Trials@uspto.gov
`571-272-7822
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Paper 22
`Date: June 8, 2020
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MEDTRONIC, INC. AND MEDTRONIC VASCULAR, INC.,
`Petitioner,
`v.
`TELEFLEX INNOVATIONS S.À.R.L.
`Patent Owner.
`
`
`IPR2020-00128
`Patent RE45,380
`
`
`
`Before SHERIDAN K. SNEDDEN, JON B. TORNQUIST, and
`CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.
`
`TORNQUIST, Administrative Patent Judge.
`
`DECISION
`Granting Institution of Inter Partes Review
`35 U.S.C. § 314
`
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`571-272-7822
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`
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Paper 22
`Date: June 8, 2020
`
`
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`
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MEDTRONIC, INC. AND MEDTRONIC VASCULAR, INC.,
`Petitioner,
`v.
`TELEFLEX INNOVATIONS S.À.R.L.
`Patent Owner.
`
`
`IPR2020-00128
`Patent RE45,380
`
`
`
`Before SHERIDAN K. SNEDDEN, JON B. TORNQUIST, and
`CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.
`
`TORNQUIST, Administrative Patent Judge.
`
`DECISION
`Granting Institution of Inter Partes Review
`35 U.S.C. § 314
`
`
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`IPR2020-00128
`Patent RE45,380
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`INTRODUCTION
`Medtronic, Inc. and Medtronic Vascular, Inc. (collectively
`“Petitioner”) filed a Petition (Paper 1, “Pet.”) requesting an inter partes
`review of claims 1–4, 6–10, 12–21, and 23 of U.S. Reissue Patent RE45,380
`(Ex. 1001, “the ’380 patent”). Teleflex Innovations S.À.R.L. (“Patent
`Owner”) filed a Preliminary Response to the Petition (Paper 8, “Prelim.
`Resp.”). Pursuant to our authorization, Petitioner filed a Reply (Paper 12)
`addressing its burden on secondary considerations and reduction to practice,
`and Patent Owner filed a Sur-Reply (Paper 14) addressing Petitioner’s
`burden on those issues. Also pursuant to our authorization, Petitioner filed
`another Reply (Paper 19) and Patent Owner filed another Sur-Reply (Paper
`20) addressing the factors for discretionary denial under 35 U.S.C. § 314(a).
`We have authority to determine whether to institute an inter partes
`review. 35 U.S.C. § 314 (2018); 37 C.F.R. § 42.4(a) (2019). The standard
`for institution is set forth in 35 U.S.C. § 314(a), which provides that an inter
`partes review may not be instituted “unless the Director determines . . . there
`is a reasonable likelihood that the petitioner would prevail with respect to at
`least 1 of the claims challenged in the petition.”
`After considering the parties’ arguments and evidence, we determine
`that Petitioner has demonstrated a reasonable likelihood that it would prevail
`with respect to at least one of the claims challenged in the Petition.
`Accordingly, we institute an inter partes review of all challenged claims and
`all asserted grounds set forth in the Petition. See SAS Inst. Inc. v. Iancu,
`138 S. Ct. 1348, 1355–56 (2018); PGS Geophysical AS v. Iancu, 891 F.3d
`1354, 1360 (Fed. Cir. 2018) (interpreting the statute to require “a simple yes-
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`or-no institution choice respecting a petition, embracing all challenges
`included in the petition”).
`A. Related Matters
`The parties indicate that the ’380 patent is the subject of litigation in
`Vascular Solutions LLC, et al. v. Medtronic, Inc., et al., No. 19-cv-01760
`(D. Minn.) (“Medtronic case”) and QXMedical, LLC v. Vascular Solutions,
`LLC, No. 17-cv-01969 (D. Minn.) (“QXM case”). Pet. 5–6; Paper 4, 2. The
`’380 patent is also at issue in IPR2020-00129, IPR2020-00130, and
`IPR2020-00131.1 Paper 4, 2–3; Pet. 6.
`B. The ’380 Patent
`The ’380 patent relates to catheters used in interventional cardiology
`procedures and, in particular, to “methods and apparatus for increasing
`backup support for catheters inserted into the coronary arteries from the
`aorta.” Ex. 1001, 1:31–35.
`“In coronary artery disease the coronary arteries may be narrowed or
`occluded by atherosclerotic plaques or other lesions.” Id. at 1:44–46. This
`narrowing is referred to as stenosis. Id. at 1:48–49. To treat a stenosis, “it is
`commonly necessary to pass a guidewire or other instruments through and
`beyond the occlusion or stenosis of the coronary artery.” Id. at 1:49–52. In
`this method, a guide catheter is inserted through the aorta and into the
`
`
`1 In accordance with our Trial Practice Guide, Petitioner provides an
`explanation of material differences and ranking for the multiple petitions
`directed to each challenged patent. Paper 3. Patent Owner responds that
`Petitioner has not justified institution on multiple petitions. Paper 11. Given
`that this is the first petition filed by Petitioner on which we are instituting
`trial for the ’380 patent, we need not and do not address Patent Owner’s
`argument for denial based on multiple petitions.
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`ostium of the coronary artery where it is typically seated into the opening or
`ostium of the artery to be treated. Id. at 1:53–57. A guidewire or other
`instrument is then passed through the lumen of the guide catheter and
`inserted into the artery beyond the stenosis. Id. at 1:39–41, 1:57–59.
`Crossing the tough lesions, however, may create enough backwards force to
`dislodge the guide catheter from the ostium of the artery being treated,
`making it difficult or impossible to treat certain forms of coronary artery
`disease. Id. at 1:59–63.
`Figures 1 and 2 of the ’380 patent are reproduced below:
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`Figure 1 is a schematic depiction of a coaxial guide catheter and a tapered
`inner catheter and Figure 2 is a schematic depiction of these two elements
`assembled together. Id. at 5:40–45. As shown in Figure 1, coaxial guide
`catheter 12 includes tip portion 16, reinforced portion 18, and rigid portion
`20. Id. at 6:34–35. Tapered inner catheter 14 includes tapered portion 46 at
`a distal end thereof and straight portion 48. Id. at 7:16–17. Clip 54
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`releasably joins tapered inner catheter 14 to coaxial guide catheter 12. Id. at
`7:21–23.
`
`Figure 8 of the ’380 patent is reproduced below:
`
`
`Figure 8 is a schematic view of a guide catheter, a guidewire, a coaxial guide
`catheter, and a tapered inner catheter located in the aortic arch and coronary
`artery. Id. at 5:61–64. In Figure 8, “coaxial guide catheter 12 with tapered
`inner catheter 14 is passed through guide catheter 56 and over guidewire 64
`into coronary artery 62 after the guidewire has been placed in the ostium 60
`of coronary artery 62.” Id. at 8:6–10. The ’380 patent explains that
`“[c]oaxial guide catheter 12, with tapered inner catheter 14, provides an
`inner support member for proper translation over guidewire 64.” Id. at
`8:10–14. “Once coaxial guide catheter 12 is in place, tapered inner catheter
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`14 is removed from the inside of coaxial guide catheter 12.” Id. at 8:14–17.
`At this point, coaxial guide catheter 12 is ready to accept a treatment
`catheter such as a stent or balloon catheter. Id. at 8:18–19. The ’380 patent
`explains that coaxial guide catheter 12 provides additional backup support to
`resist dislodging of guide catheter 56 from ostium 60 when force is applied
`to guidewire 64 to pass through stenotic lesion 66. Id. at 8:23–30.
`C. Illustrative Claim
`Independent claim 1 is illustrative of the challenged claims and is
`reproduced below.
`1. A system for use with interventional cardiology devices
`adapted to be insertable into a branch artery, the system
`comprising:
`a guide catheter having a continuous lumen extending for a
`predefined length from a proximal end at a hemostatic
`valve to a distal end adapted to be placed in the branch
`artery, the continuous lumen of the guide catheter having
`a circular cross-sectional inner diameter sized such that
`interventional cardiology devices are insertable into and
`through the continuous lumen of the guide catheter; and
`a device adapted for use with the guide catheter, including:
`a flexible tip portion defining a tubular structure and
`having a circular cross-section and a length that is
`shorter than the predefined length of the continuous
`lumen of the guide catheter, the tubular structure
`having a cross-sectional outer diameter sized to be
`insertable through the cross-sectional inner diameter
`of the continuous lumen of the guide catheter and
`defining a coaxial lumen having a cross-sectional
`inner diameter through which interventional
`cardiology devices are insertable; and
`a substantially rigid portion proximal of and operably
`connected to, and more rigid along a longitudinal axis
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`than the flexible tip portion and defining a rail
`structure without a lumen having a maximal cross-
`sectional dimension at a proximal portion that is
`smaller than the cross-sectional outer diameter of the
`flexible tip portion and having a length that, when
`combined with the length of the flexible distal tip
`portion, defines a total length of the device along the
`longitudinal axis that is longer than the length of the
`continuous lumen of the guide catheter, such that
`when at least a distal portion of the flexible tip portion
`is extended distally of the distal end of the guide
`catheter, at least a portion of the proximal portion of
`the substantially rigid portion extends proximally
`through the hemostatic valve in common with
`interventional cardiology devices that are insertable
`into the guide catheter;
`wherein the tubular structure includes a flexible cylindrical
`distal tip portion and a flexible cylindrical reinforced
`portion proximal to the flexible cylindrical distal tip
`portion and wherein the flexible cylindrical distal tip
`portion is more flexible than the flexible cylindrical
`reinforced portion.
`Ex. 1001, 10:47–11:24 (limitations added by reissue in italics).
`D. Prior Art and Asserted Grounds
`Petitioner contends claims 1–4, 6–10, 12–21, and 23 of the ’380
`patent would have been unpatentable on the following grounds (Pet. 8):
`Claims Challenged
`35 U.S.C. §
`Reference(s)/Basis
`1–4, 6–10, 12–20, 23
`102
`Itou2
`3, 14, 15
`103
`Itou, Ressemann3
`21
`103
`Itou, Berg4
`
`
`2 Itou, US 7,736,355 B2, issued June 15, 2010 (Ex. 1007) (“Itou”).
`3 Ressemann, US 7,604,612 B2, issued October 20, 2009 (Ex. 1008)
`(“Ressemann”).
`4 Berg, US 5,911,715, issued June 15, 1999 (Ex. 1051) (“Berg”).
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`Petitioner also relies on the testimony of Dr. Stephen JD Brecker
`(Ex. 1005) and Dr. Richard A. Hillstead (Ex. 1042). Pet. 8 n.2.
`ANALYSIS
`
`A. Claim Construction
`In this proceeding, the claims of the ’380 patent are construed “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).
`Under that standard, the words of a claim are generally given their “ordinary
`and customary meaning,” which is the meaning the term would have had to
`a person of ordinary skill at the time of the invention, in the context of the
`entire patent including the specification. Phillips v. AWH Corp., 415 F.3d
`1303, 1312–13 (Fed. Cir. 2005) (en banc).
`For purposes of this decision, only the term “interventional cardiology
`devices” requires construction. See Nidec Motor Corp. v. Zhongshan Broad
`Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (quoting Vivid
`Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)
`(“[O]nly those terms need be construed that are in controversy, and only to
`the extent necessary to resolve the controversy.”)).
`Claims 1 and 12 require a flexible tip portion (claim 1) or a tubular
`portion (claim 12) that defines “a coaxial lumen having a cross-sectional
`inner diameter through which interventional cardiology devices are
`insertable.” Ex. 1001, 10:58–67, 12:17–28. To that point, the Specification
`expressly defines the claim term “interventional cardiology devices” as
`follows:
`For the purposes of this application, the term “interventional
`cardiology devices” is to be understood to include but not be
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`limited to guidewires, balloon catheters, stents and stent
`catheters.
`Id. at 1:41–44.
`Petitioner contends that, in the QXM case, Patent Owner stipulated
`that the term “interventional cardiology device(s)” means “devices
`including, but not limited to, guidewires, balloon catheters, stents, and stent
`catheters.” Pet. 16 (citing Ex. 1012, 21; Ex. 1064 1 n.1). The district court,
`however, did not construe the term “interventional cardiology device(s)” in
`the QXM case. Ex. 1013 (Claim Construction Order).
`Patent Owner contends that “interventional cardiology devices,” as
`used in independent claims 1 and 12,
`requires that at least all four enumerated devices (guidewires,
`balloon catheters, stents, and stent catheters) be insertable into
`the lumen. This construction is based on the plain language of
`the claims (“interventional cardiology devices”), as well as the
`definition’s use of the inclusive conjunction “and.”
`Prelim. Resp. 17. Patent Owner further contends as follows:
`This construction is . . . consistent with the specification.
`The Summary of the Invention describes the invention as a
`“coaxial guide catheter,” i.e., a structure that serves the same
`basic function (delivering interventional cardiology devices) as
`the guide catheter in which it is placed. Exhibit 1001, 3:9–20.
`The coaxial guide catheter is contrasted from the tapered inner
`catheter that is placed within it – among other things, the tapered
`inner catheter “runs over a standard 0.014 inch coronary
`guidewire,” while the coaxial guide catheter is “typically five to
`eight French” and has an inner lumen that is preferably only
`about one French size smaller than the guide catheter. Id.; see
`also id. at 3:28–43. The Summary notes that the “invention has
`an inner diameter acceptable for delivering standard coronary
`devices after it is placed in the blood vessel.” Id. at 5:33–36.
`Merely being sized to receive a guidewire is not enough; the
`claim language requires that guidewires, stents, stent catheters
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`and balloon catheters be insertable through the claimed coaxial
`lumen.
`Id. at 18.
`Having considered the parties’ positions and evidence of record, we
`determine that the term “interventional cardiology devices” refers to at least
`two types of the devices selected from the group that includes, but is not
`limited to, guidewires, balloon catheters, stents and stent catheters. In the
`context of independent claims 1 and 12, the lumen of the recited guide
`catheter must be sized to receive at least two types of the devices selected
`from the group that includes, but is not limited to, guidewires, balloon
`catheters, stents and stent catheters. For example, the diameter of the guide
`catheter is sized to receive a guidewire and a stent or balloon. See Ex. 1001,
`7:60–64 (“Once the guidewire 64 is pushed past stenotic lesion 66 or
`occlusive lesion . . . , a treating catheter including a stent or balloon can be
`passed along the guidewire to stenotic lesion 66 or occlusive lesion . . . .”).
`Moreover, based on the current record, we do not construe the claims
`to require that more than one of guidewires, stents, stent catheters and
`balloon catheters be simultaneously insertable into and through the lumen;
`although we recognize that certain embodiments disclosed in the
`Specification show a preference for the use of a guidewire and a stent or
`balloon. Id. at 7:60–64, Figs. 7–8.
`Finally, we recognize that the Specification discloses that “the
`invention has an inner diameter acceptable for delivering standard coronary
`devices after it is placed in the blood vessel” (id. at 5:33–36) and that the
`term “interventional cardiology devices” is not limited to guidewires,
`balloon catheters, stents and stent catheters (id. at 1:41–44). To the extent
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`further discussion of what additional devices may be encompassed by this
`term is required for the purposes of our decision, we provide that discussion
`below in our analysis of the asserted grounds of unpatentability.
`B. Claims 1–4, 6–10, 12–20, and 23 in view of Itou
`Petitioner contends Itou anticipates claims 1–4, 6–10, 12–20, and 23
`of the ’380 patent. Pet. 19–65.
`1. Priority Date of the ’380 Patent
`The AIA’s first-to-file provisions apply to patent applications “that
`contain[] or contained at any time a claim to a claimed invention that has an
`effective filing date” on or after March 16, 2013. AIA § 3(n)(1). The
`application for reissue for the ’380 patent was filed November 1, 2013 and
`sought reissue of US Patent No. 8,292,850, which issued October 23, 2012
`from an application filed January 26, 2012. Ex. 1001, codes (22), (64).
`Petitioner contends that because there is no written description support for
`the subject matter of at least claim 27 of the ’380 patent, the ’380 patent has
`an effective filing date after March 16, 2013. Pet. 14. Thus, according to
`Petitioner, the ’380 patent is not supported by a pre-March 16, 2013
`application making it subject to the AIA’s first-to-file provisions. Id.
`“The effective filing date for a claimed invention in an application for
`reissue or reissued patent shall be determined by deeming the claim to the
`invention to have been contained in the patent for which reissue was
`sought.” 35 U.S.C. § 100(i)(2). As the “patent for which reissue was
`sought” in this case was issued October 23, 2012, we are not persuaded that
`AIA’s first-to-file provisions apply to the ’380 patent. Indeed, Petitioner
`provides no statutory or case law support for the proposition that a reissue
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`patent may lose the filing date of the original patent for which reissue was
`sought.5
`
`2. Prior Art Status of Itou
`Itou was filed on September 23, 2005, published on March 30, 2006,
`and issued on June 15, 2010. Ex. 1007, codes (22), (45), (65). Petitioner
`contends Itou is therefore prior art under pre-AIA § 102(e). Pet. 19.
`Patent Owner contends Itou is not prior art to the ’380 patent because
`conception of the invention claimed in the ’380 patent occurred in late 2004
`and reduction to practice occurred “in the spring and summer of 2005.”
`Prelim. Resp. 21–22 (citing Ex. 2001 ¶¶ 5–46 (Root Declaration); Exs.
`2002–2022, 2024). Patent Owner further contends that, despite having much
`of the evidence related to conception and reduction to practice, Patent
`Owner does not address it in the Petition. Id. at 23–24.
`The burden to show that Itou is prior art to the ’380 patent rests with
`Petitioner. Dynamic Drinkware, LLC v. National Graphics, Inc., 800 F.3d
`1375, 1379 (Fed. Cir. 2015). That said, once Petitioner presents evidence
`that Itou was filed and/or issued prior to the filing date of the ’380 patent,
`the burden of production shifts to Patent Owner to demonstrate that Itou is
`not prior art, for example, by presenting evidence of an earlier conception
`and reduction to practice. Id. at 1380. And although Patent Owner’s
`presents multiple pieces of evidence in the Preliminary Response to satisfy
`this burden, Petitioner has not had an opportunity to address this evidence in
`
`
`5 To the extent the original patent for which reissue was sought does not
`contain written description support for a reissue claim, that claim may be
`invalid for lack of written description support. But this is a question we may
`not address in an IPR. See 35 U.S.C. § 311(b).
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`this proceeding. Thus, we determine that genuine issues of material fact
`remain about the alleged invention date and that these questions are best
`resolved after trial and on a complete trial record.6 Id. (noting that the
`burden of production shifts back to Petitioner once sufficient evidence of
`conception and reduction to practice have been presented).
`3. Itou
`Itou discloses “an intravascular foreign matter suction assembly”
`designed to suck, sample, and remove “foreign matter such as a thrombus or
`an embolus” from a blood vessel. Ex. 1007, 1:6–9, 1:47–49. This assembly
`includes a guiding catheter and a suction catheter configured to be inserted
`into the lumen of the guiding catheter. Id. at 1:49–65.
`
`
`6 As noted by Patent Owner, Petitioner was aware of some of Patent
`Owner’s evidence of conception and reduction to practice before it filed the
`Petition. Prelim. Resp. 21. The district court, however, determined that
`Patent Owner’s evidence was “unimpressive” and insufficient to
`demonstrate, at the preliminary injunction stage, an earlier conception and
`reduction to practice. Ex. 1088, 13–14. Petitioner also notes that Patent
`Owner did not provide detailed contentions regarding conception and
`reduction to practice until less than a week before its Petition was filed, and
`the relevant evidence that was previously produced to Petitioner was marked
`“attorneys eyes only’ in the district court case and thus could not have been
`relied upon in the Petition. Paper 12, 2–5. Given that Patent Owner bears
`the burden of producing evidence to support its antedating contention, we
`determine Petitioner did not have an obligation to preemptively address
`Patent Owner’s evidence in its Petition.
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`Figure 3 of Itou is reproduced below:
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`
`Figure 3 is a cross section of a distal end portion of suction catheter 2. Id. at
`2:61–62. Suction catheter 2 includes distal side tubular portion 24 and
`proximal side wire-like portion 25, formed from a solid metal wire and an
`outer layer such as a polymer coating. Id. at 3:46–50. Tubular portion 24
`has reinforced tubular portion 21 and flexible distal tip 22. Id. at 2:15–51,
`3:50–58. Tubular portion 24 has an outer diameter that allows it to be
`inserted into the lumen of a guide catheter and wire-like portion 25 has a
`sectional area smaller than the sectional area of the tube wall of tubular
`portion 24. Id. at 3:59–63.
`
`Figure 5 of Itou is reproduced below:
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`Figure 5 shows the suction assembly “in an assembled state.” Id. at 2:66–
`67. In this state, suction catheter 2 is disposed in the lumen of guiding
`catheter 1. Id. at 5:12–14. The distal end of distal end protective catheter 5
`is inserted into the lumen of suction catheter 2 and guide wire 6 is inserted
`into the lumen of the distal end protective catheter 5. Id. at 5:14–17. The
`proximal ends of suction catheter 2, distal end protective catheter 5, and
`guide wire 6 are “introduced to the outside through main connector portion
`31 of Y-shaped connector 3.” Id. at 5:17–20. A valve is built into main
`connector 31 and “can selectively clamp and fix” guide wire 6 and wire-like
`portions 25 or 55 “to prevent leakage of the blood.” Id. at 5:20–23. In one
`embodiment, the inner diameter of the guiding catheter is 1.8 mm and the
`inner diameter of the suction catheter is 1.5 mm. Id. at 7:55–67 (Table 1).
`
`A portion of Figure 6 of Itou is reproduced below:
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`Figure 6 illustrates the disclosed apparatus disposed in a coronary artery of
`the heart. Id. at 3:1–3. In Figure 6, guiding catheter 1 is disposed in
`aorta 81 and its distal end “is secured in such a form that it is hooked at an
`ostium 821 of coronary artery 82.” Id. at 5:29–34. Tubular portion 24 of
`suction catheter 2 is inserted into coronary artery 82 and is introduced along
`guide wire 6 to target location 80. Id. at 5:35–38. According to Itou, tubular
`portion 24 of suction catheter 2 has a “sufficient axial length so that the
`proximal end of the tubular portion 24 in an open state may not leap out
`from the distal end of the guiding catheter 1.” Id. at 5:38–41.
`4. Independent Claims 1 and 12
`Petitioner contends Itou discloses every limitation of independent
`claim 1, including (1) a system for use with interventional cardiology
`devices (protective catheter 5 and guidewire 6), that is adapted to be inserted
`into a branch artery (Pet. 22 (citing Ex. 1007, 5:35–38, 43–46, 7:1–23, 7:35–
`42, Figs. 5, 6, 8; Ex. 1005 ¶¶ 160–166));7 (2) a guide catheter (guiding
`catheter 1) that has a continuous lumen extending from its proximal end at a
`hemostative valve (the valve built into main connector 31) to a distal end
`adapted to be placed in the branch artery (id. at 22–25 (citing Ex. 1007,
`1:66–2:5, 3:29–37, 5:11–23, 5:32–34, 5:65–67, 7:7–10, Figs. 1A, 5, 6;
`Ex. 1005 ¶ 167)); (3) a continuous lumen of the guide catheter that has a
`circular cross-sectional inner diameter sized such that interventional
`cardiology devices are insertable into and through the continuous lumen (id.
`at 25–27 (citing Ex. 1007, 3:59–63, 4:43–52, 4:61–63, Fig. 5, Table 1;
`
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`7 We need not determine at this time whether the preamble of claim 1 is
`limiting because Petitioner shows sufficiently for purposes of institution that
`the recitation in the preamble is disclosed in Itou.
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`Ex. 1005 ¶ 168)); (4) a device (suction catheter 2) that is adapted for use
`with guiding catheter 1 (id. at 27 (citing Ex. 1007, 2:5–11, 2:27–38, 5:12–
`17, 5:26–42, 7:7–23, Figs. 1A, 1B, 5, 6; Ex. 1005 ¶¶ 161–162));
`(5) the device having a flexible tip portion defining a tubular structure (tip
`22 and tubular portion 21) and having a circular cross-section and length that
`is shorter than the predefined length of the continuous lumen of the guide
`catheter, and a tubular structure that has a cross-sectional outer diameter
`sized to be insertable through the cross-sectional inner diameter of the
`continuous lumen of the guide catheter and defines a coaxial lumen having a
`cross-sectional inner diameter through which interventional cardiology
`devices are insertable (id. at 27–29 (citing Ex. 1007, 1:60–65, 2:12–26,
`4:48–52, 7:1–23, Figs. 3, 5, Table 1; Ex. 1005 ¶ 170)); (6) a substantially
`rigid portion (solid wire-like portion 25) that is proximal of and operably
`connected to the flexible tip portion and, when combined with the length of
`flexible distal tip portion, defines a total length of the device along the
`longitudinal axis that is longer than the length of the continuous lumen of the
`guide catheter such that when the flexible tip portion is extended beyond the
`distal end at least a portion of the substantially rigid portion extends through
`the hemostatic valve in common with interventional cardiology devices that
`are insertable into the guide catheter (id. at 29–36 (citing, inter alia, Ex.
`1007, Fig. 3 (depicting flexible tip 21, 22 operably connected to rigid wire-
`like portion 25), Fig. 5 (depicting distal portion of flexible tip 21, 22
`extending beyond the distal end of guiding catheter 1 and depicting a portion
`of wire-like portion 25 extending beyond the valve in main connector 31));
`and (7) a distal tip portion (tip 22) that is more flexible than a cylindrical
`distal reinforced portion of the tubular structure (tubular portion 21) (id. at
`
`17
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`IPR2020-00128
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`36–38 (citing Ex. 1007, Fig. 3; Ex. 1005 ¶¶ 174–177, 185; Ex. 1042 ¶¶ 21–
`24, 50, 53–58, 63)).
`Petitioner also contends that Itou discloses every limitation of
`independent claim 12, citing to essentially the same disclosures of Itou set
`forth above. Id. at 52–59.
`Patent Owner contends independent claims 1 and 12 are not
`anticipated by Itou because Petitioner has failed to demonstrate that the
`tubular structure of Itou has an inner diameter “through which interventional
`cardiology devices are insertable.” Prelim. Resp. 33–39. According to
`Patent Owner, this claim phrase requires that all “interventional cardiology
`devices” identified in the ’380 patent are insertable through the inner
`diameter of the tubular portion of a device, including “at least balloon
`catheters, stents, and stent catheters.” Id. at 33–34 (emphases omitted).
`Petitioner demonstrates that the tubular portion of Itou’s device has an
`inner diameter through which both guide wire 6 and protective catheter 5
`may be inserted. Pet. 26 (providing the inner diameters of suction catheter
`2), 29 (citing Ex. 1007, Fig. 5). Patent Owner does not dispute this
`evidence, but contends a “protective catheter” and “guide wire” are not
`“balloon catheters, stents, and stent catheters.” Prelim. Resp. 34–35. We do
`not find this argument persuasive because we do not construe the disputed
`claim phrase to require that all “interventional cardiology devices” be
`insertable through the lumen of a particular device.
`Moreover, the ’380 patent indicates that 8 French, 7 French, and
`6 French guide catheters are “commonly used in interventional cardiology
`procedures.” Ex. 1001, 3:28–31. For “a 5 French in 6 French” coaxial
`guide catheter, which appears to be the smallest diameter combination
`
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`IPR2020-00128
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`
`identified in the ’380 patent, the ’380 patent explains that the internal
`diameter of the coaxial guide catheter should be “greater than or equal to
`0.056 inches.” Id. at 3:36–43. Petitioner presents evidence that in at least
`one embodiment of Itou the inner diameter of suction catheter 2 is 1.5 mm,
`or 0.059 inches. Pet. 26 (citing Ex. 1007, Table 1). This further supports
`Petitioner’s argument that the disputed claim limitation is disclosed in Itou.
`Upon review of the parties’ arguments and supporting evidence, we
`determine that Petitioner has demonstrated a reasonable likelihood that
`claims 1 and 12 are anticipated by Itou.
`5. Dependent Claims 2–4, 6–10, 13–20 and 23
`Petitioner also contends that Itou anticipates claims 2–4, 6–10, 13–20
`and 23 of the ’380 patent. Pet. 38–51, 59–65. In support of these
`arguments, Petitioner provides a detailed analysis of Itou and supporting
`testimony from Dr. Hillstead identifying where each limitation of these
`claims is disclosed in Itou. Id. (citing generally Ex. 1042).
`Patent Owner does not address Petitioner’s specific arguments with
`respect to claims 2–4, 6–10, 13–20 and 23.
`Upon review of Petitioner’s arguments and Dr. Hillstead’s supporting
`testimony, we determine that Petitioner has demonstrated a reasonable
`likelihood that claims 2–4, 6–10, 13–20 and 23 are anticipated by Itou.
`C. Claims 3, 14, and 15 over Itou and Ressemann
`To the extent not anticipated by Itou, Petitioner contends the subject
`matter of claims 3, 14, and 15 would have been obvious over the combined
`disclosures of Itou and Ressemann, when considered in light of the
`knowledge of one of ordinary skill in the art. Pet. 65–76.
`
`19
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`IPR2020-00128
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`
`Patent Owner does not directly address Petitioner’s arguments with
`respect to claims 3, 14, and 15.
`Having determined that Petitioner presents sufficient evidence that
`Itou discloses every limitation of claims 3, 14, and 15, we need not address
`Petitioner’s obviousness arguments based on the combination of Itou and
`Ressemann.
`D. Claim 21 over Itou and Berg
`Claim 21 depends indirectly from claim 12 and further requires that
`“the first flexural modulus is about 13,000 PSI plus or minus 5000 PSI, the
`second flexural modulus is about 29,000 PSI plus or minus 10,000 PSI, and
`the third portion flexural modulus is about 49,000 PSI plus or minus 10,000
`PSI.” Ex. 1001, 13:29–33. Petitioner contends the subject matter of
`claim 21 would have been obvious over the combined disclosures of Itou
`and Berg, when considered in light of the knowledge of one of ordinary skill
`in the art. Pet. 76–80.
`1. Berg
`Berg discloses a “guiding catheter for use in coronary angioplasty and
`other cardiovascular interventions.” Ex. 1051, Abstract. In particular, Berg
`discloses a guide catheter “having a transition zone with a different
`flexibility than adjacent portions of the catheter shaft for improved catheter
`performance.” Id. at 1:21–25.
`Berg notes that in order for a physician to place a catheter at the
`correct location in a blood vessel, the physician must apply longitudinal and
`rotational forces. Id. at 1:49–51. Thus, the catheter must be rigid enough to
`push through the blood vessel and torsionally rigid enough to transmit the
`applied torque, but flexible enough to navigate the bends in the blood vessel.
`
`20
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`
`Id. at 1:49–56. Berg also notes that “it is preferable to have a soft tip or
`flexible section engage the ostium,” thereby providing a less traumatic
`section to the blood vessel. Id. at 1:63–2:4. A problem that occurs,
`however, is that more flexible tips may increase the incidence of guide
`catheter back-out, when the guide disengages from its preferred positioning
`in the coronary ostium. Id. at 2:11–15.
`Berg overcomes the deficiencies of the prior art “by providing a
`transition element in the material,”
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