[Federal Register Volume 77, Number 205 (Tuesday, October 23, 2012)]
[Notices]
[Pages 64810-64812]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-26095]


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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.

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.

Zuma Mutant Mice as a Tool for Investigating Mammalian Developmental 
Defects

    Description of Technology: In vertebrates, mutations in different 
ribosomal protein subunits result in a variety of phenotypes, 
suggesting unique and perhaps extra-ribosomal functions for these 
proteins. Diamond-Blackfan Anemia (DBA) is a ribosomal protein disease, 
in which the bone marrow fails to produce red blood cells.
    NHGRI investigators recently generated a mouse line with a mutation 
in small ribosomal protein7 (Rps7), known to be involved in DBA. This 
line named Zuma (made with the use of the mutagen N-ethyl-N-nitrosourea 
(ENU)) carries a point mutation in exon 7 of Rps7, which is predicted 
to cause a substitution of a conserved amino acid (pY177S). The 
mutation results in the disruption of ribosomal biogenesis, as well as 
in abnormal skeletal, melanocyte, and central nervous system 
development. Thus, the Zuma line can be used as a model of DBA, as well 
as a tool for investigating other defects of mammalian development.
    Potential Commercial Applications:
     Animal model of Diamond-Blackfan Anemia (DBA).
     Research tool to study other mammalian developmental 
defects.
    Competitive Advantages: Not available elsewhere.
    Development Stage:
     Prototype.
     Pre-clinical.
     In vitro data available.
    Inventors: William J. Pavan and Dawn Watkins Chow (NHGRI).
    Publication: Manuscript submitted.
    Intellectual Property: HHS Reference No. E-294-2012/0--Research 
Tool. Patent protection is not being pursued for this technology.
    Licensing Contact: Betty B. Tong, Ph.D.; 301-594-6565; 
[email protected].
    Collaborative Research Opportunity: The Mouse Embryology Section of 
the National Human Genome Research Institute is seeking statements of 
capability or interest from parties interested in collaborative 
research to further develop, evaluate, or commercialize Diamond-
Blackfan Anemia therapies. For collaboration opportunities, please 
contact Claire T. Driscoll, Director, NHGRI Technology Transfer Office, 
at [email protected] or 301-594-2235.

Magnetic Resonance Arterial Wall Imaging Methods That Compensate for 
Patient Aperiodic Intrinsic Cardiac, Chest Wall, and Blood Flow-Induced 
Motions

    Description of Technology: The technology includes MRI methods, 
systems, and software for reliably imaging vasculature and vascular 
wall thickness while compensating for aperiodic intrinsic motion of a 
patient during respiration. To overcome the loss of the orthogonality 
due to uncompensated residual motions and after a lapse of time equal 
to the trigger delay commenced at the cardiac cycle, the system 
acquires multiple consecutive time-resolved images of the arterial 
wall. The cine images are processed offline and a wall thickness 
measurement is produced.
    The method improves arterial wall imaging by increasing the success 
rate of obtaining good and excellent quality images and imaging slice-
vessel orthogonality. The method also provides more precise wall 
measurements and a more distinct difference between healthy subjects 
and patients.
    The methodology and system can be applied to any commercially 
available MRI scanner.
    Potential Commercial Applications:
     Early detection of vascular disease,
     Research in the field of vascular disease,

[[Page 64811]]

     Non-invasive assessment of the efficacy of medication and/
or lifestyle changes in vascular health status in a particular subject, 
and
     Assessment of the efficacy of new medications or new uses 
of existing medications to treat vascular disease.
    Competitive Advantages: Existing techniques suffer from image 
degradation due to aperiodic intrinsic cardiac, chest wall motions, or 
other bulk motion that often cause image blur and reduced wall 
sharpness. These techniques do not adequately address the time-
dependent angular orientation of the arteries, whereby mispositioning 
of the imaged slice may cause disappearance of the lumen-wall interface 
altogether.
    In the new technology time-resolved arterial wall imaging overcomes 
the loss of the orthogonality due to uncompensated residual motion.
    Development Stage:
     Prototype.
     Early-stage.
     Pre-clinical.
     In vivo data available (human).
    Inventors: Khaled Z. Abd-Elmoniem (NIDDK), Ahmed Gharib (NIDDK), 
Roderic Pettigrew (NIBIB).
    Publications:

    1. Plein S, et al. Three-dimensional coronary MR angiography 
performed with subject-specific cardiac acquisition windows and 
motion-adapted respiratory gating. AJR Am J Roentgenol. 2003 
Feb;180(2):505-12. [PMID 12540462]
    2. Hoffmann MH, et al. Automatic determination of minimal 
cardiac motion phases for computed tomography imaging: Initial 
experience. Eur Radiol. 2006 Feb;16(2):365-73. [PMID 16021450]
    3. Ustun A, et al. Automated identification of minimal 
myocardial motion for improved image quality on MR angiography at 3 
T. AJR Am J Roentgenol. 2007 Mar;188(3):W283-90. [PMID 17312038]
    4. Roes SD, et al. Correction for heart rate variability during 
3D whole heart MR coronary angiography. J Magn Reson Imaging. 2008 
May;27(5):1046-53. [PMID 18425831]
    5. Abd-Elmoniem KZ, et al. Phase-sensitive black-blood coronary 
vessel wall imaging. Magn Reson Med. 2010 Apr;63(4):1021-30. [PMID 
20373403]
    6. Spuentrup E, et al. The impact of navigator timing parameters 
and navigator spatial resolution on 3D coronary magnetic resonance 
angiography. J Magn Reson Imaging. 2001 Sep;14(3):311-8. [PMID 
11536409]

    Intellectual Property: HHS Reference No. E-185-2012/0--U.S. 
Provisional Application No. 61/692,191 filed 22 Aug 2012.
    Licensing Contact: Michael Shmilovich; 301-435-5019; 
[email protected].
    Collaborative Research Opportunity: The Biomedical and Metabolic 
Imaging Branch, NIDDK, NIH, is seeking statements of capability or 
interest from parties interested in collaborative research to further 
develop, evaluate, or commercialize time-resolved arterial wall 
imaging. For collaboration opportunities, please contact Khaled Z. Abd-
Elmoniem at [email protected].

Topical Antibiotic With Immune Stimulating Oligodeoxynucleotide 
Molecules To Speed Wound Healing

    Description of Technology: The present technology provides a mean 
of improving the activity of topical antibiotics. Currently available 
topical antibiotic formulations effectively eliminate bacteria at a 
wound site. But in eliminating bacteria in the wound, such antibiotics 
also eliminate the molecular signals present in bacterial DNA that 
stimulate to immune system's wound healing processes. Without these 
signals the rate of wound healing is diminished. It would be desirable 
for topical antibiotics to remove infectious bacteria but also provide 
the immune stimulating signals needed to promote and accelerate 
healing. The present formulation accomplishes these goals by 
supplementing the antibiotic formulation with immunostimulatory 
oligodeoxynucleotides (ODN). These ODN express the CpG motifs present 
in bacterial DNA and safely mimic the immune stimulation induced by 
bacterial DNA. The formulation may be applied directly to a wide 
variety of wounds to skin (such as traumatic, burn, or surgical wound), 
or the eyes (such as corneal abrasions) to effectively eliminate 
infection and stimulate rapid healing of the wound.
    Potential Commercial Applications: Topical antibiotic.
    Competitive Advantages: Eliminates wound site bacteria while 
retaining immune stimulating properties that promote faster wound 
healing.
    Development Stage:
     Early-stage.
     In vivo data available (animal).
    Inventors: Dennis Klinman, Hiroyasu Ito, Noriho Iida (all of NCI).
    Publications:

    1. Ito H, et al. Antibiotics delay wound healing: An effect 
reversed by co-administering TLR7 and 9 ligands. Current 
Angiogenesis. 2012 Apr;1(1):46-51.
    2. Sato T, et al. Accelerated wound healing mediated by 
activation of Toll-like receptor 9. Wound Repair Regen. 2010 Nov-
Dec;18(6):586-93. [PMID 20946144]
    3. Yamamoto M, et al. The acceleration of wound healing in 
primates by the local administration of immunostimulatory CpG 
oligonucleotides. Biomaterials. 2011 Jun;32(18):4238-42. [PMID 
21421264]

    Intellectual Property: HHS Reference No. E-294-2011/0--U.S. 
Provisional Application No. 61/639,688 filed 27 Apr 2012.
    Related Technology: HHS Reference No. E-242-2007/0--U.S. Patent 
Application No. 12/205,756 filed 05 Sep 2008.
    Licensing Contact: Edward (Tedd) Fenn; 301-435-5031; 
[email protected].
    Collaborative Research Opportunity: The National Cancer Institute 
is seeking statements of capability or interest from parties interested 
in collaborative research to further develop, evaluate, or 
commercialize adding immunostimulatory CpG oligonucleotides to a 
topical antibiotic formulation to accelerate wound healing. For 
collaboration opportunities, please contact John Hewes, Ph.D. at 
[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

[[Page 64812]]

channels in malaria parasite nutrient acquisition. Mol Pharmacol. 
2012 Sep 4; Epub ahead of print. [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.

Fluorescent Magnesium Indicators

    Description of Technology: A non-invasive approach in which 
Magnesium (Mg2+) ion levels can be measured in real-time. Mg2+ is 
essential to many physio-chemical processes and plays a central role in 
the biochemistry of all cells. Many epidemiological studies have 
established close association between plasma magnesium levels and 
various diseases including cardiovascular disease and hypertension. 
However, methods and tools to selectively measure cellular magnesium 
levels in the body with accuracy and reliability are still lacking in 
the market today. The present invention provides novel fluorescent 
indicators (carboxy-quinolizones) that are selective for Mg2+ and can 
be easily detected using fluorescence spectroscopy.
    Current approaches used to measure intracellular magnesium in the 
body generally involve magnetic resonance spectroscopy, which is 
extremely expensive and subject to very poor accuracy. Unlike these 
other methods, the fluorescence indicators of this invention provide a 
more accurate way to measure intracellular and extracellular Mg2+ 
levels in a wide variety of biological settings and have potential to 
be developed into diagnostic reagents.
    Potential Commercial Applications:
     Tool for measuring intracellular and extracellular 
magnesium levels.
     Diagnostic reagent for measuring magnesium levels in a 
human or animal.
    Competitive Advantages:
     Increased accuracy compared to what is available on the 
market.
     Detection is noninvasive.
     Ease of use.
    Development Stage:
     Early-stage.
     In vitro data available.
    Inventors: Robert E. London, Pieter Otten, Louis A. Levy (all of 
NIEHS).
    Publications:

    1. Raju B, et al. A fluorescent indicator for measuring 
cytosolic free magnesium. Am J Physiol. 1989 Mar;256(3 Pt 1):C540-8. 
[PMID 2923192]
    2. Otten PA, et al. 4-Oxo-4H-quinolizine-3-carboxylic acids as 
Mg2+-selective, fluorescent indicators. Bioconjugate Chem. 2001 Mar-
Apr;12(2):203-12. [PMID 11312681]
    Intellectual Property: HHS Reference No. E-067-2000/0 -- U.S. 
Patent No. 6,706,528 issued 16 Mar 2004.
    Licensing Contact: Suryanarayana Vepa, Ph.D., J.D.; 301-435-5020; 
[email protected].
    Collaborative Research Opportunity: The NIEHS is seeking statements 
of capability or interest from parties interested in collaborative 
research to further develop, evaluate, or commercialize the fluorescent 
magnesium indicators. For collaboration opportunities, please contact 
Elizabeth M. Denholm, Ph.D. at [email protected].

     Dated October 18, 2012.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2012-26095 Filed 10-22-12; 8:45 am]
BILLING CODE 4140-01-P