Federal Inventions Available for License
Taken from the online editions of the Federal Register
May 24 - May 31, 2001

DEPARTMENT OF DEFENSE
Department of the Army

The Department of the Army announces the general availability of exclusive, partially exclusive, or nonexclusive licenses under the following patent.

FOR FURTHER INFORMATION CONTACT: Mr. Robert Rosenkrans at U.S. Army Soldier and Biological Chemical Command, Kansas Street, Natick, MA 01760, phone (508) 233-4928 or e-mail: Robert.Rosenkrans@natick.army.mil.

SUPPLEMENTARY INFORMATION: Any licenses granted shall comply with 35 U.S.C. 209 and 37 CFR Part 404. The following patent number, title, and issue date is provided:

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Department of the Navy

SUMMARY: The inventions listed below are assigned to the United States Government as represented by the Secretary of the Navy and are made available for licensing by the Department of the Navy.

ADDRESSES: Requests for copies of the patents cited should be directed to the Naval Research Laboratory, Code 1008.2, 4555 Overlook Avenue, SW, Washington, DC 20375-5320, and must include the Navy Case number.

FOR FURTHER INFORMATION CONTACT: Catherine M. Cotell, Ph.D., Head, Technology Transfer Office, NRL Code 1004, 4555 Overlook Avenue, SW, Washington, DC 20375-5320, telephone (202) 767-7230.

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DEPARTMENT OF ENERGY
Savannah River Site

CentriDuti Centrifuge Unbalance Detection System
This is a special notice issued by Westinghouse Savannah River Company (WSRC), management and operating contractor for the U.S. Department of Energy's Savannah River Site near Aiken, South Carolina. WSRC wishes to determine public interest in licensing for commercial resale the CentriDuti Centrifuge Unbalance Detection System, an improved control system for detecting imbalances in centrifuges carrying large payloads. The CentriDuti system can distinguish true load imbalances from normal vibrations, including those caused by instant ramp-ups and ramp-downs. Imbalances of as small as 5 lbs. in a 200 lb. payload can be detected. The system comprises an accelerometer sensor, a processor, custom algorithm-based software, a display, and a shutdown relay. By viewing a relative imbalance value shown on the display, an operator can see the condition of the centrifuge in real time as it operates. If an imbalance does occur, the CentriDuti system automatically shuts the centrifuge down. The CentriDuti system can be incorporated in new equipment or easily retrofitted in existing equipment. For more information on the CentriDuti system and licensing opportunities, contact Dale K. Haas via telephone at (803) 725-4185 or (800) 228-4988; via Fax at (803) 725-4988; via email at dale.haas@srs.gov; or via regular mail at Westinghouse Savannah River Company, Building 773-41A #238, Aiken, SC 29808. Responses to this notice should be received by June 25, 2001. This is not a request for a formal subcontract; it is a request for interested parties and licensing opportunities only. 

BritePrint Device 
This is a special notice issued by Westinghouse Savannah River Company (WSRC), management and operating contractor for the U.S. Department of Energy's Savannah River Site near Aiken, South Carolina. WSRC wishes to determine public interest in licensing for commercial resell the BritePrint device, a portable, lightweight, and high-intensity light source for detecting and analyzing fingerprints during field investigation. The BritePrint device comprises an array of light emitting diodes (LEDs), a power source, and a personal attachment device. The high intensity wavelength-specific light source causes a dye to fluoresce and thus to provide a signal that may be detected by the human eye when light filtering goggles are worn. The LED personal attachment device allows the user to direct radiated light onto a particular surface area with latent fingerprints at the same time as applying dye to these surfaces, steps that previously had to be performed separately. The light source may be detached and easily held at arm's length to radiate light onto hard-to-reach surfaces, shortening the detection process and allowing a more thorough investigation. 

For more information on the BritePrint device and licensing opportunities contact Dale K. Haas via telephone at (803) 725-4185 or (800) 228-4988; via Fax at (803) 725-4988; via email at dale.haas@srs.gov; or via regular mail at Westinghouse Savannah River Company, Building 773-41A #238, Aiken, SC 29808. Responses to this notice should be received by June 25, 2001. This is not a request for a formal subcontract; it is a request for interested parties and licensing opportunities only. 

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

SUMMARY: The inventions listed below are owned by agencies of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 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.

ADDRESSES: 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.

Combined Inhibition of Phosphodiesterase-4 (PDE-4) and Phosphodiesterase-3 (PDF-3) as a Therapy for Th1 Mediated Autoimmune Diseases
Dr. Bibiana Bielekova et al. (NINDS)
DHHS Reference No. E-077-00/0, filed Dec 22 2000
Licensing Contact: Marlene Shinn; 301/496-7056 ext. 285; e-mail: shinnm@od.nih.gov

Hyperactive Th1-mediated immune responses are thought to be involved in the pathogenesis of many autoimmune diseases, including rheumatoid arthritis, diabetes, inflammatory bowel disease, vitiligo, and multiple sclerosis among others. Immune cells are known to produce primarily two classes of phosphodiesterases (PDE), the PDE4 and the PDE3 classes. Inhibitors of these PDEs have been shown to down-regulate the expression or production of Th1 cytokines and have either no effect or augment the production of Th2 cytokines, therefore making them good candidates for the treatment of Th1-mediated autoimmune diseases.

The NIH announces a new technology wherein PDE-4 and PDE-3 inhibitors are used in combination and a synergistic enhancement of therapeutic activity is achieved. This results in a more potent immunomodulatory effect on the immune cells and could lead to the administration of lower dose rate of the inhibitors. This new form of treatment will alleviate side effects through the use of a lower dose rate for each and will make for a more effective therapy.

Determination of AM-Binding Proteins and the Association of Adrenomedullin (AM) Therewith
F. Cuttitta et al. (NCI)
DHHS Reference No. E-256-99/1 filed, Sep 08 2000 (Note: This invention is related to E-206-95/3, filed Aug 18 1996, the disclosure of which is incorporated herein.)
Licensing Contact: Matthew Kiser; 301/496-7056 ext. 224; e-mail: kiserm@od.nih.gov

The present invention provides methods for the isolation, identification, and purification of adrenomedullin (AM)-binding proteins. Methods for utilizing the purified AM-binding proteins, or functional portions thereof, to diagnose, treat, and monitor AM-related diseases are described. A second aspect of this technology discloses the identification and isolation of a novel complex between AM and a specific AM-binding protein 1 (AMBP-1), designated factor H (fH). The identification of small molecule antagonist, which down-regulate the function of AM, factor H, and the AM/fH complex has been achieved. Collectively, the invention provides methods for treating conditions such as cancer or diabetes, via antibodies and small molecule antagonists. 

Adrenomedullin (AM) is expressed in human cancer cell lines of diverse origin and functions as a universal autocrine growth factor, driving neoplastic proliferation. Experimental models for use in identifying the role of AM in pancreatic physiology have been validated and are available for licensing. The interesting observations show that AM inhibits insulin secretion in a dose-dependent manner. Further experiments have shown that a neutralizing antibody up-regulates insulin release at least five-fold, an effect that is reversed with the addition of synthetic AM.

Novel Inhibitors of p53 for Treatment of Neurodegenerative Disorders, Myocardial Infarction and Other Tissue Insults
Nigel H. Greig, et al. (NIA) 
Serial No. 60/216,388, filed July 6, 2000 Licensing Contact: Norbert Pontzer; 301/496-7736, ext. 284; e-mail: pontzern@nih.gov

The tumor suppressor protein p53 is a key modulator of stress responses, and activation of p53 precedes apoptosis (programmed cell death) in many cell types. Conditions that stress tissue, such as deposition of amyloid b-peptide, may thus cause tissue degeneration through activation or up-regulation of p53. This invention provides novel inhibitors of p53 and methods of using these inhibitors for the prevention or treatment of the stress related tissue degeneration observed in Alzheimer's disease, myocardial infarction and stroke. In vitro and ex vivo studies demonstrated that p53 inhibition protected nerve cells from toxic insults that otherwise induced programmed cell death. In a rat model of stroke, p53 inhibition produced a 50% reduction in stroke volume.

Ocular Therapeutic Agent Delivery Devices And Methods
Michael R. Robinson (NEI), Karl G. Csaky (NEI), Peng Yuan (NEI), Cynthia Sung (EM), Robert B. Nussenblatt (NEI), Janine A. Smith (NEI)
Serial No. 09/808,149, filed Mar. 15, 2001
Licensing Contact: Dale Berkley; 301/496-7735 ext. 223; e-mail: berkleyd@od.nih.gov

The invention is directed to ocular implant devices for the delivery of therapeutic agents to the eye in a controlled and sustained manner. Implants suitable for either subconjunctival or intravitreal placement are the subject of the invention. These implants permit continuous release of therapeutic agents into the eye over specified periods of time, which can be weeks, months or years. In one aspect of the invention a therapeutic agent is included in both an inner core or pellet and an exterior composite matrix layer to provide a dual mode release of the therapeutic agent. That is, a loading dose is initially delivered to the eye by the matrix layer followed by a transition in release rate to a relatively steady maintenance dosage that is sustained over a prolonged period of time. In another aspect of the invention, methods for making and using the implants are described. The time-dependent delivery of one or more drugs to the eye by this invention makes it possible to maximize the pharmacological and physiological effects of the eye treatment for human and veterinary applications.

Vessel Surface Reconstruction with a Tubular Deformable Model
Yim et al. (CC)
DHHS Reference No. E-202-00/1, filed Feb 15, 2001
Licensing Contact: Dale Berkley; 301/496-7735 ext. 270; e-mail: berkleyd@od.nih.gov

The invention is a method for modeling a carotid or renal artery to measure stenosis from 3D angiographic data that may otherwise exhibit limited image resolution and contrast. The method reconstructs vessel surfaces from 3D angiographic data using a deformable model that employs a tubular coordinate system. Vertex merging is incorporated into the coordinate system to maintain even vertex spacing and to avoid problems of self-intersection of the surface. This method produces reconstructed surfaces that have a realistic smooth appearance and accurately represent vessel shape. The method allows for an objective evaluation of vessel shape and may improve the precision of shape measurements from 3D angiography.

User Friendly Integrated Database for the Management of Animal Study Proposals
Antonia F. Calzone (NIAAA), Etienne Lamoreaux (NIAAA), Karen Montijo (NIDDK)
DHHS Reference No. E-215-00/0
Licensing Contact: Dale Berkley; 301/496-7735 ext. 223; e-mail: berkleyd@od.nih.gov

The invention is a set of templates written in FileMaker-ProTM script that provides a convenient integrated database management system for tracking the care and disposition of laboratory animals. This software is a multifunction program that meets the needs of facility veterinarians, animal facility managers, and animal care personnel with respect to in-house records keeping and federal reporting requirements. The invention builds on the framework of the FileMaker ProTM software, and results in a database system that stores information pertinent to all current Animal Study Proposals (ASPs). This design permits users to access the data from a networked centralized Windows NT based server using either a Macintosh or IBM compatible workstation. The invention comprises features that facilitate the day-to-day management of the animal facility as well as powerful information storage capabilities.

Identification of New Malaria Parasite Erythrocyte Binding Protein (BAEBL) that Binds to Human Red Cells
Ghislaine D. Mayer, Louis H. Miller (NIAID)
DHHS Reference No. E-328-00/0, filed Apr 03, 2001
Licensing Contact: Carol Salata; 301/496-7735 ext. 232; e-mail: salatac@od.nih.gov

Malaria is endemic in many parts of the world, particularly in tropical regions such as Asia, Central America and South America. Recent estimates of the number of cases of malaria worldwide are between five hundred million and one billion. There are approximately two to three hundred million new cases of malaria each year and malaria causes a minimum of one million deaths each year. This invention relates to the identification and characterization of the binding specificity of BAEBL, a novel Plasmodium falciparum erythrocyte binding ligand that interacts with human erythrocytes in a sialic acid dependent manner. This novel Plasmodium falciparum erythrocyte binding ligand is unique and quite distinct from previously described Plasmodium falciparum erythrocyte binding proteins EBA-175. BAEBL may be used as a malaria vaccine to block human red cell recognition and invasion.

Attenuated Host-Range Restricted Dengue Viruses Derived by Site-Directed Mutagenesis of the Conserved 3'-Stem and Loop Structure in Genomic RNA for Use as Vaccines
Lingling Zeng, Lewis Markoff (CBER/FDA)
DHHS Reference No. E-067-98/2, filed Mar 02, 2001
Licensing Contact: Carol Salata; 301/496-7735 ext. 232; e-mail: salatac@od.nih.gov

Although flaviviruses cause a great deal of human suffering and economic loss, there is a shortage of effective vaccines. The present invention is directed toward vector stage replication-defective flaviviruses that are replication-defective in mosquito vectors that transmit them to humans. The replication-defective flaviviruses of the present invention demonstrate a limited ability to replicate in the vector organisms that transmit flaviviruses from one host to another. More specifically, the present invention is directed toward the construction and propagation of flaviviruses that possess 3'-noncoding regions altered in such a way as to prevent or severely limit viral reproduction in a vector organism. Not only is the dengue 1 mutant replication defective in mosquitoes, but it is also attenuated and immunogenic in monkeys. Moreover, it protects against challenge, thus it has strong potential as a dengue vaccine.

A Chimeric Protein Comprising Non-Toxic Pseudomonas Exotoxin A and Type IV Pilin Sequences
David FitzGerald (NCI)
DHHS Reference No. E-283-00/0, filed Dec 21, 2000
Licensing Contact: Carol Salata; 301/496-7735 ext. 232; e-mail: salatac@od.nih.gov

This invention provides candidate chimeric vaccines that generate antibodies which interfere with adherence of Pseudomonas aeruginosa exotoxin A to epithelial cells and neutralize the cytotoxicity of exotoxin A. This invention specifically relates to a chimeric protein wherein key sequences from a Type IV pilin protein are inserted into a non toxic version of Pseudomonas aeruginosa exotoxin A. Pilin is a protein that is present on the surface of bacteria and other microorganisms, including P. aeruginosa. The key sequences are known to interact with asialoGM1 receptors on human epithelial cells, and allow bacteria and other microorganisms to adhere to epithelial cells and colonize. The present invention may be particularly useful for cystic fibrosis patients who are prone to infections with P. aeruginosa. Also, this invention could be a broad approach to vaccines against all gram negative bacteria, not just Pseudomonas aeruginosa. Pilin epitopes of other gram negative bacteria could be inserted into the Pseudomonas aeruginosa exotoxin A and used as a vaccine against that specific bacteria.

Dr. FitzGerald and his colleagues have demonstrated that the chimeric protein reacted with asialoGM1, a receptor on epithelial cells and blocked adherence of P. aeruginosa on epithelial cells. When the chimeric protein was injected into rabbits, the rabbits produced antibodies that blocked bacterial adherence and neutralized the cell killing activity of native exotoxin A.

A Plasmid for Expression of a More Soluble Form of HIV Integrase Protein in E. coli
Robert Craigie (NIDDK)
DHHS Reference No. E-110-01/0
Licensing Contact: Sally Hu; 301/496-7056 ext. 265; e-mail: hus@od.nih.gov

The invention describes a plasmid that provides a convenient method for producing large quantities of integrase protein. This integrase protein is more soluble because amino acid residue Phe185 is changed to Lsy. This change does not affect the in vitro activity of the protein, but the improved solubility facilitates large-scale purification and handling. Since HIV integrase is a candidate target for antiviral drugs and an assay system or a source of HIV integrase is required to identify lead compounds, this invention could be very useful for an efficient means of producing integrase protein on a large scale. The integrase protein could be used in screening for integrase inhibitors that could be developed as anti-HIV drugs. This invention is available for licensing through a Biological Materials License, as no patent application exists.

Benzoylalkylindolepyridinium Compounds and Pharmaceutical Compositions Comprising Such Compounds
William G. Rice, Mingjun Huang, Robert W. Buckheit, Jr., David G, Covell, Grzegorz Czerwinski, Christopher Michejda, and Vadim Makarov (NCI)
DHHS Reference Nos. E-278-98/0 and E-278-98/1, filed Dec 18, 2000
Licensing Contact: Sally Hu; 301/496-7056 ext. 265; e-mail: hus@od.nih.gov

The present invention provides novel antiviral compounds active against HIV. These compounds, referred to as benzoylalkylindolepyridinium compounds (BAIPs) are effective against HIV isolates that have developed mutations rendering conventional drugs ineffective. BAIPs apparently do not require intracellular phosphorylation nor bind to the reverse transcriptase (RT) active site, which distinguishes their mechanism of action from the dideoxynucleoside (ddN) and acyclic nucleoside phosphonate (ANP) nucleoside analog drugs. ddN and ANP have proven clinically effective against limiting human immunodeficiency virus (HIV) infection, but resistance rapidly emerges due to mutations in and around the RT active site. The BAIPs also may be distinguished from non-nucleoside reverse transcriptase inhibitors (NNRTIs), in part because the BAIPs bind to a different site on the RT enzyme. The usage of NNRTIs is limited by the rapid emergence of resistant strains also. Moreover, unlike the NNRTIs, BAIPs of the present invention have been shown to be effective against HIV-1, HIV-2 and simian immunodeficiency virus (SIV) proliferation. Thus, BAIPs are broadly antiviral, non-nucleoside reverse transcriptase inhibitors (BANNRTIs).

This abstract modifies an abstract for this technology published in the Federal Register on Tuesday, February 13, 2001 (66 FR 10027).

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