Notice2021-28397
Prospective Grant of an Exclusive Patent License: A Diagnostic Tool Based Upon Magnetic Resonance Spectroscopy Pre-Processing and Renormalization
Primary source
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Published
January 3, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) is contemplating the grant of an Exclusive Patent License to practice the invention embodied in the U.S. Patent listed in the SUPPLEMENTARY INFORMATION section of this notice to Voxel Systems, LLC located in Houston, Texas.
Full Text
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<title>Federal Register, Volume 87 Issue 1 (Monday, January 3, 2022)</title>
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[Federal Register Volume 87, Number 1 (Monday, January 3, 2022)]
[Notices]
[Pages 92-93]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-28397]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-1243]
Prospective Grant of an Exclusive Patent License: A Diagnostic
Tool Based Upon Magnetic Resonance Spectroscopy Pre-Processing and
Renormalization
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is contemplating the
grant of an Exclusive Patent License to practice the invention embodied
in the U.S. Patent listed in the SUPPLEMENTARY INFORMATION section of
this notice to Voxel Systems, LLC located in Houston, Texas.
DATES: Only written comments and/or applications for a license that are
received by FDA's Technology Transfer Office on or before January 18,
2022, will be considered.
ADDRESSES: Inquiries and comments relating to the contemplated
Exclusive Patent License should be directed to: Ken Millburne, Food and
Drug Administration Technology Transfer Office, Bldg. 1, Rm. 4213,
Silver Spring, MD 20993, 240-478-1662; email:
<a href="/cdn-cgi/l/email-protection#9bd0fef5f5feeff3b5d6f2f7f7f9eee9f5fedbfdfffab5f3f3e8b5fcf4ed"><span class="__cf_email__" data-cfemail="49022c27272c3d2167042025252b3c3b272c092f2d286721213a672e263f">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
Intellectual Property
FDA Reference No.: E-2009-011/US-04: ``System for Magnetic Resonance
Spectroscopy of Brain Tissue for Pattern-Based Diagnostics''
I. U.S. Non-Provisional Application 13/509,539, filed November 12,
2010 (FDA Reference No.: E-2009-011/US-04).
II. U.S. Patent granted November 4, 2014: U.S. Patent 8,880,354 B2
(FDA Reference No. E-2009-011/US-04).
The patent rights in this invention have been assigned to the
Government of the United States of America.
The prospective exclusive license territory may be worldwide and in
fields of use that may be limited to: (1) Any and all in vivo use,
application, or developmental activity related to the software,
processing algorithm, and Licensed Processes and Products; (2) all
human and animal diagnostics, in pre-clinical, or clinical utilizations
for any and all maladies; (3) all human research applications for
expanded magnetic resonance imaging (MRI) utilization, application
development, drug development tools, molecular compound
characterization, algorithms, and biomarker identification and
development; and (4) all animal or other research applications and
translational studies for ultra high-field MRI investigations, drug
development, metabolite, and biomarker identification.
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.
The prospective exclusive license may be granted unless, within 15 days
from the date of this published notice, FDA 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 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.
[[Page 93]]
Dated December 27, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-28397 Filed 12-30-21; 8:45 am]
BILLING CODE 4164-01-P
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