[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