[Federal Register Volume 71, Number 244 (Wednesday, December 20, 2006)]
[Notices]
[Pages 76347-76349]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-21665]


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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.

Production, Recovery and Purification Process for Plasmid DNA Clinical 
Manufacturing

    Description of Technology: Available for licensing from NIH is a 
method for large scale production, recovery, and purification process 
for plasmid DNA manufacturing meeting human clinical trial 
requirements. DNA plasmid

[[Page 76348]]

recovery and purification methods can separate plasmid from 
contamination from a variety of sources including cellular debris and 
proteins as well as genomic DNA and RNA. Traditionally, DNA plasmid 
recovery methods utilizing column chromatography have had poor results 
such as product elutes with broad smears rather than sharp peaks, 
product elutes appearing in the flow through thereby preventing 
isolation from lysate components, and monomeric supercoiled plasmids 
are not separated from other forms of plasmids. To overcome these 
shortcomings, a fermentation, recovery, purification, and formulation 
process for the production of plasmid has been developed. The overall 
recovery of this process is greater than 400 mg of formulated final 
product per kilogram (wet weight) of E. coli cell paste.
    Applications: (1) Produce clinical grade plasmid DNA for clinical 
trials; (2) Therapeutic reagents.
    Market: This technology has potential uses in drug manufacturing 
and clinical studies. In the United States alone, there were 
approximately over 40,000 clinical trials conducted. The potential 
market is worth several billion dollars.
    Inventors: Yueqing Xie et al. (NCI/SAIC).
    Related Publications:
    1. N Horn et al. U.S. Patent No. 5,707,812, Purification of plasmid 
DNA during column chromatography.
    2. R Lemmens et al. Supercoiled plasmid DNA: selective purification 
by thiophilic/aromatic adsorption. J Chromatogr B Analyt Technol Biomed 
Life Sci. 2003 Feb 5;784(2):291-300.
    3. J Urthaler et al. Application of monoliths for plasmid DNA 
purification development and transfer to production. J Chromatogr A 
2005 Feb 11;1065(1):93-106.
    Patent Status: HHS Reference No. E-033-2007/0--Research Tool.
    Licensing Status: This technology is available as a non-exclusive 
license.
    Licensing Contact: Jennifer Wong; 301/435-4633; 
[email protected].
    Collaborative Research Opportunity: The National Cancer Institute--
Frederick is seeking statements of capability or interest from parties 
interested in collaborative research to further develop, evaluate, or 
commercialize A Production, Recovery and Purification Process for 
Plasmid DNA Clinical Manufacturing. Please contact Betty Tong, PhD at 
[email protected] for more information.

Chitosan as a Universal Vaccine Adjuvant, Antigen Depot and Cytokine 
Depot

    Description of Technology: This technology describes the use of 
chitosan depots with appropriate antigens and/or cytokines for 
generating an immune response in a subject. Such depots are made by 
mixing one or more antigens and/or cytokines with chitosan or a 
chitosan derivative. Similar compositions are described wherein 
chitosan or a derivative forms a micro-or nanoparticle, which have 
resulted in a more immunogenic presentation of antigen compared to 
antigen in solution. Using a representative antigen, the inventors 
showed that mice vaccinated with the subject depots had increased 
humoral and cellular immune responses compared to mice vaccinated with 
antigen alone.1 Furthermore, comparative mouse studies 
showed the antigen-specific immune response generated with chitosan 
depots of this invention to be equipotent to incomplete Freund's 
adjuvant (IFA) and superior to aluminum hydroxide, a widely used 
adjuvant for licensed and routinely administered vaccines.1 
Thus, this technology improves upon commonly used adjuvant technology 
and is widely applicable. This technology is the first to show that 
subcutaneous administrations of chitosan and an appropriate antigen, 
with no other component, can be used for enhancing immune responses. In 
additional studies, the inventors showed that chitosan is able to 
maintain a depot of recombinant cytokine. A single subcutaneous 
injection of chitosan-cytokine outperforms daily injections of 
recombinant cytokine in both the expansion of draining lymph nodes and 
in the antigen presenting ability of lymph node cells. This technology 
is the first to show that chitosan can maintain a depot of cytokine 
which results in a significant enhancement of the functional effects of 
a cytokine. This technology can be used for vaccines and 
immunotherapies against various infectious agents and cancer.
    Applications: Vaccine adjuvant; Immunogenic depots, including 
vaccine and cytokine.
    Development Status: Animal (mouse) data available.
    Inventor: Jeffrey Schlom et al. (NCI).
    Reference: 1 DA Zaharoff, CJ Rogers, KW Hance, J Schlom, 
JW Greiner. Chitosan solution enhances both humoral and cell-mediated 
immune responses to subcutaneous vaccination. Vaccine (accepted 
November 2006).
    Patent Status: U.S. Provisional Application No. 60/846,481 filed 22 
Sep 2006 (HHS Reference No. E-311-2006/0-US-01).
    Licensing Status: Available for non-exclusive or exclusive 
licensing.
    Licensing Contact: Susan Ano, PhD; 301/435-5515; [email protected]
    Collaborative Research Opportunity: The NCI Laboratory of Tumor 
Immunology and Biology is seeking statements of capability or interest 
from parties interested in collaborative research to further develop, 
evaluate, or commercialize chitosan-mediated immunopotentiation of 
vaccines and immunotherapies. Please contact Betty Tong, PhD at 301-
594-4263 or [email protected] for more information.

Preparative Two Dimensional Gel Electrophoresis System

    Description of Technology: The National Institute of Environmental 
Health Sciences has developed procedures and a prototype device for 
isolation of proteins from complex mixtures for protein identification. 
The system serves as a one-step purification method for isolation of 
biologically relevant proteins affected by disease or experimental 
treatment and has been described in Electrophoresis 15, 735-745, 1994. 
The system includes a preparative isoelectric focusing device for 
separation of proteins by charge, a glass mold for preparative 
polyacrylamide gel separation by mass and a protocol for use.
    The commercial advantage of the Preparative Two Dimensional Gel 
Electrophoresis system is to separate and isolate sufficient amounts of 
individual protein for sequencing in a powerful one-step purification 
method. The Preparative Two Dimensional Gel Electrophoresis system can 
resolve individual proteins by charge and mass from up to 1 to 2 mg of 
unpurified starting material from protein mixtures. Current devices for 
two dimensional gel electrophoresis are generally for analytical scale 
work and are not physically or procedurally adapted to accommodate 
preparative sample loads. Although other preparative electrophoresis 
devices do exist, they separate by either mass or charge alone and 
function as stand-alone units without ready integration into additional 
systems for resolution of individual proteins.
    Applications: Protein sequencing, protein immunization for antibody 
production, immunostaining and other modes of protein characterization.
    Development Status: The system has been tested and is operational; 
however

[[Page 76349]]

some refinements in protein resolution are still possible which may 
involve procedural, reagent or equipment modifications.
    Inventors: B. Alex Merrick (NIEHS), Rachel Patterson (NIEHS), 
Robert Hall (NIEHS), Chaoying He (NIEHS), James Selkirk (NIEHS).
    Publication: BA Merrick, RM Patterson, LL Witcher, C He, JK 
Selkirk. Separation and sequencing of familiar and novel murine 
proteins using preparative two-dimensional gel electrophoresis. 
Electrophoresis. 1994 May;15(5):735-745.
    Patent Status: U.S. Patent No. 5,534,121 issued 09 July 1996, 
claiming priority to 16 May 1994 (HHS Reference No. E-066-1994/0-US-
01).
    Licensing Status: Available for non-exclusive or exclusive 
licensing.
    Licensing Contact: Michael A. Shmilovich; 301/435-5019; 
[email protected].
    Collaborative Research Opportunity: The NIEHS National Center for 
Toxicogenomics, Proteomics Group, may consider statements of capability 
or interest from parties interested in collaborative research to 
further develop, evaluate, or commercialize this preparative two-
dimensional gel electrophoresis system. Please contact John Penta, 
NIEHS Office of Translational Research, at 919/541-3696 or 
[email protected] for additional information.

    Dated: December 8, 2006.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. E6-21665 Filed 12-19-06; 8:45 am]
BILLING CODE 4140-01-P