[Federal Register Volume 71, Number 135 (Friday, July 14, 2006)]
[Notices]
[Pages 40131-40133]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-6211]


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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: 

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otice.

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.

Method for Expanding Allodepleted Antigen Specific T Cells

    Description of Technology: Available for licensing and commercial 
development are methods of producing a population of purified non-
alloreactive antigen-specific T cells that recognize an antigen of 
interest. Thus, the population of donor T cells can be used to produce 
immune response against the antigen of interest (e.g., cytomegalovirus) 
in a recipient without producing an immune response to the recipient. 
Currently available methods for isolating and expanding antigen-
specific T cells can be inefficient and produce populations of cells 
that include donor-reactive T cells. The present method enables rapid 
production of populations of T cells that recognize an antigen of 
interest but are depleted for alloreactive T cells: A population of 
donor T cells is contacted with a population of irradiated recipient 
antigen presenting cells (T-APCs) to produce a population of 
alloreactive T cells. The alleractive T cells are removed by 
purification with an antibody that specifically binds a cell surface 
marker (e.g., CD25, CD69, CD38 or CD71). The population of allo-
depleted donor cells is then contacted with donor T antigen presenting 
cells (T-APCs) expressing an antigen of interest and produces a 
population of donor allo-depleted activated CD4 and CD8 T cells.
    Applications: Immune response to opportunistic infectious in 
immuno-compromised transplant or graft recipients.
    Market: (1) Cytomegalovirus; (2) General post-transplant 
opportunistic infections.
    Inventors: J. Joseph Melenhorst and A. John Barrett (NHLBI).
    Publications:
    1. JJ Melenhorst, TH Brummendorf, M Kirby, PM Lansdorp, AJ Barrett. 
``CD8+T cells in large granular lymphocyte

[[Page 40132]]

leukemia are not defective in activation- and replication-related 
apoptosis.'' Leuk Res. 2001 Aug;25(8):699-708.
    2. H Fujiwara, JJ Melenhorst, F El Ouriaghli, et al.``In vitro 
induction of myeloid leukemia-specified CD4 and CD8 T cells by CD40 
ligand-activated B cells gene modified to express primary granule 
proteins.'' Clin Cancer Res. 2005 Jun 15;11(12):4495-4503.
    Patent Status: U.S. Provisional Application No. 60/804,404 filed 09 
Jun 2006 (HHS Reference No. E-136-2006/0-US-01).
    Licensing Status: Available for non-exclusive or exclusive 
licensing.
    Licensing Contact: Michael A. Shmilovich, Esq.; 301/435-5019; 
[email protected].
    Collaborative Research Opportunity: The NHLBI Hematology Branch is 
seeking statements of capability or interest from parties interested in 
collaborative research to further develop, evaluate, or commercialize a 
Method for Expanding Allodepleted Antigen Specific T Cells. Please 
contact Dr. A.J. Barrett at 301/402-4170 or [email protected] for 
more information.

A Newly Discovered Bacterium in the Family Acetobacteraceae

    Description of Technology: Available for licensing and commercial 
development is a newly discovered bacterium in the Acetobacteraceae 
family. This bacterium was isolated, characterized and grown from lymph 
nodes of a patient with chronic granulomatous disease (CGD), a rare 
genetic disorder that impairs the immune system.
    This Gram-negative bacterium is an aerobic, faculatitive 
methylotroph that produces yellow pigmented colonies. The closest 
nucleic acid sequence match was to Gluconacetobacter sacchari (95.7% 
similarity) of the acetic acid bacteria. The newly descibed bacterium 
belongs to a new genus and species in the Acetobacteraceae family and 
was named Granulibacter bethesdenis. Acetobacteraceae are characterized 
by their ability to convert alcohol (ethanol) to acetic acid in the 
presence of air. Members of this family are used industrially in the 
production of vinegar, and are encountered during fermentation of wine.
    G. bethesdenis can breakdown methanol, formaldehyde, ethanol and 
their intermediate breakdown products into non-toxic end-products. 
Examples of non-toxic end-products include carbon dioxide, water, and 
acetic acid.
    The invention provides the complete genome sequence from the 
bacterium. Also included are permission to purify and utilize unique 
enzymes that the bacteriuum uses to degrade organic materials, for 
example methanol dehydrogenase, formaldehyde-activating enzyme, and 
methylenetetrahydrofolate dehydrogenase (NAPD+).
    Applications: (1) Biodegradation of organic waste; (2) Microbial 
fuel cell; (3) Production of purified polypeptide enzymes for 
industrial use.
    Inventors: Steven M. Holland (NIAID), Patrick Murray (CC), Adrian 
M. Zelazny (CC), David E. Greenberg (NIAID).
    Publication: DE Greenberg, L Ding, AM Zelazny, F Stock, A Wong, et 
al. ``A novel bacterium associated with lymphadenitis in a patient with 
chronic granulomatous disease.'' PLoS Pathog 2006 Apr;2(4):e28. Epub 
2006 Apr 14, doi: 10.1371/journal.ppat.0020028. (PubMed abstract = 
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=16617373&query_hl=1&itool=pubmed_docsum).
    Patent Status: U.S. Provisional Application No. 60/788,521 filed 31 
Mar 2006 (HHS Reference No. E-083-2006/0-US-01).
    Licensing Status: Available for non-exclusive or exclusive 
licensing.
    Licensing Contact: Chekesha Clingman, PhD.; 301/435-5018; 
[email protected]
    Collaborative Research Opportunity: The NIAID Laboratory of Host 
Defenses is seeking statements of capability or interest from parties 
interested in collaborative research to further develop, evaluate, or 
commercialize this technology. Please contact Kelly Murphy at 301-451-
3523 or [email protected] for more information.

Fluorescent Imaging and Photodynamic Treatment of Tumors

    Description of Technology: Available for licensing and commercial 
development are methods and compositions for optically detecting 
tumors, in particular disseminated intraperitoneal cancers. Unlike 
exiting detection methods using avidin and/or galactosyl serum albumin 
(GSA), the current invention allows tumors to be visualized in situ, 
with high sensitivity and without hazardous radioactive probes. The 
invention also provides methods of treating tumors.
    The invention describes the labeling of avidin and GSA with 
fluorophores. The fluorescently labeled agents selectively bind to 
cells expressing asialoglycoprotein receptors on the surface of tumor 
cells, such as in tumors of the ovary, stomach, colon or pancreas. 
Metastatic tumor cells can then be detected endoscopically, 
laparoscopically, or during surgery with an appropriate imaging system.
    The fluorescently labeled avidin and GSA can be used 
diagnostically, but also have an application for treating cancer. Using 
photoactivatable fluorophores linked to avidin or GSA, free radicals 
can be produced which results in localized death of tumor cells upon 
exposure to excitation with the appropriate wavelength.
    Applications: (1) Optical detection of tumor cells and metastatic 
nodules; (2) Photodynamic treatment of tumors.
    Inventors: Hisataka Kobayashi and Peter Choyke (NCI).
    Patent Status: U.S. Provisional Application No. 60/751,429 filed 16 
Dec 2005 (HHS Reference No. E-335-2005/0-US-01).
    Licensing Status: Available for non-exclusive or exclusive 
licensing.
    Licensing Contact: Chekesha Clingman, PhD; 301/435-5018; 
[email protected].
    Collaborative Research Opportunity: The National Cancer Institute 
Molecular Imaging Program is seeking statements of capability or 
interest from parties interested in collaborative research to further 
develop, evaluate, or commercialize tumor specific imaging agents. 
Please contact Laurie Zipper, Ph.D., at 301-594-4650 or 
[email protected] for more information.

Coacervate Microparticles Useful for the Sustained Release 
Administration of Therapeutics Agents

    Description of Technology: 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

[[Page 40133]]

time ranging from hours to weeks. This technology is an improvement of 
the microbead technology described in U.S. Patent No. 5,759,582.
    Applications: 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. This 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 microbead 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 the same environment that is used for the finding of the protein 
of interest as well.
    Inventor: Phillip F. Heller (NIA).
    Patent Status: U.S. Provisional Application No. 60/602,651 filed 19 
Aug 2004 (HHS Reference No. E-116-2004/0-US-01); PCT Application No. 
PCT/US2005/026257 filed 25 Jul 2005, which published as WO 2006/023207 
on 02 Mar 2006 (HHS Reference No. E-116-2004/0-PCF-02).
    Licensing Status: Available for non-exclusive or exclusive 
licensing.
    Licensing Contact: Susan O. Ano, Ph.D.; 301-435-5515; 
[email protected].

Methods and Compositions Related to GHS-R Antagonist

    Description of Technology: This invention describes that additional 
functional role for D-Lys3 GHRP-6 (a known GHS-R antagonist, peptide) 
as a blocker of two well-known chemokine receptors, namely CCR5 and 
CXCR4. These receptors are major HIV co-receptors and are critical for 
HIV binding, fusion and entry into human T cells, monocytes, dendritic 
cells, and various other cells within the body. Moreover, these 
receptors and their ligands play a major role in inflammation and a 
variety of acute and chronic disease states. Overall, these two 
mammalian chemokine receptors are currently major drug targets for 
treatment of AIDS, cancer and many immunoregulatory disorders. Many 
identified antogonists block one or the other receptor. Since D-Lys3 
GHRP-6 actually binds and blocks both these chemokines receptors at the 
same time hindering their activity and HIV infectivity, D-Lys3 GHRP-6 
may be a good therapeutic candidate for treatment of AIDS and 
inflammatory diseases.
    Inventors: Vishwa D. Dixit and Dennis D. Taub (NIA).
    Patent Status: U.S. Provisional application No. 60/773,076 filed 13 
Feb 2006 (HHS Reference No. E-017-2004/0-US-01).
    Licensing Status: Available for non-exclusive or exclusive 
licensing.
    Licensing Contact: Sally Hu, Ph.D., M.B.A.; 301-435-5605; 
[email protected].
    Collaborative Research Opportunity: The National Institute on 
Aging's Laboratory of Immunology is seeking statements of capability or 
interest from parties interested in collaborative research to further 
develop, evaluate, or commercialize this technology. Please contact 
Nicole D. Guyton at 301-435-3101 or [email protected] for more 
information.

    Dated: July 3, 2006
David R. Sadowski,
Acting Director, Division of Technology Development and Transfer, 
Office of Technology Transfer, National Institutes of Health.
[FR Doc. 06-6211 Filed 7-13-06; 8:45 am]
BILLING CODE 4140-01-M