Trials@uspto.gov
`571-272-7822
`
`Paper No. 74
`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 LIFE SCIENCES LIMITED,
`Patent Owner.
`
`IPR2020-01342
`Patent 8,142,413 B2
`
`
`
`
`
`
`
`
`
`Before SHERIDAN K. SNEDDEN, JAMES A. TARTAL, and
`CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.
`SNEDDEN, Administrative Patent Judge.
`
`
`
`JUDGMENT
`Final Written Decision
`Determining No Challenged Claims Unpatentable
`35 U.S.C. § 318(a)
`
`
`
`
`
`
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`IPR2020-01342
`Patent 8,142,413 B2
`
`I. INTRODUCTION
`We have jurisdiction under 35 U.S.C. § 6. We issue this Final Written
`Decision pursuant to 35 U.S.C. § 318(a) and 37 C.F.R. § 42.73 in an inter
`partes review involving Medtronic, Inc., and Medtronic Vascular, Inc.
`(“Petitioner”) and Teleflex Life Sciences Limited (“Patent Owner”).1 Based
`on the record before us, we conclude that Petitioner has not demonstrated,
`by a preponderance of the evidence, that claims 1, 2, 4, 5, and 7–14 of U.S.
`Patent No. 8,142,413 B2 (“the ’413 patent,” Ex. 1401) are unpatentable.
`
`A. Background
`Petitioner filed a Petition for inter partes review of claims 1, 2, 4, 5,
`and 7–14 of the ’413 patent. Paper 1 (“Pet.”). Patent Owner filed a
`Preliminary Response. Paper 7. We determined, based on the information
`presented in the Petition and Preliminary Response, that there was a
`reasonable likelihood that Petitioner would prevail in showing that at least
`one of the challenged claims was unpatentable over the cited art. Pursuant
`to 35 U.S.C. § 314, the Board instituted trial on February 9, 2021. Paper 9.
`Following institution, Patent Owner filed a Response to the Petition
`(Paper 24, “PO Resp.”), Petitioner filed a Reply to Patent Owner’s Response
`(Paper 40, “Reply”), and Patent Owner filed a Sur-reply (Paper 52).2
`
`
`1 Teleflex Life Sciences Limited (“Teleflex”) filed a notice identifying itself
`as the owner of U.S. Patent No. 8,142,413 B2. Paper 5, 2. Teleflex further
`explained, “Teleflex Innovations S.A.R.L. merged into Teleflex Medical
`Devices S.A.R.L., and Teleflex Medical Devices S.A.R.L. transferred
`ownership of U.S. Patent No. 8,142,413 to Teleflex Life Sciences Limited.”
`See id. at 2 n.1 (furthering stating that “[t]he assignment documents were
`recorded with the United States Patent & Trademark Office on January 27,
`2020”).
`2 Redacted versions of the PO Response and Reply are entered as Papers 25
`and 41, respectively.
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`IPR2020-01342
`Patent 8,142,413 B2
`On November 18, 2021, the parties presented arguments at an oral
`hearing. The transcript of the hearing has been entered into the record.
`Paper 73.
`
`B. Related Matters
`Petitioner filed a separate Petition for inter partes review of claims 1,
`2, 4, 5, and 7–14 of the ’413 patent as IPR2020-01341. The final written
`decision is pending in IPR2020-01341.
`Petitioner also previously 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
`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. We issued final written decisions
`determining that none of the challenged claims were unpatentable in the
`other proceedings.
`The parties indicate that the ’413 patent is the subject of litigation in
`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 5, 2.
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`IPR2020-01342
`Patent 8,142,413 B2
`C. The ’413 Patent
`1. Specification
`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
`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
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`IPR2020-01342
`Patent 8,142,413 B2
`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
`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.
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`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,
`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
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`IPR2020-01342
`Patent 8,142,413 B2
`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.
`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
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`IPR2020-01342
`Patent 8,142,413 B2
`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.
`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
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`IPR2020-01342
`Patent 8,142,413 B2
`[interventional cardiology device] is inserted into the coaxial guide catheter”
`(citing Ex. 1001, 9:55–66).
`
`2. Illustrative Claims
`Independent claim 1, reproduced below, is illustrative of the
`challenged claims.
`1. [1pre.] 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:
`[1a] inserting the standard guide catheter into a first artery
`over a guidewire, the standard guide catheter having a distal end;
`[1b] positioning the distal end of the standard guide
`catheter in a branch artery that branches off from the first artery;
`[1c] 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,
`[1d] 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
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`IPR2020-01342
`Patent 8,142,413 B2
`device along the longitudinal axis that is longer than the length
`of the continuous lumen of the guide catheter;
`[1e] 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
`[1f] 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. 1401, 10:30–11:6 (emphasis and bracketing added).
`
`D. Evidence
`Petitioner relies upon the following prior art references.
`Ex. 1409, S. B. Kontos, U.S. Patent No. 5,439,445 (issued Aug. 8,
`
`1995) (“Kontos”).
`
`Ex. 1410, S. 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) (“Takahashi”).
`
`Ex. 1435, D. O. Adams et al., U.S. Patent Application Publication No.
`2004/0010280 A1 (published Jan. 15, 2004) (“Adams”).
`Petitioner relies upon the Declarations of Dr. Stephen Brecker
`(Ex. 1405) and Dr. Richard Hillstead (Ex. 1442) in support of its Petition.
`Patent Owner relies upon the Declarations of Peter T. Keith
`(Ex. 2138) and Dr. John J. Graham, MB, ChB, MRCP (UK) (Ex. 2145).
`
`E. Asserted Grounds of Unpatentability
`Petitioner asserts that claims 1, 2, 4, 5 and 7–14 would have been
`unpatentable on the following grounds.
`
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`IPR2020-01342
`Patent 8,142,413 B2
`
`Ground
`
`Claim(s)
`
`35 U.S.C. §3
`
`References/Basis
`
`1, 2, 4, 5, 7–12, 14
`
`13
`
`103(a)
`
`103(a)
`
`Kontos, Adams
`
`Kontos, Adams, Takahashi
`
`1
`
`2
`
`
`II. ANALYSIS
`A. Level of Ordinary Skill in the Art
`The person having ordinary skill in the art is a hypothetical person
`who is presumed to be aware of all the relevant prior art. Custom
`Accessories, Inc. v. Jeffrey-Allan Indust., Inc., 807 F.2d 955, 962 (Fed. Cir.
`1986); Kimberly-Clarke Corp. v. Johnson & Johnson, 745 F.2d 1437, 1453
`(Fed. Cir. 1984). Moreover, the prior art itself is generally sufficient to
`demonstrate the level of skill in the art at the time of the invention. 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)).
`Petitioner asserts “[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. 11–12. Alternatively,
`
`
`3 The Leahy-Smith America Invents Act, Pub. L. No. 112-29, 125 Stat. 284
`(2011) (“AIA”), amended 35 U.S.C. § 103. Because the challenged claims
`of the ’413 patent have an effective filing date before the effective date of
`the applicable AIA amendments, we refer to the pre-AIA version of 35
`U.S.C. § 103 throughout this Decision.
`
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`Patent 8,142,413 B2
`Petitioner asserts “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. at 12.
`Additionally, Petitioner contends “[e]xtensive experience and technical
`training might substitute for education, and advanced degrees might
`substitute for experience.” Id. Petitioner further asserts that “a POSITA
`with a medical degree may have access to a POSITA with an engineering
`degree, and a POSITA with an engineering degree may have access to one
`with a medical degree.” Id. (citing Ex. 1405 ¶ 27; Ex. 1442 ¶¶ 18–19).
`Patent Owner does not dispute Petitioner’s proposed definition of a
`person of ordinary skill in the art.
`We apply both of Petitioner’s definitions for a POSITA, as they are
`undisputed and consistent with the level of skill reflected in the prior art and
`the specification of the ’413 patent. See Okajima, 261 F.3d at 1355 (the
`prior art itself can reflect the appropriate level of ordinary skill in the art).
`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.”).
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`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). Under this standard, we construe
`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. Furthermore, we need only construe
`the claims to the extent necessary resolve the dispute between the parties.
`See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d
`1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in
`controversy, and only to the extent necessary to resolve the controversy.’”
`(quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803
`(Fed. Cir. 1999))).
`Petitioner proposes construction for several claim terms, including
`“interventional cardiology devices,” “standard guide catheter,” and “placed
`in a branch artery.” Pet. 13–16. We determine that it is unnecessary to
`expressly construe any claim term to resolve the dispute between the parties.
`However, we address the dispute between the parties as to whether claim 1
`requires the recited steps to be performed sequentially.
`Claim 1 of the ’413 patent recites a method comprised of six steps.
`Ex. 1401, 10:28–11:6; see also, supra, Section I.D. (reproducing claim 1
`and labeling six steps [a] to [f]). Whether the steps recited in a method
`claim must be performed in a particular order is an issue 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. The claims may be so limited,
`however, if grammar, logic, the specification, or the prosecution history
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`otherwise requires the steps to be performed sequentially. 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
`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.15. In abbreviated summary,
`claim 1 recites the following six steps:
`[1a] “inserting the standard guide catheter . . . into a first artery;”
`[1b] “positioning . . . the standard guide catheter in a branch artery;”
`[1c] “inserting a flexible tip portion of a coaxial guide catheter;”
`[1d] “further inserting a substantially rigid portion . . . connected to
`the flexible tip portion;”
`[1e] “advancing . . . the flexible tip portion” beyond the “end of the
`standard guide catheter and into the second artery;” and
`[1f] “inserting the [ICD] . . . alongside of the substantially rigid
`portion and advancing the [ICD] device through and beyond a
`lumen of the flexible tip portion.”
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`Ex. 1401, 10:28–11:6. Petitioner specifically contends that step 1f allows
`for either preassembly of a coaxial guide and ICD, or sequential insertion of
`the two. Pet. 2. According to Petitioner, “[t]here is nothing in the language”
`of step [f] “that requires the coaxial guide catheter to be inserted first,
`followed (separately) by the interventional cardiology device,” and that
`“[t]he devices are inserted ‘alongside’ one another” in either instance.
`Pet. 49 n.15 (citing Interactive Gift Express, 256 F.3d at 1342). Petitioner
`further suggests that under its interpretation, step 1f
`requires that two things be positioned “alongside” each other:
`(a) the [ICD]; and (b) the coaxial guide catheter’s substantially
`rigid portion. ‘Alongside’ is an adjective that accurately reflects
`the relative positions of (a) and (b), even where the two are
`preassembled.
`Reply 3–4. Petitioner does not address in the Petition whether steps 1a to 1e
`must be performed sequentially, and, if so, how that comports with its
`argument that step 1f need not be in the sequence recited. Petitioner, in the
`Petition, also does not direct us to anything additional in the Specification of
`the ’413 patent to support its proposed construction. See generally Pet.
`In determining whether steps of a method must be performed in order,
`we must first look to the claim language to determine whether, “as a matter
`of logic or grammar,” the method steps must be performed in the order
`written. See Altiris, 318 F.3d at 1369. Patent Owner argues, and we agree,
`that the method of claim 1 “only makes sense if the steps take place in
`order.” PO Resp. 13. As Patent Owner explains, step 1b (positioning the
`standard guide catheter) cannot logically occur until after step 1a (inserting
`the standard guide catheter), steps 1c–1e (inserting various parts of the
`coaxial guide catheter) must occur in sequence, and step 1e (advancing the
`coaxial guide catheter beyond the standard guide catheter) necessarily
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`IPR2020-01342
`Patent 8,142,413 B2
`requires performing steps 1a and 1b prior to steps 1c to 1e. Id. at 13–14
`(citing Ex. 1401, 10:39–67; Ex. 2138 ¶ 102; Ex. 2145 ¶¶ 102–106; Ex. 2244,
`61:24–62:3; Ex. 2245, 87:24–88:14, 89:21–90:3, 90:13–23).
`As to the disputed step 1f, Patent Owner further explains, and we
`agree, “as a matter of logic and grammar, . . . claim 1 requires that step 1.f
`(insertion and advancement of the ICD) occur after steps 1.c-1.e. (insertion
`of the coaxial guide catheter in the guide catheter).” Id. at 16. Specifically,
`Patent Owner shows “the ICD would not be inserted ‘into and through’ the
`lumen of the guide catheter ‘alongside of’ the substantially rigid portion of
`the coaxial guide catheter unless the coaxial guide catheter is already in the
`guide catheter.” Id. at 14 (citing Ex. 2138 ¶ 103; Ex. 2145 ¶ 103). That is,
`in the context of the claim, “inserting an ICD ‘alongside of the substantially
`rigid portion’ means that the substantially rigid portion is already in place
`inside the guide catheter, and when the ICD is inserted into the guide
`catheter it moves ‘alongside’ the already positioned substantially rigid
`portion.” Id. at 14–15 (citing Ex. 2138 ¶ 103; Ex. 2145 ¶ 103).
`Furthermore, as Patent Owner notes, “Petitioner’s own expert, Dr. Hillstead,
`agrees that ‘alongside’ in this context means that the substantially rigid
`portion is already in place in the guide catheter when the ICD is inserted
`‘alongside’ of it.” Id. at 15 (citing Ex. 2244, 63:6–64:1).
`We further find that Patent Owner persuasively shows that the claim
`language of step 1f requires “advancing” the ICD “through and beyond a
`lumen of the flexible tip portion” of the coaxial guide catheter, which
`“strongly suggests that the flexible tip of the coaxial guide catheter is
`already in the anatomy.” Id. (citing Ex. 1401, 10:39–11:6; Ex. 2138 ¶ 103;
`Ex. 2145 ¶ 103). Patent Owner also shows that “Petitioner’s expert
`Dr. Hillstead agreed that step 1.f requires that insertion of the ICD in claim 1
`
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`IPR2020-01342
`Patent 8,142,413 B2
`of the ʼ413 patent ‘take place after the prior steps that are recited in the
`claim.’” Id. (citing Ex. 2244, 62:18–24; 63:13–64:1).
`Having determined that, as a matter of logic or grammar, the steps of
`claim 1 must be performed in the order written, we need not look to the
`Specification “to determine whether it directly or implicitly requires” the
`same. See Altiris, 318 F.3d at 1370. Nevertheless, we note that our
`determination that claim 1 requires the steps to be performed in the order
`written is consistent with the Specification. Patent Owner explains, and we
`agree, that the Specification describes sequential operation as follows:
`“a guide catheter 56 is inserted into a major blood vessel . . .
`[c]oaxial guide catheter 12 . . . is inserted through guide
`catheter 56 . . . coaxial guide catheter 12 achieves a deep seated
`position . . . [a]n interventional cardiology treatment device such
`as a catheter bearing a stent or balloon (not shown) is then
`inserted through the lumen of coaxial guide catheter 12, which
`remains inside guide catheter 56.”
`PO Resp. 17 (quoting Ex. 1401, 9:49–10:3 (emphasis added)).
`Petitioner’s arguments in reply in support of its proposed construction
`are not persuasive. Reply 2–4. Petitioner concedes that claim 1 requires
`some steps to be performed in the order written, including steps 1a to 1e, but
`maintains that “the plain language of the claims permits an [ICD] to be
`advanced either simultaneously with the guide extension catheter or
`sequentially.” Pet. Reply 2 (citing Ex. 1405 ¶¶ 200–205; Ex. 1806 ¶¶ 17–
`23; Pet. 49–52). Petitioner’s conclusory assertion fails to show any rationale
`based on logic or grammar in support of its assertion. Petitioner further
`argues that “[t]he [S]pecification’s disclosure of an embodiment in which
`insertion is sequential does not limit the claims.” Id. at 2–3 (citing Altiris,
`318 F.3d at 1369–1371). We agree the single embodiment disclosed does
`not limit the claims, and do not rely on the disclosed embodiment in such a
`
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`Patent 8,142,413 B2
`manner; however, the single disclosed embodiment and the Specification as
`a whole consistently require the steps recited in claim 1 to be performed in
`the order written, which is consistent with the construction we adopt. We
`have considered Petitioner’s remaining arguments and find they have no
`merit. See Reply 3–4. In sum, Petitioner seeks to show that “[t]his is not a
`case in which sequential insertion is required to perform the claimed
`method.” Id. at 3. The issue of claim construction presented is not whether
`the steps of the claimed method could, in the abstract, be performed out of
`the order in which they were written, but whether “as a matter of logic or
`grammar,” the steps of claim 1 must be performed in the order written. For
`the reasons discussed above, Patent Owner has shown that logic and
`grammar require that the steps of claim 1 must be performed in the order
`written.
`Lastly, Petitioner argues that the ’413 patent does not require every
`step to be performed in the order recited based on arguments Petitioner
`raises based on steps required by dependent claims 10 and 11. Reply 4 n.1.
`Claims 10 and 11 recite additional requirements relevant to the insertion of
`the ICD and further limit step 1f in independent claim 1. Ex. 1401, 12:14–
`25. Petitioner’s argument that claims 10 and 11 include additional steps that
`need not be performed in a specific sequence has no relevance to whether
`the steps of the method of claim 1 must be performed in the order
`written.For all of the reasons discussed above, we determine that claim 1
`recites a method comprised of a series of steps that must be performed in the
`order written in the claim.
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`Patent 8,142,413 B2
`C. Petitioner’s Patentability Challenges
`1. Ground 1: Obviousness in view of Kontos and Adams
`Petitioner asserts that claims 1, 2, 4, 5, 7–12, and 14 are unpatentable
`under 35 U.S.C. § 103(a) as obvious over Kon