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

Federal Register: April 17, 2008 (Volume 73, Number 75)              
                  Page 20928-20929

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. 
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.

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.
    Advantages:
    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

[[Page 20929]]

2008 (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; 
rodrigr@mail.nih.gov.
    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 hewesj@mail.nih.gov 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.
    Applications:
    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.
    Market:
    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 [gamma]-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; wongje@mail.nih.gov

    Dated: April 8, 2007.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. E8-8213 Filed 4-16-08; 8:45 am]

BILLING CODE 4140-01-P