Preface
v
Contributors to the Sixth Edition IX
Table of Contents - Detailed
xv
1 Patentable Subject Matter/Industrial Applicability/Utility: Legal Basis,
Summary and Discussion of the EPO, US and JPO Practice 1 1.1 Patentable Subject Matter/Industrial Applicability: EPO (Articles 52 and 53
EPC1973, Articles 52, 53 and 54[5] EPC2000, the EU Directive 98/44/EC of July
6, 1998 and its Implementation by the EPO) 1
1.2 Patentable Subject Matter/Utility: US (35 U.S.C. § 101 (1984)) 16 1.3 Patentable Subject Matter/Industrial Applicability: JPO 36
2 Patentable Subject Matter: The EPO's Case Law 43
3 The Person Skilled in the Art: Legal Basis, Summary and Discussion of the
EPO, US and JPO Practice 100
3.1 The Person Skilled in the Art: EPO 100
3.2 The Person Skilled in the Art: US 101
3.3 The Person Skilled in the Art: JPO 104
4 The Person Skilled in the Art: The EPO's Case Law 106 5 Corrections and Amendments: Legal Basis, Summary and Discussion of
the EPO, US and JPO Practice 110
5.1 Corrections and Amendments: EPO (Article 123 and Rule 88 EPC1973/Rule 139
EPC2000) 110
5.2 Corrections and Amendments: US 118
5.3 Corrections and Amendments: JPO 125
6 Corrections and Amendments: The EPO's Case Law 131
7 Clarity of Claims: Legal Basis, Summary and Discussion of the EPO, US and
JPO Practice 251
7.1 Clarity of Claims: EPO (Article 84 EPC) 251
7.2 Clarity of Claims: US 254
7.3 Clarity of Claims: JPO 259
8 Clarity of Claims: The EPO's Case Law 262
9 Enabling Disclosure: Legal Basis, Summary and Discussion of the EPO, US
and JPO Practice 313
9.1 Enabling Disclosure: EPO (Article 83 EPC) 313
9.2 Enabling Disclosure: US 324
9.3 Enabling Disclosure: JPO 342
XI
http://d-nb.info/1074206193
10 Enabling Disclosure: The EPO's Case Law 350 11 Deposit: Legal Basis, Summary and Discussion of the EPO, US and JPO
Practice 523
11.1 Deposit: EPO (Article 83 EPC and Rule 28 and Rule 28a EPC1973/Rules 31 to 34
EPC2000 of the Implementing Regulations) 523
11.2 Deposit: US 530
11.3 Deposit: JPO 533
12 Deposit: The EPO's Case Law 535
13 Priority: Legal Basis, Summary and Discussion of the EPO, US and JPO
Practice 545
13.1 Priority: EPO (Articles 87 to 89 EPC) 545
13.2 Priority: US 551
13.3 Priority: JPO 564
14 Priority: The EPO's Case Law 567
15 Novelty: Legal Basis, Summary and Discussion of the EPO, US and JPO
Practice 613
15.1 Novelty: EPO (Article 54 EPC/Article 54 EPC2000) 613
15.2 Novelty: US 631
15.3 Novelty: JPO 646
16 Novelty: The EPO's Case Law 654
17 Inventive Step: Legal Basis, Summary and Discussion of the EPO, US and
JPO Practice 831
17.1 Inventive Step: EPO (Article 56 EPC) 831
17.2 Inventive Step: US 845
17.3 Inventive Step: JPO 869
18 Inventive Step: The EPO's Case Law 879
19 Decisions of the EPO Dealing with Procedural Issues and Procedural
Changes Due to EPC2000 1264
20 Drafting Claims for a European Patent Application 1357 21 Examples of Claims for a US Patent Application 1359 22 Examples of Claims for a Japanese Patent Application 1373 23 How to Draft and File a European Patent Application 1383 24 How to Draft the Description of a US Patent Application 1395 25 How to Draft the Description of a Japanese Patent Application 1417
XII
26 How to Keep Notebooks for Successful Interferences 1423
27 Extensions to Patent Term 1428
28 AIA Post-Grant Proceedings in the United States 1438
Decisions of the EPO 1459
Decisions on U.S. Cases 1503
Decisions on Japanese Cases 1526
European Statutes ' 1529
Cross-Reference List Article EPC1973 Article/Rule EPC2000 1530
Cross-Reference List Rule EPC1973 Rule EPC2000 1532
U.S. Statutes , 1537
Japanese Statutes 1538
Index 1539
XIII
Preface V
Contributors to the Sixth Edition EX
Table of Contents - Overview XI
1 Patentable Subject Matter/Industrial Applicability/Utility: Legal Basis,
Summary and Discussion of the EPO, US and JPO Practice 1 1.1 Patentable Subject Matter/Industrial Applicability: EPO (Articles 52 and 53
EPCl 973, Articles 52, 53 and 54[5] EPC2000, theEU Directive 98/44/EC of July
6, 1998 and its Implementation by the EPO) 1
1.2 Patentable Subject Matter/Utility: US (35 U.S.C. § 101 (1984)) 16 1.3 Patentable Subject Matter/Industrial Applicability: JPO 36
2 Patentable Subject Matter: The EPO's Case Law 43
2.1 The Exclusion of »Essentially Biological Processes for the production of Plants or
Animals«: Article 53(b) EPC2000 43
2.2 The Exclusion of Plant and Animal Varieties from Patent Protection in Consid
eration of Article 53 EPC 48
2.3 To What Extent Are Embryonic Stem Cells Patentable: Rule 28(c) EPC2000/Rule
23d(c) EPC 1973 63
2.4 The patenting of human DNA is not intrinsically ethical 76 2.5 Compounds and Discoveries, Industrial Applicability 78
2.6 The Patenting of Pharmaceutical Inventions 90
2.7 The Patenting of Diagnostic Inventions and Screening Methods 98 3 The Person Skilled in the Art: Legal Basis, Summary and Discussion of the
EPO, US and JPO Practice 100
3.1 The Person Skilled in the Art: EPO 100
3.2 The Person Skilled in the Art: US 101
3.3 The Person Skilled in the Art: JPO 104
4 The Person Skilled in the Art: The EPO's Case Law 106 5 Corrections and Amendments: Legal Basis, Summary and Discussion of
the EPO, US and JPO Practice 110
5.1 Corrections and Amendments: EPO (Article 123 and Rule 88 EPC1973/Rule 139
EPC2000) 110
5.2 Corrections and Amendments: US 118
5.3 Corrections and Amendments: JPO 125
6 Corrections and Amendments: The EPO's Case Law 131
6.1 T 184/91, »Glu-Gln/CELTRIX«, EP-A 169 016, G 11/91, »Glu-Gln/CELTRDC«, EP-A 169 016; and T 1147/98, »Cartilage-inducing factor/CELTRIX PHAR
MACEUTICALS INC.«, EP-B1 169 016 131
6.2 T 161/86, »Amino acid sequence modification/ELI LILLY«, EP-A 10 421 ... 132 6.3 T 552/91, »Chroman derivatives/MERCK«, EP-A 273 262 133
XV
6.4 T 21/86, "Amendments/AMERICAN MONITOR CORP.«, EP-A 9 222 .... 134 6.5 T 365/88 "Improved vectors/BIOGEN.., EP-A 41 767 135 6.6 T 449/90, "Treatment of plasma/CEDARS-SINAI«, EP-B 94 611 135 6.7 T 157/90, »Human calcitonin structural gene/CELL-TECH«, EP-A 70 675 .. 136 6.8 T 923/92, »t-PA/GENENTECH«, EP-B1 93 619, OJ EPO 1996, 564 137 6.9 T 749/94, "Erythropoietin/GENETICS INSTITUTE.., EP-B1 209 539 140
6.10 T 379/95, »Hormones/ARS«, EP-B1 160 699 141
6.11 T 1046/96, »Pertussis/LELAND STANFORD«, EP-B1 275 689 142 6.12 T 277/95, "Production of erythropoietin/GENETICS INSTITUTE«,
EP-B1 411 678 142
6.13 T 656/94, »Colony-stimulating factor/KIRIN-AMGEN«, EP-B1 237 545 . . . 143 6.14 T 824/94, »LAV/INSTITUT PASTEUR«, EP-B1 178 978 144 6.15 T 138/95, "Intrapulmonary delivery/GENENTECH INC.«, EP-B1 257 956 . 145 6.16 T 985/95, "Treatment of infertility/NOVO NORDISK A/S«, EP-B1 300 021 145
6.17 T 289/97, »Brassica/CALGENE«, EP-B1 270 615 146
6.18 T 354/97, "Protein secretion/GENENTECH«, EP-B1 88 632 147 6.19 T 658/98, »Interferon-beta 2A/YEDA RESEARCH.., EP-A 645 542 148 6.20 T 588/95, "Chimera monoclonal antibody/RESEARCH DEVELOPMENT..,
EP-B1 171 496 .• 148
6.21 T 188/97, "NANBV/Chiron Corporation.., EP-B1 318 216 149 6.22 T 1054/97, "Insect control/AVENTIS«, EP-B1 451 878 150 6.23 T 32/97, "Deleted tk-PRV vaccines/NOVAGENE«, EP-B1 149 040 151 6.24 T 339/98, "Vitamin K-dependent proteins/ELI LILLY.., EP-B1 363 126 151 6.25 T 725/99, »Live vaccines/LELAND STANFORD JUNIOR UNIVERSITY..,
EP-B1 184 086 152
6.26 T 351/98, »HIV-I/CHIRON CORPORATION.., EP-B1 181 150 153 6.27 T 239/95, "Herpes simplex viral proteins/AMERICAN CYANAMID CO.«,
EP-B1 101 655 154
6.28 T 450/98, »BPI fragments/NEW YORK UNIVERSITY.., EP-B1 375 724 ... 154 6.29 T 93/98, »TNF inhibiting protein/BASF.., EP-B1 471 701 154 6.30 T 1118/98, ..Nucleic acids/DU PONT DE NEMOURS.., EP-B1 520 039 ... 155 6.31 T 160/99, "Chlamydia/WASHINGTON.., EP-B1 264 434 156 6.32 T 232/99, "Protein production/ALUSUISSE HOLDINGS A.G.«,
EP-B1 239 292 156
6.33 T 756/00, "Immunotherapy/CENTOCOR INC.«, EP-A 755 683 157 6.34 T 346/01, »Osteoporosis/NOVARTIS«, EP-A 560 723 157 6.35 T 216/96, "Process for amplifying, detecting and/or cloning nucleic acid sequen-
ces/F. HOFFMANN-LA ROCHE AG«, EP-B1 200 362 157
6.36 T 785/97, "Support-bound oligonucleotides/OXFORD GENE TECHNOL
OGY LIMITED.., EP-B1 386 229 158
6.37 T 310/99, "Down Syndrome/MACRI«, EP-B1 409 956 158 6.38 T 944/99, "Pesticidal toxins/MYCOGEN CORPORATION.., EP-B1 340 948 159 6.39 T 279/00, "Asymmetric reduction process/AVECLA LTD.«, EP-B1 658 211 . . 160 6.40 T 502/00, "Determination of an analyte/DADE«, EP-B1 492 499 160 6.41 T 608/00, "Transgenic bovine/PHARMING«, EP-B1 502 976 160 6.42 T 748/00, "Oligomer libraries/AFFYMAX.., EP-B1 604 552 160 6.43 T 1000/00, "Test device/ROCHE«, EP-B1 654 659 161 6.44 T 1228/01, »Zona pelucida antigens/ZONAGEN INC.«, EP-A 396 552 .... 162 6.45 T 86/01, "Engineered bacteriophages/ACAMBIS.., EP-B1 552 267 164 6.46 T 98/01, "Allergenic proteins/IMMULOGIC PHARMACEUTICAL
CORPORATION.., EP-B1 463 059 164
6.47 T 189/01, »IFN-2/IL-6R/YEDA RESEARCH AND DEVELOPMENT CO.,
LTD.«, EP-B1 413 908 164
XVI
6.48 T 1133/00, »Tumor suppression/UNIVERSITY OF CALIFORNIA«,
EP-B1 475 623 165
6.49 T 286/01, "Humanised antibodies/CELLTECH THERAPEUTICS LTD.«,
EP-B1 460 167 165
6.50 T 345/01, »Cellulose degrading enzyme/NOVOZYMES«, EP-B1 531 315 . . . 166 6.51 T 836/01, »Interferon-beta2/YEDA RESEARCH AND DEVELOPMENT CO.
LTD.«, EP-A 835 661 166
6.52 T 882/01, "Protein expression system/CELLTECH«, EP-B1 651 803 166 6.53 T 1014/01, »Recombinant immunoconjugates/BRISTOL-MYERS SQUIBB
CO.«, EP-B1 439 095 167
6.54 T 1100/01, »Truncated transmembrane PACE/GENETICS«, EP-B1 574 402 . 167 6.55 T 1080/01, .Thermostable enzyme/F. HOFFMANN-LA ROCHE«,
EP-B1 258 017 168
6.56 T 161/02, .Transgenic Zea mays plants/SYNGENTA«, EP-B1 513 849 169 6.57 T 579/01, "Cytoplasmic male sterile plants/ENZA ZADEN«, EP-B1 771 523 . 169 6.58 T 960/02, »Transfection/TRANSKARYOTIC THERAPIES«, EP-B1 649 464 170 6.59 T 1067/02, "Changed epitopes/NOVOZYMES«, EP-B1 561 907 171 6.60 T 157/03, "Reducing blood loss/ZYMOGENETICS«,EP-Bl 624 095 172 6.61 T 1050/99, »Carbonyl hydrolases/GENENCOR«, EP-B1 251 446 172 6.62 T 931/01, »Ribozyme/UNIVERSITY PATENTS«, EP-B1 291 533 173 6.63 T 877/03, »Anti-CD30 antibodies/ROCHE«, EP-B1 805 871 174 6.64 T 626/00, »Framework-mutated antibodies/WELLCOME«, EP-B1 549 581 . . 174 6.65 T 27/04, "Japanese hepatitis C virus/CHIRON«, EP-B1 419 182 175 6.66 T 20/04, »Flt3 ligands/SCHERING«, EP-B1 699 236 176 6.67 T 1331/04, »MSF/GENETICS INSTITUTE^ EP-A 567 599 177 6.68 T 342/02 and T 462/07, »End-Iabeled nucleotide probe/ENZO«,
EP-B1 330 221, 177
6.69 T 464/94, "Transformation of plant genetic material/NOVARTIS«,
EP-B1 164 575 178
6.70 T 506/02, "Measles virus/IMPFINSTITUT«, EP-B1 780 475 178 6.71 T 1052/02, "Immunochromatographic method/PACIFIC BIOTECH«,
EP-B1 466 914 178
6.72 T 937/02, "G-CSF/OSAKA BIOSCIENCE^ EP-A1 521 156 179 6.73 T 1189/02, "Homologous recombination/CELL GENESYS«, EP-B1 747 485 . 179 6.74 T 243/03, "Plant pathogens/MOGEN«, EP-B1 474 857 181 6.75 T 494/03, "Transgenic wheat/SYNGENTA«, EP-B1 674 715 181 6.76 T 79/04, "Prion proteins/PROTEUS«, EP-B1 616 613 181 6.77 T 94/04, "Cytokine antagonists/REGENERON«, EP-B1 726 954 182 6.78 T 168/04, "Yeast vector/YOCUM«, EP-B1 707 068 182 6.79 T 329/04, "Absorption of minerals/NESTLE«, EP-B1 1 003 532 183 6.80 T 491/04, »anti TNF-a antibody/PHARMACIA & UPJOHN«, EP-B1 492 448 183 6.81 T 500/01, "Humanized immunoglobulins/PROTEIN DESIGN LABS, INC.«,
EP-B1 451 216 184
6.82 T 21/05, »CTL responses to HCV/SCRIPPS«, EP-B1 759 937 185
6.83 T 35/05, »TNF ligands/YEDA«, EP-B1 585 939 186
6.84 T 59/05, »Galactopyranosides/PROCUR«, EP-A1 873 414 187 6.85 T 248/05, "Particulate direct label/INVERNESS«, EP-B1 560 411 187 6.86 T 313/05, "Apparatus for monitoring a polymerase chain reaction/APPLERA«,
EP-B1 872 562 188
6.87 T634/05, "Factor VIII:C/NOVARTIS«, EP-B 1 466 199 189 6.88 T 1470/05, »HCV T-cell epitopes/INNOGENETICS«, EP-B 1 725 824 190 6.89 T 1491/05, »Gene expression/CSIRO«, EP-A1 1 071 762 190 6.90 T 1181/06, »Polyketides/STANFORD«, EP-B1 725 778 191
XVII
6.91 T25/06, »Botulinum toxin/SOLSTICENEUROSCIENCES«, EP-B1 1 112082 191 6.92 T 1188/06, »Molecular evolution/BIOINVENT«, EP-B1 988 378 192
6.93 T 1497/06, »GPCR/ARENA«, EP-A1 1 580 271 192
6.94 T 1213/05, »Breast and ovarian cancer/UNIVERSITY OF UTAH«,
EP-B1 705 902 193
6.95 T 1048/05, »Luciferase/PERKIN ELMER LAS«, EP-B1 610 937 195 6.96 T 582/06, »DNA mutagenesis/MAXYGEN«, EP-B1 752 008 195 6.97 T 1099/06, »Transgenic plant cells/MAX PLANCK«, EP-B1 290 799 196 6.98 T 411/02, »CTLA4 receptor/BRISTOL-MYERS SQUIBB«, EP-B1 606 217 . 197 6.99 T 580/05, "Humanised antibodies/CELLTECH«, EP-B 1 626 390 197 6.100 T 542/04, »Soybean products/E.I. Du PONTDE NEMOURS«, EP-B1 608359 198 6.101 T 1443/04, "Regeneration of Gramineae plants/SYNGENTA«, EP-B1 332 581 199 6.102 T 725/05, "Humanized Immunoglobulins II/PDL«, EP-B1 682 040 199 6.103 T 795/06, "Botulinum neurotoxine/MERZ«, EP-B1 1 185 291 200 6.104 T 329/06, "Perfused microtissue/MIT«, EP-B 1 1 064 353 200 6.105 T 405/06, »Immunoglobulins/BRUSSEL«, EP-B1 656 946 201 6.106 T 801/06, "Cancer treatment with HSV mutant/CRUSADE«, EP-B1 773 785 201 6.107 T 997/06, "Insulin preparation/NOVO NORDISK«, EP-B1 921 812 202 6.108 T 1107/06, "Botulinum toxins/ALLERGAN«, EP-B1 1 005 867 202 6.109 T 1408/06, »VEGF-related protein/GENENTECH«, EP-B1 848 755 203 6.110 T 1772/06, »Clarithromycin/ABBOTT«, EP-B1 915 899 204 6.111 T 1790/06, "Expression of a gene/ALNYLAM« (December 9, 2008),
EP-B1 1 144 623 204
6.112 T 382/07, "Etheric oils/D&W TRADING«, EP-B 1 828 502 205 6.113 T 391/07, "Immunotherapy of cancer/UNIVERSITY OF PENNSYLVANIA^
EP-B1 790 835 205
6.114 T 1898/07, "Interferon Formulations/BIOGEN«, EP-B1 948 358 206 6.115 T 617/07, "Monoclonal NGF-antagonist antibodies/LAY LINE«,
EP-B1 1 181 318 207
6.116 T 665/07, "Heterologous genes/EDINBURGH«, EP-B1 695 361 208 6.117 T 762/07, "Estrogen receptor/ORGANON«, EP-B1 798 378 208 6.118 T 837/07, "Diagnostic primers/INFECTIO«, EP-B1 804 616 209 6.119 T 1068/07, "Enzymatic DNA/SCRIPPS«, EP-A1 981 646 209 6.120 T 1128/07, »HIV-2 variants/QUIAGEN«, EP-B1 655 501 211 6.121 T 1331/07, »Collagen-like polymers/PROTEIN POLYMER«, EP-B1 670 848 211 6.122 T 1437/07, "Botulinum toxin for treating smooth muscle spasm/ALLERGAN«,
EP-B1 1 010 431 212
6.123 T 1885/07, "Alphavirus vectors/BIOPTION«, EP-B1 753 053 212 6.124 T 1/08, »Alphaviruses/BIOPTION«, EP-B1 561 890 213 6.125 T 692/08, "Lawsonia intracellularis/BOEHRINGER«, EP-B1 843 818 213 6.126 T 1022/08, »Trifunctional reagent/MITRA«, EP-A1 1 569 690 214 6.127 T 1477/08, »ACE inhibitors/SANOFI-AVENTIS«, EP-B 1 1 212 081 214 6.128 T 2351/08, »Hsp70 protein/MULTHOFF«, EP-B 1 1 066 050: Recording of Oral
Proceedings by a Party 214
6.129 T 1001/07, "Ointment/KAPAJ«, EP-A1 1 532 982 215 6.130 T 1644/08, »Endoglucanases/NOVOZYMES«, EP-B1 815 209 215 6.131 T 445/09, "Treatment of autoimmune diseases/GENENTECH«,
EP-B1 1 176 981 216
6.132 T 783/09, "Antidiabetic combinations/NOVARTIS«, EP-B1 1 248 604 216 6.133 T 878/09, "Method for the detection of prion proteins/PROTHERICS«,
EP-B1 616 613 217
6.134 T 1271/09, "Expression of a gene/ALNYLAM«, EP-B1 1 214 945 217
XVIII
6.135 T 244/10, »Diagnosis autoimmune/DIAGNOSTIC HYBRIDS«,
EP-A1 1 268 846 218
6.136 T 305/07, »Trisulfides/PFIZER«, EP-B1 1 095 055 218
6.137 T 1456/06, »Telomerase/GERON«, EP-B1 841 396 219
6.138 T 1172/08, »Method for determining T-cell epitopes/GENENCOR«,
EP-B1 1 073 754 219
6.139 T 76/09, »Protein fragment complementation assay/ODYSSEY«,
EP-A1 1 305 627 ^ 220
6.140 T 341/09, »Antibody/WELLCOME«, EP-B1 1 247 865; 221 6.141 T 583/09, »Novel genes/MILLENIUM«, EP-A1 1 194 534 221 6.142 T 1803/09, »Markers congestive heart failure/SYN.X PHARMA..,
EP-A1 1 423 705 ' 222
6.143 T 191/08, »Haemagglutinin molecule complex/NOVARTIS«, EP-B1 589 348 . 223 6.144 T 1919/11, ..Production of taxanes/BIOTECH«, EP-A1 1 398 384 223 6.145 T 1205/07, ..Adenoviral packaging system/CRUCELL«, EP-B1 833 934 .... 224 6.146 T 1572/07, »TEM17/THE JOHNS HOPKINS UNIVERSITY,
EP-A1 1 307 557 225
6.147 T 611/08, ..Botulinum toxins/ALLERGAN INC.«, EP-B1 1 103 267 225 6.148 T 713/08, >.Neurotrophins/H. LUNDBECK A/S«, EP-A1 1 589 988 226 6.149 T 824/08, ..Non-segmented negative strand RNA viruses/CRUCELL«,
EP-B1 846 181 227
6.150 T 1309/08, »Exendins/AMYLIN PHARMACEUTICALS, INC.«,
EP-B1 1 246 638 227
6.151 T 1582/08, ..Collagen/INTEGRA LIFESCIENCES CORP.«, EP-B1 1 017 415 228 6.152 T 1715/08, »Fucosyltransferase/ALTMANN«, EP-B1 1 151 109 . ! 228 6.153 T 1925/08, ..Infrared dye/SIEMENS«, EP-B1 1 111 386 229 6.154 T 2003/08, ..Dilated cardiomyopathy/EDWARDS.., EP-B1 862 444 229 6.155 T 2126/08, ..Surface antigen/ORTHO-CLINICAL DIAGNOSTICS«,
EP-A1 1 114 906 230
6.156 T 250/09, ..Separation of nucleic acid mixtures/QUIAGEN GmbH«,
EP-B1 1 146 049 231
6.157 T 591/09, »c-Fos Induced Growth Factor/VEGENICS«, EP-B1 853 668 .... 231 6.158 T 1042/09, ..Bioarray chip/AFFYMETRIX«, EP-B1 764 214 231 6.159 T 1263/09, ..Coupled PCR/CORNELL«, EP-A1 1 736 554 232 6.160 T 1509/09, ..High density oligonucleotide arrays/AFFYMETRIX«,
EP-B1 853 679 234
6.161 T 2471/09, »Aminoacyl-tRNA Synthetase/SCRIPPS«, EP-A1 1 456 360 .... 234 6.162 T 2384/09, ..Treatment of connective tissue/NUTRAMAX«, EP-A1 1762 247 234 6.163 T 1592/10, ..Detection of Candida Protease/KIMBERLY-CLARK«,
EP-A1 1 960 784 235
6.164 T 610/06, »hPTH 1-34/ELI LILLY«, EP-B1 1 059 933 235 6.165 T 103/09, ..Stable liquid human EPO at room temperature/ F. Hoffmann-La
Roche AG«, EP-B1 1 311 285 235
6.166 T 1074/09, »Vaccine/SANOFI PASTEUR LIMITED«, EP-B1 1 200 122 236 6.167 T 1813/09, »Dm-resistance markers/ENZA ZADEN BEHEER«,
EP-B1 1 179 089 237
6.168 T 1912/09, ..Methods for detection of virus/ADVANCED LIFE SCIENCE..,
EP-B1 967484 238
6.169 T 1980/09, »Multi-analyte immunoassay/RANDOX«, EP-B1 1 203 957 .... -239 6.170 T 137/10, ..Human growth hormone/CSL, LTD; MONASH UNIV.«,
EP-B1 889 733 239
6.171 T 665/10, ..Marking with DNA/TRACETAG«, EP-B 1 1 171 633 241 6.172 T 1039/10, ..Copolymers/HARVARD COLLEGE.., EP-A1 1 438 061 241
XIX
6.173 T 1771/10, »Amendments - intermediate generalisation/BAYER HEALTH
CARE^ EP-A1 1 743 038 241
6.174 T 1822/10, »Nucleic acid concentration/MEDICAL« Quly 3, 2014),
EP-B1 1 482 036 242
6.175 T 1866/10, "Fluorescent PCR sequencing/LIFE TECHNOLOGIES®,
EP-B1 1368 460 242
6.176 T 2134/10, »S. Pneumonia antigen/HUMAN GENOME SCIENCES«,
EP-B1 942 983 243
6.177 T 2350/10, "Quantification of Botulinum Toxin/IPSEN«, EP-B1 1 597 584 . . 244 6.178 T 1648/11, »Chromosome specific staining/UNIVERSITY OF CALIFORNLA«,
EP-B1 885 971 245
6.179 T 494/09, "Solution de facteur VIII sdcurisde viralement/LABORATOIRE FRA-
NgAIS«, EP-B1 1 037 923 245
6.180 T 197/09, »R<5cepteur de riL-13/SANOFI«, EP-B1 876 482 247 6.181 T 730/10, »Assay/BECKMAN COULTER«, EP-B1 758 401 248 6.182 T 1094/10, »Double stranded RNA modified 2'O-Methyl aligned phase shift
pattern/SILENCE THERAPEUTICS«, EP-B1 1 527 176 249
6.183 T 715/10, »Stable liquid exendin formulations/AMYLIN
PHARMACEUTICALS.., EP-B1 1 140 145 250
7 Clarity of Claims: Legal Basis, Summary and Discussion of the EPO, US and
JPO Practice 251
7.1 Clarity of Claims: EPO (Article 84 EPC) 251
7.2 Clarity of Claims: US 254
7.3 Clarity of Claims: JPO 259
8 Clarity of Claims: The EPO's Case Law 262
8.1 T 301/87, »Alpha-interferons/BIOGEN«, EP-B 32 134, OJ EPO 1990, 335 to
358 262
8.2 T 281/86, »Preprothaumatin/UNILEVER«, EP-A 54 331, OJ EPO 1989, 202 to
209 263
8.3 T 181 /87, »DNA transfer vector/THE REGENTS OF THE UNIVERSITY OF
CALIFORNIA®, EP-A 20 251 264
8.4 T 269/87, »Prochymosin/CELLTECH«, EP-A 68 691 265
8.5 T 347/87, "Method of constructing a replicable cloning vehicle/GENENTECH«,
EP-A 22 242 265
8.6 T 130/90 "Recombinant Monoclonal Antibody/UNIVERSITY OF TEXAS
SYSTEM«, EP-B 68 763 266
8.7 T 391 /91, »Ice nucleating/UNIVERSITY OF CALIFORNIA.., EP-A 112 342 267 8.8 T 430/92, "Growth of tulips/SUMITOMO«, EP-B1 188 933 268 8.9 T 749/94, »Erythropoietin/GENETICS INSTITUTE.., EP-B 1 209 539 269 8.10 T 464/94, "Transformation of plant genetic material/NOVARTIS«,
EP-B1 164 575 269
8.11 T 250/96, »Transformation/NOVARTIS«, EP-A1 429 093 270 8.12 T 277/95, "Production of erythropoietin/GENETICS INSTITUTE..,
EP-B1 411 678 271
8.13 T 484/98, "Modified yeast/ELSWORTH«, EP-A 463 024 272 8.14 T 965/98, »DNA amplification/HOFFMANN-LA ROCHE.., EP-A 509 612 . 272 8.15 T 966/98, »DNA detection/HOFFMANN-LA ROCHE.., EP-A 502 589 .... 273 8.16 T 188/97, "NANBV/Chiron Corporation.., EP-B1 318 216 273 8.17 "Serotonin receptor/ELI LILLY.., EP-A 449 562, OJ EPO 2001, 103 273
XX
8.18 T 1044/99, »Ionophore antibiotics/UNGDA«, EP- 615 544 274 8.19 T 680/98, »Improved vectors II/BIOGEN«, EP-B1 41 767 274
8.20 T 822/98, »Probes/BIO-RAD«, EP-B1 246 864 275
8.21 T 239/95, »Herpes simplex viral proteins/AMERICAN CYANAMID CO.«,
EP-B1 101 655 276
8.22 T 64/00, ..Insecticidal plant expression/MYCOGEN.., EP-B1 359 472 276 8.23 T 984/00, »Ti-plasmid vectors/MAX-PLANCK-GESELLSCHAFT«,
EP-A 290 799 278
8.24 T 1084/00, »HIV-3 variantsAINNOGENETICS«, EP-A1 657 532 278 8.25 T 397/02, »Endogenous gene expression/APPLIED RESEARCH SYS«,
EP-B 505 500 279
8.26 T 285/01, »Bone resorption/WASHINGTON RESEARCH FOUNDATION..,
EP-B1 394 296 279
8.27 T 610/01, »Plant growth/LONG ASHTON RESEARCH STATION«,
EP-A 703 983 280
8.28 T 347/02, ..Neoplastic phenotype/UNIVERSITY OF CALIFORNIA-.,
EP-B1 440 744 280
8.29 T 1074/00, ..Hematopoietic growth factors/GENETICS INSTITUTE«,
EP-B1 314 705 281
8.30 T 378/02, ..Analysis of polynucleotide sequences/OXFORD GENE
TECHNOLOGY.., EP-B 1 373 203 282
8.31 T 1146/02, ..Vaccines containing a saponin and a sterol/SMITHKLINE
BEECHAM«, EP-B 1 822 831 283
8.32 T 741/03, ..Treatment of diabetes/LONDON HEALTH SCIENCES..,
EP-B1 762 890 283
8.33 T 748/04, ..Bioactive factors of aloe vera plants/CARRINGTON«,
EP-A1 871 460 284
8.34 T 843/04, »Gas driven fermentation/PRAXAIR.., EP-B1 829 534 284 8.35 T 1326/04, ..Avian adenovirus vector/COMMON-WEALTH CSIRO«,
EP-A1 690 612 285
8.36 T 29/05, »PVA/BRISTOL-MYERS«, EP-A1 718 402 286
8.37 T 710/05, »NMDA oxidizing agents/THE CHILDREN'S MEDICAL CEN-
TER«, EP-A1 486 621 287
8.38 T 723/05, ..Growth hormone/PHARMACIA AKTIEBO-LAG«, EP-B1 587 858 287 8.39 T 1060/05, ..Security system/CRIME SOLUTIONS.., EP-A1 1 230 392 .... 288 8.40 T 1300/05, »RET screening assay/PROGENICS«, EP-A1 847452 288 8.41 T 25/06, ..Botulinum toxin/SOLSTICE NEUROSCIEN-CES..,
EP-B1 1 112 082 289
8.42 T 18/02, ..Mutant alpha-amylase/GENENCOR«, EP-B1 689 589 289 8.43 T 412/06, ..Proteinase inhibitor/MAX-PLANCK-GESELLSCHAFT ZUR
FOERDERUNG«, EP-A1 1 207 876 290
8.44 T 1018/06, ..Ischemia detection/ISCHEMIA.., EP-A1 1 411 356 291 8.45 T 1599/06, ..Mycobacterium vaccinating agent/UNIVERSITY OF
CALIFORNIA.., EP-B1 771 322 291
8.46 T 411/02, »CTLA4 receptor/BRISTOL-MYERS SQUIBB.., EP-B1 606 217 . 292 8.47 T 640/06, »HSVparticles/BIOGEN«, EP-B1 1 135 408 292 8.48 T 936/06, ..Bacteriohage preparations/NYMOX«, EP-A1 895 534 293 8.49 T 1815/06, »Pre-ligand association domain/THE GOVERNMENT OF THE
UNITED STATES.., EP-A1 1 263 788 294
8.50 T 449/08, ..Renal clearance/U.D. TESTING.., EP-A1 817 966 294 8.51 T 692/08, »Lawsonia intracellularis/BOEHRINGER.., EP-B1 843 818 295 8.52 T 744/08, ..Recovery of virus/XENOVA«, EP-B1 1 002 055 295 8.53 T 1423/08, ..Medium supplement/LIFE TECHNOLOGIES.., EP-986 635 .. 295
XXI
8.54 T 1644/08, »Endoglucanases/NOVOZYMES«, EP-B1 815 209 296 8.55 T 878/09, »Method for the detection of prion proteins/PROTHERICS«,
EP-B1 616 613 297
8.56 T 2278/09, »Analyte capture device/ABBO i 1«, EP-A1 1 369 691 297 8.57 T 1859/08, »Anti-Erb2 antibodies/GENENTECH, INC.«, EP-A1 1 037 926 . 297 8.58 T 2181/08, »TREM-1 splice variant/GENEPRINT«, EP-A1 1 351 702 298 8.59 T 493/09, »Hepatitis C/MERCK SHARP & DOHME CORP.«, EP-B1 858 343 299 8.60 T 1398/09, -Amplification of DNA/THE SECRETARY OF STATE FOR DE-
FENCE«, EP-A1 1 109 934 300
8.61 T 2272/09, »L-threonine production/EVONIK DEGUSSA«, EP-A1 1 483 393 300 8.62 T 2311/09, >»Eotaxin/IMPERIAL INNOVATIONS LTD.«, EP-B1 719 331 . . 301 8.63 T 2101/09, »Human Delta3 - Notch/MILLENIUM«; EP-B1 972 041 301 8.64 T 18/10, »Caries lectin detection/UNIVERSITY SOUTHERN CALIFORNIA«,
EP-A1 1 616 035 302
8.65 T 2195/09, "Korianderol/UNIVERSITATSKLINIKUM FREIBURG«,
EP-A1 1 598 073 303
8.66 T 1048/10, »NaV1.8 specific zink finger proteins/SANGAMO BIOSCIENCES,
INC.«, EP-A1 1 737 498 303
8.67 T 1587/10, "Controlling infections/EGENOMICS«, EP-A1 1 315 828 305 8.68 T 2106/10, »Tenascin binding to fibronectin/NOVARTIS FORSCHUNGS-
STIFTUNG«, EP-A1 1 416 954 306
8.69 T 2184/10, »Beet necrotic yellow vein virus resistance RNA1 replicase/SES«;
EP-B1 1 169 463 306
8.70 T 2362/10, »Hybrid corn seed/MONSANTO«, EP-A1 2 059 601 307 8.71 T 2394/10, "Producing L-amino acids/AJINOMOTO«, EP-B1 1 013 765 . . . 307 8.72 T 206/11, »Bak promoter/TANOX«, EP-A1 1 009 395 308 8.73 T 865/11, »Cancer therapy/MAUDSLEY«, EP-A1 939 645 309 8.74 T 1293/11, "Transgenic plant - signal transduction stress-related protein«,
EP-A1 1 760 145 . 309
8.75 T 494/09, "Solution de facteur VIII securisde viralement/LABORATOIRE FRA-
NQAIS«, EP-B 1 1 037 923 310
8.76 T 2200/11, "Silencing interference dsRNA clusterin inhibition cancer Alzheimer/
BRITISH COLUMBIA«, EP-A1 1 532 249 310
8.77 T 818/12,'Transgenic plant-cell cycle stress related protein«, EP-A1 1 795 600 311 9 Enabling Disclosure: Legal Basis, Summary and Discussion of the EPO, US
and JPO Practice 313
9.1 Enabling Disclosure: EPO (Article 83 EPC) 313
9.2 Enabling Disclosure: US 324
9.3 Enabling Disclosure: JPO 342
10 Enabling Disclosure: The EPO's Case Law 350
10.1 Decisions on enablement of nucleic acid and protein inventions 350 10.2 Decisions on enablement of antibody technology inventions 425
10.3 Decisions on enablement of plant inventions 457
10.4 Decisions on enablement of inventions concerning viruses and their epitopes . . 467 10.5 Decisions on enablement of inventions concerning microorganisms 488
10.6 Decisions on enablement of other inventions 504
XXII
11 Deposit: Legal Basis, Summary and Discussion of the EPO, US and JPO
Practice 523
11.1 Deposit: EPO (Article 83 EPCand Rule 28 and Rule 28a EPC1973/Rules 31 to 34
EPC2000 of the Implementing Regulations) 523
11.2 Deposit: US _ 530
11.3 Deposit: JPO 533
12 Deposit: The EPO's Case Law 535
12.1 T 361/87, »Microorganisms/NABISCO«, EP-A 97 973 535
12.2 T 39/88, »Microorganisms/CPC«, EP-A 111 683 535
12.3 T 106/88, »Microorganisms/CPC«, EP-A 112 459; T 90/88, »Microorganism/
MICROLIFE«, EP-A 76 953; T 239/87, »Microorganisms/NABISCO«, EP-A 98 533; T 142/93, »Antibiotics/AMERICAN CYANAMID«, EP-A 182 152 536 12.4 T 118/87, »Amylolytic enzymes/CPC«, EP-A 34 470 536 12.5 J 8/87, J 9/87, "Submittingculture deposit information/IDAHO«, EP-A 155 476 536 12.6 Examining Division, »Deposit number/ROCKEFELLER«, EP 86 90 2639.3 . . 537 12.7 T 815/90, »Hepatitis-A virus/UNITED STATES OF AMERICA#, EP-A 196 316,
G 2/93, "Sufficiency of disclosure/Culture deposit information# 537 12.8 T 886/91, "Hepatitis B virus/BIOGEN«, EP-B1 13 828 540 12.9 T 412/93, »Erythropoietin/AMGEN«, EP-B1 148 605 540
12.10 T 923/92, »t-PA/GENENTECH«, EP-B1 63 619 541
12.11 T 128/92, »Interleukin-2/AJINOMOTO«, EP-B1 0 091 539 541 12.12 T227/97, "Protein Rib/LINDAHL«, EP-A 656 014 542 12.13 T 1147/01, »PRRS Vaccine/AKZO NOBEL N.V.«, EP-B1 610 250 542 12.14 T 328/04, »Humoral immunity/DARTMOUTH COLLEGE«, EP-B1 742 721 542 12.15 T 107/09, »CD40 counter receptor/BRISTOL-MYERS SQUIBB COMPANY«,
EP-B1 555 880 543
13 Priority: Legal Basis, Summary and Discussion of the EPO, US and JPO
Practice 545
13.1 Priority: EPO (Articles 87 to 89 EPC) 545
13.2 Priority: US 551
13.3 Priority: JPO 564
14 Priority: The EPO's Case Law 567
14.1 T 81/87, »Preprorennin/COLLABORATIVE«, EP-A 57 350, OJ EPO 1990, 250
to 259 567
14.2 T 269/87, »Prochymosin/CELLTECH«, EP-A 68 691 568
14.3 T 301/87, »Alpha-interferons/BIOGEN«, EP-B 32 134, OJ EPO 1990, 335 to
358 568
14.4 T 886/91, "Hepatitis B virus/BIOGEN«, EP-B1 13 828 568 14.5 T 296/93, »HBV antigen production/BIOGEN«, EP-B1 182 442, OJ EPO 1995,
627 569
14.6 T 65/92, >»HTLV/HARVARD COLLEGE«, EP-A 151 579 570 14.7 T 207/94, "Fibroblast interferon/BIOGEN«, EP-B1 41 313 571 14.8 T 441/93, "Cloning in Kluyveromyces/GIST BROCADES«, EP-B1 96 430 .. 572 14.9 T 413/94, "Human GM-CSF/IMMUNEX CORP.«, EP-B1 183 350 572 14.10 T 380/94, "Insect control/PGS«, EP-B1 193 259 573
XXIII
14.11 T 277/95 .Production of erythropoietin/GENETICS INSTITUTE.-,
EP-B1 411 678 574
14.12 T 236/96, »Interleukin l/DAINIPPON«, EP-B1 188 920 575 14.13 T 919/93, »Heat treated factor VIII/CEDARS-SINAI«, EP-B1 94 611 576 14.14 T 51/95, »Mature leukocyte interferons/HOFFMANN-LA ROCHE«,
EP-B1 211 148 576
14.15 T 1112/96, ..Erythropoietin production/GENETICS INSTITUTE..,
EP-B1 205 564 576
14.16 T 542/95, »TNF/YEDA«, EP-B1 186 833 576
14.17 T 1147/98, ..Cartilage-inducing factor/CELTRIX PHARMACEUTICALS
INC.«, EP-B1 169 016 577
14.18 T 188/97, »NANBV/Chiron Corporation®, EP-B1 318 216 578 14.19 T 479/97, ..Expression system/NOVARTIS«, EP-B1 353 188 578 14.20 T 351/98, »HIV-I/CHIRON CORPORATION.., EP-B1 181 150 579 14.21 T 342/98, »A. orizae/NOVOZYME«, EP-B1 238 023 580 14.22 T 93/98, »TNF inhibiting protein/BASF.., EP-B1 471 701 580 14.23 T 1099/99, ..Filamentous fungi/GENENCOR«, EP-B1 215 594 582 14.24 T 216/96, ..Process for amplifying, detecting and/or cloning nucleic acid sequen-
ces/F. HOFFMANN-LA ROCHE AG«, EP-B1 200 362 582
14.25 T 785/97, ..Support-bound oligonucleotides/OXFORD GENE TECHNOL
OGY LIMITED.., EP-B1 386 229 583
14.26 T 280/00, »Inhibin/GENENTECH«, EP-B1 222 491 583
14.27 T 120/00, »Mycobacteria/COGENT«, EP-B1 460 041 583 14.28 T 279/00, ..Asymmetric reduction process/AVECIA LTD.«, EP-B1 658 211 .. 584 14.29 T 356/00, ..Mammary gland FIX intron construct/PPL«, EP-B1 396 699 .... 584
14.30 T 552/00, »3D-MPL/SMITHKLINE«, EP-B1 689 454 585
14.31 T 1127/00, »Ribozymes/GENE SHEARS.., EP-B1 321 201 585 14.32 T 8/01, ..Chimeric chain receptors/CELL GENESYS«, EP-B1 517 895 586 14.33 T 351/01, ..Tissue factor protein/GENENTECH.., EP-B1 278 776 586 14.34 T 423/01, ..Length polymorphisms/MAX-PLANCK-GESELLSCHAFT«,
EP-B1 438 512 587
14.35 T 486/01, ..IGF-l/GENENTECH, INC.«, EP-B1 597 033 588 14.36 T 1014/01, ..Recombinant immunoconjugates/BRISTOL-MYERS SQUIBB
CO.«, EP-B1 439 095 588
14.37 T 1080/01, ..Thermostable enzyme/F. HOFFMANN LA ROCHE..,
EP-B1 258 017 589
14.38 T 1074/00, ..Hematopoietic growth factors/GENETICS INSTITUTE..,
EP-B1 314 705 589
14.39 T 843/03, ..Human papillomavirus/THE UNIVERSITY OF ROCHESTER..,
EP-A 688 227 590
14.40 T 15/01, ..Mystery swine disease/SDLO«, EP-B1 587 780 590 14.41 T 20/04, »Flt3 ligands/SCHERJNG«, EP-B1 699 236 592 14.42 T 464/94, ..Transformation of plant genetic material/NOVARTIS..,
EP-B1 164 575 592
14.43 T 676/01, ..Treatment of inflammation/SONORAN DESERT CHEMICALS
LLC«, EP-B1 512 090 593
14.44 T 1010/01, ..Acellular vaccine/MEDEVA B.V.«, EP-B1 471 726 593 14.45 T 293/04, ..Lyme vaccine/BAXTER.., EP-B1 522 560 594 14.46 T 1127/03, ..Wound healing/RENOVO«, EP-B1 585 242 594 14.47 T 70/05, ..Apoptosis receptors/GENENTECH.., EP-A1 904 366 594 14.48 T 1399/04, ..Combination therapy HCV/SCHERING.., EP-B1 956 861 .... 595 14.49 T 562/04, ..Factor Vll/von Willebrand factor complex/OCTAPHARMA..,
EP-B1 625 161 595
XXIV
14.50 T 1190/03, "Orphan receptor/KARO'BIO«, EP-B1 792 292 596 14.51 T 903/05, »Teleomerase peptides/GEMVAX«, EP-B1 1 093 381 597 14.52 T 1147/02, "Antibiotic resistance/PASTEUR«; EP-B1 639 229 598 14.53 T 1213/05, »Breast and ovarian cancer/UNIVERSITY OF UTAH«,
EP-B1 705 902 598
14.54 T 250/06, »Opioid receptor genes/UNIVERSITY OF CALIFORNIA..,
EP-B1 656 007 600
14.55 T 1380/05, "Protein stabilization/NOVOZYMES«, EP-B1 353 250 601 14.56 T80/05, "Method of diagnosis/UNIVERSITY OF UTAH«,EP-B1 699 754 . 601 14.57 T 666/05, »Mutation/UNIVERSITY OF UTAH«, EP-B1 705 903 602 14.58 T 1127/06, »Beta-amyloid peptide/ELAN«, EP-B1 736 106 602 14.59 T 1338/06, »Microarray/LELAND STANFORT JUNIOR UNIVERSITY..,
EP-B1 804 731 603
14.60 T 331/07, "Negative-strand RNA virus/CONZELMANN«, EP-B1 702 085 .. 604 14.61 T 382/07, ..Etheric oils/D&W TRADING.., EP-B1 828 502 605 14.62 T 415/07, »Ribosomal display/DISCERNA LTD.«, EP-B1 985 032 606 14.63 T 156/08, »BRCA2/UNIVERSITY OF UTAH.., EP-A1 1 260 520 606 14.64 T 1834/09, »Apo-2DcR/GENENTECH«, EP-A1 1 032 661 607 14.65 T 146/07, "Prenatal diagnosis/ISIS.., EP-B1 994 963 608 14.66 T 902/07, »>BRCA2/CANCER RESEARCH TECHNOLOGY.., EP-B1858 467 609 14.67 T 2165/08, »Bi-cyclic nucleoside analogues/EXIQON.., EP-B1 1 015 469 . . . 610 14.68 T 2226/10, »HIV-3/INNOGENETICS« Qune 28, 2012), EP-B1 657 532 .. . 611 15 Novelty: Legal Basis, Summary and Discussion of the EPO, US and JPO
Practice 613
15.1 Novelty: EPO (Article 54 EPC/Article 54 EPC2000) 613
15.2 Novelty: US 631
15.3 Novelty: JPO 646
16 Novelty: The EPO's Case Law 654
16.1 Decisions on Novelty for Protein Inventions 654
16.2 Decisions on Novelty for DNA Sequence Inventions 692 16.3 Decisions on Novelty of Inventions Relating to Systems for the Expression ofDNA
Sequences 707
16.4 Decisions on Novelty for Plasmid Inventions 722
16.5 Decisions on Novelty for Inventions on Antibody Technology 726 16.6 Decisions on Novelty for Plant and Animal Related Inventions 744
16.7 Viruses and Their Epitopes 759
16.8 PCR and Other in vitro Nucleic Acid Amplification and Detection Methods .. 774
16.9 Microorganisms and How to Modify Them 786
16.10 Other Decisions on Novelty 796
17 Inventive Step: Legal Basis, Summary and Discussion of the EPO, US and
JPO Practice 831
17.1 Inventive Step: EPO (Article 56 EPC) 831
17.2 Inventive Step: US 845
17.3 Inventive Step: JPO 869
XXV
18 Inventive Step: The EPO's Case Law 879 18.1 Decisions on Inventive Step for Protein Inventions (Including Inventions Relating
to Methods for the Preparation of Proteins and their Use) 879 18.2 Decisions on Inventive Step for Nucleic Acid (Sequence) Inventions 948 18.3 Decisions on Inventive Step of Inventions Relating to Systems for the Expression of
DNA Sequences 1017
18.4 Decisions on Inventive Step for Plasmid Inventions 1048 18.5 Decisions on Inventive Step for Inventions on Antibody Technology 1051 18.6 Decisions on Inventive Step for Plant and Animal related Inventions 1093
18.7 Viruses and Their Epitopes 1127
18.8 PCR and Other in vitro Nucleic Acid Amplification and Detection Methods .. 1170
18.9 Microorganisms and How to Modify Them 1191
18.10 Other Decisions on Inventive Step 1213
19 Decisions of the EPO Dealing with Procedural Issues and Procedural
Changes Due to EPC2000 1264
19.1 Substantive Examination: General 1264
19.2 Opposition Proceedings: Introduction of New Grounds 1279 19.3 Opposition Proceedings: The Filing of New Claim Requests 1283 19.4 Opposition Proceedings: The Filing of New Documents/Experimental and Other
Evidence and the Submission of New Arguments 1304
19.5 Opposition Proceedings: Adaption of the Description 1316 19.6 Opposition Proceedings: Third Party Intervention/Third Party Observations . . 1316
19.7 Opposition Proceedings: Strawman 1321
19.8 Opposition Proceedings: Substantial Procedural Violation and Failures in the
Opposition Division's Decision 1323
19.9 Opposition and Appeal Proceedings: Miscellaneous 1330 20 Drafting Claims for a European Patent Application 1357 21 Examples of Claims for a US Patent Application 1359
21.1 Introduction 1359
21.2 Claims Relating to Chemical Compounds 1363
21.3 Claims Relating to DNA Sequences, Vectors, Plasmids, Host Cells, and
Recombinant DNA molecules 1363
21.4 Examples of Claims Relating to Polypeptides 1365
21.5 Examples of Claims Relating to Microorganisms 1366 21.6 Examples of Claims Relating to Monoclonal Antibodies 1366 21.7 Examples of Claims Relating to Transgenic Plants and Animals 1367
21.8 Method of Treatment Claims 1369
21.9 Claims That Are Not Allowable In The U.S 1372
22 Examples of Claims for a Japanese Patent Application 1373
22.1 Introduction 1373
22.2 Claims Relating to Chemical Compounds 1375
22.3 Claims Relating to DNA Sequences 1375
22.4 Claims Relating to Recombinant Proteins 1376
22.5 Claims Relating to Vectors and Transformants 1377
22.6 Claims Relating to Microorganisms 1378
XXVI
22.7 Claims Relating to Monoclonal Antibodies 1378
22.8 Claims Relating to Transgefiic Plants 1379
22.9 Claims Relating to Transgenic Animals 1379
22.10 Claims Relating to Screening Methods 1379
22.11 Claims Relating to Antagonists/Inhibitors or Agonists 1380 22.12 Claims Relating to Pharmaceutical Inventions 1380
22.13 Claims Relating to iPS 1382
23 How to Draft and File a European Patent Application 1383
23.1 The Tide of the Invention 1383
23.2 The Indication of the Field of the Invention 1383
23.3 The Acknowledgment of the Prior Art 1383
23.4 The Technical Problem Underlying the Invention 1383
23.5 The Solution 1384
23.6 The Legends to the Figures 1386
23.7 Examples 1386
23.8 Sequence Listings 1387
23.9 The Abstract 1388
23.10 ONLINE FILING (OLF) and New Online Filing under EPO's Case Management
Systems (CMS) 1388
23.11 Unity of Invention and Divisional Applications 1389 23.12 Further Formal Issues and Changes due to EPC2000 that have to be considered
when Drafting Patent Applications 1392
24 How to Draft the Description of a US Patent Application 1395
24.1 The Elements of a U.S. Patent Application 1395
24.2 Meeting the Requirements of 35 U.S.C. § 112, first paragraph 1401 25 How to Draft the Description of a Japanese Patent Application 1417
25.1 Elements of a Japanese Patent Application 1417
25.2 Title of the Invention 1417
25.3 Technical Field 1417
25.4 Prior Art 1417
25-5 Problems to be Solved by the Invention 1418
25-6 Means for Solving the Problems 1418
25.7 Effects of the Invention 1418
25.8 Mode for Carrying out the Invention 1419
25.9 Examples 1421
25.10 Sequence Listing 1422
25.11 Abstract 1422
26 How to Keep Notebooks for Successful Interferences 1423 26.1 Record Keeping To Establish Dates Of Invention 1423
26.2 Notebooks 1425
26.3 Electronic And Other Records Of Experiments 1427
XXVII
27 Extensions to Patent Term 1428 27.1 Supplementary Protection Certificates (SPCs) for Pharmaceuticals and Plant
Protection Products in Europe 1428
27.2 Extensions to Patent Term in the US 1430
27.3 Patent Term Extensions: JPO 1435
28 AIA Post-Grant Proceedings in the United States 1438
28.1 Introduction 1438
28.2 Covered Business Method Review 1441
28.3 Inter Partes Reviews 1443
28.4 Post-Grant Review 1445
28.5 Timeline and Process of Post-Grant Reviews 1446
28.6 Illustrative Bio/Pharma Post-Grant Proceedings 1455
Decisions of the EPO 1459
Decisions on U.S. Cases 1503
Decisions on Japanese Cases 1526
European Statutes 1529
Cross-Reference List Article EPC1973 Article/Rule EPC2000 1530
Cross-Reference List Rule EPC1973 Rule EPC2000 1532
U.S. Statutes 1537
Japanese Statutes 1538
Index 1539
XXVIII
