Document Headings

                    Document headings vary by document type but may contain                    the following:                  
                -                       the agency or agencies that issued and signed a document                    
                -                       the number of the CFR title and the number of each part                      the document amends, proposes to amend, or is directly                      related to                    
                -                       the agency docket number / agency internal file number                    
                -                       the RIN which identifies each regulatory action listed in                      the Unified Agenda of Federal Regulatory and Deregulatory                      Actions                    

                    See the                                          Document Drafting Handbook                                        for more details.                  

###### Department of Health and Human Services

###### National Institutes of Health 

# 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                           ( print 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;                     *anos@mail.nih.gov.*

## 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-β-D-thioglucopyranoside, alkyl-β-D-thiomaltopyranoside, alkyl-β-D-galactopyranoside, alkyl-β-D-thiogalactopyranoside, or alkyl-β-D-maltrioside, hexyl-β-D-glucopyranoside, heptyl-β-D-glucopyranoside, octyl-β-D-glucopyranoside, nonyl-β-D-glucopyranoside, hexyl-β-D-maltopyranoside, n-octyl-β-D-maltopyranoside, n-octyl-β-D-thioglucopyranoside, 2-propyl-1-pentyl-β-D-maltopyranoside, methyl-6-O-(N-heptylcarbamoyl)-α-D-glucopyranoside, 3-cyclohexyl-1-propyl-β-D-glucoside, 6-O-methyl-n-heptylcarboxyl-α-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;                     *shmilovm@mail.nih.gov.*

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