[Federal Register Volume 64, Number 37 (Thursday, February 25, 1999)]
[Notices]
[Pages 9342-9343]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-4662]


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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, DHHS.

ACTION: Notice.

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SUMMARY: The inventions listed below are owned by agencies 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.

Chimeric Virus-Like Particles for the Induction of Autoantibodies

John T. Schiller, Bryce Chackerian and Douglas R. Lowy (NCI)
Serial No. 60/105,132 filed 21 Oct 98
Licensing Contact: Robert Benson; 301/496-7056 ext. 267; e-mail: 
[email protected]

    This invention provides methods and constructs for inducing a B 
cell mediated antibody response against a self-antigen or tolerogen. 
Given that many disease states can be alleviated by decreasing the 
effect of a self-antigen, this invention has broad applicability. 
Autoantibody therapy might be preferable to monoclonal antibody therapy 
in some instances because the concentration of the therapeutic antibody 
would likely remain in an effective range for longer periods, an 
antibody response to the therapeutic antibody response would not be 
expected, and a polyclonal autoantibody response might be more 
effective than the monospecific response of a monoclonal antibody. The 
inventors have found that by presenting an epitope from the self-
antigen as a highly organized array on the surface of virus-like 
particles (VLP), such as papillomavirus VLPs, that antibodies are 
raised against the self-antigen. Any therapeutic or prophylactic 
treatment which involves using monoclonal antibodies against a self-
antigen can be replaced with the methods and VLPs of this invention. 
Examples of such diseases include autoimmune diseases such as 
rheumatoid arthritis and inflammatory bowel disease, or cancers such as 
breast cancer. The invention is also useful for producing mouse anti-
self-antigen sera or monoclonal antibodies which should find myriad 
uses. The inventors have demonstrated a potential anti-HIV treatment by 
raising antibodies against the HIV co-receptors CCR5 in a mouse model 
system. Bovine papillomavirus L1 protein containing an epitope from an 
extracellular domain of CCR5 formed VLPs which raised anti-CCR5 
antibodies. These antibodies blocked binding by the normal CCR5 ligand, 
RANTES, and, more importantly, blocked entry of HIV into the cells.

High-Stability Prokaryotic Plasmid Vector System

Stuart J. Austin (NCI)
Serial No. 60/108,253 filed 12 Nov 1998
Licensing Contact: J. Peter Kim; 301/496-7056 ext. 264; e-mail: 
[email protected]

    Plasmids used in vaccine production, production of 
biopharmaceuticals, and products of industrial importance are often 
unstably maintained, and loss of the plasmid from the host is a common 
limitation for efficient product yield. Accordingly, the subject 
invention could be particularly useful in continuous flow applications, 
e.g, large fermentation vat productions, where accumulation of cells 
that have lost the producer plasmid leads to long-term decline in 
product yield.
    The present invention relates to the identification of a locus for 
plasmid stability. The scientists have mapped, sequenced, and 
characterized this locus. The DNA element appears to be highly 
effective in promoting the stable maintenance of a variety of unstable 
plasmids.

Identification of a Region of the Major Surface Glycoprotein (MSG) 
Gene of Human Pneumocystis carinii

Joseph Kovacs et al. (CC)
Serial No. 60/096,805 filed 17 Aug 1998
Licensing Contact: J. Peter Kim; 301/496-7056 ext. 264; e-mail: 
[email protected]

    Pneumocystis carinii is an important life-threatening opportunistic 
pathogen of immuno-compromised patients, especially for those with 
human immunodeficiency virus (HIV) infection and acquired 
immunodeficiency syndrome (AIDS).
    The present invention provides for methods and kits for detecting 
Pneumocystis carinii infection in humans. More specifically, nucleic 
acid amplification (for example, polymerase chain reaction (PCR) 
amplification of human Pneumocystis carinii MSG-encoding genes 
(approximately 100 copies of which are present per genome), may provide 
a particularly sensitive and specific technique for the detection of 
Pneumocystis carinii and the diagnosis of Pneumocystis carinii 
pneumonia (PNP).

Ratio-Based Decisions and the Quantitative Analysis of cDNA 
Microarray Images

Y Chen (NHGRI)
Serial No. 60/102,365 filed 29 Sep 98
Licensing Contact: John Fahner-Vihtelic; 301/496-7735 ext. 270; e-mail: 
[email protected]

    The present invention relates to the quantitative analysis of gene 
expression by hybridizing fluor-tagged mRNA to targets on a cDNA 
microarray. A method and system of image segmentation is provided to 
identify cDNA target sites. The comparison of gene expression levels 
arising from cohybridized samples is achieved by taking ratios of 
average expression levels for individual genes. A confidence interval 
is developed to quantify the significance of observed differences in 
expression ratios. This technology has been implemented into a computer 
program called ArraySuite and provides a user-friendly display for the 
operator to view and analyze the results of the experiment.

[[Page 9343]]

Pressure Mediated Selective Delivery of Therapeutic Substances

SM Wiener, RF Hoyt, JR DeLeonardis, RR Clevenger, RJ Lutz, B Safer 
(NHLBI)
Serial No. 60/086,565 filed 21 May 98
Licensing Contact: John Fahner-Vihtelic; 301/496-7735 ext. 270; e-mail: 
[email protected]

    The present application describes a system and method for improved 
regional, organ, tissue, tissue-compartment, and celltype-specific 
delivery of therapeutic agents via infusion of those agents into body 
lumens under controlled pressure and volume conditions. Methods of 
varying the pressure and flow rates for given body targets and depths 
are also disclosed along with methods of determining the proper 
protocol for a given target tissue. This application also includes 
designs for access cannulas, catheters, access ports, and other devices 
for controlled, targeted delivery of therapeutic agents, including 
drugs and gene therapy vectors. Local administration of drugs, gene 
therapy vectors, and other therapeutic agents in accordance with this 
invention can permit organ, tissue, tissue-compartment, and celltype-
specific delivery, thereby maximizing administration to intended tissue 
targets using therapeutically effective dosages while simultaneously 
reducing the risk of systemic delivery and toxicity.

    Dated: February 18, 1999.
Jack Spiegel,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer.
[FR Doc. 99-4662 Filed 2-24-99; 8:45 am]
BILLING CODE 4140-01-M