[Federal Register Volume 79, Number 94 (Thursday, May 15, 2014)]
[Notices]
[Pages 27880-27883]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-11146]


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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.

Real Time Medical Image Processing Using Cloud Computing

    Description of Technology: The invention pertains to a system for 
reconstructing images acquired from MR and CT scanners in a robust 
Gadgetron based cloud computing system. A hardware interface connects 
clinical imaging instruments (e.g., MR or CT scanners) with a cloud 
computing environment that includes image data reconstruction and 
processing software not limited by the computational constraints 
typical of static hardware with finite processor power. Raw imaging 
data acquired from an MR or CT instrument is evaluated and categorized 
based on a pre-prioritized dimensionality parameter (e.g., spatial 
dimension parameter; three- or two-dimensionality, a time parameter, a 
flow/velocity parameter, an experiment timing dimension parameter, a 
diffusion encoding parameter, a functional/physiological testing 
dimension parameter, or a physiologic gating index parameter) and 
transmitted to a corresponding cloud computing environment for 
processing and reconstruction. The final processed image is 
retransmitted to a user interface that can be read by a radiologist or 
technician.
    Potential Commercial Applications:

 MRI imaging
 CT imaging
 Image processing
 Diagnostic radiology

    Competitive Advantages:

 Eliminates the need for purchasing expensive data processing 
equipment that becomes obsolete
 Less equipment leads to lowers costs and space efficiency
 Exponentially more robust computer power, data acquisition and 
image reconstruction

    Development Stage:

 Early-stage
 In vitro data available
 In vivo data available (animal)
 In vivo data available (human)
 In situ data available (on-site)
 Prototype
    Inventors: Michael Hansen, Peter Kellman, Hui Xue (all of NHLBI)
    Intellectual Property:

 HHS Reference No. E-074-2014/0--U.S. Provisional Application 
No. 61/934,987 filed 03 Feb 2014
 HHS Reference No. E-074-2014/1--U.S. Provisional Application 
No. 61/953,017 filed 14 Mar 2014

    Licensing Contact: Michael Shmilovich, Esq; 301-435-5019; 
[email protected].
    Collaborative Research Opportunity: The National Heart Lung & Blood 
Institute is seeking statements of capability or interest from parties 
interested in collaborative research to further develop, evaluate or 
commercialize Gadgetron mediated clinical image processing. For 
collaboration opportunities, please contact Denise Crooks, Ph.D. at 
301-435-0103 or [email protected].

Personal Respirator Safety: Flushed Seal for an Improved, More 
Protective, Negative-Pressure Respirator

    Description of Technology: This CDC-developed technology relates to 
improved, full-face flushed-seal personal respirators for lowering 
costs, improving user mobility, and ensuring occupational health and 
safety. Currently, the most common type of respirator in use, the 
negative pressure respirator, seals to a user's face so that inhaled 
air is pulled through a purifying filter by inhalation-generated 
negative pressure; the weakest link in this type of respirator is 
typically the seal at the face-to-mask interface. When there is face-
seal leakage, toxic air will be drawn into the facepiece of the 
respirator and inhaled by the wearer, though designers and engineers of 
respirators attempt to minimize this face-seal leakage. Over the last 
several decades, facepiece design has been optimized by this design 
approach so that the ambient leakage of half-facepiece respirators and 
full-facepiece respirators are 10% and 2%, respectively.
    This technology incorporates an additional element to reduce face-
seal leakage and therefore increases user protection. In the respirator 
described by this technology, a primary sealing element is situated 
adjacent to the user's breathing space and a secondary sealing element. 
Exhaled air (i.e., clean air obtained by filter passage) is passed from 
the breathing space into a flushing channel formed between the primary 
and secondary seals. If there is leakage in the primary seal, air from 
this

[[Page 27881]]

flushing channel leaks into the breathing space rather than toxic, 
ambient air. Air within the flushing channel will predominately be air 
that has already passed through the filtering elements. The present 
invention provides, therefore, an inexpensive respirator which provides 
significantly more protection than conventional negative-pressure 
respirators. Further, at present the only alternative respirator types 
that offer such great levels of user protection are expensive, require 
heavy batteries and blowers or an airline, and have a limited service 
life.
    Potential Commercial Applications:

 Increased protection for first responders
 Biodefense, military and/or chemical/environmental clean-up 
applications
 Industrial-use personal respirator applications where 
extensive worker mobility is a requisite
 Inexpensive alternatives for air-line systems or powered air-
purifying respirators (PAPRs) that are currently in use

    Competitive Advantages:

 Inexpensive to implement
 Provides significantly more protection than conventional 
negative-pressure respirators
 Unlike PAPR devices, no heavy, mobility-limiting battery packs 
are required for this technology; no battery recharge time or noisy 
blowers with this respirator technology
 Compared to ``air-line'' respirators, this technology is 
significantly less expensive to purchase and maintain and does not 
limit the range of a user's mobility

    Development Stage:

 In situ data available (on-site)
 Prototype

    Inventors: Donald L. Campbell, Christopher C. Coffey, William A. 
Hoffman, Judith B. Hudnall (all of CDC)
    Intellectual Property: HHS Reference No. E-241-2013/0--
 PCT Application No. PCT/US2001/040957 filed 12 Jun 2001
 U.S. Patent No. 6,957,653 issued 25 Oct 2005
    Related Technologies:
 HHS Reference No. E-174-2013/0
 HHS Reference No. E-291-2013/0
    Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937; 
[email protected]

Multi-Specific Chimeric Antigen Receptors Against HIV

    Description of Technology: The present disclosure is directed to 
novel CD4-based multi-specific chimeric antigen receptor (CAR) proteins 
composed of an extracellular targeting moiety containing at least two 
HIV Env-binding motifs, linked to a transmembrane domain and a 
cytoplasmic signaling domain. The invention further discloses nucleic 
acids encoding the novel chimeric antigen receptors to enable their 
expression in host T cells for treatment of HIV infection and disease. 
Importantly, CAR-transduced CD8 T cells recognize HIV-infected target 
cells in MHC independent fashion by binding the highly conserved 
regions of the HIV Env glycoprotein, thus minimizing the selection of 
viral escape mutants. Furthermore, the present invention also relates 
to methods of generating a recombinant CD8 T cells expressing a CAR 
with a CD4-based targeting moiety that does not confer susceptibility 
to HIV infection.
Potential Commercial Applications:

 Therapy for HIV infection
 Research on antiretroviral infection
 Generate HIV-unsusceptible T cells

    Competitive Advantages:

 Target highly conserved regions of Env of HIV
 Target non-MHC-expressing HIV-infected cells
 Eliminate emergence escape HIV variants

    Development Stage:

     In vitro data available
     In vivo data available (animal)
    Inventors: Li Liu (NIAID), Bhavik Patel (NIAID), Edward Berger 
(NIAID), Steven Rosenberg (NCI), Richard Morgan (NCI)
    Publications:

1. Dey B, et al. Neutralization of human immunodeficiency virus type 
1 by sCD4-17b, a single-chain chimeric protein, based on sequential 
interaction of gp120 with CD4 and coreceptor. J Virol. 2003 
Mar;77(5):2859-65. [PMID 12584309]
2. Lagenaur LA, et al. sCD4-17b bifunctional protein: extremely 
broad and potent neutralization of HIV-1 Env pseudotyped viruses 
from genetically diverse primary isolates. Retrovirology. 2010 Feb 
16;7:11. [PMID 20158904]
3. Berger EA. Targeted cytotoxic therapy: adapting a rapidly 
progressing anticancer paradigm for depletion of persistent HIV-
infected cell reservoirs. Curr Opin HIV AIDS. 2011 Jan;6(1):80-5. 
[PMID 21242898]

    Intellectual Property: HHS Reference No. E-170-2013/0--U.S. Patent 
Application No. 61/908,691 filed 25 Nov 2013
    Licensing Contact: John Stansberry, Ph.D.; 301-435-5236; 
[email protected]

Methods for Near Real-Time Chemical Analysis of Aerosols Using 
Microwave-Induced Plasma Spectroscopy

    Description of Technology: This CDC developed technology entails a 
novel method of near real-time elemental analysis of aerosols by corona 
assisted microwave induced plasma spectroscopy (CAMPS).
    Analysis of elemental composition of aerosol particles holds 
significant implications for environmental and workplace pollution 
monitoring. Various plasma based analytical techniques, including 
laser-induced breakdown spectroscopy (LIBS) and spark-induced breakdown 
spectroscopy (SIBS), have been successfully used for multi-elemental 
analyses in solids, liquids, and gases, including aerosols. However, 
the characterization of fine and ultrafine aerosols using these 
techniques is particularly challenging due to small plasma volume, 
miniscule sample mass, and inferior sampling statistics, often leading 
to poor detection limits and precision.
    This technology utilizes a microwave plasma-based detection system 
for aerosol analysis that features increased microplasma lifetime, 
repeatability, and stability over currently-available pulsed 
microplasma-based methods. This system produces microplasma lifetimes 
in the range of 5 to 50 milliseconds, a duration that is orders of 
magnitude larger than lifetimes for laser-induced or spark plasmas, as 
well as larger plasma volumes, which together are expected to provide 
improved detection limits over currently-available techniques.
    Potential Commercial Applications:

 Elemental quantification of aerosols in near real-time
 Air pollution studies, Particulate Matter monitoring
 Hazardous materials exposure determinations and identification
 Biodefense, chemical-defense, homeland-security applications
 Environmental and occupational epidemiology
 Evaluation of engineering controls

    Competitive Advantages:

 Makes it possible to conduct accurate, near-real-time 
measurement of the elemental composition of aerosols in industrial and 
ambient atmospheres
 Corona field stabilizes the microwave plasma and results in 
repeatable plasma formation
 Larger size of CAMPS plasma provides sufficient plasma volume 
which can lead to complete ablation of deposited aerosol in the tip of 
the electrode
 Longer duration of CAMPS plasma (~10-50 ms) allows longer 
integration

[[Page 27882]]

time which results in signal enhancement

    Development Stage:

 In situ data available (on-site)
 Prototype
    Inventors:
    Pramod Kulkarni (CDC), et al.
    Intellectual Property: HHS Reference No. E-163-2013/0 -
 U.S. Patent Application 61/652,593 filed 02 May 2012
 U.S. Patent Application 13/804,512 filed 14 Mar 2013

    Related Technology: HHS Reference No. E-205-2013/0
    Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937; 
[email protected]

Local Positioning System for Increasing Occupational Safety

    Description of Technology: This CDC-developed technology describes 
an automated system for monitoring worker hazard exposures by recording 
data about where and when hazards occur in a workplace or other 
environment. This allows the hazards to be avoided and harmful 
exposures and risks reduced. This field-tested technology consists of 
an integrated, hand-held electronics instrument and software system 
that will precisely correlate multiple exposure levels with position 
coordinates of the user and features real-time data acquisition.
    Workers in many outdoor occupations move about frequently during a 
typical day of work. Certain workers, such as agricultural and 
construction workers, are particularly mobile. This exposure monitoring 
system combines geographical location with real-time sensors and 
outputs the information to a user-friendly interface. By linking worker 
location throughout the workday to exposure levels from real-time 
monitors, Local Positioning System (LPS) units (with integrated 
software processing of data) identify and document where to direct 
hazard exposure analysis and control efforts. Post-processing of LPS 
data enables researchers, regulatory inspectors, and industry safety 
and health personnel to map exposure intensity and location, reveal hot 
spots to identify sources, and provide exposure intensity distributions 
to increase workplace safety.
    Potential Commercial Applications:

 Collection of real-time condition data and real-time position 
data generated over time at one or more locations
 Outdoor occupational exposure assessment with various real-
time sensors/monitors (e.g., HAZMAT crews, safety inspection, etc.)
 Solid state ``bread crumbs'' allowing a person or machine to 
retrace their path
 Tracking of objects, animals or people at a short distance, 
including sensing of their internal condition or environmental 
conditions

    Competitive Advantages:

 Correlates real-time position and real-time condition data for 
multiple commercial/industrial applications
 An add-on capability for any sensor(s) when measurement of a 
location is also useful
 System is highly customizable and can be easily adapted for 
additional monitoring of noise, dust, gases, and vapor, heat stress, 
etc. exposures
 Automated system provides greater efficiency and greater 
feedback than video monitoring systems
 An integrated alarm will alert users to potential hazards

    Development Stage:

 In situ data available (on-site)
 Prototype

    Inventors: Larry A. Lee, Sidney C. Soderholm, Michael Flemmer, 
Jennifer L. Hornsby-Myers, Ramesh Gali (all of CDC)
    Publication: Lee LA, et al. Field test results of an automated 
exposure assessment tool, the local positioning system (LPS). J Environ 
Monit. 2005 Jul;7(7):736-42. [PMID 15986055]
    Intellectual Property: HHS Reference No. E-274-2013/0--U.S. Patent 
No. 7,191,097 issued 13 Mar 2007
    Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937; 
[email protected]

Novel Dopamine D2 Receptor Antagonists and Methods of Their Use

    Description of Technology: Investigators at the NIH have identified 
a series of novel, small molecule antagonists of the dopamine D2 
receptor. Among the dopamine receptor (DAR) subtypes, D2 DAR is 
arguably one of the most validated drug targets in neurology and 
psychiatry. For instance, all receptor-based anti-Parkinsonian drugs 
work via stimulating the D2 DAR, whereas all FDA approved antipsychotic 
agents are antagonists of this receptor. Unfortunately, most agents 
that act as antagonists of D2 DAR are problematic, either they are less 
efficacious than desired or cause multiple adverse effects. Thus, it is 
desirable to develop a class of novel therapeutic agents with high 
selectivity for the D2 DAR. This invention describes 
dihydrobenzo[b,f][1,4]thiazepine-8-carboxamide compounds, methods of 
making these compounds, methods of characterizing their in vitro 
activity, demonstration of in vivo activity in animals, as well as 
methods of using these compounds to treat central nervous system (CNS) 
related disorders
    Potential Commercial Applications:

 Antipsychotic agent
 Treatment for schizophrenia, Tourette's syndrome, depression
 Alternative therapy for disorders currently treated with non-
selective D2 antagonists

    Competitive Advantages: Highly selective

    Development Stage:
 In vitro data available
 In vivo data available (animal)
    Inventors: David Sibley (NINDS), R. Benjamin Free (NINDS), Juan J. 
Marugan (NCATS), Jingbo Xiao (NCATS), Marc Ferrer-Alegre (NCATS), Noel 
T. Southall (NCATS)
    Publication: Xiao J, et al. Discovery, optimization, and 
characterization of novel D2 dopamine receptor selective antagonists. J 
Med Chem. 2014 Apr 24;57(8):3450-63. [PMID 24666157]
    Intellectual Property: HHS Reference No. E-030-2013/0--U.S. 
Provisional Application No. 61/859532 filed 29 Jul 2013
    Licensing Contact: Charlene S. Maddox, Ph.D.; 301-435-4689; 
[email protected]
    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 Novel Dopamine D2 Receptor 
Antagonists and Methods of Their Use. For collaboration opportunities, 
please contact Laurie Arrants at [email protected].

Therapeutic Compounds Targeting Thioesterase Deficiency Disorders

    Description of Technology: Compositions comprising N-t-butyl 
hydroxylamine (NtBuHA), a small molecule that partially or fully mimics 
thioesterase activity are provided to treat or prevent thioesterase 
deficiency disorders. Lysosomal storage disorders (LSDs) represent a 
group of >50 genetically distinct, inherited diseases. Included amongst 
these are a group of neurodegenerative LSDs called neuronal ceroid 
lipofuscinoses (NCLs), also commonly known as Batten disease. The 
infantile type of NCL (or INCL) is one of the most devastating 
diseases. It is caused by mutations in the CLN1 gene encoding 
palmitoyl-protein thioesterase-1 (PPT1). Hydroxylamine (HA) is a potent 
nucleophilic small molecule and it functionally mimics thioesterase

[[Page 27883]]

activity including that of PPT1. Unfortunately, the inherent toxicity 
of HA precludes its clinical use for any disorder. The inventors 
evaluated several non-toxic derivatives of HA for anti-oxidant 
properties, the ability to cleave thioester linkage in S-acylated 
proteins, the ability to mediate ceroid depletion, to suppress 
apoptosis in cultured cells from INCL patients and in Ppt1-knockout 
(Ppt1-/-) mice. Specifically, the inventors have discovered that NtBuHA 
is non-toxic, manifests potent antioxidant property, cleaves thioester 
linkages in S-acylated proteins, depletes intracellular ceroid in Ppt1-
/- mice and extends lifespan. These results demonstrated that NtBuHA 
may be broadly useful as therapeutic agents for thioesterase deficiency 
disorders including INCL.
    Potential Commercial Applications: Compositions and methods to 
treat or prevent thioesterase deficiency disorders
    Competitive Advantages:

 Currently there are no effective treatments for INCL and N-t-
BuHA will be the first specific treatment targeting INCL
     N-t-BuHA can be developed as a broad spectrum therapeutic 
against thioesterase deficiency disorders.

    Development Stage: In vivo data available (animal)
    Inventors: Anil Baran Mukherjee, Chinmoy Sarkar, Zhongjian Zhang 
(all of NICHD)
    Publication: Sarkar C, et al. Neuroprotection and lifespan 
extension in Ppt1(-/-) mice by NtBuHA: therapeutic implications for 
INCL. Nat Neurosci. 2013 Nov;16(11):1608-17. [PMID 24056696]
    Intellectual Property: HHS Reference No. E-157-2011/0 -

     U.S. Patent Application No. 14/110,393 filed 07 Oct 2013
     EP Patent Application No. 12716889.6 filed 07 Oct 2013

    Licensing Contact: Suryanarayana Vepa, Ph.D., J.D.; 301-435-5020; 
[email protected]
    Collaborative Research Opportunity: The Eunice Kennedy Shriver 
National Institute of Child Health and Human Development is seeking 
statements of capability or interest from parties interested in 
collaborative research to further develop, evaluate or commercialize 
hydroxylamine-derivatives or other small molecules with similar 
properties for treating thioesterase deficiency diseases including 
infantile neuronal ceroid lipofuscinosis (INCL). For collaboration 
opportunities, please contact Joseph M. Conrad, Ph.D., J.D. at 
[email protected] or 240-276-5495.

Non-Invasive In Vivo MR Method to Image Salient Features of Nerves

    Description of Technology: The invention consists of a novel 
diffusion MRI experiment and modeling framework that describes white 
matter in the central nervous system (CNS) and nerves in the peripheral 
nervous system (PNS) as composite media having intra- and extra axonal 
spaces with different water diffusion characteristics. Specifically, 
fascicles in the nervous system are modeled as having a hindered 
extracellular region and a restricted intracellular or intra-axonal 
region. Diffusion of water in these two distinct compartments 
contributes to the total measured diffusion MRI signal. This method 
provides a voxel-by-voxel measurement of the intra- and extra- axonal 
volume fractions, and an estimate of the mean axon diameter. This 
technology is also incorporated in NIH's AxCaliber MRI technology, 
which extends it, treating fascicles as a bundle of impermeable 
cylinders having a distribution of internal diameters.
    The significance of this invention is that it provides measurements 
of new and useful microanatomical features of white matter (and gray 
matter) that are closely related to the function of the nervous 
system--particularly the speed that information travels along axons--
critically important in medicine and the neurosciences. Previously, the 
data provided by this non-invasive MR imaging method were only 
available using invasive and laborious histological means requiring 
tissue biopsy.
    Potential Commercial Applications:

 clinical MRI
 small animal or pre-clinical MRI
    Competitive Advantages:
 non-invasive, painless, in vivo measurement of microanatomical 
features of nerves and muscles.
 no contrast agents required
 modest data requirements allow for scans to be performed in a 
clinically feasible time-frame

    Development Stage:

 Early-stage
 In vitro data available
 In vivo data available (animal)
 In vivo data available (human)
 In situ data available (on-site)
 Prototype

    Inventors: Peter J. Basser (NICHD), Yaniv Assaf (Tel Aviv 
University)
    Publications:

1. Assaf Y, et al. New modeling and experimental framework to 
characterize hindered and restricted water diffusion in brain white 
matter. Magn Reson Med. 2004 Nov;52(5):965-78. [PMID 15508168]
2. Assaf Y, Basser PJ. Composite hindered and restricted model of 
diffusion (CHARMED) MR imaging of the human brain. Neuroimage 2005 
Aug 1;27(1):48-58. [PMID 15979342]
3. Assaf Y, Basser PJ. Combining DT and q-space MRI: a new model of 
white matter in the brain. In Proc. Intl. Soc. Mag. Reson. Med. 
2003;11:588. [http://cds.ismrm.org/ismrm-2003/ismrm03.pdf]
4. Assaf Y, et al. A New Modeling and Experimental Framework to 
Characterize Hindered and Restricted Water Diffusion in Brain White 
Matter. In Proc. Intl. Soc. Mag. Reson. Med. 2004;11:251. [http://cds.ismrm.org/ismrm-2004/Files/Program04.pdf]

    Intellectual Property: HHS Reference No. E-079-2003/1--US Patent 
No. 8,380,280 filed 19 Feb 2013
    Related Technologies:

     HHS Reference No. E-203- 1993/0--U.S. Patent No. 5,539,310 
issued 23 Jul 1996
     HHS Reference No. E-079- 2003/0--U.S. Patent No. 7,643,863 
issued 05 Jan 2010
     HHS Reference No. E-276-2008/0--U.S. Patent No. 8,704,515 
issued 22 Apr 2014

    Licensing Contact: John Stansberry, Ph.D.; 301-435-5236; 
[email protected]
    Collaborative Research Opportunity: The Eunice Kennedy Shriver 
National Institute of Child Health and Human Development is seeking 
statements of capability or interest from parties interested in 
collaborative research to further develop, evaluate or commercialize 
novel MRI methods to probe tissue structure and organization, 
particularly for neuroimaging applications. For collaboration 
opportunities, please contact Alan E. Hubbs at [email protected] or 
240-276-5530.

    Dated: May 12, 2014.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2014-11146 Filed 5-14-14; 8:45 am]
BILLING CODE 4140-01-P