West Nile Virus Recombinant DNA Vaccine and Diagnostic Antigen

Centers for Disease Control and Prevention (CDC)
National Institute for Occupational Safety and Health (NIOSH)

Eric Esswein (CDC-NIOSH co-inventor)
Dr. Kevin Ashley (CDC-NIOSH co-inventor)
Dr. Andrew Watkins (CDC Technology Transfer Program)

Lead poisoning is global problem having significant public health and occupational health consequences. Worldwide, 240 million people are estimated to have health risks from lead poisoning. There is no level of lead in blood that is considered normal or safe. Lead is the number one environmental health hazard to children. From a U.S. public health perspective, about 900,000 children ages 1 to 5 have a blood-lead level of concern. Occupational exposure to lead is one of the most common overexposures found in U.S. industry, and it is a leading cause of workplace illness. The U.S. Occupational Safety and Health Administration (OSHA) deemed the reduction of occupational lead exposure as a priority.

NIOSH inventor Mr. Eric Esswein, a Senior Industrial Hygienist in the Denver Federal Center, developed a lead hand wipe as a cost-effective way to reduce lead exposures in workers as well as the general public through risk awareness. The technology was awarded U.S. Patent 6,248,593 and is licensed to SKC, Inc. , a U.S. company that is a global leader in sampling technologies.

Initially, the licensee declined to sign an agreement over marketing concerns. To convince the company there was a market and that the invention was better than any other commercially available product, the CDC implemented a two-fold strategy. First, CDC issued a press release during National Lead Poisoning Prevention Week announcing the lead hand wipe had been granted a patent. The result was a flood of responses from potential customers wanting to know how they could buy the hand wipe – dramatic proof to the company of a public need and lucrative market. Second, the inventors personally contacted the president of the company to explain the invention and to give a detailed demonstration of the invention to company representatives. As a result, the company reversed it opinion and signed a license February 2003. The company has since created a web site for this technology and it is selling well.

Online information
Full Disclosure "The instant wipe method for the presence of lead"
SKC, Inc. "World leader in Sampling Techonlogies"
Centers for Disease Control and Prevention
National Institute for Occupational Safety and Health

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UT-Battelle/Oak Ridge National Laboratory

Members of the invention team include
Dr. John B. Bates, Dr. Nancy J. Dudney, Dr. Bernd J. Neudecker, Dr. Ashok Choudhury, Mr. Chris F. Luck, and Dr. Greg R. Grusalski.

The inventors developed two modified live vaccines to prevent the major diseases in channel catfish aquaculture--enteric septicemia and columnaris. Materials and fabrication techniques leading to a family of all-solid-state thin-film rechargeable batteries.

The goal of miniaturizing and integrating devices and components is important in many industries, but one drawback has been the size of batteries and the need for recharging by applying high current. Until now, that is. ORNL researchers pioneered the think-film battery technology as part of a basic materials science research program. An added enhancement is that the ORNL batteries can be recharged quickly by using a high current or continuously by using a trickle charge from low-power sources. No other battery currently available can be recharged continuously using a trickle charge such as from a small solar cell or from scavenged ambient power. The thin-film battery program was initiated through ORNL seed money funds in 1989 and subsequently continued under the DOE's Office of Science programs.

The resulting technology has continued to develop through a number of CRADAs (both DOE-funded and industry-funded) and Work for Others Agreements. SBIR contracts helped some licensees continue development work for particular applications, as have NIST Advanced Technology Program (ATP) awards.

Public presentations and publications fired the interest of companies and agencies needing thin-film microbatteries and/or having the capability to manufacture suitable quantities of such batteries. As a result, six US companies have licensed the thin-film battery technology for development in various fields of application, including consumer and military electronics, micromachines and microelectromechanical systems (MEMS), banking and identification cards, medical devices, and industrial and security sensors and transmitters. Each of the licensees has expertise in fabricating devices by thin-film physical vapor deposition processes and is developing partnerships with device manufacturers. The companies include Teledyne Electronic Technologies, Excellatron Solid State, Inc., Front Edge Technology, Inc., Infinite Power Solutions, Inc., Cymbet Corporation, and Oak Ridge Micro-Energy, Inc.

The patent portfolio contains 18 issued patents, and scientific results have been presented in more than 30 publications by ORNL inventors and their partners. Members of the invention team include Dr. John B. Bates, Dr. Nancy J. Dudney, Dr. Bernd J. Neudecker, Dr. Ashok Choudhury, Mr. Chris F. Luck, and Dr. Greg R. Grusalski.

Online information
Team UT-Battelle at Oak Ridge National Laboratory
Teledyne Electronic Technologies
Excellatron Solid State, Inc.
Front Edge Technology, Inc.
Infinite Power Solutions, Inc.
Cymbet Corporation
Oak Ridge Micro-Energy, Inc.

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West Nile Virus Recombinant DNA Vaccine and Diagnostic Antigen

Centers for Disease Control and Prevention (CDC)

A leading edge recombinant DNA vaccine for West Nile Virus (WNV). Introduction of WNV to the United States in 1999 has created major public health and animal welfare concern. The most serious manifestation of WNV infection is fatal encephalitis (inflammation of the brain) in humans and horses, as well as mortality in certain domestic and wild birds. In 2002, there were 4156 and 14571 reported cases of WNV human and equine infection, respectively, with the virus reaching 44 states.

Currently, no human vaccine is available to prevent WNV infection, and timely surveillance data is critical for preventing human and animal disease associated with WNV. Clinicians in the human and veterinary field require accurate and rapid diagnostic testing methods. Blood banks need rapid screening tools for donated blood. While there is currently a veterinary vaccine for horses on the market, its use does not allow researchers to distinguish between immunity acquired by natural infection and that acquired by vaccination. No vaccine is approved to protect susceptible endangered species such as birds in species recovery breeding programs such as the Mississippi Sandhill Crane and the California Condor. This recombinant DNA technology serves a dual role in providing the critical specificity needed for accurate and rapid testing for surveillance and clinical diagnosis, and as a vaccine which allows for accurate surveillance and improved efficacy.

A Cooperative Research and Development Agreement (CRADA) was instituted to facilitate the development of a vaccine in horses, and a second CRADA was instituted to develop diagnostic antigens for WNV and other flaviviruses. Ten patent licenses were completed with companies using the WNV recombinant antigen for diagnostics. Patent licenses are pending for vaccine applications in animals and with additional companies wishing to use the antigen for diagnostics. CRADAs are also being contemplated for human vaccine development and furtherance of a vaccine for birds.

The needs of the private sector include ease of manufacture and flexibility of format. The WNV recombinant antigen can be produced without specialized safety facilities using standard industrial methods and equipment. It has been incorporated into a number of diagnostic testing formats including procedures used at diagnostic service laboratories and pre-packaged test kits for medical or veterinary labs. As a result of direct CDC action through rapid license closure, technical advice and validation services, at least two private sector companies were able to provide a commercial source of purified antigen within two months of licensure, thus alleviating some of the burden of antigen production and distribution carried by CDC and the National Veterinary Services Laboratory (an arm of USDA).

As a result of direct collaboration with the academic community and the private sector, the WNV recombinant DNA has been validated as a vaccine for horses. Gwong-Jen Chang worked directly with academic institutions to provide the early efficacy testing in horses. By sharing this data and his technical expertise under the auspices of a CRADA, the vaccine is now being tested and validated by a commercial entity for USDA licensure in horses. Advantages of this DNA vaccine include improved efficacy over the current WNV killed virus vaccine, reduced production costs and support for surveillance programs by allowing researchers to distinguish between immunity resulting from natural infection and vaccination.

Online information:
Centers for Disease Control and Prevention (CDC)
National Veterinary Services Laboratory

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USDA-ARS Subtropical Plant Pathology Research Unit of the US Horticultural Research Laboratory

The Federal Laboratory Consortium's Southeast Region presents the 2003 Excellence in Technology Transfer Award to the ARS Subtropical Plant Pathology Research Unit of the U.S. Horticultural Research Laboratory for the establishment of a scientific basis for effective eradication of citrus canker and plum pox virus--diseases which have cost more than half a billion dollars to US and Canadian growers and consumers.

Citrus canker (CC), a bacterial disease, has had a tremendous impact on the Florida citrus industry, which has lost 1.77 million commercial and 632,000 dooryard trees to eradication efforts from 1995 to date. Total eradication costs are expected to exceed $500 million this year. The new 1900-ft law (eradication distance around infected trees), used in both commercial and residential situations, is designed to contain the disease with the minimum impact. The new sentinel tree survey method, which has been deployed statewide in Florida, helps detect CC outbreaks prior to disease spread. The combined technologies are anticipated to bring the eradication program to closure much sooner, with less commercial and urban tree destruction, and compensation at an anticipated savings of $100s of millions of dollars. This survey method also serves as a post-eradication survey to ensure that eradication has been achieved, detect and eliminate residual infections and protect against new introductions of CC strains.

In a similar manner, Plum Pox Virus (PPV) threatens the commercial stone fruit industries of the U.S. and Canada. Dr. Tim R. Gottwald, research leader on this project, was a driving force on the National Plum Pox Scientific Issues Working Group that determined the distance of 1600 ft was the eradication distance for this disease. Similarly he assessed the epidemic in Ontario Canada and authored a multiphase threshold-based plum pox eradication protocol, which was adopted as the operational basis of Canada’s eradication program. In addition, he provided the basis for the U.S. and Canadian national survey programs for PPV. The combination of Dr. Gottwald’s PPV research findings, eradication efficiency assessments, distance of spread calculations and sampling methods form the scientific basis of the plum pox eradication programs in both the U.S. and Canada, and will reduce disease spread and tree loss due to disease.

The result of these innovative technologies is the continued and improved protection of both American and other fruit producing countries and the maintenance of open domestic and international commerce of citrus and stone fruit.

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UT-Battelle/Oak Ridge National Laboratory

The Federal Laboratory Consortium's Southeast Region presents the 2003 Project of the Year Award to UT/Battelle Oak Ridge National Laboratory for development of a broad-based package of wireless communications technologies that provide robust communications in mountainous terrain, urban canyons, underground facilities, and metallic industrial structures. These technologies are expected to open entirely new capabilities for communications, such as industrial measurements and condition monitoring, medical sensors, asset tagging and tracking, and efficient video and data transfer.

This breakthrough technology overcomes limits of existing conventional wireless systems, including high power consumption, short operating life, and inability to operate reliably in extreme environments such as in the presence of metallic structures and in situations of electromagnetic interference. The wireless communications technologies developed by ORNL researchers will enable deployment of low-cost, highly reliable, low-power, RF communications systems capable of operating in extreme environments.

The technology has generated 11 patents and patent applications as well a numerous scientific publications and reports. Tarallax Wireless, Inc. of Salt Lake City, UT, has licensed all these wireless communications technologies and is incorporating them into the development of commercial communications devices through a $6.6 million 100% funds-in CRADA. Tarallax is a US-owned small business created to commercially develop these technologies for applications including wireless industrial sensors, radio-frequency identification (RFID) tags for warehouse inventory tracking, implantable medical sensors, and high-speed data links for point-to-point wireless Internet delivery. Tarallax has issued a sub-license to Navigational Sciences, Inc., of Charleston, SC, for development of a tagging and tracking application. Working through the Tarallax CRADA, Navigational Sciences is developing a global container security and asset tracking system for marine transportation applications. It is expected to provide real-time ship, container, and cargo tracking for port security needs and increased safety of life and property at sea. ORNL has also licensed the wireless technologies to two other start-up companies, Graviton and Care Chips for development of additional applications.

Paul D. Ewing led the ORNL technology development team consisting of Stephen F. Smigh, Gregory R. Hanson, Michael R. Moore, John P. Jones, Jr., Roberto Lenarduzzi, Michael S. Emery, Gary W. Turner, Milton N. Ericson, Timothy E. McKnight, James O. Hylton, James A. Moore, Alan L. Wintenberg, and William B. Dress. Larry M. Dickens and Grady Vanderhoofven served as the ORNL Technology Transfer Team, while Gary B. Peterson, Dan Maxwell and L. Deane Smith of Tarallax Wirless, Inc. licensed the original technologies for further development. Eric L. Dobson, Jeffrey S. Blair and John Sullivan of Navigational Sciences, Inc. are developing marine shipping container security and tracking system through a sub-license.

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Rehabilitation Engineering Research Consortium for Augmentative and Assistive Communications (AAC-RERC) led by Duke University

The partnership award is presented to a non-Federal entity in the region to recognize outstanding efforts and successes in transferring federal technology and promoting the Federal technology transfer program. The 2003 Partnership Award is presented to the Rehabilitation Engineering Research Consortium for Augmentative and Assistive Communications (AAC-RERC) led by Duke University.

The AAC-RERC championed the Communications Enhancement Technology Watch Project with the Southeast FLC, and this led to several collaborative R&D activities with NAVAIR Orlando Training Systems Division. The collaboration has resulted in two prototype technologies, currently undergoing further development and testing. The first is a "Movement Recognizer" prototype which allows a computer program to "learn" an individuals' movement patterns and thus communicate the meaning of the movement to another person or system that can respond appropriately. The second prototype is called "SeeSpeak" and is in clinical trials with autistic children. SeeSpeak converts spoken words or sounds into graphic symbols that can be read by care givers, family and others.

In addition to working directly with Southeast FLC laboratories to identify and further develop particular technologies for application in the field of augmentative and assistive communications, the AAC-RERC has actively worked to facilitate information sharing about technology development trends, unmet needs of individuals with communications-related disabilities, and manufacturing issues. One example of success was a national survey of 203 manufacturers that revealed a strong desire to improve working relationships with Microsoft Corporation. Since many assistive technology products employ Microsoft operating systems/applications, and upon learning of the survey results, the Accessible Technology Group at Microsoft has created a special new Assistive Technology Initiative to improve the quality of AT products in the marketplace. The AAC-RERC also helped develop standards for Information Technology Access Interfaces led by the V2 Technical Group of the National Committee for Information Technology Standards, which will further facilitate the transfer of Federal technology to the AAC field.

One patent and several publications have resulted from the partnership between the AAC-RERC and NAVAIR Orlando TSD. However, perhaps the most gratifying outcome of all was described in a letter from Dr. Howard Shane, AAC-RERC member and Director of Speech Language Pathology at Children's Hospital Boston to the Commanding Officer of NAVAIR Orlando TSD. In the letter, Dr. Shane describes progress with an 8-year old autistic child who, by using SeeSpeak, can now follow commands--a skill he had not previously been able to accomplish.

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Department of Energy, Oak Ridge National Laboratory

The Laboratory Representative of the Year Award is presented to a Federal laboratory technology transfer professional for outstanding contributions to his or her laboratory and to the Federal Laboratory Consortium. The FLC Southeast Region is pleased to name Mr. Larry Dickens, of the UT/Battelle Oak Ridge National Laboratory as the recipient of this award for 2003.

Highlights of Larry's contributions to the Oak Ridge National Laboratory include the following:

Negotiated FY 02 sponsored research for a total contract value in excess of $34,000,000 funds-in to the Laboratory in private funding, including a single funds-in CRADA totaling $121,000,000, of which $28,520,000 is funds-in to ORNL through 2007. This is the largest CRADA ever executed for ORNL in terms of total magnitude and funds-in and one of the larger ones ever executed by a DOE laboratory on a national level. This total also includes an additional single funds-in CRADA for $6,637,000 funds-in

He has personally negotiated over 70 royalty bearing licenses, with royalty income received from his portfolio during the past year exceeding $500,000.

He designed a process for developing award submissions at ORNL that has resulted in a substantial increase in awards.

Additionally, Larry has provided significant and sustained leadership to the FLC, by serving as Deputy Regional Coordinator for two years and on the FLC National Board of Directors. He has shared his knowledge and skills freely by presenting workshops and delivering other presentations at regional and national FLC conferences on negotiation and on developing a winning laboratory awards submission program. In 2003 he was elected Vice Chair of the Federal Laboratory Consortium.

The FLC Southeast Region congratulates Larry Dickens on these accomplishments, and recognizes him as the 2003 Laboratory Representative of the Year.

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The FLC Southeast Region recognizes the following laboratories and technologies:

UT/Battelle Oak Ridge National Laboratory for "Lab on a Chip"
Inventors: J. Michael Ramsey, Stephen C. Jacobson, Roswitha S. Ramsey
License Agreement developed by Dr. Ashok Choudhury
Caliper Technologies: Michael R. Knapp

UT/Battelle Oak Ridge National Laboratory for "New Ion Exchange and Regeneration Technology for Water Treatment"
Inventors: Baohua Gu and Gilbert M. Brown

USDA-ARS South Atlantic Area Southeast Poultry Research Laboratory for "Development and Implementation of a Rapid Test for Avian Influenza"
Inventors: David L. Suarez, Erica Spackman, Suzanne M. DeBlois, and Dennis A. Senne

USDA-ARS South Atlantic Area J. Phil Campbell, Sr. Natural Research Conservation Center for "Conservation System Technologies for Improved Soil Management"
Inventor: D. Wayne Reeves

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