03-31329. Government-Owned Inventions; Availability for Licensing

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: [phone]; fax: [phone]. A signed Confidential Disclosure Agreement will be required to receive copies of the patent applications.

A Microfluidic Flow-Through Immunoassay for a Simultaneous Detection of Multiple Proteins in a Sub-Microliter Biological Sample

Nicole Y. Morgan et al. (NIH/NIST)

DHHS Reference No. E-024-2004/0-US-01 filed 30 Oct 2003

Licensing Contact: Michael Ambrose; 301/594-6565; [e-mail].

This invention presents a high throughput, multi-analyte microfluidic chip device. This device can be used for the detection and characterization of proteins, immuno-affinity assays as well as analyte detection in biological samples or other media. The sub-microliter volumes for use make this device applicable where biological samples are rare and difficult to obtain.

The device consists of a series of channels that are connected via communication ports for sample flow. The channels can be individually loaded with detection reagents via portals at their ends. As such, the assay channels can be run in series using a single sample source or individually via the loading ports, thus increasing the utility of the microchip device. Each channel can then be detected via colorimetric, fluorimetric or other detection method as desired. The chip can be integrated into multiple detection devices or other analytical equipment.

The chip as designed, is manufactured using photolithographic etching, thus the number and size of the individual reaction channels can be modified to increase the number of channels or the volume the channels can hold. The chip should also be reusable, thus further increasing the utility of the device.

Method for Analysis of Biomarkers Concentrated With Biomarker Attractants

Arpita Mehta et al. (NCI)

DHHS Reference No. E-167-2003/0-US-01 filed 08 Oct 2003

Licensing Contact: Fatima Sayyid; 301/435-4521; [e-mail].

Biological fluids are the repositories of vast number of molecules that are excreted or otherwise shed by cells. These molecules present in biological fluids reflect the physiological and pathological states of the cells that are in contact by the fluids or the cells from which these molecules are derived. A major goal of clinical diagnostics is to correlate the particular molecules (biomarkers) present in biological fluids with particular disease states.

The present invention relates to analysis of molecules present in biological fluids. Specifically, it discloses a diagnostic method for isolating/analyzing biomarker attractant molecules for the presence of bound fragments of cellular proteins that are known to correlate with particular biological states in specific anatomic or physiologic locations.

Regulation of RNA Stability

Wi Lai et al. (NIEHS)

U.S. Provisional Application No. 60/451,976 filed 06 Mar 2003 (DHHS Reference No. E-314-2002/0-US-01)

Licensing Contact: Jesse S. Kindra; 301/435-5559; [e-mail].

This invention relates to the discovery that tristetraprolin (TTP) can promote the poly(A)RNase (PARN) mediated deadenylation of polyadenylated substrates containing AU-rich elements (AREs). As one aspect of the invention, the inventors have developed a cell free system that may be used for the purposes of assessing the effects of the various system components or their derivatives (i.e. AREs, PARN, or TTP) on the deadenylation process or the effects of various test agents on the deadenylation process. Aspects of this work have been published as follows: Lai et al., 2003, Tristetraprolin and Its Family Members Can Promote the Cell-Free Deadenylation of AU-Rich Element-Containing mRNAs by Poly(A) Ribonuclease, MCB 23(11):3798-3812.

This technology is available for licensing on an exclusive or a non-exclusive basis.

Methods for Assessing the Ability of HIV Patients To Restrict HIV Replication

Mark Connors, Stephen Migueles (NIAID)

U.S. Provisional Application No. 60/412,020 filed 20 Sep 2002 (DHHS Reference No. E-260-2002/0-US-01); PCT Application No. PCT/US03/29549 filed 22 Sep 2003 (DHHS Reference No. E-260-2002/0-PCT-02)

Licensing Contact: Susan Ano; 301/435-5515; [e-mail].

One of the current obstacles for the design and testing of effective vaccines and immunotherapies of HIV is the lack of in vitro correlates that will predict the ability to restrict virus replication. This invention relates to methods for evaluating the effectiveness of HIV therapies and vaccines and methods for assessing the ability of HIV patients to restrict virus replication. Upon restimulation of CD8+ T cells, the expression of perforin in these cells, and the cell cycle stage of these cells may be measured and used as in vitro markers for monitoring the patient's ability to restrict HIV replication and the effectiveness of the therapies and vaccines applied. Significant proliferation of CD8+ T cells, the presence of perforin in these cells, and the ability of these cells to progress beyond the G1 stage signify the patient's ability to restrict HIV replication and a favorable effect of the therapies or vaccines. These methods may be advantageously applied in conjunction with other measurements of HIV specific immune response such as HLA tetramers.

gp64 Pseudotyped Vectors and Uses Thereof

Mukesh Kumar, Joshua Zimmerberg (NICHD,

U.S. Provisional Application No. 60/425,853 filed 12 Nov 2002 (DHHS Reference No. E-191-2001/0-US-01); PCT Application filed 10 Nov 2003 (DHHS Reference No. E-191-2001/0-PCT-02)

Licensing Contact: Susan Ano; 301/435-5515; [e-mail].

This invention relates to a general gene therapy technology which uses an HIV-1 based vector containing a baculovirus gp64 protein. HIV-1 based gene therapy vectors hold great promise due to their ability to deliver genes to non-dividing cells including hematopoietic stem cells. However native HIV only binds to cells with a CD4 receptor, while gene therapy vectors would need to be delivered to a variety of cells. Various different envelope proteins have been tried to replace the native envelope protein of HIV with a new envelope protein whose origin is another enveloped virus (pseudotyping) that has more general binding capabilities. However, to date, no one has been successful for practical purposes, due to either low titers or cytotoxic effects of the expressed proteins. The inventors have developed a family of nontoxic vectors using baculovirus gp64 protein (which binds to a variety of cells) and HIV proteins that efficiently deliver genes of interest to target cells. Furthermore, since gp64 expression in producer cells is not accompanied by cytotoxic side effects, this protein is an ideal candidate for the development of cell lines for constitutive expression of gp64 for the process of construction of the hybrid HIV (packaging cell lines).

Dated: December 11, 2003.

Steven M. Ferguson,

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