UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`
`
`EDWARDS LIFESCIENCES CORPORATION
`
`Petitioner
`
`v.
`
`BOSTON SCIENTIFIC SCIMED, INC.
`
`Patent Owner
`
`
`
`
`IPR2017-
`Patent 6,712,827
`
`Filing Date: April 16, 2002
`Issue Date: March 30, 2004
`
`
`PETITION FOR INTER PARTES REVIEW
`OF U.S. PATENT 6,712,827
`
`
`
`
`
`
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`
`
`EDWARDS LIFESCIENCES CORPORATION
`
`Petitioner
`
`v.
`
`BOSTON SCIENTIFIC SCIMED, INC.
`
`Patent Owner
`
`
`
`
`IPR2017-
`Patent 6,712,827
`
`Filing Date: April 16, 2002
`Issue Date: March 30, 2004
`
`
`PETITION FOR INTER PARTES REVIEW
`OF U.S. PATENT 6,712,827
`
`
`
`
`
`Petition for Inter Partes Review
`U.S. Patent No. 6,712,827
`
`TABLE OF CONTENTS
`
`I.
`
`INTRODUCTION ...................................................................................... - 1 -
`
`II. OVERVIEW OF THE ’827 PATENT ....................................................... - 2 -
`
`A.
`
`Scope and Content of the Art Before August 23, 1996 ................... - 2 -
`
`1.
`
`2.
`
`3.
`
`History of Angioplasty and Stents ......................................... - 2 -
`
`Stent Delivery System Design Considerations ...................... - 8 -
`
`Balloon-Expandable Stents Had Known
`Advantages and Design Challenges Compared to
`Self-Expanding Stents .......................................................... - 10 -
`
`B.
`
`C.
`
`Summary of the ’827 Patent ........................................................... - 15 -
`
`Summary of Relevant Prosecution File History ............................ - 20 -
`
`III. Person of Ordinary Skill in the Art ........................................................... - 28 -
`
`IV. PROPOSED CLAIM CONSTRUCTION ................................................ - 28 -
`
`V.
`
`STATEMENT OF THE PRECISE RELIEF REQUESTED
`AND THE REASONS FOR CANCELLATION (37 C.F.R. §
`42.22(a) AND 42.104(b)) ......................................................................... - 29 -
`
`A. Ground 1: Claims 1 through 3, 5 through 14, and 16
`through 20 are Unpatentable as Obvious over Olympus in
`View of the Knowledge of a POSITA and/or Burton,
`Fischell ’507, Fischell ’274 and/or Williams ................................. - 31 -
`
`B.
`
`Ground 2: Claims 1 through 3, 5, 7 through 9, 11
`through 14, and 16 through 20 are Unpatentable as
`Obvious over Fischell ’274 View of Burton, and in
`Further View of the Knowledge of a POSITA and/or
`Williams ......................................................................................... - 59 -
`
`- i -
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`Petition for Inter Partes Review
`U.S. Patent No. 6,712,827
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`C. Ground 3: Claims 13 and 15 are Unpatentable as
`Obvious over References in Grounds 1 and 2 in Further
`View of Jendersee .......................................................................... - 79 -
`
`VI. SECONDARY CONSIDERATIONS CANNOT OVERCOME
`THE STRONG EVIDENCE OF OBVIOUSNESS .................................. - 81 -
`
`VII. REQUIREMENTS FOR INTER PARTES REVIEW ............................... - 82 -
`
`A. Ground for Standing (37 C.F.R. § 42.104(a)) ................................ - 82 -
`
`VIII. MANDATORY NOTICES UNDER 37 C.F.R. § 42.8(b) ....................... - 82 -
`
`A.
`
`B.
`
`C.
`
`Real Parties in Interest .................................................................... - 82 -
`
`Related Matters ............................................................................... - 82 -
`
`Payment of Fees ............................................................................. - 82 -
`
`D. Designation of Lead and Back-Up Counsel ................................... - 83 -
`
`Power of Attorney .......................................................................... - 83 -
`
`Service Information ........................................................................ - 83 -
`
`E.
`
`F.
`
`
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`- ii -
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`Petition for Inter Partes Review
`U.S. Patent No. 6,712,827
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`EXHIBIT LIST
`
`Exhibit No.
`
`Description
`
`1001
`
`1002
`
`1003
`
`1004
`
`1005
`
`1006
`
`1007
`
`1008
`
`1009
`
`1010
`
`1011
`
`1012
`
`1013
`
`1014
`
`1015
`
`1016
`
`1017
`
`U.S. Patent 6,712,827 (Patent at Issue)
`
`File History of U.S. Patent No. 6,712,827
`
`Declaration of Thomas Trotta (“Trotta Declaration”)
`
`CV of Thomas Trotta
`
`List of Patents Naming Thomas Trotta as an Inventor
`
`BSC’s Infringement Contentions
`
`BSC’s Proposed Claim Constructions
`
`U.S. Patent No. 4,733,665 (“Palmaz”)
`
`U.S. Patent No. 4,994,032 (“Sugiyama ’032”)
`
`U.S. Patent No. 4,768,507 (“Fischell ’507”)
`
`U.S. Patent No. 4,964,853 (“Sugiyama ’853”)
`
`Sigwart et al., Intravascular stents to prevent occlusion and
`restenosis after transluminal angioplasty, The New England
`Journal of Medicine, Vol. 316, No. 12, March 19, 1987, pp. 701-
`706 (“Sigwart”)
`
`U.S. Patent No. 5,639,274 (“Fischell ’274”)
`
`U.S. Patent No. 5,026,377 (“Burton”)
`
`Japanese Publication No. H4-64367 with English translation and
`certification of translation (“Olympus”)
`
`U.S. Patent No. 5,836,965 (“Jendersee”)
`
`U.S. Patent No. 5,702,418 (“Ravenscroft”)
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`- iii -
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`Petition for Inter Partes Review
`U.S. Patent No. 6,712,827
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`Exhibit No.
`
`Description
`
`Veldhuijzen et al., Retrieval of undeployed stents from the right
`coronary artery: report of two cases, Catheterization and
`Cardiovascular Diagnosis 30:245-248 (1993) (“Veldhuijzen”)
`
`Foster-Smith et al., Retrieval techniques for managing flexible
`intracoronary stent misplacement, Catherization and
`Cardiovascular Diagnosis 30:63-68 (1993) (“Foster-Smith”)
`
`Mohiaddin et al., Localization of a misplaced coronary artery
`stent by magnetic resonance imaging, Clin. Cardiol. 18, 175-177
`(1995) (“Mohiaddin”)
`
`U.S. Patent No. 5,108,416 (“Ryan”)
`
`U.S. Patent No. 5,304,198 (“Samson”)
`
`U.S. Patent No. 5,653,691 (“Rupp”)
`
`U.S. Patent No. 5,437,083 (“Williams”)
`
`File History of U.S. Patent No. 6,007,543 (“’150 Application”)
`
`U.S. Patent No. 5,409,495 (“Osborn”)
`
`U.S. Patent No. 5,445,646 (“Euteneuer”)
`
`U.S. Patent No. 5,158,548 (“Lau”)
`
`U.S. Patent No. 5,364,354 (“Walker”)
`
`File History of U.S. Patent No. 6,371,962 (“’962 File History”)
`
`1018
`
`1019
`
`1020
`
`1021
`
`1022
`
`1023
`
`1024
`
`1025
`
`1026
`
`1027
`
`1028
`
`1029
`
`1030
`
`
`
`
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`Petition for Inter Partes Review
`U.S. Patent No. 6,712,827
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`I.
`
`INTRODUCTION
`
`Petitioner Edwards Lifesciences Corporation (“Edwards” or “Petitioner”)
`
`respectfully petitions for initiation of inter partes review of claims 1 through 3, and
`
`5 through 20 of U.S. Patent No. 6,712,827 (“the ’827 Patent”) in accordance with
`
`35 U.S.C. §§ 311–319 and 37 C.F.R. § 42.100 et seq. (“Petition”).
`
`The ’827 Patent is directed to a “mounting body” structure (referred to as an
`
`“intermediate layer” in the ’827 Patent claims) for securing a stent to a catheter in
`
`order to facilitate delivery of the stent to the desired location in a body lumen such
`
`as a blood vessel. (Ex. 1001, 2:3-13-171). By the filing date of the earliest
`
`application to which the ’827 patent can claim priority, August 23, 1996, the use
`
`of catheter-delivered stents in the treatment of vascular disease, and particularly
`
`diseases of the coronary arteries, was well known. A host of techniques already
`
`existed for securing the stent to the catheter. The ’827 Patent adds nothing to this
`
`art and the claims of the patent merely cover known attachment techniques or
`
`obvious modifications of known attachment techniques. As a result, the
`
`
`1 Citations in the form xx:yy are to the column and line of the ’827 Patent unless
`
`indicated otherwise.
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`- - 1 - -
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`Petition for Inter Partes Review
`U.S. Patent No. 6,712,827
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`challenged claims of the ’827 Patent claims should be found unpatentable as
`
`anticipated and/or obvious.
`
`II. OVERVIEW OF THE ’827 PATENT
`A.
`Scope and Content of the Art Before August 23, 1996
`
`1. History of Angioplasty and Stents
`The ’827 Patent relates to a stent delivery system that uses a catheter with a
`
`balloon to deliver and expand a balloon-expandable stent. The use of balloon
`
`catheters and stents in the human body for repairing vessels such as coronary
`
`arteries was well known in the prior art since at least the 1980s. Ex. 1003 (Trotta
`
`Decl.) ¶29.2 In the 1980s, surgeons were using a procedure known as percutaneous
`
`transluminal coronary angioplasty (“PTCA”) to treat atherosclerosis and other
`
`forms of coronary narrowing. PTCA used a balloon catheter to enlarge the lumen
`
`of the affected vessel, inflating the balloon to cause radial expansion. See, e.g., Ex.
`
`2 Although not all of the references discussed in this section are cited in the
`
`specific invalidity grounds below, these background references serve “to document
`
`the knowledge that skilled artisans would bring to bear in reading the prior art
`
`identified as producing obviousness.” Ariosa Diagnostics v. Verinata Health, Inc.,
`
`805 F.3d 1359, 1365 (Fed. Cir. 2015).
`
`- - 2 - -
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`Petition for Inter Partes Review
`U.S. Patent No. 6,712,827
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`1008, U.S. Patent No. 4,733,665 (“Palmaz”) at 1:66-2:1; Ex. 1009, U.S. Patent No.
`
`4,994,032 (“Sugiyama ’032”) at 1:12-29; Ex. 1010, U.S. Patent No. 4,768,507
`
`(“Fischell ’507”) at 1:11-20. In a typical PTCA procedure, the physician
`
`introduces a flexible guide wire into the body through a large vessel such as the
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`femoral artery and advances the guide wire to the treatment area. The physician
`
`can then advance a balloon catheter along the guide wire to the treatment area.
`
`Using radiopaque markers on the balloon segment, the physicians positions the
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`balloon at the treatment area. When the balloon is correctly placed, the physician
`
`inflates and deflates the balloon until the vessel lumen is sufficiently enlarged. See
`
`generally Ex. 1008 at 2:1-5; Ex. 1009 at 1:10-24; Ex. 1003 ¶¶ 11-15.
`
`A typical PTCA catheter, such as shown in U.S. Patent No. 4,964,853
`
`(“Sugiyama ’853”), consists of a catheter and a balloon. The catheter features an
`
`inner tube 1 and a coaxially arranged outer tube 2. Not surprisingly, such catheters
`
`are often referred to as “coaxial catheter.” See generally, Ex. 1011 (Sugiyama
`
`’853) at 2:59-3:11; Ex. 1003 ¶31. The tubes are made of relatively flexible plastics
`
`such as polyethelyene or polyurethane. Ex. 1011 at 3:59-65, 5:3-10.
`
`The balloon, a “contractible or foldable expansible member” 3, has two
`
`openings that allow the catheter to pass through the interior of the balloon. The
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`inner tube of the catheter projects past the end of the outer tube. The balloon is
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`Petition for Inter Partes Review
`U.S. Patent No. 6,712,827
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`positioned so the end of the outer tube is just inside the balloon. At the opening of
`
`the balloon farther from the physician – distal end 7 – the balloon is attached to the
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`inner tube. At the proximal end 8, the balloon is attached to the outer tube. See id.
`
`at 2:59-3:11.
`
`The cylindrical portion of the balloon forms the working length 3a of the
`
`balloon. The Sugiyama ’853 embodiment suggests not one but two radiopaque
`
`marker bands 14, one at either end of the working length. These marker bands
`
`allow the physician to confirm the position of the working length of the balloon in
`
`the body using X-ray imaging. Id. at 6:21-31.
`
`Balloon 3
`(yellow)
`
`Radiopaque
`markers 14
`(red)
`
`Outer tube 2
`(green)
`
`Inner tube 1
`
`
`
`Although PTCA was an effective procedure for treating narrowed blood
`
`vessels, post-operative complications could occur. One of these complications was
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`Petition for Inter Partes Review
`U.S. Patent No. 6,712,827
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`“restenosis,” where the vessel would close back down to a narrower diameter, thus
`
`requiring a repeat PTCA procedure or further surgery. See Ex. 1012, Sigwart et
`
`al., “Intravascular stents to prevent occlusion and restenosis after transluminal
`
`angioplasty,” The New England Journal of Medicine, Vol. 316, No. 12, March 19,
`
`1987, pp. 701-706 (“Sigwart”) at 701; Ex. 1008 at 2:39-63; Ex. 1010 at 1:20-24,
`
`Figs. 1A-1C (illustrating angioplasty and restenosis).) Over time, surgeons
`
`developed the implantable, expandable “stent” to prevent restenosis and other
`
`complications. Ex. 1010 at 1:28-38. By 1987, researchers understood that
`
`“intravascular stents may provide a useful approach to preventing both acute
`
`occlusion and late restenosis” in human patients. Ex. 1012 at 701; Ex. 1008 at
`
`2:64-3:17. By delivering a stent to the treatment location, and then expanding it to
`
`the desired diameter, the stent would provide structural support for a mechanically
`
`dilated vessel and “prevent[] the body passageway from collapsing and decreasing
`
`the size of the expanded lumen.” Ex. 1008 at 3:7-17, 3:52-65.
`
`As of 1996, the prior art taught the use of both self-expanding and balloon-
`
`expandable metal stents. Id. at 7:44-62; Ex. 1013, U.S. Patent No. 5,639,274
`
`(“Fischell ‘274”) at 2:44-46. Physicians used both types of stent in conjunction
`
`with PTCA procedures, delivering them to the treatment site on delivery catheters.
`
`They differed primarily in their method of deployment. As illustrated in U.S.
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`Petition for Inter Partes Review
`U.S. Patent No. 6,712,827
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`Patent No. 5,026,377 (“Burton”), below, a typically deploys a self -expanding stent
`
`by advancing the contracted stent 10, enclosed in a sheath 1, to the treatment site
`
`and then retracting the sheath. As the sheath retracts, the stent expands to hold the
`
`arterial wall out to a pre-determined diameter. Ex. 1014, Burton at 6:37-39, Fig. 1
`
`(below).
`
`To deploy a balloon-expandable stent, a physician places a stent that has
`
`been crimped onto a PTCA balloon at the treatment site and then inflates the
`
`balloon, thereby expanding the stent and pushing out the arterial wall. See
`
`Ex. 1015, Japanese Publication No. H4-64367 with English translation and
`
`certification of translation (“Olympus”) at 1 (“The stent is simultaneously
`
`expanded together with the balloon dilator.”); Ex. 1013, Fig. 7F (reproduced
`
`below).
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`Petition for Inter Partes Review
`U.S. Patent No. 6,712,827
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`
`
`Both types of stent were well-known to practitioners, and while one type
`
`might be more appropriate “for a particular vascular application” than the other,
`
`many procedures could be done with either type of stent. Ex. 1013 at 2:44-46; Ex.
`
`1008 at 1:12-17; Ex. 1010 at 2:54-56. Several prior art references, including
`
`Ravenscroft, Jendersee, and Fischell ’274, for example, disclosed delivery systems
`
`designed to deliver both balloon-expandable and self-expandable stents. Ex. 1017
`
`U.S. Patent No. 5,702,418 (“Ravenscroft”) at Figs. 1, 4; Ex. 1013 at 2:44-46; Ex.
`
`1016, U.S. Patent No. 5,836,965 (“Jendersee”) at 4:7-8; see also Ex. 1010 at 4:53-
`
`54 (teaching use of angioplasty balloon to “more firmly imbed” a deployed self-
`
`expanding stent.)
`
`
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`Petition for Inter Partes Review
`U.S. Patent No. 6,712,827
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`Stent Delivery System Design Considerations
`
`2.
`Although they differed in deployment mechanisms, self-expanding and
`
`balloon-expandable stent delivery catheters shared many common design
`
`considerations. It was important that the delivery device have a small diameter or
`
`profile that could pass through a smaller entry incision and the constrained arterial
`
`lumens. The device had to be flexible so that it could navigate the sometimes
`
`tortuous arteries. Ex. 1003, ¶ 38. And a tapered distal tip assisted navigating past
`
`obstructions. See Ex. 1013 at 7:60-8:4; Ex. 1008 at 7:53-59.
`
`Another design requirement common to both self-expanding and balloon
`
`expandable stent delivery systems was that the stent remain securely attached to
`
`the delivery system while it was being advanced through a blood vessel to the
`
`treatment site. See Ex. 1013 at 2:36-39; Ex. 1016 at 2:49-3:10; Ex. 1008 at 7:53-
`
`59; Ex. 1017 at 1:44-65. Early delivery systems included an outer sheath
`
`surrounding the stent for a self-expanding stent, or an uninflated balloon that a
`
`balloon-expandable stent could be crimped onto, both of which assisted in keeping
`
`the stent on the catheter. Nonetheless, there was a risk that the stent might be
`
`displaced on the delivery catheter such that accurate placement of the stent was
`
`impaired or even separated from the catheter prematurely entirely. See Ex. 1016 at
`
`2:49-66; Ex. 1018, Veldhuijzen et al., “Retrieval of undeployed stents from the
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`Petition for Inter Partes Review
`U.S. Patent No. 6,712,827
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`right coronary artery: report of two cases,” Catheterization and Cardiovascular
`
`Diagnosis 30:245-248 (1993) (“Veldhuijzen”) at 245-477 (documenting
`
`emergency surgery after Palmaz-Schatz stent slipped off the balloon); Ex. 1019,
`
`Foster-Smith et al., “Retrieval techniques for managing flexible intracoronary stent
`
`misplacement,” Catherization and Cardiovascular Diagnosis 30:63-68 (1993)
`
`(“Foster-Smith”) at 66 (noting stent embolization “is reported to occur in up to 8%
`
`of cases in the current literature”); Ex. 1020, Mohiaddin et al., “Localization of a
`
`misplaced coronary artery stent by magnetic resonance imaging,” Clin. Cardiol.
`
`18, 175-177 (1995) (“Mohiaddin”) at 175-76.
`
`By August of 1996, catheter designers had responded to this risk in multiple
`
`ways. For example, Burton taught the use of a “grip member” around the catheter
`
`shaft that used a high friction or moldable material such as silicone rubber to
`
`closely engage a self-expanding stent and prevent it from sliding. Ex. 1014 at
`
`3:29-62. Burton also taught the use of a stop at the distal end of the stent, a
`
`retaining feature that was also taught for use in balloon-expandable stents by U.S.
`
`Patent No. 5,108,416 (“Ryan”). Ex. 1014 at 5:32-35; Ex. 1021 (Ryan) at 5:39-51.
`
`Jendersee taught a different stent securement mechanism, including a method of
`
`“encapsulating” the stent with the balloon by applying pressure to the balloon with
`
`a compacted stent mounted on it. Jendersee, taught that this encapsulation
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`Petition for Inter Partes Review
`U.S. Patent No. 6,712,827
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`technique could be used concurrently with “conventional retainers” similar to those
`
`of Ryan and Burton, located within the balloon at the proximal and distal ends of
`
`the stent could be used. See Ex. 1016 at 3:21-47, 3:58-60, 7:34-54, Fig. 8.
`
`3.
`
`Balloon-Expandable Stents Had Known Advantages and
`Design Challenges Compared to Self-Expanding Stents
`
`Catheter designers pursued both self-expanding and balloon-expandable
`
`stent designs in the prior art, as it was generally understood that one type might be
`
`more appropriate “for a particular vascular application” than the other. Ex. 1013 at
`
`2:44-46. Balloon-expandable stents, however, had certain known design
`
`advantages over self-expanding designs.
`
`First, physicians could exert more control over the diameter of a balloon-
`
`expandable stent during deployment because they could control the inflation of the
`
`balloon, and therefore more closely control the stent. Ex. 1003 ¶142. In contrast, a
`
`self-expanding stent was only capable of one expanded diameter. When the sheath
`
`was withdrawn the unconstrained stent expanded until it rested against the vessel
`
`wall. Id. at ¶ 56. If after the deployment of the self-expanding stent the physician
`
`determined the opening of the vessel was not sufficient, the only way to remedy
`
`this would be to reinsert the angioplasty catheter and perform a supplemental
`
`balloon expansion of the self-expanding stent. See id. at ¶ 45; Ex. 1010 at 4:53-54.
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`Petition for Inter Partes Review
`U.S. Patent No. 6,712,827
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`Moreover, self-expanding stents were often made of “a comparatively fragile,
`
`shape memory metal,” such as Nitinol, whereas a balloon-expandable stent could
`
`be made of a more structurally sound metal such as stainless steel that was
`
`designed to be elastically deformed by the balloon into its expanded shape. Ex.
`
`1013 at 8:46-64; Ex. 1003 ¶¶ 40, 44.
`
`Another key advantage of balloon-expandable stents was the ability to
`
`perform direct stenting. Direct stenting refers to the ability to deliver and deploy
`
`the stent directly from the balloon angioplasty catheter itself instead of having to
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`first remove the angioplasty catheter and then deploy a separate delivery catheter.
`
`A direct stenting delivery system accomplished dilatation and stenting with a
`
`single device and a single inflation, thereby significantly reducing the cost, the
`
`operating time, and the trauma to the patient. See, e.g., Ex. 1003 ¶ 22; Ex. 1013 at
`
`1:25-29 (“Since the patient is typically in some discomfort during such procedures,
`
`it is [] highly advantageous to the patient to make the interventional procedure as
`
`short as possible.”), 2:24. This direct stenting operation using a balloon catheter is
`
`illustrated in Figures 29 through 32 of Olympus:
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`Petition for Inter Partes Review
`U.S. Patent No. 6,712,827
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`Olympus Figs. 29 through 32
`
`
`
`In contrast, a typical self-expanding stent delivery system was designed to
`
`be inserted and placed at the correct location only after the balloon angioplasty
`
`catheter was removed. See Ex. 1010 at 3:23-37, 4:33-351. This use of “separate
`
`catheters for vessel dilatation and for stent delivery” not only “increases the time
`
`and cost for performing interventional procedures,” but could also make stent
`
`placement more difficult because “removing a balloon angioplasty catheter after
`
`balloon dilatation can expose an intimal dissection.” Ex. 1013 at 1:20-29. While
`
`angioplasty balloon catheters that could deliver and deploy a self-expanding stent
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`Petition for Inter Partes Review
`U.S. Patent No. 6,712,827
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`were known, such a catheter required a complicated movable outer sheath to secure
`
`and move the self-expanding stent into the delivery position, increasing the profile
`
`of the catheter and the complexity of its operation. See id. at 6:5-50, Figs. 7A-7E.
`
`Accordingly, balloon-expandable stents were known to have superior
`
`placement, sizing ability, and control during delivery compared to self-expanding
`
`stents, as well as being able to be deployed directly from the angioplasty catheter.
`
`Balloon-expandable stents, however, were more prone to being dislocated or
`
`falling off the delivery catheter during implantation. Some prior art delivery
`
`systems, such as the Palmaz patent, secured the stent using an outer sheath
`
`covering the balloon and the stent itself. While the sheath was an effective
`
`securement mechanism, it had significant disadvantages. As seen in annotated
`
`Figure 3 below, however, this outer sheath significantly increased the profile of the
`
`catheter shaft across its entire length, impeding flexibility and trackability. As
`
`Palmaz Figure 3 suggests, this sheath typically extended proximally from one end
`
`to the other end of the catheter, thus increasing profile along virtually the entire
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`length of the catheter. In addition, using a sheath added an extra step to the
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`delivery procedure, as the sheath would first need to be retracted from the stent
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`before the angioplasty procedure or deployment. Ex. 1008 at 8:20-24; Ex. 1003
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`¶19. There were efforts, therefore, to dispense with a sheath. Id. ¶146.
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`Petition for Inter Partes Review
`U.S. Patent No. 6,712,827
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`Palmaz, for example, taught that a sheath was an optional component of his
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`delivery system. Ex. 1008 at 8:20-24. Removing the sheath, however, raised the
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`question of how to reliably secure the stent. A balloon-expandable stent mounted
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`on a balloon catheter without a sheath presented a difficult compromise in how
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`tightly to crimp the stent to the balloon. On the one hand, crimping the stent
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`tightly onto the balloon and relatively narrow catheter shaft reduced the delivery
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`profile, and could help secure the stent to the catheter, but over crimping could
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`damage the stent, or tear or puncture the balloon, particularly if the balloon were in
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`tight contact between a metal stent and metal marker bands. Ex. 1003 ¶121; Ex.
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`1013 at 7:16-19 (explaining radiopaque marker bands “are typically made from a
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`dense metal”.) On the other hand, loosely crimping the stent helped avoid
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`damaging the balloon and stent, but increased the profile of the delivery catheter
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`and might cause the stent to fall off the balloon during delivery. Olympus, for
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`Petition for Inter Partes Review
`U.S. Patent No. 6,712,827
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`example, taught that metal balloon-expandable stents had exposed sharp edges that
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`risked damaging blood vessels. Ex. 1015 at 1-2. Thus, in light of this teaching, a
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`POSITA would understand that a loosely-crimped balloon-expandable stent, with
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`its exposed sharp edges, carried a significant risk of either losing the stent during
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`delivery due to snagging of the edges of the stent on the blood vessel, and/or
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`damaging the blood vessels the stent was traveling through. Ex. 1003 ¶121. A
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`POSITA would also understand, however, that stent securement mechanisms
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`located inside the balloon could make it possible to have a reliable directly stenting
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`delivery system.
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`B.
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`Summary of the ’827 Patent
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`The ’827 Patent concedes that the use of stents to “prevent restenosis and
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`strengthen the area” in balloon angioplasty procedures, was well known. Ex. 1001
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`at 1:38-40. Likewise, the ’827 Patent concedes that the use of balloon catheters to
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`deliver stents to the correct location and then expand the stent into a deployed
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`condition was also well known. Id. at 1:43-58 (incorporating by reference prior art
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`stent delivery systems.)
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`The ’827 Patent does not claim any novel aspects in the design of the
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`catheter tube, balloon, or balloon expandable stent. See id. at 2:66-3:24. The ’827
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`Patent states that “[a]ny balloon expandable stent may be used with this invention,”
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`U.S. Patent No. 6,712,827
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`and also suggests that it can be used with self-expanding stents, stating that “shape
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`memory metal stents may be used.” Id. at 3:12-18 (noting prior art included
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`“plastic and metal stents”.)
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`Instead, the purported invention of the ’827 Patent is directed to structures
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`located on the catheter shaft and inside the balloon, which are intended to help
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`secure the undeployed stent on the catheter while the delivery system is being used
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`to advance the balloon and stent through a vessel to the treatment site. Id. at 2:11-
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`17. One such structure an “outer tube” or “intermediate layer.”3 As seen in figure
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`2 of the patent, the intermediate layer 30 “is included inside balloon 14 to provide
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`a cushion or substrate of enlarged diameter relative to the stent shaft to support and
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`hold the stent [18] and secure it during crimping and the delivery procedure.” Id.
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`at 3:34-39. This intermediate layer is a cylindrical in shape, takes “the shape of a
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`sleeve carried on inner lumen 26,” and may be made of a hard material, or of a
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`softer, resiliently deformable thermoplastic such as silicone. See id. at 3:42-45,
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`3:55-65.
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`3 This structure is referred to as a “mounting body” in other patents in the ’827
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`Patent family.
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`Petition for Inter Partes Review
`U.S. Patent No. 6,712,827
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`Figure 4 of the ’827 Patent shows a different shape for the intermediate layer
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`
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`30, a “spiral cut elastomer or other suitable material,” with the spiral cut being
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`“only partly through the intermediate layer or may be all the way through as shown
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`in FIG. 4.” Id. at 4:6-13. The ’827 Patent explains that this spiral is intended “to
`
`provide separation for flexibility in that portion of the catheter, allowing more easy
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`movement or tracking around bends.” Id. at 4:9-11.
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`Petition for Inter Partes Review
`U.S. Patent No. 6,712,827
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`
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`The claims of the ’827 Patent are generally directed to systems including a
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`stent delivery system with a balloon catheter, a balloon-expandable stent
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`surrounding the balloon and crimped onto the inner catheter shaft, an intermediate
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`layer with a substantially constant diameter located inside the balloon and
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`surrounding the shaft, and a pair of marking sleeves at the ends of the intermediate
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`layers. Claim 1, reproduced below, is exemplary:
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`1. A balloon catheter for dilating vascular constrictions
`and for simultaneously introducing a deformable stent
`into a vessel to be dilated in order to stabilize the vessel
`in the dilated condition, wherein a distal region of the
`catheter, which is intended to receive the deformable
`stent, comprises:
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`Petition for Inter Partes Review
`U.S. Patent No. 6,712,827
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`an inner tube that is surrounded and crimped onto by the
`deformable stent; a balloon arranged between the
`deformable stent and the inner tube;
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`a pair of longitudinally spaced image sensitive marking
`sleeves carried on the inner tube within the balloon such
`that there is a longitudinal space on the inner tube
`extending between the pair of marking sleeves and such
`that the deformable stent is substantially centered there-
`between;
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`an outer tube disposed between the inner tube and the
`balloon as an intermediate layer, wherein the
`intermediate layer substantially covers the longitudinal
`space on the inner tube between the image sensitive
`marking sleeves,
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`the intermediate layer having an outer diameter, wherein
`the outer diameter of the intermediate layer is
`substantially constant between the pair of marking
`sleeves.
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`As seen above, the preamble of claim 1 recites language that identifies it as a
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`direct stenting system, namely, a “balloon catheter for dilating vascular
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`constrictions and for simultaneously introducing a deformable stent.” Independent
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`claims 16 and 17 claim similar subject matter, with claim 16 additionally reciting
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`that the intermediate layer is “composed of a flexible material.” Several of the
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`Petition for Inter Partes Review
`U.S. Patent No. 6,712,827
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`dependent claims recite additional features of the intermediate layer depicted in
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`Figure 4 above, such as the intermediate layer having a “separation” or “cut” that
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`may be in the form of a spiral. See claims 5 - 12. Other dependent claims recite
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`additional structures on the catheter shaft, such as stop members and marker bands
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`on the catheter shaft. See claims 13, 15. Finally, several other dependent claims
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`are directed to the shape or composition of the intermediate layer, specifying that
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`the intermediate layer be made of an elastic material, that the intermediate layer be
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`cylindrical in shape, or that the intermediate layer have an inner diameter less than
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`the outer diameter of the marking sleeve. See claims 3, 18-20.
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`C.
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`Summary of Relevant Prosecution File History
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`The ’827 Patent claims priority to U.S. Application No. 08/702,150 (the
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`“’150 Application”), which was filed on August 23, 1996, and is the grandparent
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`of the application that resulted in the ’827 patent. The ’827 patent expired on
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`August 23, 2016. Only the relevant portions of the file history are discussed here.
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`During the prosecution of the ’150 Application, the Examiner focused on the
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`prior art that disclosed mounting bodies located on the catheter shaft under the
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`balloon.
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`The Examiner rejected the claims under U.S. Patent No. 5,108,416 (“Ryan”)
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`(Ex. 1021), contending that Ryan disclosed end caps 102 and 104 in excerpted
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`Petition for Inter Partes Review
`U.S. Patent No. 6,712,827
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`Figure 15 below, which were a mounting body carried on the shaft inside the
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`balloon. Ex. 1025 File History of U.S. Patent No. 6,007,543 (“’150 Application”)
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`at 45.
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`
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`The Applicant amended the claims to require the mounting body to be
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`positioned “under the stent and between the first and second ends of the stent.” Id.
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`at 72-79. The Applicant contended that this amendment distinguished Ryan,
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`whose end cups were on either side of the stent, but not under the stent. Id. at 72-
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`74, 76-77. The Applicant never addressed whether Ryan taught spaced stops
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`rather than a mounting body.
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`The Examiner also rejected the claims as obvious over U.S. Pat. No.
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`5,304,198 (“Samson”) (Ex. 1022) in view of Ryan, contending that coil 118 of
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`Samson, seen in Fig. 1A below, was a mounting body located inside the balloon,
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`and that it would have been obvious to add a balloon-expandable stent as taught by
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`Ryan to the Samson catheter. Ex. 1025 at 45.
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`Petition for Inter Partes Review
`U.S. Patent No. 6,712,827
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`In response, the Applicant argued that Samson had a “distinctly different”
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`construction and purpose than the claimed invention, because
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