[00:00:00] Speaker 02:
The next case is 24-1062, a biomed versus maquette cardiovascular.

[00:00:07] Speaker 02:
Words I'm probably massacring on both sides.

[00:00:11] Speaker 02:
Mr. Bradley, whenever you're ready.

[00:00:14] Speaker 04:
May it please the court.

[00:00:16] Speaker 04:
The district court erred in its construction of three claim terms.

[00:00:20] Speaker 04:
For the first two terms, the court relied on statements made by McKay during the IPR process.

[00:00:27] Speaker 04:
The court found that there was, quote, clear and unmistakable.

[00:00:29] Speaker 02:
Can I ask you about these two?

[00:00:31] Speaker 02:
Do you have to prevail on both of these to send it back?

[00:00:35] Speaker 02:
In other words, if we find that the district court here had claimed instructional one but not on the other, is there still no infringement?

[00:00:44] Speaker 04:
So there's a little break.

[00:00:46] Speaker 02:
No, I'm setting aside the means plus function.

[00:00:48] Speaker 02:
I get that.

[00:00:49] Speaker 02:
OK.

[00:00:49] Speaker 02:
We've got a purge fluid claim.

[00:00:52] Speaker 02:
in a elongate luma and associated with the cannula.

[00:00:59] Speaker 02:
What happens if we split our decision on that?

[00:01:02] Speaker 02:
Does it go back, or do they still not in French?

[00:01:05] Speaker 04:
It does go back, because they affect different claims.

[00:01:08] Speaker 04:
And the blue brief outlines.

[00:01:11] Speaker 04:
Are they not in all the different claims?

[00:01:13] Speaker 04:
That is correct.

[00:01:15] Speaker 04:
Both terms are not in all the claims.

[00:01:18] Speaker ?:
OK.

[00:01:19] Speaker 03:
Just to be clear, if you prevail on any of your three arguments, at least some claims go back.

[00:01:24] Speaker 03:
That is correct, Your Honor.

[00:01:27] Speaker 04:
And I do want to start with the elongate woman associated with the cannula term.

[00:01:33] Speaker 04:
For this term, the term itself just says that the woman is associated with the cannula.

[00:01:40] Speaker 04:
But relying on IPR statements made by McKay, the district court

[00:01:44] Speaker 04:
found a clear and unmistakable disclaimer and narrowed it to not just lumens associated with a cannula, but lumens formed along the side of a cannula.

[00:01:55] Speaker 04:
And that was wrong.

[00:01:56] Speaker 04:
The court should not have done that.

[00:01:58] Speaker 04:
In the red brief, ABUMED relies primarily on the specification.

[00:02:02] Speaker 04:
That was not the basis for the district court's ruling.

[00:02:05] Speaker 04:
The district court ruled that the portions of the specification relied on by ABUMED are

[00:02:12] Speaker 04:
He said, they're preferred embodiments and do not explicitly define.

[00:02:16] Speaker 03:
We can affirm based on the specification, even though the district court wasn't persuaded by the specification, correct?

[00:02:23] Speaker 04:
Correct.

[00:02:24] Speaker 04:
This is de novo overview.

[00:02:25] Speaker 04:
I just wanted to point out that the district court did analyze this issue and found that the portions of the specification referred to by Aviamed are preferred embodiments and do not define the invention as a whole.

[00:02:37] Speaker 04:
That part was very correct.

[00:02:40] Speaker 04:
doesn't affect this claim scope.

[00:02:41] Speaker 03:
A portion of the district court construction of the Longgate-Lumen term is this permanence requirement.

[00:02:49] Speaker 03:
You don't dispute that on appeal.

[00:02:51] Speaker 03:
I think the way the judge reached that portion of his construction was also prosecution history disclaimer.

[00:02:59] Speaker 03:
Do you take the position that he got that right or he got that wrong too?

[00:03:06] Speaker 04:
We take the position that we were trying to narrow the issues for presentation on appeal.

[00:03:10] Speaker 04:
We do have issues with it, but at the end of the day, for this case,

[00:03:15] Speaker 04:
Theirs is permanent.

[00:03:16] Speaker 04:
It doesn't matter.

[00:03:17] Speaker 04:
And so the school is precedent saying that we resolve plain construction insofar as it matters for the case.

[00:03:23] Speaker 04:
And under that idea and the notion of trying to limit the number of terms for appellate consideration, we have not appealed that part.

[00:03:30] Speaker 04:
But the other part, the part where he narrowed associated with to mean formed along the side of the cannula, that part was an error.

[00:03:39] Speaker 04:
There was no disclaimer during the IPR process

[00:03:43] Speaker 04:
we were describing and refuting Abiumed's presentation of the prior art.

[00:03:48] Speaker 04:
And they relied on two references, one called Abelhausen, where there were side lumens in the cannula.

[00:03:56] Speaker 04:
They combined that with one called Jegeden that had a different place for the guide wire.

[00:04:02] Speaker 04:
Instead of it being in the side lumens for the cannula, it was in a separate device, a guide catheter.

[00:04:08] Speaker 04:
And we told the board during the IPR process that Yegiden provides a separate device.

[00:04:15] Speaker 04:
And so a skilled artisan would not combine these two together because Yegiden does this in a different way.

[00:04:22] Speaker 04:
And so there was no disclaimer.

[00:04:25] Speaker 04:
We said the part that the district relied on is where we said that Yegaden teaches away from Abiumed's proposed modification, because Yegaden teaches using a separate catheter instead of modifying the... How would one have skilled the art of reading that prosecution history

[00:04:42] Speaker 03:
understand that you didn't mean to even imply anything about your own claims.

[00:04:48] Speaker 03:
That you were only criticizing their prior art.

[00:04:51] Speaker 04:
Because the context of discussion in our Patent Owner Preliminary Response was very clear that we were saying all along that their combination of Abelhausen and Jägeden was incorrect.

[00:05:02] Speaker 04:
A person of skill in the art would not combine them.

[00:05:05] Speaker 04:
They teach different solutions to the same problem.

[00:05:08] Speaker 04:
And just because one of the prior art references talked about a guide wire and a side lumen, so when we refuted it, we talked about how you would not use that side lumen in this other reference, we weren't suddenly saying that the claims are now limited to side lumen embodiments.

[00:05:26] Speaker 04:
We were refuting the embodiment that they presented and saying why you wouldn't do it that way.

[00:05:32] Speaker 04:
And that was all there was to it.

[00:05:34] Speaker 04:
There was no clear and unmistakable disclaimer.

[00:05:37] Speaker 04:
A clear and unmistakable disclaimer is when you have a claim that says a blue widget, and they bring forth prior art that's a navy blue.

[00:05:46] Speaker 04:
And we say, no, no, we meant primary color blue.

[00:05:49] Speaker 03:
How about with respect to purge fluid, where you say, hey, it's a bad idea to do what this other prior art does.

[00:05:57] Speaker 03:
Doesn't that imply you're not doing that either?

[00:05:59] Speaker 04:
I understand the question.

[00:06:01] Speaker 04:
In the purge fluid context, they

[00:06:04] Speaker 04:
The answer is no.

[00:06:05] Speaker 04:
It does not imply that, but that's also not quite what happened.

[00:06:08] Speaker 04:
When we said it's a bad idea, the thing that's a bad idea is putting metal-bearing particles in the bloodstream.

[00:06:16] Speaker 04:
Of course, that's a bad idea.

[00:06:17] Speaker 04:
The key thing is, how did you get there?

[00:06:20] Speaker 04:
They relied on this reference called Abelhausen, same one.

[00:06:24] Speaker 04:
And the claim term requires a lumen that delivers purge fluid into the pump.

[00:06:29] Speaker 04:
Abelhausen doesn't have a lumen.

[00:06:31] Speaker 04:
So they needed to come up with some creative solution

[00:06:33] Speaker 04:
And they found in figure 10, they said, well, we think we see a gap here between the rotor shaft and the bearings that go around it.

[00:06:41] Speaker 04:
We see a gap.

[00:06:42] Speaker 04:
And we'll say that's the loom.

[00:06:43] Speaker 04:
And you can run purge fluid through that.

[00:06:46] Speaker 04:
And as a result of that, we told the patent office, we said, they're nuts.

[00:06:50] Speaker 04:
There is no gap in Abelhausen.

[00:06:53] Speaker 04:
It wouldn't even work.

[00:06:54] Speaker 04:
If you have a gap between the rotor shaft and the bearings, it would be

[00:06:59] Speaker 04:
like attempting to rotate something with greased hands, it would not work.

[00:07:02] Speaker 04:
We made all these arguments, and we also explained that having their gap theory would, we said Avumet's gap theory would require purge fluid to run directly between these bearings, meaning the gap bearings between the rotor shaft and the bearings.

[00:07:19] Speaker 00:
So let's say, I'm going to go back to the elongate lumen.

[00:07:23] Speaker 00:
OK.

[00:07:25] Speaker 00:
Let's say that we agree with you.

[00:07:27] Speaker 00:
that this is not a clear and unmistakable disclaimer or something to that effect.

[00:07:34] Speaker 00:
What do you contend would be the right construction?

[00:07:37] Speaker 04:
The right construction of that one is a plain and ordinary meaning, which is what we submitted to the district court.

[00:07:42] Speaker 04:
Persons of skill in the art, in this context, reading the full intrinsic record, including the IPR,

[00:07:47] Speaker 04:
would know, and the experts could talk about, respectively, what is and is not an elongate lumen associated with the cannula.

[00:07:55] Speaker 00:
Did you ever say what you thought that plain and ordinary meaning would be?

[00:07:59] Speaker 00:
And if you did, where did you say that in the record?

[00:08:01] Speaker 04:
We did not get that far in having to describe.

[00:08:04] Speaker 04:
And this judge does not particularly require parties to go further and say, if it is plain and ordinary meaning, what is that plain and ordinary meaning?

[00:08:12] Speaker 04:
Certainly, the specification gives many examples of lumens associated with the cannula.

[00:08:18] Speaker 04:
Part of our main point is there are many ways to have a lumen associated with the cannula that is not just the side lumen embodiment.

[00:08:26] Speaker 04:
And so the court's construction was wrong by narrowing it that way.

[00:08:30] Speaker 00:
And then you also relied on just plain ordinary meaning for the purge fluid term.

[00:08:35] Speaker 04:
That's correct.

[00:08:36] Speaker 00:
And didn't also provide any explanation of what you thought that plain ordinary meaning would be.

[00:08:40] Speaker 02:
That's true.

[00:08:40] Speaker 02:
Yes.

[00:08:41] Speaker 02:
What do you think it is for the purge fluid?

[00:08:43] Speaker 04:
The construction, it requires a woman, an actual woman.

[00:08:47] Speaker 04:
A woman is essentially like if you think of a drinking straw, there's space inside.

[00:08:51] Speaker 04:
So there needs to be some cavity and a structure, not just a gap in the middle of nowhere.

[00:08:56] Speaker 04:
A cavity with a structure, a lumen, persons of skill in the art know what a lumen is, and the lumen needs to be able to deliver purge fluid to the intravascular blood pump.

[00:09:05] Speaker 04:
These are plain and ordinary terms to persons of skill in the art.

[00:09:09] Speaker 02:
Does that construction allow purge fluid to go through the ball bearings in your invention?

[00:09:14] Speaker 04:
It does.

[00:09:15] Speaker 02:
And what's the point of saying it would be bad for purge fluid to go through the ball bearings in the

[00:09:19] Speaker 04:
Prior we were discussing because it was not going through just the ball bearings It was going through a gap between the ball bearings in the shaft Which doesn't work because if you have a shaft and the ball bearings and the prior are they're attached They said they're not attached.

[00:09:37] Speaker 02:
There's a gap between them and if you they would run purge fluid through there but the problem I have is that Why would

[00:09:49] Speaker 02:
you necessarily not get harmful materials in the blood stream from that device, the prior art device, but not yours when you're running it through the bearings.

[00:10:00] Speaker 04:
Because we explained in the IPR, and then I'll elaborate, we said that when the pump operates, under their theory, this GAPT theory, when the pump operates, the bearings wear, releasing solid particles.

[00:10:13] Speaker 00:
What page are you on reading from?

[00:10:14] Speaker 04:
That is from APPX 1230, which is the IPR statement we made.

[00:10:19] Speaker 04:
And then the district court quoted that in APPX 61.

[00:10:22] Speaker 04:
Actually, the district court quoted a paraphrase of it.

[00:10:27] Speaker 04:
The difference, Judge Hughes, is that in the gaps theory, when purge fluid is running between the shaft and the bearings, the shaft and the bearings are playing bumper cars.

[00:10:38] Speaker 04:
because there's a gap there running fluid, and so they're hitting against each other.

[00:10:42] Speaker 04:
That could slough off bearing particles.

[00:10:45] Speaker 04:
When you're normally running purge fluid through bearings, they're just going through the bearings that are sealed, and it goes through, and then there's a seal at the end so it doesn't go into the bloodstream.

[00:10:56] Speaker 04:
The difference is, in Abelhausen, they concocted this gap theory that didn't exist, and running

[00:11:05] Speaker 04:
fluid through a gap.

[00:11:07] Speaker 02:
They're allowed to create theories about prior art.

[00:11:11] Speaker 02:
It may be wrong, but they're allowed to do it.

[00:11:13] Speaker 02:
If we agree with you that it shouldn't have been narrowed to not going through the ball bearings, is there

[00:11:22] Speaker 02:
Involuntary are I mean the problem is they made this argument in an IPR and you rejected it because They were they were rejected and one of the reasons you gave was the blood should go through the ball bearings But but now you're saying the blood can go through the ball bearings.

[00:11:38] Speaker 02:
That's a problem that Understand your question.

[00:11:42] Speaker 02:
The the difference is I mean, I don't understand why I

[00:11:46] Speaker 02:
if the board accepted your reasoning on Abelhazen, or however you say it.

[00:11:54] Speaker 02:
But now you're switching your, I know you're not going to say you're switching your theory, but just go with me.

[00:11:58] Speaker 02:
I'm asking a hypothetical.

[00:11:59] Speaker 02:
I'm not going to hold you to it.

[00:12:01] Speaker 02:
Why that art wouldn't be invalidating if, in your patent, it's allowed to go through the bloodstream, or into the bloodstream.

[00:12:10] Speaker 04:
So in their theory on Abelhazen, the purge fluid was going

[00:12:15] Speaker 02:
Actually, let me ask you this question.

[00:12:18] Speaker 02:
If we take out all the statements in the IPR about it's bad for this to go through the ball bearings because it would get particles in the blood, do you think that your other arguments are insufficient to distinguish your invention from the combination of the blue board?

[00:12:40] Speaker 02:
I don't think you should be allowed to rely on this bad particles in the bloodstream argument.

[00:12:51] Speaker 02:
at the board, but not here.

[00:12:53] Speaker 02:
And so if we disregard that, is Abelhausen invalidating or not?

[00:12:58] Speaker 04:
It's not.

[00:13:00] Speaker 04:
And there's no inconsistent positions between what we're saying and what we say to the board.

[00:13:04] Speaker 02:
How do we know that?

[00:13:05] Speaker 02:
Did the board say why it wasn't instituting on that ground?

[00:13:07] Speaker 04:
It wasn't because of any of these arguments.

[00:13:10] Speaker 04:
And the difference is, and I'll try to be clear about it, in the specification, it talks about purged food going through the bearings.

[00:13:18] Speaker 04:
and it is actually going through the bearings and that is because that's how it works and that's how their to use product does it that's all we do.

[00:13:25] Speaker 02:
Can I just let me see if I can get my layman non-science view is it is your view that your invention when it goes through the bearings it's just a different structure in a different way of it going through the bearings and you're trying to distinguish that structure from

[00:13:41] Speaker 02:
from Abelhausen at the board.

[00:13:43] Speaker 02:
And so it's not that it's bad overall for it to go through the bearings.

[00:13:48] Speaker 02:
It's bad for it to go through the bearings in the Abelhausen structure.

[00:13:51] Speaker 04:
That much is true.

[00:13:52] Speaker 04:
It is bad to go through the structure of Abelhausen where the bearings first.

[00:13:56] Speaker 02:
What support is there for that notion?

[00:13:59] Speaker 04:
It's because in Abelhausen, and as we explained in the IPR, the bearings are separated from the shaft by their gap that they said exists.

[00:14:08] Speaker 04:
And when you run purge fluid through the gap, which is a totally different thing than what the specification describes, than what their accused product, and as we explained to the board, it doesn't work.

[00:14:20] Speaker 04:
I've got a few questions, if you don't mind.

[00:14:23] Speaker 03:
In your specification, does the purge fluid

[00:14:28] Speaker 03:
When it goes past the bearings, does it go into the bloodstream or does it not go into the bloodstream?

[00:14:32] Speaker 04:
It goes through the bearings and into the bloodstream.

[00:14:35] Speaker 04:
But not through a gap between the bearings and the rotor shaft, which is what their theory was, and it makes no sense.

[00:14:41] Speaker 03:
On the means plus function term, they cite in the red brief of 52, this Dybald case, that they're not required to introduce extrinsic evidence that one of ordinary skill and the art would fail to understand that the term connotes definite structure.

[00:14:59] Speaker 03:
I didn't see you respond.

[00:15:00] Speaker 03:
to that argument.

[00:15:03] Speaker 03:
Does somebody have to give us evidence as to whether one of skill in the art would know what this structure is?

[00:15:08] Speaker 04:
We cited the Diphon case.

[00:15:12] Speaker 04:
The term is guide mechanism, which is not in means plus function format, as the district court found that it is.

[00:15:19] Speaker 04:
It doesn't use the word means.

[00:15:21] Speaker 04:
So there's a rebuttable presumption that it's not in means plus function format.

[00:15:25] Speaker 04:
Under Diphon, this court said that the presumption can be overcome

[00:15:29] Speaker 04:
If a challenger, Abumed, demonstrates that the term fails to recite sufficient structure, we did not bear that burden.

[00:15:36] Speaker 03:
Even though we didn't bear it, we demonstrated how the specification- Right, but how do you square that with Dybalt where we said extrinsic evidence is not required by the challenger?

[00:15:45] Speaker 04:
They could present intrinsic evidence that exists.

[00:15:47] Speaker 04:
Extrinsic evidence is not strictly required.

[00:15:50] Speaker 04:
The point is, it's their burden.

[00:15:51] Speaker 04:
They need some evidence.

[00:15:52] Speaker 04:
They need some evidence to overcome the presumption that, because as soon as it doesn't have the word means, we are in the lead.

[00:15:59] Speaker 04:
And this term is structural to our personal skill in the art.

[00:16:03] Speaker 04:
I'd like to reserve as much time as I have.

[00:16:05] Speaker 04:
Thank you, Your Honor.

[00:16:06] Speaker 02:
You have none, but we'll restore all three minutes of your remodel.

[00:16:13] Speaker 01:
May it please the court.

[00:16:15] Speaker 01:
Let me just start with the first question, Judge, as you asked.

[00:16:19] Speaker 01:
I actually tallied up what would happen if you ruled in our favor on purge fluid, and there's no claims left of the five, not excluding.

[00:16:26] Speaker 02:
Yeah.

[00:16:28] Speaker 02:
Mr. Bradley, can you take a look at it?

[00:16:29] Speaker 02:
I looked at it, too.

[00:16:30] Speaker 02:
If he wins on purge fluid, do you agree?

[00:16:34] Speaker 04:
OK.

[00:16:35] Speaker 04:
Yes, just so I can be on the line.

[00:16:36] Speaker 02:
Yeah, can he?

[00:16:36] Speaker 04:
My colleague just corrected me that if we

[00:16:40] Speaker 04:
do not win on the purge fluid, the elongate women term doesn't really be decided.

[00:16:45] Speaker 04:
The reverse is not true.

[00:16:46] Speaker 01:
OK.

[00:16:48] Speaker 01:
Thank you.

[00:16:50] Speaker 01:
I was concerned, so I checked again.

[00:16:54] Speaker 01:
To start with the elongate women claim, it's really important to look at the actual language.

[00:17:01] Speaker 01:
Can we start with the purge fluid claim?

[00:17:02] Speaker 01:
Start with the purge fluid, sure.

[00:17:04] Speaker 01:
No problem.

[00:17:04] Speaker 02:
with approach to it this is really it's it's a disparagement of all system here's my issue and i think you've heard what asked is ike it's it's very hard for me to understand because it's kind of scant discussion whether what their disclaimer is is it's bad for the purge fluid to go through the specific structure it out the hospital in the way you said it would work versus it's bad in

[00:17:35] Speaker 01:
General for the perch fluid to go through the ball the former I think is not a disclaimer that the latter is yeah the way that they argued in their popper they had three separate arguments one was It doesn't work that way number two was There is no gap right which you can debate you can look at it either way.

[00:18:01] Speaker 01:
I mean it's

[00:18:02] Speaker 01:
You have to remember, these magnets are around the drive shaft, and there easily can be a groove through which liquid can go, and that's probably how it works.

[00:18:11] Speaker 01:
But that doesn't matter, because when they got to the third part, where they could have stopped, they could have just stopped and said, Abelhausen doesn't teach this.

[00:18:20] Speaker 01:
The combination doesn't teach this.

[00:18:21] Speaker 01:
We're done.

[00:18:23] Speaker 01:
But as the district court found, they continued.

[00:18:25] Speaker 01:
And what they say is really important, they say in addition,

[00:18:29] Speaker 01:
Figure 10 shows bearings that engage with the rotor shaft.

[00:18:35] Speaker 01:
In addition, figure 10 shows bearings engaged with the rotor shaft.

[00:18:41] Speaker 01:
So the gap theory would have to have the purge fluid go through.

[00:18:46] Speaker 01:
But then they make a broad statement.

[00:18:49] Speaker 01:
running purds through it through these bearings.

[00:18:51] Speaker 01:
And these are generic bearings, as we have in our brief.

[00:18:56] Speaker 01:
It shows that there's no difference between the bearings as they're depicted in Abelhausen and the bearings as they're depicted in the patents that are issued here.

[00:19:04] Speaker 01:
So it's through these bearings.

[00:19:05] Speaker 01:
You could say the bearings.

[00:19:06] Speaker 01:
You could say bearings.

[00:19:07] Speaker 01:
It's bearings.

[00:19:08] Speaker 01:
This is how these things operate.

[00:19:10] Speaker 01:
But you run fluid through the bearings and into the bloodstream.

[00:19:13] Speaker 01:
provides a mechanism to directly inject foreign bearing particles into the circulatory system.

[00:19:19] Speaker 01:
And then they say even more, e.g., when the pump operates, the bearings wear, it's going to happen for every pump, releasing solid particles.

[00:19:28] Speaker 01:
Opposito would recognize that in here, this is again not limited to a gap three, Opposito would recognize that injecting floating particles from bearings into a patient's bloodstream is a bad idea, generically.

[00:19:41] Speaker 01:
And so there you go.

[00:19:43] Speaker 01:
In short, the design would not be compatible with a purge fluid line.

[00:19:46] Speaker 01:
But the important point here is that they're saying generically, you cannot run blood through purge fluid, through bearings, and into the bloodstream.

[00:19:56] Speaker 01:
And in fact, that's the limit of the disclaimer here.

[00:20:00] Speaker 01:
It's possible for them to construct, under their claims, systems where the purge fluid does not go through the bearings and into the bloodstream.

[00:20:11] Speaker 01:
but where that happens there's a disclaimer and the court properly found is that a person of skill in the art reading this would understand that he disparaged those type of systems and uh... display clearly and unmistakably words of manifest exclusion where is that i i don't i mean i understand where you're putting emphasis it's not an unreasonable reading

[00:20:35] Speaker 03:
But it doesn't seem to me like it's the sole possible reasonable reading.

[00:20:39] Speaker 01:
In disclaimer cases, you always have a situation where people do not say, we hear by disclaim.

[00:20:46] Speaker 01:
This is really close.

[00:20:47] Speaker 01:
This is an unmistakable disclaimer.

[00:20:49] Speaker 01:
This is clear language.

[00:20:50] Speaker 01:
It says, the person that's going out would not do this.

[00:20:53] Speaker 00:
What about on appendix page 61, where the court is not sure what to make of the statement?

[00:20:56] Speaker 01:
No.

[00:20:58] Speaker 01:
This is something which has been made up.

[00:21:01] Speaker 01:
is faced with a conundrum.

[00:21:03] Speaker 01:
It's faced with a situation where the patents in suit describe- When you say something that's been made up, what do you mean?

[00:21:08] Speaker 00:
I mean, I just read you the sentence that is on page- Because the context in which this arises- Wait, hold on, sir.

[00:21:15] Speaker 00:
I need to ask the question, then you answer, then I ask, you answer, or they ask, okay?

[00:21:19] Speaker 00:
So let's just try to make the record clear.

[00:21:21] Speaker 00:
So it says, the court is not entirely sure what to make of the statement.

[00:21:24] Speaker 00:
May I go ahead and respond to that?

[00:21:26] Speaker 01:
Thank you, Your Honor.

[00:21:27] Speaker 01:
I apologize for interrupting.

[00:21:30] Speaker 01:
Patent describes two different systems, one where the purge fluid goes through the bloodstream, through the pump and into the bloodstream, and another one where the pump goes through basically a recirculating line and goes out and onto the bloodstream.

[00:21:44] Speaker 01:
The court is discussing, right prior to that statement, the fact that the specification has these two systems.

[00:21:53] Speaker 01:
And so he says, faced with what he considers to be a clear and unmistakable disparagement of a system

[00:22:00] Speaker 01:
where the blood, where the perch fluid goes into the blood.

[00:22:03] Speaker 01:
He says, I'm not sure what to make of that because it's inconsistent.

[00:22:08] Speaker 01:
But of course that's what you have when you have disclaimer.

[00:22:11] Speaker 01:
You have a situation where a patent is possibly could be interpreted in one way.

[00:22:17] Speaker 01:
A patentee is confronted with prior art or some inconsistency, and the patentee says, I don't mean that.

[00:22:23] Speaker 01:
I don't mean to claim that.

[00:22:25] Speaker 01:
And so that's what the court gets.

[00:22:26] Speaker 03:
It's a direct contradiction.

[00:22:28] Speaker 03:
Wouldn't one of ordinary skill in the art seeing a direct contradiction between the specification and

[00:22:35] Speaker 03:
one paragraph at the end with an end argument, a third of three in addition, be at least a little bit confused like the district court was as to whether they really meant to disclaim all embodiments which are expressly disclosed in their specification where the purge fluid does in some way get into the blustery.

[00:22:56] Speaker 01:
I don't think a person of skill in the art would be confused because a person of skill in the art would understand that when confronted

[00:23:01] Speaker 01:
with a situation that their system would not operate in the real world, which is the argument that was made here by the patentee in support of its patent.

[00:23:11] Speaker 01:
You would understand that although they had written a patent, a specification in a certain way, which happens all the time, and it turns out that the piece of prior art

[00:23:20] Speaker 01:
There's some real reason in the real world why that doesn't work.

[00:23:24] Speaker 01:
They disclaim that part of it.

[00:23:25] Speaker 03:
The district court says, when faced with this direct contradiction, A63, the district court says, under the circumstances, the narrower construction controls

[00:23:36] Speaker 03:
Doesn't cite any authority for that.

[00:23:39] Speaker 03:
I don't know if you're defending that analysis or not.

[00:23:42] Speaker 03:
Is that correct, that when you have a direct contradiction between an arguably broader understanding in the patent itself and what is later said contradictorily in IPR prosecution history, the narrower construction necessarily controls?

[00:23:58] Speaker 01:
i don't see this as a this is a narrow construction of the district court as an example of that's the way he viewed the exclusion of so i thought it was very defending that analysis yes okay do we have a party he doesn't cite any i don't have anything right here uh... i mean that only works if it actually is meets the high standards for disclaimer otherwise it's we just go with uh... what's in the past right

[00:24:27] Speaker 02:
that's true uh... there's no i think it's very hard because if they had said in talking about al-hassan nobody would ever said this her fluid through the bearings because it would get into the bloodstream and our invention doesn't do that

[00:24:46] Speaker 02:
that would be a clear disclaimer.

[00:24:49] Speaker 02:
It doesn't say that.

[00:24:51] Speaker 02:
It lops off the R invention, doesn't do that.

[00:24:54] Speaker 02:
But it does seem to have the first part.

[00:24:58] Speaker 02:
And it doesn't seem to be limited in some ways to humble housing.

[00:25:02] Speaker 02:
I understand your point on that.

[00:25:04] Speaker 02:
Is that enough for a disclaimer when it says nobody would ever do this broadly

[00:25:11] Speaker 02:
without adding on, and neither do we.

[00:25:13] Speaker 01:
I think it is.

[00:25:14] Speaker 01:
In the disparagement cases, and we cited a few of them in the State Chicago Board of Trade, there was a criticism of the use of public outcry trading floors and a mix of public outcry and automated.

[00:25:29] Speaker 01:
And so the interpretation of the claim was that it was limited to an automated system.

[00:25:35] Speaker 01:
There was no statement that said we disclaim all those types of systems.

[00:25:39] Speaker 01:
It comes by

[00:25:41] Speaker 01:
interpretation of the language.

[00:25:43] Speaker 01:
And here, what the person of skill in the art is going to take away from this is you cannot put a person through the ball bearings and into the bloodstream.

[00:25:52] Speaker 01:
And again, that's what the limitation of this disclaimer is here.

[00:25:55] Speaker 02:
And that's what we have to get from, what page is that again, like 1200 something?

[00:26:01] Speaker 01:
1230?

[00:26:01] Speaker 02:
1230 from that one paragraph, which is

[00:26:10] Speaker 02:
it's talking about how the house and the real question is do we read this is the statements as broadly disparaging for everything that you want us to or do we read it as they want to as broadly dis or it's disparaging only for this alba hoss and struck well i think you have to look how do we decide that sure i think you have to look at this way because this doesn't actually relate to you the gap here right the gap doesn't matter here because what they're talking about is

[00:26:40] Speaker 01:
the figure shows an actual structure.

[00:26:43] Speaker 01:
The structure being that the bearings engage with the rotor shaft, which is also the teaching of what they have here.

[00:26:49] Speaker 01:
So the bearings engage with the rotor shaft and would create particles that would go on the budget.

[00:26:56] Speaker 00:
But what about on appendix page 1228?

[00:26:58] Speaker 00:
It sets it up where it says, petitioners misread the disclosure in Abelhausen.

[00:27:03] Speaker 00:
And then it has a subsection A where it says, petitioners manufacture a gap in figure 10, and then

[00:27:10] Speaker 00:
At the beginning of the paragraph in Appendix Page 1230, it talks more about petitioner's gap theory will require purge fluid to run directly between these bearings.

[00:27:19] Speaker 00:
So to say that this portion that you're pointing to as a disclaimer doesn't relate to the gap theory, that seems mistaken in light of some of those portions that I just described.

[00:27:29] Speaker 01:
But the point here is that they're talking about the actual structure here, right?

[00:27:33] Speaker 01:
So they dispute that there's a gap.

[00:27:36] Speaker 01:
And they call this the gap theory.

[00:27:37] Speaker 01:
But here, in this language, in the very first sentence, they're saying figure 10, that's a Wavelhausen, shows bearings engage with the rotor shaft, an actual structure.

[00:27:47] Speaker 01:
That's an actual structure which is also used in other pumps.

[00:27:51] Speaker 01:
A person with skill in the art would understand that when you're going to rotate a rotor, you have to have bearings.

[00:27:56] Speaker 01:
You have to be able to do that.

[00:27:58] Speaker 01:
And so once you have that structure, it's that structure, not some gaps in the bearings.

[00:28:03] Speaker 01:
What do the bearings engage with in their invention?

[00:28:06] Speaker 01:
The bearings.

[00:28:07] Speaker 01:
The bearings also engage on a rotor shaft, because in their invention, there's a drive shaft, external motor, and a drive shaft.

[00:28:14] Speaker 01:
The rotor blades have to be driven by something, and they're driven by that.

[00:28:19] Speaker 01:
In that one, they're driven by a drive cable.

[00:28:25] Speaker 01:
But you have to have bearings around it to let it rotate.

[00:28:29] Speaker 01:
And so there's no dispute about that.

[00:28:30] Speaker 01:
There's a diagram in the, which I don't have my fingertips, but there's a diagram in the specification which shows bearings with the same block diagram.

[00:28:40] Speaker 01:
We call them in purple.

[00:28:41] Speaker 01:
They're called in purple in Abelhausen with the same diagrams, the same schematics.

[00:28:46] Speaker 01:
They have the same structure.

[00:28:47] Speaker 01:
So do you think if we accept

[00:28:50] Speaker 02:
If we actually agree with the way they're viewing purge fluid being OK to go through the bearings, that Abelhausen would have been invalidating.

[00:29:04] Speaker 02:
That the thing that was able to make their invention survive was this disclaimer.

[00:29:12] Speaker 01:
It's obviously in here for a reason.

[00:29:14] Speaker 01:
I can't tell you what the patent office would have done.

[00:29:18] Speaker 02:
Well, I'm asking for what the patent office would have done.

[00:29:20] Speaker 02:
I was asking for your view.

[00:29:22] Speaker 02:
If this disclaimer wasn't here, would the combination about the housing and whatever have been invalidated?

[00:29:29] Speaker 02:
I think it probably would be.

[00:29:30] Speaker 03:
Is that something that's still ripe to be litigated if we were to remand?

[00:29:35] Speaker 03:
I don't know if the stable issues have come up yet.

[00:29:38] Speaker 01:
Actually, Your Honor, I truly don't know the answer to that.

[00:29:42] Speaker 01:
I have to think about it.

[00:29:44] Speaker 01:
There are a lot of issues in this case, as you can tell.

[00:29:47] Speaker 03:
Can I ask you on the means plus function?

[00:29:50] Speaker 03:
Sure.

[00:29:53] Speaker 03:
The presumption is that guide mechanism is not means plus function.

[00:29:58] Speaker 03:
which you have to rebut.

[00:30:00] Speaker 03:
And it's not clear to me what the district court saw that persuaded it that you rebutted the presumption.

[00:30:08] Speaker 03:
It doesn't seem to cite any evidence, intrinsic or extrinsic.

[00:30:13] Speaker 03:
So how is it that you think you succeeded in rebutting the presumption?

[00:30:17] Speaker 01:
Yeah, I mean, the means plus function claim analysis starts with the claim.

[00:30:20] Speaker 01:
And the claim is part of the intrinsic evidence.

[00:30:22] Speaker 01:
And here, I mean, the claim is this.

[00:30:26] Speaker 01:
This is the claim.

[00:30:27] Speaker 01:
And the entirety of the claim is an intravascular blood pump system comprising an intravascular blood pump having a cannula coupled there too, a guide mechanism adapted to guide said intravascular blood pump, and a cannula, and then a pressure sensor.

[00:30:42] Speaker 01:
That's it.

[00:30:43] Speaker 01:
There's no structure whatsoever.

[00:30:45] Speaker 03:
Well, you say that, but neither, I mean, I don't mean to

[00:30:48] Speaker 03:
I'm not one of skill in the art, so I don't know how one of skill in the art would read that as having structure or not having structure.

[00:30:57] Speaker 01:
The other part of the extrinsic evidence here obviously is the specification.

[00:31:02] Speaker 01:
The specification does not contain the definition of guide mechanism.

[00:31:06] Speaker 01:
There's nothing in there that's described as a prior art guide mechanism except

[00:31:11] Speaker 01:
a guide catheter that separate catheter the non-integrated and the invention here is a guide mechanism integrated into the device they disparage in fact the guide catheter and distinguish it so what's going on is going to have no idea what a guide mechanism means because the only things in here that are described as guide mechanisms these three aspects of the invention are the invention here's my concern the burden was on you that has to be what the probable presumption means

[00:31:41] Speaker 03:
And I think your answer is consistent with how the district court found rebuttal is it only looked to the language of the claims.

[00:31:49] Speaker 03:
If the language of the claims are enough to rebut a presumption that's on you, then what does it mean to have a presumption on you?

[00:31:57] Speaker 03:
That means if nobody introduces any evidence, you still can win.

[00:32:01] Speaker 01:
The evidence before him was the claim, the specification, the absence of any teaching of one of the skill in the art or the guide mechanism was.

[00:32:10] Speaker 01:
The failure to advance, by McKay, a definition of guide mechanism, if it was a known term in the art, there would be something somewhere in a mechanical dictionary that said what guide mechanism was.

[00:32:21] Speaker 01:
There was nothing.

[00:32:22] Speaker 01:
That's enough.

[00:32:23] Speaker 01:
I forgot the name of the case that we cited.

[00:32:25] Speaker 03:
It's the... This is the one I referenced.

[00:32:28] Speaker 03:
It was an ITC case.

[00:32:29] Speaker 01:
The Debald case.

[00:32:29] Speaker 01:
I mean, it says, none of our cases mandate that a party seeking to overcome the presumption against application of 112 can only do so by... If the claim is just nonce words.

[00:32:40] Speaker 02:
If the claim is just non-square, it's a guide mechanism, but they didn't do anything beyond say it's a mechanism that guides, that's on its face, means plus function.

[00:32:50] Speaker 02:
I mean, and we've looked to the specification to see what examples of mechanisms that guide are, and they get limited to that, which is what happened here, right?

[00:33:02] Speaker 01:
I agree.

[00:33:02] Speaker 01:
Mechanism is basically the same as means.

[00:33:04] Speaker 01:
There's no other structure here.

[00:33:07] Speaker 01:
in the, in the claim.

[00:33:08] Speaker 01:
And do you view that's enough to overcome a rebuttable presumption?

[00:33:11] Speaker 01:
It has to be.

[00:33:12] Speaker 01:
Because otherwise, what would this claim mean?

[00:33:14] Speaker 01:
This claim, you could avoid, that means you could avoid a means plus function claim just by avoiding the word means.

[00:33:20] Speaker 01:
And that can't be the case.

[00:33:21] Speaker 01:
And it can't be the case that- Well, I think that's why we took out the presumption going the other way too.

[00:33:26] Speaker 01:
Right.

[00:33:26] Speaker 01:
And it's not a heavy presumption.

[00:33:28] Speaker 01:
Right.

[00:33:28] Speaker 02:
So the result of this would be if the claim term had the word processor in it, we could look at that and say, even though it doesn't say a means to process, unless there's any indication that processor has some specific structural meaning, it's a nonce term and a means plus function claim.

[00:33:48] Speaker 01:
Right.

[00:33:48] Speaker 01:
And there's a difference between the mechanical arts also, where your case law does say that mechanical arts is a lot more difficult

[00:33:58] Speaker 01:
to find that it has structure if there's no structure in the claim.

[00:34:02] Speaker 00:
So I just want to circle back on one aspect, and then I will at least be done with my question after you.

[00:34:08] Speaker 00:
In terms of what I want to say Judge Hughes kind of described to you in terms of the two different parts of a potential disclaimer, do you remember you were having that discussion with him?

[00:34:18] Speaker 00:
The part that we actually see on page 1230 of the appendix

[00:34:22] Speaker 00:
versus the part that we don't see on page 1230 of the appendix, saying that their invention works that way.

[00:34:28] Speaker 00:
Do you have a best case you can point us to that the language that we see on page 1230 of the appendix is sufficient to be considered a disclaimer?

[00:34:37] Speaker 00:
If you wanted to point me to one case, what would you point me to?

[00:34:39] Speaker 01:
Sure.

[00:34:40] Speaker 01:
I would say two.

[00:34:40] Speaker 01:
One is the judge cited, which was Sight, Sound, Tech versus Apple.

[00:34:44] Speaker 01:
The other one is the Chicago border options case, which I discussed.

[00:34:47] Speaker 02:
Okay.

[00:34:48] Speaker 02:
Thank you.

[00:34:49] Speaker 02:
Beyond your time.

[00:34:51] Speaker 02:
We asked you a lot of questions.

[00:34:52] Speaker 02:
Thanks.

[00:34:53] Speaker 02:
Thank you for your indulgence.

[00:35:00] Speaker 04:
I'd like to spend most of my time on the purge fluid, but quickly on the guide mechanism term.

[00:35:05] Speaker 04:
I explained a little bit, and it's in our brief, about why it's not in means plus function format.

[00:35:09] Speaker 04:
And I did want to mention that if the court thinks it is in means plus function format, we still, this court should have added clearly disclosed and linked structures that were omitted.

[00:35:19] Speaker 04:
And the summary judgment of non-imperjment should be vacated.

[00:35:23] Speaker 04:
As to the purge fluid term.

[00:35:26] Speaker 04:
I just want to try to be a little clearer about what we're talking about.

[00:35:30] Speaker 04:
At APPX 817, there's an image that AVIMED presented to the Patent Trial and Appeal Board.

[00:35:40] Speaker 04:
And it shows their gap theory.

[00:35:42] Speaker 04:
And it is an important aspect of the arguments.

[00:35:47] Speaker 04:
What happened was they showed a gap between the bearings and the rotor shaft.

[00:35:52] Speaker 04:
and ran purge fluid in that gap between the bearings and the rotor shaft.

[00:36:00] Speaker 04:
When we were distinguishing this, we explained that there is no gap.

[00:36:04] Speaker 04:
The first sentence that he pointed to, we said figure 10 of Abelhausen shows bearings engaged with rotor shaft.

[00:36:11] Speaker 04:
We said that's what Abelhausen shows.

[00:36:13] Speaker 04:
It shows it together.

[00:36:14] Speaker 04:
There is no gap.

[00:36:15] Speaker 02:
So you don't think purge fluid could flow through here at all?

[00:36:21] Speaker 04:
Correct, because there's no gap.

[00:36:23] Speaker 04:
It wouldn't work.

[00:36:23] Speaker 04:
That's what we explained to the PTAT.

[00:36:25] Speaker 04:
There's no gap between the shaft and the bearing.

[00:36:27] Speaker 02:
I get that.

[00:36:28] Speaker 02:
But then why did you go on and say, but even if it did,

[00:36:31] Speaker 02:
you would never have blood go through bearings because it would deposit stuff in the bloodstream.

[00:36:38] Speaker 04:
Because what we said, after explaining that in Abelhausen the bearings, in fact, are connected to the shaft, there is no gap, we immediately said in the next sentence, this is at APX 1230, Abiumet's gap theory would require purge fluid to run directly between these bearings, meaning the gap to bearings, the ones that have a gap between the rotor shaft and the bearings.

[00:37:01] Speaker 04:
purge fluid in between the shaft and these bearings.

[00:37:05] Speaker 02:
OK, I get that.

[00:37:06] Speaker 02:
And so you think that sentence, the running purge fluid, is still confined to the gap theory specifically.

[00:37:12] Speaker 02:
And do you think that last sentence in the paragraph, that injecting floating particles from bearings into a patient's bloodstream is a bad idea, is also still confined to that theory?

[00:37:22] Speaker 04:
It is, because when you're running purge fluid.

[00:37:24] Speaker 02:
So I guess I understand it.

[00:37:26] Speaker 02:
But does that mean that?

[00:37:30] Speaker 02:
what you can run purge fluid through ball bearings and not inject particles.

[00:37:38] Speaker 02:
And how do we know that?

[00:37:38] Speaker 04:
The thing we, if you want to say we disclaim the Abelhausen situation with a gap, it's okay with us.

[00:37:46] Speaker 04:
What you cannot do is run purge fluid

[00:37:49] Speaker 04:
between the bearings and the rotor shaft.

[00:37:51] Speaker 04:
Because doing that, they're not connected.

[00:37:53] Speaker 04:
The rotor shaft is spinning.

[00:37:55] Speaker 02:
I get that.

[00:37:57] Speaker 02:
I think the problem here is you're saying

[00:38:02] Speaker 02:
running it through the Abelhausen design would be bad.

[00:38:06] Speaker 02:
But you could still run purge fluid through ball bearings in other circumstances.

[00:38:11] Speaker 02:
How do we know that from, particularly with this last sentence, which says, a placida would recognize an injecting floating particles from bearings into a patient's bloodstream is a bad idea?

[00:38:24] Speaker 02:
Is that based upon an assumption that not all purge fluid that goes through ball bearings

[00:38:32] Speaker 02:
injects particles, and how do we know that's true?

[00:38:35] Speaker 04:
That is true.

[00:38:36] Speaker 04:
The first part of it is true that just passing purge fluid through ball bearings doesn't create ball bearing particles to go into the bloodstream.

[00:38:46] Speaker 04:
What would happen is if you're putting purge fluid in a gap between the rotor shaft and the bearings, now one of them is turning super fast.

[00:38:53] Speaker 00:
Can you point to a page of the appendix or something that supports what you're describing?

[00:38:57] Speaker 04:
It's APPX 1230.

[00:38:59] Speaker 02:
No, but it doesn't say that.

[00:39:02] Speaker 02:
It doesn't distinguish.

[00:39:03] Speaker 02:
It's very unclear, which may work in your favor because disclaimer has to be clear.

[00:39:07] Speaker 02:
But that last sentence seems to be a very broad statement.

[00:39:11] Speaker 02:
Don't put purge fluid through ball bearings because it's a bad idea.

[00:39:15] Speaker 04:
The comment I would make, because I'm out of time, is that the lead-in and the discussion make clear that we're talking about this gapped theory that they presented.

[00:39:25] Speaker 04:
Perhaps we disclaim that gapped theory.

[00:39:26] Speaker 04:
We probably did.

[00:39:27] Speaker 04:
But it doesn't matter, because it would never present itself in real life.

[00:39:31] Speaker 04:
And I would piggyback on Judge Hughes and earlier Judge Stark's comment that maybe he's just kidding him as well.

[00:39:37] Speaker 04:
that the court here said is not entirely sure what to make of this statement.

[00:39:40] Speaker 03:
Can I just ask you real quick?

[00:39:42] Speaker 03:
You emphasized these bearings as opposed to the bearings.

[00:39:46] Speaker 03:
Your friend on the other side suggested there was no dispute that the bearings you were talking about here in the prior art are the same bearings as in your patent.

[00:39:56] Speaker 03:
Is that disputed or is it not?

[00:39:58] Speaker 04:
It is disputed because these bearings are referring to the gap.

[00:40:01] Speaker 03:
Can we see in the record somewhere that there's a dispute on that point?

[00:40:06] Speaker 04:
The actual ball bearings are probably the same.

[00:40:09] Speaker 04:
But in Abelhausen, in their theory, there was a gap between the bearings and the shaft.

[00:40:15] Speaker 03:
So it's the same bearings, but they're in a different structure.

[00:40:18] Speaker 03:
Is that the bottom line?

[00:40:19] Speaker 04:
It's a different structure, because the theory they presented was one where there was a gap.

[00:40:25] Speaker 04:
And it would be running it through those gap bearings.

[00:40:28] Speaker 04:
That's the difference.

[00:40:29] Speaker 04:
It's not true for all bearings.

[00:40:31] Speaker 04:
Thank you.

[00:40:31] Speaker 02:
Thank you, Your Honors.

[00:40:32] Speaker 02:
The case is set.