Notice (C): Government-Owned Inventions; Availability for Licensing

Federal Register: March 5, 2010 (Volume 75, Number 43)            
                  Page 10285-10286

AGENCY: National Institutes of Health, Public Health Service, HHS.

ACTION: Notice.

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.

Long Acting Ophthalmic Analgesic Eye Drops

    Description of Invention: This invention is directed to the 
discovery that resiniferatoxin (RTX) produces a three to four day 
analgesic effect when topically applied to the cornea. Efficacy for RTX 
as an effective analgesic has been demonstrated in vivo in rats. 
Importantly, unlike currently available analgesics, RTX left the blink 
reflex intact and did not impact mechanical sensitivity. RTX also did 
not impair epithelial wound healing and functioned without detectable 
damage to the cornea.
    RTX is a potent agonist of the transient receptor potential 
channel, subfamily V, member 1 (TRPV1). TRPV1 is involved in pain 
sensation and is expressed only in select neurons. Unlike other local 
analgesics that target a wide breadth of neurons, RTX targets only 
those neurons that express TRPV1, leaving the important blink reflex 
and mechanical sensitivity of the eye unaffected.
    Applications:
     An ophthalmic analgesic for post-operative eye pain.
     An ophthalmic analgesic for acute or chronic eye injury.
     Applicable to both human and veterinary patients.
    Advantages:
     Both long lasting and reversible.
     Does not impair epithelial wound healing, leaves the blink 
reflex intact, and functions without detectable damage to the cornea.
    Development Status:
     Early stage.
     Demonstrated efficacy in vivo in rats.
    Market: Twenty-six million people worldwide experience neuropathic 
pain, resulting in healthcare costs of over three billion dollars per 
year.
    Inventors: Michael J. Iadarola, Andrew J. Mannes, Jason M. Keller, 
Kendall Mitchell, Brian D. Bates (NIDCR).
    Publication: In preparation.
    Patent Status: U.S. Provisional Application No. 61/247,881 filed 01 
Oct 2009 (HHS Reference No. E-117-2009/0-US-01).
    Licensing Status: Available for licensing.
    Licensing Contact: Charlene Sydnor, PhD; 301-435-4689; 
sydnorc@mail.nih.gov.
    Collaborative Research Opportunity: The National Institute of 
Dental and Craniofacial Research, Laboratory of Sensory Biology, 
Neurobiology and Pain Therapeutics Section, is seeking statements of 
capability or interest from parties interested in collaborative 
research to further develop, evaluate, or commercialize this 
technology. Please contact David W. Bradley, PhD at 301-402-0540 or 
bradleyda@nidcr.nih.gov for more information.

Novel Compositions for Use as Bone Scaffolds and Enhancers of Bone 
Regeneration

    Description of Invention: This invention is directed to the 
discovery that a mixture of an organic polymer and inorganic particles 
may hold therapeutic utility as a biomaterial for artificial bone 
scaffolds, injectable bone-filling materials, and enhancement of new 
bone generation. This composition has demonstrated utility in vivo in 
mice.
    The inventors have discovered a means of producing a stably 
homogenous mixture of the organic polymer and inorganic particles by 
crosslinking the two components. In contrast to current technologies, 
this invention not only imparts sufficient mechanical and load-bearing 
strength but also provides a suitable environment for new bone 
formation. Importantly, since the chemical reaction applied to make 
this biomaterial does not produce any harmful molecules or heat, it can 
be used in an injectable form. Bone formation or replacement is often a 
desired therapy for bone loss or defects due to fractures or bone 
degenerative diseases.
    Applications:
     Injectable bone-filling materials.
     Artificial bone sponge for bone defect.
     Artificial bone sponge for bone cell culture in bone and 
mineralization research.
    Advantages:
     Combines bone-like strength and a suitable environment for 
new bone formation
     Injectable.
    Development Status:
     Early stage.
     Tested in vivo in mice.
    Market: According to Freedoniagroup.com, the US orthopedic implant 
market was $14.3 billion in 2007 and is expected to grow 8.9 percent 
annually through 2012. (http://www.freedoniagroup.com/Orthopedic-
Implants.html, accessed December 2, 2009.)
    Inventors: EunAh Lee and Pamela Robey (NIDCR) et al.
    Publication: In preparation.
    Patent Status:

[[Page 10286]]

     U.S. Provisional Application No. 61/004,940 filed 30 Nov 
2007 (HHS Reference No. E-042-2007/0-US-01).
     PCT Application No. PCT/US2008/012064 filed 22 Oct 2008, 
which published as WO 2009/073068 on 11 Jun 2009 (HHS Reference No. E-
042-2007/0-PCT-02).
    Licensing Status: Available for licensing.
    Licensing Contact: Charlene Sydnor, PhD; 301-435-4689; 
sydnorc@mail.nih.gov.
    Collaborative Research Opportunity: The National Institute of 
Dental and Craniofacial Research, Craniofacial and Skeletal Diseases 
Branch, is seeking statements of capability or interest from parties 
interested in collaborative research to further develop, evaluate, or 
commercialize this technology. Please contact David W. Bradley, PhD at 
301-402-0540 or bradleyda@nidcr.nih.gov for more information.

Gamma Substituted Peptide Nucleic Acids

    Description of Invention: PNAs are nuclease/protease resistant 
synthetic nucleic acid analogs capable of forming very stable and 
highly sequence-specific complexes with DNA. Scientists at the NIH have 
developed novel peptide nucleic acids (PNAs) that contain a unique 
sidechain that can attach any small ligand, peptide, or carbohydrate to 
complementary DNA for rapid optimization. This invention could 
revolutionize the way in which multivalent display is used in research 
as well as help develop new medications.
    Applications:
     Controlled interactions ensure only a single stoichiometry 
is attained.
     Simple access to a wide range of multivalent platforms.
    Development Status: Early stage.
    Inventors: Daniel Appella (NIDDK)
    Patent Status: U.S. Provisional Application No. 61/162,175 filed 20 
Mar 2009 (HHS Reference No. E-151-2009/0-US-01).
    Licensing Status: Available for licensing.
    Licensing Contact: Charlene Sydnor, PhD; 301-435-4689; 
sydnorc@mail.nih.gov.
    Collaborative Research Opportunity: The National Institute of 
Diabetes and Digestive and Kidney Diseases, Laboratory of Bioorganic 
Chemistry, Drug-Receptor Interactions Section, is seeking statements of 
capability or interest from parties interested in collaborative 
research to further develop, evaluate, or commercialize this 
technology. Please contact Dr. Daniel Appella at appellad@niddk.nih.gov 
for more information.

Use of Modified Peptide Nucleic Acids for Visualizing DNA

    Description of Technology: The compounds described in this 
technology may be useful in the development of nucleic acid detection 
kits for various pathogens.
    Technologies for genomic detection most commonly use DNA probes to 
hybridize to target sequences, and require the use of Polymerase Chain 
Reaction (PCR) to amplify target sequences. Replacing the DNA probe 
with peptide nucleic acid (PNA) can greatly eliminate the need for PCR 
because the binding strength of PNAs to complementary DNA is stronger 
than DNA binding to complementary DNA. In addition, PNAs are nuclease 
and protease resistant, and form very stable and highly sequence-
specific complexes with DNA.
    This technology describes a method of making pure enantiomers of 
trans-tert-butyl-2-aminocyclopentylcarbamate (tcycp) and methods of 
modifying PNAs by incorporating tcycp compounds into the PNA. This 
technology may also be practical for detecting infectious agents such 
as anthrax, avian flu, tuberculosis (TB), severe acute respiratory 
syndrome (SARS), human papilloma virus (HPV) and human immunodeficiency 
virus (HIV).
    Applications:
     Very stable diagnostic method to detect nucleic acids 
without using Polymerase Chain Reaction (PCR).
     Binding to complementary DNA can be seen by eye.
     Visual detection of anthrax has been shown.
     Useful for outside of a laboratory environment.
    Development Status: Early stage.
    Inventors: Daniel Appella et al. (NIDDK).
    Patent Status: U.S. Patent Application No. 12/441,925 filed 19 Mar 
2009 (HHS Reference No. E-308-2006/2-US-02).
    Licensing Status: Available for licensing.
    Licensing Contact: Charlene Sydnor, PhD; 301-435-4689; 
sydnorc@mail.nih.gov.
    Collaborative Research Opportunity: The National Institute of 
Diabetes and Digestive and Kidney Diseases, Laboratory of Bioorganic 
Chemistry, Drug-Receptor Interactions Section, is seeking statements of 
capability or interest from parties interested in collaborative 
research to further develop, evaluate, or commercialize this 
technology. Please contact Dr. Daniel Appella at appellad@niddk.nih.gov 
for more information.

    Dated: March 1, 2010.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2010-4759 Filed 3-4-10; 8:45 am]
BILLING CODE 4140-01-P