Trials@uspto.gov
`571-272-7822
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`Paper 8
`Date: March 26, 2021
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`EDWARDS LIFESCIENCES CORPORATION AND
`EDWARDS LIFESCIENCES LLC,
`Petitioner,
`v.
`COLIBRI HEARTVALVE LLC,
`Patent Owner.
`
`IPR2020-01649
`Patent 9,125,739 B2
`
`Before ERICA A. FRANKLIN, JAMES A. TARTAL, and
`ERIC C. JESCHKE, Administrative Patent Judges.
`
`TARTAL, Administrative Patent Judge.
`
`DECISION
`Granting Institution of Inter Partes Review
`35 U.S.C. § 314
`
`
`
`
`
`
`
`

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`IPR2020-01649
`Patent 9,125,739 B2
`
`INTRODUCTION
`I.
`Edwards Lifesciences Corporation and Edwards Lifesciences LLC
`(“Petitioner”) filed a Petition pursuant to 35 U.S.C. §§ 311–319 requesting
`an inter partes review of claims 1–5 (“the Challenged Claims”) of U.S.
`Patent No. 9,125,739 B2 (Ex. 1001, “the ’739 patent”). Paper 2 (“Pet.”).
`Colibri Heart Valve LLC (“Patent Owner”) filed a Preliminary Response.
`Paper 6 (“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 ’739 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 ’739 Patent
`The ’739 patent, titled “Percutaneous Replacement Heart Valve and a
`Delivery and Implantation System,” issued September 8, 2015, from
`
`2
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`IPR2020-01649
`Patent 9,125,739 B2
`Application No. 14/253,650 (“the ’650 Application”), filed April 15, 2014.
`Ex. 1001, codes (21), (22), (45), (54). The ’739 patent states that the
`’650 Application is a continuation of Application No. 13/675,665 (filed on
`November 13, 2012), which is a continuation of Application No. 10/887,688
`(filed on July 10, 2004, and issued as U.S. Patent No. 8,308,797), which is a
`continuation-in-part of Application No. 10/037,266 (filed on January 4,
`2002) (“the ’266 Application”).1 Id. at code (63). The replacement heart
`valve device described by the ’739 patent “comprises a stent made of
`stainless steel or self-expanding nitinol and a completely newly designed
`artificial biological tissue valve disposed within the inner space of the stent.”
`Id. at 4:64–5:1.
`Figure 5 of the ’739 patent is reproduced below.
`
`
`Figure 5 illustrates a side view of a replacement heart valve device mounted
`within a self-expanding stent in the expanded position. Id. at 6:31–34. “The
`replacement heart valve device comprises a stent member 100 and a flexible
`valve means 200.” Id. at 6:55–57. “The stent member 100 includes a length
`of wire 110 formed in a closed zigzag configuration.” Id. at 7:32–33. The
`stent member may be a meshwork of nitinol wire formed into a tubular
`structure that “flares markedly at both ends in a trumpet-like configuration.”
`
`1 Application No. 10/887,688 was published on May 26, 2005, as
`US2005/0113910 A1, and is the reference Petitioner identifies as “Paniagua”
`(Ex. 1015).
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`IPR2020-01649
`Patent 9,125,739 B2
`Id. at 7:55–63. The “trumpet-like configuration” is not illustrated in
`Figure 5, or in any other figure of the ’739 patent.
`
`The valve means comprises “a generally tubular portion” and,
`“preferably, a peripheral upstanding cusp or leaflet portion.” Id. at 6:61–64.
`The valve means is “flexible, compressible, host-compatible, and non-
`thrombogenic.” Id. at 8:27–28. It may be made from various materials,
`preferably mammal pericardium tissue. Id. at 8:28–35. The cusp or leaflet
`portion of the valve means is generally tubular in shape and comprises two
`to four leaflets. Id. at 7:5–8. The cusp or leaflet portion of the valve means
`is “formed by folding the pericardium material used to create the valve.” Id.
`at 8:44–46. “The starting material is preferably a flat dry sheet, which can
`be rectangular or other shaped.” Id. at 8:47–49. The cusps/leaflets “open in
`response to blood flow in one direction and close in response to blood flow
`in the opposite direction.” Id. at 8:49–51.
`
`Figure 8 of the ’739 patent is reproduced below.
`
`
`Figure 8 illustrates the “delivery and implantation system of the replacement
`artificial heart valve,” including “flexible catheter 400 which may be
`
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`IPR2020-01649
`Patent 9,125,739 B2
`inserted into a vessel of the patient and moved within that vessel.” Id.
`at 11:40–44. The ’739 patent further explains as follows:
`The distal end 410 of the catheter 400, which is hollow and
`carries the replacement heart valve device of the present
`invention in its collapsed configuration, is guided to a site where
`it is desired to implant the replacement heart valve. The catheter
`has a pusher member 420 disposed within the catheter lumen 430
`and extending from the proximal end 440 of the catheter to the
`hollow section at the distal end 410 of the catheter. Once the
`distal end 410 of the catheter is positioned as desired, the pusher
`mechanism 420 is activated and the distal portion of the
`replacement heart valve device is pushed out of the catheter and
`the stent member 100 partially expands. In this position the stent
`member 100 is restrained so that it doesn't pop out and is held for
`controlled release, with the potential that the replacement heart
`valve device can be recovered if there is a problem with the
`positioning. The catheter 400 is then retracted slightly and the
`replacement heart valve device is completely pushed out of the
`catheter 400 and released from the catheter to allow the stent
`member 100 to fully expand.
`Id. at 11:44–62.
`
`Illustrative Claim
`B.
`Petitioner challenges claims 1–5 of the ’739 patent. Pet. 1. Claim 1 is
`independent and claims 2–5 depend from claim 1. Ex. 1001, 14:2–38.
`Claim 1 is illustrative of the claimed subject matter and is reproduced below.
`1. An assembly to treat a native heart valve in a patient, the
`assembly for use in combination with a guidewire, the assembly
`comprising:
`a prosthetic heart valve including:
`a stent member having an inner channel, the stent member
`collapsible, expandable and configured for transluminal
`percutaneous delivery, wherein the stent member includes
`a tubular structure away from a central portion that flares
`at both ends in a trumpet-like configuration; and
`a valve means including two to four individual leaflets made
`of fixed pericardial tissue, wherein the valve means resides
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`IPR2020-01649
`Patent 9,125,739 B2
`entirely within the inner channel of the stent member, and
`wherein no reinforcing members reside within the inner
`channel of the stent member;
`a delivery system including a pusher member and a moveable
`sheath, the pusher member including a guidewire lumen,
`wherein the pusher member is disposed within a lumen of
`the moveable sheath, wherein the prosthetic heart valve is
`collapsed onto the pusher member to reside in a collapsed
`configuration on the pusher member and is restrained in
`the collapsed configuration by the moveable sheath,
`wherein a distal end of the prosthetic heart valve is located
`at a distal end of the moveable sheath, and wherein the
`valve means resides entirely within the inner channel of
`the stent member in said collapsed configuration and is
`configured to continue to reside entirely within the inner
`channel of the stent member upon deployment in the
`patient.
`Id. at 14:2–29.
`
`Asserted Grounds of Unpatentability
`C.
`Petitioner asserts that the Challenged Claims are unpatentable based
`on the following grounds:
`Claim(s)
`Challenged 35 U.S.C. §
`1–5
`102
`1–5
`103
`1–5
`103
`
`Paniagua2
`Bessler,3 Teitelbaum4
`Bessler, Leonhardt5
`
`Reference(s)/Basis
`
`
`2 U.S. Patent App. No. 2005/0113910 A1, published May 26, 2005
`(Ex. 1015, “Paniagua”).
`3 U.S. Patent No. 5,855,601, issued January 5, 1999 (Ex. 1006, “Bessler”).
`4 U.S. Patent No. 5,332,402, issued July 26, 1994 (Ex. 1007, “Teitelbaum”).
`5 U.S. Patent No. 5,957,949, issued September 28, 1999 (Ex. 1012,
`“Leonhardt”).
`
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`IPR2020-01649
`Patent 9,125,739 B2
`
`Reference(s)/Basis
`
`Claim(s)
`Challenged 35 U.S.C. §
`Bessler, Teitelbaum, Klint6
`1–5
`103
`Bessler, Leonhardt, Klint
`1–5
`103
`Pet. 26. We refer to the ground based on Paniagua as “the Paniagua
`Ground” and to the four grounds based on Bessler, in combination with
`other asserted art, collectively as the “Bessler Grounds.” Petitioner relies on
`the supporting Declaration of Steven L. Goldberg, M.D., dated
`September 18, 2020. Ex. 1020.
`Related Proceedings
`D.
`The parties identify the ’739 patent as a subject of Colibri Heart
`Valve LLC v. Medtronic CoreValve LLC, No. 8:20-cv-847 (C.D. Cal., filed
`May 4, 2020) (the “CDCA Case”), to which Petitioner is not a party.
`Pet. 24–25; Paper 4, 1. Additionally, an inter partes review has been
`instituted for claims 1–5 of the ’739 patent in Medtronic CoreValve LLC v.
`Colibri Heart Valve LLC, IPR2020-01454 (“the Medtronic IPR”) based on a
`petition filed by the defendant to the CDCA Case that asserts combinations
`of art not asserted in this proceeding. Medtronic IPR, Paper 11 (PTAB
`Mar. 10, 2021).
`
`Real Parties in Interest
`E.
`Petitioner identifies only itself as a real party in interest. Pet. 24.
`Patent Owner identifies only itself as a real party in interest. Paper 4, 1.
`
`
`6 U.S. Patent App. No. 2001/0044633 A1, published November 22, 2001
`(Ex. 1019, “Klint”).
`
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`IPR2020-01649
`Patent 9,125,739 B2
`
`III. ANALYSIS
`A. Discretionary Denial of the Petition Under 35 U.S.C. § 314(a)
`Petitioner asserts in the Petition that discretionary denial under
`§ 314(a) is not warranted, noting that it is “not a party to the co-pending
`district court litigation [i.e. the CDCA Case].” Pet. 70–73. Patent Owner
`argues that discretionary denial under § 314(a) does not require that
`Petitioner be a party to the co-pending district court case and that we should
`exercise our discretion due to the common issues being litigated in the
`CDCA Case with respect to the ’739 patent. Prelim. Resp. 21–36. For the
`reasons that follow, we decline to exercise our discretion to deny the Petition
`under § 314(a).
`35 U.S.C. § 314(a) states that
`[t]he Director may not authorize an inter partes review to be
`instituted unless the Director determines that the information
`presented in the petition filed under section 311 and any response
`filed under section 313 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.
`The language of § 314(a) expressly provides the Director with discretion to
`deny institution of inter partes review. See 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 Inc. v. Avid Tech., Inc., 815 F.3d
`1356, 1367 (Fed. Cir. 2016) (“[T]he PTO is permitted, but never compelled,
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`IPR2020-01649
`Patent 9,125,739 B2
`to institute an IPR proceeding.”); Consolidated Trial Practice Guide
`November 2019 (“TPG”),7 55.
`In considering whether to exercise discretion to deny institution
`under § 314(a), we consider 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 part, on § 314(a)
`because the parallel district court proceeding was scheduled to finish before
`the Board reached a final decision) (“NHK”). In considering whether to
`institute trial when there is a parallel, co-pending district court case, 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.
`
`
`7 Available at https://www.uspto.gov/TrialPracticeGuideConsolidated.
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`IPR2020-01649
`Patent 9,125,739 B2
`Fintiv, 5‒6. In evaluating these Fintiv 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 in this
`proceeding, in light of the information presented concerning the CDCA
`Case, do not weigh in favor of exercising our discretion under § 314(a) to
`deny institution of inter partes review for the following reasons.
`1. Whether the Court Granted a Stay or Evidence Exists that a Stay
`may be Granted if a Proceeding is Instituted
`“If a court has denied a defendants’ motion for a stay pending
`resolution of a PTAB proceeding, and has not indicated to the parties that it
`will consider a renewed motion or reconsider a motion to stay if a PTAB
`trial is instituted, this fact has sometimes weighed in favor of exercising
`authority to deny institution.” Fintiv, 7–8. Petitioner notes a motion to stay
`was filed in the CDCA Case; however, Patent Owner explains that the
`district court denied the motion to stay the CDCA Case during a Status
`Conference held on November 17, 2020. Pet. 72; Prelim. Resp. 23 (citing
`Ex. 2009 ¶ 6). Further, no evidence exists that a stay may be granted if we
`were to institute inter partes review. To the contrary, the undisputed
`evidence shows that the district court set a trial date of September 14, 2021,
`which the district court indicated at a status conference “would not move
`under any circumstances.” Prelim. Resp. 23 (quoting Ex. 2004, 2).
`Although Petitioner is not a party to the district court proceeding, we find
`that the denial of the motion to stay the CDCA Case and the district court’s
`directive that the trial date “would not move under any circumstances”
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`IPR2020-01649
`Patent 9,125,739 B2
`weigh in favor of exercising our discretion to deny institution
`under § 314(a).
`2. Proximity of the Court’s Trial Date to the Board’s Projected Statutory
`Deadline for a Final Written Decision
`As stated in Fintiv, “[i]f the court’s trial date is earlier than the
`projected statutory deadline, the Board generally has weighed this fact in
`favor of exercising authority to deny institution.” Fintiv, 9. There is no
`dispute that the trial in the CDCA Case is scheduled to begin on
`September 14, 2021, which is over six months before a final written decision
`would be due in this proceeding. Pet. 72; Ex. 2004, 2.
`Petitioner argues that although the “trial date is earlier than a final
`written decision would be expected in this case,” the defendant in the CDCA
`Case “has filed two motions that may alter that date—a motion to dismiss, as
`well as the previously noted motion to stay.” Pet. 72. As discussed above,
`the evidence provided by Patent Owner shows the motion to stay the CDCA
`Case that Petitioner refers to was denied. See Ex. 2004, 2; Ex. 2009 ¶ 6.
`Petitioner does not otherwise explain why any pending motion to dismiss the
`CDCA Case supports the notion that the trial date may be altered,
`particularly in light of the indication by the district court that the trial date
`would not move under any circumstances. See Ex. 2004, 2.
`Thus, the evidence shows that the trial date of the CDCA Case is
`scheduled to be earlier than the projected statutory deadline for a final
`written decision in this proceeding by over six months, and persuasive
`evidence suggests that the trial date will not be changed if inter partes
`review were to be granted in this proceeding, which are considerations that
`weigh in favor of exercising our discretion to deny institution under
`§ 314(a). See, e.g., NHK, 20 (finding that the advanced state of the district
`
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`IPR2020-01649
`Patent 9,125,739 B2
`court case, which was set to go to trial approximately six months before the
`Board’s final decision would be due, weighed in favor of denial);
`GlobalFoundries Inc. v. UNM Rainforest Innovations, IPR2020-00984,
`Paper 11 at 11–16 (PTAB Dec. 9, 2020) (finding that a scheduled trial date
`four months before the statutory deadline for a final written decision was a
`factor weighing in favor of discretionary denial); NanoCellect
`Biomedical, Inc. v. Cytonome/ST, LLC, IPR2020-00551, Paper 19 at 16
`(PTAB Aug. 27, 2020) (same).
`3. Investment in the Parallel Proceeding by the Court and the Parties
`Under this factor we first consider Petitioner’s timing in filing the
`Petition. If a petitioner, “faced with the prospect of a looming trial date,
`waits until the district court trial has progressed significantly before filing a
`petition,” that decision “may impose unfair costs to a patent owner.”
`Fintiv, 11. On the other hand, “[i]f the evidence shows that the petitioner
`filed the petition expeditiously, such as promptly after becoming aware of
`the claims being asserted, this fact has weighed against exercising the
`authority to deny institution.” Id. Here, Petitioner is not a party to the
`CDCA Case and is not “faced with the prospect of a looming trial date.”
`Because Petitioner was not served with a complaint, there is no information
`in the record to measure precisely the promptness of Petitioner’s filing of the
`Petition. In the Medtronic IPR we found that the petitioner in that case
`promptly filed its petition only four months after the complaint against it
`was served. In this case, Petitioner filed the Petition less than three weeks
`after the Petition was filed in the Medtronic IPR. We find no unreasonable
`delay in Petitioner’s filing, and Patent Owner does not argue otherwise. See
`generally Prelim. Resp.
`
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`Patent 9,125,739 B2
`Second, under this factor we consider “the amount and type of work
`already completed in the parallel litigation by the court and the parties at the
`time of the institution decision.” Fintiv, 9. “Specifically, if, at the time of
`the institution decision, the district court has issued substantive orders
`related to the patent at issue in the petition, this fact favors denial.” Id. at 9–
`10.
`
`Petitioner asserts that it has “not and will not invest resources” in the
`parallel district court proceeding, because it is not a party to the CDCA
`Case. Pet. 72 (further stating that “it does not appear that the parties or the
`court have invested substantial resources” in the CDCA Case).
`Patent Owner argues that the parties to the CDCA Case and the court
`have devoted significant resources to the CDCA Case, including full briefing
`on a motion to dismiss certain counts, serving discovery requests,
`exchanging discovery, service of invalidity contentions, filing a joint claim
`construction chart, and the court’s appointment of a Technical Special
`Master whose fees and expenses will be apportioned between the parties.
`Prelim. Resp. 26–27. Patent Owner further argues that before an institution
`decision is due in this proceeding, the parties in the CDCA Case will have
`completed claim construction, a Markman hearing and technology tutorial
`will have taken place, fact discovery will have closed, and the parties will
`have filed any discovery motions under the court’s scheduling order. Id.
`at 27–28; see also Ex. 2005 (CDCA Case order setting case schedule).
`We find that the parties to the CDCA Case and the court have
`invested substantial time and resources, particularly with regard to the
`appointment of a Technical Special Master and the conduct of a Markman
`hearing, but also find no evidence in the record that any substantive
`determinations on validity issues have been made in the CDCA Case.
`
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`Further, according to the scheduling order in the CDCA Case, expert
`discovery has not yet started. Ex. 2005, 3. On balance, we find the
`timeliness of the Petition and the level of investment of time and resources
`in the CDCA Case by the parties to the CDCA Case and the court, coupled
`with the absence of any substantive determinations on validity issues by the
`court, suggests consideration of this factor is neutral with respect to our
`discretion to deny institution under § 314(a).
`4. Overlap Between Issues Raised in the Petition and in the
`Parallel Proceeding
`Fintiv states “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 [of institution].” Fintiv, 12. Fintiv
`also provides as follows:
`Even when a petitioner is unrelated to a defendant, however, if
`the issues are the same as, or substantially similar to, those
`already or about to be litigated, or other circumstances weigh
`against redoing the work of another tribunal, the Board may,
`nonetheless, exercise the authority to deny institution.” An
`unrelated petitioner should, therefore, address any other district
`court or Federal Circuit proceedings involving the challenged
`patent to discuss why addressing the same or substantially the
`same issues would not be duplicative of the prior case even if the
`petition is brought by a different party.”
`Id. at 14.
`Petitioner argues that the “co-pending district court litigation is
`currently in its early stages and as a non-party, Petitioners have no control
`over or insight into what art and arguments may be raised in that case.”
`Pet. 73.
`Patent Owner argues that Petitioner fails “to address the fact that the
`issues in this Petition ‘are the same as, or substantially similar to, those
`
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`IPR2020-01649
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`already about to be litigated.’” Prelim. Resp. 31. According to Patent
`Owner, the grounds Petitioner asserts “rely on a subset of the same art at
`issue in” the CDCA Case and the invalidity arguments raised by the
`defendant in the CDCA Case “reflect each and every one of the five grounds
`at issue” in the Petition. Id. at 32 (citing Ex. 2009 ¶ 9; Exs. 2012–2016).
`Patent Owner further states that “while the CDCA Defendant has provided
`Patent Owner with a stipulation [Ex. 2017] that if the Board institutes IPR
`on the Petitions filed by the CDCA Defendant (IPR2020-01453 and -01454
`[i.e., the Medtronic IPR]), the CDCA Defendant has not provided such a
`stipulation with respect to the current Petition.”8 Id. at 32–33 (citing
`Ex. 2017, 1).
`The stipulation in the Medtronic IPR that Patent Owner refers to
`provides, in relevant part, as follows:
`Medtronic [i.e., the CDCA Defendant] stipulates that, if the
`Patent Trial and Appeal Board institutes inter partes review on
`IPR2020‐01454,
`then Medtronic will not pursue in
`the
`corresponding district court case the specific grounds identified
`in the Petition in IPR2020‐01454 in connection with the ’739
`patent claims challenged in the Petition, or on any other ground
`that was raised or could have been reasonably raised as to these
`claims in an IPR (i.e., any ground that was raised or could have
`been reasonably raised under Sections 102 or 103 on the basis of
`prior art patents or printed publications).
`Ex. 2017 (the “Stipulation”). As noted above, the petition in IPR2020-
`01454 (the Medtronic IPR) was instituted. In accordance with the
`
`
`8 Patent Owner also argues that Petitioner “has made no promise that it
`would not seek to join in this Petition if instituted.” Prelim. Resp. 32.
`Patent Owner does not explain how that argument is relevant to whether
`there is overlap between the issues in this proceeding and the issues raised in
`the district court proceeding for purposes of discretionary denial
`under § 314(a).
`
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`Stipulation, the CDCA Defendant will not pursue in the corresponding
`district court case the specific grounds raised in the Medtronic IPR, as well
`as “any other ground that was raised or could have been reasonably raised as
`to these claims in an IPR.” Id. Accordingly, Patent Owner’s argument that
`“the CDCA Defendant has not provided such a stipulation with respect to
`the current Petition” does not address whether the grounds raised in the
`Petition may be grounds that “could have been reasonably raised as to these
`claims in an IPR,” and thus fall within the Stipulation’s provision that the
`CDCA Defendant will not pursue such grounds in district court. To be clear,
`we do not speculate on whether the grounds raised in the Petition fall within
`the Stipulation; however, we recognize that if they do, this factor would
`seem to weigh against exercising discretion to deny institution of inter
`partes review. See Sotera Wireless, Inc. v. Masimo Corp., IPR2020-01019,
`Paper 12 at 19 (PTAB Dec. 1, 2020) (precedential in relevant part)).
`Because we cannot determine on the record in this proceeding whether the
`Stipulation applies to the grounds asserted in this proceeding, we find, on
`balance, this factor is neutral.
`5. Whether Petitioner and the Defendant in the Parallel Proceeding are
`the Same Party
`According to Fintiv, “[i]f a petitioner is unrelated to a defendant in an
`earlier [district] court proceeding, the Board has weighed this fact against
`exercising discretion to deny institution.” Fintiv, 13–14. There is no dispute
`that Petitioner is not a party to the CDCA Case. Pet. 71; Prelim. Resp. 31.
`Thus, this factor weighs against exercising our discretion to deny institution
`under § 314(a).
`
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`6. Other Circumstances that Impact the Board’s Exercise of Discretion,
`Including the Merits
`The final Fintiv factor is a catch-all that takes into account any other
`relevant circumstances. A full merits analysis is not necessary as part of
`deciding whether to exercise discretion not to institute, but we consider
`particular “strengths or weaknesses” in deciding whether the merits tip the
`balance one way or another. See Fintiv, 15–16. Petitioner asserts that the
`Petition is “particularly strong,” because it relies on the publication of the
`’739 patent’s “own grandparent prior art,” Paniagua, to show anticipation
`and because the ’739 patent “is based on the applicants’ copying of portions
`of two pieces of prior art nearly word-for-word into the specification and
`then, twelve years later, filing a continuation application with claims that
`covered the copied references.” Pet. 73.
`Patent Owner argues that the Petition suffers from “numerous
`deficiencies,” including that Paniagua is not prior art and that under the
`Bessler Grounds Petitioner fails “to show that the prior art discloses that ‘the
`prosthetic heart valve is collapsed onto the pusher member,’ as claim 1
`requires.” Prelim. Resp. 36. As explained below, we are persuaded on the
`current record that Petitioner has sufficiently shown how Klint teaches that
`limitation of claim 1, which Patent Owner does not yet substantively dispute.
`See id. at 52–54 (arguing a lack of reason to combine the asserted references,
`not that Klint fails to teach the feature it is relied upon by Petitioner).
`Having considered Petitioner’s and Patent Owner’s arguments, and
`based on the limited record before us, we find that these “other” factors do
`not favor exercising our discretion to deny institution. As discussed in detail
`infra, we determine, on this record, that Petitioner has demonstrated a
`
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`IPR2020-01649
`Patent 9,125,739 B2
`likelihood of prevailing on its patentability challenges of at least one claim
`of the ’739 patent.
`7. Holistic Analysis of Fintiv Factors
`We undertake a holistic analysis of the Fintiv factors, considering
`“whether efficiency and integrity of the system are best served by denying or
`instituting review.” Fintiv, 6. We determine that the facts in this case that
`weigh against exercising discretion outweigh the facts that favor exercising
`discretion. Accordingly, we determine that the circumstances presented
`weigh against denying institution under § 314(a).
`B. Discretionary Denial of the Petition Under 35 U.S.C. § 325(d)
`Petitioner asserts in the Petition that discretionary denial under
`§ 325(d) is not warranted. Pet. 73–75. Patent Owner argues we should deny
`the Paniagua Ground under § 325(d). Prelim. Resp. 36. Patent Owner also
`states that it “acknowledges that Grounds 2–4 involve different art (other
`than Leonhardt) and arguments than those presented to the PTO,” and argues
`that Petitioner fails to show a reasonable likelihood of prevailing on those
`grounds. Id. at 36 n.1.
`In evaluating arguments under § 325(d), we use a two-part
`framework: (1) whether the same or substantially the same art previously
`was presented to the Office or whether the same or substantially the same
`arguments previously were presented to the Office; and (2) if either
`condition of first part of the framework is satisfied, whether the petitioner
`has demonstrated that the Office erred in a manner material to the
`patentability of challenged claims. Advanced Bionics, LLC v. MED-EL
`Elektromedizinische Geräte GmbH, IPR2019-01469, Paper 6 at 8 (PTAB
`Feb. 13, 2020) (precedential). In applying the two-part framework, we
`consider the non-exclusive factors set forth in Becton, Dickinson and Co. v.
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`IPR2020-01649
`Patent 9,125,739 B2
`B. Braun Melsungen AG, IPR2017-01586, Paper 8 (PTAB Dec. 15, 2017)
`(precedential in relevant part), which “provide useful insight into how to
`apply the framework” under § 325(d). Advanced Bionics, Paper 6 at 9.
`Those non-exclusive factors include:
`(a) the similarities and material differences between the
`asserted art and the prior art involved during examination;
`(b) the cumulative nature of the asserted art and the prior
`art evaluated during examination;
`(c) the extent to which the asserted art was evaluated
`during examination, including whether the prior art was the
`basis for rejection;
`(d) the extent of the overlap between the arguments made
`during examination and the manner in which Petitioner relies
`on the prior art or Patent Owner distinguishes the prior art;
`(e) whether Petitioner has pointed out sufficiently how
`the Examiner erred in its evaluation of the asserted prior art;
`and
`
`(f) the extent to which additional evidence and facts
`presented in the Petition warrant reconsideration of the prior art
`or arguments.
`Becton, Paper 8 at 17–18. “If, after review of factors (a), (b), and (d), it is
`determined that the same or substantially the same art or arguments
`previously were presented to the Office, then factors (c), (e), and (f) relate to
`whether the petitioner has demonstrated a material error by the Office.”
`Advanced Bionics, Paper 6 at 10.
`Regarding the Paniagua Ground, Patent Owner argues that “