PUBLIC VERSION
`
`Trials@uspto.gov
`571-272-7822
`
`Paper
`Date:
`
`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.
`
`IPR2020-00127
`Patent 8,048,032 B2
`
`Before SHERIDAN K. SNEDDEN, JON B. TORNQUIST, and
`CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.
`SNEDDEN, Administrative Patent Judge.
`
`JUDGMENT
`Final Written Decision
`Determining Some Challenged Claims Unpatentable
`Granting Patent Owner’s Contingent Motion to Amend
`35 U.S.C. § 318(a)
`
`PUBLIC VERSION
`
`

`

`IPR2020-00127
`Patent 8,048,032 B2
`
`I. INTRODUCTION
`Medtronic, Inc. and Medtronic Vascular, Inc. (“Petitioner”) filed a
`Petition for inter partes review of claims 1–9 and 11–20 of U.S. Patent No.
`8,048,032 (“the ’032 patent,” Ex. 1401). Paper 3 (“Pet.”). Teleflex
`Innovations S.À.R.L. (“Patent Owner”)1 filed a Preliminary Response.
`Paper 10 (“Prelim. Resp.”). Upon review of the parties’ arguments and
`supporting evidence, we instituted an inter partes review of all claims and
`grounds asserted in the Petition. Paper 20 (“Inst. Dec.”).
`Patent Owner subsequently filed a Patent Owner Response (Paper 40,
`“PO Resp.”) (redacted version available at Paper 41), Petitioner filed a
`Reply (Paper 71, “Pet. Reply”) (redacted version available at Paper 70), and
`Patent Owner filed a Sur-Reply (Paper 86, “Sur-Reply”) (redacted version
`available at Paper 87).
`Patent Owner also filed a Contingent Motion to Amend. Paper 82
`(“MTA”). The Motion requests that if claims 1 or 12 of the ’032 patent are
`determined to be unpatentable, they should be replaced by proposed
`substitute claims 23–25 (“proposed substitute claims” or “proposed claims”).
`MTA 1. Petitioner filed an Opposition to the Motion to Amend (Paper 85,
`“Pet. MTA Opp.”), to which Patent Owner filed a reply (Paper 89,
`“PO MTA Reply”), and Petitioner filed a sur-reply (Paper 95, “Pet. MTA
`Sur-reply”).
`
`
`1 Patent Owner represents that “Teleflex Innovations S.A.R.L. merged into
`Teleflex Medical Devices S.A.R.L,” which subsequently “transferred
`ownership of [the ’032 patent] to Teleflex Life Sciences Limited.” Paper 7,
`2.
`
`2
`
`PUBLIC VERSION
`
`

`

`IPR2020-00127
`Patent 8,048,032 B2
`An oral hearing was held on March 8, 2021, and a transcript of the
`hearing is included in the record. Paper 104 (“Tr.”) (redacted version
`available at Paper 103).
`A. Real Parties in Interest
`Petitioner identifies its real parties-in-interest as Medtronic, Inc. and
`Medtronic Vascular, Inc., and notes that “Medtronic plc is the ultimate
`parent of both entities.” Pet. 4.
`Patent Owner identifies its real parties-in-interest as Teleflex Medical
`Devices S.À.R.L.; Vascular Solutions LLC; Arrow International, Inc.; and
`Teleflex LLC. Paper 4, 2. Patent Owner also notes that “Teleflex
`Incorporated is the ultimate parent of the entities listed above.”
`B. Related Matters
`The parties indicate that the ’032 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) (“Medtronic”) and QXMedical, LLC v. Vascular
`Solutions, LLC, No. 17-cv-01969 (D. Minn., filed June 8, 2017). Pet. 4–5;
`Paper 4, 2.
`The ’032 patent was the subject of two previous inter partes reviews:
`IPR2014-00760, filed May 16, 2014 and terminated August 11, 2014 by way
`of joint motion to terminate, and IPR2014-00761, filed May 16, 2014 and
`terminated August 11, 2014 by way of joint motion to terminate. Paper 4,
`2–3.
`Petitioner has filed a separate Petition for inter partes review of
`claims 1–20 and 22 of the ’032 patent as IPR2020-00126.
`
`3
`
`PUBLIC VERSION
`
`

`

`IPR2020-00127
`Patent 8,048,032 B2
`C. The ’032 Patent
`Specification
`1.
`The ’032 patent, entitled “Coaxial Guide Catheter for Interventional
`Cardiology Procedures,” issued on November 1, 2011, from a non-
`provisional application filed May 3, 2006. Ex. 1401, codes (45), (54), (22).
`The ’032 patent relates generally to a coaxial guide catheter for use
`with interventional cardiology devices that are insertable into a branch artery
`that branches off from a main artery. Ex. 1401, Abstract. According to the
`’032 patent, interventional cardiology procedures often include inserting
`guidewires or other instruments through catheters into coronary arteries that
`branch off from the aorta. Id. at 1:15–17. In coronary artery disease, the
`coronary arteries may be narrowed or occluded by atherosclerotic plaques or
`other lesions in a phenomenon known as stenosis. Id. at 1:20–26. In
`treating the stenosis, a guide catheter is inserted through the aorta and into
`the ostium of the coronary artery, sometimes with the aid of a guidewire, and
`is passed beyond the occlusion or stenosis. Id. at 1:30–36. However,
`crossing tough lesions can create enough backward force to dislodge the
`guide catheter from the ostium of the artery being treated, which can make it
`difficult or impossible for the interventional cardiologist to treat certain
`forms of coronary artery disease. Id. at 1:36–40.
`To solve this problem, the ’032 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 2:53–56. The ’032 patent teaches that the coaxial guide
`catheter preferably includes a tapered inner catheter that runs over a standard
`0.014 inch coronary guidewire to allow atraumatic placement within the
`coronary artery, and this feature allows removal of the tapered inner catheter
`
`4
`
`PUBLIC VERSION
`
`

`

`IPR2020-00127
`Patent 8,048,032 B2
`after the coaxial guide catheter is in place. Id. at 2:57–61. Figures 1 and 2,
`reproduced below, show a coaxial guide catheter and a tapered inner catheter
`in accordance with the invention described in the ’032 patent:
`
`
`Figure 1 is a schematic depiction of the coaxial guide catheter and tapered
`inner catheter separately, and Figure 2 depicts those two elements assembled
`together. Id. at 5:15–21; Figs. 1 and 2. As shown above, coaxial guide
`catheter assembly 10 includes coaxial guide catheter 12 and tapered inner
`catheter 14. Id. at 6:6–8. Coaxial guide catheter 12 includes tip portion 16,
`reinforced portion 18, and rigid portion 20. Id. at 6:9–10. Tip portion 16
`generally includes bump tip 22 and marker band 24. Id. at 6:13–14. Bump
`tip 22 includes taper 26 and is relatively flexible. Id. at 6:14–15. Marker
`band 24 is formed of a radiopaque material such as platinum/iridium alloy.
`Id. at 6:19–20. Tapered inner catheter tip 42 includes tapered portion 46 at a
`distal end thereof, and straight portion 48. Id. at 6:59–60. Both tapered
`portion 46 and straight portion 48 are pierced by lumen 50 (not labeled in
`figures above). Id. at 6:60–61. Tapered inner catheter 14 may also include
`
`5
`
`PUBLIC VERSION
`
`

`

`IPR2020-00127
`Patent 8,048,032 B2
`clip 54 at a proximal end thereof to releasably join tapered inner catheter 14
`to coaxial guide catheter 12. Id. at 6:64–67.
`In operation, the tapered inner catheter is inserted inside and through
`the coaxial guide catheter. Id. at 4:12–13. The coaxial guide catheter/
`tapered inner catheter combination may then be inserted into a blood vessel
`that communicates with the aorta, and advanced until the tapered inner
`catheter is passed into the ostium of a coronary artery over the guidewire.
`Id. at 4:15–23. The tapered inner catheter may be removed once the coaxial
`guide catheter tapered inner catheter combination has been inserted
`sufficiently into the ostium of the coronary artery to achieve deep seating.
`Id. at 4:23–26. 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 4:30–33. The presence of the coaxial guide catheter
`provides additional backup support to make it less likely that the coaxial
`guide catheter/guide catheter combination will be dislodged from the ostium
`of the coronary artery while directing the coronary therapeutic device past a
`tough lesion. Id. at 4:33–39.
`Illustrative Claims
`2.
`Independent claims 1 and 11, reproduced below, are illustrative of the
`challenged claims.
`1. A device for use with 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 to the branch artery, the
`device comprising:
`
`6
`
`PUBLIC VERSION
`
`

`

`IPR2020-00127
`Patent 8,048,032 B2
`a flexible tip portion 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 guide catheter,
`the tubular structure having a cross-sectional outer diameter
`sized to be insertable through the cross-sectional inner diameter
`of the continuous lumen of the guide catheter and defining a
`coaxial lumen having a cross-sectional inner diameter through
`which interventional cardiology devices are insertable; and
`a substantially rigid portion proximal of and operably
`connected to, and more rigid along a longitudinal axis than, the
`flexible tip portion and 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,
`such that when at least a distal portion of the flexible tip
`portion is extended distally of the distal end of the guide catheter,
`at least a portion of the proximal portion of the substantially rigid
`portion extends proximally through the hemostatic valve in
`common with interventional cardiology devices
`that are
`insertable into the guide catheter.
`11. A device for use with 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-section and a
`cross-sectional inner diameter sized such that interventional
`cardiology devices are insertable into and through the lumen to
`the branch artery, the device comprising:
`an elongate structure having an overall length that is
`longer than the predefined length of the continuous lumen of the
`guide catheter, the elongate structure including:
`a flexible tip portion defining a tubular structure having a
`circular cross-section that is smaller than the circular cross-
`section of the continuous lumen of the guide catheter and a length
`
`7
`
`PUBLIC VERSION
`
`

`

`IPR2020-00127
`Patent 8,048,032 B2
`that is shorter than the predefined length of the continuous lumen
`of the guide catheter, the flexible tip portion being sized having
`a cross-sectional outer diameter sized to be insertable through the
`cross-sectional inner diameter of the continuous lumen of the
`guide catheter and defining a coaxial lumen having a cross-
`sectional inner diameter through which interventional cardiology
`devices are insertable;
`a reinforced portion proximal to the flexible tip portion;
`
`and
`
`a substantially rigid portion proximal of and connected to,
`and more rigid along a longitudinal axis than, the flexible tip
`portion and 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,
`such that when at least a distal portion of the flexible tip
`portion is extended distally of the distal end of the guide catheter
`with at least proximal portion of the reinforced portion remaining
`within the continuous lumen of the guide catheter, at least a
`portion of the proximal portion of the substantially rigid portion
`extends proximally through the hemostatic valve in common
`with interventional cardiology devices that are insertable into the
`guide catheter.
`Ex. 1401, 10:21–54, 11:28–12:4.
`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, 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”).
`Ex. 1451, T. A. Berg et al., U.S. Patent No. 5,911,715 (issued Jun. 15,
`1999) (“Berg”).
`
`8
`
`PUBLIC VERSION
`
`

`

`IPR2020-00127
`Patent 8,048,032 B2
`In support of its arguments, Petitioner relies on the expert declarations
`of Dr. Stephen Jon David Brecker (Exs. 1405, 1806, 1902), Dr. Richard A.
`Hillstead (Exs. 1442, 1905, 1907), Mr. Michael Jones (Ex. 1807), and Dr.
`Paul Zalesky (Exs. 1755, 1830, 1919). Patent Owner relies on the
`declarations of Ms. Amy Welch (Ex. 2044) (redacted), Ms. Deborah
`Schmalz (Ex. 2039), Mr. Howard Root (Ex. 2118), Mr. Gregg Sutton (Ex.
`2119), Mr. Mark Goemer (Ex. 2120), Ms. Amanda O’Neil (Ex. 2121), Mr.
`Steve Erb (Ex. 2122), Mr. Peter T. Keith (Ex. 2123, 2124, 2138, 2243), Dr.
`John J. Graham (Ex. 2145), Dr. Lorenzo Azzalini (Ex. 2151), Mr. Steve
`Jagodzinkski (Ex. 2152 (redacted), 2153 (confidential)), Ms. Heather S.
`Rosecrans (Ex. 2205), and Dr. Craig Thompson (Ex. 2215).
`E. Asserted Grounds of Unpatentability
`Petitioner asserts that claims 1–9 and 11–20 would have been
`unpatentable on the following grounds.
`
`Ground
`
`Claim(s)
`
`35 U.S.C. §2
`
`References/Basis
`
`1–7, 9, 11–16,
`18, 19
`
`103(a)
`
`Kontos, Adams
`
`8, 17
`
`20
`
`103(a)
`
`103(a)
`
`Kontos, Adams
`
`Kontos, Adams, Berg
`
`1
`
`2
`
`3
`
`
`
`2 The Leahy-Smith America Invents Act, Pub. L. No. 112-29, 125 Stat. 284
`(2011) (“AIA”), amended 35 U.S.C. §§ 102 and 103. Because the
`challenged claims of the ’032 patent have an effective filing date before the
`effective date of the applicable AIA amendments, we refer to the pre-AIA
`versions of 35 U.S.C. § 103 throughout this Decision.
`
`
`9
`
`PUBLIC VERSION
`
`

`

`IPR2020-00127
`Patent 8,048,032 B2
`
`II. ANALYSIS
`A. Priority Date of the ’032 Patent
`Petitioner argues that “[t]he ’032 patent is subject to the AIA’s first-
`to-file provisions because it contains at least one claim that lacks a written
`description, and therefore, pre-AIA priority.” Pet. 14. Petitioner advances
`this argument to preclude Patent Owner from swearing behind the Itou
`reference based on a showing of prior invention, which could otherwise be
`done for a pre-AIA “first-to-invent” application. Id. We are not persuaded
`by Petitioner’s argument.
`The AIA’s first-to-file provisions apply to patent applications “that
`contain[] or contained at any time a claim to a claimed invention that has an
`effective filing date” on or after March 16, 2013. AIA § 3(n)(1). The
`effective filing date is “the actual filing date of the patent or the application
`for the patent containing a claim to the invention; or the filing date of the
`earliest application for which the patent or application is entitled.” 35
`U.S.C. § 100(i)(1). In the present case, the ’032 patent issued from an
`application filed May 3, 2006, and does not claim the benefit of any other
`filing date. Ex. 1001, code (22). Thus, the only possible effective filing date
`of the ’032 patent is May 3, 2006, which thus qualifies it as a pre-AIA
`patent.3
`
`B. Level of Ordinary Skill in the Art
`We consider the asserted grounds of unpatentability in view of the
`understanding of a person of ordinary skill in the art (“POSITA”). Petitioner
`
`
`3 Petitioner’s priority date argument appear to be a back door attempt to have
`us address whether the ’032 patent satisfies the written description
`requirement of 35 U.S.C. § 112. But this is a question we may not address
`in an IPR. See 35 U.S.C. § 311(b).
`
`10
`
`PUBLIC VERSION
`
`

`

`IPR2020-00127
`Patent 8,048,032 B2
`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. 14. Alternatively, Petitioner
`asserts that “if a POSITA was an engineer s/he would have had (a) an
`undergraduate degree in engineering, such as mechanical or biomedical
`engineering; and (b) at least three years of experience designing medical
`devices, including catheters or catheter-deployable devices.” Id. at 14–15.
`Additionally, Petitioner contends that “[e]xtensive experience and technical
`training might substitute for education, and advanced degrees might
`substitute for experience.” Id. at 15.
`Patent Owner “does not dispute Petitioner’s proposed definition of a
`POSITA.” PO Resp. 8.
`On this record, in determining whether the evidence of record
`supports institution, we apply both of Petitioner’s definitions for a POSITA,
`as they are undisputed at this time and consistent with the level of skill
`reflected in the prior art and the Specification of the ’032 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).
`C. 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, at this stage in the
`
`11
`
`PUBLIC VERSION
`
`

`

`IPR2020-00127
`Patent 8,048,032 B2
`proceeding, we need only construe the claims to the extent necessary to
`determine whether to institute inter partes review. 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 claimed terms, including
`“standard guide catheter,” “placed in a branch artery,” “flexural modulus,”
`“interventional cardiology devices.” Pet. 13–19. For the purpose of this
`Decision, we find it helpful to address the term “interventional cardiology
`devices.”
`“interventional cardiology devices”
`1.
`Independent claims 1 and 11 of the ’032 patent recite a standard guide
`catheter having a continuous lumen sized “such that interventional
`cardiology devices are insertable into and through the lumen.” Ex. 1401,
`10:26–27, 11:34–35. To that point, the Specification expressly defines the
`claim term “interventional cardiology devices” as follows:
`For the purposes of this application, the term “interventional
`cardiology devices” is to be understood to include but not be
`limited to guidewires, balloon catheters, stents and stent
`catheters.
`Id. at 1:17–21.
`In view of the express definition provided in the ’032 patent, in the
`Institution Decision we construed claims 1 and 11 to require that the coaxial
`lumen have a cross-sectional inner diameter through which at least two types
`of interventional cardiology devices (including, but not limited to
`guidewires, balloon catheters, stents, and stent catheters) are insertable. Inst.
`Dec. 19.
`
`12
`
`PUBLIC VERSION
`
`

`

`IPR2020-00127
`Patent 8,048,032 B2
`Petitioner contends that claims 1 and 11 require that only one
`interventional cardiology device be insertable through the cross-sectional
`inner diameter of the coaxial lumen. Pet. 30, 57–58. Patent Owner contends
`claims 1 and 11 require that all four of the enumerated classes of devices
`identified in the definition of “interventional cardiology devices,” i.e.,
`“guidewires, balloon catheters, stents, and stent catheters,” are insertable
`through the cross-sectional inner diameter of the coaxial lumen. PO Resp.
`9–10. Patent Owner reasons that the use of the conjunctive “and,” rather
`than the disjunctive “or,” in the definition indicates that all of the identified
`“interventional cardiology devices” must be insertable through the coaxial
`lumen of the flexible tip portion. Id. According to Patent Owner, this
`conclusion is consistent with the written description of the ’032 patent
`because the “Summary of the Invention” section notes that the “invention
`has an inner diameter acceptable for delivering standard coronary devices
`after it is placed in the blood vessel,” and guidewires, balloon catheters,
`stents, and stent catheters are four of the most common coronary devices.
`Id. at 11 (citing Ex. 1401, 3:1–4, 5:9–12; Ex. 2145 ¶ 85; Ex. 2138 ¶ 104).
`
`In its Reply, Petitioner reiterates its position that only one
`interventional cardiology device need be insertable through the coaxial
`lumen of the tip portion, but because resolution of the question of whether
`one or two devices must be insertable into the lumen does not impact the
`outcome in this case, Petitioner asserts that “the Board can adopt its
`preliminary construction of ‘interventional cardiology devices’” in this
`proceeding. Pet. Reply 1–2. Responding to Patent Owner’s arguments,
`Petitioner contends that because the term “standard coronary devices” is
`broader than the specific set of “interventional cardiology devices” identified
`in the written description, the intrinsic record does not support limiting the
`
`13
`
`PUBLIC VERSION
`
`

`

`IPR2020-00127
`Patent 8,048,032 B2
`scope of claims 1 and 12 to require that the coaxial lumen of the tip portion
`have a cross-sectional inner diameter through which all four of the
`“interventional cardiology devices” expressly identified in the ’032 patent
`are insertable. Id. at 2 (citing Ex 1800, 63:20–64:1).
`
`As both parties agree, the ’032 patent expressly defines the term
`“interventional cardiology devices” to include, but not be limited to,
`“guidewires, balloon catheters, stents and stent catheters.” We understand
`this definition to mean that “guidewires,” “balloon catheters,” “stents,” and
`“stent catheters,” are each “interventional cardiology devices.” See Ex.
`1401, 4:46–49 (“This discussion will refer to a guide wire but it is to be
`understood that similar principles apply to other interventional cardiology
`devices including balloon catheters and stent catheters.”). The use of the
`conjunctive “and” in the definition is consistent with this understanding, as
`all the listed devices are “interventional cardiology devices.” See id.
`We further understand that an individual guidewire or stent represents
`an “interventional cardiology device.” Pet. 27 (identifying Kontos’s PTCA
`catheter as an “interventional cardiology device”); PO Resp. 21 (“Thus, the
`PTCA catheter taught by Kontos is one ‘interventional cardiology device,’
`not two.”); Ex. 1401, 4:43–46 (describing the forces in play “when a
`physician attempts to direct a guidewire or other interventional cardiology
`device past an occlusive or stenotic lesion in the branch artery”). And
`because a “guidewire” and “balloon catheter” are each an interventional
`cardiology device, as a matter of logic and grammar, to the extent both a
`“guidewire” and a “balloon catheter” are insertable through the cross-
`sectional inner diameter of the coaxial lumen, the lumen is sized to accept
`“interventional cardiology devices.”
`
`14
`
`PUBLIC VERSION
`
`

`

`IPR2020-00127
`Patent 8,048,032 B2
`
` As noted by Patent Owner, the ’032 patent indicates in the
`“Summary of the Invention” section that the “invention has an inner
`diameter that is appropriate for delivering standard coronary treatment
`devices after it is placed in the blood vessel.” Ex. 1401, 5:9–12; PO Resp.
`11. The same section clarifies, however, that this is only a preference, not a
`requirement. Ex. 1401, 3:1–4 (“In addition, the coaxial guide catheter
`preferably has an inner diameter that is appropriate for delivering standard
`coronary treatment devices after it is placed in the coronary artery.”)
`(emphasis added). In addition, Petitioner persuasively explains why the
`terms “standard coronary treatment devices” and “interventional cardiology
`devices” are not co-extensive in scope. Pet. Reply 2.
`In view of the foregoing, we determine that use of the term
`“interventional cardiology devices” in claims 1 and 11 requires that the
`coaxial lumen of a device has a cross-sectional inner diameter through which
`at least two types of the devices selected from the group that includes, but is
`not limited to, guidewires, balloon catheters, stents and stent catheters, are
`insertable. For example, the cross-sectional diameter of the lumen may be
`sized to receive a guidewire and a stent or a balloon. Ex. 1401, 7:36–40
`(“Once the guidewire 64 is pushed past stenotic lesion 66 or occlusive lesion
`(not shown), a treating catheter including a stent or balloon can be passed
`along the guidewire to stenotic lesion 66 or occlusive lesion (not shown).”).4
`
`
`4 Although we construe claims 1 and 11 to require that the coaxial lumen of
`the tip portion is sized such that two different types of “interventional
`cardiology devices” are insertable, Petitioner’s construction requiring that
`only one type of device (e.g., “stents”) be insertable through the coaxial
`lumen is not without support. Ex. 1401, 4:46–49 (“This discussion will refer
`to a guide wire but it is to be understood that similar principles apply to
`other interventional cardiology devices including balloon catheters and stent
`
`15
`
`PUBLIC VERSION
`
`

`

`IPR2020-00127
`Patent 8,048,032 B2
`Other Recited Claim Terms/Phrases
`2.
`We determine that no express construction of any other claim term is
`necessary to determine whether to institute inter partes review.
`D. Petitioner’s Patentability Challenges
`Ground 1: Obviousness of claims 1–7, 9, 11–16, 18, and 19 in
`1.
`view of Kontos and Adams
`Petitioner asserts that claims 1–7, 9, 11–16, 18, and 19 are
`unpatentable under 35 U.S.C. § 103(a) as obvious over the combination of
`Kontos and Adams. Pet. 17–69. For the reasons set forth below, we
`determine that Petitioner has not demonstrated by a preponderance of the
`evidence that claims 1–7, 9, 11–16, 18, and 19 would have been obvious
`over Kontos and Adams.
`a) Summary of the References Relied Upon
`(1) Kontos (Ex. 1409)
`
`Kontos is directed to a support catheter assembly for facilitating
`medical procedures and, in particular, to a catheter assembly that has
`“particular utility in facilitating insertion of a PTCA5 balloon into a lesion.”
`Ex. 1409, 1:9–13.
`
`
`catheters.”); Pet. 13, 27–29; Pet. Reply 1. We need not resolve this issue,
`however, because we find that at least two different types of interventional
`cardiology devices are insertable through the lumen of Kontos’s stent 10,
`and therefore Kontos teaches this limitation under Petitioner’s construction
`as well.
`5 PTCA stands for “percutaneous transluminal coronary angioplasty.”
`Ex. 1405 ¶ 37.
`
`16
`
`PUBLIC VERSION
`
`

`

`IPR2020-00127
`Patent 8,048,032 B2
`Figure 1 of Kontos is reproduced below:
`
`
`
`Figure 1 is a side plan view of a support catheter, “cut-away in part to show
`in logitudinal cross-section a tubular body having a soft tip and radiopaque
`marker, and a manipulating wire.” Ex. 1409, 2:51–54. As shown in
`Figure 1, support catheter assembly 10 is composed of two major elements,
`body 12 and insertion/manipulation wire 14. Id. at 3:45–46. Body 12,
`“which may be viewed as a mini guide catheter, includes tube 16 having a
`base portion 18 at its proximal end 20.” Id. at 3:47–49. “Tube 16 has a
`continuous lumen 22 therethrough from proximal end 20 to distal end 24.”
`Id. at 3:49–50. Body 12 also include a soft tip 28 disposed at distal end 24
`and funnel portion 26 disposed at proximal end 20. Id. at 3:50–52. Wire 14
`is attached to body 12 at base portion 18. Id. at 3:52–53. Support assembly
`10 may also include distal marker band 30 and proximal marker band 32.
`Id. at 3:53–55.
`
`Kontos explains that the size and shape of the various elements of
`support assembly 10 “may vary depending on the desired application,” but
`in the applications depicted in Figure 1, tube 16 has a 0.055 inch outer
`diameter and lumen 22 has a 0.045 inch diameter. Id. at 4:46–50.
`According to Kontos, the sizes used in these embodiments “are generally
`suitable for existing PTCA catheters.” Id. at 4:61–64.
`
`17
`
`PUBLIC VERSION
`
`

`

`IPR2020-00127
`Patent 8,048,032 B2
`
`Figure 5 of Kontos is reproduced below:
`
`
`
`Figure 5 is a side schematic view of a support catheter having a PTCA
`catheter disposed therein. Id. at 2:64–66. In this figure, PTCA catheter 40
`and its deflated balloon 48 reside in lumen 22 of support assembly 10. Id. at
`5:2–5.
`Figures 6A–6C of Kontos are reproduced below:
`
`Figures 6A–6C are cross-sectional views showing three stages in a process
`for guiding a PTCA catheter to a coronary artery lesion. Id. at 2:67–3:2. In
`Figure 6A, the PTCA catheter/support catheter assembly is fed into guide
`
`
`
`18
`
`PUBLIC VERSION
`
`

`

`IPR2020-00127
`Patent 8,048,032 B2
`catheter 38 and advanced to the distal end of this catheter by simultaneously
`exerting axial force on wire 14 and catheter tube 50. Id. at 5:25–30.
`
`In Figure 6B, when the PTCA catheter/support catheter assembly
`reaches the distal end of guide catheter 38, “it may be advanced as a unit out
`of the distal end of guide catheter 38 and into coronary ostia 39.” Id. at
`5:31–35. When extending beyond the distal end of guide catheter 38, body
`12 functions as a guide catheter extension protecting fragile balloon 48 and
`lessening “considerably the tendency of the PTCA catheter 40 to bend,
`buckle or kink.” Id. at 5:49–56.
`In Figure 6C, after body 12 has been positioned adjacent the restricted
`area, PTCA catheter 40 is advanced so that balloon 48 exits body 12 and is
`advanced into the restricted area, e.g., stenosis B. Id. at 6:9–13. Balloon 48
`is then inflated, as represented by dotted lines 48, “to effect a well-known
`angioplasty procedure.” Id. at 6:13–15. Balloon 48 is then deflated and
`PTCA catheter 40, support catheter assembly 10, and guiding catheter 38
`may be withdrawn. Id. at 6:15–18.
`
`(2) Adams (Ex. 1435)
`
`Adams discloses a device and method for treating vascular disease.
`Ex. 1435 ¶ 1. In particular, Adams discloses “a distal protection device
`which is deployed to filter or remove embolic debris” and “creates a seal to
`prevent the flow of blood during the treatment of vascular disease.” Id. ¶ 11.
`
`19
`
`PUBLIC VERSION
`
`

`

`IPR2020-00127
`Patent 8,048,032 B2
`Figure 1A of Adams is reproduced below:
`
`
`
`Figure 1A is a side view in partial cross-section of the device of Adams. Id.
`¶ 28. In this figure, Y connector 7 is attached to the proximal end of guide
`catheter 10 and control wire 5 passes through Y connector 7. Id. ¶¶ 59–60.
`To reduce blood loss, Y connector 7 has hemostasis valve 9 at its proximal
`end. Id. ¶ 60. As shown in Figure 1A, distal end 12 of guide catheter 10
`may be inserted into the ostium “O” of coronary vessel “V,” which has a
`lesion “L.” Id. ¶ 59. Guide seal 20a is then deployed beyond the distal end
`of guide catheter 10. Id.
`Adams explains that in practice, a physician advances a guidewire
`through the femoral artery into the aorta. Id. ¶ 61. “The guide catheter is
`then advanced over the guidewire until the distal tip of the guide cathete