Trials@uspto.gov
`571-272-7822
`
`Paper No.20
`Date: June 26, 2020
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MEDTRONIC, INC., AND MEDTRONIC VASCULAR,INC.,
`Petitioner,
`
`Vv.
`
`TELEFLEX INNOVATIONSS.A.R.L.,
`Patent Owner.
`
`IPR2020-00134
`Patent RE45,760 E
`
`Before SHERIDAN K. SNEDDEN,JON B. TORNQUIST,and
`CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.
`
`SNEDDEN,Administrative Patent Judge.
`
`DECISION
`Granting Institution of Inter Partes Review
`35 U.S.C. $ 314
`
`

`

`IPR2020-00134
`Patent RE45,760 E
`
`I.
`
`INTRODUCTION
`
`Medtronic, Inc. and Medtronic Vascular, Inc. (‘Petitioner’) filed a
`
`Petition for inter partes review of claims 48 and 51-53 of U.S. Patent No.
`
`RE45,760 E (“the ’760 patent,” Ex. 1601). Paper 1 (‘“Pet.”). Teleflex
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`Medical Devices S.A.R.L. (“Patent Owner”) filed a Preliminary Response.
`
`Paper 10 (“Prelim. Resp.”). Pursuant to our authorization, Petitioner filed a
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`Reply addressing its burden on secondary considerations and reduction to
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`practice, and Patent Ownerfiled a Sur-Reply addressing Petitioner’s burden
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`on those issues. Paper 14; Paper 15. Also pursuant to our authorization,
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`Petitioner filed another Reply (Paper 17) and Patent Ownerfiled another
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`Sur-Reply (Paper 18) addressing the factors for discretionary denial under
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`35 U.S.C. § 314(a).
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`To institute an inter partes review, we must determinethat the
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`information presented in the Petition shows “a reasonable likelihood that the
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`petitioner would prevail with respect to at least 1 of the claims challenged in
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`the petition.” 35 U.S.C. § 314(a) (2012). The Supreme Court has held that a
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`decision to institute under 35 U.S.C. § 314 maynot institute on fewer than
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`all claims challenged in the petition. SAS Inst., Inc. v. Iancu, 138 S. Ct.
`
`1348, 1359-60 (2018) (“SAS”). After considering the parties’ arguments
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`and evidence, we determine that Petitioner has demonstrated a reasonable
`
`likelihood that it would prevail with respect to at least one of the claims
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`challenged in the Petition. Accordingly, an inter partes review ofall of the
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`claims andall of the grounds presented in the Petition is hereby instituted.
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`A. Real Parties in Interest
`
`Petitioner identifies its real parties-in-interest as Medtronic, Inc. and
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`Medtronic Vascular, Inc., and notes that “Medtronic plc is the ultimate
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`parent of both entities.” Pet. 5. Patent Owneridentifies its real parties-in-
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`IPR2020-00134
`Patent RE45,760 E
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`interest as Teleflex Medical Devices S.A.R.L.; Vascular Solutions LLC;
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`Arrow International, Inc.; and Teleflex I.LC. Paper 4, 2. Patent Owneralso
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`notes that “Teleflex Incorporated is the ultimate parent of theentities listed
`
`above.”
`
`B. Related Matters
`
`The ’760 patentis also at issue in IPR2020-00132 and IPR2020-
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`00133. Paper 4, 2-3; Pet. 5. We instituted inter partes review in IPR2020-
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`00132 on June 9, 2020. IPR2020-00132, Paper 22.
`
`Theparties indicate that the ’760 patent is the subject oflitigation in
`Vascular Solutions LLC, et al. v. Medtronic, Inc., et al. No. 19-cv-01760 (D.
`Minn.filed July 2, 2019) (“Medtronic”) and OXMedical, LLC v. Vascular
`
`Solutions, LLC, No. 17-cv-01969 (D. Minn., filed June 8, 2017) (““OXM’).
`
`Pet. 5-6; Paper4,2.
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`The ’760 patent is a reissue of U.S. Pat. No. 8,292,850 (“the ’850
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`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 ofjoint motion to terminate, and IPR2014-00763, filed May
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`16, 2014 and terminated August 11, 2014 by way ofjoint motion to
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`terminate. Pet. 6; Paper 4, 2-3. The ’850 patent wasalso at issue in the U.S.
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`District Court for the District of Minnesota in Vascular Solutions, Inc. v.
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`Boston Scientific Corp., No. 13-cv-01172 (D. Minn., filed May 16, 2013).
`
`Id.
`
`C. The ’760 Patent
`
`1. Specification
`
`The subject matter claimed in the ’760 patentis directed to a device
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`for use with a standard guide catheter. Ex. 1601, 13:36-17:13. Figures 1
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`

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`IPR2020-00134
`Patent RE45,760 E
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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
`ve
`
`14
`
`Figure | of the ’760 patent
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`Fig. 5
`
`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. Jd. at 6:44-45. Bump
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`tip 22 includes taper 26 andis relatively flexible. Jd. at 6:45—46. Marker
`band 24 is formed of a radiopaque material such as platinum/iridium alloy.
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`Id. at 6:49-50. Tapered inner catheter tip 42 includes tapered portion 46 at a
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`distal end thereof, and straight portion 48. Jd. at 7:22—23. Both tapered
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`portion 46 andstraight portion 48 are pierced by lumen 50. Jd. at 7:23-24.
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`Tapered inner catheter 14 mayalso include clip 54 at a proximal end thereof
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`to releasably join tapered inner catheter 14 to coaxial guide catheter 12. Jd.
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`IPR2020-00134
`Patent RE45,760 E
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`at 7:27—29. Thus, tapered inner catheter 14 is keyed to coaxial guide
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`catheter 12. Id. at 7:29-30.
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`2. Illustrative Claim
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`Independent claim 48, reproducedbelow,is illustrative of the
`
`challenged claims.
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`48. 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 proximalto distal
`direction, a substantially rigid segment, a segment defining a side
`opening, and a tubular structure defining a lumen coaxial and in
`fluid communication with the lumenofthe 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 ofthe
`guide catheter, the side opening extending/or 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 ofthe 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
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`

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`IPR2020-00134
`Patent RE45,760 E
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`extension catheter extends beyond the distal end of the guide
`catheter;
`
`wherein the segment defining the side opening comprises a
`portion ofthe guide extension catheter that is more rigid thanadistal
`end portion of the tubular structure.
`
`Ex. 1601, 15:14—53.
`
`D. Evidence
`
`Petitioner relies upon the following prior art references.
`
`Ex. 1607, T. Itou et al., U.S. Patent No. 7,736,355 B2 (issued June 15,
`2010) (“Itou”).
`
`Ex. 1608, T. V. Ressemannet al., U.S. Patent No. 7,604,612 B2 (issued Oct.
`20, 2009) (“Ressemann”’).
`
`Petitioner also relies upon the Declarations of Dr. Stephen Brecker
`
`(Ex. 1605) and Richard A. Hillstead (Ex. 1642) to support its contentions.
`
`Patent Ownerrelies upon the Declaration of Peter T. Keith to support
`its contentions. Ex. 2042.
`
`E. Asserted Grounds of Unpatentability
`
`Petitioner asserts that claims 48 and 51-53 would have been
`
`unpatentable on the following grounds.
`
`
`
`
`
`
`48, 51, 53
`
`103(a)
`
`Itou, Ressemann,
`Knowledge ofa POSITA
`
`
`
`
`' 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.
`
`6
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`
`
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`48, 91-53
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`103(a)
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`
`
`
`Itou, Knowledge ofa
`
`Ressemann, Takahashi,
`Knowledge of a POSITA
`
`II.
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`ANALYSIS
`
`A. 35 U.S.C. $ 314
`
`1. Multiple Petitions
`
`Petitioner filed three petitions for inter partes review ofthe
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`760 patent. IPR2020-00132 relies on Itou as the primary reference andis
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`directed to claims 25-42, 44, and 47 of the ’760 patent. IPR2020-00133
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`relies on Ressemannas the primary reference andis directed to claims 25-
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`42, 44, and 47 of the ’760 patent. The current Petition relies primarily on
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`the combination of Itou and Ressemannas directed to claims 48 and 51-53
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`of the ’760 patent, a distinct set of claims as compared to the petitionsfiled
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`in IPR2020-00132 and IPR2020-00133. Paper 3, 1-2. Petitioner labels
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`IPR2020-00132 as “Petition 1,” IPR2020-00133 as “Petition 2,” IPR2020-
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`00134 as “Petition 3.” Id.
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`Asnoted above, weinstituted review of the ’760 patent in IPR2020-
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`00132. IPR2020-00132, Paper 22. In this Decision, we address only
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`whether we should exercise our discretion to deny the present Petition,1.e.,
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`Petition 3. We will address the parties’ arguments regarding Petition 2 in
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`our decision in IPR2020-00133.
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`Regarding the present Petition, Petitioner asserts that Petition 3
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`combinesthe Itou- and Ressemann-based groundsfor claims 48 and 51-53
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`Patent RE45,760 E
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`in a third petition, which is necessary given the numberand length of the
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`challenged claims, and given the complexity of issues presented before us
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`here. Paper 3,3. Patent Owner disagrees. Prelim. Resp. 31-33.
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`Having considered the parties’ positions and evidenceofrecord,
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`summarized above, we determine that analyzing distinct sets of claims of the
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`°760 patent in multiple petitions is reasonable andjustified given the number
`
`and length of the challenged claims, and given the complexity of the
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`disputes between the parties requiring resolution.
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`2. Parallel District Court Cases
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`Patent Ownerargues that we should exercise our discretion under
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`35 U.S.C. § 314(a) to deny institution due to the commonissues being
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`litigated in parallel district court cases. Prelim. Resp. 26-31. In particular,
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`Patent Owner contendsthat the validity of at least some of the challenged
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`claims of the ’760 patent and other related patents is the subject of active
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`litigation in two separate district court cases, the OXM case and the
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`Medtronic case, which are both currently pending in the District of
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`Minnesota. Jd.
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`In NHK Spring Co.v. Intri-Plex Techs., Inc., IPR2018-00752, Paper 8
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`(PTAB Sept. 12, 2018) (precedential, designated May 7, 2019) (“NHK’”), the
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`Board considered the fact that a parallel district court proceeding was
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`scheduled to finish before the Board reacheda final decision as a factor
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`favoring denial of institution. In the more recently designated precedential
`
`decision Apple Inc. v. Fintiv, Inc., IPR2020-00019, Paper 11 (PTAB Mar.
`
`20, 2020) (precedential, designated May 5, 2020) (“‘Fintiv”), the Board set
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`forth several other factors to consider under § 314(a) in determining whether
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`to institute trial when there is parallel, co-pending litigation concerning the
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`same patent: (1) whethera stay of the parallel litigation exists oris likely to
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`Patent RE45,760 E
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`be grantedif a trial proceedingis instituted by the Board; (2) proximity of
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`the court’s trial date to the Board’s projected statutory deadline; (3) the
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`investmentin the parallel proceeding by the court and parties; (4) the extent
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`of overlap between issues raised in the petition and in the parallel litigation;
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`(5) whether the petitioner and the defendant in the parallel proceeding are
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`the same party; and (6) and other circumstances that impact the Board’s
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`exercise of discretion, including the merits.
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`The parties address the Fintiv factors in supplemental briefing that we
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`authorized. Paper 17; Paper 18. We have considered each of these factors
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`and concludethat, on balance, the circumstances here do not favor
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`discretionary denial under § 314(a).
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`As to whethera stay of the parallel litigation exists or is likely to be
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`granted (Fintiv Factor 1), Petitioner contendsthat the presiding district court
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`judge in the Medtronic and OXM cases“has granted every post-institution
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`requestto stay litigation pending reexamination or IPR.” Paper 17, 2 (citing
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`Ex. 1693). Petitioner also points out that the OXM case, involving the ’760
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`patent and other patents in the same family, has already been stayed pending
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`our institution decisions, and the court indicated that if we institute trial “the
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`Court will invite the parties to brief whether the stay should extend through
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`the conclusion of the review process.” Jd. (citing Ex. 1694). Thus,
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`Petitioner contends that the same judgewill also entertain Petitioner’s
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`motion to stay the Medtronic case in the eventofinstitution. Jd. With
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`respect to Fintiv Factor 1, Patent Owner contendsthat Petitioner has not
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`sought a stay of the Medtroniclitigation, and the Board has previously
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`declined to infer how the district court would rule when neither party has
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`requested a stay. Paper 18, 1. Patent Owner contends that the OXM case
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`was stayed only because QXMédical agreed to exit the market and waived
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`its obviousness/anticipation defenses, and that the district court has not
`granted stays involving direct competitors or allegations of irreparablc harm.
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`Id. Having considered the parties position, we determine that Fintiv Factor |
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`favors institution, especially in view ofthe fact that a stay has already been
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`granted in the related OXM case andthedistrict court’s prior history of
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`granting stays pending resolution of related IPRs.
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`Asto the proximity of the court’s trial dates to our statutory deadlines
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`(Fintiv Factor 2), the parties agree that the district court has indicated that
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`the Medtronic case must be “Ready for Trial” by August 1, 2021, which
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`would be a few weeksafter our statutory deadline for a final written decision
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`in this proceeding and the related IPRs. Prelim. Resp. 10; Paper 17, 1.
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`Petitioner asserts the date for an actualtrial will likely be extended even
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`further, noting that district court’s final “Ready for Trial” date in patent
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`proceedings is, on average, over eight monthsafter the originally scheduled
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`date. Paper 17, 1 (citing Ex. 1689). Petitioner points out that thedistrict
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`court already extended the original “Ready for Trial” date by two monthsin
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`the Medtronic case, and thata trial date in the OXM case wasfinally set for
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`February 24, 2020—morethan ten monthsafter the original “Ready for
`
`Trial” set by the court—before that case was stayed pending ourinstitution
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`decision. We determinethat Fintiv Factor 2 also favors institution,
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`especially giventhat thetrials in the district court cases are not scheduledto
`
`take place until after we issue ourfinal written decisions in these
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`proceedings. Notably, in both the NHK and Fintiv cases, thetrial dates in
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`the parallel litigations were scheduled either before or only a few months
`
`after the Board’s institution deadlines and before the final written decision
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`deadlines. See NHK, IPR2018-00752, Paper 8 at 19 (noting trial date of
`
`March 25, 2019, where Board’s institution decision was issued September
`
`10
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`12, 2018); Fintiv, IPR2020-00019, Paper 15 at 10 (noting trial date of March
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`8, 2021 where Board’s institution decision was due May 15, 2021).
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`Asto the amount of investment by the parties and the court in the
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`parallel proceeding (Fintiv Factor 3), Patent Owner contendsthat the district
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`court is already deeply invested and has familiarity with the challenged
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`patents in light of the relatively advanced stage of the OXM case. Paper18,
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`1—2. But as noted above, the district court has indicated a preference to wait
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`for the Board’s institution decision before proceeding in the OXM case.
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`With respect to the Medtronic case, Patent Owner contends that the parties
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`have already exchanged infringement contentions, conducted extensive fact
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`discovery (set to close September 1, 2020), and addressed the issues in a
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`preliminary injunction motion. Jd; see also Prelim. Resp. 10-1. Although
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`weagree that the parties have invested sometime andeffort in the related
`
`litigation, we are not persuaded that those cases are in such an advanced
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`stage that would favor denial ofinstitution. The district court recently
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`denied the preliminary injunction motion filed by Patent Owner, noting that
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`there are substantial questions with respect to the validity of the asserted
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`claims. Ex. 1688, 9-14. However, the district court has not issued a claim
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`construction order or any other substantive order. See Fintiv, Paper 11 at 10
`
`(noting that if “the district court has not issued orders related to the patentat
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`issue in the petition, this fact weighs against exercising discretion to deny
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`institution under NHK”). We, therefore, determine that resolution of those
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`commonissues by the Board may be beneficial to the resolution of the
`
`district court proceedings. Patent Owner also contendsthat Petitioner
`
`delayed bringing these challenges. Paper 18, 2. Petitioner, however, points
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`out that it filed its IPR petitions roughly four monthsafter the district court
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`complaint in the Medtronic case, and before Patent Owner’s infringement
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`contentions were served in that case. Paper 17, 2; see Fintiv, Paper 11 at 11
`
`(noting that “it is often reasonable for a petitioner to wait to file its petition
`
`until it learns which claims are being asserted against it in the parallel
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`proceeding”). Wefind that Petitioner did not unduly delay filing its IPR
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`Petitions.
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`Wehavealso considered the remaining Fintiv factors and determine,
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`on balance, that they do not outweigh the foregoing factors in favor of
`
`institution. Fintiv, Paper 11 at 6 (explaining that when various factors weigh
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`both in favor and against exercising discretion under § 314(a), we take “a
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`holistic view of whether efficiency and integrity of the system are best
`served by denying orinstituting review”). Petitioner contends that Patent
`
`Ownerhas only asserted a sub-set of the challenged claimsin the district
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`court litigation. Paper 17,2. With respect to Fintiv Factor 4 (overlap of
`
`issues), Patent Owner respondsthat there is complete overlap of the issues
`
`raised in the parallel proceedings, including the same invalidity prior art and
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`argumentsraised in the Petitions. Paper 18,2. With respect to Fintiv
`
`Factor 5 (whether the same parties are involved), Patent Owneralso points
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`out that the Petitioner is the defendant in the Medtronic case. Id. We find
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`there is an overlap of issues and parties between the Medtronic case andthis
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`proceeding. In Fintiv, the Board notedthat “if the petition includes the same
`
`or substantially the same claims, grounds, arguments, and evidence as
`
`presented in the parallel proceeding, this fact has favored denial.” Fintiv,
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`Paper 11 at 13. In this case, however, any concerns aboutinefficiency and
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`the possibility of conflicting decisions are mitigated by the factthat the
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`district court maystay the parallel litigation and thus not reach the merits of
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`Petitioner’s invalidity defenses before we issue our Final Written Decision.
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`Indeed, the overlap may actually favorinstitution here since the Board’s
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`earlier determination on the commonpatentability issues will either be
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`dispositive at to the litigated issues, or at least provide sufficient guidance
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`for the district court’s resolution of similar issues. Finally, under Fintiv
`
`Factor 6, we have taken into account the merits of Petitioner’s challenges, as
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`discussed above, andfind that this favors institution.
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`In sum, based on our consideration of the foregoing factors, we
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`decline to exercise our discretion under § 314(a) to denyinstitution.
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`B. Level ofOrdinary Skill in the Art
`
`The person having ordinary skill in the art is a hypothetical person
`
`whois presumed to be awareofall the relevant prior art. Custom
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`Accessories, Inc. v. Jeffrey-Allan Indust., Inc., 807 F.2d 955, 962 (Fed. Cir.
`
`1986); Kimberly-Clarke Corp. v. Johnson & Johnson, 745 F.2d 1437, 1453
`
`(Fed. Cir. 1984). Moreover,the priorart itself is generally sufficient to
`
`demonstrate the level of skill in the art at the time of the invention. See
`
`Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that
`
`specific findings regarding ordinary skill level are not required “where the
`
`prior art itself reflects an appropriate level and a need for testimonyis not
`
`shown”) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755
`
`F.2d 158, 163 (Fed. Cir. 1985)).
`
`Petitioner asserts that “[i]f a person of ordinary skill in the art
`
`(‘POSITA’) was a medical doctor, s/he would have had(a) a medical
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`degree; (b) completed a coronary intervention training program,and (c)
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`experience working as an interventional cardiologist.” Pet. 15.
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`Alternatively, Petitioner asserts that “if a POSITA was an engineer s/he
`
`would have had (a) an undergraduate degree in engineering, such as
`
`mechanical or biomedical engineering; and (b)at least three years of
`
`experience designing medical devices, including catheters or catheter-
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`deployable devices.” Jd. Additionally, Petitioner contends that “[e]xtensive
`
`experience andtechnicaltraining might substitute for education, and
`
`advanced degrees might substitute for experience.” Jd. Petitioner further
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`asserts that “a POSITA with a medical degree may have access to a POSITA
`
`with an engineering degree, and a one with an engineering degree might
`
`have access to one with a medical degree.” Jd. (citing Ex. 1605 { 31; Ex.
`
`1642 JJ 18-19).
`
`Patent Ownerindicates that “[f]or purposes of this Preliminary
`
`Response only, [Patent Owner] does not currently dispute [Petitioner]’s
`
`proposed definition of a POSITA.” Prelim. Resp. 13.
`For the purposes ofthis decision, we apply Petitioner’s definition of
`the level of ordinary skill in the art becauseit is undisputed at this time and
`
`consistent with the evidence of the record. See Okajima v. Bourdeau, 261
`
`F.3d 1350, 1355 (Fed. Cir. 2001) (the priorart itself can reflect the
`
`appropriate level of ordinary skill in the art).
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`The abovedefinition is provisional and the parties are welcome to
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`present further argumentonthis topicat trial.
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`C. Claim Construction
`
`Weinterpret 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). Under this standard, we construe
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`the claim “in accordance with the ordinary and customary meaning of such
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`claim as understood by oneofordinary skill in the art and the prosecution
`
`history pertaining to the patent.” Jd.
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`Petitioner proposes constructions for several claim terms, including
`
`the term “flexural modulus.” Pet. 16-18. Patent Owner responds to
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`Petitioner’s proposed constructions by asserting that “no specific
`
`construction of claim terms is necessary for the Board to denythe Petition in
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`view ofthe deficiencies [Patent Owner] identifies in this Preliminary
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`Response.” Prelim. Resp. 13.
`
`At this stage of the proceeding, we determine that no express
`construction of any claim term is necessary to determine whetherto institute
`inter partes review. See Nidec Motor Corp. v. Zhongshan Broad Ocean
`
`Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (quoting Vivid Techs., Inc.
`
`v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (“[O]Jnly those
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`terms need be construed that are in controversy, and only to the extent
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`necessary to resolve the controversy.”)).
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`D. Prior Art Status ofItou (Ex. 1607)
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`Itou was filed on September 23, 2005, published on March 30, 2006,
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`and issued on June 15, 2010. Ex. 1607, codes (22), (45), (65). Petitioner
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`contendsItou is therefore prior art under pre-AIA § 102(e). Pet. 18-20.
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`Patent Owner arguesthat Itou does not qualify as prior art based on an
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`earlier invention date for the claimed invention of the ’760 patent. Prelim.
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`Resp. 22-25. In particular, Patent Owner contends that conception of the
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`claimed invention occurred in “late 2004,” and reduction to practice
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`occurred “in the spring and summer of 2005.” Id. at 22-23. As support for
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`this contention, Patent Ownerrelies upon the declarations of inventor
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`HowardRoot(Ex. 2001) and Deborah Schmalz (a former Vice President of
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`Regulatory Affairs at Patent Owner’s predecessor-in-interest) (Ex. 2039),
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`along with certain notebook pages and other documents (Exs. 2005-2022,
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`2024) allegedly showing prior conception and reduction to practice. Patent
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`Ownerfurther contends that, despite having much ofthe evidencerelated to
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`conception and reduction to practice, Petitioner does not address it in the
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`Petition. Prelim. Resp. 22-23.
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`The burden to show thatItouis prior art to the ’760 patent rests with
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`Petitioner. Dynamic Drinkware, LLC v. National Graphics, Inc., 800 F.3d
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`1375, 1379 (Fed. Cir. 2015). That said, because Petitioner has presented
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`evidencethat Itou was filed prior to the filing date of the °760 patent, thus
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`qualifying as § 102(e) prior art, the burden of production shifts to Patent
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`Ownerto demonstrate that Itou is not prior art, for example, by presenting
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`evidence of an earlier conception and reduction to practice. Jd. at 1380.
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`Although Patent Ownerpresents multiple pieces of evidence in the
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`Preliminary Response in support of this contention, Petitioner has not had an
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`opportunity to fully consider and address this evidencein this proceeding.’
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`Based on the present record, we determine that genuine issues of material
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`fact remain aboutthe alleged invention date, and these factual issues are best
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`resolved after the record is more fully developed. See 37 C.F.R. § 42.108(c)
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`(stating “‘a genuine issue of material fact created by [Patent Owner’s]
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`2 As noted by Patent Owner, Petitioner was aware of someof Patent
`Owner’s evidence of conception and reduction to practice beforeit filed the
`Petition. Prelim. Resp. 24. The district court, however, determined that
`Patent Owner’s evidence was “unimpressive” and insufficient to
`demonstrate, at the preliminary injunction stage, an earlier conception and
`reduction to practice. Ex. 1688, 13-14. Petitioner also notes that Patent
`Ownerdid not provide detailed contentions regarding conception and
`reduction to practice until less than a week before its Petition was filed, and
`the relevant evidence that was previously produced to Petitioner was marked
`“attorneys eyes only’ in the district court case and thus could not have been
`relied upon in the Petition. Paper 14, 2-5. Given that Patent Owner bears
`the burden of producing evidence to support its antedating contention, we
`determine Petitioner did not have an obligation to preemptively address
`Patent Owner’s evidenceinits Petition.
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`testimonial evidence will be viewedin the light most favorable to the
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`petitioner solely for purposes of deciding whetherto institute an inter partes
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`review.’’).
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`E. Petitioner ’s Patentability Challenges
`1. Ground 1: Anticipation by Itou
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`Petitioner asserts that claims 48, 51, and 53 are anticipated by Itou.
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`Pet. 19. For the reasons set forth below, we determine that Petitioner has
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`demonstrated a reasonable likelihood that claim 48, 51, and 53 are
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`anticipated by Itou.
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`a) Summary ofItou (Ex. 1607)
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`Itou discloses “an intravascular foreign matter suction assembly”
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`designed to suck, sample, and remove “foreign matter such as a thrombusor
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`an embolus” from a blood vessel. Ex. 1607, 1:6—9, 1:47-49. This assembly
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`includes a guiding catheter and a suction catheter configured to be inserted
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`into the lumenofthe guiding catheter. /d. at 1:49-65.
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`Figure 3 of Itou is reproduced below:
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`
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`Figure 3 is a cross section of a distal end portion of suction catheter 2. Jd. at
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`2:61-62. Suction catheter 2 includesdistal side tubular portion 24 and
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`proximal side wire-like portion 25, formed from a solid metal wire and an
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`outer layer such as a polymer coating. Jd. at 3:46—-50. Tubular portion 24
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`has reinforced tubular portion 21 and flexible distal tip 22. Jd. at 2:15-51,
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`3:50—58. Tubular portion 24 has an outer diameter that allowsit to be
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`inserted into the lumen ofa guide catheter and wire-like portion 25 has a
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`sectional area smaller than the sectional area of the tube wall of tubular
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`portion 24. Jd. at 3:59-63.
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`Figure 5 of Itou is reproduced below:
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`FIG.5
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`4
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`Figure 5 shows the suction assembly “in an assembledstate.” Jd. at 2:66—
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`67. In this state, suction catheter 2 is disposed in the lumen of guiding
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`catheter 1. Jd. at 5:12-14. Thedistal end of distal end protective catheter 5
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`is inserted into the lumenof suction catheter 2 and guide wire6 is inserted
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`into the lumen ofthe distal end protective catheter 5. Jd. at 5:14-17. The
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`proximalends of suction catheter 2, distal end protective catheter 5, and
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`guide wire 6 are “introduced to the outside through main connectorportion
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`31 of Y-shaped connector 3.” Jd. at 5:17-20. A valveis built into main
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`connector 31 and “can selectively clamp and fix” guide wire 6 and wire-like
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`portions 25 or 55 “to prevent leakage of the blood.” Jd. at 5:20-23. In one
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`embodiment, the inner diameter of the guiding catheter is 1.8 mm and the
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`inner diameter of the suction catheter is 1.5 mm. Jd. at 7:55—67 (Table 1).
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`A portion of Figure 6 of Itou is reproduced below:
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`Figure 6 illustrates the disclosed apparatus disposed in a coronary
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`artery of the heart. 7d. at 3:1-3. In Figure 6, guiding catheter | is disposed
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`in aorta 81 andits distal end “is secured in such a form thatit is hooked at an
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`ostium 821 of coronary artery 82.” Jd. at 5:29-34. Tubular portion 24 of
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`suction catheter 2 is inserted into coronary artery 82 and is introduced along
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`guide wire 6 to target location 80. Jd. at 5:35-38. According to Itou, tubular
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`portion 24 of suction catheter 2 has a “sufficient axial length so that the
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`proximal end ofthe tubular portion 24 in an open state maynotleap out
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`from the distal end of the guiding catheter 1.” Jd. at 5:38-41.
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`b) Discussion
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`Petitioner contends that Itou teaches each of the limitations of claims
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`48, 51, and 53. To support its position, Petitioner directs our attention to the
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`foregoing discourses of Itou and providesa detailed claim analysis
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`addressing how each element of claims 48, 51, and 53 is disclosed byItou.
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`Pet. 21-45 (citing generally Exs. 1405 and 1442).
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`Patent Ownerdisagrees. Prelim. Resp. 33-40. Claims 48, 51, and 53
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`each require, inter alia, a “guide extension catheter” including a “tubular
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`structure” where “the side opening and the lumen ofthe tubular structure
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`[are] configured to receive one or morestents or balloon catheters” whenthe
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`side opening and proximalendofthe tubular structure are within the guide
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`catheter and the distal end of the guide extension catheter extends beyond
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`the guide catheter. Ex. 1601, claims 48, 51, 53. Patent Owner contends that
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`Petitioner has not established that “Itou’s suction catheter is a guide
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`extension catheter or has a side opening and lumeninherently(i.e.
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`necessarily) configured to receive one or morestents or balloon catheters.”
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`Prelim. Resp. 35 (citing Ex. 2042 9{ 39-48). Rather, according to Patent
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`Owner,
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`Itou discloses a very different device from what is claimed. Itou
`discloses a suction (or aspiration) catheter, designed to suck
`blood clots and the like out of blood vessels in a distal-to-
`proximal direction. E.g., Ex. 1607 at Abstract. It is indisputable
`that Itou does notstate that its suction catheter can be used as a
`guide extension catheter, or that its suction catheter has a side
`opening and lumen configured to receive one or more stents or
`balloon catheters
`(which happens
`in a _proximal-to-distal
`direction).
`
`Id. at 34.
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