Notice2025-08742
Prospective Grant of an Exclusive Patent License: c-Abl Tyrosine Kinase Inhibitory Compound Embodiments and Methods of Making and Using the Same
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Published
May 16, 2025
Issuing agencies
Health and Human Services DepartmentNational Institutes of Health
Abstract
The National Center for Advancing Translational Sciences, 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 Neurala Bio, Inc. (Neurala), headquartered in Delaware.
Full Text
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<title>Federal Register, Volume 90 Issue 94 (Friday, May 16, 2025)</title>
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[Federal Register Volume 90, Number 94 (Friday, May 16, 2025)]
[Notices]
[Page 21054]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-08742]
[[Page 21054]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive Patent License: c-Abl Tyrosine
Kinase Inhibitory Compound Embodiments and Methods of Making and Using
the Same
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
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SUMMARY: The National Center for Advancing Translational Sciences, 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 Neurala Bio, Inc. (Neurala), headquartered in Delaware.
DATES: Only written comments and/or applications for a license which
are received by the National Center for Advancing Translational
Sciences' Office of Strategic Alliances on or before June 2, 2025 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: Jasmine Kalsi, M.S., Licensing and Patenting
Manager, Office of Strategic Alliances, Telephone: 301-435-0129; Email:
<a href="/cdn-cgi/l/email-protection#c4aea5b7a9adaaa1eaafa5a8b7ad84aaadaceaa3abb2"><span class="__cf_email__" data-cfemail="81ebe0f2ece8efe4afeae0edf2e8c1efe8e9afe6eef7">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
Intellectual Property
``C-Abl Tyrosine Kinase Inhibitory Compound Embodiments and Methods
of Making and Using the Same''
(1) U.S. Patent Application No. 16/976,012, HHS Ref. No. E-253-2017-0-
US-03, which was issued as Patent Number 11,649,218 on May 16, 2023
(2) Chile Patent Application No. 2317-2020, HHS Ref. No. E-253-2017-0-
CL-04, which was issued as Patent Number CL67.840 on August 2, 2023
(3) U.S. Patent Application No. 18/128,603, HHS Ref. No. E-253-2017-0-
US-02, filed on March 30, 2023 (Pending)
The patent rights in these inventions have been either assigned
and/or exclusively licensed to the government of the United States of
America and Pontificia Universidad Catolica de Chile.
The prospective exclusive license territory may be worldwide, and
the field of use may be limited to the following:
``Use of NCGC00373060, also known as ``NEUROTINIB'' and its analogs
for the treatment of central nervous system disorders, including
Epilepsy, Parkinson's Disease, Lysosomal Storage Disorders (Niemann
Pick C and A, Tay-Sachs, Gaucher's Disease), and Alzheimer's Disease.''
The inventions relate to a series of novel compounds that inhibit
c-Abl tyrosine kinase by binding to an allosteric site of the c-Abl
tyrosine kinase. These compounds have favorable tolerability, high
potency, high selectivity, good brain penetration, and robust efficacy.
All of this allows them to potentially treat diseases such as cancers
or neurodegenerative disease.
The compounds of the subject inventions can be used individually or
in combination to develop new therapies to treat diseases involving the
c-Abl tyrosine kinase, specifically diseases resulting from
overexpression of c-Abl tyrosine kinase. The diseases resulting from
overexpression of c-Abl tyrosine kinase include frontal temporal
dementia associated with ALS, primary lateral sclerosis, Sly syndrome,
glioblastoma, neuroblastoma and viral pathogenesis resulting from HV.
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
Center for Advancing Translational Sciences 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: May 12, 2025.
Joni L. Rutter,
Director, Office of the Director, National Center for Advancing
Translational Sciences.
[FR Doc. 2025-08742 Filed 5-15-25; 8:45 am]
BILLING CODE 4140-01-P
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