Trials@uspto.gov
`571-272-7822
`
`Paper 9
`Entered: February 24, 2021
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`MEDTRONIC, INC. AND MEDTRONIC VASCULAR, INC.,
`Petitioner,
`v.
`TELEFLEX LIFE SCIENCES LIMITED,
`Patent Owner.
`
`IPR2020-01343
`Patent RE46,116 E
`
`
`
`
`
`
`
`
`
`Before SHERIDAN K. SNEDDEN, JAMES A. TARTAL, and
`CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.
`
`TARTAL, Administrative Patent Judge.
`
`DECISION
`Granting Institution of Inter Partes Review
`35 U.S.C. § 314
`
`
`
`
`
`
`
`
`571-272-7822
`
`Paper 9
`Entered: February 24, 2021
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`MEDTRONIC, INC. AND MEDTRONIC VASCULAR, INC.,
`Petitioner,
`v.
`TELEFLEX LIFE SCIENCES LIMITED,
`Patent Owner.
`
`IPR2020-01343
`Patent RE46,116 E
`
`
`
`
`
`
`
`
`
`Before SHERIDAN K. SNEDDEN, JAMES A. TARTAL, and
`CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.
`
`TARTAL, Administrative Patent Judge.
`
`DECISION
`Granting Institution of Inter Partes Review
`35 U.S.C. § 314
`
`
`
`
`
`
`
`
`
`IPR2020-01343
`Patent RE46,116 E
`
`INTRODUCTION
`I.
`Medtronic, Inc., and Medtronic Vascular, Inc. (“Petitioner”) filed a
`Petition pursuant to 35 U.S.C. §§ 311–319 requesting an inter partes review
`of claims 25–40, 42, 44–48, 52, and 53 (“the Challenged Claims”) of U.S.
`Patent No. RE46,116 E (Ex. 1001, “the ’116 patent”). Paper 1 (“Pet.”).
`Teleflex Life Sciences Limited (“Patent Owner”) filed a Preliminary
`Response. Paper 7 (“Prelim. Resp.”).
`We have authority to determine whether to institute an inter partes
`review. 35 U.S.C. § 314(b) (2018); 37 C.F.R. § 42.4(a) (2019). An inter
`partes review may not be instituted “unless . . . the information presented in
`the petition . . . shows that there is 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). Upon consideration of the Petition, the
`Preliminary Response, and the evidence of record, we conclude that the
`information presented shows a reasonable likelihood that Petitioner would
`prevail in showing the unpatentability of at least one of the Challenged
`Claims. Accordingly, we authorize an inter partes review to be instituted as
`to the Challenged Claims of the ’116 patent on the grounds raised in the
`Petition. Our factual findings and conclusions at this stage of the proceeding
`are based on the evidentiary record developed thus far (prior to Patent
`Owner’s Response). This is not a final decision as to patentability of claims
`for which inter partes review is instituted. Any final decision will be based
`on the record, as fully developed during trial.
`BACKGROUND
`II.
`A.
`The ’116 Patent
`The ’116 patent, titled “Coaxial Guide Catheter for Interventional
`Cardiology Procedures,” issued August 23, 2016, from Application
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`IPR2020-01343
`Patent RE46,116 E
`No. 14/195,435, filed March 3, 2014. Ex. 1001, codes (21), (22), (45), (54).
`The ’116 patent is a reissue of U.S. Patent No. 8,292,850 (“the ’850 patent”)
`from Application No. 13/359,059 filed on January 26, 2012, which the
`’116 patent states is a continuation of an application filed on November 1,
`2013 (issued as U.S. Patent No. RE45,380), which is an application for the
`reissue of U.S. Patent No. 8,292,850, which is a division of an application
`filed on June 28, 2010 (issued as U.S. Patent No. 8,142,413), which is a
`division of an application filed on May 3, 2006 (issued as U.S. Patent
`No. 8,048,032). Id. codes (60), (64). The ’116 patent is directed to
`“methods and apparatus for increasing backup support for catheters inserted
`into the coronary arteries from the aorta.” Id. at 1:38–40.
`The ’116 patent explains, as background, that in “[i]nterventional
`cardiology procedures,” guidewires or other instruments, such as balloon
`catheters and stents, are often inserted through guide catheters into coronary
`arteries that branch off from the aorta. Id. at 1:44–50. 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 1:50–54. 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 1:59–65. However, according to the ’116 patent,
`“[c]rossing 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 1:66–2:3.
`The ’116 patent discusses four categories of previous “attempts to
`provide support to the guiding catheter to prevent backward dislodgement
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`Patent RE46,116 E
`from the coronary ostium (referred to as ‘backup support’).” Id. at 2:4–7.
`One category of guiding catheters “are configured to draw backup support
`from engaging the wall of the aortic arch opposing the ostium of the
`coronary artery that is being accessed.” Id. at 2:8–11. A second category
`are “guiding catheters that include a retractable appendage. Id. at 2:25–26.
`A third category are “guide catheters that have a portion that seeks to expand
`laterally to grip the interior wall of the ostium.” Id. at 2:36–41. A fourth
`category, or “technique,” of the prior attempts “includes the placement of a
`smaller guide catheter within a larger guide catheter in order to provide
`added support for the crossing of lesions or for the distal delivery of balloons
`and stents.” Id. at 2:50–53. The ’116 patent states this fourth technique was
`described in Takahashi,1 which uses a guide catheter inserted “more deeply
`into the ostium of the coronary artery than typically has been done before.”
`Id. at 2:53–62. The ’116 patent states that such “deep seating” by this
`technique “creates the risk that the relatively stiff, fixed curve, guide catheter
`will damage the coronary artery.” Id. at 2:63–65.
`The ’116 patent purports to resolve issues identified with the prior
`procedures by using “a coaxial guide catheter that is deliverable through
`standard guide catheters by utilizing a guidewire rail segment to permit
`delivery without blocking use of the guide catheter.” Ex. 1001, 3:20–23.
`According to the ’116 patent, 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
`
`
`1 Saeko Takahashi, et al., New Method to Increase a Backup Support
`of a 6 French Guiding Coronary Catheter, 63 CATHETERIZATION AND
`CARDIOVASCULAR INTERVENTIONS 452–456 (2004) (Ex. 1010, “Takahashi”).
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`Patent RE46,116 E
`this feature allows removal of the tapered inner catheter after the coaxial
`guide catheter is in place. Id. at 3:23–28.
`Figures 1 and 2, reproduced below, show a coaxial guide catheter and
`a tapered inner catheter in accordance with the invention described in
`the ’116 patent:
`
`
`
`Figure 1 is a schematic depiction of the coaxial guide catheter and tapered
`inner catheter separately, and Figure 2 depicts those two elements assembled
`together. Id. at 5:51–56; Figs. 1 and 2. As shown above, “coaxial guide
`catheter assembly 10” includes coaxial guide catheter 12 and tapered inner
`catheter 14. Id. at 6:42–44. Coaxial guide catheter 12 includes tip
`portion 16, reinforced portion 18, and rigid portion 20. Id. at 6:45–46.
`Tapered inner catheter 14 “includes tapered inner catheter tip 42.” Id.
`at 7:26–27. Tapered inner catheter tip 42 includes tapered portion 46 at a
`distal end thereof, and straight portion 48. Id. at 7:30–31. Both tapered
`portion 46 and straight portion 48 are pierced by lumen 50 (not labeled in
`figures above). Id. at 7:31–32. “Tapered inner catheter 14 may also include
`clip 54 at a proximal end thereof to releasably join tapered inner catheter 14
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`IPR2020-01343
`Patent RE46,116 E
`to coaxial guide catheter 12.” Id. at 7:35–37. “The tapered inner catheter
`provides a gradual transition from the standard 0.014 inch diameter
`guidewire to the diameter of the coaxial guide catheter which is typically
`five to eight French.” Id. at 3:28–31. The coaxial guide catheter is made in
`at least three sizes corresponding to sizes commonly used in interventional
`cardiology procedures. Id. at 3:39–42.
`Figure 4, reproduced below, shows a coaxial guide catheter in
`accordance with the invention described in the ’116 patent:
`
`
`
`Figure 4 is a sectional view of the coaxial guide catheter with tip portion 16
`depicted on the left side of the figure (rather than on the right side as shown
`in Figures 1 and 2). Ex. 1001, 5:60; Fig. 4. As shown above, coaxial guide
`catheter 12 has rigid portion 20 that “includes first full circumference
`portion 34, hemicylindrical portion 36, arcuate portion 38, and second full
`circumference portion 40” (second full circumference portion 40 is shown in
`Figure 3). Id. at 7:7–10.
`In operation, a guide catheter and a guidewire are used along with the
`coaxial guide catheter and the tapered inner catheter. Ex. 1001, 8:20–22.
`Figure 8, reproduced below, shows the operation of the coaxial guide
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`IPR2020-01343
`Patent RE46,116 E
`catheter assembly in accordance with the invention described in the ’116
`patent:
`
`
`Figure 8 is a schematic view of a guide catheter and a guide wire in use with
`the coaxial guide catheter assembly within the aortic arch and coronary
`artery. Id. at 6:5–8; Fig. 8. First, guidewire 64 is inserted and passed
`through aortic arch 58 into ostium 60 of coronary artery 62. Id. at 7:65–66.
`Guide catheter 56 is then passed over guidewire 64 until the distal end of
`guide catheter 56 is seated in ostium 60. Id. at 8:4–6. Next, coaxial guide
`catheter 12 with tapered inner catheter 14 is passed through guide
`catheter 56 and over guidewire 64 into coronary artery 62. Id. at 8:22–24.
`The presence of coaxial guide catheter 12 within guide catheter 56 “provides
`stiffer back up support than guide catheter 56 alone.” Id. at 8:38–40. “Once
`the coaxial guide catheter-tapered inner catheter combination has been
`inserted sufficiently into the ostium of the coronary artery to achieve deep
`seating the tapered inner catheter may be removed.” Id. at 4:58–62; see also
`id. at 8:30–32. Thereafter, coaxial guide catheter 12 can “accept a treatment
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`Patent RE46,116 E
`catheter such as a stent or a balloon catheter.” Id. at 8:33–34. “[T]he
`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 5:2–5:6. “[T]he
`invention is deliverable through an existing hemostatic valve arrangement on
`a guide catheter without preventing injections through existing Y adapters.”
`Id. at 5:42–44.
`
`Illustrative Claim
`B.
`Petitioner challenges claims 25–40, 42, 44–48, 52, and 53 of the
`’116 patent. Pet. 1. Claims 25 and 52 are independent method claims.
`Ex. 1001, 13:62–14:25, 17:10–18:10. Claims 26–40, 42, and 44–48 depend
`from claim 25 and claim 53 depends from claim 52. Id. at 14:26–15:41,
`15:47–50, 18:11–14. Claim 25 is illustrative of the claimed subject matter
`and is reproduced below.
`25. A method, comprising:
`advancing a distal end of a guide catheter having a lumen through
`a main blood vessel to an ostium of a coronary artery;
`advancing a distal end of a guide extension catheter through, and
`beyond the distal end of, the guide catheter, including
`advancing a distal end portion of a tubular structure of the
`guide extension catheter beyond the distal end of the guide
`catheter while a segment defining a side opening of the
`guide extension catheter remains within the guide catheter
`the side opening extending for a distance along a
`longitudinal axis of the guide extension catheter and
`accessible from a longitudinal side defined transverse to
`the longitudinal axis, the tubular structure having a cross-
`sectional inner diameter that is not more than one French
`size smaller than a cross-sectional inner diameter of the
`lumen of the guide catheter;
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`IPR2020-01343
`Patent RE46,116 E
`maintaining the distal end portion of the tubular structure of the
`guide extension catheter in position beyond the distal end
`of the guide catheter; and
`while maintaining the distal end of the guide extension catheter
`positioned beyond the distal end of the guide catheter
`advancing a balloon catheter or stent at least partially
`through the guide catheter and the guide extension catheter
`and into the coronary artery, including advancing the
`balloon catheter or stent through a hemostatic valve
`associated with a proximal end of the guide catheter, along
`a substantially rigid segment of the guide extension
`catheter, through the side opening, and through the tubular
`structure.
`Id. at 13:62–14:25.
`Asserted Grounds of Unpatentability
`C.
`Petitioner asserts that the Challenged Claims are unpatentable based
`on the following grounds:
`References/Basis
`35 U.S.C. §
`Claim(s) Challenged
`Ressemann2
`102
`52, 53
`Itou,3 Ressemann
`103
`25–40, 42, 44–48, 52, 53
`Itou, Ressemann, Kataishi,4
`103
`45
`Pet. 8–9. Petitioner relies on the supporting Declarations of Jon David
`Brecker, M.D., dated July 31, 2020 (Ex. 1005), and Richard A. Hillstead,
`Ph.D., dated July 30, 2020 (Ex. 1042).
`Related Proceedings
`D.
`The parties identify the ’116 patent as a subject of: (1) Vascular
`Solutions LLC, et al. v. Medtronic, Inc., et al., No. 19-cv-01760 (D. Minn.),
`
`
`2 U.S. Patent No. 7,604,612 B2, issued October 20, 2009 (Ex. 1008,
`“Ressemann”).
`3 U.S. Patent No. 7,736,355 B2, issued June 15, 2010 (Ex. 1007, “Itou”).
`4 US 2005/0015073 A1, published January 20, 2005 (Ex. 1025, “Kataishi”).
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`and (2) QXMedical, LLC v. Vascular Solutions, LLC, No. 17-cv-01969
`(D. Minn.). Pet. 5–6; Paper 4, 2. Patent Owner states that both of these
`district court proceedings are currently stayed. Paper 4, 2. The parties
`further state that the ’116 patent is a reissue of the ʼ850 patent and that the
`’850 patent was a subject of: (1) Vascular Solutions, Inc. v. Boston
`Scientific Corp., No. 13-cv-01172 (D. Minn.), and (2) Boston Scientific
`Corp. v. Vascular Solutions, Inc., IPR2014-00762, IPR2014-00763 (PTAB,
`terminated). Pet. 6; Paper 4, 2–3.
`Petitioner challenges claims 25–55 of the ’116 patent in IPR2020-
`01344 through a second petition filed concurrently with the Petition in this
`case. Pet. 6. In accordance with our Trial Practice Guide, Petitioner
`provides an explanation of material differences between the two petitions
`and seeks consideration of the Petition in this case prior to the second
`petition filed in IPR2020-01344. Paper 3. Patent Owner does not address
`Petitioner’s filing of multiple petitions challenging the ’116 patent in its
`Preliminary Response. See generally Prelim. Resp. This Decision addresses
`only the first petition filed by Petitioner and, accordingly, we need not and
`do not address in this Decision whether a second petition is warranted.
`Additionally, Petitioner identifies the following patents related to
`the ’116 patent that are the subject of inter partes review proceedings
`initiated by Petitioner: U.S. Patent Nos. 8,048,032 (IPR2020-00126;
`IPR2020-00127), RE45,830 (IPR2020-00128; IPR2020-00129; IPR2020-
`00130), RE45,760 (IPR2020-00132; IPR2020-00134), RE45,776 (IPR2020-
`00135; IPR2020-00136), RE47,379 (IPR2020-00137; IPR2020-00138),
`and 8,142,413 (IPR2020-01341; IPR2020-01342). Id. at 6–7.
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`
`Real Parties in Interest
`E.
`Petitioner identifies itself and Medtronic Vascular, Inc., as real
`parties in interest and notes “Medtronic plc is the ultimate parent of
`Medtronic, Inc.” Pet. 5. Patent Owner identifies itself, Vascular
`Solutions LLC, Arrow International, Inc., and Teleflex LLC as real parties in
`interest. Paper 4, 2. Patent Owner also notes “Teleflex Incorporated is the
`ultimate parent of the entities listed above.” Id.
`III. ANALYSIS
`A. Discretionary Denial of the Petition Under 35 U.S.C. § 314(a)
`Petitioner and Patent Owner present arguments about our discretion
`under 35 U.S.C. § 314(a). Pet. 15–16; Prelim. Resp. 5–7. 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 Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1356
`(2018) (“[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”); 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
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`part, on § 314(a) because the parallel district court proceeding was
`scheduled to finish before the Board reached a final decision).
`In considering whether to institute trial when there is a parallel,
`co-pending litigation concerning the same patent, 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.
`Fintiv, 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. We have considered the circumstances and
`facts before us in view of the Fintiv factors and determine that the
`circumstances presented here weigh 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 4, 2. The granting of a stay pending inter partes review has weighed
`strongly against exercising discretion to deny institution 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
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`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 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, 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 states that Petitioner had “knowledge of the ’116 patent
`since at least February 2019” and that it “informed Petitioner of its plan to
`assert the ’116 patent on January 24, 2020,” three weeks before Patent
`Owner filed its Amended Complaint. Prelim. Resp. 5–7. Patent Owner
`argues that Petitioner unjustifiably delayed filing the Petition until nine
`months after Petitioner filed petitions challenging related patents on similar
`art and arguments. Prelim. Resp. 5–6 (identifying the following proceedings
`between the parties in which Itou, Ressemann, and/or Kataishi are relied
`upon by Petitioner: IPR2020-00126 (Itou and Ressemann), IPR2020-00128
`(Itou and Ressemann), IPR2020-00129 (Itou, Ressemann, and Kataishi),
`IPR2020-00132 (Itou, Ressemann, and Kataishi), IPR2020-00133
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`(Ressemann and Kataishi), IPR2020-00134 (Itou and Ressemann), IPR2020-
`00135 (Itou, Ressemann, and Kataishi), IPR2020-00137 (Itou, Ressemann,
`and Kataishi), and IPR2020-00138 (Ressemann and Kataishi)). Patent
`Owner argues that Petitioner’s “unjustified delay” in filing the 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.,
`IPR20[20]-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.
`Prelim. Resp. 7.
`
`Petitioner explains the 9-month difference in its filing of the current
`Petition by noting as follows:
`When Petitioner filed IPR Petitions against related patents in
`Fall 2019, Patent Owner had not yet asserted the ʼ116 patent. As
`a result, Petitioner did not file an IPR against the ʼ116 patent at
`that time. Then, on February 14, 2020, Patent Owner filed an
`Amended Complaint that asserted the ʼ116 patent. Thereafter,
`Petitioner diligently prepared its IPRs and filed this Petition
`roughly 5 months later and more than 7 months before the
`statutory deadline.
`Pet. 16.
`We determine the evidence does not support a finding that the Petition
`was filed with delay. Rather, the filing of the Petition was timely and in
`response to Patent Owner’s Amended Complaint adding the ʼ116 patent to
`the related litigation. We further find unsupported and not persuasive Patent
`Owner’s argument that “because Petitioner buried Itou and the other prior art
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`it intended to rely on in its August 2019 discovery response,” it was
`Petitioner’s fault Patent Owner amended its complaint to add the ’116 patent
`when it did. Prelim. Resp. 6. No persuasive evidence suggests Petitioner
`bears responsibility for Patent Owner’s knowledge of relevant prior art or for
`Patent Owner’s determination of whether and when to amend its complaint.
`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 district court 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, 12. 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.
`Furthermore, 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 ’116 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 below, and find this factor favors
`institution. Balancing all of the Fintiv factors, on this record, we determine
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`the circumstances presented here weigh against exercising discretion under
`§ 314(a) to deny institution of inter partes review.
`Legal Standards
`B.
`A claim is anticipated if a single prior art reference either expressly or
`inherently discloses every limitation of the claim. Orion IP, LLC v. Hyundai
`Motor Am., 605 F.3d 967, 975 (Fed. Cir. 2010). “A single prior art reference
`may anticipate without disclosing a feature of the claimed invention if
`such feature is necessarily present, or inherent, in that reference.”
`Allergan, Inc. v. Apotex Inc., 754 F.3d 952, 958 (Fed. Cir. 2014) (citing
`Schering Corp. v. Geneva Pharm., 339 F.3d 1373, 1377 (Fed. Cir. 2003)).
`A patent claim is unpatentable under 35 U.S.C. § 1035 if the
`differences between the claimed subject matter and the prior art are such
`that the subject matter, as a whole, would have been obvious at the time the
`invention was made to a person having ordinary skill in the art to which
`said subject matter pertains. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398,
`406 (2007). In Graham v. John Deere Co., 383 U.S. 1 (1966), the
`Supreme Court set out a framework for assessing obviousness under § 103
`that requires consideration of four factors: (1) the “level of ordinary skill
`in the pertinent art,” (2) the “scope and content of the prior art,” (3) the
`“differences between the prior art and the claims at issue,”
`and (4) “secondary considerations” of nonobviousness such as “commercial
`success, long felt but unsolved needs, failure of others, etc.” Id. at 17–18;
`
`
`5 The relevant sections of the Leahy-Smith America Invents Act (“AIA”),
`Pub. L. No. 112–29, 125 Stat. 284 (2011), took effect on March 16, 2013.
`Because the application that issued as the ’116 patent indicates that its
`priority application was filed before March 16, 2013, we apply the pre-AIA
`versions of these statutes. See 35 U.S.C. § 100(i).
`
`16
`
`
`
`IPR2020-01343
`Patent RE46,116 E
`KSR, 550 U.S. at 407. At this stage of the proceeding, neither party presents
`evidence directed to secondary considerations. See Pet. 78–80; see also
`generally Prelim. Resp.
`Level of Ordinary Skill in the Art
`C.
`In determining the level of ordinary skill in the art, various factors
`may be considered, including the “type of problems encountered in the art;
`prior art solutions to those problems; rapidity with which innovations are
`made; sophistication of the technology; and educational level of active
`workers in the field.” In re GPAC Inc., 57 F.3d 1573, 1579 (Fed.
`Cir. 1995) (citation omitted). Petitioner contends a person of ordinary skill
`in the art at the time of the invention would have “(a) a medical degree, (b)
`completed a coronary intervention training program, and (c) experience
`working as an interventional cardiologist.” Pet. 13. Petitioner, alternatively,
`contends a person of ordinary skill in the art at the time of the invention
`would have had “(a) an undergraduate degree in engineering, such as
`mechanical or biomedical engineering; and (b) at least three years of
`experience designing medical devices, including catheters or catheter-
`deployable devices.” Id. at 14. Petitioner further argues “[e]xtensive
`experience and technical training might substitute for education, and
`advanced degrees might substitute for experience.” Id. Patent Owner does
`not dispute at this stage of the proceeding Petitioner’s proposed level of
`ordinary skill. See generally Prelim. Resp.
`For purposes of this Decision, we find the ’116 patent and the cited
`prior art references reflect the appropriate level of skill at the time of the
`claimed invention and that the level of appropriate skill reflected in these
`references and the ’116 patent is consistent with the definition of a person of
`ordinary skill in the art proposed by Petitioner. See Okajima v. Bourdeau,
`
`17
`
`
`
`IPR2020-01343
`Patent RE46,116 E
`261 F.3d 1350, 1355 (Fed. Cir. 2001). Accordingly, for purposes of this
`Decision, we adopt Petitioner’s asserted level of ordinary skill in the art.
`D. Claim Construction
`“In an inter partes review proceeding, a claim of a patent . . . shall be
`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) (2019). That standard “includ[es] construing 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.; see also Phillips v. AWH Corp., 415 F.3d 1303
`(Fed. Cir. 2005) (en banc).
`Petitioner proposes the following constructions: (1) “substantially
`rigid” as “rigid enough to allow the device to be advanced within the guide
`catheter,” (2) “side opening” needs no construction and should be given its
`plain and ordinary meaning, (3) “lumen” as “the cavity of a tube,”
`and (4) “flexural modulus” as “[a] measure of resistance . . . to bending.”
`Pet. 14–15 (quoting Ex. 1040, 772). Patent Owner does not dispute at this
`stage of the proceeding Petitioner’s proposed construction of these terms.
`See generally Prelim. Resp. In view of the issues we address below, we
`determine it is not necessary to address the express interpretation of any
`claim term. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co.,
`868 F.3d 1013, 1017 (Fed. Cir. 2017); 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.”).
`
`18
`
`
`
`IPR2020-01343
`Patent RE46,116 E
`Scope and Content of the Prior Art
`E.
`Petitioner relies on Ressemann, Itou, and Kataishi, each of which we
`briefly summarize in relevant part below.
`Summary of Ressemann
`1.
`Ressemann, titled “Emboli Protection Devices and Related Methods
`of Use,” states that it is directed to an apparatus “used to prevent the
`introduction of emboli into the bloodstream during and after surgery
`performed to reduce or remove blockage in blood vessels.” Ex. 1008,
`code (54), 1:13–16. Figures 1A and 1B of Ressemann are reproduced
`below:
`
`
`
`
`Figure 1A is a cross-sectional view of a partial length evacuation sheath. Id.
`at 3:16–18. Figure 1B is a cross-sectional view of the partial length
`evacuation sheath of Figure 1A, taken along line 1B–1B of Figure 1A. Id. at
`3:19–20.
`
`19
`
`
`
`IPR2020-01343
`Patent RE46,116 E
`Figure 1A depicts evacuation sheath assembly 100, which “is sized to
`fit inside a guide catheter” and be advanced “into a blood vessel to treat a
`stenosis.” Ex. 1008, 6:18–24, Fig. 5A. Evacuation sheath assembly 100
`includes a shaft having proximal shaft portion 110, intermediate shaft
`portion 120, and distal shaft portion 130 (not shown in Figure 1A). Id.
`at 10:30–35. Evacuation head 132 includes multi-lumen tube 138, having
`evacuation lumen 140 and inflation lumen 142, and is preferably made of a
`relatively flexible polymer. Id. at 6:35–64. Evacuation lumen 140 is
`preferably larger than inflation lumen 142 and “is designed to allow for the
`passage of interventional devices such as, but not limited to[,] stent delivery
`systems and angioplasty catheters.” Id. at 6:44–47. Proximal and distal
`ends of evacuation lumen 140 are angled to allow for sm
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