83_FR_55771 83 FR 55556 - Prospective Grant of Exclusive Patent License: Therapeutics for Insulin Resistance and Non-Alcoholic Fatty Liver Disease/Non-Alcoholic Steatohepatitis (NASH/NAFLD)

83 FR 55556 - Prospective Grant of Exclusive Patent License: Therapeutics for Insulin Resistance and Non-Alcoholic Fatty Liver Disease/Non-Alcoholic Steatohepatitis (NASH/NAFLD)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 83, Issue 215 (November 6, 2018)

Page Range55556-55557
FR Document2018-24225

The National Heart, Lung and Blood Institute (NHLBI), National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive commercialization patent license to Ovensa, Inc. headquartered in Ontario, Canada, to practice the inventions embodied in the patent application(s) listed in the Supplementary Information section of this notice.

Federal Register, Volume 83 Issue 215 (Tuesday, November 6, 2018) 
[Federal Register Volume 83, Number 215 (Tuesday, November 6, 2018)]
[Notices]
[Pages 55556-55557]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-24225]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive Patent License: Therapeutics for 
Insulin Resistance and Non-Alcoholic Fatty Liver Disease/Non-Alcoholic 
Steatohepatitis (NASH/NAFLD)

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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[[Page 55557]]

SUMMARY: The National Heart, Lung and Blood Institute (NHLBI), National 
Institutes of Health, Department of Health and Human Services, is 
contemplating the grant of an exclusive commercialization patent 
license to Ovensa, Inc. headquartered in Ontario, Canada, to practice 
the inventions embodied in the patent application(s) listed in the 
Supplementary Information section of this notice.

DATES: Only written comments and/or applications for a license which 
are received by the NHLBI Office of Technology Transfer and Development 
November 21, 2018 will be considered.

ADDRESSES: Requests for copies of the patent applications, inquiries, 
and comments relating to the contemplated exclusive patent license 
should be directed to: Michael Shmilovich, Esq., Senior Licensing and 
Patent Manager, 31 Center Drive, Room 4A29, MSC2479, Bethesda, MD 
20892-2479, phone number 301-435-5019, or shmilovm@mail.nih.gov.

SUPPLEMENTARY INFORMATION: The following and all continuing U.S. and 
foreign patents/patent applications thereof are the intellectual 
properties to be licensed under the prospective agreement to Ovensa: 
HHS Ref. No. E-103-2013-0, U.S. Provisional Patent Application 61/
839,239, ``Glucan-Encapsulated siRNA For Treating Type 2 Diabetes 
Mellitus,'' filed June 25, 2013, International Patent Application PCT/
2014/043924 filed June 24, 2014, European Patent Application 14818342.9 
filed June 24, 2018, and US Patent 10,077,446 filed June 24, 2014 and 
issued September 18, 2018. The patent rights in this invention have 
been assigned to the Government of the United States of America. The 
prospective license would be granted worldwide and in a field of use 
not broader than therapeutics for preventing or treating insulin 
resistance and non-alcoholic fatty liver disease/non-alcoholic 
steatohepatitis. The scope of any proposed licensed may also be limited 
to products sold that include therapeutic siRNAs encapsulated in 
nanoparticles made from either glucan based biopolymers and/or Ovensa's 
TRIOZANTM (N,N,N-Trimethyl Chitosan) proprietary biopolymer.
    The invention pertains to the use of glucan encapsulated non-
immunostimulatory small interfering RNAs (siRNAs) to treat type-2 
diabetes. Endocannabinoids (EC) are lipid signaling molecules that act 
on the same cannabinoid receptors that recognize and mediate the 
effects of endo- and phytocannabanoids. EC receptor CB1R activation is 
implicated in the development of obesity and its metabolic 
consequences, including insulin resistance and type 2 diabetes. Beta-
cell loss has been demonstrated in a Zucker diabetic fatty (ZDF) rat 
model of type-2 diabetes through CB1R-mediated activation of a 
macrophage-mediated inflammatory response. Conversely, rats treated 
with a peripheral CB1R antagonist restores normoglycemia and preserves 
beta-cell function. Similar results are seen following selective in 
vivo knockdown of macrophage CB1R by daily treatment of ZDF rats with 
the instant D-glucan-encapsulated CB1R small interfering RNA (siRNA). 
Knock-down of CB1R using glucan encapsulated siRNA represent new 
methods of treating type-2 diabetes or preventing the progression of 
insulin resistance to overt diabetes.
    This notice is made in accordance with 35 U.S.C. 209 and 37 CFR 
part 404. The prospective exclusive patent license will be royalty 
bearing and may be granted unless within fifteen (15) days from the 
date of this published notice, the NHLBI 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 prospective field of use 
that are timely filed in response to this notice will be treated as 
objections to the grant of the contemplated exclusive patent 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: October 24, 2018.
Michael A. Shmilovich,
Senior Licensing and Patenting Manager, National Heart, Lung, and Blood 
Institute, Office of Technology Transfer and Development.
[FR Doc. 2018-24225 Filed 11-5-18; 8:45 am]
 BILLING CODE 4140-01-P

55556 Federal Register / Vol. 83, No. 215 / Tuesday, November 6, 2018 / Notices funded by HHS by conducting criminal, preparedness and response. OI Time: 9:00 a.m. to 5:00 p.m. civil, and administrative investigations coordinates the adoption of advanced Agenda: To review and evaluate grant of fraud and misconduct related to HHS digital forensic acquisition and applications. Place: National Institutes of Health, 6701 programs, operations, and employees. examination and information security Rockledge Drive, Bethesda, MD 20892, The office serves as OIG’s liaison to DOJ technologies to assist in the (Virtual Meeting). on all matters relating to investigations investigation, prevention, and detection Contact Person: Shalanda A Bynum, Ph.D., of HHS programs and personnel and of fraud and abuse; maintains an Scientific Review Officer, Center for reports to the Attorney General when automated data and management Scientific Review, National Institutes of there are reasonable grounds to believe information system used by all OI Health, 6701 Rockledge Drive, Room 3206, Federal criminal law has been violated. employees; provides technical expertise Bethesda, MD 20892, 301–755–4355, OI serves as a liaison to CMS, State bynumsa@csr.nih.gov. on computer applications for licensing boards, and other outside investigations; and coordinates and Name of Committee: Center for Scientific organizations and entities with regard to Review Special Emphasis Panel; Member approves investigative computer Conflict: Bone and Cartilage. exclusion, compliance, and enforcement matches with other agencies. In Date: November 29, 2018. activities. addition, the office operates a toll-free Time: 12:00 p.m. to 5:30 p.m. Section QJ.10, Office of Investigations— hotline to permit individuals to report Agenda: To review and evaluate grant Organization suspected fraud, waste, and abuse applications. within HHS programs. Place: National Institutes of Health, 6701 OI is directed by the Deputy Inspector Rockledge Drive, Bethesda, MD 20892, General for Investigations, aided by Daniel R. Levinson, (Virtual Meeting). Assistant Inspectors General, and Inspector General. Contact Person: Richard Ingraham, Ph.D., performs the functions designated in the [FR Doc. 2018–23935 Filed 11–5–18; 8:45 am] Scientific Review Officer, Center for law (section 3(d)(1)(B) of the Inspector Scientific Review, National Institutes of BILLING CODE 4152–01–P Health, 6701 Rockledge Drive, Room 4116, General Act) for the position of MSC 7814, Bethesda, MD 20892, 301–496– Assistant Inspector General for 8551, ingrahamrh@mail.nih.gov. Investigations. The office is comprised DEPARTMENT OF HEALTH AND Name of Committee: Center for Scientific of headquarters and regional functions. HUMAN SERVICES Review Special Emphasis Panel; Role of Section QJ.20, Office of Investigations— Blood Brain Barrier in Pain and Brain National Institutes of Health Tumors, Peripheral Nerve and Brain Injury. Functions Date: November 30, 2018. OI conducts criminal, civil, and Center for Scientific Review; Notice of Time: 11:00 a.m. to 12:30 p.m. administrative investigations of Closed Meetings Agenda: To review and evaluate grant allegations of fraud, waste, abuse, applications. Pursuant to section 10(d) of the Place: National Institutes of Health, 6701 mismanagement, and violations of Federal Advisory Committee Act, as Rockledge Drive, Bethesda, MD 20892, standards of conduct within the amended, notice is hereby given of the (Telephone Conference Call). jurisdiction of OIG. OI establishes following meetings. Contact Person: Seetha Bhagavan, Ph.D., investigative priorities, evaluates the The meetings will be closed to the Scientific Review Officer, Center for progress of investigations, and reports public in accordance with the Scientific Review, National Institutes of findings to the Inspector General. The provisions set forth in sections Health, 6701 Rockledge Drive, Room 5194, office develops and implements 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., MSC 7846, Bethesda, MD 20892, (301) 237– investigative techniques, programs, 9838, bhagavas@csr.nih.gov. as amended. The grant applications and guidelines, and policies; manages OI’s the discussions could disclose (Catalogue of Federal Domestic Assistance quality assurance/peer-review program, Program Nos. 93.306, Comparative Medicine; confidential trade secrets or commercial 93.333, Clinical Research, 93.306, 93.333, and conducts peer reviews of other property such as patentable material, 93.337, 93.393–93.396, 93.837–93.844, OIGs. OI also carries out and maintains and personal information concerning 93.846–93.878, 93.892, 93.893, National an internal quality assurance system. individuals associated with the grant Institutes of Health, HHS) The system includes quality assessment applications, the disclosure of which studies and quality control reviews of Dated: October 31, 2018. would constitute a clearly unwarranted OI processes and products to ensure that David D. Clary, invasion of personal privacy. policies and procedures are followed Program Analyst, Office of Federal Advisory effectively and are functioning as Name of Committee: Center for Scientific Committee Policy. intended. The office effectuates Review Special Emphasis Panel; PAR 17– 158: Secondary Data Analyses For NIMH [FR Doc. 2018–24224 Filed 11–5–18; 8:45 am] mandatory and permissive exclusions Research Domain Criteria (R03). BILLING CODE 4140–01–P from participation in Federal health care Date: November 28, 2018. programs under the Social Security Act; Time: 12:00 p.m. to 2:00 p.m. decides on all requests for reinstatement Agenda: To review and evaluate grant DEPARTMENT OF HEALTH AND from, or waiver of, exclusions; and applications. HUMAN SERVICES participates in developing standards Place: National Institutes of Health, 6701 governing the imposition of these Rockledge Drive, Bethesda, MD 20892, National Institutes of Health exclusion authorities. The office also (Telephone Conference Call). oversees OIG’s suspension and Contact Person: Julius Cinque, MS, Prospective Grant of Exclusive Patent debarment referral program. OI Scientific Review Officer, Center for License: Therapeutics for Insulin khammond on DSK30JT082PROD with NOTICES Scientific Review, National Institutes of Resistance and Non-Alcoholic Fatty implements policies and procedures Health, 6701 Rockledge Drive, Room 5186, and plans, develops, implements, and Liver Disease/Non-Alcoholic MSC 7846, Bethesda, MD 20892, (301) 435– evaluates all levels of training for OI 1252, cinquej@csr.nih.gov. Steatohepatitis (NASH/NAFLD) employees. The staff provides for the Name of Committee: Center for Scientific AGENCY: National Institutes of Health, personal protection of the Secretary and Review Special Emphasis Panel; Member HHS. other Department officials, as needed, conflict: AIDS and Related Research. ACTION: Notice. and all emergency operations Date: November 29, 2018. VerDate Sep<11>2014 17:05 Nov 05, 2018 Jkt 247001 PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 E:\FR\FM\06NON1.SGM 06NON1

Federal Register / Vol. 83, No. 215 / Tuesday, November 6, 2018 / Notices 55557 SUMMARY: The National Heart, Lung and development of obesity and its 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Blood Institute (NHLBI), National metabolic consequences, including as amended. The grant applications and Institutes of Health, Department of insulin resistance and type 2 diabetes. the discussions could disclose Health and Human Services, is Beta-cell loss has been demonstrated in confidential trade secrets or commercial contemplating the grant of an exclusive a Zucker diabetic fatty (ZDF) rat model property such as patentable material, commercialization patent license to of type-2 diabetes through CB1R- and personal information concerning Ovensa, Inc. headquartered in Ontario, mediated activation of a macrophage- individuals associated with the grant Canada, to practice the inventions mediated inflammatory response. applications, the disclosure of which embodied in the patent application(s) Conversely, rats treated with a would constitute a clearly unwarranted listed in the Supplementary Information peripheral CB1R antagonist restores invasion of personal privacy. section of this notice. normoglycemia and preserves beta-cell Name of Committee: National Heart, Lung, DATES: Only written comments and/or function. Similar results are seen and Blood Institute Special Emphasis Panel applications for a license which are following selective in vivo knockdown Review of NHLBI Cardiac Surgery Network received by the NHLBI Office of of macrophage CB1R by daily treatment Coordinating Center. Technology Transfer and Development of ZDF rats with the instant D-glucan- Date: November 26, 2018. November 21, 2018 will be considered. encapsulated CB1R small interfering Time: 1:00 p.m. to 3:00 p.m. ADDRESSES: Requests for copies of the RNA (siRNA). Knock-down of CB1R Agenda: To review and evaluate grant using glucan encapsulated siRNA applications. patent applications, inquiries, and Place: National Institutes of Health, 6701 comments relating to the contemplated represent new methods of treating type- Rockledge Drive, Bethesda, MD 20892 exclusive patent license should be 2 diabetes or preventing the progression (Telephone Conference Call). directed to: Michael Shmilovich, Esq., of insulin resistance to overt diabetes. Contact Person: Shelley S Sehnert, Ph.D., Senior Licensing and Patent Manager, This notice is made in accordance Scientific Review Officer, Office of Scientific 31 Center Drive, Room 4A29, MSC2479, with 35 U.S.C. 209 and 37 CFR part 404. Review/DERA, National Heart, Lung, and Bethesda, MD 20892–2479, phone The prospective exclusive patent license Blood Institute, 6701 Rockledge Drive, Room number 301–435–5019, or shmilovm@ will be royalty bearing and may be 7206, Bethesda, MD 20892–7924, 301–435– mail.nih.gov. granted unless within fifteen (15) days 0303, ssehnert@nhlbi.nih.gov. SUPPLEMENTARY INFORMATION: The from the date of this published notice, Name of Committee: National Heart, Lung, following and all continuing U.S. and the NHLBI receives written evidence and Blood Institute Special Emphasis Panel and argument that establishes that the NHLBI SBIR Phase IIB Bridge Awards. foreign patents/patent applications Date: November 27, 2018. thereof are the intellectual properties to grant of the license would not be consistent with the requirements of 35 Time: 7:30 a.m. to 9:30 a.m. be licensed under the prospective Agenda: To review and evaluate grant agreement to Ovensa: HHS Ref. No. E– U.S.C. 209 and 37 CFR part 404. applications. 103–2013–0, U.S. Provisional Patent Complete applications for a license in Place: Crowne Plaza, Washington National Application 61/839,239, ‘‘Glucan- the prospective field of use that are Airport, 1489 Jefferson Davis Hwy, Arlington, Encapsulated siRNA For Treating Type timely filed in response to this notice VA 22202. 2 Diabetes Mellitus,’’ filed June 25, will be treated as objections to the grant Contact Person: William J Johnson, Ph.D., 2013, International Patent Application of the contemplated exclusive patent Scientific Review Officer, Office of Scientific license. Review/DERA, National Heart, Lung, and PCT/2014/043924 filed June 24, 2014, Blood Institute, 6701 Rockledge Drive, Room European Patent Application Comments and objections submitted to this notice will not be made available 7178, Bethesda, MD 20892–7924, 301–827– 14818342.9 filed June 24, 2018, and US 7938, johnsonwj@nhlbi.nih.gov. Patent 10,077,446 filed June 24, 2014 for public inspection and, to the extent permitted by law, will not be released Name of Committee: National Heart, Lung, and issued September 18, 2018. The and Blood Institute Special Emphasis Panel patent rights in this invention have been under the Freedom of Information Act, NHLBI SBIR Phase IIB Small Market Awards. assigned to the Government of the 5 U.S.C. 552. Date: November 27, 2018. United States of America. The Dated: October 24, 2018. Time: 9:30 a.m. to 5:00 p.m. prospective license would be granted Michael A. Shmilovich, Agenda: To review and evaluate grant worldwide and in a field of use not Senior Licensing and Patenting Manager, applications. broader than therapeutics for preventing National Heart, Lung, and Blood Institute, Place: Crowne Plaza, Washington National Office of Technology Transfer and Airport, 1489 Jefferson Davis Hwy, Arlington, or treating insulin resistance and non- VA 22202. alcoholic fatty liver disease/non- Development. Contact Person: William J Johnson, Ph.D., alcoholic steatohepatitis. The scope of [FR Doc. 2018–24225 Filed 11–5–18; 8:45 am] Scientific Review Officer, Office of Scientific any proposed licensed may also be BILLING CODE 4140–01–P Review/DERA, National Heart, Lung, and limited to products sold that include Blood Institute, 6701 Rockledge Drive, Room therapeutic siRNAs encapsulated in 7178, Bethesda, MD 20892–7924, 301–827– nanoparticles made from either glucan DEPARTMENT OF HEALTH AND 7938, johnsonwj@nhlbi.nih.gov. based biopolymers and/or Ovensa’s HUMAN SERVICES (Catalogue of Federal Domestic Assistance TRIOZANTM (N,N,N-Trimethyl Program Nos. 93.233, National Center for Chitosan) proprietary biopolymer. National Institutes of Health Sleep Disorders Research; 93.837, Heart and The invention pertains to the use of Vascular Diseases Research; 93.838, Lung National Heart, Lung, and Blood Diseases Research; 93.839, Blood Diseases glucan encapsulated non- Institute; Notice of Closed Meetings and Resources Research, National Institutes immunostimulatory small interfering khammond on DSK30JT082PROD with NOTICES of Health, HHS) RNAs (siRNAs) to treat type-2 diabetes. Pursuant to section 10(d) of the Endocannabinoids (EC) are lipid Federal Advisory Committee Act, as Dated: October 31, 2018. signaling molecules that act on the same amended, notice is hereby given of the Ronald J. Livingston, Jr., cannabinoid receptors that recognize following meetings. Program Analyst, Office of Federal Advisory and mediate the effects of endo- and The meetings will be closed to the Committee Policy. phytocannabanoids. EC receptor CB1R public in accordance with the [FR Doc. 2018–24222 Filed 11–5–18; 8:45 am] activation is implicated in the provisions set forth in sections BILLING CODE 4140–01–P VerDate Sep<11>2014 17:05 Nov 05, 2018 Jkt 247001 PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 E:\FR\FM\06NON1.SGM 06NON1


Document Created: 2018-11-06 00:18:40
Document Modified: 2018-11-06 00:18:40
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 NHLBI Office of Technology Transfer and Development November 21, 2018 will be considered.
FR Citation83 FR 55556 
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