Chemistry: molecular biology and microbiology – Virus or bacteriophage – except for viral vector or...
Reexamination Certificate
2006-03-15
2010-10-05
Lucas, Zachariah (Department: 1648)
Chemistry: molecular biology and microbiology
Virus or bacteriophage, except for viral vector or...
Reexamination Certificate
active
07807437
ABSTRACT:
The present invention relates generally to the field of Hepatitis B variants exhibiting a reduced sensitivity to nucleoside analogues both in vivo and in vitro. More in particular, reverse transcriptase mutant rt I233V is provided. Present invention provides assays and methods for detecting such variant, which assays are useful in monitoring anti-viral therapeutic regimes and adjusting patient therapy. A diagnostic kit for detecting the presence of an HBV variant in a biological sample has also been described. Finally, the use of a pharmaceutical composition to cure a subject suffering from a HBV infection, which HBV is resistant to lamuvidine and/or adefovir has been provided, which pharmaceutical composition comprises the nucleoside analogue tenofovir.
REFERENCES:
patent: 6555311 (2003-04-01), Locarnini
patent: 2003/0124096 (2003-07-01), Locarnini
patent: 2006/0165725 (2006-07-01), Bozdayi
patent: 2006/0234212 (2006-10-01), Bozdayi
patent: 2007/0042356 (2007-02-01), Schildgen
patent: WO 94/26904 (1994-11-01), None
patent: 97/40193 (1997-10-01), None
patent: WO 98/21317 (1998-05-01), None
patent: WO 00/58477 (2000-10-01), None
patent: WO 00/61758 (2000-10-01), None
patent: 03/066841 (2003-08-01), None
patent: WO 03/087351 (2003-10-01), None
patent: WO 2004/031224 (2004-04-01), None
Angus et al., Resistance to Adefovir Dipivoxil Therapy Associated With the Selection of a Novel Mutation in the HBV Polymerase, Gastroenterology, 2003, 125:292-297.
Bartholomeusz et al., Comparisons of the HBV and HIV polymerase, and antiviral resistance mutations, Antiviral Therapy, 2004, 9:149-160.
Tacke et al., Basal Core Promoter and Precore Mutations in the Hepatitis B Virus Genome Enhance Replication Efficacy of Lamivudine-Resistant Mutants, Journal of Virology, 2004, 78(16):8524-8535.
GenBank Accession No. AB367435.
GenBank Accession No. AB367434.
GenBank Accession No. AB367429.
European Search Report dated Nov. 30, 2005, issued connection with corresponding EP 05102014.7
Alexopoulou A et al, J General Virology (1996), vol. 3, pp. 173-181, “Whole genome analysis of hepatitis B virus from four cases of fulminant hepatitis: genetic variability and its potential role in disease pathogenicity” Table 3.
Aye et al, “Hepatitis B Virus Polymerase Mutations During Famciclovir Therapy in Patients Following Liver Transplantation”, Hepatology vol. 24, No. 4, Pt.2, Abstract 633, Sep. 1996.
Aye et al, “Hepatitis B Virus polymerase mutations during antiviral therapy in a patient following liver transplantation”, Journal of Hepatology, 1997; 26: 1148-1153.
Bartholomeusz et al, “Mutations in the hepatitis B virus polymerase gene that are associated with resistance to famciclovir and lamivudine”,1997, International Antiviral News , vol. 5, No. 8, pp. 123-124.
Bartholomew, “Hepatitis-B-virus resistance to lamivudine given for recurrent infection after orthotopic liver transplantation”, (Lancet 349: Jan. 20-22, 1997).
Bowyer S et al, J General Virology (1997), vol. 78, pp. 1719-1729, “A unique segment of the hepatitis B virus group A genotype identified in isolates from South Africa” Figure 5.
Bozdayi et al “A new mutation pattern (YMDD->YSDD) in the YMDD motif of HBV-DNA polymerase gene in chronic B hepatitis infection resistant to lamivudine” Journal of Hepatology, 2001, 34(1):162-162. Meeting Abstract.
Carman et al, “Vaccine-induced escape mutant . . .”, The Lancet, vol. 336, 1990 (8711) pp. 325-329.
Carman, “The clinical significance of surface antigen variants . . . ”, Journal of Viral Hepatitis, 1997. 4 (Suppl. 1) 11-20.
Chenault, “Patterns of nucleotide sequence variation among cauliflower mosaic virus isolates”, (Biochimie 76:3-8, 1994).
de Man et al, “The sequential occurrence of viral mutations in a liver transplant recipient re-infected with hepatitis B: hepatitis B immune globuline escape, famciclovir non-respnse, followed by lamivudine resistance resulting in graft loss”, Journal of Hepatology, 1998; 29: 669-675.
Delaney et al, “Phenylpropenamide Derivatives AT-61 and AT-130 Inhibit Replication of Wild-Type and Lamivudine-Resistant Strains of Hepatitis B Virus In Vitro”, Antimicrobial Agents and Chemotherapy, Sep. 2002, vol. 46, No. 9, pp. 3057-3060.
Delaney et al, “Resistance of hepatitis B virus to antiviral drugs: current aspects and directions for future investigation”, Antiviral Chemistry & Chemotherapy 12:1-35 (2001).
Fischer et al, “Generation of Duck Hepatitis B Virus Polymerase Mutants through Site-Directed Mutagenesis Which Demonstrate Resistance to Lamivudine [(-)-β-L-2′,3′-Dideoxy-3′-Thiacytidine] In Vitro”, Antimicrobial Agents & Chemotherapy 40: 1957-1960, Aug. 1996.
Fujii et al, “Gly145to Arg Substitution in HBs Antigen of . . . ”, Biochemical and Biophysical Research Communications, vol. 184, No. 3, May 15, 1992, pp. 1152-1157.
Gaillard et al, “Kinetic Analysis of Wild-Type and YMDD Mutant Hepatitis B Virus Polymerases and Effects of Deoxyribonucleotide Concentrations on Polymerase Activity”, Antimicrobial Agents and Chemotherapy, Apr. 2002, vol. 46, No. 4, pp. 1005-1013.
Gerner et al, “Hepatitis B Virus Core Promoter Mutations in Children with Multiple Anti-HBe/HBeAg Reactivations Result in Enhanced Promoter Activity”, Journal of Medical Virology 59:415-423 (1999).
Han et al, “YMDD Motif Mutants in Hepatitis B Virus Polymerase during Lamivudine Therapy”, Korean J. Genetics 24(2):219-226 (Jun. 2002).
Ho et al,, “A Family Cluster of an Immune Escape Variant of Hepatitis B Virus Infecting a Mother and Her Two Fully Immunized Children”, Clinical and Diagnostic Laboratory Immunology, 1995, vol. 2, No. 6, pp. 760-762.
Horikita M et al, J Medical Virology (1994), vol. 44(1), pp. 96-103, “Differences in the entire nucleotide sequence between hepatitis B virus genomes from carriers positive for antibody to hepatitis B e antigen with and without active disease” Table IV.
Ling (“Selection of mutations in hepatitis B virus polymerase during therapy of transplant recipients with lamivudine” Hepatology 24(3): 711-713, Sep. 1996).
Ni F et al, Research in Virology (1995), vol. 146(6), pp. 397-407, “A new immune escape mutant of hepatitis B virus with an Asp to Ala substitution in aa144 of the envelope major protein” Figure 3.
Niesters et al, “Identification of a new variant in the YMDD motif of the hepatitis B virus polymerase gene selected during lamivudine therapy”, J. Med. Microbiol., vol. 51 (2002), 695-699.
Norder , “Molecular basis of hepatitis B virus serotype variations within the four major subtypes”, (Virology 198: 489-503, 1994).
Norder et al, “Molecular basis of hepatitis B virus serotype variations within the four major subtypes”, Journal of General Virology 1992, vol. 73, pp. 3141-3145.
Norder H et al, J General Virology (1992), vol. 73(5), pp. 1201-1208, “Comparison of the amino acid sequences of nine different scrotypes of hepatitis B surface antigen and genomic classification of the corresponding hepatitis B strains” Figure 3.
Norder H et al, J General Virology (1993), vol. 74, pp. 1341-1348, “Genetic relatedness of hepatitis B viral strains of diverse geographical origin and natural variations in the primary structure of the surface antigen” Figure 2.
Okamoto F et al, J. General Virology (1988), vol 69, pp. 2575-2583, “Typing hepatitis B virsu by homology in nucleotide sequence: comparison of surface antigen subtypes” Figure 1.
Ono Y et al, Nucleic Acids Research(1983), vol. 11(6), pp. 1747-1757, “The complete nucleotide of the cloned hepatitis B virus DNA; subtypeadrandadw” Figure 2 and 3.
Pasek M et al, Nature(1979), vol. 282, pp. 575-579, “Hepatitis B virus genes and their expression inE. coli” Figure 2.
Perrillo et al, &#
Daeumer Martin
Gerlich Wolfram
Helm Martin
Kaiser Rolf
Matz Bertfried
Justus-Liebig-Universitaet Gissen
Kinsey White Nicole
Lucas Zachariah
Nixon & Vanderhye P.C.
Rheinishche Friedrich-Wilhelms-Universitaet Bonn
LandOfFree
Variants of hepatitis B virus resistant against some... does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Variants of hepatitis B virus resistant against some..., we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Variants of hepatitis B virus resistant against some... will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-4239209