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,
`
`Vv.
`
`TELEFLEX INNOVATIONSS.A.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,
`
`Vv.
`
`TELEFLEX INNOVATIONSS.A.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). Paper1 (“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 Ownerfiled a Sur-Reply addressing
`
`Petitioner’s burden on those issues. Paper 14; Paper 15. Also pursuantto
`
`our authorization, Petitioner filed another Reply and Patent Ownerfiled
`
`another Sur-Reply addressing the factors for discretionary denial under 35
`
`U.S.C. § 314(a). Paper 17; Paper 18.
`
`Wehavethe authority and discretion to determine whetherto institute
`
`an inter partes review. 35 U.S.C. § 314 (2018); 37 C_F.R. §42.4(a) (2019).
`
`We maynotinstitute an inter partes review “unless .
`
`.
`
`. there is a reasonable
`
`likelihood that the petitioner would prevail with respect to at least 1 of the
`
`claims challengedin the petition.” 35 U.S.C. § 314(a). Upon considering the
`
`arguments and evidenceof record, weinstitute 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 Owneridentifies the real parties-in-
`
`interest for itself as Teleflex Medical Devices S.A.R.L., Vascular Solutions
`
`
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`IPR2020-00136
`Patent RE45,776 E
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`LLC, Arrow Intemational, Inc., and Teleflex LLC and notes that “Teleflex
`
`Incorporated is the ultimate parent ofthe entities listed above.” Paper4, 2.
`
`C.
`
`Related Matters
`
`Patent Owneris 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 patentis also the subject of a
`
`declaratory judgementaction filed by another party, OXMedical, LLCv.
`
`Vascular Solutions, LLC, No. 17-cv-01969 (“OQXM’), which has been
`
`currently stayed pending ourinstitution 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 weinstituted inter partes review based on
`that petition on June 8, 2020. IPR2020-00135, Paper 22.' 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).
`
`Tn accordance with ourTrial Practice Guide, Petitioner provides an
`explanation of material differences and ranking for the multiple petitions
`directed to each challenged patent. Paper 3. Patent Owner respondsthat
`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.
`
`
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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 claimspriority to a non-provisional application
`filed May 3, 2006. Ex. 1401, codes (45), (60), (64).’
`The ’776 patent relates generally to a coaxial guide catheter for use
`with interventional cardiology devices that are insertable into a branchartery
`
`that branches off from a main artery. Ex. 1401, Abstract. According to the
`
`°776 patent, interventional cardiology procedures often includeinserting
`
`guidewires or other instruments through catheters into coronary arteries that
`
`branchoff from the aorta. Jd. 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. Jd. 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. Jd. at 1:59-65. However,
`
`crossing tough lesions can create enough backwardforce to dislodge the
`
`guide catheter from the ostium of the artery being treated, which can makeit
`
`difficult or impossible for the interventional cardiologistto 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
`
`* Petitioner does not contest the priority date for the ’776 patentin this
`proceeding. We consider May3, 2006 to be the effective filing date for
`purposes of our analysis.
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`
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`IPR2020-00136
`Patent RE45,776 E
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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 removalof the tapered inner catheter
`after the coaxial guide catheteris 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:
`
`Fig. 1
`“re
`145
`48
`
`YS
`/)
`127
`20
`18
`Ue”
`
`Fig. 2
`10
`f
`
`12
`
`14
`
`a2
`
`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 5:47—-52; Figs. 1 and 2. As shownabove,coaxial guide
`
`catheter assembly 10 includes coaxial guide catheter 12 and tapered inner
`
`catheter 14. Id. at 6:37—39. Coaxial guide catheter 12 includestip portion
`
`16, reinforced portion 18, and rigid portion 20. Jd. at 6:40-41. Tip portion
`16 generally includes bumptip 22 and marker band 24. Id. at 6:44-45.
`
`Bumptip 22 includes taper 26 andis relatively flexible. Jd. at 6:45—-46.
`Marker band 24 is formed of a radiopaque material such as platinum/iridium
`
`alloy. Id. at 6:49-50. Tapered inner catheter tip 42 includes tapered portion
`
`46 at a distal end thereof, and straight portion 48. Jd. at 7:22—23. Both
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`IPR2020-00136
`Patent RE45,776 E
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`tapered portion 46 andstraight portion 48 are pierced by lumen 50 (not
`
`labeled in figures above). Jd. 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. Jd. at 4:43-44. The coaxial guide catheter/
`
`tapered inner catheter combination maythen beinserted 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 oncethe 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 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 4:64—-5:3.
`
`E.
`
`Illustrative Claims
`
`Amongthe challenged claims, independent claim 25 is representative
`
`and reproducedbelow:
`
`
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`IPR2020-00136
`Patent RE45,776 E
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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
`betweena 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
`proximalendofthe tubularstructure 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|35 U.S.C. §° Reference(s)/Basis
`
`
`25-27, 29, 33, 35-37,|103(a) Kontos,* Ressemann,°
`
`
`
`39, 41-49, 52
`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”).
`‘> Ressemann, US 7,604,612 B2, issued October 20, 2009 (Ex. 1408)
`(‘“Ressemann’’).
`
`
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`IPR2020-00136
`Patent RE45,776 E
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`
`
`
`
`
`
`53-56
`
`103(a)
`
`Kontos, Ressemann, Takahashi,°
`knowledge of POSITA
`Kontos, Ressemann, Kataishi,’
`knowledge of POSITA
`Kontos, Ressemann, Takahashi,
`
`
`
`
`
`peeBO Kataishi, knowledge ofPOSITA
`
`
`
`
`
`Petitioner relies upon the expert declarations of Dr. Stephen Brecker
`
`(Ex. 1405) and Dr. Richard Hillstead (Ex. 1442) in support ofits Petition.
`
`Patent Ownerrelies upon the expert declaration of Peter Keith (Ex. 2042) in
`
`support of its Preliminary Response.
`
`Il.
`
`ANALYSIS
`
`A.
`
`Level of Ordinary Skill in the Art
`
`Weconsiderthe asserted grounds of unpatentability in view ofthe
`
`understanding of a person ofordinary 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.” Jd.
`
`Additionally, Petitioner contendsthat “‘[e]xtensive experience and technical
`
`6 Takahashi, et al., New Method to Increase a Backup Support ofa 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”).
`
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`IPR2020-00136
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`training might substitute for education, and advanced degrees might
`
`substitute for experience.” Id.
`
`Patent Ownerindicates that “[flor purposes ofthis Preliminary
`
`Responseonly, Teleflex does not currently dispute Medtronic’s proposed
`
`definition of a POSITA.” Prelim. Resp. 16.
`
`Onthis 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
`
`Weinterpret a claim “using the same claim construction standard that
`
`would be used to construe the claim in a civil action under 35 U.S.C.
`
`282(b).” 37 C.F.R. § 42.100(b) (2019). This standard requires that we
`
`construe claims “in accordance with the ordinary and customary meaning of
`
`such claim[s] as understood by oneof ordinary skill in the art and the
`
`prosecution history pertaining to the patent.” Jd.
`
`Petitioner proposes constructions for the claim terms a “concave
`
`track” and “flexural modulus.” Pet. 13-16. Patent Owner respondsto
`
`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 whetherto
`
`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
`
`
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`IPR2020-00136
`Patent RE45,776 E
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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 I: Obviousness in View ofKontos, Ressemann, and the
`Knowledge ofa 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 knowledgeof a
`
`POSITA. Pet. 8. We focus our analysis on independent claim 25 for
`
`purposesofthis decision.
`
`1.
`
`Overview ofKontos (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).
`
`Kontosis directed to a support catheter assembly for facilitating
`
`medical proceduresand, in particular, to a catheter assembly that has
`“particular utility in facilitating insertion of a PTCA®balloonintoalesion.”
`
`Id. at 1:9-13.
`
`Figure 1 of Kontos is reproduced below:
`
`panwsnwancnccnemenennconaapete” 726
`32
`
`CLTLCFLhdhedame,Ceeee Z
`besREE aeae eeae reane aaeet Seemann’
`
`
`
`te»
`1
`22
`.
`
`STENT 10 DEA
`
`8 PTCAstands for “percutaneous transluminal coronary angioplasty.”
`Ex. 1405 9 37.
`
`10
`
`
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`IPR2020-00136
`Patent RE45,776 E
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`Figure | 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.” Jd. at 2:51-54. As shownin Figure 1,
`
`support catheter assembly 10 is composed of two major elements, body 12
`
`and insertion/manipulation wire 14. Jd. 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.” Jd. at 3:47-49. “Tube 16 has a continuous
`
`lumen 22 there through from proximal end 20 to distal end 24.” Jd. 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. /d. at 3:50-52. Wire 14 is attached
`
`to body 12 at base portion 18. Jd. 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. Jd. at 4:46—-50.
`
`According to Kontos, the sizes used in these embodiments “generally are
`
`suitable for existing PTCA catheters.” Jd. at 4:61-64.
`
`Figure 5 of Kontos is reproduced below:
`5/
`
` CeCe
`teeralsisy progenyriyaaagare
`
`
`48
`
`FIG. 5
`
`Figure 5 is a side schematic view of a support catheter having a PTCA
`
`catheter disposed therein. Jd. at 2:64-66. In this figure, PTCA catheter 40
`
`11
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`
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`IPR2020-00136
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`and its deflated balloon 48 reside in lumen 22 of support assembly 10. Jd. at
`
`5:2-5.
`
`Figures 6A—6C of Kontos are reproduced below:
`
`Figures 6A—6Care cross-sectional views showing three stages in a process
`
`for guiding a PTCA catheter to a coronary artery lesion.
`
`/d. at 2:67—3:2.
`
`In
`
`Figure 6A, the PTCA catheter/support catheter assembly is fed into guide
`
`catheter 38 and advancedto the distal end of this catheter by exerting axial
`
`force on wire 14 and catheter tube 50 simultaneously. Jd. at 5:25-30.
`
`In Figure 6B, when the PTCAcatheter/support catheter assembly
`
`reachesthe distal end of guide catheter 38, “it may be advancedas a unit out
`
`of the distal end of guide catheter 38, into the coronary ostia 39.” Jd. at
`
`5:31-35. When extending beyondthe 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.” Jd. 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 advancedso that balloon 48 exits body
`
`12 and is advancedinto therestricted area, e.g., stenosis B. Jd. at 6:9-13.
`
`Balloon 48 is then inflated, as represented by dotted lines 48, “to effect a
`
`well known angioplasty procedure.” Jd. at 6:13—15. Balloon 48is then
`
`deflated and PTCA catheter 40, support catheter assembly 10, and guiding
`catheter 38 may be withdrawn. /d. at 6:15—18.
`2.
`Overview ofRessemann (Ex. 1408)
`
`Ressemannis a U.S.patent that issued on October 20, 2009 from an
`application filed on August 9, 2002. Ex. 1408. Thus,onits 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.” Jd. at 1:13-16.
`
`Figures 1A and 1B of Ressemannare reproduced below:
`
`
`
`13
`
`
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`
`
`FIG, {8
`
`Figure 1A is a cross-sectional view ofa partial length evacuation sheath. Id.
`
`at 3:16-18. Figure 1B is a cross-sectional view ofthe partial length
`
`evacuation sheath of Figure 1A, taken along line 1B-1B of Figure 1A. Jd. 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 vesselto 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). Jd. at 10:30-35.
`
`Evacuation head 132 includes multi-lumen tube 138 having evacuation
`
`lumen 140 andinflation lumen 142 and is preferably made ofa relatively
`
`flexible polymer. Jd. at 6:35-64. Evacuation lumen 140is preferably larger
`
`than inflation lumen 142 and“is designed to allow for the passage of
`
`interventional devices suchas, but not limited to, stent delivery systems and
`
`angioplasty catheters.” Jd. at 6:44-47. Proximal anddistal ends of
`
`evacuation lumen 140are angled to allow for smoother passage of
`
`evacuation sheath assembly 100 through a guide catheter andto 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 endsalso allowsfor larger deformable particulate matter to
`
`pass through the lumen more smoothly.” Jd. at 6:58-60.
`
`Stiffness transition member 135 is attached to the distal end of
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`proximalshaft portion 110,“is located co-axially in the inflation lumen
`
`142,” and extendsto soft tip 144. Jd. at 11:30-39. Inflation lumen 142,
`
`having open proximal end 142a and closeddistal 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
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`coronary guide wire is advancedto a location just proximalto the distal tip
`
`of the guiding catheter. Jd. at 12:9-14. Evacuation sheath assembly 100is
`
`then advancedover the guide wire and positioned within the blood vessel.
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`Id. at 12:19-21. In this process, evacuation head 132 is positioned withits
`
`distal end within the blood vessel while its proximal end remainsin the
`
`guiding catheter. Jd. 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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`IPR2020-00136
`Patent RE45,776 E
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`Figure 6D is a cross-sectional view ofthe partial length evacuation
`sheath of Figures 1A and 1B deployed within a blood vessel. Jd. at 3:59-61.
`
`As shownin Figure 6D, guidewire 170 may be advanced beyondstenosis
`
`180 in blood vessel 150. Jd. 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. Asindicated by arrows 195, blood flow within the blood
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`vessel is directed towards evacuation sheath 100.
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`/d. at 13:35-41.
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`According to Ressemann,“[t]his retrograde flow will carry any dislodged
`
`material out of the patient and into a collection chamber.” Jd. at 13:43-44.
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`3.
`
`Independent Claim 25
`
`Petitioner contends that the combination of Kontos and Ressemann
`
`teaches each ofthe limitations of independent claim 25 as follows:
`
`With respect to the requirementfor “[a] guide extension catheter for
`
`use with a guide catheter,” Petitioner contendsthat, to the extent the
`preamble is limiting, ? Kontos’s support catheter assembly 10 meets this
`
`limitation. Pet. 21—22 (citing Ex. 1405 4 154; Ex. 1409, 2:16—22, 3:45—46,
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`5:49-52,Fig. 1, Fig. 6B).
`
`With respect to the requirement for “a substantially rigid segment.”
`
`Petitioner contendsthat the insertion/manipulation wire 14 that is proximal
`
`of tube 16 in Kontos’s support catheter 10 meets this limitation. Jd. at 22-24
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`(citing Ex. 1405 J 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
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`overlapping with the tubular structure, and has applied the claimsas recited
`
`° Weneed not determineat this time whether the preamble ofclaim 25 is
`limiting because Petitioner showssufficiently for purposesof institution that
`the recitation in the preamble is disclosed in Kontos.
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`16
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`IPR2020-00136
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`in the ’776 patent and as interpreted by Patent Ownerin 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 requirementfor “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 1 156; 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 ofthe tubular structure” and the “segment
`
`defining the partially cylindrical opening having an angled proximal end,”
`
`Petitioner relies upon the combination of Kontos with Ressemannand/or the
`
`knowledge of a POSITA as meeting these requirements. Jd. at 25-34.
`
`Petitioner acknowledgesthat Kontos does not teach a partially cylindrical
`
`opening, but contendsthat such partially cylindrical openings were well-
`
`knownin the art. Jd. at 27 (citing Ex. 1405 FJ 90-108, 158-59; Ex. 1442 7]
`
`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 4§ 035, 49, Fig. 2; Ex. 1435 J 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/2140is
`
`“preferably angled.” Jd. (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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`IPR2020-00136
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`STENT 10
`
`
`
`64. f= 16Pay, eee -awearereet
`
`a— —
`us
`at
`'
`FIG. 1
`
`
`
`——
`
`'
`
`tubular structure
`
`partially cylindrical opening
`
`substantially rigid segment
`
`Id. at 28-29 (citing Ex. 1405 ff 161-174; Ex. 1442 9] 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 contendsthat the result of the combination would necessarily
`
`include a segmentwith an angled proximal end. Jd. 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
`
`proximalofthe tubularstructure, as taught by Ressemann. Jd. at 29 (citing
`
`Ex. 1405 99 162-72; Ex. 1442 J§ 91-99). Petitioner contendsthat 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 ofentry to the extension catheter, and this would have
`
`been beneficial for the small diameter (6 French) guiding catheters that were
`
`commonly usedas ofthepriority date of the ’776 patent. Jd. at 29-31
`
`(citing Ex. 1405 FJ 163-165; Ex. 1406, Fig. 6B; Ex. 1442 4 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 ofthe deviceas it enters the lumenofthechild catheter
`
`18
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`IPR2020-00136
`Patent RE45,776 E
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`and navigates winding vasculature. Id. at 31-32 (citing Ex. 1405 | 166-173;
`Ex. 1442 9] 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 elementto obtain predictable
`
`results. [d. at 33-34 (citing KSR Int'l co. v. Teleflex Inc., 550 U.S. 398, 417
`
`(2007)).
`
`With respect to the requirementthat the segmentis “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. Jd.
`
`at 35—36 (citing Ex. 1405 ff 176-177; 1442 Jq101-105). 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 moldedplastic material,
`
`such as polyethylene. Jd 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 segmentis “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 whenit 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
`
`4178). Petitioner also argues that the “configured to” language recites an
`
`intended use, to which no patentable weight should be given. Jd. (citing Jn
`
`re Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997)).
`
`19
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`IPR2020-00136
`Patent RE45,776 E
`Finally, with respect to the requirement “wherein a cross-section of
`the guide extension catheter at the proximal end ofthe 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 ofthe tubular structure defines a single lumen, and further
`
`contendsthat the addition of Ressemann’s support collar 2141 would not
`
`result in more than one lumen. /d. at 37—38 (citing Ex. 1405 4 179; Ex. 1442
`
`{ 107).
`
`Patent Ownerarguesthat 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 Ownerasserts 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. Jd. at 33-36 (citing Ex. 2042 4
`
`38-40, 52-56). Second, Patent Owner contendsthat 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 {f
`
`36, 57, 60). Third, Patent Owner contendsthat Petitioner’s asserted
`
`motivations ignore key considerations, such as the fact that the preferred
`
`dimensionsdisclosed 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. Jd. at 42 (citing Ex. 2042
`
`35-36, 62). Patent Owneralso contends that the opening of Ressemann’s
`
`device actually increases the likelihoodthat an interventional cardiology
`
`device could “snag” or become “hungup,” and Kontos already reduces
`
`20
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`IPR2020-00136
`Patent RE45,776 E
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`potential “hang-up” by providing a funnel. /d. at 42-43 (citing Ex. 2042 9
`
`58, 63). With respect to Petitioner’s asserted motivation to reduce the
`
`amountof force that a physician must exert to advance the catheter through
`
`winding vasculature, Patent Owner contendsthat this is illogical on its face
`
`because what the prior art may have doneona 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. Jd. 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 respectto at least claim 25 of the ’776 patent. We are not
`
`persuaded by Patent Owner’s argumentsat this preliminary stage.
`
`Asto Patent Owner’s argument that Ressemann’s support collar is
`
`buried inside and underneathother components of Ressemann’s suction
`
`catheter, and thus there is no reason a POSITA would be motivatedto useit
`
`to define the opening into Kontos’s catheter (Prelim. Resp. 33-36), we note
`
`that Ressemannteachesthat “[t]he proximal end 2140a of the evacuation
`
`lumen 2140 is preferably angled to facilitate smooth passage of other
`
`therapeutic devices through the evacuation lumen 2140 of the evacuation
`
`head 2132.” Ex. 1408, 23:17—-20. Moreover, Ressemannteachesthat the
`
`“support collar 2141 is positioned about the proximal end of the multi lumen
`
`tube 2138 and servesto reinforce the proximal opening of the evacuation
`
`lumen 2140 in the presence of deforming forces.” Jd. at 24:49-53. The tab
`
`portion 2141b of support collar 2141 “lies adjacent the exterior walls of the
`
`multi-lumen tube 2138.” J
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