Prospective Grant of an Exclusive Patent License: Natural Product Based Nanoparticles as Dietary Management and/or Treatment of Inflammatory Related Diseases, 23734-23735 [2021-09332]
Download as PDF
<![CDATA[
23734
Federal Register / Vol. 86, No. 84 / Tuesday, May 4, 2021 / Notices
before the meeting about the actual time
allotted per speaker.
If possible, oral public commenters
should send a copy of their slides and/
or statement or talking points to NTPMeetings@icf.com by June 1, 2021.
Meeting Materials: The preliminary
meeting agenda is available on the
meeting web page (https://
ntp.niehs.nih.gov/go/165) and will be
updated one week before the meeting.
Individuals are encouraged to access the
meeting web page to stay abreast of the
most current information regarding the
meeting.
Background Information on the BSC:
The BSC is a technical advisory body
comprised of scientists from the public
and private sectors that provides
primary scientific oversight to the NTP.
Specifically, the BSC advises the NTP
on matters of scientific program content,
both present and future, and conducts
periodic review of the program for the
purpose of determining and advising on
the scientific merit of its activities and
their overall scientific quality. Its
members are selected from recognized
authorities knowledgeable in fields such
as toxicology, pharmacology, pathology,
epidemiology, risk assessment,
carcinogenesis, mutagenesis, cellular
biology, computational toxicology,
neurotoxicology, genetic toxicology,
reproductive toxicology or teratology,
and biostatistics. Members serve
overlapping terms of up to four years.
The BSC usually meets periodically.
The authority for the BSC is provided by
42 U.S.C. 217a, section 222 of the Public
Health Service Act (PHS), as amended.
The BSC is governed by the
provisions of the Federal Advisory
Committee Act, as amended (5 U.S.C.
app.), which sets forth standards for the
formation and use of advisory
committees.
Dated: April 15, 2021.
Brian R. Berridge,
Associate Director, National Toxicology
Program.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; PAR20–072, NIAID
Investigator Initiated Program Project
Applications (P01 Clinical Trial Not
Allowed).
Date: May 27, 2021.
Time: 10:00 a.m. to 1:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 3G45,
Rockville, MD 20892 (Virtual Meeting).
Contact Person: Vanitha Sundaresa Raman,
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities,
National Institute of Allergy and Infectious
Diseases, National Institutes of Health, 5601
Fishers Lane, Room 3G45, Rockville, MD
20852, 301–761–7949, vanitha.raman@
nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
Dated: April 28, 2021.
Tyeshia M. Roberson,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2021–09268 Filed 5–3–21; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
BILLING CODE 4140–01–P
Prospective Grant of an Exclusive
Patent License: Natural Product Based
Nanoparticles as Dietary Management
and/or Treatment of Inflammatory
Related Diseases
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
National Institutes of Health
ACTION:
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meeting
SUMMARY:
[FR Doc. 2021–09331 Filed 5–3–21; 8:45 am]
khammond on DSKJM1Z7X2PROD with NOTICES
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
VerDate Sep<11>2014
17:13 May 03, 2021
Jkt 253001
National Institutes of Health,
HHS.
Notice.
The National Cancer Institute,
an institute of the 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
Patents and Patent Applications listed
in the Supplementary Information
PO 00000
Frm 00065
Fmt 4703
Sfmt 4703
section of this notice to MaDu, LLC
located at 2025 Broadway, Suite 23E,
New York, NY 10023.
DATES: Only written comments and/or
applications for a license which are
received by the National Cancer
Institute’s Technology Transfer Center
on or before May 19, 2021 will be
considered.
Requests for copies of the
patent applications, inquiries, and
comments relating to the contemplated
Exclusive Patent License should be
directed to: Michelle A. Favila, Ph.D.,
Technology Transfer Manager, National
Institutes of Health, NCI Technology
Transfer Center by email
(michelle.favila@nih.gov).
SUPPLEMENTARY INFORMATION:
ADDRESSES:
Intellectual Property
HHS Ref No. E–154–2018–0: Binary
Lipid Bilayer-Containing Vesicles
Comprising Embedded Cytotoxic Agents
and Methods of Making and Using the
Same
1. United States Provisional Patent
Application No. No. 62/697,287 filed
July 12, 2018. [HHS Ref No. E–154–
2018–0–US–01]
2. International Patent Application
No. PCT/US2019/041464 filed July 11,
2019. [HHS Ref. No. E–154–2018–0–
PCT–02]
3. Canadian Patent Application No.
3106008 filed July 11, 2019. [HHS Ref
No. E–154–2018–0–CA–03]
4. European Patent Application
19746275.7 filed July 11, 2019. [HHS
Ref No. E–154–2018–0–EP–04]
5. Japanese Patent Application 2021–
500734 filed July 11, 2019. [HHS Ref
No. E–154–2018–0–JP–05] and
6. United States Patent Application
17/259,499 filed January 11, 2021 [HHS
Ref No. E–154–2018–0–US–01]
The patent and patent application
rights in these inventions have been
assigned and/or exclusively licensed to
the government of the United States of
America.
The prospective exclusive license
territory may be worldwide, and will be
less than the full patent term and the
field of use may be limited to the
following: Development and
commercialization of the Binary Lipid
Nanoparticle encapsulating known
natural products curcumin, vitamin D,
and/or L-serine that are Generally
Recognized as Safe for use as medical
foods, as defined by the FDA, or overthe-counter products for the
management of pain and inflammatoryrelated diseases. The prospective
licensee plans to develop Medical
Foods, which is defined by the FDA as
E:\FR\FM\04MYN1.SGM
04MYN1
Federal Register / Vol. 86, No. 84 / Tuesday, May 4, 2021 / Notices
‘‘food which is formulated to be
consumed or administered enterally
under the supervision of a physician
and which is intended for the specific
dietary management of a disease or
condition for which distinctive
nutritional requirements, based on
recognized scientific principles, are
established by medical evaluation.’’
This technology discloses formulation
and methods of using novel stealth lipid
nanoparticles that have a high stability
and payload capacity. Combination of
these nanoparticles with selected agents
may have various medical applications
for cancer and anti-inflammatory
indications.
This notice is made in accordance
with 35 U.S.C. 209 and 37 CFR 404. The
prospective exclusive license will be
royalty bearing, and the prospective
exclusive license may be granted unless
within fifteen (15) days from the date of
this published notice, the National
Cancer Institute 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 404.
In response to this Notice, the public
may file comments or objections.
Comments and objections, other than
those in the form of a license
application, will not be treated
confidentially, and may be made
publicly available.
License applications submitted in
response to this Notice will be
presumed to contain business
confidential information and any release
of information from these license
applications will be made only as
required and upon a request under the
Freedom of Information Act, 5 U.S.C.
552.
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; NIAID Investigator Initiated
Program Project Applications (P01 Clinical
Trial Not Allowed).
Date: May 26, 2021.
Time: 10:00 a.m. to 2:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 3G41,
Rockville, MD 20892 (Virtual Meeting).
Contact Person: Tara Capece, Ph.D.,
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities,
National Institute of Allergy and Infectious
Diseases, National Institutes of Health, 5601
Fishers Lane, Room 3G41, Rockville, MD
20852, 240–191–4281, capecet2@
niaid.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
Dated: April 28, 2021.
Tyeshia M. Roberson,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2021–09270 Filed 5–3–21; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Dated: April 16, 2021.
Richard U. Rodriguez,
Associate Director, Technology Transfer
Center, National Cancer Institute.
Prospective Grant of an Exclusive
Patent License: Development and
Commercialization of Cell Therapies
for Cancer
[FR Doc. 2021–09332 Filed 5–3–21; 8:45 am]
BILLING CODE 4140–01–P
AGENCY:
National Institutes of Health,
HHS.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
ACTION:
khammond on DSKJM1Z7X2PROD with NOTICES
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
17:13 May 03, 2021
Jkt 253001
The National Cancer Institute,
an institute of the 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
Patents and Patent Applications listed
in the Supplementary Information
section of this notice to Athenex, Inc.
(‘‘Athenex’’) headquartered in Buffalo,
NY.
DATES: Only written comments and/or
applications for a license which are
SUMMARY:
National Institutes of Health
VerDate Sep<11>2014
Notice.
PO 00000
Frm 00066
Fmt 4703
Sfmt 4703
23735
received by the National Cancer
Institute’s Technology Transfer Center
on or before May 19, 2021 will be
considered.
Requests for copies of the
patent application, inquiries, and
comments relating to the contemplated
an Exclusive Patent License should be
directed to: Suna Gulay French, Ph.D.,
Technology Transfer Manager, NCI
Technology Transfer Center, Telephone:
(240) 276–5530; Email: suna.gulay@
nih.gov.
ADDRESSES:
SUPPLEMENTARY INFORMATION:
Intellectual Property
Group A
E–237–2017–0/2: T Cell Receptors
Recognizing Mutated P53
1. US Provisional Patent Application
62/565,383, filed September 29, 2017
(E–237–2017–0–US–01);
2. International Patent Application
PCT/US2018/051285, filed September
17, 2018 (E–237–2017–2–PCT–01);
3. Australian Patent Application
2018342246, filed September 17, 2018
(E–237–2017–2–AU–02);
4. Brazilian Patent Application
BR112020006012–7, filed September 17,
2018 (E–237–2017–2–BR–03);
5. Canadian Patent Application
3077024, filed September 17, 2018
(E–237–2017–2–CA–04);
6. Chinese Patent Application
201880074539.8, filed September 17,
2018 (E–237–2017–2–CN–05);
7. Costa Rica Patent Application
2020–0170, filed September 17, 2018
(E–237–2017–2–CR–06);
8. Eurasian Patent Application
202090757, filed September 17, 2018
(E–237–2017–2–EA–07);
9. European Patent Application
18780006.5, filed September 17, 2018
(E–237–2017–2–EP–08);
10. Israeli Patent Application 273515,
filed September 17, 2018 (E–237–2017–
2–IL–09);
11. India Patent Application
202047013911, filed September 17, 2018
(E–237–2017–2–IN–10);
12. Japanese Patent Application 2020–
517556, filed September 17, 2018
(E–237–2017–2–JP–11);
13. Korean Patent Application 2020–
7012344, filed September 17, 2018
(E–237–2017–2–KR–12);
14. Mexico Patent Application MX/a/
2020/003504, filed September 17, 2018
(E–237–2017–2–MX–13);
15. New Zealand Patent Application
763023, filed September 17, 2018
(E–237–2017–2–NZ–14);
16. Singapore Patent Application
11202002636P, filed September 17,
2018 (E–237–2017–2–SG–15);
E:\FR\FM\04MYN1.SGM
04MYN1
]]>Agencies
[Federal Register Volume 86, Number 84 (Tuesday, May 4, 2021)]
[Notices]
[Pages 23734-23735]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-09332]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive Patent License: Natural Product
Based Nanoparticles as Dietary Management and/or Treatment of
Inflammatory Related Diseases
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The National Cancer Institute, an institute of the 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 Patents and Patent Applications listed in
the Supplementary Information section of this notice to MaDu, LLC
located at 2025 Broadway, Suite 23E, New York, NY 10023.
DATES: Only written comments and/or applications for a license which
are received by the National Cancer Institute's Technology Transfer
Center on or before May 19, 2021 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: Michelle A. Favila, Ph.D., Technology Transfer
Manager, National Institutes of Health, NCI Technology Transfer Center
by email ([email protected]).
SUPPLEMENTARY INFORMATION:
Intellectual Property
HHS Ref No. E-154-2018-0: Binary Lipid Bilayer-Containing Vesicles
Comprising Embedded Cytotoxic Agents and Methods of Making and Using
the Same
1. United States Provisional Patent Application No. No. 62/697,287
filed July 12, 2018. [HHS Ref No. E-154-2018-0-US-01]
2. International Patent Application No. PCT/US2019/041464 filed
July 11, 2019. [HHS Ref. No. E-154-2018-0-PCT-02]
3. Canadian Patent Application No. 3106008 filed July 11, 2019.
[HHS Ref No. E-154-2018-0-CA-03]
4. European Patent Application 19746275.7 filed July 11, 2019. [HHS
Ref No. E-154-2018-0-EP-04]
5. Japanese Patent Application 2021-500734 filed July 11, 2019.
[HHS Ref No. E-154-2018-0-JP-05] and
6. United States Patent Application 17/259,499 filed January 11,
2021 [HHS Ref No. E-154-2018-0-US-01]
The patent and patent application rights in these inventions have
been assigned and/or exclusively licensed to the government of the
United States of America.
The prospective exclusive license territory may be worldwide, and
will be less than the full patent term and the field of use may be
limited to the following: Development and commercialization of the
Binary Lipid Nanoparticle encapsulating known natural products
curcumin, vitamin D, and/or L-serine that are Generally Recognized as
Safe for use as medical foods, as defined by the FDA, or over-the-
counter products for the management of pain and inflammatory-related
diseases. The prospective licensee plans to develop Medical Foods,
which is defined by the FDA as
[[Page 23735]]
``food which is formulated to be consumed or administered enterally
under the supervision of a physician and which is intended for the
specific dietary management of a disease or condition for which
distinctive nutritional requirements, based on recognized scientific
principles, are established by medical evaluation.''
This technology discloses formulation and methods of using novel
stealth lipid nanoparticles that have a high stability and payload
capacity. Combination of these nanoparticles with selected agents may
have various medical applications for cancer and anti-inflammatory
indications.
This notice is made in accordance with 35 U.S.C. 209 and 37 CFR
404. The prospective exclusive license will be royalty bearing, and the
prospective exclusive license may be granted unless within fifteen (15)
days from the date of this published notice, the National Cancer
Institute 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 404.
In response to this Notice, the public may file comments or
objections. Comments and objections, other than those in the form of a
license application, will not be treated confidentially, and may be
made publicly available.
License applications submitted in response to this Notice will be
presumed to contain business confidential information and any release
of information from these license applications will be made only as
required and upon a request under the Freedom of Information Act, 5
U.S.C. 552.
Dated: April 16, 2021.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer
Institute.
[FR Doc. 2021-09332 Filed 5-3-21; 8:45 am]
BILLING CODE 4140-01-P
