[Federal Register Volume 74, Number 174 (Thursday, September 10, 2009)]
[Notices]
[Pages 46604-46606]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-21786]


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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.

Use of a Modified Adaptor Molecule LAT to Improve Immunotherapy for 
Cancer and Other Diseases

    Description of Technology: One problem with the development of 
immunotherapy for cancer or other diseases is the inability to 
stimulate a sufficient immune response in patients to tumor associated 
antigens. The Linker Adapted for T Cell Signaling molecule (LAT) has 
been shown to be an important molecule in T cell signaling. The 
inventions described and claimed in this patent application illustrate 
a new supportive role for LAT which may be harnessed to improve a 
patient's immune response to tumor-associated antigens.
    A number of approaches to improving the immune response in cancer 
immunotherapy have been investigated. One such approach is to be able 
to influence the potency of T Cell Signaling. This invention exploits 
the role of LAT in T Cell signaling and provides a means to create a 
more intense and effective T Cell response. This would have the end 
result of improving the overall response of a patient's immune system 
to the presence of tumor-associated antigens.
    With T Cell signaling being important in the body's immune response 
to bacterial and viral antigens it may also be possible to harness the 
modified LAT molecules to improve the immune response in developing 
immunotherapy for infectious disease.

Applications

     As an adjuvant with immunotherapeutic agents to improve 
the overall response of a patient's immune system to tumor associated 
antigens.
     As an adjuvant with immunotherapeutic agents to improve 
the overall response of a patient's immune system to bacterial 
associated antigens.
     As an adjuvant with immunotherapeutic agents to improve 
the overall response of a patient's immune system to viral associated 
antigens.
    Advantages: Enhanced T Cell Signaling should improve the overall 
effectiveness of immunotherapy producing a more robust patient 
response.
    Development Status: Early stage, significant development efforts 
required to reach proof of principle.
    Inventors: Lawrence E. Samelson et al. (NCI).
    Publication: This work has not yet been published.

Patent Status

     U.S. Provisional Application No. 61/176,231 filed May 7, 
2009 (HHS Reference No. E-159-2009/0-US-01).
     Interested parties wishing to review the U.S. Patent 
Application will need to sign a CDA.
    Related Technologies: The NIH also has three patents related to the 
basic LAT molecule (HHS Reference No. E-010-1998)--US 7,118,889, AU 
750543, and AU 776495--and several pending applications in the US 
published as 20060073562 A1 and 20070134749 A1 and corresponding 
applications in Canada (2316769) and Europe (1 141 281 A1).
    Licensing Status: Available for licensing.
    Licensing Contact: Susan S. Rucker; 301-435-4478; 
[email protected].

Immunogenic Tumor-Associated Antigen SPANX-B for Selective Cancer 
Immunotherapy

    Description of Technology: Researchers at the National Institutes 
of Health (NIH) have characterized a novel tumor-associated antigen, 
SPANX-B, that is naturally immunogenic and is expressed in a variety of 
human malignancies, including melanoma and lung, colon, renal, ovarian 
and breast carcinomas. In melanoma specifically, SPANX-B expression is 
associated with advanced and metastatic disease. Moreover, the 
researchers have found several agonist epitope peptides from SPANX-B 
which can be used to activate the immune system to eradicate tumors 
utilizing T cells. SPANX-B peptides have significant clinical and 
immunotherapeutic potential for the development of cancer diagnostic 
assays and potent protective and/or therapeutic vaccines to combat a 
wide-range of cancers.

Applications

     In vitro diagnostic assays for highly-metastatic melanomas 
or other cancers.
     Therapeutic monoclonal antibodies.
     Cancer vaccine development.

Advantages

     Immunogenic: SPANX-B peptides are naturally able to elicit 
immune response.
     Expressed in a wide-range of cancers.
     Use of epitope peptides facilitates the activation of 
cells of the more therapeutically effective branch of the immune 
system.
     Small epitope peptides: Can be more easily manufactured in 
contrast to recombinant proteins.
    Development Status: Pre-clinical.
    Market: Cancer; Cancer, Therapy; Cancer, Diagnostics/Prognostics.
    Inventors: Arya Biragyn (NIA) and Vladimir Larionov (NCI).
    Publication: G Almanzar et al. Sperm-derived SPANX-B is a 
clinically relevant tumor antigen that is expressed in human tumors and 
readily recognized by human CD4+ and CD8+ T cells. Clin Cancer Res. 
2009 Mar 15;15(6):1954-1963.
    Patent Status: U.S. Provisional Application No. 61/156,435 filed 
February 27, 2009 (HHS Reference No. E-089-2009/0-US-01).
    Licensing Status: Available for licensing.
    Licensing Contact: Patrick P. McCue, Ph.D.; 301-435-5560; 
[email protected].
    Collaborative Research Opportunity: The National Institute on 
Aging, Laboratory of Immunology, is seeking statements of capability or 
interest from parties interested in collaborative research to further 
develop, evaluate, or commercialize the use of SPANX-B-based 
therapeutic approaches to combat

[[Page 46605]]

cancers. Please contact John D. Hewes, PhD at 301-435-3121 or 
[email protected] for more information.

Biomarkers for Sj[ouml]gren's Syndrome

    Description of Technology: This technology provides differentially-
expressed microRNAs that may be utilized for the development of 
diagnostics and therapeutics for Sj[ouml]gren's syndrome.
    Sj[ouml]gren's syndrome is an autoimmune disorder in which immune 
cells attack and destroy the glands that produce tears and saliva. The 
hallmark symptoms of this disorder are dry mouth and dry eyes, but it 
can also cause serious complications throughout the body. 
Sj[ouml]gren's syndrome affects as many as four million people in the 
United States, making it the second most common autoimmune rheumatic 
disease. Unfortunately, there is currently no cure for Sj[ouml]gren's 
syndrome, nor is there a specific treatment to restore gland secretion. 
Treatment is generally symptomatic and supportive, including moisture 
replacement therapies and the use of non-steroidal anti-inflammatory 
drugs to treat musculoskeletal symptoms. For individuals with severe 
complications, corticosteroids or immunosuppressive drugs are often 
prescribed, but these drugs can have serious side effects.
    The inventors have identified microRNAs that are differentially 
expressed in patients with Sj[ouml]gren's syndrome compared to the 
normal population; these biomarkers can be used to diagnose 
Sj[ouml]gren's syndrome, and are potential targets for treatment of 
this disease. The inventors have also identified microRNAs associated 
with high or low salivary flow in this patient population; these 
markers may serve as targets for therapeutics that restore salivary 
flow.
    Applications: Development of diagnostics and therapeutics for 
Sj[ouml]gren's syndrome.
    Development Status: Discovery stage.
    Market: Sj[ouml]gren's syndrome affects four million people in the 
United States.
    Inventors: Ilias Alevizos and Gabor G. Illei (NIDCR).
    Related Publication: A Michael et al. Exosomes from human saliva as 
a source of microRNA biomarkers. Oral Dis. 2009 Jul 15. Epub ahead of 
print, doi: 10.1111/j.1601-0825.2009.01604.x.
    Patent Status: U.S. Provisional Application No. 61/165,142 filed 
March 31, 2009 (HHS Reference No. E-018-2009/0-US-01).
    Licensing Status: Available for licensing.
    Licensing Contact: Tara Kirby, PhD; 301-435-4426; 
[email protected].
    Collaborative Research Opportunity: The NIDCR is seeking statements 
of capability or interest from parties interested in collaborative 
research to further develop, evaluate, or commercialize differentially-
expressed microRNAs. Please contact David Bradley at 
[email protected].

Treatment of Airway Diseases, Including Asthma and COPD, by Targeting 
Airway Hyperresponsiveness

    Description of Technology: This technology provides methods of 
treatment for airway diseases, including asthma and chronic obstructive 
pulmonary disease (COPD), utilizing molecules that target the airway 
hyperresponsiveness (AHR) pathway.
    Airway diseases are a major health burden in the developed world. A 
major component of airway disease is airway hyperresponsiveness (AHR), 
defined as the exaggerated airway constrictive response to external 
triggers. The inventors have shown that inter-alpha-trypsin inhibitor 
(IaI), a mammalian protein involved in tissue inflammation and repair, 
is necessary for the development of AHR, and that inhibitors of IaI 
prevent the development of AHR. Specifically, the inventors tested 
their hypothesis that IaI inhibition or absence modifies airway smooth 
muscle cell binding to hyaluronan, a molecule known to contribute to 
the response to non-infectious lung injury, which also mediates induced 
AHR.
    Claims in the provisional patent application are directed to 
methods of treating an airway disease or disorder by administering an 
inhibitor of IaI, such as an antibody, a polypeptide, a carbohydrate, a 
small molecule, or an antisense compound.
    Applications: Development of therapeutics for airway diseases, 
including asthma and COPD.
    Development Status: Discovery stage.
    Market: Asthma affects over six percent of the U.S. population, and 
COPD affects approximately five percent. The combined asthma/COPD 
market is expected to reach over $25 billion in 2017.
    Inventors: Stavros Garantziotis (NIEHS) et al.
    Related Publication: S Garantziotis et al. Hyaluronan mediates 
ozone-induced airway hyperresponsiveness in mice. J Biol Chem. 2009 Apr 
24;284(17):11309-11317.
    Patent Status: PCT Application Serial No. PCT/US09/039157 filed 
April 1, 2009 (HHS Reference No. E-009-2009/0-PCT-02).
    Licensing Status: Available for licensing.
    Licensing Contact: Tara Kirby, PhD; 301-435-4426; 
[email protected].
    Collaborative Research Opportunity: The NIEHS Division of 
Intramural Research is seeking statements of capability or interest 
from parties interested in collaborative research to further develop, 
evaluate, or commercialize this technology. Please contact Dr. 
Elizabeth M. Denholm, Director of the Office of Technology Transfer, at 
[email protected] for more information.

MRI Coil Holder for Both Dynamic and Static Imaging of Joints

    Description of Technology: Two new designs of the MRI coil, each of 
which can be used for both dynamic and static imaging of joints, 
particularly knee and ankle joints, have been developed. The first 
design is based on the current cylindrical coil designs: While 
maintaining the overall shape, the top portion of the coil can slide, 
providing room for joint movement during a dynamic exam. To improve the 
signal-to-noise ratio, the adjustable section would be able to transmit 
and receive the MRI signal. The second design describes a coil in the 
form of a rectangular prism. The sides would be adjustable so that the 
size and proportion of the coil can be changed. The top of the coil can 
slide, providing room for a bent knee. All four sides of the coil would 
be able to transmit and receive the MRI signal.
    Applications: MRI (human and veterinary).
    Advantages: Allows for higher quality dynamic imaging while 
maintaining current quality of static imaging, particularly useful for 
imaging knee and ankle joints while they move. Housing is adjustable to 
allow for bent joints while maintaining a favorable signal-to-noise 
ratio.
    Development Status: Detailed design drawings have been completed.
    Inventors: Frances T. (Sheehan) Gavelli and Nicole A. Wilson 
(NIHCC).
    Patent Status: U.S. Provisional Application No. 61/151,300 filed 
February 10, 2009 (HHS Reference No. E-298-2008/0-US-01).
    Licensing Status: Available for licensing.
    Licensing Contact: Bruce Goldstein, J.D., M.S.; 301-435-5470; 
[email protected].


[[Page 46606]]


    Dated: September 1, 2009.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. E9-21786 Filed 9-9-09; 8:45 am]
BILLING CODE 4140-01-P