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Notice

Government-Owned Inventions; Availability for Licensing

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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.

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; clingmac@mail.nih.gov.

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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; clingmac@mail.nih.gov.

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; shmilovm@mail.nih.gov.

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 16α-hydroxy derivatives; estradiol, its 2- and 4-methoxy derivatives, and its 2- and 16α-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; thalhamc@mail.nih.gov.

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 Start Printed Page 11215at 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; shmilovm@mail.nih.gov.

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.

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Dated: February 27, 2006.

Steven M. Ferguson,

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

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[FR Doc. 06-2097 Filed 3-3-06; 8:45 am]

BILLING CODE 4140-01-P