[Federal Register Volume 71, Number 173 (Thursday, September 7, 2006)]
[Notices]
[Pages 52804-52805]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-14831]


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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.

Oligo Microarray for Detection of All Known Mammalian and Avian 
Pathogenic Viruses

    Description of Technology: The spectrum of pathogenic viruses of 
importance in human disease, agriculture and biology is not only large 
and diverse, but continually evolving. The identification or isolation 
of viral pathogens, in correlation with the presence of specific 
disease phenotypes, is of paramount importance both to diagnosis of 
disease and the subsequent management or treatment of viral infection. 
The limitations of current viral detection methods, such as PCR and 
immunoassays, led to the development of a novel microarray system for 
specific detection of viruses. The technology offered here for 
licensing provides a method for high-throughput screening of known 
pathogenic viruses along with identification of ``new'' disease-
associated viruses.
    The novel method is based on a viral microarray containing 10,000 
immobilized DNA oligonucleotide features, representing all known 
mammalian and avian pathogenic viruses (approximately 600). Software 
was also developed to analyze the viral microarray results. The 
oligonucleotide features in this system are 60-mer long and distributed 
across both conserved and non-conserved regions of known viral 
sequences. This design serves the dual purpose of: (1) Facilitating 
validation via redundant signals associated with each represented virus 
and (2) allowing for the discovery of new viruses, which arise due to 
recombination. In addition, positive and negative controls against 
human and mouse housekeeping genes are included along with software for 
analysis of virus microarray results.
    Further advantages of the viral microarray include: (a) The use of 
sample inputs as little as 10ng of either total DNA or RNA extracted 
from virus infected cells, representing as few as 20 viral particles; 
(b) detection of viruses of both DNA and RNA classes; (c) a capacity 
for high-throughput screening of various sample types including serum, 
saliva and biopsy tissues; and (d) analysis of a large number of 
samples in parallel on identical arrays.
    The detection of viral DNA is unique to this technology, as other 
available technologies only detect viral genomic RNA or viral mRNA 
transcripts. Additionally, the viral chip was found to be highly 
specific and sensitive for detecting different viral genomic sequences 
in cell lines and multiple viral constructs co-infection in cultured 
cells.
    Applications: (1) Detection and identification of viruses that 
cause disease; (2) Efficient discovery of new pathogenic viruses; (3) 
Diagnosis of human and animal disease outbreaks; (4) Identification of 
viral agents used in bioterrorism.
    Development Status: (1) The pre-clinical performance of the viral 
microarray was evaluated by application of four virally positive 
infected cell lines (JSC-1-harboring EBV and KSHV, BCBL-1 harboring 
KSHV, HeLa-harboring HPV18, Cem X 174 harboring SIV). (2) Clinical 
performance was tested and validated through analysis of total RNA from 
cold (swab), Japanese Encephalitis, Dengue, Ebola and West Nile virus 
samples.
    Inventors: Cassio S. Baptista (NCI), Xiaolin Wu (NCI), David J. 
Munroe (NCI).
    Patent Status: U.S. Provisional Application No 60/797,334 filed 02 
May 2006 (HHS Reference No. E-206-2006/0-US-01).
    Licensing Status: Available for non-exclusive or exclusive 
licensing.
    Licensing Contact: Cristina Thalhammer-Reyero, PhD, MBA; 301/435-
4507; [email protected]
    Collaborative Research Opportunity: The NCI-Laboratory of Molecular 
Technology is seeking statements of capability or interest from parties 
interested in collaborative research to further develop, evaluate, or 
commercialize this oligo microarray for identification and detection of 
all known mammalian and avian pathogenic viruses. Please contact Betty 
Tong, PhD at 301-594-4263 or [email protected] for more information.

Novel Monoclonal Antibody Microarray

    Description of Technology: Gene expression profiling at the mRNA 
level has proven to be a powerful and useful tool, however this 
approach suffers from inherent limitations: (1) The mRNA abundance does 
not typically correlate well with protein abundance and (2) protein 
structure, activity, and function can be altered and regulated by post-
translational modifications. Thus, there is growing recognition that 
these approaches should be complemented by profiles of the gene 
products or proteins themselves. The present invention provides methods 
for constructing and using a novel Monoclonal Antibody Microarray which 
allows high-throughput determination of protein expression profiles 
from serum, tissue, and cultured cells.
    The Monoclonal Antibody Microarray consists of more than 1000 
different antibodies immobilized on a glass slide, which recognize 
antigens from several groups of proteins, including cytokines, kinases, 
apoptotic proteins, growth factor receptors, tumor suppressors, and 
oncoproteins. Protein samples to be identified and quantified are 
labeled with fluorescence and hybridized to the antibodies immobilized 
on the arrays. By differentially labeling two protein samples (dual-
color labeling) and co-hybridizing to the same microarray, a direct 
comparative analysis of protein expression can be performed using as 
little as 100 [mu]g of total protein. This method allows a large number 
of samples to be screened in parallel on identical arrays.
    Applications: (1) High-throughput analysis of protein expression; 
(2) Direct measurement of protein expression at

[[Page 52805]]

the gene product or post-translational levels.
    Development Status: (1) The microarrays' performance was tested by 
proteomic profiling of two NCI-60 cancer cell lines (Renal UO-31 and 
Leukemia HL-60), demonstrating a high level of reproducibility. (2) The 
microarrays' performance was further evaluated by analysis of the 
protein expression profiles of 12 Borderline ovarian and 9 
Adenocarcinoma ovarian tumors using normal ovarian surface epithelial 
cells as a reference cell line. It was possible to detect 77 proteins 
that showed statistically significant (p<0.05) differences 
distinguishing Borderline tumors and Adenocarcinoma tumors, 
demonstrating that the novel microarrays described are useful tools for 
proteomics.
    Inventors: Cassio S. Baptista, Lionel Best, David J. Munroe (NCI).
    Patent Status: U.S. Provisional Application No. 60/797,301 filed 02 
May 2006 (HHS Reference No. E-207-2006/0-US-01).
    Licensing Status: Available for non-exclusive or exclusive 
licensing.
    Licensing Contact: Cristina Thalhammer-Reyero, PhD, MBA; 301/435-
4507; [email protected].
    Collaborative Research Opportunity: The NCI-Laboratory of Molecular 
Technology is seeking statements of capability or interest from parties 
interested in collaborative research to further develop, evaluate, or 
commercialize this novel monoclonal antibody microarray. Please contact 
Betty Tong, PhD at 301-594-4263 or [email protected] for more 
information.

    Dated: August 31, 2006.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. E6-14831 Filed 9-6-06; 8:45 am]
BILLING CODE 4140-01-P