[Federal Register Volume 70, Number 97 (Friday, May 20, 2005)]
[Notices]
[Pages 29332-29334]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-10064]


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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 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.

Synthesis of Phosphocholine Ester Derivatives and Conjugates Thereof

Louis J. Rezanka (NIA), U.S. Provisional Application No. 60/623,762 
filed 29 Oct 2004 (DHHS Reference No. E-330-2004/0-US-01)

    Licensing Contact: Michael Shmilovich; (301) 435-5019; 
[email protected].
    Available for licensing and commercial development is a method of 
synthesizing EPC (4-Nitrophenyl-6-(O-phosphocholine) hydroxyhexanoate) 
and methods of synthesizing phosphocholine analogues and the 
phosphocholine conjugates formed therefrom. These molecules have 
clinical and research applications as anti-microbial agents. 
Specifically, EPC conjugated to protein carriers has been demonstrated 
to generate a protective immune response to Streptococcus pneumoniae. 
The invention provides a process for EPC synthesis as well as for its 
reaction intermediates for use in synthesis.
    In addition to licensing, the technology is available for further 
development through collaborative research opportunities with the 
inventors.

[[Page 29333]]

Methods and Compositions for the ex vivo High-Throughput Detection of 
Protein/Protein Interactions

Sankar Adhya and Amos Oppenheim (NCI), U.S. Provisional Application No. 
60/629,933 filed 23 Nov 2004 (DHHS Reference No. E-264-2004/0-US-01)

    Licensing Contact: Cristina Thalhammer-Reyero; (301) 435-4507; 
[email protected].
    This invention relates to methods and compositions for the high-
throughput detection of protein-protein interactions using a lambda 
phage display system. One of the central challenges in systems biology 
is defining the interactome, or set of all protein-protein interactions 
within a living cell, as a basis for understanding biological processes 
for early diagnosis of disease and for drug development. The invention 
provides a novel proteomic toolbox for high-throughput medical research 
based in combining phage lambda protein display and recent advances in 
manipulation of the phage's genome. The method uses the bacteriophage 
lambda vector to express proteins on its surface, and is based on the 
use of mutant phage vectors such that only interacting phages will be 
able to reproduce and co-infect an otherwise non-permissive host and 
produce plaques. The invention allows for the characterization of 
bacteriophage display libraries that could be easily adapted to be used 
in large-scale functional protein chip assays.
    In addition to licensing, the technology is available for further 
development through collaborative research opportunities with the 
inventors.

Coacervate Microparticles Useful for the Sustained Release 
Administration of Therapeutics Agents

Phillip Heller (NIA), U.S. Provisional Application No. 60/602,651 filed 
19 Aug 2004 (DHHS Reference No. E-116-2004/0-US-01)

    Licensing Contact: Susan O. Ano; (301) 435-5515; [email protected].
    The described technology is a biodegradable microbead or 
microparticle, useful for the sustained localized delivery of 
biologically active proteins or other molecules of pharmaceutical 
interest. The microbeads are produced from several USP grade materials, 
a cationic polymer, an anionic polymer and a binding component (e.g., 
gelatin, chondroitin sulfate and avidin), in predetermined ratios.) 
Biologically active proteins are incorporated into preformed microbeads 
via an introduced binding moiety under nondenaturing conditions.
    Proteins or other biologically active molecules are easily 
denatured, and once introduced into the body, rapidly cleared. These 
problems are circumvented by first incorporating the protein into the 
microbead. Microbeads with protein payloads are then introduced into 
the tissue of interest, where the microbeads remain while degrading 
into biologically innocuous materials while delivering the protein/drug 
payload for adjustable periods of time ranging from hours to weeks. 
This technology is an improvement of the microbead technology described 
in U.S. Patent No. 5,759,582.
    This technology has two commercial applications. The first is a 
pharmaceutical drug delivery application. The bead allows the 
incorporated protein or drug to be delivered locally at high 
concentration, ensuring that therapeutic levels are reached at the 
target site while reducing side effects by keeping systemic 
concentration low. The microbead accomplishes this while protecting the 
biologically active protein from harsh conditions traditionally 
encountered during microbead formation/drug formulation.
    The microbeads are inert, biodegradable, and allow a sustained 
release or multiple-release profile of treatment with various active 
agents without major side effects. In addition, the bead maintains 
functionality under physiological conditions.
    Second, the microbeads and microparticles can be used in various 
research assays, such as isolation and separation assays, to bind 
target proteins from biological samples. A disadvantage of the 
conventional methods is that the proteins become denatured. The 
denaturation results in incorrect binding studies or inappropriate 
binding complexes being formed. The instant technology corrects this 
disadvantage by using a bead created in a more neutral pH environment. 
It is this same environment that is used for the binding of the protein 
of interest as well.

Lepirudin Adsorbed to Catheter

McDonald Horne (CC), U.S. Provisional Application No. 60/436,439 filed 
23 Dec 2002 (DHHS Reference No. E-295-2002/0-US-01); PCT Application 
No. PCT/US03/40888 filed 22 Dec 2003, which published as WO 2004/058324 
A2 on 15 Jul 2004 (DHHS Reference No. E-295-2002/0-PCT-02)

    Licensing Contact: Michael Shmilovich; (301) 435-5018; 
[email protected].
    The invention is a method for preventing venous access device (VAD) 
thrombosis by coating the VAD catheter with lepirudin, which has been 
found to be readily adsorbed by the silicone rubber of the VADs, and is 
expected to have good retention properties. VADs typically remain in 
place for weeks or months and sometimes cause clotting (thrombosis) of 
the veins. Accordingly, the simple technique of soaking a silicone 
catheter in lepirudin before venous insertion is the gist of the 
invention. Chronically ill patients who must be catheterized for long 
periods of time will benefit particularly from this technique which 
promises to reduce swelling and pain associated with VAD-induced 
thrombosis.
    Reference: Horne, MK, Brokaw, KJ. Antithrombin activity of 
lepirudin adsorbed to silicone (polydimethylsiloxane) tubing. 
Thrombosis Research 2003; 112:111-115.
    In addition to licensing, the technology is available for further 
development through collaborative research opportunities with the 
inventors.

VAC-BAC Shuttle Vector System

Bernard Moss, Arban Domi (NIAID), U.S. Provisional Application No. 60/
371,840 filed 10 Apr 2002 (DHHS Reference No. E-355-2001/0-US-01); U.S. 
Provisional Application No. 60/402,824 filed 09 Aug 2002 (DHHS 
Reference No. E-355-2001/1-US-01); International Patent Application No. 
PCT/US03/11183 filed 10 Apr 2003, which published as WO 03/087330 A2 on 
23 Oct 2003 (DHHS Reference No. E-355-2001/2-PCT-01); U.S. Patent 
Application No. 10/959,392 filed 05 Oct 2004 (DHHS Reference No. E-355-
2001/2-US-02); European Patent Application No. 037183431 filed 10 Apr 
2003 (DHHS Reference No. E-355-2001/2-EP-03)

    Licensing Contact: Robert M. Joynes; (301) 594-6565; 
[email protected].
    This invention relates to a VAC-BAC shuttle vector system for the 
creation of recombinant poxviruses from DNA cloned in a bacterial 
artificial chromosome. A VAC-BAC is a bacterial artificial chromosome 
(BAC) containing a vaccinia virus genome (VAC) that can replicate in 
bacteria and produce infectious virus in mammalian cells.
    The following are some of the uses for a VAC-BAC:
    1. VAC-BACs can be used to modify vaccinia virus DNA by deletion, 
insertion or point mutation or add new DNA to the VAC genome with 
methods developed for bacterial plasmids, rather

[[Page 29334]]

than by recombination in mammalian cells.
    2. It can be used to produce recombinant vaccinia viruses for gene 
expression.
    3. It can be used for the production of modified vaccinia viruses 
that have improved safety or immunogenicity.
    Advantages of the VAC-BAC shuttle system:
    1. VAC-BACs are clonally purified from bacterial colonies before 
virus reconstitution in mammalian cells.
    2. Manipulation of DNA is much simpler and faster in bacteria than 
in mammalian cells.
    3. Modified genomes can be characterized prior to virus 
reconstitution.
    4. Only virus with modified genomes will be produced so that virus 
plaque isolations are not needed.
    5. Generation of a stock of virus from a VAC-BAC is accomplished 
within a week rather than many weeks.
    6. Multiple viruses can be generated at the same time since plaque 
purification is unnecessary.
    References:
    1. Domi, A., and B. Moss. 2002. Cloning the vaccinia virus genome 
as a bacterial artificial chromosome in Escherichia coli and recovery 
of infectious virus in mammalian cells. Proc. Natl. Acad. Sci. USA 
99:12415-12420.
    2. Domi, A., and B. Moss. 2005. Engineering of a vaccinia virus 
bacterial artificial chromosome in Escherichia coli by bacteriophage 
lambda-based recombination. Nature Methods 2:95-97.
    In addition to licensing, the technology is available for further 
development through collaborative research opportunities with the 
inventors.

    Dated: May 12, 2005.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 05-10064 Filed 5-19-05; 8:45 am]
BILLING CODE 4140-01-P