Trials@uspto.gov
`571-272-7822
`
`Paper 22
`Date: June 8, 2020
`
`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.
`
`IPR2020-00126
`Patent 8,048,032 B2
`
`
`
`
`
`
`
`
`
`Before SHERIDAN K. SNEDDEN, JON B. TORNQUIST, and
`CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.
`PAULRAJ, Administrative Patent Judge.
`
`DECISION
`Granting Institution of Inter Partes Review
`35 U.S.C. § 314
`
`
`
`
`
`
`
`

`

`IPR2020-00126
`Patent 8,048,032 B2
`
`INTRODUCTION
`I.
`Background and Summary
`A.
`On November 12, 2019, Medtronic, Inc. and Medtronic Vascular, Inc.
`(collectively, “Petitioner”) filed a Petition requesting an inter partes review
`of claims 1–20 and 22 of U.S. Patent No. 8,048,032 (“the ’032 patent,” Ex.
`1001). Paper 1 (“Pet.”). Teleflex Innovations S.À.R.L. (“Patent Owner”)
`filed a Preliminary Response. Papers 8 (confidential version), 9 (redacted
`version) (“Prelim. Resp.”). Pursuant to our authorization, Petitioner filed a
`Reply addressing its burden on secondary considerations and reduction to
`practice, and Patent Owner filed a Sur-Reply addressing Petitioner’s burden
`on those issues. Paper 12 (“1st Reply”); Paper 14 (“1st Sur-Reply”). Also
`pursuant to our authorization, Petitioner filed another Reply and Patent
`Owner filed another Sur-Reply addressing the factors for discretionary
`denial under 35 U.S.C. § 314(a). Paper 19 (“2nd Reply”); Paper 20 (“2nd
`Sur-Reply”).
`We have the authority and discretion to determine whether to institute
`an inter partes review. 35 U.S.C. § 314 (2018); 37 C.F.R. §42.4(a) (2019).
`We may not institute an inter partes review “unless . . . there is a reasonable
`likelihood that the petitioner would prevail with respect to at least 1 of the
`claims challenged in the petition.” 35 U.S.C. § 314(a). Upon considering
`the arguments and evidence of record, we institute inter partes review of
`claims 1–20 and 22 of the ’032 patent.
`Real Parties-in-Interest
`B.
`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. À.R.L., Vascular Solutions
`
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`IPR2020-00126
`Patent 8,048,032 B2
`LLC, Arrow International, Inc., and Teleflex LLC and notes that “Teleflex
`Incorporated is the ultimate parent of the entities listed above.” Paper 4, 2.
`Related Matters
`C.
`Patent Owner is asserting the ’032 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
`(“Medtronic”). Pet. 5; Paper 4, 2. The ’032 patent is also the subject of a
`declaratory judgement action filed by another party, QXMedical, LLC v.
`Vascular Solutions, LLC, No. 17-cv-01969 (“QXM”), which has been
`currently stayed pending our institution decision. Paper 19; Paper 20. The
`ʼ032 patent was also previously the subject of litigation in the District of
`Minnesota in Vascular Solutions, Inc. v. Boston Scientific Corp., No. 13-cv-
`01172 (D. Minn., filed May 16, 2013), and the subject of previous inter
`partes reviews in IPR2014-00760 and IPR2014-00761 filed by Boston
`Scientific Corp., which terminated based on settlement. Pet. 5.
`Petitioner has also filed another petition challenging the’032 patent
`based on different prior art. IPR2020-00127.1 In addition, Petitioner has
`filed concurrent petitions challenging related reissue patents: RE45,830
`(IPR2020-00128; IPR2020-00129; IPR2020-00130; IPR2020-00131), RE
`45,760 (IPR2020-00132; IPR2020-00133; IPR2020-00134), RE45,776
`
`
`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 ’032 patent, we need not and do not address Patent Owner’s
`argument for denial based on multiple petitions.
`
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`IPR2020-00126
`Patent 8,048,032 B2
`(IPR2020-00135; IPR2020-00136), and RE47,379 (IPR2020-00137;
`IPR2020-00138).
`
`The ’032 Patent
`D.
`The ’032 patent, entitled “Coaxial Guide Catheter for Interventional
`Cardiology Procedures,” issued on November 1, 2011, from a non-
`provisional application filed May 3, 2006. Ex. 1001, codes (45), (54), (22).
`The ’032 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. 1001, Abstract. According to the
`’032 patent, interventional cardiology procedures often include inserting
`guidewires or other instruments through catheters into coronary arteries that
`branch off from the aorta. Id. at 1:15–17. 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 1:20–26. 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 1:30–36. 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 1:36–40.
`To solve this problem, the ’032 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 2:53–56. The ’032 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
`
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`IPR2020-00126
`Patent 8,048,032 B2
`coronary artery, and this feature allows removal of the tapered inner catheter
`after the coaxial guide catheter is in place. Id. at 2:57–61. Figures 1 and 2,
`reproduced below, show a coaxial guide catheter and a tapered inner catheter
`in accordance with the invention described in the ’032 patent:
`
`
`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 5:15–21; Figs. 1 and 2. As shown above, coaxial guide
`catheter assembly 10 includes coaxial guide catheter 12 and tapered inner
`catheter 14. Id. at 6:6–8. Coaxial guide catheter 12 includes tip portion 16,
`reinforced portion 18, and rigid portion 20. Id. at 6:9–10. Tip portion 16
`generally includes bump tip 22 and marker band 24. Id. at 6:13–14. Bump
`tip 22 includes taper 26 and is relatively flexible. Id. at 6:14–15. Marker
`band 24 is formed of a radiopaque material such as platinum/iridium alloy.
`Id. at 6:19–20. Tapered inner catheter tip 42 includes tapered portion 46 at a
`distal end thereof, and straight portion 48. Id. at 6:59–60. Both tapered
`portion 46 and straight portion 48 are pierced by lumen 50 (not labeled in
`figures above). Id. at 6:60–61. Tapered inner catheter 14 may also include
`
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`IPR2020-00126
`Patent 8,048,032 B2
`clip 54 at a proximal end thereof to releasably join tapered inner catheter 14
`to coaxial guide catheter 12. Id. at 6:64–67.
`In operation, the tapered inner catheter is inserted inside and through
`the coaxial guide catheter. Id. at 4:12–13. 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 4:15–23. The tapered inner catheter may be removed once the coaxial
`guide catheter tapered inner catheter combination has been inserted
`sufficiently into the ostium of the coronary artery to achieve deep seating.
`Id. at 4:23–26. 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 4:30–33. 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 directing the coronary therapeutic device past a
`tough lesion. Id. at 4:33–39.
`Illustrative Claim
`E.
`Among the challenged claims, independent claim 1 is representative
`and reproduced below:
`1. A device for use with a standard guide catheter, the standard
`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 a branch artery, the
`continuous lumen of the guide catheter having a circular cross-
`sectional inner diameter sized such that interventional
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`IPR2020-00126
`Patent 8,048,032 B2
`cardiology devices are insertable into and through the lumen
`to the branch artery, the device comprising:
`a flexible tip portion defining a tubular structure 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 than,
`the flexible tip portion and defining a rail structure without
`a lumen and 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.
`Ex. 1001, 10:21–54 (cl. 1).
`Prior Art and Asserted Grounds
`F.
`Petitioner asserts that claims 1–20 and 22 would have been
`unpatentable based on the following grounds. Pet. 7.
`Claim(s) Challenged
`35 U.S.C. §
`Reference(s)/Basis
`1–19, 22
`102
`
`Itou2
`
`
`2 Itou, US 7,736,355 B2, issued June 15, 2010 (Ex. 1007) (“Itou”).
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`IPR2020-00126
`Patent 8,048,032 B2
`Claim(s) Challenged
`3, 13, 14
`
`20
`
`35 U.S.C. §
`103(a)
`
`103(a)
`
`Reference(s)/Basis
`Itou, Ressemann,3 and the
`knowledge of POSITA
`Itou, Berg,4 and the knowledge
`of POSITA
`Petitioner relies upon the Declarations of Dr. Stephen Brecker (Ex.
`
`1005) and Dr. Richard Hillstead (Ex. 1042) in support of its Petition.
`II. ANALYSIS
`Priority Date of the ’032 Patent
`A.
`Petitioner argues that “[t]he ’032 patent is subject to the AIA’s first-
`to-file provisions because it contains at least one claim that lacks a written
`description, and therefore, pre-AIA priority.” Pet. 14. Petitioner advances
`this argument to preclude Patent Owner from swearing behind the Itou
`reference based on a showing of prior invention, which could otherwise be
`done for a pre-AIA “first-to-invent” application. Id. We are not persuaded
`by Petitioner’s argument.
`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
`effective filing date is “the actual filing date of the patent or the application
`for the patent containing a claim to the invention; or the filing date of the
`earliest application for which the patent or application is entitled.” 35
`U.S.C. § 100(i)(1). In the present case, the ’032 patent issued from an
`application filed May 3, 2006, and does not claim the benefit of any other
`filing date. Ex. 1001, code (22). Thus, the only possible effective filing date
`
`
`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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`IPR2020-00126
`Patent 8,048,032 B2
`of the ’032 patent is May 3, 2006, which thus qualifies it as a pre-AIA
`patent.5
`
`Level of Ordinary Skill in the Art
`B.
`We consider the asserted grounds of unpatentability in view of the
`understanding of a person of ordinary skill in the art (“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. 14. 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. at 14–15.
`Additionally, Petitioner contends that “[e]xtensive experience and technical
`training might substitute for education, and advanced degrees might
`substitute for experience.” Id. at 15.
`Patent Owner indicates that “[f]or purposes of this Preliminary
`Response only, Teleflex does not currently dispute Medtronic’s proposed
`definition of a POSITA.” Prelim. Resp. 16.
`On this record, in determining whether the evidence of record
`supports institution, we apply both of Petitioner’s definitions for a POSITA,
`as they are undisputed at this time and consistent with the level of skill
`
`
`5 Petitioner’s priority date argument appear to be a back door attempt to have
`us address whether the ’032 patent satisfies the written description
`requirement of 35 U.S.C. § 112. But this is a question we may not address
`in an IPR. See 35 U.S.C. § 311(b).
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`IPR2020-00126
`Patent 8,048,032 B2
`reflected in the prior art and the specification of the ’032 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).
`Claim Construction
`C.
`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 “standard
`guide catheter,” “placed in a branch artery,” and “flexural modulus.” Pet.
`15–19. Patent Owner responds to Petitioner’s proposed constructions by
`asserting that “no specific construction of these terms (or any other terms) is
`necessary for the Board to deny the Petition.” Prelim. Resp. 19–20. Patent
`Owner also asserts that the ’032 patent provides an express definition for the
`claim term “interventional cardiology devices.” Id. at 16–19. In particular,
`Patent Owner contends that the recitation of a lumen “through which
`interventional cardiology devices are insertable” in claims 1 and 11 should
`be construed to require that “all four enumerated devices (guidewires,
`balloon catheters, stents, and stent catheters) be insertable into the lumen.”
`Id. at 17.
`At this stage of the proceeding, we determine that it is only necessary
`to construe the term “interventional cardiology devices” to resolve the
`disputed issues for purposes of this institution decision. See Vivid Techs.,
`Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 295, 803 (Fed. Cir. 1999) (holding
`
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`IPR2020-00126
`Patent 8,048,032 B2
`that “only those terms need to be construed that are in controversy, and only
`to the extent necessary to resolve the controversy”).
`Independent claims 1 and 11 of the ’032 patent recite a standard guide
`catheter having a continuous lumen sized “such that interventional
`cardiology devices are insertable into and through the lumen.” Ex. 1001,
`10:26–27, 11:34–35. 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
`limited to guidewires, balloon catheters, stents and stent
`catheters.
`Id. at 1:17–21.
`Petitioner contends that, in the QXM litigation, 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. 15–16 (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 litigation. Ex. 1013 (Claim Construction Order).
`Patent Owner contends that “interventional cardiology devices,” as
`used in independent claims 1 and 11,
`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
`
`11
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`IPR2020-00126
`Patent 8,048,032 B2
`the guide catheter in which it is placed. Exhibit 1001, 2:53–64.
`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 3:5–20. 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 5:9–12.
`Merely being sized to receive a guidewire is not enough; the
`claim language requires that guidewires, stents, stent catheters
`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 11, 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.
`1001,7:36–40 (“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 . . . .”);
`Id. at 7:42–8:7; Figs. 7–8.
`Furthermore, 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
`
`12
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`IPR2020-00126
`Patent 8,048,032 B2
`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 7:36–40, 7:42–8:7, 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 5:9–12) and that the term
`“interventional cardiology devices” is not limited to guidewires, balloon
`catheters, stents and stent catheters (id. at 1:17–21). To the extent 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.
`D. Ground 1: Anticipation of Claims 1–19 and 22 by Itou
`Petitioner asserts that claims 1–19 and 22 are anticipated by Itou. Pet.
`19. We focus our analysis on independent claim 1 for purposes of this
`decision. Before we turn to the merits of Petitioner’s anticipation challenge,
`however, we first address Patent Owner’s arguments regarding the prior art
`status of Itou.
`
`Prior Art Status of Itou
`1.
`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. 19–20.
`Patent Owner argues that Itou does not qualify as prior art based on an
`earlier invention date for the claimed invention of the ’032 patent. Prelim.
`Resp. 21–24. In particular, Patent Owner contends that conception of the
`claimed invention occurred in “late 2004,” and reduction to practice
`occurred “in the spring and summer of 2005.” Id. at 22. As support for this
`contention, Patent Owner relies upon the declarations of inventor Howard
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`Root (Ex. 2001) and Deborah Schmalz (a former Vice President of
`Regulatory Affairs at Patent Owner’s predecessor-in-interest) (Ex. 2039),
`along with certain notebook pages and other documents (Exs. 2002–2022,
`2024) allegedly showing prior conception and reduction to practice. Patent
`Owner further contends that, despite having much of the evidence related to
`conception and reduction to practice, Petitioner does not address it in the
`Petition. Id. at 24.
`The burden to show that Itou is prior art to the ’032 patent rests with
`Petitioner. Dynamic Drinkware, LLC v. National Graphics, Inc., 800 F.3d
`1375, 1379 (Fed. Cir. 2015). That said, because Petitioner has presented
`evidence that Itou was filed prior to the filing date of the ’032 patent, thus
`qualifying as § 102(e) prior art, 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.
`Although Patent Owner’s presents multiple pieces of evidence in the
`Preliminary Response in support of this contention, Petitioner has not had an
`opportunity to fully consider and address this evidence in this proceeding.6
`
`
`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
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`Based on the present record, we determine that genuine issues of material
`fact remain about the alleged invention date, and these factual issues are best
`resolved after the record is more fully developed. See 37 C.F.R. § 42.108(c)
`(stating “a genuine issue of material fact created by [Patent Owner’s]
`testimonial evidence will be viewed in the light most favorable to the
`petitioner solely for purposes of deciding whether to institute an inter partes
`review”).
`
`Overview of Itou
`2.
`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.
`Figure 3 of Itou is reproduced below:
`
`
`
`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
`
`
`determine Petitioner did not have an obligation to preemptively address
`Patent Owner’s evidence in its Petition.
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`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:
`
`
`
`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).
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`IPR2020-00126
`Patent 8,048,032 B2
`
`A portion of Figure 6 of Itou is reproduced below:
`
`
`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.
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`IPR2020-00126
`Patent 8,048,032 B2
`
`Independent Claim 1
`3.
`Petitioner contends that Itou teaches each of the limitations of
`independent claim 1.
`With respect to the requirement for “[a] device for use with a standard
`guide catheter,” Petitioner contends that Itou teaches this limitation by
`“disclos[ing] a combination of guiding catheter 1 and suction catheter 2 (i.e.
`‘a device’) and further disclos[ing] the system’s use in delivering a
`protective catheter 5 and a guidewire 6 to the location of a coronary artery
`occlusion.” Pet. 22 (citing Ex-1007, 5:35–38, 5:43–46, 7:1–23, 7:35–43,
`Figs. 5–6, 8).7
`Petitioner further contends that the guiding catheter 1 taught by Itou
`satisfies the requirements for “the standard 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 a branch artery,” and
`“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 lumen to the branch artery.” Id. at 22–26.
`Petitioner points out that Itou teaches that guiding catheter 1 “preferably has
`dimensions equal to those of a guiding catheter used in ordinary catheter
`operation,” with an inner diameter of 1.8 mm, and that protective catheter 5
`and guidewire 6 are sized to be to be insertable into and through the lumen
`of the guiding catheter. Id. at 24–26.
`With respect to the claim element reciting:
`
`
`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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`IPR2020-00126
`Patent 8,048,032 B2
`a flexible tip portion defining a tubular structure 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[,]
`Petitioner points to Itou’s tubular portion 21 and tip 22 as satisfying the
`foregoing requirements for a “flexible tip portion.” Id. at 26–28.
`
`With respect to the claim element reciting:
`substantially rigid portion proximal of and operably connected
`to, and more rigid along a longitudinal axis than, the flexible tip
`portion and defining a rail structure without a lumen and 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[,]
`Petitioner points to the wire-like portion 25 of Itou’s suction catheter 2,
`either fused to the proximal portion of an obliquely cut metal pipe 231
`(“Mapping-1”) or on its own (“Mapping-2”), as satisfying the foregoing
`requirements for a “substantially rigid portion.” Id. at 28–35.
`Based on the evidence and arguments of record, we determine that
`Petitioner has demonstrated a reasonable likelihood of prevailing with
`respect to at least claim 1 of the ’032 patent. We have considered, but are
`not persuaded by Patent Owner’s arguments.
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