Notice (B): Government-Owned Inventions; Availability for Licensing

Federal Register: September 16, 2008 (Volume 73, Number 180)   
                  Page 53430

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.

Monoclonal Antibodies Against Bordetella pertussis Filamentous 
Hemagglutinin (FHA) Protein

    Description of Technology: Filamentous hemagglutinin (FHA) is one 
of the major adhesion molecules of Bordetella pertussis, a bacterial 
infection that causes whopping cough. Once thought to be primarily a 
childhood disease, B. pertussis infection shows an increasing incidence 
among adults as well as infants. Recent CDC reports show an almost 19-
fold increase in the number of cases among 10-19 year olds and an 
almost 16-fold increase among those 20 and older. These data underscore 
the need for a new generation of vaccines and detailed studies focused 
on the pathways of B. pertussis infectivity.
    Available for licensing are three hybridoma cell lines capable of 
expressing monoclonal antibodies against FHA. ELISA and Western blot 
analyses have shown that these antibodies, map to specific epitopes, 
can successfully bind to FHA as well as prevent binding of the purified 
FHA to various cells. The additional studies showed that one antibody 
was able to prevent the adhesion of B. pertussis to epithelial cell 
monolayers. These findings show that monoclonal antibodies expressed in 
featured hybridoma cell lines can be successfully used for studies of 
infectivity mechanisms as well as development of new diagnostics and 
acellular vaccines against B. pertussis.
    Applications:
     New generation of diagnostics.
     Acellular vaccine development.
    Inventor: Michael Brennan (CBER/FDA).
    Relevant Publications:
    1. Leininger E, Probst PG, Brennan MJ, Kenimer JG. Inhibition of 
Bordetella pertussis filamentous hemagglutinin-mediated cell adherence 
with monoclonal antibodies. FEMS Microbiol Lett. 1993 Jan 1;106(1):31-
38.
    2. Leininger E, Bowen S, Renauld-Mong[eacute]nie G, Rouse JH, 
Menozzi FD, Locht C, Heron I, Brennan MJ. Immunodominant domains 
present on the Bordetella pertussis vaccine component filamentous 
hemagglutinin. J Infect Dis. 1997 Jun;175(6):1423-1431.
    Patent Status: HHS Reference No. E-044-2008/0--Research Tool. 
Patent protection is not being sought for this technology.
    Licensing Status: Available for non-exclusive licensing.
    Licensing Contact: Susan Ano, PhD; 301-435-5515; anos@mail.nih.gov.

Automated Method for Rapid Detection of Sickle Cell Disease Inhibitors

    Description of Technology: Available for licensing is a rapid and 
automated method for discovering potential drugs for the treatment of 
sickle cell anemia by determining the sickling times for a large 
population of red blood cells. The method uses a combination of laser 
photolysis and statistical processing of digital images. Sickle cell 
disease is an inherited disorder that affects over 70,000 Americans. 
The disease is characterized by presence of mutant hemoglobin S in red 
blood cells, which polymerizes to form fibers when deoxygenated. Such 
fibers lead to distortion of red blood cells into the shape of a sickle 
and alter the mechanical properties of these cells. Studies demonstrate 
that the time to polymerization involves a delay time and rapid growth 
phase and is particularly sensitive to hemoglobin concentration. As a 
result, identification of drugs that inhibit sickle cell disease is 
accomplished using an assay for delay times for populations of red 
blood cells. The invention creates a uniform time at which 
polymerization is initiated for all red blood cells in the sample 
region and accurately determines the time at which cellular distortion 
begins for each cell. Potential drugs are those compounds that 
significantly increase the delay time of sickling time, i.e. the time 
at which the cell changes shape due to intracellular polymerization.
    Applications:
     Rapid automated detection of compounds that inhibit 
sickling and are therefore potential drugs for sickle cell disease.
     Objective assay for monitoring disease severity.
    Development Status: The technology is capable of determining the 
distribution of cellular delay times in a large number of samples in 
series in a 48 well plate format
    Inventors: Jeffrey F. Smith, H. James Hofrichter, and William A. 
Eaton (NIDDK).
    Patent Status:
     U.S. Patent Application No. 11/652,843, filed 11 Jan 2007 
(HHS Reference No. E-021-2007/0-US-01).
     PCT Application No. PCT/US2008/000427 filed 11 Jan 2008 
(HHS Reference No. E-021-2007/0-PCT-02).
    Licensing Status: Available for licensing.
    Licensing Contact: Cristina Thalhammer-Reyero, PhD, M.B.A.; 301-
435-4507; thalhamc@mail.nih.gov.
    Collaborative Research Opportunity: The NIDDK Laboratory of 
Chemical Physics is seeking statements of capability or interest from 
parties interested in collaborative research to further develop, 
evaluate, or commercialize this technology. Please contact Rochelle S. 
Blaustein, J.D. at 301-451-3636 or rochelle.blaustein@nih.gov for more 
information.

    Dated: September 9, 2008.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. E8-21505 Filed 9-15-08; 8:45 am]

BILLING CODE 4140-01-P