PATENT OWNER’S DEMONSTRATIVE
`EXHIBITS
`
`DECEMBER 8, 2021
`
`ORAL ARGUMENT
`
`EDWARDS LIFESCIENCES CORP. AND EDWARDS LIFESCIENCES LLC
`
`V.
`
`COLIBRI HEART VALVE LLC
`
`U.S. PATENT NO. 9,125,739
`
`CASE NO. IPR2020-01649
`
`SARAH E. SPIRES, COUNSEL FOR PATENT OWNER
`
`
`EXHIBITS
`
`DECEMBER 8, 2021
`
`ORAL ARGUMENT
`
`EDWARDS LIFESCIENCES CORP. AND EDWARDS LIFESCIENCES LLC
`
`V.
`
`COLIBRI HEART VALVE LLC
`
`U.S. PATENT NO. 9,125,739
`
`CASE NO. IPR2020-01649
`
`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 14:2-16.
`
`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
`
`
`
` PANIAGUA IS NOT PRIOR ART
`
`PANIAGUA IS NOT PRIOR ART
`
`S | .)
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`9
`
`
`
`’739 Patent: Discloses valve means with leaflets
`constructed from multiple pieces of tissue
`material
`
`Ex. 1001 at 3:41-44, 55-58, 4:51-59; POR at 19-21; Sur-Reply at 1.
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`10
`
`
`
`’739 Patent: Not limited to specific
`embodiments
`
`Ex. 1001 at 13:30-38; Sur-Reply at 1.
`
`11
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`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`
`
` NO CONTROLLED RELEASE IN
`
`NO CONTROLLED RELEASE IN
`BESSLER/KLINT
`BESSLER/KLINT
`
`S|D
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`12
`
`
`
`Bessler: Controlled release through
`threads/sutures
`
`Ex. 1006 at 7:38-57; Petition at 66; POR at 65-66; Sur-Reply at 4.
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`13
`
`
`
`Petition: No description of controlled
`release in Bessler/Klint
`
`Petition at 69; POR at 65-66; Sur-Reply at 4.
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`14
`
`
`
`Reply: Cannot import combination from different
`embodiment Klint (not cited in Petition)
`
`Reply at 16; Sur-Reply at 10.
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`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`15
`
`
`
`COLLAPSED ONTO THE PUSHER
`MEMBER ≠ IN CONTACT WITH THE
`PUSHER MEMBER
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`16
`
`
`
`’739 Patent: Pusher Member
`
`Ex. 1001 at 11:40-55; Sur-Reply at 12-14.
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`17
`
`
`
`’739 Patent Prosecution History: Collapsed onto
`pusher member ≠ in contact with pusher member
`
`Ex. 1002 at 238, 319; POR at 15-17; Sur-Reply at 14-15.
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`18
`
`
`
`’739 Patent Prosecution History: Collapsed onto
`pusher member ≠ in contact with pusher member,
`cont’d
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`Ex. 1002 at 423-24; POR at 15-17; Sur-Reply at 14-15.
`
`19
`
`
`
`VALVE COLLAPSED ONTO THE
`
`KLINT DOES NOT DISCLOSE A HEART
`KLINT DOES NOT DISCLOSE A HEART
`VALVE COLLAPSED ONTO THE
`PUSHER MEMBER
`PUSHER MEMBER
`
`S|D
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`20
`
`
`
`Klint: No disclosure of heart valve
`collapsed onto the pusher member
`
`Ex. 1019 at ¶¶ 90-94; POR at 40-45; Sur-Reply at 19-22.
`
`21
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`
`
` NO COMBINATION OF KLINT WITH
`
`NO COMBINATION OF KLINT WITH
`BESSLER
`BESSLER
`
`S|D
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`22
`
`
`
`POSA would not have combined
`Klint with Bessler
`
`Ex. 1019 at ¶ 94; Ex. 1006 at Fig. 5; POR at 47-48; Sur-Reply at 22-24.
`
`23
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`
`
`HEART VALVE COLLAPSED ONTO
`
`LEONHARDT DOES NOT DISCLOSE A
`LEONHARDT DOES NOT DISCLOSE A
`HEART VALVE COLLAPSED ONTO
`ieeden ade
`THE PUSHER MEMBER
`
`S|D
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`24
`
`
`
`Leonhardt: Inner catheter ≠ pusher member
`
`Ex. 1012 at 7:22-42, 8:23-27; Ex. 1001 at 11:48-55, Claim 5; POR at 34-39; Sur-Reply at 24-25.
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`25
`
`
`
`Leonhardt: No heart valve collapsed onto a
`pusher member
`
`Petition at 61-62; POR at 37-39; Sur-Reply at 24-25.
`
`26
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`
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