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`Paper
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`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,
`
`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.
`
`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 106)
`37 CFR. $ 42.64(c)
`
`PUBLIC VERSION
`
`
`
`Trials@uspto.gov
`$71-272-7822
`
`Paper
`
`Date:
`
`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.
`
`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 106)
`37 CFR. $ 42.64(c)
`
`PUBLIC VERSION
`
`
`
`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
`
`Medical Devices S.A.R.L. (“Patent Owner”)! filed a Preliminary Response.
`
`Paper 10 (“Prelim. Resp.”). Upon review of the Petition and Preliminary
`
`Response, we instituted an inter partes review ofall claims on all grounds
`
`asserted in the Petition (Paper 20).
`
`Patent Ownersubsequently filed a Patent Owner Response (Paper 40,
`
`“PO Resp.”) (redacted version available at Paper 41), Petitionerfiled a
`
`Reply (Paper 79) (redacted version available at Paper 80), and Patent Owner
`
`filed a Sur-Reply (Paper 98) (redacted version available at Paper 99).
`
`With prior authorization of the Board, Patent Ownerfiled a
`
`Consolidated Response Addressing Conception and Reduction to Practice
`
`(Paper 36, “PO CRTP Resp.”), to which Petitioner filed a Reply (Paper75,
`
`“Pet. CRTP Reply”) (redacted version available at Paper 76), Patent Owner
`
`filed a Sur-Reply (Paper 93, “PO CRTP Sur-Reply”), and Petitionerfiled a
`
`Sur-Sur-Reply (Paper 107, “Pet. CRTP Sur-Sur-Reply”).
`Patent Owneralso filed a Contingent Motion to Amend. Paper 35.”
`
`The Motion requests that if any of issued claims 37, 38, 39, 48, or 51 of the
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`°760 patent are determined to be unpatentable, they should be replaced by
`
`proposed substitute claims 54-58. Jd. at 1. Petitioner filed an Opposition to
`
`' Patent Ownerrepresents that “Teleflex Innovations $.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.
`? Patent Ownerfiled a consolidated motion to amend addressing claims of
`the ’760 patent challenged in both IPR2020-00132 and IPR2020-00134.
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`the Motion to Amend(Paper82), to which Patent Ownerfiled a Reply
`| (Paper 101), and Petitioner filed a Sur-reply (Paper 109).
`An oral hearing was held on March8, 2021, and a transcript of the
`
`hearing is included in the record. Paper 121 (“Tr.”) (redacted version
`
`available at Paper 120).
`
`A. Real Parties in Interest
`
`Petitioner identifies its real parties-in-interest as Medtronic, Inc. and
`
`Medtronic Vascular, Inc., and notes that “Medtronicplc is the ultimate
`
`parent of both entities.” Pet. 5.
`
`Patent Owneridentifies its real parties-in-interest as Teleflex Medical
`
`Devices S.A.R.L.; Vascular Solutions LLC; Arrow International, Inc.; and
`
`Teleflex LLC. Paper 4, 2. Patent Owneralso notes that “Teleflex
`
`Incorporated is the ultimate parent of the entities listed above.” Jd.
`
`B. Related Matters
`
`The parties indicate that the ’760 patent is the subjectoflitigation in
`
`Vascular Solutions LLC v. Medtronic, Inc., 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. S—6;
`
`Paper4,2.
`
`The ’760 patentis a reissue of U.S. Pat. No. 8,292,850 (“the °850
`
`patent). The ’850 patent was the subject of two previous inter partes
`
`reviews: IPR2014-00762, filed May 16, 2014 and terminated August 11,
`
`2014 by way of a joint motion to terminate, and IPR2014-00763, filed May
`
`16, 2014 and terminated August 11, 2014 by wayof a joint motion to
`
`terminate. Pet. 6; Paper 4, 2-3. The ’850 patent wasalso at issue in the U.S.
`
`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.
`
`Petitioner also challenged the ’760 patent in IPR2020-00132 and
`
`IPR2020-00133. Paper 4, 2-3; Pet. 5.
`
`C. The ’760 Patent
`
`1. Specification
`
`The subject matter claimedin the ’760 patent is directed to a device
`
`for use with a standard guide catheter. Ex. 1601, 13:36—-17:13. Figures 1
`
`and 5 of the ’760 patent, reproduced below,depict a coaxial guide catheter
`
`and a tapered innercatheter.
`
`Fig. 7
`
`
`
`Figure 1 of the ’760 patent
`
`Fig. 5
`
`“——— 50
`
`Figure 5 of the ’760 patent
`
`As shownin Figures 1 and 5, above, coaxial guide catheter assembly
`
`10 includes coaxial guide catheter 12 and tapered inner catheter 14. Jd. at
`
`6:37-39. Coaxial guide catheter 12 generally includestip portion 16,
`
`reinforced portion 18, and rigid portion 20.
`
`/d. 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
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`band 24 is formed of a radiopaque material such as platinum/iridium alloy.
`
`Id. at 6:49-50. Tapered inner catheter tip 42 includes tapered portion 46 at a
`
`distal end thereof, and straight portion 48. Jd. at 7:22—23. Both tapered
`
`portion 46 and straight portion 48 are pierced by lumen 50. /d. at 7:23-24.
`
`Tapered inner catheter 14 mayalso include clip 54 at a proximal end thereof
`
`to releasably join tapered inner catheter 14 to coaxial guide catheter 12. Jd.
`
`at 7:27-29. Thus, tapered inner catheter 14 is keyed to coaxial guide
`
`catheter 12. Id. at 7:29-30.
`
`2. Illustrative Claim
`
`Independentclaim 48, reproducedbelow,isillustrative of the
`
`challenged claims.
`
`48. A system, comprising:
`
`a guide catheter configured to be advanceable through a main
`blood vessel to a position adjacent an ostium of a coronaryartery,
`the guide catheter having a lumen extending from a hemostatic valve
`at a proximal end ofthe 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
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`of the lumen of the guide catheter and having a uniform cross-
`sectional
`inner diameter that
`is not more than one French size
`smaller than the cross-sectional inner diameter of the lumen of the
`guide catheter, the side opening extending/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 lumenofthe tubular
`structure configured to receive one or more stents or balloon
`catheters when the segment defining the side opening and a
`proximal end portion of the tubular structure are positioned within
`the lumen of the guide catheter and the distal end of the guide
`extension catheter extends beyond the distal end of the guide
`catheter;
`
`wherein the segment defining the side opening comprises a
`portion ofthe guide extension catheter that is more rigid than a distal
`end portion of the tubularstructure.
`
`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’”’).
`
`Ex. 1610, Saeko Takahashi, et al., New Method to Increase a Backup
`Support ofa 6 French Guiding Coronary Catheter, Catheterization
`and Cardiovascular Interventions 63:452-456 (2004) (“Takahashi”).
`
`In support of its arguments, Petitioner relies on the expert declarations
`
`of Dr. Stephen Jon David Brecker (Exs. 1005, 1806, 1903), Dr. Richard A.
`
`Hillstead (Exs. 1642, 1905), Mr. Michael Jones (Ex. 1807), and Dr. Paul
`
`Zalesky (Exs. 1755, 1830, 1919).
`
`Patent Ownerrelies on the declarations of Mr. Peter T. Keith (Ex.
`
`2042), Ms. Amy Welch (Ex. 2044) (redacted), Ms. Deborah Schmalz
`
`(Ex. 2039), Mr. Howard Root(Ex. 2118), Mr. Gregg Sutton (Ex. 2119), Mr.
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`Mark Goemer(Ex. 2120), Ms. Amanda O’Neil (Ex. 2121), Mr. Steve Erb
`
`(Ex. 2122), Mr. Peter T. Keith (Exs. 2042, 2123, 2124, 2138, 2243), Dr.
`
`John J. Graham (Ex. 2145), Dr. Lorenzo Azzalini (Ex. 2151), Mr. Steve
`
`Jagodzinkski (Ex. 2152 (redacted), 2153 (confidential)), Ms. Heather S.
`
`Rosecrans (Ex. 2205), and Dr. Craig Thompson (Ex. 2215).
`
`E. Asserted Grounds of Unpatentability
`
`Petitioner asserts that claims 48 and 51-53 would have been
`
`unpatentable on the following grounds.
`
`
`
`48, 51-53
`
`103(a)
`
`Ressemann, Takahashi
`
`II.
`
`ANALYSIS
`
`A. Priority Date of the ’760 Patent
`
`The AIA’s first-to-file provisions apply to patent applications“that
`
`contain[] or contained at any time a claim to a claimed invention that has an
`
`effective filing date” on or after March 16, 2013. AIA § 3(n)(1). The
`
`application for reissue for the ’760 patent was filed March 3, 2014 and
`
`3 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 havean effective filing date before the
`effective date of the applicable AIA amendments (March 16, 2013), we refer
`to the pre-AIA versions of 35 U.S.C. §§ 102 and 103 throughoutthis
`Decision.
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`sought reissue of US Patent No. 8,292,850, which issued October 23, 2012
`
`from an application filed January 26, 2012. Ex. 1001, codes (22), (64).
`
`Petitioner contends,
`
`The °760 patent is subject to the AIA first-to-file provisions
`because (1) it contains claims that lack written description, and
`therefore pre-AIApriority, and (2) it claims priority to RE 45,380
`(“the °380 patent”), which is subject to the AJA first-to-file
`provisions. Thus, Patent Owner cannot swearbehindItouin 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. Pet. 14. Thus,
`
`according to Petitioner, the ’760 patent is subject to the AIA’s first-to-file
`
`provisions, which precludes Patent Owner’s from attempting to swear
`
`behind Itou’s filing date. Id.
`
`“The effective filing date for a claimed invention in an application for
`
`reissue or reissued patent shall be determined by deeming the claim to the
`invention to have been contained in the patent for which reissue was
`sought.” 35 U.S.C. § 100(i)(2) (2018). As the “patent for which reissue was
`
`.
`
`sought” in this case was issued October 23, 2012, we are not persuaded that
`
`AIA’s first-to-file provisions apply to the °760 patent. Indeed, Petitioner
`
`provides no legal support for the proposition that a reissue patent may lose
`the filing date of the original patent for which reissue was sought.’
`
`4 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 anIPR. 35 U.S.C.
`§ 311(b).
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`B. Level of Ordinary Skill in the Art
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`Weconsiderthe asserted grounds of unpatentability in view of the
`
`understanding of a person ofordinary skill in the art “CPOSITA”). Petitioner
`
`provides two alternative definitions of a person of ordinary skill in the art.
`
`First, Petitioner asserts that if a person of ordinary skill in the art “was a
`
`medical doctor, s/he would have had (a) a medical degree; (b) completed a
`
`coronary intervention training program, and (c) experience working as an
`
`interventional cardiologist.” Pet. 15. Alternatively, Petitioner asserts that if
`
`a person of ordinary skill in the art was “an engineer s/he would havehad (a)
`
`an undergraduate degree in engineering, such as mechanical or biomedical
`
`engineering; and(b)at least three years of experience designing medical
`
`devices, including catheters or catheter-deployable devices.” Jd.
`
`Additionally, Petitioner contends that “[e]xtensive experience and technical
`
`training might substitute for education, and advanced degrees might
`
`substitute for experience.” Jd.
`
`Patent Owner“does not dispute Petitioner’s proposed definition of a
`
`POSITA.” PO Resp.9.
`
`Uponreview ofthe parties’ arguments and supporting evidence, we
`
`adopt Petitioner’s definitions for a person of ordinary skill in the art, which
`
`allow the ordinarily skilled artisan to be either a medical doctor or an
`
`engineer, as they are undisputed and consistent with the level of skill
`
`reflected in the prior art and the written description of the ’760 patent. See
`
`Okajima vy. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art
`
`itself can reflect the appropriate level of ordinary skill in theart).
`
`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.
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`282(b).” 37 C.F.R. § 42.100(b) (2019). This standard requires that we
`
`construe a claim “in accordance with the ordinary and customary meaning of
`
`such claim as understood byoneofordinary skill in the art and the
`
`prosecution history pertaining to the patent.” Id.
`
`Uponreview ofthe parties’ arguments and supporting evidence, we
`
`determine that it is not necessary to construe any claim termsto resolve the
`
`disputed issues for purposes of this Final Written Decision. See Vivid
`
`Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)
`
`(holding that “only those terms need to be construed that are in controversy,
`
`and only to the extent necessary to resolve the controversy’’).
`
`D. Challenges Based on Itou
`
`Petitioner contends: i) claims 48, 51, and 53 are anticipated by Itou
`
`(Pet. 18-45); ii) claims 48, 51, and 53 would have been obviousoverthe
`
`combination of Itou and Ressemann(id. at 45-54); andiii) claim 52 would
`
`have been obviousoverItou (id. at 54-56).
`
`Critical to its grounds based on Itou, Petitioner contendsItouis prior
`
`art under 35 U.S.C. § 102(e). Pet. 19. Patent Owner contendsItou is not
`
`prior art to the 760 patent because the invention set forth in the challenged
`
`claims was conceived and reducedto practice prior to the effective filing
`
`date of Itou. PO CRTP Resp. 1. Theparties filed consolidated briefing to
`
`address those issues in IPR2020-00126, -00128, -00129, -00132,-
`
`00134, -00135, and -00137 and present the same arguments and evidence for
`
`each proceeding. The primary argumentraised by Petitioner is that Patent
`
`Owner’s core conception documents do not disclose the “side opening”
`
`feature recited in numerous challenged claims. Pet. CRTP Reply 5-7.
`
`Petitioner does not identify specifically which limitation of the ’760 patent
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`claims constitute the “side opening” limitation. However, according to
`Petitioner’s table in its CRTP Sur-Sur-Reply, the side-opening limitation
`appears in the following claims: claims 3 and 4 of the ’032 patent; claims 3,
`
`4, 36 of the ’380 patent; claims 25, 52, and 53 of the ’776 patent; and claims
`
`25, 48, 51, and 53 of the ’760 patent. Pet. CRTP Sur-Sur-Reply 14-15.
`
`Thus, the parties do not present distinct arguments with respect to
`
`challenged claims 48, 51, 52, and 53 (challenged in this proceeding) versus
`
`claims 25-42, 44, and 47 (challenged in IPR2020-00132) of the ’760 patent.
`
`Furthermore,in its consolidated briefs, Patent Owner persuasively
`
`demonstrates that its evidence of conception and reduction to practice
`
`applies to challenged claims 48, 51, 52, and 53 of the ’760 patent. Ex. 2118,
`
`Appx. B (pages 143-158); PO CRTP Resp. 3-29. Accordingly, for the
`
`reasonsset forth in IPR2020-00132, Paper 125, we find that Itou is not prior
`
`art to claims 48, 51, 52, and 53 of the ’760 patent, and that Petitioner has not
`
`demonstrated by a preponderanceof the evidencethat claims 48, 51, 52, and
`
`53 are unpatentable over the Itou-based grounds.
`
`E. Obviousness of Claims 48, 51, 52, and 53 over the Combination of
`Ressemann and Takahashi
`
`Petitioner asserts that claims 48, 51, 52, and 53 are unpatentable under
`
`35 U.S.C. § 103(a) as obvious over Ressemann and Takahashi. Pet. 56-86.
`
`For the reasons set forth below, we determine that Petitioner has not
`
`established by a preponderance of evidence that claims 48, 51, 52, and 53
`
`would have been obvious over the combination of Ressemann and
`
`Takahashi.
`
`a) Summary ofRessemann (Ex. 1608)
`
`Ressemannis directed to an apparatus “used to prevent the
`
`introduction of emboli into the bloodstream during and after surgery
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`performed to reduce or remove blockage in blood vessels.” Ex. 1608, 1:13-—
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`16. Figures 1A and 1B of Ressemann,reproducedbelow,illustrate a first
`
`embodimentof a “system and method for evacuating emboli, particulate
`
`matter, and other debris from a blood vessel.” Id. at 5:65—68.
`
`
`
`FIO. 1A
`
`Figure 1A is a cross-sectional view ofa partial length evacuation sheath
`
`assembly 100. /d. at 3:16—18. “Evacuation sheath assembly 100 includes an
`
`evacuation head and a shaft.” Jd. at 6:19-20. “Evacuation head 132
`
`includes a multi-lumen tube 138.” Jd. at 6:35-36. Evacuation sheath
`
`assembly 100 “‘is sized to fit inside a guide catheter to advancea distal end
`
`of the evacuation sheath assembly into a blood vesselto treat a stenosis.” Jd.
`
`at 6:20—24. Evacuation head 132 includes multi-lumen tube 138, which
`
`preferably is made ofa relatively flexible polymer, as well as evacuation
`
`lumen 140 and inflation lumen 142. Id. at 6:35-64. Evacuation lumen 140
`
`is preferably larger than inflation lumen 142 and is designed to allow for
`
`fluid flow and also “the passage of interventional devices such as, but not
`
`limited to, stent delivery systems and angioplasty catheters.” Jd. at 6:44—47.
`
`Proximal and distal ends of evacuation lumen 140 are angled to allow for
`
`smoother passage of evacuation sheath assembly 100 through a guide
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`catheter and to facilitate smoother passage of other therapeutic devices
`
`through evacuation lumen 140. Jd. at 6:52-57. “The larger area of the
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`angled open endsalso allowsfor larger deformable particulate matter to pass
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`through the lumen more smoothly.” Jd. at 6:58-60.
`
`Figure 1B, reproduced below,is a cross-sectional view ofthe partial
`
`length evacuation sheath of Figure 1A, taken along line 1B—1B. Jd. at 3:19-
`
`20. Figure 1B showsinflation lumen 142, and a “second andpreferably
`
`smaller lumen of the multi-lumen tube 138.” Jd. at 6:61-62.
`
`
`
`
`
`
`\)
`NS
`(2
`mY
`SS
`r
`NeePeery
`ttie>
`SEES
`
`FIG, $8
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`Inflation lumen 142, having open proximal end 142a and closed distal
`
`end 142b, is designed to provide fluid to inflate balloons on evacuation head
`
`132. Id. at 6:61-64. Evacuation sheath assembly 100 has a shaft that
`
`includes proximal shaft portion 110, intermediate shaft portion 120, and
`
`distal shaft portion 130 (not shown in Figure 1A). Jd. at 10:30-35. Stiffness
`
`transition member135 is attached to the distal end of proximal shaft portion
`
`110, “is located co-axially in the inflation lumen 142,” and extendsto soft
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`tip 144. Jd. at 11:30-39.
`
`In use, a guiding catheter is directed to a blood vessel and then a
`
`coronary guide wire is advanced to a location just proximalto the distal tip
`
`of the guiding catheter.
`
`/d. at 12:9-14. Evacuation sheath assembly 100is
`
`then advanced overthe guide wire and positioned within the blood vessel,
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`and then evacuation head 132 is positioned with its distal end within the
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`blood vessel while its proximal end remains in the guiding catheter. Jd. at
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`12:19-21, 12:37-39. Sealing balloons 136 and 134 are then inflated to
`
`providea fluid seal between the sealing balloons and the blood vessel. Jd. at
`
`12:40-45.
`
`As shownin Figure 6D, reproduced below, the guidewire may then be
`
`advanced beyonda stenosis in the blood vessel.
`
`Figure 6D is a cross-sectional view ofthe partial length evacuation sheath of
`
`Figures 1A and 1B deployed within a blood vessel. Jd. at 3:59-61. As
`
`shownin Figure 6D,in this configuration, the guide wire 170 may be
`
`advanced beyond stenosis 180 and then a therapeutic device, such as a stent,
`
`advanced over guide wire 170 and acrossstenosis 180. Jd. at 13:15-—20,
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`13:57-60. As indicated by arrows 195, blood flow within the blood vesselis
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`directed towards evacuation sheath 100.
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`/d. at 13:35-41. Accordingto
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`Ressemann,“[t]his retrograde flow will carry any dislodged material out of
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`the patient and into a collection chamber.” Jd. at 13:43-44.
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`IPR2020-00134
`Patent RE45,760 E
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`Ressemann discloses another embodiment where the “multi-lumen
`tube forming the evacuation head mayinclude three lumens,” illustrated in
`Figures 16A—16J. Jd. at 22:29-33. Figure 16A, reproduced below,is side
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`view ofa full-length evacuation sheath assembly 2100. Jd. at 5:21-23.
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`
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`Figure 16A also shows evacuation head 2132, which includes a multi-lumen
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`tube 2138. Jd. at 22:32-33. “The evacuation head includes two expandable
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`sealing surfaces on a multi-lumen tube.” Jd. at 22:40-41. Evacuation sheath
`assembly 2100 that includes a shaft, which includes two sections, a proximal
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`shaft portion 2110 and an intermediate shaft portion 2120, each having
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`distinct diameters. Id. at 27:22-36. “The proximal shaft portion 2110
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`provides fluid communication betweenan inflation apparatus (see FIG. 161)
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`and the intermediate shaft portion 2120.” Jd. at 27:37-38. “The
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`intermediate shaft portion 2120 includes a tapered metallic core wire 2135
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`inside a polymertube 2122, as shown in FIG. 16C.” Jd. at 27:51-53.
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`“(T]he evacuation head 2132 mayincludea structure to reinforce the
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`proximal opening of the multi-lumen tube 2138,” shown in Figure 16A. Id.
`at 24:47-49. Figures 16D and 16]illustrate the structure to reinforce the
`proximal opening of multi-lumen tube 2138. Jd. Figure 16D, reproduced
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`below, is an enlarged cross-sectional side view of the proximal end of an
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`evacuation sheath assembly 2100 and showsthe placement of support collar
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`2141. Id. at 5:29-31.
`2141 used in evacuation sheath assembly 2100. Jd. at 5:46—47.
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`Fra. IUD
`Figure 16J, reproduced below,is an isometric view of support collar
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`Patent RE45,760 E
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`Support collar 2141 is positioned about the proximal end of multi-lumen
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`tube 2138 and servesto reinforce the proximal opening of evacuation lumen
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`2140 “in the presence of deforming forces, particularly torsional stresses that
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`maybecreated unintentionally by rotation of the catheter shaft nearits
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`proximal end.” Id. at 24:49-55. Support collar 2141 includes cylindrical
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`portion 2141 a that fits into the proximal opening of evacuation lumen 2140.
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`Id. at 24:55-58. Preferably, support collar 2141 is fabricated from a thin
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`walled metallic tube with a series of windows 2141 c that “allow for some
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`flexibility and also allow for better adhesion of the encapsulation material
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`2133, which covers the support collar 2141, while the cylindrical portion
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`2141 a maintains hoop support to the proximal opening of the evacuation
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`lumen 2140.” Jd. at 25:1—8 (emphasis added).
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`Additionally, support collar cylindrical portion 2141 a tapers into tab
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`portion 2141 6 that extends proximally andin a direction parallel to a
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`longitudinal axis of evacuation lumen 2140 to provide a flexibility transition
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`between the proximal end of evacuation head 2131 and the shaft of
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`evacuation sheath assembly 2100. Jd. at 24:58-67. To facilitate attachment
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`between evacuation head 2132 and intermediate shaft portion 2120, a distal
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`portion of polymer tube 2122 is flared and flattened by heating with an
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`appropriately formed mandrel. Jd. at 27:59-63. “This flared section is
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`overlapped overthe walls of the multi-lumen tube 2138, which define the
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`core wire lumen 2143 and the inflation lumen 2142, as well as over the tab
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`portion 2141 5 of the support collar 2141.” Jd. at 27:63-67.
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`Figure 16E, reproduced below,is a cross-sectional view of the
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`evacuation sheath assembly 2100 and showscore wire lumen 2143 and
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`inflation lumen 2142. Jd. at 5:32—33, 23:41-52.
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`b) Summary of Takahashi (Ex. 1610)
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`Takahashiis a journalarticle entitled “New Method to Increase a
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`Backup Support of a 6 French Guiding Coronary Catheter.” Ex. 1610. It
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`bears a copyright date of 2004. Jd. at 5. Takahashi discloses a “five-in-six”
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`system wherein a 5 French guiding catheter is inserted into a 6 French
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`guiding catheter to provide increased backup support. Jd. at 452. In this
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`system, the 5 French catheter is 120 cm in length, whereas the 6 French
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`catheter is 100 cm in length. Jd. According to Takahashi, the soft end
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`portion of the 5 French catheter“can easily negotiate the tortuous coronary
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`artery with minimal damageandthenit can be inserted more deeply into the
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`artery.” Id.
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`c) Discussion
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`Petitioner contends that claims 48, 51, 52, and 53 are would have been
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`obvious over the combination of Ressemann and Takahashi. Pet. 56-86. In
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`support of its contention, Petitioner provides a detailed discussion that
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`identifies where it contends every limitation of claims 48, 51, 52, and 53 is
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`disclosed by the combination of Ressemann and Takahashi. Jd.
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`Petitioner contends that one of ordinary skill in the art would have
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`sought to remove Ressemann’s sealing balloons andinflation lumen and
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`replace the inflation lumen with a solid pushrod or wire, to allow Ressemann
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`to be used as an extension catheter. Pet. 64-67. Petitioner reasons that
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`extension catheters were known in the art, removing the sealing balloons
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`would have simplified the manufacturing process, and removal ofthe sealing
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`balloons would decrease the outer diameter of Ressemann’s assembly 100.
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`Id. at 65.
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`Petitioner contends that reducing the size of the outer diameter of
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`assembly 100 would have been advantageous because the device could then
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`be used with smaller guide catheters. Jd. Petitioner further contends that
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`Takahashi expressly discloses that using a child catheter with a lumen “not
`
`more than one Frenchsize smaller” provides better back-up support for the
`
`guide catheter and assists in deploying an angioplasty catheter across
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`chronic total occlusions. Jd. (citing Ex. 1610, 452, 454, 456; Ex. 1605
`
`4] 220-221).
`Ressemann’sinvention is directed to occluding blood flow for a
`
`minimal amountoftime to capture particulate matter during a procedure.
`
`Ex. 1608, 1:13-16, 2:56-61, 8:12—15 (sealing balloonsare inflated to “form
`
`a seal within the blood vessel”), 12:31-53 (sealing balloons facilitate “fluid
`
`communication betweenthe distal end of the evacuation sheath assembly
`
`100 anda fluid collection chamber,filter, and vacuum source”), 13:15-
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`14:39 (seal formed by inflated balloons allows capturing of “dislodged
`
`material” in the course of positioning and placing stent 194).
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`Petitioner’s extensive proposed modifications to Ressemann’s device require
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`removalofthe sealing balloonsthat are critical to Ressemann’s device and
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`its intended purpose of withdrawing particulate matter through aspiration.
`
`In
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`this case, such an intended-purpose-destroying modification counsels
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`strongly against an obviousness determination. See Polaris Indus. v. Arctic
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`Cat, Inc., 882 F.3d 1056, 1069 (Fed. Cir. 2018) (finding error in the Board’s
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`failure to consider evidence that a proposed combination wouldresult in a
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`modification “which would run contrary to one of [the reference’s] stated
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`purposes”); Plas-Pak Indus. v. Sulzer Mixpac AG, 600 F. App’x 755, 758-59
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`(Fed. Cir. 2015) (finding a proposed modification that would not perform the
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`“specific function” “repeatedly recite[d]” throughout the specification not
`obvious).
`|
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`Petitioner argues in Reply that embolic protection could be provided
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`without aspiration by using a non-occlusive, distal-protection device in
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`Ressemann. Pet. Reply 13 (citing Ex. 1806 J§ 107-110; Ex. 1807
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`119).
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`Petitioner did not makethis argumentin the Petition and the extensive
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`proposed modifications to Ressemann’s device, including adding a non-
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`occlusive, distal-protection device that was not discussedin the Petition,
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`suggest that the proposed modifications are improperly based on a hindsight
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`desire to recreate the inventionsrecited in the challenged claims, and not on
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`a known needin the art for such a device.
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`Accordingly, in view of the above, we determine that Petitioner has
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`not established by a preponderance of evidence that claims 48, 51, 52, and
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`53 would have been obvious over the combination of Ressemann and
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`Takahashi.
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`Il.
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`CONTINGENT MOTION TO AMEND
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`Patent Owner’s Motion to Amend requests that if any of issued claims
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`37, 38, 39, 48, or 51 of the ’760 patent are determined to be unpatentable,
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`the Board substitute those claims with proposed substitute claims 54-58.
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`Paper38, 1.
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`Claims 37, 38, and 39 are not challenged in this proceeding. Pet. 7
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`(setting forth the asserted grounds). 35 U.S.C. § 316(d) does not permit a
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`patent ownerto cancel or propose substitute claims for unchallenged claims.
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`35 U.S.C. § 316(d)(1)(B) (motion to amend may“[f]or each challenged
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`claim, propose a reasonable numberof substitute claims”). Thus, we do not
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`consider proposedsubstitute claims 54—56 that correspond to unchallenged
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`claims 37, 38, and 39, respectively.>
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`Because wedo notfind challenged claims 48 and 51 unpatentable in
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`this proceeding, we do not reach the merits of the Motion to Amend with
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`regard to proposed substitute claims 57 and 58 that correspondto challenged
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`claims 48 and 51, respectively.
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`IV.
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`CONSTITUTIONAL CHALLENGE
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`Patent Ownerargues that the Petition should be denied because“the
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`mannerin which administrative law judges are appointedis
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`unconstitutional.” PO Resp. 49 (citing Arthrex, Inc. v. Smith & Nephew,
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`Inc., 941 F.3d 1320, 1325 (Fed. Cir. 2019)). Patent Ownerfurther argues
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`that the remedy in the Arthrex decision “severing certain removal
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`protections, is insufficient to cure the constitutional defect, because, e.g., it
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`still does not give a properly appointed principle office the powerto review
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`administrative law judge decisions.” Jd. (citing Lucia v. SEC, 138 S. Ct.
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`2044, 2055 (2018)). We decline to consider Patent Owner’s constitutional
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`argument because the Federal Circuit addressed this issue in
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`Arthrex. Arthrex, 941 F.3d at 1328.
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`> Patent Owner’s Motion to Amendwith respect to claims 37, 38, and 39 is
`addressed in IPR2020-00132, a proceeding in which Petitioner challenges
`claims 37, 38, and 39.
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`V. MOTION TO EXCLUDE
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`Petitioner has moved to exclude Exhibit 2024, which is a Product
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`Requirements document dated August 24, 2005. Paper 106. Petitioner
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`contends that Exhibit 2024 is unreliable on its face and that none of Patent
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`Owner’s witnesses can authenticate the document. Jd. at 2-9. Patent Owner
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`respondsthat Exhibit 2024 is authenticated under Federal Rule of Evidence
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`901 based on the declaration and/or deposition testimony of Mr. Peters (Ex.
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`1926 J 18), Ms. Schmalz (Ex. 2039 J§ 6-7), Mr. Root (Ex. 2118 4 54), and
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`Mr. Sutton (Ex. 2119 744). Paper 110.
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`Documentsare authenticated by evidence “sufficient to support a
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`finding that
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