80 FR 79052 - Prospective Grant of Exclusive License: Development of a Small Molecule Farnesoid X Receptor Inhibitor

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 80, Issue 243 (December 18, 2015)

Page Range		79052-79052
FR Document		2015-31831

This notice, in accordance with 35 U.S.C. 209 and 37 CFR part 404, that the National Cancer Institute (NCI), National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the inventions embodied in the following U.S. Patents and Patent Applications to Heliome Biotech, Inc. (``Heliome'') located in New York, NY, USA. Intellectual Property:

Federal Register, Volume 80 Issue 243 (Friday, December 18, 2015)

[Federal Register Volume 80, Number 243 (Friday, December 18, 2015)]
[Notices]
[Page 79052]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-31831]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Development of a Small 
Molecule Farnesoid X Receptor Inhibitor

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 Cancer Institute (NCI), National Institutes of 
Health, Department of Health and Human Services, is contemplating the 
grant of an exclusive patent license to practice the inventions 
embodied in the following U.S. Patents and Patent Applications to 
Heliome Biotech, Inc. (``Heliome'') located in New York, NY, USA.
    Intellectual Property:

1. United States Provisional Patent Application No. 61/861,109, filed 
August 1, 2013 ``Inhibitors of the Farnesoid X Receptor and Use Thereof 
in the Prevention of Weight Gain'' [HHS Reference No. E-508-2013/0-US-
01];
2. United States Provisional Patent Application No. 62/004,436, filed 
May 29, 2014, entitled ``Methods of Treating or Preventing Obesity, 
Insulin Resistance and Non-Alcoholic Fatty Liver Disease'' [HHS 
Reference No. E-508-2013/1-US-01]; and
3. PCT Patent Application No. PCT/US2014/49460 filed August 1, 2014 
``Inhibitors of the Farnesoid X Receptor and Uses in Medicine'' [HHS 
Reference No. E-508-2013/2-PCT-01].

    The patent rights in these inventions have been assigned to the 
government of the United States of America.
    The prospective exclusive license territory may be worldwide and 
the field of use may be limited to the use of the Licensed Patent 
Rights to make or have made, use and sell a small molecule farnesoid X 
receptor inhibitor for all metabolic diseases.

DATES: Only written comments and/or applications for a license which 
are received by the NCI Technology Transfer Center on or before January 
4, 2016 will be considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
and comments relating to the contemplated exclusive license should be 
directed to: Thomas Clouse, J.D., Senior Licensing and Patenting 
Manager, NCI Technology Transfer Center, 9609 Medical Center Drive, RM 
1E530 MSC 9702, Bethesda, MD 20892-9702 (for business mail), Rockville, 
MD 20850-9702 Telephone: (240)-276-5530; Facsimile: (240)-276-5504 
Email: [email protected].

SUPPLEMENTARY INFORMATION: Remodeling the gut microbiota using specific 
compounds can affect high fat diet-induced obesity through signal 
transduction mediated by the nuclear receptor farnesoid X receptor 
(FXR). FXR is inhibited due to the altered gut microbiota as a result 
of lack of metabolism (bile salt hydrolase activity) of a potent FXR 
antagonist tauro-[beta]-muracholic acid (T[beta]MCA) that is produced 
in the liver and secreted to the intestine. The technology identifies a 
class of compounds that specifically decrease levels of Lactobacillus-
associated bile salt hydrolase activity resulting in accumulation of 
intestinal T[beta]MCA which is now identified as an antagonist of FXR. 
The technology has the potential of being developed into a therapeutic 
for various metabolic disorders associated with inhibition of the 
farnesoid X receptor pathway, including Non-Alcoholic Fatty Liver 
Disease (NAFLD), Type 2 Diabetes, and non-alcoholic steatohepatitis 
(NASH).
    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 part 
404. The prospective exclusive license 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.
    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 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.

    Dated: December 15, 2015.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2015-31831 Filed 12-17-15; 8:45 am]
 BILLING CODE 4140-01-P

79052 Federal Register / Vol. 80, No. 243 / Friday, December 18, 2015 / Notices

DEPARTMENT OF HEALTH AND Services, is contemplating the grant of intestine. The technology identifies a
HUMAN SERVICES an exclusive patent license to practice class of compounds that specifically
the inventions embodied in the decrease levels of Lactobacillus-
National Institutes of Health following U.S. Patents and Patent associated bile salt hydrolase activity
Applications to Heliome Biotech, Inc. resulting in accumulation of intestinal
National Institute on Aging; Notice of (‘‘Heliome’’) located in New York, NY, TbMCA which is now identified as an
Closed Meeting USA. antagonist of FXR. The technology has
Pursuant to section 10(d) of the Intellectual Property: the potential of being developed into a
Federal Advisory Committee Act, as 1. United States Provisional Patent therapeutic for various metabolic
amended (5 U.S.C. App.), notice is Application No. 61/861,109, filed disorders associated with inhibition of
hereby given of the following meeting. August 1, 2013 ‘‘Inhibitors of the the farnesoid X receptor pathway,
The meeting will be closed to the Farnesoid X Receptor and Use including Non-Alcoholic Fatty Liver
public in accordance with the Thereof in the Prevention of Weight Disease (NAFLD), Type 2 Diabetes, and
provisions set forth in sections Gain’’ [HHS Reference No. E–508– non-alcoholic steatohepatitis (NASH).
552b(c)(4) and 552b(c)(6), title 5 U.S.C., 2013/0–US–01]; The prospective exclusive license will
as amended. The grant applications and 2. United States Provisional Patent be royalty bearing and will comply with
the discussions could disclose Application No. 62/004,436, filed the terms and conditions of 35 U.S.C.
confidential trade secrets or commercial May 29, 2014, entitled ‘‘Methods of 209 and 37 CFR part 404. The
property such as patentable material, Treating or Preventing Obesity, prospective exclusive license may be
and personal information concerning Insulin Resistance and Non- granted unless within fifteen (15) days
individuals associated with the grant Alcoholic Fatty Liver Disease’’ from the date of this published notice,
applications, the disclosure of which [HHS Reference No. E–508–2013/1– the NCI receives written evidence and
would constitute a clearly unwarranted US–01]; and argument that establishes that the grant
invasion of personal privacy. 3. PCT Patent Application No. PCT/ of the license would not be consistent
US2014/49460 filed August 1, 2014 with the requirements of 35 U.S.C. 209
Name of Committee: National Institute on ‘‘Inhibitors of the Farnesoid X
Aging Special Emphasis Panel; AGING
and 37 CFR part 404.
Receptor and Uses in Medicine’’ Applications for a license in the field
STUDY.
Date: January 20, 2016. [HHS Reference No. E–508–2013/2– of use filed in response to this notice
Time: 2:00 p.m. to 5:00 p.m. PCT–01]. will be treated as objections to the grant
Agenda: To review and evaluate grant The patent rights in these inventions of the contemplated exclusive license.
applications. have been assigned to the government of Comments and objections submitted to
Place: National Institute on Aging, the United States of America. this notice will not be made available
Gateway Building, Suite 2C212, 7201 The prospective exclusive license for public inspection and, to the extent
Wisconsin Avenue, Bethesda, MD 20892 territory may be worldwide and the permitted by law, will not be released
(Telephone Conference Call). field of use may be limited to the use under the Freedom of Information Act,
Contact Person: Carmen Moten, Ph.D.,
M.P.H., National Institute on Aging, Gateway
of the Licensed Patent Rights to make or 5 U.S.C. 552.
Building, 7201 Wisconsin Avenue, Suite have made, use and sell a small Dated: December 15, 2015.
2C212, Bethesda, MD 20892, 301–402–7703, molecule farnesoid X receptor inhibitor Richard U. Rodriguez,
cmoten@mail.nih.gov. for all metabolic diseases. Associate Director, Technology Transfer
(Catalogue of Federal Domestic Assistance DATES: Only written comments and/or Center, National Cancer Institute.
Program Nos. 93.866, Aging Research, applications for a license which are [FR Doc. 2015–31831 Filed 12–17–15; 8:45 am]
National Institutes of Health, HHS) received by the NCI Technology BILLING CODE 4140–01–P
Dated: December 11, 2015. Transfer Center on or before January 4,
Melanie J. Gray, 2016 will be considered.
Program Analyst, Office of Federal Advisory ADDRESSES: Requests for copies of the DEPARTMENT OF HEALTH AND
Committee Policy. patent application, inquiries, and HUMAN SERVICES
[FR Doc. 2015–31771 Filed 12–17–15; 8:45 am] comments relating to the contemplated
exclusive license should be directed to: National Institutes of Health
BILLING CODE 4140–01–P
Thomas Clouse, J.D., Senior Licensing
and Patenting Manager, NCI Technology National Institute of General Medical
Transfer Center, 9609 Medical Center Sciences; Notice of Meeting
DEPARTMENT OF HEALTH AND
HUMAN SERVICES Drive, RM 1E530 MSC 9702, Bethesda, Pursuant to section 10(d) of the
MD 20892–9702 (for business mail), Federal Advisory Committee Act, as
National Institutes of Health Rockville, MD 20850–9702 Telephone: amended (5 U.S.C. App.), notice is
(240)–276–5530; Facsimile: (240)–276– hereby given of a meeting of the
Prospective Grant of Exclusive 5504 Email: thomas.clouse@nih.gov. National Advisory General Medical
License: Development of a Small SUPPLEMENTARY INFORMATION: Sciences Council.
Molecule Farnesoid X Receptor Remodeling the gut microbiota using The meeting will be open to the
Inhibitor specific compounds can affect high fat public as indicated below, with a short
AGENCY: National Institutes of Health, diet-induced obesity through signal public comment period at the end.
mstockstill on DSK4VPTVN1PROD with NOTICES

HHS. transduction mediated by the nuclear Attendance is limited by the space
ACTION: Notice. receptor farnesoid X receptor (FXR). available. Individuals who plan to
FXR is inhibited due to the altered gut attend and need special assistance, such
SUMMARY: This notice, in accordance microbiota as a result of lack of as sign language interpretation or other
with 35 U.S.C. 209 and 37 CFR part 404, metabolism (bile salt hydrolase activity) reasonable accommodations, should
that the National Cancer Institute (NCI), of a potent FXR antagonist tauro-b- notify the Contact Person listed below
National Institutes of Health, muracholic acid (TbMCA) that is in advance of the meeting. The open
Department of Health and Human produced in the liver and secreted to the session will also be videocast and can

VerDate Sep<11>2014 19:20 Dec 17, 2015 Jkt 238001 PO 00000 Frm 00025 Fmt 4703 Sfmt 4703 E:\FR\FM\18DEN1.SGM 18DEN1

Document Created: 2015-12-18 01:39:05
Document Modified: 2015-12-18 01:39:05

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 4, 2016 will be considered.
FR Citation		80 FR 79052

80 FR 79052 - Prospective Grant of Exclusive License: Development of a Small Molecule Farnesoid X Receptor Inhibitor

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

Federal Register Volume 80, Issue 243 (December 18, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health