`
` 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
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`
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`
`
`
`
`U.S. PATENT No. 6,045,501
`GROUNDS FOR
`INSTITUTION OF IPR
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`
`
`Grounds for Institution of IPR
`Institution Decision
`
`Source: Paper No. 20, Institution Decision, at 16.
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`BU RDEN OF PROOF
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`BURDEN OF PROOF
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`BURDEN OF PROOF
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`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)
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`
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`
`
`’501 Patent –
`Independent Claim 1
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`
`
`’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.
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`
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`’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.
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`PERSON OF ORDINARY
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`PERSON OF ORDINARY
`SKILL IN THE ART
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`SKILL IN THE ART
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`
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`POSA
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`Petition: Dr. Fudin’s Testimony
`
`Source: 37 C.F.R. § 42.100(b); Paper 49, Petitioner Reply, at 7.
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`
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`POSA
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`POR: Dr. Frau’s Proposed Definitions
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`Source: 37 C.F.R. § 42.100(b); Paper 49, Petitioner Reply, at 7.
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`POSA
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`Dr. Frau’s Admissions
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`Source: Ex. 1067 at 165:18-166:7.
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`POSA
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`Dr. Frau’s Admissions
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`Source: Ex. 1067 at 168:5-11.
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`POSA
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`Dr. DiPiro’s Admissions
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`Source: Ex. 1066 at 95:17-96:1.
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`POSA
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`Dr. DiPiro’s Admissions
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`Source: Ex. 1066 at 96:13-19, 99:3-13.
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`POSA
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`Dr. DiPiro’s Admissions
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`Source: Ex. 1066 at 104:23-105:5.
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`POSA
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`Dr. DiPiro’s Publication
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`Source: Ex. 1065 at 2.
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`CLAIM CONSTRUCTION
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`CLAIM CONSTRUCTION
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`CLAIM CONSTRUCTION
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`
`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.
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`CLAIM CONSTRUCTION
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`The ’501 Patent Specification
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`Source: Paper 49, Petitioner Reply, at 7-8; Ex. 1001 at 4:50–57, 10:12–13.
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`CLAIM CONSTRUCTION
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`Dr. Frau’s Misapplication of the
`Standard
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`Source: Paper 49, Petitioner Reply, at 8; Ex. 1067 at 204:10-18.
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`
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`CLAIM CONSTRUCTION
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`Dr. Frau’s Misapplication of the
`Standard
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`Source: Paper 49, Petitioner Reply, at 8; Ex. 1067 at 203:21-204:10.
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`CLAIM CONSTRUCTION
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`The Prosecution History
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`Source: Paper 49, Petitioner Reply, at 9; Ex. 1004 at 78.
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`PRIOR ART
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`PRIOR ART
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`
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`Mitchell
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`PRIOR ART
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`Source: Paper 1, Petition, at 25, 40-41, 44; Ex. 1006 at 101.
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`
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`Mitchell
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`PRIOR ART
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`Source: Paper 1, Petition, at 40; Ex. 1006 at 102.
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`Mitchell
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`PRIOR ART
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`Source: Paper 1, Petition, at 40-41; Ex. 1006 at 105.
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`PRIOR ART
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`Dr. Fudin’s Testimony
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`Source: Ex. 1002 ¶¶ 168–169.
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`PRIOR ART
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`Powell
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`Source: Paper 1, Petition, at 22, 24-25, 36, 38-42, 44, 46, 57; Ex. 1005 at 901.
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`PRIOR ART
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`Powell
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`Source: Paper 1, Petition, at 14, 24, 35, 40, 43-44; Ex. 1005 at 902.
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`PRIOR ART
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`Powell
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`Source: Paper 1, Petition, at 24, 40; Ex. 1005 at 903.
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`PRIOR ART
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`Powell
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`Source: Paper 1, Petition, at 33, 43; Ex. 1005 at 902.
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`PRIOR ART
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`Powell
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`Source: Paper 1, Petition, at 26, 33, 36-37, 39, 43; Ex. 1005 at 904.
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`
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`PRIOR ART
`Powell – The Institution Decision
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`Source: Paper 20, Institution Decision, at 15; Ex. 1005 at 904.
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`PRIOR ART
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`Mann
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`Source: Paper 1, Petition, at 23; Ex. 1018 at 7.
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`PRIOR ART
`Mann – The Institution Decision
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`Source: Paper 20, Institution Decision, at 10.
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`CFAD DX - 36
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`PRIOR ART
`Mann – The Institution Decision
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`Source: Paper 20, Institution Decision, at 11.
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`CFAD DX - 37
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`FDA Meeting
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`PRIOR ART
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`Source: Ex. 2094 at 130:10-21.
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`FDA Meeting
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`PRIOR ART
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`Source: Ex. 2094 at 7, 137:15-22.
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`Vanchieri
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`PRIOR ART
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`Source: Ex. 2064 at 951.
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`PRIOR ART
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`Dishman
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`Source: Paper 1, Petition, at 37-38, 40; Ex. 1007 at 899.
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`PRIOR ART
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`Dishman
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`Source: Paper 1, Petition, at 16, 28, 37-38, 41, 43; Ex. 1007 at 899.
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`
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`PRIOR ART
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`Dishman
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`Source: Paper 1, Petition, at 16-17, 28-29, 32, 37-38, 42-43; Ex. 1007 at 900.
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`PRIOR ART
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`Dishman – The Institution Decision
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`Source: Paper 20, Institution Decision, at 12.
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`PRIOR ART
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`Dishman – The Institution Decision
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`Source: Paper 20, Institution Decision, at 13.
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`MOTIVATION TO COMBINE
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`MOTIVATION TO COMBINE
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`MOTIVATION TO COMBINE
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`Petition
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`Source: Paper 1, Petition, at 9 - 10.
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`MOTIVATION TO COMBINE
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`Petition
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`Source: Paper 1, Petition, at 12.
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`MOTIVATION TO COMBINE
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`Petition
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`Source: Paper 1, Petition, at 11 - 12.
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`MOTIVATION TO COMBINE
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`Petition
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`Source: Paper 1, Petition, at 21 - 22.
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`MOTIVATION TO COMBINE
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`Petition
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`Source: Paper 1, Petition, at 26 - 27.
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`MOTIVATION TO COMBINE
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`Dr. Fudin’s Testimony
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`Source: Ex. 1002 ¶¶ 33 - 35.
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`MOTIVATION TO COMBINE
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`Dr. Fudin’s Testimony
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`Source: Ex. 1002 ¶ 36.
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`CFAD DX - 53
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`MOTIVATION TO COMBINE
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`Dr. Fudin’s Testimony
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`Source: Ex. 1002 ¶ 42.
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`MOTIVATION TO COMBINE
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`Bastani
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`Source: Ex. 1011 at 252, 257.
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`CFAD DX - 55
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`MOTIVATION TO COMBINE
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`Dr. Fudin’s Testimony
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`Source: Ex. 1002 ¶¶ 44 - 47.
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`MOTIVATION TO COMBINE
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`CDC Meeting Materials
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`Source: Ex. 1008 at 4.
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`MOTIVATION TO COMBINE
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`CDC Meeting Materials
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`Source: Ex. 1013 at 13158.
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`MOTIVATION TO COMBINE
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`Dr. Fudin’s Testimony
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`Source: Ex. 1002 ¶¶ 88 - 89.
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`MOTIVATION TO COMBINE
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`Dr. Fudin’s Testimony
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`Source: Ex. 1002 ¶¶ 115 - 118.
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`MOTIVATION TO COMBINE
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`Patent Owner’s Unsupported Arguments
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`●
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`)
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`Source: Paper 40, Patent Owner Response, at 2, 50.
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`MOTIVATION TO COMBINE
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`Patent Owner’s Response
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`Source: Paper 40, Patent Owner Response, at 52.
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`MOTIVATION TO COMBINE
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`Petitioner’s Reply
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`Source: Paper 49, Petitioner’s Reply, at 10.
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`CFAD DX - 63
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`MOTIVATION TO COMBINE
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`Mitchell
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`Source: Ex. 1006 at 105.
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`MOTIVATION TO COMBINE
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`Vanchieri
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`Source: Ex. 2064 at 951.
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`CFAD DX - 65
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`MOTIVATION TO COMBINE
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`Vanchieri
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`Source: Ex. 2064 at 952.
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`MOTIVATION TO COMBINE
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`Marwick
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`Source: Ex. 2063 at 1136.
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`MOTIVATION TO COMBINE
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`Zeldis
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`Source: Ex. 1068 at 329.
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`MOTIVATION TO COMBINE
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`Zeldis
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`Source: Ex. 1068 at 323.
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`MOTIVATION TO COMBINE
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`Zeldis
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`Source: Ex. 1068 at 320.
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`MOTIVATION TO COMBINE
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`Zeldis
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`Source: Ex. 1068 at 321 - 322.
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`MOTIVATION TO COMBINE
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`Zeldis
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`Source: Ex. 1068 at 323.
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`CFAD DX - 72
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`MOTIVATION TO COMBINE
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`Dr. DiPiro’s Admissions
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`Source: Ex. 1066 at 325:24-326:10, 326:20–327:5.
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`MOTIVATION TO COMBINE
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`Dr. Frau’s Admissions
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`Source: Ex. 1067 at 112:7–15, 113:3–8.
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`MOTIVATION TO COMBINE
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`Dr. Frau’s Admissions
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`Source: Ex. 1067 at 86:4–14.
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`MOTIVATION TO COMBINE
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`The Institution Decision
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`Source: Paper 20, Institution Decision, at 7.
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`Secondary Considerations
`of Non-Obviousness
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`SECONDARY CONSIDERATIONS
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`No Nexus with the Claimed Methods
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`Source: Ex. 1001 at 1:30-36.
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`SECONDARY CONSIDERATIONS
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`No Nexus with the Claimed Methods
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`Source: Ex. 2020 at 1.
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`SECONDARY CONSIDERATIONS
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`Alleged Skepticism - Marwick
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`Source: Ex. 2063 at 1135.
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`SECONDARY CONSIDERATIONS
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`Alleged Unexpected Results - Zeldis
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`Source: Ex. 1068 at 329.
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`SECONDARY CONSIDERATIONS
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`Alleged Unexpected Results
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`Source: Ex. 1001 at 10:43-45.
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`SECONDARY CONSIDERATIONS
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`Alleged Unexpected Results - Bwire
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`Source: Ex. 1068 at 5.
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`SECONDARY CONSIDERATIONS
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`Alleged Unexpected Results – Dr. Frau
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`Source: Ex. 1067 at 154:5–21.
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`SECONDARY CONSIDERATIONS
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`Alleged Unexpected Results – Dr. DiPiro
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`Source: Ex. 1066 at 170:17–171:4.
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`The Board’s Institution
`Decision
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`INSTITUTION DECISION
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`Source: Paper 20, Institution Decision, at 13.
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