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Government-Owned Inventions; Availability for Licensing

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National Institutes of Health, Public Health Service, HHS.




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.


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.

Engineered Human Antibody Constant Domains (Nanoantibodies) as Scaffolds for Binders

Description of Technology: The invention describes conceptually novel scaffolds based on engineered human antibody constant domains (nanoantibody scaffold). They are highly soluble, very stable, monomeric, and can be expressed at high levels. Furthermore, large libraries are generated from which binders to antigens are selected and characterized.


The engineered antibody domains are more stable compared to existing domain antibodies.

The nanoantibodies are derived from human sequences and are likely to have minimal toxic and immunogenic effects.

The small size of the nanoantibodies ensures efficient penetration in tissues including solid tumors and lymphoid tissues where HIV replicates, and also efficient neutralization of viruses, e.g. HIV, that have evolved to avoid neutralization by naturally occurring large size IgGs generated by the immune system.

Applications: The nanoantibodies have potential for diagnosis and treatment of cancer and AIDS as well as diseases of the immune systems and other diseases.

Development Status: Proof of concept experiments have been completed.

Inventor: Dimiter Dimitrov (NCI).

Patent Status: U.S. Provisional Application No. 61/063,245 filed 31 Jan Start Printed Page 209292008 (HHS Reference No. E-003-2007/0-US-01).

Licensing Status: Available for exclusive and non-exclusive license.

Licensing Contact: Richard Rodriguez; 301-435-4013;

Collaborative Research Opportunity: The National Cancer Institute Center for Cancer Research Nanobiology Program is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize nanoantibodies as therapeutics or diagnostics including imaging agents. Please contact John D. Hewes, PhD at 301-435-3121 or for more information.

Methods and Compositions for the Diagnosis of Neuroendocrine Lung Cancer

Description of Technology: The technology relates to the use of cDNA microarrays to facilitate the identification of pulmonary neuroendocrine tumors. In order to identify molecular markers that could be used to classify pulmonary tumors, the inventors examined the gene expression profiles of clinical samples from patients with small cell lung cancer (SCLC), large cell neuroendocrine carcinoma (LCNEC), and typical carcinoma (TC) tumors by cDNA microarray analysis to detect hybridization between cDNA from tumor cells and DNA from a panel of 8,897 human genes. Gene expression was found to be nonrandom and to exhibit highly significant clustering that divided the tumors into their assigned World Health Organization (WHO) classification with 100% accuracy. The inventors concluded that pulmonary neuroendocrine tumors could be classified based on the genome-wide expression profile of the clinical samples without further manipulations.


Method to differentiate three types of pulmonary neuroendocrine tumors;

Method to diagnose pulmonary neuroendocrine cancer;

Neuroendocrine Microarray

Advantages: Accurate, rapid, easy to use diagnostic to stratify patients according to pulmonary tumors

Development Status: The technology is currently in the pre-clinical stage of development.


An estimated 1,444,920 new cancer diagnoses in the U.S. in 2007.

Cancer is the second leading cause of death in United States.

It is estimated that the cancer therapeutic market would double to $50 billion a year in 2010 from $25 billion in 2006.

Inventors: Curtis C. Harris et al. (NCI).

Relevant Publications: P He et al. Identification of carboxypeptidase E and γ-glutamyl hydrolase as biomarkers for pulmonary neuroendocrine tumors by cDNA microarray. Human Pathol. 2004 Oct;35(10):1196-1209.

Patent Status: U.S. Patent Application No. 10/533,459 filed 02 May 2005 (HHS Reference No. E-248-2002/0-US-04).

Licensing Status: Available for exclusive or non-exclusive licensing.

Licensing Contact: Jennifer Wong; 301-435-4633;

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Dated: April 8, 2007.

Steven M. Ferguson,

Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health.

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[FR Doc. E8-8213 Filed 4-16-08; 8:45 am]