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###### 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.

## Purified Saxitoxin for Food Safety Applications

*Description of Technology:*                     Available for licensing as a biological material for research purposes is purified saxitoxin. Saxitoxin is the parent compound in a family of natural toxins that can occur in seafood and can cause food borne illness. Highly purified saxitoxin is vital for the development, validation, and calibration of detection methods for these toxins, as well as for fundamental studies in physiology and pain management. Interested parties may license the compound for conjugation chemistry and radiolabeling with the end goal of generating a research reagent.                
      ( print page 47258)    
*Applications:*
      - Investigation of food borne illness.
      - Monitoring of seafood for contamination.
      - Detection of food poisons.

*Inventor:*                     Sherwood Hall (FDA).                

*Relevant Publication:*                     EJ Schantz                     *et al.*                     Paralytic shellfish poison. VI. A procedure for the isolation and purification of the poison from toxic clam and mussel tissues. J Am Chem Soc. 1957 Oct;79(19):5230-5235, doi: 10.1021/ja01576a044.                

*Patent Status:*                     HHS Reference No. E-278-2009/0—Research Tool. Patent protection is not being pursued for this technology.                

*Licensing Status:*                     Available for licensing.                

*Licensing Contact:*                     Michael A. Shmilovich, Esq.; 301-435-5019;                     *shmilovm@mail.nih.gov*.                

## Identification of Recent HIV-I Infection by Genotypic Analysis for Treatment Strategy

*Description of Technology:*                     This invention describes a bioinformatics algorithm capable of distinguishing between recently infected and chronically infected HIV-I patients based on the genetic diversity of HIV pro-pol sequences. Directly after infection with HIV-I, genetic diversity is extremely low. Previously, single genome sequencing was used to demonstrate that HIV-I genetic diversity accumulates after infection in a linear and predictable fashion during the first 8-10 months of infection (Kearney                     *et al.,*                     2009). Using single genome sequencing, it is possible to determine whether a person had been infected with HIV-1 in the recent past. Single genome sequencing is, however, a research technique that is relatively labor intensive and somewhat expensive, making it less feasible for routine use. The invention improves on this analysis in both ease and cost, and is capable of estimating genetic diversity using a population-based sequence that is obtained by routine, commercially available genotyping through the determination of genotype sequence ambiguity, which resulted in both sensitive and specific identification of acute versus chronic infection. The algorithm is also capable of simultaneously determining drug resistance profiles, further representing significant improvement over current antibody-based methods. Since recent data have shown that patients in the primary infection stage are estimated to be 26 times more infective than patients in the chronic stage of infection (Hollingsworth                     *et al.,*                     2008), and epidemiological models of immediate antiretroviral therapy (ART) predict a shift from the endemic phase to the elimination phase within five years (Granich                     *et al.,*                     2009), this invention represents a potentially valuable diagnostic tool for clinicians as well as an improvement over the current antibody-based methods of epidemiological research for determining HIV incidence.                

*Applications:*
      - HIV Diagnostics capable of distinguishing between a recent HIV infection and a chronic one. This feature will assist clinicians in the design of HIV treatment regimen and strategy.
      - Analysis and prediction of patient's HIV drug resistance. Facilitating devising a treatment strategy.
      - Epidemiological application due to ability of the test to report HIV incidence.

*Advantages:*                     The method offers important public health benefits with regards to HIV/AIDS as elaborated below:                
      - The method adds important value to conventional HIV genotyping and enhances the diagnostic usefulness of genotyping.
      - The method offers an inexpensive and convenient way to distinguish recently infected from chronically infected subjects and thus provides important information regarding HIV drug management.
      - The method can, simultaneously with the above, provide information regarding drug resistance mutations.
      - The method is based on commercially available HIV-1 genotype sequence information and thus offers simplicity and convenience.
      - The method can provide important and useful epidemiological information.

*Market:*                     A favorable market potential for the method exists, and it may in the future be routinely used in every clinical laboratory that provides genotyping services and by manufacturers and laboratories that provide tests for drug resistance patterns.                

*Development Status:*                     Early stage.                

*Inventors:*                     Frank Maldarelli                     *et al.*                     (NCI).                

*Patent Status:*                     HHS Reference No. E-238-2009/0—Research Tool. Patent protection is not being pursued for this technology.                

*Licensing Status:*                     Available for licensing.                

*Licensing Contacts:*                     Uri Reichman, PhD, MBA, 301-435-4616,                     *UR7a@nih.gov*; John Stansberry, PhD, 301-435-5236,                     *js852e@nih.gov*.                

*Collaborative Research Opportunity:*                     The NCI HIV Drug Resistance Program, Host Virus Interaction Branch, is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize this technology. Please contact John D. Hewes, PhD at 301-435-3121 or                     *hewesj@mail.nih.gov*                     for more information.                

Dated: September 9, 2009.

Richard U. Rodriguez,

Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. 

[FR Doc. E9-22223 Filed 9-14-09; 8:45 am]

BILLING CODE 4140-01-P