[Federal Register Volume 72, Number 155 (Monday, August 13, 2007)]
[Notices]
[Pages 45252-45253]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-15749]


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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.

An Improved Chromosomal Comparative Genomic Hybridization (CGH) 
Microarray for the Detection of Cancer Associated Genome Amplification 
and Deletion Events

    Description of Technology: The progression and therapeutic response 
of cancer is closely associated with chromosomal instability (i.e. 
genomic amplifications and deletions). The most widely used technique 
to detect these small changes in the genome is CGH. CGH utilizes 
nucleic acid hybridization to oligonucleotide features corresponding to 
specific, predetermined regions of the genome to detect DNA copy number 
changes. Due to the size of the human genome, it is necessary to have 
high-density features to detect small amplification and deletion events 
within the genome.
    The current invention is based on a CGH microarray with 
oligonucleotide features that provides a high-density coverage. More 
specifically, the inventors have used 60-mer oligonucleotide features 
within a previously shown set of 36 tumor associated genes/genomic 
regions and have successfully detected small changes in DNA copy number 
with high density coverage (1 feature per 400bp). Furthermore, the 
inventors have used a fade-out design for coverage of the flanking 
regions and cover the remainder of the genome at an average density of 
1 feature per 100kb.
    Applications:
    1. CGH microarray can be used to detect small regions of genomic 
instability within cancer associated genes, while larger events can 
also be detected with similar efficacy.
    2. Gene amplification and deletion profiles of patient samples can 
be used in diagnosis and therapeutic decision making.
    Advantages:
    1. Easy to use, CGH microarray technique, based on current 
technology.
    2. Technology detects small changes in tumor associated genomic 
instability

[[Page 45253]]

more efficiently than current available technologies.
    3. The average coverage of Agilent oligoarray is 1 per 35kb of 
human genome, while the average coverage of the currently described 
technology is 1 per 400bp.
    Developmental Status: The technology is ready for use.
    Benefits: More than 600,000 cancer deaths are estimated to occur in 
2007. Efficient diagnosis and informed decision making will aid in 
improved clinical management of cancer. This technology can rapidly 
diagnose cancer and thus help in proper clinical management leading to 
improved overall survival and quality of life of patients suffering 
from cancer. The current in-vitro diagnostics market is valued at $30 
billion dollars and expected to grow.
    Inventors: Xiaolin Wu, David Munroe, Ester Rozenblum, Hongling Liao 
(NCI/SAIC).
    Patent Status: U.S. Provisional Application No. 60/911,411 filed 12 
April 2007 (HHS Reference No. E-122-2007/0-US-01).
    Licensing Contact: Thomas P. Clouse, J.D.; 301/435-4076; 
[email protected].
    Collaborative Research Opportunity: The National Cancer Institute 
Laboratory of Molecular Technology is seeking statements of capability 
or interest from parties interested in collaborative research to 
further develop, evaluate, or commercialize CGH microarrays. Please 
contact John D. Hewes, PhD at 301-435-3121 or [email protected] for 
more information.

Methods and Compositions for Treating Diseases and Disorders Associated 
with Natural Killer T-Cells

    Description of Technology: The invention relates to the discovery 
that C12 beta-D-galactosyl ceramide may be used to deplete or 
inactivate NKT cell populations. These findings suggest methods for 
using C12 beta-D-galactosyl ceramide to treat conditions that would 
benefit from depletion of NKT cells, such as certain autoimmune 
diseases (e.g. lupus, MS) and AIDS.
    The presence of NKT cells can be associated with either beneficial 
effects or pathology. Deficiencies in NKT cells are associated with at 
least some types of autoimmune disease, including type 1 diabetes and 
autoimmune gastritis in mice. In contrast, NKT cells augment 
autoantibody secretion and lupus development in lupus-prone mouse 
models and therefore lupus patients may benefit from the depletion of 
NKT cells. The remission state of multiple sclerosis (MS) is also 
associated with decreased levels of NKT cells, suggesting NKT cell 
depletion as a method of treatment for MS.
    Inventors: John R. Ortaldo and Robert H. Wiltrout (NCI).
    Patent Status:
    U.S. Provisional Application No. 60/488,339 filed 17 July 2003 (HHS 
Reference No. E-282-2002/0-US-01).
    PCT Application No. PCT/US2004/22913 filed 16 Jul 2004, which 
published as WO 2005/014008 on 17 Feb 2005 (HHS Reference No. E-282-
2002/0-PCT-02).
    European Application No. 04778424.4 filed 16 Jul 2004, which 
published as 1653977 on 10 May 2006 (HHS Reference No. E-282-2002/0-EP-
03).
    Licensing Status: Available for exclusive or non-exclusive 
licensing.
    Licensing Contact: Jennifer Wong; 301/435-4633; 
[email protected].

P53 and VGEF Regulate Tumor Growth of NO2 Expressing Cancer Cells

    Description of Technology: The increased expression of nitric oxide 
synthase 2 (NOS2), an inducible enzyme that produces nitric oxide (NO), 
has been found in a variety of human cancers. It also has been shown 
that NOS2-specific inhibitors can reduce the growth of experimental 
tumors in mice. These findings suggest a pathophysiological role for NO 
in the development and progression of cancer. However, the function of 
NO and NOS2 in carcinogenesis is uncertain. NO had been found to either 
inhibit or stimulate tumor growth, and high concentrations of NO also 
are known to induce cell death in many cell types including tumor 
cells. On the other hand, the lower concentrations of NO that are found 
in human tissue can have an opposite effect and protect against 
programmed cell death, or apoptosis, from various stimuli. The role of 
NO and NOS2 in tumor progression, particularly with respect to p53, 
therefore need to be further defined.
    This invention comprises methods of screening for modulators of 
NOS2 expression in p53 mutant cells, both in vivo and in vitro, as well 
as methods for predicting the chemotherapeutic benefit of administering 
NOS2-inhibitors to cancer patients. It has been demonstrated that NOS2-
expressing cancer cells with wild-type p53 have reduced tumor growth in 
athymic nude mice whereas NOS2-expressing cancer cells with mutated p53 
have accelerated tumor growth. Therefore, this invention has potential 
application for a number of cancers that overexpress NOS2 and have a 
high frequency of p53 mutations, including breast, brain, head, neck, 
lung and colon cancers.
    Applications:
    1. Method to treat cancer with NOS2 inhibitors.
    2. Method to screen for NOS2 modulators.
    3. Method to predict therapeutic benefits of NOS2 inhibitors in 
patients.
    Market:
    1. An estimated 1,444,920 new cancer diagnoses in the U.S. in 2007.
    2. 600,000 deaths caused by cancer in the U.S. in 2006.
    3. Cancer is the second leading cause of death in United States.
    4. It is estimated that market for cancer drugs would double to $50 
billion a year in 2010 from $25 billion in 2006.
    Development Status: The technology is currently in the pre-clinical 
stage of development.
    Inventors: Stefan Ambs and Curt Harris (NCI).
    Publications:
    1. JE Goodman et al. Nitric oxide and p53 in cancer-prone chronic 
inflammation and oxyradical overload diseases. Environ Mol Mutagen. 
2004;44(1):3-9.
    2. LJ Hofseth et al. Nitric oxide in cancer and chemoprevention. 
Free Radic Biol Med. 2003Apr 15;34(8):955-968.
    Patent Status:
    U.S. Patent Application No. 11/195,006 filed 01 Aug 2005 (HHS 
Reference No. E-223-1998/0-US-04).
    U.S. Patent Application No. 09/830,977 filed 02 May 2001 (HHS 
Reference No. E-223-1998/0-US-03).
    PCT Patent Application No. PCT/US1999/27410 filed 17 Nov 1998 (HHS 
Reference No. E-223-1998/0-PCT-02).
    U.S. Provisional Patent Application No. 60/109,563 filed 23 Nov 
1998 (HHS Reference No. E-223-1998/0-US-01).
    Licensing Status: Available for exclusive or non-exclusive 
licensing.
    Licensing Contact: Jennifer Wong; 301/435-4633; 
[email protected].

    Dated: August 3, 2007.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
 [FR Doc. E7-15749 Filed 8-10-07; 8:45 am]
BILLING CODE 4140-01-P