Edwards Lifesciences Corporation
`v.
`Boston Scientific Scimed, Inc.
`
`IPR2017-00444 (U.S. Patent No. 6,915,560)
`
`Petitioner Edwards Lifesciences’
`Demonstratives for Oral Hearing
`
`Oral Argument: March 15, 2018
`
`1
`
`EDWARDS LIFESCIENCES EX. 1130
`Edwards Lifesciences v. Boston Scientific Scimed
`IPR2017-00444
`
`
`v.
`Boston Scientific Scimed, Inc.
`
`IPR2017-00444 (U.S. Patent No. 6,915,560)
`
`Petitioner Edwards Lifesciences’
`Demonstratives for Oral Hearing
`
`Oral Argument: March 15, 2018
`
`1
`
`EDWARDS LIFESCIENCES EX. 1130
`Edwards Lifesciences v. Boston Scientific Scimed
`IPR2017-00444
`
`
`
`Overview of the ’560 Patent
`
`Overview of the ’560 Patent
`
`2
`
`
`
`The ’560 Patent
`
`• Movable dies/blades uniformly reduce the diameter of
`a polygonal aperture
`
`Movable Dies 106
`
`Petition [Paper 1] at 1-2, 11-12; Ex. 1101 [’560 Patent] at abstract, 2:56-58, 4:46-58, 9:20-22, Figs. 2a-2b; Ex. 1105 [Sheehan Decl.] at ¶¶35-36.
`
`3
`
`
`
`Variable-Sized Polygonal Apertures Were Well Known in
`the Prior Art
`
`Andrews [Ex. 1110]
`“Adjustable Die”
`
`Baker [Ex. 1111]
`“Tube Pointer”
`
`Hartley [Ex. 1112]
`“Adjustable Aperture Apparatus”
`
`Petition [Paper 1] at 5-9; Ex. 1105 [Sheehan Decl.] at ¶¶83-91.
`
`Sabbaghian [Ex. 1113]
`“Adjustable Socket Wrench”
`
`4
`
`
`
`Institution Decision and Trial
`
`5
`
`
`
`Institution Decision
`
`Reference(s)
`
`Yasumi, Fig. 8*
`
`Basis
`
`§ 103(a)
`
`Claims Challenged
`
`1, 2, 6, 8-11, 14, 15, 17-19, 23,
`25-28, 31, 33-35, 37, 39, 40
`
`Yasumi, Fig. 8 and Morales
`
`§ 103(a)
`
`11, 17, 19, 26, 34, 35, 39
`
`*The Figure 8 embodiment also includes the explanation of features in Figures 3 and 10.
`
`Institution Decision [Paper 9] at 11, 25.
`
`6
`
`
`
`Disputed Issues
`
`7
`
`Whether the preamble “a stent crimper” is limiting
`
`Whether Yasumi discloses “stationary end-walls
`operatively engaged to the dies at distinct connection
`locations”
`
`Whether Yasumi discloses dies that move “inward” and
`“outward”
`
`Whether there was a motivation to use Yasumi’s press tool
`as a stent crimper, or to combine Yasumi with Morales
`
`Whether any secondary considerations support
`nonobviousness
`
`1 2
`
`3
`
`4
`
`5
`
`
`
`The Preamble “A Stent Crimper”
`Is Not Limiting
`
`8
`
`
`
`Representative Claim 1
`
`Claim No. /
`Subpart
`1 (preamble)
`
`Claim Element
`
`A stent crimper comprising:
`
`1.1
`
`1.2
`
`1.3
`
`1.4
`
`a plurality of movable dies arranged to form an iris having a
`longitudinal axis, the iris defining an aperture, the dies disposed
`about the aperture and between stationary end-walls which are
`disposed about the longitudinal axis,
`
`at least one of the stationary end-walls operatively engaged to the
`dies at distinct connection locations such that the number of
`distinct connection locations and the number of dies are the same;
`
`each die having a first straight side and a second straight side, the
`first straight side and the second straight side [converging] to form
`a tip;
`
`wherein a portion of the first straight side of each die faces the
`aperture, each first straight side parallel to the second side of an
`adjacent die.
`
`9
`
`
`
`When Is the Preamble Limiting?
`
`• “In general, a preamble limits the invention if it
`recites essential structure or steps, or if it is
`‘necessary to give life, meaning, and vitality’ to
`the claim.”
`
`Catalina Marketing Int’l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002).
`
`Petition [Paper 1] at 31-32, 50.
`
`10
`
`
`
`When Is the Preamble Not Limiting?
`
`• A “preamble is not limiting ‘where a patentee defines
`a structurally complete invention in the claim body
`and uses the preamble only to state a purpose or
`intended use for the invention.’”
`Catalina Marketing Int’l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002).
`
`• “[S]tatements of intended use or asserted benefits in
`the preamble may, in rare instances, limit apparatus
`claims, but only if the applicant clearly and
`unmistakably relied on those uses or benefits to
`distinguish prior art.”
`Id. at 809.
`
`Petition [Paper 1] at 31-32, 50.
`
`11
`
`
`
`The Claim Body Recites a “Structurally Complete Invention”
`
`• The deletion of the preamble “a stent crimper” would
`not affect the structure of the claimed invention
`Catalina Marketing Int’l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 809 (Fed. Cir. 2002).
`
`• Boston has not identified any structure supplied by
`the preamble “a stent crimper”
`
`• The description of “stent” in the specification is
`irrelevant to the preamble “a stent crimper”
`Patent Owner’s Response [Paper 15] at 21-22.
`
`Petition [Paper 1] at 31-32, 50; Ex. 1105 [Sheehan Decl.] at ¶¶70-71; Petitioner’s Reply [Paper 17] at 6-9.
`
`12
`
`
`
`“Stent Crimper” Does Not Provide Antecedent Basis
`
`• The body of the instituted claims does not recite a
`“stent crimper”
`
`• Boston argues that uninstituted Claim 36 controls
`Patent Owner’s Response [Paper 15] at 21, n. 3.
`
`WRONG:
`
`A preamble can be limiting in one independent
`claim and not limiting in another
`Catalina Marketing Int’l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 810-811 (Fed. Cir.
`2002); Petitioner’s Reply [Paper 17] at 8-9.
`
`Petition [Paper 1] at 31-32; Petitioner’s Reply [Paper 17] at 6-9.
`
`13
`
`
`
`Boston Did Not Distinguish the Prior Art Based on a
`“Stent Crimper”
`
`Tuberman [Ex. 1116]
`“Method and Apparatus for Pointing Tubes”
`
`Whitesell [Ex. 1115]
`“Crimping Pliers with Radially Opposed Jaws”
`
`Wilhelm [Ex. 1117]
`“Crimping Tool for Crimping Lead End Sleeves
`and the Like”
`
`Petition [Paper 1] at 50; Ex. 1102 (Pros. History) at 11-12, 34-38, 63-66.
`
`14
`
`
`
`Boston’s Cases Are Distinguishable
`
`1
`
`2
`
`The ’560 Patent is not “restricted” to a “stent crimper”
`Gen. Elec. Co. v. Nintendo Co., 179 F.3d 1350, 1362 (Fed. Cir. 1999); Corning Glass Works v. Sumitomo
`Elec. U.S.A., Inc., 868 F.2d 1251, 1257 (Fed. Cir. 1989); Ex. 1101 [’560 Patent] at 2:48-55, 3:16-18, 8:36-
`38, 8:65-67.
`
`The ’560 Patent does not define “stent crimper” and
`set forth “in detail” its “structural dimensions”
`Corning Glass, 868 F.2d at 1256.
`
`SeePatent Owner’s Response [Paper 15] at 17-18 (relying on Gen. Elec. and Corning Glass); Petitioner’s Reply [Paper 17] at 7-8.
`
`15
`
`
`
`The ’560 Patent Is Not Limited to a “Stent Crimper”
`
`Ex. 1101 [’560 Patent] at 2:48-55.
`
`Id. at 3:16-18.
`
`Id. at 3:36-38.
`
`Id. at 8:65-67.
`
`16
`
`Petition [Paper 1] at 16, 32; Ex. 1105 [Sheehan Decl.] at ¶35.
`
`
`
`Boston Relegates the Other Uses to a Footnote
`
`Patent Owner’s Response [Paper 15] at 23, n. 4.
`
`17
`
`
`
`Yasumi Satisfies the
`“Operatively Engaged” Limitation
`
`18
`
`
`
`Representative Claim 1
`
`Claim No. /
`Subpart
`1 (preamble)
`
`Claim Element
`
`A stent crimper comprising:
`
`1.1
`
`1.2
`
`1.3
`
`1.4
`
`a plurality of movable dies arranged to form an iris having a
`longitudinal axis, the iris defining an aperture, the dies disposed
`about the aperture and between stationary end-walls which are
`disposed about the longitudinal axis,
`
`at least one of the stationary end-walls operatively engaged to
`the dies at distinct connection locations such that the number of
`distinct connection locations and the number of dies are the same;
`
`each die having a first straight side and a second straight side, the
`first straight side and the second straight side [converging] to form
`a tip;
`
`wherein a portion of the first straight side of each die faces the
`aperture, each first straight side parallel to the second side of an
`adjacent die.
`
`19
`
`
`
`Yasumi’s “Side Plates” Are “Operatively Engaged” to the
`“Movable Pieces”
`
`
`
`
`
`Movable pieces (12-17)Movable pieces (12-17)Movable pieces (12-17)
`
`
`
`
`
`Handle (26)Handle (26)Handle (26)
`
`Side plates (27-1, 27-2)
`
`Petition [Paper 1] at 38-43, 55-56; Ex. 1103 [Yasumi] at 7:39-8:54; Ex. 1105 [Sheehan Decl.] at ¶¶97-104, 119-122,
`126; Ex. 1127 [Sheehan Supp. Decl.] at ¶¶23-27.
`
`20
`
`
`
`Yasumi’s “Movable Pieces” Fit within the “Movable Handle”
`
`
`
`
`
`Projections (40)Projections (40)Projections (40)
`
`
`
`
`
`Movable handle (37)Movable handle (37)Movable handle (37)
`
`
`
`
`
`Frame (20)Frame (20)Frame (20)
`
`
`
`
`
`Guide grooves (39)Guide grooves (39)Guide grooves (39)
`
`Petition [Paper 1] at 38-41, 55-56; Ex. 1103 [Yasumi] at 7:46-63; Ex. 1105 [Sheehan Decl.] at ¶¶97, 102, 122, 126; Ex. 1127
`[Sheehan Supp. Decl.] at ¶¶24-25.
`
`21
`
`
`
`Yasumi’s “Movable Handle” Is “Operatively Engaged” to
`the “Setting Piece”
`
`
`
`Circular recess (38)Circular recess (38)Circular recess (38)
`
`
`receives 33-2, not shownreceives 33-2, not shownreceives 33-2, not shown
`
`
`
`
`
`Setting piece (32)Setting piece (32)Setting piece (32)
`
`
`
`
`
`Circular projection (33-1)Circular projection (33-1)Circular projection (33-1)
`
`
`
`
`
`Hole (28-1)Hole (28-1)Hole (28-1)
`
`Petition [Paper 1] at 40-43, 55-56; Ex. 1103 [Yasumi] at 8:10-22, 8:42-54; Ex. 1105 [Sheehan Decl.] at ¶¶103-104, 122, 126; Ex.
`1127 [Sheehan Supp. Decl.] at ¶¶23-26.
`
`22
`
`
`
`Yasumi’s “Support Discs” Are “Operatively Engaged” to
`the “Side Plates”
`
`
`
`
`
`Support disc (42)Support disc (42)Support disc (42)
`
`
`
`
`
`Flange (70)Flange (70)Flange (70)
`
`
`
`Circular recessCircular recessCircular recess
`
`
`(not shown)(not shown)(not shown)
`
`Side plates (27-1, 27-2)
`
`Hole (28-2)
`
`
`
`
`
`Support disc (41)Support disc (41)Support disc (41)
`
`
`
`
`
`Hole (28-1)Hole (28-1)Hole (28-1)
`
`Petition [Paper 1] at 42-43, 55-56; Ex. 1103 [Yasumi] at 8:1-9, 8:23-54; Ex. 1105 [Sheehan Decl.] at ¶¶98, 103-104, 122, 126; Ex.
`1127 [Sheehan Supp. Decl.] at ¶¶23-26.
`
`23
`
`
`
`Yasumi’s “Drive Pins” and “Screws” Hold All the Pieces
`Together
`
`
`
`
`
`Drive pin (45)Drive pin (45)Drive pin (45)
`
`Petition [Paper 1] at 38-43, 55-56; Ex. 1103 [Yasumi] at 8:23-54; Ex. 1105 [Sheehan Decl.] at ¶¶98, 103-104, 122, 126; Ex. 1127
`[Sheehan Supp. Decl.] at ¶¶23-26.
`
`24
`
`
`
`
`
`Screw (46)Screw (46)Screw (46)
`
`
`
`Yasumi’s “Side Plates” Are “Operatively Engaged” to the
`“Movable Pieces”
`
`
`
`
`
`Drive pin (45)Drive pin (45)Drive pin (45)
`
`
`
`
`
`Support disc (42)Support disc (42)Support disc (42)
`
`
`
`
`
`Side plate (27-2)Side plate (27-2)Side plate (27-2)
`
`
`
`
`
`Movable handle (37)Movable handle (37)Movable handle (37)
`
`
`
`
`
`Setting piece (32)Setting piece (32)Setting piece (32)
`
`
`
`
`
`Adjust Cam (31)Adjust Cam (31)Adjust Cam (31)
`
`
`
`
`
`Movable pieces (12-17)Movable pieces (12-17)Movable pieces (12-17)
`
`
`
`
`
`Side plate (27-1)Side plate (27-1)Side plate (27-1)
`
`
`
`
`
`Support disc (41)Support disc (41)Support disc (41)
`
`
`
`Screw (46)Screw (46)Screw (46)
`Petition [Paper 1] at 38-43, 55-56; Ex. 1103 [Yasumi] at 7:39-8:54; Ex. 1105 [Sheehan Decl.] at ¶¶97-104, 119-122, 126; Ex. 1127
`[Sheehan Supp. Decl.] at ¶¶23-27.
`
`25
`
`
`
`Yasumi’s “Side Plates” Are “Operatively Engaged” to
`the “Movable Pieces”
`
`Ex. 1103 [Yasumi] at 7:63-68.
`
`Petition [Paper 1] at 39-43, 55-56; Ex. 1105 [Sheehan Decl.] at ¶¶100-104, 122, 126; Ex. 1127 [Sheehan Supp. Decl.] at ¶¶30-45.
`
`Id. at 8:42-45.
`
`26
`
`
`
`Yasumi’s “Side Plates” Are “Operatively Engaged” to
`the “Movable Pieces”
`
`Ex. 1103 [Yasumi] at 8:45-54.
`
`Petition [Paper 1] at 39-43, 55-56; Ex. 1105 [Sheehan Decl.] at ¶¶100-104, 122, 126; Ex. 1127 [Sheehan Supp. Decl.] at ¶¶30-45.
`
`27
`
`
`
`Yasumi’s “Side Plates” Are “Operatively Engaged” to
`the “Movable Pieces”
`
`Ex. 1103 [Yasumi] at 9:26-34.
`
`Petition [Paper 1] at 39-43, 55-56; Ex. 1105 [Sheehan Decl.] at ¶¶100-104, 122, 126; Ex. 1127 [Sheehan Supp. Decl.] at ¶¶30-45.
`
`28
`
`
`
`Boston Alleges That Yasumi’s Disclosure Is “Insufficient”
`
`Patent Owner’s Response [Paper 15] at 31.
`
`29
`
`
`
`Dr. Solar Confirmed His Difficulty Understanding Yasumi
`
`Ex. 1126 [Solar Dep.] at 43:3-11; Ex. 2016 [Solar Decl.] at ¶¶40, 68.
`
`30
`
`
`
`Dr. Solar Could Not Explain the Interaction Between the
`Setting Piece and Movable Handle
`
`Ex. 1126 [Solar Dep.] at 44:7-19.
`
`31
`
`
`
`Dr. Solar Offers Differences without a Distinction
`
`Ex. 1126 [Solar Dep.] at 53:8-12.
`
`32
`
`
`
`The Claims Require Operative Engagement, Not Affixation
`
`Patent Owner’s Response [Paper 15] at 27.
`
`Ex. 2016 [Solar Decl.] at ¶51.
`
`33
`
`
`
`Dr. Solar Relies on Fixation
`
`Ex. 1126 [Solar Dep.] at 58:11-15.
`
`34
`
`
`
`The ’560 Patent Shows Operative Engagement through
`Several Parts
`
`
`
`
`
`Non-rotating Plate (156)Non-rotating Plate (156)Non-rotating Plate (156)
`
`Petition [Paper 1] at 19-20; Ex. 1101 [’560 Patent] at 5:5-62, Fig. 4c; Petitioner’s Reply [Paper 17] at 13-14; Ex. 1127 [Sheehan Supp.
`Decl.] at ¶39.
`
`35
`
`
`
`
`
`Blade (106)Blade (106)Blade (106)
`
`
`
`First Component: Connecting Link (130)
`
`
`
`
`
`Connecting Link (130)Connecting Link (130)Connecting Link (130)
`
`Petition [Paper 1] at 19-20; Ex. 1101 [’560 Patent] at 5:5-62, Fig. 4c; Petitioner’s Reply [Paper 17] at 13-14; Ex. 1127 [Sheehan Supp.
`Decl.] at ¶39.
`
`36
`
`
`
`Second Component: Bearing Block (212)
`
`
`
`
`
`Bearing Block (212)Bearing Block (212)Bearing Block (212)
`
`Petition [Paper 1] at 19-20; Ex. 1101 [’560 Patent] at 5:5-62, Fig. 4c; Petitioner’s Reply [Paper 17] at 13-14; Ex. 1127 [Sheehan Supp.
`Decl.] at ¶39.
`
`37
`
`
`
`Third Component: Linear Slide (154)
`
`
`
`
`
`Linear Slide (154)Linear Slide (154)Linear Slide (154)
`
`Petition [Paper 1] at 19-20; Ex. 1101 [’560 Patent] at 5:5-62, Fig. 4c; Petitioner’s Reply [Paper 17] at 13-14; Ex. 1127 [Sheehan Supp.
`Decl.] at ¶39.
`
`38
`
`
`
`Boston’s “Distinct Connection Locations” Arguments
`Are Unsupported
`
`• Boston argues the “distinct connection locations”
`must be on the stationary end plates
`
`Patent Owner’s Response [Paper 15] at 27.
`
`• But, Boston’s expert testified that the claims require
`“distinct connection locations” on the dies/blades
`
`Ex. 1126 [Solar Dep.] at 46:6-47:7.
`
`39
`
`
`
`Boston’s Expert Agrees with Edwards on the “Distinct
`Connection Locations”
`
`* * *
`
`Ex. 1126 [Solar Dep.] at 46:6-47:7.
`
`40
`
`
`
`Yasumi’s Dies Move
`“Inward” and “Outward”
`
`41
`
`
`
`Representative Claim 2
`
`• Claims 2, 8, 10, 18, 25, 27-28, and 33 state that the
`“dies/blades” or “straight sides of the dies” move
`“inward” and/or “outward”
`
`Claim No.
`
`2
`
`Claim Element
`
`The stent crimper of claim 1 having a rotatable
`actuation device coupled to the dies, rotation of the
`actuation device causing the dies to move inward
`and reduce the size of the aperture or outward so as
`to increase the size of the aperture.
`
`42
`
`
`
`Yasumi’s Dies Move Inward/Outward in the Same Way as
`the Dies in the ’560 Patent
`
`Yasumi
`
`’560
`
`Petitioner’s Reply [Paper 17] at 16; Ex. 1127 [Sheehan Supp. Decl.] at ¶¶52-53; Petition [Paper 1] at 66, 72; Ex. 1101 [‘560 Patent] at
`4:46-5:12, 5:46-62, Figs. 2a-2b; Ex. 1103 [Yasumi] at 5:39-6:13, 7:46-68, 8:43-54, Figs. 3, 8.
`
`43
`
`
`
`Yasumi’s Dies Move Inward/Outward in the Same Way as
`the Dies in the ’560 Patent
`
`Yasumi
`
`’560
`
`Petitioner’s Reply [Paper 17] at 16; Ex. 1127 [Sheehan Supp. Decl.] at ¶¶52-53; Petition [Paper 1] at 66, 72; Ex. 1101 [‘560 Patent] at
`4:46-5:12, 5:46-62, Figs. 2a-2b; Ex. 1103 [Yasumi] at 5:39-6:13, 7:46-68, 8:43-54, Figs. 3, 8.
`
`44
`
`
`
`Boston Misunderstands Yasumi
`
`Boston: “The arrows D suggest an essentially
`circumferential movement of the movable pieces….”
`Patent Owner’s Response [Paper 15] at 28.
`
`Ex. 1103 [Yasumi] at 5:39-62, 7:46-52; Ex. 1127 [Sheehan Supp. Decl.] at ¶¶50-52.
`
`45
`
`
`
`A POSITA Would Have Been Motivated to
`Use Yasumi’s Press Tool as a Stent Crimper
`
`46
`
`
`
`It Was Well Known to Use Pliers to Crimp Stents
`
`Ex. 1114 [Pinchasik] at 1:33-35.
`
`Ex. 1125 [Dinh] at 1:43-46.
`
`Ex. 1119 [Verbeek] at 2:1-3.
`
`Petition [Paper 1] at 11; Ex. 1105 [Sheehan Decl.] at ¶¶33, 87; Ex. 1127 [Sheehan Supp. Decl.) at ¶79.
`
`47
`
`
`
`Dr. Solar’s Declaration Is Silent Regarding This Well Known Use
`
`* * *
`
`Ex. 1126 [Solar Dep.] at 73:17-22, 77:13-17.
`
`48
`
`
`
`The Examiner Relied on Plier-Like Devices like Yasumi’s Press
`Tool during Prosecution
`
`Whitesell [Ex. 1115]
`
`Wilhelm [Ex. 1117]
`
`Petition [Paper 1] at 23-30.
`
`49
`
`
`
`Yasumi Recognized the Broad Application of a Variable-Sized
`Polygonal Aperture
`
`Ex. 1103 [Yasumi] at 1:32-39.
`
`Petition [Paper 1] at 46-47, 82-85; Ex. 1105 [Sheehan Decl.] at ¶¶156-158.
`
`50
`
`
`
`A POSITA Would Have Been Motivated to Use Yasumi’s Press
`Tool to Crimp Stents
`
`• Yasumi discloses a plier-like press tool
`Petition [Paper 1] at 46-47, 82-85; Ex. 1127 [Sheehan Supp. Decl.] at ¶¶79-81; Ex. 1103 [Yasumi] at 1:32-
`39.
`
`• Yasumi solves a problem identified by the applicant:
`uniformly changing the size of an aperture without
`introducing gaps between the dies
`Petition [Paper 1] at 47; Ex. 1103 [Yasumi] at 1:17-20; Ex. 1102 [Pros. Hist.] at 64-66.
`
`• Yasumi’s press tool is a predictable mechanical device
`that a POSITA would reasonably expect to crimp a stent
`Petition [Paper 1] at 46-47, 82-85; Ex. 1105 [Sheehan Decl.] at ¶¶110-111, 156-160; Ex. 1127 [Sheehan
`Supp. Decl.] at ¶¶54-70, 79-81;.
`
`51
`
`
`
`Boston’s Arguments Are Not Persuasive
`
`1
`
`Yasumi is only “used to shape and align an electrical wire”
`Patent Owner’s Response [Paper 15] at 2, 30.
`
`WRONG:
`
`Yasumi discloses many uses including as a chuck, a press
`tool, and a control valve
`Ex. 1103 [Yasumi] at 1:32-39; Ex. 1127 [Sheehan Supp. Decl.] at ¶69.
`
`2
`
`Yasumi is inappropriate for stent crimping because it does not
`disclose “the longitudinal dimension” of the aperture
`Patent Owner’s Response [Paper 15] at 30.
`
`WRONG:
`
`A POSITA would understand the longitudinal length of
`the aperture is dictated by the intended use
`Ex. 1127 [Sheehan Supp. Decl.] at ¶77.
`
`52
`
`
`
`Boston’s Arguments Are Not Persuasive
`
`3
`
`The 30 stent crimper patents that do not cite Yasumi show that
`Yasumi is inappropriate for stent crimping
`Patent Owner’s Response [Paper 15] at 31-32.
`
`WRONG:
`
`• There is no evidence the prior inventors knew about Yasumi.
`
`• Unlike the prior inventors, a POSITA is presumed to know of all art.
`
`• Many patentees, including Boston, and patent examiners have cited
`Yasumi in stent crimper patents.
`
`Ex. 1127 [Sheehan Supp. Decl.] at ¶76.
`
`53
`
`
`
`A POSITA Would Have Found It Obvious
`to Combine Yasumi with Morales
`
`54
`
`
`
`Representative Claims 11 and 17
`
`Claim No.
`
`Claim Element
`
`11
`
`17
`
`The stent crimper of claim 10 wherein a stent is disposed about
`a medical balloon, the medical balloon disposed about a
`catheter.
`
`The stent crimper of claim 10 wherein an entire stent is
`disposed within the aperture.
`
`• Ground 2: applies to claims 11, 17, 19, 26, 34, 35, and 39
`
`• Boston does not dispute that Morales meets the
`dependent claim limitations
`Patent Owner’s Response [Paper 15] at 34.
`
`55
`
`
`
`Morales Discloses a Stent Crimper
`
`• “A stent crimping tool for firmly and uniformly crimping a
`conventional or radioactive stent onto a balloon catheter”
`Ex. 1104 [Morales] at Abstract, Fig. 1
`
`Delivery Catheter (11)
`
`Stent (10)
`
`Balloon (14)
`
`Petition [Paper 1] at 47-49.
`
`56
`
`
`
`Morales Satisfies the Claim Limitations
`
`Balloon (14)
`
`Delivery Catheter (11)
`
`Stent (10)
`
`• The stent is
`disposed about a
`medical balloon
`and the medical
`balloon is disposed
`about a catheter
`
`• The entire stent is
`disposed within
`the aperture
`
`Teeth (30)
`
`• The teeth have a length that exceeds the length of the stent
`
`Petition [Paper 1] at 47-49, 86-94; Ex. 1105 [Sheehan Decl.] at ¶164, 166, 169-170, 173-174.
`
`57
`
`
`
`A POSITA Would Have Been Motivated to Combine Yasumi
`with Morales
`
`• The purpose of a stent crimper is to crimp a stent around an
`inflatable balloon which is disposed about a catheter
`Ex. 1105 [Sheehan Decl.] at ¶176; Ex. 1104 [Morales] at Abstract.
`
`• A POSITA would have been motivated to modify the aperture in
`Yasumi to exceed the length of the stent as shown in Morales
`because:
`
`– Positioning the entire stent in the aperture would result in
`uniform crimping along the entire stent; and
`
`– Sizing the aperture to exceed the length of the stent would
`provide a beneficial margin of error.
`
`Ex. 1105 [Sheehan Decl.] at ¶ ¶ 175-177.
`
`58
`
`
`
`Boston Failed to Meet Its Burden on
`Secondary Considerations
`
`59
`
`
`
`Boston Fails to Prove That Edwards’ Heart Valve Crimpers
`Practice Any Claim of the ’560 Patent
`
`• Boston alleges a crimper packaged with Edwards’ transcatheter
`heart valve (“TVH”) kits practices the invention
`Patent Owner’s Response [Paper 15] at 35.
`
`• Boston’s allegations of infringement are unproven and incorrect.
`
`• Edwards’ crimpers lack at least the following limitations:
`
`– “Stationary end walls” or “stationary plates”
`
`– “Rotatable actuation device” or “an actuation device”
`
`Petitioner’s Reply [Paper 17] at 23-24; Ex. 1127 [Sheehan Supp. Decl.] at ¶¶82-94.
`
`60
`
`
`
`Boston Has Not Shown a Nexus between the Patented
`Features and the Alleged “Commercial Success”
`
`• Edwards’ transcatheter heart valves (“THV”) are sold in a kit
`that includes a (1) heart valve, (2) delivery system, and (3)
`other ancillary parts including a crimper
`Petitioner Reply [Paper 17] at 24.
`
`• Boston provides no evidence that crimpers, as opposed to
`the other components, drive demand for the THV kits
`
`• Boston’s expert admits that other alternatives exist that
`provide uniform crimping
`Ex. 1126 [Solar Dep. Tr.] at 83:12-84:8, 85:8-11.
`
`61
`
`
`
`Press Release Not Evidence of Commercial Sales
`
`• Solar: “Petitioner’s crimpers…have enjoyed substantial
`sales and have been commercially successful.”
`Ex. 2016 [Solar Decl.] at ¶76 (citing Ex. 2031).
`
`• Ex. 2031 is a press release of Edwards’ 2017 2Q Results
`
`– The press release does not mention heart valve
`crimpers
`
`– The press release does not even provide any sales
`figures for specific Edwards’ products
`
`62
`
`
`
`Boston Presents No Factual Evidence of a Long-Felt but
`Unresolved Need
`
`• Boston argues “it is reasonable to infer the need
`would not have persisted had the solution been
`obvious.”
`
`Patent Owner’s Response [Paper 15] at 36 (quoting Apple Inc. v. Samsung Elecs. Co., 839 F.3d 1034,
`1056 (Fed. Cir. 2016).
`
`• Unlike in Apple, Boston offers no evidence that
`the prior art patents that addressed uneven
`crimping failed to adequately solve the problem.
`
`Petitioner’s Reply [Paper 17] at 25 (citing Apple, 839 F.3d at 1057).
`
`63
`
`
`
`Boston Presents No Evidence That Others Tried and Failed
`
`• Boston merely identifies other patents directed towards the
`same problem
`Patent Owner’s Response [Paper 15] at 36-37 (citing Ex. 2016 [Solar Decl.] at ¶¶82-83).
`
`• Unlike Boston’s cited cases, Boston provides no evidence
`that the devices in the prior art patents failed to solve the
`problem of uneven crimping
`Petitioner’s Reply [Paper 17] at 25-26 (summarizing cases).
`
`• Boston cites no cases holding that the mere existence of
`other patents addressing the same problem is evidence of
`nonobviousness
`
`64
`
`
`
`Mr. Sheehan Is Well Qualified
`
`65
`
`
`
`Mr. Sheehan Has Decades of Medical Device Experience
`
`• Mechanical engineer with nearly 50 years of engineering
`experience (over 40 in the medical device field)
`
`• High-level positions at seven different medical devices
`companies
`
`• Worked for the past 25 years as a consulting engineer and
`expert witness, specializing almost exclusively in medical
`device products
`
`• Familiar with the design and operation of stents and stent
`crimpers through previous expert witness engagements
`
`Ex. 1105 [Sheehan Decl.] at ¶¶1-8; Ex. 1106 [CV]; Ex. 1127 [Sheehan Supp. Decl.] at ¶¶2-12.
`
`66
`
`
`
`Mr. Sheehan Is Qualified to Testify from the Perspective of a
`POSITA
`
`• Boston’s expert agreed with Mr. Sheehan’s definition
`Ex. 2016 [Solar Decl.] at ¶22.
`
`• Mr. Sheehan has “a degree in mechanical
`engineering, industrial design, biomedical
`engineering or equivalent work experience, as well
`as five to ten years of experience in the design or
`development of medical devices.”
`Ex. 1105 [Sheehan Decl.] at ¶¶1-8, 66; Ex. 1106 [CV]; Ex. 1127 [Sheehan Supp. Decl.] at ¶¶2-12.
`
`67
`
`
`
`Dr. Solar’s Experience Is Less Relevant
`
`• Dr. Solar does not have a degree in mechanical engineering,
`industrial design, or biomedical engineering
`
`• Dr. Solar’s two crimper patents describe a much different
`type of crimper than the ’560 Patent
`
`– The device used a fluid compressed bladder to
`crimp a stent
`
`Ex. 1126 [Solar Dep. Tr.] at 13:16-15:17, 20:5-22:15.
`
`68
`
`
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