`
`NITED STATES PATENT AND TRADEMARK OFFICE
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`_________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_________________
`
`MEDTRONIC, INC., AND MEDTRONIC VASCULAR, INC.,
`Petitioner,
`
`v.
`
`TELEFLEX INNOVATIONS S.À.R.L.,
`Patent Owner.
`
`_________________
`
`Case No. IPR2020-00128
`Case No. IPR2020-00129
`Case No. IPR2020-00130
`U.S. Patent No. RE45,380
`_________________
`
`PETITIONER’S OPPOSITION
`TO PATENT OWNER’S MOTION TO AMEND
`
`
`
`Case Nos. IPR2020-00128, -00129, -00130
`U.S. Patent No. RE45,380
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`TABLE OF CONTENTS
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`Page
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`I.
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`II.
`
`Introduction ...................................................................................................... 1
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`Proposed Claim 44 Is Indefinite. ..................................................................... 1
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`III. The Prior Art Renders Proposed Claims 43 and 44 Unpatentable. ................. 1
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`A.
`
`B.
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`Claim Construction................................................................................ 1
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`Substitute claims 43 and 44 are unpatentable over Itou in view of
`Ressemann or Kataishi. ......................................................................... 2
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`1.
`
`2.
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`Substitute Claim 43 ..................................................................... 2
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`Substitute Claim 44 ..................................................................... 4
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`C.
`
`Substitute claims 43 and 44 are unpatentable over Kontos in view
`of Ressemann and Takahashi. .............................................................15
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`1.
`
`2.
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`Substitute Claim 43 ...................................................................15
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`Substitute Claim 44 ...................................................................25
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`D.
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`Combining Kontos with Kataishi for Claim 44 ..................................25
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`IV. Conclusion .....................................................................................................26
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`i
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`Case Nos. IPR2020-00128, -00129, -00130
`U.S. Patent No. RE45,380
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`TABLE OF AUTHORITIES
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` Page(s)
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`Federal Cases
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`KSR Int’l Co. v. Teleflex, Inc.,
`550 U.S. 398 (2007) ............................................................................................ 11
`
`In re Schreiber,
`128 F.3d 1473 (Fed. Cir. 1997) ............................................................................ 4
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`
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`ii
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`Case Nos. IPR2020-00128, -00129, -00130
`U.S. Patent No. RE45,380
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`I.
`
`INTRODUCTION
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`Medtronic, Inc., and Medtronic Vascular, Inc., (“Petitioner”) oppose Patent
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`Owner’s Contingent Motion to Amend (Paper 38, “Mot.”). Patent Owner (“PO”)
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`seeks to amend claims 1 and 12 and proposes substitute claims 43 and 44. (Mot., 1,
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`Appendix A (“App.”).) But the substitute claims are indefinite and unpatentable
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`over the prior art. PO’s Motion should be denied.
`
`II.
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`PROPOSED CLAIM 44 IS INDEFINITE.
`
`Proposed claim 44 recites “a substantially rigid portion . . . connected
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`to . . . the flexible tip portion,” even though the claim recites an intervening
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`“reinforced portion.” (App., 3-5.) 1 Based on the plain meaning of the word
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`“connected,” the claim makes little sense and is indefinite.
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`III. THE PRIOR ART RENDERS PROPOSED CLAIMS 43 AND 44
`UNPATENTABLE.
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`PO’s motion should be denied for another independent reason—the substitute
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`claims are unpatentable over the prior art.
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`A. Claim Construction
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`No express construction for any terms is necessary except that the term
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`“coaxial” means that “the axis of the lumen of the guide extension catheter is aligned
`
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`1 All emphasis and annotations are added unless otherwise specified.
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`1
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`
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`in
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`the same direction as
`
`the axis of
`
`lumen of
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`the guide catheter.”
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`Case Nos. IPR2020-00128, -00129, -00130
`U.S. Patent No. RE45,380
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`(Ex. 1806, ¶¶ 14-26.)
`
`B.
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`Substitute claims 43 and 44 are unpatentable over Itou in view of
`Ressemann or Kataishi.
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`Substitute claims 43 and 44 add to the original claims certain limitations (e.g.,
`
`the so-called “backup support” and “complex side opening”). (Mot., 13, 15.) But
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`these additions cannot overcome the prior art of record. The analysis below focuses
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`on the newly added limitations while briefly addressing the original limitations,
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`which are thoroughly addressed by the original Petitions challenging the ’380 patent
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`and supporting testimonial evidence.
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`1.
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`Substitute Claim 43
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`Itou anticipates claim 43 or renders it obvious in view of Ressemann. Itou
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`discloses a system comprising a suction catheter 2 (“device”) adapted for use with a
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`guiding catheter 1 (“guide catheter”). (Ex. 1007, 5:35-38, 5:43-46, 7:1-23, 7:35-43,
`
`Figs. 5-6, 8.) There is no dispute the guiding catheter 1 is placed in a branch artery
`
`and has a continuous lumen with a proximal end at a hemostatic valve, and
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`interventional cardiology devices can be inserted therethrough. (Ex. 1902, ¶¶ 13-18,
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`49.) Moreover, guiding catheter 1 can be 6 French and has an inner diameter of
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`1.8 mm (0.071 inches). (Ex. 1007, 5:65-67, 6:47-50; Ex. 1902, ¶ 19, 49.)
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`Itou’s suction catheter 2 (i.e. “a device”) includes tubular portion (21) and tip
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`(22) (collectively, “flexible tip portion”) that are part of tubular member (24).
`2
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`U.S. Patent No. RE45,380
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`(Id., 2:12-21, Fig. 3.) Tubular portion 24 (and therefore, flexible tip portion [21,
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`22]) has an inner diameter of 1.5 mm (id., Table 1, 1:59-65), which is larger than
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`0.056 inches (1.42 mm). (Ex. 1902, ¶¶ 20-22.) It is necessarily the case that
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`interventional cardiology devices (e.g., PTCA balloons and stents) were insertable
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`through the lumen of Itou’s “flexible tip portion.” (Ex. 2127, 2; Ex. 1902, ¶¶ 23-36.)
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`The entirety of tubular member 24 (which includes what Medtronic maps as the
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`“flexible tip portion”) is a “coaxial lumen.” (See Section III.A., supra.)
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`Tip 22 (i.e., “flexible cylindrical distal tip portion”) is soft and flexible.
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`(Ex. 1007, 2:12-17; 3:47-50). Tubular portion 21 (i.e., “flexible cylindrical
`
`reinforced portion”) is reinforced. (Id., 2:15-21, 3:50-58.) The distal end of tubular
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`structure 24 (including flexible tip portion [21, 22]) is extended beyond the distal tip
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`of guiding catheter (1) and into the branch artery. (Id., Abstract, 2:66-67, 5:11-25,
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`5:26-46, Figs. 5, 6.) Suction catheter 2 further includes solid-wire portion (25) and
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`the proximal portion of an obliquely cut metal pipe (end 231) (i.e., “substantially
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`rigid portion”) that are proximal of and operably connected to tubular member (24).
`
`(Ex. 1007,
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`3:47-50,
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`4:25-36,
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`2:32-38,
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`5:35-38,
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`5:43-46,
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`Fig. 1B;
`
`Ex. 1902, ¶¶ 37-48.)
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`While substitute claim 43 additional recites “wherein the device is configured
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`such that, when the flexible tip portion extends into the branch artery, the flexible
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`tip portion and substantially rigid portion assist in resisting forces exerted by the
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`3
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`U.S. Patent No. RE45,380
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`interventional cardiology devices passed through and beyond the coaxial lumen that
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`would otherwise tend to dislodge the guide catheter from the artery,” no patentable
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`weight should be given to such “recitation of a new intended use” for structural
`
`features well-known in the art. In re Schreiber, 128 F.3d 1473, 1477 (Fed. Cir.
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`1997). Nonetheless, even if this recitation is limiting, Itou discloses the limitations
`
`therein. (Ex. 1902, ¶ 48; see also id., ¶ 49.)
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`To the extent PO argues that Itou does not explicitly or inherently disclose
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`each limitation of substitute claim 43, Itou in view of Ressemann renders claim 43
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`obvious. (Ex. 1902, ¶¶ 49-87.) While Itou does not explicitly teach insertion of a
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`stent catheter through catheter (2), a POSITA had the motivation to do so, as well as
`
`a reasonable expectation of success, based on teachings in Ressemann. (Id.;
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`Ex. 1806, ¶¶ 64-78.)
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`2.
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`Substitute Claim 44
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`Itou renders substitute claim 44 obvious for similar reasons discussed above
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`for substitute claim 43 in Section III.B.1. (Ex. 1902, ¶¶ 88-91, 104-130.) The
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`following discussion focusses on aspects of claim 44 that are different from claim
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`43. Substitute claim 44 additionally recites “a device … including: an elongated
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`structure … including, in a distal-to-proximal direction,” features similar to that
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`claimed in substitute claim 43. Substitute claim 44 further recites a “complex side
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`opening.” These added features are not novel.
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`4
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`To begin, Itou’s suction catheter 2 (i.e. “a device”) is an elongated structure
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`having an overall length that is longer than that of guiding catheter 1.
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`(Ex. 1007, 2:23-26.) Suction catheter 2 includes, in a distal-to-proximal direction:
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`tip 22 (i.e., “cylindrical flexible tip portion”), tubular body portion 21 (i.e.,
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`“reinforced portion”), and wire-like portion 25 (i.e., “substantially rigid portion”).
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`(Id., 2:12-21, 2:23-26, 5:11-23, Figs 1B, 1E, 3, 5.) Tip 22 and tubular body portion
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`21 is part of tubular portion 24 (i.e. “tubular structure”), which has a single lumen
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`of 1.5mm (0.059 inches) inner diameter. (Id., Table 1, Figs. 5, 6.) It is necessarily
`
`the case that interventional cardiology devices (e.g., PTCA balloons and stents) were
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`insertable through the lumen of tubular portion 24. (Ex. 2127, 2; Ex. 1902, ¶¶ 22,
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`37, 81-85.) The entirety of tubular portion 24 (which includes what Medtronic maps
`
`as the “cylindrical flexible tip portion” and “reinforced portion) is a “coaxial lumen.”
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`(See Section III.A., supra.) Suction catheter 2 further includes solid-wire portion
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`(25) (i.e., “substantially rigid portion”) that is proximal of tubular member (24).
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`(Ex. 1007, 3:47-50, 4:25-36, 2:32-38, 5:35-38, 5:43-46, Fig. 1B.)
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`Complex Side Opening Limitation
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`Itou discloses tip 23, which includes a proximal side opening 231 that is
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`“inclined obliquely,” and
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`thus
`
`includes a “partially cylindrical portion.”
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`(Ex. 1007, 4:10-15.) Tip 23 is proximal to the distal end of wire-like portion 25
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`(“substantially rigid portion”). As shown in the annotation of Figure 3 below,
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`5
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`U.S. Patent No. RE45,380
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`proximal opening 231 extends for a distance from (a) to (b) along the longitudinal
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`axis of suction catheter 2, which forms a “side opening” to, inter alia, “assure a large
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`opening area on the proximal end side.” (Id.) Proximal side opening 231 is
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`“substantially rigid” because it is formed by “obliquely cutting one end of a metal
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`pipe such as a pipe of stainless steel.” (Id., 4:27-30.)
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`
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`(Id., Figs. 4 (top), 3 (bottom).)
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`While Itou’s side opening 231 does not include “a first inclined sidewall” and
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`“a second inclined sidewall” separated by “a non-inclined concave track,” it would
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`have been obvious to modify Itou to include such features in view of Ressemann or
`
`Kataishi.
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`6
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`Case Nos. IPR2020-00128, -00129, -00130
`U.S. Patent No. RE45,380
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`a)
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`Ressemann discloses a “complex side opening.”
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`Ressemann discloses an evacuation sheath assembly for treating occluded
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`vessels and reducing the risk of embolization during vascular interventions.
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`(Ex. 1008, Abstract.) The assembly includes a guiding catheter, which “may be
`
`positioned within the ostium of the target vessel” (id., 12:26-27), and an evacuation
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`sheath that is inserted through the guiding catheter and advanced beyond the guiding
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`catheter’s distal end to treat stenosis. (Id., Abstract; Figs. 6A-6F; 6:18-24;
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`12:9-14:39.)
`
`
`
`(Id., Figs. 6A (showing the guide catheter positioned at the ostium), 6B (showing
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`the evacuation sheath being extended from the distal end of the guide catheter
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`towards the stenosis).)
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`In one embodiment, Ressemann’s evacuation sheath includes a support collar
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`2141 on the proximal end of the tubular portion of the evacuation sheath. As shown
`
`in Figure 16J, reproduced below, support collar 2141 includes a concave track that
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`7
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`U.S. Patent No. RE45,380
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`runs from the proximal to the distal end of the collar. Circumferential portion 2141a
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`fits into the proximal opening of the tubular portion’s lumen. (Ex. 1008, 24:54-56.)
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`
`
`(Id., Fig. 16J.)
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`Collar 2141 has the claimed side-opening configuration—at least a first
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`inclined slope at the proximal end of support collar 2141 (shown as “1” below), a
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`second inclined slope at the distal end of support collar 2141, (shown as “2” below),
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`and a flat, non-inclined region in-between. (Ex. 1800, 166:8-12, 168:9-19
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`(identifying two inclines); see also Ex. 1005, ¶ 136 2 (construing claim term
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`“substantially rigid”).)
`
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`2 Unless otherwise noted, all cites to Ex. 1005 and Ex. 1042 are from
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`IPR2020-00128. To complete the record—as those expert declarations were not
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`submitted in IPR2020-00129 or IPR2020-00130—they can also be found at the same
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`paragraph number in Ex. 1911 and Ex. 1912, respectively. Also, for reasons of
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`8
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`(Ex. 1008, Fig. 16J and schematic of Fig. 16J.)
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`b) Motivation to Combine Itou and Ressemann
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`A POSITA would have been motivated to modify Itou’s proximal tip 23 to
`
`incorporate the structure of Ressemann’s support collar 2141 containing the claimed
`
`features of the side opening in substitute claims 23 and 24 (as shown in the figure
`
`below) so that Itou’s suction catheter 2 could alternatively be used to deliver
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`interventional cardiology devices, as disclosed in Ressemann.
`
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`conformity, Petitioner cites to the Ex. 10XX series herein, but the same exhibit can
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`also be found at the Ex. 12XX series in IPR2020-00129 and the Ex. 14XX series in
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`IPR2020-00130.
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`9
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`
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`(Ex. 1007, Fig. 3 (modification with support collar 2141 shown in gray).)
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`Itou teaches placing catheter 2 in precisely the right location to deliver a stent
`
`or balloon catheter. (Ex. 1007, Fig. 6; 5:35-42; 7:16-19; Ex. 1902, ¶¶ 50-53.) And a
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`POSITA would have understood that Itou’s suction catheter lumen was of sufficient
`
`inner
`
`diameter
`
`to
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`accommodate
`
`interventional
`
`cardiology
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`devices.
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`(Ex. 1902, ¶¶ 54-68.) A POSITA had the motivation to modify suction catheter (2)’s
`
`proximal opening with Ressemann’s collar 2141 because this increased the area for
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`receiving a
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`stent and/or balloon catheter.
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`(Ex. 1902, ¶¶ 69-80, 94-99;
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`Ex. 1807, ¶¶ 121-125.)
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`An additional motivation for modifying Itou with Ressemann’s collar is
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`explicitly taught in Ressemann. The collar serves to reinforce the proximal opening
`
`of the catheter lumen, as well as provide a flexibility transition between the distal
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`10
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`
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`tubular structure and the proximal shaft. (Ex. 1008, 24:49-67; Ex. 1902, ¶¶ 94-103,
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`Case Nos. IPR2020-00128, -00129, -00130
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`110-130; Ex. 1807, ¶¶ 126-128.)
`
`A POSITA would have looked to Ressemann when modifying Itou because
`
`both references disclose devices that address the same problem—removing coronary
`
`vessel occlusions—in the same way—by using an aspiration catheter, the distal end
`
`of which is extended past a guiding catheter’s distal end, into a coronary artery.
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`(Ex. 1007, Abstract; 1:13-16; 2:2-5, 29-38; 3:59-63; 5:32-34; Figs. 1A, 1B, 5, 6;
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`Ex. 1008, Abstract, 6:18-24; 12:9-12, 19-30; Figs. 6A, 6B; Ex. 1902, ¶¶ 94-102.) A
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`POSITA would have had a reasonable expectation of success because modifying the
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`side opening of Itou’s suction catheter to have the structure of Ressemann’s support
`
`collar is nothing more than combining prior art elements according to known
`
`methods
`
`to yield predictable
`
`results. KSR
`
`Int’l Co. v. Teleflex,
`
`Inc.,
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`550 U.S. 398, 417 (2007).
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`c) Kataishi discloses a “complex side opening.”
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`Kataishi similarly discloses
`
`the claimed “complex side opening.”
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`(Ex. 1902, ¶¶ 110-119.) Kataishi discloses a suction catheter for removing a
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`thrombus from a coronary artery. (Ex. 1025, ¶ [0001].) Kataishi’s suction catheter
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`has a distal opening extending along the longitudinal axis with two inclines and a
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`non-inclined concave track in-between:
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`11
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`U.S. Patent No. RE45,380
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`(Id., Figs. 2, 12, ¶ [0010].) This shape is nearly identical to that taught in the ’380
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`
`
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`patent in Figure 4 (the figure Patent Owner frequently identifies as providing support
`
`for this “complex side opening” limitation):
`
`
`
`(Ex. 1001, Fig. 4 (orientation modified).)
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`One benefit of this side opening design taught by Kataishi is an improvement
`
`in the catheter’s “crossing ability”— the ability to reach a desired target site by
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`advancing past bends in the vasculature. (Id., Abstract, ¶ [0001]; see also
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`Ex. 1902, ¶¶ 116-18.) Another benefit taught by Kataishi of the two-incline shape is
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`the improved ability to receive material in the opening (e.g., an improved ability to
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`suction thrombi). (Ex. 1025, Abstract [0026]-[0027]; Ex. 1902, ¶ 119.)
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`12
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`
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`(Ex. 1025, Fig. 10.)
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`d) Motivation to Combine Itou and Kataishi
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`In light of these benefits, taught by Kataishi, a POSITA would have been
`
`motivated to incorporate the shape of Kataishi’s distal opening in Itou’s proximal tip
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`23. (Ex. 1902, ¶¶ 120-129.) Regarding the first benefit, a POSITA would have
`
`recognized that improved crossability is a desirable feature in a proximal opening of
`
`a short tube for the same reasons as it is desirable in the distal opening of such a
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`tube. (Ex. 1008, 6:52-60 (“The proximal and distal ends 140a, 140b of the
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`evacuation lumen 140 are preferably angled to allow for smoother passage … .”).)
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`In particular, when retracting the device, the angled features of the Kataishi opening
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`would provide improved crossability as the proximal end would then be the leading
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`side.
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`For the second benefit, a POSITA would have recognized that the improved
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`ability of an opening to accept material would have been applicable to a proximal
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`13
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`opening accepting interventional cardiology devices in the same way as it improved
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`Kataishi’s distal end to suction a thrombus. (Ex. 1907, ¶ 118.) Allowing an
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`improved entry of materials into the lumen of Itou’s suction catheter without
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`increasing the diameter of the device would have been desirable to a POSITA, who
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`would have understood that this modification allows the catheter to receive a therapy
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`catheter and still be advanced to distal locations into the coronary vasculature
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`(compared to catheters with larger diameters). (Ex. 1025, Abstract, [0026]-[0027],
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`Fig. 10; Ex. 1055, 6, 10 (disclosing a better ability to load because of two different
`
`inclined slopes on the end); Ex. 1902, ¶¶ 113-27; Ex. 1907, ¶¶ 113-15, 119.)
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`Thus, a POSITA would have been motivated to modify Itou’s proximal tip 23
`
`to incorporate the shape of Kataishi’s opening to improve crossability of the devices,
`
`and to more easily facilitate the entry of interventional cardiology devices.
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`(Ex. 1902, ¶¶ 120-129, Ex. 1907, ¶¶ 120-22; Ex. 1055, 6.)
`
`A POSITA would have looked to Kataishi to improve Itou and Kontos
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`because Itou, Kontos, and Kataishi are all directed at the same problem—removing
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`occlusions from coronary arteries using, inter alia, a catheter. (Ex. 1007, Abstract;
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`Ex. 1025, Abstract; Ex. 1907, ¶ 112; Ex. 1902, ¶ 121.) A POSITA would have a
`
`reasonable expectation of success in modifying Itou’s section catheter and Kontos’
`
`support catheter 10 with the claimed side-opening features, as taught by Kataishi.
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`(Ex. 1902, ¶¶ 122-128.) Creating two different inclined slopes in the side opening
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`14
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`would have been a routine task when manufacturing an extension catheter. (Ex.
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`1907, ¶ 123; Ex. 1050, Fig. 7 (disclosing double incline, proximal side opening).)
`
`Itou’s wire-like portion 25 is a “substantially rigid portion” at least some
`
`portion of which extends proximally through the hemostatic valve when a distal
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`portion of the “flexible tip portion” (i.e. 21+22) extends distally of the distal end of
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`guiding
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`catheter 1.
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`(Ex. 1902, ¶¶ 22-38, 49, 86-87, 92-93, 108-109;
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`Ex. 1007, 5:26-46, Figs. 5, 6.)
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`C.
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`Substitute claims 43 and 44 are unpatentable over Kontos in view
`of Ressemann and Takahashi.
`
`1.
`
`Substitute Claim 43
`
`Kontos discloses a system comprising a support catheter assembly 10
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`(“device”) adapted for use with guide catheter 38. (Ex. 1009, 5:35-38, 5:43-46,
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`7:1-23, 7:35-43, Figs. 5-6, 8.) It is undisputed that guide catheter 38 is placed in a
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`branch artery and has a continuous lumen through which interventional cardiology
`
`devices can be inserted. (Ex. 1902, ¶¶ 131-132.) Moreover, it was well-understood
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`that a guide catheter would have a hemostatic valve at its proximal end.
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`(Ex. 1902, ¶¶ 133-134.) Similarly, 6 French was a common size for the guide
`
`catheter. (Ex. 1902, ¶¶ 139-41.) And, in the context of Kontos, such a 6 French
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`guide catheter would necessarily have an inner diameter of 1.8 mm (0.071 inches).
`
`(Id., ¶ 142-47.)
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`15
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`Kontos’ support catheter assembly 10 (i.e. “a device”) includes body 12 (i.e.,
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`“flexible tip portion”). (Ex. 1009, 3:45-55.) Body 12 defines a “coaxial lumen.”
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`(See Section III.A, supra; see also Ex. 1009, 4:5-7 (“Soft tip 28 generally is
`
`cylindrical in shape and extends coaxially from distal end 34 of tube 16.”).) Body
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`12 includes soft tip 28 (i.e., “flexible cylindrical distal tip portion”) and tube 16. As
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`discussed in more detail below, it would have been obvious to modify Kontos’ body
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`12 in view of Ressemann such that tube 16 is reinforced (i.e., “flexible cylindrical
`
`reinforced portion”).
`
` Support catheter assembly 10
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`further
`
`includes
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`insertion/manipulation wire 14 (i.e., “substantially rigid portion”) proximal of and
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`operably connected to body 12. (Ex. 1009, 4:25-38, 5:25-30, Figs. 6A-C.)
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`A POSITA would have found it obvious to combine the teachings of Kontos,
`
`Ressemann, and Takahashi for the following reasons.
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`Reinforced Portion
`
`Kontos in view of the knowledge of a POSITA and/or Ressemann discloses
`
`“flexible cylindrical reinforced portion proximal to the flexible cylindrical distal tip
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`portion.” As discussed above, body 12 includes a soft tip 28 (i.e., “flexible
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`cylindrical distal tip portion”). Body 12 further includes tube 16, which is proximal
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`to soft tip 28. (Ex. 1009, 3:45-55, Fig. 1.) While Kontos does not explicitly disclose
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`that tube 16 is reinforced, it would have been obvious in view of the knowledge of
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`a POSITA and/or Ressemann.
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`16
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`Metallic braiding or coiling was ubiquitous by the time of the claimed
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`invention and was known to prevent or impart kink-resistance, thereby improving
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`the pushability of the extension catheter. (Ex. 1008, 6:66-7:7; Ex. 1046, Abstract;
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`Ex. 1047, Abstract.) Thus, it would have been obvious based on the knowledge of
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`a POSITA to modify Kontos by adding metallic coiling or braiding (i.e.,
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`reinforcement) to tube 16.
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`To the extent Patent Owner argues that such a modification would not have
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`been known to a POSITA, it would have been obvious in view of Ressemann, which
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`discloses reinforcing the tube of a catheter, similar to Kontos’ tube 16, with
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`braiding/coiling. For example, Ressemann discloses that the reinforced portion of
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`tube 138 within the evacuation lumen 140 “may be formed around a coil 139 such
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`that coil 139 is embedded within … tube 138.” (Ex. 1008, 7:4-7.)
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`A POSITA would have been motivated to add this design feature to tube 16
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`of Kontos because s/he would have known that reinforcing polymer with metallic
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`braiding/coiling advantageously promote pushability and prevent kinking during
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`advancement of the catheter. (Ex. 1035, [0075]; Ex. 1046, Abstract; Ex. 1047,
`
`Abstract.) A POSITA would have looked to Ressemann to improve Kontos because
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`Ressemann and Kontos are directed to the same type of device, are in the same field
`
`of endeavor. (Ex. 1902, ¶¶ 172-73.) A POSITA would have been able to accomplish
`
`the modification with a reasonable expectation of success given the teachings in the
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`17
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`art. Thus, it would have been obvious to modify Kontos such that tube 16 is
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`reinforced with metallic braiding or coiling, like that taught by Ressemann, which
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`discloses a “reinforced portion” as recited in substitute claim 24 from which
`
`substitute claim 25 depends.
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`As shown in Figure 1 below, the modified Kontos-Ressemann body structure
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`12 comprises “a flexible cylindrical distal tip portion and a flexible cylindrical
`
`reinforced portion proximal to the flexible cylindrical distal tip portion,” as recited
`
`in claim 43.
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`
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`(Ex. 1009, Fig. 1 (color and annotations added).)
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`Complex Side Opening
`
`
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`Kontos’ support catheter assembly 10 does not have a side opening. However,
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`as discussed in Section III.B.2(a), Ressemann discloses a complex side opening. A
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`POSITA would have been motivated to modify Kontos’ tube 16 in view of
`
`Ressemann to have a complex side opening. In particular, a POSITA would have
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`18
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`been motivated to modify Kontos to add Ressemann’s support collar 2141 to Kontos
`
`as shown below for multiple reasons.
`
`
`
`(Ex. 1009, Fig. 1 (modified by Petitioner).)
`
`First, a POSITA would have known that use of a side opening would optimize
`
`the inner diameter of tube 16 without causing a reduction in the area of the point of
`
`entry to the extension catheter 10. (Ex. 1902, ¶¶ 142-146.) For example, as an
`
`alternative to the flared proximal opening 26, a POSITA would have been motivated
`
`to use a side opening like in Ressemann as then the diameter of the GC could be
`
`reduced without causing a commensurate reduction in the area of the proximal
`
`opening of extension catheter.
`
`
`
`(Ex. 1902, ¶¶ 189-192; Ex. 1905, ¶ 97.)
`
`Alternatively, a POSITA would have been motivated to remove Kontos’s proximal
`
`funnel, as it would permit the inner diameter of the extension catheter to be increased
`
`without causing a commensurate increase in the outer diameter of the guide catheter.
`
`(Ex. 1902, ¶¶ 193-196.)
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`19
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`Second, the side opening formed by support collar 2141 facilitates “smooth[]”
`
`reception of the interventional cardiology device as it enters the lumen of the
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`extension catheter. (Ex. 1008, 6:52-57 (100 embodiment), 24:38-41 (2100
`
`embodiment); (Ex. 1902, ¶ 197; see also Ex. 1905, ¶ 97.) That is, the side opening
`
`reduces the likelihood of device hang-up, meaning it promotes better advancement
`
`of the therapy catheter as it travels to the occlusion. (Ex. 1902, ¶¶ 197-198.)
`
`Third, the side opening, as taught by Ressemann, promotes “smoother
`
`passage” of the catheter assembly as it navigates the tortuous vasculature. (Ex. 1008,
`
`6:52-57; see also Ex. 1902, ¶ 200; Ex. 1905, ¶ 99.) Adding a side opening in the
`
`form of support collar 2141 to the lumen of the extension catheter reduces the
`
`amount of force that a physician must exert to advance the catheter through winding
`
`vasculature. (Ex. 1902, ¶ 199; Ex. 1905, ¶ 99.)
`
`Fourth, a POSITA was motivated to add a side opening to the extension catheter
`
`because doing so permitted smooth re-entry if the proximal end of the extension
`
`catheter was extended beyond the distal end of the GC. (Ex. 1902, ¶ 201; Ex. 1905,
`
`¶¶ 92-95.) For example, Kontos teaches an embodiment where “the bridge body
`
`12/PTCA catheter assembly must be passed completely out of guide catheter 38 and
`
`advanced as a unit to the site of restriction B.” (Ex. 1009, 6:22-25.)
`
`
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`20
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`
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`(Id., Fig. 7.)
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`In such an embodiment, after the angioplasty is performed, the support
`
`catheter 10 must return to the guide catheter 38. (Ex. 1902, ¶ 202; Ex. 1905, ¶ 92.)
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`A POSITA would recognize, however, that a flared proximal opening of the tubular
`
`structure (tube 12) was a poor design choice, as this protrusion could damage the
`
`internal coronary wall and hinder re-entry of the tubular structure into the GC as the
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`tubular structure travels proximally toward the GC. (Ex. 1902, ¶ 202; Ex. 1905,
`
`¶ 94.) The smaller cross-sectional diameter of a side opening would reduce the
`
`likelihood of damaging the coronary artery and result in easier re-insertion into the
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`GC. (Ex. 1902, ¶¶ 202-04; Ex. 1905, ¶ 95.)
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`0.056 Inches Coaxial Lumen
`
`Kontos discloses a cross-sectional outer diameter and inner diameter of body
`
`12 that is 0.055 inches and 0.045 inches, respectively. (Ex. 1009, 3:56-59, 4:48-50.)
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`At base portion 18, Kontos discloses a 0.065-inch outer diameter. (Id., 4:50-53.)
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`Kontos does not disclose the cross-sectional inner diameter of the guide catheter.
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`21
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`(Ex. 1902, ¶¶ 148-49.) Takahashi, however, discloses a “five-in-six” system
`
`wherein
`
`the
`
`inner diameter of
`
`the 5 French catheter
`
`is 0.059
`
`inches.
`
`(Ex. 1902, ¶¶ 150-51; Ex. 1905, ¶¶ 138-39; see also Ex. 1010, 452.)
`
`It would have been obvious to modify Kontos in light of Ressemann and
`
`Takahashi to use an extension catheter with a 0.056 or greater inner diameter.
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`(Ex. 1902, ¶¶ 152-55.) Indeed, Kontos, Ressemann, and Takahashi are directed to
`
`the same type of device, are in the same field of endeavor, and are reasonably
`
`pertinent to the problem faced by the inventors of the ʼ380 patent. (Ex. 1902, ¶ 151.)
`
`A POSITA would have been motivated to combine Takahashi with Kontos
`
`and Ressemann, given that the former teaches that using a catheter-in-catheter
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`assembly—in particular, an assembly that achieves 1 French differential between
`
`the inner and outer catheters—can improve back-up support. (Ex. 1902, ¶ 151;
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`Ex. 1905, ¶¶ 138-41.) Further, a POSITA would have been able to accomplish the
`
`claimed combination with a reasonable expectation of success given the teachings
`
`of Kontos, Ressemann, Takahashi, and/or a POSITA’s knowledge. A POSITA knew
`
`how to (i) replace the proximal funnel with a side opening, as discussed above, and
`
`(ii) recess Kontos’s distal marker bands. (Ex. 1902, ¶ 154.) Further, Kontos
`
`explicitly teaches that “tube 16 may be molded directly only application wire 14.”
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`(Ex. 1009, 4:31-32.) In so doing, to maximize the usable “real estate” in the catheter
`
`assembly, a POSITA would taper the pushrod for attachment onto the Kontos-
`
`22
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`Ressemann combination. (Ex. 1902, ¶ 154; Ex. 1807, ¶¶ 169-77.) Making these
`
`modifications would permit a POSITA to use an extension catheter with at least a
`
`0.056-inch inner diameter in a 6 French GC. (Ex. 1807, ¶¶ 178-82.) This
`
`modification would increase the outer diameter of Kontos’ body 12, but this
`
`modification was well within the skill of a POSITA, as appropriately sized catheters
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`were ubiquitous in the art. (Ex. 1902, ¶¶ 156-57; Ex. 1905, ¶¶ 141-42; Ex. 1009,
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`4:64-65; Ex. 1010, 452.) Combining the teachings of Kontos with Ressemann and
`
`Takahashi to achieve the not-more-than-one French differential would have been
`
`nothing more than combining prior art elements according to known methods to
`
`yield predictable results. (Ex. 1905, ¶ 111.)
`
`Kontos’ catheter 10 modified based on Ressemann and Takahashi discloses
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`all limitations recited in claim 43. (Ex. 1092, ¶¶ 131-81.) Moreover, as discussed
`
`above in connection with Itou, substitute claim 43’s additional recitation of “wherein
`
`the device is configured such that, when the flexible tip portion extends into the
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`branch artery, the flexible tip portion and substantially rigid portion assist in resisting
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`forces exerted by the interventional cardiology devices passed through and beyond
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`the coaxial lumen that would otherwise tend to dislodge the guide cathet
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