`
`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. IPR2020-00132
`Case No. IPR2020-00134
`U.S. Patent No. RE45,760
`_________________
`
`PETITIONER’S OPPOSITION
`TO PATENT OWNER’S MOTION TO AMEND
`
`
`
`

`

`Case Nos. IPR2020-00132, -00134
`U.S. Patent No. RE45,760
`
`TABLE OF CONTENTS
`
`Page
`
`I.
`
`II.
`
`Introduction ...................................................................................................... 1
`
`Proposed Claims 54-56 and 58 Lack Written Description Support. ............... 1
`
`A.
`
`Claims reciting a side opening outside of the substantially rigid
`portion lack support. .............................................................................. 1
`
`III.
`
`Proposed Claim 58 is a Broadening Amendment .........................................11
`
`IV. The Prior Art Renders Proposed Claims 54-58 Unpatentable ......................11
`
`A.
`
`B.
`
`Claim Construction..............................................................................11
`
`Substitute Claims 54-55 Are Unpatentable Over Itou ........................11
`
`1.
`
`2.
`
`Substitute Claim 54 ...................................................................11
`
`Substitute Claim 55 ...................................................................12
`
`C.
`
`Substitute Claims 56-58 Are Unpatentable Over Itou in View of
`Ressemann Or Itou in View of Ressemann and Kataishi ...................13
`
`1.
`
`2.
`
`3.
`
`Substitute Claim 56 ...................................................................13
`
`Substitute Claim 57 ...................................................................23
`
`Substitute Claim 58 ...................................................................25
`
`D.
`
`Substitute Claims 54-58 Are Unpatentable Over Kontos in View
`of Ressemann and Takahashi ..............................................................26
`
`1.
`
`2.
`
`3.
`
`4.
`
`5.
`
`Substitute Claim 54 ...................................................................26
`
`Substitute Claim 55 ...................................................................31
`
`Substitute Claim 56 ...................................................................31
`
`Substitute Claim 57 ...................................................................32
`
`Substitute Claim 58 ...................................................................34
`
`E.
`
`Substitute Claims 54-58 Are Unpatentable Over Kontos in View
`of Ressemann, Takahashi, and Kataishi ..............................................35
`
`V.
`
`Conclusion .....................................................................................................35
`
`
`
`i
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`Case Nos. IPR2020-00132, -00134
`U.S. Patent No. RE45,760
`
`TABLE OF AUTHORITIES
`
` Page(s)
`
`Federal Cases
`
`Gentry Gallery, Inc. v. Berkline Corp.,
`134 F.3d 1473 (Fed. Cir. 1998) ............................................................................ 5
`
`ICU Med., Inc. v. Alaris Med. Sys., Inc.,
`558 F.3d 1368 (Fed. Cir. 2009) .......................................................................... 10
`
`KSR Int’l Co. v. Teleflex, Inc.,
`550 U.S. 398 (2007) ............................................................................................ 19
`
`PowerOasis Inc. v. T-Mobile USA, Inc.,
`522 F.3d 1299 (Fed. Cir. 2008) ............................................................................ 5
`
`In re Schreiber,
`128 F.3d 1473 (Fed. Cir. 1997) .......................................................................... 12
`
`In re Schreiber,
`128 F.3d at 1447 ................................................................................................. 31
`
`Tronzo v. Biomet, Inc.,
`156 F.3d 1154 (Fed. Cir. 1998) ............................................................................ 5
`
`
`
`
`ii
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`

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`Case Nos. IPR2020-00132, -00134
`U.S. Patent No. RE45,760
`
`I.
`
`INTRODUCTION
`
`Medtronic, Inc., and Medtronic Vascular, Inc., (“Petitioner”) opposes Patent
`
`Owner’s Contingent Motion to Amend (Paper 38, “Mot.”). Patent Owner (“PO”)
`
`seeks to amend claims 37-39, 48, and 51 and proposes substitute claims 54-58.
`
`(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 54-56 AND 58 LACK WRITTEN
`DESCRIPTION SUPPORT.
`
`A. Claims reciting a side opening outside of the substantially rigid
`portion lack support.
`
`Claim 25, from which substitute claims 54-56 depend, recites a “guide
`
`extension catheter including, in a proximal to distal direction, a substantially rigid
`
`segment, a segment defining a side opening, and a tubular structure.” (Ex. 1001,
`
`13:53-57.) 1 Similarly, substitute claim 58 recites a “guide extension catheter
`
`including, in a proximal to distal direction, a substantially rigid rail structure
`
`segment, a segment defining a side opening, and a tubular structure comprising a
`
`reinforced portion and a cylindrical distal tip portion.” (App., 5.) A POSITA would
`
`understand that claims 54-56 and 58 require a side opening segment that is separate
`
`
`1 All emphasis and annotations added unless otherwise specified.
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`1
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`U.S. Patent No. RE45,760
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`from (distal to) the substantially rigid segment. (Ex. 1919, ¶¶ 53-56; see also Mot.,
`
`6 (“The claim need not expressly recite that the side opening segment 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, substitute claims 54-56 and 58 should be 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
`
`portions has a specified composition—the tip portion is “a low durometer polymer
`
`
`2 Petitioners cite 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. IPR2020-00132, Paper 38, 3 n.1.
`
`2
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`

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`U.S. Patent No. RE45,760
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`or elastomer”; the reinforced portion is made of PTFE, Pebax®, and may be
`
`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., 6-7, 9-10, 12-13.) 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. 15-16.) 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.,
`
`
`
`
`3 Petitioner uses the as-issued patent drawing—as opposed to the hand-drawn figures
`
`accompanying the patent application—for continuity with the Petition.
`
`3
`
`

`

`Ex. 1842, 16.) Likewise, Figures 12-16 illustrate a side opening in rigid portion
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`Case Nos. IPR2020-00132, -00134
`U.S. Patent No. RE45,760
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`20:
`
`
`
`(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
`
`a partially cylindrical portion defining the opening along a side thereof”), 40-41
`
`4
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`

`

`(similar for original claim 8), 43 (similar for original claim 17); see also Ex. 1919
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`Case Nos. IPR2020-00132, -00134
`U.S. Patent No. RE45,760
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`¶¶ 37-41.)
`
`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 54-56 and 58 attempt to capture this feature, and the feature is not
`
`supported by the written description (either actually or inherently), proposed claims
`
`54-56 and 58 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 54, asserting “[t]he
`
`claim need not expressly recite that the side opening is in the substantially rigid
`
`segment.” (Mot., 6 (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 portion 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
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`5
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`describes alternative proximal openings (e.g., perpendicular end openings), the side
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`opening need not be in the substantially rigid portion (id., ¶¶ 33-35, 39-40, 42).
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`These arguments are absent from PO’s motion, but regardless, both are meritless.
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`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 portion,
`
`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 portion. (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
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`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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`6
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`

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`U.S. Patent No. RE45,760
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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,”
`
`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
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`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
`
`7
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`

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`Case Nos. IPR2020-00132, -00134
`U.S. Patent No. RE45,760
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`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-
`
`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
`
`8
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`Case Nos. IPR2020-00132, -00134
`U.S. Patent No. RE45,760
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`every embodiment is the same, with an opening perpendicular to the longitudinal
`
`axis that is joined to the substantially rigid portion, as illustrated by the boxed
`
`sections below.
`
`
`
`(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
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`reinforced portion of the “distal tube,” as shown in Figure 21, and a “side opening,”
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`9
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`Case Nos. IPR2020-00132, -00134
`U.S. Patent No. RE45,760
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`as shown in Figures 4 and 12-16. (Ex. 2124 ¶¶ 39-40 (asserting the “distal tube’s
`
`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 portion, proposed claims 54-56 and 58 are unpatentable for lack of written
`
`description support under 35 U.S.C. § 112(a).4 See ICU Med., Inc. v. Alaris Med.
`
`
`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.
`
`10
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`Case Nos. IPR2020-00132, -00134
`U.S. Patent No. RE45,760
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`Sys., Inc., 558 F.3d 1368, 1376-77 (Fed. Cir. 2009) (finding a claim invalid 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).
`
`III. PROPOSED CLAIM 58 IS A BROADENING AMENDMENT
`
`Claim 58 also impermissibly broadens claim scope because it allows the
`
`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 51.
`
`IV. THE PRIOR ART RENDERS PROPOSED CLAIMS 54-58
`UNPATENTABLE
`
`PO’s motion should be denied for another independent reason—the substitute
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`claims are unpatentable over the prior art.
`
`A. Claim Construction
`
`No express construction for any terms is necessary except that the term
`
`“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.)
`
`B.
`
`Substitute Claims 54-55 Are Unpatentable Over Itou
`
`1.
`
`Substitute Claim 54
`
`Itou discloses a system comprising a suction catheter 2 (“guide extension
`
`catheter”) for use with a guiding catheter 1 (“guide catheter”). (Ex. 1007, 5:35-38,
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`11
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`5:43-46, 7:1-23, 7:35-43, Figs. 5-6, 8.) Itou’s suction catheter 2 has a wire-like
`
`portion 25 “substantially rigid segment”), proximal tip 23 (i.e., “a segment defining
`
`a side opening”), and tubular member 24 (i.e., “tubular structure”). Tubular portion
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`24 has a uniform, fixed outer diameter of 1.72 mm and inner diameter of 1.5 mm.
`
`(Id., 1:59-65, 2:12-21, 2:23-26, Table 1, Fig. 3.) A lumen of this size is necessarily
`
`configured “to allow entry and passage therethrough of stent catheters.” (Ex. 1903,
`
`¶ 33; see also id., ¶¶ 13-32.) The inner diameter of tubular portion 24 (1.5 mm) is
`
`not more than one French size (0.33 mm) smaller than the inner diameter of guiding
`
`catheter 1 (1.8 mm). (Ex. 1007, Table 1; Ex. 1062, 547; see also Ex. 1903, ¶¶ 13-33.)
`
`2.
`
`Substitute Claim 55
`
`While substitute claim 55 additionally recites “wherein the guide extension
`
`catheter is configured so that, when the tubular structure extends into the coronary
`
`artery, the tubular portion and the substantially rigid segment assist in resisting
`
`forces exerted by stent catheters passed through and beyond the coaxial lumen that
`
`would otherwise tend to dislodge the guide catheter from the artery,” no patentable
`
`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.
`
`1997). Nonetheless, even if this recitation is limiting, Itou discloses the limitations
`
`therein because it discloses a combination a guide catheter and an extension catheter
`
`inserted into a coronary ostium. (Ex. 1903 ¶ 34.)
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`12
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`Case Nos. IPR2020-00132, -00134
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`C.
`
`Substitute Claims 56-58 Are Unpatentable Over Itou in View of
`Ressemann Or Itou in View of Ressemann and Kataishi
`
`Substitute claims 56-58 add to the original claims certain limitations (e.g., the
`
`so-called “complex side opening”). (Mot., 9, 15-16.) But these additions cannot
`
`overcome the prior art of record. The analysis below focuses on the newly added
`
`limitations while briefly addressing
`
`the original
`
`limitations
`
`(Ex. 1903,
`
`¶¶ 48-54, 148), which are thoroughly addressed by the original Petition and
`
`supporting testimonial evidence.
`
`1.
`
`Substitute Claim 56
`
`Both Itou and Ressemann disclose catheters of similar structures that are
`
`extended past the distal end of a guiding catheter and into a coronary artery for the
`
`purpose of treating an occlusion. (Ex. 1007, Figs 1A-B, 5, 6, Abstract, 1:13-18,
`
`1:66-2:5, 3:59-63, 5:32-34, 7:7-10; Ex. 1008, Figs. 6A-F, Abstract, 6:18-24,
`
`12:9-4:39.) To the extent Itou does not disclose “the balloon catheter is elongated
`
`with a distal end,” and “a stent releasably joined to the distal end of the elongate
`
`balloon catheter,” Ressemann does.
`
`Ressemann teaches an “elongate balloon catheter,” stent delivery system 193,
`
`which is used to deliver a stent across a stenosis 180. (Ex. 1008, 13:57-14:16; Figs.
`
`6E-G.)
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`13
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`
`
`(Id., Figs. 6E-G.)
`
`
`
`As illustrated above, in Figure 6E (panels A, B), a “stent delivery system” is
`
`advanced across stenosis (180). (Id., 13:57-60.) Figure 6F (panel C) shows “a stent
`
`delivery balloon is inflated to expand a stent 194 against the vessel wall.” (Id.,
`
`14:7-10.) Figure 6G (panel D) shows the deflation of the balloon after the stent is
`
`in place, (id., 14:14-16), demonstrating that stent 194 is “releasably joined” to the
`
`distal end of “elongate balloon catheter” 193. (Ex. 1903, ¶ 55 Ex. 1005, ¶¶ 278-80.5)
`
`
`5 Unless otherwise noted, all cites to Ex. 1005 and Ex. 1042 are from
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`IPR2020-00132. To complete the record—as those expert declarations were not
`
`submitted in IPR2020-00134—they can also be found at the same paragraph number
`
`in Ex. 1913 and Ex. 1914, respectively. Also, for reasons of conformity, Petitioner
`
`14
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`A POSITA would be motivated to combine the disclosure in Ressemann of a
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`balloon-deliverable stent (i.e., a stent releasably joined to the distal end of the
`
`elongate balloon catheter) with Itou’s suction catheter (2), and have a reasonable
`
`expectation of success. (Ex. 1903, ¶ 56; Ex. 1005, ¶¶ 278-80.)
`
`Complex Side Opening Limitation
`
`Itou discloses tip 23, which includes a proximal side opening 231 that is
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`“inclined obliquely.” (Ex. 1007, 4:10-15.) Proximal side opening 231 is
`
`“substantially rigid” because it is formed by “obliquely cutting one end of a metal
`
`pipe such as a pipe of stainless steel.” (Id., 4:27-30.) While side opening 231 does
`
`not include “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. 1903, ¶¶ 55-86, 164.)
`
`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.
`
`(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
`
`
`cites to the Ex. 10XX series herein, but the same exhibit can also be found at the
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`Ex. 16XX series in IPR2020-00134.
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`15
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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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`(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
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`in Figure 16J, reproduced below, support collar 2141 includes a concave track that
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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. (Id., 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, ¶ 135 (construing claim term
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`“substantially rigid”).)
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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
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`incorporate the structure of Ressemann’s support collar 2141 containing the claimed
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`features of the side opening in substitute claim 56 (as shown in the figure below) so
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`that Itou’s suction catheter 2 could alternatively be used to deliver interventional
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`cardiology devices, as disclosed in Ressemann.
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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
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`or balloon catheter. (Id., Fig. 6, 5:35-42, 7:16-19; Ex. 1005, ¶ 169; Ex. 1903, ¶ 15).
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`And a POSITA would have understood that Itou’s suction catheter lumen was of
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`sufficient inner diameter to accommodate interventional cardiology devices. A
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`POSITA had the motivation to modify suction catheter (2)’s proximal opening with
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`Ressemann’s collar 2141 because this increased the area for receiving a stent and/or
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`balloon catheter. (Ex. 1807, ¶¶ 121-25; Ex. 1903, ¶¶ 57-82.)
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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
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`of the catheter lumen, as well as provide a flexibility transition between the distal
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`tubular structure and the proximal shaft. (Ex. 1008, 24:49-67; Ex. 1005, ¶ 269;
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`Ex. 1806, ¶ 89; Ex. 1807, ¶¶ 126-28; Ex. 1903, ¶¶ 48-54, 230.)
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`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, 2:29-38, 3:59-63, 5:32-34,
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`Figs. 1A-B, 5, 6; Ex. 1008, Abstract, 6:18-24, 12:9-12, 12:19-30, Figs. 6A-B.) 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
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`collar is nothing more than combining prior art elements according to known
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`methods to yield predictable results. KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398,
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`417 (2007); see also Ex. 1903, ¶¶ 82-86.
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`c) Kataishi Discloses a “Complex Side Opening”
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`Kataishi similarly discloses the claimed “complex side opening.” (Ex. 1903,
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`¶¶ 149-50.) 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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`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. 1005,
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`¶ 285; Ex. 1903, ¶¶ 151-53.) Another benefit taught by Kataishi of the two-incline
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`shape is the improved ability to receive material in the opening (e.g., an improved
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`ability to suction thrombi). (Ex. 1025, Abstract, ¶¶ [0026]-[0027]; Ex. 1005, ¶ 285;
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`Ex. 1903, ¶ 154.)
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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. 1005, ¶¶ 287-89; Ex. 1903, ¶¶ 155-64.) Regarding the first benefit, a
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`POSITA would have recognized that improved crossability is a desirable feature in
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`a proximal opening of a short tube for the same reasons as it is desirable in the distal
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`opening of such a tube. (Ex. 1008, 6:52-60 (“The proximal and distal ends 140a,
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`140b of the evacuation lumen 140 are preferably angled to allow for smoother
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`passage . . . .”).) In particular, when retracting the device, the angled features of the
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`Kataishi opening would provide improved crossability as the proximal end would
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`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, ¶¶ 108-09.) 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]-
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`[0027], Fig. 10; Ex. 1055, 6, 10 (disclosing a better ability to load because of two
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`different inclined slopes on the end); Ex. 1005, ¶¶ 285, 287-89; Ex. 1042, ¶¶ 108-
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`09.)
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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 more easily facilitate the entry of interventional cardiology devices. (Ex. 1005,
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`¶¶ 285, 287-89; Ex. 1042, ¶¶ 108-09.)
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`Itou and Kataishi are directed at the same problem—removing occlusions
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`from coronary arteries using, inter alia, a catheter. (Ex. 1007, Abstract; Ex. 1025,
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`Abstract; Ex. 1042, ¶ 104; Ex. 1005, ¶ 286.) A POSITA would have a reasonable
`
`expectation of success in modifying Itou’s suction catheter with the claimed side-
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`opening features, as taught by Kataishi. (Ex. 1005, ¶ 290.) 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, ¶ 110; Ex. 1050, Fig. 7 (disclosing
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`double incline, proximal side opening).)
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`2.
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`Substitute Claim 57
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`The combination of Itou and Ressemann or Kataishi discloses subs