Notice (C): Government-Owned Inventions; Availability for Licensing

Federal Register: January 28, 2010 (Volume 75, Number 18)          
                  Page 4571-4573

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.

[[Page 4572]]

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.

Mouse Macula Densa Cell Line

    Description of Invention: This technology provides a clonally 
derived macula densa cell line (MMDD1 cells) that closely mimics the 
known molecular expression pattern of native macula densa (MD) cells. 
MMDD1 cells are developed from SV-40 transgenic mice using 
fluorescence-activated cell sorting of renal tubular cells labeled with 
segment-specific fluorescent lectins. The MMDD1 cells of this 
technology express COX-2, bNOS, NKCC2, and ROMK, but not Tamm-Horsfall 
protein, and show rapid 86Rb+ uptake that is inhibited by a reduction 
in NaCl concentration and by bumetanide or furosemide. These MMDD1 
cells provide a useful in vitro model for the study of Macula Densa 
function.
    Inventor: J[uuml]rgen B. Schnermann (NIDDK).
    Publication: T Yang, JM Park, L Arend, Y Huang, R Topaloglu, A 
Pasumarthy, H Praetorius, K Spring, JP Briggs, J Schnermann. Low 
chloride stimulation of prostaglandin E2 release and cyclooxygenase-2 
expression in a mouse macula densa cell line. J Biol Chem. 2000 Dec 
1;275(48):37922-37929. [PubMed: 10982805].
    Patent Status: HHS Reference No. E-234-2009/0--Research Tool. 
Patent protection is not being pursued for this technology.
    Licensing Status: Available for licensing under a Biological 
Materials License Agreement.
    Licensing Contact: Suryanarayana (Sury) Vepa, Ph.D., J.D.; 301-435-
5020; vepas@mail.nih.gov.
    Collaborative Research Opportunity: The National Institute of 
Diabetes and Digestive and Kidney Diseases Kidney Disease Branch is 
seeking statements of capability or interest from parties interested in 
collaborative research to further develop, evaluate, or commercialize 
the clonally derived macula densa cell line (MMDD1 cells). Please 
contact Cindy Fuchs at 301-451-3636 for more information.

Novel Analogues of the Natural Product Schweinfurthin With Specificity 
for Tumors and Other Disease Manifestations Associated With 
Neurofibromatosis Type 1

    Description of Invention: The global anti-cancer market is forecast 
to reach $40 billion by 2012. There remains a significant unmet need 
for therapies to treat neurofibromatosis type 1 (``NF1''), a common 
genetic disease that afflicts 1 in 3500 people, and malignant tumors 
carrying NF1 mutations, including tumors of the central and peripheral 
nervous systems.
    Researchers at the National Cancer Institute (``NCI'')-Frederick 
investigating genetic influences on cancer susceptibility of the 
nervous system have synthesized novel analogues of Schweinfurthin, a 
natural compound first isolated from the tropical African plant 
Macaranga schweinfurthii, to which glioma and leukemia cell lines show 
significant sensitivity. The Schweinfurthin analogues also have 
inhibitory activity against mouse and human NF1 cancer cell lines. The 
analogues have a novel mode of action that appears to involve 
regulation of cytoskeletal reorganization.
    These inhibitors are likely to be accepted in the marketplace 
because their potent, selective activity and unique specificity in mode 
of action gives them a distinct advantage over the mechanisms of other 
existing therapies.
    Applications:
     Therapies for tumors associated with NF1 (including brain 
and peripheral nervous system tumors).
     Therapies for leukemia.
     Therapies for NF1 and associated conditions.
    Advantages:
     Utilizes proven small-molecule technology.
     Specificity of mode of action may reduce potential side-
effects.
     Novel mode of action may limit market competition.
    Development Status: Pre-clinical.
    Inventors: Karlyne Reilly et al. (NCI).
    Relevant Publication: Turbyville et al., ``Schweinfurthin A 
Selectively Inhibits Proliferation and Rho Signaling in Glioma and 
Neurofibromatosis type 1 Tumor Cells in an NF1-GRD Dependent Manner'', 
submitted.
    Patent Status: U.S. Patent Application No. 61/174,338, filed 30 Apr 
2009 (HHS Reference No. E-183-2009/0-US-01).
    Licensing Status: Available for licensing.
    Licensing Contact: Patrick P. McCue, Ph.D.; 301-435-5560; 
mccuepat@mail.nih.gov.
    Collaborative Research Opportunity: The Genetic Modifiers of 
Tumorigenesis Section at the National Cancer Institute-Frederick is 
seeking statements of capability or interest from parties interested in 
collaborative research to further develop, evaluate, or commercialize 
Schweinfurthins for the treatment of Neurofibromatosis type 1. Please 
contact John D. Hewes, Ph.D. at 301-435-3121 or hewesj@mail.nih.gov for 
more information.

Detection of Autoantibodies for the Diagnosis of Sjogren's Syndrome

    Description of Invention: This invention provides a method for 
diagnosing Sjogren's syndrome in a subject. In tests utilizing blood 
from human volunteers, this method demonstrated dramatically higher 
accuracy (76%) in positively diagnosing Sjogren's syndrome than a 
standard, currently available immunoassay (46%).
    Briefly, this invention employs a panel of mammalian-derived 
proteins and protein fragments that are often antigentic in individuals 
with Sjogren's syndrome in concert with a luciferase 
immunoprecipitation system. In contrast, most currently available 
immunoassays for diagnosis of rheumatological diseases include either 
antigens from recombinant bacterial expression systems or single 
antigens from bovine sources. These immunoassays are likely to fail to 
present the sufficient variety of specific human epitopes that are 
necessary for high accuracy diagnoses of Sjogren's syndrome.
    Applications:
     Diagnosis of Sjogren's syndrome.
     A component of a panel of diagnostic tests for patients 
with autoimmune disease symptoms.
    Advantages: Higher accuracy than currently available diagnostics of 
Sjogren's syndrome.
    Development Status: Early stage. Initial clinical screens have been 
completed.
    Market: According to the Sjogren's Syndrome Foundation, Inc., it 
takes on average seven years for a positive Sjogren's syndrome 
diagnosis as symptoms of this syndrome mimic other conditions and 
diseases. Up to four million individuals in the United States have 
Sjogren's syndrome, and half of currently diagnosed cases occur in 
concert with other autoimmune disease (http://www.sjogrens.org/home/
about-sjogrens-syndrome).

[[Page 4573]]

    Inventors: Peter D. Burbelo and Michael J. Iadarola (NIDCR).
    Related Publications:
    1. Burbelo PD, Leahy HP, Issa AT, Groot S, Baraniuk JN, Nikolov NP, 
Illei GG, Iadarola MJ. Sensitive and robust luminescent profiling of 
anti-La and other autoantibodies in Sjogren's syndrome. Autoimmunity. 
2009 Sep;42(6):515-524. [PubMed: 19657778]
    2. Burbelo PD, Ching KH, Issa AT, Loftus CM, Li Y, Satoh M, Reeves 
WH, Iadarola MJ. Rapid serological detection of autoantibodies 
associated with Sj[ouml]gren's syndrome. J Transl Med. 2009 Sep 
24;7:83. [PubMed: 19778440]
    3. Burbelo PD, Ching KH, Klimavicz CM, Iadarola MJ. Antibody 
profiling by Luciferase Immunoprecipitation Systems (LIPS). J Vis Exp. 
2009 Oct 7;(32); pii: 1549; doi: 10.3791/1549. [PubMed: 19812534]
    Patent Status: U.S. Provisional Application No. 61/224,649 filed 10 
Jul 2009 (HHS Reference No. E-070-2009/0-US-01).
    Licensing Status: Available for licensing.
    Licensing Contact: Norbert Pontzer, J.D., Ph.D.; 301-435-5502; 
pontzern@mail.nih.gov.
    Collaborative Research Opportunity: The National Institute of 
Dental and Craniofacial Research, Laboratory of Sensory Biology, 
Neurobiology and Pain Therapeutics Section, is seeking statements of 
capability or interest from parties interested in collaborative 
research to further develop, evaluate, or commercialize this 
technology. Please contact David W. Bradley, Ph.D. at 301-402-0540 or 
bradleyda@nidcr.nih.gov for more information.

    Dated: January 21, 2010.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2010-1680 Filed 1-27-10; 8:45 am]
BILLING CODE 4140-01-P