[Federal Register Volume 74, Number 70 (Tuesday, April 14, 2009)]
[Notices]
[Pages 17197-17199]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-8473]


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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, 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.

Insect Salivary Proteins as Potent Adjuvants for Enhancing Immune 
Responses

    Description of Technology: This invention relates to the discovery 
that specific sand fly salivary proteins have marked effects on the 
outcome of Leishmania infection. These proteins have the ability to 
stimulate strong Th1 and Th2 responses. The Th1 responses with one 
protein, PpSP15, result in immune protection while the Th2 responses to 
another protein, PpSP44, exacerbate infection. The protective protein 
enhanced a specific immune response to the infection, suggesting that 
it acts as an adjuvant to alter the environment and presentation of the 
parasite antigens.
    These immunogenic salivary proteins, capable of driving Th1 or Th2 
responses, can be used as adjuvants in vaccine development for a broad 
spectrum of diseases that require different immune responses. They may 
therefore be used to enhance immune responses to pathogens other than 
Leishmania parasites. They are also very potent in their effect, and 
small doses are sufficient to elicit a strong immune response. This 
potency can reduce the need to use chemical adjuvants, which often 
require large mounts of material and can have deleterious side effects.
    Applications:
     Vaccine for Leishmania parasite and other pathogenic 
infections.
     Potent adjuvant for a broad spectrum of diseases.
    Advantages: Efficient, potent, and less toxic than many chemical 
adjuvants.
    Development Status: Early Stage.
    Market:
     88 countries with an estimated 2 million people affected 
each year.
     Estimated 350 million at risk worldwide.
    Inventors: Jesus G. Valenzuela et al. (NIAID).
    Publication: F Oliveira, PG Lawyer, S Kamhawi, JG Valenzuela. 
Immunity to distinct sand fly salivary proteins primes the anti-
Leishmania immune response towards protection or exacerbation of 
disease. PLoS Negl Trop Dis. 2008 Apr 16;2(4):e226.
    Patent Status: U.S. Provisional Application No. 61/089,884 filed 08 
Aug 2008 (HHS Reference No. E-303-2008/0-US-01).
    Licensing Status: Available for licensing.
    Licensing Contact: Jeffrey A. James PhD; 301-435-5474; 
[email protected].
    Collaborative Research Opportunity: The NIAID, Office of Technology 
Development is seeking statements of capability or interest from 
parties interested in collaborative research to further develop, 
evaluate, or commercialize the Insect Salivary Proteins as potent 
immune response adjuvants. Please contact Charles Rainwater at 
[email protected] or 301/496-2644 for more information.

Anti-Cancer Oligodeoxynucleotides

    Description of Technology: A majority of human cancers originate 
from epithelial tissue. A common cancer of epithelial cell origin is 
non-melanoma skin cancer (NMSC), including basal cell carcinoma (BCC) 
and squamous cell carcinoma (SCC), with more than seven hundred 
thousand (700,000) new cases diagnosed each year in the United States 
alone. BCC is rarely life-threatening because it is slow growing and is 
mostly localized. Unlike BCC, SCC metastasizes at a rate of two (2) to 
six (6) percent over several years after the initial diagnosis. A 
highly malignant form invades and destroys tissue, and then 
metastasizes, initially to a regional lymph node before more distant 
organs such as the lungs or brain are affected. SCC is commonly 
encountered in a number of epithelial tissues, including the oral 
cavity, esophagus, larynx, bronchi, intestines, colon, genital tract, 
and skin.
    This application relates to suppressive CpG oligodeoxynucleotides 
(ODNs). This application claims suppressive ODN compositions and their 
use to prevent or delay the formation of a tumor, reducing the risk of 
developing a tumor, treating a tumor, preventing conversion of a benign 
to a malignant lesion, or preventing metastasis. Topical application of 
the ODNs of this invention in preclinical studies resulted in 
significantly fewer animals developing papillomas and fewer papillomas/
animal. The invention also relates to use of suppressive ODNs to 
prevent/delay cancer when administered systemically as well as locally.
    Application: Development of anti-cancer vaccines, therapeutics and 
diagnostics.
    Development Status: ODNs have been synthesized and preclinical 
studies have been performed.
    Inventors: Dennis M. Klinman and Hidekazu Ikeuchi (NCI)
    Patent Status: U.S. Provisional Application No. 61/119,998 filed 04 
Dec 2008 (HHS Reference No. E-296-2008/0-US-01).
    Licensing Status: Available for licensing.
    Licensing Contact: Peter A. Soukas, J.D.; 301-435-4646; 
[email protected].
    Collaborative Research Opportunity: The National Cancer Institute, 
Laboratory of Experimental Immunology, 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.

Neutralization of Hepatitis C Virus (HCV)

    Description of Technology: Available for licensing and commercial 
development are compositions and methods for preventing and/or treating 
infection caused by hepatitis C virus (HCV). The invention is based on 
mapping studies conducted by the inventors of two epitopes within HCV 
E2: epitope I and epitope II. It has been discovered that epitope I is 
involved in virus neutralization but that epitope II mediates antibody 
interference,

[[Page 17198]]

probably an adaptation of the virus to obfuscate the immune system. In 
an effort to attenuate or disable the interference effect of HCV-E2 
epitope II, the present invention is directed to a HCV E2 polypeptide 
substitution/deletion of native amino acids LFY in epitope II, a HCV E2 
polypeptide insertion of amino acids between the native LFY in epitope 
II, or the use of epitope II as a molecular decoyant or to affinity-
purify an immune globulin to deplete interfering antibodies from, and 
enrich neutralizing antibodies in, the preparation.
    Applications: HCV vaccines; HCV therapeutics.
    Advantages: Improved HCV vaccines and therapeutics.
    Development Status: The technology is currently in the preclinical 
stage of development.
    Inventors: Pei Zhang, Marian Major, Stephen Feinstone (FDA).
    Publications:
    1. P Zhang et al. Hepatitis C virus epitope-specific neutralizing 
antibodies in Igs prepared from human plasma. Proc Natl Acad Sci USA. 
2007 May 15;104(20):8449-8454.
    2. MY Yu et al. Neutralizing antibodies to hepatitis C virus (HCV) 
in immune globulins derived from anti-HCV-positive plasma. Proc Natl 
Acad Sci USA. 2004 May 18;101(20):7705-7710.
    Patent Status:
    U.S. Provisional Application No. 61/002,031 filed 06 Nov 2007 (HHS 
Reference No. E-276-2007/0-US-01).
    PCT Application No. PCT/US2008/082368 filed 04 Nov 2008 (HHS 
Reference No. E-276-2007/1-PCT-01).
    Licensing Status: Available for licensing.
    Licensing Contact: RC Tang, JD, LLM; 301-435-5031; 
[email protected].
    Collaborative Research Opportunity: The FDA Center for Biologics 
Evaluation and Research, Laboratory of Plasma Derivatives, is seeking 
statements of capability or interest from parties interested in 
collaborative research to further develop, evaluate, or commercialize 
this technology. Please contact Alice Welch, PhD at 301-827-0359 or 
[email protected] for more information.

Live-Attenuated West Nile Virus Vaccines with Improved Immune Responses

    Description of Technology: West Nile virus (WNV), the etiologic 
agent of West Nile virus fever and encephalitis, is an emerging human 
and veterinary pathogen in North America. WNV also periodically poses a 
serious threat to public health in Africa, Australia, Europe, the 
Middle East, and Asia. There is no vaccine available. WNV strains are 
phylogenetically grouped into two distinct lineages based primarily on 
differences within the envelope (Env) protein gene segment. The highly 
virulent strains recently emergent on the North American continent are 
of lineage I. Lineage I viruses are primarily also isolated in the 
Middle East, Europe, and parts of Africa. Lineage II viruses are mostly 
isolated in Africa. Both lineages include highly neurovirulent as well 
as relatively attenuated strains of WNV.
    WN vaccine viruses developed by others are chimeric live attenuated 
WN vaccine viruses. The genomes of these viruses encode the C and NS 
proteins of dengue or yellow fever virus, respectively, along with the 
WNV prM and Env proteins, which are the major targets of the humoral 
immune response to flaviviruses. These chimeric live attenuated WN 
vaccines have been successful in animal testing and some are currently 
in clinical trials. However, these vaccines have two potential 
disadvantages due to their heterogeneous genetic composition: (i) 
Animal host range may be different from that of wild-type WNV, 
rendering the vaccines less than optimal for immunization of some at-
risk species and (ii) the elicited immune response may be suboptimal in 
duration or quality, due to the absence from these vaccines of 
homologous WN NS proteins.
    FDA's technology that is available for licensing comprises live 
attenuated West Nile viruses that are not chimeric, but instead have 
one or more mutations in the 3' terminal stem loop secondary structure, 
resulting in decreased neurovirulence. The related patent application 
also claims methods of making the viruses claimed in the application 
and methods for using these viruses to prevent or treat WN infection. 
More specifically, the inventors modified infectious WN DNA such that 
all or segments of the wild-type WN 3' stem loop nucleotide sequence 
was replaced with analogous dengue virus serotype 2 3' stem loop 
sequences. The inventors also created a number of point mutations in 
the nucleotide sequence of the WN 3' stem loop sequence.
    Application: Development of live attenuated West Nile Virus 
vaccines, therapeutics and diagnostics.
    Development Status: Vaccine candidates have been prepared and 
preclinical (mouse) studies have been performed.
    Inventors: Lewis Markoff and Li Yu (FDA/CBER).
    Publication: L Yu et al. Attenuated West Nile viruses bearing 3'SL 
and envelope gene substitution mutations. Vaccine. 2008 Nov 
5;26(47):5981-5988.
    Patent Status:
    HHS Reference No. E-022-2004/0--
     U.S. Provisional Patent Application No. 60/579,396 filed 
14 Jun 2004.
     PCT Patent Application No. PCT/US2005/0207327 filed 14 Jun 
2005.
     U.S. Patent Application No. 11/629,560 filed 14 Dec 2006.
    Licensing Status: Available for licensing.
    Licensing Contact: Peter A. Soukas, J.D.; 301-435-4646; 
[email protected].
    Collaborative Research Opportunity: The FDA Office of Vaccines 
Research & Review is seeking statements of capability or interest from 
parties interested in collaborative research to further develop, 
evaluate, or commercialize West Nile Virus vaccines. Please contact 
Alice Y. Welch, PhD, at 301-827-0359 or [email protected] for 
more information.

Neuronal Decoding Algorithm for Prosthetic Limbs

    Description of Technology: The invention is a new algorithm for 
decoding neuronal responses based on the discovery that neuronal spike 
trains can be described using order statistics. The device has 
applications in the direct control of prosthetic limbs by neuronal 
signals originating from electrodes placed in the brain. The method 
allows for decoding neuronal responses by monitoring sequences of 
potentials from neurons while specific motor tasks are carried out. The 
sequences are then characterized using the innovative technique of 
applying order statistics to the spike train, such that subsequent 
action potentials representing unidentified motor tasks can be decoded 
to determine the unknown task. The invention is of substantial 
importance because it appears to have achieved a closed form 
interpretation of neuronal responses upon which a motor prosthetic 
device might be based.
    Applications: Direct control of prosthetic limbs by neurons; Closed 
form interpretation of neuronal response for prosthetic devices.
    Development Status: Early Stage.
    Inventors: Barry J. Richmond and Matthew C. Wiener (NIMH).
    Patent Status: U.S. Patent No. 7,442,212 issued 28 Oct 2008 (HHS 
Reference No. E-038-2001/0-US-03).
    Licensing Status: Available for licensing.

[[Page 17199]]

    Licensing Contact: Jeffrey A. James, PhD; 301-435-5474; 
[email protected].
    Collaborative Research Opportunity: The National Institute of 
Mental Health, Laboratory of Neuropsychology, is seeking statements of 
capability or interest from parties interested in collaborative 
research to further develop, evaluate, or commercialize decoding 
algorithm for neuronal responses. Please contact Suzanne Winfield at 
[email protected] or 301-402-4324 for more information.

    Dated: April 7, 2009.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. E9-8473 Filed 4-13-09; 8:45 am]
BILLING CODE 4140-01-P