. provisional application 61/774,878, filed March 8, 2013 entitled ``Potent and Selective Inhibitors of Monamine Transporters; Methods of Making; and Uses Thereof'' [HHS Ref. No. E-073-2013/0-US- 01]; PCT application PCT/US2014/021514, filed March 7, 2014 entitled ``Potent and Selective Analogues of: Monamine Transporters; Methods of Making; and Uses Thereof'' [HHS Ref. No. E-073-2013/0-PCT-02]; U.S. application 14/772,486, filed September 3, 2015 entitled ``Potent and Selective Analogues of Monamine Transporters; Methods of Making; and Uses Thereof'' [HHS Ref. No. E-073-2013/0-US-06]; EPO application 14714043.8, filed September 1, 2015 entitled ``Potent and Selective Analogues of Monamine Transporters; Methods of Making; and Uses Thereof'' [HHS Ref. No. E-073-2013/0-EP-05]; Australian application 2014225550, filed September 8, 2015 entitled ``Potent and Selective Analogues of Monamine Transporters; Methods of Making; and Uses Thereof'' [HHS Ref. No. E-073-2013/0-AU-03]; Canadian application 2903746, filed September 2, 2015 entitled ``Potent and Selective Analogues of Monamine Transporters; Methods of Making; and Uses Thereof'' [HHS Ref. No. E-073-2013/0-CA-04]; The patent rights to these inventions have been assigned to and/or exclusively licensed to the Government of the United States of America. The prospective exclusive start-up option licensed territory may be worldwide and the field of use may be limited to: (a) Treatment of substance use disorders and/or (b) treatment of sleep disorders. Upon the expiration or termination of the exclusive start-up option license, EncepHeal Therapeutics, Inc. will have the exclusive right to execute a start-up exclusive commercialization license which will supersede and replace the exclusive start-up option license with no greater field of use and territory than granted in the exclusive start- up option license. Dated: December 17, 2015. Richard U. Rodriguez, Associate Director, Technology Transfer Center, National Cancer Institute. [FR Doc. 2015-32141 Filed 12-21-15; 8:45 am] BILLING CODE 4140-01-P
![79594 Federal Register / Vol. 80, No. 245 / Tuesday, December 22, 2015 / Notices
decision-making processes are Burden Statement: Burden in this personnel and to be able to respond to
consistent with NEPA. context means the time expended by a collection of information; to search
Need and Proposed Use of the persons to generate, maintain, retain, data sources; to complete and review
Information: Applicants must provide disclose, or provide the information the collection of information; and to
requested. This includes the time transmit or otherwise disclose the
information and assurance of
needed to review instructions; to information. The total annual burden
compliance with NEPA on the EID
develop, acquire, install, and utilize hours estimated for this Information
checklist. This information is reviewed technology and systems for the purpose
in the Pre-Award stage. Collection Request are summarized in
of collecting, validating and verifying the table below.
Likely Respondents: HRSA applicants information, processing and
applying for federal construction grants maintaining information, and disclosing Total Estimated Annualized burden
and cooperative agreements. and providing information; to train hours:
Average
Number of
Number of Total burden per Total burden
Form name responses per
respondents responses response hours
respondent (in hours)
NEPA EID Checklist ............................................................ 1,350 1 1,350 1.0 1,350
Total .............................................................................. 1,350 1 1,350 1.0 1,350
HRSA specifically requests comments National Heart, Lung, and Blood, Office • Enhanced photothermal effect/cancer
on (1) the necessity and utility of the of Technology Transfer and therapy efficacy.
proposed information collection for the Development Office of Technology Development Stage:
proper performance of the agency’s Transfer, 31 Center Drive Room 4A29, • In vitro data
functions, (2) the accuracy of the MSC2479, Bethesda, MD 20892–2479; Inventors: Xiaoyuan (Shawn) Chen
estimated burden, (3) ways to enhance telephone: 301–402–5579. A signed and Jibin Song (both of NIBIB).
the quality, utility, and clarity of the Confidential Disclosure Agreement may Intellectual Property: HHS Reference
information to be collected, and (4) the be required to receive copies of the No. E–158–2015/0–US–01.
use of automated collection techniques patent applications. • U.S. Provisional Patent Application
or other forms of information SUPPLEMENTARY INFORMATION: 62/226,289 filed December 11, 2015.
technology to minimize the information Technology description follows. Licensing Contact: Michael
collection burden. Shmilovich, Esq, CLP; 301–435–5019;
Metallic Nanoparticles for
Jackie Painter, shmilovm@mail.nih.gov.
Photothermal Therapy
Director, Division of the Executive Secretariat.
Collaborative Research Opportunity:
Description of Technology: The The National Institute of Biomedical
[FR Doc. 2015–32004 Filed 12–21–15; 8:45 am] invention relates to the preparation and Imaging and Bioengineering seeks
BILLING CODE 4165–15–P application of 20–150nm metallic statements of capability or interest from
nanoparticulate vesicles for parties interested in collaborative
photothermal anti-cancer therapy. The research to further develop and evaluate
DEPARTMENT OF HEALTH AND vesicles comprise metallic nanoparticles
HUMAN SERVICES metallic nanoparticle vesicles for cancer
covalently bound to a hydrophilic and phototherapy. For collaboration
National Institutes of Health hydrophobic polymer. The preparation opportunities, please contact Cecilia
method generally entails dispersing a Pazman, Ph.D. at
Government-Owned Inventions; polymer-bound metallic nanoparticle in pazmance@nhlbi.nih.gov.
Availability for Licensing an organic solvent, adding an aqueous Dated: December 15, 2015.
solution with a dispersing aid,
AGENCY: National Institutes of Health, Michael Shmilovich,
sonicating the mixture, and finally
HHS. removing the organic solvent until the Senior Licensing and Patenting Manager,
ACTION: Notice National Heart, Lung, and Blood Institute,
vesicle forms. The final vesicle is stable Office of Technology Transfer and
SUMMARY: The inventions listed below wherein the metallic nanoparticle is Development.
are owned by an agency of the U.S. covalently bound to the hydrophobic [FR Doc. 2015–32096 Filed 12–21–15; 8:45 am]
Government and are available for and hydrophilic polymer. By way of a
BILLING CODE 4140–01–P
licensing in the U.S. in accordance with non-limiting example, an exemplary
35 U.S.C. 209 and 37 CFR part 404 to vesicles can be one made from gold
achieve expeditious commercialization nanorods coated with polyethylene DEPARTMENT OF HEALTH AND
of results of federally-funded research glycol and polylactic-co-glycolic acid HUMAN SERVICES
and development. Foreign patent (AuNR@PEG/PLGA) in an oil-in-water
applications are filed on selected emulsion. National Institutes of Health
inventions to extend market coverage
mstockstill on DSK4VPTVN1PROD with NOTICES
Potential Commercial Applications:
Prospective Grant of an Exclusive
for companies and may also be available • Cancer therapy Start-Up Option License: Potent and
for licensing. • Tumor therapy
Selective Analogues of Monamine
FOR FURTHER INFORMATION CONTACT: Competitive Advantages: Transporters; Methods of Making; and
Licensing information and copies of the • Prolonged circulation Uses Thereof
U.S. patent applications listed below • High tumor accumulation
may be obtained by emailing the • Rapid excretion AGENCY: National Institutes of Health,
indicated licensing contact at the • Enhanced photoacoustic signal Public Health Service, HHS.
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![Federal Register / Vol. 80, No. 245 / Tuesday, December 22, 2015 / Notices 79595
ACTION: Notice. PCT application PCT/US2014/021514, amended (5 U.S.C. App.), notice is
filed March 7, 2014 entitled ‘‘Potent and hereby given of the following meetings.
SUMMARY: This is a notice, in accordance Selective Analogues of: Monamine The meetings will be closed to the
with 35 U.S.C. 209 and 37 CFR 404, that Transporters; Methods of Making; and public in accordance with the
the National Institute of Drug Abuse, Uses Thereof’’ [HHS Ref. No. E–073– provisions set forth in sections
National Institutes of Health, 2013/0–PCT–02]; 552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
Department of Health and Human U.S. application 14/772,486, filed as amended. The grant applications and
Services is contemplating the grant of an September 3, 2015 entitled ‘‘Potent and the discussions could disclose
exclusive start-up option license to Selective Analogues of Monamine confidential trade secrets or commercial
practice the inventions embodied in the Transporters; Methods of Making; and property such as patentable material,
following Patent Applications and all Uses Thereof’’ [HHS Ref. No. E–073– and personal information concerning
related continuing and foreign patents/ 2013/0–US–06]; individuals associated with the grant
patent applications for the technology applications, the disclosure of which
EPO application 14714043.8, filed
family to EncepHeal Therapeutics, Inc., would constitute a clearly unwarranted
September 1, 2015 entitled ‘‘Potent and
located in Winston-Salem, North invasion of personal privacy.
Selective Analogues of Monamine
Carolina.
Transporters; Methods of Making; and Name of Committee: National Institute on
DATES: Only written comments and/or Uses Thereof’’ [HHS Ref. No. E–073– Aging Initial Review Group; Clinical Aging
applications for a license which are 2013/0–EP–05]; Review Committee.
received by the NCI Technology Australian application 2014225550, Date: February 4–5, 2016.
Transfer Center on or before January 6, Time: 2:00 p.m. to 3:00 p.m.
filed September 8, 2015 entitled ‘‘Potent Agenda: To review and evaluate grant
2016 will be considered. and Selective Analogues of Monamine applications.
ADDRESSES: Requests for copies of the Transporters; Methods of Making; and Place: Bethesda North Marriott and
patent application, inquiries, comments, Uses Thereof’’ [HHS Ref. No. E–073– Conference Center, 5701 Marinelli Road,
and other materials relating to the 2013/0–AU–03]; Bethesda, MD 20852.
contemplated exclusive license should Canadian application 2903746, filed Contact Person: Alicja L. Markowska,
be directed to Martha Lubet, Ph.D., Ph.D., DSC, National Institute on Aging,
September 2, 2015 entitled ‘‘Potent and
Technology Transfer Specialist, NCI National Institutes of Health, Gateway
Selective Analogues of Monamine Building 2C212, 7201 Wisconsin Avenue,
TTC, 9609 Medical Center Drive, Room Transporters; Methods of Making; and Bethesda, MD 20892, 301–496–9666
IE350, and Rockville, MD 20850. Uses Thereof’’ [HHS Ref. No. E–073– markowsa@nia.nih.gov.
Telephone: (240) 276–5508. Facsimile: 2013/0–CA–04]; Name of Committee: National Institute on
(240) 276–5505. Email: lubetm@ The patent rights to these inventions Aging Initial Review Group; Biological Aging
mail.nih.gov. have been assigned to and/or Review Committee.
SUPPLEMENTARY INFORMATION: This exclusively licensed to the Government Date: February 4–5, 2016.
of the United States of America. Time: 2:00 p.m. to 3:00 p.m.
invention concerns analogues of Agenda: To review and evaluate grant
modafinil and methods of using the The prospective exclusive start-up applications.
analogues for the treatment of substance option licensed territory may be Place: Bethesda North Marriott and
use disorders and sleep disorders. worldwide and the field of use may be Conference Center, 5701 Marinelli Road,
The prospective exclusive start-up limited to: (a) Treatment of substance Bethesda, MD 20852.
option license will be royalty bearing use disorders and/or (b) treatment of Contact Person: Bita Nakhai, Ph.D.,
and will comply with the terms and sleep disorders. Scientific Review Branch, National Institute
conditions of 35 U.S.C. 209 and 37 CFR on Aging, Gateway Bldg., 2C212, 7201
Upon the expiration or termination of
Wisconsin Avenue, Bethesda, MD 20814,
part 404. The prospective exclusive the exclusive start-up option license, 301–402–7701, nakhaib@nia.nih.gov.
start-up option may be granted unless EncepHeal Therapeutics, Inc. will have (Catalogue of Federal Domestic Assistance
within fifteen (15) days from the date of the exclusive right to execute a start-up Program Nos. 93.866, Aging Research,
this published notice, the NCI receives exclusive commercialization license National Institutes of Health, HHS)
written evidence and argument that which will supersede and replace the
establishes that the grant of the license Dated: December 16, 2015.
exclusive start-up option license with
would not be consistent with the no greater field of use and territory than Melanie J. Gray,
requirements of 35 U.S.C. 209 and 37 granted in the exclusive start-up option Program Analyst, Office of Federal Advisory
CFR part 404. Committee Policy.
license.
Complete applications for a license in [FR Doc. 2015–32036 Filed 12–21–15; 8:45 am]
Dated: December 17, 2015.
the field of use filed in response to this BILLING CODE 4140–01–P
Richard U. Rodriguez,
notice will be treated as objections to
the grant of the contemplated exclusive Associate Director, Technology Transfer
Center, National Cancer Institute. DEPARTMENT OF HEALTH AND
start-up option license. Comments and
objections submitted to this notice will [FR Doc. 2015–32141 Filed 12–21–15; 8:45 am] HUMAN SERVICES
not be made available for public BILLING CODE 4140–01–P
inspection and, to the extent permitted National Institutes of Health
by law, will not be released under the Eunice Kennedy Shriver National
Freedom of Information Act, 5 U.S.C. DEPARTMENT OF HEALTH AND
HUMAN SERVICES Institute of Child Health & Human
mstockstill on DSK4VPTVN1PROD with NOTICES
552. Development; Notice of Meeting
Intellectual Property:
National Institutes of Health
U.S. provisional application 61/ Pursuant to section 10(d) of the
774,878, filed March 8, 2013 entitled National Institute on Aging; Notice of Federal Advisory Committee Act, as
‘‘Potent and Selective Inhibitors of Closed Meetings amended (5 U.S.C. App.), notice is
Monamine Transporters; Methods of hereby given of a meeting of the
Making; and Uses Thereof’’ [HHS Ref. Pursuant to section 10(d) of the National Advisory Child Health and
No. E–073–2013/0–US–01]; Federal Advisory Committee Act, as Human Development Council.
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Document Created: 2015-12-22 02:31:17
Document Modified: 2015-12-22 02:31:17
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Only written comments and/or applications for a license which are received by the NCI Technology Transfer Center on or before January 6, 2016 will be considered. | |
| FR Citation | 80 FR 79594 |
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