PATENT OWNER’S DEMONSTRATIVE
`EXHIBITS
`
`DECEMBER 8, 2021
`
`ORAL ARGUMENT
`
`MEDTRONIC COREVALVE LLC, EDWARDS LIFESCIENCES CORP., AND EDWARDS LIFESCIENCES
`LLC
`
`V.
`
`COLIBRI HEART VALVE LLC
`
`U.S. PATENT NO. 9,125,739
`
`CASE NO. IPR2020-01454 (JOINED BY IPR2021-00775)
`
`SARAH E. SPIRES, COUNSEL FOR PATENT OWNER
`
`
`EXHIBITS
`
`DECEMBER 8, 2021
`
`ORAL ARGUMENT
`
`MEDTRONIC COREVALVE LLC, EDWARDS LIFESCIENCES CORP., AND EDWARDS LIFESCIENCES
`LLC
`
`V.
`
`COLIBRI HEART VALVE LLC
`
`U.S. PATENT NO. 9,125,739
`
`CASE NO. IPR2020-01454 (JOINED BY IPR2021-00775)
`
`SARAH E. SPIRES, COUNSEL FOR PATENT OWNER
`
`
`
`THE ’739 INSTITUTED CLAIMS
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`2
`
`
`
`The ’739 Instituted Claims
`Claim 1
`
`Claim 1 recites:
`
`An assembly to treat a native heart valve in a patient, the assembly for use
`in combination with a guidewire, the assembly comprising:
`
`a prosthetic heart valve including:
`
`a stent member having an inner channel, the stent member collapsible,
`expandable and configured for transluminal percutaneous delivery, wherein
`the stent member includes a tubular structure away from a central portion
`that flares at both ends in a trumpet-like configuration; and
`
`a valve means including two to four individual leaflets made of fixed
`pericardial tissue, wherein the valve means resides entirely within the inner
`channel of the stent member, and wherein no reinforcing members reside
`within the inner channel of the stent member;
`
`. . .
`
`Ex. 1001 at 14:2-15.
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`3
`
`
`
`The ’739 Instituted Claims
`Claim 1, cont’d
`
`Claim 1 recites:
`
`An assembly to treat a native heart valve in a patient, the assembly for use
`in combination with a guidewire, the assembly comprising:
`
`a prosthetic heart valve including:
`
`. . .
`
`a delivery system including a pusher member and a moveable sheath, the
`pusher member including a guidewire lumen of the moveable sheath,
`wherein the prosthetic heart valve is collapsed onto the pusher member to
`reside in a collapsed configuration on the pusher member and is restrained
`in the collapsed configuration by the moveable sheath, wherein a distal end
`of the prosthetic heart valve is located at a distal end of the moveable
`sheath, and wherein the valve means resides entirely within the inner
`channel of the stent member in said collapsed configuration and is
`configured to reside entirely within the inner channel of the stent member
`upon deployment in the patient.
`
`Ex. 1001 at 14:2-29.
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`4
`
`
`
`The ’739 Instituted Claims
`Claim 2
`
`Claim 2 recites:
`
`The assembly of claim 1, wherein the stent member is self-
`expanding.
`
`Ex. 1001 at 14:30-31.
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`5
`
`
`
`The ’739 Instituted Claims
`Claim 3
`
`Claim 3 recites:
`
`The assembly of claim 2, wherein the stent member comprises
`nitinol.
`
`Ex. 1001 at 14:32-33..
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`6
`
`
`
`The ’739 Instituted Claims
`Claim 4
`
`Claim 4 recites:
`
`The assembly of claim 1, wherein the stent member includes two
`circles of barbs on an outer surface of the stent member.
`
`Ex. 1001 at 14:34-36.
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`7
`
`
`
`The ’739 Instituted Claims
`Claim 5
`
`Claim 5 recites:
`
`The assembly of claim 1, wherein the pusher member includes a
`controlled release mechanism that can be activated.
`
`Ex. 1001 at 14:37-38.
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`8
`
`
`
` “LEAFLETS MADE OF FIXED
`
`“LEAFLETS MADE OF FIXED
`PERICARDIAL TISSUE”
`PERICARDIAL TISSUE”
`
`S | D
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`9
`
`
`
`Petition: no “leaflets made of fixed
`pericardial tissue” in Garrison
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`Petition at 31-32; Sur-Reply at 1.
`
`10
`
`
`
`Garrison: no “leaflets made of fixed
`pericardial tissue”
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`Ex. 1005 at 5:42-60; Sur-Reply at 1.
`
`11
`
`
`
`Petition: no “leaflets made of fixed
`pericardial tissue” in Andersen
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`Petition at 53; Sur-Reply at 1.
`
`12
`
`
`
`Andersen: no “leaflets made of fixed
`pericardial tissue”
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`Ex. 1013 at 5:18-24, 6:60-63; Sur-Reply at 1.
`
`13
`
`
`
`Reply: no “leaflets made of fixed pericardial
`tissue” in Garrison and Andersen
`
`Sur-Reply at 2-4; Reply at 3, 25.
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`14
`
`
`
`Reply: no “leaflets made of fixed pericardial
`tissue” in Garrison and Andersen
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`Sur-Reply at 4; Reply at 4, 24.
`
`15
`
`
`
`The ’739 Patent: “leaflets made of
`fixed pericardial tissue”
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`Ex. 1001 at 3:41-54; Sur-Reply at 4.
`
`16
`
`
`
`Petition: no motivation to modify Garrison or
`Andersen with Gabbay’s “leaflets made of fixed
`pericardial tissue”
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`Petition at 59; Sur-Reply at 6.
`
`17
`
`
`
`Petition: no motivation to modify Garrison or
`Andersen with “leaflets made of fixed pericardial
`tissue”
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`Petition at 31-32; Sur-Reply at 6.
`
`18
`
`
`
`Petition: no motivation to modify Garrison or
`Andersen with Nguyen’s “leaflets made of fixed
`pericardial tissue”
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`Petition at 77-78; Sur-Reply at 6.
`
`19
`
`
`
`Rygg: Advantages of pericardium shared with pig
`heart valves
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`Ex. 2022 at 2:1-16; Sur-Reply at 6-7; Ex. 1041 ¶ 22.
`
`20
`
`
`
`Fisher: No advantages of pericardium over
`natural heart valves
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`Ex. 2021 at 105; Sur-Reply at 7; Ex. 1041 ¶ 22.
`
`21
`
`
`
`’739 Patent: All tissue valves treated against
`antigenicity
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`Ex. 1001 at 4:39-59; Sur-Reply at 8-9, 12.
`
`22
`
`
`
`Nguyen: No advantage for pericardial tissue over
`intact heart valves
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`Ex. 1020 at 1:28-39; Sur-Reply at 9.
`
`23
`
`
`
` NO COMBINATION OF LIMON
`
`NO COMBINATION OF LIMON
`WITH ANDERSEN
`WITH ANDERSEN
`
`S|D
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`24
`
`
`
`Limon: Must be used with an open lattice
`structure stent in order to form attachment
`projections
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`Ex. 1008 at 4:38-42, 56-59; Sur-Reply at 13-14.
`
`25
`
`
`
`Andersen: Figure 12 consists of a closed cylinder
`surface
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`Ex. 1013 at 4:60-62, Figure 12; POR at 56-57.
`
`26
`
`
`
`Petition: No combination of open-lattice structure
`from Gabbay
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`Petition, 58-59; Sur-Reply at 15-18.
`
`27
`
`
`
`Petition: No combination of open-lattice structure
`from Phelps
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`Petition, 74-75; Sur-Reply at 15-18.
`
`28
`
`
`
`IMPLANTING CARDIAC VALVE
`
`ANDERSEN FIGURE 12: NOT FOR
`ANDERSEN FIGURE 12: NOT FOR
`IMPLANTING CARDIAC VALVE
`DEVICES
`DEVICES
`
`S|D
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`29
`
`
`
`Andersen: Figure 12 not for implanting cardiac
`valve devices
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`Ex. 1013 at 6:64-7:8; Sur-Reply at 19-22.
`
`30
`
`
`
`Andersen: Figure 12 not for implanting cardiac
`valve devices
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`Ex. 1013 at 3:10-31; Sur-Reply at 19-22.
`
`31
`
`
`
`GARRISON: FIGURE 14 DELIVERY
`
`GARRISON: FIGURE 14 DELIVERY
`REQUIRES 2-PIECE DISPLACER
`REQUIRES 2-PIECE DISPLACER
`
`S|D
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`32
`
`
`
`Garrison: Figure 14’s delivery system uses a
`valve displacer
`
`Ex. 1005 at 8:10-13, 45-64; Sur-Reply at 23.
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`33
`
`
`
`Garrison: Petitioner does not rely on Garrison’s
`two-component embodiment using a valve
`displacer
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`Ex. 2020 at 74:4-17; POR 10-21; Sur-Reply at 23.
`
`34
`
`
`
`Garrison: Petitioner does not rely on Garrison’s
`two-component embodiment using a valve
`displacer
`
`35
`Ex. 2020 at 75:10-76:4; POR 10-21; Sur-Reply at 23. DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`
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