[Federal Register Volume 65, Number 155 (Thursday, August 10, 2000)]
[Notices]
[Pages 48997-49001]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-20226]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


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.

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    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 (404) 639-6270, email 
[email protected]. 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

[[Page 48998]]

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

[[Page 48999]]

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.

[[Page 49000]]

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.

[[Page 49001]]

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.
[FR Doc. 00-20226 Filed 8-9-00; 8:45 am]
BILLING CODE 4163-18-P