[Federal Register Volume 74, Number 174 (Thursday, September 10, 2009)]
[Notices]
[Pages 46606-46607]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-21787]


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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.

Rapid Diagnostic Applications of Phage

    Description of Technology: The NIH has available for licensing two 
techniques for rapid detection of a particular bacteria strain. Similar 
detection using currently available technologies take 1-2 days; this 
technology reduces the time to less than one hour. These technologies 
utilize phage, which has no pathogenic effect on higher plants and 
animals and are part of approved food-preparation formulations, 
indicating their known safety profile and an existing regulatory 
pathway. The first technique involves a phage that incorporates a 
reporter gene (e.g., luciferase) that will be expressed only when the 
phage successfully infects a bacterium. This technique is particularly 
useful where only bacteria-killing (``lytic'') phages are known because 
the method also deactivates the lytic genes, enabling infection and 
subsequent detection. The second technique involves an engineered phage 
that will bind with quantum dots upon infection of bacteria; if a 
sample is treated first with this phage and then with quantum dots, the 
sample will only respond if the bacteria are present. Both techniques 
can be used to diagnose a clinical sample (tissue, blood, etc.) or an 
environmental isolate.

Applications

     Bacterial detection and diagnostics, including clinical or 
environment samples.
     Food safety and biodefense.

Advantages

     Detection methods are novel, rapid, and potentially 
applicable in many contexts (e.g., clinic, food preparation, bioterror 
response).
     Phage is easy and inexpensive to cultivate.
     Phage is on sale in the US for food-preparation 
formulations and thus has a known regulatory pathway.
    Development Status: A range of phages have been synthesized, many 
of which have been tested proof-of-principle using major standardized 
testing systems.
    Inventors: Dr. Carl Merrill (NIMH), Dr. Sankar Adhya (NCI), et al.

Publications

    1. R Edgar et al. High-sensitivity bacterial detection using 
biotin-tagged phage and quantum-dot nanocomplexes. Proc Natl Acad Sci. 
USA 2006 Mar 28;103(13):4841-4845.
    2. C Merril et al. The prospect for bacteriophage therapy in 
Western medicine. Nat Rev Drug Discov. 2003 Jun;2(6):489-497.

Patent Status

    HHS Reference No. E-169-2004--U.S. Patent Application No. 11/
547,587 filed 05 Oct 2006.
    HHS Reference No. E-281-2005--U.S. Patent Application No. 11/
884,604 filed 17 Aug 2007.
    HHS Reference No. E-318-2000--Research Materials (patent protection 
is not being pursued for this technology): ``Method for Determining 
Sensitivity to a Bacteriophage.''
    Licensing Status: Technologies are available for licensing, either 
individually or as a package.
    Licensing Contact: Bruce Goldstein, J.D., M.S.; 301-435-5470; 
[email protected].
    Collaborative Research Opportunity: The NCI Laboratory of Molecular 
Biology is seeking statements of capability or interest from parties 
interested in collaborative research to further develop, evaluate, or 
commercialize this technology. Please contact John D. Hewes, PhD at 
301-435-3121 or [email protected] for more information.

Therapeutic Antibacterial Applications of Phage

    Description of Technology: The NIH, in collaboration with others, 
has developed three groups of inventions related to the use of 
bacteriophages in therapeutic situations. The first group is a method 
of adapting phages to survive in the body substantially longer than 
wild-type phages, using serial passaging and/or genetic engineering. 
The second group involves phages designed to bind the toxins and 
cytokines that killed bacteria release into the bloodstream, reducing 
the pathogenic properties of the bacteria. The third group is a method 
of engineering a phage to have multiple binding sites, such that a 
single phage can target multiple types of bacteria.
    Application: Therapeutic applications of phage to treat bacterial 
infection.

Advantages

     Improved efficacy through longer circulation.
     Additional antibacterial functions.
     Can be used independently or as an adjuvant to another 
antibacterial therapy.
    Development Status: A range of phages have been synthesized and 
tested in vivo. A Phase 1 study of a phage targeting vancomycin-
resistant Enterococcus faecium was completed by Exponential 
Biotherapies, Inc., with no adverse effects reported.
    Inventors: Dr. Carl Merrill (NIMH), Dr. Sankar Adhya (NCI), et al.

Publications

    1. C Merril et al. The prospect for bacteriophage therapy in 
Western medicine. Nat Rev Drug Discov. 2003 Jun;2(6):489-497.
    2. B Biswas et al. Bacteriophage therapy rescues mice bacteremic 
from a clinical isolate of vancomycin-resistant Enterococcus faecium. 
Infect Immun. 2002 Jan;70(1):204-210.
    3. C Merrill et al. Long-circulating bacteriophage as antibacterial 
agents. Proc Natl Acad Sci. USA 1996 Apr 16;93(8):3188-3192.

Patent Status

    HHS Reference No. E-110-1993--U.S. Patent No. 5,688,601 issued 19 
Jun 1997; U.S. Patent No. 7,332,307 issued 19 Feb 2008.
    HHS Reference No. E-257-2000--U.S. Patent No. 7,163,818 issued 16 
Jan 2007.
    HHS Reference No. E-178-1996--Research Materials (patent protection 
is

[[Page 46607]]

not being pursued for this technology): ``Deletion of Lysogeny Genes 
and Toxin Genes from Bacteriophage Used in the Epidemiologic Control of 
Bacterial Illness.''
    HHS Reference No. E-179-1996--Research Materials (patent protection 
is not being pursued for this technology): ``Therapeutics Use of Phage 
Expressing Toxin-Binding and/or Cytokine-Binding Proteins and 
Elimination of Genes Associate with Lysogeny.''
    HHS Reference No. E-196-1997--Research Materials (patent protection 
is not being pursued for this technology): ``Antibacterial Therapy with 
Bacteriophage Genotypically Modified to Delay Inactivation by the Host 
Defense System.''
    HHS Reference Nos. E-089-1998 and E-257-2003--Research Materials 
(patent protection is not being pursued for this technology): ``Two 
Enterocin-Producing Strains of Bacteria and Their Enterocins, Both of 
Which Are Lethal to Vancomycin-Resistant Enterococcus faecium.''
    HHS Reference No. E-012-1999--Research Materials (patent protection 
is not being pursued for this technology): ``Long Circulating Phage 
Vectors.''
    Licensing Status: Technologies are available for licensing, either 
individually or as a package.
    Licensing Contact: Bruce Goldstein, J.D., M.S.; 301-435-5470; 
[email protected].
    Collaborative Research Opportunity: The NCI Laboratory of Molecular 
Biology is seeking statements of capability or interest from parties 
interested in collaborative research to further develop, evaluate, or 
commercialize this technology. Please contact John D. Hewes, PhD at 
301-435-3121 or [email protected] for more information.

    Dated: September 1, 2009.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. E9-21787 Filed 9-9-09; 8:45 am]
BILLING CODE 4140-01-P