Trials@uspto.gov
`571-272-7822
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Paper 20
`Date: June 26, 2020
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MEDTRONIC, INC. AND MEDTRONIC VASCULAR, INC.,
`Petitioner,
`v.
`TELEFLEX INNOVATIONS S.À.R.L.,
`Patent Owner.
`
`
`IPR2020-00130
`Patent RE45,380
`
`
`
`Before SHERIDAN K. SNEDDEN, JON B. TORNQUIST, and
`CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.
`
`TORNQUIST, Administrative Patent Judge.
`
`DECISION
`Granting Institution of Inter Partes Review
`35 U.S.C. § 314
`
`
`
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`
`571-272-7822
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Paper 20
`Date: June 26, 2020
`
`
`
`
`
`
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MEDTRONIC, INC. AND MEDTRONIC VASCULAR, INC.,
`Petitioner,
`v.
`TELEFLEX INNOVATIONS S.À.R.L.,
`Patent Owner.
`
`
`IPR2020-00130
`Patent RE45,380
`
`
`
`Before SHERIDAN K. SNEDDEN, JON B. TORNQUIST, and
`CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.
`
`TORNQUIST, Administrative Patent Judge.
`
`DECISION
`Granting Institution of Inter Partes Review
`35 U.S.C. § 314
`
`
`
`
`
`
`
`IPR2020-00130
`Patent RE45,380
`
`
`INTRODUCTION
`Medtronic, Inc. and Medtronic Vascular, Inc. (collectively
`“Petitioner”) filed a Petition (Paper 1, “Pet.”) requesting an inter partes
`review of claims 1–4, 6–9, and 12–21 of U.S. Reissue Patent RE45,380
`(Ex. 1401, “the ’380 patent”). Teleflex Innovations S.À.R.L. (“Patent
`Owner”) filed a Preliminary Response to the Petition (Paper 9, “Prelim.
`Resp.”). Pursuant to our authorization, Petitioner filed a Reply (Paper 14)
`addressing its burden on secondary considerations and reduction to practice,
`and Patent Owner filed a Sur-Reply (Paper 15) addressing Petitioner’s
`burden on those issues. 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).
`We have authority to determine whether to institute an inter partes
`review. 35 U.S.C. § 314 (2018); 37 C.F.R. § 42.4(a) (2019). The standard
`for institution is set forth in 35 U.S.C. § 314(a), which provides that an inter
`partes review may not be instituted “unless the Director determines . . . there
`is a reasonable likelihood that the petitioner would prevail with respect to at
`least 1 of the claims challenged in the petition.”
`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, we institute an inter partes review of all challenged claims and
`all asserted grounds set forth in the Petition. See SAS Inst. Inc. v. Iancu,
`138 S. Ct. 1348, 1355–56 (2018); PGS Geophysical AS v. Iancu, 891 F.3d
`1354, 1360 (Fed. Cir. 2018) (interpreting the statute to require “a simple yes-
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`Patent RE45,380
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`or-no institution choice respecting a petition, embracing all challenges
`included in the petition”).
`A. Related Matters
`The parties indicate that the ’380 patent is the subject of litigation in
`Vascular Solutions LLC, et al. v. Medtronic, Inc., et al., No. 19-cv-01760
`(D. Minn.) (“Medtronic case”) and QXMedical, LLC v. Vascular Solutions,
`LLC, No. 17-cv-01969 (D. Minn) (“QXM case”). Pet. 4–5; Paper 4, 2. The
`’380 patent is also at issue in IPR2020-00128, IPR2020-00129, and
`IPR2020-00131. Paper 4, 2–3; Pet. 5. We instituted inter partes review in
`IPR2020-00128 and IPR2020-00129 on June 8, 2020. IPR2020-00128,
`Paper 22; IPR2020-00129, Paper 22.
`B. The ’380 Patent
`The ’380 patent relates to catheters used in interventional cardiology
`procedures and, in particular, to “methods and apparatus for increasing
`backup support for catheters inserted into the coronary arteries from the
`aorta.” Ex. 1401, 1:31–35.
`“In coronary artery disease the coronary arteries may be narrowed or
`occluded by atherosclerotic plaques or other lesions.” Id. at 1:44–46. This
`narrowing is referred to as stenosis. Id. at 1:48–49. To treat this stenosis, “it
`is commonly necessary to pass a guidewire or other instruments through and
`beyond the occlusion or stenosis of the coronary artery.” Id. at 1:49–52. In
`this method, a guide catheter is inserted through the aorta and into the
`ostium of the coronary artery where it is typically seated into the opening or
`ostium of the artery to be treated. Id. at 1:53–57. A guidewire or other
`instrument is then passed through the lumen of the guide catheter and
`inserted into the artery beyond the stenosis. Id. at 1:39–41, 1:57–59.
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`Crossing the tough lesions, however, may create enough backwards force to
`dislodge the guide catheter from the ostium of the artery being treated,
`making it difficult or impossible to treat certain forms of coronary artery
`disease. Id. at 1:59–63.
`Figures 1 and 2 of the ’380 patent are reproduced below:
`
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`Figure 1 is a schematic depiction of a coaxial guide catheter and a tapered
`inner catheter and Figure 2 is a schematic depiction of these two elements
`assembled. Id. at 5:40–45. As shown in Figure 1, coaxial guide catheter 12
`includes tip portion 16, reinforced portion 18, and rigid portion 20. Id. at
`6:34–35. Tapered inner catheter 14 includes tapered portion 46 at a distal
`end thereof and straight portion 48. Id. at 7:16–17. Clip 54 releasably joins
`tapered inner catheter 14 to coaxial guide catheter 12. Id. at 7:21–23.
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`Figure 8 of the ’380 patent is reproduced below:
`
`
`Figure 8 is a schematic view of a guide catheter, a guidewire, a coaxial guide
`catheter, and a tapered inner catheter located in the aortic arch and coronary
`artery. Id. at 5:61–64. In Figure 8, “coaxial guide catheter 12 with tapered
`inner catheter 14 is passed through guide catheter 56 and over guidewire 64
`into coronary artery 62 after the guide catheter 56 has been placed in the
`ostium 60 of coronary artery 62.” Id. at 8:6–10. “Coaxial guide catheter 12,
`with tapered inner catheter 14, provides an inner support member for proper
`translation over guidewire 64.” Id. at 8:10–14. “Once coaxial guide catheter
`12 is in place, tapered inner catheter 14 is removed from the inside of
`coaxial guide catheter 12.” Id. at 8:14–17. At this point, coaxial guide
`catheter 12 is ready to accept a treatment catheter such as a stent or balloon
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`catheter. Id. at 8:18–19. The ’380 patent explains that coaxial guide
`catheter 12 provides additional backup support to resist dislodging of guide
`catheter 56 from ostium 60 when force is applied to guidewire 64 to pass
`through stenotic lesion 66. Id. at 8:23–30.
`C. Illustrative Claim
`Independent claim 1 is illustrative of the challenged claims and is
`reproduced below.
`1. A system for use with interventional cardiology devices
`adapted to be insertable into a branch artery, the system
`comprising:
`a 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 the 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 continuous lumen of the guide catheter; and
`a device adapted for use with the guide catheter, including:
`a flexible tip portion defining a tubular structure and
`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 having a maximal cross-
`sectional dimension at a proximal portion that is
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`Patent RE45,380
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`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;
`wherein the tubular structure includes a flexible cylindrical
`distal tip portion and a flexible cylindrical reinforced
`portion proximal to the flexible cylindrical distal tip
`portion and wherein the flexible cylindrical distal tip
`portion is more flexible than the flexible cylindrical
`reinforced portion.
`Ex. 1401, 10:47–11:24 (limitations added by reissue in italics).
`D. Prior Art and Asserted Grounds
`Petitioner contends claims 1–4, 6–9, and 12–21 of the ’380 patent
`would have been unpatentable on the following grounds:
`Claims Challenged
`35 U.S.C. §
`Reference(s)/Basis
`1–4, 6, 7, 9, 12–17, 19, 20
`103
`Kontos1, Adams2
`8, 18
`103
`Kontos, Adams, Takahashi3
`21
`103
`Kontos, Adams, Berg4
`
`
`1 Kontos, US 5,439,445, issued August 8, 1995 (Ex. 1409) (“Kontos”).
`2 Adams, US 2004/0010280 A1, published January 15, 2004 (Ex. 1435)
`(“Adams”).
`3 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) (Ex. 1410) (“Takahashi”).
`4 Berg, US 5,911,715, issued June 15, 1999 (Ex. 1451) (“Berg”).
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`Petitioner also relies on the testimony of Dr. Stephen JD Brecker (Ex. 1405)
`and Richard A. Hillstead (Ex. 1442).
`ANALYSIS
`
`A. Claim Construction
`In this proceeding, the claims of the ’380 patent are construed “using
`the same claim construction standard that would be used to construe the
`claim in a civil action under 35 U.S.C. § 282(b).” 37 C.F.R. § 42.100(b).
`Under that standard, the words of a claim are generally given their “ordinary
`and customary meaning,” which is the meaning the term would have had to
`a person of ordinary skill at the time of the invention, in the context of the
`entire patent including the specification. Phillips v. AWH Corp., 415 F.3d
`1303, 1312–13 (Fed. Cir. 2005) (en banc).
`For purposes of this decision, only the term “interventional cardiology
`devices” requires construction. See Nidec Motor Corp. v. Zhongshan Broad
`Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (quoting Vivid
`Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)
`(“[O]nly those terms need be construed that are in controversy, and only to
`the extent necessary to resolve the controversy.”)).
`Claims 1 and 12 require a flexible tip portion that defines “a coaxial
`lumen having a cross-sectional inner diameter through which interventional
`cardiology devices are insertable.” Ex. 1401, 10:58–67, 12:17–28. 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.
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`Id. at 1:41–44.
`Petitioner contends that, in the QXM case, 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).
`Patent Owner contends that “interventional cardiology devices,” as
`used in independent claims 1 and 12,
`requires that at least all four enumerated devices (guidewires,
`balloon catheters, stents, and stent catheters) be insertable into
`the lumen. This construction is based on the plain language of
`the claims (“interventional cardiology devices”), as well as the
`definition’s use of the inclusive conjunction “and.”
`Prelim. Resp. 15. Patent Owner further contends as follows:
`This construction is . . . consistent with the specification.
`The Summary of the Invention describes the invention as a
`“coaxial guide catheter,” i.e., a structure that serves the same
`basic function (delivering interventional cardiology devices) as
`the guide catheter in which it is placed. Exhibit 1401, 3:9–20.
`The coaxial guide catheter is contrasted from the tapered inner
`catheter that is placed within it – among other things, the tapered
`inner catheter “runs over a standard 0.014 inch coronary
`guidewire,” while the coaxial guide catheter is “typically five to
`eight French” and has an inner lumen that is preferably only
`about one French size smaller than the guide catheter. Id.; see
`also id. at 3:28–43. The Summary notes that the “invention has
`an inner diameter acceptable for delivering standard coronary
`devices after it is placed in the blood vessel.” Id. at 5:33–36.
`Merely being sized to receive a guidewire is not enough; the
`claim language requires that guidewires, stents, stent catheters
`and balloon catheters be insertable through the claimed coaxial
`lumen.
`Id. at 15–16.
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`Having considered the parties’ positions and evidence of record, we
`determine that the term “interventional cardiology devices” refers to 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. In the
`context of independent claims 1 and 12, the lumen of the recited guide
`catheter must be sized to receive 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. For example, the diameter of the guide
`catheter is sized to receive a guidewire and a stent or balloon. Ex. 1401,
`7:60–64 (“Once the guidewire 64 is pushed past stenotic lesion 66 or
`occlusive lesion . . . , a treating catheter including a stent or balloon can be
`passed along the guidewire to stenotic lesion 66 or occlusive lesion . . . .”).
`Moreover, based on the current record, we do not construe the claims
`to require that more than one of guidewires, stents, stent catheters, and
`balloon catheters be simultaneously insertable into and through the lumen;
`although we recognize that certain embodiments disclosed in the
`Specification show a preference for the use of a guidewire and a stent or
`balloon. Id. at 7:60–64, Figs. 7–8.
`B. 35 U.S.C. § 314
`1. Multiple Petitions
`Petitioner filed four petitions for inter partes review of the
`’380 patent:
`
`IPR
`Claims Challenged Primary Reference
`IPR2020-00128 1–4, 6–10, 12–21,
`23
`IPR2020-00129 25–39
`
`Ressemann
`
`Itou
`
`Petitioner’s
`Ranking
`Petition 1A
`
`Petition 1B
`
`10
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`IPR2020-00130
`Patent RE45,380
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`IPR
`Claims Challenged Primary Reference
`IPR2020-00130 1–4, 6–9, 12–21
`IPR2020-00131 25–39
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`Kontos
`Kontos
`
`Petitioner’s
`Ranking
`Petition 2A
`Petition 2B
`
`As indicated in the chart above, IPR2020-00128 relies on Itou as the primary
`reference; IPR2020-00129 relies on Ressemann as the primary reference;
`and IPR2020-00130 and IPR2020-00131 rely on Kontos as the primary
`reference. Paper 3, 1–2. Petitioner labels IPR2020-00128 as “Petition 1A,”
`IPR2020-00129 as “Petition 1B,” IPR2020-00130 as “Petition 2A,” and
`IPR2020-00131 as “Petition 2B.” Id. Petition 1A is directed to claims 1–4,
`6–10, 12–21, and 23 of the ’380 patent. Id. at 1. Petition 1B is directed to
`claims 25–39 of the ’380 patent. Id. at 1–2. Petitioner 2A is directed to
`claims 1–4, 6–9, and 12–21 of the ’380 patent. Id. at 2. Petition 2B is
`directed to claims 25–39 of the ’380 patent. Id. at 2–3.
`As noted above, we instituted review in both IPR2020-00128 and
`IPR2020-00129 because we determined that the second petition against the
`’380 patent in IPR2020-00129 was justified in view of the number and
`length of the challenged claims and in view of the unique claim construction
`issues presented in that case. IPR2020-00129, Paper 22 at 8–9.
`IPR2020-00128 and IPR2020-00130 are both directed to claims 1–4,
`6–9, and 12–21 of the ’380 patent. IPR2020-00128, Paper 1 at 8 (also
`addressing claims 10 and 23 of the ’380 patent); Pet. 7. Petitioner relies on
`Itou in every ground of unpatentability in IPR2020-00128, whereas the
`current Petition relies upon Kontos in every ground of unpatentability.
`IPR2020-00128, Paper 1, 8; Pet. 7. Petitioner contends the present third
`petition, or Petition 2A, is needed to address challenged claims 1–4, 6–9,
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`and 12–21 of the ’380 patent because Patent Owner asserts Itou is not prior
`art to the ’380 patent under § 102(e), but does not dispute that Kontos is
`§ 102(b) prior art. Paper 3, 1–3.
`The Patent Trial and Appeal Board Consolidated Trial Practice Guide
`(“Trial Practice Guide”) (Nov. 2019)5 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 three concurrent inter partes
`review proceedings directed to the ’380 patent. Thus, Petitioner must
`demonstrate that this is one of the “unlikely” and “rare” situations where
`three 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, IPR2020-00128 addresses grounds
`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
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`5 Available at https://www.uspto.gov/TrialPracticeGuideConsolidated.
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`than one petition may be necessary.” Consolidated Practice Guide at 59.
`Moreover, the challenges presented in IPR2020-00128 (Petition 1A) and
`IPR2020-00130 (Petition 2A and the present 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 IPR2020-00128. Thus, we find that the current Petition
`presents one of those “rare” and “unlikely” situations where a third 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. 22–25. In particular,
`Patent Owner contends that the validity of at least some of the challenged
`claims of the ’380 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 11–12.
`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
`decision Apple Inc. v. Fintiv, Inc., IPR2020-00019, Paper 11 at 6 (PTAB
`Mar. 20, 2020) (precedential, designated May 5, 2020) (“Fintiv”), the Board
`set forth several other factors to consider under § 314(a) in determining
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`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 ’380
`patent and other patents in this 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
`respect to Fintiv Factor 1, Patent Owner contends that Petitioner has not
`sought a stay of the Medtronic litigation, and the Board has previously
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`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. Prelim. Resp. 12; 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.
`Notably, in both the NHK and Fintiv cases, the trial dates in the parallel
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`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 15 at 10 (noting trial date of March 8, 2021
`where Board’s institution decision was due May 15, 2021).
`As to the amount of investment by the parties and the court in the
`parallel proceeding (Fintiv Factor 3), Patent Owner contends that 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. 12.
`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. 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, determine that resolution of
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`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”). 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 the Petitioner is the defendant in the Medtronic case. Id. In
`contrast to NHK and Fintiv, however, in this case the trial date is after the
`due date for our final written decision and, although there is an overlap of
`issues and parties between the Medtronic case and this proceeding, in this
`case any concerns about inefficiency and the possibility of conflicting
`decisions may be mitigated by the fact that the district court may stay the
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`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 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.
`C. Claims 1–4, 6, 7, 9, 12–17, 19, and 20 over Kontos and Adams
`Petitioner contends the subject matter of claims 1–4, 6, 7, 9, 12–17,
`19, and 20 would have been obvious over the combined disclosures of
`Kontos and Adams. Pet. 17–71.
`1. Kontos
`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 PTCA6 balloon into a lesion.”
`Ex. 1409, 1:9–13.
`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 longitudinal cross-section a tubular body having a soft tip and radiopaque
`marker, and a manipulating wire.” Ex. 1409, 2:51–54. As shown in
`
`
`
`
`6 PTCA stands for “percutaneous transluminal coronary angioplasty.”
`Ex. 1405 ¶ 41.
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`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 “generally are
`suitable for existing PTCA catheters.” Id. at 4:61–64.
`
`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.
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`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
`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.
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` 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. Ball
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