Government-Owned Inventions; Availability for Licensing, 34762-34765 [E8-13672]

Download as PDF 34762 Federal Register / Vol. 73, No. 118 / Wednesday, June 18, 2008 / Notices Licensing Contact: Peter A. Soukas, J.D.; 301/435–4646; soukasp@mail.nih.gov. rwilkins on PROD1PC63 with NOTICES gPGA Conjugates for Eliciting Immune Responses Directed Against Bacillus anthracis and Other Bacilli Description of Technology: This invention claims immunogenic conjugates of a poly-g-glutamic acid (gPGA) of B. anthracis, or of another bacillus that expresses a gPGA that elicit a serum antibody response against B. anthracis, in mammalian hosts to which the conjugates are administered. The invention also relates methods which are useful for eliciting an immunogenic response in mammals, particularly humans, including responses which provide protection against, or reduce the severity of, infections caused by B. anthracis. The vaccines claimed in this application are intended for active immunization for prevention of B. anthracis infection, and for preparation of immune antibodies. The vaccines of this invention are designed to confer specific immunity against infection with B. anthracis, and to induce antibodies specific to B. anthracis gPGA. The B. anthracis vaccine is composed of nontoxic bacterial components, suitable for infants, children of all ages, and adults. Inventors: Rachel Schneerson (NICHD), Stephen Leppla (NIAID), John Robbins (NICHD), Joseph Shiloach (NIDDK), Joanna Kubler-Kielb (NICHD), Darrell Liu (NIDCR), Fathy Majadly (NICHD). Publication: R Schneerson et al. Poly(gamma-D-glutamic acid) protein conjugates induce IgG antibodies in mice to the capsule of Bacillus anthracis: a potential addition to the anthrax vaccine. Proc Natl Acad Sci USA. 2003 Jul 22;100(15):8945–8950. Patent Status: U.S. Patent Application No. 10/559,825 filed 02 Dec 2005, claiming priority to 05 Jun 2003 (HHS Reference No. E–343–2002/0–US–04). Licensing Status: Available for licensing. Licensing Contact: Peter A. Soukas, J.D.; 301/435–4646; soukasp@mail.nih.gov. Methods for Conjugation of Oligosaccharides or Polysaccharides to Protein Carriers Through Oxime Linkages Via 3-Deoxy-D-MannoOctulsonic Acid Description of Technology: This technology comprises new methods for the conjugation of O-specific polysaccharides/oligosaccharides (OSP/OS) derived from bacterial lipooligosaccharides/ lipopolysaccharides (LOS/LPS), after their cleavage from Lipid A, to carrier VerDate Aug<31>2005 18:01 Jun 17, 2008 Jkt 214001 proteins, to serve as potential vaccines. Conjugation is performed between the carbonyl group on the terminal reducing end of the saccharide and the aminooxy group of a bifunctional linker bound further to the protein. The inventors have carried out the reaction under mild conditions and in a short time resulting in binding 3-deoxyD-manno-octulosonic acid (KDO) on the sacchride to the protein. These conjugates preserve the external nonreducing end of the sacchride, are recognized by antisera, and induce immune responses in mice to both conjugate components (i.e., the OS and the associated carrier protein). Application: Cost effective and efficient manufacturing of conjugate vaccines. Inventors: Joanna Kubler-Kielb (NICHD), Vince Pozsgay (NICHD), Gil Ben-Menachem (NICHD), Rachel Schneerson (NICHD), et al. Patent Status: PCT Application No. PCT/US2007/016373 filed 18 Jul 2007, which published as WO 2008/013735 on 31 Jan 2008; claiming priority to 21 Jul 2006 (HHS Reference No. E–183– 2005/0–PCT–02). Licensing Status: Available for exclusive or non-exclusive licensing. Licensing Contact: Peter A. Soukas, J.D.; 301/435–4646; soukasp@mail.nih.gov. Dated: June 10, 2008. Richard U. Rodriguez, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. E8–13669 Filed 6–17–08; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing National Institutes of Health, Public Health Service, HHS. ACTION: Notice. AGENCY: SUMMARY: The inventions listed below are owned by an agency 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. PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 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. ADDRESSES: Construction of Recombinant Baculoviruses Carrying the Gene Encoding the Major Capsid Protein, VP1, From Calicivirus Strains (Including Norovirus Strains Toronto, Hawaii, Desert Shield, Snow Mountain, and MD145–12) Description of Technology: The noroviruses (known as ‘‘Norwalk-like viruses’’) are associated with an estimated 23,000,000 cases of acute gastroenteritis in the United States each year. Norovirus illness often occurs in outbreaks, affecting large numbers of individuals, illustrated recently by wellpublicized reports of gastroenteritis outbreaks on several recreational cruise ships and in settings such as hospitals and schools. Norovirus disease is clearly important in terms of medical costs and missed workdays, and accumulating data support its emerging recognition as important agents of diarrhea-related morbidity. Because the noroviruses cannot be propagated by any means in the laboratory, an important strategy in their study is the development of molecular biology-based tools. This invention reports the development of recombinant baculoviruses carrying the capsid gene from several caliciviruses associated with human disease. Growth of these baculovirus recombinants in insect cells results in the expression of virus-like particles (VLPs) that are antigenically indistinguishable from the native calicivirus particle. These VLPs can be purified in large quantities for use as diagnostic reagents and potential vaccine candidates. Inventors: Kim Y. Green, Judy F. Lew, Adriene D. King, Stanislav V. Sosnovtsev, Gael M. Belliot (NIAID). Publication: An example of the application of these materials is further described in KY Green et al., ‘‘A predominant role for Norwalk-like viruses as agents of epidemic gastroenteritis in Maryland nursing homes for the elderly,’’ J. Infect. Dis. 2002 Jan. 15;185(2):133–146. Patent Status: HHS Reference No. E– 198–2003/0—Research Material. Licensing Status: The materials embodied in this invention are available E:\FR\FM\18JNN1.SGM 18JNN1 Federal Register / Vol. 73, No. 118 / Wednesday, June 18, 2008 / Notices rwilkins on PROD1PC63 with NOTICES nonexclusively through a biological materials license. Licensing Contact: Peter A. Soukas, J.D.; 301/435–4646; soukasp@mail.nih.gov. Collaborative Research Opportunity: The Laboratory of Infectious Diseases, NIAID, NIH, is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize norovirus VLP antigens. Please contact Kim Y. Green at kgreen@niaid.nih.gov for more information. Full-Length cDNA Clone Representing the Consensus Sequence of the RNA Genome of a Human Norovirus (Strain MD145–12) That Encodes Biologically Active Proteins Description of Technology: The invention provides for a full-length cloned cDNA copy of the RNA genome of a predominant norovirus strain (Genogroup II.4) designated MD145–12 that was associated with human gastrointestinal illness. The noroviruses, which were formerly known as ‘‘Norwalk-like’’ viruses are estimated to cause 23 million cases of acute gastroenteritis in the USA each year. The virus has been designated into category B of the CDC biodefenserelated priority pathogens because it can be used as an agent of bioterrorism. The subject cDNA clone of the virus encodes proteins of the MD145–12 strain that, when expressed in vitro, exhibit properties that would be expected from those produced by the original infectious virus. This cDNA clone is presently the only source to obtain norovirus proteins to facilitate studies aimed at developing control strategies such as vaccines and therapeutic drugs. Inventors: Gael M. Belliot, Kim Y. Green, Stanislav V. Sosnovtsev (NIAID). Patent Status: HHS Reference No. E– 212–2003/0—Research Material. Licensing Status: The cDNA clone for norovirus strain MD145–12 is available for licensing via a biological material license (BML). Licensing Contact: Peter A. Soukas, J.D.; 301/435–4646; soukasp@mail.nih.gov. Collaborative Research Opportunity: The Laboratory of Infectious Diseases, NIAID, NIH, is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize reagents derived from a cDNA clone of the genome of a predominant human norovirus strain, Genogroup II.4. Please contact Kim Y. Green at kgreen@niaid.nih.gov for more information. VerDate Aug<31>2005 18:01 Jun 17, 2008 Jkt 214001 Construction of an Infectious FullLength cDNA Clone of the Porcine Enteric Calicivirus RNA Genome Description of Technology: Porcine enteric calicivirus (PEC) is a member of the genus Sapovirus in the family Caliciviridae. This virus causes diarrheal illness in pigs. In addition, PEC serves as an important model for the study of enteric caliciviruses that cause diarrhea and that cannot be grown in cell culture (including the noroviruses represented by Norwalk virus and the sapoviruses represented by Sapporo virus). The development of an infectious cDNA clone is important because it enables the use of ‘‘reverse genetics’’ to engineer mutations of interest into the genome of PEC and to study their effects. In addition, it allows the introduction of foreign coding sequences into the genome of PEC that could be useful for vaccine development in swine and possibly humans. This discovery has both basic research applications such as mapping mutations involved in tissue culture adaptation, tissue tropism, and virulence as well as practical applications such as providing a genetic backbone for the development of chimeric vaccine viruses. Inventors: Kyeong-Ok Chang (NIAID), Stanislav V. Sosnovtsev (NIAID), Gael M. Belliot (NIAID), Kim Y. Green (NIAID), et al. Publication: The materials are further described in KO Chang et al., ‘‘Cellculture propagation of porcine enteric calicivirus mediated by intestinal contents is dependent on the cyclic AMP signaling pathway,’’ Virology. 2002 Dec 20;304(2):302–310. Patent Status: HHS Reference No. E– 214–2003/0—Research Material. Licensing Status: The materials embodied in this invention are available nonexclusively through a biological materials license. Licensing Contact: Peter A. Soukas, J.D.; 301/435–4646; soukasp@mail.nih.gov. Collaborative Research Opportunity: The Laboratory of Infectious Diseases, NIAID, NIH, is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize reagents derived from an infectious cDNA copy of the genome of porcine enteric calicivirus. Please contact Kim Y. Green at kgreen@niaid.nih.gov for more information. Enzymatically-Active RNA-Dependent RNA Polymerase From a Human Norovirus (Calicivirus) Description of Technology: The noroviruses (formerly known as PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 34763 ‘‘Norwalk-like viruses’’) are associated with gastroenteritis outbreaks, affecting large numbers of individuals each year. Emerging data are supporting their increasing recognition as important agents of diarrhea-related morbidity and mortality. The frequency with which noroviruses are associated with gastroenteritis as ‘‘food and water-borne pathogens’’ has led to the inclusion of caliciviruses as Category B Bioterrorism Agents/Diseases. Because the noroviruses cannot be propagated by any means in the laboratory, an important strategy in their study is development of molecular biology-based tools and replication systems. This invention reports the isolation of the first recombinant, enzymatically-active proteinase and RNA dependent RNA polymerase (RdRp) complex for a human norovirus. This enzyme should facilitate studies aimed at developing therapeutic drugs for norovirus disease. Inventors: Gael M. Belliot, Stanislav V. Sosnovtsev, Kyeong-Ok Chang, Kim Y. Green (NIAID). Publication: The materials are further described in L Wei et al., ‘‘Proteinasepolymerase precursor as the active form of feline calicivirus RNA-dependent RNA polymerase,’’ J. Virol. 2001 Feb;75(3):1211–1219. Patent Status: HHS Reference No. E– 283–2003/0—Research Material. Licensing Status: The materials embodied in this invention are available nonexclusively through a biological materials license. Licensing Contact: Peter A. Soukas, J.D.; 301/435–4646; soukasp@mail.nih.gov. Collaborative Research Opportunity: The Laboratory of Infectious Diseases, NIAID, NIH, is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize an active human norovirus proteinase-polymerase enzyme. Please contact Kim Y. Green at kgreen@niaid.nih.gov for more information. A Sensitive, High Throughput Pseudovirus-Based Papillomavirus Neutralization Assay for HPV 16 and HPV 18 Description of Technology: This invention is a research tool for measuring protective antibody responses against Human Papilloma Viruses (HPV). Sensitive highthroughput neutralization assays, based upon pseudoviruses carrying a secreted alkaline phosphatase (SEAP) reporter gene, were developed and validated by the inventors for HPV 16, HPV 18, and bovine papillomavirus 1 (BPV1). In a E:\FR\FM\18JNN1.SGM 18JNN1 34764 Federal Register / Vol. 73, No. 118 / Wednesday, June 18, 2008 / Notices 96-well plate format, the assay was reproducible and appears to be as sensitive as, but more type-specific than, a standard papillomavirus-like particle (VLP)-based enzyme-linked immunosorbent assay (ELISA). The SEAP pseudovirus-based neutralization assay should be a practical method for quantifying potentially protective antibody responses in HPV natural history and prophylactic vaccine studies. Inventors: John T. Schiller (NCI), Douglas R. Lowy (NCI), Christopher Buck (NCI), Diana V. Pastrana (NCI), et al. Publication: The assay is further described in Pastrana et al., ‘‘Reactivity of human sera in a sensitive, highthroughput pseudovirus-based papillomavirus neutralization assay for HPV16 and HPV18,’’ Virology. 2004 Apr 10;321(2):205–216. Patent Status: HHS Reference No. E– 137–2004/0—Research Material. Licensing Status: This assay is available nonexclusively through a biological materials license. Licensing Contact: Peter A. Soukas, J.D.; 301/435–4646; soukasp@mail.nih.gov. rwilkins on PROD1PC63 with NOTICES Methods for Preparing Complex Multivalent Immunogenic Conjugates Description of Invention: Claimed in this application are novel methods for preparing complex multivalent immunogenic conjugates and conjugate vaccines. The multivalent conjugates and conjugate vaccines are synthesized by conjugating mixtures of more than one polysaccharide at a desired ratio of the component polysaccharides to at least one carrier protein using hydrazide chemistry. Because of the high efficiency of hydrazide chemistry in conjugation, the polysaccharides are effectively conjugated to the carrier protein(s) so that the resulting complex synthesized vaccine conjugate products, without requiring tedious and complicated purification procedures such as chromatography and/or ammonium sulfate precipitation, are efficacious in inducing antibodies in mice against each component polysaccharide. The methods claimed in this application simplify the preparation of multivalent conjugate vaccines by utilizing simultaneous conjugation reactions in a single reaction mixture or batch that includes at least two immunogenic-distinct polysaccharides. This single-batch simultaneous reaction eliminates the need for multiple parallel synthesis processes for each polysaccharide vaccine conjugate component as employed in VerDate Aug<31>2005 18:01 Jun 17, 2008 Jkt 214001 conventional methods for making multivalent conjugate vaccines. Application: Cost effective and efficient manufacturing of conjugate vaccines. Inventors: Che-Hung Robert Lee (CBER/FDA). Patent Status: PCT Application No. PCT/US2007/006627 filed 16 Mar 2007 (HHS Reference No. E–085–2005/0– PCT–02). Licensing Status: Available for exclusive or non-exclusive licensing. The technology is not available for licensing in the field of use of multivalent meningitis vaccines. Licensing Contact: Peter A. Soukas, J.D.; 301/435–4646; soukasp@mail.nih.gov. Human Neutralizing Monoclonal Antibodies to Respiratory Syncytial Virus and Human Neutralizing Antibodies to Respiratory Syncytial Virus Description of Technology: This invention is a human monoclonal antibody fragment (Fab) discovered utilizing phage display technology. It is described in Crowe et al., Proc Natl Acad Sci USA. 1994 Feb 15;91(4):1386– 1390 and Barbas et al., Proc Natl Acad Sci USA. 1992 Nov 1;89(21):10164– 10168. This MAb binds an epitope on the RSV F glycoprotein at amino acid 266 with an affinity of approximately 109M–1. This MAb neutralized each of 10 subgroup A and 9 subgroup B RSV strains with high efficiency. It was effective in reducing the amount of RSV in lungs of RSV-infected cotton rats 24 hours after treatment, and successive treatments caused an even greater reduction in the amount of RSV detected. Applications: Research and drug development for treatment of respiratory syncytial virus. Inventors: Robert M. Chanock (NIAID), Brian R. Murphy (NIAID), James E. Crowe Jr. (NIAID), et al. Patent Status: U.S. Patent 5,762,905 issued 09 Jun 1998 (HHS Reference No. E–032–1993/1–US–01); U.S. Patent 6,685,942 issued 03 Feb 2004 (HHS Reference No. E–032–1993/1–US–02); U.S. Patent Application No. 10/768,952 filed 29 Jan 2004 (HHS Reference No. E– 032–1993/1-US–03). Licensing Status: Available for nonexclusive licensing. Licensing Contact: Peter A. Soukas, J.D.; 301/435–4646; soukasp@mail.nih.gov. Neutralizing Monoclonal Antibodies to Respiratory Syncytial Virus Description of Technology: Respiratory syncytial virus (RSV) is the PO 00000 Frm 00067 Fmt 4703 Sfmt 4703 most common cause of bronchiolitis and pneumonia among infants and children under 1 year of age. Illness begins most frequently with fever, runny nose, cough, and sometimes wheezing. During their first RSV infection, between 25% and 40% of infants and young children have signs or symptoms of bronchiolitis or pneumonia, and 0.5% to 2% require hospitalization. Most children recover from illness in 8 to 15 days. The majority of children hospitalized for RSV infection are under 6 months of age. RSV also causes repeated infections throughout life, usually associated with moderate-to-severe cold-like symptoms; however, severe lower respiratory tract disease may occur at any age, especially among the elderly or among those with compromised cardiac, pulmonary, or immune systems. This invention is a human monoclonal antibody fragment (Fab) discovered utilizing phage display technology. The neutralizing monoclonal antibody was isolated and its binding site was identified. Fab F2– 5 is a broadly reactive fusion (F) protein-specific recombinant Fab generated by antigen selection from a random combinatorial library displayed on the surface of filamentous phage. In an in vitro plaque-reduction test, the Fab RSVF2–5 neutralized the infectivity of a variety of field isolates representing viruses of both RSV subgroups A and B. The Fab recognized an antigenic determinant that differed from the only other human anti-F monoclonal antibody (RSV Fab 19) described thus far. A single dose of 4.0 mg of Fab RSVF2–5/kg of body weight administered by inhalation was sufficient to achieve a 2000-fold reduction in pulmonary virus titer in RSV-infected mice. The antigen-binding domain of Fab RSVF2–5 offers promise as part of a prophylactic regimen for RSV infection in humans. Application: Respiratory Syncytial Virus prophylaxis/therapeutic. Development Stage: The antibodies have been synthesized and preclinical studies have been performed. Inventors: Brian Murphy (NIAID), Robert Chanock (NIAID), James Crowe (NIAID), et al. Publication: JE Crowe et al. Isolation of a second recombinant human respiratory syncytial virus monoclonal antibody fragment (Fab RSVF2–5) that exhibits therapeutic efficacy in vivo. J Infect Dis. 1998 Apr;177(4):1073–1076. Patent Status: HHS Reference No. E– 001–1996/0—U.S. and Foreign Rights Available. Licensing Status: Available for exclusive or non-exclusive licensing. E:\FR\FM\18JNN1.SGM 18JNN1 Federal Register / Vol. 73, No. 118 / Wednesday, June 18, 2008 / Notices Licensing Contact: Peter A. Soukas, J.D.; 301/435–4646; soukasp@mail.nih.gov. DEPARTMENT OF HEALTH AND HUMAN SERVICES Murine Monoclonal Antibodies Effective To Treat Respiratory Syncytial Virus Center for Scientific Review; Notice of Closed Meetings National Institutes of Health Description of Technology: Available for licensing through a Biological Materials License Agreement are the murine MAbs described in Beeler et al., ‘‘Neutralization epitopes of the F glycoprotein of respiratory syncytial virus: effect of mutation upon fusion function,’’ J Virol. 1989 Jul;63(7):2941– 2950. The MAbs that are available for licensing are the following: 1129, 1153, 1142, 1200, 1214, 1237, 1112, 1269, and 1243. One of these MAbs, 1129, is the basis for a humanized murine MAb (see U.S. Patent 5,824,307 to humanized 1129 owned by MedImmune, Inc.), recently approved for marketing in the United States. MAbs in the panel reported by Beeler et al. have been shown to be effective therapeutically when administered into the lungs of cotton rats by small-particle aerosol. Among these MAbs several exhibited a high affinity (approximately 109M–1) for the RSV F glycoprotein and are directed at epitopes encompassing amino acid 262, 272, 275, 276 or 389. These epitopes are separate, nonoverlapping and distinct from the epitope recognized by the human Fab of U.S. Patent 5,762,905 owned by The Scripps Research Institute. Applications: Research and drug development for treatment of respiratory syncytial virus. Inventors: Robert M. Chanock, Brian R. Murphy, Judith A. Beeler, and Kathleen L. van Wyke Coelingh (NIAID). Patent Status: HHS Reference No. B– 056–1994/1—Research Tool. Licensing Status: Available for nonexclusive licensing under a Biological Materials License Agreement. Licensing Contact: Peter A. Soukas, J.D.; 301/435–4646; soukasp@mail.nih.gov. rwilkins on PROD1PC63 with NOTICES Dated: June 10, 2008. Richard U. Rodriguez, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. E8–13672 Filed 6–17–08; 8:45 am] BILLING CODE 4140–01–P VerDate Aug<31>2005 18:01 Jun 17, 2008 Jkt 214001 Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. appendix 2), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Center for Scientific Review Special Emphasis Panel; Health of the Population SBIR Study Section. Date: June 26–27, 2008. Time: 8:30 a.m. to 6 p.m. Agenda: To review and evaluate grant applications. Place: Brookshire Inner Harbor Suites, 120 E. Lombard Street, Baltimore, MD 21202. Contact Person: Karin F. Helmers, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3148, MSC 7770, Bethesda, MD 20892, 301–435– 1017, helmersk@csr.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: Center for Scientific Review Special Emphasis Panel; Oncology and Related Topics. Date: July 7, 2008. Time: 2 p.m. to 4 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health. 6701 Rockledge Drive, Bethesda, MD 20892, (Telephone Conference Call). Contact Person: Angela Y. Ng, PhD, MBA, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 6200, MSC 7804 (For courier delivery, use MD 20817), Bethesda, MD 20892, 301–435–1715, nga@csr.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: Center for Scientific Review Special Emphasis Panel; Xenopus Genetics and Development. Date: July 9–10, 2008. Time: 8 a.m. to 5:30 p.m. Agenda: To review and evaluate grant applications. PO 00000 Frm 00068 Fmt 4703 Sfmt 4703 34765 Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Virtual Meeting). Contact Person: Barbara J. Thomas, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 2218, MSC 7890, Bethesda, MD 20892, 301–435– 0603, bthomas@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Topics In Eukaryotic Pathogens. Date: July 9, 2008. Time: 2 p.m. to 4 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Virtual Meeting). Contact Person: Liangbiao Zheng, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3214, MSC 7808, Bethesda, MD 20892, 301–402– 5671, zhengli@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; International Bioethics. Date: July 10, 2008. Time: 8:30 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: Embassy Suites at the Chevy Chase Pavilion, 4300 Military Road, NW., Washington, DC 20015. Contact Person: Dan D. Gerendasy, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5132, MSC 7843, Bethesda, MD 20892, 301–594– 6830, gerendad@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; PAR 06– 293–Quick Trial on Imaging and Image-guide Intervention. Date: July 14, 2008. Time: 1 p.m. to 4 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Virtual Meeting). Contact Person: John Firrell, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5213, MSC 7854, Bethesda, MD 20892, 301–435– 2598, firrellj@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Data Management and Coordinating Center (DMCC) for the Rare Diseases. Date: July 15, 2008. Time: 8 a.m. to 3 p.m. Agenda: To review and evaluate grant applications. Place: One Washington Circle Hotel, One Washington Circle, Washington, DC 20037. Contact Person: Jose Fernando Arena, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3135, MSC 7770, Bethesda, MD 20892, 301–435– 1735, arenaj@mail.nih.gov. E:\FR\FM\18JNN1.SGM 18JNN1

Agencies

[Federal Register Volume 73, Number 118 (Wednesday, June 18, 2008)]
[Notices]
[Pages 34762-34765]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-13672]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Government-Owned Inventions; Availability for Licensing

AGENCY: National Institutes of Health, Public Health Service, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The inventions listed below are owned by an agency 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.

Construction of Recombinant Baculoviruses Carrying the Gene Encoding 
the Major Capsid Protein, VP1, From Calicivirus Strains (Including 
Norovirus Strains Toronto, Hawaii, Desert Shield, Snow Mountain, and 
MD145-12)

    Description of Technology: The noroviruses (known as ``Norwalk-like 
viruses'') are associated with an estimated 23,000,000 cases of acute 
gastroenteritis in the United States each year. Norovirus illness often 
occurs in outbreaks, affecting large numbers of individuals, 
illustrated recently by well-publicized reports of gastroenteritis 
outbreaks on several recreational cruise ships and in settings such as 
hospitals and schools. Norovirus disease is clearly important in terms 
of medical costs and missed workdays, and accumulating data support its 
emerging recognition as important agents of diarrhea-related morbidity.
    Because the noroviruses cannot be propagated by any means in the 
laboratory, an important strategy in their study is the development of 
molecular biology-based tools. This invention reports the development 
of recombinant baculoviruses carrying the capsid gene from several 
caliciviruses associated with human disease. Growth of these 
baculovirus recombinants in insect cells results in the expression of 
virus-like particles (VLPs) that are antigenically indistinguishable 
from the native calicivirus particle. These VLPs can be purified in 
large quantities for use as diagnostic reagents and potential vaccine 
candidates.
    Inventors: Kim Y. Green, Judy F. Lew, Adriene D. King, Stanislav V. 
Sosnovtsev, Gael M. Belliot (NIAID).
    Publication: An example of the application of these materials is 
further described in KY Green et al., ``A predominant role for Norwalk-
like viruses as agents of epidemic gastroenteritis in Maryland nursing 
homes for the elderly,'' J. Infect. Dis. 2002 Jan. 15;185(2):133-146.
    Patent Status: HHS Reference No. E-198-2003/0--Research Material.
    Licensing Status: The materials embodied in this invention are 
available

[[Page 34763]]

nonexclusively through a biological materials license.
    Licensing Contact: Peter A. Soukas, J.D.; 301/435-4646; 
soukasp@mail.nih.gov.
    Collaborative Research Opportunity: The Laboratory of Infectious 
Diseases, NIAID, NIH, is seeking statements of capability or interest 
from parties interested in collaborative research to further develop, 
evaluate, or commercialize norovirus VLP antigens. Please contact Kim 
Y. Green at kgreen@niaid.nih.gov for more information.

Full-Length cDNA Clone Representing the Consensus Sequence of the RNA 
Genome of a Human Norovirus (Strain MD145-12) That Encodes Biologically 
Active Proteins

    Description of Technology: The invention provides for a full-length 
cloned cDNA copy of the RNA genome of a predominant norovirus strain 
(Genogroup II.4) designated MD145-12 that was associated with human 
gastrointestinal illness. The noroviruses, which were formerly known as 
``Norwalk-like'' viruses are estimated to cause 23 million cases of 
acute gastroenteritis in the USA each year. The virus has been 
designated into category B of the CDC biodefense-related priority 
pathogens because it can be used as an agent of bioterrorism. The 
subject cDNA clone of the virus encodes proteins of the MD145-12 strain 
that, when expressed in vitro, exhibit properties that would be 
expected from those produced by the original infectious virus. This 
cDNA clone is presently the only source to obtain norovirus proteins to 
facilitate studies aimed at developing control strategies such as 
vaccines and therapeutic drugs.
    Inventors: Gael M. Belliot, Kim Y. Green, Stanislav V. Sosnovtsev 
(NIAID).
    Patent Status: HHS Reference No. E-212-2003/0--Research Material.
    Licensing Status: The cDNA clone for norovirus strain MD145-12 is 
available for licensing via a biological material license (BML).
    Licensing Contact: Peter A. Soukas, J.D.; 301/435-4646; 
soukasp@mail.nih.gov.
    Collaborative Research Opportunity: The Laboratory of Infectious 
Diseases, NIAID, NIH, is seeking statements of capability or interest 
from parties interested in collaborative research to further develop, 
evaluate, or commercialize reagents derived from a cDNA clone of the 
genome of a predominant human norovirus strain, Genogroup II.4. Please 
contact Kim Y. Green at kgreen@niaid.nih.gov for more information.

Construction of an Infectious Full-Length cDNA Clone of the Porcine 
Enteric Calicivirus RNA Genome

    Description of Technology: Porcine enteric calicivirus (PEC) is a 
member of the genus Sapovirus in the family Caliciviridae. This virus 
causes diarrheal illness in pigs. In addition, PEC serves as an 
important model for the study of enteric caliciviruses that cause 
diarrhea and that cannot be grown in cell culture (including the 
noroviruses represented by Norwalk virus and the sapoviruses 
represented by Sapporo virus). The development of an infectious cDNA 
clone is important because it enables the use of ``reverse genetics'' 
to engineer mutations of interest into the genome of PEC and to study 
their effects. In addition, it allows the introduction of foreign 
coding sequences into the genome of PEC that could be useful for 
vaccine development in swine and possibly humans. This discovery has 
both basic research applications such as mapping mutations involved in 
tissue culture adaptation, tissue tropism, and virulence as well as 
practical applications such as providing a genetic backbone for the 
development of chimeric vaccine viruses.
    Inventors: Kyeong-Ok Chang (NIAID), Stanislav V. Sosnovtsev 
(NIAID), Gael M. Belliot (NIAID), Kim Y. Green (NIAID), et al.
    Publication: The materials are further described in KO Chang et 
al., ``Cell-culture propagation of porcine enteric calicivirus mediated 
by intestinal contents is dependent on the cyclic AMP signaling 
pathway,'' Virology. 2002 Dec 20;304(2):302-310.
    Patent Status: HHS Reference No. E-214-2003/0--Research Material.
    Licensing Status: The materials embodied in this invention are 
available nonexclusively through a biological materials license.
    Licensing Contact: Peter A. Soukas, J.D.; 301/435-4646; 
soukasp@mail.nih.gov.
    Collaborative Research Opportunity: The Laboratory of Infectious 
Diseases, NIAID, NIH, is seeking statements of capability or interest 
from parties interested in collaborative research to further develop, 
evaluate, or commercialize reagents derived from an infectious cDNA 
copy of the genome of porcine enteric calicivirus. Please contact Kim 
Y. Green at kgreen@niaid.nih.gov for more information.

Enzymatically-Active RNA-Dependent RNA Polymerase From a Human 
Norovirus (Calicivirus)

    Description of Technology: The noroviruses (formerly known as 
``Norwalk-like viruses'') are associated with gastroenteritis 
outbreaks, affecting large numbers of individuals each year. Emerging 
data are supporting their increasing recognition as important agents of 
diarrhea-related morbidity and mortality. The frequency with which 
noroviruses are associated with gastroenteritis as ``food and water-
borne pathogens'' has led to the inclusion of caliciviruses as Category 
B Bioterrorism Agents/Diseases. Because the noroviruses cannot be 
propagated by any means in the laboratory, an important strategy in 
their study is development of molecular biology-based tools and 
replication systems. This invention reports the isolation of the first 
recombinant, enzymatically-active proteinase and RNA dependent RNA 
polymerase (RdRp) complex for a human norovirus. This enzyme should 
facilitate studies aimed at developing therapeutic drugs for norovirus 
disease.
    Inventors: Gael M. Belliot, Stanislav V. Sosnovtsev, Kyeong-Ok 
Chang, Kim Y. Green (NIAID).
    Publication: The materials are further described in L Wei et al., 
``Proteinase-polymerase precursor as the active form of feline 
calicivirus RNA-dependent RNA polymerase,'' J. Virol. 2001 
Feb;75(3):1211-1219.
    Patent Status: HHS Reference No. E-283-2003/0--Research Material.
    Licensing Status: The materials embodied in this invention are 
available nonexclusively through a biological materials license.
    Licensing Contact: Peter A. Soukas, J.D.; 301/435-4646; 
soukasp@mail.nih.gov.
    Collaborative Research Opportunity: The Laboratory of Infectious 
Diseases, NIAID, NIH, is seeking statements of capability or interest 
from parties interested in collaborative research to further develop, 
evaluate, or commercialize an active human norovirus proteinase-
polymerase enzyme. Please contact Kim Y. Green at kgreen@niaid.nih.gov 
for more information.

A Sensitive, High Throughput Pseudovirus-Based Papillomavirus 
Neutralization Assay for HPV 16 and HPV 18

    Description of Technology: This invention is a research tool for 
measuring protective antibody responses against Human Papilloma Viruses 
(HPV). Sensitive high-throughput neutralization assays, based upon 
pseudoviruses carrying a secreted alkaline phosphatase (SEAP) reporter 
gene, were developed and validated by the inventors for HPV 16, HPV 18, 
and bovine papillomavirus 1 (BPV1). In a

[[Page 34764]]

96-well plate format, the assay was reproducible and appears to be as 
sensitive as, but more type-specific than, a standard papillomavirus-
like particle (VLP)-based enzyme-linked immunosorbent assay (ELISA). 
The SEAP pseudovirus-based neutralization assay should be a practical 
method for quantifying potentially protective antibody responses in HPV 
natural history and prophylactic vaccine studies.
    Inventors: John T. Schiller (NCI), Douglas R. Lowy (NCI), 
Christopher Buck (NCI), Diana V. Pastrana (NCI), et al.
    Publication: The assay is further described in Pastrana et al., 
``Reactivity of human sera in a sensitive, high-throughput pseudovirus-
based papillomavirus neutralization assay for HPV16 and HPV18,'' 
Virology. 2004 Apr 10;321(2):205-216.
    Patent Status: HHS Reference No. E-137-2004/0--Research Material.
    Licensing Status: This assay is available nonexclusively through a 
biological materials license.
    Licensing Contact: Peter A. Soukas, J.D.; 301/435-4646; 
soukasp@mail.nih.gov.

Methods for Preparing Complex Multivalent Immunogenic Conjugates

    Description of Invention: Claimed in this application are novel 
methods for preparing complex multivalent immunogenic conjugates and 
conjugate vaccines. The multivalent conjugates and conjugate vaccines 
are synthesized by conjugating mixtures of more than one polysaccharide 
at a desired ratio of the component polysaccharides to at least one 
carrier protein using hydrazide chemistry. Because of the high 
efficiency of hydrazide chemistry in conjugation, the polysaccharides 
are effectively conjugated to the carrier protein(s) so that the 
resulting complex synthesized vaccine conjugate products, without 
requiring tedious and complicated purification procedures such as 
chromatography and/or ammonium sulfate precipitation, are efficacious 
in inducing antibodies in mice against each component polysaccharide. 
The methods claimed in this application simplify the preparation of 
multivalent conjugate vaccines by utilizing simultaneous conjugation 
reactions in a single reaction mixture or batch that includes at least 
two immunogenic-distinct polysaccharides. This single-batch 
simultaneous reaction eliminates the need for multiple parallel 
synthesis processes for each polysaccharide vaccine conjugate component 
as employed in conventional methods for making multivalent conjugate 
vaccines.
    Application: Cost effective and efficient manufacturing of 
conjugate vaccines.
    Inventors: Che-Hung Robert Lee (CBER/FDA).
    Patent Status: PCT Application No. PCT/US2007/006627 filed 16 Mar 
2007 (HHS Reference No. E-085-2005/0-PCT-02).
    Licensing Status: Available for exclusive or non-exclusive 
licensing. The technology is not available for licensing in the field 
of use of multivalent meningitis vaccines.
    Licensing Contact: Peter A. Soukas, J.D.; 301/435-4646; 
soukasp@mail.nih.gov.

Human Neutralizing Monoclonal Antibodies to Respiratory Syncytial Virus 
and Human Neutralizing Antibodies to Respiratory Syncytial Virus

    Description of Technology: This invention is a human monoclonal 
antibody fragment (Fab) discovered utilizing phage display technology. 
It is described in Crowe et al., Proc Natl Acad Sci USA. 1994 Feb 
15;91(4):1386-1390 and Barbas et al., Proc Natl Acad Sci USA. 1992 Nov 
1;89(21):10164-10168. This MAb binds an epitope on the RSV F 
glycoprotein at amino acid 266 with an affinity of approximately 
10\9\M^-\1\. This MAb neutralized each of 10 subgroup A and 9 
subgroup B RSV strains with high efficiency. It was effective in 
reducing the amount of RSV in lungs of RSV-infected cotton rats 24 
hours after treatment, and successive treatments caused an even greater 
reduction in the amount of RSV detected.
    Applications: Research and drug development for treatment of 
respiratory syncytial virus.
    Inventors: Robert M. Chanock (NIAID), Brian R. Murphy (NIAID), 
James E. Crowe Jr. (NIAID), et al.
    Patent Status: U.S. Patent 5,762,905 issued 09 Jun 1998 (HHS 
Reference No. E-032-1993/1-US-01); U.S. Patent 6,685,942 issued 03 Feb 
2004 (HHS Reference No. E-032-1993/1-US-02); U.S. Patent Application 
No. 10/768,952 filed 29 Jan 2004 (HHS Reference No. E-032-1993/1-US-
03).
    Licensing Status: Available for non-exclusive licensing.
    Licensing Contact: Peter A. Soukas, J.D.; 301/435-4646; 
soukasp@mail.nih.gov.

Neutralizing Monoclonal Antibodies to Respiratory Syncytial Virus

    Description of Technology: Respiratory syncytial virus (RSV) is the 
most common cause of bronchiolitis and pneumonia among infants and 
children under 1 year of age. Illness begins most frequently with 
fever, runny nose, cough, and sometimes wheezing. During their first 
RSV infection, between 25% and 40% of infants and young children have 
signs or symptoms of bronchiolitis or pneumonia, and 0.5% to 2% require 
hospitalization. Most children recover from illness in 8 to 15 days. 
The majority of children hospitalized for RSV infection are under 6 
months of age. RSV also causes repeated infections throughout life, 
usually associated with moderate-to-severe cold-like symptoms; however, 
severe lower respiratory tract disease may occur at any age, especially 
among the elderly or among those with compromised cardiac, pulmonary, 
or immune systems.
    This invention is a human monoclonal antibody fragment (Fab) 
discovered utilizing phage display technology. The neutralizing 
monoclonal antibody was isolated and its binding site was identified. 
Fab F2-5 is a broadly reactive fusion (F) protein-specific recombinant 
Fab generated by antigen selection from a random combinatorial library 
displayed on the surface of filamentous phage. In an in vitro plaque-
reduction test, the Fab RSVF2-5 neutralized the infectivity of a 
variety of field isolates representing viruses of both RSV subgroups A 
and B. The Fab recognized an antigenic determinant that differed from 
the only other human anti-F monoclonal antibody (RSV Fab 19) described 
thus far. A single dose of 4.0 mg of Fab RSVF2-5/kg of body weight 
administered by inhalation was sufficient to achieve a 2000-fold 
reduction in pulmonary virus titer in RSV-infected mice. The antigen-
binding domain of Fab RSVF2-5 offers promise as part of a prophylactic 
regimen for RSV infection in humans.
    Application: Respiratory Syncytial Virus prophylaxis/therapeutic.
    Development Stage: The antibodies have been synthesized and 
preclinical studies have been performed.
    Inventors: Brian Murphy (NIAID), Robert Chanock (NIAID), James 
Crowe (NIAID), et al.
    Publication: JE Crowe et al. Isolation of a second recombinant 
human respiratory syncytial virus monoclonal antibody fragment (Fab 
RSVF2-5) that exhibits therapeutic efficacy in vivo. J Infect Dis. 1998 
Apr;177(4):1073-1076.
    Patent Status: HHS Reference No. E-001-1996/0--U.S. and Foreign 
Rights Available.
    Licensing Status: Available for exclusive or non-exclusive 
licensing.

[[Page 34765]]

    Licensing Contact: Peter A. Soukas, J.D.; 301/435-4646; 
soukasp@mail.nih.gov.

Murine Monoclonal Antibodies Effective To Treat Respiratory Syncytial 
Virus

    Description of Technology: Available for licensing through a 
Biological Materials License Agreement are the murine MAbs described in 
Beeler et al., ``Neutralization epitopes of the F glycoprotein of 
respiratory syncytial virus: effect of mutation upon fusion function,'' 
J Virol. 1989 Jul;63(7):2941-2950. The MAbs that are available for 
licensing are the following: 1129, 1153, 1142, 1200, 1214, 1237, 1112, 
1269, and 1243. One of these MAbs, 1129, is the basis for a humanized 
murine MAb (see U.S. Patent 5,824,307 to humanized 1129 owned by 
MedImmune, Inc.), recently approved for marketing in the United States. 
MAbs in the panel reported by Beeler et al. have been shown to be 
effective therapeutically when administered into the lungs of cotton 
rats by small-particle aerosol. Among these MAbs several exhibited a 
high affinity (approximately 10\9\M^-\1\) for the RSV F 
glycoprotein and are directed at epitopes encompassing amino acid 262, 
272, 275, 276 or 389. These epitopes are separate, nonoverlapping and 
distinct from the epitope recognized by the human Fab of U.S. Patent 
5,762,905 owned by The Scripps Research Institute.
    Applications: Research and drug development for treatment of 
respiratory syncytial virus.
    Inventors: Robert M. Chanock, Brian R. Murphy, Judith A. Beeler, 
and Kathleen L. van Wyke Coelingh (NIAID).
    Patent Status: HHS Reference No. B-056-1994/1--Research Tool.
    Licensing Status: Available for non-exclusive licensing under a 
Biological Materials License Agreement.
    Licensing Contact: Peter A. Soukas, J.D.; 301/435-4646; 
soukasp@mail.nih.gov.

    Dated: June 10, 2008.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. E8-13672 Filed 6-17-08; 8:45 am]
BILLING CODE 4140-01-P

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