[Federal Register Volume 80, Number 170 (Wednesday, September 2, 2015)]
[Notices]
[Pages 53163-53164]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-21718]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Co-Exclusive License: Biomarkers for Acute 
Ischemic Stroke

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: This is notice, in accordance with 35 U.S.C. 209 and 37 CFR 
part 404, that the National Institutes of Health, Department of Health 
and Human Services, is contemplating the grant of a co-exclusive patent 
license to practice the inventions embodied in U.S. Patent Application 
No. 13/580,571 filed 22 August, 2012 and entitled ``Biomarkers for 
Acute Ischemic Stroke'' [HHS Ref. No. E-023-2010/0-US-03] to CereDx, 
Inc., which is located in West Virginia. The patent rights in this 
invention have been assigned to the United States of America.
    The prospective co-exclusive license territory may be worldwide and 
the field of use may be limited to the use of the diagnostics of 
ischemic stroke.

DATES: Only written comments and/or applications for a license which 
are received by the NIH Office of Technology Transfer on or before 
October 2, 2015 will be considered. This notice updates the Federal 
Register Notice published in 80 FR 28633, Tuesday May 19, 2015.

[[Page 53164]]


ADDRESSES: Requests for copies of the patent application, inquiries, 
comments, and other materials relating to the contemplated co-exclusive 
license should be directed to: Uri Reichman, Ph.D., MBA, Licensing and 
Patenting Manager, Office of Technology Transfer, National Institutes 
of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-
3804. Telephone: (301) 435-4616; Facsimile: (301) 402-0220; Email: 
[email protected].

SUPPLEMENTARY INFORMATION: This technology is directed to gene 
biomarkers for the diagnosis and potential treatment of acute ischemic 
stroke. Stroke is the third leading cause of death in the United 
States, of which 87% are ischemic stroke and result in death within 30 
days in 8-12% of the cases. Currently, recombinant tissue plasminogen 
activator (rtPA, trade name alteplase), is the only FDA approved 
ischemic stroke treatment, and it is only effective when administered 
to patients within three hours from the onset of symptoms. 
Unfortunately, the median time from stroke symptom onset to 
presentation to the emergency department is 3-6 hours. Although 
advances in neuroimaging and clinical management have helped with 
patient survival rates, these techniques are not infallible and at 
times result in misdiagnosis. The biomarkers identified in this 
technology may be used to develop a diagnostic testing device for 
determining stroke subtype in the field.
    The prospective co-exclusive license will be royalty bearing and 
will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 
part 404. The prospective co-exclusive license may be granted unless 
within thirty (30) days from the date of this published notice, the NIH 
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.
    Applications for a license in the field of use filed in response to 
this notice will be treated as objections to the grant of the 
contemplated co-exclusive license. Comments and objections submitted to 
this notice will not be made available for public inspection and, to 
the extent permitted by law, will not be released under the Freedom of 
Information Act, 5 U.S.C. 552.

    Dated: August 28, 2015.
Richard U. Rodriguez,
Acting Director, Office of Technology Transfer, National Institutes of 
Health.
[FR Doc. 2015-21718 Filed 9-1-15; 8:45 am]
BILLING CODE 4140-01-P