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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.
`
`IPR2020-00128
`Patent RE45,380
`
`Before SHERIDAN K. SNEDDEN, JON B. TORNQUIST, and
`CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.
`
`TORNQUIST, 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 111)
`37 C.F.R. § 42.64(c)
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`INTRODUCTION
`I.
`Medtronic, Inc. and Medtronic Vascular, Inc. (collectively
`“Petitioner”) filed a Petition (Paper 1, “Pet.”) requesting an inter partes
`review of claims 1–4, 6–10, 12–21, and 23 of U.S. Reissue Patent
`RE45,380E (Ex. 1001, “the ’380 patent”). Teleflex Innovations S.À.R.L.
`(“Patent Owner”) 1 filed a Preliminary Response to the Petition (Paper 8).
`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 103, “Sur-Reply”) (redacted version
`available at Paper 104).
`With prior authorization of the Board, Patent Owner filed a
`Consolidated Response Addressing Conception and Reduction to Practice
`(Paper 39, “PO CRTP Resp.”), to which Petitioner filed Reply (Paper 78,
`“Pet. CRTP Reply”) (redacted version available at Paper 79), Patent Owner
`filed a Sur-Reply (Paper 97, “PO CRTP Sur-Reply”), and Petitioner filed a
`Sur-Sur-Reply (Paper 112, “Pet. CRTP Sur-Sur-Reply”).
`Patent Owner also filed a Contingent Motion to Amend (Paper 38).
`The Motion requests that if claims 1 or 12 of the ’380 patent are determined
`
`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 ’380 patent] to Teleflex Life Sciences Limited.” Paper 7,
`2.
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`to be unpatentable, that the Board replace the unpatentable claim(s) with
`proposed substitute claims 43 and 44. Motion 1. Petitioner filed an
`Opposition to the Motion to Amend (Paper 85), to which Patent Owner filed
`a reply (Paper 106), and Petitioner filed a sur-reply (Paper 114).
`An oral hearing was held on March 8, 2021, and a transcript of the
`hearing is included in the record. Paper 126 (“Tr.”) (redacted version
`available at Paper 125).
`
`Real Parties in Interest
`A.
`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., and Teleflex LLC, and notes that “Teleflex Incorporated
`is the ultimate parent of the entities listed above.” Paper 4, 2.
`B.
`Related Matters
`The parties indicate that the ’380 patent is the subject of litigation in
`Vascular Solutions LLC, et al. v. Medtronic, Inc., et al., No. 19-cv-01760
`(D. Minn.) and QXMedical, LLC v. Vascular Solutions, LLC, No. 17-cv-
`01969 (D. Minn). Pet. 5–6; Paper 4, 2. The ’380 patent is also at issue in
`IPR2020-00129, IPR2020-00130, and IPR2020-00131 (institution denied).
`Paper 4, 3; Pet. 6.
`The following proceedings before the Board also involve the same
`parties and related patents: IPR2020-00126 (U.S. Patent No. 8,048,032 B2),
`IPR2020-00127 (U.S. Patent No. 8,048,032 B2), IPR2020-00132 (U.S.
`Patent No. RE45,760 E1), IPR2020-00134 (U.S. Patent No. RE45,760 E1),
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`IPR2020-00135 (U.S. Patent No. RE45,776 E1), IPR2020-00136 (U.S.
`Patent No. RE45,776 E1), IPR2020-00137 (U.S. Patent No. RE47379 E1),
`IPR2020-00138 (U.S. Patent No. RE47379 E1).
`C.
`The ’380 Patent
`The ’380 Patent is a reissue of U.S. Patent 8,292,850, and claims
`priority as a division of application No. 11/416,629, filed on May 3, 2006,
`now U.S. Patent 8,048,032. Ex. 1001, codes (62), (64). The ’380 patent
`relates to catheters used in interventional cardiology procedures and, in
`particular, to “methods and apparatus for increasing backup support for
`catheters inserted into the coronary arteries from the aorta.” Id. at 1:31–35.
`“In coronary artery disease the coronary arteries may be narrowed or
`occluded by atherosclerotic plaques or other lesions.” Id. at 1:44–46. This
`narrowing is referred to as stenosis. Id. at 1:48–49. To treat a stenosis, “it is
`commonly necessary to pass a guidewire or other instruments through and
`beyond the occlusion or stenosis of the coronary artery.” Id. at 1:49–52. In
`this method, a guide catheter is inserted through the aorta and into the
`ostium of the coronary artery where it is typically seated into the opening or
`ostium of the artery to be treated. Id. at 1:53–57. A guidewire or other
`instrument is then passed through the lumen of the guide catheter and
`inserted into the artery beyond the stenosis. Id. at 1:39–41, 1:57–59.
`Crossing the tough lesions, however, may create enough backwards force to
`dislodge the guide catheter from the ostium of the artery being treated,
`making it difficult or impossible to treat certain forms of coronary artery
`disease. Id. at 1:59–63.
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`Figures 1 and 2 of the ’380 patent are reproduced below:
`
`Figure 1 is a schematic depiction of a coaxial guide catheter and a tapered
`inner catheter and Figure 2 is a schematic depiction of these two elements
`assembled together. Id. at 5:40–45. As shown in Figure 1, coaxial guide
`catheter 12 includes tip portion 16, reinforced portion 18, and rigid portion
`20. Id. at 6:34–35. Tapered inner catheter 14 includes tapered portion 46 at
`a distal end thereof and straight portion 48. Id. at 7:16–17. Clip 54
`releasably joins tapered inner catheter 14 to coaxial guide catheter 12. Id. at
`7:21–23.
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`Figure 8 of the ’380 patent is reproduced below:
`
`Figure 8 is a schematic view of a guide catheter, a guidewire, a coaxial guide
`catheter, and a tapered inner catheter located in the aortic arch and coronary
`artery. Id. at 5:61–64. In Figure 8, “coaxial guide catheter 12 with tapered
`inner catheter 14 is passed through guide catheter 56 and over guidewire 64
`into coronary artery 62 after the guide catheter 56 has been placed in the
`ostium 60 of coronary artery 62.” Id. at 8:6–10. The ’380 patent explains
`that “[c]oaxial guide catheter 12, with tapered inner catheter 14, provides an
`inner support member for proper translation over guidewire 64.” Id. at
`8:10–14. “Once coaxial guide catheter 12 is in place, tapered inner catheter
`14 is removed from the inside of coaxial guide catheter 12.” Id. at 8:14–17.
`At this point, coaxial guide catheter 12 is ready to accept a treatment
`catheter such as a stent or balloon catheter. Id. at 8:18–19. The ’380 patent
`explains that coaxial guide catheter 12 provides additional backup support to
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`resist dislodging of guide catheter 56 from ostium 60 when force is applied
`to guidewire 64 to pass through stenotic lesion 66. Id. at 8:23–30.
`D.
`Illustrative Claim
`Independent claim 1 is illustrative of the challenged claims and is
`reproduced below.
`1. A system for use with interventional cardiology devices
`adapted to be insertable into a branch artery, the system
`comprising:
`a guide catheter having a continuous lumen extending for a
`predefined length from a proximal end at a hemostatic valve
`to a distal end adapted to be placed in the branch artery, the
`continuous lumen of the guide catheter having a circular
`cross-sectional inner diameter sized such that interventional
`cardiology devices are insertable into and through the
`continuous lumen of the guide catheter; and
`a device adapted for use with the guide catheter, including:
`a flexible tip portion defining a tubular structure and having a
`circular cross-section and a length that is shorter than the
`predefined length of the continuous lumen of the guide
`catheter, the tubular structure having a cross-sectional
`outer diameter sized to be insertable through the cross-
`sectional inner diameter of the continuous lumen of the
`guide catheter and defining a coaxial lumen having a
`cross-sectional
`inner
`diameter
`through which
`interventional cardiology devices are insertable; and
`a substantially rigid portion proximal of and operably
`connected to, and more rigid along a longitudinal axis than
`the flexible tip portion and defining a rail structure without
`a lumen having a maximal cross-sectional dimension at a
`proximal portion that is smaller than the cross-sectional
`outer diameter of the flexible tip portion and having a
`length that, when combined with the length of the flexible
`distal tip portion, defines a total length of the device along
`the longitudinal axis that is longer than the length of the
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`continuous lumen of the guide catheter, such that when at
`least a distal portion of the flexible tip portion is extended
`distally of the distal end of the guide catheter, at least a
`portion of the proximal portion of the substantially rigid
`portion extends proximally through the hemostatic valve
`in common with interventional cardiology devices that are
`insertable into the guide catheter;
`wherein the tubular structure includes a flexible cylindrical
`distal tip portion and a flexible cylindrical reinforced portion
`proximal to the flexible cylindrical distal tip portion and
`wherein the flexible cylindrical distal tip portion is more
`flexible than the flexible cylindrical reinforced portion.
`Ex. 1001, 10:47–11:24 (limitations added by reissue in italics).
`E.
`Prior Art and Asserted Grounds
`We instituted review of claims 1–4, 6–10, 12–21, and 23 of the ’380
`patent on the following grounds (Inst. Dec. 7, 30):
`35
`Claim(s) Challenged
`U.S.C. §
`Itou2
`102
`1–4, 6–10, 12–20, 23
`Itou, Ressemann3
`103
`3, 14, 15
`Itou, Berg4
`103
`21
`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). 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.
`
`Reference(s)/Basis
`
`2 Itou, US 7,736,355 B2, issued June 15, 2010 (Ex. 1007) (“Itou”).
`3 Ressemann, US 7,604,612 B2, issued October 20, 2009 (Ex. 1008)
`(“Ressemann”).
`4 Berg, US 5,911,715, issued June 15, 1999 (Ex. 1051) (“Berg”).
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`2119), Mr. Mark Goemer (Ex. 2120), Ms. Amanda O’Neil (Ex. 2121), Mr.
`Steve Erb (Ex. 2122), Mr. Peter T. Keith (Ex. 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).
`
`ANALYSIS
`II.
`Priority Date of the ’380 Patent
`A.
`The AIA’s first-to-file provisions apply to patent applications “that
`contain[] or contained at any time a claim to a claimed invention that has an
`effective filing date” on or after March 16, 2013. AIA § 3(n)(1). The
`application for reissue for the ’380 patent was filed November 1, 2013 and
`sought reissue of US Patent No. 8,292,850, which issued October 23, 2012
`from an application filed January 26, 2012. Ex. 1001, codes (22), (64).
`Petitioner contends that because there is no written description support for
`the subject matter of at least claim 27 of the ’380 patent, the ’380 patent has
`an effective filing date after March 16, 2013. Pet. 14. Thus, according to
`Petitioner, the ’380 patent is 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
`AIA’s first-to-file provisions apply to the ’380 patent. Indeed, Petitioner
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`provides no legal support for the proposition that claims in a reissue patent
`are not entitled to a filing date as if they appeared in the original patent for
`which reissue was sought.5
`
`Level of Ordinary Skill in the Art
`B.
`We consider the asserted grounds of unpatentability in view of the
`understanding of a person of ordinary skill in the art (“POSITA”). Petitioner
`provides two 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,
`
`5 To the extent the original patent for which reissue was sought does not
`contain written description support for a reissue claim, that claim may be
`invalid. But this is a question we may not address in an IPR. 35 U.S.C.
`§ 311(b).
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`allowing experience as a medical doctor or as an engineer, as they are
`undisputed and consistent with the level of skill reflected in the prior art and
`the written description of the ’380 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
`Before reaching the merits of the grounds in the Petition, we address
`whether Petitioner’s primary reference, 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
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`contends that Itou is prior art under pre-AIA § 102(e). Pet. 19–20.6 In the
`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 ’380
`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,
`
`6 In addition to this Petition, Petitioner similarly asserts Itou in the petitions
`in IPR2020-00126, -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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`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).
`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 the date on which Itou is effective as
`prior art (i.e., September 23, 2005) and either actually reduced the invention
`to practice prior to the critical date or diligently worked towards constructive
`reduction to practice until the first priority application for the ’380 patent
`was filed on May 3, 2006. Accordingly, we conclude that Itou does not
`qualify as prior art to the ’380 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
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`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
`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 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
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`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
`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 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.”
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`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)).
`
`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).7,8 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
`
`7 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.
`8 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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`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
`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 had 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
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`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 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).9
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`9 It is undisputed that the work done in developing the RX GuideLiner, not
`the OTW GuideLiner, must provide the basis for conception and reduction
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`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
`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:
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`to practice of the claimed invention. PO CRTP Resp. 13 n. 3; Pet. CRTP
`Reply 1.
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`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
`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
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`pages also describe the main features of the device, including: 1) an inner
`tube/dilator