2011-25730. Government-Owned Inventions; Availability for Licensing

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: [phone]; fax: [phone]. 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; [e-mail]

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 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; [e-mail]

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 [e-mail] 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; [e-mail].

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 [e-mail] 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 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; [e-mail].

Dated: September 26, 2011.

Richard U. Rodriguez,

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