Trials@uspto.gov
`571-272-7822
`
`Paper No. 93
`Date: February 7, 2022
`
`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.
`
`IPR2020-01341
`Patent 8,142,413 B2
`
`
`
`
`
`
`
`
`
`Before SHERIDAN K. SNEDDEN, JAMES A. TARTAL, and
`CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.
`TARTAL, Administrative Patent Judge.
`
`JUDGMENT
`Final Written Decision
`Determining No Challenged Claims Unpatentable
`Dismissing Petitioner’s Motion to Exclude
`35 U.S.C. § 318(a)
`
`
`
`
`
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`

`

`IPR2020-01341
`Patent 8,142,413 B2
`We have jurisdiction to conduct this inter partes review
`under 35 U.S.C. § 6. This Final Written Decision is issued pursuant
`to 35 U.S.C. § 318(a) (2018) and 37 C.F.R. § 42.73 (2019). For the reasons
`discussed below, we determine Medtronic, Inc. and Medtronic Vascular, Inc.
`(“Petitioner”)1 has not shown by a preponderance of the evidence that any of
`claims 1, 2, 4, 5, and 7–14 (“the Challenged Claims”) of U.S. Patent
`No. 8,142,413 B2 (Ex. 1001, “the ’413 patent”) are unpatentable.
`I.
`INTRODUCTION
`A. Summary of Procedural History
`Petitioner filed a Petition pursuant to 35 U.S.C. §§ 311–319
`requesting an inter partes review of the Challenged Claims. Paper 1
`(“Pet.”). We instituted an inter partes review of the Challenged Claims on
`all grounds of unpatentability asserted in the Petition. Paper 11 (“Inst.
`Dec.”). Teleflex Innovations S.À.R.L. (“Patent Owner”)2 filed a Patent
`Owner Response.3 Paper 23 (“PO Resp.”) (under seal), 24 (redacted,
`publicly accessible). Petitioner filed a Reply to the Patent Owner Response.
`Paper 51 (“Pet. Reply”) (under seal), 52 (redacted, publicly accessible).
`
`
`1 Petitioner identifies as real parties-in-interest Medtronic, Inc. and
`Medtronic Vascular, Inc., and states, “Medtronic plc is the ultimate parent of
`both entities.” Pet. 4.
`2 Patent Owner identifies as real parties-in-interest Teleflex Medical Devices
`S.À.R.L.; Vascular Solutions LLC; Arrow International, Inc.; and
`Teleflex LLC. Paper 7, 2. Patent Owner also states, “Teleflex Incorporated
`is the ultimate parent of the entities listed above.” Id.
`3 Prior to institution, Patent Owner filed a Preliminary Response to the
`Petition directed primarily to whether discretionary denial of the Petition
`was warranted, not to the merits of Petitioner’s unpatentability contentions.
`See Paper 8. Patent Owner also filed a Contingent Motion to Amend
`(Paper 26), which Patent Owner subsequently withdrew (Paper 56).
`
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`IPR2020-01341
`Patent 8,142,413 B2
`Patent Owner filed a Sur-reply in support of the Patent Owner Response.
`Paper 67 (“PO Sur-reply”).
`Following oral argument, we entered a transcript of the hearing in
`the record. Paper 92 (“Tr.”). Petitioner bears the burden of proving
`unpatentability of each claim it has challenged by a preponderance of the
`evidence, and the burden of persuasion never shifts to Patent Owner.
`See 35 U.S.C. § 316(e); 37 C.F.R. § 42.1(d); Dynamic Drinkware, LLC v.
`Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015).
`B. Related Proceedings
`Petitioner also challenges claims 1, 2, 4, 5, and 7–14 of the
`’413 patent under separate grounds in IPR2020-01342. Pet. 5–6; Paper 7, 3.
`The ’413 patent also was the subject of a previous inter partes review in
`Boston Scientific Corp. and Boston Scientific Scimed, Inc., v. Vascular
`Solutions, Inc., IPR2014-00759, which was terminated based on settlement
`and no final written decision was issued. IPR2014-00759, Paper 10, 2–3
`(PTAB August 11, 2014).
`The parties state the ’413 patent is a subject of Vascular
`Solutions LLC, et al. v. Medtronic, Inc., et al. No. 19-cv-01760 (D. Minn.
`filed July 2, 2019) and QXMedical, LLC v. Vascular Solutions, LLC, No. 17-
`cv-01969 (D. Minn. filed June 8, 2017). Pet. 4–5; Paper 7, 2. Patent Owner
`indicates that both of these district court proceedings currently are stayed.
`Paper 7, 2.
`Additionally, Petitioner filed petitions challenging patents related to
`the ’413 patent in the following proceedings: IPR2020-00126 and IPR2020-
`00127 (Patent 8,048,032 B2); IPR2020-00128, IPR2020-00129, IPR2020-
`00130, and IPR2020-00131 (Patent RE45,380 E); IPR2020-00132,
`IPR2020-00133, and IPR2020-00134 (Patent RE45,760 E); IPR2020-00135
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`IPR2020-01341
`Patent 8,142,413 B2
`and IPR2020-00136 (Patent RE45,776 E); IPR2020-00137 and IPR2020-
`00138 (Patent RE47,379 E); and IPR2021-01343 and IPR2021-01344
`(Patent RE46,116 E). Institution of inter partes review was denied in
`IPR2020-00131 and IPR2020-00133. Final written decisions are pending in
`IPR2021-01343 and IPR2021-01344. In the remaining listed proceedings,
`final written decisions were entered determining that a preponderance of the
`evidence did not show any claim challenged was unpatentable.
`C. The ’413 Patent
`The ’413 patent, titled “Coaxial Guide Catheter for Interventional
`Cardiology Procedures,” issued on March 27, 2012, from a non-provisional
`application filed June 28, 2010. Ex. 1001, codes (45), (54), (22). The ’413
`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. 1001, Abstract.
`According to the ’413 patent, interventional cardiology procedures
`often include inserting guidewires or other instruments through catheters
`into coronary arteries that branch off from the aorta. Id. at 1:21–23.
`In coronary artery disease, atherosclerotic plaques or other lesions may
`narrow or occlude the coronary arteries. Id. at 1:26–30. The ’413 patent
`states that “[n]arrowing is referred to as stenosis.” Id. at 1:30–31.
`“In treating a stenosis, a guide catheter is typically inserted through the aorta
`and into the ostium of the coronary artery,” sometimes with the aid of a
`guidewire. Id. at 1:35–37. The ’413 patent further states as follows:
`A guide catheter is typically seated into the opening or ostium of
`the artery to be treated and a guidewire or other instrument is
`passed through the lumen of the guide catheter and inserted into
`the artery beyond the occlusion or stenosis. Crossing tough
`lesions can create enough backward force to dislodge the guide
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`IPR2020-01341
`Patent 8,142,413 B2
`catheter from the ostium of the artery being treated. This can
`make it difficult or impossible for the interventional cardiologist
`to treat certain forms of coronary artery disease.
`Id. at 1:37–45. The ’413 patent discusses “four categories” of “[p]rior
`attempts to provide support to the guiding catheter to prevent backward
`dislodgement from the coronary ostium (referred to as ‘backup support’),”
`consisting of: (1) “guiding catheters that, through a combination of shape
`and stiffness, are configured to draw backup support from engaging the wall
`of the aortic arch;” (2) “guiding catheters that include a retractable
`appendage;” (3) guide catheters that have apportion that seeks to expand
`laterally;” and, (4) “placement of a smaller guide catheter within a larger
`guide catheter in order to provide add support.” Id. at 1:46–2:39. The
`’413 patent identifies various deficiencies with these prior attempts,
`including an increased risk of damage to the aortic wall and mechanical
`complexity. See id. Specifically, with regard to the fourth category of prior
`attempts, the ’413 patent states as follows:
`This technique is used in order to provide a method of deep
`seating the guide catheter within the ostium of the coronary
`artery. Deep seating refers to inserting the catheter more deeply
`into the ostium of the coronary artery than typically has been
`done before. Unfortunately, deep seating by this technique with
`a commonly available guide catheter creates the risk that the
`relatively stiff, fixed curve, guide catheter will damage the
`coronary artery. This damage may lead to dissection of the
`coronary artery when the catheter is advanced past the ostium.
`Several other problems arise when using a standard guide
`catheter in this catheter-in-a-catheter fashion. First, the inner
`catheters must be substantially longer than the one hundred
`centimeter guide catheter. Second, a new hemostasis valve must
`be placed on the inner guide catheter which prevents the larger
`guide catheter from being used for contrast injections or pressure
`measurements. Third, the smaller guide catheter still must be
`inserted into the coronary vessel with great care since the smaller
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`guide catheter has no tapered transition or dilator at its tip and
`does not run over a standard 0.014 inch guidewire.
`Id. at 2:30–50. The ’413 patent states “a system that would be deliverable
`through standard guide catheters for providing backup support by providing
`the ability to effectively create deep seating in the ostium of the coronary
`artery” would be beneficial to “the interventional cardiology art.” Id.
`at 2:51–55.
`The ’413 patent describes “a coaxial guide catheter that is deliverable
`through standard catheters by utilizing a guidewire rail segment to permit
`delivery without blocking use of the guide catheter.” Id. at 2:59–62. “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,” allowing “removal of the tapered
`inner catheter after the coaxial guide catheter is in place.” Id. at 2:62–67.
`Figures 1 and 2, reproduced below, show a coaxial guide catheter and a
`tapered inner catheter as described in the ’413 patent:
`
`
`Figure 1 depicts tapered inner catheter 14 separate and above coaxial guide
`catheter 12, and Figure 2 depicts coaxial guide catheter 12 and tapered inner
`catheter 14 assembled as coaxial guide catheter assembly 10. Id. at 5:22–27,
`
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`IPR2020-01341
`Patent 8,142,413 B2
`6:12–14; Figs. 1 and 2. Coaxial guide catheter 12 includes tip portion 16,
`reinforced portion 18, and rigid portion 20. Id. at 6:15–16. Tip portion 16
`generally includes bump tip 22 and marker band 24. Id. at 6:20–21. Bump
`tip 22 includes taper 26 and is relatively flexible. Id. at 6:21. Marker
`band 24 is formed of a radiopaque material such as platinum/iridium alloy.
`Id. at 6:25–26. Tapered inner catheter tip 42 includes tapered portion 46 at a
`distal end thereof, and straight portion 48. Id. at 6:65–66. Both tapered
`portion 46 and straight portion 48 are pierced by lumen 50 (not labeled in
`figures above). Id. at 6:65–67. 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 7:3–5.
`
`Figures 8 and 9 of the ’413 patent are reproduced below.
`
`Figures 8 and 9 are schematic illustrations of guide catheter 56 with coaxial
`guide catheter 12 inserted into ostium 60 of coronary artery 62. Id. at 5:43–
`49, 7:53–55, 7:67–8:4. The catheter assembly of Figure 8 includes optional
`tapered inner catheter 14, whereas the apparatus of Figure 9 does not. Id.
`
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`IPR2020-01341
`Patent 8,142,413 B2
`The ’413 patent states “the presence of coaxial guide catheter 12
`within guide catheter 56” provides “improved distal anchoring of guide
`catheter 56 and coaxial guide catheter 56” and “stiffer back up support than
`guide catheter 56 alone.” Id. at 7:67–8:6. The ’413 patent describes in
`detail a method of use, as follows:
`In operation, a guide catheter 56 is inserted into a major blood
`vessel in the body such as aortic arch 58 over guidewire 64 and
`the distal end 68 of guide catheter 56 is brought into proximity
`of ostium 60 of a smaller branch blood vessel, such as coronary
`artery 62, that it is desired to enter. Coaxial guide catheter 12,
`with tapered inner catheter 14, is inserted through guide
`catheter 56 and over guidewire 64. Guide catheter 56,
`guidewire 64, coaxial guide catheter 12, and tapered inner
`catheter 14 are manipulated to insert tapered inner catheter tip 42
`into the ostium 60 of the blood vessel that branches off from the
`major blood vessel. The bump tip 22 of coaxial guide catheter 12
`is inserted with tapered inner catheter tip 42 well into ostium 60
`of coronary artery 62 or other blood vessel until bump tip 22 of
`coaxial guide catheter 12 achieves a deep seated position.
`Tapered inner catheter 14 is then withdrawn from the lumen of
`coaxial guide catheter 12. An interventional cardiology
`treatment device such as a catheter bearing a stent or a balloon
`(not shown) is then inserted through the lumen of coaxial guide
`catheter 12 which remains inside guide catheter 56.
`When the interventional cardiology device reaches a steno sis
`or blockage in coronary artery 62 or another branch blood vessel,
`force may be applied to the interventional cardiology device
`catheter while reinforced portion 18 and rigid portion 20 of
`coaxial guide catheter 12 provide back up support. The back
`force that would tend to dislodge bump tip 22 from a deep seated
`position in the ostium in the branch blood vessel is transferred
`through reinforced portion 18 to rigid portion 20 of coaxial guide
`catheter 12. A physician may apply a force to the proximal end
`of the coaxial guide catheter 12 to resist dislodging of bump
`tip 22 from the ostium of the branch artery.
`
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`IPR2020-01341
`Patent 8,142,413 B2
`Id. at 9:51–10:15; see also id. at 1:23–26 (stating that “the term
`‘interventional cardiology devices’ is to be understood to include but not be
`limited to guidewires, balloon catheters, stents and stent catheters”). Patent
`Owner summarizes the method described in the ’413 patent and notes the
`use of the tapered inner catheter is optional. See PO Resp. 3 (stating that
`“[o]ptionally, a tapered inner catheter may be inserted with the coaxial guide
`catheter and advanced to the second vessel, and removed before an
`[interventional cardiology device] is inserted into the coaxial guide catheter”
`(citing Ex. 1001, 9:55–66).
`D. Illustrative Claim of the ’413 Patent
`Petitioner challenges claims 1, 2, 4, 5, and 7–14 of the ’413 patent.
`Pet. 1. Claim 1, reproduced below, is the only independent claim of
`the ’413 patent and is illustrative of the claimed subject matter.
`1. A method of providing backup support for an interventional
`cardiology device for use in the coronary vasculature, the
`interventional cardiology device being adapted to be passed
`through a standard guide catheter, the standard guide catheter
`having a continuous lumen extending for a predefined length
`from a proximal end at a hemostatic valve to a distal end adapted
`to be placed in a branch artery, the continuous lumen of the guide
`catheter having a circular cross-sectional inner diameter sized
`such that interventional cardiology devices are insertable into
`and through the lumen, the method comprising:
`[1.a] inserting the standard guide catheter into a first artery over
`a guidewire, the standard guide catheter having a distal end;
`[1.b] positioning the distal end of the standard guide catheter in
`a branch artery that branches off from the first artery;
`[1.c] inserting a flexible tip portion of a coaxial guide catheter
`defining a tubular structure having a circular cross-section and a
`length that is shorter than the predefined length of the continuous
`lumen of the standard guide catheter, into the continuous lumen
`of the standard guide catheter, and,
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`[1.d] further inserting a substantially rigid portion that is
`proximal of, operably connected to, and more rigid along a
`longitudinal axis than the flexible tip portion, into the continuous
`lumen of the standard guide catheter, the substantially rigid
`portion defining a rail structure without a lumen and having a
`maximal cross-sectional dimension at a proximal portion that is
`smaller than the cross-sectional outer diameter of the flexible tip
`portion and having a length that, when combined with the length
`of the flexible distal tip portion, defines a total length of the
`device along the longitudinal axis that is longer than the length
`of the continuous lumen of the guide catheter;
`[1.e] advancing a distal portion of the flexible tip portion
`distally beyond the distal end of the standard guide catheter and
`into the second artery such that the distal portion extends into the
`second artery and such that at least a portion of the proximal
`portion of the substantially rigid portion extends proximally
`through the hemostatic valve; and
`[1.f]
`inserting the interventional cardiology device into and
`through the continuous lumen of the standard guide catheter
`alongside of the substantially rigid portion and advancing the
`interventional cardiology device through and beyond a lumen of
`the flexible tip portion into contact with or past a lesion in the
`second artery.
`Ex. 1001, 10:28–11:6 (bracketed labeling added).
`E. References and Testimony
`Petitioner’s contentions rely, in part, on testimony from Dr. Brecker,
`Dr. Hillstead, and Mr. Jones. Dr. Brecker states that he has been an
`interventional cardiologist for over 24 years, that he has been Chief of
`Cardiology at St. Georges University Hospitals London since 2015, and that
`he is a Professor of Cardiology and Chief of Cardiology Clinical Academic
`Group at St. George’s University. Ex. 1005 ¶¶ 4, 5, 7. Dr. Hillstead states
`that he is CEO of a medical device development and entrepreneurship
`consulting firm, the Chairman of a wound healing device company, a named
`
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`IPR2020-01341
`Patent 8,142,413 B2
`inventor on numerous patents and pending applications related to catheter
`design, and that he has been involved in the design and development of
`medical devices for more than thirty years. Ex. 1042 ¶¶ 5, 10, 12. Mr. Jones
`states that he has worked in contract mechanical engineering since 1997 on
`projects including “prototype designs for minimally invasive, surgical, and
`implantable devices, development and fabrication for surgical devices, test
`fixture design and fabrication, and process validation,” that he previously
`worked as an engineer on medical device design, development and
`manufacturing, including on catheters, and that he is a named inventor on
`over 100 patents. Ex. 1807 ¶¶ 8–10.
`Patent Owner’s arguments rely, in part, on testimony from Mr. Keith
`and Dr. Graham. Mr. Keith states that his work between 1987 and 1996 as
`an engineer at a medical device company focused in the field of
`interventional cardiology and catheter design, that since 1997 he has served
`as an independent consultant for early stage medical device companies in
`product design and intellectual property development, that he co-founded a
`medical device company “focused on catheter-based treatments for chronic
`sinusitis,” and that he is a named inventor on over 140 patents. Ex. 2138
`¶¶ 3–6. Dr. Graham states that he is an interventional cardiologist at St.
`Michael’s Hospital, an Assistant Professor in the Division of Cardiology at
`the University of Toronto, and that he has over twenty years of experience in
`interventional cardiology. Ex. 2145 ¶ 1.
`Below we provide a table identifying the references asserted by
`Petitioner, as well as the exhibits corresponding to the declarations and
`
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`IPR2020-01341
`Patent 8,142,413 B2
`deposition testimony in the record for Dr. Brecker, Dr. Hillstead, Mr. Jones,
`Mr. Keith, and Dr. Graham.4
`References and Witness Testimony
`
`Date
`
`U.S. Patent No. 7,736,355 B2 (“Itou”)
`U.S. Patent No. 7,604,612 B2 (“Ressemann”)
`
`Ex.
`No.
`June 15, 2010 1007
`October 20,
`1008
`2009
`July 30, 2020
`
`1005
`
`1806
`
`Declaration of Stephen Jon David Brecker, MD,
`FRCP, FESC, FACC
`August 6,
`Supplemental Declaration of Stephen Jon David
`2021
`Brecker, MD, FRCP, FESC, FACC
`Deposition Transcript of Stephen Brecker, M.D. April 20, 2021 2245
`Deposition Transcript of Stephen Brecker, M.D.
`September 14,
`2260
`2021
`1042
`July 30, 2020
`Declaration of Dr. Richard A. Hillstead, Ph.D.
`Deposition Transcript of Richard Hillstead, Ph.D. April 13, 2021 2244
`Declaration of Michael Jones Submitted in
`August 6,
`1807
`Support of Petitioner’s Replies and Petitioner’s
`2021
`Opposition to Patent Owner’s Motion to Amend
`Deposition Transcript of Michael Jones
`
`Declaration of Peter T. Keith
`Deposition Transcript of Peter T. Keith
`Declaration of Dr. John J. Graham, MB, ChB,
`MRCP (UK)
`Deposition Transcript of Dr. John J. Graham,
`MB, ChB, MRCP (UK)
`
`2259
`
`September 9,
`2021
`May 14, 2021 2138
`July 8, 2021
`1797
`May 13, 2021 2145
`
`June 10, 2021 1846
`
`
`4 The table provided identifies only a select number of documents.
`A complete identification of the papers and exhibits that form the record of
`this case is available in the docket of this proceeding. See also Paper 68
`(Patent Owner’s Exhibit List); Paper 74 (Petitioner’s Exhibit List).
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`IPR2020-01341
`Patent 8,142,413 B2
`F. Asserted Grounds of Unpatentability
`Petitioner alleges unpatentability of the Challenged Claims on the
`following grounds:
`Claims
`Challenged
`1, 2, 4, 7–14
`1, 2, 4, 5, 7–14
`1, 2, 4, 5, 7–14
`
`35 U.S.C. §5
`
`Reference(s)/Basis
`
`103(a)
`103(a)
`103(a)
`
`Itou
`Itou
`Itou, Ressemann
`
`Pet. 7.
`
`II. MOTION TO EXCLUDE
`The party moving to exclude evidence bears the burden of proving
`that it is entitled to the relief requested—namely, that the material sought to
`be excluded is inadmissible under the Federal Rules of Evidence (“FRE”).
`See 37 C.F.R. §§ 42.20(c), 42.62(a) (2019). In an inter partes review in
`which we both decide admissibility and serve as the fact-finder, we are well-
`positioned to determine and assign appropriate weight to evidence presented,
`and we recognize that a complete record of the evidence is preferable to
`facilitate public access as well as appellate review. See, e.g., Sony Computer
`Entm’t Am. LLC v. Game Controller Tech. LLC, IPR2013-00634,
`Paper 32 at 31 (PTAB Apr. 14, 2015); see also Gnosis S.p.A. v. S. Alabama
`Med. Sci. Found., IPR2013-00118, Paper 64 at 43 (PTAB June 20, 2014)
`(citing Donnelly Garment Co. v. NLRB, 123 F.2d 215, 224 (8th Cir. 1941)
`
`
`5 The Leahy-Smith America Invents Act (“AIA”) included revisions to
`35 U.S.C. §§ 102, 103 that became effective on March 16, 2013. Pub. L.
`No. 112-29, §§ 3(b)–3(c), 3(n)(1), 125 Stat. 284, 285–87, 293 (2011). There
`is no dispute that the Challenged Claims have an effective filing date before
`March 16, 2013, and we apply the pre-AIA versions of these statutes.
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`(“If the record on review contains not only all evidence which was clearly
`admissible, but also all evidence of doubtful admissibility, the court which is
`called upon to review the case can usually make an end of it, whereas if
`evidence was excluded which that court regards as having been admissible, a
`new trial or rehearing cannot be avoided.”)).
`
`Petitioner moves to exclude Exhibit 2024, a document titled “Product
`Requirements: Guideliner Catheter System,” as well as certain portions of
`the deposition testimony of Steven Erb (specifically, Ex. 1799, 37:2–7,
`37:20–38:6, 39:17–40:20). Paper 73 (the “Motion”); see also Paper 82
`(Petitioner’s reply in support of its motion to exclude). Patent Owner
`opposes the Motion. Paper 77.
`
`Petitioner argues Patent Owner failed to authenticate Exhibit 2024,
`citing FRE 901. Paper 73, 3–10. Petitioner also argues that the portions of
`the testimony of Mr. Erb it seeks to exclude are prejudicial, citing FRE 403.
`Id. at 10–15. For purposes of this Decision, we do not rely on either
`Exhibit 2024 or the portions of Mr. Erb’s testimony Petitioner seeks to
`exclude. Accordingly, we dismiss the Motion as moot.
`III. ANALYSIS OF PATENTABILITY
`In our analysis of Petitioner’s unpatentability contentions with respect
`to the Challenged Claims, we next address the applicable principles of law;
`the level of ordinary skill in the art; the proposed construction of claim
`terms; the scope and content of the asserted prior art; and then further
`analyze Petitioner’s contentions with respect to each alleged ground of
`unpatentability for purposes of determining whether Petitioner shows by a
`preponderance of the evidence the unpatentability of the Challenged Claims.
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`
`A. Principles of Law
`Petitioner contends under one ground that claims of the ’413 patent
`are unpatentable based on anticipation. Pet. 21–70. A claim is anticipated if
`a single prior art reference either expressly or inherently discloses every
`limitation of the claim. Orion IP, LLC v. Hyundai Motor Am., 605 F.3d 967,
`975 (Fed. Cir. 2010). “A single prior art reference may anticipate without
`disclosing a feature of the claimed invention if such feature is necessarily
`present, or inherent, in that reference.” Allergan, Inc. v. Apotex Inc.,
`754 F.3d 952, 958 (Fed. Cir. 2014) (citing Schering Corp. v. Geneva
`Pharm., 339 F.3d 1373, 1377 (Fed. Cir. 2003)).
`Petitioner contends under two grounds that claims of the ’413 patent
`are unpatentable based on obviousness. Pet. 70–95. As set forth in
`35 U.S.C. § 103(a),
`[a] patent may not be obtained . . . if the differences between the
`subject matter sought to be patented and the prior art are such
`that the subject matter as a whole would have been obvious at the
`time the invention was made to a person having ordinary skill in
`the art to which said subject matter pertains.
`The question of obviousness is resolved on the basis of underlying factual
`determinations including (1) the scope and content of the prior art; (2) any
`differences between the claimed subject matter and the prior art; (3) the level
`of ordinary skill in the art; and (4) when in evidence, objective evidence of
`nonobviousness. Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966).
`An obviousness analysis “need not seek out precise teachings directed to the
`specific subject matter of the challenged claim, for a court can take account
`of the inferences and creative steps that a person of ordinary skill in the art
`would employ.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007);
`accord In re Translogic Tech., Inc., 504 F.3d 1249, 1259 (Fed. Cir. 2007).
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`However, Petitioner cannot satisfy its burden of proving obviousness by
`employing “mere conclusory statements.” In re Magnum Oil Tools
`Int’l, Ltd., 829 F.3d 1364, 1380 (Fed. Cir. 2016). Instead, Petitioner must
`articulate a reason why a person of ordinary skill in the art would have
`combined the prior art references. In re NuVasive, 842 F.3d 1376, 1382
`(Fed. Cir. 2016).
`
`B. 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
`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
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`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. 1005 ¶ 31; Ex. 1042 ¶¶ 18–19).
`Patent Owner does not dispute Petitioner’s proposed level of ordinary
`skill. PO Resp. 6. 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.
`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. 1042 ¶¶ 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.”).
`C. 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.
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`Patent 8,142,413 B2
`§ 42.100(b). 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).
`1. Whether the Steps of Claim 1 Must be Performed in
`the Order Written
`Claim 1 of the ’413 patent recites a method comprised of six steps.
`Ex. 1001, 10:28–11:6; see also, supra, Section I.D. (reproducing claim 1
`and labeling six steps [1.a] to [1.f]). Whether the steps recited in a method
`claim must be performed in a particular order is properly a part of claim
`construction. See, e.g., Altiris, Inc. v. Symantec Corp., 318 F.3d 1363,
`1371–72 (Fed. Cir. 2003). Steps in a method claim need not necessarily be
`performed in the order they are written, but if grammar, logic, the
`specification, or the prosecution history require the steps to be performed
`sequentially, then the claims are so limited. Id. at 1369; see also Loral
`Fairchild Corp. v. Sony Corp., 181 F.3d 1313, 1322 (Fed. Cir. 1999)
`(“Although not every process claim is limited to the performance of its steps
`in the order written, the language of the claim, the specification and the
`prosecution history support a limiting construction in this case.”).
`“Interactive Gift recites a two-part test for determining if the steps of a
`method claim that do not otherwise recite an order, must nonetheless be
`performed in the order in which they are written.” Altiris, 318 F.3d 1369
`(citing Interactive Gift Express, Inc. v. CompuServe Inc., 256 F.3d 1323,
`1342–43 (Fed. Cir. 2001)). “First, we look to the claim language to
`determine if, as a matter of logic or grammar, they must be performed in the
`order written.” Id. “If not, we next look to the rest of the specification to
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`determine whether it directly or implicitly requires such a narrow
`construction.” Id. at 1370 (citation omitted).
`Petitioner argues that certain steps of claim 1 need not be performed
`in the order recited in the claim. Pet. 49 n.12. In abbreviated summary,
`claim 1 recites the follo