[Federal Register Volume 78, Number 224 (Wednesday, November 20, 2013)]
[Notices]
[Pages 69700-69701]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-27739]


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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. 209 and 37 CFR part 404 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.

FOR FURTHER INFORMATION CONTACT: 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.

Surgical Tool for Ocular Tissue Transplantation

    Description of Technology: The invention pertains to a device for 
delivering in a precise and controlled way a piece of tissue or sheet 
of cells into the eye such that manipulation of and damage to the 
tissue, cells, and eye are minimized. The device features a handle with 
actuating means, a stationary needle extending from the handle to the 
distal tip, and a pair of grasping arms at the distal tip configured 
for holding tissue or a sheet of cells. An outer tip needle is slidably 
disposed along a length the stationary needle. When the outer tip 
needle is disposed over the pair of grasping arms, the arms are 
collapsed. When the outer tip needle is withdrawn away from the 
grasping arms, the arms are expanded. The outer tip needle, when 
disposed over the grasping arms, also allows for protection of the 
tissue or sheet of cells during surgical manipulation.
    Potential Commercial Applications:
 Ocular transplantation

 Ocular surgery

    Competitive Advantages: Can perform transplantation of micron-sized 
tissue or cell grafts.
    Development Stage: Prototype
    Inventor: Arvydas Maminishkis (NEI)
    Intellectual Property: HHS Reference No. E-105-2013/0--US 
Provisional Application No. 61/845,598 filed 12 July 2013
    Licensing Contact: Michael Shmilovich; 301-435-5019; 
[email protected].

High-Affinity Dopamine D3 Receptor Antagonists and Partial Agonists

    Description of Technology: Investigators at the National Institute 
on Drug Abuse (NIDA) have synthesized a novel class of dopamine D3 
receptor ligands using click chemistry. These novel compounds contain a 
triazole instead of an amide group between the primary and secondary 
pharmacophore. Although the amide linker has been shown to be essential 
for high affinity and selectivity in certain D3 receptor ligands, NIDA 
investigators have determined that the triazole linker maintains 
desired D3 receptor-binding functionality, and may improve 
bioavailability because of its resistance to metabolic amidases.
    Potential Commercial Applications:

 Therapeutic agent for substance abuse (such as alcohol, 
nicotine, cocaine, methamphetamine, opioids)
 Therapeutic agent for cognitive disorders (such as 
schizophrenia, Parkinson's disease, dyskinesia, depression)

 Therapeutic agent for restless legs syndrome

    Competitive Advantages:

 Higher affinity for the dopamine D3 receptor
 Improved bioavailability

    Development Stage: Early-stage.
    Inventors: Amy H. Newman, Ashwini Banala, Thomas M. Keck (all of 
NIDA).
    Intellectual Property: HHS Reference No. E-086-2013/0--US 
Application No. 61/788,167 filed 15 March 2013.
    Related Technologies:
 HHS Reference No. E-251-2002--US Provisional Application No. 
60/410,715
 HHS Reference No. E-128-2006--PCT Application No. PCT/US2007/
071412
    Licensing Contact: Charlene Sydnor, Ph.D.; 301-435-4689; 
[email protected].
    Collaborative Research Opportunity: The National Institute on Drug 
Abuse is seeking statements of capability or interest from parties 
interested in collaborative research to further develop, evaluate or 
commercialize D3 receptor selective antagonists/agonists. For 
collaboration opportunities, please contact Michelle Kim Leff, MD, MBA 
at [email protected].

[[Page 69701]]

Recombinant NIE Antigen From Strongyloides stercoralis

    Description of Technology: Strongyloides stercoralis is an 
intestinal nematode endemic that affects an estimated 30 to 100 million 
people worldwide. Many of these individuals may be asymptomatic for 
decades. The present invention discloses a NIE recombinant antigen that 
can be used in improved assays and diagnostics for S. stercoralis 
infection. The NIE antigen is the only one that is non-cross-reactive 
with sera from humans with other related filaria infections. The NIE 
antigen can be utilized as a skin test antigen for immediate 
hypersensitivity as well as for use in ELISA or other assays.
    Potential Commercial Applications: Assays and diagnostics for S. 
stercoralis infection.
    Competitive Advantages:

 Only non-cross-reactive Strongyloides antigen
 Use in a variety of formats

    Development Stage:

 Prototype
 Pilot
 Pre-clinical
 In vitro data available
 In vivo data available (human).

    Inventors: Thomas B. Nutman, Ravi Varatharajalu, Franklin A. Neva 
(all of NIAID).
    Publications:

1. Krolewiecki AJ, et al. Improved diagnosis of Strongyloides 
stercoralis using recombinant antigen-based serologies in a 
community-wide study in northern Argentina. Clin Vaccine Immunol. 
2010 Oct;17(10):1624-30. [PMID 20739501]
2. Ramanathan R, et al. A luciferase immunoprecipitation systems 
assay enhances the sensitivity and specificity of diagnosis of 
Strongyloides stercoralis infection. J Infect Dis. 2008 Aug 
1;198(3):444-51. [PMID 18558872]
3. Ravi V, et al. Strongyloides stercoralis recombinant NIE antigen 
shares epitope with recombinant Ves v 5 and Pol a 5 allergens of 
insects. Am J Trop Med Hyg. 2005 May;72(5):549-53. [PMID 15891128]
4. Ravi V, et al. Characterization of a recombinant immunodiagnostic 
antigen (NIE) from Strongyloides stercoralis L3-stage larvae. Mol 
Biochem Parasitol. 2002 Nov-Dec;125(1-2):73-81. [PMID 12467975]

    Intellectual Property: HHS Reference No. E-081-2012/0--Research 
Material. Patent protection is not being pursued for this technology.
    Licensing Contact: Edward (Tedd) Fenn, J.D.; 424-500-2005; 
[email protected].

Therapeutic Hepatitis C Virus Antibodies

    Description of Technology: Therapeutic antibodies against Hepatitis 
C Virus (HCV) have not been very effective in the past and there is 
evidence that this may result in part from interfering antibodies 
generated during infection that block the action of neutralizing 
antibodies. These neutralizing antibodies prevent HCV infection of a 
host cell.
    The subject technologies are monoclonal antibodies against HCV that 
can neutralize different genotypes of HCV. Both antibodies bind to the 
envelope (E2) protein of HCV found on the surface of the virus. One of 
the monoclonal antibodies neutralizes HCV genotype 1a, the most 
prevalent HCV strain in the U.S., infection and in vitro data show that 
it is not blocked by interfering antibodies. The second antibody binds 
a conserved region of E2 and can cross neutralize a number of genotypes 
including genotypes 1a and 2a. The monoclonal antibodies have the 
potential to be developed either alone or in combination into 
therapeutic antibodies that prevent or treat HCV infection. These 
antibodies may be particularly suited for preventing HCV re-infection 
in HCV patients who undergo liver transplants; a population of patients 
that is especially vulnerable to the side effects of current treatments 
for HCV infection.
    Potential Commercial Applications: Therapeutic antibodies for the 
prevention and/or treatment of HCV infection.
    Competitive Advantages:

 Therapeutic antibodies have generally fewer side effects than 
current treatments for HCV infection.
 Potential to be developed into an alternative treatment for 
HCV infected liver transplant patients, who often cannot tolerate the 
side effects of current drug treatments.

    Development Stage:

 Early-stage
 Pre-clinical
 In vitro data available
    Inventors: Stephen M. Feinstone, Hongying Duan, Pei Zhang, Marian 
E. Major, Alla V. Kachko (all of FDA)
    Publications:

1. Kachko A, et al. New neutralizing antibody epitopes in hepatitis 
C virus envelope glycoproteins are revealed by dissecting peptide 
recognition profiles. Vaccine. 2011 Dec 9;30(1):69-77. [PMID 
22041300]
2. Duan H, et al. Amino acid residue-specific neutralization and 
nonneutralization of hepatitis C virus by monoclonal antibodies to 
the E2 protein. J Virol. 2012 Dec;86(23):12686-94. [PMID 22973024]

    Intellectual Property:

 HHS Reference No. E-002-2012/0--US Provisional Patent 
Application No. 61/648,386 filed 17 May 2012; International PCT 
Application No. PCT/US13/41352 filed 16 May 2013
 HHS Reference No. E-167-2012/0--International PCT 
Application No. PCT/US12/62197 filed 26 October 2012

    Licensing Contact: Kevin W. Chang, Ph.D.; 301-435-5018; 
[email protected].

    Dated: November 13, 2013.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2013-27739 Filed 11-19-13; 8:45 am]
BILLING CODE 4140-01-P