[Federal Register Volume 74, Number 177 (Tuesday, September 15, 2009)]
[Notices]
[Pages 47257-47258]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-22223]


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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.

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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.

[[Page 47258]]

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    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; 
[email protected].

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, 
[email protected]; John Stansberry, PhD, 301-435-5236, [email protected].
    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 
[email protected] 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