throbber
Filed on behalf of:
`Edwards Lifesciences Corporation
`By: Craig S. Summers
`Brenton R. Babcock
`Christy G. Lea
`Cheryl T. Burgess
`KNOBBE, MARTENS, OLSON & BEAR, LLP
`2040 Main Street, 14th Floor
`Irvine, CA 92614
`Tel.: (949) 760-0404
`Fax: (949) 760-9502
`Email: BoxEdwards@knobbe.com
`
`
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________________________
`
`EDWARDS LIFESCIENCES CORPORATION,
`Petitioner
`
`v.
`
`BOSTON SCIENTIFIC SCIMED, INC.,
`Patent Owner
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`Case No. IPR2017-00444
`Patent 6,915,560
`
`
`
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`
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`
`
`
`PETITION FOR INTER PARTES REVIEW OF U.S. PATENT NO. 6,915,560
`
`
`

`
`TABLE OF CONTENTS
`
`Page No.
`
`I.
`
`II.
`
`SUMMARY OF THE ISSUE PRESENTED ................................................ 1
`
`INTRODUCTION TO THE STATE OF THE ART .................................... 9
`
`III. MANDATORY NOTICES UNDER 37 C.F.R. § 42.8(a)(1) ...................... 14
`
`A.
`
`B.
`
`C.
`
`D.
`
`Real Party-in-Interest (37 C.F.R. § 42.8(b)(1)) ................................. 14
`
`Related Matters (37 C.F.R. § 42.8(b)(2)) .......................................... 14
`
`Lead and Back-up Counsel Under 37 C.F.R. § 42.8(b)(3) ............... 15
`
`Service Information Under 37 C.F.R. § 42.8(b)(4) ........................... 15
`
`IV. GROUNDS FOR STANDING UNDER 37 C.F.R. § 42.104(a) ................. 15
`
`V. U.S. PATENT NO. 6,915,560 ..................................................................... 16
`
`A.
`
`B.
`
`Specification and Claims ................................................................... 16
`
`Prosecution History ........................................................................... 23
`
`1.
`
`2.
`
`3.
`
`October 22, 2003 Office Action and Response ...................... 23
`
`April 22, 2004 Office Action and Response ........................... 27
`
`October 19, 2004 Office Action and Response ...................... 29
`
`VI.
`
`IDENTIFICATION OF CHALLENGE PURSUANT TO 37
`C.F.R. § 42.104(B) ...................................................................................... 30
`
`VII. PERSON HAVING ORDINARY SKILL IN THE ART ........................... 30
`
`VIII. CLAIM CONSTRUCTION AND RELATED ISSUES ............................. 31
`
`A.
`
`B.
`
`“A stent crimper comprising” ........................................................... 31
`
`“Dies” and “blades” ........................................................................... 32
`
`-i-
`
`

`
`TABLE OF CONTENTS
`(cont’d)
`
`Page No.
`
`C.
`
`“Stationary end-walls” and “stationary plates” ................................. 34
`
`IX. THE PRIOR ART ........................................................................................ 35
`
`A. Analogous Art ................................................................................... 35
`
`1.
`
`2.
`
`Field Of Endeavor ................................................................... 35
`
`Pertinent To The Particular Problem ...................................... 36
`
`B. Applicant’s Admitted Prior Art ......................................................... 37
`
`C. Yasumi ............................................................................................... 38
`
`D. Morales .............................................................................................. 47
`
`X.
`
`STATEMENT OF THE PRECISE RELIEF REQUESTED AND
`THE REASONS FOR CANCELLATION (37 C.F.R. § 42.22(a)
`AND 42.104(b)) ........................................................................................... 49
`
`A.
`
`Claims 1, 2, 6, 8-10, 14, 15, 18, 23, 25, 27, 28, 31, 33, 37,
`and 40 Are Invalid As Obvious Over Yasumi In View Of
`The AAPA ......................................................................................... 49
`
`1.
`
`2.
`
`3.
`
`4.
`
`5.
`
`6.
`
`7.
`
`Claim 1 .................................................................................... 49
`
`Claim 10 .................................................................................. 58
`
`Claim 18 .................................................................................. 67
`
`Claim 27 .................................................................................. 71
`
`Claim 37 .................................................................................. 74
`
`Claim 40 .................................................................................. 77
`
`Claims 2 and 28 ....................................................................... 79
`
`-ii-
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`

`
`TABLE OF CONTENTS
`(cont’d)
`
`Page No.
`
`8.
`
`9.
`
`Claims 6 and 15 ....................................................................... 80
`
`Claims 8, 25, and 33 ............................................................... 80
`
`10. Claims 9, 14, 23, and 31 ......................................................... 81
`
`11. Reason, Basis, or Motivation to Combine .............................. 81
`
`B. Ground 2: Claims 11, 17, 19, 26, 34, 35, and 39 Are
`Obvious Over Yasumi In View Of the AAPA and Morales ............. 85
`
`1.
`
`2.
`
`3.
`
`4.
`
`Claim 39 .................................................................................. 85
`
`Claims 11, 19, and 35 ............................................................. 92
`
`Claims 17, 26, and 34 ............................................................. 93
`
`Reason, Basis, or Motivation to Combine .............................. 94
`
`XI. THIS PETITION IS NOT REDUNDANT UNDER 35 U.S.C. §
`325(D) .......................................................................................................... 95
`
`XII. SECONDARY CONSIDERATIONS CANNOT OVERCOME
`THE STRONG EVIDENCE OF OBVIOUSNESS ..................................... 97
`
`XIII. CONCLUSION ............................................................................................ 97
`
`
`
`-iii-
`
`
`
`

`
`TABLE OF AUTHORITIES
`
`Page No(s).
`
`Allied Erecting & Dismantling Co. v. Genesis Attachments, LLC,
`No. 2015-1533, slip op. (Fed. Cir. June 15, 2016) ............................................. 80
`
`Boston Scientific Corp. and Boston Scientific Scimed, Inc. v. Edwards
`Lifesciences Corp.,
`Civil Action No. 8:16-cv-0730 (C.D. Cal.) ........................................................ 15
`
`In re Casey,
`370 F.2d 576 (C.C.P.A. 1967) ............................................................................ 50
`
`Catalina Marketing International, Inc. v. Coolsavings.com, Inc.,
`289 F.3d 801 (Fed. Cir. 2002) ...................................................................... 31, 32
`
`In re Clay,
`966 F.2d 656 (Fed. Cir. 1992) ............................................................................ 35
`
`In re Cuozzo Speed Techs., LLC,
`793 F.3d 1268 (Fed. Cir. 2015), aff’d, 136 S. Ct. 2131 (2016) .......................... 31
`
`Innovention Toys, LLC v. MGA Entm't, Inc.,
`637 F.3d 1314 (Fed. Cir. 2011) .......................................................................... 35
`
`Intri-Plex Tech., Inc. v. Mmi Holdings Saint-Gobain Performance
`Plastics Rencol Ltd., IPR2014-00309 ................................................................. 37
`
`Leapfrog Enters., Inc. v. Fisher-Price, Inc.,
`485 F.3d 1157 (Fed. Cir. 2007) .......................................................................... 96
`
`Newell Cos., Inc. v. Kenney Mfg. Co.,
`864 F.2d 757 (Fed. Cir. 1988) ............................................................................ 96
`
`OTHER AUTHORITIES
`
`35 U.S.C. § 102 ............................................................................................ 38, 47, 96
`
`35 U.S.C. § 103 .................................................................................................. 30, 80
`
`-iv-
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`

`
`TABLE OF AUTHORITIES
`(cont’d)
`
`Page No(s).
`
`35 U.S.C. §§ 311–319 ................................................................................................ 1
`
`35 U.S.C. § 325 ........................................................................................................ 94
`
`37 C.F.R. § 42.8 ........................................................................................... 14, 15, 16
`
`37 C.F.R. § 42.10 ..................................................................................................... 15
`
`37 C.F.R. § 42.22 ..................................................................................................... 49
`
`37 C.F.R. § 42.100 ............................................................................................... 1, 31
`
`37 C.F.R. § 42.104 ....................................................................................... 16, 30, 49
`
`
`
`-v-
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`

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`
`
`EXHIBIT LIST
`
`Exhibit No.
`
`Description
`
`1101
`
`1102
`
`1103
`
`1104
`
`1105
`
`1106
`
`1107
`
`1108
`
`1109
`
`1110
`
`1111
`
`1112
`
`1113
`
`1114
`
`1115
`
`1116
`
`1117
`
`U.S. Patent No. 6,915,560 (“the ’560 patent”)
`
`U.S. Patent No. 6,915,560 File History Excerpts
`
`U.S. Patent No. 4,454,657 (“Yasumi”)
`
`U.S. Patent No. 5,893,852 (“Morales”)
`
`Declaration of Neil Sheehan in Support of Petition for Inter Partes
`Review of U.S. Patent No. 6,915,560
`
`Curriculum Vitae of Neil Sheehan
`
`Materials Considered by Neil Sheehan
`
`German Patent No. DE9034 (“Nix”)
`
`Certified Translation of Nix
`
`U.S. Patent No. 2,664,996 (“Andrews”)
`
`U.S. Patent No. 4,308,744 (“Baker”)
`
`International Patent Publication No. WO1994014573 A1
`(“Hartley”)
`
`U.S. Patent No. 5,918,511 (“Sabbaghian”)
`
`U.S. Patent No. 6,364,870 (“Pinchasik”)
`
`U.S. Patent No. 5,261,263 (“Whitesell”)
`
`U.S. Patent No. 3,695,087 (“Tuberman”)
`
`U.S. Patent No. 6,176,116 (“Wilhelm”)
`
`-vi-
`
`

`
`
`
`
`
`Exhibit No.
`
`Description
`
`1118
`
`1119
`
`1120
`
`1121
`
`1122
`
`1123
`
`1124
`
`1125
`
`U.S. Patent No. 6,051,002 (“Morales 2”)
`
`U.S. Patent No. 5,951,540 (“Verbeek”)
`
`U.S. Patent No. 7,892,201 (“Laguna”)
`
`U.S. Patent No. 6,125,523 (“Brown”)
`
`U.S. Patent No. 3,370,451(“Schuetz”)
`
`U.S. Patent No. 3,154,978 (“Baker 2”)
`
`U.S. Patent No. 3,417,598 (“Valente”)
`
`U.S. Patent No. 6,074,381 (“Dinh”)
`
`-vii-
`
`

`
`Edwards Lifesciences Corporation
`IPR of U.S. Pat. 6,915,560
`
`Edwards Lifesciences Corporation (“Petitioner”) requests inter partes
`
`review pursuant to 35 U.S.C. §§ 311–319 and 37 C.F.R. § 42.100 et seq. of Claims
`
`1, 2, 6, 8-11, 14, 15, 17-19, 23, 25-27, 28, 31, 33-35, 37, 39 and 40 of U.S. Patent
`
`No. 6,915,560 (“the ’560 patent”), owned by Boston Scientific Scimed, Inc.
`
`(“Patent Owner”).
`
`I.
`
`SUMMARY OF THE ISSUE PRESENTED
`
`The claims of the ’560 patent recite a device for crimping a stent onto a
`
`balloon catheter. The claimed device has three basic features: (a) movable blades
`
`or dies arranged to form a variable-sized polygonal aperture, (b) a rotatable
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`actuation device coupled to the blades or dies, and (c) stationary end-walls on
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`either sides of the blades or dies. By moving the dies, the size of the aperture can
`
`be increased (Fig. 2a) or decreased (Fig. 2b) while maintaining the same polygonal
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`shape throughout.
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`-1-
`
`

`
`Edwards Lifesciences Corporation
`IPR of U.S. Pat. 6,915,560
`
`
`Polygonal
`Aperture 118
`
`Movable Dies 106
`
`
`Ex. 11011. Figure 4a is a partial front view that shows the dies, portions of the
`
`rotatable actuation device, and one end-wall. As the dies move, the sides of the
`
`dies push or squeeze the stent into a smaller size.
`
`
`1 For clarity, the Figures in this Petition have been colored and annotated.
`
`-2-
`
`

`
`Edwards Lifesciences Corporation
`IPR of U.S. Pat. 6,915,560
`
`
`Rotatable Actuation
`Plate 142
`
`Stationary End-wall 156
`
`Die 106
`
`
`
`There was nothing inventive about such a device at the time of the ’560
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`patent’s earliest possible priority date of September 22, 1999. As the ’560 patent
`
`admits, a stent crimper with dies coupled to a rotatable actuation device 28 and
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`between stationary end-walls was already well known in the art. Ex. 1101 at 1:62-
`
`2:21 (describing “prior art” Figure 1). The ’560 patent illustrates and describes the
`
`following admitted prior art stent crimper that embodies each of these well-known
`
`features:
`
`
`
`-3-
`
`

`
`Edwards Lifesciences Corporation
`IPR of U.S. Pat. 6,915,560
`
`
`Stationary
`End-walls
`
`Id., Fig. 1.
`
`Rotatable Actuation
`Device 28
`
`Dies
`
`
`
`The only feature missing from the admitted prior art stent crimper is the dies
`
`arranged to form a variable-sized polygonal aperture.
`
`During prosecution, the Examiner rejected the claims several times over the
`
`prior art, including over the admitted prior art stent crimper. To overcome the
`
`rejections, the Applicant amended the claims, ultimately focusing on the die
`
`configuration forming the polygonal-shaped aperture, illustrated in Fig. 2a and 2b
`
`above, to distinguish the prior art.
`
`But the arrangement of dies to form a polygonal-shaped aperture is nothing
`
`new. For more than a century, skilled artisans have used such a configuration with
`
`tools that require increasing and decreasing the size of an aperture, such as
`
`-4-
`
`

`
`Edwards Lifesciences Corporation
`IPR of U.S. Pat. 6,915,560
`
`wrenches, drawing dies, tube pointers, setting devices, chucks, press tools, electric
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`wire guide devices, and control valves.
`
`For example, in 1880 Nix disclosed an adjustable wrench that used
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`trapezoidal “jaws” arranged to form a “hexagonal opening” that varies in size with
`
`movement of the “jaws”:
`
`
`
`Polygonal Aperture
`
`Dies
`
`
`
`-5-
`
`
`
`Exs. 1108 and 1109.
`
`

`
`Edwards Lifesciences Corporation
`IPR of U.S. Pat. 6,915,560
`
`
`In 1954, Andrews disclosed an adjustable die for drawing, forming, or
`
`extruding bars of varying sections. Andrews disclosed “die blocks D7” arranged to
`
`form a polygonal “die hole 31” that varies in size with movement of the “die
`
`blocks D7”:
`
`Polygonal
`Aperture
`31
`
`Dies D7
`
`
`
`Ex. 1110.
`
`In 1982, Baker disclosed a tube pointer for compressing metal tubes. Baker
`
`disclosed a plurality of “jaws” 30-35 arranged to form a polygonal aperture that
`
`varies in size with movement of the “jaws”:
`
`-6-
`
`

`
`Edwards Lifesciences Corporation
`IPR of U.S. Pat. 6,915,560
`
`
`Polygonal Aperture
`
`Dies 30-35
`
`
`
`Ex. 1111.
`
`Also in 1982, Yasumi disclosed “an aperture setting device in which the size
`
`of the predetermined polygonal aperture can be changed, retaining the polygonal
`
`configuration.” Yasumi cited many uses for the disclosed device, including in a
`
`press tool.
`
`Polygonal Aperture
`
`Movable Dies 12-19
`
`
`
`-7-
`
`

`
`Edwards Lifesciences Corporation
`IPR of U.S. Pat. 6,915,560
`
`Ex. 1103.
`
`In 1992, Hartley disclosed an adjustable aperture apparatus having an “iris-
`
`type” arrangement providing an adjustable diameter aperture. Hartley disclosed a
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`plurality of “jaw members 12” arranged to form a “hexagonal aperture 14” that
`
`varies in size with movement of the “jaw members 12”:
`
`Polygonal Aperture 14
`
`Dies 12
`
`
`
`Ex. 1112.
`
`In July of 1999, Sabbaghian disclosed an adjustable socket for a wrench
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`having a plurality of “gripping members 6” arranged to form a “gripping region
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`14” that varies in size with movement of the “gripping members 6”:
`
`-8-
`
`

`
`Edwards Lifesciences Corporation
`IPR of U.S. Pat. 6,915,560
`
`
`Dies 6
`
`Polygonal Aperture
`14
`
`
`
`Ex. 1113.
`
`The ’560 patent’s broad claims recite nothing more than a crimper with dies
`
`arranged to form a polygonal aperture, as was well known to a person of ordinary
`
`skill in the art (“POSITA”) long before 1999. Thus, the claims of the ’560 patent
`
`are unpatentable over the prior art and should be cancelled.
`
`II.
`
`INTRODUCTION TO THE STATE OF THE ART
`
`The ’560 patent discloses a crimper for reducing the size of a stent. Stents
`
`are well-known medical devices used to open and reinforce an obstructed blood
`
`vessel. Stents are generally cylindrical wire-mesh devices that can be introduced
`
`via a delivery catheter into the blood vessel at a reduced diameter and then later
`
`expanded to the diameter of the vessel at the implantation site. Ex. 1105 ¶¶ 27-30.
`
`-9-
`
`

`
`Edwards Lifesciences Corporation
`IPR of U.S. Pat. 6,915,560
`
`
`Stent
`
`
`
`As part of the angioplasty procedure, a crimper is used to crimp the stent
`
`around an uninflated balloon located at the tip of a catheter. In this reduced-
`
`diameter configuration, the stent is able to travel through a patient’s blood vessel in
`
`a smaller profile designed to prevent abrasion and trauma to the vessel wall. Once
`
`the stent is correctly positioned at the implantation site, the balloon is inflated and
`
`expands the stent to the proper size. Ex. 1105 ¶¶ 31-33, 159-160.
`
`Balloon Catheter & Stent Within Vessel Before & After Inflation
`
`
`
`-10-
`
`

`
`Edwards Lifesciences Corporation
`IPR of U.S. Pat. 6,915,560
`
`
`Stents must be crimped uniformly to avoid damaging the stent. Ex. 1105 ¶¶
`
`159-160. Many conventional stent crimping techniques in the early 1990’s did not
`
`apply optimal uniform crimping forces. As explained in Pinchasik:
`
`[C]rimping is often done utilizing the fingers or a plier-like device to
`pinch the stent. One shortcoming of this conventional mounting and
`securing means is that it often produces irregular distortion of the
`stent which could cause trauma to the lumen being treated. Another
`shortcoming is that it may weaken a portion or portions of the stent
`which could result in stent failure.
`
`Ex. 1114 at 1:33-40.
`
`The ’560 patent sought to solve this problem using a plurality of movable
`
`blades or dies arranged so that the inward facing flat surfaces of the dies form a
`
`polygonal crimping aperture. By moving the dies, the size of the aperture can be
`
`increased (Fig. 2a) or decreased (Fig. 2b) while maintaining the same polygonal
`
`shape throughout.
`
`Polygonal
`Aperture 118
`
`Dies 106
`
`-11-
`
`
`
`

`
`Edwards Lifesciences Corporation
`IPR of U.S. Pat. 6,915,560
`
`
`According to the ’560 patent, this die configuration improves upon the prior
`
`art because the polygonal-shaped aperture is capable of applying uniform forces to
`
`crimp a stent without distorting, scoring, or marking the stent during the crimping
`
`process. Ex. 1101 at 2:27-30.
`
`As discussed above, this die configuration has been used for decades in
`
`connection with tools that require increasing and decreasing the size of an aperture
`
`to grip, compress, or form an object. Notably, the Examiner relied on prior art
`
`directed to a variety of these types of tools to reject the claims during prosecution.
`
`For example, the Examiner cited a reference directed to radial pliers or a wrench.
`
`Ex. 1102 at 72-73, Ex. 1115, Fig. 8. The Examiner relied upon a crimping tool for
`
`crimping lead end sleeves onto electrical conductors.
`
`
`
`-12-
`
`

`
`Edwards Lifesciences Corporation
`IPR of U.S. Pat. 6,915,560
`
`
`Ex. 1102 at 46, Ex. 1117, Fig. 1. The Examiner also relied upon a tube pointer.
`
`
`
`Ex. 1102 at 45-49; Ex. 1116, Fig. 21.
`
`
`
`Like the Examiner, a POSITA would have looked to these closely related
`
`types of mechanisms to improve upon known stent crimpers. A POSITA would
`
`-13-
`
`

`
`Edwards Lifesciences Corporation
`IPR of U.S. Pat. 6,915,560
`
`have viewed Yasumi as a stent crimper because it is capable of crimping a stent. A
`
`POSITA also would have had a reason, basis, or motivation to use Yasumi, with its
`
`dies that form a polygonal aperture, as a stent crimper in order to provide uniform
`
`crimping forces and thereby avoid distorting, scoring, or marking of the stent
`
`during the crimping process. Furthermore, to the extent necessary, a POSITA
`
`would have had a reason, basis, or motivation to use Yasumi as a stent crimper in
`
`view of the AAPA. Ex. 1105 ¶¶ 81-92, 155-160.
`
`As further explained below, each of the challenged claims is unpatentable as
`
`obvious.
`
`III. MANDATORY NOTICES UNDER 37 C.F.R. § 42.8(a)(1)
`A. Real Party-in-Interest (37 C.F.R. § 42.8(b)(1))
`Petitioner Edwards Lifesciences Corporation is the real party-in-interest.
`
`B. Related Matters (37 C.F.R. § 42.8(b)(2))
`Patent Owner has asserted the ’560 patent against Petitioner in a lawsuit
`
`filed on April 19, 2016, captioned Boston Scientific Corp. and Boston Scientific
`
`Scimed, Inc. v. Edwards Lifesciences Corp., Civil Action No. 8:16-cv-0730 (C.D.
`
`Cal.).
`
`-14-
`
`

`
`Edwards Lifesciences Corporation
`IPR of U.S. Pat. 6,915,560
`
`C. Lead and Back-up Counsel Under 37 C.F.R. § 42.8(b)(3)
`Pursuant to 37 C.F.R. §§ 42.8(b)(3) and 42.10(a), Petitioner provides the
`
`following designation of counsel, all of whom are included in Customer No.
`
`20,995:
`
`Lead Counsel
`Craig S. Summers (Reg. No. 31,430)
`2css@knobbe.com
`BoxEdwards@knobbe.com
`
`Postal and Hand-Delivery Address:
`Knobbe, Martens, Olson & Bear, LLP
`2040 Main Street, 14th Floor
`Irvine, CA 92614
`Telephone: 949-760-0404
`Fax:
`
`949-760-9502
`
`
`
`Back-up Counsel
`Brenton R. Babcock (Reg. No. 39,592)
`2brb@knobbe.com
`Christy G. Lea (Reg. No. 51,754)
`2cgl@knobbe.com
`Cheryl T. Burgess (Reg. No. 55,030)
`2ctb@knobbe.com
`
`Postal and Hand-Delivery Address:
`Knobbe, Martens, Olson & Bear, LLP
`2040 Main Street, 14th Floor
`Irvine, CA 92614
`Telephone: 949-760-0404
`Fax:
`
`949-760-9502
`
`Service Information Under 37 C.F.R. § 42.8(b)(4)
`
`D.
`Please address all correspondence to lead counsel and back-up counsel at the
`
`address shown above. Petitioner also consents to electronic service by email to:
`
`BoxEdwards@knobbe.com.
`
`IV. GROUNDS FOR STANDING UNDER 37 C.F.R. § 42.104(a)
`Petitioner certifies that the ’560 patent is available for inter partes review
`
`and that Petitioner is not barred or estopped from requesting inter partes review
`
`challenging the patent claims on the grounds identified in this Petition.
`
`-15-
`
`

`
`Edwards Lifesciences Corporation
`IPR of U.S. Pat. 6,915,560
`
`V. U.S. PATENT NO. 6,915,560
`A.
`Specification and Claims
`The ’560 patent describes an apparatus formed of coupled movable blades
`
`that are disposed about a reference circle to form a shrinkable aperture. Ex. 1101,
`
`Abstract, 9:20-22. The apparatus may be used for multiple purposes. For
`
`example, it may be used as a crimper to reduce the size of a medical device (such
`
`as a stent), or as a mold to blow mold a medical balloon to a particular size. Id. at
`
`2:48-55, 8:65-67.
`
`The ’560 patent notes that prior art crimping of stents often applied uneven
`
`crimping forces that could distort the stent and require re-crimping. However,
`
`crimping the same stent multiple times can damage the stent. Ex. 1101 at 1:42-55.
`
`The ’560 patent also illustrates and discusses an admitted prior art stent
`
`crimper (“Applicant Admitted Prior Art” or “AAPA”):
`
`-16-
`
`

`
`Edwards Lifesciences Corporation
`IPR of U.S. Pat. 6,915,560
`
`
`Linear Tracks or Rails
`
`Linear Bearings 24
`
`Cam Follower Bearings 22
`
`Rotating Cam Plate 28
`
`Crimping Blades
`
`Fixed Plates
`
`
`
`Ex. 1101, Fig. 1. The AAPA is a stent crimper that uses eight movable crimping
`
`blades (green) positioned between two fixed plates (blue). The end of each
`
`crimping blade is attached to a linear bearing 24 (red), which has a corresponding
`
`linear track (yellow) mounted onto the larger of the two fixed plates. Id. at Fig. 1,
`
`1:65-2:21. Each linear bearing 24 (red) is connected to its corresponding linear
`
`track (yellow) via a cam follower bearing 22 (orange) that fits within an arc-shaped
`
`slot on a rotating cam plate 28 (purple). Because the slots are not concentric with
`
`respect to the rotational axis 26, rotation of the cam plate 28 (purple) causes the
`
`linear bearings 24 (red) to slide along the linear tracks (yellow) and move the
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`crimping blades (green) radially outward or inward to crimp a stent. Id.
`
`-17-
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`

`
`Edwards Lifesciences Corporation
`IPR of U.S. Pat. 6,915,560
`
`
`The ’560 patent proposes a crimper that is “capable of crimping a stent
`
`uniformly while minimizing the distortion of and scoring and marking of the stent
`
`due to the crimping.” Ex. 1101 at 2:26-29. As shown in Figures 2a and 2b below,
`
`the crimper uses movable blades 106 (green) disposed about a reference circle 114
`
`to form a polygonal aperture 118 whose size may be varied. Id. at 4:46-62, 4:66-
`
`5:3.
`
`Polygonal
`Aperture 118
`
`Movable Blades/Dies 106
`
`
`
`Id., Figs. 2a, 2b.
`
`Each blade 106 (green) has an inner end 108 and an outer end 110. The
`
`inner end 108 is beveled 111 so that it cooperates with the adjacent blade. Ex.
`
`1101 at Fig. 3a, 4:59-62. Each blade is connected to an actuation device 138 that
`
`simultaneously moves the blades 106 (green) to increase or decrease the size of the
`
`aperture 118 while maintaining the polygonal shape of the aperture. Id. at 5:5-12.
`
`-18-
`
`

`
`Edwards Lifesciences Corporation
`IPR of U.S. Pat. 6,915,560
`
`
`Figures 4A and 4c of the ’560 patent show one embodiment of the invention
`
`with additional structure depicted.
`
`Cam Follower Bearing 150
`
`Radial Slot 146
`
`Actuation Plate 142
`
`Connecting Link 130
`
`Linear Slide 154
`
`Non-rotating Plate 156
`
`Blade 106
`
`
`
`-19-
`
`

`
`Edwards Lifesciences Corporation
`IPR of U.S. Pat. 6,915,560
`
`
`Non-rotating Plate 156
`
`Linear Slide 154
`
`Actuation Plate 142
`
`Cam Follower Bearing 150
`
`Slot 146
`
`Connecting Link 130
`
`Blade 106
`
`
`
`Ex. 1101 at Figs. 4A, 4c. In this embodiment, each crimping blade 106 (green) is
`
`attached to a connecting link 130 (red). Id. at 5:6-7. One side of each connecting
`
`link 130 (red) is adapted to slide along a linear slide 154 (yellow) mounted on a
`
`non-rotating plate 156 (blue). Id. at 5:17-24. The other side of the connecting link
`
`130 (red) has a cam follower bearing 150 (orange) that extends into a slot 146 in an
`
`actuation plate 142 (purple). Id. at 5:17-21. When the actuation plate 142 (purple)
`
`is rotated, the connecting links 130 (red) slide along the linear slides 154 (yellow)
`
`and simultaneously move the crimping blades 106 (green) radially in and out to
`
`change the size of the aperture. Id. at 5:7-62.
`
`Figures 5a and 8a disclose an alternative embodiment of the invention.
`
`-20-
`
`

`
`Edwards Lifesciences Corporation
`IPR of U.S. Pat. 6,915,560
`
`
`Actuation Plate 142
`
`Cam Slot 146
`
`Linear Slide 154
`
`Cam Follower Bearing 150
`
`Connecting Link 130
`
`Blade 106
`
`Cam Follower Bearing 150
`
`Linear Slide 154
`
`Connecting Link 130
`
`Blade 106
`
`Non-rotating Plate 156
`
`Actuation Plate 142
`Non-rotating Plate 156
`
`
`
`-21-
`
`

`
`Edwards Lifesciences Corporation
`IPR of U.S. Pat. 6,915,560
`
`Ex. 1101 at Figs. 5a, 8a. This embodiment operates in a manner similar to the
`
`embodiment described above. Id. at 5:66-6:42. The primary difference is that the
`
`blades 106 (green) in the alternative embodiment are attached to the connecting
`
`links 130 (red) at an angle, and the linear slides 154 (yellow) are arranged to slide
`
`along a line (158) that runs along a radius of the aperture. Id. at 5:67-6:2; 6:14-17.
`
`There are 7 independent claims and 17 dependent claims challenged in this
`
`Petition. Claim 10 is a representative independent claim and reads:
`
`A stent crimper comprising:
`
`a plurality of movable dies arranged to form an iris, the dies
`disposed about an aperture, the aperture having a longitudinal
`axis and a substantially regular polygonal shape, each of the
`dies having an inward facing straight side which faces the
`longitudinal axis of the aperture, both when the dies move to
`maximize the aperture and when the dies move to minimize the
`aperture, the dies between two stationary end-walls disposed
`about the longitudinal axis, the longitudinal axis passing
`through a point substantially centered on the end-walls,
`
` rotatable actuation device coupled to the dies, rotation of the
`actuation device causing the inward facing straight sides of the
`dies to move inward and reduce the size of the aperture or
`outward so as to increase the size of the aperture.
`
`
` a
`
`-22-
`
`

`
`Edwards Lifesciences Corporation
`IPR of U.S. Pat. 6,915,560
`
`B.
`Prosecution History
`U.S. Patent Application No. 10/444,807, which issued as the ’560 patent,
`
`was filed on May 23, 2003 with 26 claims.2 Ex. 1102 at 153-157. On October 9,
`
`2003, the Applicant responded to a restriction requirement by canceling the
`
`original claims and submitting 35 new claims. Id. at 93-98.
`
`1. October 22, 2003 Office Action and Response
`
`In an Office Action dated October 22, 2003, the Patent Examiner rejected all
`
`claims. Ex. 1102 at 69-80. Independent Claims 27, 36, 44, and 52 were rejected
`
`as anticipated by or obvious over U.S. Patent No. 5,261,263 (“Whitesell”). The
`
`Examiner found that Whitesell teaches a crimper comprising a plurality of movable
`
`dies 18 arranged to form an iris, with the dies 18 disposed about an aperture 30
`
`with a substantially regular polygonal shape, and a rotatable actuation device 26
`
`coupled to the dies, whereby rotation of the actuation device causes the dies to
`
`move inward to reduce the size of the aperture or outward to increase the size of
`
`the aperture. Id. at 72-73.
`
`
`2 The application for the ’560 patent is a continuation of one parent and one
`grandparent application. The prosecution histories of these applications are not
`relied upon for the purposes of this Petition.
`
`-23-
`
`

`
`Edwards Lifesciences Corporation
`IPR of U.S. Pat. 6,915,560
`
`
`Movable
`Wedge-Shaped
`Dies 18
`
`Rotatable Actuation Device 26
`
`Movable Wedge-Shaped Dies 18
`
`Rotatable Actuation Device 26
`
`
`
`Ex. 1102 at 84 (Whitesell, Ex. 1115, Figs. 1 and 2, handwritten notes in original;
`
`colored annotations added).
`
`-24-
`
`

`
`Edwards Lifesciences Corporation
`IPR of U.S. Pat. 6,915,560
`
`
`Whitesell discloses pliers for gripping and crimping cylindrical objects. Ex.
`
`1115 at 1:28-36. The Examiner considered Whitesell a stent crimper because
`
`“Whitesell is capable of performing crimping of a stent.” Ex. 1102 at 72. The
`
`Applicant did not dispute the Examiner’s position. Id. at 62-67.
`
`The Examiner also rejected Claims 27, 36, 44, and 52 as obvious over the
`
`AAPA in view of Whitesell. Ex. 1102 at 74-76. The Examiner found that the
`
`AAPA teaches a stent crimper comprising a plurality of movable dies 24 arranged
`
`to form an iris, with the dies disposed about an aperture 26, and a rotatable
`
`actuation device 28. Id. at 74-75.
`
`Rotatable Actuation Device 28
`
`Crimping Blades
`
`Ex. 1101, Fig. 1. The Examiner explained that it would have been obvious “to
`
`have provided the invention of [the AAPA] with dies having a longitudinal axis
`
`
`
`-25-
`
`

`
`Edwards Lifesciences Corporation
`IPR of U.S. Pat. 6,915,560
`
`which is tangent to the aperture, in light of the teachings of Whitesell, in order to
`
`provide a symmetric crimping deformation. It is noted that Whitesell recognizes
`
`the benefits of using radial applying crimping forces over linearly applied forces
`
`like the one taught by [AAPA].” Ex. 1102 at 74-75.
`
`In response, on January 22, 2004, the Applicant amended independent
`
`Claims 27, 36, 44, and 52 by adding limitations resulting in dies with straight or
`
`flat sides facing a substantially polygonal aperture when moved to open or close
`
`the aperture (the “straight-sided die/polygonal aperture limitation”). Ex. 1102 at
`
`57-60. The Applicant argued that Whitesell’s dies did not have a flat side facing
`
`the aperture, and did not form a polygonal shape, when closed. Id. at 63-64. The
`
`Applicant further argued that the AAPA did not disclose the new limitations,
`
`noting that “an iris defining an aperture with a substantially regular polygonal
`
`shape acts about an opening or aperture such that the opening or aperture maintains
`
`a similar geometric shape while minimizing or maximizing the size of the aperture.
`
`. . . the AAPA manipulates the stent to be crimped by having elongate portions
`
`poke radially inward and press portions of the stent in order to minimize the size of
`
`the stent.” Id. at 65-66. The Applicant also added new independent claims,
`
`including Claim 63. Id. at 60-61.
`
`-26-
`
`

`
`Edwards Lifesciences Corporation
`IPR of U.S. Pat. 6,915,560
`
`2.
`April 22, 2004 Office Action and Response
`
`On April 22, 2004, the Examiner rejected independent Claims 27, 36, 52,
`
`and 63 as anticipated by either U.S. Patent No. 3,695,087 (“Tuberman”) or U.S.
`
`Patent No. 6,176,116 (“Wilhelm”). Ex. 1102 at 42-52. The Examiner found that
`
`both taught dies arranged to form an iris with angles that remain substantially the
`
`same when the dies move to open or close. Id. at 45-46.
`
`Tuberman, depicted below, describes an apparatus for drawing or forming
`
`cylindrical points on metal tubes. Ex. 1116 at Abstract.
`
`Die Blocks 71-74
`
`Id., Figs. 2

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