[Federal Register Volume 78, Number 81 (Friday, April 26, 2013)]
[Notices]
[Pages 24758-24759]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-09901]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Government-Owned Inventions; Availability for Licensing

April 23, 2013.
AGENCY: National Institutes of Health, 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.

FOR FURTHER INFORMATION CONTACT: 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.

Device for Non-Surgical Tricuspid Valve Annuloplasty

    Description of Technology: This is a non-surgical tricuspid 
annuloplasty to treat functional tricuspid valve regurgitation, meaning 
regurgitation with intact valve leaflets. The device is delivered using 
novel catheter techniques into the pericardial space and positioned 
along the atrioventricular groove. A compression member is positioned 
along the tricuspid annular free wall and tension applied through a 
variably-applied tension element. In the best embodiment, the 
compression member has an M shaped portion with at least two inflection 
points between the segments of difference curvatures.
    Potential Commercial Applications:
     Valvular heart disease.
     Tricuspid valve annuloplasty.
    Competitive Advantages:
     Non-surgical catheter treatment of valve disease.
     Tricuspid valve.
    Development Stage:
     Prototype.
     Pre-clinical.
     In vitro data available.
     In vivo data available (animal).
    Inventors: Robert Lederman, Kanishka Ratnayaka, Toby Rogers 
(NHLBI).
    Intellectual Property: HHS Reference No. E-027-2013--US Provisional 
Patent Application 61/785,652 filed 14 Mar 2013.
    Related Technologies: HHS Reference Nos. E-112-2010; E-108-2010; E-
165-2008; E-249-2006/0,/1,/2.
    Licensing Contact: Michael A. Shmilovich, Esq., CLP; 301-435-5019; 
[email protected].
    Collaborative Research Opportunity: The NHLBI is seeking statements 
of capability or interest from parties interested in collaborative 
research to further develop, evaluate or commercialize technologies for 
functional tricuspid valve regurgitation. For collaboration 
opportunities, please contact Peg Koelble at [email protected].

Urine-Based Diagnostic Assay for the Early Detection of Cancer

    Description of Technology: NIH scientists have identified a panel 
of metabolite biomarkers capable of predicting the onset of cancer with 
an accuracy approaching 100%. Concerted changes in the levels of select 
amino acid, nucleic acid and methylation metabolites in the urine of 
mice strongly correlated with tumor formation and reflected the 
progressive derangement in their underlying biochemical pathways. 
Researchers have developed high-throughput screening methodology to 
quantify the levels of these metabolites in biological samples for the 
purposes of assessing cancer risk, determining disease prognosis and 
monitoring response to therapy. While applicable to many cancers, use 
of this technology for the detection of colorectal cancer represents a 
first-in-class diagnostic for this particular disease.
    Despite therapeutic advances, colorectal cancer remains a 
significant clinical burden in terms of morbidity and mortality. Early 
detection is a key predictor of treatment outcome; however, current 
diagnostic methods are unsuitable for widespread implementation. The 
ability to analyze noninvasively obtained patient samples in a high-
throughput manner suggests that this technology is well positioned to 
serve as a population-level screening tool for the early detection of 
many cancers, including, colorectal.
    Potential Commercial Applications:
     A diagnostic screen for the detection of colorectal and 
other cancers.
     Assay to monitor response to therapy and disease 
recurrence.
    Competitive Advantages:

[[Page 24759]]

     Non-invasive sample collection (e.g., urine specimen).
     Metabolite profiling can be performed on an ELISA 
platform.
     High predictive accuracy.
    Development Stage:
     Pre-clinical.
     In vivo data available (animal).
    Inventors: Soumen K. Manna, Kristopher W. Krausz, Frank J. Gonzalez 
(NCI).
    Intellectual Property: HHS Reference No. E-020-2013/0--US 
Application No. 61/755,891 filed 23 Jan 2013.
    Licensing Contact: Sabarni Chatterjee, Ph.D., MBA; 301-435-5587; 
[email protected].
    Collaborative Research Opportunity: The National Cancer Institute, 
Laboratory of Metabolism, is seeking statements of capability or 
interest from parties interested in collaborative research to further 
develop, evaluate or commercialize a non-invasive assay for the 
detection of colorectal cancer. For collaboration opportunities, please 
contact John D. Hewes, Ph.D. at [email protected].

User-Friendly, Powerful Software for Analyzing ChIP-Seq Data

    Description of Technology: The present invention provides a user-
friendly software, called PAPST (Peak Assignment and Profile Search 
Tool for ChIP-Seq), for bench scientists to work with ChIP-Seq data in 
seconds, allowing the scientists to screen genes against multiple 
genomic features with ease and efficiency previously not realized. 
Furthermore, PAPST may be used to identify genes of special 
significance in a wide variety of biological and biomedical fields, 
which could lead the discovery of disease-associated genes and the 
development of therapeutic methods for human diseases. Lastly, this 
powerful, easy-to-use software does not require any special computation 
expertise.
    Potential Commercial Applications:
     Genomic analysis.
     Drug target identification.
    Competitive Advantages:
     Easy to use.
     Fast.
     Either a stand-alone software or as an add-on to existing 
commercial software.
    Development Stage:
     Prototype.
     Pilot.
    Inventors: Paul W. Bible (NIAMS), Hong-Wei Sun (NIAMS), Yuka Kanno 
(NIAMS), Lai Wei (NEI).
    Publications:
    1. Yang XP, et al. Opposing regulation of the locus encoding IL-17 
through direct, reciprocal actions of STAT3 and STAT5. Nat Immunol. 
2011 Mar;12(3):247-54. [PMID 21278738]
    2. Yamane A, et al. Deep-sequencing identification of the genomic 
targets of the cytidine deaminase AID and its cofactor RPA in B 
lymphocytes. Nat Immunol. 2011 Jan;12(1):62-9. [PMID 21113164]
    3. Ghoreschi K, et al. Generation of pathogenic T(H)17 cells in the 
absence of TGF-beta signalling. Nature. 2010 Oct 21;467(7318):967-71. 
[PMID 20962846]
    Intellectual Property: HHS Reference No. E-008-2012/0--Research 
Tool. Patent protection is not being pursued for this technology.
    Licensing Contact: Michael A. Shmilovich, Esq., CLP; 301-435-5019; 
[email protected].
    Collaborative Research Opportunity: The Biodata Mining & Discovery 
Section of NIAMS is seeking statements of capability or interest from 
parties interested in collaborative research to further develop, 
evaluate or commercialize PAPST (Peak Assignment and Profile Search 
Tool for ChIP-Seq). For collaboration opportunities, please contact 
Hong-Wei Sun at 301-496-0016 or [email protected].

Antimalarial Inhibitors That Target the Plasmodial Surface Anion 
Channel (PSAC) Protein and Development of the PSAC Protein as Vaccine 
Targets

    Description of Technology: There are two related technologies, the 
first being small molecule inhibitors of the malarial plasmodial 
surface anion channel (PSAC) and the second being the PSAC protein 
itself as a vaccine candidate. The PSAC protein is produced by the 
malaria parasite within host erythrocytes and is crucial for mediating 
nutrient uptake. In vitro data show that the PSAC inhibitors are able 
to inhibit growth of malaria parasites, have high specificity, and low 
toxicity. Portions of the PSAC protein are found on the outer surface 
of infected host erythrocytes and the protein was recently shown to be 
encoded by the clag3 gene. This discovery opens the possibility of 
developing the PSAC protein as a potential vaccine candidate against 
malaria.
    Potential Commercial Applications:
     Antimalarial drugs.
     Malaria vaccine.
    Competitive Advantages:
     Novel target against malaria.
     Small molecule inhibitors of PSAC inhibit malarial 
parasite growth, have low toxicity, and high specificity.
     PSAC protein is exposed on the surface of the infected 
host erythrocytes, making it an attractive vaccine candidate.
    Development Stage:
     Early-stage.
     Pre-clinical.
     In vitro data available.
    Inventor: Sanjay Desai (NIAID).
    Publications:
    1. Pillai AD, et al. Solute restriction reveals an essential role 
for clag3-associated channels in malaria parasite nutrient acquisition. 
Mol Pharmacol. 2012 Dec;82(6):1104-14. [PMID 22949525]
    2. Desai SA. Ion and nutrient uptake by malaria parasite-infected 
erythrocytes. Cell Microbiol. 2012 Jul;14(7):1003-9. [PMID 22432505]
    3. Nguitragool W, et al. Malaria parasite clag3 genes determine 
channel-mediated nutrient uptake by infected red blood cells. Cell. 
2011 May 27;145(5):665-77. [PMID 21620134]
    4. Pillai AD, et al. A cell-based high-throughput screen validates 
the plasmodial surface anion channel as an antimalarial target. Mol 
Pharmacol. 2010 May;77(5):724-33. [PMID 20101003]
    Intellectual Property: HHS Reference No. E-145-2011/0--
International PCT Patent Application No. PCT/US12/33072 filed 11 Apr 
2012.
    Related Technology: HHS Reference No. E-202-2008/0--Patent family 
filed in the U.S., Europe, Brazil, India, and China.
    Licensing Contact: Kevin W. Chang, Ph.D.; 301-435-5018; 
[email protected].
    Collaborative Research Opportunity: The National Institute of 
Allergy and Infectious Diseases is seeking statements of capability or 
interest from parties interested in collaborative research to further 
develop, evaluate, or commercialize Antimalarial Inhibitors that Target 
the Plasmodial Surface Anion Channel (PSAC) Protein. For collaboration 
opportunities, please contact Dana Hsu at [email protected] or 301-
451-3521.

    Dated: April 23, 2013.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2013-09901 Filed 4-25-13; 8:45 am]
BILLING CODE 4140-01-P