Trials@uspto.gov
`571-272-7822
`
`Paper No. 9
`Date: February 9, 2021
`
`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.
`
`IPR2020-01342
`Patent 8,142,413 B2
`
`
`
`
`
`
`
`
`
`Before SHERIDAN K. SNEDDEN, JAMES A. TARTAL, and
`CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.
`SNEDDEN, Administrative Patent Judge.
`
`DECISION
`Granting Institution of Inter Partes Review
`35 U.S.C. § 314
`
`
`
`
`
`
`
`
`571-272-7822
`
`Paper No. 9
`Date: February 9, 2021
`
`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.
`
`IPR2020-01342
`Patent 8,142,413 B2
`
`
`
`
`
`
`
`
`
`Before SHERIDAN K. SNEDDEN, JAMES A. TARTAL, and
`CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.
`SNEDDEN, Administrative Patent Judge.
`
`DECISION
`Granting Institution of Inter Partes Review
`35 U.S.C. § 314
`
`
`
`
`
`
`
`
`
`IPR2020-01342
`Patent 8,142,413 B2
`
`I.
`INTRODUCTION
`Medtronic, Inc. and Medtronic Vascular, Inc. (“Petitioner”) filed a
`Petition for inter partes review of claims 1, 2, 4, 5, and 7–14 of U.S. Patent
`No. 8,142,413 B2 (“the ’413 patent,” Ex. 1401). Paper 1 (“Pet.”). Teleflex
`Innovations S.À.R.L. (“Patent Owner”) filed a Preliminary Response.
`Paper 7 (“Prelim. Resp.”).
`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-
`interest as Teleflex Medical Devices S. À.R.L.; Vascular Solutions LLC;
`Arrow International, Inc.; and Teleflex LLC. Paper 5, 2. Patent Owner also
`notes that “Teleflex Incorporated is the ultimate parent of the entities listed
`above.” Id.
`
`2
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`IPR2020-01342
`Patent 8,142,413 B2
`B. Related Matters
`Petitioner filed a separate Petition for inter partes review of claims 1,
`2, 4, 5, and 7–14 of the ’413 patent as IPR2020-01341.
`The parties indicate that the ’413 patent is the subject of litigation in
`Vascular Solutions LLC, et al. v. Medtronic, Inc., et al. No. 19-cv-01760
`(D. Minn. filed July 2, 2019) (“Medtronic”) and QXMedical, LLC v.
`Vascular Solutions, LLC, No. 17-cv-01969 (D. Minn., filed June 8, 2017)
`(“QXM”). Pet. 4–5; Paper 5, 2. Patent Owner indicates that both of these
`district court proceedings are currently stayed. Paper 5, 2.
`Petitioner also filed petitions challenging patents related to the ’413
`patent in the following currently pending proceedings: IPR2020-00126
`(Patent 8,048,032 B2), IPR2020-00127 (Patent 8,048,032 B2), IPR2020-
`00128 (Patent RE45,380), IPR2020-00129 (Patent RE45,380), IPR2020-
`00130 (Patent RE45,380), IPR2020-00132 (Patent RE45,760), IPR2020-
`00134 (Patent RE45,760), IPR2020-00135 (Patent RE45,776), IPR2020-
`00136 (Patent RE45,776), IPR2020-00137 (Patent RE47,379), and
`IPR2020-00138 (Patent RE47,379).
`The ’413 patent was the subject of a previous inter partes review in
`IPR2014-00759 involving a distinct set of grounds, filed May 15, 2014, and
`terminated August 11, 2014, by way of joint motion to terminate. Paper 5,
`2–3.
`C. The ’413 Patent
`1.
`Specification
`The ’413 patent, entitled “Coaxial Guide Catheter for Interventional
`Cardiology Procedures,” issued on March 27, 2012, from a non-provisional
`application filed June 28, 2010. Ex. 1401, codes (45), (54), (22).
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`Patent 8,142,413 B2
`The ’413 patent relates generally to a coaxial guide catheter for use
`with interventional cardiology devices that are insertable into a branch artery
`that branches off from a main artery. Ex. 1001, Abstract. According to the
`’413 patent, interventional cardiology procedures often include inserting
`guidewires or other instruments through catheters into coronary arteries that
`branch off from the aorta. Id. at 1:21–23. In coronary artery disease, the
`coronary arteries may be narrowed or occluded by atherosclerotic plaques or
`other lesions in a phenomenon known as stenosis. Id. at 1:27–28. 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 1:35–37. 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 1:41–45.
`To solve this problem, the ’413 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 2:59–62. The ’413 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 2:63–67. Figures 1 and 2,
`reproduced below, show a coaxial guide catheter and a tapered inner catheter
`in accordance with the invention described in the ’413 patent:
`
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`IPR2020-01342
`Patent 8,142,413 B2
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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 5:22–27; Figs. 1 and 2. As shown above, coaxial guide
`catheter assembly 10 includes coaxial guide catheter 12 and tapered inner
`catheter 14. Id. at 6:12–14. Coaxial guide catheter 12 includes tip portion
`16, reinforced portion 18, and rigid portion 20. Id. at 6:15–16. Tip portion
`16 generally includes bump tip 22 and marker band 24. Id. at 6:20–21.
`Bump tip 22 includes taper 26 and is relatively flexible. Id. at 6:21–22.
`Marker band 24 is formed of a radiopaque material such as platinum/iridium
`alloy. Id. at 6:25–26. Tapered inner catheter tip 42 includes tapered portion
`46 at a distal end thereof, and straight portion 48. Id. at 6:65–66. Both
`tapered portion 46 and straight portion 48 are pierced by lumen 50 (not
`labeled in figures above). Id. at 6:66–67. Tapered inner catheter 14 may
`also include clip 54 at a proximal end thereof to releasably join tapered inner
`catheter 14 to coaxial guide catheter 12. Id. at 7:3–5.
`In operation, the tapered inner catheter is inserted inside and through
`the coaxial guide catheter. Id. at 4:17–17. The coaxial guide catheter/
`
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`IPR2020-01342
`Patent 8,142,413 B2
`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 4:21–28. 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 4:28–31. 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 4:35–38. 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 4:39–44.
`2.
`Illustrative Claims
`Independent claim 1, reproduced below, is illustrative of the
`challenged claims.
`1. A method of providing backup support for an interventional
`cardiology device for use in the coronary vasculature, the
`interventional cardiology device being adapted to be passed
`through a standard guide catheter, the standard guide catheter
`having a continuous lumen extending for a predefined length
`from a proximal end at a hemostatic valve to a distal end adapted
`to be placed in a branch artery, the continuous lumen of the guide
`catheter having a circular cross-sectional inner diameter sized
`such that interventional cardiology devices are insertable into
`and through the lumen, the method comprising:
`inserting the standard guide catheter into a first artery over
`a guidewire, the standard guide catheter having a distal end;
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`IPR2020-01342
`Patent 8,142,413 B2
`positioning the distal end of the standard guide catheter in
`a branch artery that branches off from the first artery;
`inserting a flexible tip portion of a coaxial guide catheter
`defining a tubular structure having a circular cross-section and a
`length that is shorter than the predefined length of the continuous
`lumen of the standard guide catheter, into the continuous lumen
`of the standard guide catheter, and,
`further inserting a substantially rigid portion that is
`proximal of, operably connected to, and more rigid along a
`longitudinal axis than the flexible tip portion, into the continuous
`lumen of the standard guide catheter, the substantially rigid
`portion defining a rail structure without a lumen and having a
`maximal cross-sectional dimension at a proximal portion that is
`smaller than the cross-sectional outer diameter of the flexible tip
`portion and having a length that, when combined with the length
`of the flexible distal tip portion, defines a total length of the
`device along the longitudinal axis that is longer than the length
`of the continuous lumen of the guide catheter;
`advancing a distal portion of the flexible tip portion
`distally beyond the distal end of the standard guide catheter and
`into the second artery such that the distal portion extends into the
`second artery and such that at least a portion of the proximal
`portion of the substantially rigid portion extends proximally
`through the hemostatic valve; and
`inserting the interventional cardiology device into and
`through the continuous lumen of the standard guide catheter
`alongside of the substantially rigid portion and advancing the
`interventional cardiology device through and beyond a lumen of
`the flexible tip portion into contact with or past a lesion in the
`second artery.
`Ex. 1401, 10:3011:6.
`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”).
`
`7
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`IPR2020-01342
`Patent 8,142,413 B2
`
`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”).
`Petitioner relies upon the Declarations of Dr. Stephen Brecker (Ex.
`1405) and Dr. Richard Hillstead (Ex. 1442) in support of its Petition.
`E. Asserted Grounds of Unpatentability
`Petitioner asserts that claims 1, 2, 4, 5 and 7–14 would have been
`unpatentable on the following grounds.
`
`Ground
`
`Claim(s)
`
`35 U.S.C. §1
`
`References/Basis
`
`1, 2, 4, 5, 7–12,
`14
`
`103(a)
`
`Kontos, Adams
`
`13
`
`103(a)
`
`Kontos, Adams,
`Takahashi
`
`1
`
`2
`
`
`
`II. ANALYSIS
`A. 35 U.S.C. § 314: Parallel District Court Cases
`Under 35 U.S.C. § 314(a), the Director has discretion to deny
`institution of an inter partes review. Cuozzo Speed Techs., LLC v. Lee,
`136 S. Ct. 2131, 2140 (2016) (“[T]he agency’s decision to deny a petition is
`a matter committed to the Patent Office’s discretion.”); SAS, 138 S. Ct. at
`
`
`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 ’413 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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`IPR2020-01342
`Patent 8,142,413 B2
`1356. (“[Section] 314(a) invests the Director with discretion on the question
`whether to institute review.” (emphasis omitted)); Harmonic v. Avid Tech.,
`Inc., 815 F.3d 1356, 1367 (Fed. Cir. 2016) (“[T]he PTO is permitted, but
`never compelled, to institute an IPR proceeding.”).
`In determining whether to exercise discretion to deny institution under
`35 U.S.C. § 314(a), the Board considers an early trial date in related
`litigation as part of an assessment of all relevant circumstances of the case,
`including the merits, in an effort to balance considerations such as system
`efficiency, fairness, and patent quality. Apple Inc. v. Fintiv, Inc., IPR2020-
`00019, Paper 11, 5–6 (PTAB Mar. 20, 2020) (precedential) (“Fintiv Order”);
`see also NHK Spring Co. v. Intri-Plex Techs., Inc., IPR2018-00752, Paper 8,
`19–20 (PTAB Sept. 12, 2018) (precedential) (denying institution relying, in
`part, on § 314(a) because the parallel district court proceeding was
`scheduled to finish before the Board reached a final decision).
`When considering an early trial date in related litigation, the Board
`evaluates the following factors (“Fintiv factors”):
`1. whether the court granted a stay or evidence exists that one
`may be granted if a proceeding is instituted;
`2. proximity of the court’s trial date to the Board’s projected
`statutory deadline for a final written decision;
`3. investment in the parallel proceeding by the court and the
`parties;
`4. overlap between issues raised in the petition and in the parallel
`proceeding;
`5. whether the petitioner and the defendant in the parallel
`proceeding are the same party; and
`6. other circumstances that impact the Board’s exercise of
`discretion, including the merits.
`
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`Patent 8,142,413 B2
`Fintiv Order 5–6. In evaluating these factors, “the Board takes a holistic
`view of whether efficiency and integrity of the system are best served by
`denying or instituting review.” Id. at 6.
`1.
`Analysis
`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. 5–7. We have
`considered the circumstances and facts before us in view of the Fintiv
`factors and determine that the circumstances presented here weigh heavily
`against exercising discretion under § 314(a) to deny institution of inter
`partes review.
`Relevant to Fintiv factors 1 and 2, the parties acknowledge that the
`parallel district court proceeding is stayed. Pet. 16; Prelim. Resp. 1;
`Paper 5, 2. The granting of a stay pending inter partes review has weighed
`strongly against exercising discretion to deny institution under NHK as it is a
`strong indication that the district court has a preference to wait for the
`Board’s final resolution of the patentability issues raised in the petition
`before proceeding with the parallel litigation. See Fintiv at 6–7.
`Accordingly, consideration of the first and second Fintiv factors weighs
`strongly against exercising discretion to deny institution.
`The third Fintiv factor also provides that a petitioner’s diligence or
`delay in filing a petition may be relevant. See Fintiv at 11–12. If the
`evidence shows that a petitioner filed its petition expeditiously, such as
`promptly after becoming aware of the claims being asserted, this fact has
`weighed against denying institution. See id. at 11 (citing Intel Corp. v.
`VLSI Tech. LLC, IPR2019-01192, Paper 15 at 12–13 (PTAB Jan. 9, 2020);
`Illumina Inc. v. Natera, Inc., IPR2019-01201, Paper 19 at 8 (PTAB Dec. 18,
`
`10
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`IPR2020-01342
`Patent 8,142,413 B2
`2019)). If, however, the evidence shows that the petitioner did not file its
`petition expeditiously, such as at or around the same time that the patent
`owner responded to the petitioner’s invalidity contentions, or even if a
`petitioner cannot explain the delay in filing its petition, these facts have
`favored denial. See Fintiv at 11–12 (citing Next Caller, Inc. v.
`TRUSTID, Inc., IPR2019-00961, Paper 10 at 16 (PTAB Oct. 16, 2019)).
`Patent Owner contends that Petitioner’s delay in filing the petition
`weighs in favor of denying institution under § 314(a). See Prelim.
`Resp. 46–47 (quoting Next Caller, Paper 10 at 15–16; Fintiv at 11–12). In
`particular, Patent Owner contends that Petitioner unjustifiably delayed filing
`this Petition (and the Petition in IPR2020-01342) as compared to challenges
`against related patents brought 9 months earlier, which rely on similar art
`and arguments. Id. at 5–6; see IPR2020-00126 (Itou and Ressemann),
`IPR2020-00128 (Itou and Ressemann), IPR2020-00129 (Itou and
`Ressemann), IPR2020-00132 (Itou and Ressemann), IPR2020-00133
`(Ressemann), IPR2020-00134 (Itou and Ressemann), IPR2020-00135 (Itou
`and Ressemann), IPR2020-00137 (Itou and Ressemann), IPR2020-00138
`(Ressemann). Patent Owner contends that Petitioner’s “unjustified delay” in
`filing this petition prejudices Patent Owner. Prelim. Resp. 7. In particular,
`Patent Owner contends as follows:
`Petitioner has already relied on the present IPR petitions as a
`basis to seek an unprecedented extension of the one year
`statutory deadline in the eleven pending IPRs, even though it
`expressly and repeatedly relied on that one year deadline to
`convince the district court to stay the litigation. See, e.g.,
`IPR2020- 00126, Papers 56 and 61. If the present IPR petitions
`are granted, Petitioner will undoubtedly continue such delay
`tactics, such as by asking the district court to maintain the stay as
`to all patents in view of the present Petition.
`
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`IPR2020-01342
`Patent 8,142,413 B2
`Prelim. Resp. 7.
`
`Petitioner explains the 9-month difference in its filing of the current
`Petitions by noting as follows:
`When Petitioner filed IPR Petitions against related patents in Fall
`2019, Patent Owner had not yet asserted the ʼ413 patent. As a
`result, Petitioner did not file an IPR against the ʼ413 patent at that
`time. Then, on February 14, 2020, Patent Owner filed an
`Amended Complaint that asserted the ʼ413 patent. Ex-1514.
`Thereafter, Petitioner diligently prepared its IPRs and filed this
`Petition roughly five months later and more than seven months
`before the statutory deadline.
`Pet. 17.
`We find that the current record does not support a finding that the
`Petition was filed with delay. Rather, the filing of the Petition was in
`response to Patent Owner’s Amended Complaint adding the ʼ413 patent to
`the related litigation. Ex. 1514. We do not consider, based on the current
`record, the filing of the Petition within 6 months of the filing of the
`Amended Complaint that asserted the ʼ413 patent to be unjustified.
`With respect to Fintiv Factor 4 (overlap of issues) and Fintiv Factor 5
`(whether the same parties are involved), we find there is an overlap of issues
`and parties between the Medtronic case and this proceeding. In Fintiv, the
`Board noted “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, 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 has
`stayed the parallel litigation and thus will not reach the merits of Petitioner’s
`invalidity defenses before we issue our final written decision.
`
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`Furthermore, we note that the district court’s stay of the litigation
`pending denial of institution or a final written decision allays concerns about
`inefficiency and duplication of efforts. Id. To the contrary, exercising our
`discretion to deny the Petition would force inefficiency and the possibility of
`conflicting decisions because the district court would then have to resolve
`similar and overlapping issues presented in the context of only the ’413
`patent, one of several related patents being asserted by Patent Owner in the
`related litigation.
`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.
`Balancing all of the Fintiv factors, on this record, we determine that
`the circumstances presented here weigh against exercising discretion under
`§ 314(a) to deny institution of inter partes review
`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)).
`
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`Petitioner asserts “[i]f a person of ordinary skill in the art (‘POSITA’)
`was a medical doctor, s/he would have had (a) a medical degree; (b)
`completed a coronary intervention training program, and (c) experience
`working as an interventional cardiologist.” Pet. 11–12. Alternatively,
`Petitioner asserts “if a POSITA was an engineer s/he would have had (a) an
`undergraduate degree in engineering, such as mechanical or biomedical
`engineering; and (b) at least three years of experience designing medical
`devices, including catheters or catheter-deployable devices.” Id. at 12.
`Additionally, Petitioner contends “[e]xtensive experience and technical
`training might substitute for education, and advanced degrees might
`substitute for experience.” Id. Petitioner further asserts that “a POSITA
`with a medical degree may have access to a POSITA with an engineering
`degree, and a POSITA with an engineering degree may have access to one
`with a medical degree.” Id. (citing Ex. 1405 ¶ 27; Ex. 1442 ¶¶ 18–19).
`Patent Owner does not address the level of ordinary skill in its
`Preliminary Response.
`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 ’413 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
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`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.
`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
`“interventional cardiology devices,” “standard guide catheter,” and “placed
`in a branch artery” Pet. 13–16. Patent Owner does not address claim
`construction in its Preliminary Response, although Patent Owner previously
`addressed the term “interventional cardiology devices” in the related IPRs.
`For the purpose of this Decision, we find it helpful to address the term
`“interventional cardiology devices.”
`1.
`“interventional cardiology device(s)”
`Independent claim 1 of the ’413 patent recites a standard guide
`catheter having a continuous lumen sized “such that interventional
`cardiology devices are insertable into and through the lumen.” Ex. 1401,
`10:36–37. To that point, the Specification in regard to 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 1:23–26.
`Petitioner contends that, in the QXM litigation, Patent Owner
`stipulated that the term “interventional cardiology device(s)” means “devices
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`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,
`however, did not construe the term “interventional cardiology device(s)” in
`the QXM litigation. Ex. 1413 (Claim Construction Order).
`Based on the current 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
`claim 1, 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. See Ex. 1001, 7:42–46 (“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 . . . .”); id. at 7:47–65, Figs. 7–8.
`Furthermore, 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 7:36–65, Figs. 7–8.
`Finally, we recognize that the Specification discloses that “the
`invention has an inner diameter acceptable for delivering standard coronary
`devices after it is placed in the blood vessel” (id. at 5:15–18) and that the
`term “interventional cardiology devices” is not limited to guidewires,
`balloon catheters, stents and stent catheters (id. at 1:24–26). To the extent
`
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`further discussion of what additional devices may be encompassed by this
`term is required for the purposes of this Decision, we provide that discussion
`below in our analysis of the asserted grounds of unpatentability.
`1.
`Other Recited Claim Terms/Phrases
`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
`1.
`Ground 1: Obviousness in view of Kontos and Adams
`Petitioner asserts that claims 1, 2, 4, 5, 7–12, and 14 are unpatentable
`under 35 U.S.C. § 103(a) as obvious over Kontos and Adams. Pet. 18–71.
`For the reasons set forth below, we determine that Petitioner has
`demonstrated a reasonable likelihood that claims 1, 2, 4, 5, 7–12, and 14
`would have been obvious over the combination of Kontos, Adams, and the
`knowledge of a person of ordinary skill in the art.
`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 PTCA2 balloon into a lesion.”
`Ex. 1409, 1:9–13.
`
`
`2 PTCA stands for “percutaneous transluminal coronary angioplasty.”
`Ex. 1405 ¶ 37.
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`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
`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.
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`IPR2020-01342
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`
`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
`
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`IPR2020-01342
`Patent 8,142,413 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 dise
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