`
`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. IPR2020-00126
`Case No. IPR2020-00127
`U.S. Patent No. 8,048,032
`_________________
`
`PETITIONER’S OPPOSITION
`TO PATENT OWNER’S MOTION TO AMEND
`
`
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`Case Nos. IPR2020-00126, -00127
`U.S. Patent No. 8,048,032
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`TABLE OF CONTENTS
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`Page
`
`I.
`
`II.
`
`Introduction ...................................................................................................... 1
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`Proposed Claims 23-25 Lack Written Description or Are Indefinite. ............. 1
`
`A.
`
`Claims reciting a side opening outside of the substantially rigid
`portion lack support. .............................................................................. 1
`
`B.
`
`Proposed claims 23-25 are indefinite. .................................................11
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`III. The Prior Art Renders Proposed Claims 23-25 Unpatentable ......................11
`
`A.
`
`B.
`
`Claim Construction..............................................................................12
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`Substitute claims 23-25 are unpatentable over Itou in view of
`Ressemann or Kataishi. .......................................................................12
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`1.
`
`2.
`
`3.
`
`Substitute Claim 23 ...................................................................12
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`Substitute Claim 24 ...................................................................22
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`Substitute Claim 25 ...................................................................24
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`C.
`
`Substitute claims 23-25 are unpatentable over Kontos in view of
`Ressemann and Takahashi. .................................................................25
`
`1.
`
`2.
`
`3.
`
`Substitute Claim 23 ...................................................................25
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`Substitute Claim 24 ...................................................................30
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`Substitute Claim 25 ...................................................................35
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`D.
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`Combining Kontos with Kataishi for Claims 23-25 ...........................35
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`IV. Conclusion .....................................................................................................35
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`
`
`
`
`i
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`Case Nos. IPR2020-00126, -00127
`U.S. Patent No. 8,048,032
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`TABLE OF AUTHORITIES
`
` Page(s)
`
`Federal Cases
`
`Gentry Gallery, Inc. v. Berkline Corp.,
`134 F.3d 1473 (Fed. Cir. 1998) ............................................................................ 5
`
`ICU Medical, Inc. v. Alaris Medical Sys., Inc.,
`558 F.3d 1368 (Fed. Cir. 2009) .......................................................................... 10
`
`KSR Int’l Co. v. Teleflex, Inc.,
`550 U.S. 398 (2007) ............................................................................................ 18
`
`PowerOasis Inc. v. T-Mobile USA, Inc.,
`522 F.3d 1299 (Fed. Cir. 2008) ............................................................................ 4
`
`In re Schreiber,
`128 F.3d 1473 (Fed. Cir. 1997) .......................................................................... 23
`
`Tronzo v. Biomet, Inc.,
`156 F.3d 1154 (Fed. Cir. 1998) ............................................................................ 5
`
`
`
`
`ii
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`
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`Case Nos. IPR2020-00126, -00127
`U.S. Patent No. 8,048,032
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`I.
`
`INTRODUCTION
`
`Medtronic, Inc., and Medtronic Vascular, Inc., (“Petitioner”) opposes Patent
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`Owner’s Contingent Motion to Amend (Paper 38, “Mot.”). Ptent Owner (“PO”)
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`seeks to amend claims 1, 11, and 16 and proposes substitute claims 23-25. (Mot., 1,
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`Appendix A (“App.”).) But the substitute claims are not supported by the original
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`disclosure and are unpatentable over the prior art. PO’s Motion should be denied.
`
`II.
`
`PROPOSED CLAIMS 23-25 LACK WRITTEN DESCRIPTION OR
`ARE INDEFINITE.
`
`A. Claims reciting a side opening outside of the substantially rigid
`portion lack support.
`
`Proposed claim 23 recites a “device for use with a standard 6 French guide
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`catheter … comprising, in a distal-to-proximal direction … a flexible tip portion …
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`[a] side opening … and a substantially rigid portion[.]” (App., 1-2.)1 Similarly,
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`proposed claim 24 recites “a side opening positioned between a proximal end of the
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`reinforced portion and a distal end of the substantially rigid portion.” (Id., 4.) A
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`POSITA would understand that claims 23 and 24 require a side opening that is
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`separate from (distal to) the “substantially rigid portion.” (Ex. 1919, ¶¶ 48-52;
`
`see also Mot., 4 (“The claim need not expressly recite that the side opening is in the
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`substantially rigid segment.”).) But the written description exclusively and
`
`
`1 All emphasis and annotations added unless otherwise specified.
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`1
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`Case Nos. IPR2020-00126, -00127
`U.S. Patent No. 8,048,032
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`repeatedly describes the side opening as part of the substantially rigid portion of the
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`claimed device. Thus, proposed claims 23 and 24 should be rejected for lack of
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`written description.
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`The original patent application describes the invention as a device that is used
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`with “standard guide catheters” in “interventional cardiology procedures.”
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`(Ex. 1842, 7-8.) The claims of the original patent application (and the proposed
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`claims 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
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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;
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`see also Ex. 1919, ¶¶ 28-41, 46-47.) Indeed, PO points to these portions as
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`supporting the “side opening” limitations of the proposed claims. (Mot., 4, 7.)
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`2
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`Case Nos. IPR2020-00126, -00127
`U.S. Patent No. 8,048,032
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`For instance, PO frequently points to Figure 4 of the specification as providing
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`support for the side opening of the claims:
`
`
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`(Ex. 1001, Fig. 42 (color and annotations added); see Mot. 9-10.). 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.,
`
`Ex. 1842, 16.) Likewise, Figures 12-16 illustrate a side opening in rigid portion
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`20:
`
`
`2 Petitioner uses the as-issued patent drawing—as opposed to the hand-drawn figures
`
`accompanying the patent application—for continuity with the Petition. The parties
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`stipulated that each application in the priority chain contains substantively identical
`
`disclosures. (IPR2020-00126, Paper 38, 2 n.1.)
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`3
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`Case Nos. IPR2020-00126, -00127
`U.S. Patent No. 8,048,032
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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
`
`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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`(similar for original claim 8), 43 (similar for original claim 17); see also
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`Ex. 1919, ¶¶ 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.
`
`PowerOasis Inc. v. T-Mobile USA, Inc., 522 F.3d 1299, 1306-07 (Fed. Cir. 2008);
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`4
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`Case Nos. IPR2020-00126, -00127
`U.S. Patent No. 8,048,032
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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 23 and 24 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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`23 and 24 are unpatentable. See Gentry Gallery, Inc. v. Berkline Corp.,
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`134 F.3d 1473, 1479-80 (Fed. Cir. 1998) (rejecting claims that did not limit the
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`location of the claimed “controls” where “the original disclosure clearly identifies
`
`the console as 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 23, asserting “[t]he
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`claim need not expressly recite that the side opening is in the substantially rigid
`
`segment.” (Mot., 4 (citing Ex. 2124, ¶¶ 30-44, 51); see also id., 7 (ignoring this
`
`defect for the “side opening” limitation in proposed claim 24).) PO’s Motion,
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`however, provides no rationale for why this is so, and it relies entirely on the
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`arguments made in its expert’s declaration. Those arguments boil down to two
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`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
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`(2) because the specification describes alternative proximal openings (e.g.,
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`perpendicular end openings), the side opening need not be in the substantially rigid
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`portion (id., ¶¶ 33-35, 39-40, 42). These arguments are absent from PO’s motion,
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`but regardless, both are meritless.
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`5
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`Case Nos. IPR2020-00126, -00127
`U.S. Patent No. 8,048,032
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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;
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`see 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.
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`(Id., 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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`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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`6
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`Case Nos. IPR2020-00126, -00127
`U.S. Patent No. 8,048,032
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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.)
`
`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.
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`(Ex. 2124, ¶¶ 34, 39.)
`
`
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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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`a side thereof”) during prosecution. (Ex. 1906, 11, 13.) To gain issuance of the ʼ032
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`patent, PO argued that the below-prior art “disclose[d] no ‘opening along a side’”
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`and that “[t]hese ends are not generally parallel to a long axis.” (Id., 13.)
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`7
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`Case Nos. IPR2020-00126, -00127
`U.S. Patent No. 8,048,032
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`
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`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,
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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
`
`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 the braided portion 112 [i.e., the ‘reinforced portion’ of
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`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
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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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`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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`8
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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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`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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`9
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`Case Nos. IPR2020-00126, -00127
`U.S. Patent No. 8,048,032
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`Because there is no support for a side opening outside of the substantially
`
`rigid portion, proposed substitute claims 23 and 24 are unpatentable for lack of
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`written description support under 35 U.S.C. § 112(a).3 See ICU Medical, Inc. v.
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`Alaris Medical Sys., Inc., 558 F.3d 1368, 1376-77 (Fed. Cir. 2009) (finding a claim
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`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
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`spikes).
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`3 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 Petitioner here—because the patent “is very clear that the
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`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
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`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. IPR2020-00126, -00127
`U.S. Patent No. 8,048,032
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`B.
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`Proposed claims 23-25 are indefinite.
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`Proposed claim 23 requires that the length of the substantially rigid portion
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`“when combined with the length of the flexible [] tip portion, defines a total length
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`of the device.” (App., 1-2.) But the proposed claim now recites a “substantially
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`rigid side opening” that is outside of both the “flexible tip portion” and the
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`“substantially rigid portion.” It is unclear how the device can also include such a
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`“side opening” when the total length of the device is defined by the combination of
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`“flexible tip portion” and the “substantially rigid portion.” Proposed claim 23 is
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`therefore indefinite.
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`Proposed claim 24 is indefinite for two reasons. First, it recites a
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`“substantially rigid portion . . . connected to . . . the flexible tip portion,” even though
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`there is an intervening “reinforced portion.” (App., 2-4.) Based on the plain
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`meaning of the word “connected,” the claim makes little sense and is indefinite.
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`Second, there is no antecedent basis for “substantially rigid segment.” (Id., 4.)
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`Proposed claim 25 is also indefinite based on its dependency.
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`III. THE PRIOR ART RENDERS PROPOSED CLAIMS 23-25
`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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`11
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`Case Nos. IPR2020-00126, -00127
`U.S. Patent No. 8,048,032
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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
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`the same direction as
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`the axis of
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`lumen of
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`the guide catheter.”
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`(Ex. 1806, ¶¶ 14-26.)
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`B.
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`Substitute claims 23-25 are unpatentable over Itou in view of
`Ressemann or Kataishi.
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`Substitute claims 23 and 24 add to the original claims certain limitations
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`(e.g., the so-called “complex side opening”). (Mot., 9.) 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 the original limitations, which are thoroughly
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`addressed by the original Petition and supporting testimonial evidence.
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`1.
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`Substitute Claim 23
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`Itou discloses a suction catheter 2 (“device”) for use with a guiding catheter 1
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`(“guide catheter”). (Ex. 1007, 5:35-38, 5:43-46, 7:1-23, 7:35-43, Figs. 5-6, 8.) There
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`is no dispute the guiding catheter 1 is placed in a branch artery and has a continuous
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`lumen with a proximal end at a hemostatic valve and that interventional cardiology
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`devices can be inserted therethrough. (Ex. 1900, ¶¶ 12-16, 62-74.) Moreover,
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`guiding catheter 1 can be 6 French. (Ex. 1007, 5:65-67, 6:47-50; Ex. 1900, ¶¶ 14,
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`18, 88.)
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`12
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`Itou’s suction catheter 2 (i.e. “a device”) comprises, in a distal-to-proximal
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`direction, tubular portion (21) and tip (22) (collectively, “flexible tip portion”) that
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`are part of tubular member (24). (Ex. 1007, 2:12-21, Fig. 3.) Tubular portion 24
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`(and therefore, flexible tip portion [21, 22]) have an inner diameter of 1.5 mm
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`(id., Table 1, 1:59-65), which is larger than 0.056 inches (1.42 mm). (Ex. 1900,
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`¶¶ 17-18.) It is necessarily the case that interventional cardiology devices
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`(e.g., PTCA balloons and stents) were insertable through the lumen of Itou’s
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`“flexible tip portion.” (Ex. 2127, 2; Ex. 1900, ¶ 18.) The entirety of tubular member
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`24 (which includes what Medtronic maps as the “flexible tip portion”) is a “coaxial
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`lumen.” (Section III.A, supra.) Finally, proximal of the side opening discussed
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`below, catheter 2’s wire-like portion 25 forms a “substantially rigid portion” that
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`defines a rail structure without a lumen. (Ex. 1900, ¶¶ 19-61.)
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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.) As shown in the annotation of Figure 3,
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`infra Section III.B.1.b., proximal opening 231 extends for a distance from (a) to (b)
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`along the longitudinal axis of suction catheter 2, which forms a “side opening” to,
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`inter alia, “assure a large opening area on the proximal end side.” (Id.) Proximal
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`side opening 231 is “substantially rigid” because it is formed by “obliquely cutting
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`one end of a metal pipe such as a pipe of stainless steel.” (Id., 4:27-30.)
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`13
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`While Itou’s side opening 231 does not include “a first inclined region,” “a
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`second inclined region,” and “a non-inclined concave track” between the first and
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`second inclined regions, it would have been obvious to modify Itou to include such
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`features in view of Ressemann or Kataishi. (Ex. 1900, ¶¶ 19, 55-61, 101-18.)
`
`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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`sheath that is inserted through the guiding catheter and advanced beyond the guiding
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`catheter’s distal end to treat stenosis. (Id., Abstract; Figs. 6A-6F; 6:18-24;
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`12:9-14:39.)
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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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`
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`towards the stenosis).)
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`14
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`U.S. Patent No. 8,048,032
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`In one embodiment, Ressemann’s evacuation sheath includes a support
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`collar 2141 on the proximal end of the tubular portion of the evacuation sheath.
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`(Ex. 1900, ¶¶ 20-24.) As shown in Figure 16J, reproduced below, support
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`collar 2141 includes a concave track that runs from the proximal to the distal end of
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`the collar. Circumferential portion 2141a fits into the proximal opening of the
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`tubular portion’s lumen. (Ex. 1008, 24:54-56.)
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`
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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
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`flat, non-inclined
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`region
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`in-between.
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`(Ex. 1800, 166:8-12, 168:9-19
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`15
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`(identifying two inclines); see also Ex. 1005 ¶ 1384 (IPR2020-00126) (construing
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`claim term “substantially rigid”).)
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`
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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 claims 23 and 24 (as shown in Figure 3
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`4 Unless otherwise noted, all cites to Ex. 1005 and Ex. 1042 are from
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`IPR2020-00126. To complete the record—as those expert declarations were not
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`submitted in IPR2020-00127—they can also be found at the same paragraph number
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`in Ex. 1909 and Ex. 1910, respectively.
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`16
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`below) so that Itou’s suction catheter 2 could alternatively be used to deliver
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`interventional cardiology devices, as disclosed in Ressemann.
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`(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. (Ex. 1007, Fig. 6; 5:35-42; 7:16-19; Ex. 1900, ¶ 19.) And a
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`POSITA would have understood that Itou’s suction catheter lumen was of sufficient
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`inner diameter to accommodate interventional cardiology devices. A POSITA had
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`the motivation to modify the 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. 1900, ¶¶ 20-61; Ex. 1807, ¶¶ 121-25.)
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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. 1900, ¶ 58;
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`Ex. 1806, ¶ 89; Ex. 1807, ¶ 126-128.)
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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. 1007, Abstract; 1:13-16; 2:2-5, 29-38; 3:59-63; 5:32-34; Figs. 1A, 1B, 5, 6;
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`Ex. 1008, Abstract, 6:18-24; 12:9-12, 12:19-30; Figs. 6A, 6B.) A POSITA would
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`have had a reasonable expectation of success because modifying the side opening of
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`Itou’s suction catheter to have the structure of Ressemann’s support collar is nothing
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`more than combining prior art elements according to known methods to yield
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`predictable results. KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398, 417 (2007).
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`c) Kataishi Discloses a “Complex Side Opening”
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`Kataishi similarly discloses
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`the claimed “complex side opening.”
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`(Ex. 1900, ¶¶ 97-108.) Kataishi discloses a suction catheter for removing a
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`thrombus from a coronary artery. (Ex. 1025, ¶ [0001].) Kataishi’s suction catheter
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`has a distal opening extending along the longitudinal axis with two inclines and a
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`non-inclined concave track in-between:
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`(Id., Figs. 2, 12, ¶ [0010].) This shape is nearly identical to that taught in the ’032
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`patent in Figure 4 (the figure PO frequently identifies as providing support for this
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`“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]; Ex. 1900,
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`¶¶ 105-07.) Another benefit taught by Kataishi of the two-incline shape is the
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`improved ability to receive material in the opening (e.g., an improved ability to
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`suction thrombi). (Ex. 1025, Abstract [0026]-[0027]; Ex. 1900, ¶ 108.)
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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. 1900, ¶¶ 109-18.) Regarding the first benefit, a POSITA would have
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`recognized that improved crossability is a desirable feature in a proximal opening of
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`a short tube for the same reasons as it is desirable in the distal opening of such a
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`tube. (Ex. 1008, 6:52-60 (“The proximal and distal ends 140a, 140b of the
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`evacuation lumen 140 are preferably angled to allow for smoother passage . . . .”).)
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`In particular, when retracting the device, the angled features of the Kataishi opening
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`would provide improved crossability as the proximal end would then be the leading
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`side.
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`For the second benefit, a POSITA would have recognized that the improved
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`ability of an opening to accept material would have been applicable to a proximal
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`opening accepting interventional cardiology devices in the same way as it improved
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`Kataishi’s distal end to suction a thrombus. (Ex. 1907, ¶ 119.) Allowing an
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`improved entry of materials into the lumen of Itou’s suction catheter without
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`increasing the diameter of the device would have been desirable to a POSITA, who
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`would have understood that this modification allows the catheter to receive a therapy
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`catheter and still be advanced to distal locations into the coronary vasculature
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`(compared to catheters with larger diameters). (Ex. 1025, Abstract, [0026]-[0027],
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`Fig. 10; Ex. 1055, 6, 10 (disclosing a better ability to load because of shape of distal
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`opening); Ex. 1900, ¶¶ 108-17; Ex. 1907, ¶¶ 113-15, 119.)
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`Thus, a POSITA would have been motivated to modify Itou’s proximal tip 23
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`to incorporate the shape of Kataishi’s opening to improve crossability of the devices
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`and to more easily facilitate the entry of interventional cardiology devices.
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`(Ex. 1900, ¶¶ 109-18; Ex. 1907, ¶¶ 120-22; Ex. 1055, 6.)
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`A POSITA would have looked to Kataishi to improve Itou because Itou and
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`Kataishi are all directed at the same problem—removing occlusions from coronary
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`arteries using, inter alia, a catheter. (Ex. 1007, Abstract; Ex. 1025, Abstract;
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`Ex. 1907, ¶ 112; Ex. 1900 ¶ 110.) A POSITA would have a reasonable expectation
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`of success in modifying Itou’s suction catheter with the claimed side opening
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`features, as taught by Kataishi. (Ex. 1900, ¶¶ 111-17.) 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. 1907, ¶ 123; Ex. 1050, Fig. 7 (disclosing
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`double incline, proximal side opening).
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`Itou’s wire-like portion 25 is a “substantially rigid portion” at least some
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`portion of which extends proximally through the hemostatic valve when a distal
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`portion of the “flexible tip portion” (i.e. 21+22) extends distally of the distal end of
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`guiding catheter 1. (Ex. 1900, ¶¶ 119-28; Ex. 1007, 5:26-46, Figs. 5, 6.)
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`2.
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`Substitute Claim 24
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`Itou discloses substitute claim 24 for similar reasons discussed above for
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`substitute claim 23. (Ex. 1900, ¶¶ 75-77, 80-81, 129-136.) The following discussion
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`focusses on aspects of claim 24 that are different from claim 23.
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`First, Itou’s suction catheter 2 (i.e. “a device”) is an elongated structure having
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`an overall length that is longer than that of guiding catheter 1. (Ex. 1007, 2:23-26.)
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`Itou’s tip 22 is a “flexible tip portion” and tubular body portion 21 is a “reinforced
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`portion.” (Id., 2:12-21, 2:23-26, Fig. 3.) Tubular portion 24 (and thus “reinforced
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`portion” 21) has a uniform, fixed cross-sectional outer diameter of 1.72 mm. (Id.)
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`The entirety of tubular member 24 (which includes what Medtronic maps as the
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`“flexible tip portion” and the “reinforced portion”) is a “coaxial lumen.” Itou’s
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`suction catheter 2 further comprises wire-like portion 25 (i.e., “substantially rigid
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`portion”), proximal of and connected to tip 22. (Id., 2:15-21, Figs 1B, 1E, 5,
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`5:11-23.) Itou in view of Ressemann or Kataishi discloses the “complex” side
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`opening limitation for reasons discussed above in Section III.B.1, supra. The side
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`opening is positioned between the “reinforced portion” and the wire portion 24
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`(“substantially rigid portion”). (Ex. 1900, ¶¶ 78-80(i).)
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`While substitute claim 24 additionally recites “the reinforced portion and the
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`substantially rigid segment assist in resisting forces exerted by the interventional
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`cardiology devices passed through and beyond the coaxial lumen that would
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`otherwise tend to dislodge the guide catheter from the artery,” no patentable weight
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`should be given to such “recitation of a new intended use” for stru