[Federal Register Volume 78, Number 192 (Thursday, October 3, 2013)]
[Page 61375]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-24141]



National Institutes of Health

Prospective Grant of Exclusive License: Use of Quaking-Induced 
Conversion (QUIC) for Detection of Prions

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.


SUMMARY: This is notice, in accordance with 35 U.S.C. 209 and 37 CFR 
part 404, that the National Institutes of Health (NIH), Department of 
Health and Human Services, is contemplating the grant of an exclusive 
license to practice the inventions embodied in U.S. provisional 
Application 60/961,364 filed July 20, 2007 [E-109-2007/0-US-01], PCT/
US2008/070656, filed July 21, 2008; [E-109-2007/1-PCT-01], EPC 
application No 08796382.3 filed July 21, 2008 [E-109-2007/1-EP-03], US 
Application No. 12/177,012, filed July 21, 2008 and issued as US patent 
8,216,788 on July 10, 2012 [E-109-2007/1-US-02], and US Application No. 
13/489,321, filed June 5, 2012 [E-109-2007/1-US-04]; Each entitled 
``Detection of Infectious Prion Protein by Seeded Conversion of 
Recombinant Prion Protein'' By Byron Caughey et al. to Prionics AG 
having a place of business at Wagistrasse 27a CH-8952 Schlieren-Zurich, 
Switzerland. The patent rights in this invention have been assigned to 
the United States of America.

DATES: Only written comments and/or application for a license that are 
received by the NIH Office of Technology Transfer on or before November 
4, 2013 will be considered.

ADDRESSES: Requests for a copy of the patent application, inquiries, 
comments and other materials relating to the contemplated license 
should be directed to: Tedd Fenn, Office of Technology Transfer, 
National Institutes of Health, 6011 Executive Boulevard, Suite 325, 
Rockville, MD 20852-3804; Email: [email protected]; Telephone: 
301-435-5031; Facsimile: 301-402-0220.

    The prospective worldwide 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 exclusive license may be granted unless, 
within thirty (30) days from the date of this published Notice, 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.
    The invention relates to methods and compositions for the detection 
of infectious proteins or prions and diagnosis of prion related 
diseases. Prion diseases are neurodegenerative diseases of great public 
concern because humans may be infected from hoofed animals used as 
food, food products such as milk, or blood products. Currently 
available tests for disease-causing prions are either incapable of 
detecting low concentrations of prions and must be used post-mortem or 
are incapable of detecting low concentrations of prions economically or 
accurately. This technology enables rapid and economical detection of 
sub-lethal concentrations of prions by using recombinant, normal, prion 
protein (rPrP-sen) as a marker or indicator of infectious prions in a 
sample. Specifically, prions (contained in a sample) seed the 
polymerization of rPrP-sen, and polymerized rPrP-sen is detected as an 
amplified indicator of prions in the sample. This assay differs from 
the protein-misfolding cyclic amplification assay (PMCA) because it 
enables the effective use of rPrP-sen and does not require multiple 
amplification cycles unless a higher degree of sensitivity is required. 
It is anticipated that this technology can be combined with additional 
prion-detection technologies to further improve the sensitivity of the 
assay. In its current embodiment, this assay has been used to detect 
prions in brain tissue or cerebral spinal fluid (CSF) from humans 
(variant CJD), sheep (scrapie), and hamsters (scrapie).
    The proposed field of exclusivity may be limited to diagnostics 
requiring premarket approval by a U.S. or a foreign regulatory agency.
    Properly filed competing applications for a license filed in 
response to this notice will be treated as objections to the 
contemplated license. Comments and objections submitted in response 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: September 27, 2013.
Richard U. Rodriguez,
Director, Division of Technology Development & Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2013-24141 Filed 10-2-13; 8:45 am]