[00:00:04] Speaker 01:
First case for argument this morning was 151549 LifeNet Health versus LifeCell Corporation.

[00:00:11] Speaker 01:
Mr. Demaris.

[00:00:16] Speaker 07:
May it please the court, John Demaris for LifeCell.

[00:00:19] Speaker 07:
Good morning.

[00:00:21] Speaker 07:
No reasonable juror could find direct infringement in this case.

[00:00:25] Speaker 07:
In its J-Mall opinion, the district court characterized the major dispute for trial

[00:00:31] Speaker 07:
as, quote, whether plasticizers were removed from the internal matrix by surgeons.

[00:00:38] Speaker 07:
The court further held that if surgeons did, in fact, remove that plasticizer, there would be no infringement.

[00:00:45] Speaker 07:
Then, rather than evidence of direct infringement to sustain the jury verdict, the district court relied on traditional proof of inducement.

[00:00:54] Speaker 07:
What do the instructions for use say?

[00:00:56] Speaker 07:
How do surgeons use this device in the operating room?

[00:01:00] Speaker 07:
This is not a direct infringement case.

[00:01:02] Speaker 07:
As this court held in Cross Medical, if the surgeons are assembling the final product in the operating room, the apparatus claims do not infringe directly and no reasonable juror could find so.

[00:01:14] Speaker 05:
I seem to recall, you're right, that the district court initially said that he was going to focus at the time of transplantation for the not-removed limitation.

[00:01:25] Speaker 05:
That's correct.

[00:01:26] Speaker 05:
But then ultimately got to

[00:01:29] Speaker 05:
what could be regarded as the right place, which is what matters is at the time of production, in terms of the not removing plasticizer from the internal matrix.

[00:01:42] Speaker 07:
Yes, if you look at the district court's opinions, both at summary judgment and at J-Mall, they're entirely inconsistent.

[00:01:50] Speaker 07:
Some portions of the opinions the judge is talking about, the final act is planned

[00:01:56] Speaker 07:
transplantation, what's relevant is what happens at the time of transplantation.

[00:02:00] Speaker 07:
Other times in the opinion, the court then says, so it infringed at the time it was packaged.

[00:02:07] Speaker 07:
But then when you look at the proof the court relied on to sustain the verdict, the court then talks about what were the instructions for use and how did surgeons handle the products in the operating room.

[00:02:19] Speaker 05:
Well, could it be that he was looking at that to determine if, in fact, at the time of transplantation or at the time of surgery, there was, in fact, plasticizer being removed from the internal matrix?

[00:02:34] Speaker 05:
And if so, then there's no infringement.

[00:02:37] Speaker 05:
There's no infringement.

[00:02:39] Speaker 05:
Right, but if he sees the proof,

[00:02:44] Speaker 05:
the evidence is proving that there in fact was plasticizer being removed from the internal matrix, then of course your side doesn't infringe.

[00:02:54] Speaker 05:
That's correct.

[00:02:55] Speaker 07:
But he concluded otherwise.

[00:02:58] Speaker 07:
By looking at what happened in the operating room, by looking at what surgeons were doing, and by looking at what the instructions for use say.

[00:03:05] Speaker 07:
So that is traditionally inducement proof or contributory infringement proof.

[00:03:11] Speaker 07:
It is not proof of direct infringement.

[00:03:12] Speaker 07:
If you have to look at

[00:03:14] Speaker 07:
what's happening in the operating room, there may very well be a case for induced infringement or contributory infringement.

[00:03:19] Speaker 07:
But if you're looking in the operating room, it is not a case of direct infringement, which is what Michael Hein is charged with here.

[00:03:27] Speaker 07:
Indirect infringement wasn't pledged and was not tried.

[00:03:30] Speaker 07:
So going back to cross-medical, this is clearly four square with cross-medical.

[00:03:34] Speaker 07:
There can be no direct infringement here, and no reasonable juror could have found otherwise.

[00:03:38] Speaker 07:
Similarly for the method claims, as this court held in Akamai, if all the steps are not being

[00:03:44] Speaker 07:
performed by the accused infringer, it is not direct infringement.

[00:03:48] Speaker 07:
And there's no evidence here that LifeCell was somehow controlling the doctors or in any sort of joint enterprise with the doctors.

[00:03:57] Speaker 07:
If you look at the language of this limitation- Why would we look in the surgery room?

[00:04:02] Speaker 02:
Are we dealing with products here that are prepared for insertion in the human body or to be grafted in the human body?

[00:04:11] Speaker 02:
And so it's a state of being up until the time that the surgeon uses the product.

[00:04:20] Speaker 07:
Up until the time this surgeon actually does the transplantation.

[00:04:23] Speaker 07:
If you look at the words in the claim, and it's are not removed prior to transplantation, that's a verb clause.

[00:04:32] Speaker 07:
It's expressing an action, and it's talking about actions happening in the operating room by the surgeons.

[00:04:38] Speaker 07:
That's what takes it clearly out of direct infringement.

[00:04:41] Speaker 07:
If you have to look at what's going on in the operating room, on that verb clause is saying, in the operating room, you're not removing plasticizers, then my client can't infringe.

[00:04:50] Speaker 07:
My client sells a product in the package.

[00:04:52] Speaker 07:
My client doesn't go into the operating room, doesn't do transplantation, and does not remove plasticizers.

[00:04:57] Speaker 05:
I guess the response to that would be, at least the other side's response, would be that what that not removal limitation is really talking about is a property, a feature,

[00:05:08] Speaker 05:
of the claimed product, and that basically at the time of production, once you produce the graph, you can't remove the plasticizer from the internal matrix at any point in time after production without actually destroying the graph.

[00:05:27] Speaker 07:
Well, that certainly is LifeNet's argument, but it's clearly wrong.

[00:05:31] Speaker 07:
And the district court addressed that force whereby pointing out that the language isn't

[00:05:36] Speaker 07:
You need not remove the plasticizers.

[00:05:39] Speaker 07:
The language in the claim limitation is the plasticizers are not removed.

[00:05:43] Speaker 07:
It's a verb requiring action.

[00:05:46] Speaker 07:
Not removed means there's a remover, and that remover is the surgeon.

[00:05:49] Speaker 07:
So even if it is a quality, if you wanted to go with a quality, it's a quality at the time of transplantation.

[00:05:56] Speaker 07:
It's not a quality at the time the graft is in the package.

[00:06:00] Speaker 07:
You could think about this as a contributory infringement case, for instance, where

[00:06:05] Speaker 07:
you make a machine that if you use it necessarily infringes, that's not a direct infringement case.

[00:06:11] Speaker 07:
If my client made a graph that necessarily infringes when used, they might very well be subject to liability for contributory infringement.

[00:06:21] Speaker 07:
This isn't a contributory infringement case.

[00:06:23] Speaker 07:
That graph, whether it necessarily infringes when used or not, doesn't directly infringe when it's in the packet when my client sells it.

[00:06:30] Speaker 07:
So if we're looking at what happens in the operating room, if we're looking at what surgeons do, this is not a direct infringement case.

[00:06:37] Speaker 07:
The direct infringement verdict can't stand.

[00:06:40] Speaker 07:
Moving on to claim construction, this is also a very interesting issue in this case, because as LifeNet says in their brief at page 38, they argued that there's no O2 microissue here, because the trial resolved a factual dispute.

[00:06:54] Speaker 07:
And they characterized the factual dispute as, and this is a quote, the fundamental dispute at trial

[00:06:59] Speaker 07:
was over where the plasticizer that Lifesell said was removed, was removed from.

[00:07:05] Speaker 07:
That's how they characterized the disputed trial.

[00:07:06] Speaker 07:
That is not what this trial was about.

[00:07:08] Speaker 07:
The record flatly contradicts that.

[00:07:11] Speaker 07:
Their own expert, Dr. Kaplan, admitted at trial where the plasticizer comes from.

[00:07:17] Speaker 02:
If you remove the plasticizer from a soft tissue grant, does that necessary also remove it from the tissue matrix?

[00:07:25] Speaker 07:
not necessarily because some could be on the top some could be on the top so but their expert admitted in his direct testimony this is a quote that the plasticizer comes from quote the gaps among the solid matrix close quote that's what their expert admitted in direct testimony in their closing argument they told the jury the plasticizer comes from the voids and the gaps in the internal matrix even in their brief here on appeal at page thirty they talk about the

[00:07:55] Speaker 07:
The plasticizers are coming from the bulk plasticizer in the matrix.

[00:07:59] Speaker 07:
So there's no dispute between the parties where the plasticizer comes from.

[00:08:03] Speaker 07:
We agree with them.

[00:08:04] Speaker 07:
And we said this in our appeal briefs.

[00:08:07] Speaker 07:
The disputed trial was, do the claims cover that or not?

[00:08:10] Speaker 07:
If everyone agrees the plasticizer is coming from those gaps and voids in the matrix, there's not a dispute about how the product works.

[00:08:16] Speaker 07:
There's nothing to try.

[00:08:17] Speaker 07:
The question is, does the not remove limitation cover removing plasticizer from the gaps and the voids?

[00:08:24] Speaker 01:
No, I guess I beg to differ.

[00:08:27] Speaker 01:
And what I'm not arguing with real hard at the claim construction here is what it means to come from the internal matrix.

[00:08:34] Speaker 01:
The dispute it seemed to me at the end, particularly between the experts, bore down to when we say internal matrix, which as you know is defined in the spec and the parties stipulated to that definition, what that means.

[00:08:47] Speaker 01:
Isn't that what the parties were fighting about at the end and what the experts were disputing?

[00:08:53] Speaker 07:
Yes and no.

[00:08:54] Speaker 07:
Let me put a little bit of a different spin on that, Your Honor.

[00:08:57] Speaker 07:
What we asked for below, repeatedly, from the beginning at the Markman hearing, through the pretrial, in motions of limiting, during objections in trial, and at the end, we asked the court to rule that the limitation not removed means no plasticizer is removed.

[00:09:17] Speaker 07:
of any kind in the way we said.

[00:09:19] Speaker 00:
But you're forgetting about those two keywords, three keywords, from the internal matrix.

[00:09:24] Speaker 07:
Yes, but the way we characterized it below was bound or unbound, which is, this is why I said let me give a different spin on it.

[00:09:31] Speaker 07:
At several occasions we told the court any removal of plasticizer, whether bound or unbound,

[00:09:37] Speaker 07:
from the internal matrix is violation of that provision.

[00:09:42] Speaker 01:
Where did you say that?

[00:09:44] Speaker 01:
I mean, I see it in your grade brief, but somewhere in your briefs, you refer to portions of the record.

[00:09:50] Speaker 07:
Yes, if you look at the appendix at A6085, that's one example.

[00:10:02] Speaker 07:
This is a motion and limine filed during the trial.

[00:10:07] Speaker 07:
and look at 6088 in particular, we say at the top of 6088, nonetheless, plaintiff's expert Dr. Kaplan now offers infringement theories premised on the notion that there are different types of plasticizer defined by how strongly they are chemically bonded, and that some types of plasticizer.

[00:10:31] Speaker 01:
That stuff is more confidential than mine.

[00:10:34] Speaker 07:
I'm sorry, I won't read it, so I'll just direct you.

[00:10:36] Speaker 07:
Thank you.

[00:10:37] Speaker 07:
I'm not sure if this part is the confidential part.

[00:10:39] Speaker 01:
Well, if you want to waive confidentiality, that's fine with me.

[00:10:41] Speaker 07:
So I think this is not the confidential part, so let me just read this part.

[00:10:45] Speaker 07:
Different types of plasticizer defined by how strongly they are chemically bonded, and that some types of plasticizer, so-called free or bulk plasticizer, may be removed from the tissue while still satisfying the not remove limitation.

[00:10:57] Speaker 07:
And there's footnote one where we go into detail about that.

[00:10:59] Speaker 07:
So it was clearly brought up to, so we were characterizing it below.

[00:11:03] Speaker 07:
to answer your honor's questions about what is from the internal matrix.

[00:11:06] Speaker 07:
We were using different words below saying bound or unbound.

[00:11:10] Speaker 07:
It's the same thing because their position is it only comes from the matrix if it's bound.

[00:11:15] Speaker 07:
So we were saying you can't have it that way.

[00:11:17] Speaker 07:
The limitation applies to both bound and unbound.

[00:11:20] Speaker 07:
This is only one example.

[00:11:22] Speaker 07:
We brought it up also

[00:11:24] Speaker 07:
on several other occasions.

[00:11:25] Speaker 01:
So you referred to the jury instructions, and I can't find that now, but I didn't see it in your dispute over the jury instructions.

[00:11:31] Speaker 01:
It seemed to me you were still asking for, I think that's on 7689, the construction you were asking for was plain meaning that no plasticizer is deliberately, so that's a new word, removed from the internal matrix of the soft tissue graph.

[00:11:47] Speaker 01:
Yes.

[00:11:48] Speaker 01:
That doesn't seem to me any different.

[00:11:50] Speaker 01:
than what we were doing in the first instance, which is different from asking for a definition or proposing a definition of what we mean by internal matrix.

[00:11:58] Speaker 07:
Yes.

[00:12:00] Speaker 07:
It's two sides of the same coin, is what I'm saying.

[00:12:02] Speaker 07:
We brought up repeatedly to the district court that the phrase no plasticizers removed should be all plasticizers, whether bound or unbound.

[00:12:10] Speaker 07:
That was brought up in the motion limiting here.

[00:12:13] Speaker 07:
It was brought up again during the trial.

[00:12:14] Speaker 07:
We objected when Dr. Kepler was test-funded.

[00:12:16] Speaker 02:
Did you make that argument in the context of construing not removed?

[00:12:19] Speaker 07:
Yeah, so we could look again at appendix 8196, which is the objection we made during Dr. Kaplan's testimony.

[00:12:29] Speaker 07:
And I'll turn to 8196 and just show you what we said there.

[00:12:34] Speaker 07:
So Dr. Kaplan testified.

[00:12:36] Speaker 07:
And if we look particularly on 8197 at the top, this is our objection during the trial.

[00:12:45] Speaker 07:
We're talking about Dr. Kaplan's direct.

[00:12:47] Speaker 07:
We said what they are arguing, this is that sidebar.

[00:12:50] Speaker 07:
You can remove what they call bulk plasticizer, and that's OK.

[00:12:54] Speaker 07:
But if the claims require removal of other kinds of plasticizer, what they are called loosely bound or tightly bound, that is inconsistent with the court's claim construction.

[00:13:03] Speaker 07:
We believe it's inconsistent with the claims.

[00:13:05] Speaker 07:
It's argument that it's plasticizer only contained in the matrix is bound to the matrix is contrary to the claim language.

[00:13:13] Speaker 07:
And it goes on.

[00:13:14] Speaker 07:
Clearly, it was raised in the motion of limiting.

[00:13:17] Speaker 07:
It was raised during Dr. Kaplan's direct.

[00:13:19] Speaker 07:
So Your Honor, back to your question.

[00:13:21] Speaker 07:
We were phrasing it as bound or unbound, but it is the internal matrix issue.

[00:13:25] Speaker 02:
Counselor, if the district court had construed not removed in line of your argument, what would the district court have construed it as?

[00:13:33] Speaker 07:
The proper construction that would have resolved this issue that was raised to the court would be the not removed limitation refers to all plasticizers, whether bound or unbound to the internal matrix.

[00:13:46] Speaker 07:
That's what the dispute was raised to the district court.

[00:13:49] Speaker 05:
Let me try to redefine that or translate that.

[00:13:53] Speaker 05:
It means not removing any plasticizer from the actual fibers themselves that make up the internal matrix, as well as the voids, gaps between all those different fibers?

[00:14:07] Speaker 07:
Yes, your honor.

[00:14:07] Speaker 07:
That's exactly what the issue was presented to the district court, and that's how the claim term should have been interpreted.

[00:14:13] Speaker 07:
Light cell below was asking for it to that term to apply to all plasticizers.

[00:14:17] Speaker 07:
That's what they meant.

[00:14:18] Speaker 07:
And that's what they raised to the court.

[00:14:19] Speaker 05:
I guess I have a couple concerns.

[00:14:21] Speaker 05:
One is I didn't see any moment where your side said we need a claim construction right now.

[00:14:30] Speaker 05:
And we need a claim construction because there's a debate over what does it mean from the original matrix.

[00:14:35] Speaker 05:
And we need it to make it clear that when you're

[00:14:39] Speaker 05:
withdrawing plasticizer, it's from either the gaps in between the different collagen fibers that make up the internal matrix, as well as the fibers themselves that make up the internal matrix.

[00:14:51] Speaker 05:
And then the second part is that the other side is going to come up and say that when it comes to this very specific issue, your side was very happy to say that this is a fact question for the jury.

[00:15:08] Speaker 07:
The scope of the claim, whether it applies to bound and unbound plasticizer from the gaps and the voids, can't possibly be a fact issue.

[00:15:21] Speaker 07:
It is true that below we tried it as a fact issue.

[00:15:24] Speaker 07:
The parties disputed what this claim covered.

[00:15:27] Speaker 07:
Did it cover just the bound plasticizer, or did it cover also the gaps and voids?

[00:15:32] Speaker 07:
So we did try that as if it was a factual dispute, but we were essentially presenting to the jury

[00:15:37] Speaker 07:
competing claim constructions.

[00:15:38] Speaker 05:
There's no dispute that it comes from the Gaussian voids.

[00:15:40] Speaker 05:
What is the district court supposed to do when both sides agree to the meaning of internal matrix?

[00:15:46] Speaker 05:
Both sides, you know, that they're given the charge that we're going to go with the plain meaning of the phrase and then both sides are telling the judge that it's just a fact question.

[00:16:01] Speaker 05:
Are you saying that it's an error for a district court then to

[00:16:04] Speaker 05:
not treated as such when it presented and litigated in that manner?

[00:16:08] Speaker 07:
Here was where the error was.

[00:16:10] Speaker 07:
At the Markman hearing, when both sides were arguing this issue, the district court said in the Markman opinion, no removal of plasticizer means no removal of plasticizer, because LifeNet was arguing at the time that some could come out.

[00:16:26] Speaker 07:
And the district court said, no, none can come out.

[00:16:30] Speaker 01:
But then the issue boiled down to somewhere, maybe at trial, maybe before trial, maybe after trial, how we are defining the internal matrix.

[00:16:39] Speaker 01:
And that seems to be the dispute the experts were having, what is or is not considered the internal matrix.

[00:16:45] Speaker 01:
And in that regard, both parties stipulated that the definition and the specification was the definition of internal matrix.

[00:16:52] Speaker 07:
But the internal matrix definition does not answer this question.

[00:16:55] Speaker 07:
What the internal matrix agreed construction was was that it includes the collagen and elastin and the other fibers that are together in a matrix format.

[00:17:05] Speaker 07:
It is inherently, it has gaps and voids in it.

[00:17:08] Speaker 07:
By defining a matrix as the structure that creates it, it doesn't rule out the gaps and voids.

[00:17:14] Speaker 07:
If you just think about this in normal English parlance, if you think of a sponge,

[00:17:18] Speaker 07:
When you squeeze a sponge, what comes out of that sponge is coming from the gaps in the voids.

[00:17:22] Speaker 07:
And you would say it's coming from the internal mixtures of the sponge.

[00:17:25] Speaker 02:
You're not talking about what's bound to it.

[00:17:27] Speaker 02:
At the end of the day, you can't remove all the plasticizer from the tissue graph, can you?

[00:17:32] Speaker 02:
I mean, otherwise, you'd destroy it.

[00:17:35] Speaker 02:
So there's got to be some plasticizer left.

[00:17:38] Speaker 07:
Yes, there is some plasticizer left in the products when they are, whether they're rinsed or not, there is some left.

[00:17:43] Speaker 07:
But that doesn't answer the question.

[00:17:45] Speaker 07:
The claim scope dispute here.

[00:17:47] Speaker 07:
is what plasticizers this claim element was referring to.

[00:17:51] Speaker 07:
And if you look at the patent specification, you can't come to any other conclusion other than it's referring to what comes out of the gaps.

[00:17:58] Speaker 02:
But doesn't it make a difference if you're talking about the soft tissue graft versus the tissue matrix?

[00:18:02] Speaker 07:
I'm sorry.

[00:18:03] Speaker 02:
Doesn't it make a difference if you're referring to which plasticizer you're removing if you're referring to the soft tissue graft versus the tissue matrix?

[00:18:13] Speaker 07:
Well, yes, because if you're referring to the graph, you could be talking about the plasticizer that's on the top as opposed to what comes from the inside.

[00:18:19] Speaker 07:
But there's no dispute of factor.

[00:18:22] Speaker 07:
Everyone agrees that the plasticizer coming out is the plasticizer that was in the gaps and voids.

[00:18:27] Speaker 07:
They said it.

[00:18:28] Speaker 07:
Their experts said it.

[00:18:29] Speaker 01:
So the argument is whether or not the gaps and voids are the internal matrix that's referred to in the claim.

[00:18:36] Speaker 07:
That's one way to look at it.

[00:18:37] Speaker 07:
And as I was just saying, they agreed upon construction

[00:18:40] Speaker 07:
allows for that.

[00:18:40] Speaker 07:
The construction says the internal matrix includes the collagen.

[00:18:45] Speaker 07:
It doesn't say it excludes the gaps and voids, it includes as open-ended.

[00:18:49] Speaker 07:
And human normal parlance is that when you have a matrix that has

[00:18:53] Speaker 07:
By definition, gaps and voids, that's what a matrix is.

[00:18:56] Speaker 01:
So is the claim construction dispute that you're saying was avoided and should have been dealt with by the district court, one which defines what means taking from the internal matrix, whether that includes gaps and voids or not?

[00:19:08] Speaker 07:
It could have been resolved that way.

[00:19:10] Speaker 07:
It was presented to the district court as whether the plasticizer removal is bound or unbound.

[00:19:16] Speaker 07:
And it answers the same question, whether you approach it from how you define the plasticizers or how you define the matrix.

[00:19:21] Speaker 07:
You get to the same answer.

[00:19:23] Speaker 07:
Because there's no fact dispute on the products.

[00:19:24] Speaker 01:
Can you tell me again where this bound and unbound dispute was taking place?

[00:19:28] Speaker 01:
I mean, in the J-Mall, for example, where there was a claim construction question raised, the district court, at least in 23, says that your proposed claim construction is that there is no partial or full removal of plasticizers from the internal matrix prior to transplantation.

[00:19:45] Speaker 01:
that still doesn't get into the nuanced argument about we're just differentiating between bound and unbound classes.

[00:19:53] Speaker 07:
Yes, Your Honor.

[00:19:54] Speaker 07:
There are two places that it very clearly was teed up to the district court.

[00:19:58] Speaker 07:
One was in a motion in limiting.

[00:20:00] Speaker 07:
When Dr. Kaplan was giving his testimony in the expert reports and that deposition, when he started to argue that it was coming, it was only bound, we made a motion in limiting.

[00:20:11] Speaker 07:
And it's on A60.

[00:20:14] Speaker 07:
6,088, where we told the court, please preclude Kaplan from testifying about this internal matrix bound-unbound.

[00:20:24] Speaker 07:
And we say at the top, nonetheless, plaintiff's expert, Dr. Kaplan, now offers infringement theories premised on the notion that there are different types of plasticizer defined by how strongly they are chemically bonded, and that some types of plasticizer, so-called free or bulk plastic, that's the stuff in the gaps and the voids,

[00:20:44] Speaker 07:
may be removed from the tissue graft while still satisfying the not remove limitation.

[00:20:49] Speaker 07:
And then we have a footnote with the details and we ask the court to bar Dr. Kaplan from

[00:20:54] Speaker 02:
testifying that way because it's contrary to the court's construction.

[00:20:56] Speaker 02:
You're not arguing a different construction there.

[00:20:59] Speaker 02:
You're basing this argument on what the court had already said, how the court was going to construe, not remove.

[00:21:08] Speaker 02:
Yes, you put your finger on it.

[00:21:09] Speaker 02:
You're making an argument today, which I appreciate and I understand.

[00:21:13] Speaker 02:
I don't see that you made that clear of an argument below.

[00:21:17] Speaker 07:
That is from below.

[00:21:18] Speaker 07:
That's the motion limited to the district court.

[00:21:20] Speaker 07:
So what happened below, just to be clear,

[00:21:22] Speaker 07:
At the markman, when the court ruled, the court said in words, no removal means no removal of any plasticizer.

[00:21:31] Speaker 07:
That's what the court said.

[00:21:32] Speaker 07:
But then the court didn't construe it.

[00:21:34] Speaker 07:
The court just said, no construction necessary.

[00:21:37] Speaker 07:
But that's what I mean by it.

[00:21:38] Speaker 07:
So what we were saying here in the motion and limiting is, you told us what you meant.

[00:21:43] Speaker 07:
Please put words on that and tell that to the jury.

[00:21:46] Speaker 07:
And the court refused that the motion eliminate states to do that.

[00:21:49] Speaker 07:
Then during the trial, and this goes back to the Judge Prost question, during the trial when Kaplan testified that way, we brought it up again, Your Honor, and this is on 8197, where we said very clearly to the district court at the sidebar, what they are arguing is you can remove what they are calling bulk plasticizer, and that's OK.

[00:22:11] Speaker 07:
But if the claims require removal of other kinds of plasticizer,

[00:22:15] Speaker 07:
what they are called loosely bound or tightly bound, that is inconsistent with the court's claim construction.

[00:22:20] Speaker 07:
Now the claim construction was no further construction necessary.

[00:22:23] Speaker 07:
What we were telling the court is you told us what you mean by those words.

[00:22:26] Speaker 07:
You said all plasticizer can't be removed.

[00:22:29] Speaker 07:
Tell the jury that.

[00:22:31] Speaker 07:
So we go on to say we believe it's inconsistent with the claims.

[00:22:34] Speaker 07:
It's argument that plasticizer only contained in the matrix is bound to the matrix is contrary to the claim.

[00:22:40] Speaker 07:
So we told the court at sidebar during the trial

[00:22:44] Speaker 07:
This is contrary, Judge, to what you think the claims mean.

[00:22:47] Speaker 07:
Tell the jury.

[00:22:49] Speaker 07:
And the court refused.

[00:22:50] Speaker 07:
So it is a claim construction.

[00:22:51] Speaker 01:
It was teed up from the very beginning.

[00:22:53] Speaker 01:
What you cite in your brief as another example of where you teed this up under the 02 micro is on 7689, which we've already looked at.

[00:23:01] Speaker 01:
This is where you asked for a jury instruction.

[00:23:04] Speaker 07:
Yes.

[00:23:05] Speaker 01:
Well, it doesn't seem to me that what you were proposing to say, we need to clean this up, your proposal is plain meaning that no plasticizer is deliberately removed from the internal matrix of transplantation.

[00:23:16] Speaker 01:
Somewhere in there, maybe somebody was thinking about a bound or unbound distinction, but it's not called out.

[00:23:23] Speaker 01:
That bound and unbound distinction wouldn't have been any clearer to the jury if the judge had given them this instruction.

[00:23:30] Speaker 07:
Right?

[00:23:31] Speaker 07:
I think that Your Honor has a point, so I'm not disputing that.

[00:23:35] Speaker 07:
But in the context of what was going on below, the court's mind was that limitation applied to all plasticizers, and that's what the court said.

[00:23:43] Speaker 07:
So what we were saying here is tell the jury it applies to all plasticizers.

[00:23:48] Speaker 07:
That's the plain language is no removal of plasticizers means all plasticizers.

[00:23:53] Speaker 07:
You have to view that language in the context of what we were arguing about.

[00:23:57] Speaker 07:
We argued in the motion and limited to the court.

[00:23:59] Speaker 07:
We argued it side by side.

[00:24:00] Speaker 07:
The court knew what the issue was.

[00:24:01] Speaker 07:
Did it apply to some plasticizer, or did it apply to all plasticizers?

[00:24:04] Speaker 01:
Well, if someone had jury instruction, maybe the court knew.

[00:24:06] Speaker 01:
But the purpose of a jury instruction is to make sure the jury knows that.

[00:24:09] Speaker 07:
Well, that's why we were asking the court to tell the jury what the jury heard.

[00:24:13] Speaker 07:
was one expert saying that limitation applied to some of the plasticizer.

[00:24:17] Speaker 01:
But how would the jury instruction that you were proposing, which you said was your revised claim construction, make it any clearer to the jury as to whether or not to accept Dr. Kaplan or your expert on this bound or unbound issue?

[00:24:30] Speaker 07:
Because the jury instruction we asked for said all plasticizers.

[00:24:39] Speaker 01:
We're way beyond what we should be.

[00:24:42] Speaker 01:
So we'll restore four minutes of rebuttal.

[00:24:46] Speaker 01:
Thank you, Your Honor.

[00:24:51] Speaker 03:
Thank you, Your Honor.

[00:24:57] Speaker 03:
May it please the court

[00:24:59] Speaker 03:
There is no claim construction issue here.

[00:25:01] Speaker 01:
Can you start, though, just with the point that your friend started off with?

[00:25:05] Speaker 01:
Oh, sure.

[00:25:06] Speaker 01:
Direct infringement and the inducement.

[00:25:08] Speaker 01:
There is some weirdness in the claim language.

[00:25:11] Speaker 03:
Yes.

[00:25:12] Speaker 03:
And I readily concede that.

[00:25:13] Speaker 03:
And actually, I'll talk about that.

[00:25:16] Speaker 03:
But I think it's important to remember here that the reason that we were talking about what surgeons do, the reason that was in the case at all

[00:25:26] Speaker 03:
was because that was life cells of defense.

[00:25:29] Speaker 03:
There was no dispute that they produced plasticized soft tissue grafts that had plasticizer in the internal matrix and were suitable for transplantation.

[00:25:38] Speaker 03:
Their argument was, but our instructions require a two-minute rinse.

[00:25:43] Speaker 03:
And that takes place in the operating room.

[00:25:45] Speaker 03:
And that rinse, which they said was necessary, removes plasticizer from the internal matrix.

[00:25:51] Speaker 03:
Now, the evidence at trial was, A, that rinse isn't necessary.

[00:25:54] Speaker 03:
And B, it doesn't remove plasticizer.

[00:25:56] Speaker 03:
And in fact, our expert testified, and the jury apparently agreed, that you can't remove the plasticizer from the internal matrix of their graphs.

[00:26:08] Speaker 03:
So whatever might happen in some other case, in this case, surgeon activity could have no effect on their product.

[00:26:15] Speaker 03:
And their product infringed when it was in the surgeon's hands.

[00:26:18] Speaker 03:
Nothing the surgeon did has anything to do with that.

[00:26:21] Speaker 05:
But the claim is written.

[00:26:22] Speaker 05:
It's strange.

[00:26:23] Speaker 05:
It is strange.

[00:26:24] Speaker 05:
The reference point with this not remove limitation is at the time of implantation, not at the time of production.

[00:26:32] Speaker 05:
So what is the intent behind this limitation about are not removed?

[00:26:40] Speaker 03:
The intent, Judge Chen, I think, is it's a structural requirement of the claim graphed.

[00:26:46] Speaker 03:
And I think that becomes clear when you look back at how it came to be.

[00:26:53] Speaker 03:
So it was not originally part of the claims.

[00:26:56] Speaker 03:
In prosecution, the claims were rejected in light of the Cavallaro patent.

[00:26:59] Speaker 03:
Now, the Cavallaro patent was about individual collagen strands, not about soft tissues or matrices or anything like that.

[00:27:08] Speaker 03:
And it was a process for strengthening these collagen fibers.

[00:27:11] Speaker 03:
The process required removal of the plasticizer.

[00:27:15] Speaker 03:
And the examiner thought, I guess since there was collagen and there was plasticizer that Cavallaro anticipated,

[00:27:21] Speaker 03:
And we came back, LifeNet came back and said, no, plasticizer in ours is not removed.

[00:27:29] Speaker 03:
That's a structural feature of these graphs.

[00:27:33] Speaker 03:
In fact, they wouldn't be plasticized soft tissue graphs if you took the plasticizer out of the internal matrix.

[00:27:37] Speaker 03:
It then wouldn't preserve them.

[00:27:39] Speaker 03:
It wouldn't keep the structure and material properties.

[00:27:43] Speaker 05:
Do you have examples in your spec where plasticizer is being removed?

[00:27:47] Speaker 03:
Where some plasticizer is removed, but the spec, and I think it's

[00:27:52] Speaker 03:
I may get this wrong.

[00:27:53] Speaker 04:
I think it's in college.

[00:27:54] Speaker 04:
In fact, that might have been.

[00:27:55] Speaker 04:
And then there's one part of the citation in the prosecution history in your office action response, citing to a specific.

[00:28:03] Speaker 03:
Well, it says support for the not removed addition is present throughout the specification.

[00:28:11] Speaker 03:
And it cites as one example, an example where the graft is directly implanted without any sort of preparation.

[00:28:18] Speaker 03:
But it's clear throughout the specification

[00:28:21] Speaker 03:
that what we're talking about is plasticizer that is bound to the molecular structure of the tissue matrix.

[00:28:27] Speaker 03:
That's in column one.

[00:28:28] Speaker 03:
It's throughout.

[00:28:29] Speaker 03:
And there's even an example where it says, you can even centrifuge this thing for an hour.

[00:28:35] Speaker 03:
And although you're going to remove some plasticizer from the graft, you're not going to remove the tightly bound plasticizer from the internal matrix.

[00:28:43] Speaker 03:
enables it to retain these favorable properties.

[00:28:46] Speaker 01:
Just reading all this stuff, it seems to me there are some choices.

[00:28:50] Speaker 01:
I mean, some say that plasticizers are in the gaps or in the holes.

[00:28:55] Speaker 01:
Then there's bound.

[00:28:56] Speaker 01:
And isn't there an argument somewhere between the experts on whether or not they're on the surface versus being bound?

[00:29:03] Speaker 01:
This is lightly bound versus tightly bound.

[00:29:05] Speaker 03:
Well, I don't think there is a difference between free plasticizer, tightly bound, and loosely bound.

[00:29:12] Speaker 03:
I don't know that it has anything to do with the surface.

[00:29:14] Speaker 01:
But you're saying that the loosely bound plasticizers are not covered, as those who we were talking about in the claim, which say from the internal matrix.

[00:29:22] Speaker 01:
Oh, no.

[00:29:22] Speaker 03:
Those are in the internal matrix as well.

[00:29:24] Speaker 03:
And Dr. Kaplan testified.

[00:29:25] Speaker 01:
OK, so those don't come out.

[00:29:26] Speaker 03:
Those don't come out, nor do the tightly bound plasticizer.

[00:29:29] Speaker 03:
What comes out is the free plasticizer that's in the gaps or on the surface of the graph.

[00:29:33] Speaker 03:
And that was a factual issue.

[00:29:35] Speaker 03:
That was a factual dispute between the experts and Judge Jen.

[00:29:38] Speaker 03:
You were right.

[00:29:39] Speaker 03:
I am going to point out that Lifesell repeatedly told the court that there's no question that plasticizers came out.

[00:29:49] Speaker 03:
Where the plaintiffs and defendants part company is, according to Kaplan, pardon me, it's not coming out of the internal matrix.

[00:29:55] Speaker 03:
Once we demonstrate that it's removed, our expert is going to tell you, and indeed comes out of the internal matrix.

[00:30:00] Speaker 03:
And we agree that question will unquestionably be for the jury.

[00:30:04] Speaker 03:
That's what this trial was about.

[00:30:06] Speaker 03:
There was no dispute about the claim construction of the not removed limitation.

[00:30:11] Speaker 03:
The court said not removed means not removed.

[00:30:14] Speaker 03:
That's what they say in their brief.

[00:30:15] Speaker 03:
For example, reply brief page 12, it says it means what it says.

[00:30:18] Speaker 03:
Not removed means not removed.

[00:30:20] Speaker 05:
But what about the motion to eliminate?

[00:30:21] Speaker 05:
Where they are pointing out that Kaplan, Dr. Kaplan, is essentially performing a claim construction and then applying a claim construction in his testimony on infringement.

[00:30:32] Speaker 03:
Well, first of all, I don't think that the motion in Lumine says that.

[00:30:38] Speaker 03:
They tried to argue that it was inconsistent with the claim construction, because they had moved in Lumine to say, and their motion didn't have anything to do with bound or unbound.

[00:30:48] Speaker 03:
Their motion in Lumine said,

[00:30:49] Speaker 03:
Don't let them say that some kinds of plasticizer can come out and other kinds can't.

[00:30:54] Speaker 03:
And remember, their product, their solution E, has three different plasticizers in it.

[00:30:59] Speaker 03:
So that's the background against which this motion comes.

[00:31:03] Speaker 03:
And the court, in ruling on their motion in Lemony, said plaintiff, and this is A7609, plaintiff may offer testimony that the plasticizers removed do not come from the internal matrix.

[00:31:17] Speaker 03:
It did not have this, it did not interpret its claim construction the way they say it did, or certainly the way they interpreted it.

[00:31:25] Speaker 03:
This was always about, this isn't about different types of plasticizers.

[00:31:29] Speaker 03:
This was a dispute about where are these plasticizers coming from?

[00:31:33] Speaker 03:
They coming from the internal matrix, or are they?

[00:31:36] Speaker 01:
Yeah, but one of the, if you just step back a minute, one of the arguments that your friend makes is this is the classic, or somewhat like the O2 micro situation, where there was initially a broad claim construction.

[00:31:47] Speaker 01:
And then as we drill down, people figured out, well, wait a minute.

[00:31:51] Speaker 01:
That aspect of the claim construction doesn't really answer the true claim construction issue here.

[00:31:56] Speaker 01:
And so they pressed in their motion and limiting

[00:31:59] Speaker 01:
the suggestion let, no, no, no.

[00:32:01] Speaker 01:
OK, you said it broadly.

[00:32:03] Speaker 01:
We didn't differentiate between plasticizers.

[00:32:06] Speaker 01:
But now this expert testimony is going to do so.

[00:32:09] Speaker 01:
And that's not consistent with the claim construction we thought we got.

[00:32:12] Speaker 01:
Whether they're right or wrong is another matter.

[00:32:15] Speaker 01:
But the threshold question is whether or not this is a claim construction dispute.

[00:32:19] Speaker 03:
I don't think it is, Your Honor.

[00:32:21] Speaker 03:
And I hearken back to something that Mr. DeMera said.

[00:32:24] Speaker 03:
I think it may have been Judge Chen asked him, what should the instruction have said?

[00:32:29] Speaker 03:
And he said, and I may not get this exactly right, but he said, it should have said, no plasticizer can be removed, whether bound or unbound.

[00:32:39] Speaker 03:
You will search this record to eternity, and you are never going to find a proposal for an instruction anywhere near that.

[00:32:48] Speaker 03:
That was not what this case was about.

[00:32:51] Speaker 03:
What they kept asking the judge to do, the judge said, look, it's plain meaning.

[00:32:55] Speaker 03:
Not removed means no plasticizer is removed.

[00:32:59] Speaker 03:
They agreed with that.

[00:33:00] Speaker 03:
And they repeatedly told them, we're not asking you to change your construction.

[00:33:04] Speaker 03:
We just want you to clarify it.

[00:33:05] Speaker 03:
We want you to say, plain meaning means no plasticizer is removed.

[00:33:12] Speaker 03:
Judge Prost, I think, as you pointed out, how is that going to tell the jury anything about bound and unbound, which the experts have been arguing about and the attorneys have told the jury, this is a factual issue.

[00:33:24] Speaker 03:
Dr. Kaplan says that there are gaps.

[00:33:25] Speaker 03:
These gaps are in the tissue.

[00:33:27] Speaker 03:
They're not part of the internal matrix.

[00:33:29] Speaker 03:
Dr. Bad, like I said, there are no gaps.

[00:33:32] Speaker 03:
There are absolutely no gaps.

[00:33:33] Speaker 03:
I'm 100% confident that there are no gaps.

[00:33:36] Speaker 03:
And therefore, any plasticizer that comes out of this graph necessarily comes out of the internal matrix, because they are one in the same thing.

[00:33:45] Speaker 03:
That was a dispute presented to the jury.

[00:33:47] Speaker 01:
And even as late as the motion is back to the motion of limiting briefly,

[00:33:52] Speaker 01:
They made, it seems to me, they made that point.

[00:33:54] Speaker 01:
They said, wait a minute.

[00:33:55] Speaker 01:
We thought not removed meant not removed, everybody.

[00:33:58] Speaker 01:
But now we're drilling down and we're seeing that this expert is going to differentiate what not removed means, not removed including the non-loosely bound and including the loosely.

[00:34:11] Speaker 01:
Why is it they weren't drilling down on what the claim construction that they thought was fine until they saw the expert report and saw that he was going to differentiate between the plasticizers?

[00:34:22] Speaker 03:
Let's assume that that's what they were doing.

[00:34:24] Speaker 03:
I don't think the motion to eliminate says that.

[00:34:26] Speaker 03:
But let's assume that's what they were doing.

[00:34:28] Speaker 03:
Then what they should have done was gone to the court with the proposed instruction that Mr. DiMera said today is the instruction that they wanted, which is no plasticizer, whether bound or unbound, can be removed from these graphs.

[00:34:44] Speaker 03:
That's not what the claim language says.

[00:34:46] Speaker 03:
It's not what the experts testified about.

[00:34:48] Speaker 03:
And most importantly, it is not what they asked the district court

[00:34:51] Speaker 03:
It's not how they asked a district court to instruct the jury.

[00:34:54] Speaker 03:
This is an argument that is being made for the first time on appeal after everybody was perfectly happy.

[00:35:01] Speaker 03:
Well, certainly Licell was perfectly happy with plain meaning of this, which is not removed from the internal matrix.

[00:35:11] Speaker 05:
Well, they were making multiple objections real time during the trial while your expert was being examined, right?

[00:35:19] Speaker 03:
Well, they made one objection.

[00:35:21] Speaker 03:
And it essentially repeated their motion and limine argument.

[00:35:26] Speaker 03:
And interestingly, what they told the court is, hey, judge, you ruled on this on your motion and limine.

[00:35:30] Speaker 03:
And look, he's doing it.

[00:35:31] Speaker 03:
And the judge said, you're misinterpreting my order.

[00:35:34] Speaker 03:
That is not what my motion and limine said.

[00:35:36] Speaker 03:
And harkening back to that, plaintiff may offer testimony that the plasticizers removed do not come from the internal matrix.

[00:35:42] Speaker 03:
This was a pure dispute between experts, the way this case was tried.

[00:35:46] Speaker 03:
Pardon me.

[00:35:47] Speaker 03:
And there was nothing about the jury instructions that they requested that would have changed that.

[00:35:52] Speaker 03:
And I think it's important to point out that Dr. Kaplan expressly agreed with the construction that if any plasticizers come out of the internal matrix, then there's no infringement.

[00:36:06] Speaker 03:
So this was not a case like O2 micro or the recent decision in the Eon case where the experts were presenting conflicting

[00:36:15] Speaker 03:
claim constructions to the jury.

[00:36:17] Speaker 03:
The construction of the not-removed limitation was not in dispute both.

[00:36:21] Speaker 02:
Isn't that the problem that we have here?

[00:36:23] Speaker 02:
Just all the different arguments.

[00:36:25] Speaker 02:
And some of them, they're pretty fundamental, each one of these arguments.

[00:36:29] Speaker 02:
It seems to me that maybe we go back to the question, didn't the district court err in not construing not removed?

[00:36:37] Speaker 03:
Well, Your Honor, I think not.

[00:36:40] Speaker 03:
And here's why.

[00:36:41] Speaker 03:
The life cell argued.

[00:36:45] Speaker 03:
that plain meaning, not removed means not removed.

[00:36:48] Speaker 03:
Page 12 of the reply brief, they say it again.

[00:36:50] Speaker 03:
Not removed means not removed.

[00:36:52] Speaker 03:
The judge agreed with that and essentially said, these are plain English terms.

[00:36:57] Speaker 03:
Plasticizers are not removed from the internal matrix.

[00:37:01] Speaker 03:
No further construction needed.

[00:37:04] Speaker 03:
Basically, what they were asking them to do was sort of imp... And even they said so.

[00:37:09] Speaker 03:
We're not asking for a different construction.

[00:37:10] Speaker 03:
We want you to clarify it.

[00:37:12] Speaker 03:
So they were basically, they basically wanted him to.

[00:37:15] Speaker 02:
I see that maybe the parties were in agreement.

[00:37:20] Speaker 02:
I don't see anybody pushing for a construing not removed.

[00:37:26] Speaker 02:
But it seems to me that the whole case was headed to this perfect storm that we're now involved in.

[00:37:32] Speaker 02:
And the court should have seen that and said, I'm getting, now I'm receiving these different arguments with respect to which plasticizers.

[00:37:41] Speaker 02:
Or is it from the soft tissue graft or from the tissue matrix?

[00:37:45] Speaker 02:
And to what extent, bound, unbound?

[00:37:49] Speaker 02:
Wouldn't it have been better if the court had just construed the not-removed limitation?

[00:37:56] Speaker 03:
Well, Your Honor, I don't think so.

[00:37:59] Speaker 03:
First of all, I don't think that the case was moving toward a perfect storm.

[00:38:02] Speaker 03:
I think the case ended the way it started, which was the dispute was plasticizers come out of these grafts.

[00:38:10] Speaker 03:
We know that.

[00:38:11] Speaker 03:
From what part of the graphs did they come?

[00:38:13] Speaker 03:
That was the issue at trial.

[00:38:16] Speaker 03:
And everybody agreed that was the issue at trial.

[00:38:19] Speaker 03:
Now, could the judge have used different words?

[00:38:26] Speaker 03:
Maybe.

[00:38:26] Speaker 03:
But what he would have been doing was just, particularly if he accepted the only proposal that was put in front of him, he would have just been rearranging the words he was already using to say, OK, plasticizers are not removed means no plasticizers are removed.

[00:38:42] Speaker 03:
Maybe that would have been a clarification, maybe not.

[00:38:46] Speaker 03:
But it certainly would not have gone to the issue that Mr. Tamaris now says is the key issue, this bound and unbound stuff.

[00:38:54] Speaker 05:
And again, the- Let me restate Judge Raina's question.

[00:38:59] Speaker 05:
Because I think he's making a point, which is, does a district court have an obligation when it sees, as the trial is moving forward,

[00:39:09] Speaker 05:
that what the dispute is really about is more akin to a claim construction dispute than a fact question about infringement.

[00:39:19] Speaker 05:
Does a district court judge have an obligation under those circumstances to say, we need to do a claim construction on this very drilled down issue before moving forward?

[00:39:32] Speaker 03:
I'll start by briefly disputing the premise, which is I don't think this was at any point moving toward a claim.

[00:39:39] Speaker 03:
It's a hypothetical.

[00:39:40] Speaker 03:
I understand.

[00:39:40] Speaker 03:
OK, so I won't fight the hypothetical.

[00:39:42] Speaker 03:
I don't think that a district judge, Sue Esponte, has the obligation to do that.

[00:39:48] Speaker 03:
Trials are adversary proceedings.

[00:39:50] Speaker 03:
The parties have to present positions to the district court.

[00:39:52] Speaker 03:
Would it be error for a district court to do that?

[00:39:55] Speaker 03:
No, I don't think it would be error for a district court to do that.

[00:39:57] Speaker 03:
Nor Judge Raina do I think it would have been error for the district court

[00:40:01] Speaker 03:
to accept what their actual proposal was, plain meaning, no plasticizers are removed.

[00:40:08] Speaker 03:
But that's not the issue here.

[00:40:10] Speaker 03:
The issue is, was it reversible error for him not to do that?

[00:40:13] Speaker 03:
And I think given the way this case was tried, given the proposed instructions he was presented with, there's no way that this was error for him essentially to try the case that the parties wanted to try using the constructions that everybody agreed it was

[00:40:30] Speaker 03:
It was correct.

[00:40:31] Speaker 03:
It was just a question of should he say more to clarify it?

[00:40:34] Speaker 03:
He decided not to.

[00:40:35] Speaker 03:
And that is not error on this record.

[00:40:39] Speaker 01:
Can I take you to another smaller issue that your friend did not raise, but it's raised elsewhere, which is there seems to have been arguably a burden shifting thing going on here.

[00:40:49] Speaker 01:
I mean, your witness didn't do any tests himself, Dr. Kaplan.

[00:40:54] Speaker 01:
They complained about that.

[00:40:55] Speaker 01:
And even in the closing argument,

[00:40:58] Speaker 01:
you know, your side says this is the internal matrix, and they would have to prove to show not infringement that the plasticizer is removed from this internal matrix.

[00:41:07] Speaker 03:
Is that really right?

[00:41:08] Speaker 03:
It burns on you.

[00:41:10] Speaker 03:
Oh, absolutely.

[00:41:10] Speaker 03:
The burns on us.

[00:41:12] Speaker 03:
And I think it's important to note, Dr. Kaplan didn't do any testing of his own because there was a wealth of test information from life cells.

[00:41:22] Speaker 03:
put into the record that he relied on.

[00:41:24] Speaker 03:
And actually, they crossed him on this, as you would expect.

[00:41:27] Speaker 03:
You didn't do any testing of your own, did you?

[00:41:29] Speaker 03:
He said, no, I didn't need to, because you did.

[00:41:31] Speaker 03:
And looking at your tests, I can see that plasticizer remains in there.

[00:41:36] Speaker 03:
The structural qualities of the graft have not changed.

[00:41:39] Speaker 03:
And because of the nature of the binding reactions that take place between the plasticizer and the matrix components, I can tell you that plasticizer does not come out of your internal matrix.

[00:41:52] Speaker 03:
So there was plenty of evidence here, whether he did his own tests or not.

[00:41:55] Speaker 03:
There was plenty of evidence here on which the jury could conclude that plasticizer does not come up.

[00:42:00] Speaker 03:
And the reason for the closing argument, Your Honor, is because, as I said at the outset, there was no dispute that they have plasticized soft tissue grafts with plasticizer in the internal matrix.

[00:42:11] Speaker 03:
The issue was their defense, which is we have instructions for use that have to be followed.

[00:42:20] Speaker 03:
If you follow those instructions for use, plasticizer comes out.

[00:42:23] Speaker 03:
So that's the context in which this closing argument was made.

[00:42:27] Speaker 03:
It was because their whole argument was, OK, fine.

[00:42:31] Speaker 03:
We have these plasticized soft tissue graphs.

[00:42:33] Speaker 03:
But our instructions require, essentially, that plasticizer come out of the internal matrix.

[00:42:40] Speaker 03:
And that didn't happen.

[00:42:41] Speaker 03:
And they weren't able to prove that.

[00:42:43] Speaker 03:
So that's the context.

[00:42:44] Speaker 03:
I don't think there was any burden shifting here, Your Honor.

[00:42:47] Speaker 03:
It was really just a matter of what the evidence showed and the positions the parties took.

[00:42:53] Speaker 03:
And if I could just, I see I still have a couple of minutes left.

[00:42:57] Speaker 03:
Just to get back to the point that Mr. Damaris started on.

[00:43:02] Speaker 03:
And Judge Chet, I think you commented that this is sort of an unusual limitation, this not removed limitation.

[00:43:10] Speaker 03:
And I agreed with that.

[00:43:14] Speaker 03:
And I think I explained where it came from in terms of the prosecution history.

[00:43:19] Speaker 03:
But what's unusual about the limitation, I think, is that it states expressly what's actually implicit in any claim that claims a device designed for a particular use.

[00:43:31] Speaker 03:
Every claim that defines a product for a particular application implicitly says, here's this device, and don't change it before you use it, because it's designed for this particular application.

[00:43:43] Speaker 03:
I mean, think about a claim to a wooden structure suitable for sitting upon, consisting of a seat and four legs of equal length.

[00:43:52] Speaker 03:
If you added a limitation wherein no leg is sawed off before sitting upon it, that doesn't change the fundamental structural nature of the product.

[00:44:04] Speaker 03:
But you can imagine that if the claim was rejected over a three-legged stool in prosecution, you can see where such a limitation might have come from.

[00:44:12] Speaker 03:
doesn't change the fact that it's a structural limitation.

[00:44:15] Speaker 03:
It doesn't mean that you have to actually sit on the chair to infringe the claim to it, which is essentially Life Cell's argument that if you don't actually transplant these things, you haven't infringed a claim.

[00:44:28] Speaker 03:
The claims are to a graph suitable for transplantation, having a particular structure.

[00:44:36] Speaker 03:
Those are the graphs they made, and those graphs infringe.

[00:44:39] Speaker 03:
The court has no further questions.

[00:44:41] Speaker 03:
Thank you and thank you for the additional time.

[00:44:48] Speaker 07:
Thank you.

[00:44:49] Speaker 07:
A few points.

[00:44:50] Speaker 07:
I think it has to be recognized at bottom there is no factual dispute.

[00:44:58] Speaker 07:
Both sides agree the plasticizer removed by the surgeons in the operating room comes from the gaps in the voids.

[00:45:05] Speaker 07:
This isn't a trial about how do the products work.

[00:45:07] Speaker 07:
It's not a trial about

[00:45:09] Speaker 07:
Do they come from the internal matrix?

[00:45:11] Speaker 07:
They come from the gaps and the voids in the internal matrix.

[00:45:14] Speaker 07:
Everybody agrees to that.

[00:45:15] Speaker 07:
The question is, legally, does the claim cover that or not?

[00:45:19] Speaker 07:
And if we have to look at what the claim means.

[00:45:22] Speaker 07:
And it's not correct, as counsel said, that this wasn't teed up for the district court.

[00:45:27] Speaker 07:
And by the way, it wasn't just teed up once.

[00:45:29] Speaker 07:
It was brought up multiple times.

[00:45:30] Speaker 07:
We referred to two of them on my opening comments.

[00:45:33] Speaker 07:
There was a written motion in Lumine.

[00:45:35] Speaker 07:
which was clear as can be about bound versus unbound gaps and voids and bulk versus non-bulk.

[00:45:42] Speaker 07:
It was brought up an objection I showed you in Dr. Kaplan's testimony.

[00:45:46] Speaker 07:
We went up to the sidebar.

[00:45:48] Speaker 07:
We explained, hey, this dispute is going on.

[00:45:50] Speaker 07:
This is not what the claim means.

[00:45:53] Speaker 07:
It was brought up again.

[00:45:54] Speaker 07:
We rejected more than one's turn, Dr. Kaplan's.

[00:45:57] Speaker 07:
We objected also at A8271.

[00:46:01] Speaker 07:
So twice during Dr. Kaplan's testimony, then at the end of LifeNet's proof, we wrote a written 50A motion where we briefed again this bound-on-bound issue, and that's at A7671.

[00:46:15] Speaker 07:
Then at the conclusion of the trial, we submitted a trial brief.

[00:46:19] Speaker 07:
So this was not brought up once to the district court.

[00:46:23] Speaker 07:
It was brought up once in the motion to eliminate crystal clear.

[00:46:27] Speaker 07:
brought up twice during Dr. Kaplan's testimony, crystal clear on this issue, and briefed in a Rule 50 motion at the close of life cells evidence.

[00:46:36] Speaker 07:
The judge had every opportunity to say what this claim meant legally.

[00:46:41] Speaker 07:
And if we look at the claim, the claim construction, it can't mean what Life Net wants it to mean.

[00:46:48] Speaker 07:
The claim language doesn't say bound or unbound.

[00:46:53] Speaker 07:
It says removal.

[00:46:54] Speaker 07:
No plasticizer shall be removed from the internal matrix.

[00:46:58] Speaker 07:
And if we look at the specification, it's very clear that the applicants knew how to say bound or tightly bound or loosely bound.

[00:47:05] Speaker 07:
Those are words in the specification.

[00:47:07] Speaker 07:
They don't put those words in the claim.

[00:47:09] Speaker 07:
They say no plasticizer shall be removed.

[00:47:12] Speaker 07:
They don't say no removal of the bound plasticizer.

[00:47:16] Speaker 07:
And those are the terms they use in the specification.

[00:47:18] Speaker 02:
If you look at the specifications... Isn't that somewhat inherent in the device that we're looking at?

[00:47:23] Speaker 02:
Because you can't remove the bound plasticizers.

[00:47:28] Speaker 07:
Right.

[00:47:29] Speaker 07:
That's the whole point.

[00:47:30] Speaker 07:
The way they're reading limitation makes zero sense.

[00:47:33] Speaker 07:
If you read that specification, it talks all throughout the specification.

[00:47:37] Speaker 07:
How do you remove the plasticizers?

[00:47:40] Speaker 07:
Do you have to remove the plasticizers?

[00:47:41] Speaker 07:
You can do a direct implantation where you don't remove them.

[00:47:45] Speaker 07:
lightly rinse it where you remove the plasticizers on the exterior.

[00:47:48] Speaker 07:
You can do a more thorough washing where you remove almost all of the plasticizers.

[00:47:52] Speaker 07:
That's what the specification is talking about.

[00:47:55] Speaker 07:
When the specification talks about removal of plasticizers, it's talking about removing them.

[00:48:00] Speaker 07:
It's not talking about the ones that can't be removed.

[00:48:03] Speaker 06:
It never says that.

[00:48:03] Speaker 06:
I'm sorry.

[00:48:04] Speaker 06:
You cited a 7671 of your 50A motion as objecting to the claim construction.

[00:48:14] Speaker 06:
7671.

[00:48:16] Speaker 07:
Right.

[00:48:16] Speaker 06:
Or somehow insisting that the claim construction need to be repaired.

[00:48:21] Speaker 07:
I mean, no, it refers to the bound, unbound issue is what I was saying.

[00:48:25] Speaker 04:
I'm sorry.

[00:48:28] Speaker 05:
You were on the fly.

[00:48:29] Speaker 05:
You were building a lot of momentum.

[00:48:31] Speaker 04:
Can you tell me where on 876-71?

[00:48:34] Speaker 04:
Let me find it.

[00:48:43] Speaker 07:
So I'm sorry.

[00:48:44] Speaker 07:
It's 7672.

[00:48:45] Speaker 07:
Thank you, Your Honor.

[00:48:46] Speaker 07:
If you look at the top of 7672,

[00:48:49] Speaker 07:
Because, second paragraph, first whole paragraph, because Dr. Kaplan's opinion regarding the removal of non-bound plasticizers contradicted the court's client construction, violated the court's preliminary order, and could not in any event be accepted by any reasonable juror, there is no substantial evidence that defendants accused products infringement.

[00:49:07] Speaker 07:
So that's where it was on the second page, sorry about that.

[00:49:09] Speaker 05:
How did it violate the judge's preliminary order?

[00:49:14] Speaker 07:
The way the judge ordered the inlimity in response to the motion that I said, he said, you can't say that some types of plasticizers can be removed and some type of plasticizers can't.

[00:49:26] Speaker 05:
I thought he said it's OK to testify that there's removal of some plasticizers long as there isn't any plasticizers being removed from the internal matrix of the tissue graph.

[00:49:37] Speaker 07:
Exactly.

[00:49:37] Speaker 07:
It was a confusing order.

[00:49:39] Speaker 07:
So we were explaining there that

[00:49:42] Speaker 07:
when the judge said, you can't testify that some can be removed and some can't, that was this bound, unbound issue.

[00:49:48] Speaker 07:
So that's what we were trying to bring to the court's attention.

[00:49:52] Speaker 07:
But to go back to what they're saying, the term means.

[00:49:55] Speaker 07:
It can't mean what they say.

[00:49:56] Speaker 07:
This application, all through the application, the specification, talks about removing the plasticizers by rinse.

[00:50:03] Speaker 07:
It's never talking about not removing the ones that can't be removed.

[00:50:08] Speaker 05:
So it's sort of a made-up understanding.

[00:50:11] Speaker 05:
Maybe column 11 about tightly associating plasticizer to the molecular structure of the graph, right?

[00:50:17] Speaker 07:
That would be the internal matrix.

[00:50:19] Speaker 07:
Yes, your honor.

[00:50:20] Speaker 07:
I was talking about the removal language.

[00:50:21] Speaker 07:
Everywhere the specification talks about removing plasticizers, it's talking about how you do it through a rinse.

[00:50:26] Speaker 07:
But then more fundamentally, the application was rejected over caviaro.

[00:50:31] Speaker 07:
Caviaro isn't just a single strand.

[00:50:33] Speaker 07:
Caviaro also talks about bunches of collagen fibers.

[00:50:37] Speaker 07:
And the patent office said the original claims couldn't be patentable over Caviaro, which was the original claims allowed removal or not removal, allowed both.

[00:50:47] Speaker 07:
The applicant didn't fight the rejection, but amended the claims to say no removal.

[00:50:53] Speaker 07:
And the only way that makes sense is if it's talking about the plasticizers that can be removed, because otherwise it wouldn't distinguish Caviaro.

[00:51:01] Speaker 07:
So you can't read this patent and come away

[00:51:04] Speaker 07:
with the understanding of the limitation that they have because there's no support for it in this spec.

[00:51:08] Speaker 07:
And lastly, on the direct infringement issue, you cannot read that limitation with the words no removal prior to transplantation and change those words to in the package or prior to packaging.

[00:51:22] Speaker 07:
And the district court found that.

[00:51:23] Speaker 07:
It means prior to transplantation, which happens in the operating room, by the surgeon, and there can't be any direct infringement here.

[00:51:31] Speaker 00:
Thank you.

[00:51:32] Speaker 00:
Thank you.