[Federal Register Volume 75, Number 18 (Thursday, January 28, 2010)]
[Notices]
[Pages 4569-4570]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-1667]


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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.

Diagnostic Tool for Diagnosing Benign Versus Malignant Thyroid Lesions

    Description of Invention: This technology describes a 72 gene model 
that has been developed for diagnosing less common forms of thyroid 
cancer like follicular carcinoma and others. The technology detects 
thyroid cancer using fine needle aspiration (FNA) biopsy and the 
analysis of differentially expressed thyroid (DET) genes and their 
encoded proteins. These results provide a molecular classification 
system for thyroid tumors and this in turn provides a more accurate 
diagnostic tool for the clinician managing patients with suspicious 
thyroid lesions. It is related to earlier technology out of the 
laboratory of Dr. Libutti, US Application No. 11/547,995 entitled 
``Diagnostic Tool for Diagnosing Benign vs. Malignant Thyroid Lesions'' 
(HHS Reference No. E-124-2004). This latter invention was drawn to a 6 
and 10 gene model that distinguishes benign vs. malignant papillary 
thyroid lesions.
    Application: The identification of markers that can determine a 
specific type of tumor, predict patient outcome or the tumor response 
to specific therapies.
    Advantage: The use of gene profiles to detect thyroid malignancy 
has the advantage that it complements the current method of diagnosis 
using FNA, but greatly increases the accuracy of detecting malignant 
thyroid lesions.
    Development Status: The technology is currently in the pre-clinical 
stage of development.
    Market: It is expected that more than 37,340 new cases of thyroid 
cancer will be diagnosed in the United States this year. Women will be 
disproportionately affected constituting 76% of these new cases. 
Fortunately, this is one of the least deadly cancers; the percentage of 
people living at least 5 years after being diagnosed is about 97%. 
However, current methods of diagnosis are inaccurate and many biopsy 
results are inconclusive and labeled as suspicious or indeterminate 
because of difficulties in distinguishing benign and malignant thyroid 
tumors solely on cellular features. Since most nodules usually end up 
being benign, treatment decisions are greatly impacted because patients 
with benign nodules may be subjected to unnecessary surgery that will 
impact their lives considerably. Thus, there is a compelling need to 
develop more accurate diagnostic tests to detect thyroid cancer.
    Inventors: Steven K. Libutti (NCI) et al.
    Related Publications:
    1. Prasad NB, Somervell H, Tufano RP, Dackiw AP, Marohn MR, 
Califano JA, Wang Y, Westra WH, Clark DP, Umbricht CB, Libutti SK, 
Zeiger MA. Identification of genes differentially expressed in benign 
versus malignant thyroid tumors. Clin Cancer Res. 2008 Jun 
1;14(11):3327-3337. [PubMed: 18519760]
    2. Rosen J, He M, Umbricht C, Alexander HR, Dackiw AP, Zeiger MA, 
Libutti SK. A six-gene model for differentiating benign from malignant 
thyroid tumors on the basis of gene expression. Surgery. 2005 
Dec;138(6):1050-1056; discussion 1056-1057. [PubMed: 16360390]
    3. Mazzanti C, Zeiger MA, Costouros NG, Umbricht C, Westra WH, 
Smith D, Somervell H, Bevilacqua G, Alexander HR, Libutti SK. Using 
gene expression profiling to differentiate benign versus malignant 
thyroid tumors. Cancer Res.

[[Page 4570]]

2004 Apr 15;64(8):2898-2903. [PubMed: 15087409]
    Patent Status: PCT Application No. PCT/US2008/10139 entitled 
``Diagnostic Tool for Diagnosing Benign Versus Malignant Thyroid 
Lesions'' filed August 27, 2008 (HHS Reference No. E-326-2007/0-PCT-
02).
    Licensing Status: Available for licensing.
    Licensing Contact: Whitney Hastings; 301-451-7337; 
[email protected].
    Collaborative Research Opportunity: The Center for Cancer Research, 
Surgery Branch, is seeking statements of capability or interest from 
parties interested in collaborative research to further develop, 
evaluate, or commercialize Diagnostic Tool for Diagnosing Benign Versus 
Malignant Thyroid Lesions. Please contact John D. Hewes, Ph.D. at 301-
435-3121 or [email protected] for more information.

Imaging of Extracellular Proteases in Cells Using Mutant Anthrax Toxin 
Protective Antigens

    Description of Invention: The claimed invention provides highly 
specific and sensitive methods for in vivo, in vitro, or ex vivo 
imaging of specific extracellular protease activity using an anthrax 
binary toxin system. The system targets cells that express 
extracellular proteases of interest. Such a system would be highly 
useful since various studies have demonstrated a positive correlation 
between the activity of extracellular proteases and various diseases 
and undesirable physiological conditions. For example, breakdown of the 
extracellular matrix by extracellular proteases is a prerequisite for 
the invasive growth of malignant cells, metastatic spread of tumors, 
and other pathological remodeling of tissue. In this case, methods are 
provided for the imaging of a specific extracellular protease by 
contacting a cell with: (1) A mutant anthrax toxin protective antigen 
(mPrAg) that binds to a cell surface receptor of a cell expressing an 
extracellular protease and is cleaved by a specific extracellular 
protease expressed by the cell and 2) a ligand that specifically binds 
to the cleaved mPrAg and is linked to a moiety that is detected by an 
imaging procedure, thereby forming a ligand-mPrAg complex that is 
translocated into the cell. The detectable moiety linked to the ligand 
in the ligand-mPrAg complex can be imaged before, during, or after 
translocation. Specific disease examples might include, but are not 
necessarily limited to, cancer, inflammation, and tumor progression or 
regression.
    Inventors: Thomas H. Bugge et al. (NIDCR).
    Patent Status: U.S. Patent Application No. 10/488,806 filed 04 Mar 
2004 (HHS Reference No. E-295-2001/0-US-03).
    Licensing Status: Available for licensing.
    Licensing Contact: Whitney Hastings; 301-451-7337; 
[email protected].

A Basal Cell Carcinoma Tumor Suppressor Gene

    Description of Invention: Novel human nucleic acid sequences and 
polypeptides derived from the tumor suppressor, PTC or patched gene 
which have been mapped to human chromosome 9q22.3-q31, have been 
discovered for use in cancer diagnosis and therapy. Mutations of this 
gene are associated with Nevoid Basal Cell Carcinoma Syndrome (NBCCS) a 
disease associated with skin cancer and human developmental defects 
such as Gorlin Syndrome comprising skeletal defects, craniofacial and 
brain abnormalities. Methods of detection of PTC in a tissue sample 
have been found as well as recombinant cells, antibodies, and 
pharmacological compositions useful in treatment of the disease. 
Methods of diagnosis of and therapy for NBCCS have also been found. The 
PTC gene is thought to encode a protein which selectively switches off 
growth factor production in certain cells by interaction with members 
of the family of proteins encoded by the ``hedgehog'' gene, which 
instructs cells during development and growth. NBCCS is the result of 
abnormal PTC gene products that encode non-functional or functionally 
reduced NBCCS polypeptides. This lack of function may be caused by 
insertions, deletions, point mutations, splicing errors, premature 
termination codons, missing initiators, etc. The tumors caused by NBCCS 
are slow growing tumors that rarely metastasize, but which can cause 
significant morbidity and occasional mortality from local invasion. The 
PTC gene is also associated with medulloblastomas and 
trichoepitheliomas.
    Newly discovered germline and sporadic mutations associated with 
NBCCS have been disclosed and claimed in the International (PCT) 
application.
    Inventors: Michael C. Dean (NCI) et al.
    Patent Status:
     U.S. Patent No. 6,552,181 issued 22 Apr 2003 (HHS 
Reference No. E-104-1996/1-US-01).
     U.S. Patent No. 7,317,086 issued 08 Jan 2008 (HHS 
Reference No. E-104-1996/1-US-02).
     Related international patents/patent applications.
    Licensing Status: Available for licensing.
    Licensing Contact: Whitney Hastings; 301-451-7337; 
[email protected].

    Dated: January 21, 2010.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2010-1667 Filed 1-27-10; 8:45 am]
BILLING CODE 4140-01-P