00-20226. Government-Owned Inventions; Availability for Licensing and Collaborative Research and Development Agreements (CRADA)

AGENCY:

Centers for Disease Control and Prevention, Technology Transfer Office, Department of Health and Human Services.

ACTION:

Notice.

The inventions named in this notice are owned by agencies of the United States Government and are available for licensing in the United States (U.S.) in accordance with 35 U.S.C. 207, and are available for cooperative research and development agreements (CRADAs) in accordance with 15 U.S.C. 3710, 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 U.S. companies and may also be available for licensing.

ADDRESSES:

Licensing and CRADA information, and copies of the U.S. patent applications listed below, may be obtained by writing to Thomas E. O'Toole, M.P.H., Deputy Director, Technology Transfer Office, Centers for Disease Control and Prevention (CDC), Mailstop E-67, 1600 Clifton Rd., Atlanta, GA 30333, telephone [phone], email [e-mail]. Please note that a signed Confidential Disclosure Agreement will be required to receive copies of the patent application.

Nucleic Acids Encoding Norwalk-Like Viruses (NLVs), Their Sequences, and Uses Thereof

Reverse transcription-polymerase chain reaction (RT-PCR) has been used worldwide for the diagnosis of Norwalk-like virus (NLV) infection, yet a commonly accepted genetic classification scheme has not been established. On the basis of the analysis of amino acid sequences in the second open reading frame (ORF2) regions from a total of 101 NLV strains, including 2 bovine strains, a genetic classification scheme is proposed that differentiates 99 human strains into 2 major genetic groups, consisting of 5 and 10 genetic clusters, respectively. The 2 bovine strains constitute a newly defined third major genetic group composed of two putative clusters represented by each strain. This classification scheme is well supported by the analysis of the entire ORF2 sequences from 38 strains selected to represent the genetic diversity of the human strains used above. This scheme should provide a firm scientific basis for designation and evaluation of improved molecular methods for the diagnosis of NLV infection.

CDC Ref.#: I-025-99/0.

Inventor(s): Tamie Ando; Stephen S Monroe; Roger Glass.

Identification of a 54kDa Antigen of Mycoplasma pneumoniae, as Well as Specific Antibodies to This Antigen, in Urine of Infected Individuals

M. pneumoniae is a common cause of atypical pneumonia, tracheobronchitis, and pharyngitis. M. pneumoniae is difficult to culture for diagnostic purposes and serum antibodies used for diagnostic confirmation often arise too late for timely treatment decisions. A specific M. pneumoniae antigen has been identified which is present during acute infection. This antigen may be used as a diagnostic marker and may also be used to monitor treatment efficacy.

CDC Ref.#: I-026-99/0.

Inventor(s): Stephanie Schartz; Deborah Talkington.

Serotype-Specific Identification of Enterovirus 71 by RT-PCR

Enterovirus 71 (EV71) has been responsible for many outbreaks throughout the world since the early 1970s. Infections can result in severe neurologic symptoms including poliomyelitis-like paralysis. Recently, EV71 caused large outbreaks of hand-foot-mouth disease in Asia with thousands of reported cases. This invention provides a method for the rapid serotype identification of EV71. There are over 780 serotypes of Enteroviruses and many of them have potential for causing diseases with similar symptoms, so viral identification is necessary. Many diagnostic labs would like to implement simple and fast tests to identify viruses. The primer pairs described by these researchers are specific for the Enterovirus agent EV71. The virus is known to be fairly prevalent and the sequencing studies indicate that there are two genetically different groups of this virus. The amplicons produced with these primers allow sequencing and even resolution to which genetic group the virus belongs.

U.S. Patent Application Serial No. 60/164,520

CDC Ref.#: I-027-99/0.

Inventor(s): Betty A Brown; David Kilpatrick; Mark Pallansch; Steven Oberste.

CD40 Ligand Adjuvant for Respiratory Syncytial Virus

CD40 Ligand (CD40L) is an important costimulatory molecule on the T-cell and is central to the development of immunity. CD40L expression can influence cytokine response and is responsible for immunoglobulin class switching in B-cells. CD40L can be used as an adjuvant to enhance cytokine and antibody response to RSV. CD40L can be used as an adjuvant to enhance any immune response, particularly to weak antigens. Expression of CD40L with antigens may enhance the potency or efficacy of vaccines, by enhancing both the antibody response and the T-cell response in terms of cytokine production.

U.S. Patent Application Serial No. 60/179,905

CDC Ref.#: I-029-99/0.

Inventor(s): Ralph A Tripp; Michael Brown.

A Novel Method for the Isolation of Helicobacter pylori From Highly Contaminated Specimens

H. pylori is an established cause of chronic gastritis, duodenal and gastric ulcer, and is linked to gastric cancer. H. pylori is difficult to culture from extra-gastric and environmental samples due to heavy contamination with other microorganisms that inhibit the growth of H. pylori on commercially available media. New sample treatment methods which eliminate all other microorganisms while not affecting H. pylori allow diagnostic and environmental samples to be grown on non-selective growth media.

CDC Ref.#: I-030-99/0.

Inventor(s): Qunsheng Song; Gerald W Zirnstein; Ben Gold.

Cloning of a Diagnostic Antigen (gp50) for Taenia solium Cysticercosis

Cysticercosis (pork tapeworm disease) is acquired by ingestion of Taenia solium cysticerci found in raw and undercooked pork muscle or food contaminated with human or pig feces. Native gp50 antigen from Taenia solium has been shown to be highly sensitive and specific in detecting individuals with neurocysticercosis. The gp50 antigen has been cloned and may be useful for improvements over the existing Western blot diagnostic method.

CDC Ref.#: I-031-99/0.

Inventor(s): Victor Tsang; Ryan M Greene; Patricia P Wilkins; Kathy Hancock.

Software for Calculating and Graphing Magnetic Field Characteristics and Exposure Metrics From Waveform Measurements

Magnetic fields are suspected of causing cancer, Alzheimer's disease, and other serious health problems. In order to measure individual magnetic field exposures, multiwave instruments measure magnetic field undulations in three perpendicular directions. This software analyzes the exposure metrics using standard and novel mathematical manipulations leading to highly accurate exposure calculations applicable to large scale epidemiological studies of magnetic field health risks or surveys of the geomagnetic environment.

CDC Ref.#: I-032-99/0.

Inventor(s): Joseph Bowman; Richard M Edwards.

Jet Aerosol Vaccination System

This invention comprises an aerosol vaccination system designed for the administration of measles vaccine. The device is a hand held, jet aerosol vaccine delivery system which delivers vaccine to the respiratory tract via disposable nasal prongs. The jet aerosol is generated with a hand pump or compressed gas. The prototype vaccine is measles; however, this device may be adapted for any vaccine suitable for respiratory administration.

CDC Ref.#: I-033-99/0.

Inventor(s): Mark J Papania.

Hand-held, Rechargeable Battery Powered Ultrasonic Aerosol Vaccination Device

This invention comprises an aerosol vaccination system designed for the administration of measles vaccine. The device is a hand held, battery powered ultrasonic nebulizer which delivers vaccine to the respiratory tract via disposable nasal prongs. The prototype vaccine is measles; however, this device may be adapted for any vaccine suitable for respiratory administration.

CDC Ref.#: I-034-99/0.

Inventor(s): Mark J Papania.

Mosquito Midgut Antigen-based Monoclonal Antibodies That Inhibit the Transmission of Different Species of Human Malaria in Different Mosquito Vectors

Current malaria vaccine development efforts focus primarily on moderating infection in the human host rather than targeting the mosquito vectors responsible for the spread of malaria. A set of monoclonal antibodies has been developed which inhibit the development of human malaria parasites in different species of mosquitos by blocking specific mosquito antigens. It may be possible to develop a malaria transmission blocking vaccine by immunizing humans with DNA or protein forms of the identified mosquito antigens. The human antibodies elicited against such antigens, when ingested by the mosquito along with infectious parasites, may prevent the development of parasites in the mosquito and thus halt malaria transmission.

CDC Ref. #: I-002-00/0.

Inventor(s): Altaf Lal; Pamela Patterson.

In Vitro Granuloma as a Model To Examine Tuberculosis Latency

Tuberculin skin testing for M. tuberculosis cannot distinguish between active or latent M. tuberculosis infections; nontuberculosis mycobacteria infections; and BCG vaccine exposure. Nor can skin testing positively identify M. tuberculosis infections in some immunosuppressed individuals. It is suspected that asymptomatic individuals may harbor latent M. tuberculosis bacilli within lung or lymph node granulomas. An in vitro granuloma model has been developed and four suspected latency genes have been identified. These gene products may be useful for differentiating between latent and active M. tuberculosis infections and for efficacy testing of drug regimens against latent infections.

CDC Ref. #: I-003-00/0.

Inventor(s): Fred D Quinn; Kristin A Birkness; Manon Deslauriers.

Design of Ergonomic Handle for Roll-on/Carry-on Luggage

This invention improves user's comfort through two ergonomic handle design features. A handle orientation feature enables the user to pull the luggage while maintaining a natural and comfortable posture. The second feature relates to the adjustability of the handle length according to the height of the user, thus minimizing the lifting force needed when pulling the luggage.

CDC Ref. #: I-004-00/0.

Inventor(s): Awwad J Dababneh.

Model Bladder for Foley Catheter Testing

This model enables growth of bacterial biofilms in foley catheters for gene transfer and other experiments. It is comprised of 4 bladders in a heated water bath and mimics the action of a urinary tract. This device will enable us to determine microbial biofilm formation of urinary catheters and study methods to control this process.

CDC Ref. #: I-005-00/0.

Inventor(s): Amy Norton; Wayne Kirby; Rodney Donlan.

Flushed-seal Respirator: A More Protective, Negative Pressure Respirator

This invention reduces face seal leakage to increase respirator safety by forcing the outside seal to be flushed with clean air.

CDC Ref. #: I-006-00/0.

Inventor(s): Donald L. Campbell; Christopher C. Coffey; Judith B. Hudnell; William A. Hoffman.

Isolation and Characterization of Nucleic Acids of the Bartonella henselae virB Operon and Polypeptides Encoded by the virB Operon Nucleic Acids

We have sequenced the VirB virulence operon of B. henselae. This operon consists of 10 genes that could possibly play a role in the pathogensis of Bartonella infections. These genes would therefore be valuable as candidates for diagnostic tools and vaccines. One of the genes within this operon (virB4) encodes a protein of molecular weight 89.5 kDa. This size closely resembles the size (83 kDa) of an immunodominant antigen of B. henselae that has been shown to be reactive with sera from patients diagnosed with cat scratch disease. If these antigens represent the same protein, the 89.5 kDa (virB4) protein could be a viable candidate for developing a diagnostic tool because of the fact that it is a highly conserved, immunodominant antigen. In addition, the lack of cross reactivity of the 83 kDa antigen with other Bartonella species suggests that it would be useful as a candidate antigen for a species-specific diagnostic test to differentiate Bartonella species.

CDC Ref. #: I-008-00/0.

Inventor(s): Indira Padmalayam; Robert Massung; Kevin Karem; Barbara Baumstark.

Chimeric Dengue Viruses as Candidate Vaccines for Humans

This invention takes advantage of the attenuating mutations found in the nonstructural regions of a Dengue 2 virus (strain PDK-53). The inventors have created a Dengue 1/Dengue 2 chimera with the nonstructural genes of the avirulant DEN-2 vaccine strain and the structural genes of DEN-1 (strain16007). This recombination provides an attenuated vaccine-type virus which retains the immunogenic properties of DEN-1. New developments for this invention also include a chimeric DEN-2/DEN-3 and DEN-2/DEN-4 virus. These chimeric DEN-2/DEN-1, DEN-2/DEN-3, and DEN-2/DEN-4 viruses are possible components for a tetravalent vaccine to protect humans from all four serotypes of DEN virus.

CDC Ref. #: I-009-00/0.

U.S. Patent Application Serial No. 60/182,829

Inventor(s): Claire Huang; Richard Kinney; Siritorn Butrapet; Duane J. Gubler; Natth Bhamarapravati.

Electrical Injury Protection System Using Radio Frequency Transmission

This electrical injury protection system protects electricians and other workers who work with or near energized low voltage (less than 600 volts) power lines by warning them if they come too close to the line and instantly turning off the power if they touch the bare power line. This system reduces the potential for severe injury or death from electrical shock.

CDC Ref. #: I-010-00/0.

U.S. Patent Application Serial No. 60/186,660

Inventor(s): Shengke Zeng; John R. Powers; Larry L. Jackson; David L. Conover.

PCR Primers Specific For 14 Genetic Types of Norwalk-like Viruses, Their Sequences and Use Thereof

This invention provides a set of 17 primers and their sequences for use in one-tube multi-plex RT-PCR to detect 13 genetic clusters of Norwalk-like viruses (NLVs) and simultaneously determine the genetic type on the basis of sequences of the second open reading frame (ORF2) encoding the viral capsid protein. The availability of a rapid, broad, and sensitive detection test for NLVs should facilitate the testing of clinical, food, and environmental specimens to elucidate the modes of transmission of NLVs.

CDC Ref. #: I-012-00/0.

Inventor(s): Tamie Ando; Stephen S. Monroe; Roger Glass.

Neutralizing Immunogenic Hepatitis E Virus (HEV) Polypeptides

This recombinant protein is being utilized as a diagnostic reagent in the development of immunoassays for the detection of anti-HEV activity in human sera. This protein may also have potential for use as a vaccine to prevent HEV infection.

CDC Ref. #: I-013-00/0

Inventor(s): Jihong Meng; Yury Khudyakov; Howard A. Fields.

Combination Peptide Construct of Antigenic Epitopes of PsaA (37 kDa) Protein From Streptococcus pneunoniae

An improved peptide construct consisting of a combination of antigenic epitopes of the PsaA (37 kDa) protein from Streptococcus pneumoniae. This construct is a possible vaccine candidate which may provide better immune stimulation over the previous invention (I-017-97/0) which was based on individual rather than combination epitopes.

CDC Ref. #: I-014-00/0.

Inventor(s): Edwin W Ades; Danny Jue; Scott E. Johnson; Jacqueline Sampson; George Carlone.

Diagnostic Peptide Sequence Discovered from Mouse Monoclonal Antibody 8A6 that Binds Specifically to Chlamydophilia pneumoniae and Recognized by Human Anti-Chlamydophilia pneumoniae Antibodies

Currently, there are few standardized assays for the detection of Chlamydophilia pneumoniae infection of humans. This invention is a peptide sequence that specifically binds C. pneumoniae and is recognized by anti-C. pneumoniae antibodies. This peptide may be useful for improving diagnostic methods by reducing the variability and high backgrounds found with methods that rely on whole organisms for detection. This peptide may also be useful for production of peptide or DNA vaccines.

CDC Ref. #: I-016-00/0

Inventor(s): Eric Marston; Jackie Sampson; Stephen Skelton; George Carlone; Trudy Messmer.

Method and Composition of Using HCV Specific Antigens in a Lateral Flow Rapid Assay for the Detection of Anti-HCV Activity in Human Sera

The hepatitis C virus (HCV) is a major causative agent of parenterally transmitted non-A, non-B hepatitis worldwide and is now considered the major causative agent responsible for post-transfusion hepatitis in the United States. This invention uses recombinant proteins of HCV for the detection of antibodies to HCV in human samples. The assay is an immunogold based detection system which will provide accurate and sensitive results in 15 minutes.

CDC Ref.#: I-017-00/0.

Inventor(s): Fields Howard; Yury Khudyakov; Yair Devash.

Isotropic Magnetic Field Based Proximity Receiver With Multiple Warning and Machine Shutdown Capabilities

This invention is an improvement to the receiver included in the Mobile Machine Hazardous Working Zone Warning System (US Pat. #5,939,986). The receiver is designed to warn machine operators when they are entering dangerous areas (such as unsupported roofs, limited visibility, operating machinery, etc.) and to shut down the equipment if desired. The improved receiver has the additional ability to disable the machinery to prevent restarting and also has improved accuracy in determining distance by virtue of a special design which operates regardless of the orientation of the receiver.

CDC Ref.#: I-018-00/0.

Inventor(s): William Schiffbauer.

Respiratory Syncytical Virus (RSV) G Glycoprotein Contains a CX3C Chemokine Motif Having Biological and Structural Similarities to the CX3C Chemokine Fractalkine: Implications for Vaccine Design and Therapeutic Treatments

RSV is the single most important cause of lower respiratory tract disease in children. Many vaccination strategies have been attempted, but as of yet none have been successful. This invention relates to the discovery of functional motifs in the RSV G protein that may provide new insights into the past vaccine failures and may lead to immunogenic modifications that would provide a safe and efficient RSV vaccine.

CDC Ref.#: I-022-00/0.

Inventor(s): Ralph A Tripp; Les Jones; Larry J Anderson.

Determination of the Full Length Genomic Sequence of SFVhu1 a Foamy Virus Isolated From a Human Infection

This invention comprises the full length sequence of the simian foamy virus SFVhu1. This virus may have potential as a noninfectious viral vector for gene therapy and vaccine delivery systems.

CDC Ref.#: I-023-00/0.

Inventor(s): Margaret E Callahan; Paul Sandstrom; Subbarao Shambavi; Thomas Folks.

Use of Novel Compounds for Pest Control: Insecticidal and Acaricidal Eremophilane Sesquiterpenes

The control of public health pests is critical for preventing numerous vector borne diseases throughout the world. New insecticidal compounds and application strategies are needed to protect both public health and the environment, and to combat chemical resistance. In this invention, biologically active fractions of essential oil of Alaska yellow cedar have been identified which are insecticidal and acaricidal. These natural compounds were found to be active for up to 11 weeks against the tick vector, Ixodes scapularis; the mosquito vector, Aedes aegypti; and the flea vector, Xenopsylla cheopsis.

CDC Ref.#: I-024-00/0.

Inventor(s): Gary O Maupin; Joe Karchesy; Nicholas A Panella.

Gene Coding for a Putative Insecticidal Protein From the Human Pathogen Burkholderia pseudomallei

Burkholderia pseudomallei (previously called Pseudomonas pseudomallei) is a human bacterial pathogen which causes meliodosis, a disease which is endemic in southeast Asia. This discovery of a putative insecticidal protein expressed by B. pseudomallei may have dual functions. A primary application would allow for the development of serological tests for human infection using antibodies derived from the protein and PCR based detection methods derived from the gene sequence. A second possible application of this new protein could include the exploitation of its potential insecticidal properties. These applications might be similar to the methods used to produce a variety of transgenic crops incorporating the Bacillus thuriengensis toxin gene which has been used to create crops resistant to a variety of insect pests.

CDC Ref.#: I-025-00/0.

Inventor(s): Bret M Steiner.

Rapid Identification of Nocardia farcinica by a PCR Assay Targeting a 409-bp Species-specific DNA Fragment

The bacterial complex Nocardia asteroides is a serious threat to immunosuppressed individuals, especially those with organ transplants, lung disease, and AIDS. Nocardia farcinica is the most clinically significant species because it characteristically demonstrates resistance to multiple, extended spectrum antimicrobial agents. Traditional identification methods are time consuming and labor-intensive (up to 8 weeks for definitive results). This invention comprises a unique DNA sequence within the N. farcinica genome which allows for PCR-based diagnostics which are specific to the species and do not cross react with closely related species and genera.

CDC Ref.#: I-027-00/0.

Inventor(s): Brent A Lasker; June M Brown; Kim T Pham.

Laboratory Butane Burner Safety Stand

Some new laboratory facilities are being built without laboratory gas for safety reasons. Bacteriologists conducting classical bacteriology have occasional need for open flame sources in the lab. Portable butane systems are available, but lack stability in the base and are therefore easy to knock over. A laboratory stand has been developed which will provide a wider base and can be easily decontaminated.

CDC Ref.#: I-028-00/0.

Inventor(s): Joanne J Jones; Gerald J Pellegrini; Michael Stepp; Kenneth C Demons.

Hydraulic Impact Hammer Pincher Arm Attachment

This device is designed to pick up and remove debris from grizzlies (rock screens) in mines and quarries, thus preventing debris from entering and plugging crushing equipment during the oversized rock breaking process. It consists of a hydraulically activated pincher arm which is attached to an impact hammer head. The advantage of this device is a reduction in the number of injuries associated with manual clearing of debris and a reduction in the amount of time needed to rake fine particles which cover debris and oversized rock.

CDC Ref.#: I-029-00/0.

Inventor(s): Bill M Stewart; Dean Eisenbacher; Matt Kopp; Tom Zysk.

Joseph R. Carter,

Associate Director for Management and Operations, Centers for Disease Control and Prevention.