[Federal Register Volume 74, Number 183 (Wednesday, September 23, 2009)]
[Notices]
[Pages 48570-48572]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-22975]


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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

[[Page 48571]]

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.

Osmogels: A New Method for Stabilizing Weak Molecular Complex 
Interactions

    Description of Invention: This invention describes a new method for 
stabilizing molecular complexes in polyacrylamide gels for analysis by 
the electrophoretic mobility shift assay. By adding specific osmolytes 
directly to the gel, investigators have found that weakly interacting 
molecular complexes can be sufficiently stabilized to allow 
quantitative analysis of the binding. Experiments with nonspecific 
labile complexes of two restriction endonucleases, EcoRI and BamHI, 
show that one of these added solutes is particularly effective at 
inhibiting complex dissociation, does not interfere with normal gel 
polymerization, and does not significantly slow normal gel migration. 
The results also demonstrate that sharp bands can be obtained for non-
specific complexes of both enzymes on gels prepared with this solute 
while only smeared and distorted bands are observed on regular gels 
prepared without the solute. This method can be used for protein-
protein, DNA-protein, and RNA-protein complexes, and can also be 
extended to include other techniques for separating complexes from free 
components using gel chromatography and capillary electrophoresis.
    The potential market for gels that allow researchers to detect and 
quantify weak molecular complex interactions is significant; ranging 
from molecular biologists searching for novel regulatory DNA-binding 
proteins and convenient ways to detect protein-protein, or protein-DNA/
RNA complexes to crystallographers needing reliable techniques to 
search for optimal conditions of complex formation. This technology has 
the potential to significantly impact biomedical research and 
development across many fields.
    Application: Detection of weak molecular complex interactions for 
research and commercial use.
    Development Status: Late stage.
    Inventors: Nina Y. Sidorova and Donald C. Rau (NICHD).
    Publications:
    1. NY Sidorova, S Muradymov, DC Rau. Trapping DNA-protein binding 
reactions with neutral osmolytes for the analysis by gel mobility shift 
and self-cleavage assays. Nucleic Acids Res. 2005 Sep 9;33(16):5145-
5155.
    2. NY Sidorova and DC Rau. Differences between EcoRI nonspecific 
and ``star'' sequence complexes revealed by osmotic stress. Biophys J. 
2004 Oct;87(4):2564-2576.
    Patent Status: U.S. Patent Application No. 12/485,481 filed 16 Jun 
2009 (HHS Reference No. E-214-2009/0-US-01); No foreign patent rights 
available.
    Licensing Status: Available for licensing.
    Licensing Contact: Jeffrey A. James, Ph.D.; 301-435-5474; 
[email protected].
    Collaborative Research Opportunity: The National Institute of Child 
Health and Human Development, Program in Physical Biology, Laboratory 
of Physical and Structural Biology, is seeking statements of capability 
or interest from parties interested in collaborative research to 
further develop, evaluate, or commercialize osmogels for analysis of 
weak complexes by the electrophoretic mobility shift assay with 
potential extension of the technique to other separation methods. 
Please contact Joseph Conrad III, Ph.D. at 301-435-3107 or 
[email protected] for more information.

RNA Nanoparticles and Methods of Use

    Description of Invention: The invention hereby offered for 
licensing is in the field of nanoparticles and their usefulness in a 
variety of medical applications. More specifically the invention 
describes the design and synthesis of various RNA nanoparticles. These 
polyvalent nanoparticles comprise RNA motifs as building blocks that 
give the particles their unique characteristics. Moreover, the motifs 
can be pre-defined and chosen to give the particles desired 
characteristics (e.g. size and shape) tailored for a variety of 
applications. The polyvalent particles can utilize multiple unique 
positions to carry functional groups for cell recognition (e.g. cancer 
cells), therapy and detection. For therapeutic or detection 
applications the particles typically encompass at least two functional 
groups, a therapeutic or imaging agent and a targeting agent that will 
direct the particles to the targeted tissue.
    RNA nanoparticles have the potential to serve as excellent drug or 
imaging delivery systems due to their designability and versatility. 
Furthermore, the RNA nanoparticles of the invention are also capable of 
self-assembly and potentially form nanotubes of various shapes which 
offer potentially broad uses in medical implants, gene therapy, 
nanocircuits, scaffolds and medical testing.
    Applications: The technology can be primarily used for therapeutic 
and diagnostic applications.
    Advantages: RNA nanoparticles potentially offer advantages compared 
to other conventional nanoparticles:
     They are compatible with biological systems and thus may 
be readily used for in vivo applications such as therapeutic and 
diagnostic.
     They are small and have a potential to move efficiently 
through biological barriers to a target tissue.
     They have multiple binding sites and thus can readily be 
conjugated with several functional groups (e.g. therapeutic molecule 
and targeting molecule).
     They are versatile and can be designed in different shapes 
and sizes for different applications.
    Development Status: Early stage.
    Market:
     According to U.S. National Science Foundation estimates, 
by 2015 the annual global market for nano-related goods and services 
will top $1 trillion, thus making it one of the fastest-growing 
industries in history. Assuming that these figures prove to be 
accurate, nanotechnology will emerge as a larger economic force than 
the combined telecommunications and information technology industries 
at the beginning of the technology boom of the late 1990s.
     The interest in nanoparticles as carriers of biological 
materials for medical applications has been growing exponentially in 
recent years and the commercial potential in the medical field is vast.
     According to market research reports the global medical 
market for nanotechnology applications is expected to increase from 
about $1.7 billion in 2007 to an estimated $3.8 billion by 2013, a 
compound annual growth rate (CAGR) of 14.9%.
     Nanoparticles have the largest share of the market, worth 
$1.6 billion in 2007. This segment is expected to be worth $3.4 billion 
in 2013, a CAGR of 13.4%.
     Other nanostructured materials represent the second 
largest segment, generating $36.5 million in 2007 and an $304.7 million 
in 2013, for a CAGR of 46.5%.
     Some therapeutics and imaging medical products based on 
nanoparticles have recently received FDA approval and are ready for 
commercialization. For example, the Rexin G, a targeted Delivery System 
(TRS) for treatment of solid tumors is already used commercially in the

[[Page 48572]]

Philippine and is currently being commercialized in the US by Epeius 
Biotechnologies.
    Inventor: Bruce A. Shapiro (NCI).
    Publications:
    1. E Bindewald, C Grunewald, B Boyle, M O'Connor, BA Shapiro. 
Computational strategies for the automated design of RNA nanoscale 
structures from building blocks using NanoTiler. J Mol Graph Model. 
2008 Oct;27(3):299-308.
    2. B Shapiro, E Bindewald, W Kasprzak, Y Yingling. (E Gazit, F 
Nussinov, eds.) Protocols for the In silico Design of RNA 
Nanostructures. In: Nanostructure Design Methods and Protocols. Totowa, 
NJ: Humana Press; 2008. p. 93-115.
    3. HM Martinez, JV Maizel Jr, BA Shapiro. RNA2D3D: a program for 
generating, viewing, and comparing 3-dimensional models of RNA. J 
Biomol Struct Dyn. 2008 Jun;25(6):669-683.
    4. I Severcan, C Geary, L Jaeger, E Bindewald, W Kasprzak, B 
Shapiro. (G Alterovitz, M Ramoni, R Benson, eds.) Computational and 
Experimental RNA Nanoparticle Design. In: Automation in Genomics and 
Proteomics: An Engineering Case-Based Approach. Hoboken: Wiley 
Publishing; 2009.
    5. E Bindewald, R Hayes, YG Yingling, W Kasprzak, BA Shapiro. 
RNAJunction: a database of RNA junctions and kissing loops for three-
dimensional structural analysis and nanodesign. Nucleic Acids Res. 2008 
Jan;36:D392-397.
    6. YG Yingling and BA Shapiro. Computational design of an RNA 
hexagonal nanoring and an RNA nanotube. Nano Lett. 2007 Aug;7(8):2328-
2334.
    7. BA Shapiro and YG Yingling. PCT Application No. PCT/US2007/13027 
filed 31 May 2007, which published as WO 2008/039254 on 03 Apr 2008, 
and U.S. Patent Application No. 12/227,955 filed 02 Dec 2008; both 
entitled ``RNA Hexagonal Ring and RNA Nanotube.''
    Patent Status: U.S. Provisional Application No. 61,187,495 filed 16 
Jun 2009 (HHS Reference No. E-059-2009/0-US-01).
    Licensing Status: Available for licensing.
    Licensing Contacts: Uri Reichman, Ph.D., MBA; 301-435-4616; 
[email protected]; John Stansberry, Ph.D.; 301-435-5236; [email protected]
    Collaborative Research Opportunity: The National Cancer Institute's 
Nanobiology Program is seeking statements of capability or interest 
from parties interested in collaborative research to further develop, 
evaluate, or commercialize RNA nanostructures. Please contact John D. 
Hewes, Ph.D. at 301-435-3121 or [email protected] for more 
information.

Bactericidal Peptides From Avian Leukocyte Ribonuclease A-2

    Description of Invention: These bactericidal polypeptides offer a 
novel alternative to conventional antibiotics that are used to treat 
and prevent bacterial infections. As infection-causing bacteria 
continue to develop antibiotic resistance to first line antibiotics 
there will always be a need for new antibiotic alternatives. 
Additionally, a greater understanding of the specific cytoxic activity 
of RNase A ribonucleases, their functional domains, and their roles in 
promoting anti-pathogen host defense may provide insight into new 
therapeutic agents.
    This invention includes a novel RNase A ribonuclease from chicken 
leukocytes and polypeptides that have bactericidal activities against 
both gram positive and gram negative bacteria, including such pathogens 
as Escherichia coli, Salmonella spp., and Staphylococcus.
    Applications:
     Polypeptides exhibiting bactericidal, bacteriostatic, and 
ribonuclease activity.
     Pharmaceutical compositions comprising the bactericidal 
polypeptides.
     Methods for treating bacterial infections.
    Development Status: Early stage.
    Market: With the increase in antibiotic and antibacterial drug 
resistance, the market for alternatives is growing.
    Inventors: Helene F. Rosenberg et al. (NIAID).
    Related Publication: T Nitto, KD Dyer, M Czapiga, HF Rosenberg. 
Evolution and function of leukocyte RNase A ribonucleases of the avian 
species, Gallus gallus. J Biol Chem. 2006 Sep 1;281(35):25622-25634.
    Patent Status: U.S. Patent Application No. 12/438,700 filed 24 Feb 
2009, claiming priority to 24 Aug 2006 (HHS Reference No. E-281-2006/0-
US-03)
    Licensing Status: Available for licensing.
    Licensing Contact: RC Tang JD LLM; 301-435-5031; 
[email protected].
    Collaborative Research Opportunity: The NIAID Laboratory of 
Allergic Diseases is seeking statements of capability or interest from 
parties interested in collaborative research to further develop, 
evaluate, or commercialize this technology. Please contact William 
Ronnenberg, NIAID Office of Technology Development, at 301-451-3522 or 
[email protected] for more information.

    Dated: September 17, 2009.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. E9-22975 Filed 9-22-09; 8:45 am]
BILLING CODE 4140-01-P