UNITED STATES PATENT AND TRADEMARK OFFICE
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`
`
`
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`EDWARDS LIFESCIENCES CORPORATION
`
`Petitioner
`
`v.
`
`BOSTON SCIENTIFIC SCIMED, INC.
`
`Patent Owner
`
`
`
`IPR2017-
`Patent 6,371,962
`Filing Date: October 19, 1999
`Issue Date: April 16, 2002
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`
`
`
`
`
`PETITION FOR INTER PARTES REVIEW
`OF U.S. PATENT 6,371,962
`
`
`
`
`
`
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`EDWARDS LIFESCIENCES CORPORATION
`
`Petitioner
`
`v.
`
`BOSTON SCIENTIFIC SCIMED, INC.
`
`Patent Owner
`
`
`
`IPR2017-
`Patent 6,371,962
`Filing Date: October 19, 1999
`Issue Date: April 16, 2002
`
`
`
`
`
`
`PETITION FOR INTER PARTES REVIEW
`OF U.S. PATENT 6,371,962
`
`
`
`Petition for Inter Partes Review
`U.S. Patent No. 6,371,962
`
`TABLE OF CONTENTS
`
`I.
`
`INTRODUCTION ........................................................................................... 1
`
`II. OVERVIEW OF THE ’962 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 ........................... 9
`
`B.
`
`C.
`
`Summary of the ’962 Patent ................................................................ 11
`
`Summary of Relevant Prosecution File History ................................. 15
`
`III. PERSON OF ORDINARY SKILL IN THE ART .................................... 22
`
`IV. PROPOSED CLAIM CONSTRUCTION ..................................................... 23
`
`1.
`
`2.
`
`3.
`
`“expandable inflatable means” ................................................. 24
`
`“mounting and retaining means” .............................................. 24
`
`“means for inflating the balloon” .............................................. 25
`
`V.
`
`STATEMENT OF THE PRECISE RELIEF REQUESTED AND THE
`REASONS FOR CANCELLATION (37 C.F.R. § 42.22(a) AND 42.104(b))25
`
`A. Ground 1: Claims 1 through 3, 6 through 8, 11 through 13, 20
`through 22, 25, 26, 29, 30, 35, and 36 are Unpatentable as
`Obvious over Olympus in View of the Knowledge of a
`POSITA and/or Burton, Fischell ’274, and/or Fischell ’507 .............. 27
`
`B.
`
`Ground 2: Claims 1 through 3, 6, 11 through 13, 20 through 22,
`25, 29, 30, 35, and 36 are Unpatentable as Obvious over
`Fischell ’274 in View of Burton .......................................................... 52
`
`C. Ground 3: Claims 1 through 3, 6, 12, 20 through 22, and 30 are
`Anticipated by Ravenscroft ................................................................. 71
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`Petition for Inter Partes Review
`U.S. Patent No. 6,371,962
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`D. Ground 4: Claims 9, 10, 13, 27, and 28 are Unpatentable as
`Obvious over References in Grounds 1 and 2 in Further View
`of Jendersee ......................................................................................... 82
`
`E.
`
`Ground 5: Claim 8 is Unpatentable as Obvious over References
`in Grounds 1 through 3 in Further View of the Knowledge of a
`POSITA and/or Burton, Fischell ’274, Fischell ’507 and/or
`Williams .............................................................................................. 84
`
`VI. SECONDARY CONSIDERATIONS CANNOT OVERCOME THE
`STRONG EVIDENCE OF OBVIOUSNESS ............................................... 87
`
`VII. REQUIREMENTS FOR INTER PARTES REVIEW .................................... 87
`
`A. Ground for Standing (37 C.F.R. § 42.104(a)) ..................................... 88
`
`VIII. MANDATORY NOTICES UNDER 37 C.F.R. § 42.8(b) ............................ 89
`
`A.
`
`B.
`
`C.
`
`Real Parties in Interest ......................................................................... 89
`
`Related Matters .................................................................................... 89
`
`Payment of Fees .................................................................................. 89
`
`D. Designation of Lead and Back-Up Counsel ........................................ 89
`
`Power of Attorney ............................................................................... 90
`
`Service Information ............................................................................. 90
`
`E.
`
`F.
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`Petition for Inter Partes Review
`U.S. Patent No. 6,371,962
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`EXHIBIT LIST
`
`Exhibit No. Description
`
`1001
`
`1002
`
`1003
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`1004
`
`1005
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`1006
`
`1007
`
`1008
`
`1009
`
`1010
`
`1011
`
`1012
`
`1013
`
`1014
`
`1015
`
`1016
`
`1017
`
`U.S. Patent No. 6,371,962 (Patent at Issue)
`
`File History of U.S. Patent No. 6,371,962
`
`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. 6,371,962
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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. 5,409,495 (“Osborn”)
`
`File History of U.S. Patent No. 6,007,543 (“’150 Application”)
`
`U.S. Patent No. 5,445,646 (“Euteneuer”)
`
`U.S. Patent No. 5,741,323 (“Pathak”)
`
`U.S. Patent No. 5,437,083 (“Williams”)
`
`U.S. Patent No. 5,158,548 (“Lau”)
`
`U.S. Patent No. 5,364,354 (“Walker”)
`
`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. 6,371,962
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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, 6
`
`through 13, 20 through 22, 25 through 30, 35, and 36 of U.S. Patent No. 6,371,962
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`(“the ’962 Patent”) in accordance with 35 U.S.C. §§ 311–319 and 37 C.F.R. §
`
`42.100 et seq. (“Petition”).
`
`The ’962 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 at 2:3-61. By the ’962 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 ’962 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 ’962 Patent unless
`
`indicated otherwise.
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`Petition for Inter Partes Review
`U.S. Patent No. 6,371,962
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`attachment techniques. As a result, the challenged claims of the ’962 Patent claims
`
`should be found unpatentable as anticipated and/or obvious.
`
`II. OVERVIEW OF THE ’962 PATENT
`A.
`Scope and Content of the Art Before August 23, 1996
`
`1. History of Angioplasty and Stents
`The ’962 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. ¶ 33.2 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).
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`Petition for Inter Partes Review
`U.S. Patent No. 6,371,962
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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
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`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. ¶¶ 10, 21.
`
`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 a “coaxial catheter.” See generally, Ex. 1011, U.S. Patent
`
`No. 4,964,853 (“Sugiyama ’853”) at 2:59-3:11; Ex. 1003 (Trotta Decl.) ¶ 30. The
`
`tubes are made of relatively flexible plastics such as polyethylene or polyurethane.
`
`Ex. 1011 (Sugiyama ’853) at 3:59-65, 5:3-10.
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`Petition for Inter Partes Review
`U.S. Patent No. 6,371,962
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`The balloon, a “contractible or foldable expansible member” 3, has two
`
`openings that allow the catheter to pass through the interior of the balloon. Ex.
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`1003 ¶ 30. The inner tube of the catheter projects past the end of the outer tube.
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`The balloon is 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
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`outer tube. Ex. 1011 at 2:59-3:3. The cylindrical portion of the balloon forms the
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`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
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`allow the physician to confirm the position of the working length of the balloon in
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`the body using X-ray imaging. Id. at 6:21-31.
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`U.S. Patent No. 6,371,962
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`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. Ex. 1003 ¶ 31. One of these
`
`complications was “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
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`Petition for Inter Partes Review
`U.S. Patent No. 6,371,962
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`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
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`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
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`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. 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 figure 1
`
`of 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 (below).
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`Petition for Inter Partes Review
`U.S. Patent No. 6,371,962
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`To deploy a balloon-expandable stent, a physician uses a stent that has been
`
`crimped onto a PTCA balloon and using the PTCA catheter, maneuvers the balloon
`
`and stent to the treatment site. Once the balloon and stent are in place, the
`
`physician 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) at Fig. 7F (reproduced below) depicts the inflated balloon 23, pushing the
`
`stent 15 (visible only as cross-sections of the stent wire) radially outward and into
`
`the arterial wall.
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`Petition for Inter Partes Review
`U.S. Patent No. 6,371,962
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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, 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 (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. 6,371,962
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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.) ¶¶ 10-13. And a tapered distal tip
`
`assisted navigating past obstructions. See Ex. 1013 (Fischell ’274) at 7:63-8:4;
`
`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 7:53-59; Ex. 1017 (Ravenscroft) 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. See Ex.
`
`1003 ¶ 39. 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
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`Petition for Inter Partes Review
`U.S. Patent No. 6,371,962
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`separated 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.
`
`By August of 1996, catheter designers had responded to this risk in multiple
`
`ways. See Ex. 1003 ¶ 40. 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,
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`Petition for Inter Partes Review
`U.S. Patent No. 6,371,962
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`including a method of “encapsulating” the stent with the balloon by applying
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`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 could be used. See Ex. 1016 (Jendersee) at
`
`3:21-47, 3:58-60, 7:34-54, Fig. 8.
`
`B.
`
`Summary of the ’962 Patent
`
`The ’962 Patent concedes that the use of stents to “prevent restenosis and
`
`strengthen the area” in balloon angioplasty procedures, was well known. Ex. 1001
`
`at 1:37-40. Likewise, the ’962 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 1:40-58 (incorporating by reference prior art
`
`stent delivery systems.)
`
`The ’962 Patent does not claim any novel aspects in the design of the
`
`catheter tube, balloon, or balloon expandable stent. See 2:66-3:24. The ’962
`
`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 3:13-20 (noting prior art included
`
`“plastic and metal stents”.) Instead, the purported invention of the ’962 Patent
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`Petition for Inter Partes Review
`U.S. Patent No. 6,371,962
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`involves a “mounting body” structure located on the catheter shaft and 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 2:10-16. As seen in figure 2 of the patent, 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 3:33-38. This
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`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 3:42-44,
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`3:55-65.
`
`Figure 4 of the ’962 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 4:6-13. The ’962 Patent explains that this spiral is intended “to
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`Petition for Inter Partes Review
`U.S. Patent No. 6,371,962
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`provide separation for flexibility in that portion of the catheter, allowing more easy
`
`movement or tracking around bends.” Id. at 4:9-11.
`
`The claims of the ’962 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. Claim 1, reproduced below, is exemplary:
`
`1. A stent delivery system for carrying and delivering a
`stent having a first end and a second end and a contracted
`state and an expanded state, the system comprising:
`
`a catheter having a shaft having a diameter and
`expandable inflatable means associated therewith at a
`distal part of the shaft and
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`including mounting and retaining means for receiving the
`stent on the expandable inflatable means whereby the
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`Petition for Inter Partes Review
`U.S. Patent No. 6,371,962
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`stent is radially expanded upon inflation of the inflatable
`means, the mounting and retaining means including at
`least one mounting body,
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`the at least one mounting body having a length and an
`outer surface diameter and being carried on and
`surrounding the shaft inside the inflatable means whereby
`the diameter of the shaft is increased at the distal part for
`facilitating the mounting and retaining of the stent and
`wherein, when the stent is mounted on the catheter, the at
`least one mounting body is between the stent and the
`shaft,
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`the outer surface diameter of the at least one mounting
`body being substantially constant along its length.
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`Independent claims 20 and 35 claim similar subject matter, with claim 35
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`additionally reciting that the mounting body is “at least 2/3 the length of the stent.”
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`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
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`separation in the form of a spiral. See claims 6-7, 25-26. Other dependent claims
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`recite additional structures on the catheter shaft, such as stop members and marker
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`bands on the catheter shaft. See claims 9-11, 13, 27-29. Finally, several other
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`dependent claims are directed to the shape or composition of the mounting body,
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`Petition for Inter Partes Review
`U.S. Patent No. 6,371,962
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`specifying that the mounting body be made of a resiliently deformable material
`
`such as an elastomer, that the mounting body be uniformly cylindrical in shape, or
`
`the mounting body be composed of only one layer of material. See claims 2, 3, 20-
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`23, 30, 36.
`
`C.
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`Summary of Relevant Prosecution File History
`
`The ’962 Patent claims priority to U.S. Application No. 08/702,150 (the
`
`“’150 Application”), which was filed on August 23, 1996. The ’962 Patent expired
`
`on August 23, 1996. Only the relevant portions of the file history are discussed
`
`here.
`
`During the prosecution of the ’150 Application, 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. Patent No. 6,007,543 (“’150 Application”) at 45.
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`Petition for Inter Partes Review
`U.S. Patent No. 6,371,962
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`
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`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
`
`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
`
`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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`Petition for Inter Partes Review
`U.S. Patent No. 6,371,962
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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.
`
`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
`
`(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.
`
`
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`Petition for Inter Partes Review
`U.S. Patent No. 6,371,962
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`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 4-5.
`
`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 “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
`
`(1/1/99 Response). The Applicant further contended that the amended claims
`
`distinguished over Osborn because they required mounting bodies inside the
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`Petition for Inter Partes Review
`U.S. Patent No. 6,371,962
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`balloon, and Osborn had only elastic restraining bands located on the outside of a
`
`balloon. See id. at 108-110.
`
`The prosecution of the ’150 Application 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), at 76 (3/31/98 Action); see also id. at 91 (7/31/98
`
`Amendment and Remarks) (noting but not addressing Euteneuer’s teaching).
`
`On May 10, 1999, the Examiner issued a Notice of Allowability for the ’150
`
`Application, 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.)
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`Petition for Inter Partes Review
`U.S. Patent No. 6,371,962
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`The application that resulted in the ’962 Patent was filed on October 19,
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`1999 as a continuation of the ’150 Application. During prosecution, the Examiner
`
`again cited Ryan, Samson, and Rupp as primary references, in addition to new
`
`references U.S. Patent Nos. 5,158,548 (“Lau”) (Ex. 1029), and 5,364,354
`
`(“Walker”) (Ex. 1030).
`
`The Applicant distinguished over Ryan and Samson with similar arguments
`
`as it made in the ’150 Application, contending that Samson’s narrow coil design
`
`was not appropriate for use as a stent mounting body, and that Ryan’s end cups
`
`were not located under the stent when the stent was loaded onto the balloon. See
`
`Ex. 1002 File History of U.S. Patent No. 6,371,962 (“’962 File History”) at 63-66
`
`(8/15/00 Action); 76, 80, 82-84 (11/20/00 Response).
`
`The Examiner contended that Lau in view of Walker disclosed a mounting
`
`body in the shape of a spiral because it would have been obvious to “modify the
`
`shape of the[sic] Lau’s marker with a coil configuration as taught by Walker, since
`
`it is a matter of design for art recognized equivalents.” Id. at 67 (8/15/00 Action).
`
`Coiled marker 62 is seen below in Figure 2 of Walker.
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`Petition for Inter Partes Review
`U.S. Patent No. 6,371,962
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`
`
`In traversing this rejection, the Applicant argued that a marker band would
`
`not be suitable for a stent mounting body because “marker bands are quite thin and
`
`would not increase the diameter of the shaft to facilitate mounting and retaining of
`
`the stent.” Id. at 80-81 (11/20/00 Response.) The Applicant did not address
`
`whether a coiled mounting body configuration was an obvious design choice. Id.
`
`at 86.
`
`With respect to Rupp, the Examiner again asserted that Rupp’s built-up
`
`section under the balloon was a mounting body. Id. at 93 (2/8/01 Action). The
`
`Examiner also asserted that Rupp in view of Ryan, taught either a mounting body
`
`with separations, or a mounting body used in conjunction with stops, because
`
`Ryan’s stops that “could be considered as part of the mounting and retaining means
`
`or the second and third mounting bodies since the stops [are] being used to mount
`
`and retain the stent on the catheter.” Id. at 94. In response, the Applicant amended
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`Petition for Inter Partes Review
`U.S. Patent No. 6,371,962
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`claims 1 and 203 to require the mounting body to have a “substantially constant”
`
`outer surface diameter, contending that the built-up layer of Rupp lacked this
`
`feature. Id. at 102, 104, 106 (6/7/01 Response). The Applicant also amended
`
`claim 35 to recite that the mounting body was “at least 2/3 the length of the stent,”
`
`contending that Rupp only disclosed a mounting body at most ½ the length of the
`
`stent. Id. at 127-130 (11/20/01 Response).
`
`As with the parent application, the Applica
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