Presentation of Patent Owner
`Celgene Corporation
`
`Coalition for Affordable Drugs VI LLC
`v.
`Celgene Corporation
`Case IPR 2015-01092, -1096, -1102, -1103
`
`Before the Honorable Michael P. Tierney,
`Tina E. Hulse, and Grace Karaffa Obermann
`Administrative Patent Judges
`United States Patent and Trademark Office
`
`
`Celgene Corporation
`
`Coalition for Affordable Drugs VI LLC
`v.
`Celgene Corporation
`Case IPR 2015-01092, -1096, -1102, -1103
`
`Before the Honorable Michael P. Tierney,
`Tina E. Hulse, and Grace Karaffa Obermann
`Administrative Patent Judges
`United States Patent and Trademark Office
`
`
`
`“Computer Readable Storage Medium”: The Parties’ Constructions
`
`Celgene
`
`CFAD
`
`a centralized database that
`includes all registration
`information regarding the
`claimed prescribers, pharmacies,
`and patients
`
`No specific construction offered
`
`Only a critique of Celgene's
`construction
`
`Argues that there can be more
`than one computer readable
`storage medium
`
`IPR2015-01092, Paper 40 (“’501 Resp.”) at
`22-25; Ex. 2059 (“’501 Frau Decl.”) ¶¶72-73;
`Ex. 2060 (“’501 DiPiro Decl.”) ¶¶21-24
`
`IPR2015-01092, Paper 49 (“’501 Reply”) at 7-9
`
`2
`
`
`
`“Computer Readable Storage Medium” Claim Construction:
`The Claims Support Celgene’s Construction
`
`IPR2015-01092, Ex. 1001 (“’501 patent”) at Claim 1; ’501 Resp. at 24;
`’501 Frau Decl. ¶73; ’501 DiPiro Decl. ¶23
`
`3
`
`
`
`“Computer Readable Storage Medium” Claim Construction:
`The File History Supports Celgene’s Construction
`
`This Office’s Rejection
`
`The Inventor’s Response
`
`IPR2015-01092, Ex. 1004 (“’501 File History”) at 63;
`’501 Resp. at 22
`
`’501 File History at 78; ’501 Resp. at 22-23;
`’501 Frau Decl. ¶72; ’501 DiPiro Decl. ¶22
`
`4
`
`
`
`“Computer Readable Storage Medium” Claim Construction:
`Dr. Fudin’s Testimony Supports Celgene’s Construction
`
`IPR2015-01092, -1096, -1102, -1103, Ex. 2061 (“Fudin Tr.”) at 307:9-17;
`’501 Resp. at 23
`
`5
`
`
`
`The Asserted References Do Not Teach Or Suggest The
`“Computer Readable Storage Medium”: No Centralized Database
`
`Celgene argued:
`
`’501 Resp. at 42
`
`6
`
`
`
`The Asserted References Do Not Teach Or Suggest The
`“Computer Readable Storage Medium”: No Centralized Database
`
`CFAD acknowledges the “fact” that each hospital has its own separate system
`
`Dr. Fudin agrees that the NCCC’s two databases—the hospital laboratory database and
`the outpatient pharmacy software—existed separate and apart from the NCCC
`
`’501 Reply at 19
`
`Fudin Tr. 304:4-19; ’501 Resp. at 33;
`’501 Frau Decl. ¶ ¶ 115; ’501 DiPiro Decl. ¶72
`
`7
`
`
`
`The Asserted References Do Not Teach Or Suggest The
`“Computer Readable Storage Medium”: No Pharmacy Registration
`
`Dr. Fudin admitted that
`Powell does not:
`
`• Mention any registry
`
`• Mention keeping any
`records in any
`computer readable
`storage medium
`
`• Mention retrieving any
`information from any
`computer readable
`storage medium
`
`Fudin Tr. 261:12-25; ’501 Resp. at 26, 36;
`’501 Frau Decl. ¶107; ’501 DiPiro Decl. ¶56
`
`8
`
`
`
`The Asserted References Do Not Teach Or Suggest The
`“Computer Readable Storage Medium”: No Pharmacy Registration
`
`Dishman discloses only prescriber and patient registration:
`
`IPR2015-01092, Ex. 1007 (“Dishman”) at 899; ’501 Resp. at 38-39;
`’501 Frau Decl. ¶112; ’501 DiPiro Decl. ¶¶62-63
`
`9
`
`
`
`A POSA Would Not Have Been Motivated
`To Arrive At The Claimed Male Subpopulation
`
`IPR2015-01092, Ex. 1005 (“Powell”) at 903; ’501 Resp. at 43;
`’501 Frau Decl. ¶124; ’501 DiPiro Decl. ¶¶ 74, 75, 80
`
`10
`
`
`
`CFAD Has No Evidence That Thalidomide, Administered To A Father,
`Can Cause A Malformation Of An Embryo
`
`* * *
`
`Fudin Tr. at 258:20-25, 260:21-25; ’501 Resp. at 26-27, 43;
`’501 Frau Decl. ¶124; ’501 DiPiro Decl. ¶75
`
`Fudin Tr. at 205:8-18; ’501 Resp. at 44
`
`11
`
`
`
`No Motivation To Arrive At The ’720 Patent’s Inventions:
`S.T.E.P.S. Has Been 100% Successful In Preventing Birth Defects
`
`Dr. Fudin agreed that there have been no birth defects under S.T.E.P.S.® and
`that there was no problem with S.T.E.P.S.® as of October 2000
`
`Fudin Tr. at 239:23-240:11; IPR2015-01096, Paper 40 (“-1096 Resp.”) at 17;
`IPR2015-01102, Paper 41 (“-1102 Resp.”) at 17;
`IPR2015-01103, Paper 42 (“-1103 Resp.”) at 17
`
`Fudin Tr. at 380:5-22; -1096 Resp. at 4, 5, 17;
`-1102 Resp. at 4, 5, 17; -1103 Resp.at 4, 5, 17
`
`12
`
`
`
`No Motivation To Arrive At The ’720 Patent’s Inventions:
`S.T.E.P.S. Has Been 100% Successful In Preventing Birth Defects
`
`Celgene’s Head of Global Drug Safety & Risk Management
`
`IPR2015-01096, -1102, Ex. 2068; IPR2015-01103, Ex. 2069 (“Freeman Decl.”) at ¶¶ 6-7; IPR2015-01096, Ex. 2059 (“-1096 Frau Decl.”) ¶21; Ex.
`2060 (“-1096 DiPiro Decl.”) ¶20; IPR2015-01102, Ex. 2059 (“-1102 Frau Decl.”) ¶21; Ex. 2060 (“-1102 DiPiro Decl.”) ¶20;
`IPR2015-01103, Ex. 2059 (“-1103 Frau Decl.”) ¶21; Ex. 2060 (“-1103 DiPiro Decl.”) ¶20; -1096 Resp. at 4; -1102 Resp. at 4; -1103 Resp.at 4
`
`13
`
`
`
`No Motivation To Arrive At The ’720 Patent’s Inventions:
`CFAD’s Motivation Is Based On Non-Existent Hypothetical Drugs
`
`Dr. Fudin could only speculate about “future drugs” that “might” require modifying S.T.E.P.S. ®
`
`Fudin Tr. at 591:15-592:2; -1096 Resp. at 18-20; -1102 Resp. at 18-20; -1103 Resp. at 18-20
`
`14
`
`
`
`No Motivation To Arrive At The ’720 Patent’s Inventions:
`No Motivation To Arrive At The Specifically Claimed Elements
`
`Dr. Fudin admitted that a POSA “would not know . . . what kind of development or changes
`need to be made to the original S.T.E.P.S.”
`
`Fudin Tr. at 590:15-591:8; -1096 Resp. at 18-20;
`-1102 Resp. at 18-20; -1103 Resp. at 18-20
`
`15
`
`
`
`No Motivation To Arrive At The ’720 Patent’s Inventions:
`Confidential Surveys Cannot Provide A Motivation
`
`IPR2015-01096, Ex. 1076; IPR2015-01102, -1103, Ex. 1012 (“FDA
`Meeting Part 1”) at 118-19; IPR2015-01096, Paper 52 (“-1096 Reply”) at
`13-14; IPR2015-01102, Paper 54 (“-1102 Reply”) at 11; IPR2015-01103,
`Paper 55 (“-1103 Reply”) at 11; IPR2015-01096, Paper 60 at 13-15;
`IPR2015-01102, Paper 62 at 14-15; IPR2015-01103, Paper 63 at 14-15.
`
`16
`
`
`
`No Motivation To Arrive At The ’720 Patent’s Inventions:
`CFAD’s Reliance On Cunningham Is Based On Hindsight
`
`Fudin Tr. at 415:11-25; -1096 Resp. at 51-52; -1102 Resp. at 51-52; -1103 Resp. at 52-53
`
`17
`
`
`
`No Motivation To Arrive At The ’720 Patent’s Inventions:
`CFAD’s Reliance On Cunningham Is Based On Hindsight
`
`Dr. Fudin admitted that Cunningham’s system would not be applicable to distributing
`drugs with dangerous side effects like thalidomide, isotretinoin, and clozapine
`
`Fudin Tr. at 437:11-438:7, 438:20-25; -1096 Resp. at 56; -1102 Resp. at 56-
`57; -1103 Resp. at 56-57; ‘1096 Frau Decl. ¶¶ 61, 75-76; -1096 DiPiro Decl.
`¶¶118-19; -1102 Frau Decl. ¶¶70, 84-85; -1102 DiPiro Decl. ¶¶122-23;
`-1103 Frau Decl. ¶¶68, 82, 84; -1103 DiPiro Decl. ¶¶ 123-24
`
`18
`
`
`
`“Prescription Approval Code”: The Parties’ Constructions
`
`Celgene
`
`CFAD
`
`a code representing that an affirmative
`risk assessment has been made
`based upon risk-group assignment
`and the information collected from the
`patient, and that is generated only
`upon a determination that the risk of a
`side effect occurring is acceptable
`
`No specific construction offered
`
`Only a critique of Celgene's
`construction
`
`Argues that the only requirement for
`retrieval of the prescription approval
`code is registration
`
`-1096 Resp. at 21-24; -1102 Resp. at 21-24; -1103 Resp. at 21-24;
`‘1096 Frau Decl. ¶¶ 50-52; -1096 DiPiro Decl. ¶¶36-40; -1102 Frau
`Decl. ¶¶50-52; -1102 DiPiro Decl. ¶¶36-40; -1103 Frau Decl. ¶¶50-52;
`-1103 DiPiro Decl. ¶¶36-40
`
`-1096 Reply at 8-12; -1102 Reply at 6-9; -1103 Reply at 6-9
`
`19
`
`
`
`“Prescription Approval Code” Claim Construction:
`The File History Supports Celgene’s Construction
`
`This Office’s Rejection:
`
`IPR2015-01096, -1102, -1103, Ex. 1002 (“’720 File History”) at 92;
`-1096 Resp. at 22; -1102 Resp. at 22; -1103 Resp. at 21-22; ‘1096 Frau Decl. ¶50; -1096 DiPiro Decl. ¶37;
`-1102 Frau Decl. ¶50; -1102 DiPiro Decl. ¶37; -1103 Frau Decl. ¶50; -1103 DiPiro Decl. ¶37
`
`20
`
`
`
`“Prescription Approval Code” Claim Construction:
`The File History Supports Celgene’s Construction
`
`This Inventor’s Response:
`
`’720 File History at 106-107; -1096 Resp. at 22-23; -1102 Resp. at 22-23; -1103 Resp. at 22-23;
`‘1096 Frau Decl. ¶51; -1096 DiPiro Decl. ¶¶37-38; -1102 Frau Decl. ¶51;
`-1102 DiPiro Decl. ¶¶37-38; -1103 Frau Decl. ¶51; -1103 DiPiro Decl. ¶¶37-38
`
`21
`
`
`
`“Prescription Approval Code” Claim Construction:
`Dr. Fudin’s Testimony Supports Celgene’s Construction
`
`Fudin Tr. at 434:7-15; -1096 Resp. at 23; -1102 Resp. at 23; -1103 Resp. at 23
`
`22
`
`
`
`The Asserted References Do Not Teach Or Suggest
`The Claimed “Prescription Approval Code”
`
`Dr. Fudin admitted that
`Cunningham does not:
`
`• Collect patient data
`
`• Register patients in
`any system
`
`• Use an approval code
`in connection with
`side effects
`
`* * *
`
`Fudin Tr. at 428:11-16, 432:14-20; -1096 Resp. at 27-28, 37-38; -1102 Resp. at 29-30, 38-39;
`-1103 Resp. at 30, 39-40; ‘1096 Frau Decl. ¶64; -1096 DiPiro Decl. ¶53; -1102 Frau Decl. ¶73;
`-1102 DiPiro Decl. ¶64; -1103 Frau Decl. ¶71; -1103 DiPiro Decl. ¶65
`
`23
`
`
`
`The Asserted References Do Not Teach Or Suggest
`The Claimed “Prescription Approval Code”
`
`Dr. Fudin admitted that Dishman does not disclose a prescription approval code at all
`
`Fudin Tr. at 420:18-20; -1102 Resp. at 27, 35;
`-1103 Resp. at 28, 35
`
`24
`
`
`
`The Asserted References Do Not Teach Or Suggest Prescriber Verification
`Of Informed Consent At The Time Of Patient Registration
`
`The prior art taught that the pharmacist verifies informed consent when registering the patient
`
`IPR2015-01096, Ex. 2063; IPR2015-01102, -1103, Ex. 2064 (“Pharmacist Letter”); IPR2015-01096, -1102, Ex. 2065;
`IPR2015-01103, Ex. 2063 (“Patient Registration Form”); -1096 Resp. at 41-45; -1102 Resp. at 43-46; -1103 Resp. at 44-47
`
`25
`
`
`
`The Asserted References Do Not Teach Or Suggest Genetic Testing
`
`“The link between teratology and genetic testing” was not made “explicit” in FDA Meeting
`Part 1, as CFAD alleges
`
`FDA Meeting Part 1 at 137; -1096 Reply at 25-26; -1102 Reply at 23; -1103 Reply at 22-23
`
`26
`
`
`
`’720 Patent, Claim 1
`
`IPR2015-01096, -1102, -1103, Ex. 1001 (“’720 patent”) at Claim 1;
`-1096 Resp. at 1; -1102 Resp. at 1; -1103 Resp. at 1
`
`27
`
`
`
`’501 Patent
`
`CFAD failed to show that the
`prior art teaches or suggests the claimed
`“computer readable storage medium”
`
`28
`
`
`
`’501 Patent
`
`CFAD failed to show that
`the prior art teaches or suggests
`including a male subpopulation
`
`29
`
`
`
`’501 Patent
`
`CFAD failed to show that
`the prior art teaches or suggests
`actually providing contraception to a patient,
`as required by claim 10
`
`30
`
`
`
`’501 Patent
`
`CFAD failed to provide a motivation
`to combine elements from
`Powell, Mitchell, and Dishman to arrive at
`the claimed inventions as a whole
`
`31
`
`
`
`’501 Patent
`
`CFAD failed to show that the claimed
`inventions achieve only predictable results
`
`32
`
`
`
`’501 Patent
`
`Secondary considerations support the
`nonobviousness of the claimed inventions
`
`33
`
`
`
`’720 Patent
`
`CFAD failed to provide a
`motivation to modify the prior art, and
`ignores that STEPS was 100% successful
`
`34
`
`
`
`’720 Patent
`
`CFAD failed to provide a motivation
`to combine Cunningham with the
`other asserted references
`
`35
`
`
`
`’720 Patent
`
`CFAD failed to show that
`the prior art teaches or suggests the claimed
`“prescription approval code”
`
`36
`
`
`
`’720 Patent
`
`CFAD does not dispute that
`actual application of Cunningham’s
`“pharmacy approval code”
`is above the level of skill in the art
`
`37
`
`
`
`’720 Patent
`
`CFAD failed to show that
`the prior art teaches or suggests
`prescriber verification of informed
`consent at the time of patient registration,
`as recited in claims 5 and 6
`
`38
`
`
`
`’720 Patent
`
`CFAD failed to show that
`the prior art teaches or suggests the
`genetic testing in claim 10
`
`39
`
`
`
`’720 Patent
`
`CFAD failed to show that
`the prior art teaches or suggests
`the IVR surveys in claim 17
`
`40
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