[Federal Register Volume 71, Number 43 (Monday, March 6, 2006)]
[Notices]
[Pages 11213-11215]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-2097]


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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.

Method for Determining Redox Status of a Tissue

James B. Mitchell et al. (NCI).
U.S. Provisional Application No. 60/707,518 filed August 11, 2005 (HHS 
Reference No. E-258-2005/0-US-01).
Licensing Contact: Chekesha Clingman; 301/435-5018; 
[email protected].


[[Page 11214]]


    This invention describes methods for diagnosis and therapy of 
cancer and other pathologies associated with oxidative stress by 
administering a nitroxyl contrast agent and employing magnetic 
resonance imaging (MRI). Tumor tissues exhibit viable but hypoxic 
regions that allow them to reduce nitroxide compounds more efficiently 
than normal tissue. The paramagnetic relaxivity of nitroxide compounds 
makes it possible to use standard MRI scanners to determine the redox 
status of tissue in vivo. By determining the redox status of a tumor it 
is possible to not only diagnose a tumor due to its enhanced reduction 
of intracellular nitroxide contrast agent, but also to determine 
appropriate radiation treatment fields spatially to deliver therapeutic 
doses of radiation, and to determine appropriate timing sequences after 
the administration of a nitroxide contrast agent such that the maximum 
difference between normal and tumor tissue with respect to the 
radioprotective form of the nitroxide is present in the normal tissue, 
thereby limiting collateral damage to the normal tissue.
    In addition to licensing, the technology is available for further 
development through collaborative research opportunities with the 
inventors.

Susceptibility-Matched Multiwell Plates for High-Throughput Screening 
by Magnetic Resonance Imaging and Spectroscopy

Kenneth W. Fishbein (NIA).
U.S. Provisional Application No. 60/725,299 filed October 12, 2005 (HHS 
Reference No. E-243-2005/0-US-01).
Licensing Contact: Chekesha Clingman; 301/435-5018; 
[email protected].

    This invention describes the development of a multi-well assay 
plate for high-throughput screening by magnetic resonance imaging (MRI) 
and nuclear magnetic resonance (NMR) spectroscopy. Multi-well plates 
are used in a wide variety of high-throughput measurements in clinical 
chemistry and immunology, as well as in drug discovery and other 
research applications. Magnetic resonance imaging (MRI) of multi-well 
plates offers the possibility of performing new kinds of high-
throughput assays, including the detection of magnetic nanoparticles 
attached to or within cells. Moreover, MRI-guided localized nuclear 
magnetic resonance (NMR) spectroscopy could be used to perform detailed 
chemical analysis of complex mixtures of metabolites not possible by 
any other common analytical technique. Best of all, conventional MRI 
techniques exist which would permit all samples in one or more multi-
well plate(s) to be analyzed simultaneously. Unfortunately, 
conventional multi-well plates typically give poor performance for MRI-
based assays since they provide inadequate matching of magnetic 
susceptibility between the plate, the sample and their surroundings. 
This results in distortion of the magnetic field within the scanner and 
thus reduces the sensitivity for detecting magnetic particles and the 
resolution of NMR spectra. This invention relates to a new multi-well 
plate design incorporating one-piece polyetherimide plastic 
construction for improved magnetic susceptibility matching for aqueous 
samples. This design can easily be extended to non-aqueous samples by 
the selection of an appropriate, commercially-available plastic resin 
or resin blend. Further enhancement in susceptibility matching can be 
accomplished by combining the new plate design with plugs for each well 
constructed from the same plastic as the plate. These plugs would allow 
the entire thickness of each sample to be scanned in chemical analyses, 
improving signal-to-noise ratio and sensitivity. These plugs can be 
integrated into a single ``cap mat'' so that the entire assembly can be 
filled and manipulated by standard robotic laboratory equipment already 
in wide use in the pharmaceutical industry. Alternatively, spherical 
wells, accessed by narrow fill holes, may be molded into a solid plate, 
eliminating the need for individual plugs to seal each well. The new 
multi-well plate/plug design reduces magnetic field distortions and 
should dramatically improve spectral resolution and sensitivity for NMR 
and MRI-based high-throughput screening.
    In addition to licensing, the technology is available for further 
development through collaborative research opportunities with the 
inventors.

Measuring Fifteen Endogenous Estrogens Simultaneously in Human Urine by 
High-Performance Liquid Chromatography-Mass Spectrometry

Xia Xu, Timothy Veenstra, Larry Keefer, Regina Ziegler (NCI).
U.S. Provisional Application No. 60/688,160 filed June 7, 2005 (HHS 
Reference No. E-207-2005/0-US-01).
Licensing Contact: Michael Shmilovich; 301/435-5019; 
[email protected].

    Available for licensing and commercial development is a patent-
pending, validated high-performance liquid chromatography-electrospray 
ionization-tandem mass spectrometry method for measuring the absolute 
quantities of fifteen endogenous estrogens and their metabolites in 
human urine. The method is sensitive, specific, accurate, and precise. 
It requires a single hydrolysis/extraction/derivatization step and only 
0.5 mL of urine, yet is capable of simultaneously quantifying estrone, 
its 2- and 4-methoxy derivatives, and its 2-, 4-, and 16[alpha]-hydroxy 
derivatives; estradiol, its 2- and 4-methoxy derivatives, and its 2- 
and 16[alpha]-hydroxy derivatives; 2-hydroxyestrone-3-methyl ether; 16-
epiestriol; 17-epiestriol; and 16-ketoestradiol in premenopausal and 
postmenopausal women as well as men. Standard curves are linear over a 
103-fold concentration range with the relative standard 
error of the estimate for the linear regression line ranging from 1.2 
to 7.3%, respectively. The lower limit of quantitation for each 
estrogen is 0.02 ng per 0.5-mL urine sample (only 2 pg placed on 
column). The percent recovery of a known added amount of estrogen 
metabolite ranges from 96 to 107%. The overall precision, including the 
hydrolysis, extraction, and derivatization steps, is 1-5% relative 
standard deviation for samples prepared concurrently and 1-12% relative 
standard deviation for samples prepared in separate batches.

Immunogenic T Cell Targets in Autoimmune Hepatitis and Methods of Use

Barbara Rehermann (NIDDK) et al.
U.S. Provisional Application No. 60/659,513 filed March 7, 2005 (HHS 
Reference No. E-263-2003/0-US-01)
Licensing Contact: Cristina Thalhammer-Reyero; 301/435-4507; 
[email protected].

    Available for licensing and commercial development are new methods 
of diagnosing and monitoring the progression or response to therapy of 
subjects with autoimmune hepatitis (AIH) by quantitating the frequency 
and determining the function of autoantigen-specific CD4+ T cells in 
the peripheral blood with HLA-DRB1*0301 tetramers that display the 
autoepitopes. The invention identifies the immunogenic peptide regions 
that are targets of the T-cell immune response in two types of 
autoimmune hepatitis: (1) Anti-SLA (soluble liver antigen)-positive 
autoimmune hepatitis type 3 and (2) anti-LKM (liver kidney microsomal 
antigen)-positive autoimmune hepatitis type 2. Upon mapping the 
immunogenic regions within SLA and P450 2D6 using short, overlapping 
peptides, the inventors discovered at least four immunogenic peptides 
within SLA and

[[Page 11215]]

at least one peptide within P450 2D6 that were recognized by HLA-
DRB*0301-restricted T cells. The technology is partially described in 
Hepatology 2005; 42: 291A-292A.
    In addition to licensing, the technology is available for further 
development through collaborative research opportunities with the 
inventors.

Methods for Rapid and Specific Fluorescent Staining of Biological 
Tissue for Laser Capture Microdissection

Robert A. Star (NIDDK), Hiroshi Murakami (NIDDK), Lance A. Liotta 
(NCI), Kenneth R. Spring (NHLBI)
U.S. Patent No. 6,790,636 issued 14 Sep 2004 (HHS Reference No. E-133-
2000/0-US-02).
Licensing Contact: Michael Shmilovich; 301-435-5019; 
[email protected].

    Available for licensing and commercial development are methods for 
rapid and specific fluorescent staining of biological tissue samples 
that substantially preserve biological molecules such as mRNA. Also 
within the scope of the invention are methods for microdissecting 
tissue to obtain pure populations of cells or tissue structures based 
upon identifying and excising cells or tissue structures that are 
labeled with fluorescent specific binding agents. A laser capture 
microdissection (LCM) apparatus useful for identifying and isolating 
cells and tissue structures following rapid immunofluorescent staining 
is also disclosed. Other LCM devices are available for purchase from 
Arcturus Engineering.

    Dated: February 27, 2006.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 06-2097 Filed 3-3-06; 8:45 am]
BILLING CODE 4140-01-P