Trials@uspto.gov
`571-272-7822
`
`Paper 20
`Date: June 26, 2020
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MEDTRONIC, INC. and MEDTRONIC VASCULAR, INC.,
`Petitioner,
`
`v.
`
`TELEFLEX INNOVATIONS S.À.R.L.,
`Patent Owner.
`
`IPR2020-00136
`Patent RE45,776 E
`
`
`
`
`
`
`
`
`
`Before SHERIDAN K. SNEDDEN, JON B. TORNQUIST, and
`CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.
`
`PAULRAJ, Administrative Patent Judge.
`
`DECISION
`Granting Institution of Inter Partes Review
`35 U.S.C. § 314
`
`
`
`
`
`
`
`
`571-272-7822
`
`Paper 20
`Date: June 26, 2020
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MEDTRONIC, INC. and MEDTRONIC VASCULAR, INC.,
`Petitioner,
`
`v.
`
`TELEFLEX INNOVATIONS S.À.R.L.,
`Patent Owner.
`
`IPR2020-00136
`Patent RE45,776 E
`
`
`
`
`
`
`
`
`
`Before SHERIDAN K. SNEDDEN, JON B. TORNQUIST, and
`CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.
`
`PAULRAJ, Administrative Patent Judge.
`
`DECISION
`Granting Institution of Inter Partes Review
`35 U.S.C. § 314
`
`
`
`
`
`
`
`
`
`IPR2020-00136
`Patent RE45,776 E
`
`I.
`
`INTRODUCTION
`
`A.
`
`Background and Summary
`
`On November 12, 2019, Medtronic, Inc. and Medtronic Vascular, Inc.
`
`(“Petitioner”) filed a Petition requesting an inter partes review of claims 25–
`
`27, 29–33, 35–39, 41–49, and 52–56 of U.S. Patent No. RE45,776 (“the
`
`’776 patent,” Ex. 1401). Paper 1 (“Pet.”). Vascular Solutions, Inc. (“Patent
`
`Owner”) filed a Preliminary Response. Papers 9 (confidential version), 10
`
`(redacted version) (“Prelim. Resp.”). Pursuant to our authorization,
`
`Petitioner filed a Reply addressing its burden on secondary considerations
`
`and reduction to practice, and Patent Owner filed a Sur-Reply addressing
`
`Petitioner’s burden on those issues. Paper 14; Paper 15. Also pursuant to
`
`our authorization, Petitioner filed another Reply and Patent Owner filed
`
`another Sur-Reply addressing the factors for discretionary denial under 35
`
`U.S.C. § 314(a). Paper 17; Paper 18.
`
`We have the authority and discretion to determine whether to institute
`
`an inter partes review. 35 U.S.C. § 314 (2018); 37 C.F.R. §42.4(a) (2019).
`
`We may not institute an inter partes review “unless . . . there is a reasonable
`
`likelihood that the petitioner would prevail with respect to at least 1 of the
`
`claims challenged in the petition.” 35 U.S.C. § 314(a). Upon considering the
`
`arguments and evidence of record, we institute inter partes review of claims
`
`25–27, 29–33, 35–37, 39, 41–49, and 52–56 of the ’776 patent.
`
`B.
`
`Real Parties-in-Interest
`
`Petitioner identifies Medtronic, Inc. and Medtronic Vascular, Inc. as
`
`the real parties-in-interest, and notes that “Medtronic plc is the ultimate
`
`parent of both entities.” Pet. 5. Patent Owner identifies the real parties-in-
`
`interest for itself as Teleflex Medical Devices S.A.R.L., Vascular Solutions
`
`2
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`Patent RE45,776 E
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`LLC, Arrow International, Inc., and Teleflex LLC and notes that “Teleflex
`
`Incorporated is the ultimate parent of the entities listed above.” Paper 4, 2.
`
`C.
`
`Related Matters
`
`Patent Owner is asserting the ’776 patent against Petitioner in the
`
`United States District Court for the District of Minnesota in Vascular
`
`Solutions LLC, et al. v. Medtronic, Inc., et al. No. 19-cv-01760
`
`(“Medtronic”). Pet. 5–6; Paper 4, 2. The ’776 patent is also the subject of a
`
`declaratory judgement action filed by another party, QXMedical, LLC v.
`
`Vascular Solutions, LLC, No. 17-cv-01969 (“QXM”), which has been
`
`currently stayed pending our institution decision. Paper 17; Paper 18.
`
`Petitioner further notes that the ’776 patent is a reissue of U.S. Patent No.
`
`8,292,850, which was the subject of a prior district court action and inter
`
`partes reviews in IPR2014-00762 and IPR2014-00763 filed by a different
`
`petitioner. Pet. 6.
`
`Petitioner has also filed another petition challenging the ’776 patent
`
`based on different prior art, and we instituted inter partes review based on
`
`that petition on June 8, 2020. IPR2020-00135, Paper 22.1 In addition,
`
`Petitioner filed concurrent petitions challenging other related patents: U.S.
`
`Patent No. 8,048,032 (IPR2020-00126; IPR2020-00127), RE45,830
`
`(IPR2020-00128; IPR2020-00129; IPR2020-00130; IPR2020-00131), RE
`
`45,760 (IPR2020-00132; IPR2020-00133; IPR2020-00134), and RE47,379
`
`(IPR2020-00137; IPR2020-00138).
`
`
`1 In accordance with our Trial Practice Guide, Petitioner provides an
`explanation of material differences and ranking for the multiple petitions
`directed to each challenged patent. Paper 3. Patent Owner responds that
`Petitioner has not justified institution on multiple petitions. Paper 8. We
`address Patent Owner’s arguments for discretionary denial based on the
`multiple petitions below.
`
`3
`
`
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`IPR2020-00136
`Patent RE45,776 E
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`D.
`
`The ’776 Patent
`
`The ’776 patent, entitled “Coaxial Guide Catheter for Interventional
`
`Cardiology Procedures,” issued on October 27, 2015, as a re-issue of U.S.
`
`Patent No. 8,292,850, which claims priority to a non-provisional application
`
`filed May 3, 2006. Ex. 1401, codes (45), (60), (64).2
`
`The ’776 patent 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. 1401, Abstract. According to the
`
`’776 patent, interventional cardiology procedures often include inserting
`
`guidewires or other instruments through catheters into coronary arteries that
`
`branch off from the aorta. Id. at 1:45–47. 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 1:50–55. 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,
`
`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. at 1:65–67.
`
`To solve this problem, the ’776 patent 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. Id. at 3:15–18. The ’776 patent teaches that the coaxial guide
`
`
`2 Petitioner does not contest the priority date for the ’776 patent in this
`proceeding. We consider May 3, 2006 to be the effective filing date for
`purposes of our analysis.
`
`4
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`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 3:24–27. Figures 1 and 2,
`
`reproduced below, show a coaxial guide catheter and a tapered inner catheter
`
`in accordance with the invention described in the ’776 patent:
`
`
`
`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 5:47–52; Figs. 1 and 2. As shown above, coaxial guide
`
`catheter assembly 10 includes coaxial guide catheter 12 and tapered inner
`
`catheter 14. Id. at 6:37–39. Coaxial guide catheter 12 includes tip portion
`
`16, reinforced portion 18, and rigid portion 20. Id. at 6:40–41. Tip portion
`
`16 generally includes bump tip 22 and marker band 24. Id. at 6:44–45.
`
`Bump tip 22 includes taper 26 and is relatively flexible. Id. at 6:45–46.
`
`Marker 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. Id. at 7:22–23. Both
`
`5
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`tapered portion 46 and straight portion 48 are pierced by lumen 50 (not
`
`labeled in figures above). Id. at 7:23–24. 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 7:27–29.
`
`In operation, the tapered inner catheter is inserted inside and through
`
`the coaxial guide catheter. Id. at 4:43–44. The coaxial guide catheter/
`
`tapered inner catheter combination may then be inserted into a blood vessel
`
`that communicates with the aorta, and advanced until the tapered inner
`
`catheter is passed into the ostium of a coronary artery over the guidewire.
`
`Id. at 4:47–54. The tapered inner catheter may be removed once the coaxial
`
`guide catheter tapered inner catheter combination has been inserted
`
`sufficiently into the ostium of the coronary artery to achieve deep seating.
`
`Id. at 4:54–57. Once the tapered inner catheter is removed, a cardiac
`
`treatment device, such as a guidewire, balloon, or stent, may be passed
`
`through the coaxial guide catheter within the guide catheter and into the
`
`coronary artery. Id. at 4:61–64. The presence of the 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 4:64–5:3.
`
`E.
`
`Illustrative Claims
`
`Among the challenged claims, independent claim 25 is representative
`
`and reproduced below:
`
`6
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`25. A guide extension catheter for use with a guide catheter,
`comprising:
`
`a substantially rigid segment;
`
`a tubular structure defining a lumen and positioned distal to
`the substantially rigid segment; and
`
`a segment defining a partially cylindrical opening positioned
`between a distal end of the substantially rigid segment and
`a proximal end of the tubular structure, the segment
`defining the partially cylindrical opening having an angled
`proximal end, formed from a material more rigid than a
`material or material combination forming the tubular
`structure, and configured
`to receive one or more
`interventional cardiology devices
`therethrough when
`positioned within the guide catheter,
`
`wherein a cross-section of the guide extension catheter at the
`proximal end of the tubular structure defines a single lumen.
`
`Ex. 1401, 13:35–52 (cl. 25).
`
`F.
`
`Prior Art and Asserted Grounds
`
`Petitioner asserts that claims 25–27, 29–33, 35–37, 39, 41–49, and
`
`52–56 would have been unpatentable based on the following grounds. Pet.
`
`8.
`
`Claim(s) Challenged
`25–27, 29, 33, 35–37,
`39, 41–49, 52
`
`35 U.S.C. §3
`103(a)
`
`Reference(s)/Basis
`Kontos,4 Ressemann,5
`knowledge of POSITA
`
`
`3 The Leahy-Smith America Invents Act (“AIA”), Pub. L. No. 112-29, 125
`Stat. 284, 287–88 (2011), amended 35 U.S.C. § 103, effective March 16,
`2013. Because the application from which the ’776 patent issued was filed
`before this date, the pre-AIA version of § 103 applies.
`4 Kontos, US 5,439,445, issued August 8, 1995 (Ex. 1409) (“Kontos”).
`5 Ressemann, US 7,604,612 B2, issued October 20, 2009 (Ex. 1408)
`(“Ressemann”).
`
`7
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`30–32, 53–56
`
`103(a)
`
`52
`
`53–56
`
`103(a)
`
`103(a)
`
`Kontos, Ressemann, Takahashi,6
`knowledge of POSITA
`Kontos, Ressemann, Kataishi,7
`knowledge of POSITA
`Kontos, Ressemann, Takahashi,
`Kataishi, knowledge of POSITA
`
`
`
`Petitioner relies upon the expert declarations of Dr. Stephen Brecker
`
`(Ex. 1405) and Dr. Richard Hillstead (Ex. 1442) in support of its Petition.
`
`Patent Owner relies upon the expert declaration of Peter Keith (Ex. 2042) in
`
`support of its Preliminary Response.
`
`II. ANALYSIS
`
`A.
`
`Level of Ordinary Skill in the Art
`
`We consider the asserted grounds of unpatentability in view of the
`
`understanding of a person of ordinary skill in the art (“POSITA”). Petitioner
`
`provides two alternatives for a person having ordinary skill in the art. First,
`
`Petitioner asserts that “[i]f a person of ordinary skill in the art (‘POSITA’)
`
`was a medical doctor, s/he would have had (a) a medical degree; (b)
`
`completed a coronary intervention training program, and (c) experience
`
`working as an interventional cardiologist.” Pet. 13. Alternatively, Petitioner
`
`asserts that “if a POSITA was an engineer s/he would have had (a) an
`
`undergraduate degree in engineering, such as mechanical or biomedical
`
`engineering; and (b) at least three years of experience designing medical
`
`devices, including catheters or catheter-deployable devices.” Id.
`
`Additionally, Petitioner contends that “[e]xtensive experience and technical
`
`
`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”).
`7 Kataishi, US 2005/0015073 A1, published January 20, 2005 (Ex. 1425)
`(“Kataishi”).
`
`8
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`training might substitute for education, and advanced degrees might
`
`substitute for experience.” Id.
`
`Patent Owner indicates that “[f]or purposes of this Preliminary
`
`Response only, Teleflex does not currently dispute Medtronic’s proposed
`
`definition of a POSITA.” Prelim. Resp. 16.
`
`On this record, in determining whether the evidence of record
`
`supports institution, we apply both of Petitioner’s definitions for a POSITA,
`
`as they are undisputed at this time and consistent with the level of skill
`
`reflected in the prior art and the specification of the ’776 patent. See
`
`Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art
`
`itself can reflect the appropriate level of ordinary skill in the art).
`
`B.
`
`Claim Construction
`
`We interpret a claim “using the same claim construction standard that
`
`would be used to construe the claim in a civil action under 35 U.S.C.
`
`282(b).” 37 C.F.R. § 42.100(b) (2019). This standard requires that we
`
`construe claims “in accordance with the ordinary and customary meaning of
`
`such claim[s] as understood by one of ordinary skill in the art and the
`
`prosecution history pertaining to the patent.” Id.
`
`Petitioner proposes constructions for the claim terms a “concave
`
`track” and “flexural modulus.” Pet. 13–16. Patent Owner responds to
`
`Petitioner’s proposed constructions by asserting that “no specific
`
`construction of claim terms [or any other terms] is necessary for the Board to
`
`deny the Petition.” Prelim. Resp. 18.
`
`At this stage of the proceeding, we do not perceive a need to construe
`
`any claim terms of the ’776 patent for purposes of determining whether to
`
`institute trial. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 295,
`
`803 (Fed. Cir. 1999) (holding that “only those terms need to be construed
`
`9
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`that are in controversy, and only to the extent necessary to resolve the
`
`controversy”); see also Nidec Motor Corp. v. Zhongshan Broad Ocean
`
`Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (applying Vivid Techs. in
`
`the context of an inter partes review).
`
`C. Ground 1: Obviousness in View of Kontos, Ressemann, and the
`Knowledge of a POSITA
`
`Petitioner asserts that claims 25–27, 29, 33, 35–37, 39, 41–49, and 52
`
`are rendered obvious in view of Kontos, Ressemann, and the knowledge of a
`
`POSITA. Pet. 8. We focus our analysis on independent claim 25 for
`
`purposes of this decision.
`
`1.
`
`Overview of Kontos (Ex. 1409)
`
`Kontos is a U.S. patent that issued from an application filed on June
`
`27, 1994. Ex. 1409. Thus, on its face, Kontos qualifies as prior art under
`
`pre-AIA 35 U.S.C. § 102(b).
`
`Kontos 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 PTCA8 balloon into a lesion.”
`
`Id. at 1:9–13.
`
`Figure 1 of Kontos is reproduced below:
`
`
`
`
`8 PTCA stands for “percutaneous transluminal coronary angioplasty.”
`Ex. 1405 ¶ 37.
`
`10
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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.” Id. at 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 there through from proximal end 20 to distal end 24.” Id. at 3:49–
`
`50. Body 12 also include 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. Id. at 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. Id. at 2:64–66. In this figure, PTCA catheter 40
`
`
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`11
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`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. Id. at 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.” Id. at
`
`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.
`
`12
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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. Id. at 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.
`
`2.
`
`Overview of Ressemann (Ex. 1408)
`
`Ressemann is a U.S. patent that issued on October 20, 2009 from an
`
`application filed on August 9, 2002. Ex. 1408. Thus, on its face,
`
`Ressemann qualifies as prior art under pre-AIA 35 U.S.C. § 102(e).
`
`Ressemann 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.” Id. at 1:13–16.
`
`Figures 1A and 1B of Ressemann are reproduced below:
`
`
`
`
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`13
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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.” Id. at 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
`
`14
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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. Id. at 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. Id. at 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.
`
`Figure 6D of Ressemann is reproduced below:
`
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`15
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`Figure 6D is a cross-sectional view of the partial length evacuation
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`sheath of Figures 1A and 1B deployed within a blood vessel. Id. at 3:59–61.
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`As shown in Figure 6D, guidewire 170 may be advanced beyond stenosis
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`180 in blood vessel 150. Id. at 13:3–16. A therapeutic device, such as a
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`stent, may then be advanced over guide wire 170 and across stenosis 180.
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`Id. at 13:57–60. As indicated by arrows 195, blood flow within the blood
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`vessel is directed towards evacuation sheath 100. Id. at 13:35–41.
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`According to Ressemann, “[t]his retrograde flow will carry any dislodged
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`material out of the patient and into a collection chamber.” Id. at 13:43–44.
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`3.
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`Independent Claim 25
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`Petitioner contends that the combination of Kontos and Ressemann
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`teaches each of the limitations of independent claim 25 as follows:
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`With respect to the requirement for “[a] guide extension catheter for
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`use with a guide catheter,” Petitioner contends that, to the extent the
`
`preamble is limiting, 9 Kontos’s support catheter assembly 10 meets this
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`limitation. Pet. 21–22 (citing Ex. 1405 ¶ 154; Ex. 1409, 2:16–22, 3:45–46,
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`5:49–52, Fig. 1, Fig. 6B).
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`With respect to the requirement for “a substantially rigid segment.”
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`Petitioner contends that the insertion/manipulation wire 14 that is proximal
`
`of tube 16 in Kontos’s support catheter 10 meets this limitation. Id. at 22–24
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`(citing Ex. 1405 ¶ 155; Ex. 1409, Abstract, 5:25–30, Fig. 1). Petitioner
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`notes that the ’776 patent precludes the substantially rigid segment from
`
`overlapping with the tubular structure, and has applied the claims as recited
`
`
`9 We need not determine at this time whether the preamble of claim 25 is
`limiting because Petitioner shows sufficiently for purposes of institution that
`the recitation in the preamble is disclosed in Kontos.
`
`16
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`in the ’776 patent and as interpreted by Patent Owner in the district court.
`
`Id. at 23 n.6 (citing Ex. 1477, 127:24–128:14, 144:9–22, 145:9–17).
`
`With respect to the requirement for “a tubular structure defining a
`
`lumen and positioned distal to the substantially rigid segment,” Petitioner
`
`identifies the tube 16 in Kontos’s support catheter as meeting this limitation.
`
`Id. at 24–25 (citing Ex. 1405 ¶ 156; Ex. 1409, 3:49–50, 3:56–57, Figs. 1,
`
`6C).
`
`With respect to the requirements for “a segment defining a partially
`
`cylindrical opening positioned between a distal end of the substantially rigid
`
`segment and a proximal end of the tubular structure” and the “segment
`
`defining the partially cylindrical opening having an angled proximal end,”
`
`Petitioner relies upon the combination of Kontos with Ressemann and/or the
`
`knowledge of a POSITA as meeting these requirements. Id. at 25–34.
`
`Petitioner acknowledges that Kontos does not teach a partially cylindrical
`
`opening, but contends that such partially cylindrical openings were well-
`
`known in the art. Id. at 27 (citing Ex. 1405 ¶¶ 90–108, 158–59; Ex. 1442 ¶¶
`
`73-78; Ex. 1407, 4:11; Ex. 1408, 12:9–13:60, Figs. 6A–6E; Ex. 1418, Fig. 7;
`
`Ex. 1432, 119, Fig. 1; Ex. 1433 ¶¶ 035, 49, Fig. 2; Ex. 1435 ¶ 66; Ex. 1450,
`
`Fig. 7; Ex. 1461, 6:9–11, Fig. 1B). As one such example, Petitioner
`
`contends that Ressemann teaches an evacuation assembly 100/2100
`
`(“extension catheter”) where the entry to the evacuation lumen 140a/2140 is
`
`“preferably angled.” Id. (citing Ex. 1405 ¶¶ 160–161; Ex. 1408, 6:52–60
`
`(100 embodiment), 24:33–38 (2100 embodiment)).
`
`Petitioner contends that a POSITA would have been motivated, with a
`
`reasonable expectation of success, to add Ressemann’s partially cylindrical
`
`opening to Kontos’s structure as shown in the annotated figure below:
`
`17
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`
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`Id. at 28–29 (citing Ex. 1405 ¶¶ 161–174; Ex. 1442 ¶¶ 91–100; Ex. 1409,
`
`Fig. 1). The annotated figure above shows a magnified version of Kontos’s
`
`Figure 1 modified to include Ressemann’s support collar (labeled the
`
`“partially cylindrical opening”) in between the wire 14 (labeled the
`
`“substantially rigid segment”) and tube 16 (labeled the “tubular structure”).
`
`Petitioner contends that the result of the combination would necessarily
`
`include a segment with an angled proximal end. Id. at 35 (citing Ex. 1405 ¶
`
`175).
`
`Petitioner identifies multiple reasons as to why a POSITA would have
`
`been motivated to modify Kontos to add a partially cylindrical opening
`
`proximal of the tubular structure, as taught by Ressemann. Id. at 29 (citing
`
`Ex. 1405 ¶¶ 162–72; Ex. 1442 ¶¶ 91–99). Petitioner contends that the use of
`
`a partially cylindrical opening could permit a reduction of the outer diameter
`
`of the catheter assembly without resulting in a commensurate reduction in
`
`the area of the point of entry to the extension catheter, and this would have
`
`been beneficial for the small diameter (6 French) guiding catheters that were
`
`commonly used as of the priority date of the ’776 patent. Id. at 29–31
`
`(citing Ex. 1405 ¶¶ 163–165; Ex. 1406, Fig. 6B; Ex. 1442 ¶ 96). Petitioner
`
`further contends that a POSITA would have been motivated to use a
`
`partially cylindrical opening in order to facilitate “smoother” reception,
`
`passage, and reentry of the device as it enters the lumen of the child catheter
`
`18
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`and navigates winding vasculature. Id. at 31–32 (citing Ex. 1405 ¶ 166–173;
`
`Ex. 1442 ¶¶ 80, 89–95, 98–100). Petitioner also contends that employing
`
`Ressemann’s partially cylindrical opening (as opposed to an opening
`
`perpendicular to the longitudinal axis) with Kontos’s device would have
`
`amounted to a simple substitution of a known element to obtain predictable
`
`results. Id. at 33–34 (citing KSR Int’l co. v. Teleflex Inc., 550 U.S. 398, 417
`
`(2007)).
`
`With respect to the requirement that the segment is “formed from a
`
`material more rigid than a material or material combination forming the
`
`tubular structure,” Petitioner contends that the incorporation of Ressemann’s
`
`support collar 2141 to Kontos’s structure would meet this requirement. Id.
`
`at 35–36 (citing Ex. 1405 ¶¶ 176–177; 1442 ¶¶101–105). Petitioner points
`
`out that Ressemann’s support collar is preferably “a metallic material” with
`
`“suitable rigidity to prevent kinking,” while Kontos’s tube 16 includes “any
`
`pliable material,” but preferably is composed of a molded plastic material,
`
`such as polyethylene. Id at 36 (citing Ex. 1408, 24:47–55, 24:62–67, 25:13–
`
`16; Ex. 1409, 4:1–4).
`
`With respect to the requirement that the segment is “configured to
`
`receive one or more interventional cardiology devices therethrough when
`
`positioned within the guide catheter,” Petitioner contends that Kontos
`
`teaches that the extension catheter (support catheter 10) is positioned within
`
`the guide catheter when it receives the interventional cardiology device. Id.
`
`at 37 (citing Ex. 1409, 4:66–5:2, 5:16–18, 7:45–52, Figs. 6A–C; Ex. 1405
`
`¶ 178). Petitioner also argues that the “configured to” language recites an
`
`intended use, to which no patentable weight should be given. Id. (citing In
`
`re Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997)).
`
`19
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`Finally, with respect to the requirement “wherein a cross-section of
`
`the guide extension catheter at the proximal end of the tubular structure
`
`defines a single lumen,” Petitioner contends that Kontos discloses an
`
`extension catheter (support catheter 10) where a cross-section at the
`
`proximal end of the tubular structure defines a single lumen, and further
`
`contends that the addition of Ressemann’s support collar 2141 would not
`
`result in more than one lumen. Id. at 37–38 (citing Ex. 1405 ¶ 179; Ex. 1442
`
`¶ 107).
`
`Patent Owner argues that Petitioner has not shown, for several
`
`reasons, that the claimed guide extension catheter, including a “partially
`
`cylindrical opening,” would have been obvious based on Kontos and
`
`Ressemann. Prelim. Resp. 31. First, Patent Owner asserts that the Petition
`
`does not adequately address why a POSITA would be motivated to focus on
`
`Ressemann’s support collar, which Patent Owner contends does not form the
`
`proximal opening in Ressemann’s device. Id. at 33–36 (citing Ex. 2042 ¶¶
`
`38–40, 52–56). Second, Patent Owner contends that the Petition does not
`
`address reasons why a POSITA would be motivated not to make the
`
`combination, such as that removing the proximal funnel from Kontos would
`
`be contrary to Kontos’s intended purpose. Id. at 36–41 (citing Ex. 2042 ¶¶
`
`36, 57, 60). Third, Patent Owner contends that Petitioner’s asserted
`
`motivations ignore key considerations, such as the fact that the preferred
`
`dimensions disclosed in Kontos already permit use within a 6 French guide
`
`catheter and that removing the funnel from Kontos’s device would not
`
`facilitate use of a smaller diameter guide catheter. Id. at 42 (citing Ex. 2042
`
`¶¶ 35–36, 62). Patent Owner also contends that the opening of Ressemann’s
`
`device actually increases the likelihood that an interventional cardiology
`
`device could “snag” or become “hung up,” and Kontos already reduces
`
`20
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`potential “hang-up” by providing a funnel. Id. at 42–43 (citing Ex. 2042 ¶¶
`
`58, 63). With respect to Petitioner’s asserted motivation to reduce the
`
`amount of force that a physician must exert to advance the catheter through
`
`winding vasculature, Patent Owner contends that this is illogical on its face
`
`because what the prior art may have done on a distal or leading end opening
`
`of a catheter that interacts with the vasculature has nothing to do with an
`
`opening in a middle section of a device that does not interact with the
`
`vasculature, but rather is inside an enclosed guide catheter. Id. at 44 (citing
`
`Ex. 2042 ¶ 64).
`
`Based on the evidence and arguments of record, we determine that
`
`Petitioner has demonstrated a reasonable likelihood of prevailing as to this
`
`ground with respect to at least claim 25 of the ’776 patent. We are not
`
`persuaded by Patent Owner’s arguments at this preliminary stage.
`
`As to Patent O
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