IPR2020-01341, -01342
`Patent 8,142,413
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
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`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`MEDTRONIC, INC., AND MEDTRONIC VASCULAR, INC.,
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`Petitioner,
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`v.
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`TELEFLEX LIFE SCIENCES LIMITED,
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`Patent Owner.
`
`
`
`
`Case No. IPR2020-01341
`Case No. IPR2020-01342
`U.S. Patent No. 8,142,413
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`
`
`
`
`
`PETITIONER’S OPPOSITION TO
`PATENT OWNER’S CONTINGENT MOTION TO AMEND
`
`
`
`
`
`
`Patent 8,142,413
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`
`
`
`MEDTRONIC, INC., AND MEDTRONIC VASCULAR, INC.,
`
`Petitioner,
`
`v.
`
`TELEFLEX LIFE SCIENCES LIMITED,
`
`Patent Owner.
`
`
`
`
`Case No. IPR2020-01341
`Case No. IPR2020-01342
`U.S. Patent No. 8,142,413
`
`
`
`
`
`
`PETITIONER’S OPPOSITION TO
`PATENT OWNER’S CONTINGENT MOTION TO AMEND
`
`
`
`
`
`
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`IPR2020-01341, -01342
`Patent 8,142,413
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`TABLE OF CONTENTS
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`I.
`II.
`
`B.
`
`INTRODUCTION ........................................................................................... 1
`PROPOSED CLAIMS 15-17 ARE UNPATENTABLE. ............................... 1
`A.
`Substitute claims 15-17 are unpatentable over Itou in view of
`Ressemann or Kataishi. ......................................................................... 1
`1.
`Substitute Claim 15 ..................................................................... 2
`2.
`Substitute Claim 16 ..................................................................... 6
`3.
`Substitute Claim 17 ..................................................................... 7
`Substitute claims 15-17 are unpatentable over Kontos in view of
`Ressemann and Takahashi and/or Kataishi. ........................................12
`1.
`Substitute claims 15-17 are unpatentable over Kontos in
`view of Ressemann and Takahashi. ..........................................13
`Substitute claim 17 is unpatentable over Kontos in view of
`Ressemann, Takahashi, and Kataishi. .......................................18
`SECONDARY CONSIDERATIONS DO NOT OVERCOME THE
`STRONG SHOWING OF OBVIOUSNESS. ...............................................19
`A.
`Teleflex is not entitled to a presumption of nexus. .............................19
`B.
`Teleflex’s secondary consideration evidence all relates to prior
`art features and functionality. ..............................................................22
`1.
`Teleflex’s alleged evidence of copying is actually copying
`of the prior art. ..........................................................................23
`2. Medtronic did not copy GuideLiner. ........................................24
`IV. CONCLUSION ..............................................................................................25
`
`
`2.
`
`III.
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`
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`i
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`IPR2020-01341, -01342
`Patent 8,142,413
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`TABLE OF AUTHORITIES
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` Page(s)
`
`Cases
`Fox Factory, Inc. v. SRAM, LLC,
`944 F.3d 1366 (Fed. Cir. 2019) .......................................................................... 19
`In re Kao,
`639 F.3d 1057 (Fed. Cir. 2011) .............................................................. 23, 24, 25
`Interval Licensing LLC v. AOL, Inc.,
`766 F.3d 1364 (Fed. Cir. 2014) .......................................................................... 21
`Iron Barbell Co. v. USA Sports, Inc.,
`392 F.3d 1317 (Fed. Cir. 2004) .................................................................... 24, 25
`KSR Int’l Co. v. Teleflex, Inc.,
`550 U.S. 398 (2007) ............................................................................ 9, 12, 13, 18
`Tyco Healthcare Grp. LP v. Ethicon Endo-Surgery, Inc.,
`774 F.3d 968 (Fed. Cir. 2014) .............................................................................. 3
`WBIP, LLC v. Kohler Co.,
`829 F.3d 1317 (Fed. Cir. 2016) .......................................................................... 19
`ZUP, LLC v. Nash Mfg., Inc.,
`896 F.3d 1365 (Fed. Cir. 2018) .......................................................................... 23
`
`
`ii
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`IPR2020-01341, -01342
`Patent 8,142,413
`INTRODUCTION
`I.
`Medtronic, Inc., and Medtronic Vascular, Inc., (collectively “Petitioner” or
`
`“Medtronic”) submits this opposition to Patent Owner’s Contingent Motion to
`
`Amend (MTA).1 Patent Owner (“Teleflex”) seeks to amend claims 1, 7, and 8 and
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`proposes substitute claims 15-17. MTA, 1, Appendix A (“App.”). But the substitute
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`claims are unpatentable over the prior art. Teleflex’s motion should be denied.
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`II.
`
`PROPOSED CLAIMS 15-17 ARE UNPATENTABLE.
`Substitute claims 15-17 are unpatentable over Itou in view of
`A.
`Ressemann or Kataishi.
`Unlike original claim 1, substitute claim 15 requires each step of the claimed
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`method to be performed in the order recited. MTA, App. It also recites a “treatment
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`catheter that includes a stent,” instead of an “interventional cardiology device.”
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`Additional limitations added to the substitute claims relate to a size differential
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`between the lumen of the guide catheter and the lumen of the coaxial guide catheter
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`(claim 15), or recite specific sizes for each (claim 16). Limitations added to substitute
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`claim 17 add limitations to the shape of the coaxial guide catheter’s side opening.
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`But these additions cannot overcome the prior art of record. The analysis below
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`focuses on the newly added limitations while briefly addressing the original
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`1 Papers or Exhibits cited herein are in Case No. IPR2020-01341 unless indicated
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`otherwise. Counterpart exhibits beginning Ex-14XX are filed in IPR2020-01342.
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`1
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`Patent 8,142,413
`limitations, which are thoroughly addressed by the original Petition and supporting
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`testimonial evidence.
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`Substitute Claim 15
`1.
`First, even if the preamble of substitute claim 15 is construed to be limiting,
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`see Petition (Pet.), 21 n.6, Itou renders the claim obvious. Itou discloses providing
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`backup support. A POSITA knew that to advance an interventional cardiology
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`device through a guide catheter (“GC”) and into the coronary vasculature, the GC
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`had to provide sufficient backup support. Ex-1015, 548; Ex-1847 ¶17. The ’413
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`patent similarly teaches that because the disclosed coaxial guide catheter is
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`“extended through the lumen of the guide catheter and beyond the distal end of the
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`guide catheter and inserted into the branch artery,” it “assists in resisting axial and
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`shear forces exerted by an interventional cardiology device passed through the
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`second lumen and beyond the flexible distal tip portion.” Ex-1001, Abstract, 4:64-
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`5:9. As the ’413 patent makes clear, it is the combination of a GC and an extension
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`catheter inserted into the coronary ostium that provides the claimed backup support.
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`Pet., 22. The exact same configuration of catheters is disclosed in Itou.2 Id., 23-24;
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`Ex-1847 ¶¶13-24.
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`2 As explained in Petitioner’s Reply in IPR2020-01341 (filed concurrently
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`herewith), Itou is prior art.
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`2
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`Patent 8,142,413
`Second, adding the limitation “a treatment catheter that includes a stent” to
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`claim 15 does not render it patentable. Teleflex dismisses Itou’s catheter 2 because
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`it is “meant for an entirely different purpose” than delivering a stent. MTA, 16. But
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`while Itou does not disclose a “treatment catheter that includes a stent,” Itou in view
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`of Ressemann renders this limitation obvious. Itou and Ressemann are analogous
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`art. Pet., 17-21. See Tyco Healthcare Grp. LP v. Ethicon Endo-Surgery, Inc., 774
`
`F.3d 968, 979 (Fed. Cir. 2014) (finding that references to two different surgical
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`instruments were analogous even though they did not share the same field of
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`endeavor because they were reasonably pertinent to a particular problem with which
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`the inventor was involved). Here, Itou, Ressemann, and the ’413 claims all share the
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`same field of endeavor, which is removing occlusions from the coronary vasculature.
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`Ex-1847 ¶¶26-60, 118; see also Ex-1805, 20:7-21:1, 70:13-72:1.
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`Itou discloses that catheter 2 is placed in
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`precisely the correct location to deliver a
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`treatment catheter that includes a stent across a
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`coronary artery lesion, which is shown below
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`at 80. Ex-1847 ¶28. See Ex-1007, Fig. 6 (color
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`added), 5:35-42, 7:13-19.
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`Itou also teaches that catheter 2 is
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`suitable for delivering a treatment catheter that
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`Patent 8,142,413
`includes a stent. Pet., 72-74; Ex-1847 ¶28. Teleflex wrongly suggests that the
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`“effective size” of the opening of catheter 2 is 0.046 inches. MTA, 17. That is
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`inaccurate for reasons set forth in Petitioner’s Reply (Reply) (IPR2020-01341),
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`§V.B., filed herewith.
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`But—even if that were correct—Itou still discloses that catheter 2’s tubular
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`structure is a suitable one through which to advance a treatment catheter that includes
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`a stent. Before the alleged invention of the ’413 patent, a POSITA was aware of
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`several stents that were deliverable through a catheter with an I.D. of 0.046 inches.
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`Ex-1847 ¶52; see, e.g., Ex-1015, 641 (“All current slotted tube designs are ‘bare
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`mounted’ on a delivery balloon, with deflated profiles smaller than 0.040-in.
`
`(1mm)....”); Ex-1802, 101, 104 (balloon-expandable Genic® stent with less than 0.9
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`mm (0.035 inch) profile), 142-143 (balloon-mounted Lunar stent with 0.0382 inch
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`profile); Ex-1804, Table 1, Fig. 3 (disclosing several commercially available stents
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`with crossing profiles well under 0.046 inches, including those with profiles of 0.99
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`mm (0.038 inch), 0.93 mm (0.036 inch) and 0.84 mm (0.033 inch)).
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`Teleflex cannot credibly argue otherwise. Its expert, Keith, admits (as he
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`must) that Itou’s catheter 2 is suitably placed for delivering a stent. Ex-1805, 137:7-
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`138:16. He also admits that a guidewire could be navigated into guiding catheter 1—
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`and then through the guide catheter and right up to the opening of catheter 2—but
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`then he has no idea whether it would be able to enter the opening. Id., 143:3-145:20.
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`Patent 8,142,413
`Keith’s opinion is questionable given that the 5 French version of GuideLiner v.3
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`also has an I.D. of 0.046 inches and is marketed for delivering stents, which are, of
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`course, much larger than a guidewire. Ex-2164, 5.
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`A POSITA would be motivated to use catheter 2 to deliver a treatment catheter
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`that includes a stent because this is exactly what is taught in Ressemann. Pet., 77-
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`83; Ex-1847 ¶¶30-31. Teleflex argues that “using a suction catheter to deliver a stent
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`could be dangerous.” MTA, 16. In doing so, it ignores explicit teachings in the prior
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`art to do just that. Ex-1019, 3:4-6, 3:34-36; Ex-1847 ¶¶ 39, 49. Moreover, Teleflex’s
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`position is belied by real-world evidence that the same catheter may be used to
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`suction a thrombus—and then deliver a stent—without removing the catheter from
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`the coronary vasculature. Teleflex’s expert’s patent explicitly teaches using a suction
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`catheter to suction thrombus, and then—while the aspiration sheath is still in
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`position—use it to place a stent. Ex-1930, [0084]-[0085], Figs. 28-29. Similarly,
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`even the GuideLiner has been used to first aspirate thrombus from “thrombus-laden
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`lesion[s]”—and to then deliver stents—with no requirement that it be removed from
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`the coronary vasculature between the two procedures. Ex-1127, 250.
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`Finally, the remaining limitations added to claim 15 do nothing more than
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`recite additional disclosures in Itou: (A) guide catheter 1 has a distal end adapted to
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`be placed in an ostium of a branch artery that branches off from a first artery
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`(Ex-1007, Abstract, 5:29-34); (B) catheter 2 has a cylindrical flexible tip portion and
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`a single lumen that is coaxial with the lumen of guide catheter 1 (id., Fig. 3, 3:47-
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`58, Table 1); (C) catheter 2 has an inner diameter not more than about one French
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`smaller than the inner diameter of guide catheter 1 (id., Table 1); and (D) the distal
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`portion of catheter 2’s substantially rigid portion includes a side opening configured
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`to receive a treatment catheter that includes a stent. Supra, 3-5; Ex-1847 ¶¶28, 74.
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`Claim 15 is obvious.
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`Substitute Claim 16
`2.
`One of the limitations added to substitute claim 16 recites that when the distal
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`portion of the coaxial guide catheter’s tubular structure is extended beyond the distal
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`end of the guide catheter, its proximal portion remains in the guide catheter lumen.
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`This is disclosed in Itou. Ex-1007, Figs. 5-6, 3:1-3, 5:26-46, Table 1; Ex-1847 ¶85.
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`Claim 16 also requires a 6 French guide catheter, and a coaxial guide catheter
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`that has a tubular structure with an inner diameter that is “at least 0.056 inches.” This
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`is also taught in Itou. Table 1 explains that guide catheter 1 has an inner diameter of
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`1.8 mm. Ex-1007. This is equivalent to 0.070 inches, and a 6 French guide catheter
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`has an internal diameter greater than or equal to 0.070 inches. Ex-1847 ¶88.
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`Similarly, Table 1 teaches that the inner diameter of the tubular structure of catheter
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`2 is 1.5 mm, Ex-1007, Table 1, which is 0.059 inches. Ex-1847 ¶89. Thus, Itou
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`teaches a coaxial guide catheter tubular structure with an inner diameter that is “at
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`least 0.056 inches.” Claim 16 is obvious.
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`Patent 8,142,413
`Substitute Claim 17
`3.
`It would have been obvious to modify the proximal opening of Itou’s catheter
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`2, in view of Ressemann or Kataishi, so that it had two inclined sidewalls spaced
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`apart by a non-inclined concave track. Ex-1847 ¶¶92-123. Like Itou, both
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`Ressemann and Kataishi disclose catheters for treating occluded vessels. Ex-1008,
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`Abstract; Ex-1025, Abstract, [0001], and a POSITA had the motivation to modify
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`Itou based on the teachings of Ressemann and Kataishi for this reason and for those
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`discussed below. Ex-1847 ¶¶92, 117-23.
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`Ressemann
`a)
`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. Ex-1847
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`¶¶93-95. As shown in Figure 16J, below, support collar 2141 includes a concave
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`track that runs from the proximal to the distal end of the collar. Circumferential
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`portion 2141a fits into the proximal opening of the tubular portion’s lumen. Ex-1008,
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`24:54-56.
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`Patent 8,142,413
`Id., Fig. 16J (bottom) and schematic of Fig. 16J (top).
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`Collar 2141 has the claimed side-opening configuration—two inclined
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`sidewalls (1, 2) spaced apart by a non-inclined concave track. Ex-1800, 166:8-12,
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`168:9-19 (identifying two inclines); Ex-1847 ¶106.
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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 because Itou’s suction
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`catheter 2 could be used to deliver a treatment catheter that includes a stent, as taught
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`in Ressemann. Supra, 3-5. And the reason a POSITA would do so is because
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`modifying catheter 2’s proximal opening with Ressemann’s collar 2141 increased
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`the area for receiving a stent. Ex-1847 ¶97; Ex-1807 ¶¶58-59.
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`Two additional motivations for modifying Itou with Ressemann’s collar are
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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-1847 ¶¶94-95. A
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`POSITA would have looked to Ressemann when modifying Itou because both
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`references disclose devices that address the same problem—removing coronary
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`vessel occlusions—in the same way—by using a rapid-exchange child catheter, the
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`distal end of which is extended past a guiding catheter’s distal end, into a coronary
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`artery. Ex-1007, Abstract, 1:13-16, 2:2-5, 2:29-38, 3:59-63, 5:32-34, Figs. 1A, 1B,
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`5, 6; Ex-1008, Abstract, 6:18-24, 12:9-12, 19-30, Figs. 6A, 6B. In both Itou and
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`Patent 8,142,413
`Ressemann, occlusive material is suctioned out of the coronary vasculature. Id. 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).
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`b) Kataishi
`Kataishi similarly discloses a side opening on the distal end of a catheter that
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`has two inclined sidewalls spaced apart by a non-inclined concave track (below, top-
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`left). Ex-1025, Figs. 2, 12, [0010] (annotation added).
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`This shape is nearly identical to that taught in the ’413 patent in Figure 4 (the figure
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`Patent Owner frequently identifies as providing support for this “complex side
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`opening” limitation) (above, right). Ex-1001, Fig. 4 (rotated, annotation added).
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`Patent 8,142,413
`Kataishi teaches specific benefits to the shape of this side opening. First, it
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`improves a catheter’s “crossing ability”—the ability to reach a desired target site by
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`advancing past bends in the vasculature. Ex-1025, Abstract, [0001]; Ex-1847 ¶109;
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`and see Ex-1055, 6, 8 (testing the Kataishi device via a “passing ability test” that
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`measured “[t]he length between the ostium and the distal tip of the aspiration
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`catheter” and found that Kataishi’s shape had improved crossability). Another
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`benefit is the improved ability of the two-incline-opening is that it improves the
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`ability to receive material through the opening (e.g., an improved ability to suction
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`thrombi). Ex-1025, Abstract, [0026]-[0027]; Ex-1847 ¶¶110-11.
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`Ex-1025, Fig. 10.
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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-1847 ¶122. Regarding the first benefit, a POSITA would have recognized
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`that improved crossability is a desirable feature in a proximal opening of a short tube
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`for the same reasons as it is desirable in the distal opening of such a tube. Ex-1008,
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`6:52-60 (“The proximal and distal ends 140a, 140b of the evacuation lumen 140 are
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`Patent 8,142,413
`preferably angled to allow for smoother passage….”). In particular, when retracting
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`the device, the angled features of the Kataishi opening would provide improved
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`crossability as the proximal end would then be the leading side.
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`For the second benefit, a POSITA would have recognized that the improved
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`ability of an opening to accept material would have been applicable to a proximal
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`opening accepting a treatment catheter that includes a stent in the same way as it
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`improved Kataishi’s distal end to suction a thrombus. Similar to modifying the
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`proximal opening of Itou’s catheter 2 with Ressemann’s collar 2141, a POSITA had
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`the motivation to modify catheter 2’s proximal opening with the shape of Kataishi’s
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`distal end because this increased the area for receiving a treatment catheter that
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`includes a stent. Ex-1847 ¶¶117-22; Ex-1807 ¶¶89-93.
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`Allowing an improved entry of materials into the lumen of Itou’s suction
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`catheter without increasing the diameter of the device would have been desirable to
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`a POSITA, who would have understood that this modification allows the catheter to
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`receive a therapy catheter and still be advanced to distal locations into the coronary
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`vasculature (compared to catheters with larger diameters). Ex-1025, Abstract,
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`[0026]-[0027], Fig. 10; Ex-1055, 300, 304 (disclosing a better ability to load because
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`of shape of distal opening); Ex-1847 ¶123; Ex-1807 ¶91.
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`Similar to modifying Itou’s catheter 2 to include the Ressemann collar at its
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`proximal end, a POSITA would have a reasonable expectation of success in
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`modifying Itou’s suction catheter with the claimed side-opening features, as taught
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`by Kataishi. Ex-1847 ¶124. Creating two different inclined slopes would have been
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`a routine task when manufacturing an extension catheter. Id.
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`B.
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`Substitute claims 15-17 are unpatentable over Kontos in view of
`Ressemann and Takahashi and/or Kataishi.
`Teleflex’s MTA alleges two principal reasons why the substitute claims are
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`valid over the Kontos grounds: (1) none of the art discloses or suggests the claimed
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`“backup support” provided by a 6 French guide catheter with a guide extension
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`catheter less than “about” one French size smaller used to deliver a stent and a stent
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`catheter, and (2) none of the art discloses or suggests the claimed double incline side
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`opening. MTA, at 8-10. But Kontos inherently teaches backup support, and
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`Takahashi taught that 5-in-6 French catheter sizing improved backup support for
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`delivery of interventional cardiology devices like stents. Ressemann also teaches
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`delivery of stents through a guide extension catheter with a side opening—indeed,
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`Teleflex itself admitted that Ressemann anticipated similar claims in related patents
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`in other IPRs. For the double incline, the exact structure claimed is already disclosed
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`for use in two suction catheters, Ressemann and Kataishi. It would be no more than
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`common sense and routine engineering to take known structures (with known
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`benefits for better trackability and better entry/exit of matter through the opening)
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`and apply those teachings to Kontos to achieve predictable results.
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`Kontos discloses a support catheter assembly 10 (“guide extension catheter”)
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`for use with a guide catheter 38. Ex-1009, 5:35-38, 5:43-46, 7:1-23, 7:35-43, Figs.
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`5-6, 8. 6 French was a common size for the guide catheter that would have an inner
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`diameter of 1.8mm (0.071 inches). Ex-1847 ¶¶186, 189. Support catheter assembly
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`10 has an insertion/manipulation wire 14 (“substantially rigid segment”) and body
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`12 (i.e., “tubular structure”), which includes soft tip 28 and tube 16. Ex-1009, 3:45-
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`55, 4:5-7, 4:25-38, 5:25-30, Figs. 6A-C. This support catheter assembly is used to
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`“pass further through the coronary ostia than can guide catheter 38” and to function
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`as a “guide extension catheter” when “extending beyond the distal end of guide
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`catheter 38” for a PTCA balloon catheter. Ex-1009, 5:40-56. This procedure “lessens
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`considerably the tendency of the PTCA catheter 40 to bend, buckle or kink.” Id.
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`1.
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`Substitute claims 15-17 are unpatentable over Kontos in
`view of Ressemann and Takahashi.
`Sequence Delivery of Stents
`a)
`Substitute claim 15 specifies that the method limitations are performed “in the
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`order recited.” MTA, App. The parties dispute whether the last element in substitute
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`claim 15 (to insert a treatment catheter that includes a stent) is suggested by the art
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`in the order claimed. It is. Kontos itself explains that “[b]ody 12 could be inserted
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`first” into the guide catheter 38, and then “followed by the PTCA catheter 40.”
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`Ex-1009, 7:45-49; see also id., 5:16-28; Ex-1847 ¶¶181-82. Teleflex cannot dispute
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`this explicit disclosure. And while Kontos does not disclose delivery of a stent and
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`stent catheter, Kontos is sufficiently sized and configured to permit the passage of
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`stents and stent catheters through guide catheter 38. Ex-1847 ¶125. Kontos’s tube 16
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`of the guide catheter, which is positioned inside guide catheter 38, has an inner
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`diameter of 0.045 inches. Ex-1009, 4:46-50. It was known that stents and stent
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`catheters could be advanced through the guide catheter of Kontos. Id., see also Ex-
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`1015, 641 (“All current slotted tube designs are ‘bare mounted’ on a delivery
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`balloon, with deflated profiles smaller than 0.040-in. (1mm)”); Ex-1097, 104
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`(Genic® stent with less than 0.9 mm (0.035 inch) profile), 143 (Lunar stent with
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`0.0382 inch profile), 269 (Spiral Force stent with 0.039 to 0.042 inch profile), 274
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`(Tsunami stent with 0.95 mm (0.038 inch) profile). Further, stent delivery was
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`disclosed in both Ressemann and Takahashi—Takahashi says its inner lumen of the
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`5 French child catheter has a 0.059 inch inner diameter and can accept both balloons
`
`and stent delivery systems less than 4.0 mm in diameter. Ex-1010, 5.
`
`b)
`
`6 French Guide Catheter and One French Size
`Smaller Lumen
`Kontos discloses a cross-sectional outer diameter and inner diameter of body
`
`12 that is 0.055 inches and 0.045 inches, respectively. Ex-1009, 3:56-59, 4:48-52.
`
`At base portion 18, Kontos discloses a 0.065-inch outer diameter. Id., 4:50-53.
`
`Kontos does not disclose the cross-sectional inner diameter of the guide catheter.
`
`Takahashi, however, discloses a “five-in-six” system wherein the inner diameter of
`
`14
`
`
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`IPR2020-01341, -01342
`Patent 8,142,413
`the 5 French catheter is 0.059 inches. Ex-1847 ¶¶186, 189; Ex-1442 ¶¶97-103; see
`
`also Ex-1010, 452.
`
`It would have been obvious to look at modifying Kontos in light of Ressemann
`
`and Takahashi to use an extension catheter with a 0.056 or greater inner diameter.
`
`Ex-1847 ¶¶186, 189. Indeed, Kontos, Ressemann, and Takahashi are directed to the
`
`same type of device, are in the same field of endeavor, and are reasonably pertinent
`
`to the problem faced by the inventors of the ʼ413 patent. Ex-1847 ¶186.
`
`A POSITA would have been motivated to combine Takahashi with Kontos
`
`and Ressemann, given that the former teaches that using a catheter-in-catheter
`
`assembly—in particular, an assembly that achieves 1 French differential between
`
`the inner and outer catheters—can improve back-up support. Ex-1847 ¶¶186, 189;
`
`Ex-1442 ¶¶97-103. Further, a POSITA would have been able to accomplish the
`
`claimed combination with a reasonable expectation of success given the teachings
`
`of Kontos, Ressemann, Takahashi, and/or a POSITA’s knowledge. A POSITA knew
`
`how to (i) replace the proximal funnel with a side opening, as discussed above, and
`
`(ii) recess Kontos’s distal marker bands. Ex-1847 ¶189. Further, Kontos explicitly
`
`teaches that “tube 16 may be molded directly only application wire 14.” Ex-1009,
`
`4:31-32.
`
`In so doing, to maximize the usable “real estate” in the catheter assembly, a
`
`POSITA would taper the pushrod for attachment onto the Kontos-Ressemann
`
`15
`
`
`
`IPR2020-01341, -01342
`Patent 8,142,413
`combination. Ex-1847 ¶152; Ex-1807 ¶¶131-34, 143-44. Making
`
`these
`
`modifications would permit a POSITA to use an extension catheter with at least a
`
`0.056-inch inner diameter in a 6 French GC. Ex-1807 ¶¶134-36. This is modification
`
`would increase the outer diameter of Kontos’s body 12, but this modification was
`
`well within the skill of a POSITA, as appropriately sized catheters were ubiquitous
`
`in the art. See, e.g., Ex-1847 ¶¶163-65; Ex-1442 ¶¶141-42; Ex-1009, 4:64-65;
`
`Ex-1010, 452. Combining the teachings of Kontos with Ressemann and Takahashi
`
`to achieve the not-more-than-one French differential would have been nothing more
`
`than combining prior art elements according to known methods to yield predictable
`
`results. Ex-1847 ¶192; Ex-1442 ¶103.
`
`Complex Side Opening
`c)
`Kontos’s support catheter assembly 10 does not have a side opening.
`
`However, Ressemann discloses a complex side opening. A POSITA would have
`
`been motivated to modify Kontos’s tube 16 in view of Ressemann to have a complex
`
`side opening. In particular, a POSITA would have been motivated to modify Kontos
`
`to add Ressemann’s support collar 2141 to Kontos for multiple reasons.
`
`
`
`16
`
`
`
`IPR2020-01341, -01342
`Patent 8,142,413
`First, a POSITA would have known that use of a side opening would optimize
`
`the inner diameter of tube 16 without causing a reduction in the area of the point of
`
`entry to the extension catheter 10. Ex-1847 ¶¶162-63. For example, as an alternative
`
`to the flared proximal opening 26, a POSITA would have been motivated to use a
`
`side opening like in Ressemann as then the diameter of the GC could be reduced
`
`without causing a commensurate reduction in the area of the proximal opening of
`
`extension catheter. Id. Alternatively, a POSITA would have been motivated to
`
`remove Kontos’s proximal funnel, as it would permit the inner diameter of the
`
`extension catheter to be increased without causing a commensurate increase in the
`
`outer diameter of the guide catheter. Ex-1847 ¶¶193-94.
`
`Second, the side opening formed by support collar 2141 facilitates “smooth[]”
`
`reception of the interventional cardiology device as it enters the lumen of the
`
`extension catheter. Ex-1008, 6:52-57 (100 embodiment), 24:38-41 (2100
`
`embodiment); see also Ex-1847 ¶194. That is, the side opening reduces the
`
`likelihood of device hang-up, meaning it promotes better advancement of the therapy
`
`catheter as it travels to the occlusion. Ex-1847 ¶¶194-95.
`
`Third, the side opening, as taught by Ressemann, promotes “smoother
`
`passage” of the catheter assembly as it navigates the tortuous vasculature. Ex-1008,
`
`6:52-57; see also Ex-1847 ¶167; Ex-1442 ¶87. Adding a side opening in the form of
`
`support collar 2141 to the lumen of the extension catheter reduces the amount of
`
`17
`
`
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`IPR2020-01341, -01342
`Patent 8,142,413
`force that a physician must exert to advance the catheter through winding
`
`vasculature. Ex-1847 ¶162.
`
`Teleflex alleges this motivation is impermissible hindsight, but “[t]he
`
`combination of familiar elements according to known methods is likely to be
`
`obvious when it does no more than yield predictable results.” KSR Int’l Co. v.
`
`Teleflex Inc., 550 U.S. 398, 416 (2007). Teleflex narrowly focuses on specific
`
`embodiments and argues because they are not combinable without making some
`
`modifications, the invention is not obvious. Teleflex ignores that these modifications
`
`were well-understood routine engineering concepts within the capability of a
`
`POSITA, who had motivation to make them. Taking well-defined structures with
`
`known benefits, like the shape of various catheter openings, and applying those
`
`structures to other catheters to achieve predictable results is not inventive. Thus, the
`
`proposed amended claims are invalid.
`
`2.
`
`Substitute claim 17 is unpatentable over Kontos in view of
`Ressemann, Takahashi, and Kataishi.
`Ressemann (and Keith’s patent, Teleflex’s own expert) gives an explicit
`
`teaching why Kataishi’s double incline shape would be combined into Kontos:
`
`The proximal and distal ends 140a, 140b of the evacuation lumen 140
`are preferably angled to allow for smoother passage of the evacuation
`sheath assembly 100 through a guide catheter, and into a blood vessel,
`and to facilitate smoother passage of other therapeutic devices
`through the evacuation lumen 140 of the evacuation head 132. The
`
`18
`
`
`
`IPR2020-01341, -01342
`Patent 8,142,413
`larger area of the angled open ends also allows for larger deformable
`particulate matter to pass through the lumen more smoothly.
`
`Ex-1008, 6:52-60 (emphasis added). The shape gives benefits to trackability of the
`
`catheter itself, as well as smoother passage of catheters and other interventional
`
`devices and particular matter. Kataishi offers those same benefits and a POSITA
`
`would recognize that Kataishi’s shape would have similar and predictable benefits
`
`if incorporated onto the proximal opening. Ex-1847 ¶¶215-16.
`
`III. SECONDARY CONSIDERATIONS DO NOT OVERCOME THE
`STRONG SHOWING OF OBVIOUSNESS.
`A. Teleflex is not entitled to a presumption of nexus.
`Teleflex recites secondary considerations for substitute claims 15 and 17, each
`
`of which requires the inner lumen to have “an inner diameter not more than about
`
`one French smaller than the inner diameter of the standard guide catheter.” MTA,
`
`App. A rebuttable presumption of nexus exists “when the patentee shows that the
`
`asserted objective evidence is tied to a specific product and that product is the
`
`invention disclosed and claimed in the patent.” WBIP, LLC v. Kohler Co., 829 F.3d
`
`1317, 1329 (Fed. Cir. 2016). Conversely, “when the thing that is commercially
`
`successful is not coextensive with the patented invention . . . the patentee is not
`
`entitled to a presumption of nexus.” Fox Factory, Inc. v. SRAM, LLC, 944 F.3d 1366,
`
`1373 (Fed. Cir. 2019).
`
`19
`
`
`
`IPR2020-01341, -01342
`Patent 8,142,413
`GuideLiner does not practice substitute claim 15 of the ’413 patent. See
`
`Ex-2250, App’x B.
`
`
`
`
`
`. Ex-1851, 154:13-155:4 (testifying about “not more than one French” language
`
`of similar claim). Further, Teleflex’s own expert previously testified that
`
`“[m]athmatically, those of ordinary skill in the art define one French as .0131
`
`inches.” Ex-1825 ¶¶43-48 (testifying that Boosting Catheter infringes due to the
`
`0.0131 difference); see also Ex-1844, 27:3-9 (Judge Schiltz noting that Teleflex’s
`
`attorneys “stood before [him] in QXMedical and told [him] one French meant 0.0131
`
`inches”).
`
`But the difference for both GuideLiner and Telescope is 0.014 inches.
`
`Ex-1082 ¶58 (red
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