`571-272-7822
`
`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 U.S.C. § 318(a)
`
`
`
`
`
`IPR2020-01344
`Patent RE46,116 E
`
`I.
`INTRODUCTION
`We have jurisdiction under 35 U.S.C. § 6. We issue 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”).1 Based
`on the record before us, we conclude that Petitioner has not demonstrated,
`by a preponderance of the evidence, that claims 25–55 (“the Challenged
`Claims”) of U.S. Patent No. RE46,116 E (Ex. 1401, “the ’116 patent”) are
`unpatentable.
`
`A. Background
`Petitioner filed a Petition requesting an inter partes review of
`claims 25–55 of the ‘116 patent. Paper 1 (“Pet.”). Patent Owner filed 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 showing that at least
`one of the challenged claims was unpatentable over the cited art. Pursuant
`to 35 U.S.C. § 314, the Board instituted trial on February 24, 2021. Paper 9.
`
`
`1 Teleflex Life Sciences Limited (“Teleflex”) filed a notice identifying itself
`as the owner of 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”).
`
`2
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`IPR2020-01344
`Patent RE46,116 E
`Following institution, Patent Owner filed a Response to the Petition
`(Paper 21, “PO Resp.”), Petitioner filed a Reply to Patent Owner’s Response
`(Paper 37, “Reply”), and Patent Owner filed a Sur-reply (Paper 47).2
`On November 18, 2021, the parties presented arguments at an oral
`hearing. The transcript of the hearing has been entered into the record.
`Paper 68.
`
`II.
`
`BACKGROUND
`
`A. The ’116 patent
`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, which is 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). Id. 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, that in “[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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`3
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`catheters and stents, are often inserted through guide catheters into coronary
`arteries that branch off from the aorta. Id. 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. Id. at 1:50–54. In treating the stenosis, “a guide catheter is
`inserted through the aorta and into the ostium of the coronary artery,”
`sometimes with the aid of a guidewire, and is passed beyond the occlusion
`or stenosis. Id. 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 make it 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’).” Id. 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.” Id. at 2:8–11. A second category
`are “guiding catheters that include a retractable appendage. Id. 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.” Id. at 2:36–41. A fourth
`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.” Id. at 2:50–53. The ’116 patent states this fourth technique was
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`IPR2020-01344
`Patent RE46,116 E
`described in Takahashi,3 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.” Id. 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. Id. at 3:23–28.
`Figures 1 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
`of a 6 French Guiding Coronary Catheter, 63 CATHETERIZATION AND
`CARDIOVASCULAR INTERVENTIONS 452–456 (2004) (Ex. 1410, “Takahashi”).
`
`5
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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. Id. 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. Id. at 6:42–44. Coaxial guide catheter 12 includes tip
`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. Id. at 7:30–31. Both tapered
`portion 46 and straight portion 48 are pierced by lumen 50 (not labeled in
`figures above). Id. at 7:31–32. “Tapered inner catheter 14 may also include
`clip 54 at a proximal end thereof to releasably join tapered inner catheter 14
`to coaxial guide catheter 12.” Id. at 7:35–37. “The tapered inner catheter
`provides a gradual transition from the standard 0.014 inch diameter
`guidewire to the diameter of the coaxial guide catheter which is typically
`five to eight French.” Id. at 3:28–31. The coaxial guide catheter is made in
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`IPR2020-01344
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`at least three sizes corresponding to sizes commonly used in interventional
`cardiology procedures. Id. at 3:39–42.
`Figure 4, reproduced below, shows a coaxial guide catheter in
`accordance with the invention described in 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 shown above, coaxial guide
`catheter 12 has a rigid portion 20, which “includes first full circumference
`portion 34, hemicylindrical portion 36, arcuate portion 38, and second full
`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, shows the operation of the coaxial guide
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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. Id. 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. Id. 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. Id. at 8:22–24.
`The presence of 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.” Id. 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
`catheter such as a stent or [a] balloon catheter.” Id. at 8:33–34. “[T]he
`presence of coaxial guide catheter provides additional backup support to
`make it 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.” Id. 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. Id. 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 beyond the distal end of, the guide catheter,
`[25c] including advancing a distal end portion of a tubular
`structure of the guide extension catheter beyond the distal
`end of the guide catheter while a segment defining a side
`opening of the 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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`[25e] the tubular structure having a cross-sectional inner
`diameter that is not more than one French size 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
`beyond the distal end of the guide catheter; and
`[25g] while maintaining the distal end of the guide
`extension catheter positioned beyond the distal end of the
`guide catheter advancing a balloon catheter or 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 tubular structure.
`Id. at 13:62–14:25.
`
`C. Asserted Grounds of Unpatentability
`Petitioner asserts that the Challenged Claims are unpatentable based
`on the following grounds:
`
`Ground
`
`1
`
`2
`
`Claim(s)
`Challenged
`
`52, 53
`25–40, 42, 44–
`48
`
`35
`U.S.C.
`§
`103
`
`References/Basis
`
`Kontos,4 Ressemann5
`
`103
`
`Kontos, Ressemann, Takahashi6
`
`
`4 U.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 Method to Increase a Backup Support of a 6 French
`Guiding Coronary Catheter, Catheterization and Cardiovascular
`Interventions 63:452–456 (2004) (Ex. 1410) (“Takahashi”).
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`10
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`
`Ground
`
`Claim(s)
`Challenged
`
`3
`
`4
`
`5
`
`45
`
`25–55
`
`45, 46
`
`35
`U.S.C.
`§
`
`103
`
`103
`
`103
`
`References/Basis
`
`Kontos, Ressemann, Takahashi,
`Kataishi7
`Root8
`Kontos, Ressemann, Takahashi,
`Root
`
`Pet. 8.
`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 Owner relies 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.
`Manager Finance, Teleflex Inc. (Ex. 2153).
`
`D. Related Proceedings
`The parties 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) QXMedical, LLC v. Vascular Solutions, LLC, No. 17-cv-01969
`(D. Minn.). Pet. 5; Paper 4, 2. Patent Owner states 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 ʼ850 patent and that the
`
`
`7 US 2005/0015073 A1, published January 20, 2005 (Ex. 1425, “Kataishi”).
`8 US 2007/0260219 A1, published November 8, 2007 (Ex. 1512, “Root”)
`(publication of App. No. 11/416,629 (Ex. 1500), filed May 3, 2006, issued
`as U.S. Patent No. 8,048,032).
`
`11
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`IPR2020-01344
`Patent RE46,116 E
`ʼ850 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 another petition 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 proceedings initiated 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
`
`GC
`IVCD
`PTCA
`
`POSITA
`RX
`
`
`
`Guide Catheter
`Intervascular Cardiac Device
`Percutaneous Transluminal Coronary
`Angioplasty
`Person of Ordinary Skill in the Art
`Rapid Exchange
`
`III. ANALYSIS
`
`A. Level of Ordinary Skill in the Art
`In determining whether an invention would have been obvious at the
`time it was made, 35 U.S.C. § 103 requires us to resolve the level of
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`IPR2020-01344
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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 who is presumed to have known the relevant art 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 encountered in 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.” Id. (citation omitted).
`Petitioner contends that a person of ordinary skill in the art at the time
`of the invention would have been either: (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.” Id. at 12. Further, according to Petitioner,
`a person of ordinary skill in the art “with a medical degree” and a person of
`ordinary skill in the art “with an engineering degree” may have had access to
`each other. Id. (citing Ex. 1405 ¶ 27; Ex. 1442 ¶¶ 24-25).
`Patent Owner does not dispute Petitioner’s proposed level of ordinary
`skill. PO Resp. 7. We adopt Petitioner’s proposed level 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 Okajima v.
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`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 testimony is not shown”)
`(quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158,
`163 (Fed. Cir. 1985)).
`As their qualifications are undisputed, we also determine that 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 ¶¶ 5, 10, 12
`(Dr. Hillstead’s qualifications); Ex. 1807 ¶¶ 8–10 (Mr. Jones’s
`qualifications); Ex. 2138 ¶¶ 3–6 (Mr. Keith’s qualifications); Ex. 2145 ¶ 1
`(Dr. Graham’s qualifications); see Kyocera Senco Indus. Tools Inc. 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 one of ordinary skill in the art and the prosecution history
`pertaining to the patent.” Id.; 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 given its plain and ordinary
`meaning, (2) “lumen” as “the cavity of a tube,” and (3) “flexural modulus”
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`as “[a] measure of resistance . . . to bending.” Pet. 12–13 (quoting Ex. 1440,
`722).
`Patent Owner does not dispute Petitioner’s proposed construction of
`these terms. See generally PO Resp.
`In view of the issues we address below, we determine it 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 of the Prior Art
`Petitioner relies on Kontos, Ressemann, Takahashi, Kataishi, and
`Root, each of which we briefly summarize in relevant part below.
`
`1. Summary of Kontos (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
`PTCA9 balloon into a lesion.” Ex. 1409, code (54), 1:9–13.
`Figure 1 of Kontos is reproduced below:
`
`
`9 PTCA stands for “percutaneous transluminal coronary angioplasty.”
`Ex. 1405 ¶ 37.
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`Figure 1 is a side plan view of a support catheter, “cut-away in part to show
`in longitudinal cross-section a tubular body having a soft tip and radiopaque
`marker, and a manipulating wire.” Ex. 1409, 2:51–54. As shown in
`Figure 1, support catheter assembly 10 is composed of two major elements,
`body 12 and insertion/manipulation wire 14. Id. at 3:45–46. Body 12,
`“which may be viewed as a mini guide catheter, includes a tube 16 having a
`base portion 18 at its proximal end 20.” Id. at 3:47–49. “Tube 16 has a
`continuous lumen 22 therethrough from proximal end 20 to distal end 24.”
`Id. at 3:49–50. Body 12 also includes a soft tip 28 disposed at distal end 24
`and funnel portion 26 disposed at proximal end 20. Id. at 3:50–52. Wire 14
`is attached to body 12 at base portion 18. Id. at 3:52–53. Support
`assembly 10 may also include distal marker band 30 and proximal marker
`band 32. Id. at 3:53–55.
`Kontos explains that the size and shape of the various elements of
`support assembly 10 “may vary depending on the desired application,” but
`in the applications depicted in Figure 1, tube 16 has a 0.055 inch outer
`diameter and lumen 22 has a 0.045 inch diameter. Ex. 1409, 4:46–50.
`According to Kontos, the sizes used in these embodiments “generally are
`suitable for existing PTCA catheters.” Id. at 4:61–64.
`Figure 5 of Kontos is reproduced below:
`
`
`Figure 5 is a side schematic view of a support catheter having a PTCA
`catheter disposed therein. Ex. 1409, 2:64–66. In this figure, PTCA catheter
`
`16
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`40 and its deflated balloon 48 reside in lumen 22 of support assembly 10.
`Id. at 5:2–5.
`Figures 6A–6C of Kontos are reproduced below:
`
`
`
`Figures 6A–6C are cross-sectional views showing three stages in a process
`for guiding a PTCA catheter to a coronary artery lesion. Ex. 1409, 2:67–3:2.
`In Figure 6A, the PTCA catheter/support catheter assembly is fed into guide
`catheter 38 and advanced to the distal end of this catheter by exerting axial
`force on wire 14 and catheter tube 50 simultaneously. Id. at 5:25–30.
`In Figure 6B, when the PTCA catheter/support catheter assembly
`reaches the distal end of guide catheter 38, “it may be advanced as a unit out
`of the distal end of guide catheter 38, into the coronary ostia 39.” Ex. 1409,
`5:31–35. When extending beyond the distal end of guide catheter 38,
`body 12 functions as a guide catheter extension protecting fragile balloon 48
`and lessening “considerably the tendency of the PTCA catheter 40 to bend,
`buckle or kink.” Id. at 5:52–56.
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`In Figure 6C, after body 12 has been positioned adjacent the restricted
`area, PTCA catheter 40 is advanced so that balloon 48 exits body 12 and is
`advanced into the restricted area, e.g., stenosis B. Ex. 1409, 6:9–13.
`Balloon 48 is then inflated, as represented by dotted lines 48, “to effect a
`well known angioplasty procedure.” Id. at 6:13–15. Balloon 48 is then
`deflated and PTCA catheter 40, support catheter assembly 10, and guiding
`catheter 38 may be withdrawn. Id. at 6:15–18.
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`2. Summary of Ressemann (Ex. 1408)
`Ressemann, titled “Emboli Protection Devices and Related Methods
`of Use,” states that it is directed to an apparatus “used to prevent the
`introduction of emboli into the bloodstream during and after surgery
`performed to reduce or remove blockage in blood vessels.” Ex. 1408,
`code (54), 1:13–16. Figures 1A and 1B of Ressemann are reproduced
`below:
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`Figure 1A is a cross-sectional view of a partial length evacuation sheath. Id.
`at 3:16–18. Figure 1B is a cross-sectional view of the partial length
`evacuation sheath of Figure 1A, taken along line 1B–1B of Figure 1A. Id.
`at 3:19–20.
`Figure 1A depicts evacuation sheath assembly 100, which “is sized to
`fit inside a guide catheter” and be advanced “into a blood vessel to treat a
`stenosis.” Ex. 1408, 6:18–24, Fig. 5A. Evacuation sheath assembly 100
`includes a shaft having proximal shaft portion 110, intermediate shaft
`portion 120, and distal shaft portion 130 (not shown in Figure 1A). Id.
`at 10:30–35. Evacuation head 132 includes multi-lumen tube 138, having
`evacuation lumen 140 and inflation lumen 142, and is preferably made of a
`relatively flexible polymer. Id. at 6:35–64. Evacuation lumen 140 is
`preferably larger than inflation lumen 142 and “is designed to allow for the
`passage of interventional devices such as, but not limited to, stent delivery
`systems and angioplasty catheters.” Id. 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 catheter and to facilitate
`smoother passage of other therapeutic devices through evacuation
`lumen 140. Id. at 6:52–57. According to Ressemann, “[t]he larger area of
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`the angled open ends also allows for larger deformable particulate matter to
`pass through the lumen more smoothly.” Id. at 6:58–60.
`Stiffness transition member 135 is attached to the distal end of
`proximal shaft portion 110, “is located co-axially in the inflation
`lumen 142,” and extends to soft tip 144. Ex. 1408, 11:30–39. 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.
`In use, a guiding catheter is directed to a blood vessel, and then a
`coronary guide wire is advanced to a location just proximal to the distal tip
`of the guiding catheter. Ex. 1408, 12:9–14. Evacuation sheath
`assembly 100 is then advanced over the guide wire and positioned within the
`blood vessel. Id. at 12:19–21. In this process, evacuation head 132 is
`positioned with its distal end within the blood vessel while its proximal end
`remains in the guiding catheter. Id. at 12:37–39. Sealing balloons 136
`and 134 are then inflated to provide a fluid seal between the sealing balloons
`and the blood vessel. Id. at 12:40–45.
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`Figure 6D of Ressemann is reproduced below:
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`Figure 6D is a cross-sectional view of the partial length evacuation sheath of
`Figures 1A and 1B deployed within a blood vessel. Ex. 1408, 3:59–61. As
`shown in Figure 6D, guidewire 170 may be advanced beyond stenosis 180 in
`blood vessel 150. Id. at 13:3–16. A therapeutic device, such as a stent, may
`then be advanced over guide wire 170 and across stenosis 180. Id. at 13:57–
`60. As indicated by arrows 195, blood flow within the blood vessel is
`directed towards evacuation sheath 100. Id. at 13:35–41. According to
`Ressemann, “[t]his retrograde flow will carry any dislodged material out of
`the patient and into a collection chamber.” Id. at 13:43–44. The assembly,
`which includes a guide catheter, “may be positioned within the ostium of the
`target vessel.” Id. at 12:26–27.
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`3. Summary of Takahashi (Ex. 1410)
`Takahashi, titled “New Method to Increase a Backup Support of a 6
`French Guiding Coronary Catheter,” discusses the use of a guiding catheter
`in percutaneous coronary intervention (PCI). See generally Ex. 1410.
`Takahashi discloses a “five-in-six” system wherein a 5 French guiding
`catheter is inserted into a 6 French guiding catheter to provide increased
`backup support. Id. at 452. In this system, the 5 French catheter is 120 cm
`in length, whereas the 6 French catheter is 100 cm in length. Id. According
`to Takahashi, the soft end portion of the 5 French catheter “can easily
`negotiate the tortuous coronary artery with the minimal damage and then it
`can be inserted more deeply into the artery.” Id.
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`4. Summary of Kataishi (Ex. 1425)
`Kataishi, titled “Thrombus Suction Catheter with Improved Suction
`and Crossing,” teaches “a thrombus suction catheter with improved suction
`and crossing having a small pressure loss, which is a tube having a lumen
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`passing through from a proximal end to a distal end, a distal end opening
`having an angled cut surface.” Ex. 1425, code (54), ¶ 10. Figure 1 of
`Kataishi, reproduced below, is a front view of a thrombus suction catheter.
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`As shown in Figure 1, a thrombus suction catheter includes a catheter
`body 1, a connector 2 provided at a proximal end of the catheter body 1, a
`distal end opening 12 formed by an angled cut surface, and a guide wire
`insertion port 13. Id. ¶¶ 27, 29.
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`5. Summary of Root (Ex. 1512)
`The disclosure of Root, titled “Coaxial Guide Catheter for
`Interventional Cardiology Procedures,” is substantially similar and related to
`the ’116 patent. Compare Ex. 1512 to Ex. 1401. Root relates generally to a
`coaxial guide catheter for use with interventional cardiology devices that are
`insertable into a branch artery that branches off from a main artery.
`Ex. 1512, code (54), Abstract.
`Root discloses that interventional cardiology procedures often include
`inserting guidewires or other instruments through catheters into coronary
`arteries that branch off from the aorta. Id. ¶ 2. In coronary artery disease,
`the coronary arteries may be narrowed or occluded by atherosclerotic
`plaques or other lesions in a phenomenon known as stenosis. Id. In treating
`the stenosis, a guide catheter is inserted through the aorta and into the ostium
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`of the coronary artery, sometimes with the aid of a guidewire, and is passed
`beyond the occlusion or stenosis. Id. ¶ 3. However, crossing tough lesions
`can create enough backward force to dislodge the guide catheter from the
`ostium of the artery being treated, which can make it difficult or impossible
`for the interventional cardiologist to treat certain forms of coronary artery
`disease. Id.
`To solve this problem, Root describes a coaxial guide catheter that is
`deliverable through standard guidewires by utilizing a guidewire rail
`segment to permit delivery without blocking use of the guide catheter.
`Ex. 1512 ¶ 11. Root teaches that 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. Id.
`Figures 1 and 2, reproduced belo