[Federal Register Volume 80, Number 184 (Wednesday, September 23, 2015)]
[Notices]
[Pages 57380-57383]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-24137]


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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, 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. 209 and 37 CFR part 404 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.

SUPPLEMENTARY INFORMATION: Technology descriptions follow.

A Novel Rapid Point-of-Care Diagnostic Method for Infectious and 
Autoimmune Diseases

    Description of Technology: Rapid point-of-care, antibody-based 
testing is not available for the diagnosis of autoimmune and most 
infectious diseases. For detecting autoantibodies associated with most 
autoimmune conditions, fluid-phase immunoprecipitation assays are 
required. However, these assays usually involve radioactivity and are 
not feasible for point-of-care applications. The subject invention 
describes methods of using neodymium magnet for diagnosis of infectious 
and autoimmune diseases including lupus, Sj[ouml]gren's syndrome, type 
I diabetes, HIV and Lyme disease. The assay takes 3.5 minutes, is 
highly efficient, and has low background.

Potential Commercial Applications

     A rapid assay for point-of-care diagnosis of infectious 
and autoimmune diseases.
     Applications to different assay platforms, such as a 
portable, commercially available hand-held luminometer or an automated, 
high-throughput device.

Competitive Advantages

     Highly efficient, rapid, and easy to perform.
     Low background signals.

Development Stage

     Early-stage
     In vitro data available
     Prototype.

    Inventor: Peter D. Burbelo (NIDCR)

Publications

    1. Burbelo PD, et al. Luciferase immunoprecipitation systems for 
measuring antibodies in autoimmune and infectious diseases. Transl 
Res. 2015 Feb; 165(2):325-335. [PMID 25241936]
    2. Burbelo PD, et al. New autoantibody detection technologies 
yield novel insights into autoimmune disease. Curr Opin Rheumatol. 
2014 Nov; 26(6):717-723. [PMID 25203116]
    3. Burbelo PD, et al. Searching for biomarkers: humoral response 
profiling with luciferase immunoprecipitation systems. Expert Rev 
Proteomics. 2011 Jun; 8(3):309-316. [PMID 21679112]
    4. Burbelo PD, et al. Antibody profiling by luciferase 
immunoprecipitation systems (LIPS). J Vis Exp. 2009 Oct 7; (32). 
[PMID 19812534]

    Intellectual Property: HHS Reference No. E-190-2015/0--US 
Provisional Application No. 62/212,973 filed 01 Oct 2015.

Related Technologies

     E-036-2010 family: PCT/US2011/027888, US 8,926,989, 
issued. US 14/562,068 and EP 11730770.1, pending.
     E-281-2010: US 13/882,850, allowed.
     E-063-2009: US 8,951,723, issued.

    Licensing Contact: Sally Hu, Ph.D., M.B.A.; 301-435-5606; 
[email protected].
    Collaborative Research Opportunity: The National Institute of 
Dental and Craniofacial Research is seeking statements of capability or 
interest from parties interested in collaborative research to further 
develop, evaluate or commercialize using neodymium magnet for rapid 
diagnosis. For collaboration opportunities, please contact David 
Bradley, Ph.D. at [email protected].

A Mobile Health Platform

    Description of Technology: The NIH inventors have developed a 
mobile health technology to monitor and predict a user's psychological 
status and to deliver an automated intervention when needed. The 
technology uses smartphones to monitor the user's location and ask 
questions about psychological status throughout the day. Continuously 
collected ambulatory psychological data are fused with data on location 
and responses to questions. The mobile data are combined with 
geospatial risk maps to quantify exposure to risk and predict a future 
psychological state. The future predictions are used to warn the user 
when he or she is at especially high risk of experiencing a negative 
event that might lead to an unwanted outcome (e.g., lapse to drug use 
in a recovering addict).
    An internally developed mobile app is now being deployed to deliver 
an intervention in the context of drug addiction. The inventors are 
also seeking to test the technology for other health applications.

Potential Commercial Applications

     Real time behavior monitoring
     Therapeutic delivery of an intervention via a mobile 
device

Competitive Advantages

     Mobile device
     Real time
     Exposure to risk

    Development Stage: Prototype
    Inventors: Kenzie L. Preston, David H. Epstein, Matthew Tyburski, 
Massoud Vahabzadeh (all of NIDA)

Publications

    1. Epstein DH, et al. Real-time tracking of neighborhood 
surroundings and mood in urban drug misusers: Application of a new 
method to study behavior in its geographical context. Drug Alcohol 
Depend. 2014 Jan 1;134:22-9. [PMID 24332365]
    2. Kennedy AP, et al. Continuous in-the-field measurement of 
heart rate: Correlates of drug use, craving, stress and mood in 
polydrug users. Drug Alcohol Depend. 2015 June 1;151:159-66. [PMID 
25920802]

    Intellectual Property: HHS Reference No. E-049-2015/0--US 
Provisional Application No. 62/186, 983 filed 30 June 2015
    Licensing Contact: Betty B. Tong, Ph.D.; 301-594-6565; 
[email protected]
    Collaborative Research Opportunity: The National Institute on Drug 
Abuse is seeking statements of capability or interest from parties 
interested in collaborative research to further develop, evaluate or 
commercialize

[[Page 57381]]

mhealth system to analyze and intervene. For collaboration 
opportunities, please contact Vio Conley at [email protected].

Detection and Discrimination of Classical and Atypical L-Type BSE 
Strains by RT-QuIC

    Description of Technology: Statutory surveillance of bovine 
spongiform encephalopathy (BSE) indicates that cattle are susceptible 
to both classical (C-BSE) and atypical forms of BSE. Atypical forms of 
BSE appear to be sporadic and thus may never be eradicated. A major 
challenge is the lack of sufficiently practical and sensitive tests for 
routine BSE detection and strain discrimination. The RT-QuIC test, 
which is based on prion-seeded fibrillization of recombinant prion 
protein (rPrPSen), is known to be highly specific and 
sensitive for detection of multiple human and animal prion diseases, 
but not BSE. This application claims methods for distinguishing whether 
a sheep, cow or goat has atypical L-bovine spongiform encephalopathy 
prion or classical bovine spongiform encephalopathy.

Potential Commercial Applications

     Detection and distinguishing of both BSE forms
     Rapid detection and discrimination of BSE forms

Competitive Advantages

     Orders of magnitude more sensitive than ELISA tests
     Eliminates need for multi-phase analyses of samples
     Can be applied to large scale testing of multiple samples

Development Stage

     In vitro data available
     In vivo data available (animal)
     Prototype

    Inventors: Byron W. Caughey (NIAID), Christina D. Orr[uacute] 
(NIAID), Alessandra Favolez (EM), Cristina Casalone (EM), Maria Mazza 
(EM), Cristiano Corona (EM)

Publications

    1. Orr[uacute] CD, et al. Detection and discrimination of 
classical and atypical L-type bovine spongiform encephalopathy by 
real-time quaking-induced conversion. J Clin Microbiol. 2015 
Apr;53(4):1115-20. [PMID 25609728]
    2. Orr[uacute] CD, et al. Correction: Bank Vole Prion Protein As 
an Apparently Universal Substrate for RT-QuIC-Based Detection and 
Discrimination of Prion Strains. PLoS Pathog. 2015 Aug 
18;11(8):e1005117. [PMID 26284358]
    3. Orr[uacute] CD, et al. Bank Vole Prion Protein As an 
Apparently Universal Substrate for RT-QuIC-Based Detection and 
Discrimination of Prion Strains. PLoS Pathog. 2015 Jun 
18;11(6):e1004983. [PMID 26086786]

    Intellectual Property: HHS Reference E-048-2015/0--US Provisional 
Application No. 62/092,645 filed 16 Dec 2014
    Licensing Contact: Peter A. Soukas; 301-435-4646; [email protected]

Lenalidomide Analogs for the Treatment of Neurodegenerative Disorders 
and Cancer

    Description of Technology: Inflammatory processes associated with 
the over-production of tumor necrosis-alpha (TNF-alpha), a potent 
activator of the immune system accompany numerous neurodegenerative 
diseases. TNF-alpha has been validated as a drug target with the 
development of the inhibitors Enbrel and Remicade (fusion antibodies) 
as prescription medications. Both, however, are large macromolecules 
that require direct injection and have limited brain access. The 
classical drug, thalidomide is being increasingly used in the clinical 
management of a wide spectrum of immunologically-mediated and 
infectious diseases, and cancers. The NIA inventors developed and 
assessed novel thio analogs of lenalidomide (Celegene's Revlimid and an 
analog of thalidomide) as immunomodulatory agents, with the potential 
to reduce chronic systemic and central nervous system inflammation. 
These compounds were synthesized and evaluated for their TNF-alpha 
inhibitory activity. This invention was extended from the inventors' 
prior work to develop potent compounds to reduce neuroinflammation as a 
treatment strategy for neurodegenerative disorders. The current studies 
focus the compounds activity in classical models of neurodegeneration 
as well as cancer.

Potential Commercial Applications

     Treatment for blood disorders (myelodysplastic syndrome), 
cancer (multiple myeloma), inflammatory processes and erythema
     Immunomodulatory agents
     Reduce chronic systemic and central nervous system 
inflammation

Competitive Advantages

     Effective smaller molecular weight compound that can enter 
brain among current agents
     Experimental therapeutic to reduce inflammation 
systematically and within the brain
     Effective in reducing proinflammatory cytokines than 
existing agents

Development Stage

     In vitro data available
     In vivo data available (animal)
     Prototype

    Inventors: Nigel H. Greig, Weiming Luo, David Tweedie, Harold W. 
Holloway, Qian-sheng Yu (all of NIA)
    Publication: Luo W, et al. Design, synthesis and biological 
assessment of novel N-substituted 3-(phthalimidin-2-yl)-2,6-
dioxopiperidines and 3-substituted 2,6-dioxopiperidines for TNF-alpha 
inhibitory activity. Bioorg Med Chem. 2011 Jul 1;19(13):3965-3972. 
[PMID 21658960]
    Intellectual Property: HHS Reference No. E-045-2012/0--
     US Patent No. 8,927,725 issued 06 Jan 2015
     US Patent No. 9,084,783 issued 21 Jul 2015
     US Patent Application No. 14/746,512 filed 22 Jun 2015
    Related Technologies: HHS Reference No. E-189-2003/0--
     US Patent No. 7,973,057 issued 05 Jul 2011
     US Patent No. 8,546,430 issued 01 Oct 2013
     US Patent Application No. 13/648,625 filed 10 Oct 2012
     US Patent Application No. 14/314,124 filed 25 Jun 2014
     and related international patents/patent applications
    Licensing Contact: Betty B. Tong, Ph.D.; 301-594-6565; 
[email protected]

Novel Regulatory B Cells for Treatment of Cancer and Autoimmune Disease

    Description of Technology: The manner by which cancers evade the 
immune response is not well-understood. What is known is that the 
manner is an active process that regulates immune responses employing 
at least two types of suppressive cells, myeloid-derived suppressive 
cells and regulatory T cells (Tregs), a key subset of CD4\+\ T cells 
that controls peripheral tolerance to self- and allo-antigens. Tregs 
are considered to play a key role in the escape of cancer cells from 
anti-tumor effector T cells.
    Cancer cells have been found to directly activate resting B cells 
to form suppressive regulatory B cells (tBregs) and utilize them to 
evade immune surveillance and mediate metastasis. tBregs directly 
inhibit CD4\+\ and CD8\+\ T cell activity in a cell contact-dependent 
manner, induce FoxP3\+\ T cell activity, and promote Treg-dependent 
metastasis.
    Researchers from the National Institute on Aging (NIA), NIH, have 
developed methods for the generation of tBregs, and for using tBregs to 
produce

[[Page 57382]]

Tregs, and methods that inactivate or deplete tBregs. These methods 
have significant therapeutic value in the combat with cancer immune 
escape and metastasis, and in the control of harmful autoimmune 
diseases.

Potential Commercial Applications:

     Production of cellular cancer vaccines
     Treatments for immune-mediated disorders
     Treatments for cancer
     Treatments for chronic viral infections

Development Stage:

     Early-stage
     In vitro data available
     In vivo data available (animal)
     In situ data available
     Ex vivo data available

    Inventors: Bira Arya and Purevdorj Olkhanud (NIA)
    Intellectual Property: HHS Reference No. E-101-2010/0--US Patent 
Application No. 13/577,226 filed 03 Aug 2012
    Licensing Contact: Betty B. Tong, Ph.D.; 301-594-6565; 
[email protected]
    Collaborative Research Opportunity: The National Institute on 
Aging, Laboratory of Molecular Biology and Immunology, is seeking 
statements of capability or interest from parties interested in 
collaborative research to further develop, evaluate, or commercialize 
the utilization of regulatory B cells to control autoimmune diseases 
and strategies that inactivate tBregs to control cancer immune escape. 
Please contact Nicole Darack, Ph.D. at 240-276-5493 or 
[email protected] for more information.

Immunogenic Tumor-associated Antigen SPANX-B for Selective Cancer 
Immunotherapy

    Description of Technology: Researchers at the National Institute on 
Aging (NIA) have characterized a novel tumor-associated antigen, SPANX-
B, which is naturally immunogenic and is expressed in a variety of 
human malignancies, including melanoma and lung, colon, renal, ovarian 
and breast carcinomas. In melanoma specifically, SPANX-B expression is 
associated with advanced and metastatic disease. Moreover, the 
researchers have found several agonist epitope peptides from SPANX-B 
which can be used to activate the immune system to eradicate tumors 
utilizing T cells. SPANX-B peptides have significant clinical and 
immunotherapeutic potential for the development of cancer diagnostic 
assays and potent protective and/or therapeutic vaccines to combat a 
wide-range of cancers.

Potential Commercial Applications:

     In vitro diagnostic assays for highly-metastatic melanomas 
or other cancers
     Therapeutic monoclonal antibodies
     Cancer vaccine development

Competitive Advantages:

     Immunogenic: SPANX-B peptides are naturally able to elicit 
immune response.
     Expressed in a wide-range of cancers.
     Use of epitope peptides facilitates the activation of 
cells of the more therapeutically effective branch of the immune 
system.
     Small epitope peptides: Can be more easily manufactured in 
contrast to recombinant proteins.

Development Stage:

     In vitro data available
     In vivo data available (animal)

    Publication: Almanzar G, et al. Sperm-derived SPANX-B is a 
clinically relevant tumor antigen that is expressed in human tumors and 
readily recognized by human CD4+ and CD8+ T cells. Clin Cancer Res. 
2009 Mar 15;15(6):1954-63. [PMID 19276289]
    Inventors: Bira Arya (NIA) and Vladimir Larionov (NCI)
    Intellectual Property: HHS Reference No. E-089-2009/0--
     US Patent No. 8,664,183 issued 04 Mar 2014
     US Patent Application No. 14/155,230 filed 14 Jan 2014
    Licensing Contact: Betty B. Tong, Ph.D.; 301-594-6565; 
[email protected]
    Collaborative Research Opportunity: The National Institute on 
Aging, Laboratory of Molecular Biology and Immunology, is seeking 
statements of capability or interest from parties interested in 
collaborative research to further develop, evaluate, or commercialize 
the use of SPANX-B-based therapeutic approaches to combat cancers. 
Please contact Nicole Darack, Ph.D. at 240-276-5493 or 
[email protected] for more information.

Method for the Diagnosis and Prognosis of Age-Related Cardiovascular 
Disorders

    Description of Technology: NIH investigators have discovered a 
method for the diagnosis and prognosis of cardiovascular aging. Current 
methodologies include the measurement of patient lipid profiles or 
expression of up to two proteins. In contrast, this technology utilizes 
the expression levels of a panel of proteins not previously known to be 
related to cardiovascular aging and may prove to be a more accurate 
diagnostic or prognostic of cardiovascular aging than currently 
available tests or it may improve the accuracy of currently available 
tests when used in concert.
    The technology relates to methods for determining susceptibility to 
having an extremely common age-associated vascular disorder. It also 
describes the subsequent use of these proteins as markers for disease. 
While the underlying cellular and molecular mechanisms of age-related 
vascular disease remain largely undefined, the expression levels of the 
genes described in this technology have been empirically determined to 
differ between healthy and age-inflamed arterial tissue. Further, this 
technology includes a companion mass spectroscopic-based methodology 
for reproducible quantification of specific expression levels of 
interest.
    Potential Commercial Applications: Diagnosis of age-related 
vascular disorder.
    Inventors: Mingyi Wang et al. (NIA)
    Intellectual Property: HHS Reference No. E-219-2008/0--US Patent 
Application No. 13/202,319 filed 18 Aug 2011
    Licensing Contact: Betty B. Tong, Ph.D.; 301-594-6565; 
[email protected]
    Collaborative Research Opportunity: The National Institute on 
Aging, Laboratory of Cardiovascular Science, Cardiac Biology Section--
Vascular Group, is seeking statements of capability or interest from 
parties interested in collaborative research to further develop, 
evaluate, or commercialize idea of how to assess and retard accelerated 
arterial aging and its attendant risks for atherosclerosis and 
hypertension. Please contact Vio Conley at 240-276-5531 or 
[email protected] for more information.

A Novel and Efficient Technology for Targeted Delivery of siRNA

    Description of Technology: The biological phenomenon of RNA 
interference (RNAi) has much promise for developing therapeutics to a 
variety of diseases. However, development of RNAi therapies remains 
mainly in preclinical stages largely because of difficulties in 
delivering small inhibitory RNAs (siRNA) and short hairpin RNAs (shRNA) 
into target cells. Although viral vector-based siRNA delivery systems 
have been widely used, their specificity and safety remains significant 
issue. Without a

[[Page 57383]]

solution to this delivery problem, RNAi cannot fulfill its therapeutic 
promise.
    Investigators at the National Institutes of Health have developed 
novel compositions and methods for delivering inhibitory 
oligonucleotides to cells in a targeted and efficient manner. The 
compositions and methods are based on utilizing a cell surface receptor 
targeting ligand, such as cytokine or chemokine, and a domain that 
binds an inhibitory oligonucleotide, to efficiently deliver the 
inhibitory oligonucleotide to the cell that expresses the cell surface 
receptor targeting ligand. Chemokine receptors are differentially 
expressed on various cells, including tumors; hence this technology 
allows targeting siRNA to aberrant cells. Gene silencing can also be 
achieved in variety of immune cells by targeting cytokine receptors. 
This technology has great potential for developing into a safe and 
effective means of delivering therapeutic siRNAs.

Potential Commercial Applications

     Treatment of cancers and autoimmune diseases by delivery 
of siRNA to tumor cells or various aberrantly functioning immune cells.
     This technology can be used to boost vaccine responses 
against cancers and chronic infectious diseases.
     Targeted delivery of fluorochrome-labeled RNA both in 
vitro and in vivo for diagnostic purposes, for example, to trace or 
localize various cells and to determine tumor metastasis and aberrant 
proliferation or homing of immune cells.

Competitive Advantages

     Simple method for linking siRNA to polypeptides to create 
non-covalent or covalent complexes
     In vivo targeted delivery of inhibitory RNAs into cells 
rather than systemically
     Delivery of multiple inhibitory RNAs to target multiple 
genes
     Long-term repression of target gene expression through 
RNAi phenomenon

Development Stage

     In vitro data available
     In vivo data available (animal)
     In situ data available

    Inventors: Bira Arya, Purevdorj Olkhanud, Juan Espinoza (all of 
NIA)
    Intellectual Property: HHS Reference No. E-051-2008/0--
     US Patent No. 8,703,921 issued 22 Apr 2014
     US Patent Application No. 14/220,726 filed 20 Mar 2014
     Various international patents/patent applications
    Licensing Contact: Betty B. Tong, Ph.D.; 301-594-6565; 
[email protected]
    Collaborative Research Opportunity: The National Institute on 
Aging, Laboratory of Molecular Biology and Immunology, is seeking 
statements of capability or interest from parties interested in 
collaborative research to further develop, evaluate, or commercialize 
chemokine-based siRNA/shRNA technology for treatment of cancers and 
autoimmune diseases, i.e. to control expression of immunomodulatory 
cytokines and other factors that facilitate tumor escape, activity of 
regulatory T cells or Th2 type of cells. This technology can be also 
utilized to boost vaccine responses against cancers and chronic 
infectious diseases. Please contact John D. Hewes, Ph.D. at 240-276-
5515 or [email protected] for more information.

    Dated: September 17, 2015.
Richard U. Rodriguez,
Acting Director, Office of Technology Transfer, National Institutes of 
Health.
[FR Doc. 2015-24137 Filed 9-22-15; 8:45 am]
 BILLING CODE 4140-01-P