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`571-272-7822
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`Paper No. 25
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________
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`EDWARDS LIFESCIENCES CORPORATION and
`EDWARDS LIFESCIENCES, LLC,
`Petitioner,
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`v.
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`COLIBRI HEART VALVE, LLC,
`Patent Owner.
`__________
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`IPR2020-01649
`Patent 9,125,739 B2
`____________
`
`Record of Oral Hearing
`Oral Hearing Held: December 8, 2021
`_____________
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`
`Before ERICA A. FRANKLIN, JAMES A. TARTAL, and
`ERIC C. JESCHKE, Administrative Patent Judges.
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`Paper No. 25
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`EDWARDS LIFESCIENCES CORPORATION and
`EDWARDS LIFESCIENCES, LLC,
`Petitioner,
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`v.
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`COLIBRI HEART VALVE, LLC,
`Patent Owner.
`__________
`
`IPR2020-01649
`Patent 9,125,739 B2
`____________
`
`Record of Oral Hearing
`Oral Hearing Held: December 8, 2021
`_____________
`
`
`Before ERICA A. FRANKLIN, JAMES A. TARTAL, and
`ERIC C. JESCHKE, Administrative Patent Judges.
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`IPR2020-01649
`Patent 9,125,739 B2
`
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`APPEARANCES:
`
`ON BEHALF OF THE PETITIONER:
`
`
`BRIAN EGAN, ESQ.
`Morris, Nichols, Arsht & Tunnell LLP
`1201 North Market Street, 16th Floor
`PO Box 1347
`Wilmington, Delaware 19899-1347
`(302) 351-9454
`Began@morrisnichols.com
`
`GREGORY CORDREY, ESQ.
`Jeffer Mangels Butler & Mitchell LLP
`3 Park Plaza, #1100
`Irvine, California 92614
`(949) 623-7236
`GCordrey@jmbm.com
`
`
`
`ON BEHALF OF THE PATENT OWNER:
`
`
`SARAH SPIRES, ESQ.
`Skiermont Derby, LLP
`1601 Elm Street, Suite 4400
`Dallas, Texas 75201
`(214) 978-6613
`sspires@skiermontderby.com
`
`
`
`The above-entitled matter came on for hearing on Wednesday, December
`
`8, 2021, commencing at 12:00 p.m., by video/by telephone.
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`IPR2020-01649
`Patent 9,125,739 B2
`
`P-R-O-C-E-E-D-I-N-G-S
`
`12:00 p.m.
`JUDGE TARTAL: Good afternoon and welcome. We are here for
`
`
`a virtual hearing by videoconference in an inter parte review case captioned
`Edwards Lifesciences Corporation and Edwards Lifesciences, LLC, Petitioner,
`versus Colibri Heart Valve, LLC, Patent Owner, Case IPR 2020-01649,
`concerning U.S. Patent No. 9,125,739 B2. Next, we will begin by introducing the
`panel. I am joined by Judge Franklin and Judge Jeschke, and I am Judge Tartal.
`
`
`Can we please have the parties' appearances? Who do we have
`appearing today on behalf of Petitioner?
`
`
`MR. EGAN: Good afternoon, Your Honors. Brian Egan from
`Morris, Nichols, Arsht & Tunnell on behalf of Petitioner, Edwards Lifesciences.
`Also joining me here today is my colleague, Matthew Middleton. Also on the
`screen is Greg Cordrey from the Jeffer Mangels law firm, and we have joining on
`the public line Avi Schwartz from Edwards Lifesciences.
`JUDGE TARTAL: Thank you, counsel, and welcome.
`Now, for Patent Owner, who do we have appearing today?
`MS. SPIRES: Good afternoon, Your Honor. Good to see you
`again. This is Sarah Spires from Skiermont Derby on behalf of Colibri Heart
`Valve.
`JUDGE TARTAL: Thank you and welcome back. We set forth the
`
`
`procedure for today's hearing in our trial order, and as a reminder, each party will
`have 60 minutes of total time to present arguments in the case. Petitioner has the
`burden of proof and will go first. Patent Owner will then present opposition
`arguments for the case. And then, to the extent Petitioner has reserved time,
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`IPR2020-01649
`Patent 9,125,739 B2
`Petitioner will present arguments in reply for the case. Finally, if Patent Owner
`has reserved time, it may present sur-reply arguments.
`We will try to provide a reminder of the time remaining but ask
`each party to also endeavor to keep track of the time they have available as well.
`Again, reminders. For clarity in the transcript, when you refer to
`an exhibit, please state for the record the exhibit page number or for
`demonstratives the slide number to which you are referring.
`When you are not speaking, please remember to mute your
`connection for clarity of the transcript and the line. We'd also remind each party
`that under no circumstances are they to interrupt the other party while that party is
`presenting its arguments and demonstratives.
`Are there any questions on behalf of Patent Owner at this time?
`MS. SPIRES: No, Your Honor.
`JUDGE TARTAL: And are there any questions on behalf of
`Petitioner at this time?
`MR. EGAN: No, Your Honor.
`JUDGE TARTAL: Petitioner, would you like to reserve
`tentatively a certain amount of time for reply?
`MR. EGAN: Yes, Your Honors. We would request to reserve 15
`minutes for rebuttal.
`JUDGE TARTAL: Okay. And then, that will allocate you 45
`minutes to begin with. We will try to give you a five-minute warning as that 45
`minutes is about to expire, and you can begin when you are ready.
`MR. EGAN: Okay. Thank you, Your Honors. Again, Brian Egan
`on behalf of Petitioner, Edwards LifeSciences.
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`IPR2020-01649
`Patent 9,125,739 B2
`I'll be referring to the slides that have been submitted by Petitioner
`as Exhibit 1040 throughout today's presentation, and I will certainly do my best to
`be clear as to which slide number we are referring to throughout the session.
`If I could turn Your Honors to start with Slide 2 of Exhibit 1040.
`Now, you already heard argument this morning concerning the
`‘739 patent, and IPR 2020-01454, so I don't plan to belabor the background
`discussion of the ‘739 patent.
`As you will see on Slide 2, in Edwards' petition, we present five
`grounds of invalidity. Grounds 2 through 5 rely primarily on the teachings of the
`Bessler prior art reference, and then rely on Teitelbaum and Leonhardt,
`respectively, for Grounds 2 and 3; and in Grounds 4 and 5, we also add the
`teachings of the Klint reference. And then finally, Ground 1 is an anticipation-
`based argument that's based on a lack of written description in the ‘739 patent, and
`the prior art we rely on there is the printed publication of the grandparent
`application to the ‘739 patent.
`We would propose addressing the grounds in reverse order today
`so first addressing Grounds 4 through 5, then stepping through Grounds 3, 2, and
`1. Obviously, I'm happy to answer any questions on any of the grounds as we
`proceed.
`
`If I could turn Your Honors to Slide 5.
`Slide 5 provides a breakdown of Claim 1 of the ‘739 patent. At a
`high level, the ‘739 patent claims an assembly to treat a native heart valve that
`includes a prosthetic heart valve with a stent member, and a valve means, a delivery
`system that includes, among other elements, a, quote, pusher member.
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`IPR2020-01649
`Patent 9,125,739 B2
`Now, we've highlighted in yellow the two elements of Claim 1 that
`have been disputed in the parties' briefing. Element 1B requires that the stent
`member flare at both ends in a trumpet-like configuration, and element 1(i)
`requires the prosthetic valve to be collapsed onto the pusher member of the
`delivery system.
`Now, based on Patent Owner's sur-reply and the slides that they
`filed for today's presentation, it does not appear that the trumpet-like
`configuration limitation remains in dispute. I am happy to answer any questions
`that the Board has on the trumpet-like configuration limitation, but we think that
`the best use of time, at least initially, is to go straight to the pusher member
`limitation, which we believe appears to be the heart of the dispute between the
`parties, along with the limitation that you will find in dependent claim 5 that
`requires the delivery system to include a, quote, controlled release mechanism.
`JUDGE TARTAL: Counsel, this is Judge Tartal.
`MR. EGAN: Yes.
`JUDGE TARTAL: I just want to, sort of as a preface to your
`comments: You are welcome to focus on what you think the most important
`issues are. Our presumption would be unless Patent Owner has unequivocally
`disclaimed an argument made in the Patent Owner response, that what it disputes
`in the Patent Owner response is still in dispute.
`So just as an advisement that we haven't made a determination that
`they've waived some sort of argument or anything they've asserted, or the Patent
`Owner response is no longer in a position of maintaining, and I'm sure Patent
`Owner will fill us in when it's their opportunity to speak, but I wanted to make that
`clear.
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`Patent 9,125,739 B2
`MR. EGAN: Sure. Understood. Thank you, Your Honor.
`If I could turn Your Honors to Slide 7.
`Slide 7 includes a number of figures from the Bessler prior art
`reference, which is Exhibit 1006 in the record. There is no dispute among the
`parties that Bessler discloses almost all of the elements of Claim 1. As you can
`see in figures 4 and 5 that are on the left-hand side of Slide 7, Bessler discloses a
`collapsible and expandable stent structure which he numbers 32. Bessler also
`discloses a multi-leaflet valve structure, which is number 35 and 36 in figure 4.
`And then, Bessler separately discloses a delivery system with a pusher member.
`One embodiment of that delivery system is shown on the right-hand side of Slide
`7, which is figures 12 and 13, where the pusher member is number 93.
`Now, it's clear from the -- the briefing that the parties dispute
`whether the pusher member described by Bessler is a pusher member as claimed
`by the ‘739 patent, which is why Petitioner has also relied on the teachings of
`Klint in Grounds 4 through 5, and so we would like to first start with Grounds 4
`through 5 and the teachings of Klint's pusher member embodiments.
`So if I could turn Your Honors' attention to Slide 27.
`On Slide 27, what we are conveying is that there are at least two
`types of pusher members that we've identified in the prior art for use with
`transcatheter heart valves, both of which are taught by Klint, among other
`references that have been provided in the record.
`Now, first, there are pusher members that extend from the handle
`of the delivery system and extend through the catheter and then terminate proximal
`to the valve prosthesis. And that's what's described in what we referred to here on
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`IPR2020-01649
`Patent 9,125,739 B2
`Slide 27 as embodiment 1 of Klint. That embodiment is also what's pictured in
`Klint at figures 13 and 16, which are shown on the left-hand side of Slide 27.
`Now, Klint also teaches a second embodiment of a pusher
`member, and the second embodiment of a pusher member is one that extends from
`the handle of the delivery system through the catheter and then through the valve
`prosthesis so the valve prosthesis is collapsed onto the -- the pusher member
`which then pushes -- as Klint describes -- pushes and pulls the valve prosthesis out
`of the end of the catheter.
`What happens in the first embodiment is, rather than having a
`pusher member that both pushes and pulls the valve prosthesis out of the catheter,
`what you have is more of a plunger effect, in that -- the first embodiment which
`just pushes the valve prosthesis from behind and pushes it out of the delivery
`catheter.
`
`Now, we relied on both types of pusher member embodiments in
`our petition, but Patent Owner has taken a narrower position, I would say, than the
`Petitioner in arguing that the ‘739 patent excludes pusher members that terminate
`proximal to the valve prosthesis, akin to what you see in this first embodiment of
`Klint, and that's also what's shown in the Figure 12 embodiment of Bessler that we
`have back on Slide 7.
`Now, anticipating that Patent Owner's position may be -- may be
`this, we applied the narrower interpretation of the claims in our Grounds 4 and 5
`of the Petition, and so, as you will see in Grounds 4 and 5 of our Petition, we rely
`only on Klint's second embodiment -- second pusher member embodiment in
`support of these grounds.
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`IPR2020-01649
`Patent 9,125,739 B2
`So if I could turn Your Honors next to Slide 28. As set forth in
`the petition at pages 69 to 70, a person of skill in the art would have been
`motivated to combine the teachings of Bessler and Klint and would have
`understood that Klint's second pusher member embodiment could be used as an
`alternative to a pusher member that terminates proximal to the valve prosthesis.
`Klint, himself, provides a very clear motivation as to why you might consider this
`second embodiment, as opposed to his first embodiment, and he says that you
`might adopt a pusher member that extends through the valve prosthesis to avoid the
`risk that a prosthesis might buckle or be damaged during the delivery process when
`you have a pusher member that is only pushing the valve prosthesis from behind.
`Second, we provided in our petition that a person of ordinary skill
`in the art also would have been motivated to use the second embodiment of Klint
`to better hold the prosthesis during deployment by having a pusher member that a
`valve prosthesis is latched onto and helps keep the valve prosthesis more stable in
`the patient during the process of deploying it into the patient's native valve.
`We also provide, at pages 69 to70 of the Petition, that there would
`have been a reasonable expectation of success in making this combination
`foremost because Bessler and Klint are both directed to delivery systems for
`transcatheter heart valves. Klint actually teaches that the delivery system could be
`used not only for valves but other medical devices, such as stents. And we also
`think that there is a reasonable expectation of success given that the first
`embodiment of Klint has a parallel to the embodiment that is shown in Figure 12
`of Bessler, and then, in the second embodiment of Klint, is taught as an alternative
`to that structure.
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`So we think that a person of ordinary skill in the art, seeing the
`parallel between Figure 12 in Bessler and the first embodiment in Klint, would
`look to the teachings of Klint's second embodiment as an alternative that would be
`successfully used for a transcatheter heart valve.
`Now, if I could turn Your Honors to Slide 29. Patent Owner
`makes two primary arguments against combining the teachings of Bessler with the
`teachings of Klint's pusher member. The first argument that Patent Owner makes
`is that they interpret Klint's second embodiment as a pusher member that, just like
`the first embodiment, is positioned proximal to the valve prosthesis, and only after
`the valve prosthesis is collapsed is the second embodiment pushed through the
`valve prosthesis.
`Their second argument is that the second embodiment of Klint, if
`used, would damage the valve leaflets of a prosthetic heart valve. And this relies
`on a disclosure in Klint wherein, in discussing his second embodiment, he says
`that regular projections, hooks, and ridges could be used with the second
`embodiment, and it's Patent Owner's position that using that type of pusher
`member could damage the valve structure of the prosthesis.
`So if I could turn Your Honors next to Slide 30 and address Patent
`Owner's first argument.
`It's Petitioner's position that Patent Owner's first argument is
`contradicted by the claim line of Klint. As you will see on the top left-hand
`corner of Slide 30, we've quoted Klint from paragraph 94; and that's Exhibit 1019
`in the record. And in describing the second embodiment, Klint explicitly says the
`engagement means can also be designed as an elongate member that, quote,
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`IPR2020-01649
`Patent 9,125,739 B2
`extends coaxially inside the radially compressed prosthesis and engages the
`prosthesis at several locations along the length thereof.
`From Petitioner's perspective, that disclosure is quite clear in
`showing that it's an alternative to what's shown in the first embodiment where you
`have a pusher member that terminates proximal to the valve prosthesis and pushes
`that prosthesis out. What this is showing is that the second embodiment alters that
`construction and adopts a construction instead that extends through the middle of
`the valve prosthesis so that the valve prosthesis can be collapsed on whatever type
`of engagement means is adopted and that once you have it in a collapsed
`configuration, the valve prosthesis is, as the paragraph 94 explains, is pushed and
`pulled out of the catheter to deploy the device in the patient.
`We think it's instructive if we go sentence by sentence in
`paragraph 94 just so that we are clear in terms of the teachings of Klint. You'll see
`the first sentence of paragraph 94 in Klint says, quote, at the distal end of the
`pusher member 216, an engagement means 222 can act on the prosthesis.
`Paragraph 94 then continues, and in referring to the first
`embodiment of the pusher member, it says, quote, the engagement means can be,
`for example, a plate of a dimension fitting into receptacle 208 and abutting the
`proximal end of the prosthesis so that the plate pushes the prosthesis out of the
`receptacle when pusher member is pushed forwardly.
`The next sentence in paragraph 94 transitions then to the second
`embodiment as described by Klint, and it says, quote, the engagement means can
`also be designed as an elongate member that extends coaxially inside the radially
`compressed prosthesis and engages the prosthesis at several locations along the
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`IPR2020-01649
`Patent 9,125,739 B2
`length thereof so that the prosthesis is partly pulled, partly pushed out of the
`receptacle.
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`So the second embodiment is not described as one that abuts the
`proximal end of the prosthesis like the first embodiment is described and which
`Patent Owner suggests is the teaching of the second embodiment. The second
`pusher member embodiment wouldn't be even able to achieve the advantages that
`are described in paragraph 94, if it was a pusher member that started from being in
`the prosthesis.
`What a -- the very point and the very motivation that we describe
`to use the second pusher member embodiment is to avoid the buckling that could
`be caused when you have a pusher member that starts from behind the prosthesis
`and pushes it out of the catheter. If you had, in the second embodiment, another
`pusher member that is starting from behind the valve prosthesis, the risk of bus --
`the buckling still exists. So it can't be that the second embodiment, like the first
`embodiment, starts proximal to the valve prosthesis. We think the teachings are
`very clear in paragraph 94 that the second embodiment extends through the valve
`prosthesis. The valve prosthesis is collapsed on the pusher member so that the
`pusher member can push and pull the valve prosthesis out of the catheter.
`JUDGE TARTAL: Counsel, this is Judge Tartal.
`MR. EGAN: Now the other -- yes?
`JUDGE TARTAL: Is what you are arguing at this point even in
`dispute? It seems like on your Slide 29, that's not what Patent Owner is arguing.
`They are not arguing the second embodiment merely is at the end of the valve
`device but that the valve device is already collapsed when the pusher member is
`inserted into the valve device.
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`Isn't that more accurately what their point is?
`MR. EGAN: I think if we look to Slide 31, which is the mock-up
`that Dr. Dasi, who is Patent Owner's expert, provided in his declaration, this is
`what he is suggesting is taught by Klint, and in his deposition and in his
`declaration, what he has described is a pusher member under the second
`embodiment that starts from behind the valve prosthesis, and that after the
`prosthesis is collapsed, then you push the pusher member through the valve
`prosthesis. And that's what we believe he is trying to show on his mock-up of
`figure 16.
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`So I think there is a dispute here, and I think that the Patent Owner
`does dispute what the starting point is of the second pusher member. We would
`argue that the teachings of paragraph 94 are clear that the starting point is a pusher
`member that is inside the valve prosthesis, and the valve prosthesis is collapsed
`onto that pusher member. What we understand Patent Owner's argument to be, that
`you have a delivery system that up until the valve prosthesis is getting deployed,
`the pusher member is behind the valve prosthesis, and only once you decide to
`deploy the valve do you push the pusher member through that valve prosthesis.
`And that, we don't think is supported by the discussion or the description provided
`in paragraph 94 of Klint.
`The second argument we made with respect to this argument that's
`been set forth by Dr. Dasi is that even if you accept their argument that a -- the
`second embodiment starts from behind the valve prosthesis and then is pushed
`through the -- the prosthesis to deploy the valve, we would -- we would make clear
`that -- and this is Slide 30 -- that the claim at issue is a device claim. It's not a
`method claim.
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`And so, really what we are looking for to meet the limitations of
`the Klint aim is: do we have a valve prosthesis that's in a collapsed relationship
`with the -- with the pusher member? And turning back to his mock-up that's shown
`on Slide 31, if you take Dr. Dasi's figure 16 as a snapshot, what a person of
`ordinary skill in the art sees is a prosthetic heart valve that 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 movable sheathe. So in our view,
`even under what Dr. Dasi has drawn here in his mock-up of figure 16, it
`demonstrates that the limitation of Element 1(i) of Claim 1 of the ‘739 patent is
`met.
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`Also on Slide 31, we address the second argument that's been
`raised by Patent Owner, and that's whether or not the second pusher member
`embodiment would damage the valve leaflets in use. Our concern with respect to
`this argument is that the Patent Owner has limited its argument to Klint's
`disclosure of the use of radial projections, hooks, and ridges. And if you see back
`on -- I believe it's Slide 29 where we actually quote their argument -- on Slide 29,
`what they've said at the Patent Owner response, pages 46 to 47, they are looking at
`a prosthesis using, quote, radial projections, hooks, ridges or the like, is what they
`say in their argument.
`But when you turn back to Slide 31, Klint says more than that.
`Klint says not only radial projections, hooks, and ridges; he also says, or another
`kind of engagement means such as a high-friction material. So what we've
`provided in our argument is that even if there were a concern of using hooks,
`projections, or ridges with a valve prosthesis, a person of ordinary skill in the art
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`IPR2020-01649
`Patent 9,125,739 B2
`would know it could also select a structure that was just a high-friction material
`that would not create the risks that Dr. Dasi elicits in his declaration.
`Second, we've also provided in our papers and provided the
`argument that even if you accept or limited the second pusher member -- the
`second pusher member embodiment to the use of hooks, ridges, or projections,
`you could still use that with a valve prosthesis, as long as the hooks and ridges are
`aligned with portions of the valve prosthesis where valve tissue is not positioned.
`And if you look, for example, at figure 5 and figure 4 of Bessler,
`it's clear that a transcatheter heart valve like Bessler is taught and described to
`have portions of stent structure that extends beyond the valve structure. And so, if
`there were this concern that Dr. Dasi sets forth that hooks and ridges could
`damage the valve structure, you could design the projections in a way so that they
`only engage the prosthesis where the valve tissue is not located and therefore
`alleviate any concerns that those hooks and ridges would damage the valve
`structure.
`
`If I could next turn Your Honors' attention to the dependent claims
`under Grounds 4 and 5 and Slide 33, in particular, where it set forth the language
`of the depend claims.
`Patent Owner does not dispute the limitations set forth in Claims
`2 through 4 are taught by Bessler. Patent Owner also does not dispute that Bessler
`teaches a delivery system with a controlled release mechanism. Patent Owner's
`only dispute that we take from their papers is limited to Grounds 4 through 5 and
`whether combining the teachings of Bessler and Klint render obvious claim -- that
`the Claim 5 requirement for a, quote, controlled release mechanism.
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`IPR2020-01649
`Patent 9,125,739 B2
`If I could turn Your Honors next to Slide 35. We show here on
`Slide 35 a side-by-side comparison between the disclosure of the ‘739 patent
`discussion of the controlled release mechanism and the discussion in Bessler of
`its controlled release mechanism and we've highlighted a number of paragraphs in
`our petition where the ‘739 patent has incorporated language word-for-word from
`Bessler and this is one of those examples where the ‘739 patent has incorporated
`the language from Bessler in describing a controlled release mechanism.
`So, to Petitioner, it didn't come as a surprise that we'll see, if you
`turn to Slide 36, that Dr. Dasi, at paragraph 188 of his declaration, does not
`dispute that Bessler discloses a controlled release mechanism. And the Patent
`Owner's response is in agreement with Dr. Dasi here and recognizes that Bessler's
`threads or sutures are the portions of that device that allow for controlled release
`of the valve device. And specifically, that's at Patent Owner response page 66 and
`Dasi -- the Dasi declaration at paragraph 188. And Bessler describes the operation
`of his controlled release mechanism at column 7, lines 53 to 64 of Exhibit 1006.
`If I could turn Your Honors next to Slide 37. What the Patent
`Owner is arguing is that the controlled release mechanism of Bessler would have
`to be removed when combining the teachings of Bessler and Klint because Klint
`contains no indication it has an opening in its pusher member for sutures to be
`looped. Now, I want to make clear for the record (audio interference).
`MR. EGAN: Did we lose someone?
`JUDGE TARTAL: I think -- we'll confirm, but I think we're still all
`online and it may just have been the originally scheduled -- is that correct if we
`have the custodian in?
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`IPR2020-01649
`Patent 9,125,739 B2
`MR. EGAN: I think we just lost Medtronics’ room. They signed
`
`off.
`
`JUDGE TARTAL: All right. Let's not continue any of your
`discussion at this point, and let me see if we can get the custodian.
`MR. EGAN: I don't know that they are joining this proceeding. I
`think they had -- someone had just left the video feed on in their room, and it
`looks like someone simply stepped in to turn that video feed.
`JUDGE TARTAL: Patent Owner, are you still able to see and
`
`hear?
`
`Okay. Then I think we are fine to proceed.
`MS. SPIRES: I can confirm that I saw a little thing go across
`Medtronics' screen that said meeting ending -- scheduled meeting ending in one
`minute. And then it disappeared so I think it was an automatic thing of theirs.
`JUDGE TARTAL: Okay. Just great. Then we can proceed.
`I did have one question, counsel for Petitioner, before you
`continue, and that's if you can explain what Petitioner contends Claim 5 requires
`that goes beyond what is required by Claim 1 and, in that context, whether
`Petitioner has construed what controlled release means and what it is that that is to
`distinguish Claim 5 over Claim 1?
`MR. EGAN: Sure. And I think I'd start by saying that neither party
`has proposed to construe controlled release mechanism. The parties -- there is no
`dispute that what Bessler describes in Bessler is a controlled release mechanism.
`So at least with respect to Claim 5, we would argue that a controlled release
`mechanism is at least what Bessler teaches, but we have not -- neither party has
`tried to define the actual scope or limits to that term.
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`IPR2020-01649
`Patent 9,125,739 B2
`With respect to your question on what's the difference between
`Claim 5 and Claim 1, our understanding is that a pusher member in Claim 1 is
`really just a mechanism to help deploy or push the valve prosthesis out of the
`delivery catheter.
`And then, what, in Claim 5, is added by a controlled release
`mechanism is that a controlled release mechanism prevents the valve prosthesis
`from just popping out of the end of the catheter. You still have control over the --
`the valve prosthesis until you ultimately want to fully deploy it. So when you look
`at the teachings of Bessler, for example, what he has is not only pusher member
`but also threads that are looped around the back of the valve prosthesis so that not
`only does the pusher member push the valve prosthesis out of the end of the
`delivery catheter, you also have another attachment means by the sutures that, once
`you've decided to fully release it from the catheter, you can -- you can extract
`those sutures and then completely disconnect the valve prosthesis from the
`delivery catheter.
`JUDGE TARTAL: Thank you, counsel.
`MR. EGAN: And to be clear, when you look at Grounds 4 through
`5, Bessler's teachings of the controlled release mechanism are explicitly
`incorporated into our Grounds 4 and 5 at page 66 of the petition.
`So we would disagree with the suggestion that somehow we are
`doing away with the controlled release mechanism of Bessler when you combine
`Bessler with Klint, as Patent Owner has -- has suggested.
`Now, if we look at Slide 37, and I think we were here before the --
`the break in -- in attendees to the hearing, what Patent Owner argues is that a
`controlled release mechanism of Bessler would have to be removed when
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`IPR2020-01649
`Patent 9,125,739 B2
`combining the teachings of Bessler and Klint because Klint contains no indication
`that it has an opening in its pusher member for sutures to be looped through.
`And I turn Your Honors to Slide 39.
`What Patent Owner is essentially arguing is that a person of
`ordinary skill in the art would not be able to physically combine the controlled
`release mechanism of Bessler with Klint's pusher member. But the proper
`obviousness analysis, as we provided in our papers, is not whether the references
`could be physically combined with -- to meet the limitation, but what the teachings
`as a whole would teach a person of ordinary skill in the art.
`We've also said, though, that even if you were to impose a
`requirement that these devices or these teachings have to be physically combined,
`that a person of ordinary skill in the art would know how to do so. And indeed, we
`pointed in Klint, that Klint recognizes in other embodiments of the invention that,
`quote, two mating parts can be held together by a thread that could be pulled out
`for detachment of the device, and recognized, again, that, quote, these kinds of
`connection means are well known in the art.
`So even if you want to accept this argument from Patent Owner
`that there needs to be some kind of physical combination of the controlled release
`mechanism of Bessler with the pusher member of Klint, Klint recognizes that you
`can use sutures to tie two elements together and release them to separate the
`components, which is exactly what is happening with Bessler's controlled release
`mechanism as described in Exhibit 10
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