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 6,007,543
`Filing Date: August 23, 1996
`Issue Date: December 28, 1999
`
`
`
`
`
`
`PETITION FOR INTER PARTES REVIEW
`OF U.S. PATENT 6,007,543
`
`

`

`Petition for Inter Partes Review
`U.S. Patent No. 6,007,543
`
`TABLE OF CONTENTS
`
`I. 
`
`INTRODUCTION ........................................................................................... 1 
`
`II.  OVERVIEW OF THE ’543 PATENT ............................................................ 2 
`
`A. 
`
`Scope and Content of the Art Before August 23, 1996 ........................ 2 
`
`1. 
`
`2. 
`
`History of Angioplasty and Stents .............................................. 2 
`
`Stent Delivery System Design Considerations ........................... 8 
`
`B. 
`
`C. 
`
`Summary of the ’543 patent ................................................................ 10 
`
`Summary of Relevant Prosecution File History ................................. 13 
`
`III.  PERSON OF ORDINARY SKILL IN THE ART ........................................ 17 
`
`IV.  PROPOSED CLAIM CONSTRUCTION ..................................................... 17 
`
`A. 
`
`B. 
`
`C. 
`
`“expandable inflatable means” ............................................................ 19 
`
`“mounting and retaining means” ......................................................... 19 
`
`“means for inflating the balloon” ........................................................ 19 
`
`V. 
`
`STATEMENT OF THE PRECISE RELIEF REQUESTED AND THE
`REASONS FOR CANCELLATION (37 C.F.R. § 42.22(A) AND
`42.104(B)) ...................................................................................................... 20 
`
`A.  Ground 1: Claims 1 through 3, 6, 7, 11, 12, 19 through 21, 24,
`25, 28, and 29 are Unpatentable as Obvious over Olympus in
`View of the Knowledge of a POSITA and/or Burton, Fischell
`’274, and/or Fischell ’507 ................................................................... 22 
`
`B. 
`
`Ground 2: Claims 1 through 3, 6, 11, 12, 19 through 21, 24, 28,
`and 29 are Unpatentable as Obvious over Fischell ’274 in View
`of Burton .............................................................................................. 40 
`
`C.  Ground 3: Claims 1, 2, 6, 7, 11, 19, 20, 24, 25, 28, and 29 are
`obvious over Sugiyama ’032 in view of Fischell ’507 ....................... 55 
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`Petition for Inter Partes Review
`U.S. Patent No. 6,007,543
`
`D.  Ground 4: Claims 1 through 3, 11, 19 through 21, 28, and 29
`are Unpatentable as Anticipated by Pathak ......................................... 70 
`
`E. 
`
`F. 
`
`Ground 5: Claims 9, 10, 12, 26, and 27 are Unpatentable as
`Obvious over References in Grounds 1 through 3 in Further
`View of Jendersee ............................................................................... 79 
`
`Ground 6: Claim 8 is Unpatentable as Obvious over
`References in Grounds 1 through 3 in Further View of the
`Knowledge of a POSITA or Williams ................................................ 82 
`
`VI.  SECONDARY CONSIDERATIONS CANNOT OVERCOME THE
`STRONG EVIDENCE OF OBVIOUSNESS ............................................... 84 
`
`VII.  REQUIREMENTS FOR INTER PARTES REVIEW .................................... 84 
`
`A.  Ground for Standing (37 C.F.R. § 42.104(a)) ..................................... 84 
`
`VIII.  MANDATORY NOTICES UNDER 37 C.F.R. § 42.8(B) ........................... 84 
`
`A. 
`
`B. 
`
`C. 
`
`Real Parties in Interest ......................................................................... 84 
`
`Related Matters .................................................................................... 85 
`
`Payment of Fees .................................................................................. 85 
`
`D.  Designation of Lead and Back-Up Counsel ........................................ 85 
`
`Power of Attorney ............................................................................... 86 
`
`Service Information ............................................................................. 86 
`
`E. 
`
`F. 
`
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`Petition for Inter Partes Review
`U.S. Patent No. 6,007,543
`
`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 No. 6,007,543 (Patent at Issue)
`
`File History of U.S. Patent No. 6,007,543
`
`Declaration of Thomas Trotta (“Trotta Decl.”)
`
`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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`

`Petition for Inter Partes Review
`U.S. Patent No. 6,007,543
`
`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. 5,409,495 (“Osborn”)
`
`U.S. Patent No. 5,445,646 (“Euteneuer”)
`
`U.S. Patent No. 5,741,323 (“Pathak”)
`
`U.S. Patent No. 5,437,083 (“Williams”)
`
`1018
`
`1019
`
`1020
`
`1021
`
`1022
`
`1023
`
`1024
`
`1025
`
`1026
`
`1027
`
`
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`Petition for Inter Partes Review
`U.S. Patent No. 6,007,543
`
`I.
`
`INTRODUCTION
`
`Petitioner Edwards Lifesciences Corporation (“Edwards” or “Petitioner”)
`
`respectfully petitions for initiation of inter partes review of claims 1 through 3, 6
`
`through 12, 19 through 21, and 24 through 29 of U.S. Patent No. 6,007,543 (“the
`
`’543 patent”) in accordance with 35 U.S.C. §§ 311–319 and 37 C.F.R. § 42.100 et
`
`seq. (“Petition”).
`
`The ’543 patent is directed to a “mounting body” structure 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, 2:3-6.1) By the ’543 patent
`
`filing date of August 23, 1996, however, 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 ’543 patent adds nothing to this art and the claims of the patent
`
`merely cover known attachment techniques or obvious modifications of known
`
`
`1 Citations in the form xx:yy are to the column and line of the ’543 Patent unless
`
`indicated otherwise.
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`Petition for Inter Partes Review
`U.S. Patent No. 6,007,543
`
`attachment techniques. As a result, the challenged claims of the ’543 patent claims
`
`should be found unpatentable as anticipated and/or obvious.
`
`II. OVERVIEW OF THE ’543 PATENT
`A.
`Scope and Content of the Art Before August 23, 1996
`
`1. History of Angioplasty and Stents
`The ’543 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 has been well known since at least the 1980s. (Ex. 1003, Trotta Decl.
`
`¶ 29.2) In the 1980s, surgeons were using percutaneous transluminal coronary
`
`angioplasty (“PTCA”) to treat atherosclerosis and other forms of coronary
`
`narrowing. (See, e.g., Ex. 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.
`
`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).
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`Petition for Inter Partes Review
`U.S. Patent No. 6,007,543
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`Patent No. 4,768,507 (“Fischell ’507”) at 1:11-20.) In PTCA, 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 physician positions the
`
`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, Palmaz at 2:1-5; Ex. 1009, Sugiyama ’032 at 1:10-24; Ex.
`
`1003, Trotta Decl. ¶ 11.)
`
`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, 2:59-3:11; Ex. 1003, Trotta Dec. ¶ 31.) The tubes are made of relatively
`
`flexible plastics such as polyethylene or polyurethane. (Ex. 1011, Sugiyama ’853,
`
`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
`
`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. 6,007,543
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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
`
`inner tube. At the proximal end 8, the balloon is attached to the outer tube. Id. at
`
`2:59-3:3. The cylindrical portion of the balloon forms the working length 3a of the
`
`balloon. Id. at 5:34-41.
`
`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. 6,007,543
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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, Palmaz at 2:39-63; Ex. 1010,
`
`Fischell ’507 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, Fischell ’507 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,
`
`Sigwart at 701; Ex. 1008, Palmaz 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, Palmaz 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. (Ex. 1008, Palmaz 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
`
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`Petition for Inter Partes Review
`U.S. Patent No. 6,007,543
`
`delivery catheters. They differed primarily in their method of deployment. As
`
`illustrated in U.S. Patent No. 5,026,377 (“Burton”), below, a physician 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, U.S. Patent No. 5,026,377 (“Burton”) at 6:37-39, Fig. 1.
`
`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, Fischell ’274, Fig. 7F
`
`(reproduced below)(inflating balloon 23’ expands stent 15 against the walls of the
`
`artery).)
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`Petition for Inter Partes Review
`U.S. Patent No. 6,007,543
`
`
`
`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, Fischell ’274
`
`at 2:44-46; Ex. 1008, Palmaz at 1:12-17; Ex. 1010, Fischell ’507 at 2:54-56.)
`
`Several prior art referencesndisclose delivery systems designed to deliver both
`
`balloon-expandable and self-expandable stents. (See e.g., Ex. 1017, U.S. Patent
`
`No. 5,702,418 (“Ravenscroft”) at Figs. 1, 4; Ex. 1013, Fischell ’274 at 2:44-46; Ex.
`
`1016, U.S. Patent No. 5,836,965 (“Jendersee”) at 4:7-8; see also Ex. 1010, Fischell
`
`’507 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. 6,007,543
`
`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 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, Trotta Decl. ¶¶ 13, 38.) And a tapered
`
`distal tip assisted navigating past obstructions. (See Ex. 1013, Fischell ’274 at
`
`7:64-8:4; Ex. 1008, Palmaz 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, Fischell ’274 at 2:36-39; Ex. 1016, Jendersee at
`
`2:49-3:10; Ex. 1008, Palmaz at 7:52-59; Ex. 1017, Ravenscroft at 1:44-64.) 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
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`Petition for Inter Partes Review
`U.S. Patent No. 6,007,543
`
`from the catheter prematurely entirely. (See Ex. 1016, Jendersee at 2:49-66;
`
`Ex. 1018, 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”) 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.)
`
`Catheter designers had responded to this risk in multiple ways. 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, Burton 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, Burton at 5:32-35; Ex. 1021, Ryan at 5:39-51.) Jendersee
`
`taught a different stent securement mechanism, including a method of
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`Petition for Inter Partes Review
`U.S. Patent No. 6,007,543
`
`“encapsulating” the stent with the balloon by applying pressure to the balloon with
`
`a compacted stent mounted on it. Jendersee taught that this encapsulation
`
`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. (See Ex. 1016, Jendersee at 3:21-47, 3:58-60, 7:34-54, Fig. 8.)
`
`B.
`
`Summary of the ’543 patent
`
`The ’543 patent concedes that the use of stents to “prevent restenosis and
`
`strengthen the area” in balloon angioplasty procedures, was well known. (Ex.
`
`1001, 1:31-34.) Likewise, the ’543 patent concedes that the use of balloon
`
`catheters to deliver stents to the correct location and then expand the stent into a
`
`deployed condition was also well known. (Id. at 1:34-51 (incorporating by
`
`reference prior art stent delivery systems).)
`
`The ’543 patent does not claim any novel aspects in the design of the
`
`catheter tube, balloon, or balloon expandable stent. (See id. at 2:59-3:16.) The
`
`’543 patent states that “[a]ny balloon expandable stent may be used with this
`
`invention,” and also suggests that it can be used with self-expanding stents, stating
`
`that “shape memory metal stents may be used.” (Id. at 3:6-16 (noting prior art
`
`included “plastic and metal stents”).) Instead, the purported invention of the ’543
`
`patent is directed to a “mounting body” structure located on the catheter shaft and
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`Petition for Inter Partes Review
`U.S. Patent No. 6,007,543
`
`inside the balloon, which is intended to help secure the undeployed stent on the
`
`catheter while the delivery system is being used to advance the balloon and stent
`
`through a vessel to the treatment site. (Id. at 2:3-9.) As seen in figure 2 of the
`
`patent, the mounting body 30 “is included inside balloon 14 to provide a cushion
`
`and/or substrate of enlarged diameter relative to the stent shaft to support and hold
`
`the stent [18] and secure it during crimping and the delivery procedure.” (Id. at
`
`3:27-31.) This mounting body is cylindrical in shape, and may be made of a hard
`
`material or of a softer, resiliently deformable thermoplastic such as silicone. (See
`
`id. at 3:34-38, 3:48-57.)
`
`
`
`Figure 4 of the ’543 patent shows a different shape for the mounting body
`
`30, a “spiral cut elastomer or other suitable material,” with the spiral cut being
`
`“only partly through the mounting body or may be all the way through as shown in
`
`FIG. 4.” (Id. at 3:66-4:6.) The ’543 patent explains that this spiral is intended “to
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`Petition for Inter Partes Review
`U.S. Patent No. 6,007,543
`
`provide separation for flexibility in that portion of the catheter, allowing more easy
`
`movement or tracking around bends.” (Id. at 4:2-4.)
`
`
`
`The claims of the ’543 patent are generally directed to systems including a
`
`stent delivery system with a balloon catheter, a balloon-expandable stent
`
`surrounding the balloon, and at least one mounting body on the catheter, inside the
`
`balloon and surrounding the shaft. Several of the dependent claims recite
`
`additional features of the mounting body depicted in figure 4 above, such as the
`
`mounting body having at least one separation in the form of a spiral. (See id. at
`
`claims 6-7, 24-25.) Other dependent claims recite additional structures on the
`
`catheter shaft, such as stop members and marker bands on the catheter shaft. (See
`
`id. at claims 9-12, 26-28.) Finally, several other dependent claims are directed to
`
`the composition of the mounting body, specifying that the mounting body be made
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`Petition for Inter Partes Review
`U.S. Patent No. 6,007,543
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`of a resiliently deformable material such as an elastomer or silicone. (See id. at
`
`claims 2-5, 20-23.)
`
`C.
`
`Summary of Relevant Prosecution File History
`
`The application that issued as the ’543 patent was filed on August 23, 1996.
`
`The ’543 patent expired on August 23, 2016. Only the relevant portions of the file
`
`history are discussed here.
`
`During prosecution, the examiner rejected the claims over U.S. Patent
`
`No. 5,108,416 (“Ryan”), contending that Ryan disclosed end caps 102 and 104 in
`
`excerpted figure 15 below, which were a mounting body carried on the shaft inside
`
`the balloon. (Ex. 1002, File History of U.S. Patent No. 6,007,543 at 45 (8/20/97
`
`Office Action).)
`
`
`
`To distinguish over Ryan, the applicant amended the claims to require the
`
`mounting body to be positioned “under the stent and between the first and second
`
`ends of the stent.” (Id. at 62-64 (1/20/98 Response).) The applicant contended that
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`Petition for Inter Partes Review
`U.S. Patent No. 6,007,543
`
`this amendment distinguished Ryan, whose end cups were on either side of the
`
`stent, but not under the stent. (Id. at 65-66.)
`
`The examiner also rejected the claims over U.S. Patent No. 5,304,198
`
`(“Samson”), stating that coil 118 of seen in Fig. 1A below, was a mounting body
`
`located inside the balloon, and that it would have been obvious to add a balloon-
`
`expandable stent as taught by Ryan to the Samson catheter. (Id. at 47-48 (8/20/97
`
`Action).)
`
`
`
`The applicant responded that Samson had a “distinctly different”
`
`construction and purpose than the claimed invention, because Samson’s design
`
`used a spring coil in the place of a section of the inner shaft. (Id. at 66-67 (1/20/98
`
`Response).) As a result, Samson taught that the coil should be the same diameter
`
`as the inner shaft. It would not have been obvious to add a stent to the angioplasty
`
`catheter of Samson, due to the increased profile added by the stent, and the risk of
`
`losing a crimped stent because it would not be securely held by the narrow
`
`spring/mesh of Samson. (Id.)
`
`- 14 -
`
`

`

`Petition for Inter Partes Review
`U.S. Patent No. 6,007,543
`
`The examiner cited U.S. Patent No. 5,653,691 (“Rupp”) as having a built up
`
`layer 20, located beneath balloon 35 and stent 100 that is a mounting body within
`
`the claims. (Id. at 73-74 (3/31/98 Action).)
`
`
`
`To overcome Rupp, applicant amended the claims to require that the
`
`mounting body be “substantially the same length as the stent.” (Id. at 84-86.) The
`
`applicant contended that the difference in length between Rupp’s built-up section
`
`and the stent was a patentable distinction. (Id. at 87-88.)
`
`Finally, the examiner rejected the claims under U.S. Patent No. 5,409,495
`
`(“Osborn”), contending that Osborn taught a mounting body, central balloon 30
`
`surrounding the shaft under the expandable inflatable means, elastic sleeve 24. (Id.
`
`at 95-96.) The examiner further contended that configuring stent 25 of Osborn to
`
`be substantially the same length as central balloon 30 was an obvious design
`
`choice. (Id. at 95.)
`
`- 15 -
`
`

`

`Petition for Inter Partes Review
`U.S. Patent No. 6,007,543
`
`Central balloon 30
`
`Stent 25
`
`
`
`
`
`The examiner did, however, state that dependent claim 12, reciting that “the
`
`inflatable means comprises a balloon …” was allowable subject matter. (Id. at 97.)
`
`The applicant therefore distinguished over Osborn by amending the independent
`
`claims to include the allowable subject matter of claim 12, reciting that the
`
`inflatable means “comprises a balloon.” (Id. at 104.) The applicant further
`
`contended that the amended claims distinguished over Osborn because they
`
`required mounting bodies inside the balloon, and Osborn had only elastic
`
`restraining bands located on the outside of a balloon. (See id. at 108-110.)
`
`While the examiner specifically contended that the dependent claims
`
`requiring marker bands were obvious in view of U.S. Pat. No. 5,445,646
`
`(“Euteneuer”) (Ex. 1002 at 47, 76), the applicant did not address or refute
`
`Euteneuer’s teaching of marker bands, or dispute that the use of marker bands was
`
`well known (id. at 91-92 (noting but not addressing Euteneuer’s teaching).
`
`- 16 -
`
`

`

`Petition for Inter Partes Review
`U.S. Patent No. 6,007,543
`
`On May 10, 1999, the examiner issued a Notice of Allowability. (Id. at 127-
`
`28.) The ’543 patent issued on December 28, 1999. (Ex. 1001.)
`
`III. PERSON OF ORDINARY SKILL IN THE ART
`A person of ordinary skill in the art (“POSITA”) is a hypothetical person
`
`presumed to know the relevant prior art. Gnosis S.p.A. v. South Alabama Med. Sci.
`
`Found., IPR2013-00116, Final Written Decision (Paper 68) at 9. Such person is of
`
`ordinary creativity, and not an automaton, and is capable of making inferences and
`
`combining teachings in the prior art. See id. (citing KSR Int’l Co. v. Teleflex Inc.,
`
`550 U.S. 398, 420-21 (2007)). A POSITA at time of the earliest claimed effective
`
`filing date of the ’543 patent (August 23, 1996) would have had an undergraduate
`
`degree in science in mechanical, manufacturing, or material science engineering, as
`
`well as at least five years’ experience in designing minimally invasive catheter-
`
`based interventions. (See Ex. 1003, Trotta Decl. ¶ 79.) With an undergraduate
`
`degree in a different subject matter, one of ordinary skill in the art would have had
`
`five to ten years of experience in the industry in designing minimally invasive
`
`catheter-based interventions.
`
`IV. PROPOSED CLAIM CONSTRUCTION
`Because the ’543 patent has expired, its claim terms are construed under the
`
`Phillips standard, considering the plain meaning of the claim terms to a person of
`
`- 17 -
`
`

`

`Petition for Inter Partes Review
`U.S. Patent No. 6,007,543
`
`ordinary skill in the art, in light of the intrinsic record. In re CSB-System Int’l,
`
`Inc., 832 F.3d 1335, 1341-42 (Fed. Cir. 2016) (citing Phillips v. AWH Corp., 415
`
`F.3d 1303, 1312-15 (Fed. Cir. 2005) (en banc)); In re Rambus Inc., 694 F.3d 42, 46
`
`(Fed. Cir. 2012).
`
`The Patent Owner has asserted the ’543 patent in co-pending district court
`
`litigation against Petitioner. Boston Scientific Corp. v. Edwards Lifesciences
`
`Corp., No. 16-CV-0730-CJC-GJS (C.D. Cal. filed April 19, 2016). In the co-
`
`pending litigation, the Patent Owner has served infringement contentions on
`
`Petitioner, Ex. 1006, and has also proposed Phillips constructions for three claim
`
`terms of the ’543 patent, Ex. 1007. The Patent Owner has asserted that the other
`
`claim terms in the patent should receive their “plain and ordinary meaning,” and
`
`thus has offered no constructions. For the purposes of this IPR only, the Petitioner
`
`has adopted the Patent Owner’s proposed Phillips constructions for the below
`
`terms.3
`
`
`3 The Petitioner reserves its right to pursue other claim constructions of the
`
`identified terms in other proceedings, including the co-pending case in the Central
`
`District of California.
`
`- 18 -
`
`

`

`Petition for Inter Partes Review
`U.S. Patent No. 6,007,543
`
`“expandable inflatable means”
`
`A.
`In the district court, the Patent Owner argued the term “expandable
`
`inflatable means” is “not subject to 35 U.S.C. § 112, ¶ 6.” Ex. 1007 at 2. The
`
`Patent Owner argued the term means “a structure capable of being expanded and
`
`inflated.”
`
`“mounting and retaining means”
`
`B.
`In the district court, the Patent Owner argued the term “mounting and
`
`retaining means” is “not subject to 35 U.S.C. § 112, ¶ 6.” Ex. 1007 at 2. The
`
`Patent Owner argued the term means “a structure on which another structure can
`
`be mounted and retained.”
`
`“means for inflating the balloon”
`
`C.
`In the district court, the Patent Owner argued the term “means for inflating
`
`the balloon” is “subject to 35 U.S.C. § 112, ¶ 6.” Ex. 1007 at 2. The Patent Owner
`
`argued the corresponding structure is “fluid (gas or liquid) from an inflation port
`
`and equivalents thereof.”
`
`Except as set forth above, Petitioner is not offering constructions for any
`
`other claim terms in this IPR Petition. Petitioner is merely applying those other
`
`claim terms as the Patent Owner has applied them in its infringement contentions.
`
`Accordingly, in this petition, Petitioner has identified structure in the prior art that
`
`- 19 -
`
`

`

`Petition for Inter Partes Review
`U.S. Patent No. 6,007,543
`
`is either the same as or similar to the structure of Petitioner’s accused products that
`
`the Patent Owner has alleged satisfy those claim terms.
`
`V.
`
`STATEMENT OF THE PRECISE RELIEF REQUESTED AND THE
`REASONS FOR CANCELLATION (37 C.F.R. § 42.22(a) AND
`42.104(b))
`
`The Office is requested to find that there is a reasonable likelihood that
`
`Edwards will prevail with respect to each of the challenged claims: claims 1-3, 6-
`
`12, 19-21, and 24-29 of the ’543 patent. These claims are taught by the references
`
`identified below, alone or in combination with each other:
`
` Certified English translation of Japanese Patent Publication No. H4-
`
`64367, filed on July 3, 1990 and published on February 28, 1992
`
`(“Olympus”), Ex. 1015;
`
` U.S. Patent No. 5,026,377, filed on August 17, 1990 and issued on
`
`June 25, 1991 (“Burton”), Ex. 1014;
`
` U.S. Patent No. 5,639,274, filed on June 2, 1995 and issued on June
`
`17, 1997 (“Fischell ’274”), Ex. 1013;
`
` U.S. Patent No. 4,994,032, filed on November 29, 1988 and issued on
`
`February 19, 1991 (“Sugiyama ’032”), Ex. 1009;
`
`- 20 -
`
`

`

`Petition for Inter Partes Review
`U.S. Patent No. 6,007,543
`
` U.S. Patent No. 4,768,507, filed on August 31, 1987 and issued on
`
`September 6, 1988 (“Fischell ’507”), Ex. 1010;
`
` U.S. Patent No. 5,741,323, filed on June 7, 1995 and issued on April
`
`21, 1998 (“Pathak”), Ex. 1026;
`
` U.S. Patent No. 5,836,965, filed on June 7, 1995 and issued on
`
`November 17, 1998 (“Jendersee”), Ex. 1016; and
`
` U.S. Patent No. 5,437,083, filed on May 24, 1993 and issued on
`
`August 1, 1995 (“Williams”), Ex. 1027.
`
`Each of the foregoing references is prior art to the August 23, 1996 filing
`
`date of the ’543 patent under pre-AIA section 102(b) of the Patent Statute, except
`
`Fischell ’274, Pathak, and Jendersee, which are prior art under pre-AIA sections
`
`102 (e). With the exception of Burton, none of these references were cited during
`
`prosecution of the ’543 patent.
`
`This petition requests cancellation of the challenged claims on the following
`
`grounds.
`
`- 21 -
`
`

`

`Petition for Inter Partes Review
`U.S. Patent No. 6,007,543
`
`A. Ground 1: Claims 1 through 3, 6, 7, 11, 12, 19 through 21, 24, 25,
`28, and 29 are Unpatentable as Obvious over Olympus in