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`IPR2016-00208, Paper No. 27
`March 29, 2017
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`trials@uspto.gov
`571-272-7822
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
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`NEOCHORD, INC.,
`Petitioner,
`
`v.
`
`UNIVERSITY OF MARYLAND, BALTIMORE and
`HARPOON MEDICAL, INC.,
`Patent Owner.
`____________
`
`Case IPR2016-00208
`Patent 7,635,386 B1
`____________
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`Held: January 31, 2017
`____________
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`
`
`
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`BEFORE: SALLY C. MEDLEY, ERICA A. FRANKLIN, and
`JAMES A. WORTH, Administrative Patent Judges.
`
`
`The above-entitled matter came on for hearing on Tuesday,
`January 31, 2017, commencing at 1:59 p.m., at the U.S. Patent
`and Trademark Office, 600 Dulany Street, Alexandria, Virginia.
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`Case IPR2016-00208
`Patent 7,635,386 B1
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`APPEARANCES:
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`ON BEHALF OF THE PETITIONER:
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`ON BEHALF OF PATENT OWNER:
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`BRAD D. PEDERSEN, ESQUIRE
`CHAD WICKMAN, ESQUIRE
`Patterson Thuente Pedersen, P.A.
`4800 IDS Center
`80 South 8th Street
`Minneapolis, Minnesota 55402
`
`ERIK B. MILCH, ESQUIRE
`C. SCOTT TALBOT, ESQUIRE
`Cooley LLP
`One Freedom Square
`Reston Town Center
`11951 Freedom Drive
`Reston, Virginia 20190-5656
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`Case IPR2016-00208
`Patent 7,635,386 B1
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`
`P R O C E E D I N G S
`- - - - -
`JUDGE WORTH: Good morning. This is an oral
`hearing in PTAB Case Number IPR2016-00208 between
`Petitioner Neochord, Inc. and the owner of U.S. Patent 7,635,386,
`University of Maryland, Baltimore.
`My name is Judge Worth. On my left is Judge Franklin.
`On my right is Judge Medley.
`As you know per our order, each party has 30 minutes
`to present their argument. Because Petitioner has the burden to
`show unpatentability of the original claims, Petitioner will
`proceed first followed by Patent Owner. Petitioner may reserve
`rebuttal time, but may only use its time to rebut Patent Owner's
`arguments.
`Before we begin, we understand that the parties
`contacted the Board because they were interested in having a
`conference call to gain authorization for briefing. We appreciate
`that contact and because that issue has not been briefed up to this
`point, we're going to ask the parties to hold on off on commenting
`on that issue. And if the parties are interested in pursuing that
`issue after this hearing on the merits, then please contact us again
`and we will set up a conference call for that purpose.
`MR. MILCH: Your Honor, if I may make a comment
`to that issue.
`JUDGE WORTH: Please.
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`MR. MILCH: With respect to the recent decision in the
`Covidien case, which was just handed down last week, it's our
`opinion that given the fact that the University of Maryland,
`Baltimore is an arm of the state, in light of that decision the
`PTAB does not have jurisdiction over this matter and for that
`reason we believe that at least some briefing should be heard or
`the trial dismissed.
`JUDGE WORTH: Right. So we appreciate your
`standing statement and because there has been no briefing up
`until this point, we don't think that this would be the best use of
`time to have an oral hearing. And if University of Maryland
`would like to have briefing, then we suggest that pursuant to the
`Board's rules that Patent Owner seek a conference call for
`authorization to submit a motion or a briefing.
`MR. MILCH: Thank you, Your Honor.
`JUDGE WORTH: Does Petitioner have any comment
`on that?
`MR. PEDERSEN: Yes. Thank you, Your Honors, for
`that because that was the point that Petitioner was going to make
`was that there is nothing in the record or the papers that would
`address this and so discussion of that issue would be not
`warranted at this time given that the record is devoid of any
`discussion of either the facts or the law that would be surrounding
`this issue.
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`Our primary point with respect to this issue would be
`that this is late, that if the evidence that would be necessary for
`them to establish the ability to utilize sovereign immunity were to
`be introduced, it would have to be introduced as supplemental
`disclosure and they would have to prove why the information
`could not have been introduced previously.
`Given that we are here now at the oral hearing, we think
`that there was plenty of opportunity to have raised this issue
`previously and that Patent Owner has effectively waived this
`issue.
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`JUDGE MEDLEY: Well, I think what Judge Worth's
`point is that we're going to table all this.
`MR. PEDERSEN: And we totally agree with that.
`JUDGE MEDLEY: We don't want to hear your
`arguments as to why they were late and we don't really want to
`hear any arguments as to why you don't think you're late. I think
`what we want to do today is get to the merits of the case and
`what's been briefed before us. And then once you guys get
`together and determine when you're available, give us some
`times, then we can pick a time and we can discuss this at a later
`date.
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`MR. PEDERSEN: And we're fine with that, Your
`
`Honor.
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`JUDGE WORTH: Also first things first, I'd like to ask
`the parties to state their appearance for the record.
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`Patent 7,635,386 B1
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`MR. PEDERSEN: Appearance for the record, my name
`is Brad Pedersen. I'm counsel for the Petitioner Neochord. With
`me at counsel table is my partner, Chad Wickman.
`MR. MILCH: I'm Erik Milch, counsel for the Patent
`Owner, and with me at counsel table is my partner, Scott Talbot.
`JUDGE WORTH: Okay. So Petitioner has the
`remanence (phonetic).
`MR. PEDERSEN: And we would like to reserve half of
`our time for rebuttal, Your Honor.
`JUDGE WORTH: One moment, please. Okay.
`Petitioner, you may begin when you're ready.
`MR. PEDERSEN: Thank you, Your Honors. May it
`please the Board, we believe that there are simply four arguments
`that merit the attention during this oral hearing and we've
`summarized those on this slide as to whether or not Speziali in
`the first ground is art, the claim construction, if there should be
`one, with respect to percutaneously accessing and then our
`reasons for why the grounds on which the Board instituted trial
`should be maintained.
`With respect to the issue of why are we here today, we
`wanted to previously say, as we noted in our Petition, that
`Neochord is the exclusive licensee of the Speziali patent and
`Claim 1 of Exhibit 1013 is on the board there because this was
`the claim that Speziali was originally going for in its PCT
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`Patent 7,635,386 B1
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`application, and you can see that the claimed subject matter was a
`very similar scope to that which was granted in the '368 patent.
`During prosecution, the version of this claim in the
`corresponding U.S. National Stage case was rejected over Lattouf
`and Bachman, the references on which the grounds have been
`initiated in this trial.
`So my client is here today because we believe that the
`Patent Office made a serious mistake with respect to the '386
`patent because these claims we had tried to get before and were
`not able to get them and we do not think that the University of
`Maryland is entitled to them, seeing as they are the second filer in
`this process.
`JUDGE WORTH: Is that other Patent Office matter in
`your briefing?
`MR. PEDERSEN: Yes, it is, and it's an exhibit -- the
`rejection based on Lattouf and Bachman is one of the exhibits in
`the file history of the Speziali patent is one of the exhibits that
`was referenced in the Petition.
`JUDGE FRANKLIN: Will you direct us to that portion
`of your Petition?
`MR. PEDERSEN: Yes. I will have counsel take a look
`at that so that we can get the page cite for that.
`JUDGE WORTH: And are you arguing that it would be
`that this IPR is bound by that?
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`Patent 7,635,386 B1
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`MR. PEDERSEN: No, we are not arguing that. We
`understand that this -- you know, the Patent Office is free to make
`decisions. The two disclosures are different disclosures and so
`different results could be accorded. But what we are arguing is
`that Speziali is prior art for that which is being claimed in the '386
`patent.
`
`And our argument is that Speziali is prior art because of
`the earlier filing date as shown here in the priority claim and
`Speziali's priority claim. You can see that the Speziali priority
`claim predates the '386 patent.
`More importantly, the argument and the only argument
`which the Patent Owner has raised against Ground 1 based on
`Speziali is that Speziali is not prior art. Because as Petitioners,
`we supposedly had a burden to establish the priority date which
`according to Patent Owner we did not meet.
`And our position is that this case is not like the case in
`which we would be claiming priority to a U.S. provisional
`application. Instead under 35 U.S.C. 363, our priority date is
`based on the PCT application date which predates the '386 patent
`and the statute, of course, is that filing date.
`In our Reply in addition, we've also gone through the
`extra step of establishing why, in fact, we are entitled to that
`priority date because of the commonality of the disclosure
`between the two filings.
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`Case IPR2016-00208
`Patent 7,635,386 B1
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`So the Petitioner in its Petition proposed a definition for
`percutaneously accessing. The Board's decision concluded that
`plain and ordinary meaning applied in no specific construction of
`that term was needed. It was not until the Patent Owner's
`Response that the Patent Owner proposed a definition for the
`term percutaneously accessing, and we think that at best the
`Patent Owner's proposed construction is confusing and the
`confusion we believe stems from a mixing of two terms and what
`those two terms are understanding.
`The ordinary meaning of percutaneous is through the
`skin. The Petitioner's expert testifies to that. The Patentee's
`expert agrees with that. So the ordinary meaning of percutaneous
`is through the skin.
`The ordinary meaning of transmyocardial access is
`through the heart wall. And in order to access the apical region
`of the heart, you're going through multiple layers of tissue, the
`outermost layer being the skin layer, the innermost layer, as you
`access the left ventricle of the heart being the heart wall.
`And so transmyocardial access is referring to that last
`step of getting access to the interior of the left ventricular
`chamber.
`JUDGE WORTH: I don't believe that your own expert
`had that expansive a definition for percutaneous. I thought your
`own expert --
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`MR. PEDERSEN: We just said it meant through the
`skin. That's all.
`JUDGE WORTH: But the Patent Owner was pointing
`to expert testimony from Dr. Aklog differentiating between
`different sizes of incisions. So it might be more nuanced, even
`according to your own expert.
`MR. PEDERSEN: It may be more nuanced in terms of
`what standard surgical procedure is, but the single terms
`transmyocardial versus percutaneous have a common and
`ordinary meaning and it's simply through the particular layer
`that's involved there. How do you get through that layer is where
`the Patent Owner is asserting that they have been as best I can
`understand it their own lexicographer in attempting to define a
`definition of percutaneously accessing that is unique from the
`ordinary definition of just getting through the skin regardless of
`how you do that.
`And so that's really where our position and with the
`Reply is that the Patent Owner has not carried their burden, a
`heavy presumption that you should apply the common and
`ordinary meaning, percutaneous being the skin layer,
`transmyocardial being the heart layer, access being getting
`through and that that's, in fact, what the Board did in your
`Decision to Institute was talk about the definition of accessing as
`getting through.
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`Now, the Patent Owner raises the incision argument in
`an attempt to support the patentability of Claim 19, but they do so
`and they can only do so by having imported limitations
`supposedly from the specification to define this unique
`construction.
`Our position is, as we take a look at it, that the
`specification teaches incisions of many different sizes. And so if
`the Patentee is going to say percutaneously accessing was
`uniquely defined by the patent applicant as its own lexicographer
`as being something other than just through the skin, then that has
`to be a very expressly clearly set forth definition and Petitioner's
`position is that the '386 patent talks about lots of different things.
`JUDGE WORTH: So when the '386 patent says that is
`-- it's column 7, line 44 --
`MR. PEDERSEN: Yes. So if we see --
`JUDGE WORTH: Percutaneously, that is.
`MR. PEDERSEN: If we skip ahead to slide 11, this is I
`believe the passage that you're quoting there. And in the Patent
`Owner's proposed construction, they say percutaneously
`accessing has two different options, direct needle puncture or
`endovascular access.
`This is from column 7 talking about direct needle
`access. Where direct needle access to the heart is sought, the
`methods of the invention may be performed with even smaller
`incisions.
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`Now, what's interesting there is they don't say incisions
`in the skin or incisions in the transmyocardial layer. It's not clear
`what's going on there. So the Patent Owner relies on the last
`clause of that sentence to say, or even percutaneously that is
`without the need for an incision.
`But if we back up one slide, what you can see is, as we
`cited to our Petition in describing the second option of
`endovascular access, in the middle of this sentence you see, still
`yet, other percutaneous approaches may be employed where
`access is made endovascularly through a cut-down -- that's an
`incision -- or puncture in the femoral internal jugular veins.
`So two options for how to do percutaneously accessing
`according to the Patent Owner. One is direct needle, which says
`it can be done with a smaller incision. The other is
`endovascularly, which says it can be done with a cut-down. The
`'386 patent does not clearly set forth the definition that if as we go
`back to slide 8 is what the Patent Owner argues in their Response
`at page 5, any suggestion that percutaneously can include an
`incision is inconsistent with the '386 patent. That doesn't stand
`up.
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`Moreover, their addition of through unbroken skin in
`the first half of that two-option definition relied on this external
`dictionary definition for which the last half of the underlying
`portion was not presented in their Response.
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`JUDGE WORTH: I'd like to go back to -- and I don't
`know your slide number, but line 44, column 7.
`MR. PEDERSEN: Slide 11.
`JUDGE WORTH: It says, or even percutaneously, that
`is. Why is anything before the word or part of the definition?
`MR. PEDERSEN: Because their definition is
`transmyocardial puncture is the direct needle access approach in
`the Patentee's proposed construction. That's what the first
`underlying passage is referring to.
`JUDGE WORTH: So if we're defining the term
`percutaneous, why would we look at anything before the word
`or?
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`MR. PEDERSEN: Because that's what the Patent
`Owner asked you to do.
`If you go to slide 8, Patent Owner proposes
`percutaneously accessing an apical region of the heart should be
`construed as direct transmyocardial puncture, needle puncture
`through the unbroken skin -- that's the definition that they
`added -- or, alternative, or endovascularly accessing.
`So our position is when you go to the '386 patent at
`column 7, we're talking about where they talked about direct
`needle access puncture to the heart. When you go to the previous
`slide, column 11, this is where they describe endovascular access.
`So in order to construe those claims of what's being
`meant by the two options the Patent Owner proposes, this is
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`where in the specification we think you have to look. And so as a
`result of that, we don't think that there is any ability to carry that
`presumption that they meant to redefine those terms.
`Moreover, in the prosecution of the patent originally,
`Claim 1 had an incision in the heart wall. Claim 19 had
`percutaneously accessing. To overcome the rejection of Lattouf,
`the Patentee did not separately argue Claim 19 from Claim 1.
`Instead, they made the very same amendment that the suture
`would be directly connected to the leaflet.
`So at least during prosecution there was no position that
`the Patent Owner had taken that percutaneously accessing would
`define over the Lattouf reference, which was the primary
`rejection used by the Examiner. They used the same amendment,
`is it directly accessing the leaflet by the suture as their grounds
`for overcoming that objection.
`JUDGE WORTH: Can you talk about the other claim
`construction term artificial chordae? Patent Owner is arguing that
`Carpentier does not disclose an artificial chordae. Carpentier is
`not replacing the cord entirely.
`MR. PEDERSEN: If you go to slide 15. The secondary
`references that we're using with Lattouf are based on the
`examination. Lattouf was found to have everything except the
`direct access connection to the leaflet by the suture. Carpentier,
`Bachman and Downing all teach a suture directly connected to
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`the leaflet and that's the only aspect of each of those references
`that is being used as a secondary reference.
`The Patent Owner's arguments in their Response tend to
`attack the references individually and our position is these are the
`teachings for why you would directly put a suture into the leaflet.
`Principally for Carpentier, an open-heart procedure is the gold
`standard and that's the way that it was done in Carpentier as a
`gold standard.
`Now, here in Carpentier, yes, they were going leaflet to
`leaflet to do the suture, but that's not the part of Carpentier that is
`being applied in the obviousness rejection here. The chordae is
`taught by Lattouf. What was missing, according to the Examiner
`and the Patent Owner, was directly suturing the leaflet with that
`artificial chordae.
`And Carpentier as the gold standard said, yeah, you can
`suture leaflets directly. Bachman shows it right there in that
`picture. Downing the same thing. And as the Board noted in
`Footnote 12 of its Decision to Institute, in fact, Lattouf shows it.
`And the Petitioner's position is the fact that Lattouf
`shows direct suture attachment to the leaflet is strong, if not
`compelling evidence of the reasoned rationale and the motivation
`to combine each of those secondary references with Lattouf.
`JUDGE WORTH: Well, your own expert said he
`would not rely on that. They asked Dr. Aklog at the deposition,
`they said what do you think of the Board's footnote where the
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`Board discussed that Lattouf might use a suture through the part
`of the leaflet tissue and Dr. Aklog said he would not rely on that.
`MR. PEDERSEN: No. If I'm remembering right, I
`think he did not need to rely on that was I think a more fair
`characterization of it. Because his position is the gold standard
`you would go to open-heart because now you can, as a surgeon,
`see what's going on inside the heart, you know what you're doing.
`You can see it.
`So any minimally invasive endovascular puncture
`access version, whatever you want say, anything other than an
`open-heart procedure, you would want to as closely mimic the
`gold standard as you could and that was the motivation that Dr.
`Aklog testified as to why to do it.
`JUDGE WORTH: And the Patent Owner says that
`neither the Petition nor Dr. Aklog goes to the how and why. So is
`it contemplated by the Petition that it would be Lattouf's
`instrument that would do the stitching --
`MR. PEDERSEN: Yes.
`JUDGE WORTH: -- in this combination?
`MR. PEDERSEN: Yes. And the question is where are
`you stitching it or what are you doing, are you doing that through
`a clip which was the previously known procedure in some of the
`other predecessor art, how do you get this into the heart without
`an open-heart procedure? It turns out you just don't have the
`same access as you do if it's an open-heart procedure.
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`So you've got get your attachment mechanism in there
`and the early versions used clips. That was the way that they had
`gotten in there, but the gold standard has always been and will
`always be using the suture directly and that's the Petitioner's
`position.
`JUDGE WORTH: And the Petitioner's position is that
`it would be Lattouf's instrument itself that would be doing that
`stitching?
`MR. PEDERSEN: Yes. Because Carpentier is an
`open-heart procedure, so how you're doing the stitching there is
`different than when you're doing it using the non-open-heart
`procedure taught by Lattouf.
`JUDGE WORTH: Okay. And this is in your Petition?
`MR. PEDERSEN: Yes.
`JUDGE WORTH: In the text section?
`MR. PEDERSEN: Yes, in the text section and in the
`claim charts particularly talking about which reference is being
`used for each of those claimed elements of Claim 1 and Claim 19.
`As we take a look, the other thing that the Patent Owner
`did argue in their Response was that Lattouf supposedly did not
`teach direct myocardial access or puncture access and that,
`therefore, Lattouf was not teaching Claim 19, but the Patentee's
`expert in paragraph 55 of the Patentee's declaration, expert's
`declaration there, it talks about the difference between making an
`incision in the chest, first the skin, and then placing a trocar in.
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`And it's the Petitioner's position that the trocar as a tube
`with either an orbiter or a sharp end on the tube effectively acts as
`a large needle and that a person skilled in the art would certainly
`understand that whether you say needle or trochar or catheter, all
`of those are tubes. Differences in degree and size, how sharp,
`exactly how you might use those can come about, but to a person
`skilled in the art these are all very similar instruments for
`obtaining access.
`JUDGE WORTH: This goes to the incision issue.
`MR. PEDERSEN: Yes, it does.
`JUDGE WORTH: As is argued by the Patent Owner.
`MR. PEDERSEN: Right. We do not believe that that
`claim construction is correct. But if you're thinking about that
`issue and wanted to know about the incision, Lattouf talks about
`incision in the skin and then punch the trocar through the
`ventricular wall and that's how you would gain access to the left
`ventricle, and that's consistent with the disclosure that we find in
`the '386 patent and what Dr. Aklog testified to.
`So at this point I've run a little bit over and I still would
`like to reserve some time for rebuttal.
`There are no further questions at this point?
`JUDGE WORTH: Thank you.
`MR. MILCH: Thank you, Your Honors. Again, I'm
`Erik Milch, counsel for the Patent Owner University of Maryland,
`Baltimore. I want to address a few things that we just heard.
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`Primarily I'd like to focus on the term percutaneously. Patent
`Owner will rely generally on the papers for the majority of the
`arguments in support of the fact that all of the claims are
`patentable.
`We're going to show that the Patent Owner's definition
`is the broadest reasonable interpretation in light of the
`specification and that the Petitioner's definition is so broad as to
`read the term percutaneous right out of the claims and render it
`meaningless.
`A couple things I wanted -- we were waiting for a cite
`on the Speziali file wrapper. I know that it's not on Petitioner's
`exhibit list. I don't know if we have that cite.
`MR. PEDERSEN: It's page 10 of the Reply, Exhibit
`
`1015.
`
`MR. MILCH: Okay. I didn't see it on the exhibit list
`quickly.
`So focusing on Claim 19 where you see the term
`percutaneously accessing an apical region of the heart and, again,
`you've got to keep that whole phrase in mind. It's not simply
`percutaneously accessing. We're talking about accessing a
`specific region of the heart.
`The Patent Owner's construction is direct
`transmyocardial puncture through unbroken skin or
`endovascularly accessing the apical region of a heart. And, again,
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`Case IPR2016-00208
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`this expands beyond the conventional definition of percutaneous
`no doubt, but it is entirely consistent with the specification.
`And as the Board well knows, you can't ignore the
`specification. We heard some comment about there was no
`specific definition. I think that's a new argument. I could have
`missed it in the Reply, but, again, you can't ignore the
`specification. The words are in there and you have to give them
`effect and the term percutaneous has to be given effect.
`JUDGE WORTH: Well, are you arguing that there is
`lexicography in that that is definitional?
`MR. MILCH: I'm arguing that the manner in which the
`specification was drafted, the term percutaneous was given
`meaning. So if that's lexicography, then, yes. While it doesn't
`put quotes around the term percutaneous and say percutaneous
`means X, it does give meaning to the term percutaneous as we'll
`talk about in a second.
`If you look at the specification, again, you've got to
`consider the specification. The term percutaneous includes two
`things and Petitioner did get it right that it has two components.
`One is direct transmyocardial access through the skin, through
`unbroken skin, and the other is endovascular.
`If you look at the area of the specification that Petitioner
`was talking about --
`JUDGE WORTH: And when you say unbroken, what
`you mean is no incision.
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`Case IPR2016-00208
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`MR. MILCH: I mean no incision, that's correct. If you
`look at column 7, and we're on slide 4, column 7, lines 35 to 44, I
`think this is instructive. If you read a few lines up from where
`Petitioner started and where you talk about -- again, we're talking
`about minimally invasive incisions. We're talking about a small
`incision.
`And then you get down to the bottom where it says,
`additionally, where direct needle access to the heart is sought. So
`we're not talking about direct puncture or direct transmyocardial
`puncture into the heart. We're talking where that access is sought,
`the methods of the invention may be performed, and here's where
`they get into small incisions, 1 millimeter, 3 millimeters, 5. And
`then as Your Honor pointed out, or even percutaneously, that is
`without the need for incision.
`And so we're talking about not direct access in
`puncturing the heart. We're talking about access to the heart
`through the skin. And I think there might be some confusion
`about the construction and I -- with that, I will agree with
`Petitioner.
`Again, we talked about the fact that there are two parts.
`You've got the direct transmyocardial puncture which we just
`addressed and then you've got endovascularly and we've got some
`cites from the specification on slide 5 and from column 11, lines
`35 to 52, where it talks about percutaneous access through direct
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`Case IPR2016-00208
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`puncture of the heart may also be used. We've ellipsed out some
`of the text.
`And then further down, still yet, other percutaneous
`approaches may be employed where access is made
`endovascularly, and I've grayed out some of the text, but you can
`still see it. That might not have been the best move, but through a
`cut-down or puncture, absolutely. We're not saying that
`endovascular access can't be through a cut-down.
`The Patentee says there are percutaneous approaches
`that may be employed for access. Those are endovascular and
`those can be made either through a cut-down or with a puncture.
`And, again, in that context we would say a puncture means
`through unbroken skin.
`JUDGE WORTH: Well, what if it is a cut-down, what
`if it's endovascular, does that mean that it's a percutaneous
`approach?
`MR. MILCH: Based on the language of the
`specification, based on the language that the Patentee used, yes.
`If you have a cut-down using an endovascular approach, that
`would be considered percutaneous.
`JUDGE FRANKLIN: How, can you explain that?
`MR. MILCH: You explain it based on -- again, it's
`outside the bounds of the conventional definition for sure, but this
`is where the Patentee has used these words and said, look,
`percutaneous can be endovascular and endovascular can be --
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`Case IPR2016-00208
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`JUDGE FRANKLIN: I understand. I just want you to
`explain to us how that's so.
`MR. MILCH: So, again, if you think about the context
`-- again, I mentioned this earlier about we're talking about
`accessing an apical region of the heart. So percutaneous without
`breaking the skin of the heart for sure and without breaking skin
`around the heart. There's no incision in the chest, there's no
`incision in the heart and endovascular means you're going in
`through the vasculature.
`JUDGE FRANKLIN: Okay. I'm going to stop you.
`You caught me there. So to make this definition work with this
`disclosure here at column 11, you have to consider skin including
`the tissue of the heart. You're saying that the heart now has skin
`and tissue.
`MR. MILCH: It's without making an incision in the
`heart, so, again, it's percutaneously accessing an apical region of
`the heart. So the access is made endovascularly, again, through
`the -- you know, we saw the text earlier, femoral vein and there
`was also femoral artery or an internal jugular vein.
`When you access through the vasculature, you're not
`making an incision around the heart or in the heart. So that's how
`it's consistent because you're not breaching the wall of the heart.
`We have direct transmyocardial puncture as one way.
`Endovascularly you're not breaching any part of the heart other
`than through the vasculature.
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`Case IPR2016-00208
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