`
`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 INNOVATIONSS.A.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 US.C. § 318(a)
`
`ORDERS
`Denying Petitioner’s Motion to Exclude (Paper 109)
`37 CFR. § 42.64(c)
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`PUBLIC VERSION
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`I.
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`INTRODUCTION
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`Medtronic, Inc. and Medtronic Vascular, Inc. (“Petitioner”) filed a
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`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.A.R.L.(“Patent Owner”)! filed a Preliminary Response.
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`Papers 8 (confidential version), 9 (redacted version) (“Prelim. Resp.”).
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`Uponreview ofthe Petition and Preliminary Response, weinstituted an inter
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`partes review ofall claims on all groundsasserted in the Petition (Paper 22,
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`“Inst. Dec.” or “Institution Decision”).
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`Patent Ownersubsequently filed a Patent Owner Response (Paper 43,
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`“PO Resp.”) (redacted version available at Paper 44), Petitioner filed a
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`Reply (Paper 83, “Pet. Reply”) (redacted version available at Paper 82), and
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`Patent Ownerfiled a Sur-Reply (Paper 101, “Sur-Reply”) (redacted version
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`available at Paper 102).
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`With prior authorization of the Board, Patent Ownerfiled a
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`Consolidated Response Addressing Conception and Reduction to Practice
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`(Paper 39, “PO CRTP Resp.” or “PO CRTP Response”’), to which Petitioner
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`filed a Reply (Paper 78, “Pet. CRTP Reply”) (redacted version availableat
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`Paper 79), Patent Ownerfiled a Sur-Reply (Paper 96, “PO CRTP Sur-
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`Reply’), and Petitioner filed a Sur-Sur-Reply (Paper 110, “Pet. CRTP Sur-
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`Sur-Reply”).
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`Patent Owneralso filed a Contingent Motion to Amend. Paper38.
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`The Motion requeststhat if any of issued claims 37, 38, 39, 48, or 51 of the
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`' Patent Ownerrepresents 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.” Paper7, 2.
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`760 patent are determinedto be unpatentable, they should be replaced by
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`proposed substitute claims 54-58. /d. at 1. Petitioner filed an Opposition to
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`the Motion to Amend (Paper85), to which Patent Ownerfiled a reply (Paper
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`104), and Petitionerfiled a sur-reply (Paper 112).
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`Anoral hearing was held on March 8, 2021, and a transcript of the
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`hearing is included in the record. Paper 124 (“Tr.”) (redacted version
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`available at Paper 123).
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`A. Real Parties in Interest
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`Petitioner identifies its real parties-in-interest as Medtronic, Inc. and
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`Medtronic Vascular, Inc., and notes that “Medtronicplc is the ultimate
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`parent of both entities.” Pet. 5.
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`Patent Owneridentifies its real parties-in-interest as Teleflex Medical
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`Devices S.A.R.L.; Vascular Solutions LLC; Arrow International, Inc.; and
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`Teleflex LLC. Paper 4, 2. Patent Owneralso notes that “Teleflex
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`Incorporated is the ultimate parent of the entities listed above.” Paper7, 2.
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`B. Related Matters
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`The ’760 patentis at issue in Vascular Solutions LLC, et al. v.
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`Medtronic, Inc., et al. No. 19-cv-01760 (D. Minn. filed July 2, 2019) and
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`OXMedical, LLC v. Vascular Solutions, LLC, No. 17-cv-01969 (D. Minn.,
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`filed June 8, 2017) (“OXM”’). Pet. 56; Paper 4, 2. The ’760 patent is a
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`reissue of U.S. Pat. No. 8,292,850 (‘the ’850 patent).
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`The ’850 patent was the subject of two previous inter partes reviews:
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`IPR2014-00762, filed May 16, 2014 and terminated August 11, 2014 by way
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`ofjoint motion to terminate, and IPR2014-00763, filed May 16, 2014 and
`terminated August 11, 2014 by way ofjoint motionto terminate. Pet. 6;
`Paper 4, 2-3. The ’850 patent wasalso at issue in the U.S. District Court for
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`the District of Minnesota in Vascular Solutions, Inc. v. Boston Scientific
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`Corp., No. 13-cv-01172 (D. Minn., filed May 16, 2013). Id.
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`Petitioner has filed two additional Petitions for inter partes review of
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`the ’760 patent as IPR2020-00133 and IPR2020-00134.
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`C. The ’760 Patent
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`1. Specification
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`The subject matter claimed in the ’760 patent is directed to a device
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`for use with a standard guide catheter. Ex. 1001, 13:36—17:13. Figures 1
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`and 5 of the ’760 patent, reproduced below, depict a coaxial guide catheter
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`and a tapered inner catheter.
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`Fig. 1
`1o
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`a
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`14
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`48
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`Figure 1 of the ’760 patent
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`Fig. 5
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`Figure 5 of the ’760 patent
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`As shownin Figures 1 and 5, above, coaxial guide catheter assembly
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`10 includes coaxial guide catheter 12 and tapered inner catheter 14. Jd. at
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`6:37-39. Coaxial guide catheter 12 generally includestip portion 16,
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`reinforced portion 18, and rigid portion 20. Jd. at 6:40-41. Tip portion 16
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`generally includes bumptip 22 and marker band 24. Id. at 6:44-45. Bump
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`tip 22 includes taper 26 andis relatively flexible. Id. at 6:45-46. Marker
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`band 24 is formed of a radiopaque material such as platinum/iridiumalloy.
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`Id. at 6:49-50. Tapered inner catheter tip 42 includes tapered portion 46at a
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`distal end thereof, andstraight portion 48. Jd. at 7:22—23. Both tapered
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`portion 46 andstraight portion 48 are pierced by lumen 50. /d. at 7:23—24.
`Tapered innercatheter 14 mayalso includeclip 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
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`catheter 12. Jd. at 7:29-30.
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`2. Illustrative Claim
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`Independent claim 25, reproduced below,is illustrative of the
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`challenged claims.
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`25. A system, comprising:
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`a guide catheter configured to be advanceable through a
`main blood vesselto 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
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`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 beyondthe 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,
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`the guide extension catheter including, in a proximal to
`distal direction, a substantially rigid segment, a segmentdefining
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`a side opening, and a tubular structure defining a lumen coaxial
`and in fluid communication with the lumenof the guide catheter,
`the lumen of the tubular structure having a length that is shorter
`than the length of the lumenof 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 diameterof 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
`lumenofthe tubular structure configured to receive one or more
`stents or balloon catheters when the segment defining the side
`opening and a proximalend portion of the tubular structure are
`positioned within the lumen of the guide catheter and the distal
`end ofthe guide extension catheter extends beyondthe distal end
`of the guide catheter;
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`wherein a material forming the segment defining the side
`opening is morerigid than the tubularstructure.
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`Ex. 1001, 13:36—-14:7.
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`D. Evidence
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`Petitioner relies upon the following prior art references.
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`Ex. 1007, T. Itou et al., U.S. Patent No. 7,736,355 B2 (issued
`June 15, 2010) (“Itou”).
`
`Ex. 1008, T. V. Ressemannet 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. Engeret al., U.S. Patent No. 5,980,486 (issued
`Nov. 9, 1999) (“Enger”).
`In supportofits 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.
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`Paul Zalesky (Exs. 1755, 1830, 1919).
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`Patent Ownerrelies on the declarations of Ms. Amy Welch (Ex. 2044)
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`(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,
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`2123, 2124; 2138, 2243), Dr. John J. Graham (Ex. 2145), Dr. Lorenzo
`
`Azzalini (Ex. 2151), Mr. Steve Jagodzinkski (Ex. 2152 (redacted), 2153
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`(confidential)), Ms. Heather S. Rosecrans (Ex. 2205), and Dr. Craig
`Thompson(Ex. 2215).
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`|
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`E. Asserted Grounds of Unpatentability
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`Petitioner asserts that claims 25-42, 44, and 47 would have been
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`unpatentable on the following grounds.
`
`
`35 U.S.C. §?
`_Reference(s)/Basis _
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`
`
`
`
`
`
`
`
`
`
`[en
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`* 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, werefer to the pre-AIA
`versions of 35 U.S.C. § 103 throughout this Decision.
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`Il.
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`ANALYSIS
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`A. Priority Date of the ’760 Patent
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`The AIA’s first-to-file provisions apply to patent applications “that
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`contain[] or contained at any time a claim to a claimed invention that has an
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`effective filing date” on or after March 16, 2013. AIA § 3(n)(1). The
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`application for reissue for the °760 patent was filed March 3, 2014 and
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`sought reissue of US Patent No. 8,292,850, which issued October 23, 2012
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`from an application filed January 26, 2012. Ex. 1001, codes (22), (64).
`
`Petitioner contends,
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`The °760 patent is subject to the AIA first-to-file provisions
`because (1) it contains claims that lack written description, and
`therefore pre-AIApriority, 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 swearbehindItou 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. Jd. at 14. Thus,
`according to Petitioner, the ’760 patent is subject to the AIA’s first-to-file
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`provisions, which precludes Patent Owner’s from attempting to swear
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`behind Itou’s filing date. Id.
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`“The effective filing date for a claimed invention in an application for
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`reissue or reissued patent shall be determined by deemingthe claim to the
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`invention to have been contained in the patent for which reissue was
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`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 persuadedthat
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`the AIA’s first-to-file provisions apply to the ’760 patent. Indeed, Petitioner
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`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 appearedin the original
`patent for which reissue was sought.’
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`B. Level of Ordinary Skill in the Art
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`Weconsider the asserted grounds of unpatentability in view ofthe
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`understanding of a person of ordinary skill in the art ““POSITA”). Petitioner
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`provides twoalternative 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
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`coronary intervention training program, and (c) experience working as an
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`interventional cardiologist.” Pet. 15. Alternatively, Petitioner asserts that if
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`a person of ordinary skill in the art was “an engineer s/he would havehad(a)
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`an undergraduate degree in engineering, such as mechanical or biomedical
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`engineering; and (b) at least three years of experience designing medical
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`devices, including catheters or catheter-deployable devices.” Id.
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`Additionally, Petitioner contendsthat “[e]xtensive experience and technical
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`training might substitute for education, and advanced degrees might
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`substitute for experience.” Id.
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`Patent Owner“does not dispute [Petitioner]’s proposed definition of a
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`POSITA.” PO Resp.9.
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`Uponreview ofthe parties’ arguments and supporting evidence, we
`adopt Petitioner’s definitions for a person of ordinary skill in the art, which
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`allow the ordinarily skilled artisan to be either a medical doctor or an
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`engineer, as they are undisputed and consistent with the level ofskill
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`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
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`Okajima v, Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art
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`itself can reflect the appropriate level of ordinary skill in theart).
`
`C. Claim Construction
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`Weinterpret a claim “using the same claim construction standard that
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`would be usedto 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
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`construe a claim “in accordance with the ordinary and customary meaning of
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`such claim as understood by one ofordinary skill in the art and the
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`prosecution history pertaining to the patent.” Id.
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`Uponreview ofthe parties’ arguments and supporting evidence, we
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`determinethatit is not necessary to construe any claim termsto resolve the
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`disputed issues for purposes of this Final Written Decision. See Vivid
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`Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 295, 803 (Fed. Cir. 1999)
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`(holding that “only those terms need to be construedthat are in controversy,
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`and only to the extent necessary to resolve the controversy”).
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`D. Status ofItou as Prior Art - Conception and Reduction to Practice
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`Thedispositive issue in this case is whetherItou, which is relied upon
`
`for all groundsin the Petition, qualifies as priorart.
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`Itou wasfiled on September 23, 2005, published on March 30, 2006,
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`and issued on June 15, 2010. Ex. 1007, codes (22), (45), (65). Petitioner
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`contendsthat Itouis prior art under pre-AIA § 102(e). Pet. 19-20.* In the
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`In additionto this Petition, Petitioner similarly asserts Itou in the petitions
`4
`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
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`authorized for these proceedings, Patent Ownerarguesthat Itou does not
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`qualify as prior art based on research and developmentrelated to the claimed
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`invention that took place at Vascular Solutions, Inc. (“VSI”), Patent Owner’s
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`predecessor-in-interest, starting around early 2005 and continuing through
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`the May 3, 2006, filing of the original priority application for the °760
`patent. See generally PO CRTP Resp.; PO CRTP Sur-Reply. Petitioner
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`disputes these contentions. See generally Pet. CRTP Reply; Pet. CRTP Sur-
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`Sur-Reply.
`In its CRTP Response, Patent Owneridentifies the evidence on which
`it relies to antedate Itou, including certain inventor testimony, non-inventor
`
`testimony, and other documentary evidence. PO CRTP Resp. 2. Asto
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`inventor testimony, Patent Ownerrelies on the respective declarations of co-
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`inventors Howard Root(Ex. 2118) and Gregg Sutton (Ex. 2119). As to non-
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`inventor testimony, Patent Ownerrelies 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 Ownerrelies on nearly seventy-
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`five exhibits. These documents include inventor lab notebooks and
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`handwritten notes (Exs. 2002, 2004); internal company memoranda,
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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);
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`invoices, sales orders, and certificates of completion from technical
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`equipment vendors (Exs. 2006-2011, 2013, 2016, 2020-2021, 2026-2035,
`2089-2095, 2097, 2104, 2106-2108, 2110-2112); a photograph (Ex. 2014);
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`deposition transcripts (Exs. 2015, 2116); communications with and
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`documents from VSI’s outside patent counsel (Exs. 2019, 2023, 2096, 2098,
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`2101-2103, 2117); and engineering drawings (Exs. 2022, 2113-2115).
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`Wehaveconsidered this evidence and other rebuttal evidence offered
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`by Petitioner. For the following reasons, we conclude that a preponderance
`
`of the evidence demonstrates that Patent Owner conceived the subject matter
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`recited in the challenged claims before September 23, 2005, the date on
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`whichItou is effective as prior art (“critical date”) and either actually
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`reduced the invention to practice prior to the critical date or diligently
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`worked towards constructive reduction to practice until the priority
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`application for the challenged patent wasfiled on May3, 2006.
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`Accordingly, we conclude that Itou does not qualify as prior art to the °760
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`patent.
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`Forouranalysis, we first set forth the relevant legal standards,
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`followed by ourfact findings and analysis on conception, actual reduction to
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`practice, and diligence towards constructive reduction to practice.
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`1. Legal Standards
`
`“To antedate (or establish priority) of an invention, a [patent owner]
`must showeitheran 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 mindof the inventor, of a definite and
`permanentidea 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
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`practice, which occurs whena patent application is filed, or an actual
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`reduction to practice.” Jd. “In orderto establish an actual reduction to
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`practice, the inventor must provethat: (1) he constructed an embodiment or
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`performeda processthat metall the limitations of the [claimed invention];
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`and (2) he determined that the invention would workforits intended
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`purpose.” Id.
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`If a patent owner has not shownactual reductionto practice prior to
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`the “critical date” of a reference, the patent owner may nonetheless antedate
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`the reference by establishing prior conception and reasonable diligence
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`towards a constructive reduction to practice. Purdue Pharma, 237 F.3d at
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`1365. “Reasonable diligence must be shown throughoutthe entire critical
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`period, which beginsjust prior to the competing reference’s effective date
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`and endson the date of the invention’s reduction to practice.” Arctic Cat
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`Inc. v. GEP PowerProds., Inc., 919 F.3d 1320, 1331 (2019). However,the
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`“diligence need not be perfectly continuous—only reasonably continuous.”
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`Id.
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`To be persuasive, an inventor’s testimony of conception and reduction
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`to practice must be corroborated by other independent evidence.
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`“Conception must be proved by corroborating evidence which showsthat
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`the inventor disclosed to others his completed thought expressed in such
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`clear terms as to enable those skilled in the art to make the invention.” REG
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`Synthetic Fuels, LLC v. Neste Oil Oyj, 841 F.3d 954, 962 (Fed. Cir. 2016)
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`(internal quotation marks omitted). “However, there is no final single
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`formula that must be followed in proving corroboration.” Jd. (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.,
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`437 F.3d 1157, 1169-70 (Fed. Cir. 2006).
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`“Tn the final analysis, each corroboration case must be decided onits
`ownfacts 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).
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`Corroborating evidence mayconsist of “testimony of a witness, other than
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`the inventor,” or “evidence of surrounding facts and circumstances
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`independentof information received from the inventor.” Medichem, 437
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`F.3d at 1171. “Even the most credible inventor testimonyis a fortiori
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`required to be corroborated by independent evidence, which may consist of
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`documentary evidenceas well as the testimony of non-inventors.” Jd. at
`1171-72. We assess whether evidence corroborates conception and
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`reduction to practice under a “rule of reason” analysis. Cooper, 154 F.3dat
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`1330.
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`In an inter partes review, 35 U.S.C. § 316(e) imposes the ultimate
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`burden of persuassian to “prove unpatentability by a preponderanceof the
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`evidence”onto the petitioner. This burden nevershifts to the patent owner.
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`Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378
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`(Fed. Cir. 2015). However, when the patent owner attempts to antedate the
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`priorart, “[a] second and distinct burden, the burden of production” can shift
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`betweenthe petitioner and the patentee. Jd. at 1379; see In re Magnum Oil
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`Tools Int’l, Ltd., 829 F.3d 1364, 1375-76 (Fed. Cir. 2016). Specifically, the
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`patent owner“bears the burden ofestablishing that its claimed invention is
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`entitled to an earlier priority date than an assertedpriorart reference.”
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`_
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`Magnum Oil Tools, 829 F.3d at 1375-76. Once the patent ownerestablishes
`it is entitled to an earlier priority date, the burden ofproduction then shifts
`back to the petitioner “to convince the court that [the patent owner] is not
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`entitled to the benefit” of the earlier priority date. Dynamic Drinkware, 800
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`F.3d at 1379 (citing Tech. Licensing Corp. v. Videotek, Inc., 545 F.3d 1316,
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`1328 (Fed. Cir. 2008)).
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`2. Conception
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`To show prior conception, Patent Ownerrelies primarily upon Mr.
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`Root’s testimony submitted in support of its CRTP Response. Ex. 2118
`(Root Declaration in support of CRTP).°° Mr. Root was the founder and
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`Chief Executive Officer of VSI from 1997 to 2017. Jd. J] 1-2. Patent
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`Owneralso relies upon the testimony of co-inventor Mr. Sutton, who was
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`Vice President, Research & Developmentat VSI from 2004 until mid-2006.
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`Ex. 2119 (Sutton Declaration in support of CRTP). As additional
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`documentary corroboration for this inventor testimony, Patent Ownerrelies
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`upon certain pages from Mr. Sutton’s laboratory notebook dated January 4,
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`2005 (Ex. 2002), a “market feasibility” memorandum from Mr. Rootdated
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`February 4, 2005 (Ex. 2003), and some additional handwritten notes and
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`drawings from Mr. Root dated February 7, 2005 (Ex. 2004). Wefirst set
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`forth the relevant facts based on these declarants’ testimony and
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`> Patent Ownerpreviously 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 Ownerpresents in support of
`conceptionis largely undisputed. Indeed, during a teleconference addressing
`Patent Owner’s requestto presentlive testimony from Mr. Rootin these
`proceedings, Petitioner’s counsel acknowledged that Mr. Root’s testimony
`was not disputed in a mannerthat would require our credibility assessment.
`See Ex. 1920, 11:10-11 (“And I don’t think we have, you know,directly
`said Mr. Rootis 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
`conclusionthat “the credibility of Mr. Root is not in question,” we denied
`Patent Owner’s request to present live testimony from Mr. Rootat theoral
`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
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`and legal issues as neededin ouranalysis.
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`a)
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`Fact Findingsfor Conception
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`In his declaration, Mr. Root attests that conception started around the
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`time he attended the Transcatheter Cardiovascular Therapeutics (“TCT”)
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`conference from September 27 to October 1, 2004, by which time he had
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`recognized the issue of “guide catheter backout” that physicians were
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`experiencing when performing complex interventional coronary procedures.
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`Ex. 211895. Accordingly, Mr. Root asserts that he recognized a need for a
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`solution “that provided better guide positioning, device delivery, and
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`procedural conveniences” than what previously existed in the market. Jd.
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`To solve this problem, Mr. Rootindicates that he came up with “the idea for
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`a guide extension catheter that would provide improved back-up support
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`with rapid exchange delivery, which would offer far more convenience than
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`other options available at the time.” /d. ]6. And “[s]ometime after the TCT
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`conference, but before 2005,” Mr. Root met with his co-inventors, including
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`Mr. Sutton, to discuss more particular ideas for how to makethis device. Jd.
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`The “guide extension catheter” device that the inventors thoughtofat
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`this time included certain key features. It was to be used within a standard
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`guide catheter that was one “Frenchsize” larger than the “guide extension
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`catheter,” and was parsed into two distinct portions—a substantially rigid
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`proximal portion comprising a “rail” structure and a distal tubular portion
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`with a lumen—whichtogether were longer than a standard guide catheter.
`Id. 47. During an operation,after the standard guide catheter wasinserted
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`into the vasculature so its distal end was in the ostium ofa cardiacartery, the
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`guide extension catheter would be inserted into the lumen until the distal end
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`of the tubular portion wentpast the distal end of the guide catheter and into
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`the cardiac artery. Jd. With both catheters in place, an interventional
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`cardiology device could be thereafter inserted through the standard guide
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`catheter (running alongtherail of the guide extension catheter) until it
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`reachedthe distal end of the distal tubular portion of the guide extension
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`catheter, thereby entering the cardiac artery. Id.
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`The device they undertook to develop was initially called the “Guide-
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`Liner” device, but the hyphen was later dropped and it became knownas the
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`“GuideLiner” device. Jd. 79. Although the original idea for the GuideLiner
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`was a “rapid exchange” (“RX’’) version of the guide extension catheter,
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`“Ts]ometime between February and June of 2005, a decision was made to
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`concurrently pursue development of an over-the-wire ((OTW’) version of
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`GuideLiner.” Jd 919. Mr. Root acknowledges, however,that “[t]he OTW
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`GuideLiner was notpart of the inventions of the [challenged] patents,” but
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`instead was more akin to the “mother-in-child” design that was knownin the
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`prior art and discussed in the backgroundofthe challenged patents. Id.
`(citing Ex. 1001, 2:17-44).’
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`Mr. Sutton in his own declaration sets forth a story consistent with
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`that set forth by Mr. Root. Heattests that “[s]tarting in late-2004 until [he]
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`left VSI, [he] performed research and development work on what became
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`the GuideLiner guide extension catheter.” Ex. 21192. Although VSI did
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`not retain all of its files from that time, Mr. Sutton recalls, based on his
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`memory and documents he reviewed,that “we knewvery early on that the
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`Tt 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 forits intended purpose,”
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`and that “[t]he research and developmentthat followed our original
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`conception of the GuideLiner rapid exchange was to optimize materials,
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`dimensions, and design details that would allow us to manufacture and bring
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`the product to market in a way that would be commercially viable.” Id.
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`6.
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`The earliest documentary evidence that corroborates this testimonyis
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`Mr. Sutton’s laboratory notebook pagesrelating to the conceptfor a “Guide-
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`Liner” device. Ex. 2002. Mr. Sutton signed the relevant pages on January 4,
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`2005, and Jeffrey Welch, another co-inventor and engineer at VSI, witnessed
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`those pages on March 2, 2005. Jd. at 7-8; see Ex. 2119 J 7.
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`A portion of one page from Mr. Sutton’s notebook is reproduced
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`below:
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`+eioei:ie
`4ceneeae,Istéeedle
`paxeepie
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`%aeeae“csMatCeri,ated|
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`“]-_eoo
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`netfeertensen
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`|
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`eosaeaes|penceerent fern
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`Ex. 2002, 7. As shown above, Mr. Sutton’s notebooksets forth an “idea”
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`that “relates to interventional coronary procedures and specifically to
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`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
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`back-up support for the stent device.” Jd.; Ex. 211899. Mr. Sutton’s lab
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`notebook also includes drawings of the cross section of various portions of
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`the guide extension catheter and a drawing of how the Guide-Liner would be
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`used that are similar to figures included in the challenged patents. Cf Ex.
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`1001, Figs. 1, 2, 5, 6 (depicting patent drawings of the guide extension
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`catheter that are similar to Mr. Sutton’s drawings). For example,his
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`notebook includes a drawing of a “SF” (5-French) Guide-Liner in operation
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`and notes that the Guide-Linera) “is used wherethere is difficulty crossing
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`lesions,” b) “allows back-up support distally,” c) “allows for Rapid X
`change,” and d) “wouldfit 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 stainlesssteel (“SS”) half-tube; 2) a
`reinforced distal tube section with a braided “PTFE/SS/PEBAX”material
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`that is “soft for coronaries”; and 3) a design that “allowsfor rapid
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`exchange.” Id. at 7. Additionally, the notebook identifies the “SF Design
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`Specs,” including an overall device length of between 105 cm and 115 cm.
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`Id. Both Mr. Root and Mr. Sutton authenticate the contents of the notebook
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`pages and Mr.Sutton attests that his notebook was“issued and maintained in
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`the regular course of VSI’s business.” Ex. 2118 4] 9-11; Ex. 2119 4] 7-14.
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`By early February 2005, Mr. Rootrealized this device would have
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`“substantial market potential,” so he wrote a “Market Feasibility”
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`memorandum (“memo”) for GuideLiner catheters, dated February 4, 2005.
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`Ex. 2118 7 11; Ex. 2003 (confidential); Ex. 2127 (public). Mr. Rootattests
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`that he would only have drafted this kind of memoif he “had developed high
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`confidence that a concept would work,”so that non-inventors in the
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`company(e.g., regulatory personnel and engineers) could join a project to
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`bring the new product to market. Ex. 2118 411. The memoitself
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`recognizes the “substantial market potential” for the RX GuideLiner device
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`based on an estimated 30,000 procedures a year. Ex. 2003, 1. The memo
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`indicates that three versions wereanticipated(i.e., a “5in6,” a “6in7,” anda
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`“7in8” GuideLiner), and notes problems with the prior art OTW methods.
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`Id. The memoalso generally describes the RX GuideLiner in a manner
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`consistent with the description in Mr. Sutton’s notebook including, among
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`other features, that it would be delivered within a standard guide catheter for
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`interventional cardiology procedures; it had a short distal t