Free Declaration - District Court of Delaware - Delaware

Case 1:07-cv-00780-SLR

Document 31

Filed 05/23/2008

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Case 1:07-cv-00780-SLR

Document 31

Filed 05/23/2008

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Case 1:07-cv-00780-SLR

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EXHIBIT A

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United States Patent and Trademark Office

POLICY

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Boards & Counsel > BPAI > Efiling for Board of Patent Appeals and Interferences

This site contains PDF documents click here to download Adobe Reader Download PDF Plugin Interference Number 105240 Go Application Numbers Involved
09378045 v. 09565009

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Interference No
105240

Style Name
RAUCH v. NI

File Wrapper Bibliographic Info File Contents Help

Interference File Contents Display Exhibits
Document Name Document Document Page Filing Entered/Filed Count Date By 12/12/2007 113 BPAI

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142

NOTICE OF JUDICIAL OTHER INCOMING REVIEW UNDER 37 CORRESPONDENCE C.F.R. 41.8(b) JUDGMENT JUDGMENT - ORDER TO SHOW CAUSE Bd.R. 202(d)

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141 140 139

11/20/2007

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OTHER INCOMING HGS'S RESPONSE TO 10/29/2007 CORRESPONDENCE PAPER 139 ORDER ORDER MISCELLANEOUS BD.R. 104(a) 10/16/2007

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PARTY NI'S REQUEST FOR ADVERSE OTHER INCOMING 10/09/2007 JUDGMENT TO CORRESPONDENCE INITIATE REVIEW UNDER 35 U.S.C. 146 HUMAN GENOME SCIENCES,INC.

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NOTICE OF CHANGE OTHER INCOMING IN LEAD COUNSEL CORRESPONDENCE AND BACKUP COUNSEL JOINT STIPULATION OF SETTEMENT OTHER INCOMING DISCUSSION AFTER CORRESPONDENCE SUBSTANTIVE MOTIONS DECISION REDECLARATION ORDER DECISION ON MOTIONS REDECLARATION BD.R.203(RES) ORDER - PRIORITY TIMES - Bd.R. 104(c) DECISION-MOTIONSBd.R. 125(a) CONSOLIDATED EXHIBIT LIST OF EXHIBITS FILED IN PATENT INTERFERENCES 105240; 105380; AND 105381 JOINT SUBMISSION OF TRANSCRIPT APPEARANCE RECORD ORDER MISCELLANEOUS BD.R. 104(a)

09/24/2007

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135 134 133

08/24/2007 07/27/2007 07/26/2007

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132

LIST OF EXHIBITS

09/22/2006

12

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131 130 129

TRANSCRIPT APPEARANCE RECORD ORDER

09/22/2006 09/07/2006 09/05/2006

96 0 0

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128

RAUCH DEMONSTRATIVE OTHER INCOMING EXHIBITS (FOR ORAL 08/31/2006 CORRESPONDENCE ARGUMENT OF SEPTEMBER 7, 2006) RAUCH NOTICE OF OTHER INCOMING TRANSCRIPTION OF CORRESPONDENCE ORAL ARGUMENT 08/31/2006

0

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127

0

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126

NOTICE OF SERVICE OTHER INCOMING OF DEMONSTRATIVE 08/30/2006 CORRESPONDENCE EXHIBITS NOTICE OF FILING OTHER INCOMING PAPER COPY OF CORRESPONDENCE RECORD 08/02/2006

0

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125

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124

OBJECTIONS TO THE ADMISSIBILITY OF OTHER INCOMING RAUCH EXHIBIT 1104 07/10/2006 CORRESPONDENCE (CONTINUED IN 103001) NOTICE OF FILING OF OTHER INCOMING RECORD FOR 07/10/2006 CORRESPONDENCE DECISIONS ON MOTIONS

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NOTICE OF FILING OF OTHER INCOMING THE RECORD FOR 07/07/2006 CORRESPONDENCE DECISIONS ON MOTIONS REPLY REPLY ORDER REPLY 8 REPLY 7 ORDER MISCELLANOEUS Bd.R 104(a) 07/03/2006 07/03/2006 06/29/2006 06/28/2006

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119 118 117 116

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OTHER INCOMING NI EXHIBIT LIST CORRESPONDENCE NI NOTICE OF OTHER INCOMING SERVICE OF CASE CORRESPONDENCE LAW AND CD'S ON PARTY ADAMS NI NOTICE OF SERVICE OF NI OTHER INCOMING RECORD ON CORRESPONDENCE COUNSEL FOR IMMUNEX

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06/28/2006

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114

06/28/2006

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113

RESUBMISSION OF NI MOTION 7 TO OTHER INCOMING EXCLUDE EVIDENCE 06/28/2006 CORRESPONDENCE (APPENDIX A TO NI ERRATA TO MOTION 7) NI ERRATA TO OTHER INCOMING MOTION 7 EXCLUDE CORRESPONDENCE EVIDENCE OPPOSITION OPPOSITION 7 06/28/2006 06/22/2006

0

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112 110

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RESPONSE TO OTHER INCOMING OBSERVATIONS ON CORRESPONDENCE DEPOSITION OF GAVIN SCREATON OPPOSITION OPPOSITION 8 TO RAUCH SUBSTANTIVE MOTION 8

06/22/2006

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108

06/22/2006

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107 106 105

ORDER-EXPUNGING OTHER OUTGOING PAPERS 101-103 CORRESPONDENCE BD.R.7(A) OTHER INCOMING NI EXHIBIT LIST CORRESPONDENCE OTHER INCOMING NI REQUEST FOR CORRESPONDENCE ORAL HEARING NI OBSERVATIONS OTHER INCOMING ON CROSS CORRESPONDENCE EXAMINTATION OF GAVIN R. SCREATON OTHER INCOMING NI MOTION 7 TO

06/20/2006 06/13/2006 06/13/2006

0 0 0

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104

06/13/2006

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100

06/13/2006

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CORRESPONDENCE EXCLUDE EVIDENCE RAUCH EXHIBIT LIST, EXHIBITS 1001-1096 OTHER INCOMING 06/13/2006 (ACCOMPANYING CORRESPONDENCE TPS MOTIONS TO EXCLUDE) RAUCH REQUEST OTHER INCOMING FOR ORAL CORRESPONDENCE ARGUMENT RAUCH MISCELLANEOUS OTHER INCOMING MOTION 8 (TO CORRESPONDENCE EXCLUDE NI'S EVIDENCE) 06/13/2006

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98

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97

06/13/2006

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96

DECISIONOTHER OUTGOING REHEARING-BD.R.125 06/08/2006 CORRESPONDENCE (C) RAUCH NOTICE OF OTHER INCOMING DEPOSITION OF CORRESPONDENCE GAVIN SCREATON MOTION JOINT STIPULATION EXTENDING TIME PERIODS 5 AND 6 05/26/2006

0

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95

0

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94

05/10/2006

0

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ORDER OTHER OUTGOING MISCELLANEOUSCORRESPONDENCE BD.R.104 JOINT STIPULATION OTHER INCOMING EXTENDING TIME CORRESPONDENCE PERIOD 5 OTHER INCOMING EXHIBIT LIST, CORRESPONDENCE EXHIBITS 1001-1088 REPLY REPLY REPLY REPLY REPLY REPLY REPLY 7 REPLY 6 REPLY 5 REPLY 4 REPLY 3 REPLY 2

05/05/2006

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c d e f g c d e f g c d e f g c d e f g c d e f g c d e f g c d e f g c d e f g c d e f g c d e f g c d e f g c d e f g c d e f g

92 91 90 89 88 87 86 85 84 83 82 81 80

05/04/2006 04/24/2006 04/24/2006 04/24/2006 04/24/2006 04/24/2006 04/24/2006 04/24/2006 04/21/2006 04/21/2006 04/21/2006 04/21/2006

0 0 0 0 0 0 0 0 0 0 0 0 0

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OTHER INCOMING EXHIBIT LIST CORRESPONDENCE REPLY REPLY REPLY MOTION REPLY 6 REPLY 4 REPLY 3

JOINT STIPULATION ON CHANGE OF TIME 04/06/2006 PERIOD 4

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c d e f g

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NI NOTICE OF OTHER INCOMING DEPOSITION UNDER CORRESPONDENCE 37 C.F.R. 41.157(C) DECISION REQUEST OTHER OUTGOING FOR REHEARING CORRESPONDENCE BD.R.125(C) REQUEST FOR REHEARING OTHER INCOMING REGARDING NI CORRESPONDENCE SUBSTANTIVE MOTION 5

03/29/2006

0

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78

03/16/2006

0

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77

03/03/2006

0

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RAUCH EXHIBIT LIST, OTHER INCOMING EXHIBITS 1001-1063 02/23/2006 CORRESPONDENCE (ACCOMPANYING OPPOSITIONS) OTHER INCOMING RAUCH OPPOSITION CORRESPONDENCE 6 OTHER INCOMING RAUCH OPPOSITION CORRESPONDENCE 4 OTHER INCOMING RAUCH OPPOSITION CORRESPONDENCE 3 OTHER INCOMING NI EXHIBIT LIST CORRESPONDENCE 02/23/2006 02/23/2006 02/23/2006 02/23/2006

0

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75 74 73 72 71

0 0 0 0 0

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c d e f g
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NI OPPOSITION 7 TO OTHER INCOMING RAUCH RESPONSIVE 02/23/2006 CORRESPONDENCE MOTION 7 NI OPPOSITION 6 TO OTHER INCOMING RAUCH SUBSTNTIVE CORRESPONDENCE MOTION 6 NI OPPOSITION 5 TO OTHER INCOMING RAUCH CORRESPONDENCE SUBSTANTIVE MOTION 5 NI OPPOSITION 4 TO OTHER INCOMING RAUCH CORRESPONDENCE SCUBSTANTIVE MOTION 4 NI OPPOSITION 3 TO OTHER INCOMING RAUCH CORRESPONDENCE SUBSTANTIVE MOTION 3 NI OPPOSITION 2 TO OTHER INCOMING RAUCH CORRESPONDENCE SUBSTANTIVE MOTION 2 ORDER DECISION INTERLOCUTORY MOTIONS BD.R. 125 (b) RESPONSE TO NI'S REQUEST FOR RECONSIDERATION 02/23/2006

c d e f g

70

0

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69

02/23/2006

0

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68

02/23/2006

0

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c d e f g

67

02/23/2006

0

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c d e f g

66

02/23/2006

0

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65

02/16/2006

0

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OTHER INCOMING

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CORRESPONDENCE OF DENIAL MOTION FOR COMPULSION OF TESTIMONY AND DOCUMENTS JOINT STIPULATION OTHER INCOMING EXTENDING TIME CORRESPONDENCE PERIODS 3 AND 4 RAUCH NOTICE OF OTHER INCOMING DEPOSITION OF CORRESPONDENCE GENHONG CHENG OTHER INCOMING NI EXHIBIT LIST CORRESPONDENCE REQUEST FOR REHEARING OTHER INCOMING RGARDING NI CORRESPONDENCE MISCELLANEOUS MOTION 2 UNDER 37 C.F.R. 41.125(C) ORDER ORDER-ADDITIONAL DISCOVERY -Bd.R. 150(c)

02/10/2006

0

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63

02/08/2006

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62 61

01/30/2006 01/27/2006

0 0

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60

01/27/2006

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59 58

01/12/2006 01/05/2006

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OTHER INCOMING RESPONSIVE CORRESPONDENCE MOTION 7 RESPONSIVE OTHER INCOMING MOTION 6 CORRESPONDENCE REQUESTING BENEFIT ORDER ORDERMISCELLANEOUSBd.R. 104

c d e f g

57

01/05/2006

0

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56

01/04/2006

0

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55 54

NOTICE OF SERVING OTHER INCOMING PRIORITY CORRESPONDENCE STATEMENT OTHER INCOMING EXHIBIT LIST, CORRESPONDENCE EXHIBITS 1001-1037 CLEAN CPY OF OTHER INCOMING CLAIMS AND CORRESPONDENCE BIOTECHNOLOGY SEQUENCES OTHER INCOMING ANNOTATED COPY CORRESPONDENCE OF CLAIMS PROPOSED OTHER INCOMING AMENDMENT IN CORRESPONDENCE APPLICATION 09/378,045 NOTICE OF FILING OTHER INCOMING PRIORITY CORRESPONDENCE STATEMENT

12/16/2005 12/08/2005

0 0

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53

12/08/2005

0

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52

12/08/2005

0

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12/08/2005

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50 49 48

12/08/2005

0 0 0

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OTHER INCOMING SUBSTANTIVE MOTIO 12/08/2005 CORRESPONDENCE 6 OTHER INCOMING SUBSTANTIVE CORRESPONDENCE MOTION 5 12/08/2005

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c d e f g

47 46 45 44 43

OTHER INCOMING SUBSTANTIVE CORRESPONDENCE MOTION 4 OTHER INCOMING SUBSTANTIVE CORRESPONDENCE MOTION 3 OTHER INCOMING SUBSTANTIVE CORRESPONDENCE MOTION 2 NI NOTICE OF FILING OTHER INCOMING PRIORITY CORRESPONDENCE STATEMENT OTHER INCOMING NI EXHIBIT LIST CORRESPONDENCE NI SUBSTANTIVE MOTION 5 (UNPATENTABILITY OTHER INCOMING OF IMMUNEX'S CORRESPONDENCE INVOLVED CLAIMS UNDER 35 U.S.C.105 (E) AND/OR 102 (C)/103) NI SUBSTANTIV OTHER INCOMING MOTION 4 TO CORRESPONDENCE SUBSTITUTE NEW COUNT 2

12/08/2005 12/08/2005 12/08/2005 12/08/2005 12/08/2005

0 0 0 0 0

BPAI BPAI BPAI BPAI BPAI

c d e f g c d e f g c d e f g c d e f g

c d e f g

42

12/08/2005

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41

12/08/2005

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NI SUBSTANTIVE MOTION 3 (TO OTHER INCOMING CHANGE BENFIT 12/08/2005 CORRESPONDENCE ACCORDED FOR THE CONTESTED SUBJECT MATTER) STATEMENT OTHER INCOMING REGARDING CORRESPONDENCE SETTLEMENT DISCUSSION ORDEROTHER OUTGOING MISCELLANEOUSCORRESPONDENCE BD.R.104 ORDER OTHER OUTGOING MISCELLANEOUS CORRESPONDENCE BD.R. 104(a) OTHER INCOMING RAUCH OPPOSITION CORRESPONDENCE 2 ORDEROTHER OUTGOING INTERLOCUTORY CORRESPONDENCE MOTIONS-BD.R. 125 (B) (IMMUNEX) ORDERINTERLOCUTORY OTHER OUTGOING MOTIONS-BD.R. 125 CORRESPONDENCE (B)(HUMAN GENOME SCIENCES) OTHER INCOMING NI EXHIBIT LIST CORRESPONDENCE 12/05/2005

0

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39

0

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c d e f g

38

11/29/2005

0

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37 36

11/22/2005 11/22/2005

0 0

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35

11/15/2005

0

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34

11/15/2005

0

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c d e f g

33

11/10/2005

0

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OTHER INCOMING NI MISCELLANEOUS CORRESPONDENCE MOTION 2 RAUCH EXHIBT LIST, OTHER INCOMING EHBITIS 1001-1013 CORRESPONDENCE (FILED WITH RAUCH OPPOSITION 1) OTHER INCOMING RAUCH OPPOSITION CORRESPONDENCE 1

11/10/2005

0

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31

11/10/2005

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30 29 28 27.025 27.024 27.023 27.022 27.021 27.02 27.019 27.018 27.017 27.016 27.015 27.014 27.013 27.012 27.011 27.01 27.009 27.008

11/10/2005

0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0

BPAI BPAI BPAI BPAI BPAI BPAI BPAI BPAI BPAI BPAI BPAI BPAI BPAI BPAI BPAI BPAI BPAI BPAI BPAI BPAI BPAI

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OTHER INCOMING RAUCH EXHIBIT LIST, 11/07/2005 CORRESPONDENCE EXHIBITS 1001-1012 RAUCH OTHER INCOMING MISCELLANEOUS CORRESPONDENCE MOTION 1 OTHER INCOMING EXHIBITS CORRESPONDENCE OTHER INCOMING EXHIBITS CORRESPONDENCE OTHER INCOMING EXHIBITS CORRESPONDENCE OTHER INCOMING EXHIBITS CORRESPONDENCE OTHER INCOMING EXHIBITS CORRESPONDENCE OTHER INCOMING EXHIBITS CORRESPONDENCE OTHER INCOMING EXHIBITS CORRESPONDENCE OTHER INCOMING EXHIBITS CORRESPONDENCE OTHER INCOMING EXHIBITS CORRESPONDENCE OTHER INCOMING EXHIBITS CORRESPONDENCE OTHER INCOMING EXHIBITS CORRESPONDENCE OTHER INCOMING EXHIBITS CORRESPONDENCE OTHER INCOMING EXHIBITS CORRESPONDENCE OTHER INCOMING EXHIBITS CORRESPONDENCE OTHER INCOMING EXHIBITS CORRESPONDENCE OTHER INCOMING EXHIBITS CORRESPONDENCE OTHER INCOMING EXHIBITS CORRESPONDENCE OTHER INCOMING EXHIBITS 11/07/2005 11/07/2005 11/07/2005 11/07/2005 11/07/2005 11/07/2005 11/07/2005 11/07/2005 11/07/2005 11/07/2005 11/07/2005 11/07/2005 11/07/2005 11/07/2005 11/07/2005 11/07/2005 11/07/2005 11/07/2005 11/07/2005

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CORRESPONDENCE

c d e f g

27.007 27.006 27.005 27.004 27.003 27.002 27.001 27

OTHER INCOMING EXHIBITS CORRESPONDENCE OTHER INCOMING EXHIBITS CORRESPONDENCE OTHER INCOMING EXHIBITS CORRESPONDENCE OTHER INCOMING EXHIBITS CORRESPONDENCE OTHER INCOMING EXHIBITS CORRESPONDENCE OTHER INCOMING EXHIBITS CORRESPONDENCE OTHER INCOMING EXHIBIT CORRESPONDENCE OTHER INCOMING EXHIBIT LIST CORRESPONDENCE MISCELLANEOUS MOTION 1 (REQUESTING OTHER INCOMING SYNCHRONIZATION CORRESPONDENCE OF TIMES AND/OR DELAYED DISCLOURE) ORDEROTHER OUTGOING MISCELLANEOUS CORRESPONDENCE BD.R. 104(a) ORDER OTHER OUTGOING MISCELLANEOUSCORRESPONDENCE BD.R. 104(a) ORDEROTHER OUTGOING MISCELLANEOUSCORRESPONDENCE BD.R.104(A) NOTICE OF OTHER INCOMING CONFIDENTIAL CORRESPONDENCE INFORMATION OTHER INCOMING LIST OF INTENDED CORRESPONDENCE MOTIONS LIST OF INTENDED OTHER INCOMING SUBSTATNTIVE CORRESPONDENCE MOTIONS OTHER INCOMING ANNOTATED COPY CORRESPONDENCE OF CLAIMS OTHER INCOMING ANNOTATED COPY CORRESPONDENCE OF CLAIMS ORDER POWER OF ATTORNEY ORDER POWER OF ATTORNEY COPY OF CLAIMS

11/07/2005 11/07/2005 12/07/2005 11/07/2005 11/07/2005 11/07/2005 11/07/2005 11/07/2005

0 0 0 0 0 0 0 0

BPAI BPAI BPAI BPAI BPAI BPAI BPAI BPAI

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26

11/07/2005

0

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25

11/03/2005

0

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11/03/2005

0

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11/02/2005

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22 21 20 19 18 17 16

11/01/2005 10/27/2005 10/27/2005 09/29/2005 09/29/2005 09/27/2005 09/15/2005

0 0 0 0 0 0 0

BPAI BPAI BPAI BPAI BPAI BPAI BPAI

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c d e f g c d e f g c d e f g c d e f g c d e f g

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AND OTHER INCOMING BIOTECHNOLOGY CORRESPONDENCE SEQUENCES OTHER INCOMING REQUEST FOR FILE CORRESPONDENCE COPIES REAL PARTY IN INTEREST DESIGNATION OF REAL PARTY IN INTEREST

09/15/2005 09/15/2005 09/15/2005

0 0 0 0 0

BPAI BPAI BPAI BPAI BPAI

OTHER INCOMING NOTICE OF RELATED 09/15/2005 CORRESPONDENCE PROCEEDINGS DESIGNATION OF LEAD ATTORNEY ORDER DESIGNATION OF LEAD AND BACKUP COUNSEL ORDERMISCELLANEOUS Bd.R. 104(a) 09/15/2005

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10 9 8 7 6 5 4 3 2 1

09/21/2005 09/15/2005 09/15/2005 09/15/2005 09/15/2005 09/15/2005 08/31/2005 08/31/2005 08/31/2005 08/31/2005

0 0 0 0 0 0 0 0 0 0

BPAI BPAI BPAI BPAI BPAI BPAI BPAI BPAI BPAI BPAI

OTHER INCOMING REQUEST FOR FILE CORRESPONDENCE COPIES CLEAN COPY OF OTHER INCOMING CLAIMS AND CORRESPONDENCE SEQUENCE OTHER INCOMING NOTICE OF CHILD CORRESPONDENCE APPLICATIONS REAL PARTY IN INTEREST DESIGNATION OF LEAD ATTORNEY ORDER ORDER REAL PARTY-ININTEREST IDENTIFICATION OF LEAD AND BACKUP LEAD COUNSEL ORDER-RULE 123(a) ORDERMISCELLANEOUSBd.R. 104(a)

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OTHER OUTGOING STANDING ORDER CORRESPONDENCE NOTICE TO DECLARE INTERFERENCE DECLARATION

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Last Modified: 05/22/2008 15:53:07

Case 1:07-cv-00780-SLR

Document 31-2

Filed 05/23/2008

Page 12 of 16

United States Patent and Trademark Office
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POLICY

Boards & Counsel > BPAI > Efiling for Board of Patent Appeals and Interferences

Interference No
105240

Style Name
RAUCH v. NI

Application Numbers Involved
09378045 v. 09565009

The following exhibits were filed for the interference number:- 105240

Interference File Contents
Click on Document Type to view documents Download Document Document Document Name Files Number Type The following Exhibits were filed by BPAI Document Document Page Entered/Filed Filing Count By Date 09/22/2006 07/07/2006 07/07/2006 07/07/2006 07/07/2006 07/07/2006 07/07/2006 07/07/2006 07/07/2006 07/07/2006 07/07/2006 07/07/2006 07/07/2006 07/07/2006 07/07/2006 07/07/2006 07/07/2006 93 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 BPAI BPAI BPAI BPAI BPAI BPAI BPAI BPAI BPAI BPAI BPAI BPAI BPAI BPAI BPAI BPAI BPAI

c d e f g c d e f g c d e f g c d e f g c d e f g c d e f g c d e f g c d e f g

131.197 122.052 122.053 122.056 122.057 122.058 122.059 122.06 122.061 122.062 122.063 122.064 122.065 122.066 122.067 122.068 122.069

EXHIBIT EXHIBIT EXHIBIT EXHIBIT EXHIBIT EXHIBIT EXHIBIT EXHIBIT EXHIBIT EXHIBIT EXHIBIT EXHIBIT EXHIBIT EXHIBIT EXHIBIT EXHIBIT EXHIBIT

TRANSCRIPT OF ORAL ARUGMENT (SEPTEMBER 7, 2006) FILED AS EXHIBIT 2197 EXHIBIT 2052 EXHIBIT 2053 EXHIBIT 2056 EXHIBIT 2057 EXHIBIT 2058 EXHIBIT 2059 EXHIBIT 2060 EXHIBIT 2061 EXHIBIT 2062 EXHIBIT 2063 EXHIBIT 2064 EXHIBIT 2065 EXHIBIT 2066 EXHIBIT 2067 EXHIBIT 2068 EXHIBIT 2069

c d e f g c d e f g c d e f g c d e f g c d e f g c d e f g c d e f g c d e f g c d e f g

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122.07 122.071 122.072 122.073 122.074 122.075 122.076 122.077 122.078 122.079 122.08 122.081 122.082 122.083 122.084 122.085 122.086 122.087 122.088 122.089 122.09 122.001 122.002 122.003 122.004 122.005 122.006 122.007 122.008 122.009 122.01

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c d e f g c d e f g c d e f g c d e f g c d e f g c d e f g c d e f g c d e f g c d e f g c d e f g c d e f g c d e f g c d e f g c d e f g c d e f g c d e f g

122.011 122.012 122.013 122.014 122.015 122.016 122.017 122.018 122.019 122.02 122.021 122.022 122.023 122.024 122.025 122.026 122.027 122.028 122.029 122.03 122.031 122.032 122.033 122.034 122.035 122.036 122.037 122.038 122.039 122.04 122.041 122.042

EXHIBIT EXHIBIT EXHIBIT EXHIBIT EXHIBIT EXHIBIT EXHIBIT EXHIBIT EXHIBIT EXHIBIT EXHIBIT EXHIBIT EXHIBIT EXHIBIT EXHIBIT EXHIBIT EXHIBIT EXHIBIT EXHIBIT EXHIBIT EXHIBIT EXHIBIT EXHIBIT EXHIBIT EXHIBIT EXHIBIT EXHIBIT EXHIBIT EXHIBIT EXHIBIT EXHIBIT EXHIBIT

EXHIBIT 2011 EXHIBIT 2012 EXHIBIT 2013 EXHIBIT 2014 EXHIBIT 2015 EXHIBIT 2016 EXHIBIT 2017 EXHIBIT 2018 EXHIBIT 2019 EXHIBIT 2020 EXHIBIT 2021 EXHIBIT 2022 EXHIBIT 2023 EXHIBIT 2024 EXHIBIT 2025 EXHIBIT 2026 EXHIBIT 2027 EXHIBIT 2028 EXHIBIT 2029 EXHIBIT 2030 EXHIBIT 2031 EXHIBIT 2032 EXHIBIT 2033 EXHIBIT 2034 EXHIBIT 2035 EXHIBIT 2036 EXHIBIT 2037 EXHIBIT 2038 EXHIBIT 2039 EXHIBIT 2040 EXHIBIT 2041 EXHIBIT 2042

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EXHIBIT 2043 EXHIBIT 2044 EXHIBIT 2045 EXHIBIT 2046 EXHIBIT 2047 EXHIBIT 2048 EXHIBIT 2049 EXHIBIT 2050 EXHIBIT 2051 CONSOLIDATED EXHIBIT LIST OF EXHIBITS IN PATENT INTERFERENCE NOS. 105240; 105380; AND 105381 EXHIBIT LIST, EXHIBITS 1001-1104 (ACCOMPANYING TP7 REPLY TO MOTION TO EXCLUDE) EXHIBIT LIST, EXHIBITS 1001-1101 (accompanying TP6 Oppositions to Motions to Exclude) EXHIBITS 2036 EXHIBITS 2037 EXHIBITS 2038 EXHIBITS 2039 EXHIBITS 2040 EXHIBITS 2041 EXHIBITS 2026 EXHIBITS 2027 EXHIBITS 2028 EXHIBITS 2029 EXHIBITS 2030 EXHIBITS 2031 EXHIBITS 2032 EXHIBITS 2033 EXHBITS 2034 EXHIBITS 2035 EXHIBITS

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111 33.011 33.012 33.013 33.014 33.015 33.016 33.001 33.002 33.003 33.004 33.005 33.006 33.007 33.008 33.009 33.01 31.001

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EXHIBITS EXHIBITS EXHIBITS EXHIBITS EXHIBITS EXHIBITS EXHIBITS EXHIBITS EXHIBITS EXHIBITS EXHIBITS EXHIBITS

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EXHIBIT B

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Paper Filed on behalf of: By: Party Ni Jorge A. Goldstein, Esq. Eldora L. Ellison, Esq. Sterne, Kessler, Goldstein & Fox, P.L.L.C. 1100 New York Avenue, NW Washington, D.C. 20005-3934 Tel: (202) 371-2600 Fax: (202) 371-2540

UNITED STATES PATENT AND TRADEMARK OFFICE

BEFORE THE BOARD OF PATENT APPEALS AND INTERFERENCES (Administrative Patent Judge Richard E. Schafer) Human Genome Sciences, Inc. Junior Party (Patent 6,872,568; Inventors: Jian Ni, Reiner L. Gentz, Guo-Liang Yu, Craig A. Rosen),

Imrnunex Corp. Senior Party (Application 091378,045; Inventors: Charles Rauch, Henning Walczak). Patent Interference No. 105,240 (RES)

N SUBSTANTIVE MOTION 3 I (To Change Benefit Accorded for the Contested Subject Matter)

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-1Ni Substantive Motion 3 (To Change Benefit Accorded for the Contested Subject Matter) Patent Interference No. 105,240
I. Statement of Precise Relief Requested

Party Ni ("Human Genome Sciences" or "HGS") requests that the Board accord HGS the benefit of the following priority applications for the subject matter of count 1 of the present interference and, contingent upon the granting of HGS's SUBSTANTIVE MOTION 4 TO SUBSTITUTE NEW COUNT 2, to accord HGS the benefit of the following priority applications for the subject matter of proposed count 2:

+

U.S. Provisional Appl. No. 601040,846 (the "March 17, 1997 priority application");

+ +
+

U.S. Provisional Appl. No. 60/054,02 1 (the "July 29, 1997 priority application"); U.S. Appl. No. 091042,583, filed March 17, 1998; U.S. Provisional Appl. No. 601132,498, filed May 4, 1999; U.S. Provisional Appl. No. 601133,238, filed May 7, 1999; and U.S. Provisional Appl. No. 60/148,939, filed August 13,1999.

+
+
ZI.

The Evidence

The evidence relied upon in support of this motion is set forth as Appendix A to this motion, which is attached hereto. 11 1
Statement of Material Facts

A statement of material facts in support of this motion is set forth as Appendix B to this motion, which is attached hereto.

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-2Ni Substantive Motion 3 (To Change Benefit Accorded for the Contested Subject Matter) Patent Interference No. 105,240

IV.

Argument A. Overview

HGSts involved patent claims the benefit of six priority applications (Fact I), as shown in Appendix C to this motion. In the Notice of Allowability for the application that resulted in HGS's involved patent, the Examiner explicitly acknowledged that the March 17, 1997 priority application enables and describes antagonistic antibodies specific for DR5 that are the subject of the count of this interference. (Fact 2). Nonetheless, HGS has not been accorded the benefit of any of its priority applications in this interference. (Fact 3). In this Motion, Party Ni will demonstrate beyond any question that HGSts priority applications, including its March 17, 1997 priority application, indeed fully enable and describe the contested subject matter of the present interference. Thus, HGS is entitled to the benefit of its priority applications. The count generally relates to antibodies that specifically bind to the extracellular domain (ECD) of a receptor molecule known alternatively as DR5, Apo-2, or TRAIL-R2. The amino acid sequence of DR5 is set forth in HGS's involved patent as SEQ ID NO: 2. (Fact 4). DR5 is a death domain-containing member of the tumor necrosis factor receptor (TNFR) superfamily (a "death receptor") and is involved in the induction of apoptosis in cells. (Fact 5). The antibodies of the count are specified as being antagonists of the DR5 protein. (Fact 6).

As explained in detail below, HGS's March 17, 1997 priority application, inter alia, (i)
provides the complete amino acid sequence of DR5 (SEQ ID NO: 2), (ii) identifies the amino acid residues that correspond to the ECD of DR5, (iii) recognizes that, because of the sequence similarity between DR5 and other death receptors, DR5 is also a death receptor, (iv) teaches

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-3Ni Substantive Motion 3 (To Change Benefit Accorded for the Contested Subject Matter)

Patent Interference No. 105,240 methods for cloning, expressing and isolating DR5 and portions thereof (including the extracellular domain), (v) teaches methods for making and using antagonistic antibodies (e.g., monoclonal antibodies) that specifically bind to the extracellular domain of DR5, (vi) teaches methods for confirming that antibodies that specifically bind to the extracellular domain of DR5 are antagonists of DR5, and (vii) provides clear and practical uses for such antibodies. Therefore, in view of the disclosure of the March 17, 1997 application and the advanced state of the art relating to the production of antibodies in general, as well as the production of antagonistic antibodies against death receptors in particular, it is clear that HGS's March 17, 1997 priority application provides a fully enabled written description of the subject matter of count 1 and of proposed count 2. HGS's later filed priority applications, including the July 29, 1997 application, include all of the information fi-om the March 17, 1997 application and provide additional worlung examples confirming that DR5 induces apoptosis, (Fact 7), and that the extracellular domain of DR5 interacts with the apoptosis-inducing ligand TRAIL. (Fact 8). These examples reinforce the enablement and written description of antibodies that fall within the scope of count 1 and of proposed count 2. Thus, for at least the same reasons that HGS should be accorded the benefit of the March 17,1997 priority application, HGS should also be accorded the benefit of its later filed priority applications.

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-4Ni Substantive Motion 3 (To Change Benefit Accorded for the Contested Subject Matter) Patent Interference No. 105,240

B.

The Legal Requirements for Being Accorded Benefit o an Earlier Application f

Under 37 C.F.R. $ 41.201, "accord benefit" is defined as Board recognition that a patent application provides a proper constructive reduction to practice under 35 U.S.C. tj 102(g)(l). "Constructive reduction to practice means a described and enabled anticipation under 35 U.S.C.
tj 102(g)(l) in a patent applicatian of the subject matter of a count." Id. Therefore, to be

accorded the benefit of an earlier application for purposes of priority, a party need only have provided an enabled description of a single species within the scope of the count. See Scripps Research Institute v. Genentech, Inc., 2005 WL 596764 (Bd. Pat. App. & Interf.) (citing Hunt v. Treppschuh, 523 F.2d 1389,187 U.S.P.Q. 426,429 (CCPA 1975)). To satisfy the enablement requirement, the specification of a patent application must enable a person of ordinary skill in the art to make and use the claimed invention without undue experimentation. See In re Wands, 858 F.2d 731, 737, 8 U.S.P.Q.2d 1400, 1404 (Fed. Cir.
1988). A specification, however, need not enable information within the knowledge of an

ordinary skilled artisan. See Chiron Corp. v. Genentech, Inc., 363 F.3d 1247, 1254, 70 U.S.P.Q.2d 1321, 1325 (Fed. Cir. 2004). In the context of assessing the enablement requirement for monoclonal antibodies specifically, the court in Wands stated in its 1988 decision that "the nature of monoclonal antibody technology is that it involves screening hybridomas to determine which ones secrete antibody with desired characteristics. Practitioners of this art are prepared to screen negative hybridomas in order to find one that makes the desired antibody." Wands, 858 F.2d at 740,8 U.S.P.Q.2d at 1406.

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-5Ni Substantive Motion 3 (To Change Benefit Accorded for the Contested Subject Matter) Patent Interference No. 105,240

An application also must describe the subject matter of the count in terms that establish
that the party was in possession of the invention, including all of the elements and limitations presented in the count, at the time of the earlier filing. Hyatt v. Boone, 146 F.3d 1348, 1353,47 U.S.P.Q.2d 1128, 1131 (Fed. Cir. 1998). The descriptive text needed to satisfy the written description requirement varies with the nature and scope of the invention at issue, and with the scientific and technologic knowledge already in existence. Capon v. Eshhar, 418 F.3d 1349, 1357,76 U.S.P.Q.2d 1078, 1084 (Fed. Cir. 2005). The written description requirement can be met by: "showing that an invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics

. . . i.e.,

complete or partial structure, or other physical andfor chemical properties, functional characteristics when coupled with a known or disclosed correlation between function and structure, or some combination of such characteristics." Enzo Biochem, Inc. v. Gen-Probe Inc., 296 F.3d 1316, 1324, 63 U.S.P.Q.2d 1609, 1613 (Fed. Cir. 2002)). In the context of satisfying the written description requirement for antibodies in particular, the Federal Circuit has recently stated that: based on our past precedent, as long as an applicant has disclosed a "fully characterized antigen," either by its structure, formula, chemical name, or physical properties, or by depositing the protein in a public depository, the applicant can then claim the antibody by its binding affinity to that described antigen. Noelle v. Lederman, 355 F.3d 1343,1349,69 U.S.P.Q.2d 1508, 1514 (Fed. Cir. 2004).

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-6Ni Substantive Motion 3 (To Change Benefit Accorded for the Contested Subject Matter)

Patent Interference No. 105,240
C. HGS's March 17,1997 Priority Application Provides an Enabled Description of an Embodiment of Count 1 and of Proposed Count 2 1. Count 1

Count 1 is represented, in one alternative, by claim 21 of HGS's '568 patent. (Fact 9). Claim 21 (re-written in independent form with all the limitations of claim 15 fiom which it depends) is as follows: An isolated monoclonal antibody or fiagment thereof that specifically binds to a protein consisting of amino acid residues 1 to 133 of SEQ ID NO:2, wherein said antibody or fiagment thereof is an antagonist of the protein of SEQ ID NO:2. (Fact 10). SEQ ID NO:2 is the amino acid sequence of the full-length DR5 protein. (Fact 11). Amino acid residues 1 to 133 of SEQ ID NO:2 represent the extracellular domain of DR5. (Fact 12). For simplicity, the count will be referred to herein as being directed to antagonistic antibodies or fiagments thereof which specifically bind to the extracellular domain of DR5. To be accorded benefit of the March 17, 1997 priority application, HGS need only show that the priority application enables and describes an antagonistic monoclonal antibody or fiagment thereof that specifically binds to a protein consisting of the extracellular domain of DR5. As explained below, the March 17, 1997 priority application provides a fully enabled description of antagonistic antibodies of count 1.

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-7Ni Substantive Motion 3 (To Change Benefit Accorded for the Contested Subject Matter) Patent Interference No. 105,240

(a)

The Expert Opinion ofDr. John Reed

Party Ni has asked Dr. John Reed to evaluate the descriptions of HGS's priority
documents in order to provide his opinion as to what a person of ordinary skill in the art would have understood upon reading the documents at the time of their filing. Dr. Reed's Declaration is specifically referenced in various places throughout t h s Motion. Dr. Reed is a highly recognized expert in the field of apoptosis and cell death regulation. He is currently the President and Chief Executive Officer of the Burnham Institute where he is also the head of a research laboratory. (Fact 13). Dr. Reed has authored or co-authored over 600 publications and has received several awards and honors fi-om the scientific community (e.g., the Decade's Most Highly Cited Apoptosis Researcher fi-om 1991-2001, and the #1 Hottest Researcher in Life Sciences Worldwide (2000 and 1999)). (Fact 14). Dr. Reed's credentials and credibility are beyond challenge.

(b)

Count 1 is Fully Enabled

After reading HGS's March 17, 1997 priority application, a person of ordinary skill in the

art would have been able to make and use, without undue experimentation, a monoclonal
antibody that specifically binds to the extracellular domain of DR5 and that is an antagonist of DR5. As confirmed by Dr. Reed, to make and use an antibody of the count, one of ordinary skill in the art would typically: (1) produce monoclonal antibodies that specifically bind to the ECD

of DR5; and (2) determine by routine screening whether the monoclonal antibodies are
antagonists of DR5. (Fact 15). These two processes would not have involved undue

experimentation at the time of filing.

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-8Ni Substantive Motion 3 (To Change Benefit Accorded for the Contested Subject Matter) Patent Interference No. 105,240
The March 17, 1997 Priority Application Indicates that DR5 is a Novel Apoptosis-Inducing Death Receptor

(i)

As confirmed by Dr. Reed, in view of HGS's March 17, 1997 application, including the disclosed similarity of DR5 to previously-known death receptors (TNFR1, Fas and DR3, each of which was known to induce apoptosis), and in view of the state of the art prior to March 17, 1997, the most reasonable conc~nsion draw fkom HGS's March 17, 1997 application is that to DR5 is expected, by persons of ordinary skill in the art, to be a novel death receptor. (Fact 16). Additionally, it is noted by Dr. Reed that, in view of HGS's March 17, 1997 application and the state of the art, a person of ordinary skill in the art would have predicted that activation of DR5 would induce apoptosis. (Fact 17). This conclusion is explicitly stated in Nits March 17, 1997 application. (Fact 18). According to Dr. Reed, based on the information provided in HGS's March 17, 1997 application and what was known at the time, a person of ordinary skill in the art would have reasonably believed the assertion that activation of Dl25 would induce apoptosis. (Fact 19).
(ii) Expression and Purification of DRS Polypeptides Would Not Have Required Undue Experimentation

The March 17, 1997 priority application discloses the complete amino acid sequence of DR5, which is represented by SEQ ID NO:2. (Fact 20). The specification also identifies amino acid residues 52 to 184 as constituting the extracellular domain of DR5. (Fact 21). In HGS's subsequent applications, residues 52-184 are referred to as residues 1-133.' (Fact 23). The March

Subsequent to the March 17, 1997 application, the amino acids in SEQ ID NO:2 were renumbered in the sequence listing so that the residues of the leader sequence were designated

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-9Ni Substantive Motion 3 (To Change Benefit Accorded for the Contested Subject Matter) Patent Interference No. 105,240 17, 1997 priority application also describes a cDNA sequence encoding the amino acid sequence of SEQ ID NO:2. (Fact 24). Also, a clone containing a cDNA encoding SEQ ID NO:2 was deposited at the American Type Culture Collection. (Fact 25). As confirmed by the Declaration of Dr. Reed, the DR5 cDNA described in the March 17, 1997 priority application could have been used to express the extracellular domain of DR5 in various expression systems. (Fact 26). The March 17, 1997 priority application also teaches exemplary antigenic polypeptides and peptides for use in generating DR5-specific antibodies, including a polypeptide comprising amino acid residues fiom about 62 to about 110, and a polypeptide comprising amino acid residues fiom about 119 to about 164. (Fact 27). Both of these exemplary antigenic

polypeptides include sequences witlun the DR5 extracellular domain. (Fact 28). According to Dr. Reed, based on the description in HGS's March 17, 1997 application and knowledge in the art by March 17, 1997, expression of the extracellular domain of DR5 for the purposes of creating a purified protein for antibody production would have been routine to one of ordinary skill in the art. (Fact 29). In addition, Dr. Reed notes that, by using techniques that were routine by March 17, 1997, one of ordinary skill in the art could have purified the expressed DR5 polypeptide (or a fiagment thereof) without undue experimentation. (Fact 30).

-51 to -1, and the first residue of the extracellular domain was designated 1. (Fact 22). Therefore, amino acid residues 52 to 184 of SEQ ID NO:2 in the March 17, 1997 application are the same as amino acid residues 1 to 133 in the later applications and the involved '568 patent. (Fact 23). An illustration of the two numbering schemes is set forth in the attached Appendix D.

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- 10Ni Substantive Motion 3 (To Change Benefit Accorded for the Contested Subject Matter)

Patent Interference No. 105,240
(iii) A Person of Ordinary Skill in the Art Could Have Made Monoclonal Antibodies that Specifically Bind the Extracellular Domain of DRS

With respect to making antibodies specific for DR5, the March 17, 1997 priority application states that: Antibodies according to the present invention may be prepared by any of a variety of methods using DR5 irnrnunogens of the present invention. As indicated, such DR5 immunogens include the full length DR5 polypeptide (which may or may not include the leader sequence) and DR5 polypeptide fragments such as the ligand binding domain, the transmembrane domain, the intracellular domain and the death domain. (Fact 3 1). As confirmed by Dr. Reed, techniques for producing monoclonal antibodies were well known in the art by March 17, 1997. (Fact 32). Dr. Reed notes that, in view of the March 17, 1997 priority application, persons of ordinary skill in the art could have, without undue experimentation, used such techniques to produce monoclonal antibodies that bind to the extracellular domain of DR5. (Fact 33). Although monoclonal antibody technology involves screening hybridomas to identify those that secrete the desired antibody, such screening at the time of the March 17, 1997 priority application was considered routine in the art, as confirmed almost a decade earlier by the court in Wands. 858 F.2d at 740, 8 U.S.P.Q.2d at 1406.

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- 11 Ni Substantive Motion 3 (To Change Benefit Accorded for the Contested Subject Matter)
Patent Interference No. 105,240
(iv) A Person of Ordinary Skill in the Art Could Have Identified Antagonistic Antibodies Specific for the Extracellular Domain of DRS.

After making monoclonal antibodies that specifically bind to the extracellular domain of

DR5, a person of ordinary skill in the art could have, as of the March 17, 1997 priority date,
determined whether the antibodies were antagonists of DR5. As confirmed by Dr. Reed, and discussed below, such a determination could have been made without undue experimentation. (Fact 34). Antagonists are described in the March 17, 1997 priority application as "naturally occurring and synthetic compounds capable of inhibiting apoptosis." (Fact 35). Thus, as confirmed by Dr. Reed, a person of ordinary skill in the art would have simply needed to determine whether a particular monoclonal antibody that specifically binds to the extracellular domain of DR5 inhibited apoptosis. (Fact 36). The March 17, 1997 priority application teaches an exemplary method for assaying for DRS-induced apoptosis and cites several scientific references that illustrate the general method. (Fact 37). As summarized in this example, cells in which apoptosis is induced by DR5

expression become rounded and condensed and detach from the culture dish, which can be observed experimentally. According to the Declaration of Dr. Reed, as of the March 17, 1997 priority date, a person of ordinary skill in the art would have understood that the apoptosis assay of this Example could have been conducted in the presence and absence of a candidate antibody. (Fact 38). If

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-12Ni Substantive Motion 3 (To Change Benefit Accorded for the Contested Subject Matter) Patent Interference No. 105,240 the addition of the antibody resulted in a decrease in the extent of apoptosis as compared to the extent of apoptosis observed in the control experiment lacking the antibody, then a skilled person would conclude that the antibody was an antagonist of DR5. (Fact 38). As confirmed by Dr. Reed, conducting such screening experiments as of the March 17, 1997 priority date would not have required undue experimentation. (Fact 39).
An analysis of the factors set forth in In re Wands, 858 F.2d at 737, 8 U.S.P.Q.2d at 1404,

coniirms the conclusion of Dr. Reed that malung and using antibodies of the count would not have involved undue experimentation. First, the nature of the invention is antagonistic

monoclonal antibodies. (Fact 6). The field of the invention was well-developed as of March 17, 1997. By March 17, 1997, others had demonstrated that antagonistic monoclonal antibodies could be made that bind to the death receptors Fas and TNFR1, which are highly similar to DR5. (Fact 44). Thus, the state of the prior art was sufficiently advanced. A person of ordinary skill in the art would have had knowledge of the scientific literature concerning TNFRs and at least a general familiarity with techniques involved in recombinant DNA, molecular biology and antibodies, including monoclonal antibodies. (Fact 40). A person of ordinary skill in the art would have had a Bachelor's degree or higher in the biological sciences. (Fact 40). Thus, the level of one of ordinary skill was high. Moreover, by March 17, 1997, others had made antagonistic monoclonal antibodies specific for death receptors (Fact 44), and there is no indication that making such antibodies involved anything more than the application of routine techniques and screening. Thus, the level of predictability in the art was high. The March 17, 1997 priority application, in view of the existing knowledge in the art, provides all of the

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-13Ni Substantive Motion 3 (To Change Benefit Accorded for the Contested Subject Matter) Patent Interference No. 105,240 information necessary for one of ordinary skill in the art to make antagonistic monoclonal antibodies of the count, including, inter alia, the amino acid sequence of DR5, identification of the ECD, and sequence comparisons of DR5 to other death receptors. (Facts 20 and 21). Accordingly, the amount of direction provided by the March 17, 1997 priority application is substantial. In view of the substantial direction provided in the March 17, 1997 application, and the advanced state of the art, the absence of a working example in the application is immaterial. Finally, while making antibodies that fall within the scope of the count would have involved some screening, just like in Wands, persons of ordinary skill in the art would have been prepared to engage in such screening. Therefore, the quantity of experimentation needed to make the antibodies of the count, based on the March 17, 1997 application and the knowledge that existed in the art, would not have been undue.

I light of the foregoing considerations, balanced in view of what was known by March n
17, 1997 and what is disclosed in HGS's March 17, 1997 priority application, screening for antagonistic antibodies that bind to the ECD of DR5 would not have required undue experimentation.

(v)

The "How to Use" Prong of 35 U S C ... Paragraph is Also Clearly Satisfed

8

112, First

The enablement requirement of 35 U.S.C. § 112, first paragraph, also includes a 'how to use' prong. This prong is satisfied if a person of ordinary skill in the art would have reasonably believed the applicant's assertion of utility. Because the March 17, 1997 priority application

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- 14Ni Substantive Motion 3 (To Change Benefit Accorded for the Contested Subject Matter)
Patent Interference No. 105,240 includes at least one believable asserted utility for the antibodies of the count, it is clear that the 'how to use' prong of 35 U.S.C.

5 112, first paragraph is fully met for the count.

The specification describes therapeutic utilities for antagonistic antibodies against DR5. More specifically, the specification teaches that antagonistic monoclonal antibodies against DR5 polypeptide, are useful for treating diseases associated with increased apoptosis, including AIDS/HIV infection. (Fact 42). As confirmed by Dr. Reed, by March 17, 1997, persons of ordinary skill in the art reasonably expected that antagonists of death receptors, including antagonistic antibodies, could be used for treating various inflammatory diseases and HIV due to the well known role of TNF-family receptors in these diseases. (Fact 43). Thus, the above-noted therapeutic utilities set forth in the March 17, 1997 priority application would have been believable to persons of ordinary skill in the art.

In addition, as confirmed by Dr. Reed, monoclonal antibodies against TNFRl and Fas,
death receptors that share substantial sequence similarity with DR5, had been shown in the art to be antagonists of their respective receptors (i.e.,to inhibit the apoptotic signal induced by these receptors). (Fact 44). Thus, according to Dr. Reed, it would have been reasonable for one of ordinary skill in the art to believe that antagonistic antibodies that specifically bind to DR5 would suppress apoptosis in cells. (Fact 45). As confirmed by Dr. Reed, the above-mentioned therapeutic utilities of antagonistic antibodies against DR5 asserted in HGS's March 17, 1997 priority application would have been regarded as believable by persons of ordinary skill in the art in view of what was known of the value of therapeutic antagonistic antibodies that bind to

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- 15 Ni Substantive Motion 3 (To Change Benefit Accorded for the Contested Subject Matter)

Patent Interference No. 105,240 apoptosis-inducing molecules. (Fact 46). The March 17, 1997 priority application therefore satisfies the 'how to use' prong of 35 U.S.C. 5 112, first paragraph. A second utility asserted in the March 17, 1997 application for antibodies against DR5 relates to diagnostic applications. (Fact 47). For example, the specification describes the use of antibodies to DR5 in assays for detecting over-expression of DR5 compared to normal control tissue. (Fact 48). The Declaration of Dr. Reed confirms that the diagnostic utilities for DR5specific antibodies asserted in the March 17, 1997 priority application would have been believable to one of ordinary skill in the art reading HGS's March 17, 1997 priority application. (Fact 49).

In summary, a person of ordinary skill in the art, in view of the March 17, 1997
specification and coupled with what was known in the art, could have made an isolated monoclonal antibody that specifically binds to the extracellular domain of DR5 and that is an antagonist of DR5, without undue experimentation. Additionally, at least one utility for such antibodies asserted in the March 17, 1997 specification would have been believable to one of ordinary skill in the art for the count. Accordingly, it is clear that the March 17, 1997 priority application fully enables the subject matter of Count 1.

(vi)

The USPTO Has Explicitly Acknowledged That the March 17, 1997 Priority Application Enables and Describes Antagonistic Antibodies Specific for The ECD of DR5

Additionally, Party Ni respectfully reminds the Board that in the Notice of Allowability for the application that directly led to HGS's involved patent, the Examiner explicitly

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- 16Ni Substantive Motion 3 (To Change Benefit Accorded for the Contested Subject Matter)

Patent Interference No. 105,240 acknowledged that the March 17, 1997 priority application enables and describes antagonistic antibodies specific for the ECD of DR5. (Fact 2). According to the Examiner: The structure of DR5 is shown in Fig. 1 of 601040,846, with delineation of domains described in the Brief Description on page
5, lines 1-7, including the extracellular ligand-binding domain. It

is also disclosed on page 32, lines 11-14, that DR5 agonists enhance apoptosis, and in Example 5 (pp. 43-44) that activation of DR5 is expected to result in induction of apoptosis. Therefore, with both the structure and the function of DR5 in hand, as well as a teaching of agonists and antagonists, which include antibodies (p. 29, lines 14-19 and p. 27, lines 16-17, respectively), the skilled artisan would have been able to make and use the instantly claimed agonist and antagonist antibody without undue experimentation and would have recognized the hventors to be in possession of the claimed antibodies. (Fact 2). Although the Board is not bound by the Examiner's statements, Party Ni respectfully urges the Board to consider the Examiner's position as further support for HGS1srequest to be accorded the benefit of the March 17, 1997 priority application.

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-17Ni Substantive Motion 3 (To Change Benefit Accorded for the Contested Subject Matter) Patent Interference No. 105,240
(c) HGS 's March 1 7, 199 7 Priority Application Fully Describes the Invention of Count 1

As confirmed by the accompanying Declaration of John Reed, a person of ordinary slull in the art would recognize that the March 17, 1997 priority application fully describes the subject matter of Count 1. (Fact 50). As discussed below, the March 17, 1997 priority application provides adequate written description of antibodies that fall within the scope of count 1.

(9

The Sequence of DR5 and Its Extracellular Domain Are Described

The Federal Circuit has recently confirmed that disclosure of a fully characterized antigen will satisfy the written description requirement for antibodies specific to that antigen. Noelle, 355 F.3d at 1349, 69 U.S.P.Q.2d at 1514. The March 17, 1997 specification provides the complete sequence of DR5, including the portion of the sequence corresponding to the extracellular domain (amino acids 1-133), as recited in the count. (Facts 20 and 21). The March 17, 1997 priority application fully characterizes the extracellular domain of DR5 (e.g., by disclosing the amino acid residues of the DR5 protein that correspond to the extracellular domain: residues 52 to 184 (which in subsequent applications were re-numbered as residues 1133)). Thus, under the Noelle analysis, the March 17, 1997 priority application adequately describes antibodies that specifically bind to the extracellular domain of DR5 by virtue of the identification and disclosure of the amino acid sequence of the DR5 extracellular domain. The March 17, 1997 priority application also provides a detailed description of antigenic portions of DM, which are "useful to raise antibodies, including monoclonal antibodies that bind specifically to a polypeptide of the invention." (Fact 51). The specification also provides

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-18Ni Substantive Motion 3 (To Change Benefit Accorded for the Contested Subject Matter) Patent Interference No. 105,240 examples of such polypeptides that fall within the ECD, including "a polypeptide comprising amino acid residues from about 62 to about 110 in Figure 1 (SEQ ID NO:2); [and] a polypeptide comprising amino acid residues from about 119 to about 164 in Figure 1 (SEQ ID NO:2) . . . ." (Fact 27). As further confirmation that HGS had full possession of antibodies to the extracellular domain of DR5, the specification states that "polypeptide fragments such as the ligand binding domain" can be used as immunogens. (Fact 52). The "ligand binding domain" is identified as being within residues from about 52 to about 184 of SEQ ID NO:2 (i.e.,within the extracellular domain). (Fact 53).
(ig Antagonistic Antibodies to the Extracellular Domain of DR5 are Described

As noted by Dr. Reed, the March 17, 1997 priority application provides a clear description of antagonistic monoclonal antibodies that bind to the ECD of DR5. (Fact 54). By providing the amino acid sequence of the ECD of DR5, along with methods for producing and screening antagonistic antibodies, HGS's March 17, 1997 priority application clearly sets forth the invention. (Fact 55). In view of the level of detail set forth in HGS's March 17, 1997 priority application regarding antagonistic antibodies, a person of ordinary skill in the art could distinguish such antibodies from other antagonistic monoclonal antibodies. (Fact 56). Thus, as noted by Dr. Reed, HGS's March 17, 1997 priority application clearly conveys to a person of ordinary skill in the art that the inventors had described monoclonal antagonistic antibodies that

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-19Ni Substantive Motion 3 (To Change Benefit Accorded for the Contested Subject Matter) Patent Interference No. 105,240 specifically bind to the ECD of DR5, and that the inventors recognized that they had described such antibodies. (Fact 57). The level of disclosure needed to satisfy the written description requirement of 35 U.S.C.
$ 112, first paragraph, varies depending on the state of the art. See Capon, 418 F.3d at 1357, 76

U.S.P.Q.2d at 1084. According to Dr. Reed, the state of the art as it existed by March 17, 1997 included demonstrations by others that antagonistic antibodies could be made that bind to the death receptors Fas and TNFR1, which are highly similar to DR5. (Fact 58). In addition, as noted by Dr. Reed, monoclonal antibody technology was well-known to persons of ordinary skill in the art by March 17, 1997. (Fact 59). Thus, the state of the art relating to the production of monoclonal antibodies, including monoclonal antibodies against death receptors, was advanced and well developed by March 17, 1997. Accordingly, the disclosure set forth in the March 17, 1997 priority application is more than sufficient to describe the subject matter of count 1.
2.

HGS's March 17,1997 Priority Document Fully Describes and Enables Proposed Count 2

HGS has filed concurrently herewith SUBSTANTIVE MOTION 4 TO SUBSTITUTE NEW COUNT 2, requesting that count 1 be replaced with proposed count 2. The proposed modified count is identical to count 1 except that the limitation to monoclonal antibodies has been removed. HGS's March 17, 1997 priority application also provides an enabled description of an embodiment of proposed count 2. As explained above, HGS's March 17, 1997 priority

application filly enables and describes isolated monoclonal antibodies that fall within the scope

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- 20 Ni Substantive Motion 3 (To Change Benefit Accorded for the Contested Subject Matter)
Patent Interference No. 105,240 of count 1. Such monoclonal antibodies necessarily fall within the scope of proposed count 2, which is slightly broader than the existing count.

In addition, the March 17, 1997 priority application enables and describes antagonistic
antibodies generally, and polyclonal antibodies in particular, wherein the antibodies specifically bind the extracellular domain of DR5. For example, the March 17, 1997 priority application states that "[alntigenic epitope-bearing peptides and polypeptides of the invention are therefore useful to raise antibodies, including monoclonal antibodies, that bind specifically to a polypeptide of the invention." (Fact 60). T h s passage clearly describes all types of antibodies for use with the invention. As confirmed by Dr. Reed, the March 17, 1997 application provides
a clear description of polyclonal antibodies that bind to the ECD of DR5. (Fact 61).

Thus, HGS's March 17, 1997 priority application fully enables and describes antagonistic antibodies that specifically bind to the extracellular domain of DR5, including monoclonal and polyclonal antibodies. Therefore, HGS's March 17, 1997 priority application fully enables and describes embodiments of proposed count 2 for at least the same reasons that the application hlly enables and describes embodiments of count 1.

D.

HGS's July 29, 1997 Priority Application Provides an Enabled Description of an Embodiment of Count 1 and of Proposed Count 2
1. Count 1

HGS's July 29, 1997 priority application contains all of the disclosure found in HGS's March 17, 1997 application. (Fact 62). Therefore, the July 29, 1997 application would have

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- 21 Ni Substantive Motion 3 (To Change Benefit Accorded for the Contested Subject Matter)

Patent Interference No. 105,240 fully enabled the invention of count 1 for at least the same reasons that the March 17, 1997 application would have fully enabled the invention of count I. In addition, as confirmed by Dr. Reed, HGS's July 29, 1997 application supplements the disclosure in Ni's March 17, 1997 application and also contains data that confirm various assertions made in the March 17, 1997 application. (Fact 63). For example, as acknowledged by Dr. Reed, the July 29, 1997 application provides a working example (Example 5) confirming that overexpression of DR5 in mammalian cells induces apoptosis. (Fact 64). Such an apoptosis assay, including the expected results, was prophetically described in Example 5 of the March 17, 1997 priority application. (Fact 65). Accordingly, the July 29, 1997 priority application provides more than an adequate written description of the subject matter of the count. HGS's July 29, 1997 priority application also provides a working example (Example 6) that confirms that the extracellular domain of DR5 binds the cytotoxic ligand TRAIL and blocks TRAIL-induced apoptosis. (Fact 66). Also, a DR5-Fc fusion construct was shown to idubit TRAIL-induced apoptosis. (Fact 66). As indicated by Dr. Reed, the results presented in the July 29, 1997 priority application confirm the teachings from HGS's March 17, 1997 application which identified DR5 as an apoptosis-inducing death receptor. (Fact 67). As confirmed by Dr. Reed, HGS's July 29, 1997 priority application provides further support for the asserted uses of antagonistic antibodies that bind to the extracellular domain of DR5 as agents that inhibit DR5-mediated apoptosis. (Fact 68).

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- 22 Ni Substantive Motion 3 (To Change Benefit Accorded for the Contested Subject Matter)
Patent Interference No. 105,240 As noted above, the July 29, 1997 application contains all of the disclosure that is found

in HGS's March 17, 1997 priority application. (Fact 62). Thus, the July 29, 1997 application
fully describes the invention of count 1 for at least the same reasons that HGS's March 17, 1997 priority application fully describes the invention of count 1. In addition, as confirmed by Dr. Reed, the working examples in the July 29, 1997 application provide further confirmation that the applicants adequately described an embodim