Notice: Government-Owned Inventions; Availability for Licensing

Federal Register: Volume 76, Number 160 (Thursday, August 18, 2011)
                  Pages 51376-51378

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.

Quantitative Measurement of Syndesmophytes in Ankylosing Spondylitis 
Using Computed Tomography (CT)

    Description of Technology: Syndesmophyte (abnormal bone) growth in 
the spine is a hallmark of Ankylosing Spondylitis, a type of 
inflammatory arthritis. Syndesmophyte growth is currently monitored 
using semi-quantitative scoring of radiographs, but radiographs 
consider only a small part of the vertebra, and the method is subject 
to reader error. Because syndesmophytes grow slowly, radiographs also 
lack sensitivity. The invention provides a method to measure 
syndesmophytes using data from computed tomography scans of the lumbar 
spine. It provides computer algorithm that fully quantitates 
syndesmophyte volumes in three-dimension space. This method allows 
precise and accurate measurement of the presence and rate of growth of 
syndesmophytes over time, which for the first time will permit testing 
of whether any treatments can slow the progression of this type of 
spinal arthritis.
    Potential Commercial Applications:
     The method would be useful for clinical trials of drugs 
against Syndesmophyte growth.
     Because of the improved precision, achieving statistical 
significance in assessing the efficacy of a drug would require smaller 
samples.
    Competitive Advantages:
     The present method is more automated than existing 
methods.
     The method is more precise and sensitive than existing 
methods, thus providing more reliable statistical analysis and improved 
planning in treatment regimen.
    Development Stage: In vivo data available (human).
    Inventors: Sovira Tan (NIAMS), et al.
    Publication: Tan S, Yao J, Ward MM, Yao L, Summers RM. Computer 
aided evaluation of ankylosing spondylitis using high-resolution CT. 
IEEE Trans Med Imaging 2008 Sep;27(9):1252-1267. [PMID 18779065].
    Intellectual Property: HHS Reference No. E-167-2011/0--Software. 
Patent protection is not being pursued for this technology.
    Licensing Contact: Michael Shmilovich, Esq.; 301-435-5019; 
shmilovm@mail.nih.gov.
    Collaborative Research Opportunity: The National Institute of 
Arthritis and Musculoskeletal and Skin Diseases is seeking statements 
of capability or interest from parties interested in collaborative 
research to further develop, evaluate or commercialize this technology. 
For collaboration opportunities, please contact Brian W. Bailey, Ph.D. 
at bbailey@mail.nih.gov.

[[Page 51377]]

An Automated Method for Precise Measurement of Vertebral Body Height 
and Intervertebral Disk Height Using Computed Tomography

    Description of Technology: Vertebral fractures due to osteoporosis 
result in loss of vertebral height. Degenerative disk disease in the 
spine results in loss of disk height. Currently, radiography and 
magnetic resonance imaging are used to assess vertebral and disk 
height, and measurements are done manually. The present invention 
offers improved method to measure vertebral and disk heights. The 
invention provides computer algorithm that substantially automates the 
task, and uses computed tomography. The advantage of computed 
tomography over radiography is that of 3D imaging over 2D imaging. 
Computed tomography's advantage over MRI is better image resolution. 
The combination of automation and superior imaging capability makes the 
method substantially more precise than previous ones. This allows 
better detection of changes in vertebral height and disk height over 
time, and thus aids in the planning of appropriate medical treatment in 
cases associated with the loss of vertebral or disk heights, such as in 
osteoporosis for example.
    Potential Commercial Applications:
     The method would be useful for clinical trials of drugs 
for osteoporosis.
     Because of the improved precision, achieving statistical 
significance in assessing the efficacy of a drug would require smaller 
samples.
    Competitive Advantages:
     The present method is semi-automated.
     The method is more precise and sensitive than existing 
methods, thus providing more reliable statistical analysis and improved 
planning in treatment regimen.
    Development Stage: In vivo data available (human).
    Inventors: Sovira Tan (NIAMS), et al.
    Intellectual Property: HHS Reference No. E-166-2011/0--Software. 
Patent protection is not being pursued for this technology.
    Licensing Contact: Michael Shmilovich, Esq.; 301-435-5019; 
shmilovm@mail.nih.gov.
    Collaborative Research Opportunity: The National Institute of 
Arthritis and Musculoskeletal and Skin Diseases is seeking statements 
of capability or interest from parties interested in collaborative 
research to further develop, evaluate or commercialize this technology. 
For collaboration opportunities, please contact Brian W. Bailey, Ph.D. 
at bbailey@mail.nih.gov.

Monoclonal Antibodies Against Poliovirus

    Description of Technology: Early work by Hammond et al. showed 
gamma globulin to be effective for the prevention of poliomyelitis. 
Therefore, passive immunotherapy could be another way to treat chronic 
excretors. Even though prior attempts to use intravenous immunoglobulin 
(IVIG) and breast milk were unsuccessful, there is reason to think that 
higher doses of antipoliovirus antibodies could result in complete 
clearance of poliovirus from chronically infected individuals. Six 
poliovirus-neutralizing MAbs were recovered from a combinatorial Fab 
phage display library constructed from bone marrow-derived lymphocytes 
of immunized chimpanzees. The six MAbs neutralized vaccine strains and 
virulent strains of poliovirus. Five MAbs were serotype specific, while 
one MAb cross-neutralized serotypes 1 and 2. Both serotype 2-specific 
antibodies recognized antigenic site 1. No escape mutants to serotype 
3-specific MAbs could be generated. The administration of a serotype 1-
specific MAb to transgenic mice susceptible to poliovirus at a dose of 
5 [mu]g/mouse completely protected them from paralysis after challenge 
with a lethal dose of wild-type poliovirus. Moreover, MAb injection 6 
or 12 h after virus infection provided significant protection. This 
application claims the antibodies described above and methods for their 
use.
    Potential Commercial Applications:
     Prophylaxis/therapeutic for poliovirus.
     Post-exposure emergency prophylaxis of poliovirus.
    Competitive Advantages:
     No humanization required.
     Highly potent neutralizing antibodies.
     Biological materials available.
    Development Stage:
     Pre-clinical.
     In vitro data available.
     In vivo data available (animal).
    Inventors: Zhaochun Chen, Robert H. Purcell, Konstantin Chumakov 
(NIAID).
    Publication: Chen Z, et al. Chimpanzee-human monoclonal antibodies 
for treatment of chronic poliovirus excretors and emergency 
postexposure prophylaxis. J Virol. 2011 May;85(9):4354-4362. [PMID: 
21345966].
    Intellectual Property: HHS Reference No. E-076-2011/0--U.S. 
Provisional Application No. 61/443,915 filed 17 Feb 2011.
    Licensing Contact: Peter Soukas, J.D.; 301-435-4646; 
soukasp@mail.nih.gov.

Methods of Treating Giardiasis Using FDA-Approved Compounds

    Description of Technology: This technology includes a group of at 
least twenty-nine, diverse, commercially available compounds that are 
newly identified for activity against Giardia lamblia parasites. At 
least six of the candidate compounds, Bortezomib, Decitabine, 
Hydroxocobalamin, Amlexanox, Idarubicin, and Auranofin have preexisting 
FDA approval for human use for other (non-Giardia) conditions. Another 
three compounds, Fumagillin, Nitarsone and Carbadox have preexisting 
approval for veterinary use for non-Giardia conditions. Additional 
active compounds identified include: Acivicin, Riboflavin butyrate, 
BTO-1, GW9662, Dinitroph-dfgp, Deserpidine, Tetramethylthiuram 
disulsulfide, Disulfiram, Mitoxantrone, Ecteinascidin 743, 17-
allyaminogeldanamycin, Carboquone and Nocodazole. The anti-Giardial 
activity of these compounds presents a cost saving opportunity for the 
rapid development of new, better tolerated treatments for the most 
prevalent human intestinal parasite infection in the United States and 
the world.
    Potential Commercial Applications:
     Treatment of Giardia in humans.
     Treatment of Giardia in animals--dogs and cats.
    Competitive Advantages: These compounds have currently been 
approved for human and veterinary uses of other indications which 
provides an opportunity to greatly reduce risk and pre-market 
investments both in terms of time and costs associated with development 
and regulatory approval for new Giardia applications including the drug 
resistant Giardiasis.
    Development Stage:
     Early-stage.
     Pre-clinical.
     In vitro data available.
    Inventors:
     Wei Zheng, Catherine Chen, Juan J. Marugan, Noel T. 
Southall, Christopher P. Austin (NHGRI).
     Osnat Hertzberg, Luidmila Kulakova, Andrey Galkin 
(Institute for Bioscience & Biotechnology Research, University of 
Maryland).
    Publication: Chen CZ, et al. High-throughput Giardia lamblia 
viability assay using bioluminescent ATP content measurements. 
Antimicrob Agents Chemother. 2011 Feb;55(2):667-675. [PMID 21078930].
    Intellectual Property: HHS Reference No. E-211-2010/1--U.S. 
Provisional Application No. 61/411,509 filed 09 Nov 2010.
    Licensing Contact: Tedd Fenn; 301-435-5031; Tedd.Fenn@nih.gov.

[[Page 51378]]

    Collaborative Research Opportunity: The NHGRI is seeking statements 
of capability or interest from parties interested in collaborative 
research to further develop, evaluate, or commercialize Novel Compounds 
for Treatment of Giardiasis. For collaboration opportunities, please 
contact Claire Driscoll, NHGRI, at cdriscol@mail.nih.gov.

    Dated: August 12, 2011.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2011-21155 Filed 8-17-11; 8:45 am]
BILLING CODE 4140-01-P