Trials@uspto.gov
`$71-272-7822
`
`Paper 69
`Date: February 23, 2022
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MEDTRONIC, INC. AND MEDTRONIC VASCULAR,INC.,
`Petitioner,
`
`V.
`
`TELEFLEX LIFE SCEINCES LIMITED,
`Patent Owner.
`
`IPR2020-01344
`Patent RE46,116 E
`
`Before SHERIDAN K. SNEDDEN, JAMES A. TARTAL,and
`CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.
`
`SNEDDEN,Administrative Patent Judge.
`
`JUDGMENT
`Final Written Decision
`Determining No Challenged Claims Unpatentable
`35 US.C. § 318(a)
`
`
`$71-272-7822
`
`Paper 69
`Date: February 23, 2022
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MEDTRONIC, INC. AND MEDTRONIC VASCULAR,INC.,
`Petitioner,
`
`V.
`
`TELEFLEX LIFE SCEINCES LIMITED,
`Patent Owner.
`
`IPR2020-01344
`Patent RE46,116 E
`
`Before SHERIDAN K. SNEDDEN, JAMES A. TARTAL,and
`CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.
`
`SNEDDEN,Administrative Patent Judge.
`
`JUDGMENT
`Final Written Decision
`Determining No Challenged Claims Unpatentable
`35 US.C. § 318(a)
`
`
`
`IPR2020-01344
`Patent RE46,116E
`
`I.
`
`INTRODUCTION
`
`Wehavejurisdiction under 35 U.S.C. § 6. Weissue this Final Written
`
`Decision pursuant to 35 U.S.C. § 318(a) and 37 C.F.R. § 42.73 in an inter
`
`partes review involving Medtronic, Inc., and Medtronic Vascular,Inc.
`(“Petitioner”) and Teleflex Life Sciences Limited (“Patent Owner”).' Based
`on the record before us, we conclude that Petitioner has not demonstrated,
`
`by a preponderanceofthe evidence, that claims 25—S5 (“the Challenged
`Claims”) of U.S. Patent No. RE46,116 E (Ex. 1401, “the ’116 patent”) are
`
`unpatentable.
`
`A. Background
`
`Petitionerfiled a Petition requesting an inter partes review of
`
`claims 25—55 of the ‘116 patent. Paper 1 (“Pet.”). Patent Ownerfiled a
`
`Preliminary Response. Paper 7. We determined, based on the information
`
`presented in the Petition and Preliminary Response,that there was a
`
`reasonable likelihood that Petitioner would prevail in showingthatat least
`
`one of the challenged claims was unpatentable overthe cited art. Pursuant
`to 35 U.S.C. § 314, the Boardinstituted trial on February 24, 2021. Paper9.
`
`1 Teleflex Life Sciences Limited (“Teleflex”) filed a notice identifying itself
`as the ownerof U.S. Patent No. 8,142,413 B2. Paper 5, 2. Teleflex further
`explained, “Teleflex Innovations S.A.R.L. merged into Teleflex Medical
`Devices S.A.R.L., and Teleflex Medical Devices S.A.R.L. transferred
`ownership of U.S. Patent No. 8,142,413 to Teleflex Life Sciences Limited.”
`See id. at 2 n.1 (furthering stating that “[t]he assignment documents were
`recorded with the United States Patent & Trademark Office on January 27,
`2020”).
`
`
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`IPR2020-01344
`Patent RE46,116 E
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`Following institution, Patent Ownerfiled a Responseto the Petition
`
`(Paper 21, “PO Resp.”), Petitioner filed a Reply to Patent Owner’s Response
`(Paper37, “Reply”), and Patent Ownerfiled a Sur-reply (Paper 47).
`
`On November18, 2021, the parties presented argumentsat an oral
`
`hearing. The transcript of the hearing has been entered into the record.
`
`Paper68.
`
`A. The *116 patent
`
`0.
`
`BACKGROUND
`
`The °116 patent, titled “Coaxial Guide Catheter for Interventional
`
`Cardiology Procedures,” issued August 23, 2016, from Application
`
`No. 14/195,435, filed March 3, 2014. Ex. 1401, codes (21), (22), (45), (54).
`
`The ’116 patent is a reissue of U.S. Patent No. 8,292,850 (“the ’850 patent”)
`
`from Application No. 13/359,059 (“the ?059 application’) filed on
`
`January 26, 2012, which the ’116 patent states is a continuation of an
`
`application filed on November 1, 2013 (issued as U.S. Patent
`
`No. RE45,380), which is an application for the reissue of U.S. Patent
`
`No. 8,292,850, whichis a division of an application filed on June 28, 2010
`
`(issued as U.S. Patent No. 8,142,413), which is a division of an application
`
`filed on May 3, 2006 (issued as U.S. Patent No. 8,048,032). Jd. codes (60),
`
`(64). The ’116 patent is directed to “methods and apparatus for increasing
`
`backup support for catheters inserted into the coronary arteries from the
`
`aorta.” Id. at 1:38-40.
`
`The ’116 patent explains, as background,thatin “[i]nterventional
`
`cardiology procedures,” guidewires or other instruments, such as balloon
`
`2 Redacted versions of the PO Response and Reply are entered as Papers 22
`and 38, respectively.
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`
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`IPR2020-01344
`Patent RE46,116E
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`catheters and stents, are often inserted through guide catheters into coronary
`
`arteries that branch off from the aorta. Jd. at 1:44—50. In coronary artery
`
`disease, “the coronary arteries may be narrowed or occluded by
`
`atherosclerotic plaques or other lesions” in a phenomenon known as
`| stenosis. Jd. at 1:50—54. In treating the stenosis, “a guide catheteris
`inserted through the aorta and into the ostium of the coronary artery,”
`
`sometimes with the aid of a guidewire, and is passed beyondthe occlusion
`
`or stenosis. Jd. at 1:59-65. However, “[c]rossing tough lesions can create
`
`enough backward force to dislodge the guide catheter from the ostium of the
`
`artery being treated,” which can makeit difficult or impossible for the
`interventional cardiologist to treat certain forms of coronary artery disease.
`
`Id. at 1:66—2:3.
`
`The ’116 patent discusses four categories of previous “attempts to
`
`provide support to the guiding catheter to prevent backward dislodgement
`
`from the coronary ostium (referred to as ‘backup support’).” Jd. at 2:4~7.
`
`One category of guiding catheters “are configured to draw backup support
`
`from engaging the wall of the aortic arch opposing the ostium of the
`
`coronary artery that is being accessed.” Jd. at 2:8-11. A second category
`
`are “guiding catheters that include a retractable appendage. Jd. at 2:25—26.
`
`A third category are “guide catheters that have a portion that seeks to expand
`
`laterally to grip the interior wall of the ostium.” Jd. at 2:36-41. A fourth
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`category, or “technique,” of the prior attempts “includes the placement of a
`
`smaller guide catheter within a larger guide catheter in order to provide
`
`added support for the crossing of lesions or for the distal delivery of balloons
`
`and stents.” Jd. at 2:50-53. The ’116 patent states this fourth technique was
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`Patent RE46,116E
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`described in Takahashi,’ which uses a guide catheter inserted “more deeply
`
`into the ostium of the coronary artery than typically has been done before.”
`
`Id. at 2:53-62. The ’116 patent states that such “deep seating” by this
`
`technique “creates the risk that the relatively stiff, fixed curve, guide catheter
`
`will damage the coronary artery.” Jd. at 2:63-65.
`
`The ’116 patent purports to resolve issues identified with the prior
`
`procedures by using “a coaxial guide catheter that is deliverable through
`
`standard guide catheters by utilizing a guidewire rail segment to permit
`
`delivery without blocking use of the guide catheter.” Ex. 1401, 3:20-23.
`
`According to the ’116 patent, the coaxial guide catheter “preferably includes
`
`a tapered inner catheter that runs over a standard 0.014 inch coronary
`
`guidewire to allow atraumatic placement within the coronary artery,” and
`
`this feature allows removal of the tapered inner catheter after the coaxial
`
`guide catheter is in place. Jd. at 3:23-28.
`
`Figures | and 2, reproduced below, show a coaxial guide catheter and
`
`a tapered inner catheter in accordance with the invention described in
`
`the ’116 patent:
`
`3 Saeko Takahashi,et al., New Method to Increase a Backup Support
`ofa 6 French Guiding Coronary Catheter, 63 CATHETERIZATION AND
`CARDIOVASCULAR INTERVENTIONS 452-456 (2004) (Ex. 1410, “Takahashi’).
`
`5
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`
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`IPR2020-01344
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`Patent RE46,116E
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`Figure 1 is a schematic depiction of the coaxial guide catheter and tapered
`
`inner catheter separately, and Figure 2 depicts those two elements assembled
`
`together. Jd. at 5:51-56; Figs. 1 and 2. As shown above,“coaxial guide
`
`catheter assembly 10”includes coaxial guide catheter 12 and tapered inner
`
`catheter 14. Jd. at 6:42-44. Coaxial guide catheter 12 includestip
`portion 16, reinforced portion 18, and rigid portion 20. Id. at 6:45—-46.
`Tapered inner catheter 14 “includes tapered inner catheter tip 42.” Id.
`
`at 7:26—-27. Tapered inner catheter tip 42 includes tapered portion 46 at a
`
`distal end thereof, and straight portion 48. Jd. at 7:30-31. Both tapered
`
`portion 46 andstraight portion 48 are pierced by lumen 50 (not labeled in
`
`figures above). Jd. at 7:31-32. “Tapered inner catheter 14 mayalso include
`clip 54 at a proximal end thereofto releasably join tapered inner catheter 14
`to coaxial guide catheter 12.” Jd. at 7:35—37. “The tapered inner catheter
`
`provides a gradualtransition from the standard 0.014 inch diameter
`
`guidewire to the diameter of the coaxial guide catheter whichis typically
`
`five to eight French.” Jd. at 3:28-31. The coaxial guide catheter is made in
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`IPR2020-01344
`Patent RE46,116 E
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`at least three sizes corresponding to sizes commonly usedin interventional
`
`cardiology procedures. Jd. at 3:39-42.
`
`Figure 4, reproduced below, showsa coaxial guide catheter in
`accordancewith the invention describedin the °116 patent:
`
`
`
`Figure 4 is a sectional view of the coaxial guide catheter with tip portion 16
`
`depicted on the left side of the figure (rather than on the right side as shown
`
`in Figures 1 and 2). Ex. 1401, 5:60; Fig. 4. As shownabove, coaxial guide
`
`catheter 12 has a rigid portion 20, which “includesfirst full circumference
`
`portion 34, hemicylindrical portion 36, arcuate portion 38, and secondfull
`
`circumference portion 40” (second full circumference portion 40 is shown in
`
`Figure 3). Id. at 7:7-10.
`
`In operation, a guide catheter and a guidewire are used along with the
`
`coaxial guide catheter and the tapered inner catheter. Ex. 1401, 8:20—22.
`
`Figure. 8, reproduced below, showsthe operation of the coaxial guide
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`
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`IPR2020-01344
`Patent RE46,116 E
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`catheter assembly in accordance with the invention described in the ’116
`
`patent:
`
`Figure 8 is a schematic view of a guide catheter and a guide wire in use with
`
`the coaxial guide catheter assembly within the aortic arch and coronary
`
`artery. Id. at 6:5-8; Fig. 8. First, guidewire 64 is inserted and passed
`
`through aortic arch 58 into ostium 60 of coronary artery 62. Jd. at 7:65—66.
`
`Guide catheter 56 is then passed over guidewire 64 until the distal end of
`
`guide catheter 56 is seated in ostium 60. Jd. at 8:4-6. Next, coaxial guide
`
`catheter 12 with tapered inner catheter 14 is passed through guide
`
`catheter 56 and over guidewire 64 into coronary artery 62. Jd. at 8:22-24.
`
`The presenceof coaxial guide catheter 12 within guide catheter 56 “provides
`
`stiffer back up support than guide catheter 56 alone.” Id. at 8:38-40. “Once
`
`the coaxial guide catheter-tapered inner catheter combination has been
`
`inserted sufficiently into the ostium of the coronary artery to achieve deep
`
`seating the tapered inner catheter may be removed.” Jd. at 4:58-62; see also
`
`id. at 8:30-32. Thereafter, coaxial guide catheter 12 can “accept a treatment
`
`
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`IPR2020-01344
`Patent RE46,116 E
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`catheter such as a stent or [a] balloon catheter.” Jd. at 8:33-34. “[T]he
`
`presence of coaxial guide catheter provides additional backup support to
`
`makeit less likely that the coaxial guide catheter guide catheter combination
`
`will be dislodged from the ostium of the coronary artery while directing the
`
`coronary therapeutic device past a tough lesion.” Jd. at 5:2-6. “[T]he
`
`invention is deliverable through an existing hemostatic valve arrangement on
`
`a guide catheter without preventing injections through existing Y adapters.”
`
`Id. at 5:42-44.
`
`B. Illustrative Claim
`
`Petitioner challenges claims 25—55 of the ’116 patent. Pet. 1.
`
`Claims 25, 51, and 52 are independent. Ex. 1401, 13:62—14:25, 15:51—
`
`16:15, 16:53-18:10. Claims 26-42 and 44-50 depend from claim 25 and
`
`claims 53-55 depend from claim 52. Jd. at 14:62-18:26. Claim 25 is
`
`illustrative of the claimed subject matter and is reproduced below.
`
`25. A method, comprising:
`
`[25a] advancing a distal end of a guide catheter having a
`lumen through a main blood vessel to an ostium of a
`coronary artery;
`
`[25b] advancing a distal end of a guide extension catheter
`through, and beyondthe distal end of, the guide catheter,
`
`[25c] including advancinga distal end portion of a tubular
`structure of the guide extension catheter beyondthe distal
`end of the guide catheter while a segment defining a side
`opening ofthe guide extension catheter remains within the
`guide catheter,
`
`[25d] the side opening extending for a distance along a
`longitudinal axis of the guide extension catheter and
`accessible from a longitudinal side defined transverse to
`the longitudinal axis,
`
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`IPR2020-01344
`Patent RE46,116 E
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`[25e] the tubular structure having a cross-sectional inner
`diameterthat is not more than one Frenchsize smaller than
`a cross-sectional inner diameter of the lumen of the guide
`catheter;
`
`[25f] maintaining the distal end portion of the tubular
`structure of the guide extension catheter
`in position
`beyondthedistal end of the guide catheter; and
`
`[25g] while maintaining the distal end of the guide
`extension catheter positioned beyond the distal end ofthe
`guide catheter advancinga balloon catheteror stent at least
`partially through the guide catheter and the guide
`extension catheter and into the coronary artery, including
`advancing the balloon catheter or
`stent
`through a
`hemostatic valve associated with a proximal end of the
`guide catheter, along a substantially rigid segment of the
`guide extension catheter, through the side opening, and
`through the tubularstructure.
`
`Id. at 13:62—14:25.
`
`C. Asserted Grounds of Unpatentability
`
`Petitioner asserts that the Challenged Claims are unpatentable based
`
`on the following grounds:
`
`Claim(s)
`Challenged
`
`
`
`
`
`: f
`
`
`f 42, 44—
`
`
`
`4U.S. Patent No. 5,439,445, issued August 8, 1995 (Ex. 1409, “Kontos”).
`5 U.S. Patent No. 7,604,612 B2, issued October 20, 2009 (Ex. 1408,
`“Ressemann”’).
`6 Takahashi, et al., New Methodto Increase a Backup Support of a 6 French
`Guiding Coronary Catheter, Catheterization and Cardiovascular
`Interventions 63:452-456 (2004) (Ex. 1410) (‘Takahashi’).
`
`10
`
`
`
` 35
`References/Basis
`
`U.S.C.
`§
`
`
`
`
`
`
`
`
`
`Kontos, Ressemann, Takahashi®
`
`
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`IPR2020-01344
`Patent RE46,116 E
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`Ground
`
`3
`
`
`
`
`
`Claim(s)
`35
`
`
`U.S.C.
`Challenged
`§
`
`45
`
`References/Basis
`
`Kontos, Ressemann, Takahashi,
`Kataishi’
`
`Kontos, Ressemann, Takahashi,
`Root
`
`
`
`
`
`Petitioner relies on the supporting Declarations of Dr. Stephen Jon
`
`David Brecker (Ex. 1405, 1806), Dr. Richard A. Hillstead (Ex. 1442),
`
`Mr. Michael Jones (Ex. 1807), Dr. Paul Zalesky (Ex. 1830).
`
`Patent Ownerrelies on the supporting Declarations of Peter Keith
`(with attached Appendix B) (Exs. 2138), Dr. John Graham, MB ChB,
`MRCP(UK)(Ex. 2145); Dr. Lorenzo Azzalini, MD, PhD (Ex. 2151);
`
`Dr. Craig Thompson, MD, MMSc(Ex. 2215), Steve Jagodzinski,Sr.
`
`ManagerFinance, Teleflex Inc. (Ex. 2153).
`
`'D. Related Proceedings
`
`Theparties identify the 116 patent as a subject of: (1) Vascular
`
`Solutions LLC, et al. v. Medtronic, Inc., et al., No. 19-cv-01760 (D. Minn.),
`
`and (2) OXMedical, LLC v. Vascular Solutions, LLC, No. 17-cv-01969
`
`(D. Minn.). Pet. 5; Paper 4, 2. Patent Ownerstates that both of these
`
`district court proceedings are currently stayed. Paper 4, 2. The parties
`
`further state that the ’116 patent is a reissue of the ’850 patent and that the
`
`TUS 2005/0015073 Al, published January 20, 2005 (Ex. 1425, “Kataishi”).
`8 US 2007/0260219 Al, published November8, 2007 (Ex. 1512,“Root”)
`(publication of App. No. 11/416,629 (Ex. 1500), filed May 3, 2006, issued
`as U.S. Patent No. 8,018,032).
`
`1]
`
`
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`IPR2020-01344
`Patent RE46,116 E
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`’850 patent was previously the subject of: (1) Vascular Solutions, Inc. v.
`
`Boston Scientific Corp., No. 13-cv-01172 (D. Minn.), and (2) Boston
`
`Scientific Corp. v. Vascular Solutions, Inc., IPR2014-00762, IPR2014-
`
`00763 (PTAB, terminated). Pet. 5-6.
`
`Petitioner challenges claims 25—40, 42, 44-48, 52, and 53 of the ‘116
`
`patent in IPR2020-01343 through anotherpetition filed concurrently with
`
`the Petition in this case. Pet. 6 Additionally, Petitioner identifies the
`following patents related to the ’116 patent that have been subject of inter .
`partes review proceedingsinitiated by Petitioner: U.S. Patent Nos.
`
`8,048,032 (IPR2020-00126; IPR2020-00127), RE45,830 (IPR2020-00128;
`
`IPR2020-00129; IPR2020-00130), RE45,760 (IPR2020-00132; IPR2020-
`
`00134), RE45,776 (IPR2020-00135; IPR2020-00136), RE47,379 (IPR2020-
`
`00137; IPR2020-00138), and 8,142,413 (IPR2020-01341; IPR2020-01342).
`
`Id.
`
`E. Abbreviations
`
`
`
`
`
`
`
`
`IVCD
`
`PTCA
`
`POSITA
`
`Intervascular Cardiac Device
`
`Percutaneous Transluminal Coronary
`Angioplasty
`
`Person of Ordinary Skill in the Art
`
`
`
`
`
`
`
`
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`
`
`OI. ANALYSIS
`
`A. Level of Ordinary Skill in the Art
`
`In determining whether an invention would have been obviousat the
`
`time it was made, 35 U.S.C. § 103 requires us to resolvethe level of
`
`12
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`ordinary skill in the pertinent art at the time of the invention. Graham,
`
`383 U.S. at 17. The person of ordinary skill in the art is a hypothetical
`
`person whois presumed to have knowntherelevantart at the time of the
`
`invention. In re GPAC,Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995). In
`
`determining the level of ordinary skill in the art, various factors may be
`
`considered, including the “type of problems encounteredin the art; prior art
`
`solutions to those problems; rapidity with which innovations are made;
`
`sophistication of the technology; and educational level of active workers in
`
`the field.” Jd. (citation omitted).
`
`Petitioner contends that a person of ordinary skill in the art at the time
`
`of the invention would have beeneither: (1) a medical doctor who would
`
`have had “(a) a medical degree; (b) completed a coronary intervention
`
`training program, and (c) experience working as an interventional
`
`cardiologist;” or (2) an engineer who “would have had (a) an undergraduate
`
`degree in engineering, such as mechanical or biomedical engineering;
`
`-
`
`and (b) at least three years of experience designing medical devices,
`
`including catheters or catheter-deployable devices.” Pet. 11-12.
`
`Additionally, Petitioner contends “[e]xtensive experience and technical
`
`training might substitute for education, and advanced degrees might
`
`substitute for experience.” Jd. at 12. Further, according to Petitioner,
`
`a person ofordinary skill in the art “with a medical degree” and a person of
`
`ordinary skill in the art “with an engineering degree” may havehadaccessto
`
`each other. Jd. (citing Ex. 1405 § 27; Ex. 1442 7 24-25).
`
`Patent Ownerdoesnot dispute Petitioner’s proposed level of ordinary
`
`skill. PO Resp. 7. We adopt Petitioner’s proposedlevel of ordinary skill in
`
`the art as it is undisputed and consistent with the level of skill reflected in
`
`the prior art and the specification of the “413 patent. See Okajimav.
`
`13
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`IPR2020-01344
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`Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific
`
`findings regarding ordinary skill level are not required “wherethe prior art
`
`itself reflects an appropriate level and a need for testimony is not shown”)
`
`(quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158,
`
`163 (Fed. Cir. 1985)).
`
`Astheir qualifications are undisputed, we also determinethat the
`
`parties’ experts are qualified to opine on the issues in this proceeding from
`
`the perspective of a person of ordinary skill in the art. Ex. 1442 9{ 5, 10, 12
`
`(Dr. Hillstead’s qualifications); Ex. 1807 Ff] 8—10 (Mr. Jones’s
`
`1
`qualifications); Ex. 2138 J{ 3-6 (Mr. Keith’s qualifications); Ex. 2145
`(Dr. Graham’s qualifications); see Kyocera Senco Indus. Tools Ine. v. Int’l
`Trade Comm’n, 22 F.4th 1369 (Fed. Cir. 2022) (“To offer expert testimony
`
`from the perspective of a skilled artisan in a patent case .
`
`.
`
`. a witness must at
`
`least have ordinary skill in the art.”).
`
`B. Claim Construction
`
`“In an inter partes review proceeding, a claim of a patent. .
`
`. shall be
`
`construed 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). That standard “includ[es] construing the claim in
`
`accordance with the ordinary and customary meaning of such claim as
`
`understood by oneofordinary skill in the art and the prosecution history
`
`pertaining to the patent.” Jd.; see also Phillips v. AWH Corp., 415 F.3d 1303
`
`(Fed. Cir. 2005) (en banc).
`
`Petitioner proposes the following constructions: (1) “side opening”
`
`needs no construction and should be givenits plain and ordinary
`
`meaning,(2) “lumen”as“the cavity of a tube,” and (3) “flexural modulus”
`
`14
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`as “[a] measure of resistance... to bending.” Pet. 12-13 (quoting Ex. 1440,
`
`722).
`
`Patent Ownerdoes not dispute Petitioner’s proposed construction of
`these terms. See generally PO Resp.
`
`In view of the issues we address below, we determineit is not
`
`necessary to address the express interpretation of any claim term. See Nidec
`
`Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017
`
`(Fed. Cir. 2017); Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795,
`
`803 (Fed. Cir. 1999) (“{O]nly those terms need be construed that are in
`
`controversy, and only to the extent necessary to resolve the controversy.”).
`
`C. Scope and Content ofthe Prior Art
`
`Petitioner relies on Kontos, Ressemann, Takahashi, Kataishi, and
`
`Root, each of which we briefly summarizein relevant part below.
`
`1. Summary ofKontos (Ex. 1409)
`
`Kontos,titled “Support Catheter Assembly,” is directed to a support
`
`catheter assembly for facilitating medical procedures and,in particular, to a
`
`catheter assembly that has “particular utility in facilitating insertion of a
`
`PTCA?balloon into a lesion.” Ex. 1409, code (54), 1:9-13.
`
`Figure 1 of Kontos is reproduced below:
`
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`° PTCAstandsfor “percutaneous transluminal coronary angioplasty.”
`Ex. 1405 4 37.
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`IPR2020-01344
`Patent RE46,116 E
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`Figure 1 is a side plan view of a support catheter, “cut-away in part to show
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`in longitudinal cross-section a tubular body having a soft tip and radiopaque
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`marker, and a manipulating wire.” Ex. 1409, 2:51-54. As shownin
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`Figure 1, support catheter assembly 10 is composed of two major elements,
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`body 12 and insertion/manipulation wire 14. Jd. at 3:45-46. Body 12,
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`“which may be viewed as a mini guide catheter, includes a tube 16 having a
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`base portion 18 at its proximal end 20.” Id. at 3:47-49. “Tube 16 has a
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`continuous lumen 22 therethrough from proximal end 20 to distal end 24.”
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`Id. at 3:49-50. Body 12 also includesa soft tip 28 disposed at distal end 24
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`and funnel portion 26 disposed at proximal end 20. Jd. at 3:50-52. Wire 14
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`is attached to body 12 at base portion 18. /d. at 3:52-53. Support
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`assembly 10 mayalso include distal marker band 30 and proximal marker
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`band 32. Jd. at 3:53-55.
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`Kontos explains that the size and shape of the various elements of
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`support assembly 10 “may vary depending on the desired application,” but
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`in the applications depicted in Figure 1, tube 16 has a 0.055 inch outer
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`diameter and lumen 22 has a 0.045 inch diameter. Ex. 1409, 4:46—50.
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`According to Kontos, the sizes used in these embodiments “generally are
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`suitable for existing PTCA catheters.” Jd. at 4:61-64.
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`Figure 5 of Kontos is reproduced below:
`46: 28
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`FIG. 5
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`Figure 5 is a side schematic view of a support catheter having a PTCA
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`catheter disposed therein. Ex. 1409, 2:64—66. In this figure, PTCA catheter
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`16
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`IPR2020-01344
`Patent RE46,116E
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`40 andits deflated balloon 48 reside in lumen 22 of support assembly 10.
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`Id. at $:2—-5.
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`Figures 6A—6C of Kontos are reproduced below:
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`Figures 6A—6Care cross-sectional views showing three stages in a process
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`for guiding a PTCAcatheter to a coronary artery lesion. Ex. 1409, 2:67—3:2.
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`In Figure 6A, the PTCA catheter/support catheter assembly is fed into guide
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`catheter 38 and advancedto the distal end of this catheter by exerting axial
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`force on wire 14 and catheter tube 50 simultaneously. Jd. at 5:25—30.
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`In Figure 6B, when the PTCAcatheter/support catheter assembly
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`reachesthe distal end of guide catheter 38, “it may be advancedas a unit out
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`of the distal end of guide catheter 38, into the coronary ostia 39.” Ex. 1409,
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`5:31-35. When extending beyondthe distal end of guide catheter 38,
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`body 12 functions as a guide catheter extension protecting fragile balloon 48
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`and lessening “considerably the tendency of the PTCAcatheter 40 to bend,
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`buckle or kink.” Id. at 5:52-56.
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`IPR2020-01344
`Patent RE46,116 E
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`In Figure 6C, after body 12 has been positioned adjacenttherestricted
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`area, PTCA catheter 40 is advanced so that balloon 48 exits body 12 andis
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`advancedinto the restricted area, e.g., stenosis B. Ex. 1409, 6:9-13.
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`Balloon 48 is then inflated, as represented by dotted lines 48,“to effect a
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`well known angioplasty procedure.” Jd. at 6:13-15. Balloon 48is then
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`deflated and PTCAcatheter 40, support catheter assembly 10, and guiding
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`catheter 38 may be withdrawn. Id. at 6:15-18.
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`2. Summary ofRessemann (Ex. 1408)
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`Ressemann,titled ‘““Emboli Protection Devices and Related Methods
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`of Use,”states that it is directed to an apparatus “used to prevent the
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`introduction of emboli into the bloodstream during and after surgery
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`performed to reduce or remove blockagein blood vessels.” Ex. 1408,
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`code (54), 1:13-16. Figures 1A and 1B of Ressemann are reproduced
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`below:
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`18
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`IPR2020-01344
`Patent RE46,116E
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`
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`FIG. {8
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`Figure 1A is a cross-sectional view ofa partial length evacuation sheath. Jd.
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`at 3:16-18. Figure 1B is a cross-sectional view ofthe partial length
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`evacuation sheath of Figure 1A, taken along line 1B—1B of Figure 1A. Jd.
`at 3:19-20.
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`Figure 1A depicts evacuation sheath assembly 100, which “‘is sized to
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`fit inside a guide catheter” and be advanced “into a blood vesselto treat a
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`stenosis.” Ex. 1408, 6:18—24, Fig. SA. Evacuation sheath assembly 100
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`includes a shaft having proximal shaft portion 110, intermediate shaft
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`portion 120, and distal shaft portion 130 (not shownin Figure 1A). Jd.
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`at 10:30-35. Evacuation head 132 includes multi-lumen tube 138, having
`evacuation lumen 140 andinflation lumen 142, andis preferably made of a
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`relatively flexible polymer. Jd. at 6:35-64. Evacuation lumen 140is
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`preferably larger than inflation lumen 142 and “is designed to allow for the
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`passage of interventional devices such as, but not limited to, stent delivery
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`systems and angioplasty catheters.” Id. at 6:44—47. Proximal anddistal
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`ends of evacuation lumen 140 are angled to allow for smoother passage of
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`evacuation sheath assembly 100 through a guide catheter andto facilitate
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`smoother passage of other therapeutic devices through evacuation
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`lumen 140. Jd. at 6:52-57. According to Ressemann,“[t]he larger area of
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`19
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`IPR2020-01344
`Patent RE46,116E
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`the angled open endsalso allowsfor larger deformable particulate matter to
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`pass through the lumen more smoothly.” Jd. at 6:58—60.
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`Stiffness transition member 135 is attached to the distal end of
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`proximal shaft portion 110, “is located co-axially in the inflation
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`lumen 142,” and extendsto soft tip 144. Ex. 1408, 11:30-39. Inflation
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`lumen 142, having open proximal end 142a and closed distal end 142b,is
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`designed to providefluid to inflate balloons on evacuation head 132. Id.
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`at 6:61-64.
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`In use, a guiding catheter is directed to a blood vessel, and then a
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`coronary guide wire is advanced to a location just proximalto the distal tip
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`of the guiding catheter. Ex. 1408, 12:9-14. Evacuation sheath
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`assembly 100 is then advancedoverthe guide wire and positioned within the
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`blood vessel. Jd. at 12:19-21. In this process, evacuation head 132 is
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`positioned with its distal end within the blood vessel while its proximal end
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`remains in the guiding catheter. /d. at 12:37—39. Sealing balloons 136
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`and 134 are then inflated to provide a fluid seal between the sealing balloons
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`and the blood vessel. Jd. at 12:40-45.
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`Figure 6D of Ressemannis reproduced below:
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`20
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`IPR2020-01344
`Patent RE46,116 E
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`Figure 6D is a cross-sectional view of the partial length evacuation sheath of
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`Figures 1A and 1B deployed within a blood vessel. Ex. 1408, 3:59-61. As
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`shownin Figure 6D, guidewire 170 may be advanced beyondstenosis 180 in
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`blood vessel 150. Jd. at 13:3-16. A therapeutic device, such as a stent, may
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`then be advanced over guide wire 170 and across stenosis 180. Jd. at 13:57-
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`60. As indicated by arrows 195, blood flow within the blood vesselis
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`directed towards evacuation sheath 100. /d. at 13:35-41. According to
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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. The assembly,
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`which includes a guide catheter, “may be positioned within the ostium of the
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`target vessel.” Id. at 12:26—27.
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`3. Summary of Takahashi (Ex. 1410)
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`Takahashi,titled “New Methodto Increase a Backup Support of a 6
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`French Guiding Coronary Catheter,” discusses the use of a guiding catheter
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`in percutaneous coronary intervention (PCI). See generally Ex. 1410.
`Takahashidiscloses a “five-in-six” system wherein a 5 French guiding
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`catheter is inserted into a 6 French guiding catheter to provide increased
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`backup support. Jd. at 452. In this system, the 5 French catheter is 120 cm
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`in length, whereas the 6 French catheter is 100 cm in length. Jd. According
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`to Takahashi, the soft end portion of the 5 French catheter “can easily
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`negotiate the tortuous coronary artery with the minimal damage and thenit
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`can be inserted more deeply into the artery.” Jd.
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`4. Summary ofKataishi (Ex. 1425)
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`Kataishi, titled ““Thrombus Suction Catheter with Improved Suction
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`and Crossing,” teaches ‘“‘a thrombussuction catheter with improvedsuction
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`and crossing having a small pressure loss, which is a tube having a lumen
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`21
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`IPR2020-01344
`Patent RE46,116 E
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`passing through from a proximal endto a distal end, a distal end opening
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`having an angled cut surface.” Ex. 1425, code (54), 9 10. Figure 1 of
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`Kataishi, reproduced below,is a front view of a thrombus suction catheter.
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`Fig.
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`1
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`As shownin Figure 1, a thrombussuction catheter includes a catheter
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`body 1, a connector 2 provided at a proximalend ofthe catheter body 1, a
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`distal end opening 12 formed by an angledcut surface, and a guide wire
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`insertion port 13. Jd. J] 27, 29.
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`5. Summary ofRoot (Ex. 1512)
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`The disclosure of Root, titled “Coaxial Guide Catheter for
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`Interventional Cardiology Procedures,” is substantially similar and related to
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`the ?116 patent. Compare Ex. 1512 to Ex. 1401. Root relates generally to a
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`coaxial guide catheter for use with interventional cardiology devicesthat are
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`insertable into a branch artery that branches off from a main artery.
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`Ex. 1512, code (54), Abstract.
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`Rootdiscloses that interventional cardiology procedures often include
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`inserting guidewires or other instruments through catheters into coronary
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`arteries that branch offfrom the aorta. Jd. § 2. In coronary artery disease,
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`the coronary arteries may be narrowed or occludedby atherosclerotic
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`plaquesor other lesions in a phenomenon knownas stenosis. Jd. In treating
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`the stenosis, a guide catheter is inserted through the aorta and into the ostium
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`22
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`IPR2020-01344
`Patent RE46,116 E
`
`of the coronary artery, sometimes with the aid of a guidewire, and is passed
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`beyondthe occlusion or stenosis. Jd. § 3. However, crossing tough lesions
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`can create enough backward force to dislodge the guide catheter from the
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`ostium ofthe artery being treated, which can makeit difficult or impossible
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`for the interventional cardiologist to treat certain forms of coronary artery
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`disease. Id.
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`To solve this problem, Root describes a coaxial guide catheterthat is
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`deliverable through standard guidewires by utilizing a guidewire rail
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`segment to permit delivery without blocking use of the guide catheter.
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`Ex. 1512911. Root teaches that the coaxial guide catheter preferably
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`includes a tapered inner catheter that runs over a standard 0.014 inch
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`coronary guidewire to allow atraumatic placement within the coronary
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`artery, and this feature allows removalof the tapered inner catheter after the
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`coaxial guide catheter is in place. Jd.
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`Figures | and 2, reproduced below, show a coaxial guide catheter and
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`a tapered innercatheter:
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`Fig 2
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`23
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`IPR2020-01344
`Patent RE46,116 E
`
`Figure 1 is a schematic depiction of the coaxial guide catheter and tapered
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`inner catheter separately, and Figure 2 depicts those two elements assembled
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`together. Ex. 1512, J§ 28-29; Figs. 1 and 2. As shown above, coaxial guide
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`catheter assembly 10 includes coaxial guide catheter 12 and tapered inner
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`catheter 14. Jd. § 50. Coaxial guide catheter 12 includestip portion 16,
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`reinforced portion 18, and rigid portion 20. Jd. 451. Tip portion 16
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`generally includes bumptip 22 and marker band 24. Id. 452. Bumptip 22
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`includes taper 26 andis relatively flexibl
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