Prospective Grant of an Exclusive Patent License: Development and Commercialization of Cell Therapies for Cancer, 52890-52891 [2019-21519]
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Federal Register / Vol. 84, No. 192 / Thursday, October 3, 2019 / Notices
entitled ‘‘Devices for Tissue
Cryopreservation and Recovery’’ and;
United States Patent App. No. pending
(NIH Ref. E–094–2016–0–US–03);
Australia Patent App. No. 2018214954
filed 01/31/18 (NIH Ref. E–094–2016–0–
AU–04); Canada Patent App. No.
pending (NIH Ref. E–094–2016–0–CA–
05); EPC Patent App. No. pending (NIH
Ref. E–094–2016–0–EP–06); Japan
Patent App. No. pending (NIH Ref. E–
094–2016–0–JP–07); each ‘‘A Selfcontained Cryopreservation and
Recovery Device for Tissue Storage,
Shipping and Recovery’’;
• United States Provisional Patent
App. No. 62/644,175, filed 03/16/18
(NIH Ref. E–058–2018–0–US–01)
entitled ‘‘Using Machine Learning And/
or Neural Networks to Validate Stem
Cells and Their Derivatives for Use in
Cell Therapy, Drug Discovery and
Diagnostics’’; PCT Patent App. No.
pending (NIH Ref. E–058–2018–0–PCT–
02) entitled ‘‘Using Machine Learning
And/or Neural Networks to Validate
Stem Cells and Their Derivatives (2–D
Cells And 3–D Tissues) for Use in Cell
Therapy And Tissue Engineered
Products’’;
• United States Patent App. No 62/
769,484, filed 11/19/18 (NIH Ref. E–
015–2019–0–US–01) entitled
‘‘Biodegradable Tissue Replacement
Implant and its Use’’;
and all U.S. and foreign patent
applications claiming priority to the
aforementioned applications.
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
following:
‘‘The development, production and
commercialization of allogeneic cell
grafts of manufactured Retinal Pigment
Epithelium cell(s) alone, or in
combination with photoreceptor cells,
and on a biodegradable support scaffold
transplanted subretinally for intraocular ophthalmic treatment of
conditions of degeneration, dysfunction
or terminal injury of retinal pigment
epithelium and/or photoreceptors in
humans.’’
The technologies relate to
development of compositions, devices
and processes for production and
delivery of RPE-containing tissue graft
therapies for treating a range of retinal
function disorders, including retinal
degenerative conditions in humans.
This notice is made in accordance
with 35 U.S.C. 209 and 37 CFR part 404.
The prospective exclusive license will
be royalty bearing, and the prospective
VerDate Sep<11>2014
17:22 Oct 02, 2019
Jkt 250001
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 part 404.
In response to this Notice, the public
may file comments or objections.
Comments and objections, other than
those in the form of a completed 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 in 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: September 26, 2019.
Richard U. Rodriguez,
Associate Director, Technology Transfer
Center, National Cancer Institute.
[FR Doc. 2019–21520 Filed 10–2–19; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive
Patent License: Development and
Commercialization of Cell Therapies
for Cancer
AGENCY:
National Institutes of Health,
HHS.
ACTION:
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
section of this Notice to Ziopharm
Oncology, Inc. (‘‘Ziopharm’’),
headquartered in Boston, MA.
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 October 18, 2019 will be
considered.
SUMMARY:
Requests for copies of the
patent applications, inquiries, and
comments relating to the contemplated
Exclusive Patent License should be
directed to: Andrew Burke, Ph.D.,
ADDRESSES:
PO 00000
Frm 00023
Fmt 4703
Sfmt 4703
Senior Technology Transfer 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) 276–5484;
Facsimile: (240) 276–5504; Email:
andy.burke@nih.gov.
SUPPLEMENTARY INFORMATION:
Intellectual Property
Group A
E–029–2019: HLA Class II-Restricted T
Cell Receptors Against RAS With G12R
Mutation
1. U.S. Provisional Patent Application
62/795,203, filed January 22, 2019 (E–
029–2019–0–US–01).
Group B
E–135–2019: T Cell Receptors
Recognizing R175H or Y220C Mutation
in P53
1. U.S. Provisional Patent Application
62/867,619, filed June 27, 2019 (E–135–
2019–0–US–01).
The patent 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 the
fields of use may be limited to the
following:
Fields of Use Applying to Intellectual
Property Group A
‘‘Development, manufacture and
commercialization of autologous,
peripheral blood T cell therapy products
engineered by transposon-mediated
gene transfer to express T cell receptors
reactive to mutated KRAS, as claimed in
the Licensed Patent Rights, for the
treatment of human cancers.
Specifically excluded from this field of
use are, (a) retrovirally-engineered
peripheral blood T cell therapy products
for the treatment of human cancers, and
(b) CRISPR-engineered peripheral blood
T cell therapy products for the treatment
of human cancers.
Development, manufacture and
commercialization of companion
diagnostics approved or cleared by the
FDA or equivalent foreign regulatory
agency for Licensee-proprietary T cell
therapy products.’’
Fields of Use Applying to Intellectual
Property Group B
‘‘Development, manufacture and
commercialization of autologous,
peripheral blood T cell therapy products
engineered by transposon-mediated
gene transfer to express T cell receptors
reactive to mutated P53, as claimed in
E:\FR\FM\03OCN1.SGM
03OCN1
52891
Federal Register / Vol. 84, No. 192 / Thursday, October 3, 2019 / Notices
the Licensed Patent Rights, for the
treatment of human cancers.
Specifically excluded from this field of
use are CRISPR-engineered peripheral
blood T cell therapy products for the
treatment of human cancers.
Development, manufacture and
commercialization of companion
diagnostics approved or cleared by the
FDA or equivalent foreign regulatory
agency for Licensee-proprietary T cell
therapy products.’’
Intellectual Property Group A is
primarily directed to isolated T cell
receptors (TCRs) reactive to mutated
Kirsten rat sarcoma viral oncogene
homolog (KRAS), within the context of
several human leukocyte antigens
(HLAs). Mutated KRAS, which plays a
well-defined driver role in oncogenesis,
is expressed by a variety of human
cancers, including: Pancreatic, lung,
endometrial, ovarian and prostate. Due
to its restricted expression in
precancerous and cancerous cells, this
antigen may be targeted on mutant
KRAS-expressing tumors with minimal
normal tissue toxicity.
Intellectual Property Group B is
primarily directed to isolated TCRs
reactive to mutated tumor protein 53
(TP53 or P53), within the context of
several HLAs. P53 is the archetypal
tumor suppressor gene and the most
frequently mutated gene in cancer.
Contemporary estimates suggest that
>50% of all tumors carry mutations in
P53. Because of its prevalence in cancer
and its restricted expression to
precancerous and cancerous cells, this
antigen may be targeted on mutant P53expressing tumors with minimal normal
tissue toxicity.
This Notice is made in accordance
with 35 U.S.C. 209 and 37 CFR part 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 part 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: September 26, 2019.
Richard U. Rodriguez,
Associate Director, Technology Transfer
Center, National Cancer Institute.
[FR Doc. 2019–21519 Filed 10–2–19; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HOMELAND
SECURITY
U.S. Customs and Border Protection
Accreditation and Approval of
Chemical and Petrochemical
Inspections (Groves, TX), as a
Commercial Gauger and Laboratory
U.S. Customs and Border
Protection, Department of Homeland
Security.
ACTION: Notice of accreditation and
approval of Chemical and Petrochemical
Inspections (Groves, TX), as a
commercial gauger and laboratory.
AGENCY:
Notice is hereby given,
pursuant to CBP regulations, that
Chemical and Petrochemical
Inspections (Groves, TX), has been
approved to gauge petroleum and
certain petroleum products and
SUMMARY:
accredited to test petroleum and certain
petroleum products for customs
purposes for the next three years as of
September 25, 2018.
DATES: Chemical and Petrochemical
Inspections (Groves, TX) was approved
and accredited, as a commercial gauger
and laboratory as of September 25, 2018.
The next triennial inspection date will
be scheduled for September 2021.
FOR FURTHER INFORMATION CONTACT: Dr.
Justin Shey, Laboratories and Scientific
Services Directorate, U.S. Customs and
Border Protection, 1300 Pennsylvania
Avenue NW, Suite 1500N, Washington,
DC 20229, tel. 202–344–1060.
SUPPLEMENTARY INFORMATION: Notice is
hereby given pursuant to 19 CFR 151.12
and 19 CFR 151.13, that Chemical and
Petrochemical Inspection, 5300 39th
Street, Groves, TX 77619 has been
approved to gauge petroleum and
certain petroleum products and
accredited to test petroleum and certain
petroleum products for customs
purposes, in accordance with the
provisions of 19 CFR 151.12 and 19 CFR
151.13. Chemical and Petrochemical
Inspections (Groves, TX) is approved for
the following gauging procedures for
petroleum and certain petroleum
products from the American Petroleum
Institute (API):
API chapters
Title
3 .....................
7 .....................
8 .....................
12 ...................
17 ...................
Tank Gauging.
Temperature Determination.
Sampling.
Calculations.
Marine Measurement.
Chemical and Petrochemical
Inspections (Groves, TX) is accredited
for the following laboratory analysis
procedures and methods for petroleum
and certain petroleum products set forth
by the U.S. Customs and Border
Protection Laboratory Methods (CBPL)
and American Society for Testing and
Materials (ASTM):
CBPL No.
ASTM
Title
27–05 ..............................................
D 4928 ...........................................
27–08 ..............................................
27–48 ..............................................
D 86 ...............................................
D 4052 ...........................................
Standard Test Method for Water in Crude Oils by Coulometric Karl
Fischer Titration.
Standard Test Method for Distillation of Petroleum Products.
Standard Test Method for Density and Relative Density of Liquids by
Digital Density Meter.
Anyone wishing to employ this entity
to conduct laboratory analyses and
gauger services should request and
receive written assurances from the
entity that it is accredited or approved
by the U.S. Customs and Border
Protection to conduct the specific test or
VerDate Sep<11>2014
17:22 Oct 02, 2019
Jkt 250001
gauger service requested. Alternatively,
inquiries regarding the specific test or
gauger service this entity is accredited
or approved to perform may be directed
to the U.S. Customs and Border
Protection by calling (202) 344–1060.
The inquiry may also be sent to
PO 00000
Frm 00024
Fmt 4703
Sfmt 4703
CBPGaugersLabs@cbp.dhs.gov. Please
reference the website listed below for a
complete listing of CBP approved
gaugers and accredited laboratories.
https://www.cbp.gov/about/labsscientific/commercial-gaugers-andlaboratories.
E:\FR\FM\03OCN1.SGM
03OCN1
]]>Agencies
[Federal Register Volume 84, Number 192 (Thursday, October 3, 2019)]
[Notices]
[Pages 52890-52891]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-21519]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive Patent License: Development and
Commercialization of Cell Therapies for Cancer
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 Ziopharm
Oncology, Inc. (``Ziopharm''), headquartered in Boston, MA.
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 October 18, 2019 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: Andrew Burke, Ph.D., Senior Technology Transfer
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) 276-5484; Facsimile: (240)
276-5504; Email: [email protected].
SUPPLEMENTARY INFORMATION:
Intellectual Property
Group A
E-029-2019: HLA Class II-Restricted T Cell Receptors Against RAS With
G12R Mutation
1. U.S. Provisional Patent Application 62/795,203, filed January
22, 2019 (E-029-2019-0-US-01).
Group B
E-135-2019: T Cell Receptors Recognizing R175H or Y220C Mutation in P53
1. U.S. Provisional Patent Application 62/867,619, filed June 27,
2019 (E-135-2019-0-US-01).
The patent 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
the fields of use may be limited to the following:
Fields of Use Applying to Intellectual Property Group A
``Development, manufacture and commercialization of autologous,
peripheral blood T cell therapy products engineered by transposon-
mediated gene transfer to express T cell receptors reactive to mutated
KRAS, as claimed in the Licensed Patent Rights, for the treatment of
human cancers. Specifically excluded from this field of use are, (a)
retrovirally-engineered peripheral blood T cell therapy products for
the treatment of human cancers, and (b) CRISPR-engineered peripheral
blood T cell therapy products for the treatment of human cancers.
Development, manufacture and commercialization of companion
diagnostics approved or cleared by the FDA or equivalent foreign
regulatory agency for Licensee-proprietary T cell therapy products.''
Fields of Use Applying to Intellectual Property Group B
``Development, manufacture and commercialization of autologous,
peripheral blood T cell therapy products engineered by transposon-
mediated gene transfer to express T cell receptors reactive to mutated
P53, as claimed in
[[Page 52891]]
the Licensed Patent Rights, for the treatment of human cancers.
Specifically excluded from this field of use are CRISPR-engineered
peripheral blood T cell therapy products for the treatment of human
cancers.
Development, manufacture and commercialization of companion
diagnostics approved or cleared by the FDA or equivalent foreign
regulatory agency for Licensee-proprietary T cell therapy products.''
Intellectual Property Group A is primarily directed to isolated T
cell receptors (TCRs) reactive to mutated Kirsten rat sarcoma viral
oncogene homolog (KRAS), within the context of several human leukocyte
antigens (HLAs). Mutated KRAS, which plays a well-defined driver role
in oncogenesis, is expressed by a variety of human cancers, including:
Pancreatic, lung, endometrial, ovarian and prostate. Due to its
restricted expression in precancerous and cancerous cells, this antigen
may be targeted on mutant KRAS-expressing tumors with minimal normal
tissue toxicity.
Intellectual Property Group B is primarily directed to isolated
TCRs reactive to mutated tumor protein 53 (TP53 or P53), within the
context of several HLAs. P53 is the archetypal tumor suppressor gene
and the most frequently mutated gene in cancer. Contemporary estimates
suggest that >50% of all tumors carry mutations in P53. Because of its
prevalence in cancer and its restricted expression to precancerous and
cancerous cells, this antigen may be targeted on mutant P53-expressing
tumors with minimal normal tissue toxicity.
This Notice is made in accordance with 35 U.S.C. 209 and 37 CFR
part 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 part 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: September 26, 2019.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer
Institute.
[FR Doc. 2019-21519 Filed 10-2-19; 8:45 am]
BILLING CODE 4140-01-P
