Government-Owned Inventions; Availability for Licensing, 3437-3440 [2013-00738]

Download as PDF mstockstill on DSK4VPTVN1PROD with Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Notices reporting is launched, CTP estimates that it will receive, on average, 100 voluntary adverse event and product problem reports annually over the next 3 years. Thus, FDA estimates that over the next 3 years it will receive annually 1,513 voluntary adverse event reports submitted via the SRP, with a burden of 907.8 hours, rounded to 908 hours, as reported in table 2, row 1 (1,413 + 100 = 1,513). Mandatory adverse event reports submitted via the SRP (other than RFR Reports) include reports of adverse animal drug experiences and product/ manufacturing defects associated with approved NADAs and ANADAs. CVM received 144 such adverse event reports in 2010, 537 reports in 2011, and 212 reports in the first four months of 2012, and estimates that for the full 12 months of 2012 it will receive 636 reports. Based on this experience, CVM estimates that it will receive, on average, 636 reports of adverse drug experiences and product/manufacturing defects associated with approved NADAs and ANADAs annually over the next 3 years. Thus, FDA estimates that over the next 3 years it will receive annually 636 mandatory adverse event reports submitted via the SRP, with a burden of 636 hours, as reported in table 2, row 2. Adverse event reports submitted via the ESG include reports of adverse experiences related to drugs, biological products, and medical devices, as well as, adverse animal drug experiences and product/manufacturing defects associated with approved NADAs and ANADAs. FDA received 586,229 such adverse event reports in 2010; 850,161 reports in 2011; and 497,076 reports in the first 4 months of 2012; and estimates that for the full 12 months of 2012 it will receive 1,491,228 reports. Based on this experience, FDA estimates that it will receive, on average, 1,491,228 adverse event reports submitted via the ESG, with a burden of 894,736.8 hours, rounded to 894,737 hours, as reported in table 2, row 3. FDA estimates that over the next 3 years it will receive annually 1,413 mandatory and voluntary RFR Reports submitted via the SRP, as reported in table 2, row 4. The Center for Food Safety and Applied Nutrition (CFSAN) received 845 such adverse event reports in 2010; 1,293 reports in 2011; and 471 reports in the first four months of 2012; and estimates that for the full 12 months of 2012 it will receive 1,413 reports. Based on this experience, CFSAN estimates that it will receive, on average, 1,413 mandatory and voluntary RFR Reports submitted via the SRP annually over the next 3 years, with a burden of VerDate Mar<15>2010 17:01 Jan 15, 2013 Jkt 229001 847.8 hours, rounded to 848 hours, as reported in table 2, row 4. The burden hours required to complete paper FDA reporting forms (Forms FDA 3500, 3500A, 1932, and 1932a) are reported under OMB control numbers 0910–0284 and 0910–0291. While FDA does not charge for the use of the ESG, FDA requires respondents to obtain a public key infrastructure certificate in order to set up the account. This can be obtained inhouse or outsourced by purchasing a public key certificate that is valid for 1 year to 3 years. The certificate typically costs from $20 to $30. Dated: January 10, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–00761 Filed 1–15–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing National Institutes of Health, Public Health Service, HHS. ACTION: Notice. AGENCY: 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. SUMMARY: Optical Microscope Software for Breast Cancer Diagnosis Description of Technology: The instant invention discloses a software to analyze optical microscopic images of human breast tissue sections for diagnosing cancer by using the differences in spatial positioning of PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 3437 certain genes. The software uses the inherent hierarchy in the data and stores all the analysis and manual interaction information in a highly structured XML file. It is a user-friendly software to discriminate normal and cancerous human breast tissue section images that can be used for large experiments. Additionally the software uses a cluster of computers in the background to reduce the analysis time for large image datasets. Furthermore, the software of instant invention provides a set of tools for performing diagnostic or prognostic assays on new unseen datasets. Potential Commercial Applications: • The software could be an essential part of an integrated diagnostic or prognostic assay for breast cancer detection. • The software could be a key tool for biomedical research to test new markers and their applicability for diagnostic purposes. • The use of the software could provide important information for understanding the underlying causes of gene repositioning. Competitive Advantages: • The software of instant invention can be used to analyze relatively large datasets. • To reduce the processing time by at least 10 fold. • The software can be used in a broad range of quantitative image analysis applications. Development Stage: • Prototype • Clinical • In vitro data available (human) Inventors: Kaustav Nandy (SAICFrederick, Inc), Stephen J. Lockett (SAIC-Frederick, Inc), Prabhakar R. Gudla (SAIC-Frederick, Inc), William Cukierski (NCI), Renee Qian (NCI), Karen J. Meaburn (NCI), Tom Misteli (NCI). Publications: 1. Gudla PR, et al. A high-throughput system for segmenting nuclei using multiscale techniques. Cytometry A. 2008 May;73(5):451–66. [PMID 18338778] 2. Nandy K, et al. Automatic nuclei segmentation and spatial FISH analysis for cancer detection. Conf Proc IEEE Eng Med Biol Soc. 2009;2009:6718–21. [PMID 19963931]. 3. Meaburn KJ, et al. Disease-specific gene repositioning in breast cancer. J Cell Biol. 2009 Dec 14;187(6):801–12. [PMID 19995938]. 4. Cukierski WJ, et al. Ranked retrieval of segmented nuclei for objective assessment of cancer gene repositioning. BMC Bioinformatics. 2012 Sep 12;13:232. [PMID: 22971117]. 5. Nandy K, et al. Supervised learning framework for screening nuclei in tissue E:\FR\FM\16JAN1.SGM 16JAN1 3438 Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Notices sections. Conf Proc IEEE Eng Med Biol Soc. 2011;2011:5989–92. [PMID 22255704] Intellectual Property: HHS Reference No. E–286–2012/0—Software. Patent protection is not being pursued for this technology. Licensing Contact: Susan Ano, Ph.D.; 301–435–5515; anos@mail.nih.gov. Collaborative Research Opportunity: The SAIC-Frederick Optical Microscopy and Analysis Laboratory 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 John Hewes, Ph.D., at hewesj@mail.nih.gov. mstockstill on DSK4VPTVN1PROD with Simple Direct Zirconium-89 Cell PET Label, 89Zr-Labeled Cells, and Methods for Real-Time In Vivo Pet Imaging Description of Technology: The capability to image cells and cellular processes in real time over a scale of days could dramatically improve research insights and the effectiveness of cell-based therapies. Zirconium-89 (89Zr) has a half-life of over three days (78.4 hours) over 44 times longer compared to Fluorine (18F) the most commonly used PET isotope (half-life of 1 hour and 50 minutes). 89Zr is also advantageous compared to other long half-life isotopes because it is not limited by high background activity and cell toxicity. Labeling cells with 89Zr, is currently accomplished by indirect methods using secondary cell-type specific reagents such as antibodies. This technology is a PET imaging complex of 89Zr and polycation that is internalized by the cells. This complex has been able to directly label a wide range of cells, without the use of secondary reagents. 89Zr-labeled cells of lymphocytic lineage, including T cells, natural killer T-cells, macrophages, dendritic cells, and stem cells, have been produced and imaged in vivo with minimal damage to the cells. This PET imaging agent can be readily combined with an MR imaging agent for combined PET/MR imaging of cells. The imaging capabilities enabled by this technology may significantly improve cell therapies, cell level diagnostics and aid research for non-cell based therapies. Potential Commercial Applications: • Imaging • Diagnostic • Cell therapies • Transplantation and transfusion Competitive Advantages: • Direct labeled cells (versus indirect techniques) • Longer half-life VerDate Mar<15>2010 17:01 Jan 15, 2013 Jkt 229001 • Not limited by high background activity and cell toxicity Development Stage: • Early-stage • Pre-clinical • In vivo data available (animal) Inventors: Omer Aras (CC), Peter Choyke (NCI), Joseph Frank (CC), Noriko Sato (CC), Jeremy Pantin (NHLBI). Intellectual Property: HHS Reference No. E–056–2012/0—US Provisional Application No. 61/611964 filed 16 Mar 2012. Licensing Contact: Tedd Fenn; 301– 435–5031; Tedd.Fenn@nih.gov Collaborative Research Opportunity: The NCI 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 John Hewes, Ph.D., at hewesj@mail.nih.gov. Small, Stable, Functional, Soluble, Monomeric IgG1 Fc Molecules Engineered Therapies Description of Technology: This technology relates to small (∼27 kDa) antibody fragments that are potentially useful for therapeutic development. These are monomeric IgG fragment crystalizable (mFc) compositions; they are long half-lived, functional (pH dependent binders of neonatal Fc receptor—FcRn); and they are soluble and express efficiently in E. coli. These molecules may serve as a platform for development of engineered mFc-based antibodies and fusion proteins with therapeutic applications. Efforts to engineer antibody-based therapeutics, to date, have encountered technical limitations due to the relatively large fragment size and short fragment halflife. The IgG fragment crystalizable (Fc) is a dimer of two constant domains (CH2–CH3 chains). Fc has a long halflife, which makes it promising as a candidate for engineering antibody therapeutics. Fusion proteins based on Fc dimer molecules demonstrate extended half-life, due to the ability to bind FcRn at acidic pH. However, the relatively large size of the Fc domains (∼50 kD) is not optimal. This technology uses smaller (∼27 kDa) mFc compositions that retain efficient binding to human FcRn and demonstrate long half-life. These mFc compositions are promising for the development of novel therapeutics because the smaller size may allow for superior access to targets and tissues compared to full sized mAbs and larger fragment-based therapeutics, while also PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 retaining important function characteristics. Potential Commercial Applications: Therapeutics—human and veterinary, engineered antibody and fusion proteins. Competitive Advantages: Smaller size results better tissue penetration, reduced steric hindrance, increased therapeutic efficiency and lower cost. Development Stage: • Early-stage • Pre-clinical Inventors: Dimiter S. Dimitrov and Tianlei Ying (NCI). Publication: Ying T, et al. Soluble monomeric IgG1 Fc. J Biol Chem. 2012 Jun 1; 287(23):19399–408. [PMID 22518843]. Intellectual Property: HHS Reference No. E–019–2012/0—U.S. Patent Application No. 61/612,138 filed 16 Mar 2012. Related Technologies: HHS Reference No. E–003–2007/0— • U.S. Patent Application No. 61/ 063,245 filed 31 Jan 2008 • PCT Application No. PCT/US2009/ 0326 and related international applications filed on 30 Jan 2009 in Australia, Canada, China, Europe, Japan, and India • U.S. Patent Application No. 12/ 864,758 filed 27 Jul 2010 Licensing Contact: Tedd Fenn; 301– 435–5031; Tedd.Fenn@nih.gov Collaborative Research Opportunity: The NCI/CCR/NP is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate or commercialize Small, Stable, Functional, Soluble, Monomeric IgG1 Fc Molecules Engineered Therapies. For collaboration opportunities, please contact John Hewes, Ph.D., at #hewesj@mail.nih.gov. Virus-Like Particles Mediated Protein and RNA Delivery Description of Technology: The invention is directed to novel virus-like particles (VLPs) that are capable of binding to and replicating within a target mammalian cell, including human cells. The claimed VLPs are safer than viral delivery because they are incapable of re-infecting target cells. The present VLPs can optionally comprise inhibitory recombinant polynucleotides, such as microRNA, antisense RNA or small hairpin RNA, to down regulate or turn off expression of a particular gene within the target cell. Alternatively, recombinant polynucleotides packaged within VLPs can comprise a gene encoding a therapeutic protein so as to enable expression of that protein within the E:\FR\FM\16JAN1.SGM 16JAN1 Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Notices target cell. Specifically, VLPs of the invention are composed of an alphavirus replicon that contains a recombinant polynucleotide, a retroviral gag protein, and a fusogenic envelope glycoprotein. While the claimed VLPs have a variety of applications, therapeutic uses of the VLPs include directing antibody synthesis and converting cancer cells into antigen presenting cells. Additional applications include using VLPs to induce fast (approx. 3–4 hrs) and high levels of protein production in mammalian cells. Potential Commercial Applications: • Delivery of microRNA and small hairpin RNA to reduce express of targeted genes in a human cell • Delivery of coding RNA for robust expression in mammalian systems • Direct antibody production by in vivo injection of replicons (no antigen purification) • Therapeutic applications Competitive Advantages: • High level (∼million copies per cell) of RNA production/synthesis within target cell • Fast expression (approx. 3–4 hrs compared to 1–2 days) following VLP introduction into target cells • Obviates need to use expensive antigen purification for proteins or antigens produced inside target cells Development Stage: • Pilot • Pre-clinical • In vitro data available • In vivo data available (animal) Inventors: Stanislaw J. Kaczmarczyk and Deb K. Chatterjee (NCI). Intellectual Property: HHS Reference No. E–264–2011/0—US Application No. 61/615,687 filed 26 Mar 2012. Licensing Contact: Lauren NguyenAntczak, Ph.D., J.D.; 301–435–4074; lauren.nguyen-antczak@nih.gov. 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 Novel Delivery of Packaged RNA to Mammalian Cells. For collaboration opportunities, please contact Kevin Brand at brandk@mail.nih.gov. mstockstill on DSK4VPTVN1PROD with A Combinatorial Cloning Platform for Construction of Expression Vectors for Protein Production Description of Technology: The Combinatorial Cloning Platform (CCP) of this invention is a collection of vectors for use with the Gateway Multisite Recombination System (Life Technologies). The CCP that is currently available includes plates of 192 glycerol VerDate Mar<15>2010 17:01 Jan 15, 2013 Jkt 229001 stocks of E. coli each containing one of the library plasmids, and a collection of 24 DNAs that are the downstream vectors for expression in different hosts. Uses of this CCP include construction of protein expression constructs with various fusion tags, generation of expression constructs with different promoters for in vivo expression, and production of clones with fluorescent tags for localization experiments. The advantage of the CCP is based on the exquisite specificity of the Multisite Gateway reactions, which permit linkage of multiple elements in a directional fashion and involve no additional DNA amplification. There is also no need for restriction-based cloning processes, which have a high rate of failure and may require optimization depending on the sites available in a given clone. The CCP library includes clones for fluorescent and luminescent reporters, epitope and solubility fusion tags, bimolecular fluorescence complementation (BiFC) fusions, 18 different eukaryotic promoters, and many other useful clones. In addition, the destination vector collection contains two flavors of Gateway destination vectors for E. coli, baculovirus, mammalian, and lentiviral expression. Potential Commercial Applications: • Construction of protein expression constructs with various fusion tags • Generation of expression constructs with different promoters for in vivo expression • Production of clones with fluorescent tags for localization experiments • Generation of constructs for making mutant cell lines or transgenic animals • Production of vectors for shRNA or miRNA delivery Competitive Advantages: The CCP is considerably more flexible than currently available commercial systems for construction of protein expression constructs. Development Stage: • Prototype • Pre-clinical • In vitro data available Inventor: Dominic Esposito (NCI). Publication: Hopkins RF, et al. Optimizing transient recombinant protein expression in mammalian cells. Methods Mol Biol. 2012;801:251–68. [PMID 21987258]. Intellectual Property: HHS Reference No. E–164–2011/0—Research Tools. Patent protection is not being pursued for these technologies. Licensing Contact: Suryanarayana Vepa, Ph.D., J.D.; 301–435–5020; vepas@mail.nih.gov. PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 3439 Therapeutic Peptide Treatment for Dyslipidemic and Vascular Disorders Description of Technology: This invention is directed to use of certain peptide analogs comprising multiple amphipathic helical domains that are able to promote cellular lipid efflux and stimulate lipoprotein lipase activity. As a result, administration of invention peptides lead to reduced incidences of hypertriglyceridemia without inducing toxicity. Existing peptides that stimulate efflux of lipids from cells exhibit unacceptably high toxicity. Invention peptides are superior to existing peptides and can also be used to treat or prevent a vast range of vascular diseases, and their dyslipidemic precursors. Exemplary vascular diseases and conditions that could benefit from treatment with the invention peptides include: dyslipidemia, hyperlipidemia, hypercholesterolemia, HDL deficiency, coronary heart disease, atherosclerosis, and thrombic stroke. Potential Commercial Applications: • Treatment of dyslipidemic and vascular disorders • Method of identifying therapeutic non-cytotoxic peptides Competitive Advantages: • Specific control of lipid efflux and transport • Transient hypertriglyceridemia with no reported toxicity Development Stage: • Early-stage • Pre-clinical • In vitro data available • In vivo data available (animal) Inventors: Alan T Remaley and Marcelo A Amar (NHLBI). Publications: 1. Remaley AT, et al. Synthetic amphipathic helical peptides promote lipid efflux from cells by an ABCA1dependent and an ABCA1-independent pathway. J Lipid Res. 2003 Apr;44(4):828–36. [PMID 12562845]. 2. Sviridov DO, et al. Helix stabilization of amphipathic peptides by hydrocarbon stapling increases cholesterol efflux by the ABCA1 transporter. Biochem Biophys Res Commun. 2011 Jul 8;410(3):446–51. [PMID 21672528]. 3. Osei-Hwedieh DO, et al. Apolipoprotein mimetic peptides: Mechanisms of action as antiatherogenic agents. Pharmacol Ther. 2011 Apr;130(1):83–91. [PMID 21172387]. Intellectual Property: HHS Reference No. E–138–2008/0—US Patent Application No. 12/937,974 filed 14 Oct 2010. Licensing Contact: Lauren NguyenAntczak, Ph.D., J.D.; 301–435–4074; lauren.nguyen-antczak@nih.gov. E:\FR\FM\16JAN1.SGM 16JAN1 3440 Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Notices Dated: January 10, 2013. Richard U. Rodriguez, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. 2013–00738 Filed 1–15–13; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing National Institutes of Health, Public Health Service, HHS. ACTION: Notice. AGENCY: 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. mstockstill on DSK4VPTVN1PROD with SUMMARY: Transmission-Blocking Malaria Vaccine Description of Technology: There is no vaccine for malaria, and there is growing resistance to existing antimalarial drugs. Sexual stage-specific antigens are of interest as vaccine candidates because disruption of these antigens would reduce the fertility and, thus, the infectivity of the parasite. This invention claims methods and compositions for delivering a Plasmodium P47 vaccine or antibody to P47 to prevent Plasmodium falciparum or Plasmodium vivax malaria. P47 and other antigens have been mentioned as potential transmission-blocking vaccines due to their surface location on gametes. The gene for P47 antigens is also well characterized. Recent discoveries have noted that P47 allows the parasite to suppress or evade the immune system, thereby ensuring the VerDate Mar<15>2010 17:01 Jan 15, 2013 Jkt 229001 mosquitoes’ survival. Recent discoveries have also shown the mechanism by which P47 enables survival of the parasite by manipulation of the mosquito immune system. Based on the critical role of P47 antigens in transmission, the disruption of the function of P47 by various means can be an innovative and forceful means to control and/or reduce the prevalence of malaria. Potential Commercial Applications: Malaria vaccine, diagnostic and therapeutic. Competitive Advantages: • Single protein malaria transmission-blocking vaccine. • Cost-effective, simple manufacturing process for vaccine. • Potentially lower-cost malarial vaccine for developing/developed countries. Development Stage: • Pre-clinical. • In vitro data available. • In vivo data available (animal). Inventors: Carolina Barillas-Mury and Alvaro Molina-Cruz (NIAID). Publication: Molina-Cruz A, et al. Some strains of Plasmodium falciparum, a human malaria parasite, evade the complement-like system of Anopheles gambiae mosquitoes. Proc Natl Acad Sci U S A. 2012 Jul 10;109(28):E1957–62. [PMID 22623529] Intellectual Property: HHS Reference No. E–222–2012/0 — US Application No. 61/684,333 filed 17 Aug 2012. Licensing Contact: Peter A. Soukas; 301–435–4646; soukasp@mail.nih.gov. Collaborative Research Opportunity: The National Institute of Allergy and Infectious Diseases (NIAID) is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate or commercialize malaria vaccines, diagnostics and therapeutics. For collaboration opportunities, please contact Tristan J. Mahyera at tristan.mahyera@nih.gov or 301–827– 0251. Methods and Composition for Identification of Variants of JC Virus DNA; An Etiologic Agent for Progressive Multifocal Leukoencephalopathy (PML) Description of Technology: JC Virus causes a fatal disease in the brain called progressive multifocal leukoencephalopathy (PML) that occurs in many patients with immunocompromised conditions. The finding of JCV DNA in the patients with neurological symptoms of PML is a diagnostic criterion and is needed to confirm the diagnosis of PML to rule out other neurological conditions. Certain PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 JC virus variants are known to have a greater association with PML. For example, ‘‘Prototype’’ JC virus is far more pathogenic than ‘‘Archetype’’ JC virus. This invention claims novel assays for identifying Archetype and/or Prototype JC virus by detecting the presence or absence of the unique Archetype nucleic acid sequence in the non-coding regulatory region of JC virus. While the sequences of Archetype and Prototype JC virus are known, these are the first assays that allow discrimination between Prototype and Archetype JC virus in a simple assay without the need for DNA sequencing. The identification of a JC virus as a prototype can lead to early treatment of infected individuals. Potential Commercial Applications: • JCV diagnostic kits. • JCV diagnostics. Competitive Advantages: • DNA sequencing not required. • Single assay format using same template to identify prototype and archetype with 10c/ml sensitivity. Development Stage: • Clinical. • In vitro data available. • In vivo data available (human). Inventors: Eugene O. Major and Caroline F. Ryschkewitsch (NINDS). Publication: Perkins MR, et al. Changes in JC Virus-Specific T Cell Responses during Natalizumab Treatment and in NatalizumabAssociated Progressive Multifocal Leukoencephalopathy. PLoS Pathog. 2012 Nov;8(11):e1003014. [PMID 23144619] Intellectual Property: HHS Reference No. E–088–2012—US Application No. 61/661,289 filed 18 Jun 2012. Related Technology: HHS Reference No. E–152–2009/0—Research Material. Patent protection is not being pursued for this technology. Licensing Contact: Peter A. Soukas; 301–435–4646; soukasp@mail.nih.gov. Collaborative Research Opportunity: The National Institute of Neurological Disorders and Stroke is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate or commercialize assays for the detection of JC Virus. For collaboration opportunities, please contact Melissa Maderia at maderiam@mail.nih.gov or 301–451–3943. Cross-Reactive Dengue Fully Human Monoclonal Antibodies Description of Technology: Among the arthropod-borne flaviviruses, the four dengue virus serotypes, dengue type 1 virus (DENV–1), dengue type 2 virus (DENV–2), dengue type 3 virus (DENV– E:\FR\FM\16JAN1.SGM 16JAN1

Agencies

[Federal Register Volume 78, Number 11 (Wednesday, January 16, 2013)]
[Notices]
[Pages 3437-3440]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-00738]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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.

Optical Microscope Software for Breast Cancer Diagnosis

    Description of Technology: The instant invention discloses a 
software to analyze optical microscopic images of human breast tissue 
sections for diagnosing cancer by using the differences in spatial 
positioning of certain genes. The software uses the inherent hierarchy 
in the data and stores all the analysis and manual interaction 
information in a highly structured XML file. It is a user-friendly 
software to discriminate normal and cancerous human breast tissue 
section images that can be used for large experiments. Additionally the 
software uses a cluster of computers in the background to reduce the 
analysis time for large image datasets. Furthermore, the software of 
instant invention provides a set of tools for performing diagnostic or 
prognostic assays on new unseen datasets.
    Potential Commercial Applications:
     The software could be an essential part of an integrated 
diagnostic or prognostic assay for breast cancer detection.
     The software could be a key tool for biomedical research 
to test new markers and their applicability for diagnostic purposes.
     The use of the software could provide important 
information for understanding the underlying causes of gene 
repositioning.
    Competitive Advantages:
     The software of instant invention can be used to analyze 
relatively large datasets.
     To reduce the processing time by at least 10 fold.
     The software can be used in a broad range of quantitative 
image analysis applications.
    Development Stage:
     Prototype
     Clinical
     In vitro data available (human)
    Inventors: Kaustav Nandy (SAIC-Frederick, Inc), Stephen J. Lockett 
(SAIC-Frederick, Inc), Prabhakar R. Gudla (SAIC-Frederick, Inc), 
William Cukierski (NCI), Renee Qian (NCI), Karen J. Meaburn (NCI), Tom 
Misteli (NCI).
    Publications:
    1. Gudla PR, et al. A high-throughput system for segmenting nuclei 
using multiscale techniques. Cytometry A. 2008 May;73(5):451-66. [PMID 
18338778]
    2. Nandy K, et al. Automatic nuclei segmentation and spatial FISH 
analysis for cancer detection. Conf Proc IEEE Eng Med Biol Soc. 
2009;2009:6718-21. [PMID 19963931].
    3. Meaburn KJ, et al. Disease-specific gene repositioning in breast 
cancer. J Cell Biol. 2009 Dec 14;187(6):801-12. [PMID 19995938].
    4. Cukierski WJ, et al. Ranked retrieval of segmented nuclei for 
objective assessment of cancer gene repositioning. BMC Bioinformatics. 
2012 Sep 12;13:232. [PMID: 22971117].
    5. Nandy K, et al. Supervised learning framework for screening 
nuclei in tissue

[[Page 3438]]

sections. Conf Proc IEEE Eng Med Biol Soc. 2011;2011:5989-92. [PMID 
22255704]
    Intellectual Property: HHS Reference No. E-286-2012/0--Software. 
Patent protection is not being pursued for this technology.
    Licensing Contact: Susan Ano, Ph.D.; 301-435-5515; 
anos@mail.nih.gov.
    Collaborative Research Opportunity: The SAIC-Frederick Optical 
Microscopy and Analysis Laboratory 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 John Hewes, Ph.D., at 
hewesj@mail.nih.gov.

Simple Direct Zirconium-89 Cell PET Label, \89\Zr-Labeled Cells, and 
Methods for Real-Time In Vivo Pet Imaging

    Description of Technology: The capability to image cells and 
cellular processes in real time over a scale of days could dramatically 
improve research insights and the effectiveness of cell-based 
therapies. Zirconium-89 (\89\Zr) has a half-life of over three days 
(78.4 hours) over 44 times longer compared to Fluorine (\18\F) the most 
commonly used PET isotope (half-life of 1 hour and 50 minutes). \89\Zr 
is also advantageous compared to other long half-life isotopes because 
it is not limited by high background activity and cell toxicity. 
Labeling cells with \89\Zr, is currently accomplished by indirect 
methods using secondary cell-type specific reagents such as antibodies. 
This technology is a PET imaging complex of \89\Zr and polycation that 
is internalized by the cells. This complex has been able to directly 
label a wide range of cells, without the use of secondary reagents. 
\89\Zr-labeled cells of lymphocytic lineage, including T cells, natural 
killer T-cells, macrophages, dendritic cells, and stem cells, have been 
produced and imaged in vivo with minimal damage to the cells. This PET 
imaging agent can be readily combined with an MR imaging agent for 
combined PET/MR imaging of cells. The imaging capabilities enabled by 
this technology may significantly improve cell therapies, cell level 
diagnostics and aid research for non-cell based therapies.
    Potential Commercial Applications:
     Imaging
     Diagnostic
     Cell therapies
     Transplantation and transfusion
    Competitive Advantages:
     Direct labeled cells (versus indirect techniques)
     Longer half-life
     Not limited by high background activity and cell toxicity
    Development Stage:
     Early-stage
     Pre-clinical
     In vivo data available (animal)
    Inventors: Omer Aras (CC), Peter Choyke (NCI), Joseph Frank (CC), 
Noriko Sato (CC), Jeremy Pantin (NHLBI).
    Intellectual Property: HHS Reference No. E-056-2012/0--US 
Provisional Application No. 61/611964 filed 16 Mar 2012.
    Licensing Contact: Tedd Fenn; 301-435-5031; Tedd.Fenn@nih.gov
    Collaborative Research Opportunity: The NCI 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 John Hewes, Ph.D., at 
hewesj@mail.nih.gov.

Small, Stable, Functional, Soluble, Monomeric IgG1 Fc Molecules 
Engineered Therapies

    Description of Technology: This technology relates to small (~27 
kDa) antibody fragments that are potentially useful for therapeutic 
development. These are monomeric IgG fragment crystalizable (mFc) 
compositions; they are long half-lived, functional (pH dependent 
binders of neonatal Fc receptor--FcRn); and they are soluble and 
express efficiently in E. coli. These molecules may serve as a platform 
for development of engineered mFc-based antibodies and fusion proteins 
with therapeutic applications. Efforts to engineer antibody-based 
therapeutics, to date, have encountered technical limitations due to 
the relatively large fragment size and short fragment half-life. The 
IgG fragment crystalizable (Fc) is a dimer of two constant domains 
(CH2-CH3 chains). Fc has a long half-life, which makes it promising as 
a candidate for engineering antibody therapeutics. Fusion proteins 
based on Fc dimer molecules demonstrate extended half-life, due to the 
ability to bind FcRn at acidic pH. However, the relatively large size 
of the Fc domains (~50 kD) is not optimal. This technology uses smaller 
(~27 kDa) mFc compositions that retain efficient binding to human FcRn 
and demonstrate long half-life. These mFc compositions are promising 
for the development of novel therapeutics because the smaller size may 
allow for superior access to targets and tissues compared to full sized 
mAbs and larger fragment-based therapeutics, while also retaining 
important function characteristics.
    Potential Commercial Applications: Therapeutics--human and 
veterinary, engineered antibody and fusion proteins.
    Competitive Advantages: Smaller size results better tissue 
penetration, reduced steric hindrance, increased therapeutic efficiency 
and lower cost.
    Development Stage:
     Early-stage
     Pre-clinical
    Inventors: Dimiter S. Dimitrov and Tianlei Ying (NCI).
    Publication: Ying T, et al. Soluble monomeric IgG1 Fc. J Biol Chem. 
2012 Jun 1; 287(23):19399-408. [PMID 22518843].
    Intellectual Property: HHS Reference No. E-019-2012/0--U.S. Patent 
Application No. 61/612,138 filed 16 Mar 2012.
    Related Technologies: HHS Reference No. E-003-2007/0--
     U.S. Patent Application No. 61/063,245 filed 31 Jan 2008
     PCT Application No. PCT/US2009/0326 and related 
international applications filed on 30 Jan 2009 in Australia, Canada, 
China, Europe, Japan, and India
     U.S. Patent Application No. 12/864,758 filed 27 Jul 2010
    Licensing Contact: Tedd Fenn; 301-435-5031; Tedd.Fenn@nih.gov
    Collaborative Research Opportunity: The NCI/CCR/NP is seeking 
statements of capability or interest from parties interested in 
collaborative research to further develop, evaluate or commercialize 
Small, Stable, Functional, Soluble, Monomeric IgG1 Fc Molecules 
Engineered Therapies. For collaboration opportunities, please contact 
John Hewes, Ph.D., at hewesj@mail.nih.gov">#hewesj@mail.nih.gov.

Virus-Like Particles Mediated Protein and RNA Delivery

    Description of Technology: The invention is directed to novel 
virus-like particles (VLPs) that are capable of binding to and 
replicating within a target mammalian cell, including human cells. The 
claimed VLPs are safer than viral delivery because they are incapable 
of re-infecting target cells. The present VLPs can optionally comprise 
inhibitory recombinant polynucleotides, such as microRNA, antisense RNA 
or small hairpin RNA, to down regulate or turn off expression of a 
particular gene within the target cell. Alternatively, recombinant 
polynucleotides packaged within VLPs can comprise a gene encoding a 
therapeutic protein so as to enable expression of that protein within 
the

[[Page 3439]]

target cell. Specifically, VLPs of the invention are composed of an 
alphavirus replicon that contains a recombinant polynucleotide, a 
retroviral gag protein, and a fusogenic envelope glycoprotein.
    While the claimed VLPs have a variety of applications, therapeutic 
uses of the VLPs include directing antibody synthesis and converting 
cancer cells into antigen presenting cells. Additional applications 
include using VLPs to induce fast (approx. 3-4 hrs) and high levels of 
protein production in mammalian cells.
    Potential Commercial Applications:
     Delivery of microRNA and small hairpin RNA to reduce 
express of targeted genes in a human cell
     Delivery of coding RNA for robust expression in mammalian 
systems
     Direct antibody production by in vivo injection of 
replicons (no antigen purification)
     Therapeutic applications
    Competitive Advantages:
     High level (~million copies per cell) of RNA production/
synthesis within target cell
     Fast expression (approx. 3-4 hrs compared to 1-2 days) 
following VLP introduction into target cells
     Obviates need to use expensive antigen purification for 
proteins or antigens produced inside target cells
    Development Stage:
     Pilot
     Pre-clinical
     In vitro data available
     In vivo data available (animal)
    Inventors: Stanislaw J. Kaczmarczyk and Deb K. Chatterjee (NCI).
    Intellectual Property: HHS Reference No. E-264-2011/0--US 
Application No. 61/615,687 filed 26 Mar 2012.
    Licensing Contact: Lauren Nguyen-Antczak, Ph.D., J.D.; 301-435-
4074; lauren.nguyen-antczak@nih.gov.
    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 
Novel Delivery of Packaged RNA to Mammalian Cells. For collaboration 
opportunities, please contact Kevin Brand at brandk@mail.nih.gov.

A Combinatorial Cloning Platform for Construction of Expression Vectors 
for Protein Production

    Description of Technology: The Combinatorial Cloning Platform (CCP) 
of this invention is a collection of vectors for use with the Gateway 
Multisite Recombination System (Life Technologies). The CCP that is 
currently available includes plates of 192 glycerol stocks of E. coli 
each containing one of the library plasmids, and a collection of 24 
DNAs that are the downstream vectors for expression in different hosts. 
Uses of this CCP include construction of protein expression constructs 
with various fusion tags, generation of expression constructs with 
different promoters for in vivo expression, and production of clones 
with fluorescent tags for localization experiments. The advantage of 
the CCP is based on the exquisite specificity of the Multisite Gateway 
reactions, which permit linkage of multiple elements in a directional 
fashion and involve no additional DNA amplification. There is also no 
need for restriction-based cloning processes, which have a high rate of 
failure and may require optimization depending on the sites available 
in a given clone. The CCP library includes clones for fluorescent and 
luminescent reporters, epitope and solubility fusion tags, bimolecular 
fluorescence complementation (BiFC) fusions, 18 different eukaryotic 
promoters, and many other useful clones. In addition, the destination 
vector collection contains two flavors of Gateway destination vectors 
for E. coli, baculovirus, mammalian, and lentiviral expression.
    Potential Commercial Applications:
     Construction of protein expression constructs with various 
fusion tags
     Generation of expression constructs with different 
promoters for in vivo expression
     Production of clones with fluorescent tags for 
localization experiments
     Generation of constructs for making mutant cell lines or 
transgenic animals
     Production of vectors for shRNA or miRNA delivery
    Competitive Advantages: The CCP is considerably more flexible than 
currently available commercial systems for construction of protein 
expression constructs.
    Development Stage:
     Prototype
     Pre-clinical
     In vitro data available
    Inventor: Dominic Esposito (NCI).
    Publication: Hopkins RF, et al. Optimizing transient recombinant 
protein expression in mammalian cells. Methods Mol Biol. 2012;801:251-
68. [PMID 21987258].
    Intellectual Property: HHS Reference No. E-164-2011/0--Research 
Tools. Patent protection is not being pursued for these technologies.
    Licensing Contact: Suryanarayana Vepa, Ph.D., J.D.; 301-435-5020; 
vepas@mail.nih.gov.

Therapeutic Peptide Treatment for Dyslipidemic and Vascular Disorders

    Description of Technology: This invention is directed to use of 
certain peptide analogs comprising multiple amphipathic helical domains 
that are able to promote cellular lipid efflux and stimulate 
lipoprotein lipase activity. As a result, administration of invention 
peptides lead to reduced incidences of hypertriglyceridemia without 
inducing toxicity. Existing peptides that stimulate efflux of lipids 
from cells exhibit unacceptably high toxicity. Invention peptides are 
superior to existing peptides and can also be used to treat or prevent 
a vast range of vascular diseases, and their dyslipidemic precursors. 
Exemplary vascular diseases and conditions that could benefit from 
treatment with the invention peptides include: dyslipidemia, 
hyperlipidemia, hypercholesterolemia, HDL deficiency, coronary heart 
disease, atherosclerosis, and thrombic stroke.
    Potential Commercial Applications:
     Treatment of dyslipidemic and vascular disorders
     Method of identifying therapeutic non-cytotoxic peptides
    Competitive Advantages:
     Specific control of lipid efflux and transport
     Transient hypertriglyceridemia with no reported toxicity
    Development Stage:
     Early-stage
     Pre-clinical
     In vitro data available
     In vivo data available (animal)
    Inventors: Alan T Remaley and Marcelo A Amar (NHLBI).
    Publications:
    1. Remaley AT, et al. Synthetic amphipathic helical peptides 
promote lipid efflux from cells by an ABCA1-dependent and an ABCA1-
independent pathway. J Lipid Res. 2003 Apr;44(4):828-36. [PMID 
12562845].
    2. Sviridov DO, et al. Helix stabilization of amphipathic peptides 
by hydrocarbon stapling increases cholesterol efflux by the ABCA1 
transporter. Biochem Biophys Res Commun. 2011 Jul 8;410(3):446-51. 
[PMID 21672528].
    3. Osei-Hwedieh DO, et al. Apolipoprotein mimetic peptides: 
Mechanisms of action as anti-atherogenic agents. Pharmacol Ther. 2011 
Apr;130(1):83-91. [PMID 21172387].
    Intellectual Property: HHS Reference No. E-138-2008/0--US Patent 
Application No. 12/937,974 filed 14 Oct 2010.
    Licensing Contact: Lauren Nguyen-Antczak, Ph.D., J.D.; 301-435-
4074; lauren.nguyen-antczak@nih.gov.


[[Page 3440]]


    Dated: January 10, 2013.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2013-00738 Filed 1-15-13; 8:45 am]
BILLING CODE 4140-01-P