`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`_________________
`
`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. IPR2020-00135
`Case No. IPR2020-00136
`U.S. Patent No. RE45,776
`_________________
`
`PETITIONER’S OPPOSITION
`TO PATENT OWNER’S CORRECTED MOTION TO AMEND
`
`

`

`Case Nos. IPR2020-00135, -00136
`U.S. Patent No. RE45,776
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`TABLE OF CONTENTS
`
`Page
`Introduction ...................................................................................................... 1
`
`Proposed Claims 58-62 and 65 Lack Written Description Support. ............... 1
`
`I.
`
`II.
`
`A.
`
`Claims reciting a side opening outside of the substantially rigid
`segment lack support. ............................................................................ 1
`
`III.
`
`Proposed Claim 65 is a Broadening Amendment .........................................11
`
`IV. The Prior Art Renders Proposed Claims 58-65 Unpatentable. .....................11
`
`A.
`
`B.
`
`C.
`
`D.
`
`E.
`
`F.
`
`G.
`
`Claim Construction..............................................................................11
`
`Substitute claims 58-60 and 63-65 are unpatentable over Itou in
`view of Ressemann and/or Kataishi. ...................................................12
`
`1.
`
`2.
`
`Substitute Claims 58-60 ............................................................12
`
`Substitute Claims 63-65 ............................................................21
`
`Substitute claims 61 and 62 are unpatentable over Itou in view of
`Ressemann or Kataishi and Eidenschink. ...........................................22
`
`Substitute claims 58 & 60 are unpatentable over Kontos in view
`of Ressemann. .....................................................................................26
`
`Substitute claims 61 and 62 are unpatentable over Kontos in view
`of Ressemann and Eidenschink. ..........................................................29
`
`Substitute claims 63-65 are unpatentable over Kontos in view of
`Ressemann and Takahashi. .................................................................30
`
`Substitute claims 58-60, 61-62, and 63-65 are unpatentable over
`Kontos in view of Kataishi, Kontos in view of Kataishi and
`Eidenschink; and Kontos in view of Ressemann, Kataishi and
`Takahashi, respectively. ......................................................................34
`
`V.
`
`Conclusion .....................................................................................................34
`
`
`
`i
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`Case Nos. IPR2020-00135, -00136
`U.S. Patent No. RE45,776
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`TABLE OF AUTHORITIES
`
` Page(s)
`
`Federal Cases
`
`Gentry Gallery, Inc. v. Berkline Corp.,
`134 F.3d 1473 (Fed. Cir. 1998) ............................................................................ 5
`
`ICU Medical, Inc. v. Alaris Medical Sys., Inc.,
`558 F.3d 1368 (Fed. Cir. 2009) .......................................................................... 10
`
`KSR Int’l Co. v. Teleflex, Inc.,
`550 U.S. 398 (2007) ................................................................................ 17, 26, 30
`
`PowerOasis Inc. v. T-Mobile USA, Inc.,
`522 F.3d 1299 (Fed. Cir. 2008) ............................................................................ 5
`
`Tronzo v. Biomet, Inc.,
`156 F.3d 1154 (Fed. Cir. 1998) ............................................................................ 5
`
`
`
`
`ii
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`Case Nos. IPR2020-00135, -00136
`U.S. Patent No. RE45,776
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`I.
`
`INTRODUCTION
`
`Medtronic, Inc., and Medtronic Vascular, Inc., (“Petitioner”) opposes Patent
`
`Owner’s Corrected Contingent Motion to Amend (“Mot.”). Patent Owner (“PO”)
`
`seeks to amend claims 27, 33, 37, 42, 43, 45, 47, and 56 and proposes substitute
`
`claims 58-65. (Mot., 1, Appendix A (“App.”).) But the substitute claims are not
`
`supported by the original disclosure and are unpatentable over the prior art. PO’s
`
`Motion should be denied for all these reasons.
`
`II.
`
`PROPOSED CLAIMS 58-62 AND 65 LACK WRITTEN
`DESCRIPTION SUPPORT.
`
`A. Claims reciting a side opening outside of the substantially rigid
`segment lack support.
`
`Claim 25 (from which substitute claims 58-60 depend), claim 52 (from which
`
`substitute claim 65 depends), and substitute claims 61-62 recite “[a] guide extension
`
`catheter for use with a guide catheter, comprising: a substantially rigid segment; a
`
`tubular structure . . . ; and a segment defining a partially cylindrical opening
`
`positioned between a distal end of the substantially rigid segment and a proximal
`
`end of the tubular structure.” (Ex. 1001, 13:36-49, 15:15-28; App., 1-3.) 1 A
`
`POSITA would understand that claims 58-62 and 65 require a side opening segment
`
`that is separate from (distal to) the substantially rigid segment. (Ex. 1919, ¶¶ 57-65;
`
`
`1 All emphasis and annotations added unless otherwise specified.
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`1
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`see also Mot., 5 (“The claim need not expressly recite that the partially cylindrical
`
`opening is in the substantially rigid segment.”).) But the written description
`
`exclusively and repeatedly describes the side opening as part of the substantially
`
`rigid segment of the claimed device. Thus, proposed claims 58-62 and 65 should be
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`rejected for lack of written description.
`
`The original patent application2 describes the invention as a device that is used
`
`with “standard guide catheters” in “interventional cardiology procedures.”
`
`(Ex. 1842, 7-8.) The claims of the original patent application (and the proposed
`
`claims here) are generally directed to the “coaxial guide catheter” described in the
`
`specification. (See, e.g., id., 38-44; see also POR, 4 (also describing the invention
`
`as a “guide extension catheter”).) This coaxial guide catheter is consistently
`
`described as being made of three distinct portions: “a tip portion, a reinforced
`
`portion, and a substantially rigid portion.” (Ex. 1842, 9; see also id., 16
`
`(alternatively describing the final section as a “rigid portion 20”).) Each of these
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`portions has a specified composition—the tip portion is “a low durometer polymer
`
`or elastomer”; the reinforced portion is made of PTFE, Pebax®, and may be
`
`
`2 Petitioner cites the parent patent application—the ’629 application (issued as the
`
`’032 patent)—as the parties have stipulated that each application in the priority chain
`
`contains substantively identical disclosures. (IPR2020-00135, Paper 38, 2 n.1.)
`
`2
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`reinforced with “metallic fibers in a braided or coiled pattern”; and the rigid portion
`
`is “formed from a stainless steel or Nitinol tube.” (Id., 9.)
`
`The only portions of the specification that describe a side opening are in the
`
`parts describing the “rigid portion.” (Id., 9-10, 13-20, 38-41, 43, Figs. 4, 12-16;
`
`see also Ex. 1919, ¶¶ 28-41, 46-47.) Indeed, PO points to these portions as
`
`supporting the “side opening” limitations of the proposed claims. (Mot., 4-13.) For
`
`instance, PO frequently points to Figure 4 of the specification as providing support
`
`for the side opening of the claims:
`
`(Ex. 1001, Fig. 43 (color and annotations added); see Mot., 14.) In the figure above,
`
`the alleged “side opening” (boxed in red) is included in the portion designated by
`
`the reference numeral 20, which is the “rigid portion.” (See, e.g., Ex. 1842, 16.)
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`Likewise, Figures 12-16 illustrate a side opening in rigid portion 20:
`
`
`
`
`3 Petitioner uses the as-issued patent drawing—as opposed to the hand-drawn figures
`
`accompanying the patent application—for continuity with the Petition.
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`3
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`
`
`(Ex. 1001, Figs. 12-16 (color and annotations added).)
`
`Nowhere does the specification describe a side opening outside of the rigid
`
`portion. (Ex. 1919, ¶¶ 28-36, 46-47.) And the originally filed claims of the ʼ629
`
`application (which are part of the written description) confirm that the side opening
`
`is located in the “substantially rigid portion.” (Ex. 1842, 38 (original claim 1 reciting
`
`a “substantially rigid portion having an opening along a side thereof”), 39 (original
`
`claim 4 reciting “substantially rigid portion . . . comprises a cylindrical portion and
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`a partially cylindrical portion defining the opening along a side thereof”), 40-41
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`(similar for original claim 8), 43 (similar for original claim 17); see also Ex. 1919,
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`¶¶ 37-41.)
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`4
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`For a claim to have written description support, the specification must
`
`“actually or inherently disclose[] the claim element”; obviousness is not sufficient.
`
`PowerOasis Inc. v. T-Mobile USA, Inc., 522 F.3d 1299, 1306-07 (Fed. Cir. 2008);
`
`see also Tronzo v. Biomet, Inc., 156 F.3d 1154, 1158 (Fed. Cir. 1998). Because
`
`proposed claims 58-62 and 65 attempt to capture this feature, and the feature is not
`
`supported by the written description (either actually or inherently), proposed claims
`
`58-62 and 65 are unpatentable. See Gentry Gallery, Inc. v. Berkline Corp.,
`
`134 F.3d 1473, 1479-80 (Fed. Cir. 1998) (rejecting claims that did not limit the
`
`location of the claimed “controls” where “the original disclosure clearly identifies
`
`the console as the only possible location for the controls”).
`
`PO’s Motion largely ignores this glaring defect in the proposed claims,
`
`addressing it only in a single sentence regarding proposed claim 58, asserting “[t]he
`
`claim need not expressly recite that the partially cylindrical opening is in the
`
`substantially rigid segment.” (Mot., 5 (citing Ex. 2124, ¶¶ 30-44, 51).) PO’s Motion,
`
`however, provides no rationale for why this is so, and it relies entirely on the
`
`arguments made in its expert’s declaration. Those arguments boil down to two
`
`assertions: (1) that the substantially rigid segment need not be substantially rigid
`
`because it can be designed to be less rigid (Ex. 2124, ¶¶ 32, 36-38, 42), and
`
`(2) because
`
`the
`
`specification describes
`
`alternative proximal openings
`
`(e.g., perpendicular end openings), the side opening need not be in the substantially
`
`5
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`rigid segment (id., ¶¶ 33-35, 39-40, 42). These arguments are absent from PO’s
`
`motion, but regardless, both are meritless.
`
`Regarding the first assertion, to the extent PO takes issue with how its own
`
`invention is described (e.g., id., ¶ 36 (“so-called rigid portion”)), it is a problem of
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`PO’s own making that cannot be cured in an IPR proceeding. The legally relevant
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`inquiry is whether a POSITA would have understood the inventor(s) to have had
`
`possession of a device with a side opening outside of the substantially rigid segment,
`
`as claimed. PO’s expert fixated on the wrong question: whether the side opening
`
`can be made less rigid despite being in the substantially rigid segment. (Id., ¶ 31;
`
`see also id., ¶ 41.) But he was forced to admit that there is no description of a side
`
`opening in the reinforced portion, and all examples are in rigid portion 20 and were
`
`“cut into a tube of substantially rigid material.” (Ex. 1764, 10:2-18, 23:25-26:18.)
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`Further, he admitted that the relief cuts he points to are in rigid portion 20.
`
`(Id., 20:4-7.) Whether or not the rigid tubular material of the rigid portion can be
`
`designed to be less rigid is irrelevant. The specification consistently describes the
`
`side opening as being located within a part of the device defined by the original
`
`application as
`
`the “rigid portion” or
`
`the “substantially
`
`rigid portion.”
`
`(See, e.g., Ex. 1842, 16; see also Ex. 1919, ¶¶ 71-72.)
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`Regarding the second assertion, PO’s expert opines that the original
`
`application describes a “range of options . . . for the distal tube’s proximal opening,”
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`6
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`but announces only two—a proximal opening perpendicular to the longitudinal axis
`
`(i.e., an end opening) and a side opening extending longitudinally. (Ex. 2124,
`
`¶¶ 33-35, 39-40, 42.) To begin, PO’s expert’s use of the term “distal tube”—a term
`
`not found in the original application—obfuscates the three distinct portions of the
`
`claimed device as described in the specification. A closer look at the specification,
`
`however, dispels this confusion and confirms that the “side opening” described is
`
`located only in the “rigid portion.” (See, e.g., Ex. 1842, 10, 18, 19.)
`
`PO’s expert points to Figure 21 as an alternative configuration for “the distal
`
`tube’s proximal opening”—an opening perpendicular to the longitudinal axis.
`
`(Ex. 2124, ¶¶ 34, 39.)
`
`(Ex. 1001, Fig. 21 (annotation added); see also id., Fig. 1 (showing a similar
`
`
`
`configuration).)
`
`As admitted by PO’s expert, though, Figure 21 does not show a side opening.
`
`(Ex. 1764, 16:19-24.) For instance, PO distinguished the end opening shown in
`
`Figure 21 from a side opening (i.e., “a cylindrical portion defining an opening along
`
`a side thereof”) during prosecution of the ’032 patent (the family’s parent).
`
`(Ex. 1906, 11, 13.) To gain issuance of that parent patent, PO argued that the below
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`7
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`prior art “disclose[d] no ‘opening along a side’” and that “[t]hese ends are not
`
`generally parallel to a long axis.” (Id., 13.)
`
`
`
`PO cannot now point to a similar disclosure, Figure 21, to provide written
`
`description support for a side opening. What is more, in past litigation, PO’s expert,
`
`Mr. Keith, distinguished a side opening from the type of opening identified in
`
`Figure 21. (Ex. 1825, ¶¶ 81-83.)
`
`In the Figure 21 embodiment, the rigid portion includes no “full
`
`circumference” portion at the rigid portion’s distal end. (Ex. 1919, ¶¶ 73-74.)
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`Instead, the rigid portion, described as “hemi-tube portion 110,” forms only part of
`
`a cylinder and is “joined to braided portion 112 [i.e., the ‘reinforced portion’ of the
`
`claims], for example, by adhesive, bonding, or welding.” (Ex. 1842, 22.) The
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`principal difference between this embodiment and the ones shown in Figure 4 and
`
`Figures 12-16 is that the rigid portion in the Figure 4 and Figures 12-16 embodiments
`
`include a full circumference portion and a side opening. The reinforced portion in
`
`every embodiment is the same, with an opening perpendicular to the longitudinal
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`8
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`

`

`axis that is joined to the substantially rigid portion, as illustrated by the boxed
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`Case Nos. IPR2020-00135, -00136
`U.S. Patent No. RE45,776
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`sections below.
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`
`
`(Ex. 1001, Figs. 4, 12-13 (annotations added).)
`
`The fact that the rigid portion may or may not include a side opening does not
`
`mean that the specification provides written description of a side opening outside of
`
`the rigid portion, as PO’s expert asserts. (See Ex. 2124, ¶ 35 (identifying the
`
`specification’s permissive language that the “rigid portion may include a cutout
`
`portion and a full circumference portion”) (emphasis original).) Indeed, PO’s expert
`
`himself appeared to draw a distinction between a bare “proximal opening” of the
`
`reinforced portion of the “distal tube,” as shown in Figure 21, and a “side opening,”
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`as shown in Figures 4 and 12-16. (Ex. 2124, ¶¶ 39-40 (asserting the “distal tube’s
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`9
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`proximal opening . . . can be perpendicular” or “[i]t also can be a side opening with
`
`various sloped configurations”).) Importantly, in denying a motion for preliminary
`
`injunction, the District Court rejected PO’s argument that use of the word “may” in
`
`the specification indicated that the location of the side opening could be outside of
`
`the rigid segment. (Ex. 1088, 8.)
`
`Because there is no support for a side opening outside of the substantially rigid
`
`segment, proposed claims 58-62 and 65 are unpatentable for lack of written
`
`description support under 35 U.S.C. § 112(a).4 See ICU Medical, Inc. v. Alaris
`
`Medical Sys., Inc., 558 F.3d 1368, 1376-77 (Fed. Cir. 2009) (finding a claim invalid
`
`
`4 PO’s expert also includes an argument based on the prosecution history of a
`
`different patent—another argument not found in PO’s motion. (Ex. 2124, ¶ 43.) To
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`the extent this extra argument is even considered, the prosecution history, in fact,
`
`contradicts PO’s argument. The Examiner explicitly rejected the pending claims for
`
`the exact reasons urged by Petitioners here—because the patent “is very clear that
`
`the side opening . . . is a part of rigid portion 20 and not its own segment apart from
`
`the rigid portion.” (Ex. 1908, 41-42; see also Ex. 1919, ¶¶ 42-45.) And although it
`
`is unclear how PO overcame this rejection (because the Examiner’s notice of
`
`allowance, regrettably, does not address this issue), PO should not be allowed to
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`recapture this claim scope in this IPR.
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`10
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`for lack of written description support when the full claim scope covered valves with
`
`and without spikes but the specification only disclosed valves with spikes).
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`III. PROPOSED CLAIM 65 IS A BROADENING AMENDMENT
`
`Claim 65 also impermissibly broadens claim scope because it allows the
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`differential between the tubular structure and guide catheter inner diameters to be
`
`0.014 inches, which is more than “1 French” (0.0131 inches) as required by original
`
`claim 53 from which claim 65 depends.
`
`IV. THE PRIOR ART RENDERS PROPOSED CLAIMS 58-65
`UNPATENTABLE.
`
`PO’s motion should be denied for another independent reason—the substitute
`
`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
`
`in the same direction as the axis of lumen of the guide catheter.” (Ex. 1806,
`
`¶¶ 14-26.)
`
`
`
`
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`11
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`B.
`
`Substitute claims 58-60 and 63-65 are unpatentable over Itou in
`view of Ressemann and/or Kataishi.
`
`1.
`
`Substitute Claims 58-60
`
`As explained in the Petition and briefly summarized below, Itou alone
`
`discloses claim 25. (See Ex. 1904, ¶¶ 12-21.) Substitute claims 58-60 add to original
`
`claim 25 limitations relating to a “complex side opening.” (Mot., 14-20.) Such
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`features, however, are obvious in view of Ressemann or Kataishi.
`
`Itou discloses a suction catheter 2 (“guide extension catheter”) 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.) Suction catheter 2 has a wire-like portion 25 (“substantially rigid
`
`segment”), tubular member 24 (i.e., “tubular structure”), and proximal tip 23
`
`(i.e., “a segment defining a partially cylindrical opening”). (Ex. 1904, ¶¶ 17-20.)
`
`Proximal tip 23 is formed from a metal pipe, which is more rigid than the material
`
`combination forming tubular member 24 (resin material reinforced with metal wire).
`
`(Id., 3:50-58; 4:27-30.) Tubular portion 24 defines a single lumen with an inner
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`diameter of 1.5 mm. (Id., 1:59-65, 2:12-21, 2:23-26, Table 1, Fig. 3.)
`
`Complex Side Opening Limitation
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`Itou discloses tip 23, which includes a proximal side opening 231 that is “inclined
`
`obliquely” (i.e., “segment defining the partially cylindrical opening having an angled
`
`proximal end” (claim 25) and “a portion having an arcuate cross-sectional shape”
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`(substitute claim 58)). (Ex. 1007, 4:10-15.) While side opening 231 does not include
`
`12
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`a “non-inclined concave track” (substitute claims 58-60) and “two inclined slopes
`
`separated by [a] non-inclined concave track,” it would have been obvious to modify
`
`Itou to include such features in view of Ressemann or Kataishi. (Ex. 1904,
`
`¶¶ 22-39.)
`
`a)
`
`Ressemann discloses a “complex side opening.”
`
`Ressemann discloses an evacuation sheath assembly for treating occluded
`
`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-F; 6:18-24;
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`12:9-14:39.)
`
`
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`13
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`(Id., Figs. 6A (showing the guide catheter positioned at the ostium), 6B (showing
`
`the evacuation sheath being extended from the distal end of the guide catheter
`
`towards the stenosis).)
`
`In one embodiment, Ressemann’s evacuation sheath includes a support collar
`
`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
`
`runs from the proximal to the distal end of the collar. Circumferential portion 2141a
`
`fits into the proximal opening of the tubular portion’s lumen. (Ex. 1008, 24:54-56.)
`
`
`
`(Id., Fig. 16J.)
`
`Collar 2141 has the claimed side-opening configuration—at least a first
`
`inclined slope at the proximal end of support collar 2141 (shown as “1” below), a
`
`second inclined slope at the distal end of support collar 2141, (shown as “2” below),
`
`and a flat, non-inclined region in-between. (Ex. 1800, 166:8-12, 168:9-19
`
`14
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`(identifying two inclines); see also Ex. 1005, ¶ 138 5 (construing claim term
`
`“substantially rigid”).)
`
`(Ex. 1008, Fig. 16J and schematic of Fig. 16J; Ex. 1904, ¶¶ 23-24.)
`
`b) Motivation to Combine Itou and Ressemann
`
`A POSITA would have been motivated to modify Itou’s proximal tip 23 to
`
`
`
`
`5 Unless otherwise noted, all cites to Ex. 1005 and Ex. 1042 are from
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`IPR2020-00135. To complete the record—as those expert declarations were not
`
`submitted in IPR2020-00136—they can also be found at the same paragraph number
`
`in Ex. 1915 and Ex. 1916, respectively. Also, for reasons of conformity, Petitioner
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`cites to the Ex. 10XX series herein, but the same exhibit can also be found at the
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`Ex. 14XX series in IPR2020-00136.
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`15
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`incorporate the structure of Ressemann’s support collar 2141 containing the claimed
`
`features of the side opening (as shown in the figure below) so that Itou’s suction
`
`catheter 2 could alternatively be used to deliver interventional cardiology devices,
`
`as disclosed in Ressemann.
`
`
`
`(Ex. 1007, Fig. 3 (modification with support collar 2141 shown in gray).)
`
`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. 1806, ¶ 71; Ex. 1904,
`
`¶ 16.) And a POSITA would have understood that Itou’s suction catheter lumen was
`
`of sufficient inner diameter to accommodate interventional cardiology devices. A
`
`POSITA had the motivation to modify suction catheter (2)’s proximal opening with
`
`Ressemann’s collar 2141 because this increased the area for receiving a stent and/or
`
`balloon catheter. (Ex. 1005, ¶¶ 119, 203; Ex. 1807, ¶¶ 121-25; Ex. 1904, ¶¶ 22-28).
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`16
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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
`
`tubular structure and the proximal shaft. (Ex. 1008, 24:49-67; Ex. 1806, ¶ 89;
`
`Ex. 1807 ¶¶ 126-27; Ex. 1904, ¶¶ 26-29.)
`
`A POSITA would have looked to Ressemann when modifying Itou because
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`both references disclose devices that address the same problem—removing coronary
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`vessel occlusions—in the same way—by using an aspiration catheter, the distal end
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`of which is extended past a guiding catheter’s distal end, into a coronary artery.
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`(Ex. 1806, ¶¶ 63-78; Ex. 1007, Abstract; 1:13-16; 2:2-5, 29-38; 3:59-63; 5:32-34;
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`Figs. 1A, 1B, 5, 6; Ex. 1008, Abstract, 6:18-24; 12:9-12, 19-30; Figs. 6A, 6B;
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`Ex. 1904, ¶¶ 30-38.) A POSITA would have had a reasonable expectation of success
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`because modifying the side opening of Itou’s suction catheter to have the structure
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`of Ressemann’s support collar is nothing more than combining prior art elements
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`according to known methods to yield predictable results. KSR Int’l Co. v.
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`Teleflex, Inc., 550 U.S. 398, 417 (2007).
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`Itou in view of Ressemann renders obvious claims 58, 60 and 63-65.
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`(Ex. 1904, ¶¶ 39-70, 82-124.)
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`c) Kataishi discloses a “complex side opening.”
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`Kataishi similarly discloses the claimed “complex side opening.” (Ex. 1904,
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`¶¶ 84-86.) Kataishi discloses a suction catheter for removing a thrombus from a
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`coronary artery. (Ex. 1025, ¶ [0001].) Kataishi’s suction catheter has a distal
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`opening extending along the longitudinal axis with two inclines and a non-inclined
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`concave track in-between:
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`(Id., Figs. 2, 12, ¶ [0010].) This shape is nearly identical to that taught in the ’760
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`
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`
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`patent in Figure 4 (the figure Patent Owner frequently identifies as providing support
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`for this “complex side opening” limitation):
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`
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`(Ex. 1008, Fig. 4.)
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`One benefit of this side opening design taught by Kataishi is an improvement
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`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 Ex. 1904,
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`¶¶ 87-89.) Another benefit taught by Kataishi of the two-incline shape is the
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`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. 1904, ¶ 90.)
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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
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`motivated to incorporate the shape of Kataishi’s distal opening in Itou’s proximal tip
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`23. (Ex. 1904, ¶¶ 93-99.) Regarding the first benefit, a POSITA would have
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`recognized that improved crossability is a desirable feature in a proximal opening of
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`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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`Ex. 1904, ¶¶ 94-95.) In particular, when retracting the device, the angled features of
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`the Kataishi opening would provide improved crossability as the proximal end
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`would then be the leading 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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`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. 1042, ¶¶ 118-22.) 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
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`to catheters with
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`larger diameters).
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`
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`(Ex. 1025, Abstract,
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`¶¶ [0026]-[0027], Fig. 10; Ex. 1055, 6, 10 (disclosing a better ability to load);
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`Ex. 1005, ¶¶ 115-19; Ex. 1042, ¶¶ 118-22; Ex. 1904, ¶¶ 96-101.)
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`Thus, a POSITA would have been motivated to modify Itou’s proximal tip 23
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`to incorporate the shape of Kataishi’s opening to improve crossability of the devices,
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`and to more easily facilitate the entry of interventional cardiology devices.
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`(Ex. 1005, ¶¶ 115-19; Ex. 1904, ¶¶ 93-99; Ex. 1042, ¶¶ 121-22.) Itou and Kataishi
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`are directed at the same problem—removing occlusions from coronary arteries
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`using, inter alia, a catheter. (Ex. 1007, Abstract; Ex. 1025, Abstract; Ex. 1042,
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`¶ 117; Ex. 1005, ¶ 202.) A POSITA would have a reasonable expectation of success
`
`in modifying Itou’s suction catheter with the claimed side-opening features, as
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`taught by Kataishi. (Ex. 1005, ¶ 205; Ex. 1806, ¶¶ 93-98.) Creating two different
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`inclined slopes in the side opening would have been a routine task when
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`manufacturing an extension catheter. (Ex. 1042, ¶ 123; Ex. 1050, Fig. 7 (disclosing
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`double incline, proximal side opening).)
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`2.
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`Substitute Claims 63-65
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`Itou discloses a suction catheter 2 (“guide extension catheter”) for use with a
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`guiding catheter 1 (“guide catheter”), which can be 6 French and has an inner
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`diameter of 1.8mm (0.071 inches). (Ex. 1007, 5:35-38, 5:43-46, 5:65-67, 6:47-50,
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`7:1-23, 7:35-43, Figs. 5-6, 8.) Suction catheter 2 has a wire-like portion 25 (i.e.,
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`“first substantially rigid segment”), tubular member 24 (i.e., “tubular structure”), and
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`proximal tip 23 (i.e., “second substantially rigid segment”). Tubular member 24
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`includes distal tip 22 (i.e., “distal tip portion”) and tubular portion 21 (i.e.,
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`“reinforced segment”). Proximal tip 23 is formed from a metal pipe, which is more
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`rigid than the material combination forming tubular member 24 (resin material
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`reinforced with metal wire). (Id., 3:50-58; 4:27-30.) Tubular portion 24 defines a
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`single coaxial lumen with an inner diameter of 1.5mm, (id., Table 1, 1:59-65), which
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`is larger than 0.056 inches (1.42mm). (Id., 2:15-17, 4:4-5, 4:48-51; Ex. 1005,
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`¶¶ 178-83; see supra Section III.A; Ex. 1904, ¶¶ 42-58, 70, 106-112, 124.)
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`As discussed in Section III.B.1, it would have been obvious to modify Itou to include
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`a complex side opening in view of Ressemann or Kataishi.
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`C.
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`Substitute claims 61 and 62 are unpatentable over Itou in view of
`Ressemann or Kataishi and Eidenschink.
`
`Substitute claim 61, from which substitute claim 62 depends, is disclosed by
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`the combination of Itou and Ressemann or Kataishi for similar reasons discussed
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`above in Section III.B.1. Substitute claims 61 and 62 additionally recites limitations
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`relating to increasing the flexibility of the segment defining the partially cylindrical
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`opening. However, these limitations are obvious in view of Eidenschink.
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`(See Ex. 1904, ¶¶ 71-80.)
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`Increase Flexibility and Relief Cuts Limitations
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`Substitute claim 61 recites “wherein the segment defining the partially
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`cylindrical opening comprises a continuation of the metal rail structure that has been
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`processed to increase the flexibility of the segment defining the partially cylindrical
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`opening.” (App., 3.) Substitute claims 62 further recites “the flexibility of the
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`segment defining the partially cylindrical opening is increased by forming transverse
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`relief cuts in the segment defining the partially cylindrical opening.” (Id.) These
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`features would have been obvious in further view of Eidenschink. (Ex. 1904,
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`¶¶ 137-38.)
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`Eidenschink discloses a “hypotube for use with a catheter … that provides
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`improved stain relief or transitioning stiffness characteristics between a distal end of
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`the hypotube and a proximal end of the catheter.” (Ex. 1827, ¶ [0002].) Eidenschink
`
`explains that to be effective, a catheter assembly must have: (1) “sufficient
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`‘pushability’ or axial strength thereby enabling a longitudinal force to be transmitted
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`through the assembly so that the physician can push the catheter assembly through
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`the vascular system to the stenosis”; and (2) “sufficiently flexible so that the catheter
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`assembly has good ‘trackability’ so as to enable the physician to navigate the
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`tortuous passages of the patient's vascular system.” (Id., ¶ [0007].)
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`To satisfy these criteria, “catheter assemblies typically h