`571-272-7822
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`Paper # 68
`Entered: 1/06/2022
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`___________
`
`MEDTRONIC INC., and MEDTRONIC VASCULAR, INC.,
`Petitioner,
`
`v.
`
`TELEFLEX LIFE SCIENCES LIMITED,
`Patent Owner.
`___________
`
`IPR2020-01341
`Patent 8,142,413 B2
`IPR2020-01342
`Patent 8,143,413 B2
`IPR2020-01343
`Patent RE46,116 E
`IPR2020-01344
`Patent RE46,116 E
`___________
`
`Record of Oral Hearing
`Held: November 18, 2021
`_____________
`
`
`
`
`Before SHERIDAN K. SNEDDEN, JAMES A. TARTAL, and
`CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.
`
`
`
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`IPRs 2020-01341 2020-01342 2020-01343 & 2020-01344
`Patents 8,142,413 B2 8,143,413 B2 RE46,116 E
`
`APPEARANCES:
`
`ON BEHALF OF THE PETITIONER:
`
`
`CYRUS MORTON, ESQUIRE
`EMILY TREMBLAY, ESQUIRE
`SHARON ROBERG-PEREZ, ESQUIRE
`Robins Kaplan, LLP
`600 Lasalle Avenue
`# 2800
`Minneapolis, MN 55402
`
`
`
`
`ON BEHALF OF PATENT OWNER:
`
`
`J. DEREK VANDENBURGH, ESQUIRE
`PETER M. KOHLHEPP, ESQUIRE
`MEGAN CHRISTNER, ESQUIRE
`Carlson, Caspers, Vandenburgh & Lindquist, PC
`223 S. 6th Street
`# 4200
`Minneapolis, MN 55402
`
`
`
`
`The above-entitled matter came on for hearing on Friday,
`November 18, 2021, commencing at 1:00 p.m., EDT, at the U.S. Patent and
`Trademark Office, by video/by telephone, before Walter Murphy, Notary
`Public.
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`Patents 8,142,413 B2 8,143,413 B2 RE46,116 E
`
` P R O C E E D I N G S
` - - - - -
`JUDGE SNEDDEN: Good afternoon. This is the consolidated oral
`
`hearing in a series of Inter partes Reviews involving Petitioner Medtronic
`and Patent Owner Teleflex. These are IPR 2020-01341, 01342, 01343, and
`01344. I am Judge Snedden and appearing via video with me today will be
`Judge Paulraj and Judge Tartal. Let's start with appearances starting with
`Petitioner's counsel first and then Patent Owner's counsel.
`
`MR. MORTON: Yes, Your Honor. (Audio interference) Robins
`Kaplan for Petitioner. Can you hear me? There were a couple of beeps
`there.
`JUDGE SNEDDEN: Yes. Please start over. I missed -- I think there
`
`were some beeps over, yes, we couldn't hear you so well.
`MR. MORTON: Yes, Your Honor. (Audio interference). So, Your
`Honor, again this is Cy Morton of Robins Kaplan for Petitioner Medtronic.
`With me today also is Sharon Roberg-Perez and Emily Tremblay. We may
`have Chad Hanson from the client on the public line as well.
`JUDGE SNEDDEN: Okay. Welcome, Mr. Morton.
`MR. VANDENBURGH: Your Honor, this is Derek Vandenburgh of
`Carlson Caspers firm for Patent Owner Teleflex. Also appearing today but
`on a separate line will be Mr. Peter Kohlhepp and Megan Christner of the
`Carlson Caspers firm. I believe also with them is Ken Levitt of the Dorsey
`firm and we may have Greg Smock and Howard Cyr of Teleflex on the
`public line.
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`JUDGE SNEDDEN: Okay. Thank you. Welcome, Mr.
`Vandenburgh and I understand that I believe it's Petitioner, so Mr. Morton,
`you'll have a LEAP practitioner so I just want to remind everyone for the
`benefit of our court reporter and the transcript we ask everyone to
`reintroduce themselves as they begin speaking and arguing their particular
`sections today.
`I just want to remind everyone this is a public hearing and we do have
`a public line where members of the public can dial in. I'm not sure if we
`have actual members of the public outside of the client representatives but to
`the extent that confidential information will be discussed today we ask
`counsel to announce the need to discuss that information so we can mute the
`public line.
`We are in receipt of the parties' demonstratives and we have access to
`the record in each of these cases. So as you proceed through your
`presentations today we ask counsel to identify the specific slide numbers that
`they're discussing during the arguments so we can follow along and also for
`the benefit of the record.
`We have received the parties' objections to the other side's
`demonstratives and we'll take those objections under advisement but we will
`not exclude counsel from presenting arguments based on those
`demonstratives today. We generally remind the parties that demonstratives
`are not evidence themselves and cannot be used to supplement the record
`and as such we ask counsel to refrain from making any objections until the
`end of the other side's arguments unless of course there's a risk that a party
`may be getting into confidential information while on the public line.
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`As set forth in our Hearing Order we will be dividing the hearing into
`two segments. We will begin with Patent Owner and the segment on
`conception and reduction to practice or CRTP. Each side will have 30
`minutes and each side may reserve a portion of that for rebuttal time. After
`that we will take a ten minute break and when we return Petitioner will
`begin argument relating to its petition and issues in which Petitioner has the
`burden and due to the appearance of the LEAP practitioner Petitioner will
`have 75 minutes to argue its positions. Patent Owner will have 60 minutes.
`Each side may reserve some amount of rebuttal time for their respective
`arguments and I imagine we'll have another ten minute break prior to the
`rebuttal period but if additional breaks are needed please let me know at any
`time throughout the hearing today and I'm sure we can accommodate that.
`Finally, I'll keep a clock but as we don't have a mechanism to stream
`my clock that I'm using here, we ask each party to also keep a clock and I'll
`try to give a warning when we get below five minutes or so. All right. Any
`questions before we begin.
`MR. VANDENBURGH: No, Your Honor.
`JUDGE SNEDDEN: Okay. All right, Mr. Vandenburgh, we'll start
`with you when you're ready.
`MR. VANDENBURGH: Thank you very much and again for the
`record this is Derek Vandenburgh representing the Patent Owner Teleflex. I
`would like to reserve ten minutes of my time on this section if I could.
`JUDGE SNEDDEN: Okay.
`MR. VANDENBURGH: And I'd like to start with a brief explanation
`of why we have this second round of IPRs on issues that are so similar to the
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`earlier 11 IPRs that we argued in March and that the Board resolved in
`June of this year. So when Teleflex brought suit against Medtronics in July
`of 2019 we only asserted the five patents that were the subject of the first
`round of IPRs. The method of use claims that we're dealing with today just
`weren't viewed as adding anything to the case at that point so they weren't
`included. Shortly after suit was filed Medtronic came forward with the Itou
`reference that is at issue here and of course our position from day one has
`always been that Itou is not prior art, does not qualify as prior art but we
`didn't know at the time how that was going to be resolved. So we revisited
`the method of use claims which of course in our view are patentable over
`Itou even if it is prior art. Itou is directed to a suction catheter. It has
`nothing to do with the device delivery method that is the subject of the
`claims here and which is the reason why the real world guideline of the
`product has been such a successful, industry changing, life saving product.
`So we subsequently added the method of use claim patents to the case.
`Medtronic responded with these four IPRs raising essentially the same prior
`art in argument.
`So with that background if I could direct the Board's attention to start
`with slide 4 from my presentation where I basically have a summary of the
`issues that come up in a conception reduction to practice analysis and it's
`helpful to start with is just to look at the fact that this time around Petitioner
`has not disputed conception. They disputed it first time around. The Board
`ruled against them. They have not maintained that argument this time.
`For actual reduction to practice, as I've laid out here, they have I
`would say three different arguments or categories of arguments that they
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`make. First of all, they say that there's insufficient evidence to corroborate
`assembly of prototypes and second that there was insufficient evidence,
`corroborating evidence of testing sufficient to show that those prototypes
`would work. Now before I get to the third I'd like to talk about those two in
`particular because those two really are exactly the same as the issues that
`were resolved in the first set of IPRs. All the arguments that Medtronic is
`making here were resolved against them in the first round of IPRs and
`correctly so.
`If you turn ahead if you would to slide 5 I'm not planning today to go
`through all of the detailed evidence like I did last time but I would like to go
`through a summary of it. We of course have on the testimony side we have
`a total of seven declarations. We have two detailed declarations from
`inventors and I want to remind the Board what I said last time which is we
`shouldn't look at these inventor declarations as somehow second class
`evidence. It's not second class evidence.
`JUDGE PAULRAJ: Mr. Vandenburgh?
`MR. VANDENBURGH: We think of that because of the -- yes.
`JUDGE PAULRAJ: This is Judge Paulraj and before you get into the
`actual evidence and, you know, at least two of the Judge on the panel here
`did hear a lot of that evidence in the prior set of case. But we are in receipt
`of the parties' collateral estoppel briefing and I would like you to address a
`finality issue because frankly I see cases going both sides from the Federal
`Circuit on this and I want you to, you know, I want your position on how we
`can resolve that conflict. It seems like the Federal Circuit has taken
`somewhat of an inconsistent position in these cases and what's your position
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`on which cases? I can imagine which cases we should follow, but how do
`we resolve the cases on the other side?
`MR. VANDENBURGH: I think what the Federal Circuit has clearly
`resolved that perhaps might raise an appearance of inconsistency is when
`you have parallel proceedings going on in the Patent Office and in the
`District Court and in that circumstance the Federal Circuit I think has pretty
`clearly said look, we're going to look at the one that gets to appellate finality
`first. But the Federal Circuit simply has not been directly presented with or
`decided the issue of as between two proceedings in the Patent Office to use -
`-
`
`JUDGE PAULRAJ: Why does that matter?
`MR. VANDENBURGH: -- (indiscernible).
`JUDGE PAULRAJ: I think the question though is -- I mean we know
`that the Supreme Court has said collateral estoppel applies in the, you know,
`in the administrative context; right? So the collateral estoppel does apply
`when we have a prior Board decision at least in the context where that prior
`Board decision has been affirmed or, you know, the appeals have been
`exhausted; right? So whether or not the second case is in the District Court
`as maybe the situation of some of the cases you cited or the second case is
`back before the Board as in this situation, are you saying that there's a
`distinction in that situation?
`MR. VANDENBURGH: Well, all I'm saying is I get the -- the
`Federal Circuit I think was concerned with all these parallel proceedings
`going on with IPRs and District Court cases at the same time and for
`whatever reason they decided in one of the Fresenius cases and then
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`subsequent follow-on cases that they were going to look at the first one that
`went to finality. Was that consistent with Supreme Court or other District
`Court case law on finality that holds the opposite if you don't wait until
`appeal? They seem to have carved out an exception in that instance. But
`what I, you know, it is a different situation when you're talking about the
`same either be it court or agency, same level of and position in the legal
`system tribunal addressing the same issue twice.
`JUDGE PAULRAJ: All right. So --
`MR. VANDENBURGH: So in that situation Federal Circuit --
`JUDGE PAULRAJ: -- so what about like the statement from like the
`XY LLC case? You know, I think that's cited in one of the briefs where the
`court said that we find that an affirmant of (audio interference) finding
`whether from the District Court or the Board has a collateral estoppel effect;
`right? So I certainly know that you're going to cite some cases that may
`suggest otherwise but it certainly seems like, at least in some instances, the
`Fed. Circuit has waited for that affirmance or at least when all appeals have
`been exhausted.
`MR. VANDENBURGH: Right. Of course they said that in that case
`but they then clearly were addressing the opposite. Let me get to the end
`point of what our position is here. Our position as law is unclear. We're not
`really strongly advocating a particular outcome here. What we know is that
`at least one Board panel has said as between two panels of the PTAB that
`collateral estoppel can apply, should apply even if the first decision is on
`appeal. But what they did there because they weren't sure of the law was to
`adopt the prior findings from the earlier case in the later case because there
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`was no reason to reach a different decision and that at the end of the day is
`our position on what the Board should do. We are not -- we cannot say for
`certain what the law is on this point so we think that the Board could apply
`collateral stoppel but that it should in any event reach the merits either by
`adopting, you know, incorporating its prior analysis or cutting and pasting it
`into an updated final written decision.
`JUDGE SNEDDEN: Can we speak to that a little bit, like just in
`terms of cutting and pasting we are looking at slightly different claims or
`method claims as opposed to the device and one of the issues that Petitioner
`is raising, you know, is that and whether this method was tested, you know,
`as set forth in the claims? Is there any differences between --
`MR. VANDENBURGH: Well, let me --
`JUDGE SNEDDEN: -- what we saw between earlier cases and here?
`MR. VANDENBURGH: There is a distinction and back on my slide
`4, my third bullet point, I acknowledge that there is new aspect to this
`analysis. But before I get to that let me reiterate on the evidence of whether
`the claimed method was performed it's one sided and undisputed. Similar to
`the first time, we had the inventor, Mr. Root, put together detailed claim
`charts going element by element through the claims attached as an exhibit to
`his declaration setting forth why each element of the claims was part of what
`was tested and reduced to practice in 2005. In response, they didn't put in
`new charts. Their expert simply attached his old charts from last time of the
`product claims. So to the extent there's any difference there, they don't have
`any evidence to support the new claims.
`But they do make the separate argument that's a bit of -- that’s really a
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`legal argument and it's based on a high level statement of the law that in
`order to reduce something to practice you have to, in the case of a machine,
`you have to build it and in the case of a process you have to perform it. That
`general statement of the law when you get to a method can start to conflict
`with another set rule of law which is that you don't need the reduction to
`practice for testing purposes doesn't need to occur in the actual environment
`that the product or process is going to be used in and the important part of
`my point here is there is no case law that says that that rule -- that you don't
`need to be in the intended environment -- doesn’t apply to method claims.
`You know, keep in mind that for product claims building the product
`and testing it are two separate things. But when you have a method claim
`they combine together. You test the method by performing the method and
`that's what was done here. They have no case law on point that applies to
`the situation here where the facts are undisputed the product was tested but
`simply not in a human being. It was tested in a model and not in a human
`being as some of the limitations of the claim refer to anatomy of an animal at
`least.
`
`So what we have, their primary case on this is -- and just a second, I
`have this written down -- their primary case is the TC Technology, LLC v.
`Spring Corp., case that they cite in their reply brief. We have a case that has
`the same facts as TC Technology. It's the Huawei case, and they reach
`different results. They reach different conclusions but it really I would
`suggest doesn't matter because the facts of those cases are different from
`here. Those were ones where the method simply wasn't performed. The
`method involved sending data back between different discrete elements in a
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`communication system and the party asserting reduction to practice didn't do
`that. They just performed a simulation inside a computer. Huawei found
`that could be good enough. TC Technology found it wasn't. Doesn't matter
`because it's not our facts.
`Our facts involve a situation where the claimed method was
`performed and it simply wasn't performed in the exact environment recited
`in the claims. For that situation I think the closest case that the Board could
`look at on this point, there just isn't a lot of case law on this point, but the
`Taskett v. Dentlinger case which is cited in both parties' briefs involved the
`situation where the party at issue simulated a financial transaction to
`purchase telephone services. There was no real transaction. It didn't happen
`in the real world and it deals in part with the simple question (audio
`interference) authorization had to come from an actual third party and they
`did a claim construction that said no, it didn't. But more importantly, there
`were also other terms about actually purchasing telephone services. That
`wasn't done in that case. That was simply the environment of that claim and
`they still found the invention reduced to practice. You know, that is the case
`here. The Board found the first time that testing in a model was good
`enough to know that this invention would work and there's no reason to
`reach a different result here just because we're dealing with method claims.
`JUDGE PAULRAJ: So, Mr. Vandenburgh, you mentioned the claim
`charts that were appended to Mr. Root's declarations and so other than that
`claim chart or those claim charts in these sets of cases which I imagine map
`the evidence to these specific claim limitations, is there any other difference
`in any of the declarations that you point to in the declarations that are cited
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`in your demonstrative slide No. 5?
`MR. VANDENBURGH: I'm sorry, in slide 5?
`JUDGE PAULRAJ: Yes. So that's where I see the declarations
`listed.
`MR. VANDENBURGH: Right, right. Yes, yes. So we did update
`some paragraphs of the Root declaration prior to the attachments really to try
`to respond to issues raised by the Petitioner the first time around and just to
`add some additional material to make sure that we were putting forth the
`best case we could. So that is not -- that's been updated slightly. The same
`with the Erb declaration. You know, we went back to their arguments and
`we went back to Mr. Erb and said okay, what do you recall, and so we
`updated it and he added some additional material relative to the first round
`of IPRs corroborating his knowledge of, and at least observing, the testing of
`the April and July prototypes. So again, nothing's been removed. The same
`level of evidence that was there is still there but there is some additional
`evidence in his declaration as well (indiscernible).
`JUDGE PAULRAJ: If I recall from the earlier set of cases the testing
`evidence -- there was a dispute over this in the earlier set of cases -- was
`limited to just certain models and I think the only evidence, at least
`documentary evidence we had, was an image of one of those models that
`were used. Do we have anything else, I mean other than the testimony that
`you, you know?
`MR. VANDENBURGH: My recollection as I'm standing here is that
`the documentary evidence is the same. But the documentary, again, the
`evidence was found to be sufficient the first time and no reason to change
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`this time.
`JUDGE PAULRAJ: So obviously we're going to have to assess that
`in the context of these claims, you know, and especially given that we're
`dealing with method of use claims and I understand your position as to
`whether or not that makes a real big difference here. But in terms of the
`testimony, and we'll certainly go back to look at the declaration testimony
`and what's been added since the last time around, but is there any evidence
`of record from any of these declarants that testing went beyond just the in
`vitro models that we considered in the prior set --
`MR. VANDENBURGH: No, Your Honor. Yes. No, and that's why I
`addressed the method issue really as a legal issue because there's no dispute
`here that the testing that was done was done in a cardiac model. Now,
`there's extensive evidence that for this type of invention a cardiac model is
`sufficient to know that both a product and a method will work. Certainly
`Mr. Keith updated his declaration to refer to the fact that in this industry
`people know that a method will work testing it in a cardiac model but there
`is no evidence that there was any sort of human testing here. So their
`argument that in vivo testing was required here --
`JUDGE SNEDDEN: You have about a minute and a half left in time.
`MR. VANDENBURG: -- is still (indiscernible) purely a legal issue.
`I'm sorry?
`JUDGE SNEDDEN: You have about a minute and a half left on time.
`MR. VANDENBURGH: Yes, yes. And I'm going to go ahead and
`wrap up. I mean, slide 5 summarizes everything but the important point is
`that it was all the same evidence that ultimately is proving the same thing,
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`that the product was made, built and tested to perform this method in a
`cardiac model and then the last point I'll make is that the evidence relating to
`constructive reduction to practice, the issue is also completely the same this
`time around. I don't think there's any argument that the diligence in reducing
`to practice a product or the method that this product was intended to perform
`is any different whether the, you know, we're dealing with the product
`claims or the method claims. So again, the Board can and should adopt the
`same analysis that it did in the first set of IPRs and with that I will go ahead
`and turn it over to Mr. Morton.
`JUDGE SNEDDEN: Okay. Thank you. Mr. Morton, when you're
`ready.
`MS. TREMBLAY: If it's all right with Your Honors, Ms. Tremblay
`will go instead of Mr. Morton.
`JUDGE SNEDDEN: That's fine.
`MS. TREMBLAY: Good afternoon. Emily Tremblay on behalf of
`Petitioner. I'll be addressing the conception reduction to practice
`component.
`JUDGE SNEDDEN: And will you be reserving any rebuttal time?
`MS. TREMBLAY: Yes, Your Honors. I'll reserve two minutes,
`please.
`JUDGE SNEDDEN: Yes.
`MS. TREMBLAY: Petitioner appreciates that the Board addressed
`conception and reduction to practice in the first set of IPRs and Petitioner
`acknowledges that Patent Owner has submitted substantially the same
`evidence that the Board has seen previously. That said, Patent Owner has to
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`prove reduction to practice of new inventions. We already heard from Mr.
`Vandenburgh that we're dealing with for the very first time method of use
`claims and more than the axiomatic principle that separate patents require
`separate analyses and different claims recite separate inventions is the idea
`that that reduction to practice test legally is different for method claims. I'm
`going to begin on slide 3 of my deck.
`JUDGE PAULRAJ: Ms. Tremblay, before you go too far down the
`road of the evidence that you're going to address could you address the
`finality issue and legal issue that I asked Mr. Vandenburgh about. I
`understand you've cited case law perhaps pointing in a different direction in
`terms of what constitutes a final decision for collateral estoppel, but I'd like
`you to at least address the other side's cases and how we should resolve that.
`MS. TREMBLAY: Yes, Your Honor. So I think the collateral
`estoppel briefing sets out that in the context of IPRs yes, to Your Honor's
`earlier point, it is possible for a final written decision in IPR to be final and
`to have preclusive effect once the appeals are exhausted. I think the case
`law is very clear that there's a distinction that the Federal Circuit is making
`between Article I corps and Article III corps and the fact that in the IPR
`context the appeal has to be exhausted before collateral estoppel can attach
`as a matter of law.
`JUDGE PAULRAJ: I'm not sure I understand why the case law
`draws a distinction between Article I and Article III because I think at least
`we know collateral estoppel applies regardless of whether or not it's an
`Article I or Article III, so the general principles of collateral estoppel apply.
`So why draw this distinction as to finality and then I would also point to, and
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`I think this is some of the cases that were cited, that the older SSIH
`Equipment S.A. v. United States International Trade Commission case;
`right? So that involved an Article I administrative tribunal just like the
`PTAB and I think the case law that the Federal Circuit said, and it's been
`reaffirmed in more recent cases, the law is well settled that the pendency of
`an appeal has no effect on the finality or binding effect of a trial court's
`holding. So could you address that, you know, that statement which has
`been repeated a few times by the Fed. Circuit?
`MS. TREMBLAY: Yes, Your Honor. So in general, yes, is the case
`law crystal clear on this point? No. But I do think that more recent Federal
`Circuit authority has made clear that pending appeal collateral estoppel just
`does not attach because the final written decision is not final. There is no
`effect judgement while an appeal remains open or prior to the exhaustion of
`taking the appeal. I think Mr. Vandenburgh mentioned an IPR decision, I
`believe it was Mobil case that they're primarily relying on and I'd just like to
`point out that factually the facts at issue in that case are distinct from the
`ones at issue here. In that case, that was the case where the Board said we
`could apply collateral estoppel but we're going to get to the merits anyway
`out of an abundance of caution because we're not really sure what's required
`of us.
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`In that case eight of the eleven appeals had resolved when the court
`was determining whether it could apply collateral estoppel in that context
`which is not the case here. All of the appeals are pending. No final written
`decision has been reduced to an effective judgement and as a result I do
`think that there is an open issue as to finality here.
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`JUDGE PAULRAJ: What happens in the situation --
`MS. TREMBLAY: More to the point --
`JUDGE PAULRAJ: No, let me follow up on that. So, you know,
`certainly we don't know what's going to happen on those appeals. I imagine
`the Federal Circuit may well not reach the merits of those appeals before we
`issue our final written decision. But there's a lot of things that could happen
`between now and when we issue our final written decision. Your client may
`decide to drop those appeals; right? So in that case there's no longer a
`pending appeal and then it becomes a final decision and then does the
`finality issue go away at that point?
`MS. TREMBLAY: Is in this scenario the appeals are dropped prior to
`the Board reaching final written decision in these proceedings?
`JUDGE PAULRAJ: Right, right.
`MS. TREMBLAY: I just want to make sure I'm understanding your
`question.
`JUDGE PAULRAJ: Yes. So let me ask that situation.
`MS. TREMBLAY: I would say that if -- sure. If the Board has not
`issued a final written decision in these four IPRs and the appeals exhaust
`themselves in the other eleven for whatever reason, yes I would say that
`those proceedings have reached finality and the Board can apply collateral
`estoppel here.
`JUDGE PAULRAJ: Thank you.
`MS. TREMBLAY: Provided that there's an identicality of the issues
`and I do want to address how the conception reduction to practice issues in
`particular are not identical between these proceedings and the original
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`eleven.
`JUDGE PAULRAJ: All right. Yes, you can proceed. I would also
`like you to address, you know, you brought up conception. It didn't seem
`like Petitioner was contesting conception in these set of cases; is that right?
`MS. TREMBLAY: That's correct.
`JUDGE PAULRAJ: Okay. So can we then regardless --
`MS. TREMBLAY: (Indiscernible).
`JUDGE PAULRAJ: -- regardless of whether or not we apply it as a
`collateral estoppel basis or we just adopt the findings, can we adopt t