Chemistry: molecular biology and microbiology – Measuring or testing process involving enzymes or... – Involving virus or bacteriophage
Reexamination Certificate
2008-07-29
2008-07-29
Campell, Bruce (Department: 1648)
Chemistry: molecular biology and microbiology
Measuring or testing process involving enzymes or...
Involving virus or bacteriophage
C424S184100, C424S185100, C424S189100
Reexamination Certificate
active
07405039
ABSTRACT:
The present invention relates generally to viral variants exhibiting reduced sensitivity to particular agents and/or reduced interactivity with immunological reagents. More particularly, the present invention is directed to hepatitis B virus (HBV) variants exhibiting complete or partial resistance to nucleoside analogs and/or reduced interactivity with antibodies to viral surface components including reduced sensitivity to these antibodies. The present invention further contemplates assays for detecting such viral variants, which assays are useful in monitoring anti-viral therapeutic regimens and in developing new or modified vaccines directed against viral agents and in particular HBV variants. The present invention also contemplates the use of the viral variants to screen for agents capable of inhibiting infection, replication and/or release of the virus.
REFERENCES:
patent: 2003/0124096 (2003-07-01), Locamini et al.
patent: 2004/0005541 (2004-01-01), Bartholomeusz et al.
patent: 2006/0051743 (2006-03-01), Bartholomeusz et al.
patent: WO 98 21317 (1998-05-01), None
patent: WO 01 57244 (2001-08-01), None
patent: WO 01 94559 (2001-12-01), None
Allen et al., Identification and Characterization of Mutations in Hepatitis B Virus Resistant to Lamivudine, 1998, Hepatology, vol. 27, pp. 1670-1677.
Farrell, Clinical Potential of Emerging New Agents in Hepatitis B, 2000, Drugs, vol. 60, No. 4, pp. 701-710.
Gaillard et al., “Kinetic analysis of wild-type and YMDD mutant hepatitis B virus polymerases and effects of deoxyribonucleotide concentrations on polymerase activity,” Antimicrob Agents Chemother. 46(4): 1005-1013, 2002.
Colonno et al., “Long-term entecavir treatment results in sustained antiviral efficacy and prolonged life span in the woodchuck model of chronic hepatitis infection,” JID 184: 1236-45 2001.
Das et al., “Molecular Modeling and Biochemical Characterization Reveal the Mechanism of Hepatitis B Virus Polymerase Resistance to Lamivudine (3TC) and Emtricitabine (FTC)”, J. Virol. 75(10):4771-4779, 2001.
Delaney et al., “Cross-resistance testing of antihepadnaviral compounds using novel recombinant baculoviruses which encode drug-resistant strains of hepatitis B virus,” Antimicrobial Agents Chemother 45(6): 1705-1713, 2001.
Ren and Nassal, “Hepatitis B virus (HBV) virion and covalently closed circular DNA formation in primary tupaia hepatocytes and human hepatoma cell lines upon HBV genome transduction with replication-defective adenovirus vectors,” J. Virol. 75(3): 1104-1116, 2001.
Stuyver et al., “Nomenclature for antiviral-resistant human hepatitis B virus mutations in the polymerase region,” Hepatology 33: 751-757, 2001.
Yamanaka et al., “Metabolic studies on BMS-200475, a new antiviral compound active against hepatitis B virus,” Antimicrobial Agent Chem 43: 190-193, 1999.
Allen et al., “Identification and characterization of mutations in hepatitis B virus resistant to lamivudine. Lamivudine Clinical Investigation Group,” Hepatology 27(6): 1670-1677, 1998.
Genovesi et al., “Efficacy of the carbocyclic 2′-deoxyguanosine nucleoside BMS-200475 in the woodchuck model of hepatitis B virus infection,” Antimicrobial Agent Chem 42: 3209-3217, 1998.
Seifer et al., “In Vitro Inhibition of Hepadnavirus Polymerases by the Triphosphates of BMS-200475 and Lobucavir,” Antimicrobial Agent Chem 28; 3200-3208, 1998.
Xiong et al., “Mutations in hepatitis B DNA polymerase associated with resistance to lamivudine do not confer resistance to adefovir in vitro,” Hepatology. 28(6): 1669-73, 1998.
Aye et al., “Hepatitis B virus polymerase mutations during antiviral therapy in a patient following liver transplantation,” J Hepatol. 26: 1148-53, 1997.
Bartholomeusz et al., “Clinical experience with famciclovir against hepatitis B virus,” Intervirology 40(5-6): 337-342 1997.
Bisacchi et al., “BMS-200475, a novel carbocyclic 2′-deoxyguanosine analog with potent and selective anti-hepatitis B virus activity in vitro,” Bioorg. Med. Chem. Lit. 7: 127-132, 1997.
Innaimo et al., “Identification of BMS-200475 as a potent and selective inhibitor of hepatitis B virus,” Antimicrobial Agent Chem 44: 1444-1448, 1997.
Main et al., “double blind, placebo-controlled study to assess the effect of famciclovir on virus replication in patients with chronic hepatitis B virus infection,” J. Viral Hepatitis 3: 211-215, 1996.
Dienstag et al., “A preliminary trial of lamivudine for chronic hepatitis B infection,” New England J Med 333: 1657-1661, 1995.
Hendricks DA, et al., “Quantitation of HBV DNA in human serum using a branched DNA (bDNA) signal amplification assay,” Am J Clin Pathol 104: 537-46, 1995.
Severini et al., “Mechanism of inhibition of duck hepatitis B virus polymerase by (-)-beta-L-2′,3′-dideoxy-3′-thiacytidine,” Antimicrobial Agents Chemother 39: 1430-1435, 1995.
Norder et al., “Genetic relatedness of hepatitis B viral strains of diverse geographical origin and natural variations in the primary structure of the surface antigen,” (J. Gen. Virol. 74: 1341-1348, 1993.
Vere Hodge, “Famciclovir and penciclovir. The mode of action of famciclovir including its conversion to peciclovir,” Antiviral Chem Chemother 4: 67-84, 1993.
Boyd et al., “Antiherpesvirus activity of 9-(4-hydroxy-3-hydroxymethylbut-1-yl) guanine (BRL 39123) in animals,” Antiviral Chem Chemother. 32: 358-363, 1987.
Summers and Mason, “Replication of the genome of a hepatitis B—like virus by reverse transcription of an RNA intermediate,” Cell 29: 403-415, 1982.
HBV Gen bank Accession No. M38454.
Ono et al., 2001, The polymerase L528M mutation cooperates with nucleotide binding-site mutations, increasing hepatitis B virus replication and drug resistance, J. Clin. Invest 107(4):449-55.
Xiong et al., 2000, In vitro evaluation of hepatitis B virus polymerase mutations associated with famciclovir resistance, Hepatology 31(1):219-224.
Ono-Nita et al., 1999, YMDD motif in hepatitis B virus DNA polymerase influences on replication and lamivudine resistance: A study by in vitro full-length viral DNA transfection, Hepatology 29(3):939-45.
Cane et al., 1999, Analysis of hepatitis B virus quasispecies changes during emergence and reversion of lamivudine resistance in liver transplantation, Antiviral Therapy 4:7-14.
Oon et al., 1999, Hepatitis B virus variants with lamivudine-related mutations in the DNA polymerase and the ‘a’ epitope of the surface antigen are sensitive to ganciclovir, Antiviral Research 41:113-8.
Delaney et al., 1998, Hepatitis B virus replication in human HepG2 cells mediated by hepatitis B virus recombinant baculovirus, Hepatology 28(4):1134-46.
Kruger et al. Famciclovir treatment of hepatitis B recurrence after orthotopic liver transplantation—a pilot study (Abstract), Hepatology 22:219A, 1995.
Database Uniprot [Online] EBI Hinxton U.K.; Nov. 1, 1996, Preisler-Adams et al.: “DNA Polymerase (fragment)” XP-002455528; http://beta.uniprot.org/uniprot(Q67907.txt?version=1).
Preisler-Adams et al., Jun. 24, 1993: “Sequence analysis of hepatitis B virus DNA in immunologically negative infection” Arch. Virol., vol. 133, 1993, pp. 385-396, XP000672310.
Angus Peter William
Ayres Anna
Bartholomeusz Angeline Ingrid
Locarnini Stephen Alister
Sievert William
Austin Health
Baker & Botts LLP
Blumel Benjamin P
Campell Bruce
Melbourne Health
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