[Federal Register Volume 81, Number 124 (Tuesday, June 28, 2016)]
[Notices]
[Page 41979]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-15165]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Start-up Exclusive License: Premarket 
Approved Diagnostic for Identifying JC Virus

AGENCY: National Institutes of Health.

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 Institute of Neurological Disorders and 
Stroke (NINDS), National Institutes of Health (NIH), Department of 
Health and Human Services, is contemplating the grant of a start-up 
exclusive license to Pro Arc Diagnostics, Inc., which is located in 
Missouri, to practice the inventions embodied in the following patents: 
U.S. Patent Application 14/408,919, filed December 17, 2014 (HHS 
reference E-088-2012/0-US-03).
    The patent rights in these inventions have been assigned to the 
United States of America. The prospective start-up exclusive license 
territory may be worldwide and the field of use may be limited to FDA 
premarket approved (PMA) diagnostics for the detection of JC Virus.

DATES: Only written comments and/or applications for a license which 
are received by NINDS Technology Transfer on or before July 13, 2016 
will be considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
comments, and other materials relating to the contemplated start-up 
exclusive license should be directed to: Susan Ano, Ph.D., NINDS 
Technology Transfer, 31 Center Drive, Suite 8A52, MS2540, Bethesda, MD 
20892; Telephone: (301) 435-5515; Email: [email protected].

SUPPLEMENTARY INFORMATION: This invention provides a multiplex PCR-
based method for detecting JC virus, and distinguishing between the 
non-pathogenic and pathogenic JC virus that causes progressive 
multifocal leukoencephalopathy (PML) in individuals that are 
immunocompromised. The invention helps to identify individuals at risk 
of developing PML by detecting two regions of the viral genome. The 
assay detects JC viral DNA with high sensitivity using the T protein 
coding DNA that is highly specific and does not allow mutations. It 
also detects a genome variable region in the non-coding region that 
detects changes from the nonpathogenic genotype in the urine to the 
pathogenic type seen in tissues especially in the brain, bone marrow, 
plasma/serum or immune cells of PML patients.
    The prospective start-up exclusive license may be granted unless 
within fifteen (15) 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.
    Complete 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 start-up 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: June 21, 2016.
Susan Ano,
Technology Development Coordinator NINDS Technology Transfer, National 
Institutes of Health.
[FR Doc. 2016-15165 Filed 6-27-16; 8:45 am]
 BILLING CODE 4140-01-P