Extract from the Register of European Patents

About this file: EP2813568

EP2813568 - MODIFIED FC REGION OF ANTIBODY [Right-click to bookmark this link]
StatusExamination is in progress
Status updated on  01.09.2017
Database last updated on 19.10.2019
Most recent event   Tooltip31.08.2019New entry: Despatch of examination report + time limit 
Applicant(s)For all designated states
Chugai Seiyaku Kabushiki Kaisha
5-1, Ukima 5-chome Kita-ku
Tokyo 115-8543 / JP
[2014/51]
Inventor(s)01 / KURAMOCHI, Taichi
c/o CHUGAI SEIYAKU KABUSHIKI KAISHA
135 Komakado 1-chome
Gotemba-shi Shizuoka 412-8513 / JP
02 / KAWAZOE, Meiri
c/o CHUGAI SEIYAKU KABUSHIKI KAISHA
135 Komakado 1-chome
Gotemba-shi Shizuoka 412-8513 / JP
03 / MIMOTO, Futa
c/o CHUGAI SEIYAKU KABUSHIKI KAISHA
135 Komakado 1-chome
Gotemba-shi Shizuoka 412-8513 / JP
04 / MAEDA, Atsuhiko
c/o CHUGAI SEIYAKU KABUSHIKI KAISHA
135 Komakado 1-chome
Gotemba-shi Shizuoka 412-8513 / JP
05 / IGAWA, Tomoyuki
c/o CHUGAI SEIYAKU KABUSHIKI KAISHA
135 Komakado 1-chome
Gotemba-shi Shizuoka 412-8513 / JP
 [2014/51]
Representative(s)Vossius & Partner Patentanwälte Rechtsanwälte mbB
Siebertstrasse 3
81675 München / DE
[N/P]
Former [2014/51]Vossius & Partner
Siebertstrasse 4
81675 München / DE
Application number, filing date13746387.308.02.2013
WO2013JP53011
Priority number, dateJP2012002637109.02.2012         Original published format: JP 2012026371
[2014/51]
Filing languageJA
Procedural languageEN
PublicationType: A1  Application with search report
No.:WO2013118858
Date:15.08.2013
Language:JA
[2013/33]
Type: A1 Application with search report 
No.:EP2813568
Date:17.12.2014
Language:EN
[2014/51]
Search report(s)International search report - published on:JP15.08.2013
(Supplementary) European search report - dispatched on:EP07.03.2016
ClassificationInternational:C12N15/09, A61K38/00, A61K39/395, A61P1/04, A61P3/06, A61P3/10, A61P7/00, A61P7/06, A61P9/10, A61P11/00, A61P11/02, A61P11/06, A61P13/12, A61P15/08, A61P17/00, A61P17/06, A61P19/00, A61P19/10, A61P25/00, A61P29/00, C07K16/00
[2016/14]
Former International [2014/51]C12N15/09, A61K38/00, A61K39/395, A61P1/04, A61P3/06, A61P3/10, A61P7/00, A61P7/06, A61P9/10, A61P11/00, A61P11/02, A61P11/06, A61P13/12, A61P15/08, A61P17/00, A61P17/06, A61P19/00, A61P19/10, A61P25/00, A61P29/00
Designated contracting statesAL,   AT,   BE,   BG,   CH,   CY,   CZ,   DE,   DK,   EE,   ES,   FI,   FR,   GB,   GR,   HR,   HU,   IE,   IS,   IT,   LI,   LT,   LU,   LV,   MC,   MK,   MT,   NL,   NO,   PL,   PT,   RO,   RS,   SE,   SI,   SK,   SM,   TR [2014/51]
TitleGerman:MODIFIZIERTE FC-ANTIKÖRPERREGIONEN[2014/51]
English:MODIFIED FC REGION OF ANTIBODY[2014/51]
French:RÉGION FC MODIFIÉE D'UN ANTICORPS[2014/51]
Entry into regional phase26.08.2014Translation filed 
26.08.2014National basic fee paid 
26.08.2014Search fee paid 
26.08.2014Designation fee(s) paid 
26.08.2014Examination fee paid 
Examination procedure26.08.2014Examination requested  [2014/51]
04.10.2016Amendment by applicant (claims and/or description)
31.08.2017Despatch of a communication from the examining division (Time limit: M06)
15.02.2018Reply to a communication from the examining division
10.07.2018Despatch of a communication from the examining division (Time limit: M06)
18.01.2019Reply to a communication from the examining division
04.09.2019Despatch of a communication from the examining division (Time limit: M04)
Divisional application(s)The date of the Examining Division's first communication in respect of the earliest application for which a communication has been issued is  31.08.2017
Fees paidRenewal fee
23.02.2015Renewal fee patent year 03
22.02.2016Renewal fee patent year 04
21.02.2017Renewal fee patent year 05
23.02.2018Renewal fee patent year 06
21.02.2019Renewal fee patent year 07
Documents cited:Search[XI]WO2010085682  (BIOGEN IDEC INC [US], et al) [X] 1,2,11-13,23 * table 9.2 * [I] 14-19,21,22;
 [X]US2006275282  (MOORE GREGORY L [US], et al) [X] 3,6-8,10,23-28 * sequences 534,829,830 * * page 22 - page 23 * * paragraph [0204] *;
 [X]US2005054832  (LAZAR GREGORY ALAN [US], et al) [X] 4,5,7,8,10,23-28 * tables 68,70 * * paragraphs [0028] , [0029] *;
 [X]WO2006076594  (XENCOR INC [US], et al) [X] 3,6-8,10,23-28 * paragraph [0019] * * paragraph [0022] * * page 24 - page 25 *;
 [XI]  - DEMAREST S J ET AL, "Optimization of the Antibody CH3 Domain by Residue Frequency Analysis of IgG Sequences", JOURNAL OF MOLECULAR BIOLOGY, ACADEMIC PRESS, UNITED KINGDOM, (20040102), vol. 335, no. 1, doi:10.1016/J.JMB.2003.10.040, ISSN 0022-2836, pages 41 - 48, XP004476444 [X] 1,2,11-13,23 * figure 1; table 1 * [I] 14-19,21,22

DOI:   http://dx.doi.org/10.1016/j.jmb.2003.10.040
 [A]  - GONG RUI ET AL, "Engineered human antibody constant domains with increased stability", JOURNAL OF BIOLOGICAL CHEMISTRY, AMERICAN SOCIETY FOR BIOCHEMISTRY AND MOLECULAR BIOLOGY, US, (20090522), vol. 284, no. 21, doi:10.1074/JBC.M900769200, ISSN 0021-9258, pages 14203 - 14210, XP002537697 [A] 1-8,10-19,21-28 * the whole document *

DOI:   http://dx.doi.org/10.1074/JBC.M900769200
International search[X]WO2010085682  (BIOGEN IDEC MA INC.);
 [X]JP2007525443  (XENCOR, INC.);
 [X]JP2005501514  (MEDIMMUNE, INC.)
by applicantWO2007092772
 WO2010085682
 WO2006019447
 WO2006053301
 WO2009086320
 WO2009041613
 WO2007114319
 WO2009041643
 US4816567
 WO2008081008
 WO9954342
 WO0061739
 WO0231140
 WO2006067847
 WO2006067913
 WO02079255
 EP0239400
 WO9602576
 WO9312227
 WO9203918
 WO9402602
 WO9425585
 WO9634096
 WO9633735
 WO9201047
 WO9220791
 WO9306213
 WO9311236
 WO9319172
 WO9501438
 WO9515388
 EP0125023
 WO2009125825
 WO2005037989
 WO2004058821
 WO03002609
 WO0220565
 WO9501937
 WO2004044011
 WO2005040229
 WO0232925
    - JANICE M REICHERT; CLARK J ROSENSWEIG; LAURA B FADEN; MATTHEW C DEWITZ, NATURE BIOTECHNOLOGY, (2005), vol. 23, pages 1073 - 1078
    - PAVLOUAK, BELSEY MJ., "The therapeutic antibodies market to 2008.", EUR J PHARM BIOPHARM., (200504), vol. 59, no. 3, pages 389 - 96
    - HINTON PR; XIONG JM; JOHLFS MG; TANG MT; KELLER S; TSURUSHITA N., "An engineered human IgGl antibody with longer serum half-life.", J IMMUNOL., (20060101), vol. 176, no. 1, pages 346 - 56
    - GHETIE V; POPOV S; BORVAK J; RADU C; MATESOI D; MEDESAN C; OBER RJ; WARD ES, "Increasing the serum persistence of an IgG fragment by random mutagenesis.", NAT BIOTECHNOL., (199707), vol. 15, no. 7, doi:doi:10.1038/nbt0797-637, pages 637 - 40, XP000876642

DOI:   http://dx.doi.org/10.1038/nbt0797-637
    - OGANESYAN V; DAMSCHRODER MM; LEACH W; WU H; DALL'ACQUA WF., "Structural characterization of a mutated, ADCC-enhanced human Fc fragment.", MOL IMMUNOL., (200804), vol. 45, no. 7, doi:doi:10.1016/j.molimm.2007.10.042, pages 1872 - 82, XP022478949

DOI:   http://dx.doi.org/10.1016/j.molimm.2007.10.042
    - OGANESYAN V; GAO C; SHIRINIAN L; WU H; DALL'ACQUA WF, "Structural characterization of a human Fc fragment engineered for lack of effector functions.", BIOL CRYSTALLOGR., (200806), vol. 64, doi:doi:10.1107/S0907444908007877, pages 700 - 4, XP009108181

DOI:   http://dx.doi.org/10.1107/S0907444908007877
    - LIU H; BULSECO GG; SUN J., "Effect ofposttranslational modifications on the thermal stability of a recombinant monoclonal antibody.", IMMUNOL LETT., (20060801), vol. 06, no. 2, pages 144 - 53
    - GAZA-BULSECO G; LIU H., "Fragmentation of a recombinant monoclonal antibody at various pH.", PHARM RES., (200808), vol. 25, no. 8, pages 1881 - 90, XP019613172
    - RAJU TS; SCALLON BJ., "Glycosylation in the Fc domain of IgG increases resistance to proteolytic cleavage by papain.", BIOCHEM BIOPHYS RES COMMUN., (200603), vol. 341, no. 3, doi:doi:10.1016/j.bbrc.2006.01.030, pages 797 - 803, XP024923854

DOI:   http://dx.doi.org/10.1016/j.bbrc.2006.01.030
    - GONG R; VU BK; FENG Y; PRIETO DA; DYBA MA; WALSH JD; PRABAKARAN P; VEENSTRA TD; TARASOV SG; ISHIMA R, "Engineered human antibody constant domains with increased stability", J BIOL CHEM., (200903), vol. 284, no. 21, doi:doi:10.1074/JBC.M900769200, pages 14203 - 14210, XP002557527

DOI:   http://dx.doi.org/10.1074/JBC.M900769200
    - REMMELE RL JR; CALLAHAN WJ; KRISHNAN S; ZHOU L; BONDARENKO PV; NICHOLS AC; KLEEMANN GR; PIPES GD; PARK S; FODOR S, "Active dimer of Epratuzumab provides insight into the complex nature of an antibody aggregate", J PHARM SCI., (200601), vol. 95, no. 1, pages 126 - 45
    - ROSENBERG AS, "Effects of Protein Aggregates: An Immunologic Perspective.", AAPS J., (200608), vol. 8, no. 3, doi:doi:10.1208/aapsj080359, pages E501 - E507, XP003021154

DOI:   http://dx.doi.org/10.1208/aapsj080359
    - J. EXP. MED, (1990), vol. 172, pages 19 - 25
    - PROC. NATL. ACAD. SCI. USA, (2006), vol. 103, no. 11, pages 4005 - 4010
    - PROC. NATL. ACAD. SCI USA, (2006), vol. 103, no. 11, pages 4005 - 4010
    - J. IMMUNOL., (20060101), vol. 176, no. 1, pages 346 - 56
    - J BIOL CHEM., (20060818), vol. 281, no. 33, pages 23514 - 24
    - INT. IMMUNOL., (200612), vol. 18, no. 12, pages 1759 - 69
    - NAT BIOTECHNOL., (201002), vol. 28, no. 2, pages 157 - 9
    - J. IMMUNOL., (2006), vol. 176, no. 1, pages 346 - 356
    - NAT. BIOTECHNOL., (1997), vol. 15, no. 7, pages 637 - 640
    - THE JOURNAL OF BIOLOGICAL CHEMISTRY, (2001), vol. 276, no. 9, pages 6591 - 6604
    - MOLECULAR CELL, (2001), vol. 7, pages 867 - 877
    - IMMUNOLOGY, (2002), vol. 105, pages 9 - 19
    - GEIGER ET AL., J. BIO. CHEM., (1987), vol. 262, pages 785 - 794
    - HASHIMOTO-GOTOH, T; MIZUNO, T; OGASAHARA, Y; NAKAGAWA, M., "An oligodeoxyribonucleotide-directed dual amber method for site-directed mutagenesis", GENE, (1995), vol. 152, doi:doi:10.1016/0378-1119(94)00750-M, pages 271 - 275, XP004042690

DOI:   http://dx.doi.org/10.1016/0378-1119(94)00750-M
    - ZOLLER, MJ; SMITH, M, "Oligonucleotide-directed mutagenesis of DNA fragments cloned into M13 vectors", METHODS ENZYMOL., (1983), vol. 100, doi:doi:10.1016/0076-6879(83)00074-9, pages 468 - 500, XP001088749

DOI:   http://dx.doi.org/10.1016/0076-6879(83)00074-9
    - KRAMER, W; DRUTSA, V; JANSEN, HW; KRAMER, B; PFLUGFELDER, M; FRITZ, HJ, "The gapped duplex DNA approach to oligonucleotide-directed mutation construction", NUCLEIC ACIDS RES., (1984), vol. 12, pages 9441 - 9456, XP002026371
    - KRAMER W; FRITZ HJ, "Oligonucleotide-directed construction of mutations via gapped duplex DNA Methods", ENZYMOL., (1987), vol. 154, pages 350 - 367
    - KUNKEL, TA, "Rapid and efficient site-specific mutagenesis without phenotypic selection", PROC NATL ACAD SCI U S A., (1985), vol. 82, doi:doi:10.1073/pnas.82.2.488, pages 488 - 492, XP002052322

DOI:   http://dx.doi.org/10.1073/pnas.82.2.488
    - MABS., (201009), vol. 2, no. 5, pages 519 - 27
    - KOHLER; MILSTEIN, NATURE, (1975), vol. 256, page 495
    - CLACKSON ET AL., NATURE, (1991), vol. 352, pages 624 - 628
    - MARKS ET AL., J.MOL.BIOL., (1991), vol. 222, pages 581 - 597
    - BERNASCONI ET AL., SCIENCE, (2002), vol. 298, pages 2199 - 2202
    - "Hormones and their Actions Part II", COOKE BA., KING RJB., VAN DER MOLEN HJ., New Comprehesive Biochemistry, ELSEVIER SCIENCE PUBLISHERS BV, (1988), vol. 18B, pages 1 - 46
    - PATTHY, CELL, (1990), vol. 61, no. 1, pages 13 - 14
    - ULLRICH ET AL., CELL, (1990), vol. 61, no. 2, pages 203 - 212
    - MASSAGUE, CELL, (1992), vol. 69, no. 6, pages 1067 - 1070
    - MIYAJIMA ET AL., ANNU. REV. IMMUNOL., (1992), vol. 10, pages 295 - 331
    - TAGA ET AL., FASEB J., (1992), vol. 6, pages 3387 - 3396
    - FANTL ET AL., ANNU. REV. BIOCHEM., (1993), vol. 62, pages 453 - 481
    - SMITH ET AL., CELL, (1994), vol. 76, no. 6, pages 959 - 962
    - FLOWER DR., BIOCHIM. BIOPHYS. ACTA, (1999), vol. 1422, no. 3, pages 207 - 234
    - BLOOD, (1990), vol. 76, no. 1, pages 31 - 35
    - CELL, (1989), vol. 57, no. 2, pages 277 - 285
    - PROC. NATL. ACAD. SCI. USA., (1990), vol. 87, no. 22, pages 8702 - 8706
    - CELL, (1990), vol. 61, no. 2, pages 341 - 350
    - PROC NATL ACAD SCI U S A., (1992), vol. 89, no. 12, pages 5640 - 5644
    - EMBO J., (1993), vol. 12, no. 7, pages 2645 - 53
    - NATURE, (1985), vol. 313, no. 6005, pages 756 - 761
    - PROC. NATL. ACAD. SCI. USA., (1994), vol. 91, no. 2, pages 459 - 463
    - PROC. NATL. ACAD. SCI. USA., (1988), vol. 85, no. 10, pages 3435 - 3439
    - CELL, (1990), vol. 60, no. 2, pages 225 - 234
    - CELL, (1994), vol. 77, no. 3, pages 391 - 400
    - INT J CANCER., (2003), vol. 103, no. 4, pages 455 - 65
    - PROC NATL ACAD SCI USA., (1989), vol. 86, no. 1, pages 27 - 31
    - CHOTHIA ET AL., NATURE, (1989), vol. 342, page 877
    - NAT MED., (200301), vol. 9, no. 1, pages 47 - 52
    - BIODRUGS, (2006), vol. 20, no. 3, pages 151 - 60
    - CURRENT OPINION IN BIOTECHNOLOGY, (2006), vol. 17, pages 653 - 658
    - CURRENT OPINION IN BIOTECHNOLOGY, (2007), vol. 18, pages 1 - 10
    - CURRENT OPINION IN STRUCTURAL BIOLOGY, (1997), vol. 7, pages 463 - 469
    - PROTEIN SCIENCE, (2006), vol. 15, pages 14 - 27
    - WARD ET AL., NATURE, (1989), vol. 341, pages 544 - 546
    - FASEB J., (1992), vol. 6, pages 2422 - 2427
    - BETTER ET AL., SCIENCE, (1988), vol. 240, pages 1041 - 1043
    - LEI, S. P. ET AL., J. BACTERIOL., (1987), vol. 169, page 4379
    - NUCLEIC ACIDS. RES., (1990), vol. 18, no. 17, page 5322
    - MULLIGAN ET AL., NATURE, (1979), vol. 277, page 108
    - MIZUSHIMA ET AL., NUCLEIC ACIDS RES., (1990), vol. 18, page 5322
    - GENE, (1990), vol. 18, page 5322
    - Sequences of proteins of immunological interest, NIH PUBLICATION NO. 91-3242
    - BIOCHEMISTRY, (1994), vol. 33, pages 5510 - 5517
    - NATURE, (1994), vol. 367, pages 660 - 663
    - NATURE, (2000), vol. 406, pages 267 - 273
    - J BIOL. CHEM., (2009), vol. 284, pages 14203 - 14210
    - CURRENT OPINION, (2009), vol. 20, pages 685 - 691
    - PROTEIN SCIENCE, (1995), vol. 4, pages 2411 - 2423
    - JOURNAL OF PHARMACEUTICAL SCIENCE, (2010), vol. 4, pages 1707 - 1720