[Federal Register Volume 87, Number 1 (Monday, January 3, 2022)]
[Notices]
[Pages 92-93]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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: 
[email protected].

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


