Trials@uspto.gov
`571-272-7822
`
`Paper No. 20
`Date: June 26, 2020
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MEDTRONIC, INC., AND MEDTRONIC VASCULAR, INC.,
`Petitioner,
`v.
`TELEFLEX INNOVATIONS S.À.R.L.,
`Patent Owner.
`
`IPR2020-00127
`Patent 8,048,032 B2
`
`
`
`
`
`
`
`
`
`Before SHERIDAN K. SNEDDEN, JON B. TORNQUIST, and
`CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.
`SNEDDEN, Administrative Patent Judge.
`
`DECISION
`Granting Institution of Inter Partes Review
`35 U.S.C. § 314
`
`
`
`
`
`
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`IPR2020-00127
`Patent 8,048,032 B2
`
`INTRODUCTION
`I.
`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”) filed a Preliminary Response. Paper
`10 (“Prelim. Resp.”). Pursuant to our authorization, Petitioner filed a Reply
`addressing its burden on secondary considerations and reduction to practice,
`and Patent Owner filed a Sur-Reply addressing Petitioner’s burden on those
`issues. Paper 14; Paper 15. Also pursuant to our authorization, Petitioner
`filed another Reply (Paper 17) and Patent Owner filed another Sur-Reply
`(Paper 18) addressing the factors for discretionary denial under 35 U.S.C.
`§ 314(a).
`To institute an inter partes review, we must determine that the
`information presented in the Petition shows “a reasonable likelihood that the
`petitioner would prevail with respect to at least 1 of the claims challenged in
`the petition.” 35 U.S.C. § 314(a) (2012). The Supreme Court has held that a
`decision to institute under 35 U.S.C. § 314 may not institute on fewer than
`all claims challenged in the petition. SAS Inst. Inc. v. Iancu, 138 S. Ct. 1348,
`1359–60 (2018) (“SAS”). After considering the parties’ arguments and
`evidence, we determine that Petitioner has demonstrated a reasonable
`likelihood that it would prevail with respect to at least one of the claims
`challenged in the Petition. Accordingly, an inter partes review of all of the
`claims and all of the grounds presented in the Petition is hereby instituted.
`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-
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`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
`Petitioner has filed a separate Petition for inter partes review of
`claims 1–20 and 22 of the ’032 patent as IPR2020-00126. We instituted
`inter partes review in IPR2020-00126 on June 9, 2020. IPR2020-00126,
`Paper 22.
`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) (“QXM”).
`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.
`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
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`’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
`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:
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`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
`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/
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`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:
`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
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`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
`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-
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`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”).
`Petitioner relies upon the Declarations of Dr. Stephen Brecker (Ex.
`1405) and Dr. Richard Hillstead (Ex. 1442) in support of its Petition.
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`IPR2020-00127
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`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. §1
`
`References/Basis
`
`1–7, 9, 11–16,
`18, 19
`
`103(a)
`
`Kontos, Adams,
`Knowledge of a POSITA
`
`8, 17
`
`103(a)
`
`20
`
`103(a)
`
`Kontos, Adams,
`Takahashi, Knowledge of
`a POSITA
`
`Kontos, Adams, Berg,
`Knowledge of a POSITA
`
`1
`
`2
`
`3
`
`
`
`II. ANALYSIS
`
`A. 35 U.S.C. § 314
`1. Multiple Petitions
`Petitioner filed another petition for inter partes review of the
`’032 patent in IPR2020-00126 and, as noted above, we instituted review
`based on that petition. IPR2020-00126, Paper 22. The petition in IPR2020-
`
`
`1 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.
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`00126 challenges claims 1–20 and 22 of the ’032 patent (id.), while the
`current Petition challenges claims 1–9 and 11–20.
`Petitioner relies on Itou2 in every ground of unpatentability in
`IPR2020-00126, whereas the current Petition relies upon Kontos in every
`ground of unpatentability. IPR2020-00126, Paper 1, 8; Pet. 7. Petitioner
`contends the current Petition is needed to address challenged claims 1–9 and
`11–20 of the ’032 patent because Patent Owner asserts Itou is not prior art to
`the ’032 patent under § 102(e), but does not dispute that Kontos is § 102(b)
`prior art. IPR2020-00126, Paper 3, 1–3.
`The Consolidated Trial Practice Guide (November 2019)3 explains
`that “there may be circumstances in which more than one petition may be
`necessary, including, for example, . . . when there is a dispute about priority
`date requiring arguments under multiple prior art references.” Trial Practice
`Guide at 59. “In such cases two petitions by a petitioner may be needed,
`although this should be rare.” Id. The Trial Practice Guide further instructs
`that “it is unlikely that circumstances will arise where three or more petitions
`by a petitioner with respect to a particular patent will be appropriate.” Id.
`Institution in this case would result in two concurrent inter partes
`review proceedings directed to the ’032 patent. Thus, Petitioner must
`demonstrate that this is one of the “unlikely” and “rare” situations where two
`petitions against the same patent are justified. As noted above, the Trial
`Practice Guide instructs that “more than one petition may be necessary . . .
`when there is a dispute about priority date requiring arguments under
`multiple prior art references.” Id. Here, IPR2020-00126 addresses grounds
`
`2 Ex. 1407, Itou, US 7,736,355 B2, issued June 15, 2010 (“Itou”).
`
` 3
`
` Available at https://www.uspto.gov/TrialPracticeGuideConsolidated.
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`based on Itou, a § 102(e) reference, and the current Petition addresses
`grounds based on Kontos, a § 102(b) reference. Given the possibility that
`we may determine that Itou does not qualify as prior art after fully
`considering Patent Owner’s priority date arguments, this is precisely one of
`the circumstances recognized in our Trial Practice Guide “in which more
`than one petition may be necessary.” Consolidated Practice Guide at 59.
`Moreover, the challenges presented in IPR2020-00126 and the current
`Petition do not significantly overlap with each other. For example, the
`obviousness challenges in the present Petition require an assessment of
`motivation to combine Kontos and Adams, which is not relevant to the
`anticipation and obviousness challenges presented in IPR2020-00126. Thus,
`we find that the current Petition presents a circumstance where a second
`petition against the same patent is justified.
`2. Parallel District Court Cases
`Patent Owner argues that we should exercise our discretion under
`35 U.S.C. § 314(a) to deny institution due to the common issues being
`litigated in parallel district court cases. Prelim. Resp. 25–30. In particular,
`Patent Owner contends that the validity of at least some of the challenged
`claims of the ’032 patent and other related patents is the subject of active
`litigation in two separate district court cases, the QXM case and the
`Medtronic case, which are both currently pending in the District of
`Minnesota. Id. at 12.
`In NHK Spring Co. v. Intri-Plex Techs., Inc., IPR2018-00752, Paper 8
`(PTAB Sept. 12, 2018) (precedential, designated May 7, 2019) (“NHK”), the
`Board considered the fact that a parallel district court proceeding was
`scheduled to finish before the Board reached a final decision as a factor
`favoring denial of institution. In the more recently designated precedential
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`decision Apple Inc. v. Fintiv, Inc., IPR2020-00019, Paper 11 (PTAB Mar.
`20, 2020) (precedential, designated May 5, 2020) (“Fintiv”), the Board set
`forth several other factors (the “Fintiv Factors”) to consider under § 314(a)
`in determining whether to institute trial when there is parallel, co-pending
`litigation concerning the same patent: (1) whether a stay of the parallel
`litigation exists or is likely to be granted if a trial proceeding is instituted by
`the Board; (2) proximity of the court’s trial date to the Board’s projected
`statutory deadline; (3) the investment in the parallel proceeding by the court
`and parties; (4) the extent of overlap between issues raised in the petition
`and in the parallel litigation; (5) whether the petitioner and the defendant in
`the parallel proceeding are the same party; and (6) and other circumstances
`that impact the Board’s exercise of discretion, including the merits.
`The parties address the Fintiv Factors in supplemental briefing that we
`authorized. Paper 17; Paper 18. We have considered each of these factors
`and conclude that, on balance, the circumstances here do not favor
`discretionary denial under § 314(a).
`As to whether a stay of the parallel litigation exists or is likely to be
`granted (Fintiv Factor 1), Petitioner contends that the presiding district court
`judge in the Medtronic and QXM cases “has granted every post-institution
`request to stay litigation pending reexamination or IPR.” Paper 17, 2 (citing
`Ex. 1493). Petitioner also points out that the QXM case, involving the ’032
`patent and other patents in the same family, has already been stayed pending
`our institution decisions, and the court indicated that if we institute trial “the
`Court will invite the parties to brief whether the stay should extend through
`the conclusion of the review process.” Id. (citing Ex. 1494). Thus,
`Petitioner contends that the same judge will also entertain Petitioner’s
`motion to stay the Medtronic case in the event of institution. Id. With
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`respect to Fintiv Factor 1, Patent Owner contends that Petitioner has not
`sought a stay of the Medtronic litigation, and the Board has previously
`declined to infer how the district court would rule when neither party has
`requested a stay. Paper 18, 1. Patent Owner contends that the QXM case
`was stayed only because QXMédical agreed to exit the market and waived
`its obviousness/anticipation defenses, and that the district court has not
`granted stays involving direct competitors or allegations of irreparable harm.
`Id. Having considered the parties position, we determine that Fintiv Factor 1
`favors institution, especially in view of the fact that a stay has already been
`granted in the related QXM case and the district court’s prior history of
`granting stays pending resolution of related IPRs.
`As to the proximity of the court’s trial dates to our statutory deadlines
`(Fintiv Factor 2), the parties agree that the district court has indicated that
`the Medtronic case must be “Ready for Trial” by August 1, 2021, which
`would be a few weeks after our statutory deadline for a final written decision
`in this proceeding and the related IPRs. PO Resp. 23; Paper 17, 1.
`Petitioner asserts the date for an actual trial will likely be extended even
`further, noting that district court’s final “Ready for Trial” date in patent
`proceedings is, on average, over eight months after the originally scheduled
`date. Paper 17, 1 (citing Ex. 1489). Petitioner points out that the district
`court already extended the original “Ready for Trial” date by two months in
`the Medtronic case, and that a trial date in the QXM case was finally set for
`February 24, 2020—more than ten months after the original “Ready for
`Trial” set by the court—before that case was stayed pending our institution
`decision. We determine that Fintiv Factor 2 also favors institution,
`especially given that the trials in the district court cases will not likely take
`place until after we issue our final written decisions in these proceedings.
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`Notably, in both the NHK and Fintiv cases, the trial dates in the parallel
`litigations were scheduled either before or only a few months after the
`Board’s institution deadlines and before the final written decision deadlines.
`See NHK, IPR2018-00752, Paper 8 at 19 (noting trial date of March 25,
`2019, where Board’s institution decision was issued September 12, 2018);
`Fintiv, IPR2020-00019, Paper 11 at 1 (noting trial date of November 16,
`2020 where Board’s institution decision was due May 15, 2020).
`As to the amount of investment by the parties and the court in the
`parallel proceeding (Fintiv Factor 3), Patent Owner contends that the district
`court is already deeply invested and has familiarity with the challenged
`patents in light of the relatively advanced stage of the QXM case. Paper 18,
`1–2. But as noted above, the district court has indicated a preference to wait
`for the Board’s institution decision before proceeding in the QXM case.
`With respect to the Medtronic case, Patent Owner contends that the parties
`have already exchanged infringement contentions, conducted extensive fact
`discovery (set to close September 1, 2020), and addressed the issues in a
`preliminary injunction motion. Id.; see also Prelim. Resp. 22. Although we
`agree that the parties have invested some time and effort in the related
`litigation, we are not persuaded that those cases are in such an advanced
`stage that would favor denial of institution. The district court recently
`denied the preliminary injunction motion filed by Patent Owner, noting that
`there are substantial questions with respect to the validity of the asserted
`claims. Ex. 1488, 9–14. However, the district court has not issued a claim
`construction order or any other substantive order in the Medtronic case. See
`Fintiv, Paper 11 at 10 (noting that if “the district court has not issued orders
`related to the patent at issue in the petition, this fact weighs against
`exercising discretion to deny institution under NHK”). We, therefore,
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`determine that resolution of those common issues by the Board may be
`beneficial to the resolution of the district court proceedings. Patent Owner
`also contends that Petitioner delayed bringing these challenges. Paper 18, 2.
`Petitioner, however, points out that it filed its IPR petitions roughly four
`months after the district court complaint in the Medtronic case, and before
`Patent Owner’s infringement contentions were served in that case. Paper 17,
`2; see Fintiv, Paper 11 at 11 (noting that “it is often reasonable for a
`petitioner to wait to file its petition until it learns which claims are being
`asserted against it in the parallel proceeding”). We find that Petitioner did
`not unduly delay filing its IPR Petitions.
`We have also considered the remaining Fintiv Factors and determine,
`on balance, that they do not outweigh the foregoing factors in favor of
`institution. Fintiv, Paper 11 at 6 (explaining that when various factors weigh
`both in favor and against exercising discretion under § 314(a), we take “a
`holistic view of whether efficiency and integrity of the system are best
`served by denying or instituting review”). Petitioner contends that Patent
`Owner has only asserted a subset of the challenged claims in the Medtronic
`litigation. Paper 17, 1. With respect to Fintiv Factor 4 (overlap of issues),
`Patent Owner responds that there is complete overlap of the issues raised in
`the parallel proceedings, including the same invalidity prior art and
`arguments raised in the Petitions. Paper 18, 2. With respect to Fintiv Factor
`5 (whether the same parties are involved), Patent Owner also points out that
`Petitioner is the defendant in the Medtronic case. Id. We find there is an
`overlap of issues and parties between the Medtronic case and this
`proceeding. In Fintiv, the Board noted that “if the petition includes the same
`or substantially the same claims, grounds, arguments, and evidence as
`presented in the parallel proceeding, this fact has favored denial.” Fintiv,
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`Paper 11 at 13. In this case, however, any concerns about inefficiency and
`the possibility of conflicting decisions may be mitigated by the fact that the
`district court may stay the parallel litigation and thus not reach the merits of
`Petitioner’s invalidity defenses before we issue our final written decision.
`Finally, under Fintiv Factor 6, we have taken into account the merits of
`Petitioner’s challenges, as discussed above, and find that this favors
`institution.
`In sum, based on our consideration of the foregoing factors, we
`decline to exercise our discretion under § 314(a) to deny institution.
`B. 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 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. 12.
`Alternatively, Petitioner asserts that “if a POSITA was an engineer s/he
`would have had (a) an undergraduate degree in engineering, such as
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`IPR2020-00127
`Patent 8,048,032 B2
`mechanical or biomedical engineering; and (b) at least three years of
`experience designing medical devices, including catheters or catheter-
`deployable devices.” Id. Additionally, Petitioner contends that “[e]xtensive
`experience and technical 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. at 12–13 (citing Ex.
`1405 ¶ 27; Ex. 1442 ¶¶ 18–19).
`Patent Owner indicates that “[f]or purposes of this Preliminary
`Response only, Teleflex does not currently dispute Medtronic’s proposed
`definition of a POSITA.” Prelim. Resp. 12.
`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
`proceeding, we need only construe the claims to the extent necessary to
`determine whether to institute inter partes review. See Nidec Motor Corp. v.
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`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. With the exception of
`“interventional cardiology devices,” Patent Owner contends that “no specific
`construction of [any other term] is necessary for the Board to deny the
`Petition.” Prelim. Resp. 18.
`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.
`Petitioner contends that, in the QXM litigation, Patent Owner
`stipulated that the term “interventional cardiology device(s)” means “devices
`including, but not limited to, guidewires, balloon catheters, stents, and stent
`catheters.” Pet. 13 (citing Ex. 1412, 21; Ex. 1464, 1 n.1). The district court,
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