[Federal Register Volume 79, Number 32 (Tuesday, February 18, 2014)]
[Notices]
[Pages 9236-9243]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-03411]
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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.
Multiple Antigenic Peptide Assays for Detection of HIV and SIV Type
Retroviruses
Description of Technology: CDC scientists have developed multiple
antigenic peptide immunoassays for the detection of human
immunodeficiency virus (HIV) and/or simian immunodeficiency virus
(SIV). HIV can be subdivided into two major types, HIV-1 and HIV-2,
both of which are believed to have originated as result of zoonotic
transmission. Humans are increasingly exposed to many different SIVs by
wild primates. For example, human exposure to SIVs frequently occurs as
a consequence of the bush meat hunting and butchering trade in Africa.
Human exposure to SIVs may lead, or may have already led, to
transmission of SIVs with potential for new virus induced
immunodeficiency epidemics. Unfortunately, new cases of
[[Page 9237]]
zoonotic virus transmission may go undetected because of the lack of
SIV-specific tests. Thus, there is the potential to compromise the
safety of the blood donor supply system and seed a new HIV-like
epidemic. This invention addresses these problems by providing a way to
test all primates for the many divergent lentivirus strains to identify
primary infections and prevent secondary transmission.
Potential Commercial Applications:
Detection and differentiation of HIV-1, HIV-2 and SIVs
HIV/SIV surveillance
SIV/HIV/AIDS research
Sero-monitoring of potential zoonotic transmissions
Blood-donation supply assurance tool
Competitive Advantages:
Fills an unmet need for SIV-specific tests
Sensitive and specific
Easily adapted to kit/array format
Research indicates greater sensitivity than standard HIV
enzyme immunoassays (EIAs) for detecting SIV infections
Development Stage: In vitro data available.
Inventors: Marcia L. Kalish, Clement B. Ndongmo, Chou-Pong Pau,
William M. Switzer, Thomas M. Folks (all of CDC).
Publication:
1. Ndongmo CB, et al. New multiple antigenic peptide-based enzyme
immunoassay for detection of simian immunodeficiency virus infection
in nonhuman primates and humans. J Clin Microbiol. 2004
Nov;42(11):5161-9. [PMID 15528710]
2. Kalish ML, et al. Central African hunters exposed to simian
immunodeficiency virus. Emerg Infect Dis. 2005 Dec;11(12):1928-30.
[PMID 16485481]
Intellectual Property: HHS Reference No. E-294-2013/0--
PCT Application No. PCT/US2004/011022 filed 08 Apr 2004
US Patent No. 8,254,461 issued on 03 Sep 2013
Various international patent applications pending or issued
Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937;
[email protected]
Auscultatory Training System and Telemedicine Tool with Accurate
Reproduction of Physiological Sounds
Description of Technology: This CDC developed auscultatory training
apparatus includes a database of prerecorded physiological sounds
(e.g., lung, bowel, or heart sounds) stored on a computer for playback.
Current teaching tools, which utilize previously recorded sounds,
suffer from the disadvantage that playback environments cause
considerable distortion and errors in sound reproduction. For example,
to those trainees using such systems, the reproduced respiratory sounds
do not ``sound'' as if they are being generated by a live patient.
Moreover, the aforementioned playback distortions often make it
difficult for the listener to hear and interpret the subtleties of a
recorded respiratory maneuver.
This device includes a software program that allows a user to
select prerecorded sounds for playback. The program will also generate
an inverse model of the playback system in the form of a digital
filter. The inverse model processes a selected sound to cancel the
distortions of the playback system so the sound is accurately
reproduced. The program also permits the extraction of a specific sound
component from a prerecorded sound so only the extracted sound
component is audible during playback. In addition to the obvious role
of a teaching tool for medical professionals, this invention could have
applications as a diagnostic screening and/or telemedicine tool.
Potential Commercial Applications:
Auscultatory training for health care professionals
Telemedicine tool
Diagnostic screening comparison and control
Competitive Advantages:
Accurate, realistic reproduction of in situ physiological
sounds
Apparatus features noise-cancelling filter to eliminate
ambient distortion artifacts during playback
Device is extremely portable
Allows for isolation and playback of specific elements of a
recording
Development Stage:
In situ data available (on-site)
Prototype
Inventors: Walter G. McKinney, Jeff S. Reynolds, Kimberly A.
Friend, William T. Goldsmith, David G. Frazer (all of CDC).
Publications:
1. Goldsmith WT, et al. A system for recording high fidelity cough
sound and airflow characteristics. Ann Biomed Eng. 2010
Feb;38(2):469-77. [PMID 19876736]
2. Abaza AA, et al. Classification of voluntary cough sound and
airflow patterns for detecting abnormal pulmonary function. Cough.
2009 Nov 20;5:8. [PMID 19930559]
Intellectual Property: HHS Reference No. E-283-2013/0--
U.S. Patent No. 7,209,796 issued 24 Apr 2007
International patent application pending (Canada)
Related Technology: HHS Reference No. E-245-2013/0.
Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937;
[email protected].
Enterovirus Molecular Diagnostic Test Kit
Description of Technology: CDC researchers have developed a reverse
transcription/semi-nested polymerase chain reaction (RT-snPCR) assay
for diagnosis of enterovirus infections within clinical specimens.
Clinical laboratories currently identify enteroviruses by virus
isolation and subsequent virus neutralization tests, or serological
assays. In addition to being time consuming, these approaches are
labor, cost and material intensive.
The enterovirus molecular diagnostic test is prepared in a kit
form, consisting of three reagent preparations (three separate test
steps), to which a technician adds enzymes and RNA extracted from a
clinical specimen. This format is amenable to commercial manufacturing
processes. The assay primers were designed for broad specificity and
amplify all recognized enterovirus serotypes. In the course of assay
development, PCR products have been successfully amplified and
sequenced from cerebrospinal fluid, nasopharyngeal swabs, eye swabs,
rectal swabs and stool suspensions, allowing for unambiguous
identification of the infecting virus in all cases. This assay will be
useful for the diagnosis of numerous common illnesses, such as foot-
and-mouth disease, respiratory illness, conjunctivitis, neonatal
illness, and myocarditis, among several others.
Potential Commercial Applications:
Detection and identification of enterovirus infections, such
as foot-and-mouth disease
Diagnostic evaluations of respiratory or neonatal illnesses
Enterovirus surveillance programs for humans and animals/
livestock
Competitive Advantages:
Ready for commercialization
Easily adaptable to kit form
Rapid, cost-efficient serotype identification
High specificity and precision
Assay covers all known human enterovirus serotypes
Development Stage: In vitro data available
Inventors: William A. Nix and M. Steven Oberste (CDC)
Publications:
1. Nix WA, et al. Sensitive, seminested PCR
[[Page 9238]]
amplification of VP1 sequences for direct identification of all
enterovirus serotypes from original clinical specimens. J Clin
Microbiol. 2006 Aug;44(8):2698-704. [PMID 16891480]
2. Nix WA, et al. Identification of enteroviruses in naturally
infected captive primates. J Clin Microbiol. 2008 Sep;46(9):2874-8.
[PMID 18596147]
Intellectual Property: HHS Reference No. E-257-2013/0--
U.S. Patent No. 7,247,457 issued 24 Jul 2007
U.S. Patent No. 7,714,122 issued 11 May 2010
Various international patents issued or pending
Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937;
[email protected]
Generation of Artificial Mutation Controls for Diagnostic Testing
Description of Technology: This technology relates to a method of
generating artificial compositions that can be used as positive
controls in a genetic testing assay, such as a diagnostic assay for a
particular genetic disease. Such controls can be used to confirm the
presence or absence of a particular genetic mutation. The lack of
easily accessible, validated mutant controls has proven to be a major
obstacle to the advancement of clinical molecular genetic testing,
validation, quality control (QC), quality assurance (QA), and required
proficiency testing. This method provides a consistent and renewable
source of positive control material, as well as an alternative to
patient-derived mutation-positive samples.
Potential Commercial Applications: Generation of positive controls
for molecular genetic tests, particularly for tests to detect cystic
fibrosis.
Competitive Advantages:
Positive controls can be included in new kits or packaged with
pre-existing assays
Increased accuracy in diagnosis compared to current controls
Consistent and renewable source for high-quality controls
containing mutations of interest
Development Stage:
Early-stage
In vitro data available
Inventors: Wayne W. Grody (Regents of Univ of CA), Michael R.
Jarvis (Regents of Univ of CA), Ramaswamy K. Iyer (Regents of Univ of
CA), Laurina O. Williams (CDC).
Intellectual Property: HHS Reference No. E-255-2013/0--
U.S. Patent No. 8,603,745 issued 10 Dec 2013
Various international patent applications pending or issued
Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937;
[email protected]
Novel In Vitro Granuloma Model for Studying Tuberculosis and Drug
Efficacy
Description of Technology: CDC researchers have developed an in
vitro model system designed to simulate early-stage Mycobacterium
tuberculosis infection and induced granuloma formation. This modeling
platform can be used for studying tuberculosis pathogenicity,
identifying phenotypically-interesting clinical isolates, studying
early-stage host cytokine/chemokine responses, and in vitro candidate-
drug screening. The approach incorporates autologous human macrophages,
human peripheral blood mononuclear cells, and mycobacteria to mimic in
situ granuloma formation in a controllable in vitro environment. This
technology would be broadly useful for investigations into the numerous
facets of early granuloma host-pathogen interaction, ultimately leading
to improved prevention, intervention, and treatment strategies.
Potential Commercial Applications:
In vitro modeling system
Basic research into tuberculosis-host interactions
Drug candidate screening
Competitive Advantages:
Low-cost alternative for modeling mycobacterial infections
within complex tissue systems
Allows researchers to examine early-stage granuloma formation
in a highly controllable, human-based modeling system
Cost-effective screening of potential therapeutic compounds
and/or phenotypically-interesting mycobacteria
Development Stage:
In vitro data available
Prototype
Inventors: Frederick D. Quinn, et al. (CDC).
Publication: Birkness KA, et al. An in vitro model of the leukocyte
interactions associated with granuloma formation in Mycobacterium
tuberculosis infection. Immunol Cell Biol. 2007 Feb-Mar;85(2):160-8.
[PMID 17199112].
Intellectual Property: HHS Reference Nos. E-249-2013/0 and E-249-
2013/2--
PCT Application No. PCT/US2002/000309 filed on 07 Jan 2002,
which published as WO 2002/054073 on 11 Jul 2002 (claiming priority to
08 Jan 2001)
U.S. Patent No. 7,105,170 issued 12 Sep 2006
Various international patents issued or pending
Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937;
[email protected].
Diagnostic Antigens for the Identification of Latent Tuberculosis
Infection
Description of Technology: CDC researchers have developed
technology for sero-diagnosis of typically symptomless latent stage
tuberculosis disease, posing a threat to individuals under
immunosuppressive or anti-inflammatory therapies. Specifically, this
diagnostic approach exploits M. tuberculosis secreted latency specific
antigens, such as alpha-crystallin, in the blood or urine of patients.
This type of test could easily be developed into an inexpensive dip-
stick format with high specificity (no cross-reactivity with other
mycobacteria), rapidity, and sensitivity (fewer bacteria needed for a
positive identification). Because secreted antigens are recognized more
readily by the immune system, serum-derived antibodies to these
antigens can correspondingly be used for diagnostic or research use.
Potential Commercial Applications:
Development of a latent tuberculosis diagnostic
Improvements to current diagnostics
Public health/tuberculosis monitoring programs
Screening elderly patients before beginning anti-
inflammatory and/or anti-arthritis therapy
Competitive Advantages:
Rapid and inexpensive diagnostic for latent stage tuberculosis
Specific for latent form, unlike current IGRA/TST diagnostics
Easily developed as a cost effective dip-stick test
Provides high specificity (no cross-reactivity with other
mycobacteria) and sensitivity (fewer bacteria needed for a positive
identification)
Development Stage:
In vitro data available
In vivo data available (human)
Inventors: Frederick D. Quinn, et al. (CDC).
Publication: Stewart JN, et al. Increased pathology in lungs of
mice after infection with an alpha-crystallin mutant of Mycobacterium
tuberculosis: Changes in cathepsin proteases and certain cytokines.
Microbiology. 2006 Jan;152(Pt 1):233-44. [PMID 16385133].
[[Page 9239]]
Intellectual Property: HHS Reference Nos. E-249-2013/1 and E-249-
2013/2--
PCT Application No. PCT/US2002/000309 filed on 07 Jan 2002,
which published as WO 2002/054073 on 11 Jul 2002 (claiming priority to
08 Jan 2001)
U.S. Patent No. 7,105,170 issued 12 Sep 2006
Various international patents issued or pending
Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937;
[email protected].
Methods and Apparatus for Computer-Aided Cough Sound Analysis
Description of Technology: CDC researchers have developed a system
that allows subjects to cough into a tubing system allowing the
acoustics generated to be recorded with high fidelity and generated
data is transferred to a computer for subsequent analysis. Lung
diseases can be differentiated by the location of effect in the lungs
that produce variations in cough sounds and patterns. Based on these
differences, analysis software estimates the lung disease type of the
subject. Those who benefit from cough sound analysis include subjects
in the early stages of undetected lung disease, subjects with
conditions not easily diagnosed by standard techniques, subjects who
demonstrate difficulty performing forced expiratory maneuvers and other
pulmonary function tests (e.g., elderly, young and very sick patients),
and workers whose respiratory functioning may change during the
workday.
Potential Commercial Applications:
Clinical screening for early-stage respiratory illnesses
Occupational health and safety
Physiological data collection and algorithmic analysis
Preventative and early intervention health care
Competitive Advantages:
Increased accuracy in recorded observations
Improved objectivity in analysis compared to traditional
auscultatory methods
Broadens the diagnostic toolset of primary/initial care
physicians and respiratory therapists
Portable for field studies and on-site screening/diagnostic
uses
Development Stage:
In situ data available (on-site)
Prototype
Inventors: William T. Goldsmith, David Frazer, Jeffrey Reynolds,
Aliakbar Afshari, Kimberly Friend, Walter McKinney (all of CDC).
Publications:
1. Wysong P. Ever Wonder What a Cough Looks Like? The Medical Post
1998;34(21):14. (Third-party Magazine Article about this technology)
2. Abaza AA, et al. Classification of voluntary cough sound and
airflow patterns for detecting abnormal pulmonary function. Cough.
2009 Nov 20;5:8. [PMID 19930559]
3. Goldsmith WT, et al. A system for recording high fidelity cough
sound and airflow characteristics. Ann Biomed Eng. 2010
Feb;38(2):469-77. [PMID 19876736]
Intellectual Property: HHS Reference No. E-245-2013/0--
U.S. Patent No. 6,436,057 issued 20 Aug 2002
Canada Patent 2,269,992 issued 22 Dec 2009
Related Technology: HHS Reference No. E-283-2013/0.
Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937;
[email protected].
Methods of Retaining Methylation Pattern Information in Globally
Amplified DNA
Description of Technology: CDC researchers have developed a novel
method that generates globally amplified DNA copies retaining parental
methylation information; making accurate DNA-archiving for methylation
studies much more feasible and cost-effective than undertaking such an
endeavor with alternate technologies. This unique approach eliminates a
significant bottleneck in the collection of methylation information in
the genome(s) of an individual organism, hosts and pathogens. Thus,
this technology provides numerous opportunities for investigations into
cytosine methylation patterns, ultimately benefiting efforts of early
detection, control and prevention of many chronic and infectious
diseases.
Potential Commercial Applications:
Epigenetics investigators and related products manufacturers
Studies into pathogenesis regulation, chronic diseases, gene
silencing, etc.
Cancer and obesity research
Basic research applications
Competitive Advantages:
Overcomes a significant barrier inhibiting efficient DNA
methylation archival studies
Substantially reduces the required quantity of sample DNA
Developed kits will be universally applicable to all species
using DNA methylation as regulatory mechanisms of growth, development
and/or pathogenesis
Usable in all situations of limited amounts of DNA, including
studies with single cells
Improved cost effectiveness and study feasibility compared to
alternate technologies
Development Stage: In vitro data available.
Inventors: Mangalathu Rajeevan and Elizabeth R. Unger (CDC).
Publication: Rajeevan MS, et al. Quantitation of site-specific HPV
16 DNA methylation by pyrosequencing. J Virol Methods. 2006 Dec;138(1-
2):170-6. [PMID 17045346].
Intellectual Property: HHS Reference No. E-243-2013/0--U.S. Patent
No. 7,820,385 issued 26 Oct 2010.
Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937;
[email protected].
Inexpensive, Personal Dust Detector Tube/Dosimeter Operating on a Gas
Detector Tube Platform
Description of Technology: This CDC developed dust detector tube is
designed to provide inexpensive, short-term, time weighted average dust
exposure data feedback directly to device users. This invention
operates upon a conventional gas detector tube platform and can be used
with any low volume pump that can electronically measure pump back
pressure. The device consists of three sections: the first defines the
size of the dust and removes moisture, the second uses a filter whose
pressure differential corresponds with cumulative dust loading, and a
final section employs a pressure transducer.
Current methods require expensive instantaneous and short-term
monitors or gravimetric filters that must be carefully pre- and post-
weighed to determine the average dust exposure of a user's work-shift.
This novel dust dosimeter fills the need for an inexpensive short-term
determination of personal dust exposure aiding in the assessment and
preservation of worker respiratory health.
Potential Commercial Applications:
Dust, gas and particulate detector/dosimeter manufacturers
Industry applications where worker-exposure to dust will be a
concern, especially mining, construction and demolition fields
Worker health and safety, related insurance agency concerns
Competitive Advantages:
Provides inexpensive, short-term assessment of personal dust
exposure
Gas detector tube platform makes commercialization of this
instrument
[[Page 9240]]
quite simple and efficient for related manufacturers/distributors
Standardizing detection platforms increases cost-
efficiency (especially for smaller companies) as the same pump can be
used to measure both dust and gas
Development Stage: In situ data available (on-site).
Inventors: Jon Volkwein, Harry Dobroski, Steven Page (all of CDC).
Publication: Volkwein JC, et al. Laboratory evaluation of pressure
differential-based respirable dust detector tube. Appl Occup Environ
Hyg. 2000 Jan;15(1):158-64. [PMID 10712071].
Intellectual Property: HHS Reference No. E-238-2013/0--U.S. Patent
No. 6,401,520 issued 11 Jun 2002.
Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937;
[email protected].
Peptide Sequences for Chlamydophila pneumoniae Vaccine and Serological
Diagnosis
Description of Technology: CDC researchers have isolated select
Chlamydophila pneumoniae peptide epitopes for development of vaccines
and diagnostic assays. Currently, C. pneumoniae infection of humans has
been linked to a wide variety of acute and chronic diseases, such as
asthma, endocarditis, atherosclerotic vascular disease, chronic
obstructive pulmonary disease, sarcoidosis, reactive arthritis and
multiple sclerosis. There is presently no available peptide vaccine for
the pathogen and reliable and accurate diagnostic methods are limited.
This technology encompasses polypeptide sequences that are
specifically recognized by anti-C. pneumoniae antibodies. These
antigens may be useful for improving diagnostic methods by reducing the
variability and high backgrounds found with methods that rely on whole
organisms for detection. Further, this technology may also be useful
for production of peptide or DNA-based vaccines directed against C.
pneumoniae.
Potential Commercial Applications:
C. pneumoniae vaccine and/or therapeutic developments
Public health surveillance programs
Clinical serological diagnostics development
Competitive Advantages:
No peptide vaccine for C. pneumoniae is presently available
Present assays for the diagnosis of C. pneumoniae infections
are laborious and limited in efficacy
Development Stage: In vitro data available.
Inventors: Eric L. Marston, Jacquelyn S. Sampson, George M.
Carlone, Edwin W. Ades (all of CDC).
Publication: Marston EL, et al. Newly characterized species-
specific immunogenic Chlamydophila pneumoniae peptide reactive with
murine monoclonal and human serum antibodies. Clin Diagn Lab Immunol.
2002 Mar;9(2):446-52. [PMID 11874892].
Intellectual Property: HHS Reference No. E-235-2013/0--U.S. Patent
No. 7,223,836 issued 29 May 2007.
Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937;
[email protected].
CD40 Ligand: Adjuvant for Enhanced Immune Response to Respiratory
Syncytial Virus
Description of Technology: CDC researchers have developed methods
and adjuvants for enhancing a subject's immune response to respiratory
syncytial virus (RSV) by inclusion of a CD40 binding protein. RSV has
long been recognized as a major respiratory tract pathogen of infants,
as well as older children and the elderly. Established, successful
methods for preventing RSV are currently unavailable. CD40 ligand
(CD40L, also known as CD154) is an important costimulatory molecule
found on the T-cell and is critical for the development of immunity.
CD40L may provide a novel adjuvant to enhance cytokine and antibody
response to RSV, directing a subject's immune response further towards
Th1-mediated outcomes rather than a less effective Th2-type response.
This Th2-type response has been previously suggested as the cause of
previous live-RSV vaccine failures. This technology, appropriately
developed and integrated into an RSV vaccination agenda, may be useful
in improving the efficacy of current or future RSV vaccines.
Potential Commercial Applications:
Improvements to current RSV vaccines
Public health vaccination programs
Enhancing antibody response and T-cell costimulation for
targeted immunogenic outcomes
Pharma development programs focusing on care for neonates,
children and the elderly
Competitive Advantages:
Increased expression of Th1-type cytokines and antibody
production
Enhanced CD40 costimulation
May overcome prior live-RSV vaccine issues (which generated a
primarily Th2-type immune response) by steering post-vaccination
immunity further towards a preferred Th1-type (IL-2 and IFN-gamma)
response, enhancing virus clearance in vivo
Development Stage:
In vitro data available
In vivo data available (animal)
Inventors: Ralph A. Tripp, Larry J. Anderson, Michael P. Brown (all
of CDC)
Publication: Tripp RA, et al. CD40 ligand (CD154) enhances the Th1
and antibody responses to respiratory syncytial virus in the BALB/c
mouse. J Immunol. 2000 Jun 1;164(11):5913-21. [PMID 10820273]
Intellectual Property: HHS Reference No. E-233-2013/0--
PCT Application No. PCT/US2001/003584 filed 02 Feb 2001, which
published as WO 2001/056602 on 09 Aug 2001
U.S. Patent No. 7,371,392 issued 13 May 2008
U.S. Patent No. 8,354,115 issued 15 Jan 2013
Various international patents issued
Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937;
[email protected].
Recombinant Polypeptides for Clinical Detection of Taenia solium and
Diagnosis of Cysticercosis
Description of Technology: CDC scientists have developed synthetic/
recombinant polypeptides that can be used for the creation of
inexpensive, high-quality cysticercosis diagnostic assays. Taenia
solium is a species of pathogenic tapeworm. Intestinal infection with
this parasite is referred to as taeniasis and it is acquired by
ingestion of T. solium cysticerci found in raw and undercooked pork, or
food contaminated with human or porcine excrement. Many infections are
asymptomatic, but infection may be characterized by insomnia, anorexia,
abdominal pain and weight loss. Cysticercosis is the formation of
cysticerci in various body tissues resulting from the migration of the
T. solium larvae out of the intestine. Although infection with T.
solium is itself not dangerous, cysticercosis can be fatal. In the
present invention, specific antigen encoding nucleotide sequences have
been cloned; assays based on the produced antigens may be useful for
improvements over the existing Western blot diagnostic method for
identifying individuals with cysticercosis. Additionally, these
polypeptides may have applications in developing vaccines and
therapeutics to prevent taeniasis.
Potential Commercial Applications:
[[Page 9241]]
Diagnosis of T. solium infection and confirmation of
cysticercosis
Zoonotic disease research and surveillance
Public health monitoring programs
Livestock health and food-source monitoring
Therapeutics/vaccine development
Competitive Advantages:
May provide a rapid, accurate, sensitive and safe alternative
to current radiologic, Western blot and biopsy diagnostic methods
Can be easily formatted as a simple-to-use assay kit for FAST-
ELISA
Cost-effective, and quite useful for developing regions of the
world
Development Stage: In vitro data available
Inventors: Victor C. Tsang, Ryan M. Greene, Patricia P. Wilkins,
Kathy Hancock (all of CDC)
Publication: Greene RM, et al. Taenia solium: molecular cloning and
serologic evaluation of 14- and 18-kDa related, diagnostic antigens. J
Parasitol. 2000 Oct;86(5):1001-7. [PMID 11128471]
Intellectual Property: HHS Reference No. E-230-2013/0--
PCT Application No. PCT/US2001/003584 filed 02 Feb 2001,
which published as WO 2001/075448 on 11 Oct 2011
U.S. Patent No. 7,094,576 issued 22 Aug 2006
U.S. Patent No. 7,595,059 issued 29 Sep 2009
Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937;
[email protected].
Automated Microscopic Image Acquisition, Compositing and Display
Software Developed for Applied Microscopy/Cytology Training and
Analysis
Description of Technology: Micro-Screen is a CDC developed software
program designed to capture images and archive and display a compiled
image(s) from a portion of a microscope slide in real time. This
program allows for the re-creation of larger images that are
constructed from individual microscopic fields captured in up to five
focal planes and two magnifications. This program may be especially
useful for the creation of data archives for diagnostic and teaching
purposes and for tracking histological changes during disease
progression.
Potential Commercial Applications:
Medical/cytology training, education and certification
All aspects of applied microscopy/histology, microbial smears,
hematology, parasitology, etc.
Clinical diagnostics
Basic and applied biology lab research
Forensic analysis
Competitive Advantages:
Readily adaptable to other microscopic disciplines
Automated imaging and display provides increased cost
efficiency and improves objectivity of analysis and testing
Can be used to develop a database of standards or reference
images for a variety of pathologies and/or applied microscopy concerns
Development Stage:
In vitro data available
In situ data available (on-site)
Inventors: MariBeth Gagnon, Roger Taylor, James V. Lange, Tommy
Lee, Carlyn Collins, Richard Draut, Edward Kujawski (all of CDC).
Publication: Taylor RN, et al. CytoView. A prototype computer
image-based Papanicolaou smear proficiency test. Acta Cytol. 1999 Nov-
Dec;43(6):1045-51. [PMID 10578977]
Intellectual Property: HHS Reference No. E-228-2013/0--
U.S. Patent No. 7,027,628 issued 11 Apr 2006
U.S. Patent No. 7,305,109 issued 04 Dec 2007
Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937;
[email protected]
Ultrasonic in situ Respirator Seal-Leakage Detection With Real-time
Feedback Capabilities
Description of Technology: This CDC invention entails methods and
apparatuses for in situ testing seal integrity and improved operation
of respiratory masks (respirators). A variety of external factors, such
as individual face shape, user environment, mask age and material used
to construct the respirator, can lead to device malfunction and failure
to sufficiently protect a user. To address these limitations, this
invention relies on ultrasonic wave detection to assess face seal
quality and other potential leak paths, as needed. Airborne ultrasound
travel through atmosphere and will travel through respirator leaks.
Applying this phenomena to occupational health and safety, CDC
researchers have developed novel ultrasonics technology to identify and
quantify respirator seal leakage in real-time. Small, low power
consuming, and inexpensive apparatuses and methods for generating and
detecting ultrasound may be easily obtained and customized for a given
respirator and/or application.
By correlating user activity to seal sensor data, a precise
understanding and awareness of respirator integrity may be obtained.
When coupled with a subject alarm, these integrated values can
immediately alert a user when a threshold of environmental exposure has
been reached. Such real-time feedback will be invaluable to users in
dangerous occupational activities, such as firefighters, biodefense and
chemical spill first responders, mining applications, etc.
Additionally, this invention possesses immense value for respirator
mask manufacturers and workplace training programs for employees
engaged in mandatory respirator usage applications.
Potential Commercial Applications:
Manufacturers of respirators, leakage assessment devices and
applied ultrasonic technology
Regulators of respiratory protection plans
Biohazard, biodefense and hazardous chemical handling and
disposal
Surgery/hospital training and use
Competitive Advantages:
Small, low power consuming, and inexpensive apparatuses and
methods may be employed
Real-time monitoring and feedback greatly diminish risk of
user exposure to environmental hazards
Development Stage:
In situ data available (on-site)
Prototype
Inventors: Jonathan Szalajda and William King (CDC)
Intellectual Property: HHS Reference No. E-174-2013/0--U.S. Patent
No. 8,573,199 issued 05 Nov 2013
Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937;
[email protected].
Physiologic Sampling Pump Capable of Rapidly Adapting to User Breathing
Rate
Description of Technology: This CDC developed physiologic sampling
pump (PSP) overcomes shortcomings of previous devices by the use of
calibrated valves in conjunction with a constant speed pump. This novel
approach obviates typical PSP inertia that inherently limits system
response, functionality and accuracy. All prior PSP designs have
attempted to follow a user's breathing pattern by changing pump speed,
thereby altering sampling rate. In that approach, pump inertia will
limit system response and function due to the time required to adjust
speed. Additionally, variable pump speeds often produce size selective
sampling errors at low flow rates.
Performance of this PSP is not degraded by pump inertia or low flow
size selective sampling errors. This
[[Page 9242]]
design maintains a consistent pump speed, controlling PSP sampling rate
with calibrated valves that redirect air flow almost instantaneously.
In situ device testing demonstrated that when this air-flow valve is
properly integrated into a sampling head, response time of the PSP is
essentially mutually exclusive of the magnitude of changes in the
effective flow, facilitating consistently small error in sampling
performance regardless of user-exertion scenario.
Potential Commercial Applications:
Air sampling device manufacturers
Assessing airborne hazard exposures for workplace safety
Industrial hygiene programs
Respiration monitoring device for patients
Aerobic training system for athletes
Competitive Advantages:
Allows for air sampling to be modulated to follow breathing
rate
Design obviates the sluggishness inherent in prior art
physiologic sampling pumps (PSPs) caused by variable pump speed effect
on sampling rate
Improved accuracy compared to earlier PSPs, irrelevant of
user-exertion scenarios
Follows inhalation on a breath-by-breath basis
Development Stage:
In situ data available (on-site)
Prototype
Inventors: Larry Lee and Michael Flemmer (CDC)
Publication: Lee L, et al. A novel physiologic sampling pump
capable of rapid response to breathing. J Environ Monit. 2009
May;11(5):1020-7. [PMID 19436860]
Intellectual Property: HHS Reference No. E-169-2013/0--U.S. Patent
No. 8,459,098 issued 11 Jun 2013
Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937;
[email protected].
Cylindrical Handle Dynamometer for Improved Grip-Strength Measurement
Description of Technology: CDC researchers have developed an
improved dynamometer device and method for measuring maximum hand grip
force or grip-strength. Human test subjects were used in conducting
experiments to evaluate the handle and to assess the measurement
method. In contrast to the currently used ``Jamar handle'' grip
strength dynamometer devices, the cylindrical handle proved to be able
to determine the overall grip strength for a subject, as well as show
the grip force distribution around the circumference of the handle. The
cylindrical dynamometer handle is accurate with less than 4% error, and
it demonstrates that the measurement is independent of the loading
position along the handle. For real-world applications, the device can
be used to help diagnose the musculoskeletal disorders of the hand,
monitor the recovery progress after hand surgery or injury, and collect
grip strength data for tool and machine design.
Potential Commercial Applications:
Useful for engineering functional design and ergonomic
considerations for developing new tools and machinery
Monitoring post-operative, post-stroke rehabilitation
Diagnosis of carpel tunnel syndrome, musculoskeletal disorders
and hand-arm vibration syndrome
Training feedback for grip-strength focused athletes--
climbing, gymnastics, rugby, martial arts, etc.
Competitive Advantages: Compared to currently used ``Jamar'' grip
test devices:
Cylindrical handle shape more comparable with real-world/
workplace machinery
Improved comfort
Cylindrical meter assesses the total grip force, together with
the friction force and torque
Grip force distributed at the different parts of the hand can
be measured with cylindrical meter--important information for the
diagnosis of hand disorders
Development Stage:
In situ data available (on-site)
Prototype
Inventors: Bryan Wimer, Daniel E. Welcome, Christopher Warren,
Thomas W. McDowell, Ren G. Dong (all of CDC)
Publication: Wimer B, et al. Development of a new dynamometer for
measuring grip strength applied on a cylindrical handle. Med Eng Phys.
2009 Jul;31(6):695-704. [PMID 19250853]
Intellectual Property: HHS Reference No. E-143-2013/0--U.S. Patent
No. 8,240,202 issued 14 Aug 2012
Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937;
[email protected].
Methods for the Simultaneous Detection of Multiple Analytes
Description of Technology: CDC researchers have developed a method
of simultaneously detecting and distinguishing multiple antigens within
a biological sample. Epidemiological and vaccine studies require
species serotype identification. Current methods of serotyping are
labor intensive and can easily give subjective, errant results. This
technology utilizes serotype specific antibodies bound to fluorescent
beads, allowing for simultaneous single tube capture and detection of
multiple antigens in one rapid, high-throughput flow cytometry assay.
Such technology has an extremely wide range of useful applications,
including but not limited to complex serotyping investigations for
vaccine development and formulation, as a tool for rapid clinical
prognosis or diagnosis, and the assay can be formatted as a kit for any
number of laboratory research uses.
Potential Commercial Applications:
Complex serotyping and/or multi-antigen composition
investigations
Tool for clinical diagnosis or prognosis of a disease or
infection
Tool for basic research
Competitive Advantages:
Rapid flow cytometry assay
Simultaneous detection of multiple different antigens and
antibodies
Excellent for high-throughput usage
Provides a reliable, reproducible measurements of serotype-
specific antigens within a sample
Technology particularly well-developed for addressing S.
pneumoniae serotyping concerns
Development Stage: In vitro data available
Inventors: Joseph E. Martinez and George M. Carlone (CDC)
Intellectual Property: HHS Reference No. E-142-2013/0--U.S. Patent
No. 7,659,085 issued 09 Feb 2010
Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937;
[email protected].
Extension-Ladder Safety: Multimodal-feedback Indicator for Improved
Ladder Positioning Safety and Efficiency
Description of Technology: Improper positioning of an extension
ladder frequently results in ``ladder slide-outs,'' which are the most
common cause of ladder-fall scenarios. This invention relates to an
extension ladder positioning indicator which is easily installed in a
ladder rung; provides multiple cues (visual, sound, and vibration) for
rapidly identifying and positioning correct ladder inclination.
CDC-NIOSH researchers found that this technology improved accuracy
and efficiency of ladder positioning for both ``experienced'' and
``novice'' ladder users, as compared to the ``no instruction'' method
and the standard anthropometric method, and that it was also
significantly faster than the bubble indicator method. When properly
implemented, this effective and easy to use ladder positioning
indicator will
[[Page 9243]]
reduce the risk of extension ladder slipping and tipping and,
ultimately, will reduce the number of fall incidents and injuries--
benefitting construction workers, employers, contractors and workplace
insurers.
Potential Commercial Applications:
Retrofitting existing ladders to provide automated,
multisensory feedback for improved compliance with OSHA and ANSI
ladder-angle safety guidelines
Ladder manufacturing companies
Construction contractors, retailers and insurers
Training tool to aid worker safety education and adherence
Competitive Advantages:
Direct, multimodal user feedback reduces the time for
accurate, safe ladder positioning compared to bubble-level indicator,
anthropometric and sight- based ladder-positioning methods
Visual, auditory and tactile feedback provide increased
efficient-setup and safety
Technology can be incorporated as an attachable, device which
may be affixed to a ladder or integrated as an app for a mobile/tablet
device
Automated feedback ensures ladders are angled to OSHA and ANSI
safety specifications
Development Stage:
In situ data available (on-site)
Prototype
Inventors: Peter Simeonov, Hongwei Hsiao, John Powers (all of CDC)
Publication: Simeonov P, et al. Research to improve extension
ladder angular positioning. Appl Ergon. 2013 May;44(3):496-502. [PMID
23177178]
Intellectual Property: HHS Reference No. E-141-2013/0--U.S. Patent
No 8,167,087 issued 01 May 2012
Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937;
[email protected].
Dates: February 13, 2014.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. 2014-03411 Filed 2-14-14; 8:45 am]
BILLING CODE 4140-01-P