IPR2020-01454
`
`U.S. Patent No. 9,125,739
`
`
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`____________
`
`MEDTRONIC COREVALVE LLC,
`
`Petitioner,
`
`v.
`
`COLIBRI HEART VALVE LLC,
`
`Patent Owner.
`
`____________
`
`Case IPR2020-01454
`
`U.S. Patent No. 9,125,739
`
`____________
`
`
`PETITIONER’S REPLY BRIEF IN SUPPORT OF
`PETITION FOR INTER PARTES REVIEW
`
`
`
`
`
`U.S. Patent No. 9,125,739
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`____________
`
`MEDTRONIC COREVALVE LLC,
`
`Petitioner,
`
`v.
`
`COLIBRI HEART VALVE LLC,
`
`Patent Owner.
`
`____________
`
`Case IPR2020-01454
`
`U.S. Patent No. 9,125,739
`
`____________
`
`
`PETITIONER’S REPLY BRIEF IN SUPPORT OF
`PETITION FOR INTER PARTES REVIEW
`
`
`
`
`
`IPR2020-01454
`
`U.S. Patent No. 9,125,739
`
`
`
`Exhibit
`(“Ex.”)
`1001
`
`1002
`
`1003
`
`1004
`
`1005
`
`1006
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`1007
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`1008
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`1009
`
`1010
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`1011
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`1012
`
`1013
`
`1014
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`1015
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`1016
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`1017
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`1018
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`LIST OF EXHIBITS
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`Description
`
`U.S. Patent No. 9,125,739 (“’739”)
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`Declaration of William J. Drasler, Ph.D. (“Drasler”)
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`File History of U.S. Patent No. 9,125,739
`
`Reserved
`
`U.S. Patent No. 6,425,916 to Garrison
`
`U.S. Patent No. 5,957,949 to Leonhardt
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`Reserved
`
`U.S. Patent No. 6,077,295 to Limon
`
`U.S. Patent No. 7,025,780 to Gabbay
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`International Patent No. WO 00/15147 to Phelps
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`File History of U.S. Patent 8,900,294
`
`International Patent No. WO 98/29057 to Letac
`
`U.S. Patent No. 5,840,081 to Andersen
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`Reserved
`
`File History of U.S. Patent Application No. 09/659,882
`
`File History of U.S. Patent Application No. 10/887,688
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`File History of U.S. Patent Application No. 13/675,665
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`File History of U.S. Patent Application No. 10/037,266
`
`i
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`
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`1019
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`1020
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`1021
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`1022
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`1023
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`1024
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`1025
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`1026
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`1027
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`1028
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`1029
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`1030
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`1031
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`1032
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`1033
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`1034
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`1035
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`1036
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`IPR2020-01454
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`U.S. Patent No. 9,125,739
`AneuRX Stent Graft System.pdf available at
`https://www.accessdata.fda.gov/cdrh_docs/pdf/P990020c.pdf
`
`U.S. Patent No. 5,961,549 to Nguyen
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`U.S. Patent No. 5,713,950 to Cox
`
`Screenshot of Docket Navigator Time-to-Milestone Report for the
`United States District Court of the Central District of California
`
`Stipulation Regarding IPRs, dated September 1, 2020
`
`Declaration of Crena Pacheco
`
`Stipulation Regarding IPRs, dated December 22, 2020
`
`Jane Doe et al. v. Xavier Becerra et al., No. 8:19-cv-02105, U.S.
`District Court Docket (C.D. Cal.)
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`Shuthima Pongsai V. Am. Express Co., No. 8:19cv1628, U.S. District
`Court Docket (C.D. Cal.)
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`C.D. Cal. General Order 20-12 dated September 14, 2020
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`C.D. Cal. General Order 20-15 dated November 25, 2020
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`C.D. Cal. General Order 20-05 dated April 13, 2020
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`C.D. Cal. General Order 20-08 dated May 28, 2020
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`C.D. Cal. General Order 20-09 dated August 6, 2020
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`C.D. Cal. Order of the Chief Judge 20-042 dated March 19, 2020
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`Activation of Continuity of Operations Plan dated December 7, 2020
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`Press Release - Activation of Continuity of Operations Plan dated
`December 7, 2020
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`Colibri Heart Valve LLC v Medtronic Corevalve LLC, No. 8:20-cv-
`00847, U.S. District Court Docket (C.D. Cal.)
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`1037
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`Extension of Continuity of Operations Plan dated January 6, 2021
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`ii
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`1038
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`1039
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`IPR2020-01454
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`U.S. Patent No. 9,125,739
`Colibri Heart Valve LLC v Medtronic Corevalve LLC, No. 8:20-cv-
`00847-DOC-JDE, Dkt. 73, Scheduling Order (C.D. Cal. November 24,
`2020)
`
`Medtronic, Inc. v. Axonics Modulation Techns., Inc., No. 8:19-cv-
`02115-DOC-JDE, Dkt. 55, Order Granting Defendant’s Motion to Stay
`Litigation Pending Inter Partes Review (C.D. Cal. May 8, 2020)
`
`1040
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`Declaration of Crena Pacheco
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`
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`iii
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`IPR2020-01454
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`U.S. Patent No. 9,125,739
`The Board should not exercise its §314(a) discretion to deny institution. The
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`Board’s recent precedential decision in Sotera Wireless, Inc. v. Masimo Corp.,
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`IPR2020-01019, Pap. 12, *14-21 (designated 12/17/2020), Petitioner’s subsequent
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`stipulation tracking Sotera, Petitioner’s prompt Petition filing 8 months before the
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`statutory bar, and the court’s recent decisions indefinitely continuing other trial dates
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`in addition to a 9+ month trial backlog outweigh any factors weighing against
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`institution. A “holistic review of the Fintiv factors, namely that the timing of the
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`Petition was reasonable, the relatively limited investment in the parallel proceeding
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`to date, and that there is minimal potential overlap of the two proceedings, indicates
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`that the Fintiv factors weigh in favor of instituting inter partes review.” Sotera, *20.
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`Factor 1: While the district judge indicated during a 11/17/2020 conference
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`that he intended to deny the motion to stay and that the trial date would not move,
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`an order has not issued to date and the judge has contemporaneously continued other
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`trial dates in light of COVID (e.g., Exs. 1026, *16, 1027, *18). Moreover, pandemic
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`conditions worsened shortly after that status conference. Compare Ex. 1028 (C.D.
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`Cal. 9/14/2020 Order permitting in-person hearings in emergency civil matters in
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`district judge’s courthouse), with Ex. 1029 (C.D. Cal. 11/25/2020 Order closing
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`district judge’s courthouse to public because “local COVID-19 exposure
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`risks…have increased”), Exs. 1034-1035, 1037 (C.D. Cal. 12/7/2020 Operations
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`Plan continuing closure/extension). The same judge also granted a similarly-situated
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`IPR2020-01454
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`U.S. Patent No. 9,125,739
`pre-institution stay motion filed 5 months after the complaint. Ex. 1039, *1-2. Here,
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`the stay motion was filed 4 months post-complaint. Ex. 1036, *1, 7. Even if the
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`motion is denied at this stage, the Sotera-stipulation avoids any duplication of efforts.
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`Factor 2: While the current trial date is 6 months before the expected final
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`written decision (“FWD”), Petitioner is not aware of any C.D. Cal. trials since
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`3/23/2020—creating a backlog of 9+ months. Exs. 1028-1035, 1037. The district
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`and the district judge are continuing to push trial dates out indefinitely—extending
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`that backlog further. Exs. 1034-1035, 1037, 1026, *16, 1027, *18. PO does not
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`dispute that the average time to trial for patent cases in the district is 2 years 8 months,
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`which would result in a 1/2023 trial date (9 months after the FWD) even without the
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`9+ month backlog due to the pandemic. Ex. 1036, *8. Petitioner is not aware of any
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`patent case that has previously gone to trial before the district judge. Given the trial
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`date’s uncertainty, this factor should not weigh for or against exercising discretion.
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`Regardless, there can be no duplication of efforts due to the Sotera-stipulation.
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`Factor 3: This factor weighs in favor of not exercising discretionary denial.
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`The Petition was filed 4 months after the complaint was served (Ex. 1036, *4) and
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`over 2 months before initial responses to both infringement and invalidity
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`interrogatories were due. See Snap, Inc. v. SRK Tech. LLC, IPR2020-00820, Pap. 15,
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`*11 (precedential) (filing promptly after asserted claims are identified favors
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`institution). While the district court has put the case on a 16-month schedule from
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`2
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`IPR2020-01454
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`U.S. Patent No. 9,125,739
`complaint to trial, that should not outweigh the diligence with which Petitioner has
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`acted—let alone foreclose Petitioner’s ability to pursue an IPR. Indeed, in Snap and
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`Sotera, the petitions were filed close to the one-year bar date (id., *12-13; Sotera,
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`Pap. 12, *17), whereas here the Petition was filed 8 months before the bar date (Ex.
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`1036, *4 (service 5/5/2020)). PO’s allegations regarding its initial 12/2019
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`complaint (POPR 21) are irrelevant as it was never served. Even if it had been, the
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`Petition still would have been over 3 months before the bar date.
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`Even without further delays, the district court case will be at most only half-
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`way complete at the time of the institution (3/10/2021)—5 months after the
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`8/31/2020 Rule 26(f) report and 6 months before trial. Ex. 1036, *7-8. Fact discovery
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`will close late February, with additional discovery available in the event of a later-
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`issued Markman order. Ex. 1038, *2-3. In addition, to date, the court has not ruled
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`on Petitioner’s motion to dismiss and Petitioner has not filed an answer. Ex. 1036.
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`Factor 4: Given that Petitioner’s stipulation (Ex. 1025) is the same as the
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`stipulation in Sotera, this factor “weighs strongly in favor of not exercising
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`discretion to deny institution.” Sotera, Pap. 12, *19. PO’s only case addressing a
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`similar stipulation applied the wrong weight. IPR2020-00718, Pap. 12, *11 (“weighs
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`slightly in favor of not exercising…discretion”); see id. *13 (dissenting). Petitioner
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`stipulated that it will not raise any grounds that it raised or reasonably could have
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`raised in this IPR in district court if the IPR is instituted. Ex. 1025. The stipulation
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`3
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`IPR2020-01454
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`U.S. Patent No. 9,125,739
`“mitigates any concerns of duplicative efforts between the district court and the
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`Board, as well as concerns of potentially conflicting decisions.” Sotera, *19.
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`Factor 6: Petitioner’s trial grounds are especially strong—going well beyond
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`the required “reasonable likelihood” showing—and each of PO’s §314(a) merits-
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`based arguments (POPR 27-28) fails. Valve means residing entirely within stent
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`member’s inner channel when collapsed: Grounds 1, 3: While PO’s strawman
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`arguments wrongly focus on Garrison’s inverted-delivery embodiment (Figs. 31-38),
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`the trial grounds instead rely on Garrison’s separate embodiment in Figs. 8-11,
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`which readily meets the limitation under both of Garrison’s alternative teachings:
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`where the support structure’s ends have the same “trumpet-like” “features” as the
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`valve displacer or when “integrated” with the valve displacer. Pet. 29, 35, 42-43.
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`Each alternative changes the support structure’s shape—not the valve’s location in
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`its inner channel. Id. Grounds 2, 4: PO’s strawman arguments again mischaracterize
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`the trial grounds, which rely on Leonhardt’s teaching that the valve is always within
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`its stent (regardless of whether collapsed or expanded)—advantageously protecting
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`the valve at each of these stages, including from the trocar and sheath discussed by
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`PO. Pet. 47-52. Prosthetic heart valve’s distal end is located at the sheath’s distal
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`end: Grounds 1-10: PO’s arguments that the valve and not the stent must be located
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`at sheath’s distal end mischaracterize claim 1. POPR 50 (“Petitioner…mislabeled
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`the entire stent as the valve”), 52, 59-61 (distinguishing Limon and Anderson’s
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`4
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`IPR2020-01454
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`U.S. Patent No. 9,125,739
`valves/stents). Claim 1 instead recites that the stent is part of the prosthetic heart
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`valve (“a prosthetic heart valve including: a stent member…”) and thus the stent can
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`satisfy the limitation. Pet. 40-42, 69-71. Stent including tubular structure away
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`from central portion flares at both ends in a trumpet-like configuration:
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`Grounds 1-4, 6-7, 9-10: PO’s argument that the stent’s ends cannot be formed of
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`individual “fingers” or “points,” but instead must be flat like a trumpet (POPR 62-
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`65) is unsupported by the intrinsic evidence, which only depicts stent ends formed
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`by individual fingers/points, and belied by PO’s infringement contentions—the
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`accused device’s ends are formed of such fingers/points. Compare Garrison Fig. 9;
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`Leonhardt Figs. 1-4; Phelps Figs. 7-8; ’739 Fig. 8; Ex. 2001 (complaint), 9.
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`Motivation to apply Limon’s teachings to Andersen: Grounds 5-10: PO’s
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`strawman arguments regarding the application of heat to conform attachment
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`projections to a stent (POPR 54-55) fail to address the trial grounds’ reliance on
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`Limon’s alternative teachings of attachment projections that are “soft by design”—
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`enabling the projections to protect the stented valve and aid in pushing it out (Pet.
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`56-57, 68). And under the Petition’s alternative showing that does not rely on such
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`projections (Pet. 56), Limon’s pusher functionality mirrors the ’739’s, which also
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`does not have a mechanism beyond the catheter to push the valve out—contrary to
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`PO’s baseless assertion that the ’739’s pusher member has “a larger circumference
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`than the stented valve on the proximal end” (POPR 55).
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`5
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`Dated: January 8, 2021
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`IPR2020-01454
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`U.S. Patent No. 9,125,739
`Respectfully submitted,
`
`
`By: /James L. Davis, Jr./
`
`James L. Davis, Jr.
`Reg. No. 57,325
`ROPES & GRAY LLP
`1900 University Avenue, 6th Floor
`East Palo Alto, CA 94303-2284
`P: 650-617-4794 / F: 617-235-9492
`james.l.davis@ropesgray.com
`
`Counsel for Petitioner
`MEDTRONIC COREVALVE LLC
`
`6
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`IPR2020-01454
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`U.S. Patent No. 9,125,739
`CERTIFICATE OF SERVICE
`
`The undersigned certifies that the foregoing PETITIONER’S REPLY BRIEF
`
`IN SUPPORT OF PETITION FOR INTER PARTES REVIEW was served in its
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`entirety by filing through the Patent Trial and Appeal Board End to End (PTAB E2E),
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`as well as providing a courtesy copy via e-mail to the following attorneys of record
`
`for Patent Owner listed below:
`
`Lead Counsel
`Sarah E. Spires
`Registration No: 61,501
`SKIERMONT DERBY LLP
`1601 Elm Street, Suite 4400
`Dallas, Texas 75201
`Tel: (214) 978-6600
`Fax: (214) 978-6601
`sspires@skiermontderby.com
`
`
`
`Counsel for Patent Owner Colibri Heart Valve LLC
`
`
`
`Dated: January 8, 2021
`
`Back-up Counsel
`Paul J. Skiermont
`Pro Hac Vice
`SKIERMONT DERBY LLP
`1601 Elm Street, Suite 4400
`Dallas, Texas 75201
`Tel: (214) 978-6600
`Fax: (214) 978-6601
`pskiermont@skiermontderby.com
`
`
`By: /Crena Pacheco/
`Name: Crena Pacheco
`ROPES & GRAY LLP
`
`
`
`
`
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`
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`
`
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