[Federal Register Volume 63, Number 138 (Monday, July 20, 1998)] [Notices] [Pages 38840-38842] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 98-19146] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing AGENCY: National Institutes of Health, Public Health Service, DHHS. ACTION: Notice. ----------------------------------------------------------------------- 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. Murine Intracisternal a Particle Constitutive Transport Elements and Uses Thereof BK Felber, C Tabernero, AS Zolotukhin (NCI) Serial No. 60/070,204 filed 31 Dec 97 Licensing Contact: Robert Benson, 301/496-7056 ext. 267 This invention concerns 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. Responsive Element) is an HIV encoded nucleo-cytoplasmic transport element (NCTE), which is part of every HIV RNA encoding the structural genes (gas/pol and env). Rev is an HIV encoded protein which binds to the RRE. This interaction is essential for the nucleo-cytoplasmic transport of the RRE-containing viral mRNAs and the expression of Gap/Pol and Env proteins. The inventors have produced an attenuated HIV by disabling rev/RRE, by point mutations, and inserting in its place a novel murine NCTE, isolated form an intracisternal A-type particle (IAP). The resultant HIV is attenuated between 50 and 200 fold compared to wild-type HIV. Claimed are the novel murine NCTE, recombinant retroviruses comprising the NCTE, and vaccines. The use of another NCTE is described in Zolotukhin et al., (1994) J. Virology 68:7944-7952. Design and Construction of Non-Infectious Human Retroviral Mutants Deficient in Genomic RNA RJ Gorelick, LO Arthur, A Rein, LE Henderson, S Oroszlan (NCI) U.S. Patent No. 5,674,720 issued 07 Oct 97 Licensing Contract: Robert Benson, 301/496-7056 ext. 267 This invention describes methods for generating non-replicating (i.e. non-infectious) virus-like particles that mimic HIV-1, SIV and other retroviruses, which are capable of generating a protective immune response. In addition to being replication defective, these virus like particles are deficient in packaged genomic RNA but have the added benefit of a normal compliment of viral and cellular proteins that remain in their native conformations. Also claimed are methods of making the mutant retroviruses which may potentially be used as immunogens for vaccines, particularly against HIV-1. The basis of the method and the mutant viruses of the claims is the finding that a conserved amino acid sequence motif, found in the nucleocapsid domain of [[Page 38841]] the Gag precursor polyprotein of all retroviruses, when mutated resulted in virions with much lower or zero infectivity. This concept has been tested in the primate lentivirus, SIV, which is related to HIV-1. Mutations were introduced into the gene coding for the conserved sequence motif found in the nucleocapsid domain of the Gag precursor polyprotein of SIV. The viruses obtained upon transfection were defective in replication. Plasmid DNA containing the mutated provirus was injected into five pig tailed macques and the vector without the provirus was injected into four control animals. The vaccinated animals were either partially or fully protected when challenged with infectious SIV(Mne) whereas three of the four control animals became persistently infected and developed AIDS as indicated by a marked decline in CD4 cell numbers. The invention has been filed in foreign countries and has been granted in Europe (No. 91900636.1) and Japan (No. Hei 7-16420). The Application of Induction Tolerance by Oral Feeding of Myelin Basic Protein to the Generation of Increased Resistance to Stroke KJ Becker, JM Hallenbeck, RM McCarron (NINDS) Serial No. 08/994,293 filed 19 Dec 97 Licensing Contact: Stephen Finley, 301/496-7735 ext. 215 In vivo experiments have shown that immunosuppression in the brain can be achieved through oral tolerance to myelin basic protein (MBP). Following exposure to MBP again which has the effect of suppressing the inflammatory reaction associated with stroke. This possible new means of minimizing the severity of damage from stroke, the number three killer of Americans and leading cause of disability, does not result in detrimental systemic side effects as other immunosuppressive agents do. This treatment could be administered to those considered at significantly increased risk for a stroke including those with a previous stroke, diabetes mellitus, hypertension, hypercholesteremia, or a history of smoking as well as those undergoing a medical or surgical treatment which increases the possibility of an ischemic event. Salivary Prolactin Test for Serotonergic Activity JD Higley (NIAAA), S Lindell (NICHD) Serial No. 60.082,126 filed 16 April 98 Licensing Contact: Stephen Finley, 301/496-7735 ext. 215 A noninvasive diagnostic assay improves on previous methods for determining central serotonin functioning, an indicator of susceptibility to aggression, alcohol abuse, obsessive-compulsive disorder and eating disorders. Levels of salivary prolactin can be assayed to determine susceptibility to the set of pysychiatric disorders related to central serotonin functioning. Levels of salivary prolactin were found to be positively correlated with levels of cerebrospinal fluid (CSF) 5-hydroxyindol acetic acid (5-HIAA), the current measurement of central serotonin functioning. Elevated CSF levels of 5-HIAA are associated with obsessive-compulsive disorders, and reduced levels are associated with violent behavior, alcohol abuse and bulimia. There are an estimated 9 million alcoholics in the United States and currently 0.5% of women 10 to 30 years old have anorexia nervosa while 5% of college-age women have bulimia. The user- friendliness and reduced costs of the saliva assay suggest possible candidacy for mass screenings to determine susceptibility to various psychiatric disorders. Conjugate Vaccine for Salmonella Paratyphi A E Konadu and S Szu (NICHD) Serial No. PCT/US96/19978 filed 18 Dec 96 Licensing Contact: Robert Benson, 301/496-7056 ext. 267 This invention concerns a conjugate vaccine against Salmonella paratyphi A comprising the o-specific polysaccharide bound to a carrier protein. Salmonella paratyphi A infection causes enteritis and enteric fever. The emergence of multidrug resistant strains has raised alarms. The present invention offers a method of preventing the disease. The conjugate is made by isolating lipopolysaccharide, detoxifying by removing the lipid A, while retaining substantially all the O-acetyl groups, and conjugating by known means to a carrier protein such as tetanus toxoid or detoxified exoprotein A. In a Phase I clinical trial the vaccine has been given to healthy adults and elicited anti-LPS IgG levels at least 4-fold higher compared to preimmune serum in 85% of volunteers. The invention is also described in Konadu et al., Infection and Immunity 64(7), 2709-2715, 1996. Cloning of GMEB 1 and 2: Two Proteins Involved in the Modulation of Glucocorticoid Regulated Gene Transcription S. Stoney Simons, Jr., et al. (NIDDK) DDH Reference No. E-070-97/0 filed 25 Jul 97 Licensing Contact: Charles Maynard, 301/496-7735 ext. 243 This technology relates to a previously identified DNA element from a naturally occurring gene that has the properties of causing glucocorticoid induction at lower steroid concentrations than for other glucocorticoid inducible genes in the same cell. This DNA element, also called a glucocorticoid modulatory element, or GME, has been found to involve two proteins of 88 and 67 kDa. This technology has succeeded in cloning and characterizing both the 67 kDa protein and the 88 kDa protein which together offer a unique and not previously described method of using genetic engineering to achieve selective regulation of glucocorticoid responsive genes. This group of proteins appears to be members of a larger class of related proteins which may have similar roles in modifying the activity of RNA polymerase II transcriptional complex. Gated RF Preamplifier for Use in Pulsed Radiofrequency Electron Paramagnetic Resonance and MRI RG Tschudin (NIDDK), R Murugesan (NCI), MK Cherukuri (NCI), JB Mitchell (NCI), S Subramanian (NCI) Serial No. 08/699,383 filed 19 Aug 96 Licensing Contact: John Fahner-Vihtelic, 201/496-7735 ext. 270 The present application describes a radiofrequency preamplifier featuring very fast recovery after the transmit cycle to allow for ultrafast data acquisition, intended for use in pulsed EPR, MRI and related computed imaging applications. One advantage of this device is that it allows the use of low frequency EPR, which offers better tissue penetration during in vivo diagnostic studies. The invention permits the use of a pulsed EPR method, which offers improved speed and sensitivity over existing methods. A prototype device has been made and the design has proven to work in an EPR system. Lipopolysaccharide Carriers for Use in Vaccines B Golding (FDA) Serial No. 08/369,565 filed 06 Jan 95 (allowed) Licensing Contact: Robert Benson, 301/496-7056 ext. 267 This invention is a new carrier for conjugate vaccines. The carrier is lipopolysaccharide (LPS) isolated from Brucella abortus (BA). The claims of the patent cover all conjugates comprising BA-LPS and an antigen from an infectious agent or tumor. BA-LPS, like other LPSs from gram-negative bacteria, [[Page 38842]] raises antibody responses in a T-independent fashion, which allows antibodies to be raised in the absence of T cell help. BA-LPS is much less toxic than LPS from other bacteria, and is much less potent than other bacterial LPS in including inflammatory cytokines. Thus, BA-LPS is much less likely to cause endotoxic shock. There are no foreign patent rights. The invention is further described in Infection & Immunity 61(5), pp. 1722-1729, 1993. Dated: July 6, 1998. Jack Spiegel, Director, Division of Technology Development and Transfer, Office of Technology Transfer. [FR Doc. 98-19146 Filed 7-17-98; 8:45 am] BILLING CODE 4140-01-M