Petition for Inter Partes Review
`U.S. Patent No. 6,203,558
`
`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 6,203,558
`
`
`
`
`PETITION FOR INTER PARTES REVIEW
`OF U.S. PATENT 6,203,558
`
`
`U.S. Patent No. 6,203,558
`
`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 6,203,558
`
`
`
`
`PETITION FOR INTER PARTES REVIEW
`OF U.S. PATENT 6,203,558
`
`
`
`Petition for Inter Partes Review
`U.S. Patent No. 6,203,558
`
`TABLE OF CONTENTS
`
`Contents
`I.
`
`INTRODUCTION ...................................................................................... - 1 -
`
`II. OVERVIEW OF THE ’558 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 ’558 Patent ........................................................... - 10 -
`
`Summary of Relevant Prosecution File History ............................ - 14 -
`
`III. PERSON OF ORDINARY SKILL IN THE ART ................................... - 20 -
`
`IV. PROPOSED CLAIM CONSTRUCTION ................................................ - 20 -
`
`V.
`
`STATEMENT OF THE PRECISE RELIEF REQUESTED AND THE
`REASONS FOR CANCELLATION (37 C.F.R. § 42.22(a) AND 42.104(b))- 22 -
`
`A. Ground 1: Claims 1, 2, 9, 14, 20, and 21 are Unpatentable as
`Obvious over Olympus in View of the Knowledge of a
`POSITA and/or Burton, Fischell ’274, and/or Fischell ’507 ......... - 24 -
`
`B.
`
`Ground 2: Claims 1, 2, 9, 20, and 21 are obvious over
`Sugiyama ’032 in view of Fischell ’507 ........................................ - 38 -
`
`C. Ground 3: Claims 1 is anticipated by Ravenscroft ........................ - 52 -
`
`D. Ground 4: Claim 14 is Unpatentable as Obvious over
`References in Grounds 1 and 2 in Further View of Jendersee ....... - 58 -
`
`E.
`
`Ground 5: Claim 22 is Unpatentable as Obvious over Ground 4,
`in Further View of the Knowledge of a POSITA or Fischell
`’274. ................................................................................................ - 61 -
`
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`Petition for Inter Partes Review
`U.S. Patent No. 6,203,558
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`VI. SECONDARY CONSIDERATIONS CANNOT OVERCOME THE
`STRONG EVIDENCE OF OBVIOUSNESS .......................................... - 63 -
`
`VII. REQUIREMENTS FOR INTER PARTES REVIEW ............................... - 63 -
`
`A. Ground for Standing (37 C.F.R. § 42.104(a)) ................................ - 63 -
`
`VIII. MANDATORY NOTICES UNDER 37 C.F.R. § 42.8(b) ....................... - 63 -
`
`A.
`
`B.
`
`C.
`
`Real Parties in Interest .................................................................... - 63 -
`
`Related Matters ............................................................................... - 64 -
`
`Payment of Fees ............................................................................. - 64 -
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`D. Designation of Lead and Back-Up Counsel ................................... - 64 -
`
`Power of Attorney .......................................................................... - 64 -
`
`Service Information ........................................................................ - 65 -
`
`E.
`
`F.
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`U.S. Patent No. 6,203,558
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`EXHIBIT LIST
`
`1012
`
`Exhibit No. Description
`1001
`U.S. Patent 6,203,558 (Patent at Issue)
`1002
`File History of U.S. Patent 6,203,558
`1003
`Declaration of Thomas Trotta (“Trotta Declaration”)
`1004
`CV of Thomas Trotta
`1005
`List of Patents Naming Thomas Trotta as an Inventor
`1006
`BSC’s Infringement Contentions
`1007
`BSC’s Proposed Claim Constructions
`1008
`U.S. Patent No. 4,733,665 (“Palmaz”)
`1009
`U.S. Patent No. 4,994,032 (“Sugiyama ’032”)
`1010
`U.S. Patent No. 4,768,507 (“Fischell ’507”)
`1011
`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”)
`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”)
`File History of U.S. Application No. 08/702,150 (“’150
`Application”)
`
`1013
`1014
`1015
`1016
`1017
`
`1018
`
`1019
`
`1020
`
`1021
`1022
`1023
`1024
`1025
`
`iii
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`Petition for Inter Partes Review
`U.S. Patent No. 6,203,558
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`Exhibit No. Description
`1026
`U.S. Patent No. 5,445,646 (“Euteneuer”)
`1027
`U.S. Patent No. 6,007,543 (“Ellis”)
`
`
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`iv
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`Petition for Inter Partes Review
`U.S. Patent No. 6,203,558
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`I.
`
`INTRODUCTION
`
`Petitioner Edwards Lifesciences Corporation (“Edwards” or “Petitioner”)
`
`respectfully petitions for initiation of inter partes review of claims 1 1, 2, 9, 14,
`
`and 20 through 22 of U.S. Patent No. 6,203,558 (“the ’558 Patent”) in accordance
`
`with 35 U.S.C. §§ 311–319 and 37 C.F.R. § 42.100 et seq. (“Petition”).
`
`The ’558 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, 2:3-61). By the ’558 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 ’558 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 challenged claims of the ’558 Patent claims
`
`should be found unpatentable as anticipated and/or obvious.
`
`
`
`1 Citations in the form xx:yy are to the column and line of the ’558 Patent unless
`
`indicated otherwise.
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`Petition for Inter Partes Review
`U.S. Patent No. 6,203,558
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`II. OVERVIEW OF THE ’558 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 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. 1008, U.S. Patent No. 4,733,665 (“Palmaz”) at 1:66-2:1; Ex. 1009, U.S. Patent
`
`
`
`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. 6,203,558
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`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
`
`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, U.S. Patent
`
`No. 4,964,853 (“Sugiyama ’853”),, 2:59-3:11; Ex. 1003, Trotta Decl. ¶ 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
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`Petition for Inter Partes Review
`U.S. Patent No. 6,203,558
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`inner tube of the catheter projects past the end of the outer tube. The balloon is
`
`positioned so the end of the outer tube is just inside the balloon. At the opening of
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`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. Id. at
`
`2:59-3:3. The cylindrical portion of the balloon forms the working length 3a of the
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`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. 6,203,558
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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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` - 5 -
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`Petition for Inter Partes Review
`U.S. Patent No. 6,203,558
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`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. 6,203,558
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`
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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, Fischell ’274
`
`at 2:44-46; Ex. 1008, Palmaz at 1:12-17; Ex. 1010, Fischell ’507 at 2:54-56.)
`
`Several prior art references, including Ravenscroft, Jendersee, and Fischell ’274,
`
`for example, disclose 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, 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
`
` - 7 -
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`self-expanding stent).)
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`Petition for Inter Partes Review
`U.S. Patent No. 6,203,558
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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, 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
`
`from the catheter prematurely entirely. (See Ex. 1016, Jendersee at 2:49-66;
`
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`Petition for Inter Partes Review
`U.S. Patent No. 6,203,558
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`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.)
`
`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,
`
`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 “encapsulating” the stent with the balloon by applying
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`Petition for Inter Partes Review
`U.S. Patent No. 6,203,558
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`pressure to the balloon with a compacted stent mounted on it. Jendersee taught
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`that this encapsulation technique could be used concurrently with “conventional
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`retainers” similar to those of Ryan and Burton, located within the balloon at the
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`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 ’558 Patent
`
`The ’558 Patent concedes that the use of stents to “prevent restenosis and
`
`strengthen the area” in balloon angioplasty procedures, was well known. (Ex.
`
`1001, 1:49-52.) Likewise, the ’558 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 1:52-2:3 (incorporating by
`
`reference prior art stent delivery systems).)
`
`The ’558 Patent does not claim any novel aspects in the design of the
`
`catheter tube, balloon, or balloon expandable stent. (See id. at 9:1-26.) The ’558
`
`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 9:16-26 (noting prior art included
`
`“plastic and metal stents”).) Instead, the purported invention of the ’558 Patent is
`
`directed to structures located on the catheter shaft and inside the balloon, which are
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`Petition for Inter Partes Review
`U.S. Patent No. 6,203,558
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`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 8:18-20.) One such structure is a “mounting body.” The
`
`mounting body 30 “is included inside balloon 14 to provide a cushion or substrate
`
`of enlarged diameter relative to the stent shaft to support and hold the stent [18]
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`and secure it during crimping and the delivery procedure.” (Id. at 9:43-40.) The
`
`mounting body in Figure 7 below is a “two-piece mounting body made up of
`
`spaced mounting bodies 30a and 30b” that are shown interlocking with the stent
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`“so that the stent cannot slide proximally or distally on the balloon until it is
`
`deformed, such as by expansion.” (Id. at 10:27-37.) Figure 7 also depicts a
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`radiopaque marker band 34. (Id. at 9:47-49.) Stop member 36 helps secure the
`
`stent by “provid[ing] additional resistance to stent movement during delivery and
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`[] protect[ing] the leading edge of the stent during delivery.” (Id. at 3:41-47.)
`
`Figure 5 of the ’558 Patent shows a different shape for the mounting body
`
`30, a “spiral cut elastomer or other suitable material,” with the spiral cut being
`
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`Petition for Inter Partes Review
`U.S. Patent No. 6,203,558
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`“only partly through the mounting body or may be all the way through as shown in
`
`FIG. 5.” (Id. at 10:8-15.) The ’558 Patent explains that this spiral is intended “to
`
`provide separation for flexibility in that portion of the catheter, allowing more easy
`
`movement or tracking around bends.” (Id. at 10:9-13.) Figure 5 also shows a
`
`“stop member 36…at the distal end portion of the catheter,” which is intended to
`
`“provide additional resistance to stent movement during delivery and to protect the
`
`leading edge of the stent during delivery.” (Id. at 9:49-54, 10:15-17.)
`
`
`
`The claims of the ’558 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 inside the balloon and
`
`surrounding the shaft, the mounting body including at least one separation. Claim
`
`1, reproduced below, is exemplary:
`
`1. A system/assembly for delivery and deployment of an
`inflation expandable stent within a vessel, comprising:
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`Petition for Inter Partes Review
`U.S. Patent No. 6,203,558
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`a catheter having proximal and distal ends;
`
`a stent, inflation expandable from a delivery diameter to
`a deployment diameter, such that the delivery diameter is
`reduced from the deployment diameter for conforming
`the stent to the catheter, such that the stent, in its delivery
`diameter, is coaxially mounted on the catheter near the
`catheter distal end;
`
`an expandable inflation means coaxially mounted on the
`catheter within the stent, for expansion of the stent from
`the delivery diameter to the deployment diameter upon
`application of deployment pressure to the expandable
`inflation means; and
`
`a mounting and retaining means coaxially mounted on
`the catheter within the expandable inflation means, the
`mounting and retaining means designed and adapted to
`provide a securement for the stent in the delivery
`diameter to maintain the stent in position on the catheter
`during delivery to the deployment site, the catheter
`having a shaft and the expandable inflation means being
`positioned at a distal part of the shaft, the mounting and
`retaining means being positioned for receiving the stent
`on the expandable inflation means for radial expansion of
`the stent upon expansion of the expandable inflation
`means,
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`Petition for Inter Partes Review
`U.S. Patent No. 6,203,558
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`the mounting and retaining means including at least one
`mounting body carried by the shaft inside the expandable
`inflation means whereby the diameter of the shaft and
`expandable inflation means are increased at the distal
`part for facilitating the mounting and retaining of the
`stent,
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`the mounting body including at least one separation,
`whereby the flexibility of the body and catheter is
`increased
`
`The dependent claims recite additional features of the mounting body, or
`
`other features on the catheter shaft. Claims 2 and 21 recite that the mounting body
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`is substantially the same length as the stent. Claim 9 recites that the mounting
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`body separation is “in the form of a spiral,” whereas claim 20 recites that the
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`separation is “substantially along the entire length of the mounting body.” Claim
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`14 recites a stop positioned on the catheter shaft, under the balloon at the distal end
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`of the catheter. Finally, claim 22 recites marker bands positioned on the catheter
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`shaft proximally and distally of the stent.
`
`C.
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`Summary of Relevant Prosecution File History
`
`The ’558 Patent claims priority to three different applications filed on
`
`August 23, 1996: U.S. Application No. 08/702,150 (“’150 Application”), which
`
`issued as U.S. Patent No. 6,007,543, U.S. Application No. 08/701,979, which
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` - 14 -
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`
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`Petition for Inter Partes Review
`U.S. Patent No. 6,203,558
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`issued as U.S. Patent No. 6,395,008, and U.S. Application No. 08/697,453, which
`
`was abandoned. Only the relevant portions of the file history are discussed here.
`
`During prosecution of the ’150 Application, the Applicant and the Examiner
`
`focused on the prior art that disclosed mounting bodies located on the catheter
`
`shaft under the balloon, citing U.S. Patent Nos. 5,108,416 (“Ryan”) (Ex. 1021),
`
`5,304,198 (“Samson”) (Ex. 1022), 5,653,691 (“Rupp”) (Ex. 1023), and 5,409,495
`
`(“Osborn”) (Ex. 1024) as primary references.
`
`The Examiner rejected the claims under 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. 1025 (File History of
`
`U.S. Application No. 08/702,150 (“’150 Application”) at 45 (8/20/97 Action.)
`
`
`
`In traversing 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 72-79, 1/23/98 Response.) The Applicant contended that
`
`this amendment distinguished Ryan, whose end cups were on either side of the
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` - 15 -
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`
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`Petition for Inter Partes Review
`U.S. Patent No. 6,203,558
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`stent, but not under the stent. (Id. at 72-74, 76-77.) The Applicant never addressed
`
`whether Ryan taught spaced stops rather than a mounting body.
`
`The Examiner also rejected the claims as obvious over U.S. Pat. No.
`
`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,
`
`and that it would have been obvious to add a balloon-expandable stent as taught by
`
`Ryan to the Samson catheter. (Ex. 1025 (’150 Application) at 45, 8/20/97 Action.)
`
`
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`In response, the Applicant argued 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 77-78, 1/23/98
`
`Response.) The Applicant argued that Samson taught that the coil should be the
`
`same diameter as the inner shaft, such that it would not have an increased profile
`
`over the catheter shaft. Therefore, 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.)
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` - 16 -
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`
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`Petition for Inter Partes Review
`U.S. Patent No. 6,203,558
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`With respect to Rupp, the Examiner asserted that Rupp disclosed a mounting
`
`body, built up layer 20, located beneath balloon 35 and stent 100. (Id. at 73-74,
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`3/31/98 Action.)
`
`
`
`The Applicant distinguished over Rupp by amending the claims to further
`
`require that the mounting body be “substantially the same length as the stent.” (Id.
`
`at 81-83, 7/31/98 CPA.) The Applicant contended that this amendment
`
`distinguished over Rupp because Rupp’s built-up section was only approximately
`
`one-third the length of the stent. (Id. at 87-88.)
`
`Finally, the Examiner rejected the claims under 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, 10/22/98 Action.)
`
`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.) Notably, the Examiner found that dependent claim 12, reciting that
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` - 17 -
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`
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`Petition for Inter Partes Review
`U.S. Patent No. 6,203,558
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`“the inflatable means comprises a balloon…” was allowable subject matter. (Id. at
`
`97.)
`
`
`
`In accordance with this suggestion, the Applicant 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,
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`1/1/99 Response.) The Applicant further contended that the amended claims
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`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.)
`
`The prosecution did not significantly address the dependent claims. 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. 1026),
`
`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 47, 8/20/97 Action;
`
`76, 3/31/98 Action; see also id. at 91, 7/31/98 Amendment and Remarks (noting
`
`but not addressing Euteneuer’s teaching.)
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` - 18 -
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`
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`Petition for Inter Partes Review
`U.S. Patent No. 6,203,558
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`On May 10, 1999, the Examiner issued a Notice of Allowability, explaining
`
`that:
`
`Claims 1-13 and 20-34 are allowable because the prior
`art of record does not disclose the specific structure and
`relationship as recited in these claims such that a stent
`delivery balloon catheter comprising at least one
`mounting body carried on and surrounding a shaft inside
`an inflatable means for radial expansion of the stent upon
`inflation of the inflation means, and the at least one
`mounting body being substantially the same length as the
`stent and being positioned on the shaft.
`
`(Id. at 126-130, 5/10/99 Notice of Allowability.)
`
`The application that resulted in the ’558 Patent was filed on October 14,
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`1999 as a continuation of U.S. Application No. 08/916,554, which was a
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`continuation-in-part of the ’150 Application. The pending claims were allowed as
`
`preliminarily amended. On September 10, 2000, the Examiner issued a Notice of
`
`Allowability, explaining that “[t]he prior art of record does not disclose a system
`
`having a catheter, a mounting and retaining means with at least one mounting body
`
`which includes at least one separation, an expandable inflation means, a stent and
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`other elements in the claims.” (Ex. 1002, File History of U.S. Patent 6,203,558
`
`(“’558 File History”) at 145, 9/10/00 Notice of Allowability.) The Examiner
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` - 19 -
`
`
`
`Petition for Inter Partes Review
`U.S. Patent No. 6,203,558
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`issued a formalistic amendment which changed “the mounting body configuration
`
`including…” to state “the mounting body including…” in claim 1. (Id.)
`
`The ’558 Patent issued on March 20, 2001, and expired on August 23, 2016.
`
`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.,
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`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
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`five to ten years of experience in the industry in designing minimally invasive
`
`catheter-based interventions. (Id.)
`
`IV. PROPOSED CLAIM CONSTRUCTION
`Because the ’558 Patent has expired, its claim terms are construed under the
`
`Phillips standard, considering the plain meaning of the claim terms to a person of
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` - 20 -
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`
`
`Petition for Inter Partes Review
`U.S. Patent No. 6,203,558
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`ordinary skill in the art, in light of the intrinsic record. In re CSB-System Int’l,
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`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
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`(Fed. Cir. 2012).
`
`The Patent Owner has asserted the ’558 Patent in co-pending district court
`
`litigation against Petitioner. Boston Scientific Corp. v. Edwards Lifesci
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