Trials@uspto.gov
`571-272-7822
`
`Paper 8
`Date: August 13, 2021
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`EDWARDS LIFESCIENCES CORPORATION AND
`EDWARDS LIFESCIENCES LLC,
`Petitioner,
`v.
`COLIBRI HEART VALVE LLC,
`Patent Owner.
`
`IPR2021-00775
`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
`Granting Motion for Joinder
`35 U.S.C. § 315(c); 37 C.F.R. § 42.122
`
`
`
`
`
`
`
`
`571-272-7822
`
`Paper 8
`Date: August 13, 2021
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`EDWARDS LIFESCIENCES CORPORATION AND
`EDWARDS LIFESCIENCES LLC,
`Petitioner,
`v.
`COLIBRI HEART VALVE LLC,
`Patent Owner.
`
`IPR2021-00775
`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
`Granting Motion for Joinder
`35 U.S.C. § 315(c); 37 C.F.R. § 42.122
`
`
`
`
`
`
`
`
`
`IPR2021-00775
`Patent 9,125,739 B2
`
`INTRODUCTION
`I.
`On April 6, 2021, Edwards Lifesciences Corporation and Edwards
`Lifesciences LLC (“Petitioner” or “Edwards”) 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.”). Concurrently, Petitioner filed a Motion
`for Joinder seeking to join Medtronic CoreValve LLC v. Colibri Heart
`Valve LLC, IPR2020-01454 (the “Medtronic IPR”). Paper 3 (the “Motion”
`or “Mot.”). Inter partes review was instituted in the Medtronic IPR on
`March 10, 2021. Medtronic IPR, Paper 11 (PTAB March 10, 2021) (the
`“Medtronic IPR Institution Decision”). The Petition is substantively
`identical to the petition on which inter partes review was instituted in the
`Medtronic IPR. See Ex. 1025 (comparison of the Petition to the petition in
`the Medtronic IPR). Colibri Heart Valve LLC (“Patent Owner”) did not file
`a preliminary response to the Petition or an opposition to the Motion.
`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) (2020). 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 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. This is not a final
`decision as to patentability of claims for which inter partes review is
`
`2
`
`
`
`IPR2021-00775
`Patent 9,125,739 B2
`instituted. Any final decision will be based on the record, as fully developed
`during trial. We also grant the unopposed Motion and join Petitioner to the
`Medtronic IPR (IPR2020-01454).
`II. BACKGROUND
`The ’739 Patent
`A.
`The ’739 patent, titled “Percutaneous Replacement Heart Valve and a
`Deliver and Implantation System,” issued September 8, 2015, from
`Application No. 14/253,650 (“the ’650 Application”), filed April 15, 2014.
`Ex. 1001, codes (21), (22), (45), (54). 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. Ex. 1001, 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
`
`3
`
`
`
`IPR2021-00775
`Patent 9,125,739 B2
`tubular structure that “flares markedly at both ends in a trumpet-like
`configuration.” 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 of 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.
`
`4
`
`
`
`IPR2021-00775
`Patent 9,125,739 B2
`
`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
`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
`
`5
`
`
`
`IPR2021-00775
`Patent 9,125,739 B2
`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 (all of the claims) 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
`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
`
`6
`
`
`
`IPR2021-00775
`Patent 9,125,739 B2
`configured to continue to reside entirely within the inner
`channel of the stent member upon deployment in the
`patient.
`Id. at 14:2–29.
`
`Reference(s)/Basis
`
`Garrison1
`Garrison, Leonhardt2
`Garrison, Nguyen3
`Garrison, Leonhardt, Nguyen
`Andersen, 4 Limon, 5 Gabbay6
`Andersen, Limon, Phelps7
`Andersen, Limon, Phelps, Nguyen
`Andersen, Limon, Gabbay, Garrison
`Andersen, Limon, Phelps, Garrison
`Andersen, Limon, Phelps, Nguyen, Garrison
`
`Asserted Grounds of Unpatentability
`C.
`Petitioner asserts that the Challenged Claims are unpatentable based
`on the following grounds, which are the same grounds asserted in the
`Medtronic IPR:
`Claim(s)
`Challenged 35 U.S.C. §
`1–5
`103
`1–5
`103
`1–5
`103
`1–5
`103
`1–3, 5
`103
`1–3, 5
`103
`1–3, 5
`103
`4
`103
`4
`103
`4
`103
`Pet. 10–11.
`
`1 U.S. Patent No. 6,425,916 B1, issued July 30, 2002 (Ex. 1005, “Garrison”).
`2 U.S. Patent No. 5,957,949, issued September 28, 1999 (Ex. 1006,
`“Leonhardt”).
`3 U.S. Patent No. 5,961,549, issued October 5, 1999 (Ex. 1020, “Nguyen”).
`4 U.S. Patent No. 5,840,081, issued November 24, 1998 (Ex. 1013,
`“Andersen”).
`5 U.S. Patent No. 6,077,295, issued June 20, 2000 (Ex. 1008, “Limon”).
`6 U.S. Patent No. 7,025,780 B2, issued April 11, 2006 (Ex. 1009,
`“Gabbay”).
`7 WO 00/15147, published March 23, 2000 (Ex. 1010, “Phelps”).
`
`7
`
`
`
`IPR2021-00775
`Patent 9,125,739 B2
`Petitioner relies on the supporting Declaration of William J.
`Drasler, Ph. D., dated September 1, 2020, which is the same declaration filed
`in support of the petition in the Medtronic IPR. Ex. 1002.
`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). Pet. 7; Paper 7, 1. All of the claims of the ’739 patent are
`also challenged in the Medtronic IPR, as well as in Edwards Lifesciences
`Corp. and Edwards Lifesciences LLC v. Colibri Heart Valve LLC, IPR2020-
`01649 (the “First Edwards IPR”).8 Paper 4, 1.
`Real Parties in Interest
`E.
`Petitioner identifies no additional real parties in interest. Pet. 7.
`Patent Owner identifies no additional real parties in interest. Paper 7, 1
`III. ANALYSIS OF PETITION
`The Petition is substantively identical to the petition in the
`Medtronic IPR. See Ex. 1025; see also Mot. 1 (stating that the Petition “and
`the Medtronic IPR petition are substantially identical; they contain the same
`grounds (based on the same prior art combinations and supporting evidence)
`against the same claims”). For the same reasons provided in the Medtronic
`IPR Institution Decision, which we incorporate expressly herein, we find
`
`8 Concurrent with the Petition, Petitioner filed a Notice Regarding Multiple
`Petitions, which acknowledges that the Petition is the second petition filed
`by Petitioner challenging all claims of the ’739 patent. Paper 4 (the
`“Notice”), 1. In the Notice, Petitioner asserts that the Board should not
`exercise its discretion to deny the Petition, because this case presents
`circumstances in which more than one petition may be necessary. Id. at 3.
`Patent Owner has not argued that the Petition should be denied in light of the
`First Edwards IPR. Accordingly, we decline to exercise our discretion to
`deny the Petition under the circumstances presented.
`
`8
`
`
`
`IPR2021-00775
`Patent 9,125,739 B2
`that Petitioner demonstrates a reasonable likelihood of prevailing with
`respect to at least one of the Challenged Claims of the ’739 patent.
`Medtronic IPR Institution Decision, 1–47.
`IV. ANALYSIS OF MOTION
`Acting under the designation of the Director, we have discretion to
`determine whether to join a party to an instituted inter partes review.
`35 U.S.C. § 315(c); 37 C.F.R. § 42.122(a). We may
`join as a party to [an instituted] inter partes review any person
`who properly files a petition under section 311 that . . . after
`receiving a preliminary response under section 313 or the
`expiration of the time for filing such a response . . . warrants the
`institution of an inter partes review under section 314.
`35 U.S.C. § 315(c). “Any request for joinder must be filed . . . no later than
`one month after the institution date of any inter partes review for which
`joinder is requested.” 37 C.F.R. § 42.122(b). Petitioner shows that the
`Motion is timely as it was filed within one month of the Medtronic IPR
`Institution Decision. See Mot. 1.
`
`A motion for joinder should (1) explain why joinder is
`appropriate, (2) discuss whether any new grounds of unpatentability are
`asserted in the second petition, (3) explain what impact, if any, joinder
`would have on the cost and schedule for the existing proceeding,
`and (4) address whether granting joinder will add to the complexity of
`briefing and/or discovery. See Consolidated Trial Practice Guide, 76
`(Nov. 2019) (https://www.uspto.gov/TrialPracticeGuideConsolidated)
`(citing Kyocera Corp. v. Softview LLC, IPR2013-00004, Paper 15, 4 (PTAB
`Apr. 24, 2013)).
`As for why joinder is appropriate and whether any new grounds of
`unpatentability are asserted in this proceeding, Petitioner states that the
`
`9
`
`
`
`IPR2021-00775
`Patent 9,125,739 B2
`“Petition and the Medtronic IPR petition contain the same grounds (based on
`the same prior art combinations and supporting evidence) against the same
`claims [of the ’739 patent].” Mot. 3.
`Regarding what impact, if any, joinder would have on the cost,
`schedule, or complexity of the existing proceeding, Petitioner argues that
`joinder “will have minimal impact, if any,” because the Petition “presents no
`new issues or grounds of unpatentability,” that Petitioner consents “to the
`existing trial schedule,” and that “Patent Owner will not be required to
`present any additional responses or arguments.” Id. at 6. Petitioner further
`states that, because the “Petition relies on the same expert and the same
`declaration, only a single deposition is needed for the proposed joined
`proceeding.” Id. Petitioner also “explicitly agrees to take an ‘understudy’
`role, which will simplify briefing and discovery.” Id. at 7.
`Petitioner states that if joinder is granted, Petitioner “will not assume
`an active role” as long as the existing petitioner in the Medtronic IPR
`actively participates in the inter partes review, whereby Petitioner explicitly
`agrees to the following conditions:
`a) Edwards shall not make any substantive filings, unless a filing
`concerns termination and settlement, or issues solely involving
`Edwards;
`b) Edwards shall not present any argument or make any
`presentation at the oral hearing on issues not solely involving
`Edwards;
`c) Edwards shall not seek to cross-examine or defend the cross-
`examination of any witness, unless the topic of cross-
`examination concerns issues solely involving Edwards; and
`d) Edwards shall not seek discovery from Patent Owner on issues
`not solely involving Edwards.
`
`10
`
`
`
`IPR2021-00775
`Patent 9,125,739 B2
`Id. (citing Noven Pharms., Inc. v. Novartis AG, IPR2014-00550, Paper 38, 5
`(PTAB Apr. 10, 2015). Patent Owner did not file a preliminary response to
`the Petition or an opposition to the Motion. In view of Petitioner’s
`representations, we are persuaded that joinder is appropriate. We, therefore,
`grant the Motion.
`
`IV. CONCLUSION
`Based on the evidence before us, we determine Petitioner
`demonstrates a reasonable likelihood of prevailing in its assertions that the
`Challenged Claims of the ’739 patent are unpatentable over the asserted
`prior art. Accordingly, inter partes review shall proceed in this case on all
`of the grounds raised in the Petition. See SAS Inst., Inc. v. Iancu, 138 S. Ct.
`1348, 1359–60 (2018) (holding that a decision to institute under 35 U.S.C.
`§ 314 may not institute on fewer than all claims challenged in the petition);
`PGS Geophysical AS v. Iancu, 891 F.3d 1354, 1360 (Fed. Cir. 2018) (stating
`the decision whether to institute inter partes review requires “a simple yes-
`or-no institution choice respecting a petition, embracing all challenges
`included in the petition”).
`Our determination in this Decision is not a final determination on
`either the patentability of any challenged claims or the construction of any
`claim term and, thus, leaves undecided any remaining fact issues necessary
`to determine whether sufficient evidence supports Petitioner’s contentions
`by a preponderance of the evidence in the final written decision. See
`Trivascular, Inc. v. Samuels, 812 F.3d 1056, 1068 (Fed. Cir. 2016) (noting
`that “there is a significant difference between a petitioner’s burden to
`establish a ‘reasonable likelihood of success’ at institution, and actually
`proving invalidity by a preponderance of the evidence at trial”)
`(quoting 35 U.S.C. § 314(a) and comparing id. § 316(e)).
`
`11
`
`
`
`IPR2021-00775
`Patent 9,125,739 B2
`We also find that Petitioner has made a sufficient showing in support
`of its unopposed Motion for Joinder. Accordingly, we grant Petitioner’s
`Motion for Joinder and join Petitioner to IPR2020-01454.
`V. ORDER
`Upon consideration of the record before us, it is:
`ORDERED that, pursuant to 35 U.S.C. § 314(a), an inter partes
`review of claims 1–5 of U.S. Patent No. 9,125,739 B2 is instituted with
`respect to all grounds set forth in the Petition;
`FURTHER ORDERED that, pursuant to 35 U.S.C. § 314(c) and
`37 C.F.R. § 42.4(b), inter partes review of U.S. Patent No. 9,125,739 B2
`shall commence on the entry date of this Order, and notice is hereby given of
`the institution of a trial;
`FURTHER ORDERED that, pursuant to 35 U.S.C. § 315(c)
`and 37 C.F.R. § 42.122(a), Petitioner’s Motion for Joinder is granted, and
`Petitioner is joined as a petitioner in IPR2020-01454;
`FURTHER ORDERED that, in view of the joinder, all further filings
`shall be made only in IPR2020-01454;
`FURTHER ORDERED that the asserted grounds of unpatentability on
`which the Board instituted inter partes review in IPR2020-01454 are
`unchanged and remain the only instituted grounds;
`FURTHER ORDERED that the Scheduling Order in IPR2020-01454,
`and any modifications thereto, shall govern the schedule of the joined
`proceeding;
`FURTHER ORDERED that, in IPR2020-01454, Petitioner will file
`each paper, except for any paper that does not involve the other party, as a
`single, consolidated filing with Medtronic CoreValve LLC, subject to the
`
`12
`
`
`
`IPR2021-00775
`Patent 9,125,739 B2
`page limits set forth in 37 C.F.R. § 42.24, and shall identify such filing as a
`consolidated filing;
`FURTHER ORDERED that, for any consolidated filing, if Petitioner
`wishes to file an additional paper to address points of disagreement with
`Medtronic CoreValve LLC, Petitioner must request authorization from the
`Board to file a motion for an additional paper or pages;
`FURTHER ORDERED that Petitioner shall collectively designate
`attorneys with Medtronic CoreValve LLC to conduct the cross-examination
`of any witness produced by Patent Owner and the redirect of any witness
`produced by Medtronic CoreValve LLC and Petitioner, within the
`timeframes set forth in 37 C.F.R. § 42.53(c) or agreed to by the parties;
`FURTHER ORDERED that Petitioner shall collectively designate
`attorneys with Medtronic CoreValve LLC to present at the oral hearing, if
`requested and scheduled, in a consolidated argument;
`FURTHER ORDERED that the caption in IPR2020-01454 shall be
`changed to reflect joinder of Petitioner in accordance with the attached
`example; and
`FURTHER ORDERED that a copy of this Decision shall be entered
`into the record of IPR2020-01454.
`
`
`
`
`
`
`13
`
`
`
`IPR2021-00775
`Patent 9,125,739 B2
`FOR PETITIONER:
`Brian Egan
`MORRIS, NICHOLS, ARSHT & TUNNELL LLP
`began@mnat.com
`
`Gregory Cordrey
`JEFFER MANGELS BUTLER & MITCHELL, LLP
`gcordrey@jmbm.com
`
`FOR PATENT OWNER:
`
`Sarah Spires
`SKIERMONT DERBY LLP
`sspires@skiermontderby.com
`
`
`
`14
`
`
`
`IPR2021-00775
`Patent 9,125,739 B2
`Example Case Caption for Joined Proceeding
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`MEDTRONIC COREVALVE LLC, EDWARDS LIFESCIENCES
`CORPORATION, AND
`EDWARDS LIFESCIENCES LLC,
`Petitioner,
`v.
`COLIBRI HEART VALVE LLC,
`Patent Owner.
`
`IPR2021-007759
`Patent 9,125,739 B2
`
`
`
`
`
`
`
`
`
`
`
`
`9 Edwards Lifesciences Corporation and Edwards Lifesciences LLC filed a
`petition in IPR2021-00775, and have been joined as petitioner in this
`proceeding.
`
`15
`
`
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