UNITED STATES PATENT AND TRADEMARK OFFICE
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`
`
`
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`
`
`EDWARDS LIFESCIENCES CORPORATION
`Petitioner
`v.
`
`BOSTON SCIENTIFIC SCIMED, INC.
`Patent Owner
`
`
`
`
` IPR2017-
`Patent 7,749,234
`
`
`
`
`PETITION FOR INTER PARTES REVIEW
`OF U.S. PATENT 7,749,234
`
`
`
`
`
`
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`EDWARDS LIFESCIENCES CORPORATION
`Petitioner
`v.
`
`BOSTON SCIENTIFIC SCIMED, INC.
`Patent Owner
`
`
`
`
` IPR2017-
`Patent 7,749,234
`
`
`
`
`PETITION FOR INTER PARTES REVIEW
`OF U.S. PATENT 7,749,234
`
`
`
`Petition for Inter Partes Review
`U.S. Patent No. 7,749,234
`
`TABLE OF CONTENTS
`
`Contents
`I.
`
`INTRODUCTION ...................................................................................... - 1 -
`
`II. OVERVIEW OF THE ’234 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 ’234 Patent ........................................................... - 11 -
`
`Summary of Relevant Prosecution File History ............................ - 15 -
`
`III. PERSON OF ORDINARY SKILL IN THE ART ................................... - 22 -
`
`IV. PROPOSED CLAIM CONSTRUCTION ................................................ - 23 -
`
`V.
`
`STATEMENT OF THE PRECISE RELIEF REQUESTED AND THE
`REASONS FOR CANCELLATION (37 C.F.R. § 42.22(a) AND 42.104(b))- 24 -
`
`A. Ground 1: Claims 1through 3, 5 through 8, 13, 15, and 18
`through 20 are Obvious over Olympus in View of the
`Knowledge of a POSITA and/or Burton, Fischell ’507,
`Williams, or Fischell ’274 .............................................................. - 26 -
`
`B.
`
`Ground 2: Claims 1-3, 5, 13, 15 and 18-20 are Obvious over
`Fischell ’274 in View of Burton, in Further View of Knowledge
`of a POSITA and/or Williams ........................................................ - 47 -
`
`C. Ground 3: Claims 1, 6 through 8, 13, 15 and 18 through 20 are
`Obvious over Sugiyama ’032 in view of Fischell ’507 and in
`Further View of the Knowledge of a POSITA and/or Williams ... - 61 -
`
`D. Ground 4: Claims 1 through 3, 5, 13, 15, 19, and 20 are
`Anticipated by Ravenscroft and/or Obvious in View of the
`Knowledge of a POSITA and/or Williams .................................... - 75 -
`
`i
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`Petition for Inter Partes Review
`U.S. Patent No. 7,749,234
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`VI. SECONDARY CONSIDERATIONS CANNOT OVERCOME THE
`STRONG EVIDENCE OF OBVIOUSNESS .......................................... - 86 -
`
`VII. REQUIREMENTS FOR INTER PARTES REVIEW ............................... - 87 -
`
`A. Ground for Standing (37 C.F.R. § 42.104(a)) ................................ - 87 -
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`VIII. MANDATORY NOTICES UNDER 37 C.F.R. § 42.8(b) ....................... - 87 -
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`A.
`
`B.
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`C.
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`Real Parties in Interest .................................................................... - 87 -
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`Related Matters ............................................................................... - 87 -
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`Payment of Fees ............................................................................. - 87 -
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`D. Designation of Lead and Back-Up Counsel ................................... - 88 -
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`Power of Attorney .......................................................................... - 88 -
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`Service Information ........................................................................ - 88 -
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`E.
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`F.
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`ii
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`Petition for Inter Partes Review
`U.S. Patent No. 7,749,234
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`EXHIBIT LIST
`
`Exhibit No. Description
`1001
`U.S. Patent 7,749,234 (Patent at Issue)
`1002
`File History of U.S. Patent No. 7,749,234
`1003
`Declaration of Thomas Trotta (“Trotta Decl.”)
`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”)
`U.S. Patent No. 5,445,646 (“Euteneuer”)
`U.S. Patent No. 5,741,323 (“Pathak”)
`
`1021
`1022
`1023
`1024
`1025
`1026
`
`1012
`
`1013
`1014
`1015
`1016
`1017
`
`1018
`
`1019
`
`1020
`
`iii
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`Petition for Inter Partes Review
`U.S. Patent No. 7,749,234
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`Exhibit No. Description
`1027
`U.S. Patent No. 5,437,083 (“Williams”)
`File History of U.S. Application Nos. 08/702,150 (“the ’150
`1028
`Application”)
`1029
`U.S. Patent No. 6,007,543 (“’543 Patent”)
`
`
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`Petition for Inter Partes Review
`U.S. Patent No. 7,749,234
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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, 5
`
`through 8, 13, 15, and 18 through 20 of U.S. Patent No. 7,749,234 (“the ’234
`
`Patent”) in accordance with 35 U.S.C. §§ 311–319 and 37 C.F.R. § 42.100 et seq.
`
`(“Petition”).
`
`The ’234 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 time of the
`
`earliest possible filing to which the ’234 Patent can claim priority, August 23,
`
`1996, the use of catheter-delivered stents in the treatment of vascular disease, and
`
`particularly diseases of the coronary arteries, was well known. A host of
`
`techniques already existed for securing the stent to the catheter. The ’234 Patent
`
`
`
`
`
`1 Citations in the form xx:yy are to the column and line of the ’234 Patent unless
`
`indicated otherwise.
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`- 1 -
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`Petition for Inter Partes Review
`U.S. Patent No. 7,749,234
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`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 ’234 Patent claims should be found
`
`unpatentable as anticipated and/or obvious.
`
`II. OVERVIEW OF THE ’234 PATENT
`A.
`Scope and Content of the Art Before August 23, 1996
`
`1. History of Angioplasty and Stents
`The ’062 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
`
`
`
`
`
`2 Although not all of the references discussed in this section are cited in the
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`specific invalidity grounds below, these background references serve “to document
`
`the knowledge that skilled artisans would bring to bear in reading the prior art
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`- 2 -
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`Petition for Inter Partes Review
`U.S. Patent No. 7,749,234
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`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 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
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`as the femoral artery and advances the guide wire to the treatment area. The
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`physician can then advance a balloon catheter along the guide wire to the treatment
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`area. Using radiopaque markers on the balloon segment, the physician positions
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`the balloon at the treatment area. When the balloon is correctly placed, the
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`
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`
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`identified as producing obviousness.” Ariosa Diagnostics v. Verinata Health, Inc.,
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`805 F.3d 1359, 1365 (Fed. Cir. 2015).
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`physician inflates and deflates the balloon until the vessel lumen is sufficiently
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`enlarged. (See generally Ex. 1008 at 2:1-5; Ex. 1009 at 1:10-24; Ex. 1003 ¶¶ 10-
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`11.)
`
`A typical PTCA catheter, such as shown in U.S. Patent No. 4,964,853
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`(“Sugiyama ’853”), consists of a catheter and a balloon. The catheter features an
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`inner tube 1 and a coaxially arranged outer tube 2. Not surprisingly, such catheters
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`are often referred to as a “coaxial catheter.” See generally, Ex. 1011, U.S. Patent
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`No. 4,964,853 (“Sugiyama ’853”) at 2:59-3:11; Ex. 1003 ¶ 31. The tubes are made
`
`of relatively flexible plastics such as polyethylene or polyurethane. Ex. 1011 at
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`3:59-65, 5:3-10.
`
`The balloon, a “contractible or foldable expansible member” 3, has two
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`openings that allow the catheter to pass through the interior of the balloon. The
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`inner tube of the catheter projects past the end of the outer tube. The balloon is
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`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
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`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.
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`Petition for Inter Partes Review
`U.S. Patent No. 7,749,234
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`The Sugiyama ’853 embodiment suggests not one but two radiopaque
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`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.
`
`Balloon 3
`(yellow)
`
`Radiopaque
`markers 14
`(red)
`
`Outer tube 2
`(green)
`
`Inner tube 1
`
`
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`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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`“restenosis,” where the vessel would close back down to a narrower diameter, thus
`
`requiring a repeat PTCA procedure or further surgery. See Ex. 1012, Sigwart et
`
`al., “Intravascular stents to prevent occlusion and restenosis after transluminal
`
`angioplasty,” The New England Journal of Medicine, Vol. 316, No. 12, March 19,
`
`1987, pp. 701-706 (“Sigwart”) at 701; Ex. 1008 at 2:39-63; Ex. 1010 at 1:20-24,
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`Figs. 1A-1C (illustrating angioplasty and restenosis). Over time, surgeons
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`Petition for Inter Partes Review
`U.S. Patent No. 7,749,234
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`developed the implantable, expandable “stent” to prevent restenosis and other
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`complications. Ex. 1010 at 1:28-38. By 1987, researchers understood that
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`“intravascular stents may provide a useful approach to preventing both acute
`
`occlusion and late restenosis” in human patients. Ex. 1012 at 701; Ex. 1008 at
`
`2:64-3:17. By delivering a stent to the treatment location, and then expanding it to
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`the desired diameter, the stent would provide structural support for a mechanically
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`dilated vessel and “prevent[] the body passageway from collapsing and decreasing
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`the size of the expanded lumen.” Ex. 1008 at 3:7-17, 3:52-65.
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`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
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`self -expanding stent by advancing the contracted stent 10, enclosed in a sheath 1,
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`to the treatment site and then retracting the sheath. As the sheath retracts, the stent
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`expands to hold the arterial wall out to a pre-determined diameter. Ex. 1014,
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`Burton at 6:37-39, Fig. 1 (below).
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`U.S. Patent No. 7,749,234
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`To deploy a balloon-expandable stent, a physician uses a stent that has been
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`crimped onto a PTCA balloon and using the PTCA catheter, maneuvers the balloon
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`and stent to the treatment site. Once the balloon and stent are in place, the
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`physician inflates the balloon, thereby expanding the stent and pushing out the
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`arterial wall. See Ex. 1015 at 1 (“The stent is simultaneously expanded together
`
`with the balloon dilator.”). Ex. 1013, Fig. 7F (reproduced below) depicts the
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`inflated balloon 23, pushing the stent 15 (visible only as cross-sections of the stent
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`wire) radially outward and into the arterial wall.
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`Petition for Inter Partes Review
`U.S. Patent No. 7,749,234
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`Both types of stent were well-known to practitioners, and while one type
`
`might be more appropriate “for a particular vascular application” than the other,
`
`many procedures could be done with either type of stent. (Ex. 1013 at 2:44-46; Ex.
`
`1008 at 1:12-17; Ex. 1010 at 2:54-56.) Several prior art references, including
`
`Ravenscroft, Jendersee, and Fischell ’274, for example, disclosed delivery systems
`
`designed to deliver both balloon-expandable and self-expandable stents. (Ex.
`
`1017, U.S. Patent No. 5,702,418 (“Ravenscroft”) at Figs. 1, 4; Ex. 1013 at 2:44-46;
`
`Ex. 1016, U.S. Patent No. 5,836,965 (“Jendersee”) at 4:7-8; see also Ex. 1010 at
`
`4:53-54 (teaching use of angioplasty balloon to “more firmly imbed” a deployed
`
`self-expanding stent).)
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`U.S. Patent No. 7,749,234
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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
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`lumens. The device had to be flexible so that it could navigate the sometimes
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`tortuous arteries. (Ex. 1003 ¶ 38.) And a tapered distal tip assisted navigating past
`
`obstructions. (See Ex. 1013 at 7:64-8:4, Ex. 1008 at 7:53-59.)
`
`Another design requirement common to both self-expanding and balloon
`
`expandable stent delivery systems was that the stent remain securely attached to
`
`the delivery system while it was being advanced through a blood vessel to the
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`treatment site. (See Ex. 1013 at 2:36-39; Ex. 1016 at 2:49-3:10; Ex. 1008 at 7:53-
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`59; Ex. 1017 at 1:44-65.) Early delivery systems included an outer sheath
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`surrounding the stent for a self-expanding stent, or an uninflated balloon that a
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`balloon-expandable stent could be crimped onto, both of which assisted in keeping
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`the stent on the catheter. Nonetheless, there was a risk that the stent might be
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`displaced on the delivery catheter such that accurate placement of the stent was
`
`impaired or even separated from the catheter prematurely entirely. (See Ex. 1016
`
`at 2:49-66; Ex. 1018, Veldhuijzen et al., “Retrieval of undeployed stents from the
`
`right coronary artery: report of two cases,” Catheterization and Cardiovascular
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`U.S. Patent No. 7,749,234
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`Diagnosis 30:245-248 (1993) (“Veldhuijzen”) at 245-477 (documenting
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`emergency surgery after Palmaz-Schatz stent slipped off the balloon); Ex. 1019,
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`Foster-Smith et al., “Retrieval techniques for managing flexible intracoronary stent
`
`misplacement,” Catherization and Cardiovascular Diagnosis 30:63-68 (1993)
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`(“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
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`misplaced coronary artery stent by magnetic resonance imaging,” Clin. Cardiol.
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`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
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`shaft that used a high friction or moldable material such as silicone rubber to
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`closely engage a self-expanding stent and prevent it from sliding. (Ex. 1014 at
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`3:29-62.) Burton also taught the use of a stop at the distal end of the stent, a
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`retaining feature that was also taught for use in balloon-expandable stents by U.S.
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`Patent No. 5,108,416 (“Ryan”). (Id. 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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`“encapsulating” the stent with the balloon by applying pressure to the balloon with
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`a compacted stent mounted on it. Jendersee, taught that this encapsulation
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`technique could be used concurrently with “conventional retainers” similar to those
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`Petition for Inter Partes Review
`U.S. Patent No. 7,749,234
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`of Ryan and Burton, located within the balloon at the proximal and distal ends of
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`the stent could be used. (See Ex. 1016 at 3:21-47, 3:58-60, 7:34-54, Fig. 8.)
`
`B.
`
`Summary of the ’234 Patent
`
`The ’234 Patent concedes that the use of stents to “prevent restenosis and
`
`strengthen the area” in balloon angioplasty procedures, was well known. (Ex.
`
`1001, 1:41-44.) Likewise, the ’234 Patent concedes that use of balloon catheters to
`
`deliver stents to the correct location and then expand the stent into a deployed
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`condition was also well known. (Id. at 1:47-63 (incorporating by reference prior
`
`art stent delivery systems).)
`
`The ’234 Patent does not claim any novel aspects in the design of the
`
`catheter tube, balloon, or balloon expandable stent. (See id. at 4:16-41.) The ’234
`
`Patent states that “[a]ny balloon expandable stent may be used with this invention,”
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`and also suggests that it can be used with self-expanding stents, stating that “shape
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`memory metal stents may be used.” (Id. at 9:16-26 (noting prior art included
`
`“plastic and metal stents”).) Instead, the purported invention of the ’234 Patent is
`
`directed to a “mounting body” located on the catheter shaft and inside the balloon,
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`which is intended to help secure the undeployed stent on the catheter while the
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`delivery system is being used to advance the balloon and stent through a vessel to
`
`the treatment site. (Id. at 2:27-29.) The ’234 Patent focuses on a particular
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`Petition for Inter Partes Review
`U.S. Patent No. 7,749,234
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`mounting body configuration seen below in Figure 6. The cylindrical mounting
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`body 30 is located inside balloon 14, and is “made up of a plurality of separate
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`adjacent rings 30a.” (Id. at 5:33-36.) These rings “may be individual bodies
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`carried on the sheath or bodies cut from a cylinder to partially separate them or
`
`fully separate them.” (Id. at 5:36-37.) In a passage added to the specification
`
`during prosecution, the ’234 Patent explains that “at least one separation may be
`
`present between the rings,” such that the separation faces outward toward balloon
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`14, and “noting extends between the separation and the portion of the medical
`
`balloon to which it is exposed.” (Id. at 5:40-47.)
`
`Figure 5 of the ’234 Patent shows a different shape for the mounting body
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`30, a “spiral cut elastomer or other suitable material,” with the spiral cut being
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`“only partly through the mounting body or may be all the way through as shown in
`
`FIG. 5.” (Id. at 5:23-29.) The ’234 Patent explains that this spiral is intended “to
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`Petition for Inter Partes Review
`U.S. Patent No. 7,749,234
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`provide separation for flexibility in that portion of the catheter, allowing more easy
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`movement or tracking around bends.” (Id.)
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`
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`The claims of the ’234 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 being made of a material which
`
`resiliently deforms under radial pressure and including at least one separation in its
`
`circumferential surface that is exposed to the medical balloon. Claim 1,
`
`reproduced below, is exemplary:
`
`1. A stent delivery catheter comprising:
`
`[1.1] an inner shaft, the inner shaft having a proximal
`portion and a distal portion and a center axis, an
`inflatable medical balloon positioned about the distal
`portion of the inner shaft, the medical balloon having an
`expanded state, a contracted state, a proximal end and a
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`Petition for Inter Partes Review
`U.S. Patent No. 7,749,234
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`distal end, wherein the medical balloon can be expanded
`from its contracted state to its expanded state, and
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`[1.2] at least one mounting body secured to the inner
`shaft, inside the medical balloon and around the center
`axis, the mounting body having a length, a
`circumferential surface, wherein the circumferential
`surface is a surface of the mounting body that is
`outermost relative to the center axis and that faces
`radially away from the center axis and toward the
`medical balloon, and
`
`[1.3] having at least one separation in the circumferential
`surface, wherein the at least one separation is exposed to
`a portion of the medical balloon which is located along a
`radial line which extends from the center axis and
`through the separation, the at least one separation being a
`circumferential separation,
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`[1.4] wherein the mounting body is formed of a material
`which resiliently deforms under radial pressure.
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`The dependent claims recite additional features of the mounting body, or
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`other features on the catheter shaft. Several of the dependent claims recite a
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`further limitations relating to the separations, such as a plurality of separations,
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`parallel separations, or separations in the form of a spiral that forms “separate
`
`rings,” or separations that form linearly positioned rings. (See Ex. 1001, claims 2,
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`- 14 -
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`
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`Petition for Inter Partes Review
`U.S. Patent No. 7,749,234
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`3, 5-7.) Claim 18 recites that the mounting body is substantially the same length as
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`the stent, whereas claim 19 recites that the mounting body has a constant outer
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`diameter. Claim 13 recites a stent crimped to the balloon, whereas claim 20
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`similarly recites a “tubular medical device” mounted to the balloon and mounting
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`body. Finally, claim 15 recites marker bands positioned on the catheter shaft
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`proximally and distally of the stent.
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`C.
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`Summary of Relevant Prosecution File History
`
`The ’234 Patent claims priority to two applications filed on August 23, 1996:
`
`U.S. Application No. 08/702,150 (“the ’150 Application”), which issued as U.S.
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`Patent No. 6,007,543, and U.S. Application No. 08/697,453, which was
`
`abandoned. The ’234 Patent expired on August 23, 2016. Only the relevant
`
`portions of the file history are discussed here.
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`During prosecution of the ’150 Application, the Examiner focused on the
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`prior art that disclosed mounting bodies located on the catheter shaft under the
`
`balloon. The Examiner rejected the claims under U.S. Patent No. 5,108,416
`
`(“Ryan”) (Ex. 1021), contending that Ryan disclosed end caps 102 and 104 in
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`excerpted Figure 15 below, which were a mounting body carried on the shaft
`
`inside the balloon. Ex. 1028, File History of U.S. Application Nos. 08/702,150
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`(“the ’150 Application”) at 45.
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`- 15 -
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`
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`Petition for Inter Partes Review
`U.S. Patent No. 7,749,234
`
`
`
`Applicant amended the claims to require the mounting body to be positioned
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`“under the stent and between the first and second ends of the stent.” Id. at 72-79.
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`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 rejected the claims as obvious over U.S. Pat. No. 5,304,198
`
`(“Samson”) 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. Id. at 45.
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`
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`- 16 -
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`
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`Petition for Inter Partes Review
`U.S. Patent No. 7,749,234
`
`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. 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.
`
`The Examiner asserted that U.S. Patent No. 5,653,691 (“Rupp”) (Ex. 1023)
`
`disclosed a mounting body, built up layer 20, located beneath balloon 35 and stent
`
`100. Id. at 73-74.
`
`The Applicant responded by amending the claims to further require that the
`
`mounting body be “substantially the same length as the stent.” Id. at 81-83. The
`
`
`
`
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`- 17 -
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`
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`Petition for Inter Partes Review
`U.S. Patent No. 7,749,234
`
`Applicant contended that this amendment traversed 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 U.S. Patent No. 5,409,495
`
`(“Osborn”) (Ex. 1024), 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.) 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 amended each independent
`
`
`
`claim 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.)
`
`- 18 -
`
`
`
`Petition for Inter Partes Review
`U.S. Patent No. 7,749,234
`
`With respect to the dependent claims requiring marker bands, the Examiner
`
`asserted obviousness in view of U.S. Pat. No. 5,445,646 (“Euteneuer”)(Ex. 1025).
`
`The Applicant did not directly address or refute this teaching of marker bands, or
`
`dispute that the use of marker bands was well known. Ex. 1028 at 47, 76; see also
`
`id. at 91 (noting but not addressing Euteneuer’s teaching.)
`
`The Examiner then allowed the claims. Id. at 126-130.
`
`The application that resulted in the ’234 Patent was filed on August 26, 2003
`
`as a continuation of U.S. Application No. 10/004,729, which was a continuation-
`
`in-part of the ’150 Application. In response to a restriction requirement at the
`
`outset of prosecution, the Applicant elected the species of Figure 6, and contended
`
`that pending claims 32-35 and 40-52 read on the elected species. (Ex. 1002, File
`
`History of U.S. Patent No. 7,749,234 (“’234 File History”) at 97, 90-91.)
`
`During prosecution, the Applicant and the Examiner focused on U.S. Patent
`
`Nos. 5,344,402 (“Pathak”) and 5,899,882 (“Waksman”) as primary references.
`
`
`
`
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`- 19 -
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`
`
`Petition for Inter Partes Review
`U.S. Patent No. 7,749,234
`
`The Examiner asserted that Pathak disclosed inner shaft 22/23, balloon 24,
`
`flexible sleeve 30 as a mounting body, polymeric stent 36, and marker band 34.
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`(Id. at 107-108.)
`
`
`
`The Applicant argued that Pathak lacked a “mounting body...having at least
`
`one separation” as required by the claims. (Id. at 141 (emphasis in original).) The
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`Applicant did not address the other structures of Pathak that the Examiner
`
`identified.
`
`The Examiner rejected the claims based on two embodiments disclosed by
`
`Waksman. The Examiner first asserted that rings 22 of Waksman Figure 11 were a
`
`mounting body.
`
`
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`- 20 -
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`
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`
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`Petition for Inter Partes Review
`U.S. Patent No. 7,749,234
`
`To distinguish this structure, the Applicant amended the claims to require
`
`the mounting body to be “formed of a material which resiliently deforms under
`
`radial pressure,” and argued that rings 22 of Waksman were not resiliently
`
`deformable because it was not clear what they were made of. (Id. at 577-578, 580-
`
`582.)
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`Subsequently, the Examiner rejected the claims over “rings 286 and 284 as a
`
`mounting body” in Figure 12 of Waksman, contending that ring 286 was made of a
`
`flexible material. (Id. at 605.) The Examiner remained unpersuaded when the
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`Applicant argued that 286 and 284 were “tubes” rather than “rings,” and asserted
`
`that Waksman disclosed circumferential separations between the rings. (See id. at
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`612-615, 647 (“Ring 284 defines two cylindrical outer surfaces parallel to the
`
`longitudinal axis of the device, the outer surface closer to the longitudinal axis of
`
`the device defines two circumferential separations between ring 284 and ring 286
`
`or ring 296.”).)
`
`
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`- 21 -
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`
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`Petition for Inter Partes Review
`U.S. Patent No. 7,749,234
`
`Ultimately, to distinguish Waksman, the Applicant further amended the
`
`claims to recite that the “circumferential surface is a surface of the mounting body
`
`that is outermost relative to the center axis and that faces radially away from the
`
`center axis and toward the medical balloon,” and that the “at least one separation is
`
`exposed to a portion of the medical balloon.” (Id. at 661.)
`
`The Applicant amended the specification to add language similar to the
`
`allowable claim amendment above, explaining that this was intended to “clarify the
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`language of ‘exposed to a portion of the medical balloon….’” (Id. at 697-698.)
`
`The Examiner then allowed the claims. (Id. at 739.) The ’234 Patent issued on
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`July 6, 2010.
`
`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
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`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 ’234 Patent (August 23, 1996) would have had an undergraduate
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`degree in science in mechanical, manufacturing, or material science engineering, as
`
`well as at least five years’ experience in designing minimally invasive catheter-
`
`- 22 -
`
`
`
`Petition for Inter Partes Review
`U.S. Patent No. 7,749,234
`
`based interventions. 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
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`industry in designing minimally invasive catheter-base
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