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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.
`
`IPR2020-00132
`Patent RE45,760 E
`
`Before SHERIDAN K. SNEDDEN, JON B. TORNQUIST, and
`CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.
`SNEDDEN, 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)
`
`ORDERS
`Denying Petitioner’s Motion to Exclude (Paper 109)
`37 C.F.R. § 42.64(c)
`
`PUBLIC VERSION
`
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`
`Trials@uspto.gov
`571-272-7822
`
`Paper
`Date:
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MEDTRONIC, INC., and MEDTRONIC VASCULAR, INC.,
`Petitioner,
`v.
`TELEFLEX INNOVATIONS S.À.R.L.,
`Patent Owner.
`
`IPR2020-00132
`Patent RE45,760 E
`
`Before SHERIDAN K. SNEDDEN, JON B. TORNQUIST, and
`CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.
`SNEDDEN, 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)
`
`ORDERS
`Denying Petitioner’s Motion to Exclude (Paper 109)
`37 C.F.R. § 42.64(c)
`
`PUBLIC VERSION
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`IPR2020-00132
`Patent RE45,760 E
`
`I.
`
`INTRODUCTION
`
`Medtronic, Inc. and Medtronic Vascular, Inc. (“Petitioner”) filed a
`Petition for inter partes review of claims 25–42, 44, and 47 of U.S. Patent
`No. RE45,760 E (“the ’760 patent,” Ex. 1001). Paper 1 (“Pet.”). Teleflex
`Medical Devices S.À.R.L. (“Patent Owner”)1 filed a Preliminary Response.
`Papers 8 (confidential version), 9 (redacted version) (“Prelim. Resp.”).
`Upon review of the Petition and Preliminary Response, we instituted an inter
`partes review of all claims on all grounds asserted in the Petition (Paper 22,
`“Inst. Dec.” or “Institution Decision”).
`Patent Owner subsequently filed a Patent Owner Response (Paper 43,
`“PO Resp.”) (redacted version available at Paper 44), Petitioner filed a
`Reply (Paper 83, “Pet. Reply”) (redacted version available at Paper 82), and
`Patent Owner filed a Sur-Reply (Paper 101, “Sur-Reply”) (redacted version
`available at Paper 102).
`With prior authorization of the Board, Patent Owner filed a
`Consolidated Response Addressing Conception and Reduction to Practice
`(Paper 39, “PO CRTP Resp.” or “PO CRTP Response”), to which Petitioner
`filed a Reply (Paper 78, “Pet. CRTP Reply”) (redacted version available at
`Paper 79), Patent Owner filed a Sur-Reply (Paper 96, “PO CRTP Sur-
`Reply”), and Petitioner filed a Sur-Sur-Reply (Paper 110, “Pet. CRTP Sur-
`Sur-Reply”).
`Patent Owner also filed a Contingent Motion to Amend. Paper 38.
`The Motion requests that if any of issued claims 37, 38, 39, 48, or 51 of the
`
`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 U.S. Patent No. RE45,760E to Teleflex Life Sciences
`Limited.” Paper 7, 2.
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`’760 patent are determined to be unpatentable, they should be replaced by
`proposed substitute claims 54–58. Id. at 1. Petitioner filed an Opposition to
`the Motion to Amend (Paper 85), to which Patent Owner filed a reply (Paper
`104), and Petitioner filed a sur-reply (Paper 112).
`An oral hearing was held on March 8, 2021, and a transcript of the
`hearing is included in the record. Paper 124 (“Tr.”) (redacted version
`available at Paper 123).
`
`A. Real Parties in Interest
`
`Petitioner identifies its real parties-in-interest as Medtronic, Inc. and
`Medtronic Vascular, Inc., and notes that “Medtronic plc is the ultimate
`parent of both entities.” Pet. 5.
`Patent Owner identifies its real parties-in-interest as Teleflex Medical
`Devices S.A.R.L.; Vascular Solutions LLC; Arrow International, Inc.; and
`Teleflex LLC. Paper 4, 2. Patent Owner also notes that “Teleflex
`Incorporated is the ultimate parent of the entities listed above.” Paper 7, 2.
`
`B. Related Matters
`
`The ’760 patent is at issue in Vascular Solutions LLC, et al. v.
`Medtronic, Inc., et al. No. 19-cv-01760 (D. Minn. filed July 2, 2019) and
`QXMedical, LLC v. Vascular Solutions, LLC, No. 17-cv-01969 (D. Minn.,
`filed June 8, 2017) (“QXM”). Pet. 5–6; Paper 4, 2. The ’760 patent is a
`reissue of U.S. Pat. No. 8,292,850 (“the ʼ850 patent).
`The ’850 patent was the subject of two previous inter partes reviews:
`IPR2014-00762, filed May 16, 2014 and terminated August 11, 2014 by way
`of joint motion to terminate, and IPR2014-00763, filed May 16, 2014 and
`terminated August 11, 2014 by way of joint motion to terminate. Pet. 6;
`Paper 4, 2–3. The ’850 patent was also at issue in the U.S. District Court for
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`the District of Minnesota in Vascular Solutions, Inc. v. Boston Scientific
`Corp., No. 13-cv-01172 (D. Minn., filed May 16, 2013). Id.
`Petitioner has filed two additional Petitions for inter partes review of
`the ’760 patent as IPR2020-00133 and IPR2020-00134.
`
`C. The ’760 Patent
`
`1. Specification
`
`The subject matter claimed in the ’760 patent is directed to a device
`for use with a standard guide catheter. Ex. 1001, 13:36–17:13. Figures 1
`and 5 of the ’760 patent, reproduced below, depict a coaxial guide catheter
`and a tapered inner catheter.
`
`Figure 1 of the ’760 patent
`
`Figure 5 of the ’760 patent
`As shown in Figures 1 and 5, 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 generally includes tip portion 16,
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`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. Id. at 7:23–24.
`Tapered inner catheter 14 may also include clip 54 at a proximal end thereof
`to releasably join tapered inner catheter 14 to coaxial guide catheter 12. Id.
`at 7:27–29. Thus, tapered inner catheter 14 is keyed to coaxial guide
`catheter 12. Id. at 7:29–30.
`
`2. Illustrative Claim
`
`Independent claim 25, reproduced below, is illustrative of the
`challenged claims.
`25. A system, comprising:
`a guide catheter configured to be advanceable through a
`main blood vessel to a position adjacent an ostium of a coronary
`artery, the guide catheter having a lumen extending from a
`hemostatic valve at a proximal end of the guide catheter to a
`distal end of the guide catheter that is adapted to be positioned
`adjacent the ostium of the coronary artery; and
`a guide extension catheter configured to be partially
`advanceable through the guide catheter and into the coronary
`artery, the guide extension catheter having a length such that a
`distal end of the guide extension catheter is extendable through
`the lumen and beyond the distal end of the guide catheter, and a
`proximal end of the guide extension catheter is extendable
`through the hemostatic valve at the proximal end of the guide
`catheter,
`the guide extension catheter including, in a proximal to
`distal direction, a substantially rigid segment, a segment defining
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`a side opening, and a tubular structure defining a lumen coaxial
`and in fluid communication with the lumen of the guide catheter,
`the lumen of the tubular structure having a length that is shorter
`than the length of the lumen of the guide catheter and having a
`uniform cross-sectional inner diameter that is not more than one
`French size smaller than the cross-sectional inner diameter of the
`lumen of the guide catheter, the side opening extending for a
`distance along a longitudinal axis of the segment defining the
`side opening and accessible from a longitudinal side defined
`transverse to the longitudinal axis, and the side opening and the
`lumen of the tubular structure configured to receive one or more
`stents or balloon catheters when the segment defining the side
`opening and a proximal end portion of the tubular structure are
`positioned within the lumen of the guide catheter and the distal
`end of the guide extension catheter extends beyond the distal end
`of the guide catheter;
`wherein a material forming the segment defining the side
`opening is more rigid than the tubular structure.
`Ex. 1001, 13:36–14:7.
`
`D. Evidence
`
`Petitioner relies upon the following prior art references.
`Ex. 1007, T. Itou et al., U.S. Patent No. 7,736,355 B2 (issued
`June 15, 2010) (“Itou”).
`Ex. 1008, T. V. Ressemann et al., U.S. Patent No. 7,604,612 B2
`(issued Oct. 20, 2009) (“Ressemann”).
`Ex. 1025, Y. Kataishi et al., U.S. Patent Application Publication
`No. 2005/0015073 A1 (published Jan. 20, 2005) (“Kataishi”).
`Ex. 1050, C. D. Enger et al., U.S. Patent No. 5,980,486 (issued
`Nov. 9, 1999) (“Enger”).
`In support of its arguments, Petitioner relies on the expert declarations
`of Dr. Stephen Jon David Brecker (Exs. 1005, 1806, 1902), Dr. Richard A.
`Hillstead (Exs. 1042, 1905, 1907), Mr. Michael Jones (Ex. 1807), and Dr.
`Paul Zalesky (Exs. 1755, 1830, 1919).
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`Patent Owner relies on the declarations of Ms. Amy Welch (Ex. 2044)
`(redacted), Ms. Deborah Schmalz (Ex. 2039), 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 (Ex. 2042,
`2123, 2124, 2138, 2243), Dr. John J. Graham (Ex. 2145), Dr. Lorenzo
`Azzalini (Ex. 2151), Mr. Steve Jagodzinkski (Ex. 2152 (redacted), 2153
`(confidential)), Ms. Heather S. Rosecrans (Ex. 2205), and Dr. Craig
`Thompson (Ex. 2215).
`
`E. Asserted Grounds of Unpatentability
`
`Petitioner asserts that claims 25–42, 44, and 47 would have been
`unpatentable on the following grounds.
`
`Claim(s) Challenged
`
`35 U.S.C. §2
`
`Reference(s)/Basis
`
`25–31, 33–38, 41, 42, 44, 47
`
`25, 30, 32, 39, 40
`
`32
`
`32
`
`102(e)
`
`103(a)
`
`103(a)
`
`103(a)
`
`Itou
`
`Itou, Ressemann
`
`Itou, Kataishi
`
`Itou, Enger
`
`2 The Leahy-Smith America Invents Act, Pub. L. No. 112-29, 125 Stat. 284
`(2011) (“AIA”), amended 35 U.S.C. §§ 102 and 103. Because the
`challenged claims of the ’760 patent have an effective filing date before the
`effective date of the applicable AIA amendments, we refer to the pre-AIA
`versions of 35 U.S.C. § 103 throughout this Decision.
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`II.
`
`ANALYSIS
`
`A. Priority Date of the ’760 Patent
`
`The AIA’s first-to-file provisions apply to patent applications “that
`contain[] or contained at any time a claim to a claimed invention that has an
`effective filing date” on or after March 16, 2013. AIA § 3(n)(1). The
`application for reissue for the ’760 patent was filed March 3, 2014 and
`sought reissue of US Patent No. 8,292,850, which issued October 23, 2012
`from an application filed January 26, 2012. Ex. 1001, codes (22), (64).
`Petitioner contends,
`The ’760 patent is subject to the AIA first-to-file provisions
`because (1) it contains claims that lack written description, and
`therefore pre-AIA priority, and (2) it claims priority to RE 45,380
`(“the ’380 patent”), which is subject to the AIA first-to-file
`provisions. Thus, Patent Owner cannot swear behind Itou in this
`proceeding.
`Pet. 14. Petitioner contends that because there is no written description
`support for the subject matter of at least claim 32 of the ’760 patent, the ’760
`patent has an effective filing date after March 16, 2013. Id. at 14. Thus,
`according to Petitioner, the ’760 patent is subject to the AIA’s first-to-file
`provisions, which precludes Patent Owner’s from attempting to swear
`behind Itou’s filing date. Id.
`“The effective filing date for a claimed invention in an application for
`reissue or reissued patent shall be determined by deeming the claim to the
`invention to have been contained in the patent for which reissue was
`sought.” 35 U.S.C. § 100(i)(2) (2018). As the “patent for which reissue was
`sought” in this case was issued October 23, 2012, we are not persuaded that
`the AIA’s first-to-file provisions apply to the ’760 patent. Indeed, Petitioner
`provides no legal support for the proposition that claims in a reissue patent
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`are not entitled to an effective filing date as if they appeared in the original
`patent for which reissue was sought.3
`
`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 alternative definitions of a person of ordinary skill in the art.
`First, Petitioner asserts that if a person of ordinary skill in the art “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. 15. Alternatively, Petitioner asserts that if
`a person of ordinary skill in the art was “an engineer s/he would have had (a)
`an undergraduate degree in engineering, such as mechanical or biomedical
`engineering; and (b) at least three years of experience designing medical
`devices, including catheters or catheter-deployable devices.” Id.
`Additionally, Petitioner contends that “[e]xtensive experience and technical
`training might substitute for education, and advanced degrees might
`substitute for experience.” Id.
`Patent Owner “does not dispute [Petitioner]’s proposed definition of a
`POSITA.” PO Resp. 9.
`Upon review of the parties’ arguments and supporting evidence, we
`adopt Petitioner’s definitions for a person of ordinary skill in the art, which
`allow the ordinarily skilled artisan to be either a medical doctor or an
`engineer, as they are undisputed and consistent with the level of skill
`
`3 To the extent the original patent for which reissue was sought does not
`contain written description support for a reissue claim, that claim may be
`invalid. But this is a question we may not address in an IPR. 35 U.S.C.
`§ 311(b).
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`reflected in the prior art and the written description 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).
`
`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.
`282(b).” 37 C.F.R. § 42.100(b) (2019). This standard requires that we
`construe a claim “in accordance with the ordinary and customary meaning of
`such claim 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 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. 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 that Itou is prior art under pre-AIA § 102(e). Pet. 19–20.4 In the
`
`4 In addition to this Petition, Petitioner similarly asserts Itou in the petitions
`in IPR2020-00126, -00128, -00129, -00134, -00135, and -00137. Our
`analysis regarding the prior art status of Itou is similar for each of these
`proceedings.
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`Conception and Reduction to Practice (“CRTP”) briefing that we separately
`authorized for these proceedings, Patent Owner argues that Itou does not
`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 May 3, 2006, filing of the original priority application for the ’760
`patent. See generally PO CRTP Resp.; 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 seventy-
`five 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
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`documents from VSI’s outside patent counsel (Exs. 2019, 2023, 2096, 2098,
`2101–2103, 2117); and engineering drawings (Exs. 2022, 2113–2115).
`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 ’760
`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.
`
`1. Legal Standards
`
`“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
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`practice, the inventor must prove that: (1) he constructed an embodiment or
`performed a process that met all the limitations of the [claimed invention];
`and (2) he 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 a 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)
`(internal quotation marks omitted). “However, there is no final single
`formula that must be followed in proving corroboration.” Id. (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 persuassian 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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`2. Conception
`
`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).5,6 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
`
`5 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.
`6 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 108, 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 an operation, after the standard guide catheter was inserted
`into the vasculature so its distal end was in the ostium of a cardiac artery, the
`guide extension catheter would be inserted into the lumen until the distal end
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`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-in-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).7
`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 on his
`memory and documents he reviewed, that “we knew very early on that the
`
`7 It is undisputed that the work done in developing the RX GuideLiner, not
`the OTW GuideLiner, must provide the basis for conception and reduction
`to practice of the claimed invention. PO CRTP Resp. 13 n.3; Pet. CRTP
`Reply 1.
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`GuideLiner rapid exchange device would work for its intended purpose,”
`and that “[t]he research and development that followed our original
`conception of the GuideLiner rapid exchange was to optimize materials,
`dimensions, and design details that would allow us to manufacture and bring
`the product to market in a way that would be commercially viable.” Id. ¶ 6.
`The earliest documentary evidence that corroborates this testimony is
`Mr. Sutton’s laboratory notebook pages relating to the concept for a “Guide-
`Liner” device. Ex. 2002. Mr. Sutton signed the relevant pages on January 4,
`2005, and Jeffrey Welch, another co-inventor and engineer at VSI, witnessed
`those pages on March 2, 2005. Id. at 7–8; see Ex. 2119 ¶ 7.
`A portion of one page from Mr. Sutton’s notebook is reproduced
`below:
`
`Ex. 2002, 7. As shown above, Mr. Sutton’s notebook sets forth an “idea”
`that “relates to interventional coronary procedures and specifically to
`accessing & crossing tough or chronic occlusions,” which “is to provide a
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`guide or support catheter more distally into the coronary to provide more
`back-up support for the stent device.” Id.; Ex. 2118 ¶ 9. Mr. Sutton’s lab
`notebook also includes drawings of the cross section of various portions of
`the guide extension catheter and a drawing of how the Guide-Liner would be
`used that are similar to figures included in the challenged patents. Cf. Ex.
`1001, Figs. 1, 2, 5, 6 (depicting patent drawings of the guide extension
`catheter that are similar to Mr. Sutton’s drawings). For example, his
`notebook includes a drawing of a “5F” (5-French) Guide-Liner in operation
`and notes that the Guide-Liner a) “is used where there is difficulty crossing
`lesions,” b) “allows back-up support distally,” c) “allows for Rapid X
`change,” and d) “would fit std. 6F Guides.” Ex. 2002, 8. The notebook
`pages also describe the main features of the device, including: 1) an inner
`tube/dilator that “fits snugly” within a stainless steel (“SS”) half-tube; 2) a
`reinforced distal tube section with a braided “PTFE/SS/PEBAX” material
`that is “soft for coronaries”; and 3) a design that “allows for rapid
`exchange.” Id. at 7. Additionally, the notebook identifies the “5F Design
`Specs,” including an overall device length of between 105 cm and 115 cm.
`Id. Both Mr. Root and Mr. Sutton authenticate the contents of the notebook
`pages and Mr. Sutton attests that his notebook was “issued and maintained in
`the regular course of VSI’s business.” Ex. 2118 ¶¶ 9–11; Ex. 2119 ¶¶ 7–14.
`By early February 2005, Mr. Root realized this device would have
`“substantial market potential,” so he wrote a “Market Feasibility”
`memorandum (“memo”) for GuideLiner catheters, dated February 4, 2005.
`Ex. 2118 ¶ 11; Ex. 2003 (confidential); Ex. 2127 (public). Mr. Root attests
`that he would only have drafted this kind of memo if he “had developed high
`confidence that a concept would work,” so that non-inventors in the
`company (e.g., regulatory personnel and engineers) could join a project to
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