`
`UNITED 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. IPR2020-00132
`Case No. IPR2020-00134
`U.S. Patent No. RE45,760
`_________________
`
`PETITIONER’S OPPOSITION
`TO PATENT OWNER’S MOTION TO AMEND
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`
`
`
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`Case Nos. IPR2020-00132, -00134
`U.S. Patent No. RE45,760
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`TABLE OF CONTENTS
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`Page
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`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
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`III.
`
`Proposed Claim 58 is a Broadening Amendment .........................................11
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`IV. The Prior Art Renders Proposed Claims 54-58 Unpatentable ......................11
`
`A.
`
`B.
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`Claim Construction..............................................................................11
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`Substitute Claims 54-55 Are Unpatentable Over Itou ........................11
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`1.
`
`2.
`
`Substitute Claim 54 ...................................................................11
`
`Substitute Claim 55 ...................................................................12
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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 ...................13
`
`1.
`
`2.
`
`3.
`
`Substitute Claim 56 ...................................................................13
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`Substitute Claim 57 ...................................................................23
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`Substitute Claim 58 ...................................................................25
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`D.
`
`Substitute Claims 54-58 Are Unpatentable Over Kontos in View
`of Ressemann and Takahashi ..............................................................26
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`1.
`
`2.
`
`3.
`
`4.
`
`5.
`
`Substitute Claim 54 ...................................................................26
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`Substitute Claim 55 ...................................................................31
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`Substitute Claim 56 ...................................................................31
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`Substitute Claim 57 ...................................................................32
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`Substitute Claim 58 ...................................................................34
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`E.
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`Substitute Claims 54-58 Are Unpatentable Over Kontos in View
`of Ressemann, Takahashi, and Kataishi ..............................................35
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`V.
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`Conclusion .....................................................................................................35
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`
`
`i
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`Case Nos. IPR2020-00132, -00134
`U.S. Patent No. RE45,760
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`TABLE OF AUTHORITIES
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` 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
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`I.
`
`INTRODUCTION
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`Medtronic, Inc., and Medtronic Vascular, Inc., (“Petitioner”) opposes 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 37-39, 48, and 51 and proposes substitute claims 54-58.
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`(Mot., 1, Appendix A (“App.”).) But the substitute claims are not supported by the
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`original disclosure and are unpatentable over the prior art. PO’s Motion should be
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`denied for all these reasons.
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`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
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`extension catheter including, in a proximal to distal direction, a substantially rigid
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`segment, a segment defining a side opening, and a tubular structure.” (Ex. 1001,
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`13:53-57.) 1 Similarly, substitute claim 58 recites a “guide extension catheter
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`including, in a proximal to distal direction, a substantially rigid rail structure
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`segment, a segment defining a side opening, and a tubular structure comprising a
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`reinforced portion and a cylindrical distal tip portion.” (App., 5.) A POSITA would
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`understand that claims 54-56 and 58 require a side opening segment that is separate
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`1 All emphasis and annotations added unless otherwise specified.
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`1
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`from (distal to) the substantially rigid segment. (Ex. 1919, ¶¶ 53-56; see also Mot.,
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`6 (“The claim need not expressly recite that the side opening segment is in the
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`substantially rigid segment.”).) But the written description exclusively and
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`repeatedly describes the side opening as part of the substantially rigid segment of
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`the claimed device. Thus, substitute claims 54-56 and 58 should be rejected for lack
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`of written description.
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`The original patent application2 describes the invention as a device that is used
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`with “standard guide catheters” in “interventional cardiology procedures.” (Ex.
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`1842, 7-8.) The claims of the original patent application (and the proposed claims
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`here) are generally directed to the “coaxial guide catheter” described in the
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`specification. (See, e.g., id., 38-44; see also POR, 4 (also describing the invention
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`as a “guide extension catheter”).) This coaxial guide catheter is consistently
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`described as being made of three distinct portions: “a tip portion, a reinforced
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`portion, and a substantially rigid portion.” (Ex. 1842, 9; see also id., 16
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`(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
`
`
`2 Petitioners cite the parent patent application—the ’629 application (issued as the
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`’032 patent)—as the parties have stipulated that each application in the priority chain
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`contains substantively identical disclosures. IPR2020-00132, Paper 38, 3 n.1.
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`2
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`or elastomer”; the reinforced portion is made of PTFE, Pebax®, and may be
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`reinforced with “metallic fibers in a braided or coiled pattern”; and the rigid portion
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`is “formed from a stainless steel or Nitinol tube.” (Id., 9.)
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`The only portions of the specification that describe a side opening are in the
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`parts describing the “rigid portion.” (Id., 9-10, 13-20, 38-41, 43, Figs. 4, 12-16; see
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`also Ex. 1919 ¶¶ 28-41, 46-47.) Indeed, PO points to these portions as supporting
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`the “side opening” limitations of the proposed claims. (Mot., 6-7, 9-10, 12-13.) For
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`instance, PO frequently points to Figure 4 of the specification as providing support
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`for the side opening of the claims:
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`(Ex. 1001, Fig. 43 (color and annotations added); see Mot. 15-16.) In the figure
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`above, the alleged “side opening” (boxed in red) is included in the portion
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`designated by the reference numeral 20, which is the “rigid portion.” (See, e.g.,
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`
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`3 Petitioner uses the as-issued patent drawing—as opposed to the hand-drawn figures
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`accompanying the patent application—for continuity with the Petition.
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`3
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`
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`Ex. 1842, 16.) Likewise, Figures 12-16 illustrate a side opening in rigid portion
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`U.S. Patent No. RE45,760
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`20:
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`
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`(Ex. 1001, Figs. 12-16 (color and annotations added).)
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`Nowhere does the specification describe a side opening outside of the rigid
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`portion. (Ex. 1919 ¶¶ 28-36, 46-47.) And the originally filed claims of the ʼ629
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`application (which are part of the written description) confirm that the side opening
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`is located in the “substantially rigid portion.” (Ex. 1842, 38 (original claim 1 reciting
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`a “substantially rigid portion having an opening along a side thereof”), 39 (original
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`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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`4
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`
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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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`For a claim to have written description support, the specification must
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`“actually or inherently disclose[] the claim element”; obviousness is not sufficient.
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`PowerOasis Inc. v. T-Mobile USA, Inc., 522 F.3d 1299, 1306-07 (Fed. Cir. 2008);
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`see also Tronzo v. Biomet, Inc., 156 F.3d 1154, 1158 (Fed. Cir. 1998). Because
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`proposed claims 54-56 and 58 attempt to capture this feature, and the feature is not
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`supported by the written description (either actually or inherently), proposed claims
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`54-56 and 58 are unpatentable. See Gentry Gallery, Inc. v. Berkline Corp., 134 F.3d
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`1473, 1479-80 (Fed. Cir. 1998) (rejecting claims that did not limit the location of the
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`claimed “controls” where “the original disclosure clearly identifies the console as
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`the only possible location for the controls”).
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`PO’s Motion largely ignores this glaring defect in the proposed claims,
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`addressing it only in a single sentence regarding proposed claim 54, asserting “[t]he
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`claim need not expressly recite that the side opening is in the substantially rigid
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`segment.” (Mot., 6 (citing Ex. 2124, ¶¶ 30-44, 51).) PO’s Motion, however,
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`provides no rationale for why this is so, and it relies entirely on the arguments made
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`in its expert’s declaration. Those arguments boil down to two assertions: (1) that the
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`substantially rigid portion need not be substantially rigid because it can be designed
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`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
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`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
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`possession of a device with a side opening outside of the substantially rigid portion,
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`as claimed. PO’s expert fixated on the wrong question: whether the side opening
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`can be made less rigid despite being in the substantially rigid portion. (Id., ¶ 31; see
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`also id., ¶ 41.) But he was forced to admit that there is no description of a side
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`opening in the reinforced portion, and all examples are in rigid portion 20 and were
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`“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.,
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`20:4-7.) Whether or not the rigid tubular material of the rigid portion can be
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`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
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`application as the “rigid portion” or the “substantially rigid portion.” (See, e.g.,
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`Ex. 1842, 16; see also Ex. 1919 ¶¶ 71-72.)
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`6
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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
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`application describes a “range of options . . . for the distal tube’s proximal opening,”
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`but announces only two—a proximal opening perpendicular to the longitudinal axis
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`(i.e., an end opening) and a side opening extending longitudinally. (Ex. 2124
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`¶¶ 33-35, 39-40, 42.) To begin, PO’s expert’s use of the term “distal tube”—a term
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`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,
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`however, dispels this confusion and confirms that the “side opening” described is
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`located only in the “rigid portion.” (See, e.g., Ex. 1842, 10, 18, 19.)
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`PO’s expert points to Figure 21 as an alternative configuration for “the distal
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`tube’s proximal opening”—an opening perpendicular to the longitudinal axis.
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`(Ex. 2124 ¶¶ 34, 39.)
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`
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`(Ex. 1001, Fig. 21 (annotation added); see also id., Fig. 1 (showing a similar
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`configuration).)
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`As admitted by PO’s expert, though, Figure 21 does not show a side opening.
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`(Ex. 1764, 16:19-24.) For instance, PO distinguished the end opening shown in
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`Figure 21 from a side opening (i.e., “a cylindrical portion defining an opening along
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`7
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`U.S. Patent No. RE45,760
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`a side thereof”) during prosecution of the ’032 patent (the family’s parent).
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`(Ex. 1906, 11, 13.) To gain issuance of that parent patent, PO argued that the below-
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`prior art “disclose[d] no ‘opening along a side’” and that “[t]hese ends are not
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`generally parallel to a long axis.” (Id., 13.)
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`
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`PO cannot now point to a similar disclosure, Figure 21, to provide written
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`description support for a side opening. What is more, in past litigation, PO’s expert,
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`Mr. Keith, distinguished a side opening from the type of opening identified in Figure
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`21. (Ex. 1825 ¶¶ 81-83.)
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`In the Figure 21 embodiment, the rigid portion includes no “full
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`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
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`a cylinder and is “joined to braided portion 112 [i.e., the ‘reinforced portion’ of the
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`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
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`Figures 12-16 is that the rigid portion in the Figure 4 and Figures 12-16 embodiments
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`include a full circumference portion and a side opening. The reinforced portion in
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`8
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`every embodiment is the same, with an opening perpendicular to the longitudinal
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`axis that is joined to the substantially rigid portion, as illustrated by the boxed
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`sections below.
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`
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`(Ex. 1001, Figs. 4, 12-13 (annotations added).)
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`The fact that the rigid portion may or may not include a side opening does not
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`mean that the specification provides written description of a side opening outside of
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`the rigid portion, as PO’s expert asserts. (See Ex. 2124 ¶ 35 (identifying the
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`specification’s permissive language that the “rigid portion may include a cutout
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`portion and a full circumference portion.”) (emphasis original).) Indeed, PO’s expert
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`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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`as shown in Figures 4 and 12-16. (Ex. 2124 ¶¶ 39-40 (asserting the “distal tube’s
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`proximal opening . . . can be perpendicular” or “[i]t also can be a side opening with
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`various sloped configurations.”).) Importantly, in denying a motion for preliminary
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`injunction, the District Court rejected PO’s argument that use of the word “may” in
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`the specification indicated that the location of the side opening could be outside of
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`the rigid segment. (Ex. 1088, 8.)
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`Because there is no support for a side opening outside of the substantially
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`rigid portion, proposed claims 54-56 and 58 are unpatentable for lack of written
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`description support under 35 U.S.C. § 112(a).4 See ICU Med., Inc. v. Alaris Med.
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`4 PO’s expert also includes an argument based on the prosecution history of a
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`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,
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`contradicts PO’s argument. The Examiner explicitly rejected the pending claims for
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`the exact reasons urged by Petitioners here—because the patent “is very clear that
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`the side opening . . . is a part of rigid portion 20 and not its own segment apart from
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`the rigid portion.” (Ex. 1908, 41-42; see also Ex. 1919 ¶¶ 42-45.) And although it
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`is unclear how PO overcame this rejection (because the Examiner’s notice of
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`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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`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
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`lack of written description support when the full claim scope covered valves with
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`and without spikes but the specification only disclosed valves with spikes).
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`III. PROPOSED CLAIM 58 IS A BROADENING AMENDMENT
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`Claim 58 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
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`0.014 inches, which is more than “1 French” (0.0131 inches) as required by original
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`claim 51.
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`IV. THE PRIOR ART RENDERS PROPOSED CLAIMS 54-58
`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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`in the same direction as the axis of lumen of the guide catheter.” (Ex. 1806,
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`¶¶ 14-26.)
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`B.
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`Substitute Claims 54-55 Are Unpatentable Over Itou
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`1.
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`Substitute Claim 54
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`Itou discloses a system comprising a suction catheter 2 (“guide extension
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`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
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`portion 25 “substantially rigid segment”), proximal tip 23 (i.e., “a segment defining
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`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.
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`(Id., 1:59-65, 2:12-21, 2:23-26, Table 1, Fig. 3.) A lumen of this size is necessarily
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`configured “to allow entry and passage therethrough of stent catheters.” (Ex. 1903,
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`¶ 33; see also id., ¶¶ 13-32.) The inner diameter of tubular portion 24 (1.5 mm) is
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`not more than one French size (0.33 mm) smaller than the inner diameter of guiding
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`catheter 1 (1.8 mm). (Ex. 1007, Table 1; Ex. 1062, 547; see also Ex. 1903, ¶¶ 13-33.)
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`2.
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`Substitute Claim 55
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`While substitute claim 55 additionally recites “wherein the guide extension
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`catheter is configured so that, when the tubular structure extends into the coronary
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`artery, the tubular portion and the substantially rigid segment assist in resisting
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`forces exerted by stent catheters 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
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`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
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`therein because it discloses a combination a guide catheter and an extension catheter
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`inserted into a coronary ostium. (Ex. 1903 ¶ 34.)
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`12
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`C.
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`Substitute Claims 56-58 Are Unpatentable Over Itou in View of
`Ressemann Or Itou in View of Ressemann and Kataishi
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`Substitute claims 56-58 add to the original claims certain limitations (e.g., the
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`so-called “complex side opening”). (Mot., 9, 15-16.) But these additions cannot
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`overcome the prior art of record. The analysis below focuses on the newly added
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`limitations while briefly addressing
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`the original
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`limitations
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`(Ex. 1903,
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`¶¶ 48-54, 148), which are thoroughly addressed by the original Petition and
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`supporting testimonial evidence.
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`1.
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`Substitute Claim 56
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`Both Itou and Ressemann disclose catheters of similar structures that are
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`extended past the distal end of a guiding catheter and into a coronary artery for the
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`purpose of treating an occlusion. (Ex. 1007, Figs 1A-B, 5, 6, Abstract, 1:13-18,
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`1:66-2:5, 3:59-63, 5:32-34, 7:7-10; Ex. 1008, Figs. 6A-F, Abstract, 6:18-24,
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`12:9-4:39.) To the extent Itou does not disclose “the balloon catheter is elongated
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`with a distal end,” and “a stent releasably joined to the distal end of the elongate
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`balloon catheter,” Ressemann does.
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`Ressemann teaches an “elongate balloon catheter,” stent delivery system 193,
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`which is used to deliver a stent across a stenosis 180. (Ex. 1008, 13:57-14:16; Figs.
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`6E-G.)
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`13
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`(Id., Figs. 6E-G.)
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`
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`As illustrated above, in Figure 6E (panels A, B), a “stent delivery system” is
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`advanced across stenosis (180). (Id., 13:57-60.) Figure 6F (panel C) shows “a stent
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`delivery balloon is inflated to expand a stent 194 against the vessel wall.” (Id.,
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`14:7-10.) Figure 6G (panel D) shows the deflation of the balloon after the stent is
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`in place, (id., 14:14-16), demonstrating that stent 194 is “releasably joined” to the
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`distal end of “elongate balloon catheter” 193. (Ex. 1903, ¶ 55 Ex. 1005, ¶¶ 278-80.5)
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`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
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`submitted in IPR2020-00134—they can also be found at the same paragraph number
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`in Ex. 1913 and Ex. 1914, respectively. Also, for reasons of conformity, Petitioner
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`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
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`elongate balloon catheter) with Itou’s suction catheter (2), and have a reasonable
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`expectation of success. (Ex. 1903, ¶ 56; Ex. 1005, ¶¶ 278-80.)
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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.” (Ex. 1007, 4:10-15.) 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.) While side opening 231 does
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`not include “two inclined slopes separated by a non-inclined concave track,” it
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`would have been obvious to modify Itou to include such features in view of
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`Ressemann or Kataishi. (Ex. 1903, ¶¶ 55-86, 164.)
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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
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`positioned within the ostium of the target vessel” (id., 12:26-27), and an evacuation
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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. 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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`(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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`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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`(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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`(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
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`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