Federal Tech Transfer Opportunities

During the past two weeks, the following agencies have listed inventions and trademarks available for licensing.

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 available for licensing by the Department of the Navy.

ADDRESSES: Requests for copies of the provisional patent applications cited should be directed to the Naval Surface Warfare Center, Dahlgren Laboratory, Code CD222, 17320 Dahlgren Road, Building 183, Room 015, Dahlgren, VA 22448-5100, and must include the Navy Case number. Interested parties will be required to sign a Confidentiality, Non-Disclosure and Non-Use Agreement before receiving copies of requested patent applications.

FOR FURTHER INFORMATION CONTACT: James B. Bechtel, Patent Counsel, Naval Surface Warfare Center, Dahlgren Laboratory, Code CD222, 17320 Dahlgren Road, Building 183, Room 015, Dahlgren, VA 22448-5100, telephone (540) 653-8016.

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NATIONAL INSTITUTES OF HEALTH 
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.

A Plasmid for Expression of a Soluble Form of HIV-1 Integrase Protein
Robert Craigie et al. (NIDDK), NIH Reference No. E-108-00/0; Licensing Contact: J.P. Kim; 301/496-7056 ext. 264; e-mail: kimj@od.nih.gov.

Integrase is an essential HIV enzyme and a promising target for antiviral therapy. Integrase protein is required to assay for inhibitors of this enzyme and for mechanistic studies on HIV DNA integration. Further, drugs targeted to integrase would provide a new therapeutic approach to the treatment of AIDS and could be used in combination therapy with drugs that target RT and protease. The subject plasmid can be used to produce large quantities of a soluble form of HIV-1 integrase protein for such work.

TTP as a Regulator of GM-CSF mRNA Deadenylation and Stability

Ester Carballo-Jane, Wi S. Lai, Perry J. Blackshear (NIEHS), NIH Reference No. E-204-99/0 filed 13 Aug 1999; Licensing Contact: Vasant Gandhi; 301/496-7056 ext. 244; e-mail: gandhiv@od.nih.gov.

The disclosed invention provides materials and methods to treat granulocytopenia (low white cell count in the blood) which is characterized by a reduced number of granulocytes (relative) or an absence of granulocytes (absolute). This condition is commonly associated with cancer chemotherapy, but is seen less frequently in a number of conditions including the use of propylthiouracil, radiotherapy for marrow ablation for bone marrow transplantation, aplastic anemia, systemic lupus erythematosus, AIDS and a variety of other situations. The invention proposes a method to increase GM-CSF levels in a treated subject, and this increase is achieved by inhibiting the degradation of GM-CSF messenger RNA (mRNA). Tristetraprolin (TTP) is one member of a family of cys-cys-cys-his (CCCH) zinc finger proteins, and it is a factor that binds to and causes the instability of GM-CSF mRNA. Methods are provided for the development of screening assays for molecules that inhibit the binding of TTP and its related proteins to GM-CSF mRNA, or otherwise inhibit the effect of TTP to promote breakdown of the mRNA, leading in turn to increased mRNA stability and enhanced production of GM-CSF. Compounds identified by such screens, and their derivatives, could be useful in treating granulocytopenia from whatever cause.

Novel Post-Transcriptional Regulatory Elements and Uses Thereof

George N. Pavlakis and Filomena Nappi (NCI), NIH Reference Nos. E-143-98/0 filed 22 May 1998 and E-143-98/1 filed 22 May 1999; Licensing Contact: Carol Salata; 301/496-7735 ext. 232; e-mail: salatac@od.nih.gov.

This invention concerns a novel post-transcriptional regulatory element that can function as an RNA nucleo-cytoplasmic transport element (NCTE) and its use to make recombinant attenuated HIV strains useful as vaccines. HIV regulates its expression by controlling the nuclear transport of unspliced mRNA encoding structural proteins. HIV utilizes the Rev/RRE system. RRE (Rev responsible element) is an HIV encoded NCTE, which is part of every HIV RNA encoding the structural genes (Gag/Pol and Env). Rev is an HIV encoded protein which binds to RRE. This interaction is essential for nucleo-cytoplasmic transport of the RRE containing viral mRNAs and the expression of Gag/Pol and Env proteins. The inventors have produced an attenuated HIV by disabling Rev/RRE, by point mutations, and inserting in its place the novel murine NCTE of the invention. The resultant HIV is attenuated between 50 and 200 fold compared to wild type HIV. Claimed at the novel NCTE, recombinant retroviruses comprising the NCTE and vaccines.

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.

A Cultured Cell Line which Expresses the GLU4 Glucose Transporter Isoform Labeled with a Short Hemaglutinin Peptide and a Modified Green Fluorescence Protein
Samuel W. Cushman (NIDDK), DHHS Reference No. E-264-00/0 filed 26 Jul 2000; Licensing Contact: Marlene Shinn; 301/496-7056 ext. 285; email: shinnm@od.nih.gov.

The aforementioned invention is currently available through a Biological Materials License as a research tool. Insulin regulates glucose uptake by inducing the translocation of GLUT4, a glucose transporter isoform expressed in fat and muscle, from intracellular components to the plasma membrane. The NIH announces the discovery of a cell line that expresses the GLUT4 glucose transporter isoform with a short hemaglutin peptide (HA) and a modified green fluorescent protein (GFP). The HA peptide is recognized by a specific antibody when GLUT4 is in the plasma membrane but not when GLUT4 is sequestered inside the cell. The modified GFP can be detected by its fluorescence whether it is inside the cell or on the cell surface. This allows the HA label to quantitate the GLUT4 subcellular distribution and the GFP label, the total GLUT4 expression. Therefore, this invention can be used in high through-put screening, as an assay reagent, and it may aid specifically in ascertaining compounds that have the insulin-like effect of stimulating GLU4 translocation from an intracellular compartment to the cell surface.

Dmt-tic Di- and Tri-Peptidic Derivatives and Related Compositions and Methods of Use

Lawrence H. Lazarus (NIEHS), DHHS Reference No. E-103-00/0 filed 24 Mar 2000; Licensing Contact: Marlene Shinn; 301/496-7056 ext. 285; e-mail: shinnm@od.nih.gov.

A major obstacle in the treatment of many cancers involves the clinical manifestation of drug resistance. Currently, toxic substances are used in clinical and therapeutic settings to inhibit glycoproteins in the cell membrane of some cancer cells that have the ability to pump out of the cell drugs that would be potentially lethal. The most common of these glycoproteins is the 170-kd ATP-dependent transmembrane efflux pump. The multidrug resistance (MDR1) phenotype, however, is not the sole source of drug resistance since MDR1 is a member of a superfamily of proteins structurally related to the transmembrane P-glycoproteins.NIH scientists have prepared a series of -opiod analogs of Dmt-tic (2',6'-dimethyl-L-tyrosine-1,2,3,4-tetrahydroisoquinoline-3-carboxylic acid). At least one of the analogs, which is biologically stable and exerts no known side effects, has been observed to inhibit the ability of MDR1 to pump out a fluorescent probe from the cell membrane. Thus, these analogs might represent novel chemosensitizing agents to treat both hematologic malignancies (lymphomas) and solid tumors (e.g. breast and colon) without toxic effects in patients. In addition, this invention provides more potent -opioid antagonists and -opiod antagonists with duel binding affinity and biological activity toward -opiod and -opiod receptors. These compounds therefore, have the potential to treat opiate and alcohol abuse, neurological diseases, neuropeptide or neurotransmitter imbalances, neurological and immune dysfunction, graft rejections through immunosuppression with antagonists, pain control through short half-life agonists, and shock and brain injuries.

Scratch Wound Assay Device

Katherine Malinda et al. (NINR), Serial No. 09/496,134 filed 01 Feb 2000; Licensing Contact: Dale Berkley; 301/496-7735 ext. 223; e-mail: berkleyd@od.nih.gov.

Tissue wounds undergo a complex and ordered series of events to repair tissue. These events may include infiltration of inflammatory immune cells as part of the process to remove and destroy necrotic tissue, increased vascularization by angiogenic factors, and increased cell proliferation and extracellular matrix deposition. Although the basic process of tissue repair has been characterized, the individual steps and factors necessary to carry out this complex series of events are not yet well understood or fully identified. Accordingly, there is a need to develop a way of reproducibly injuring a layer of cells to study the effects of different compounds of treatments on the ability of the remaining cells to repair the damaged area.

The present invention provides a device that reproducibly makes a wound of a desired size in a cell layer grown on a cell culture material. The device allows researchers to use small volumes of cells and test materials suggesting its use as a tool in high throughput screening of compounds. This provides researchers with a faster, more accurate way of screening large numbers of factors and determining the effects of cell growth and migration agents in model wounds produced in the cell, organ, or tissue layer.

Method of in vitro T cell Differentiation of CD34+ Progenitor Cells

Ruiz et al. (NIAID), DHHS Reference No. E-206-98/0 filed 29 Oct 1999; 
Licensing Contact: J. P. Kim; 301/496-7056 ext. 264; e-mail: kimj@od.nih.gov.

The present invention relates to a human in vitro system for inducing the growth and de novo differentiation of T cells from CD34+ progenitor cells in the presence of various cytokine cocktails and lymph node stroma. The mature T cells which are generated may be used to treat individuals with primary or acquired T cell immunodeficiencies, including HIV infection.

ADDRESSES: Licensing information may be obtained by contacting Uri Reichman, Ph.D., M.B.A., at the Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852-3804; Telephone: 301/496-7736 ext. 240; Fax: 301/402-0220; E-mail: reichmau@od.nih.gov. A signed Confidential Disclosure Agreement will be required to receive copies of the patent applications.

Advances in medical research and the successful development of new, improved diagnostic tools and therapeutic agents are often dependent on the ability to screen thousands of clinical samples for molecular markers in a high-throughput fashion. This is particularly critical in the ``post-genomics'' era, where the number of genes to be analyzed is often much high than the number of samples evaluated. DNA microarray (``DNA chip'') and related genome-screening tools have made it possible to screen the genome to discover genes with medical utility. However, before they can be utilized in developing improved diagnostics and therapeutic applications these early discoveries in genomics and proteomics need to be tested and validated.

The technology presented here, called Tissue Microarrays or ``Tissue Chips"' is specifically designed to fill the need of the medical community for high throughput screening of hundreds of molecular markers in thousands of cell or tissue samples on a single microscope slide.

Tissue Microarrays include hundreds or even thousands of tiny discs (approx. 1 mm in diameter) of tissue specimens, fixed and arranged on a single microscope slide. The technology provides an automated means to generate thousands of copies of this kind of slide, slides that then can be used for specific molecular analyses, such as DNA and mRNA in situ hybridization and protein immunostaining.

A typical application of tissue microarrays in cancer research and product development is the analysis of several hundred breast tumors from patients at different stages of disease development (normal breast, atypia, in situ cancer, invasive cancer, metastases) to identify the specific step at which gene alterations take place, as well as the frequency of these alterations. In another example, tissue microarrays can be constructed from tissue materials in a retrospective study design, where one can immediately correlate the expression of a molecular marker with poor prognosis. Furthermore, tissue microarrays can be used to screen many different diseases at once, such as multiple different tumor types, non-malignant tissues, and normal tissues and cells.

The data accumulated from these type of studies can serve as the basis for the development of diagnostic and prognostic tools for disease, classification of diseases into molecularly defined subgroups, as well as for identifying targets for therapeutic regimens for treating the disease.

Tissue microarrays are useful in the early-stage discovery of gene targets in genomic research, in validation of such targets, in the testing and optimization of diagnostic tests, as well as in the quality control of molecular detection schemes. In the quality control field, it would be possible to provide a copy of a tissue microarray with commercial histological (IHC or ISH) test kits for QC procedure. Tissue microarrays could also be used to standardize pathology interpretations by sending copies of the same slides to different pathologists. Electronic database archives of previously analyzed tissue arrays could also be utilized as a teaching tool of anatomy and pathology for students, clinical lab technicians and physicians.The manufacturing of tissue microarrays is a critical step in the success of the technology. The NIH group has developed a manual tissue microarray device, which facilitates development of tissue microarrays. In addition, a prototype of an automated tissue microarrayer has been developed. This instrument consists of a donor specimen station and a recipient block station. An XY robotic arm retrieves cylindrical tissue specimens from the donor block and inserts them into assigned locations at cylindrical receptacles in the donor paraffin block. When the recipient tissue microarray block has been constructed, it is sectioned into 200 to 300 thin sections with a microtome. The resulting sections are then laid down and fixed on a microscope slide. The apparatus is controlled by a computer, which also stores the addressable sample locations.

The commercial potential of the present technology is enormous. It is estimated that the total market for microarray high-throughput screening in 1999 was $176 million. With an estimated annual rate growth of 33%, the market size is expected to approach $1 billion by 2005 (Source: Biosearch Online). Tissue microarray market is tied in with the other biochip markets, but it also presents an opportunity to expand microarray research and development into an entirely new direction. For example, most of the current microscopic tissue based analyses could in the future take place in a tissue microarray format, which provides several hundred-fold higher throughput than conventional  analyses. The technology is available for licensing in its entirety or in parts. A list of the inventions available for licensing, along with a brief summary of each invention, is shown below.

Licensing of Tissue Microarrays Instrumentation and Related Fluorescence Systems

(1) NIH Reference No. E-002-98/0 (USSN 60/075,979, PCT/US99/04001), entitled ``Tumor Tissue Microarrays for Rapid Molecular Profiling'', 
originally filed 02/25/98, PCT filed 02/24/99. Inventors: S. Leighton, O. Kallionemi and J. Kononen.

(2) NIH Reference No. E-273-99/0 (USSN 60/170,461), entitled ``Methods and Apparatus for Constructing Tissue Microarrays'', filed 12/13/99. Inventors: O. Kallionemi, G. Sauter, S. Leighton and J. Kononen.

These two patent applications disclose the specifics of the microarray-maker instrument. With the advances in the field of genomics it is predicted that the demand for tissue microarrays and thus the demand for tissue microarray instruments will increase rapidly in the next several years. Also offered for licensing (E-273-90/0) is an integrated tissue microarray system. The system includes three stations, i.e. array-making station, array processing station and a detection system (fluorescent imager). Licensing of either and/or both of the instrument inventions is particularly recommended for manufacturers of scientific and medical instrumentation.

Signal Counting for In Situ Hybridization
NIH Reference No. E-272-99/0 (USSN 60/154,601), filed 9/17/99. 
Inventors: O. Kallionemi, J. Kononen, L. Buendorf, E. Dougherty and A. Grigoryan.

The accurate detection and quantitation of fluorescence signal associated with FISH is critical for the molecular analysis of arrayed tissue specimens. In spite of recent improvements in fluorescence optics and related techniques, quantitation of FISH has not been perfected yet. This invention discloses a device and method for improving the accuracy of fluorescence spot counting. This has been accomplished mainly through the following improvements: (1) A method to analyze ratios of test and reference spot signals in a field of view, (2) an imaging system to acquire confocal images to cells to provide a set of different layers of the same cells, at different positions along the Z-axis, and (3) a software program to make use of the three-dimensional nature of the images, which makes the identification of FISH signals more accurate. Licensing of an algorithm for automated FISH spot counting is recommended for manufacturers of scientific and medical instrumentation and in particular for manufacturers of commercial imaging devices as well as companies that specialize in providing fluorescent probes for molecular biology research.

Licensing of Applications of Tissue Microarrays
NIH Reference No. E-007-99/0 (USSN 60/106,038, PCT/US99/04000), entitled ``Tissue Microarrays for Rapid Molecular Profiling'' originally filed 10/28/98, PCT filed 02/24/99. Inventors: O. Kallioniemi, G. Sauter and J. Kononen.

NIH Reference No. E-274-99/0 (USSN 60/171,262), entitled ``Methods of Making and Using Microarrays'', filed 12/15/99 
Inventors: O. Kallionemi and G. Sauter.

These two inventions disclose methods of using tissue microarrays for a wide variety of clinical applications. E-007-99/0 describes in great detail high-throughput screening studies of thousands of tissue samples. These studies, ordinarily requiring many days to perform, can be completed in only a few hours when tissue microarrays are used. Licensees of this invention will be able to manufacture tissue microarrays using clinical samples and distribute the panels and companion reagents to the medical and research community. Commercially produced microarrays could be developed for use as reference standards for certain diseases or custom made for specific needs. E-274-99/0 describes the use of tissue microarrays for educational, standardization and OC (histological test kits) purposes. With respect to the first proposed use, licensees will be able, for example, to distribute microarray panels and companion reagents in medical teaching institutions. With respect to the latter two uses, standard microrray panels could be included in clinical test kits that are histological (IHC or ISH) procedures. 

Tissue Microarray technology and its applications have been described in several publications, such as Nature Medicine 4:844 (1998), Cancer Research 59:803 (1999), J Natl Cancer Inst. 91:1758 (1999), Clin Cancer Res 5:1966 (1999), J Natl Cancer Inst, 92:1252 (2000).

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.

Virus-Like Particles as Unlinked Adjuvants

John Schiller, Bryce Chackerian, Joseph Lee, Douglas Lowy (NCI), DHHS Reference No. E-231-00/0 filed 20 Jul 2000.
Licensing Contact: Peter Soukas; 301/496-7056 ext. 268; e-mail: soukasp@od.nih.gov

This invention claims immunostimulating or vaccine compositions in which non-infectious virus-like particles (VLPs) serve as unlinked adjuvants. Co-administration of VLPs with an antigen enhances induction of high titer IgG antibodies to self or foreign antigens and promotes T cell responses to foreign antigens. The VLP-target antigen combination can be administered alone or with a traditional adjuvant. The VLPs of the current invention are contemplated to comprise capsid protein(s) of a virus assembled into a shell resembling a virion, but not containing pathogenic viral DNA or RNA. The VLPs are unlinked, rather than physically linked to the antigen because this may reduce the manufacturing complexity of the vaccine. Unlinked VLP adjuvants, for example papillomavirus VLPs, of the invention have a number of advantages: (1) They are non-inflammatory in humans, (2) are potent at amplifying IgG antibody responses to self antigens, (3) induce a pronounced Th1 type of T cell response, and (4) may provide two-fold protection, against the virus corresponding to the VLP type, as well as against the disease associated with the other component in the VLP-target antigen combination.

System and Method for Representing Knowledge in a Distributed System

Stephen J. Shaw (NCI), Serial No. 09/470,684 filed 23 Dec 1999.
Licensing Contact: Dale Berkley; 301/496-7735 ext. 223; e-mail: berkleyd@od.nih.gov

This invention relates to a knowledge base (KB) system for storing data in a computer system. More specifically, this invention relates to systems and methods for representing, manipulating, and displaying knowledge consisting of categories, entities and relationships stored in a plurality of databases. The invention contemplates providing a user-friendly computer-based distributed system of databases which enables its users to create, use and share a knowledge base of information consisting of diverse entities related to each other by semantically meaningful links. The system generates a knowledge base that allows individuals to store information on a virtually unlimited range of entities. Due to its design as a distributed system, it is well suited to preserve the autonomy and portability of data belonging to each individual and workgroup, while maintaining links of that data to publicly available data elsewhere in the system and even links to information on entities external to the system. Diverse strategies are employed to simplify the implementation and use of the system. Some unique features of this software-based invention are: (1) The ability to handle any number of conceptually distinct categories of items (such as people, events, institutions, tasks, concepts, processes, document types); (2) tools for creating relationships between any two or more objects, with the ability to categorize types of relationships and decide which categories they apply to; (3) use of parent-child relationships to organize, view and navigate information; (4) flexibility in adding diverse categories of objects and relationships, while maintaining a simple underlying data structure and programming environment; and (5) the ability to view complex relationships in flexible and informative ways; (6) tools for managing names which are indispensable for finding the relevant objects; and (7) efficient ways to search information and filter retrievals to limit to relevant information.

Peptides that Stabilize Protein Antigens and Enhance Presentation to CD8+ T Cells
Roger Kurlander, Elizabeth Chao, Janet Fields (CC), DHHS Reference No. E-172-99/0 filed 06 Dec 1999.
Licensing Contact: Peter Soukas; 301/496-7056, ext. 268; e-mail: soukasp@od.nih.gov

This invention relates to compositions and methods for stabilizing an antigen against proteolytic degradation and enhancing its presentation to CD8+ cells. The invention claims ``fusion agents,'' isolated molecules comprising a hydrophobic peptide joined to an epitope to which a CD8+ T cell response is desired. Also claimed in the invention are the nucleic acid sequences that encode the fusion agents. Recently, there has been great interest in developing vaccines to induce protective CD8+ T cell responses, however, there are practical obstacles to this goal. Although purified antigenic peptides are effectively presented in vitro, introduced in a purified form they often do not stimulate effective T cell responses in vivo because the antigens are insufficiently immunogenic and too easily degraded. Adjuvants or infectious ``carriers'' often can enhance these immune responses, however, these added agents can cause unacceptable local or systemic side effects. The present invention increases antigen stability and promotes in vivo responses in the absence of an adjuvant or active infection.

The invention describes three variants of lemA, an antigen recognized by CD8+ cells in mice infected with Listeria monocytogenes. The antigenic and stabilizing properties of lemA can be accounted for by the covalent association of the immunogenic aminoterminal hexapeptide with the protease resistant scaffolding provided by amino acids 7 to 33 of the lemA sequence (lemA(7-33)). Variants t-lemA, and s-lemA bearing an antigenic sequence immediately preceding lemA(7-33), and lemS containing an immunogenic sequence immediately after lemA(7-33), each induce a CD8+ T cell response and protect the crucial immunogenic oligopeptide from protease degradation. The site of antigen insertion relative to lemA(7-33) can influence antigen processing by preferentially promoting processing either in the cytoplasm or endosomal compartment. Therefore, several embodiments of the invention involve the construction of antigen processing protein molecules and their methods of use. Alternatively, a DNA sequence coding lemA(7-33) may be inserted at an appropriate site to enhance the immunogenicity of the antigenic element coded by a DNA vaccine. In sum, this invention is an attractive, nontoxic alternative to protein/adjuvant combinations in eliciting CD8 responses in vivo and a useful element for enhancing the efficiency with which products coded by DNA vaccines are processed and presented in vivo. Because lemA(7-33) is particularly effective in protecting oligopeptides from proteases, this invention may have particular usefulness in enhancing local T cell at sites such as mucosal surfaces where there may be high proteolytic activity.

For more specific information about the invention or to request a copy of the patent application, please contact Peter Soukas at the telephone number or e-mail listed above. Additionally, please see a related article published in the Journal of Immunology at: 1999;163:6741-6747.

Major Neutralization Site of Hepatitis E Virus and Use of this Neutralization Site in Methods of Vaccination

Darren Schofield, Suzanne U. Emerson, Robert H. Purcell (NIAID), DHHS 
Reference No. E-043-00/0 filed 01 Dec 1999.
Licensing Contact: Carol Salata; 301/496-7735 ext. 232; e-mail: salatac@od.nih.gov

Hepatitis E is endemic in many countries throughout the developing world, in particular on the continents of Africa and Asia. The disease generally affects young adults and has a very high mortality rate, up to 20%, in pregnant women. This invention relates to the identification of a neutralization site of hepatitis E virus (HEV) and neutralizing antibodies that react with it. The neutralization site is located on a polypeptide from the ORF2 gene (capsid gene) of HEV. This neutralization site was identified using a panel of chimpanzee monoclonal antibodies that are virtually identical to human antibodies. Since this neutralization site is conserved among genetically divergent strains of HEV, the neutralizing monoclonal antibodies may be useful in the diagnosis, treatment and/or prevention of hepatitis E. Furthermore, immunogens that encompass this neutralization site may be used in vaccination to effectively prevent, and/or reduce the incidence of HEV infection. Polypeptides containing this neutralization site may be useful in evaluating vaccine candidates for the production of neutralizing antibodies to HEV.

Viral Glycoprotein Subunit Vaccine

Richard Compans, Ranjit Ray, U.S. Patent 4,790,987 issued 13 Dec 1988.
Licensing Contact: Peter Soukas; 301/496-7056 ext. 268; e-mail: soukasp@od.nih.gov

The present invention relates to a vaccine composition useful in the prevention of virus-caused disease comprising as its active agent at least one immunogenically effective amount of immunogenic viral envelope glycoprotein complexed with a lipid. These subunit vaccine compositions are useful for the prevention of viral infections including influenza virus, parainfluenza virus, herpes virus, paramyxoviruses, rabies virus, and human T-cell lymphotrophic viruses. The patent also discloses a method for preparing the vaccine compositions. A novel feature of the invention is the utilization of a dialyzable detergent for solubilization of the active component, which allows a relatively simple purification process on a large scale. Thus, these vaccines are easier to prepare than other glycoprotein subunit vaccines and retain their antigenicity to a greater extent than formalin-inactivated subunit vaccines.

ADDRESSES: Licensing information and a copy of the U.S. patent application referenced below may be obtained by contacting J. R. Dixon, Ph.D., at the Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852_ 3804 (telephone 301/496_7056 ext 206; fax 301/402_0220; e_mail jd212g@NIH.GOV). A signed Confidential Disclosure Agreement is required to receive a copy of any patent application.

USE OF 14_3_3 AS A DIAGNOSTIC MARKER AND THERAPEUTIC TARGET 
'A Method to Diagnosis and Determine the Prognosis of Breast and/or Ovarian Cancers. 
Inventors: Drs. Olga Aprelikova (NCI) and Edison T. Liu (NCI) DHHS Ref. No. E_307_00/0, Filed with the USPTO on September 7, 2000. 

Breast cancer is one of the most significant cancerous diseases that affects women. At the current rate, American women have a 1 in 8 risk of developing breast cancer by age 95 (American Cancer Society, 1992). Treatment of breast cancer at later stages is often futile and disfiguring, making early detection a high priority in medical management of the disease. Ovarian cancer, although less frequent than breast cancer is often rapidly fatal and is the fourth most common cause of cancer mortality in American women. Genetic factors contribute to an ill_defined proportion of breast cancer incidence, estimated to be about 5% of all cases but approximately 25% of cases diagnosed before age 40. Breast cancer has been subdivided into two types, early-age onset and late_age onset, based on an inflection in the age-specific incidence curve around age 50. Mutation of one gene, BRCA1, is thought to account for approximately 45% of familial breast cancer, but at least 80% of families with both breast and ovarian cancer. The 14_3_3 checkpoint control gene is significantly downregulated in BRCA1 _/_cells. The cell cycle profile of these cells treated with ionizing radiation showed an inability to sustain G2/M growth arrest typical for 14_3_3 deprived cells. In addition, 14_3_3 has been identified as a p53 inducible gene after DNA damage. Thus, BRCA1 synergistically activates p53 dependent transcription of 14_3_3 gene. These observations demonstrate the role of 14_3_3, and the interaction of BRCA1, p53, and 14_3_3 in neoplastic conditions, such as breast cancer or ovarian cancer.

The technology disclosed in the E_307_00/0 patent application is directed to a method to identify an agent that modulates 14_3_3. The 14_3_3 checkpoint control gene is significantly downregulated in BRCA1 _/_cells. The method includes incubating the agent and a sample of interest, wherein the sample is capable of expressing 14_3_3, under conditions sufficient to allow the compound of interest to interact with the sample, and determining the effect of the compound on the expression or activity of 14_3_3. The effect of an agent on the interaction of 14_3_ 3 with p53 and/or BRCA1 can also be assessed. A method is also provided for determining the prognosis of a subject diagnosed with a 14_3_3_associated disorder. The method includes contacting a sample from the subject with a reagent that binds to 14_3_3, detecting binding of the reagent to 14_3_3; and correlating the binding of the reagent to the sample with the prognosis of the disorder. The method can also include detecting p53 and/or BRCA1 mutations.

The above mentioned invention is available for licensing on an exclusive or non_exclusive basis.


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DEPARTMENT OF COMMERCE

The inventions listed below are owned in whole or in part by the U.S. Government, as represented by the Department of Commerce, and are available for licensing in accordance with 35 U.S.C. 207 and 37 CFR part 404 to achieve expeditious commercialization of results of federally funded research and development.

FOR FURTHER INFORMATION CONTACT: Technical and licensing information on these inventions may be obtained by writing to: National Institute of Standards and Technology, Office of Technology Partnerships, Building 820, Room 213, Gaithersburg, MD 20899; Fax 301-869-2751. Any request for information should include the NIST Docket No. and Title for the relevant invention as indicated below.

SUPPLEMENTARY INFORMATION: NIST may enter into a Cooperative Research 
and Development Agreement (``CRADA'') with the licensee to perform 
further research on the inventions for purposes of commercialization. 
The inventions available for licensing are:

Power Sensor
NIST Docket Number: 96-049US.

Abstract: A method for forming a single cavity in a substrate, which may extend approximately the length of a device located on top of the substrate, and device produced thereby. The device has a length and a width, and may extend approximately the length of the substrate. After locating the device on the surface of the substrate, a first etchant is applied through openings on the surface of the substrate. Subsequently, a second etchant is applied through the same openings on the surface of the substrate. As a result, a single cavity is formed beneath the surface of the device, suspending the device and minimizing electrical coupling. This invention is jointly owned by the Government and another party. The Government's interest is available for licensing.

Polymer Layered Inorganic Nanocomposites
NIST Docket Number: 99-007PCT.

Abstract: Polymer layered silicate nanocomposites are novel materials that have improved stiffness, barrier properties, and flammability properties. Although melt intercalation has been shown for some systems this approach has limitations and may not produce the same type of nanocomposites as the in situ polymerization approach. Several examples have shown that the driving force of a polymerization reaction is required to obtain complete dispersion of the silicate in the polymer. This in situ polymerization method has been proven for polyamides, polyesters and epoxies; however, new methods of preparation are needed, especially for non-polar polymers. This demonstrates that novel exfoliated polymer layered silicate nanocomposites can be prepared using metal catalysts, which have been intercalated into layered silicates. This process we define as ``in situ transition-metal mediated polymerization.'' This invention is available only for non-exclusive licensing.

Method of Manufacture of Convective Accelerometers 
NIST Docket Number: 98_032US. 

Abstract: This invention is jointly owned by the Department of Commerce and RF Microsystems. The Department's interest in the invention is available for licensing. A gamma radiation sensing device is described which can be used to create a detailed three dimensional intensity distribution of a high radiation zone and to map the radiation intensity as a registered color contour field of a three dimensional geometric model of the radiation zone. The device consists of two mated hemispheres fabricated from material with high-gamma blocking capability. The hemispheres contain an offset mating surface that precludes the mating surface functioning as a radiation channel to the center of the mated sphere. A small-bore linear collimation channel is machined into each hemisphere to create a single, narrow bore viewing path to a central radiation sensing means located at the core of the sphere. The sensing element (an ionization probe, scintillator, or similar radiation sensitive means) is positioned so that it is at the terminus of the radiation channel. A circuitous path means machined into the hemisphere mating surfaces carries the signal (through the use of a flexible cable means -- either coaxial or fiber optic) from the sensor to a remote electronic diagnostic and data logging means located well outside the high radiation environment. The circuitous path serves to restrict direct radiation entry to the sensor from all sources except those in line-of-sight with the collimated radiation channel.

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