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.
`
`IPR2020-00135
`Patent RE45,776 E
`
`
`
`
`
`
`
`
`
`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
`
`
`
`
`
`
`
`

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`IPR2020-00135
`Patent RE45,776 E
`
`I.
`
`INTRODUCTION
`Background and Summary
`A.
`On November 12, 2019, Medtronic, Inc. and Medtronic Vascular, Inc.
`(“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 (“the
`’776 patent,” Ex. 1001). Paper 1 (“Pet.”). Vascular Solutions, Inc. (“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; Paper 14. 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
`25–27, 29–33, 35–39, 41–49, and 52–56 of the ’776 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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`IPR2020-00135
`Patent RE45,776 E
`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 ’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
`(“Medtronic”). Pet. 5; Paper 4, 2. The ’776 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.
`Petitioner further notes that the ’776 patent is a reissue of U.S. Patent No.
`8,292,850, 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. 5.
`Petitioner has also filed another petition challenging the ’776 patent
`based on different prior art. IPR2020-00136.1 In addition, Petitioner has
`filed concurrent petitions challenging other related patents: U.S. Patent No.
`8,048,032 (IPR2020-00126; IPR2020-00127), RE45,830 (IPR2020-00128;
`IPR2020-00129; IPR2020-00130; IPR2020-00131), RE 45,760 (IPR2020-
`00132; IPR2020-00133; IPR2020-00134), and RE47,379 (IPR2020-00137;
`IPR2020-00138).
`
`
`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 ’776 patent, we need not and do not address Patent Owner’s
`arguments for denial based on multiple petitions.
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`IPR2020-00135
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`
`The ’776 Patent
`D.
`The ’776 patent, entitled “Coaxial Guide Catheter for Interventional
`Cardiology Procedures,” issued on October 27, 2015, as a re-issue of U.S.
`Patent No. 8, 292,850 which itself issued from a non-provisional application
`filed January 26, 2012. Ex. 1001, codes (45), (64).
`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. 1001, 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
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`IPR2020-00135
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`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:
`
`
`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 and 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 figures above). Id. at 7:23–24. Tapered inner catheter 14 may
`
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`IPR2020-00135
`Patent RE45,776 E
`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.
`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 tapered inner 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 directing the coronary therapeutic device past a
`tough lesion. Id. at 4:64–5:3.
`Illustrative Claims
`E.
`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
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`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. 1001, 13:35–52 (cl. 25).
`Prior Art and Asserted Grounds
`F.
`Petitioner asserts that claims 25–27, 29–33, 35–39, 41–49, and 52–56
`would have been unpatentable based on the following grounds. Pet. 7.
`Claim(s) Challenged
`35 U.S.C. §
`Reference(s)/Basis
`25–27, 29–33, 35–37,
`102
`41–45, 47–49
`39, 46
`
`Itou
`Itou and the knowledge of
`POSITA
`Itou, Kataishi, and the
`knowledge of POSITA
`Itou, Ressemann, and the
`knowledge of POSITA
`Itou, Enger, and the knowledge
`of POSITA
`Petitioner relies upon the expert declarations of Dr. Stephen Brecker
`
`(Ex. 1005) and Dr. Richard Hillstead (Ex. 1042) in support of its Petition.
`Patent Owner relies upon the expert declaration of Peter Keith (Ex. 2042) in
`support of its Preliminary Response.
`II. ANALYSIS
`Priority Date for the ’776 Patent
`A.
`Petitioner argues that “[t]he ’776 patent is subject to the AIA’s first-
`to-file provisions because (1) it contains claims that lack written description,
`
`52–56
`
`103(a)
`
`7
`
`103(a)
`
`36, 37, 52–56
`
`103(a)
`
`32, 36–38, 46, 52–56 103(a)
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`IPR2020-00135
`Patent RE45,776 E
`and therefore pre-AIA priority, and (2) it claims priority to RE45,380 (“the
`’380 patent”), which is subject to the AIA first-to-file provisions.” Pet. 12.
`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 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 ’776 patent. Indeed, Petitioner
`provides no statutory or case law support for the proposition that a reissue
`patent may lose the filing date of the original patent for which reissue was
`sought.2
`
`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. 13. Alternatively, Petitioner
`
`
`2 Petitioner’s priority date argument appear to be a back door attempt to have
`us address whether the ’776 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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`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 indicates that “[f]or purposes of this Preliminary
`Response only, Teleflex does not currently dispute Medtronic’s proposed
`definition of a POSITA.” Prelim. Resp. 18.
`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
`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 “concave
`track” and “flexural modulus.” Pet. 15–16. Patent Owner responds to
`Petitioner’s proposed constructions by asserting that “no specific
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`IPR2020-00135
`Patent RE45,776 E
`construction of these terms (or any other terms) is necessary for the Board to
`deny the Petition.” Prelim. Resp. 18.
`At this stage of the proceeding, we do not perceive a need to construe
`any claim terms of the ’776 patent for purposes of determining whether to
`institute trial. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 295,
`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.”).
`
`D. Ground 1: Anticipation by Itou
`Petitioner asserts that claims 25–27, 29–33, 35–37, 39, 41–43, 45, and
`47–49 are anticipated by Itou. Pet. 7. We focus our analysis on independent
`claim 25 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. 16.
`Patent Owner argues that Itou does not qualify as prior art based on an
`earlier invention date for the claimed invention of the ’776 patent. Prelim.
`Resp. 26–29. 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 26. As support for this
`contention, Patent Owner relies upon the declarations of inventor Howard
`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,
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`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 26–27.
`The burden to show that Itou is prior art to the ’776 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 ’776 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. 3
`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
`
`
`3 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. 27–28. 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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`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 (Ex. 1007)
`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
`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
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`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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`
`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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`
`Independent Claim 25
`3.
`Petitioner contends that Itou teaches each of the limitations of
`independent claim 25 as follows:
`With respect to the requirement for “[a] guide extension catheter for
`use with a guide catheter,”4 Petitioner contends that, to the extent the
`preamble is limiting, Itou discloses this requirement by its combination of a
`guiding catheter 1 and suction catheter 2. Pet. 18–19 (citing Ex. 1007, 1:66–
`2:11, 7:1–23, 7:35–43, Abstract, Figs. 1B, 5–6, 8; Ex. 1005 ¶¶ 153–155).
`With respect to the requirement for “a substantially rigid segment.”
`Petitioner contends that Itou’s wire-like portion 25 is a “substantially rigid”
`segment because it is used to advance suction catheter 2 through guiding
`catheter 1. Id. at 19–20 (citing Ex. 1007, 2:32–36, 5:35–46, Abstract, Figs.
`5–6; Ex. 1005 ¶ 156).
`With respect to the requirement for “a tubular structure defining a
`lumen and positioned distal to the substantially rigid segment,” Petitioner
`identifies Itou’s tubular body portion 21. Id. at 20 (citing Ex. 1007,
`Abstract, 3:47–58, 4:48–52, 5:14–15, Figs. 1B, 3, 4; Ex. 1005 ¶ 157).
`With respect to the requirement for “the segment defining a partially
`cylindrical opening positioned between a distal end of the substantially rigid
`segment and a proximal end of the tubular structure,” Petitioner contends
`that a partially cylindrical opening is positioned between a distal end of the
`wire-like portion 25 and a proximal end of the tubular structure 21. Id. at
`21–22 (citing Ex-1007, Fig. 4, 3:47–48, 4:10–11, 4:27–30; Ex. 1005 ¶ 158).
`
`
`4 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 Itou.
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`With respect to the requirement for the “segment defining the partially
`cylindrical opening having an angled proximal end,” Petitioner contends that
`Itou discloses that the opening is “inclined obliquely” and “formed by
`obliquely cutting one end of a metal pipe.” Id. at 22 (citing Ex. 1007, 4:10–
`11, 4:27–32, Figs. 3–4; Ex. 1005 ¶ 159).
`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 Itou satisfies this requirement by
`disclosing that the partially cylindrical opening is “formed by obliquely
`cutting one end of a metal pipe” that is encased in resin layers, whereas the
`tubular structure 21 has “an inner layer 210 made of a resin material . . . a
`reinforcing layer 211 made of a metal wire made of stainless steel or the
`like, and an outer layer 212 for covering the reinforcing layer 211[.]” Id. at
`22 (citing Ex. 1007, 3:45–58, 4:27–30 (“end 231”), 4:36–38, Figs. 3–4; Ex.
`1005 ¶ 160; Ex. 1042 ¶¶ 66–73).
`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 Itou discloses
`this requirement by teaching that suction catheter 2 is long enough so while
`its distal end is advanced to a target location—distal to the distal end of the
`guiding catheter 1—its proximal end remains in the guiding catheter. Id. at
`24–25 (citing Ex-1007, 4:48–50, 5:15, 5:35-42, 6:30-35, Figs. 5-6; Ex-1005,
`¶ 161). Petitioner also argues that the “configured to” language recites an
`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
`the guide extension catheter at the proximal end of the tubular structure
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`defines a single lumen,” Petitioner contends that Itou disclosed only a single
`lumen for the suction catheter 2, thereby satisfying this requirement. Id. at
`25 (citing Ex. 1007, 4:48–50, 5:15, Fig. 3; Ex. 1005 ¶ 162).
`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 25 of the ’776 patent. We have considered, but are
`not persuaded by Patent Owner’s arguments.
`Patent Owner argues that Petitioner has not shown that Itou expressly
`or inherently discloses the limitation in the preamble of claim 25 reciting
`“[a] guide extension catheter for use with a guide catheter.” Prelim. Resp.
`35. Patent Owner contends the preamble is limiting and that Itou does not
`disclose that its suction catheter can be used as a guide extension catheter or
`that its suction catheter is configured to guide any interventional cardiology
`device. Id. at 36 (citing Ex. 2042 ¶ 48). We are not persuaded by this
`argument on the present record because Petitioner’s expert Dr. Brecker has
`opined that Itou’s “suction catheter 2 is insertable into guiding catheter 1 and
`may be used as a guide extension catheter.” Ex. 1005 ¶ 154. Although
`Patent Owner’s expert has opined that Itou’s suction catheter is not a guide
`extension catheter (Ex. 2042 ¶ 48), we find there are genuine issues of
`material fact as to this dispute that are best resolved after a full trial record.
`See 37 C.F.R. § 42.108(c).
`Patent Owner further argues that Petitioner has not shown that Itou
`expressly or inherently discloses the requirement that the guide catheter is
`“configured to receive one or more interventional cardiology devices
`therethrough when positioned within the guide catheter.” Prelim. Resp. 37–
`40. Patent Owner contends that “Itou teaches that the suction catheter 2 and
`distal end protective catheter 5 are assembled outside the body and inserted
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`into a delivery catheter together in the pre-assembled state,” but this “is not
`the same as advancing an interventional cardiology device into an opening
`positioned within a guide catheter.” Id. (citing Ex. 2042 ¶¶ 50–51). We
`recognize that the “configured to” language may not be purely functional
`and thus disregarded in the patentability analysis. See Aspex Eyewear, Inc.
`v. Marchon Eyewear, Inc., 672 F.3d 1335, 1349 (Fed. Cir. 2012) (“In
`common parlance, the phrase ‘adapted to’ is frequently used to mean ‘made
`to,’ ‘designed to,’ or ‘configured to,’ but it can also be used in a broader
`sense to mean ‘capable of’ or ‘suitable for.’”). However, Patent Owner does
`not identify what particular structure is required by this claim that is lacking
`in Itou. To the extent that Patent Owner’s expert opines that Itou’s structure
`cannot meet this claim requirement (Ex. 2042 ¶¶ 50–51), we find there are
`genuine issues of material fact as to this dispute that are best resolved after a
`full trial record. See 37 C.F.R. § 42.108(c).
`Having determined that Petitioner meets the threshold for review of
`claim 25 based on anticipation by Itou, we institute a review as to all of
`challenged claims and grounds contained in the Petition.
`Claims 26, 27, 29–33, 35–37, 39, 41–45, and 47–49
`4.
`Petitioner also contends that Itou anticipates claims 26, 27, 29–33,
`35–37, 39, 41–45, and 47–49 of the ’776 patent. Pet. 26–43.5 In support of
`these arguments, Petitioner provides a detailed analysis of Itou and
`supporting testimony from Dr. Brecker identifying where each limitation of
`these claims is disclosed in Itou. Id. (citing generally Ex. 1005). Patent
`
`
`5 We note that the Petition’s heading for ground 1 does not include claim 44
`(Pet. 16), but the Petition nonetheless provides an analysis for why Itou
`anticipates claim 44. Id. at 36. Thus, we treat claim 44 as within the scope
`of the Petition’s anticipation challenge.
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`Owner does not present separate arguments as to these claims in response to
`Petitioner’s anticipation challenge.
`Upon review of Petitioner’s arguments and the supporting evidence,
`we determine that Petitioner has demonstrated a reasonable likelihood that
`claims 26, 27, 29–33, 35–37, 39, 41–45, and 47–49 are anticipated by Itou.
`E. Ground 2: Obviousness in view of Itou and the Knowledge of a
`POSITA
`Petitioner separately asserts that claims 39 and 46 would have been
`obvious in view of Itou and the knowledge of a POSITA. Pet. 43–46.
`Claim 39 depends from claim 25 and recites “wherein the
`substantially rigid segment is formed from a section of stainless steel.” Ex.
`1001, 14:32–34. With respect to this requirement, Petitioner points out that
`Itou’s proximal end portion 231 is formed by obliquely cutting one end of a
`metal pipe such as a pipe of stainless steel and a distal end portion 232, and
`contends a POSITA would have understood that stainless steel was
`commonly used for monorail style pushrods. Pet. 43–44 (citing Ex. 1007,
`4:27–30, 4L33–34, 4:58–61; Ex. 1042 ¶ 78; Ex. 1050, 5:1–2). As discussed
`above, we determine that Petitioner presents sufficient evidence that Itou
`anticipates claim 39, and thus we need not address Petitioner’s obviousness
`arguments for that claim based on Itou.
`Claim 46 depends from claim 45, which in turn depends from claim
`25, and recites “wherein a length of the reinforcing braid or coil is 20 to 30
`cm.” Ex. 1001, 14:62–63. With respect to this requirement, Petitioner
`contends that although the reinforcing braid or coil of Itou’s tubular structure
`does not extend 20 to 30 cm, a POSITA would have motivation to lengthen
`the tubular structure “to accommodate reaching lesions located in
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`particularly tortuous vessels.” Pet. 44–46 (citing Ex. 1005 ¶¶ 193–196; Ex.
`1042 ¶¶ 131–135).
`Patent Owner’s only argument in response to ground 2 is that it fails
`for the same reason as ground 1. Prelim. Resp. 40–41. As discussed above,
`we determine that Petitioner has made a sufficient showing for ground 1.
`And upon review of Petitioner’s arguments and the supporting evidence, we
`determine that Petitioner has demonstrated a reasonable likelihood that
`claims 39 and 46 would have been obvious based on Itou in view of the
`knowledge of a POSITA.
`F. Ground 3: Obviousness in view of Itou, Kataishi, and the Knowledge
`of a POSITA
`Petitioner asserts that claims 36, 37, and 52–56 would have been
`obvious in view of Itou, Kataishi, and the knowledge of a POSITA. Id. at
`46–61. Petitioner relies upon Itou in