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PETITIONER’S DEMONSTRATIVES
`
` July 21, 2016
`Oral Argument
`
`
`
`Coalition for Affordable Drugs VI LLC,
`Petitioner
`
`v.
`
`Celgene Corporation,
` Patent Owner
`
`
`
`
`
` IPR2015-01092, -01096, -01102, -01103
`
`CFAD DX - 1
`
`
`
`

`
`
`
`U.S. PATENT No. 6,045,501
`GROUNDS FOR
`INSTITUTION OF IPR
`
`CFAD DX - 2
`
`

`
`Grounds for Institution of IPR
`Institution Decision
`
`Source: Paper No. 20, Institution Decision, at 16.
`
`CFAD DX - 3
`
`

`
`
`
`BU RDEN OF PROOF
`
`BURDEN OF PROOF
`
`
`
`CFAD DX - 4
`
`

`
`BURDEN OF PROOF
`
`In an inter partes review instituted under this
`chapter, the petitioner shall have the burden of
`proving a proposition of unpatentability by a
`preponderance of the evidence.
` 35 U.S.C. § 316(e)
`
`Source: 35 U.S.C. § 316(e)
`
`CFAD DX - 5
`
`

`
`
`
`’501 Patent –
`Independent Claim 1
`
`CFAD DX - 6
`
`

`
`’501 Patent — Claim 1
`
`
`prescriber registration
`
`pharmacist registration
`
`patient registration
`
`retrieving information
`on ability to become
`pregnant or
`impregnate
`
`counseling
`
`pregnancy
`determination
`
`authorizing filling Rx
`
`Source: Ex. 1001 at claims.
`
`CFAD DX - 7
`
`

`
`’501 Patent — Dependent Claims
`
`
`Patent Owner makes additional arguments for only claims 2, 5, 6, 7, and 10.
`
`
`Source: Ex. 1001 at claims; Paper 40, Patent Owner Response, at 46.
`
`CFAD DX - 8
`
`

`
`
`
`PERSON OF ORDINARY
`
`PERSON OF ORDINARY
`SKILL IN THE ART
`
`SKILL IN THE ART
`
`CFAD DX - 9
`
`

`
`POSA
`
`Petition: Dr. Fudin’s Testimony
`
`Source: 37 C.F.R. § 42.100(b); Paper 49, Petitioner Reply, at 7.
`
`CFAD DX - 10
`
`

`
`POSA
`
`POR: Dr. Frau’s Proposed Definitions
`
`Source: 37 C.F.R. § 42.100(b); Paper 49, Petitioner Reply, at 7.
`
`CFAD DX - 11
`
`

`
`POSA
`
`Dr. Frau’s Admissions
`
`Source: Ex. 1067 at 165:18-166:7.
`
`CFAD DX - 12
`
`

`
`POSA
`
`Dr. Frau’s Admissions
`
`Source: Ex. 1067 at 168:5-11.
`
`CFAD DX - 13
`
`

`
`POSA
`
`Dr. DiPiro’s Admissions
`
`Source: Ex. 1066 at 95:17-96:1.
`
`CFAD DX - 14
`
`

`
`POSA
`
`Dr. DiPiro’s Admissions
`
`Source: Ex. 1066 at 96:13-19, 99:3-13.
`
`CFAD DX - 15
`
`

`
`POSA
`
`Dr. DiPiro’s Admissions
`
`Source: Ex. 1066 at 104:23-105:5.
`
`CFAD DX - 16
`
`

`
`POSA
`
`Dr. DiPiro’s Publication
`
`Source: Ex. 1065 at 2.
`
`CFAD DX - 17
`
`

`
`
`
`CLAIM CONSTRUCTION
`
`CLAIM CONSTRUCTION
`
`CFAD DX - 18
`
`

`
`CLAIM CONSTRUCTION
`
`
`Standard:
`“…broadest reasonable interpretation in light of the specification.”
`
`Claim term in dispute:
`
`“computer readable storage medium”
`
`
`Petitioner:
`
`Patent Owner:
`
`No construction necessary.
`
`“centralized database that includes
`all registration information
`regarding the claimed prescribers,
`pharmacies, and patients”
`
`Source: 37 C.F.R. § 42.100(b); Paper 49, Petitioner Reply, at 7.
`
`CFAD DX - 19
`
`

`
`CLAIM CONSTRUCTION
`
`The ’501 Patent Specification
`
`Source: Paper 49, Petitioner Reply, at 7-8; Ex. 1001 at 4:50–57, 10:12–13.
`
`CFAD DX - 20
`
`

`
`CLAIM CONSTRUCTION
`
`Dr. Frau’s Misapplication of the
`Standard
`
`Source: Paper 49, Petitioner Reply, at 8; Ex. 1067 at 204:10-18.
`
`CFAD DX - 21
`
`

`
`CLAIM CONSTRUCTION
`
`Dr. Frau’s Misapplication of the
`Standard
`
`Source: Paper 49, Petitioner Reply, at 8; Ex. 1067 at 203:21-204:10.
`
`CFAD DX - 22
`
`

`
`CLAIM CONSTRUCTION
`
`The Prosecution History
`
`Source: Paper 49, Petitioner Reply, at 9; Ex. 1004 at 78.
`
`CFAD DX - 23
`
`

`
`
`
`PRIOR ART
`
`PRIOR ART
`
`
`CFAD DX - 24
`
`

`
`Mitchell
`
`PRIOR ART
`
`
`Source: Paper 1, Petition, at 25, 40-41, 44; Ex. 1006 at 101.
`
`CFAD DX - 25
`
`

`
`Mitchell
`
`PRIOR ART
`
`
`Source: Paper 1, Petition, at 40; Ex. 1006 at 102.
`
`CFAD DX - 26
`
`

`
`Mitchell
`
`PRIOR ART
`
`
`Source: Paper 1, Petition, at 40-41; Ex. 1006 at 105.
`
`CFAD DX - 27
`
`

`
`PRIOR ART
`
`Dr. Fudin’s Testimony
`
`Source: Ex. 1002 ¶¶ 168–169.
`
`CFAD DX - 28
`
`

`
`PRIOR ART
`
`Powell
`
`Source: Paper 1, Petition, at 22, 24-25, 36, 38-42, 44, 46, 57; Ex. 1005 at 901.
`
`CFAD DX - 29
`
`

`
`PRIOR ART
`
`Powell
`
`Source: Paper 1, Petition, at 14, 24, 35, 40, 43-44; Ex. 1005 at 902.
`
`CFAD DX - 30
`
`

`
`PRIOR ART
`
`Powell
`
`Source: Paper 1, Petition, at 24, 40; Ex. 1005 at 903.
`
`CFAD DX - 31
`
`

`
`PRIOR ART
`
`Powell
`
`Source: Paper 1, Petition, at 33, 43; Ex. 1005 at 902.
`
`CFAD DX - 32
`
`

`
`PRIOR ART
`
`Powell
`
`Source: Paper 1, Petition, at 26, 33, 36-37, 39, 43; Ex. 1005 at 904.
`
`CFAD DX - 33
`
`

`
`PRIOR ART
`Powell – The Institution Decision
`
`Source: Paper 20, Institution Decision, at 15; Ex. 1005 at 904.
`
`CFAD DX - 34
`
`

`
`PRIOR ART
`
`Mann
`
`Source: Paper 1, Petition, at 23; Ex. 1018 at 7.
`
`CFAD DX - 35
`
`

`
`PRIOR ART
`Mann – The Institution Decision
`
`Source: Paper 20, Institution Decision, at 10.
`
`CFAD DX - 36
`
`

`
`PRIOR ART
`Mann – The Institution Decision
`
`Source: Paper 20, Institution Decision, at 11.
`
`CFAD DX - 37
`
`

`
`FDA Meeting
`
`PRIOR ART
`
`
`Source: Ex. 2094 at 130:10-21.
`
`CFAD DX - 38
`
`

`
`FDA Meeting
`
`PRIOR ART
`
`
`Source: Ex. 2094 at 7, 137:15-22.
`
`CFAD DX - 39
`
`

`
`Vanchieri
`
`PRIOR ART
`
`
`Source: Ex. 2064 at 951.
`
`CFAD DX - 40
`
`

`
`PRIOR ART
`
`Dishman
`
`Source: Paper 1, Petition, at 37-38, 40; Ex. 1007 at 899.
`
`CFAD DX - 41
`
`

`
`PRIOR ART
`
`Dishman
`
`Source: Paper 1, Petition, at 16, 28, 37-38, 41, 43; Ex. 1007 at 899.
`
`CFAD DX - 42
`
`

`
`PRIOR ART
`
`Dishman
`
`Source: Paper 1, Petition, at 16-17, 28-29, 32, 37-38, 42-43; Ex. 1007 at 900.
`
`CFAD DX - 43
`
`

`
`
`PRIOR ART
`
`
`Dishman – The Institution Decision
`
`Source: Paper 20, Institution Decision, at 12.
`
`CFAD DX - 44
`
`

`
`
`PRIOR ART
`
`
`Dishman – The Institution Decision
`
`Source: Paper 20, Institution Decision, at 13.
`
`CFAD DX - 45
`
`

`
`
`
`MOTIVATION TO COMBINE
`
`MOTIVATION TO COMBINE
`
`CFAD DX - 46
`
`

`
`MOTIVATION TO COMBINE
`
`Petition
`
`Source: Paper 1, Petition, at 9 - 10.
`
`CFAD DX - 47
`
`

`
`MOTIVATION TO COMBINE
`
`Petition
`
`Source: Paper 1, Petition, at 12.
`
`CFAD DX - 48
`
`

`
`MOTIVATION TO COMBINE
`
`Petition
`
`Source: Paper 1, Petition, at 11 - 12.
`
`CFAD DX - 49
`
`

`
`MOTIVATION TO COMBINE
`
`Petition
`
`Source: Paper 1, Petition, at 21 - 22.
`
`CFAD DX - 50
`
`

`
`MOTIVATION TO COMBINE
`
`Petition
`
`Source: Paper 1, Petition, at 26 - 27.
`
`CFAD DX - 51
`
`

`
`MOTIVATION TO COMBINE
`
`Dr. Fudin’s Testimony
`
`Source: Ex. 1002 ¶¶ 33 - 35.
`
`CFAD DX - 52
`
`

`
`MOTIVATION TO COMBINE
`
`Dr. Fudin’s Testimony
`
`Source: Ex. 1002 ¶ 36.
`
`CFAD DX - 53
`
`

`
`MOTIVATION TO COMBINE
`
`Dr. Fudin’s Testimony
`
`Source: Ex. 1002 ¶ 42.
`
`CFAD DX - 54
`
`

`
`MOTIVATION TO COMBINE
`
`Bastani
`
`Source: Ex. 1011 at 252, 257.
`
`CFAD DX - 55
`
`

`
`MOTIVATION TO COMBINE
`
`Dr. Fudin’s Testimony
`
`Source: Ex. 1002 ¶¶ 44 - 47.
`
`CFAD DX - 56
`
`

`
`MOTIVATION TO COMBINE
`
`CDC Meeting Materials
`
`Source: Ex. 1008 at 4.
`
`CFAD DX - 57
`
`

`
`MOTIVATION TO COMBINE
`
`CDC Meeting Materials
`
`Source: Ex. 1013 at 13158.
`
`CFAD DX - 58
`
`

`
`MOTIVATION TO COMBINE
`
`Dr. Fudin’s Testimony
`
`Source: Ex. 1002 ¶¶ 88 - 89.
`
`CFAD DX - 59
`
`

`
`MOTIVATION TO COMBINE
`
`Dr. Fudin’s Testimony
`
`Source: Ex. 1002 ¶¶ 115 - 118.
`
`CFAD DX - 60
`
`

`
`MOTIVATION TO COMBINE
`
`Patent Owner’s Unsupported Arguments
`
`●
`
`
` ●
`
`
` ●
`)
`
` ●
`
` ●
`
`Source: Paper 40, Patent Owner Response, at 2, 50.
`
`CFAD DX - 61
`
`

`
`MOTIVATION TO COMBINE
`
`Patent Owner’s Response
`
`Source: Paper 40, Patent Owner Response, at 52.
`
`CFAD DX - 62
`
`

`
`MOTIVATION TO COMBINE
`
`Petitioner’s Reply
`
`Source: Paper 49, Petitioner’s Reply, at 10.
`
`CFAD DX - 63
`
`

`
`MOTIVATION TO COMBINE
`
`Mitchell
`
`Source: Ex. 1006 at 105.
`
`CFAD DX - 64
`
`

`
`MOTIVATION TO COMBINE
`
`Vanchieri
`
`Source: Ex. 2064 at 951.
`
`CFAD DX - 65
`
`

`
`MOTIVATION TO COMBINE
`
`Vanchieri
`
`Source: Ex. 2064 at 952.
`
`CFAD DX - 66
`
`

`
`MOTIVATION TO COMBINE
`
`Marwick
`
`Source: Ex. 2063 at 1136.
`
`CFAD DX - 67
`
`

`
`MOTIVATION TO COMBINE
`
`
`Zeldis
`
`Source: Ex. 1068 at 329.
`
`CFAD DX - 68
`
`

`
`MOTIVATION TO COMBINE
`
`
`Zeldis
`
`Source: Ex. 1068 at 323.
`
`CFAD DX - 69
`
`

`
`MOTIVATION TO COMBINE
`
`
`Zeldis
`
`Source: Ex. 1068 at 320.
`
`CFAD DX - 70
`
`

`
`MOTIVATION TO COMBINE
`
`
`Zeldis
`
`Source: Ex. 1068 at 321 - 322.
`
`CFAD DX - 71
`
`

`
`MOTIVATION TO COMBINE
`
`
`Zeldis
`
`Source: Ex. 1068 at 323.
`
`CFAD DX - 72
`
`

`
`
`MOTIVATION TO COMBINE
`
`
`Dr. DiPiro’s Admissions
`
`Source: Ex. 1066 at 325:24-326:10, 326:20–327:5.
`
`CFAD DX - 73
`
`

`
`
`MOTIVATION TO COMBINE
`
`
`Dr. Frau’s Admissions
`
`Source: Ex. 1067 at 112:7–15, 113:3–8.
`
`CFAD DX - 74
`
`

`
`
`MOTIVATION TO COMBINE
`
`
`Dr. Frau’s Admissions
`
`Source: Ex. 1067 at 86:4–14.
`
`CFAD DX - 75
`
`

`
`
`MOTIVATION TO COMBINE
`
`
`The Institution Decision
`
`Source: Paper 20, Institution Decision, at 7.
`
`CFAD DX - 76
`
`

`
`
`
`Secondary Considerations
`of Non-Obviousness
`
`CFAD DX - 77
`
`

`
`
`SECONDARY CONSIDERATIONS
`
`
`No Nexus with the Claimed Methods
`
`Source: Ex. 1001 at 1:30-36.
`
`CFAD DX - 78
`
`

`
`
`SECONDARY CONSIDERATIONS
`
`
`No Nexus with the Claimed Methods
`
`Source: Ex. 2020 at 1.
`
`CFAD DX - 79
`
`

`
`
`SECONDARY CONSIDERATIONS
`
`
`Alleged Skepticism - Marwick
`
`Source: Ex. 2063 at 1135.
`
`CFAD DX - 80
`
`

`
`
`SECONDARY CONSIDERATIONS
`
`
`Alleged Unexpected Results - Zeldis
`
`Source: Ex. 1068 at 329.
`
`CFAD DX - 81
`
`

`
`
`SECONDARY CONSIDERATIONS
`
`
`Alleged Unexpected Results
`
`
`
`Source: Ex. 1001 at 10:43-45.
`
`CFAD DX - 82
`
`

`
`
`SECONDARY CONSIDERATIONS
`
`
`Alleged Unexpected Results - Bwire
`
`
`
`Source: Ex. 1068 at 5.
`
`CFAD DX - 83
`
`

`
`
`SECONDARY CONSIDERATIONS
`
`
`Alleged Unexpected Results – Dr. Frau
`
`Source: Ex. 1067 at 154:5–21.
`
`CFAD DX - 84
`
`

`
`
`SECONDARY CONSIDERATIONS
`
`
`Alleged Unexpected Results – Dr. DiPiro
`
`
`
`Source: Ex. 1066 at 170:17–171:4.
`
`CFAD DX - 85
`
`

`
`
`
`The Board’s Institution
`Decision
`
`CFAD DX - 86
`
`

`
`
`INSTITUTION DECISION
`
`
`
`Source: Paper 20, Institution Decision, at 13.
`
`CFAD DX - 87

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