[Federal Register Volume 73, Number 219 (Wednesday, November 12, 2008)]
[Notices]
[Pages 66910-66912]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-26787]


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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.

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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.

Therapeutic Targeting of CSN5, a Negative Regulator of p53 and p27, in 
Human Hepatocellular Carcinoma

    Description of Technology: Hepatocellular carcinoma (HCC) 
represents an extremely poor prognostic cancer that remains one of the 
most common and aggressive malignancies worldwide. Elevated expression 
of COP9 complex homolog subunit 5 (CSN5) in early HCC indicates that 
CSN5 is one of the early markers of malignant conversion. COP9 complex 
homolog subunit 5 (CSN5) is a multifunctional protein that interacts 
with a variety of proteins and targets p53 for cell degradation.
    Available for licensing are CSN5 siRNAs and nucleic acid-lipid 
siRNA particles as cancer therapies. HCC cells treated with CSN5 siRNAs 
inhibited HCC progression and increased apoptosis in vitro and in vivo 
suggesting that CSN5 is an effective target for the development of 
cancer treatments.
    Applications:
     siRNA cancer therapeutics.
     Nucleic acid-lipid siRNA particles for targeted drug 
delivery.
     Method to treat cancer.
    Development Status: Early stage of development.
    Market:
     HCC is the most frequent primary malignant tumor of the 
liver with a world incidence of 1 million new cases per year.
     The global cancer therapeutic market is expected to grow 
from $23.1 billion in 2004 to $60.6 billion in 2011. The targeted 
therapy segment is providing the growth of the entire market with an 
expected compound annual growth rate of 24.1 percent for 2004-2011.
    Inventors: Snorri Thorgeirsson (NCI), Yun-Han Lee (NCI), et al.
    Patent Status: U.S. Provisional Application No. 61/045,251 filed 15 
Apr 2008 (HHS Reference No. E-174-2008/0-US-01).
    Publication: JS Lee et al. Classification and prediction of 
survival in hepatocellular carcinoma by gene expression profiling. 
Hepatology 2004 Sept;40(3):667-676.
    Licensing Status: Available for non-exclusive licensing.
    Licensing Contact: Jennifer Wong; 301-435-4633; 
[email protected].

Computer Aided Scoring and Analysis (CASA) for Rapid and Robust 
Detection of Biological Molecules in Tissue Microarrays

    Description of Technology: Tissue Microarray (TMA) technology is a 
technique that allows tissue samples to be miniaturized and 
biologically characterized. The results can be stored digitally and 
analyzed manually for the expression of biological molecules which can 
permit the diagnosis or prognosis of disease. Despite its practical 
use, the current method of manually analyzing TMA samples is subjective 
and lacks the standardization and concordance needed to support 
consistent interpretation of the results. This leads to a low 
correlation in the results obtained amongst different laboratories and 
detection agents.
    The current invention, Computer Aided Scoring and Analysis (CASA), 
provides a means of rapidly and consistently analyzing the expression 
patterns of biological molecules in large quantities of tissue samples. 
This software uses novel algorithms which normalize the pixel data 
obtained from digital images of the samples, statistically determines 
which biological molecules are diagnostic markers for the disease, and 
compares these data to normal, as well as diseased or abnormal tissue 
samples, to diagnose or predict susceptibility to the disease. In some 
applications, two or more biological molecules can be simultaneously 
screened or identified using two or more detection agents making the 
CASA system amenable to methods such as cluster analysis. This type of 
analysis can not only identify groups of antigens that are associated 
with a disease, but can also combine this information with 
characteristics of the patient population, such as age, gender or 
ethnicity to achieve a predictive output. The CASA system can analyze 
data from a broad range of detection agents such as antibodies, 
radionuclides, dyes and quantum dots making it a very attractive tool 
for high throughput TMA analysis.
    The system has already been used successfully for the diagnosis and 
prognosis of non-small cell lung cancer in tissue samples and can be 
adapted for use in many diseases where changes in the expression of one 
or more biological molecules will to be detected.
    Applications:
     Large scale diagnosis of tissue expression patterns of 
biological molecules.
     Rapid, robust tissue diagnosis or prognosis of disease.
     Compatible with wide range of detection agents.
    Development Status: Early Stage.
    Inventors: Abbas Shakoori and Jin Jen (NCI).
    Patent Status: U.S. Provisional Application No. 61/034,868 filed 07 
Mar 2008 (HHS Reference No. E-126-2008/0-US-01).
    Licensing Status: Available for exclusive or non-exclusive 
licensing.
    Licensing Contact: Jeffrey A. James, PhD; 301-435-5474; 
[email protected].

Predictive Test for Age-Related Macular Degeneration in Asymptomatic 
Individuals

    Description of Technology: Age-related macular degeneration (ARMD) 
is the leading cause of severe, irreversible vision loss for those over 
the age of fifty in the United States and in other developed countries. 
Thirteen million Americans over the age of forty have ARMD. ARMD is 
caused by the deterioration of the central area of the retina, or 
macula, resulting in a loss of central vision. This disease is believed 
to be a multigenic disorder, and is triggered by environmental factors 
such as smoking, age or diet in genetically susceptible individuals.
    The present invention describes a highly predictive genetic test 
for universal practical clinical use to identify individuals at 
increased risk for ARMD. It comprises a rapid, accurate and affordable 
genetic screen, utilizing DNA microarray technology on a single chip. 
Sixteen genes are screened for 90 mutations/polymorphisms associated 
with ARMD, with a high predictive power (up to 92.7%) to identify 
asymptomatic carriers at risk. Accurate prediction of genetic 
susceptibility to this disorder will allow interventions to protect at-
risk individuals.
    Applications:
     Method to diagnose ARMD.
     Diagnostic kit to identify asymptomatic individuals at 
risk for ARMD.
     Method to identify genetic factors in an affected 
individual, aiding in the

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development of a tailored therapeutic plan.
     Provide genetic epidemiologic data to elucidate the role 
of genetic factors in the progression of the disease.
    Advantage: Easy, rapid high-throughput method to diagnose ARMD.
    Development Status: This technology requires analytic validation 
before commercialization.
    Market: There are an estimated 15 million cases of age-related 
macular degeneration in the United States, and 50 million cases 
worldwide.
    Inventors: Cigdem F. Dogulu, Owen M. Rennert, Wai-Yee Chan (NICHD)
    Patent Status:
     U.S. Patent Application No. 12/089,694 filed 09 Apr 2008 
(HHS Reference No. E-023-2006/0-US-07).
     Australian Patent Application No. 2006311966 filed 02 Nov 
2006 (HHS Reference No. E-023-2006/0-AU-03).
     Canadian Patent Application No. 2,627,686 filed 02 Nov 
2006 (HHS Reference No. E-023-2006/0-CA-04).
     European Patent Application No. 06836855.4 filed 02 Nov 
2006 (HHS Reference No. E-023-2006/0-CA-04).
     Japanese Patent Application No. 2008-539046 filed 01 May 
2008 (HHS Reference No. E-023-2006/0-JP-06).
    Licensing Status: Available for exclusive or non-exclusive 
licensing.
    Licensing Contact: Jennifer Wong; 301-435-4633; 
[email protected].
    Collaborative Research Opportunity: The NICHD Section on Clinical 
Genomics is seeking statements of capability or interest from parties 
interested in collaborative research to further develop, evaluate, or 
commercialize Method Evolved for Recognition and Testing of Age-Related 
Macular Degeneration (MERT-ARMD). Please contact John D. Hewes, PhD at 
301-435-3121 or [email protected] for more information.

    Dated: November 3, 2008.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. E8-26787 Filed 11-10-08; 8:45 am]
BILLING CODE 4140-01-P