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`Trials@uspto.gov
`571-272-7822
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`Paper
`Date:
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MEDTRONIC, INC. and MEDTRONIC VASCULAR, INC.,
`Petitioner,
`v.
`TELEFLEX INNOVATIONS S.À.R.L.,
`Patent Owner.
`
`IPR2020-00126
`Patent 8,048,032 B2
`
`Before SHERIDAN K. SNEDDEN, JON B. TORNQUIST, and
`CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.
`PAULRAJ, Administrative Patent Judge.
`
`JUDGMENT
`Final Written Decision
`Determining No Challenged Claims Unpatentable
`Not Deciding Patent Owner’s Contingent Motion to Amend
`35 U.S.C. § 318(a)
`
`ORDER
`Denying Petitioner’s Motion to Exclude (Paper 111)
`37 C.F.R. § 42.64(c)
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`INTRODUCTION
`I.
`A. Background and Summary
`This is our Final Written Decision entered pursuant to 35 U.S.C.
`§ 318(a) and 37 C.F.R. § 42.73. For the reasons explained in our analysis
`below, we determine that the primary reference relied upon by Petitioner for
`all its patentability challenges does not qualify as prior art because Patent
`Owner has antedated that reference. Thus, Petitioner has not demonstrated
`that any of the challenged claims are unpatentable in this proceeding.
`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 B2 (“the ’032 patent,”
`Ex. 1001). Paper 1 (“Pet.”). Teleflex Innovations S.À.R.L. (“Patent
`Owner”)1 filed a Preliminary Response. Papers 8 (confidential version), 9
`(redacted version) (“Prelim. Resp.”). In our Institution Decision, we
`determined that there was a reasonable likelihood that Petitioner would
`prevail with respect to at least one challenged claim and accordingly,
`instituted an inter partes review pursuant to 35 U.S.C. § 314 based on all
`challenges presented in the Petition. Paper 22 (“Institution Decision” or
`“Inst. Dec.”).
`Following institution, Patent Owner filed two post-institution
`responses: (1) a Consolidated Response Addressing Conception and
`
`1 Patent Owner represents that “Teleflex Innovations S.A.R.L. merged into
`Teleflex Medical Devices S.A.R.L,” which subsequently “transferred
`ownership of [the ’032 patent] to Teleflex Life Sciences Limited.” Paper 7,
`2.
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`Reduction to Practice (Paper 39 (“PO CRTP Response” or “PO CRTP
`Resp.”)) and (2) a post-institution Response addressing Petitioner’s
`anticipation and obviousness arguments (Papers 43 (confidential version), 44
`(redacted version) (“PO Resp.”)).
`Petitioner filed a Reply to Patent Owner’s Response Addressing
`Conception and Reduction to Practice (Papers 78 (confidential version), 79
`(redacted version) (“Pet. CRTP Reply”)) and a Reply to Patent Owner’s
`Response (Papers 83 (confidential version), 82 (redacted version)
`(“Reply”)). Patent Owner then filed its post-institution Sur-Reply
`Addressing Conception and Reduction to Practice (Paper 97 (“PO CRTP
`Sur-Reply”)), and Petitioner filed its post-institution Sur-Reply Addressing
`Conception and Reduction to Practice (Paper 112 (“Pet. CRTP Sur-Sur-
`Reply”)). Patent Owner also filed a post-institution Sur-Reply to
`Petitioner’s Reply to Patent Owner’s Response (Papers 103 (confidential
`version), 104 (redacted version) (“PO Sur-Reply”)).
`Patent Owner also filed a Contingent Motion to Amend. Paper 38
`(original), Paper 96 (corrected) (“Motion”).2 The Motion requests that if
`any of claims 1, 11, or 16 is found unpatentable, they should be replaced by
`proposed substitute claims 23–25. Motion 1. Petitioner filed an Opposition
`to Motion to Amend. Paper 102. Patent Owner filed a Reply in Support of
`the Corrected Motion to Amend (Paper 106), and Petitioner filed a Sur-
`Reply (Paper 114).
`
`2 Pursuant to a stipulation by the parties, we authorized the filing of the
`corrected Motion to Amend in order to clarify certain antecedent bases and
`thereby simplify the issues.
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`An oral hearing was held on March 8, 2021, and a transcript of the
`hearing is included in the record. Papers 125 (redacted version) (“Tr.”), 126
`(confidential version).
`
`B. Real Parties-in-Interest
`Petitioner identifies Medtronic, Inc. and Medtronic Vascular, Inc., as
`the real parties-in-interest, and notes that “Medtronic plc is the ultimate
`parent of both entities.” Pet. 5. Patent Owner identifies the real parties-in-
`interest for itself as Teleflex Medical Devices S.À.R.L., Vascular Solutions
`LLC, Arrow International, Inc., Teleflex LLC, and Teleflex Life Sciences
`Limited and notes that “Teleflex Incorporated is the ultimate parent of the
`entities listed above.” Paper 4, 2; Paper 7, 2.
`
`C. Related Matters
`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 (D. Minn.,
`filed July 2, 2019). 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 (D. Minn., filed June 8, 2017),
`which was 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.
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`Petitioner has also filed another petition challenging the ’032 patent
`based on different prior art. IPR2020-00127. We also instituted inter partes
`review in IPR2020-00127. IPR2020-00127, Paper 20. In addition,
`Petitioner has filed concurrent petitions challenging related reissue patents:
`RE45,380 (IPR2020-00128; IPR2020-00129; IPR2020-00130; IPR2020-
`00131), RE45,760 (IPR2020-00132; IPR2020-00133; IPR2020-00134),
`RE45,776 (IPR2020-00135; IPR2020-00136), and RE47,379 (IPR2020-
`00137; IPR2020-00138).
`
`D. The ’032 Patent (Ex. 1001)
`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
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`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
`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, 2. As shown above, coaxial guide catheter
`assembly 10 includes coaxial guide catheter 12 and tapered inner catheter
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`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
`the figures above). Id. at 6:60–61. Tapered inner catheter 14 may also
`include clip 54 at a proximal end thereof to releasably join tapered inner
`catheter 14 to coaxial guide catheter 12. Id. at 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/guide 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.
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`E. Illustrative Claim
`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 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).
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`F. Prior Art and Asserted Grounds
`We instituted review of claims 1–20 and 22 of the ’032 patent on the
`following grounds (Inst. Dec. 7–8, 31):
`Claim(s) Challenged
`35 U.S.C. §
`1–19, 22
`102
`
`Reference(s)/Basis
`
`3, 13, 14
`
`20
`
`103(a)
`
`103(a)
`
`Itou3
`Itou, Ressemann,4 the
`knowledge of a person of
`ordinary skill in the art
`(“POSITA”)
`Itou, Berg,5 the knowledge of
`POSITA
`In support of its arguments, Petitioner relies on declarations
`submitted by Dr. Stephen Jon David Brecker (Exs. 1005, 1806), Dr. Richard
`A. Hillstead (Ex. 1042), Mr. Michael Jones (Ex. 1807), and Dr. Paul Zalesky
`(Exs. 1755, 1830, 1919). Patent Owner relies on the declarations submitted
`by Ms. Deborah Schmalz (Ex. 2039), Ms. Amy Welch (Ex. 2044), Mr.
`Howard Root (Ex. 2118), Mr. Gregg Sutton (Ex. 2119), Mr. Mark Goemer
`(Ex. 2120), Ms. Amanda O’Neil (Ex. 2121), Mr. Steve Erb (Ex. 2122), Mr.
`Peter T. Keith (Exs. 2123, 2124, 2138, 2243), Dr. John J. Graham (Ex.
`2145), Dr. Lorenzo Azzalini (Ex. 2151), Mr. Steve Jagodzinkski (Exs. 2152
`(redacted), 2153 (confidential)), Ms. Heather S. Rosecrans (Ex. 2205), and
`Dr. Craig Thompson (Ex. 2215).
`
`3 Itou et al., US 7,736,355 B2, issued June 15, 2010 (Ex. 1007) (“Itou”).
`4 Ressemann et al., US 7,604,612 B2, issued October 20, 2009 (Ex. 1008)
`(“Ressemann”).
`5 Berg et al., US 5,911,715, issued June 15, 1999 (Ex. 1051) (“Berg”).
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`ANALYSIS
`II.
`A. Priority Date of the ’032 Patent
`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
`of the ’032 patent is May 3, 2006, which thus qualifies it as a pre-AIA
`patent.6
`
`6 Petitioner’s priority date argument appears 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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`B. Level of Ordinary Skill in the Art
`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 does not dispute Petitioner’s proposed definition of a
`POSITA. PO Resp. 8.
`Upon review of the parties’ arguments and supporting evidence, we
`adopt Petitioner’s definitions for a POSITA, as they are undisputed and
`consistent with the evidence of record. 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).
`
`C. Claim Construction
`We interpret a claim “using the same claim construction standard that
`would be used to construe the claim in a civil action under 35 U.S.C.
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`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.
`Upon review of the parties’ arguments and supporting evidence, we
`determine that it is not necessary to construe any claim terms to resolve the
`disputed issues for purposes of this Final Written Decision. See Vivid
`Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)
`(holding that “only those terms need to be construed that are in controversy,
`and only to the extent necessary to resolve the controversy”); see also Nidec
`Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017
`(Fed. Cir. 2017) (applying Vivid Techs. in the context of an inter partes
`review).
`
`D. Status of Itou as Prior Art - Conception and Reduction to Practice
`The dispositive issue in this case is whether Itou, which is relied upon
`for all grounds in the Petition, qualifies as prior art.
`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 prior art under pre-AIA § 102(e). Pet. 19–20.7 In the
`Conception and Reduction to Practice (“CRTP”) briefing that we separately
`authorized for these proceedings, Patent Owner argues that Itou does not
`
`7 In addition to this Petition, Petitioner similarly asserts Itou in the petitions
`in IPR2020-00128, -00129, -00132, -00134, -00135, and -00137. Our
`analysis regarding the prior art status of Itou is similar for each of these
`proceedings.
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`qualify as prior art based on research and development related to the claimed
`invention that took place at Vascular Solutions, Inc. (“VSI”), Patent Owner’s
`predecessor-in-interest, starting around early 2005 and continuing through
`the filing of the priority application for the challenged patent. See generally
`PO CRTP Response; PO CRTP Sur-Reply. Petitioner disputes these
`contentions. See generally Pet. CRTP Reply; Pet. CRTP Sur-Sur-Reply.
`In its CRTP Response, Patent Owner identifies the evidence on which
`it relies to antedate Itou, including certain inventor testimony, non-inventor
`testimony, and other documentary evidence. PO CRTP Resp. 2. As to
`inventor testimony, Patent Owner relies on the respective declarations of co-
`inventors Howard Root (Ex. 2118) and Gregg Sutton (Ex. 2119). As to non-
`inventor testimony, Patent Owner relies on the declaration of its expert Peter
`T. Keith (Ex. 2123), the declarations of VSI employees Steven Erb (Ex.
`2122) and Deborah Schmalz (Ex. 2039), and the declarations of employees
`of third-party vendors, Amanda O’Neil (Ex. 2121) and Mark Goemer (Ex.
`2120). As to documentary evidence, Patent Owner relies on nearly 75
`exhibits. These documents include inventor lab notebooks and handwritten
`notes (Exs. 2002, 2004); internal company memoranda, presentations, and
`other similar documents (Exs. 2003, 2005, 2017–2018, 2024, 2025, 2036–
`2038, 2040–2041, 2099–2100, 2105, 2109, 2127–2134); invoices, sales
`orders, and certificates of completion from technical equipment vendors
`(Exs. 2006–2011, 2013, 2016, 2020–2021, 2026–2035, 2089–2095, 2097,
`2104, 2106–2108, 2110–2112); a photograph (Ex. 2014); deposition
`transcripts (Exs. 2015, 2116); communications with and documents from
`VSI’s outside patent counsel (Exs. 2019, 2023, 2096, 2098, 2101–2103,
`2117); and engineering drawings (Exs. 2022, 2113–2115).
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`We have considered this evidence and other rebuttal evidence offered
`by Petitioner. For the following reasons, we conclude that a preponderance
`of the evidence demonstrates that Patent Owner conceived the subject matter
`recited in the challenged claims before September 23, 2005, the date on
`which Itou is effective as prior art (“critical date”) and either actually
`reduced the invention to practice prior to the critical date or diligently
`worked towards constructive reduction to practice until the priority
`application for the challenged patent was filed on May 3, 2006.
`Accordingly, we conclude that Itou does not qualify as prior art to the
`challenged patent.
`For our analysis, we first set forth the relevant legal standards,
`followed by our fact findings and analysis on conception, actual reduction to
`practice, and diligence towards constructive reduction to practice.
`
`Legal Standards
`1.
`“To antedate (or establish priority) of an invention, a [patent owner]
`must show either an earlier reduction to practice, or an earlier conception
`followed by a diligent reduction to practice.” Purdue Pharma L.P. v.
`Boehringer Ingelheim GMBH, 237 F.3d 1359, 1365 (Fed. Cir. 2001).
`“Conception is the formation, in the mind of the inventor, of a definite and
`permanent idea of the complete and operative invention, as it is thereafter to
`be applied in practice.” Cooper v. Goldfarb, 154 F.3d 1321, 1327 (Fed. Cir.
`1998). “A reduction to practice can be either a constructive reduction to
`practice, which occurs when a patent application is filed, or an actual
`reduction to practice.” Id. “In order to establish an actual reduction to
`practice, the [patent owner] must prove that: (1) [the inventors] constructed
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`an embodiment or performed a process that met all the limitations of the
`[claimed invention]; and (2) [the inventors] determined that the invention
`would work for its intended purpose.” Id.
`If a patent owner has not shown actual reduction to practice prior to
`the “critical date” of a reference, the patent owner may nonetheless antedate
`the reference by establishing prior conception and reasonable diligence
`towards the constructive reduction to practice. Purdue Pharma, 237 F.3d at
`1365. “Reasonable diligence must be shown throughout the entire critical
`period, which begins just prior to the competing reference’s effective date
`and ends on the date of the invention’s reduction to practice.” Arctic Cat
`Inc. v. GEP Power Prods., Inc., 919 F.3d 1320, 1331 (2019). However, the
`“diligence need not be perfectly continuous—only reasonably continuous.”
`Id.
`
`To be persuasive, an inventor’s testimony of conception and reduction
`to practice must be corroborated by other independent evidence.
`“Conception must be proved by corroborating evidence which shows that
`the inventor disclosed to others his completed thought expressed in such
`clear terms as to enable those skilled in the art to make the invention.” REG
`Synthetic Fuels, LLC v. Neste Oil Oyj, 841 F.3d 954, 962 (Fed. Cir. 2016)
`(citations and quotation marks omitted). “However, there is no final single
`formula that must be followed in proving corroboration.” Id. (citations and
`quotation marks omitted); see also Kolcraft Enters., Inc. v. Graco Children’s
`Prods., Inc., 927 F.3d 1320, 1324 (Fed. Cir. 2019); Medichem, S.A. v.
`Rolabo, S.L., 437 F.3d 1157, 1169–70 (Fed. Cir. 2006).
`“In the final analysis, each corroboration case must be decided on its
`own facts with a view to deciding whether the evidence as a whole is
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`persuasive.” Berges v. Gottstein, 618 F.2d 771, 776 (CCPA 1980).
`Corroborating evidence may consist of “testimony of a witness, other than
`the inventor,” or “evidence of surrounding facts and circumstances
`independent of information received from the inventor.” Medichem, 437
`F.3d at 1171. “Even the most credible inventor testimony is a fortiori
`required to be corroborated by independent evidence, which may consist of
`documentary evidence as well as the testimony of non-inventors.” Id. at
`1171–72. We assess whether evidence corroborates conception and
`reduction to practice under a “rule of reason” analysis. Cooper, 154 F.3d at
`1330.
`
`In an inter partes review, 35 U.S.C. § 316(e) imposes the ultimate
`burden of persuasion to “prove unpatentability by a preponderance of the
`evidence” onto the petitioner. This burden never shifts to the patent owner.
`Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378
`(Fed. Cir. 2015). However, when the patent owner attempts to antedate the
`prior art, “[a] second and distinct burden, the burden of production” can shift
`between the petitioner and the patentee. Id. at 1379; see In re Magnum Oil
`Tools Int’l, Ltd., 829 F.3d 1364, 1375–76 (Fed. Cir. 2016). Specifically, the
`patent owner “bears the burden of establishing that its claimed invention is
`entitled to an earlier priority date than an asserted prior art reference.”
`Magnum Oil Tools, 829 F.3d at 1375–76. Once the patent owner establishes
`it is entitled to an earlier priority date, the burden of production then shifts
`back to the petitioner “to convince the court that [the patent owner] is not
`entitled to the benefit” of the earlier priority date. Dynamic Drinkware, 800
`F.3d at 1379 (citing Tech. Licensing Corp. v. Videotek, Inc., 545 F.3d 1316,
`1328 (Fed. Cir. 2008)).
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`Conception
`2.
`To show prior conception, Patent Owner relies primarily upon Mr.
`Root’s testimony submitted in support of its CRTP Response. Ex. 2118
`(Root Declaration in support of CRTP).8,9 Mr. Root was the founder and
`Chief Executive Officer of VSI from 1997 to 2017. Id. ¶¶ 1–2. Patent
`Owner also relies upon the testimony of co-inventor Mr. Sutton, who was
`Vice President, Research & Development at VSI from 2004 until mid-2006.
`Ex. 2119 (Sutton Declaration in support of CRTP). As additional
`documentary corroboration for this inventor testimony, Patent Owner relies
`upon certain pages from Mr. Sutton’s laboratory notebook dated January 4,
`2005 (Ex. 2002), a “market feasibility” memorandum from Mr. Root dated
`February 4, 2005 (Ex. 2003), and some additional handwritten notes and
`drawings from Mr. Root dated February 7, 2005 (Ex. 2004). We first set
`forth the relevant facts based on these declarants’ testimony and
`
`8 Patent Owner previously submitted a declaration by Mr. Root with its
`Preliminary Response (Ex. 2001), but withdrew that declaration in favor of
`Ex. 2118. PO CRTP Resp. 2 n.1.
`9 The testimonial evidence that Patent Owner presents in support of
`conception is largely undisputed. Indeed, during a teleconference addressing
`Patent Owner’s request to present live testimony from Mr. Root in these
`proceedings, Petitioner’s counsel acknowledged that Mr. Root’s testimony
`was not disputed in a manner that would require our credibility assessment.
`See Ex. 1920, 11:10–11 (“And I don’t think we have, you know, directly
`said Mr. Root is lying on this topic.”); id. at 17:17–18 (“We don’t have any
`issue at play here that goes to credibility.”). Accordingly, in view of our
`conclusion that “the credibility of Mr. Root is not in question,” we denied
`Patent Owner’s request to present live testimony from Mr. Root at the oral
`hearing. See Paper 110, 4–5 (distinguishing K-40 Elecs., LLC v. Escort,
`Inc., IPR2013-00203, Paper 34 (PTAB May 21, 2014) (precedential)).
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`corroborating evidence, and then address any disputed issues of material fact
`and legal issues as needed in our analysis.
`
`Fact Findings for Conception
`a)
`In his declaration, Mr. Root attests that conception started around the
`time he attended the Transcatheter Cardiovascular Therapeutics (“TCT”)
`conference from September 27 to October 1, 2004, by which time he had
`recognized the issue of “guide catheter backout” that physicians were
`experiencing when performing complex interventional coronary procedures.
`Ex. 2118 ¶ 5. Accordingly, Mr. Root asserts that he recognized a need for a
`solution “that provided better guide positioning, device delivery, and
`procedural conveniences” than what previously existed in the market. Id.
`To solve this problem, Mr. Root indicates that he came up with “the idea for
`a guide extension catheter that would provide improved back-up support
`with rapid exchange delivery, which would offer far more convenience than
`other options available at the time.” Id. ¶ 6. And “[s]ometime after the TCT
`conference, but before 2005,” Mr. Root met with his co-inventors, including
`Mr. Sutton, to discuss more particular ideas for how to make this device. Id.
`The “guide extension catheter” device that the inventors thought of at
`this time included certain key features. It was to be used within a standard
`guide catheter that was one “French size” larger than the “guide extension
`catheter,” and was parsed into two distinct portions—a substantially rigid
`proximal portion comprising a “rail” structure and a distal tubular portion
`with a lumen—which together were longer than a standard guide catheter.
`Id. ¶ 7. During a procedure, after the standard guide catheter was inserted
`into the vasculature so its distal end was in the ostium of a cardiac artery, the
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`guide extension catheter would be inserted into the lumen until the distal end
`of the tubular portion went past the distal end of the guide catheter and into
`the cardiac artery. Id. With both catheters in place, an interventional
`cardiology device could be thereafter inserted through the standard guide
`catheter (running along the rail of the guide extension catheter) until it
`reached the distal end of the distal tubular portion of the guide extension
`catheter, thereby entering the cardiac artery. Id.
`The device they undertook to develop was initially called the “Guide-
`Liner” device, but the hyphen was later dropped and it became known as the
`“GuideLiner” device. Id. ¶ 9. Although the original idea for the GuideLiner
`was a “rapid exchange” (“RX”) version of the guide extension catheter,
`“[s]ometime between February and June of 2005, a decision was made to
`concurrently pursue development of an over-the-wire (‘OTW’) version of
`GuideLiner.” Id. ¶ 19. Mr. Root acknowledges, however, that “[t]he OTW
`GuideLiner was not part of the inventions of the [challenged] patents,” but
`instead was more akin to the “mother-and-child” design that was known in
`the prior art and discussed in the background of the challenged patents. Id.
`(citing Ex. 1001, 2:17–44).10
`Mr. Sutton in his own declaration sets forth a story consistent with
`that set forth by Mr. Root. He attests that “[s]tarting in late-2004 until [he]
`left VSI, [he] performed research and development work on what became
`the GuideLiner guide extension catheter.” Ex. 2119 ¶ 2. Although VSI did
`not retain all of its files from that time, Mr. Sutton recalls, based o