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| Hai Lama Dia Tetan Ari Dia Tela a to Od |HAI LAMA DIA TETANUS010035826B2 ARI DIA TELA A TOOD HOT (12 ) United States Patent ( 10 ) Patent No. : US 10 , 035 ,826 B2 Masignani et al. (45 ) Date of Patent: Jul. 31 , 2018 ( 54 ) PROTEINS AND NUCLEIC ACIDS FROM ( 56 ) References Cited MENINGITIS /SEPSIS - ASSOCIATED ESCHERICHIA COLI U . S . PATENT DOCUMENTS 7 ,424 , 370 B2 9 / 2008 Sachdeva et al . ( 71 ) Applicants :GlaxoSmithKline Biologicals SA , 8 ,758 , 764 B2 6 / 2014 Masignani et al . Rixensart (BE ) ; J . Craig Venter 2003 /0165870 A1 9 / 2003 Blattner et al. Institute , Inc . , Rockville , MD (US ) 2004 /0123343 A1 6 /2004 La Rosa et al. FOREIGN PATENT DOCUMENTS (72 ) Inventors: Vega Masignani, Siena (IT ) ; Danilo Gomes Moriel, Monteriggioni (IT ) ; EP 1342784 A1 9 / 2003 wo 1998 / 022575 A2 5 / 1998 Francesco Berlanda Scorza , Trento WO 2001 / 066572 A2 9 / 2001 ( IT ) ; Nathalie Norais , Siena ( IT ) ; WO 2002 /016439 A2 2 / 2002 Maria Rita Fontana , Siena (IT ) ; WO 2002 /059320 A2 8 / 2002 Mariagrazia Pizza , Siena (IT ) ; Laura WO 2002 /077183 A2 10 / 2002 Serino , Monticiano (IT ); Herve WO 2004 /005535 A2 1 / 2004 Tettelin , Gaithersburg , MD (US ) WO 2005 /076010 A2 8 /2005 ( 73 ) Assignees: GlaxoSmithKline Biologicals SA , OTHER PUBLICATIONS Rixensart (BE ) ; J . Craig Venture Accession No . A0A0D8W5Q4 , May 27 , 2015 . * Institute , Inc. , Rockville , MD (US ) Accessio No . 046837 2002 (or 02M9M2 or 046838 or 06BF5 ) or Science 277, 1997 , pp . 1453 - 1474 . EBI accession No. Q8FKK3, Version 56 , Mar. 1 , 2003 , 2 pages . ( * ) Notice : Subject to any disclaimer, the term of this EBI accession No . Q8X6G3, Version 71, Mar. 1 , 2002 , 3 pages . patent is extended or adjusted under 35 Escherichia coli pathogenicity island V , strain 536 , retrieved from U . S .C . 154 (b ) by 0 days . EBI accession No . EMBL : AJ617685 Database accession , May 11 , 2004 , 54 pages. Escherichia coli strain BEN2908 pathogenicity island AGI- 1 , com (21 ) Appl. No. : 15 / 150 , 204 plete sequence , retrieved from EBI accession No. EM _ PRO : AY395687 , Oct . 24 , 2003, 18 pages. RecName: Full = Putative lipoprotein acfD homolog ; •Flags : Precur (22 ) Filed : May 9 , 2016 sor; ADHKTEDSLK AAKEKIFAAF PGLKECTNPA YHYEVNCLEY RPGTGVPVTG GMYVPQYTQ , retrieved from EBI accession No . UNIPROT: Q46837 , Apr. 16 , 2002 , 2 pages . (65 ) Prior Publication Data Sequence Analysis of the Vibrio CholeraeacfD Gene Reveals the Presence of an Overlapping Reading Frame, OrfZ , which Encodes US 2016 /0244489 A1 Aug. 25 , 2016 a Protein that Shares Sequence Similarity to the FliA and Flic Products of Salmonella , Gene, Elsevier, Amsterdam , NL , vol . 146 , No. 1 , Aug . 19 , 1994 , pp . 79 -82 . Related U . S . Application Data European Examination Report dated Dec . 29 , 2008 , for EP Patent Application No . 06748228 . 1 , filed Feb . 17 , 2006 . (62 ) Division of application No. 14 /293 , 967, filed on Jun . Extended European Search Report ( includes Supplementary Euro 2 , 2014 , now Pat . No . 9 , 334 ,313 , which is a division pean Search Report and Search Opinion ) received for European of application No . 11 /884 ,812 , filed as application Patent Application No. 06748228. 1 , dated Dec . 23 , 2008 , 4 pages. No . PCT/ US2006 /005913 on Feb . 17 , 2006 , now Pat . Office Action Received for European Patent Application No . 06748228 . 1 , dated Dec . 29 , 2008 , 4 pages . No. 8 ,758 , 764 . Final Office Action received for U . S . Appl. No. 11/ 884 ,812 , dated Feb . 1 , 2010 , 4 pages . Non -Final Office Action received for U . S . Appl . No . 11 / 884 ,812 , (60 ) Provisional application No . 60 / 712, 720 , filed on Aug . dated Jun . 23 , 2009 , 12 pages. 29, 2005 , provisional application No . 60 /654 ,632 , Non - Final Office Action received for U . S . Appl . No. 11 / 884 ,812 , filed on Feb . 18 , 2005 . dated Sep . 23 , 2013 , 4 pages . Notice of Allowance received for U . S . Appl . No. 11 / 884 ,812 , dated Feb . 5 , 2014 , 8 pages . ( 51) Int. CI. Non Final Office Action received for U . S . Appl. No . 14 /293 , 967 A61K 39 / 02 ( 2006 . 01 ) dated Jul. 29 , 2015 , 15 pages . CO7K 14 /245 ( 2006 .01 ) CO7K 16 / 12 ( 2006 .01 ) (Continued ) A61K 39 / 108 ( 2006 . 01 ) Primary Examiner — Padmavathi Baskar A61K 39 /00 (2006 . 01) ( 74 ) Attorney , Agent, or Firm — Morrison & Foerster ( 52 ) U . S . CI. LLP CPC . .. C07K 14 /245 ( 2013 . 01 ) ; A61K 39 /0258 (57 ) ABSTRACT (2013 .01 ) ; CO7K 16 / 1232 ( 2013 .01 ) ; A61K Disclosed herein are various open reading frames from a 39 /00 (2013 . 01 ) ; A61K 2039 /505 ( 2013 . 01 ) ; strain of E . coli responsible for neonatal meningitis A61K 2039 /523 ( 2013 .01 ) (MNEC ) , and a subset of these that is of particular interest ( 58 ) Field of Classification Search for preparing compositions for immunizing against MNEC None infections. See application file for complete search history . 4 Claims, 4 Drawing Sheets US 10 ,035 ,826 B2 Page 2 (56 ) References Cited McGuinnes et al . Lancet , vol. 337, Mar. 1991, pp . 514 - 517 . McGuinness et al. , “ Class 1 Outer Membrane protein of Neisseria Meningitidis: Epitope Analysis of the Antigenic Diversity Between OTHER PUBLICATIONS Strains , Implications for Subtype Definition and Molecular Epide Notice of Allowance received for U . S . Appl. No . 14 /293 , 967, dated miology ” , Mol . Microbiology , vol. 7 , Feb . 1993 , pp . 505 -514 . Jan . 7 , 2016 , 8 pages. International Preliminary Report on Patentability received for PCT Abaza et al ., “ Effects of Amino Acid Substitutions Outside an Patent Application No . PCT/ US2006 /005913 , dated Aug . 21 , 2007 , Antigenic Site on Protein Binding to Monoclonal Antibodies of 9 pages . Predetermined Specificity Obtained by Peptide Immunization : International Search Report and Written Opinion received for PCT Demonstration with Region 94 - 100 (antigenic site 3 ) of Patent Application No. PCT/US2006 / 005913 , dated Feb . 15 , 2007 , Myoglobin ” , Journal of Protein Chemistry , vol. 11 , No . 5 , 1992, pp . 14 pages . 433 -444 . Perna et al . , “ Genome sequence of enterohaemorrhagic Escherichia Accession D85521, Feb . 16 , 2001 . coli 0157 :H7 ” , Nature , vol. 409 , No. 6819 , 2001 , pp . 529 - 533 . Accession H90670 , Jul. 18 , 2001 . Rode et al. , “ Type - Specific Contributions to Chromosome Size Bernadac et al. , “ Escherichia coli tol- pal mutants form outer Differences in Escherichia Coli, Infection and Immunity ” , vol. 67 , membrane vesicles ” , Journal of Bacteriology , vol. 180 , No . 8 , 1998 , No. 1 , Jan . 1999 , pp . 230 -236 . pp . 4872 -4878 . Thomas et al. , “ Improved Methods for Producing OuterMembrane Bonacorsi et al ., “ Identification of Regions of the Escherichia coli Vesicles in Gram -Negative Bacteria ” , Research in Microbiology , Chromosome Specific for Neonatal Meningitis - Associated Strains” , vol. 155 , No. 6 , Jul. 2004 , pp . 437 -446 . Infection and Immunity , vol. 68 , No. 4 , Apr. 2000 , pp . 2096 -2101 . Welch et al. , “ Extensive Mosaic Structure Revealed by the Com Coleman et al. , “ Effects of Amino Acid Sequence Changes on plete Genome Sequence of Uropathogenic Escherichia coli ” , Antibody - Antigen Interactions” , Research in Immunology , vol. PNAS , vol. 99 , No. 26 , 2002 , pp . 17020 - 17024 . 145 , No. 1 , 1994 , pp . 33 - 36 . Wu, “ The relationship between outer membrane vesicles and patho Dean -Nystrom et al. , “ Vaccination of Pregnant Dams with Intimin genicity ” , Foreign Medicine (Microbiology Section ) , vol. 4 , 2002 , (0157 ) Protects Suckling Piglets from Escherichia coli 0157 :H7 pp . 13 - 15 . Infection ” , Infect Immun , vol. 70 , No. 5 , 2002 , pp . 2414 - 2418 . Zhang et al ., “ Molecular Epidemiologic Approaches to Urinary Gonzalez et al ., “ Adaptation of Signature - Tagged Mutagenesis to Tract Infection Gene Discovery in Uropathogenic Escherichia Escherichia coli K1 and the Infant -Rat Model of Invasive Disease” , Coli ” , Infection and Immunity , vol. 68 , No . 4 , Apr . 2000 , pp . FEMS Microbiology Letters , vol. 198 , No. 2 , May 1 , 2001, pp . 2009 - 2015 . 125 - 128 . Decision to Grant received for European Patent Application No . Holmes “ PSMA Specific Antibodies and their Diagnostic and 06748228 . 1 , dated Jan . 8 , 2016 , 3 pages . Therapeutic Use ” , Exp . Opin . Invest . Drugs , vol. 10 , No . 3 , 2001 , Intention to Grant received for European Patent Application No . pp . 511 -519 . 06748228 . 1 , dated Jan . 27 , 2015 , 6 pages . Houghten et al. , “ New Approaches to Immunization ” , Vaccines 86 , Intention to Grant received for European Patent Application No. Cold Spring Harbor Laboratory , 1986 , pp . 21 - 25 . 06748228 . 1 , dated Jul. 21 , 2015 , 6 pages . Janke et al ., “ A Subtractive Hybridisation Analysis of Genomic Office Action Received for European Patent Application No. Differences Between the Uropathogenic E . Coli Strain 536 and the 06748228 . 1 , dated Dec. 9 , 2011, 4 pages. E . Coli K - 12 Strain MG1655 ” , FEMS Microbiology Letters , vol. Office Action Received for European Patent Application No. 199 , No . 1 , May 2001, pp . 61- 66 . 06748228 . 1 , dated Feb . 28 , 2013 , 4 pages . Judge et al ., “ Plant Cell -Based Intimin Vaccine given Orally to Mice Office Action Received for European Patent Application No. Primed with Intimin Reduces Time of Escherichia coli 0157 :H7 06748228 . 1 , dated Sep . 4 , 2012 , 3 pages . SheddinQ in Feces” , Infection and Immunity , vol. 72 , No . 1 , 2008 , pp . 168 - 175 . * cited by examiner U . S . Patent Jul. 31, 2018 Sheet 1 of 4 US 10 ,035 , 826 B2 FIG . 1A anagedienocoq{ flooooooooooook - -- - -- - - -- -
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