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`104 571-272-7822
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`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.
`
`IPR2020-00136
`Patent RE45,776 E
`
`Before SHERIDAN K. SNEDDEN, JON B. TORNQUIST, and
`CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.
`PAULRAJ, Administrative Patent Judge.
`
`JUDGMENT
`Final Written Decision
`Determining No Challenged Claims Unpatentable
`Not Deciding Patent Owner’s Motion to Amend
`35 U.S.C. § 318(a)
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`PUBLIC VERSION
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`
`
`Trials@uspto.gov
`104 571-272-7822
`
`Paper
`
`Date:
`
`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.
`
`IPR2020-00136
`Patent RE45,776 E
`
`Before SHERIDAN K. SNEDDEN, JON B. TORNQUIST, and
`CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.
`PAULRAJ, Administrative Patent Judge.
`
`JUDGMENT
`Final Written Decision
`Determining No Challenged Claims Unpatentable
`Not Deciding Patent Owner’s Motion to Amend
`35 U.S.C. § 318(a)
`
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`Patent RE45,776 E
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`INTRODUCTION
`I.
`This is our Final Written Decision entered pursuant to 35 U.S.C.
`§ 318(a) and 37 C.F.R. § 42.73. For the reasons explained in our analysis
`below, we determine that Petitioner has not demonstrated that any of the
`challenged claims are unpatentable in this proceeding.
`On November 14, 2019, Medtronic, Inc. and Medtronic Vascular, Inc.
`(collectively, “Petitioner”) filed a Petition requesting an inter partes review
`of claims 25–27, 29–33, 35–39, 41–49, and 52–56 of U.S. Patent No.
`RE45,776 E (“the ’776 patent,” Ex. 1401). Paper 1 (“Pet.”). Teleflex
`Innovations S.À.R.L. (“Patent Owner”)1 filed a Preliminary Response.
`Papers 9 (confidential version), 10 (redacted version) (“Prelim. Resp.”). In
`our Institution Decision, we determined that there was a reasonable
`likelihood that Petitioner would prevail with respect to at least one
`challenged claim and accordingly, instituted an inter partes review pursuant
`to 35 U.S.C. § 314 based on all challenges presented in the Petition. Paper
`20 (“Institution Decision” or “Inst. Dec.”).
`Following institution, Patent Owner filed a post-institution Response
`(Papers 39 (confidential), 40 (redacted), “PO Resp.”) and Petitioner filed a
`Reply (Papers 69 (redacted), 70 (confidential), “Reply”). Patent Owner then
`filed a Sur-reply. Papers 85 (confidential), 86 (redacted) (“PO Sur-Reply”).
`Patent Owner also filed a Contingent Motion to Amend. Paper 35 (original),
`
`1 Patent Owner represents that “Teleflex Innovations S.A.R.L. merged into
`Teleflex Medical Devices S.A.R.L,” which subsequently “transferred
`ownership of [the ’776 patent] to Teleflex Life Sciences Limited.” Paper 7,
`2
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`Paper 81 (corrected) (“Motion”).2 The Motion requests that if any of claims
`27, 33, 37, 42, 43, 45, 47, or 56 is found unpatentable, they should be
`replaced by proposed substitute claims 58–65. Motion 1. Petitioner filed
`Oppositions to the original and corrected Motions to Amend. Papers 72, 84
`(“Opp.”). Patent Owner filed a Reply in Support of the Corrected Motion to
`Amend (Paper 88), and Petitioner filed a Sur-Reply (Paper 94).
`An oral hearing was held on March 8, 2021, and a transcript of the
`hearing is included in the record. Papers 102 (redacted version), 103
`(confidential version).
`
`A. Real Parties-in-Interest
`Petitioner identifies Medtronic, Inc. and Medtronic Vascular, Inc. as
`the real parties-in-interest, and notes that “Medtronic plc is the ultimate
`parent of both entities.” Pet. 5. Patent Owner identifies the real parties-in-
`interest for itself as Teleflex Medical Devices S.A.R.L., Vascular Solutions
`LLC, Arrow International, Inc., Teleflex LLC, and Teleflex Life Sciences
`Limited and notes that “Teleflex Incorporated is the ultimate parent of the
`entities listed above.” Paper 4, 2; Paper 7, 2.
`
`B. Related Matters
`Patent Owner is asserting the ’776 patent against Petitioner in the
`United States District Court for the District of Minnesota in Vascular
`Solutions LLC, et al. v. Medtronic, Inc., et al. No. 19-cv-01760. Pet. 5–6;
`
`2 Pursuant to a stipulation by the parties, we authorized the filing of the
`corrected Motion to Amend in order to clarify certain antecedent bases and
`thereby simplify the issues.
`
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`Paper 4, 2. The ’776 patent is also the subject of a declaratory judgement
`action also in the United States District Court for the District of Minnesota
`filed by another party, QXMedical, LLC v. Vascular Solutions, LLC, No. 17-
`cv-01969, which was stayed pending our Institution Decision. Paper 17;
`Paper 18. Petitioner further notes that the ’776 patent is a reissue of U.S.
`Patent No. 8,292,850 (“’850 patent”, which was the subject of a prior district
`court action and inter partes reviews in IPR2014-00762 and IPR2014-00763
`filed by a different petitioner. Pet. 6.
`Petitioner has also filed another petition challenging the ’776 patent
`based on different prior art, and we instituted inter partes review based on
`that petition on June 8, 2020. IPR2020-00135, Paper 22. In addition,
`Petitioner filed concurrent petitions challenging other related patents: U.S.
`Patent No. 8,048,032 (IPR2020-00126; IPR2020-00127), RE45,380
`(IPR2020-00128; IPR2020-00129; IPR2020-00130; IPR2020-00131), RE
`45,760 (IPR2020-00132; IPR2020-00133; IPR2020-00134), and RE47,379
`(IPR2020-00137; IPR2020-00138).
`
`C. The ’776 Patent
`The ’776 patent, entitled “Coaxial Guide Catheter for Interventional
`Cardiology Procedures,” issued on October 27, 2015, as a re-issue of the
`’850 patent, which claims priority to a non-provisional application filed May
`3, 2006. Ex. 1401, codes (45), (60), (64).3
`
`3 We consider May 3, 2006 to be the effective filing date for purposes of our
`analysis here, but note that we determined in IPR2020-00135 that Patent
`Owner demonstrated an earlier conception and reduction to practice in order
`to antedate the prior art reference at issue in that proceeding. The priority
`date for the ’776 patent is not contested in this proceeding.
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`The ’776 patent relates generally to a coaxial guide catheter for use
`with interventional cardiology devices that are insertable into a branch artery
`that branches off from a main artery. Ex. 1401, Abstract. According to the
`’776 patent, interventional cardiology procedures often include inserting
`guidewires or other instruments through catheters into coronary arteries that
`branch off from the aorta. Id. at 1:45–47. In coronary artery disease, the
`coronary arteries may be narrowed or occluded by atherosclerotic plaques or
`other lesions in a phenomenon known as stenosis. Id. at 1:50–55. In
`treating the stenosis, a guide catheter is inserted through the aorta and into
`the ostium of the coronary artery, sometimes with the aid of a guidewire, and
`is passed beyond the occlusion or stenosis. Id. at 1:59–65. However,
`crossing tough lesions can create enough backward force to dislodge the
`guide catheter from the ostium of the artery being treated, which can make it
`difficult or impossible for the interventional cardiologist to treat certain
`forms of coronary artery disease. Id. at 1:65–67.
`To solve this problem, the ’776 patent describes a coaxial guide
`catheter that is deliverable through standard guidewires by utilizing a
`guidewire rail segment to permit delivery without blocking use of the guide
`catheter. Id. at 3:15–18. The ’776 patent teaches that the coaxial guide
`catheter preferably includes a tapered inner catheter that runs over a standard
`0.014 inch coronary guidewire to allow atraumatic placement within the
`coronary artery, and this feature allows removal of the tapered inner catheter
`after the coaxial guide catheter is in place. Id. at 3:24–27. Figures 1 and 2,
`reproduced below, show a coaxial guide catheter and a tapered inner catheter
`in accordance with the invention described in the ’776 patent:
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`Figure 1 is a schematic depiction of the coaxial guide catheter and tapered
`inner catheter separately, and Figure 2 depicts those two elements assembled
`together. Id. at 5:47–52, Figs. 1, 2. As shown above, coaxial guide catheter
`assembly 10 includes coaxial guide catheter 12 and tapered inner catheter
`14. Id. at 6:37–39. Coaxial guide catheter 12 includes tip portion 16,
`reinforced portion 18, and rigid portion 20. Id. at 6:40–41. Tip portion 16
`generally includes bump tip 22 and marker band 24. Id. at 6:44–45. Bump
`tip 22 includes taper 26 and is relatively flexible. Id. at 6:45–46. Marker
`band 24 is formed of a radiopaque material such as platinum/iridium alloy.
`Id. at 6:49–50. Tapered inner catheter tip 42 includes tapered portion 46 at a
`distal end thereof, and straight portion 48. Id. at 7:22–23. Both tapered
`portion 46 and straight portion 48 are pierced by lumen 50 (not labeled in
`the figures above). Id. at 7:23–24. Tapered inner catheter 14 may also
`include clip 54 at a proximal end thereof to releasably join tapered inner
`catheter 14 to coaxial guide catheter 12. Id. at 7:27–29.
`Figure 4 of the ’776 patent is reproduced below:
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`Figure 4 is a sectional view of a coaxial guide catheter. Id. at 5:58–60. As
`shown in Figure 4, rigid portion 20 includes first full circumference portion
`34, hemicylindrical portion 36, and arcuate portion 38. Id. at 6:64–7:3.
`Hemicylindrical portion 36 includes 40% to 70% of the circumference of the
`rigid portion tube, and may extend approximately 20 to 75 cm in length. Id.
`at 7:7–10. Hemicylindrical portion 36 tapers into arcuate portion 38, which
`extends from 25% to 40% of the circumference of the tube. Id. at 7:11–14.
`In operation, the tapered inner catheter is inserted inside and through
`the coaxial guide catheter. Id. at 4:43–44. The coaxial guide catheter/
`tapered inner catheter combination may then be inserted into a blood vessel
`that communicates with the aorta, and advanced until the tapered inner
`catheter is passed into the ostium of a coronary artery over the guidewire.
`Id. at 4:47–54. The tapered inner catheter may be removed once the coaxial
`guide catheter/guide catheter combination has been inserted sufficiently into
`the ostium of the coronary artery to achieve deep seating. Id. at 4:54–57.
`Once the tapered inner catheter is removed, a cardiac treatment device, such
`as a guidewire, balloon, or stent, may be passed through the coaxial guide
`catheter within the guide catheter and into the coronary artery. Id. at 4:61–
`64. The presence of the coaxial guide catheter provides additional backup
`support to make it less likely that the coaxial guide catheter/guide catheter
`combination will be dislodged from the ostium of the coronary artery while
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`directing the coronary therapeutic device past a tough lesion. Id. at 4:64–
`5:3.
`
`D. Illustrative Claims
`Among the challenged claims, independent claim 25 is representative
`and reproduced below:
`25. A guide extension catheter for use with a guide
`catheter, comprising:
`a substantially rigid segment;
`a tubular structure defining a lumen and positioned distal
`to the substantially rigid segment; and
`a segment defining a partially cylindrical opening
`positioned between a distal end of the substantially rigid segment
`and a proximal end of the tubular structure, the segment defining
`the partially cylindrical opening having an angled proximal end,
`formed from a material more rigid than a material or material
`combination forming the tubular structure, and configured to
`receive one or more
`interventional cardiology devices
`therethrough when positioned within the guide catheter,
`wherein a cross-section of the guide extension catheter at
`the proximal end of the tubular structure defines a single lumen.
`Ex. 1401, 13:35–52 (cl. 25).
`
`E. Prior Art and Asserted Grounds
`We instituted review of claims 25–27, 29–33, 35–37, 39, 41–49, and
`52–56 of the ’776 patent on the following grounds (Inst. Dec. 7–8, 41):
`Claim(s) Challenged
`35 U.S.C. §4
`Reference(s)/Basis
`
`4 The Leahy-Smith America Invents Act (“AIA”), Pub. L. No. 112-29, 125
`Stat. 284, 287–88 (2011), amended 35 U.S.C. § 103, effective March 16,
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`30–32, 53–56
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`53–56
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`103(a)
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`103(a)
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`25–27, 29, 33, 35–37,
`39, 41–49, 52
`
`103(a)
`
`Kontos,5 Ressemann,6 the
`knowledge of a person of
`ordinary skill in the art
`(“POSITA”)
`Kontos, Ressemann, Takahashi,7
`the knowledge of POSITA
`Kontos, Ressemann, Kataishi,8
`the knowledge of POSITA
`Kontos, Ressemann, Takahashi,
`Kataishi, the knowledge of
`POSITA
`Petitioner relies on the expert declarations of Dr. Stephen Jon David
`Brecker (Ex. 1405, 1806, 1904), Dr. Richard A. Hillstead (Ex. 1442, 1905),
`Mr. Michael Jones (Ex. 1807), Dr. Paul Zalesky (Ex. 1830, 1919). Patent
`Owner relies on the declarations of Mr. Peter T. Keith (Ex. 2042, 2124,
`2138, 2243), Dr. John J. Graham (Ex. 2145), Dr. Lorenzo Azzalini (Ex.
`2151), Mr. Steve Jagodzinkski (Ex. 2152 (redacted), 2153 (confidential)),
`Ms. Heather S. Rosecrans (Ex. 2205), and Dr. Craig Thompson (Ex. 2215).
`
`2013. Because the application from which the ’776 patent issued was filed
`before this date, the pre-AIA version of § 103 applies.
`5 Kontos, US 5,439,445, issued August 8, 1995 (Ex. 1409) (“Kontos”).
`6 Ressemann, US 7,604,612 B2, issued October 20, 2009 (Ex. 1408)
`(“Ressemann”).
`7 Takahashi, et al., New Method to Increase a Backup Support of a 6 French
`Guiding Coronary Catheter, Catheterization and Cardiovascular
`Interventions 63:452–456 (2004) (Ex. 1410) (“Takahashi”).
`8 Kataishi, US 2005/0015073 A1, published January 20, 2005 (Ex. 1425)
`(“Kataishi”).
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`ANALYSIS
`II.
`A. Level of Ordinary Skill in the Art
`We consider the asserted grounds of unpatentability in view of the
`understanding of a POSITA. Petitioner provides two alternatives for a
`person having ordinary skill in the art. First, Petitioner asserts that “[i]f a
`person of ordinary skill in the art (‘POSITA’) was a medical doctor, s/he
`would have had (a) a medical degree; (b) completed a coronary intervention
`training program, and (c) experience working as an interventional
`cardiologist.” Pet. 13. Alternatively, Petitioner asserts that “if a POSITA
`was an engineer s/he would have had (a) an undergraduate degree in
`engineering, such as mechanical or biomedical engineering; and (b) at least
`three years of experience designing medical devices, including catheters or
`catheter-deployable devices.” Id. Additionally, Petitioner contends that
`“[e]xtensive experience and technical training might substitute for education,
`and advanced degrees might substitute for experience.” Id.
`Patent Owner “does not dispute Medtronic’s proposed definition of a
`POSITA.” PO Resp. 8.
`Upon review of the parties’ arguments and supporting evidence, we
`adopt Petitioner’s definitions for a POSITA, as they are undisputed and
`consistent with the level of skill reflected in the prior art and the
`specification of the ’776 patent. See Okajima v. Bourdeau, 261 F.3d 1350,
`1355 (Fed. Cir. 2001) (the prior art itself can reflect the appropriate level of
`ordinary skill in the art).
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`B. Claim Construction
`We interpret a claim “using the same claim construction standard that
`would be used to construe the claim in a civil action under 35 U.S.C.
`282(b).” 37 C.F.R. § 42.100(b) (2019). This standard requires that we
`construe claims “in accordance with the ordinary and customary meaning of
`such claim[s] as understood by one of ordinary skill in the art and the
`prosecution history pertaining to the patent.” Id.
`Petitioner proposes constructions for the claim terms a “concave
`track” and “flexural modulus.” Pet. 13–16. Patent Owner does not propose
`any claim constructions of its own for these terms, but argues that claim 36
`does not require two inclines. PO Resp. 1–2.
`Upon review of the parties’ arguments and supporting evidence, we
`determine that no terms of the ’776 patent require construction for purposes
`of this Decision. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d
`795, 803 (Fed. Cir. 1999) (holding that “only those terms need to be
`construed that are in controversy, and only to the extent necessary to resolve
`the controversy”); see also Nidec Motor Corp. v. Zhongshan Broad Ocean
`Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (applying Vivid Techs. in
`the context of an inter partes review).
`
`C. Ground 1: Obviousness in View of Kontos, Ressemann, and the
`Knowledge of a POSITA
`Petitioner asserts that claims 25–27, 29, 33, 35–37, 39, 41–49, and 52
`are rendered obvious in view of Kontos, Ressemann, and the knowledge of a
`POSITA. Pet. 8.
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`1. Overview of Kontos (Ex. 1409)
`Kontos is a U.S. patent that issued from an application filed on June
`27, 1994. Ex. 1409. Thus, on its face, Kontos qualifies as prior art under
`pre-AIA 35 U.S.C. § 102(b).
`Kontos is directed to a support catheter assembly for facilitating
`medical procedures and, in particular, to a catheter assembly that has
`“particular utility in facilitating insertion of a PTCA9 balloon into a lesion.”
`Id. at 1:9–13.
`Figure 1 of Kontos is reproduced below:
`
`Figure 1 is a side plan view of a support catheter, “cut-away in part to show
`in longitudinal cross-section a tubular body having a soft tip and radiopaque
`marker, and a manipulating wire.” Id. at 2:51–54. As shown in Figure 1,
`support catheter assembly 10 is composed of two major elements, body 12
`and insertion/manipulation wire 14. Id. at 3:45–46. Body 12, “which may
`be viewed as a mini guide catheter, includes a tube 16 having a base portion
`18 at its proximal end 20.” Id. at 3:47–49. “Tube 16 has a continuous
`lumen 22 there through from proximal end 20 to distal end 24.” Id. at 3:49–
`50. Body 12 also include a soft tip 28 disposed at distal end 24 and funnel
`portion 26 disposed at proximal end 20. Id. at 3:50–52.
`
`9 PTCA stands for “percutaneous transluminal coronary angioplasty.”
`Ex. 1405 ¶ 37.
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`Insertion/manipulation wire 14 is attached to body 12 at base portion 18. Id.
`at 3:52–53. Support assembly 10 may also include distal marker band 30
`and proximal marker band 32. Id. at 3:53–55.
`Kontos explains that the size and shape of the various elements of
`support assembly 10 “may vary depending on the desired application,” but
`in the applications depicted in Figure 1 tube 16 has a 0.055-inch outer
`diameter and lumen 22 has a 0.045-inch diameter. Id. at 4:46–50.
`According to Kontos, the sizes used in these embodiments “generally are
`suitable for existing PTCA catheters.” Id. at 4:61–64.
`Figure 5 of Kontos is reproduced below:
`
`Figure 5 is a side schematic view of a support catheter having a PTCA
`catheter disposed therein. Id. at 2:64–66. In this figure, PTCA catheter 40
`and its deflated balloon 48 reside in lumen 22 of support assembly 10. Id. at
`5:2–5.
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`Figures 6A–6C of Kontos are reproduced below:
`
`Figures 6A–6C are cross-sectional views showing three stages in a process
`for guiding a PTCA catheter to a coronary artery lesion. Id. at 2:67–3:2. In
`Figure 6A, the PTCA catheter/support catheter assembly is fed into guide
`catheter 38 and advanced to the distal end of this catheter by exerting axial
`force on wire 14 and catheter tube 50 simultaneously. Id. at 5:25–30.
`In Figure 6B, when the PTCA catheter/support catheter assembly
`reaches the distal end of guide catheter 38, “it may be advanced as a unit out
`of the distal end of guide catheter 38, into the coronary ostia 39.” Id. at
`5:31–35. When extending beyond the distal end of guide catheter 38, body
`12 functions as a guide catheter extension protecting fragile balloon 48 and
`lessening “considerably the tendency of the PTCA catheter 40 to bend,
`buckle or kink.” Id. at 5:52–56. “To help ensure that proximal end 20 does
`not unintentionally exit from the guide catheter,” guide catheter 38 may be
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`provided with “a radially inwardly formed annular ridge 44 for impeding
`further axial movement of funnel 26 beyond the distal end of guide catheter
`38.” Id. at 5:59–6:2.
` In Figure 6C, after body 12 has been positioned adjacent the
`restricted area, PTCA catheter 40 is advanced so that balloon 48 exits body
`12 and is advanced into the restricted area, e.g., stenosis B. Id. at 6:9–13.
`Balloon 48 is then inflated, as represented by dotted lines 48, “to effect a
`well known angioplasty procedure.” Id. at 6:13–15. Balloon 48 is then
`deflated and PTCA catheter 40, support catheter assembly 10, and guiding
`catheter 38 may be withdrawn. Id. at 6:15–18.
`Although the Figures depict the use of a PTCA catheter, Kontos
`discloses that, “[o]f course, the device of the present invention may be used
`with almost any type of catheter, including over-the-wire catheters as well as
`catheters with captive guide wires.” Id. at 9:47–50.
`2. Overview of Ressemann (Ex. 1408)
`Ressemann is a U.S. patent that issued on October 20, 2009 from an
`application filed on August 9, 2002. Ex. 1408. Thus, on its face,
`Ressemann qualifies as prior art under pre-AIA 35 U.S.C. § 102(e).
`Ressemann is directed to an apparatus “used to prevent the
`introduction of emboli into the bloodstream during and after surgery
`performed to reduce or remove blockage in blood vessels.” Id. at 1:13–16.
`Figures 1A and 1B of Ressemann are reproduced below:
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`Figure 1A is a cross-sectional view of a partial length evacuation sheath
`assembly 100. Id. at 3:16–18. Figure 1B is a cross-sectional view of the
`partial length evacuation sheath of Figure 1A, taken along line 1B-1B of
`Figure 1A. Id. at 3:19–20.
`Figure 1A depicts evacuation sheath assembly 100, which “is sized to
`fit inside a guide catheter” and be advanced “into a blood vessel to treat a
`stenosis.” Id. at 6:18–24, Fig. 5A. Evacuation sheath assembly 100 includes
`a shaft having proximal shaft portion 110, intermediate shaft portion 120,
`and distal shaft portion 130 (not shown in Figure 1A). Id. at 10:30–35.
`Evacuation head 132 includes multi-lumen tube 138, which preferably is
`made of a relatively flexible polymer, as well as evacuation lumen 140 and
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`inflation lumen 142. Id. at 6:35–64. Evacuation lumen 140 is preferably
`larger than inflation lumen 142 and “is designed to allow for the passage of
`interventional devices such as, but not limited to, stent delivery systems and
`angioplasty catheters.” Id. at 6:44–47. Proximal and distal ends of
`evacuation lumen 140 are angled to allow for smoother passage of
`evacuation sheath assembly 100 through a guide catheter and to facilitate
`smoother passage of other therapeutic devices through evacuation
`lumen 140. Id. at 6:52–57. According to Ressemann, “[t]he larger area of
`the angled open ends also allows for larger deformable particulate matter to
`pass through the lumen more smoothly.” Id. at 6:58–60.
`Figure 1B shows inflation lumen 142, a “second and preferably
`smaller lumen of the multi-lumen tube 138.” Id. at 6:61–62. Inflation
`lumen 142, having open proximal end 142a and closed distal end 142b, is
`designed to provide fluid to inflate balloons on evacuation head 132. Id. at
`6:61–64. Evacuation sheath assembly 100 has a shaft that includes proximal
`shaft portion 110, intermediate shaft portion 120, and distal shaft portion 130
`(not shown in Figure 1A). Id. at 10:30–35. Stiffness transition member 135
`is attached to the distal end of proximal shaft portion 110, “is located co-
`axially in the inflation lumen 142,” and extends to soft tip 144. Id. at 11:30–
`39. Inflation lumen 142, having open proximal end 142a and closed distal
`end 142b, is designed to provide fluid to inflate balloons on evacuation head
`132. Id. at 6:61–64.
`In use, a guiding catheter is directed to a blood vessel and then a
`coronary guide wire is advanced to a location just proximal to the distal tip
`of the guiding catheter. Id. at 12:9–14. Evacuation sheath assembly 100 is
`then advanced over the guide wire and positioned within the blood vessel.
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`Id. at 12:19–21. In this process, evacuation head 132 is positioned with its
`distal end within the blood vessel while its proximal end remains in the
`guiding catheter. Id. at 12:37–39. Sealing balloons 136 and 134 are then
`inflated to provide a fluid seal between the sealing balloons and the blood
`vessel. Id. at 12:40–45.
`Figure 6D of Ressemann is reproduced below:
`
`Figure 6D is a cross-sectional view of the partial length evacuation
`sheath of Figures 1A and 1B deployed within a blood vessel. Id. at 3:59–61.
`As shown in Figure 6D, guidewire 170 may be advanced beyond stenosis
`180 in blood vessel 150. Id. at 13:3–16. A therapeutic device, such as a
`stent, may then be advanced over guide wire 170 and across stenosis 180.
`Id. at 13:57–60. As indicated by arrows 195, blood flow within the blood
`vessel is directed towards evacuation sheath 100. Id. at 13:35–41.
`According to Ressemann, “[t]his retrograde flow will carry any dislodged
`material out of the patient and into a collection chamber.” Id. at 13:43–44.
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`3. The Parties’ Arguments
`Petitioner contends that the combination of Kontos and Ressemann, as
`set forth above, teaches each of the claim limitations. Petitioner identifies
`where each limitation of independent claim 25 is taught or suggested by
`Kontos and Ressemann. Pet. 21–38. Petitioner relies upon the same
`teachings and assertions with regard to independent claim 52. Id. at 53–56.
`We focus on the parties’ arguments with regard to independent claim 25 as it
`is dispositive to our conclusion for all the claims challenged under Ground 1.
`With regard to independent claim 25, Petitioner asserts the following:
`With respect to the requirement for “[a] guide extension catheter for
`use with a guide catheter,” Petitioner contends that, to the extent the
`preamble is limiting, 10 Kontos’s support catheter assembly 10 meets this
`limitation. Pet. 21–22 (citing Ex. 1405 ¶ 154; Ex. 1409, 2:16–22, 3:45–46,
`5:49–52, Fig. 1, Fig. 6B).
`With respect to the requirement for “a substantially rigid segment.”
`Petitioner contends that the insertion/manipulation wire 14 that is proximal
`of tube 16 in Kontos’s support catheter 10 meets this limitation. Id. at 22–24
`(citing Ex. 1405 ¶ 155; Ex. 1409, Abstract, 5:25–30, Fig. 1). Petitioner
`notes that the ’776 patent precludes the substantially rigid segment from
`overlapping with the tubular structure, and has applied the claims as recited
`in the ’776 patent and as interpreted by Patent Owner in the district court.
`Id. at 23 n.6 (citing Ex. 1477, 127:24–128:14, 144:9–22, 145:9–17).
`
`10 We need not determine at this time whether the preamble of claim 25 is
`limiting because Petitioner shows sufficiently for purposes of institution that
`the recitation in the preamble is disclosed in Kontos.
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`With respect to the requirement for “a tubular structure defining a
`lumen and positioned distal to the substantially rigid segment,” Petitioner
`identifies the tube 16 in Kontos’s support catheter as meeting this limitation.
`Id. at 24–25 (citing Ex. 1405 ¶ 156; Ex. 1409, 3:49–50, 3:56–57, Figs. 1,
`6C).
`
`With respect to the requirements for “a segment defining a partially
`cylindrical opening positioned between a distal end of the substantially rigid
`segment and a proximal end of the tubular structure” and the “segment
`defining the partially cylindrical opening having an angled proximal end,”
`Petitioner relies upon the combination of Kontos with Ressemann and/or the
`knowledge of a POSITA as meeting these requirements. Id. at 25–34.
`Petitioner acknowledges that Kontos does not teach a partially cylindrical
`opening, but contends that such partially cylindrical openings were well-
`known in the art. Id. at 27 (citing Ex. 1405 ¶¶ 90–108, 158–59; Ex. 1442 ¶¶
`73-78; Ex. 1407, 4:11; Ex. 1408, 12:9–13:60, Figs. 6A–6E; Ex. 1418, Fig. 7;
`Ex. 1432, 119, Fig. 1; Ex. 1433 ¶¶ 035, 49, Fig. 2; Ex. 1435 ¶ 66; Ex. 1450,
`Fig. 7; Ex. 1461, 6:9–11, Fig. 1B). As one such example, Petitioner
`contends that Ressemann teaches an evacuation assembly 100/2100
`(“extension catheter”) where the entry to the evacuation lumen 140a/2140 is
`“preferably angled.” Id. (citing Ex. 1405 ¶¶ 160–161; Ex. 1408, 6:52–60
`(100 embodiment), 24:33–38 (2100 embodiment)).
`Petitioner contends that a POSITA would have been motivated, with a
`reasonable expectation of success, to add Ressemann’s partially cylindrical
`opening to Kontos’s structure as shown in the annotated figure below:
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`Id. at 28–29 (citing Ex. 1405 ¶¶ 161–174; Ex. 1442 ¶¶ 91–100; Ex. 1409,
`Fig. 1). The annotated figure above shows a magnified version of Kontos’s
`Figure 1 modified to include Ressemann’s support collar (labeled the
`“partially cylindrical opening”) in between the wire 14 (labeled the
`“substantially rigid segment”) and tube 16 (labeled the “tubular structure”).
`Petitioner contends that the result of the combination would necessarily
`include a segment with an angled proximal end. Id. at 35 (citing Ex. 1405 ¶
`175).
`
`Petitioner identifies multiple reasons as to why a POSITA would have
`been motivated to modify Kontos to add a partially cylindrical opening
`proximal of the tubular structure, as taught by Ressemann. Id. at 29 (citing
`Ex. 1405 ¶¶ 162–72; Ex. 1442 ¶¶ 91–99). Petitioner contends that the use of
`a partially cylindrical opening could permit a reduction of the outer diameter
`of the catheter assembly without resulting in a commensurate reduction in
`the area of the point of entry to the extension catheter, and this would have
`been beneficial for the small diameter (6 French) guiding catheters that were
`commonly used as of the priority date of the ’776 patent. Id. at 29–31
`(citing Ex. 1405 ¶¶ 163–165; Ex. 1406, Fig. 6B; Ex. 1442 ¶ 96). Petitioner
`further contends that a POSITA would have been motivated to use a
`partially cylindrical opening in order to facilitate “smoother” reception,
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`passage, and reentry of the device as it enters the lumen of the child catheter
`and navigates winding vasculature. Id. at 31–32 (citing Ex. 1405 ¶ 166–173;
`Ex. 1442 ¶¶ 80, 89–95, 98–100). Petitioner also contends that employing
`Ressemann’s partially cylindrical opening (as opposed to an opening
`perpendicular to the longitudinal axis) with Kontos’s device would have
`amounted to a simple substitution of a known element to obtain predictable
`results. Id. at 33–34 (citing KSR Int’l co. v. Teleflex Inc., 550 U.S. 398, 417
`(2007)).
`With respect to the requirement that the segment is “formed from a
`material more rigid than a material or material combination forming the
`tubular structure,” Petitioner contends that the incorporation of Ressemann’s
`support collar 2141 to Kontos’s structure would meet this requirement. Id.
`at 35–36 (citing Ex. 1405 ¶¶ 176–177; 1442 ¶¶101–105). Petitioner points
`out that Ressemann’s support collar is preferably “a metallic material” with
`“suitable rigidity to prevent kinking,” while Kontos’s tube 16 includes “any
`pliable material,” but preferably is composed of a molded plastic material,
`such as polyethylene. Id at 36 (citing Ex. 1408, 24:47–55, 24:62–67, 25:13–
`16; Ex. 1409, 4:1–4).
`With respect to the requirement that the segment is “configured to
`receive one or more interventional cardiology devices therethrough when
`positioned within the guide catheter,” Petitioner contends that Kontos
`teaches that the extension catheter (support catheter 10) is positioned within
`the guide catheter when it receives the interventional cardiology device. Id.
`at 37 (citing Ex. 1409, 4:66–5:2, 5:16–18, 7:45–52, Figs. 6A–C; Ex. 1405
`¶ 178). Petitioner also argues that the “configured to” language recites an
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`intended use, to which no patentable weight should be given. Id. (citing In
`re Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997)).
`Finally, with respect to the requirement “wherein a cross-section of
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