[Federal Register Volume 79, Number 223 (Wednesday, November 19, 2014)]
[Notices]
[Pages 68892-68893]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-27342]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Detection of Infectious 
Prion Protein by Seeded Conversion of Recombinant Prion Protein

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 
patent license to Amprion, Inc. located in Houston Texas, USA, to 
practice the inventions embodied in the following Patents and Patent 
Applications, each entitled ``Detection of Infectious Prion Protein by 
Seeded Conversion of Recombinant Prion Protein'':
    1. US provisional Application 60/961,364 filed July 20, 2007 [HHS 
Ref. No. E-109-2007/0-US-01]
    2. PCT/US2008/070656, filed July 21, 2008; [HHS Ref. No E-109-2007/
1-PCT-01]
    3. EPC application No 08796382.3 filed July 21, 2008 [HHS Ref. No 
E-109-2007/1-EP-03]

[[Page 68893]]

    4. US Application No. 12/177,012, filed July 21, 2008 and issued as 
US patent 8,216,788 on July 10, 2012 [HHS Ref. No E-109-2007/1-US-02];
    5. US Application No. 13/489,321, filed June 5, 2012 [E-109-2007/1-
US-04];
    6. US Application No. 14/263,703, filed April 28, 2014 [E-109-2007/
1-US-011]
    The patent rights in these inventions have been assigned to the 
United States of America.
    The prospective exclusive licensed territory may be worldwide and 
the field of use may be limited to in vitro diagnostics of prion-
associated diseases requiring FDA premarket approval, or the equivalent 
thereof outside of the United States, and USDA licensed veterinary 
diagnostics, or the equivalents thereof outside of the United States.

DATES: Only written comments and/or application for a license that are 
received by the NIH Office of Technology Transfer on or before 11:59 
p.m. Eastern Time on December 19, 2014 will be considered.

ADDRESSES: Requests for a copy of the patents and applications, 
inquiries, comments and other materials relating to the contemplated 
license should be directed to: Tedd Fenn, Senior Licensing and 
Patenting Manager, Office of Technology Transfer, National Institutes 
of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-
3804; Email: <a href="/cdn-cgi/l/email-protection#b1d7d4dfdfd4d0f1dcd0d8dd9fdfd8d99fd6dec7"><span class="__cf_email__" data-cfemail="e187848f8f8480a18c80888dcf8f8889cf868e97">[email protected]</span></a>; Telephone: 424-297-0336; Facsimile: 
301-402-0220.

SUPPLEMENTARY INFORMATION: The invention relates to methods and 
compositions for the detection of infectious prions and diagnosis of 
prion related diseases. Currently, available tests for disease-causing 
prions are incapable of detecting low concentrations and must be 
confirmed post-mortem. This technology enables rapid and economical 
detection of sub-lethal concentrations of prions by using recombinant 
protein (rPrP-sen) as a marker. A seeded sample polymerizes rPrP-sen, 
which is detected as an amplified indicator of prions in the sample. 
This assay does not require multiple amplification cycles unless a 
higher degree of sensitivity is required. This technology potentially 
may be combined with additional prion-detection technologies to further 
improve the sensitivity of the assay.
    The prospective 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, 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.
    Any additional 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 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: November 10, 2014.
Richard U. Rodriguez,
Acting Director, Office of Technology Transfer, National Institutes of 
Health.
[FR Doc. 2014-27342 Filed 11-18-14; 8:45 am]
BILLING CODE 4140-01-P


</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>