[Federal Register Volume 68, Number 244 (Friday, December 19, 2003)]
[Notices]
[Pages 70824-70825]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-31329]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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.

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; 
[email protected].

    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; [email protected].

    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; [email protected].

    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.

[[Page 70825]]

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; [email protected].
    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; [email protected].

    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.
[FR Doc. 03-31329 Filed 12-18-03; 8:45 am]
BILLING CODE 4140-01-P