Drug – bio-affecting and body treating compositions – Antigen – epitope – or other immunospecific immunoeffector – Virus or component thereof
Reexamination Certificate
2005-10-19
2011-10-04
Chen, Stacy B. (Department: 1648)
Drug, bio-affecting and body treating compositions
Antigen, epitope, or other immunospecific immunoeffector
Virus or component thereof
C424S199100, C424S202100, C435S005000
Reexamination Certificate
active
08029802
ABSTRACT:
The invention provides attenuatedFlavivirusvaccines, such as vaccines against Japanese encephalitis virus and West Nile virus, as well as methods of making and using these vaccines.
REFERENCES:
patent: 6184024 (2001-02-01), Lai et al.
patent: 6497884 (2002-12-01), Pletnev et al.
patent: 6660273 (2003-12-01), Pletnev et al.
patent: 6676936 (2004-01-01), Lai et al.
patent: 6696281 (2004-02-01), Chambers et al.
patent: 6962708 (2005-11-01), Chambers et al.
patent: 7189403 (2007-03-01), Despres et al.
patent: 2008/0175862 (2008-07-01), Pugachev et al.
patent: 1809325 (2006-04-01), None
patent: WO 98/37911 (1998-09-01), None
patent: WO 99/18216 (1999-04-01), None
patent: WO 01/39802 (2001-06-01), None
patent: WO 02/081753 (2002-10-01), None
patent: WO 03/103571 (2003-12-01), None
patent: WO 2004/045529 (2004-06-01), None
patent: WO 2005/082020 (2005-09-01), None
patent: WO 2006/044857 (2006-04-01), None
patent: WO 2006/116182 (2006-11-01), None
Arroyo et al. J. Virology, 2004, 78(22):12497-12507.
Mustafa et al. MJAFI, 2008, 64:161-164.
Maier et al. Virology, 2007, 362:468-474.
Arroyo et al. Trends in Molecular Medicine, 2001, 7(8):350-354.
Chambers et al., “Neuroadapted Yellow Fever Virus 17D: Genetic and Biological Characterization of a Highly Mouse-Neurovirulent Virus and Its Infectious Molecular Clone,” J. Virology 75:10912-10922, 2001.
Definition of “attenuate” from http://dictionary.com dated Dec. 8, 2008.
Definition of “attenuate” from http://www.thefreedictionary.com dated Dec. 8, 2008.
Written Opinion of International Searching Authority from International Application No. PCT/US2005/037369, completed May 30, 2006.
Monath et al., “Recombinant, Chimaeric Live, Attenuated Vaccine (ChimeriVax™) Incorporating the Envelope Genes of Japanese Encephalitis (SA14-14-2) Virus and the Capsid and Nonstructural Genes of Yellow Fever (17D) Virus Is Safe, Immunogenic and Protective in Non-Human Primates,” Vaccine 17:1869-1882, 1999.
International Search Report from International Application No. PCT/US2005/037369, dated Jun. 20, 2006.
International Preliminary Report on Patentability from International Application No. PCT/US2005/037369, mailed Mar. 5, 2007.
Abe et al., “Establishment of an Analyzing Method for a Japanese Encephalitis Virus Neutralization Test in Vero Cells,” Vaccine 21:1989-1994, 2003.
Arroyo et al., “Molecular Basis for Attenuation of Neurovirulence of a Yellow Fever Virus/Japanese Encephalitis Virus Chimera Vaccine (ChimeriVax-JE),” J. Virol. 75:934-942, 2001.
Chambers et al., “Yellow Fever/Japanese Encephalitis Chimeric Viruses: Construction and Biological Properties,” J. Virol. 73:3095-3101, 1999.
“Guidelines for the Production and Control of Japanese Encephalitis Vaccine (Live) for Human Use,” W.H.O. Technical Report Series, No. 910, pp. 66-98, 2002.
Guirakhoo et al., “Immunogenicity, Genetic Stability, and Protective Efficacy of a Recombinant, Chimeric Yellow Fever-Japanese Encephalitis Virus (ChimeriVax-JE) as a Live, Attenuated Vaccine Candidate Against Japanese Encephalitis,” Virology 257:363-372, 1999.
Holbrook et al., “Amino Acid Substitution(s) in the Stem-Anchor Region of Langat Virus Envelope Protein Attenuates Mouse Neurovirulence,” Virology 286:54-61, 2001.
Hombach et al., “Report on a WHO Consultation on Immunological Endpoints for Evaluation of New Japanese Encephalitis Vaccines, WHO, Geneva, Sep. 2-3, 2004,” Vaccine 23:5205-5211, 2005.
Lai et al., “Chimeric Flaviviruses: Novel Vaccines Against Dengue Fever, Tick-borne Encephalitis, and Japanese Encephalitis,” Adv. Virus Res. 61:469-509, 2003.
Meeting Report: WHO Informal Consultation on the Scientific Basis of Specifications for Production and Control of Inactivated Japanese Encephalitis Vaccines for Human Use, Geneva, Switzerland, pp. 1-19, Jun. 1-2, 2006.
Sumiyoshi et al., “Complete Nucleotide Sequence of the Japanese Encephalitis Virus Genome RNA,” Virology 161:497-510, 1987.
Yoshii et al., “Single Point Mutation in Tick-borne Encephalitis Virus prM Protein Induces a Reduction of Virus Particle Secretion,” J. Gen. Virol. 85:3049-3058, 2004.
Extended European Search Report for EP 05811861.3-2406, mailed Jun. 23, 2009 (search completed Jun. 8, 2009).
Guirakhoo et al., “Fusion Activity of Flaviviruses: Comparison of Mature and Immature (prM-containing) Tick-Borne Encephalitis Virions,” J. Gen. Virol. 72:1323-1329, 1991.
Guirakhoo et al., “The Murray Valley Encephalitis Virus prM Protein Confers Acid Resistance to Virus Particles and Alters the Expression of Epitopes within the R2 Domain of E Glycoprotein,” Virology 191:921-931, 1992.
Guirakhoo et al., “A Single Amino Acid Substitution in the Envelope Protein of Chimeric Yellow Fever-Dengue 1 Vaccine Virus Reduces Neurovirulence for Suckling Mice and Viremia/Viscerotropism for Monkeys,” J. Virol. 78:9998-10008, 2004.
Guirakhoo et al., “Safety and Efficacy of Chimeric Yellow Fever-Dengue Virus Tetravalent Vaccine Formulations in Nonhuman Primates,” J. Virol. 78:4761-4775, 2004.
Hurrelbrink et al., “Molecular Determinants of Virulence: The Structural and Functional Basis for Flavivirus Attenuation,” Adv. Virus Res. 60:1-42, 2003.
Kofler et al., “Capsid Protein C of Tick-borne Encephalitis Virus Tolerates Large Internal Deletions and is a Favorable Target for Attenuation of Virulence,” J. Virol. 76:3534-3543, 2002.
Lorenz et al., “Folding and Dimerization of Tick-Borne Encephalitis Virus Envelope Proteins prM and E in the Endoplasmic Reticulum,” J. Virol. 76:5480-5491, 2002.
Men et al., “Dengue Type 4 Virus Mutants Containing Deletions in the 3′ Noncoding Region of the RNA Genome: Analysis of Growth Restriction in Cell Culture and Altered Viremia Pattern and Immunogenicity in Rhesus Monkeys,” J. Virol. 70:3930-3937, 1996.
Monath et al., “Chimeric Live, Attenuated Vaccine Against Japanese Encephalitis (ChimeriVax-JE): Phase 2 Clinical Trials for Safety and Immunogenicity, Effect of Vaccine Dose and Schedule, and Memory Response to Challenge with Inactivated Japanese Encephalitis Antigen,” J. Infect. Dis. 188:1213-1230, 2003.
Monath et al., “Clinical Proof of Principle for ChimeriVax™: Recombinant Live, Attenuated Vaccines Against Flavivirus Infections,” Vaccine 20:1004-1018, 2002.
Monath et al., “Single Mutation in the Flavivirus Envelope Protein Hinge Region Increases Neurovirulence for Mice and Monkeys but Decreases Viscerotropism for Monkeys: Relevance to Development and Safety Testing of Live, Attenuated Vaccines,” J. Virol. 76:1932-1943, 2002.
Pugachev et al., “Heterogeneous Nature of the Genome of the ARILVAX Yellow Fever 17D Vaccine Revealed by Consensus Sequencing,” Vaccine 20:996-999, 2002.
Rey et al., “The Envelope Glycoprotein from Tick-Borne Encephalitis at 2 Å Resolution,” Nature 375:291-298, 1995.
Tesh et al., “Efficacy of Killed Virus Vaccine, Live Attenuated Chimeric Virus Vaccine, and Passive Immunization for Prevention of West Nile Virus Encephalitis in Hamster Model,” Emerg. Infect. Dis. 8:1392-1397, 2002.
Communication from European Patent Application No. 05811861.3-2406, mailed Sep. 11, 2009.
Examination Report from New Zealand Patent Application No. 554542, mailed Aug. 1, 2008.
Examination Report from Singapore Patent Application No. 200702692-5, mailed Feb. 3, 2009.
Written Opinion from Singapore Patent Application No. 200702692-5, mailed May 27, 2008.
Official Action from Eurasian Patent Application No. 200700904, mailed Jul. 24, 2008.
Official Action from Eurasian Patent Application No. 200700904, mailed Apr. 9, 2009.
Substantive Examination Adverse Report from Malaysian Patent Application No. PI 20054938, mailed Aug. 11, 2008.
Official Action from Chinese Patent Application No. 200580043790.0, dated Aug. 21, 2009.
dos San
Catalan John A.
Guirakhoo Farshad
Liu J. Jian
Monath Thomas P.
Pugachev Konstantin V.
Chen Stacy B.
Clark & Elbing LLP
Sanofi Pasteur Biologics Co.
LandOfFree
Vaccines against Japanese encephalitis virus and West Nile... does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Vaccines against Japanese encephalitis virus and West Nile..., we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Vaccines against Japanese encephalitis virus and West Nile... will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-4258313