[Federal Register Volume 72, Number 57 (Monday, March 26, 2007)]
[Notices]
[Pages 14124-14125]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-5426]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Government-Owned Inventions; Availability for Licensing

AGENCY: National Institutes of Health, Public Health Service, HHS.

ACTION: Notice.

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

SUMMARY: The inventions listed below are owned by an agency of the U.S. 
Government and are available for licensing in the U.S. in accordance 
with 35 U.S.C. 207 to achieve expeditious commercialization of results 
of federally-funded research and development. Foreign patent 
applications are filed on selected inventions to extend market coverage 
for companies and may also be available for licensing.

ADDRESSES: Licensing information and copies of the U.S. patent 
applications listed below may be obtained by writing to the indicated 
licensing contact at the Office of Technology Transfer, National 
Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, 
Maryland 20852-3804; telephone: 301/496-7057; fax: 301/402-0220. A 
signed Confidential Disclosure Agreement will be required to receive 
copies of the patent applications.

Rapid Universal and/or Type-Specific Assay for Clostridium Botulinum

    Description of Technology: The urgent need for a rapid diagnostic 
test capable of detecting all serotypes of C. botulinum is well known. 
Botulinum neurotoxins (BoNTs) are the most potent biological toxins 
known and are categorized as category A biodefense agents because of 
lethality and ease of production. Current diagnostic methods include 
clinical observation of symptoms that could be mistaken for other 
neurological conditions and a mouse protection bioassay that takes as 
long as four days and has a number of disadvantages. The subject 
technology utilizes unique PCR primers for the detection of the non-
toxin non-hemaglutinin (NTNH) gene of C. botulinum; this gene is highly 
conserved in all C. botulinum toxin types and subtypes. Thus, samples 
that contain botulinum can be determined regardless of serotype 
involved, providing a universal means of diagnosis. Further, the 
technology describes different PCR primers and flurogenic probes for a 
BoNT-specific assay. The type-specific assay can be used independently 
or in conjunction with the universal assay described above. The 
universal and type-specific assays were successfully used first to

[[Page 14125]]

identify positively botulinum DNA samples in a test of botulinum and 
non-botulinum clostridia species then to determine the toxin type. The 
diagnostic testing described by the subject technology requires 
significantly less time than the current gold standard diagnostic test.
    Applications: (1) Universal diagnostic test for C. botulinum; (2) 
Diagnostic test for C. botulinum capable of detecting all seven toxin 
types; (3) Combination diagnostic.
    Development Status: Fully developed.
    Inventors: Daniel C. Douek (VRC/NIAID) et al.
    Patent Status: U.S. Provisional Application No. 60/884,539 filed 11 
Jan 2007 (HHS Reference No. E-046-2007/0-US-01).
    Licensing Status: Available for non-exclusive or exclusive 
licensing.
    Licensing Contact: Susan Ano, Ph.D.; 301/435-5515; 
<a href="/cdn-cgi/l/email-protection#42232c2d31022f232b2e6c2c2b2a6c252d34"><span class="__cf_email__" data-cfemail="b8d9d6d7cbf8d5d9d1d496d6d1d096dfd7ce">[email protected]</span></a>.

Methods and Compositions for Protecting Cells From Ultrasound-Mediated 
Cytolysis

    Description of Invention: Available for licensing and commercial 
development are methods for protecting cells from ultrasound-mediated 
cytolysis. The in vitro exposure of cells to ultrasound and the 
therapeutic uses of ultrasound (e.g., sonoporation, thrombolysis, HIFU, 
sonophoresis, acoustic hemostasis) may induce changes in tissue state, 
including apoptosis and cytolysis, through thermal effects (e.g., 
hyperthermia), mechanical effects (e.g., acoustic cavitation or through 
radiation force, acoustic streaming and other ultrasound induced 
forces), and chemical effects (via sonochemistry or by the activation 
of solutes by sonoluminescence). Ultrasound exposure conditions in 
these biomedical and in biological processes (e.g. ultrasound 
bioreactors) are limited by the need to increase the beneficial effects 
of ultrasound, while at the same time limiting the detrimental effects, 
such as apoptosis and cytolysis. Accordingly, the protecting molecules 
used to carry out the methods of the invention possess the ability to 
protect cells against ultrasound mediated cytolysis, without hindering 
ultrasound induced physical effects that could be utilized to create 
beneficial effects. The protecting solutes are surface active and 
possess at least one ``carbohydrate unit'' as described. The solutes 
include, but are not limited to: alkyl-[beta]-D-thioglucopyranoside, 
alkyl-[beta]-D-thiomaltopyranoside, alkyl-[beta]-D-galactopyranoside, 
alkyl-[beta]-D-thiogalactopyranoside, or alkyl-[beta]-D-maltrioside, 
hexyl-[beta]-D-glucopyranoside, heptyl-[beta]-D-glucopyranoside, octyl-
[beta]-D-glucopyranoside, nonyl-[beta]-D-glucopyranoside, hexyl-[beta]-
D-maltopyranoside, n-octyl-[beta]-D-maltopyranoside, n-octyl-[beta]-D-
thioglucopyranoside, 2-propyl-1-pentyl-[beta]-D-maltopyranoside, 
methyl-6-O-(N-heptylcarbamoyl)-[alpha]-D-glucopyranoside, 3-cyclohexyl-
1-propyl-[beta]-D-glucoside, 6-O-methyl-n-heptylcarboxyl-[alpha]-D-
glucopyranoside.
    Inventors: Joe Z. Sostaric (NCI), Peter Riesz (NCI), et al.
    Publications:
    1. Joe Z. Sostaric, Norio Miyoshi, Peter Riesz, William G. DeGraff 
and James B. Mitchell. n-Alkyl glucopyranosides completely inhibit 
ultrasound-induced cytolysis. Free Radic Biol Med. 2005 Dec 
15;39(12):1539-1548.
    2. Joe Z. Sostaric, Norio Miyoshi, Peter Riesz, William G. Degraff 
and James B. Mitchell. Complete inhibition of ultrasound-induced 
cytolysis in the presence of inertial cavitation. AIP Conf Proc. 2006 
May 8;829:39-43.
    Patent Status: PCT Application No. PCT/US2005/037912 filed 19 Oct 
2005, which published as WO 2006/045050 on 27 Apr 2006; claiming 
priority to 19 Oct 2004 (HHS Reference No. E-311-2004/0-PCT-02).
    Licensing Status: Available for non-exclusive or exclusive 
licensing.
    Licensing Contact: Michael Shmilovich, Esq.; 301/435-5019; 
<a href="/cdn-cgi/l/email-protection#1e6d767377727168735e737f77723070777630797168"><span class="__cf_email__" data-cfemail="f2819a9f9b9e9d849fb29f939b9edc9c9b9adc959d84">[email protected]</span></a>.

    Dated: March 12, 2007.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
 [FR Doc. E7-5426 Filed 3-23-07; 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>