[Federal Register Volume 76, Number 193 (Wednesday, October 5, 2011)]
[Notices]
[Pages 61717-61719]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-25730]


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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.

Humanized Monoclonal Antibodies Efficient for Neutralization of Tick-
Borne Encephalitis Virus (TBEV)

    Description of Technology: TBEV causes serious illnesses from 
meningitis to meningo-encephalitis, totaling 3,000 cases of 
hospitalization in Europe and between 5,000-10,000 cases in Russia 
reported every year. The Far Eastern hemorrhagic TBEV strains are 
associated with a mortality rate (between 1-2%), higher than other 
strains isolated in the Siberia or Western Europe. There is a high 
proportion (up to 46%) of TBEV patients with temporary or permanent 
neurological sequelae. The number of TBEV infections has increased 
steadily and TBEV cases have been reported in new areas, probably 
reflecting an increased spread of vector tick species. Prevention of 
TBEV infections has been carried out in a few countries in Europe by 
immunization using an inactivated TBEV vaccine. The vaccine carries a 
high manufacturing cost and requires a regimen of multiple doses, and 
for this reason, vaccination is not generally carried out. The 
materials disclosed are humanized monoclonal antibodies derived from 
TBEV-neutralizing Fab antibodies isolated from infected chimpanzees by 
repertoire cloning. One antibody in particular, MAb 2E6, has been 
demonstrated to bind to and neutralize a TBEV/dengue type 4 virus 
chimera (via interaction with the TBEV antigenic determinants) as well 
as the related Langat virus. Protection against TBEV/DEN-4 infection 
and Langat infection has been demonstrated using animal models of 
infection. The antibodies disclosed, in particular MAb 2E6, have the 
potential for use as prophylactic and therapeutic agents against TBEV 
and Langat virus. Additionally, these antibodies may be suitable as 
diagnostic reagents for the detection of TBEV and/or Langat virus.
    Potential Commercial Applications:
     TBEV Prophylaxis.
     TBEV Therapy.
     TBEV Diagnostics.
    Competitive Advantages:
     Cost effective alternative to existing vaccine.
     Fully humanized antibody.
     Strongly neutralizing antibody.
     Efficient production methods.
    Development Stage:
     Pre-clinical.
     In vitro data available.
     In vivo data available (animal).
    Inventors: C. J. Lai, Robert Purcell, Alexander Pletnev (NIAID).
    Intellectual Property: HHS Reference No. E-231-2011/0--Research 
Tool. Patent protection is not being pursued for this technology.
    Licensing Contact: Peter Soukas; 301-435-4646; [email protected]
    Collaborative Research Opportunity: The NIAID is seeking statements 
of capability or interest from parties interested in collaborative 
research to further develop, evaluate or commercialize TBEV monoclonal 
antibodies. For collaboration opportunities, please contact Wade 
Williams at 301-827-0258.

Rapid Molecular Assays for Specific Detection and Quantitation of Loa 
Loa Microfilaremia

    Description of Technology: The risk of fatal reactions in some 
infected individuals administered drug treatments for Loa loa 
infection, and the lack of accurate, convenient, diagnostics for this 
infection have thwarted efforts to eradicate the disease. Time 
consuming, labor intensive and training intensive microscope-based 
analysis of blood samples is the standard available diagnostic for Loa 
loa infection. This new assay technology introduces an easy to use, 
species-specific, highly sensitive, diagnostic that is able to be 
performed with minimal training. Positive test results may be indicated 
by an easily visualized color change and this test may be run without 
the need for expensive equipment such as a thermocycler. Because this 
test is rapid, cost efficient, labor efficient, accurate, and simple to 
run and read, it may be readily incorporated into portable point-of-
care formats. These attributes make it ideally suited for use in 
locations where Loa loa infection is endemic. These advantages may lead 
to this technology becoming the new standard for diagnosis of Loa loa 
infections and a valuable tool, in control programs, to

[[Page 61718]]

identify risks for adverse treatment reactions.
    Potential Commercial Applications:
     Diagnostics testing.
     Infectious disease monitoring.
    Competitive Advantages: Greater speed cost and labor efficiencies, 
accurate, and simple to run and read and ability to be incorporated 
into portable point-of-care format, ideally suited for Loa loa endemic 
regions.
    Development Stage:
     Early-stage.
     Pre-clinical.
    Inventors: Doran Fink and Thomas Nutman (NIAID).
    Publications:
    1. Fink DL, et al. Rapid molecular assays for specific detection 
and quantitation of Loa loa microfilaremia. PLoS Negl Trop Dis. 2011 
Aug 30; 5(8): e1299; doi:10.1371/journal.pntd.0001299.
    2. Klion AD, et al. Cloning and characterization of a species-
specific repetitive DNA sequence from Loa loa. Mol Biochem Parasitol. 
1991 Apr; 45(2): 297-305. [PMID: 2038361].
    Intellectual Property: HHS Reference No. E-014-2011/0--U.S. 
Application No. 61/410,232 filed 04 Nov 2010.
    Related Technologies:
     HHS Reference No. E-281-2010/0--U.S. Application No. 61/
410,239 filed 04 Nov 2010.
     HHS Reference No. E-084-2010/0--PCT Application No. PCT/
US2011/023320 filed 01 Feb 2011.
    Licensing Contact: Tedd Fenn; 301-435-5031; [email protected]
    Collaborative Research Opportunity: The National Institute of 
Allergy and Infectious Disease (NIAID) is seeking statements of 
capability or interest from parties interested in collaborative 
research to further develop, evaluate or commercialize Rapid Molecular 
Assays for Specific Detection and Quantitation of Loa Loa 
Microfilaremia. For collaboration opportunities, please contact Johanna 
Schneider, PhD. at [email protected] or 301-451-9824.

Diagnostic Assays and Methods of Use for Detection of Filarial 
Infection

    Description of Technology: The effort targeting the mosquito borne 
neglected tropical disease lymphatic filariasis for elimination through 
mass drug administration by 2020 will require accurate, cost effective 
methods for detecting early infections. The World Health Organization-
recommended immunochromatographic test detects adult Wuchereria 
bancrofti (Wb) antigen in blood, but shows variable efficacy due to the 
complex life cycle of the parasites and cross reactivity with other 
organisms. This variability may hinder effective lymphatic filariasis 
elimination efforts. This new technology improves available detection 
methods through use of an isolated immunoreactive antigen, Wb123, from 
infective stage larvae (L3) Wb; which results in specific detection 
early in the infective cycle with reduced cross reactivity. This 
technology may see wide application in testing and surveillance of 
lymphatic filariasis as part of the effort to eliminate the disease 
worldwide.
    Potential Commercial Applications:
     Diagnostics testing.
     Infectious disease monitoring.
    Competitive Advantages: Improved detection of early stage lymphatic 
filariasis.
    Development Stage:
     Early-stage.
     Pre-clinical.
    Inventors: Doran Fink (NIAID), Joseph Kubofcik (NIAID), Peter 
Burbelo (NIDCR), Thomas Nutman (NIAID).
    Publications:
    1. Senbagavalli P, et al. Heightened measures of immune complex and 
complement function and immune complex-mediated granulocyte activation 
in human lymphatic filariasis. Am J Trop Med Hyg. 2011 Jul;85(1):89-96. 
[PMID 21734131]
    2. Bennuru S, et al. Stage-specific proteomic expression patterns 
of the human filarial parasite Brugia malayi and its endosymbiont 
Wolbachia. Proc Natl Acad Sci USA. 2011 Jun;7;108 (23):9649-9654. [PMID 
21606368].
    3. Steel C, et al. PLoS One. Altered T cell memory and effector 
cell development in chronic lymphatic filarial infection that is 
independent of persistent parasite antigen. 2011 Apr 29;6(4):e19197. 
[PMID 21559422].
    4. Fink DL, et al. Toward molecular parasitologic diagnosis: 
enhanced diagnostic sensitivity for filarial infections in mobile 
populations. J Clin Microbiol. 2011 Jan;49(1):42-47. [PMID 20980560].
    5. Bennuru S, et al. Elevated levels of plasma angiogenic factors 
are associated with human lymphatic filarial infections. Am J Trop Med 
Hyg. 2010 Oct;83(4):884-890. [PMID 20889885].
    Intellectual Property: HHS Reference No. E-281-2010/0--U.S. 
Application No. 61/410,239 filed 04 Nov 2010.
    Related Technologies:
     HHS Reference No. E-084-2010/0--PCT Application No. PCT/
US2011/023320 filed 01 Feb 2011.
     HHS Reference No. E-014-2011/0--U.S. Application No. 61/
410,232 filed 04 Nov 2010.
    Licensing Contact: Tedd Fenn; 301-435-5031; [email protected].
    Collaborative Research Opportunity: The National Institute of 
Allergy and Infectious Disease (NIAID) is seeking statements of 
capability or interest from parties interested in collaborative 
research to further develop, evaluate or commercialize Diagnostic 
Assays and Methods of Use for Detection of Filarial Infection. For 
collaboration opportunities, please contact Johanna Schneider, Ph.D. at 
[email protected] or 301-451-9824.

A System and Method for Detecting Untoward Events in Hospitals

    Description of Technology: This invention is of potential benefit 
to public health and patient care and can be commercially utilized by 
medical centers, hospitals and commercial developers of hospital 
information systems. It is basically a computer science based 
technology that may provide the capability of detecting untoward events 
such as patient crises, individual clinic adverse occurrences and 
adverse reactions related to new medication lots and inconsistencies in 
ordered and delivered patient medications and other treatments. The 
technology is comprised of a dedicated computer server that executes 
specially designed software with input data from a main hospital 
information system and other relevant patient data sensors and systems. 
The technology also includes design specifications for constructing a 
``patient registration system'', an untoward event specification 
catalogue, intelligent software for detecting untoward events, and a 
report listing untoward alerts, as well as a light and sound panel 
design for signaling untoward alerts. The preferred embodiment for this 
technology is the NIH Clinical Center Clinical Research Informatics 
System (CRIS) presently operational in the NIH Clinical Center in 
Bethesda, Maryland.
    Potential Commercial Applications: The technology can be 
commercially utilized by medical centers, hospitals and commercial 
developers of hospital information centers to improve patient medical 
treatment and clinical outcome.
    Competitive Advantages: The design of the system is novel and 
practical. It fulfills and automates the need for a system and 
methodology that predicts, detects and signals untoward patient events 
and other untoward clinical events.
    Development Stage: Prototype.
    Inventors: James M. DeLeo and Patricia P. Sengstack (NIHCC).
    Publications:
    1. Heldt T, et al. Integrating Data, Models, and Reasoning in 
Critical Care. Proceedings of the 28th IEEE EMBS Annual International 
Conference, New

[[Page 61719]]

York City, USA, Aug 30-Sept 3, 2006, pp 350-353; doi 10.1109/
IEMBS.2006.259734.
    2. Hripcsak G, et al. Mining complex clinical data for patient 
safety research: a framework for event discovery. J Biomed Inform. 2003 
Feb-Apr;36(1-2):120-130. [PMID 14552853].
    3. Horsky J, et al. A framework for analyzing the cognitive 
complexity of computer assisted clinical ordering. J Biomed Inform. 
2003 Feb-Apr;36(1-2):4-22. [PMID 14552843].
    Intellectual Property: HHS Reference No. E-227-2009/0--Research 
Tool. Patent protection is not being pursued for this technology.
    Licensing Contact: Michael Shmilovich, Esq.; 301-435-5019; 
[email protected].

    Dated: September 26, 2011.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2011-25730 Filed 10-4-11; 8:45 am]
BILLING CODE 4140-01-P