[00:00:00] Speaker 02:
Next case is Bluecap Bio Bar versus Yantai House Bio Laboratories, 2022, 1450.

[00:00:09] Speaker 02:
Mr. Willie, when you are ready.

[00:00:16] Speaker 02:
Is it Willie?

[00:00:18] Speaker 02:
Is it Willie?

[00:00:20] Speaker 02:
Did I pronounce your name correctly?

[00:00:22] Speaker 01:
Michael Rader.

[00:00:24] Speaker 02:
Oh, sorry.

[00:00:25] Speaker 02:
Oh, sorry.

[00:00:25] Speaker 02:
I'm looking at the next one, Rader.

[00:00:28] Speaker 02:
Not even close.

[00:00:31] Speaker 01:
Thank you, Your Honor.

[00:00:32] Speaker 01:
May I proceed?

[00:00:33] Speaker 02:
Please proceed.

[00:00:35] Speaker 01:
Thank you, Your Honors, and may it please the court.

[00:00:37] Speaker 01:
My name is Michael Rader from Wolf Greenfield on behalf of the appellant Blue Cat Bio.

[00:00:44] Speaker 01:
I'd like to focus my argument time today on two aspects of the claim construction issue before your honors, the file history and the embodiments and the specification of the patent.

[00:00:56] Speaker 01:
I'd like to start with the file history

[00:00:58] Speaker 01:
because it presents an unusually compelling set of facts and errors by the board.

[00:01:04] Speaker 01:
We're here because in the final written decision, the board found that the gyro washer, the prior art from the petition, did not practice the wind limitation of these claims because there was some liquid left behind.

[00:01:19] Speaker 01:
And in particular, there were drops, according to the patent owner's expert,

[00:01:24] Speaker 01:
that fell from the inner surface of the housing back onto the microplates.

[00:01:29] Speaker 01:
So in other words, the board agreed with AUSBIO that the wind limitation excludes this phenomenon of drops dripping back onto the microplates.

[00:01:38] Speaker 01:
That dripping phenomenon is exactly what the examiner found the claims on the wind limitation do cover.

[00:01:46] Speaker 01:
So the board reached a claim construction that was the exact diametric opposite of that

[00:01:52] Speaker 01:
of the examiner during prosecution.

[00:01:54] Speaker 01:
So this led to three separate, somewhat related legal errors.

[00:02:00] Speaker 01:
The first is that by crediting Al Spio's argument to the examiner, the board was effectively applying the canon or the doctrine of prosecution history disclaimer.

[00:02:11] Speaker 01:
An applicant's narrowing argument for narrow claim instruction is relevant when it works a prosecution history disclaimer.

[00:02:18] Speaker 01:
But this court has been clear that when the examiner expressly disagrees and rejects that narrow construction, the doctrine of prosecution history disclaimer does not apply.

[00:02:28] Speaker 01:
This effectively neutralizes any potential effect that the applicant's narrowing claim construction argument otherwise could have had.

[00:02:38] Speaker 04:
Let me just ask you.

[00:02:40] Speaker 04:
So we've made clear in a number of cases, like what is it?

[00:02:44] Speaker 04:
personalized communication and a number of cases that in fact prosecution history, including narrowing, can have a very important effect.

[00:02:55] Speaker 04:
Even when it's not a disclaimer, disclaimer or disavowal that's working against

[00:03:02] Speaker 04:
what one would otherwise conclude from the claim language or the specification.

[00:03:08] Speaker 04:
It can, in fact, resolve a potential uncertainty that one would have before getting to the prosecution history.

[00:03:17] Speaker 04:
And I guess I took the district court here to be saying, in effect, at least are we on the district court or the board?

[00:03:28] Speaker 04:
The board, sorry.

[00:03:30] Speaker 04:
The next case is the district court.

[00:03:31] Speaker 04:
at least saying that the prosecution history here powerfully supports one available view available from the text and the spec.

[00:03:44] Speaker 01:
So I think your honor is referring to the separate line of cases that says

[00:03:48] Speaker 01:
an argument or a statement made during prosecution, even if it fails to meet the threshold of a clear and unmistakable surrender of subject matter, that's surrender of claim scope that's required for prosecution history disclaimer, it can nevertheless, quote unquote, inform the proper claim construction.

[00:04:07] Speaker 01:
Well, what we have here is an examiner expressly disagreeing and rejecting that construction.

[00:04:12] Speaker 01:
We know that in the context of prosecution history disclaimer, in both EchoLab and Galderma, this court explained

[00:04:19] Speaker 01:
that the examiner's contrary view neutralizes what the applicant said.

[00:04:22] Speaker 01:
And Alice Bio has not cited, and I'm not aware of any case under the informing the claim instruction doctrine that Your Honor is talking about in which this court has ever held that the examiner expressing a contrary view would do anything but neutralize the effect of the applicant's narrowing statement either.

[00:04:48] Speaker 03:
But when you say neutralize, you mean we can't consider it, or the board can't consider it at all, as helping the patent owner's proposed construction?

[00:04:58] Speaker 01:
That's what this court expressly said in Ecolab and Galdermo with respect to prosecution of street disclaimer.

[00:05:03] Speaker 01:
And I'm not aware of any decision from this court reaching a different conclusion under the less often applied, but existing doctrine of informing claim construction that Judge Charonto raised.

[00:05:15] Speaker 01:
The district court committed a second error here, though, which is that the board made a second error here, which is that in addition to neutralizing the applicant's narrowing argument, under the St.

[00:05:34] Speaker 01:
Clair case, the examiner's view of the claim construction itself has independent affirmative significance.

[00:05:42] Speaker 01:
because the examiner is considered to be one of ordinary skill in the art.

[00:05:46] Speaker 01:
We all know that the patent office is organized into art units, and so the person examining that patent application is considered to have that background, and therefore, as this court said in St.

[00:05:58] Speaker 01:
Clair, the examiner's view of claim construction, quote, carries significant weight, unquote.

[00:06:03] Speaker 01:
This makes sense, Your Honors, because

[00:06:05] Speaker 01:
The in-bank court in the Phillips case explained that the reason we look to the prosecution history in the first place is for evidence of how both the PTO and the applicant understood the claim language in question.

[00:06:19] Speaker 02:
But look, we're talking about the meaning of all or nearly all, right?

[00:06:24] Speaker 01:
That's the board's construction.

[00:06:26] Speaker 02:
And when you look at the patent, the patent supports that.

[00:06:31] Speaker 02:
It is possible to withdraw completely

[00:06:34] Speaker 02:
all liquid contained in the reaction vessel.

[00:06:37] Speaker 02:
In other words, it's possible, but not necessarily.

[00:06:42] Speaker 02:
And a little further up, it talks about the main part.

[00:06:46] Speaker 02:
And so the specification supports that it isn't necessarily all.

[00:06:53] Speaker 01:
And that's where I'd like to go next, Your Honor, because it's really important to look at those three embodiments that the parties have been talking about here.

[00:07:00] Speaker 01:
There's the so-called reversal embodiment, which is the embodiment at the top of column 13, where the patent says, after you run the centrifuge in one direction, which is what the independent claims here cover, there will be liquid left behind, which is, quote, preferably, unquote, removed.

[00:07:18] Speaker 01:
Why is it preferably removed?

[00:07:20] Speaker 01:
Because it is

[00:07:22] Speaker 01:
It's problematic, it's undesirable.

[00:07:24] Speaker 01:
They admit that on page 37 of the red brief.

[00:07:27] Speaker 01:
Why is it undesirable?

[00:07:30] Speaker 01:
As they admit on page three of the red brief, it's undesirable because remaining liquid causes or can cause cross-contamination.

[00:07:38] Speaker 01:
The board's construction was entirely aimed at supposedly avoiding cross-contamination.

[00:07:45] Speaker 01:
Yet that embodiment, and I'm getting to the other two in a moment, that embodiment clearly leaves behind liquid

[00:07:50] Speaker 01:
that causes cross-contamination.

[00:07:52] Speaker 01:
And therefore, it's excluded by the board's construction, at least as the board applied it.

[00:07:59] Speaker 01:
The board's construction was a bit of an onion.

[00:08:00] Speaker 01:
The first layer was the main part.

[00:08:02] Speaker 01:
That was in the institution decision.

[00:08:04] Speaker 01:
Then they said, we're construing the construction of main parts to mean all or nearly all.

[00:08:09] Speaker 01:
But what does that mean?

[00:08:10] Speaker 01:
So they said, well, all or nearly all means that you avoid cross-contamination.

[00:08:16] Speaker 01:
And that all came from Alice Bio's

[00:08:19] Speaker 01:
That construction, as applied to the gyro washer, would then exclude that so-called reversing embodiment in column 13.

[00:08:26] Speaker 01:
And it would also exclude the aspiration pump embodiment in the middle of column three that Judge Lurie, that you were just mentioning.

[00:08:32] Speaker 01:
Because that embodiment also says, after you run the centrifuge in one direction, which again is what claims one and 12 cover, there will be residual liquid that can be removed manually.

[00:08:47] Speaker 01:
Now why would you need to remove it manually between uses?

[00:08:50] Speaker 01:
Because as Al Spio admits in his red brief at 38, it is undesirable liquid.

[00:08:55] Speaker 01:
Why is it undesirable?

[00:08:57] Speaker 01:
Because as they admit on page three of their red brief, it causes cross-contamination.

[00:09:01] Speaker 03:
Let me stop you.

[00:09:02] Speaker 03:
Doesn't all of this, including what Judge Laurie cited to suggest, that the patentee envisioned there would be very little water left

[00:09:10] Speaker 03:
and your construction is so broad it could allow almost all of the water to be left.

[00:09:15] Speaker 03:
Isn't that the problem for you?

[00:09:17] Speaker 01:
Well, I think the issue here, Your Honor, is that the claim construction should cover, as ours does, all of the embodiments.

[00:09:25] Speaker 03:
They chose to write the... I understand that argument, but what about the response to my question?

[00:09:29] Speaker 03:
Isn't yours broad enough that it would include embodiments where perhaps almost all of the water is left?

[00:09:36] Speaker 03:
And that's clearly not what's going on here in the patentees.

[00:09:40] Speaker 01:
you know marked uh... it it absolutely would cover that and it from it there's no doctrine of claim construction that says the proper construction needs to be tailored only to the embodiments disclosed in the specification that the opposite what's left out there fundamental doctrine that one of word there is still in the heart looking at the patent and looking at the terms that were concerned with it would not think there'd be a lot of water left in yet your construction allows a lot of water to be left

[00:10:08] Speaker 01:
Well, again, the issue is what's the problem with the water being left?

[00:10:12] Speaker 01:
Potentially cross-contamination.

[00:10:16] Speaker 01:
And not only did the examiner find that the claim limitation here permits cross-contamination, embraces cross-contamination.

[00:10:22] Speaker 01:
If you look at the top of column 8 of this patent, it specifically talks about this dripping phenomenon and water being left behind.

[00:10:29] Speaker 01:
And it says, the way to avoid this is not through this wind.

[00:10:34] Speaker 01:
The way to avoid this is by turning the microplate over first, shaking out most of the water, and then spinning it with only a little bit of the water left.

[00:10:42] Speaker 01:
So the patent itself on the top of column eight identifies and recognizes that this invention will not cause most of the water or the liquid to be withdrawn from the housing.

[00:10:55] Speaker 01:
this is something completely different indefiniteness uh... i was talking one paragraph with a couple of sentences that don't really say anything uh... did you really preserve this argument uh... at the board yes we made the same argument to the board that that we're making now we cited the fact that the construction itself that the book that the board adopted uh... that i was fired had proffered below that that now that the board has adopted offers no objective

[00:11:22] Speaker 01:
uh... uh... standard by which to determine how much liquid is necessary they say what has to avoid cross-contamination.

[00:11:29] Speaker 03:
I understand the argument, but was it anything more than the two paragraphs that are referenced in your briefing here?

[00:11:36] Speaker 01:
Well, it addressed all the same things that we argue here.

[00:11:40] Speaker 01:
All we did here was we cited a couple more cases and used a few more words, but it focused, for example, on the testimony of their expert, Dr. Nissen, who was their cross-contamination expert.

[00:11:51] Speaker 01:
We focused on that testimony and focused on it again here, where he says, even one drop of liquid left behind is too much.

[00:11:58] Speaker 01:
It will be excluded from the claim.

[00:12:01] Speaker 01:
But then he said, well, maybe a film of liquid, but not a drop of liquid, could be sufficient.

[00:12:06] Speaker 01:
But then when asked, by the way, the patent never tells you what the difference is between a film and a drop.

[00:12:11] Speaker 01:
Then when asked about it, he said, well, he couldn't tell you whether a film would or would not be sufficient to take the device outside the scope of the claim.

[00:12:21] Speaker 01:
When asked whether the risk of cross-contamination has to be reduced to zero, he refused to answer that question.

[00:12:28] Speaker 01:
It was asked at least 10 times.

[00:12:30] Speaker 01:
He refused to answer it.

[00:12:31] Speaker 01:
And then he said the risk of cross-contamination has to be, quote, greatly reduced.

[00:12:36] Speaker 01:
And when he was asked what that meant, he had no answer for that.

[00:12:39] Speaker 01:
He couldn't say what that meant.

[00:12:41] Speaker 01:
We argued all of that, Your Honor, below to the board.

[00:12:44] Speaker 01:
And then we argued it again here.

[00:12:47] Speaker 01:
I see I'm into my rebuttal time.

[00:12:48] Speaker 02:
You can save it.

[00:12:50] Speaker 01:
We will save it for you.

[00:12:50] Speaker 01:
Thank you, Your Honor.

[00:12:52] Speaker 02:
Mr. Shapiro.

[00:12:53] Speaker 02:
Good morning, your honor.

[00:12:55] Speaker 00:
May it please the court?

[00:12:57] Speaker 00:
I'm Jason Shapiro.

[00:12:58] Speaker 00:
I represent Pelley House Bio Laboratories, Untied House Bio Laboratories.

[00:13:05] Speaker 00:
Lookout Bios Council made a lot of allegations about the board's construction being wrong.

[00:13:12] Speaker 00:
And one of the things he said was that the board's decision is wrong here because

[00:13:20] Speaker 00:
It was applying disclaimer.

[00:13:24] Speaker 00:
And I'd like to point out that in the final written decision, the board was very careful to indicate that it was not applying disclaimer or surrender.

[00:13:38] Speaker 00:
And in fact, that term, the idea of surrender or disclaimer was actually brought up by Blue Cat Bio.

[00:13:46] Speaker 00:
And the board said there is no disclaimer here in his final written decision.

[00:13:50] Speaker 00:
And yet on appeal, Blue Camp Bio is now turning around and said, well, the board made a mistake.

[00:13:55] Speaker 00:
They said that there's disclaimer.

[00:13:57] Speaker 00:
So there was no disclaimer.

[00:13:58] Speaker 00:
If you look, for example, at Appendix 25, which is the board's final written decision, it expressly states, we didn't find a disclaimer.

[00:14:06] Speaker 00:
We were just looking at the prosecution history to see if it was consistent with the claim construction that we've arrived at.

[00:14:15] Speaker 00:
And they did look at the prosecution history.

[00:14:18] Speaker 00:
They looked at the interaction between the applicant and the examiner.

[00:14:24] Speaker 00:
And they saw that the applicant was making the same arguments that it was making before the board in the PGR.

[00:14:33] Speaker 00:
And that during the patent prosecution, it didn't change its arguments.

[00:14:39] Speaker 00:
It didn't back off.

[00:14:40] Speaker 00:
It didn't disclaim anything.

[00:14:44] Speaker 00:
So that's really a red herring.

[00:14:48] Speaker 00:
The other thing that opposing counsel brought up is that the fact that the applicant raised this argument and was unsuccessful in convincing the examiner that it was the case and then found another way to get the claim allowed that had nothing to do with that argument was somehow

[00:15:13] Speaker 00:
somehow means that the board then couldn't agree that the applicant was right during patent prosecution.

[00:15:20] Speaker 00:
In other words, what Blue Cat Bile's counsel is arguing is that the board is bound by the examiner's position, which is ridiculous.

[00:15:32] Speaker 00:
And they cited to Ecolab and said, well, that's what Ecolab says.

[00:15:36] Speaker 00:
Well, Ecolab doesn't say anything of the sort.

[00:15:38] Speaker 00:
It was a disclaimer case.

[00:15:40] Speaker 00:
And what Ecolab said was,

[00:15:42] Speaker 00:
Well, we looked at this, and they recognized their error, and then they didn't repeat it.

[00:15:50] Speaker 00:
And their statements are not clear and unmistakable enough to invoke the doctrine of prosecution history disclaimer.

[00:15:58] Speaker 00:
And again, the board is not relying on disclaimer.

[00:16:02] Speaker 00:
This is something Blue Cat Bio brought up during the proceeding.

[00:16:06] Speaker 00:
So again, it doesn't seem relevant here.

[00:16:10] Speaker 03:
Do you cite any cases where we've said, in that type of context, it's OK to nonetheless consider that whole back and forth during examination, and while it doesn't rise to the level of disclaimer, it can inform the proper construction?

[00:16:25] Speaker 03:
Have we said that?

[00:16:27] Speaker 03:
Because your friend seems to say we haven't said that.

[00:16:29] Speaker 00:
Well, I don't have a case directly on point.

[00:16:32] Speaker 00:
But we did cite a case that I think is broad enough to stand for that proposition, Phillips.

[00:16:38] Speaker 00:
which says that you should look at the prosecution history to see how the applicant understood its invention.

[00:16:44] Speaker 00:
And from day one, the applicant has said, because of this wind that's generated by the gap that you have in the claim, we can remove the liquid from the inner housing of the centrifuge and avoid contamination.

[00:17:03] Speaker 00:
And that's been from day one.

[00:17:05] Speaker 00:
It was during prosecution, it was during the PGR, and now it's on appeal.

[00:17:10] Speaker 00:
Al's file has not changed its position.

[00:17:12] Speaker 00:
That is how it has always construed the claim.

[00:17:17] Speaker 00:
And Phillips says that that's okay.

[00:17:20] Speaker 00:
You should actually look at the patent prosecution and to see how the applicant understood the event.

[00:17:26] Speaker 00:
Who best understand the invention and the applicant?

[00:17:31] Speaker 00:
Blue Cat Bios counsel also said,

[00:17:33] Speaker 00:
that he was talking about the embodiments and he was saying, well, the reversing embodiment, it doesn't avoid contamination because that film that's left on the backside of the housing to the rear of the drain, that's undesirable liquid.

[00:17:53] Speaker 00:
It is undesirable liquid.

[00:17:55] Speaker 00:
It's undesirable because it came out of the microplate that was centrifuged, right?

[00:18:01] Speaker 00:
He says, it doesn't avoid contamination stuff.

[00:18:05] Speaker 00:
That means that their claim construction must be wrong because it's undesirable liquid and it doesn't completely avoid contamination.

[00:18:13] Speaker 00:
But that's not what the specification says.

[00:18:16] Speaker 00:
The specification says, we have embodiments where we do remove it all and completely, it says completely avoid contamination.

[00:18:26] Speaker 00:
And we have other ones where we remove

[00:18:29] Speaker 00:
nearly all of it.

[00:18:31] Speaker 00:
They don't use the term nearly all, but that's the way it's been construed.

[00:18:35] Speaker 00:
And in those embodiments, it says greatly reduced.

[00:18:38] Speaker 00:
So we can either eliminate completely or greatly reduce.

[00:18:42] Speaker 00:
So that's an embodiment where it's been greatly reduced.

[00:18:45] Speaker 00:
And I should add here too that the board was very careful to say that they weren't reading into the claim a requirement that you avoid contamination.

[00:18:59] Speaker 00:
They didn't read that into the claim.

[00:19:00] Speaker 00:
They were reading the claim in the context of the specification in the prosecution history that it's an important aspect of the invention that you avoid contamination.

[00:19:13] Speaker 00:
That doesn't mean the claim says, you know, we do these things.

[00:19:17] Speaker 00:
And you have to avoid contamination.

[00:19:21] Speaker 00:
But it's important to keep in mind when you're reading those claims.

[00:19:25] Speaker 00:
A person of ordinary skill in the art, if they were reading those claims, they're going to read the specification.

[00:19:31] Speaker 00:
Maybe they should look at the prosecution history, too, under Phillips.

[00:19:37] Speaker 00:
But they're certainly going to read the specification.

[00:19:39] Speaker 00:
And they're going to see that avoiding contamination is emphasized.

[00:19:47] Speaker 00:
Something that you should keep in mind here is that Blue Cat Bio themselves, at appendix 172, admitted that the patent emphasizes the importance of avoiding contamination.

[00:20:07] Speaker 00:
So you can't argue that a person of ordinary skill in the arts is not going to reach the same conclusion.

[00:20:12] Speaker 03:
So does the board's construction exclude any of the embodiments that are disclosed in the patent?

[00:20:17] Speaker 00:
No.

[00:20:19] Speaker 00:
Let me clarify.

[00:20:20] Speaker 00:
The board's construction does not exclude any of the relevant embodiments.

[00:20:27] Speaker 00:
The patent discusses multiple embodiments.

[00:20:31] Speaker 00:
They have embodiments that we call the wind embodiments, where you are creating a gap between the rotor and the inner surface of the housing to generate a wind that will remove liquid that's expelled onto the inner surface.

[00:20:46] Speaker 00:
So there's three embodiments that we've identified that are disclosed in this patent that have this wind limitation, where what you're trying to do is basically clean the inner surface of the housing, like a self-cleaning device, almost.

[00:21:00] Speaker 00:
And the board's construction is consistent with all of those.

[00:21:04] Speaker 03:
And I should mention here... Because it does not exclude any wind embodiments.

[00:21:09] Speaker 03:
That's correct, Your Honor.

[00:21:11] Speaker 00:
And while we're here, I should also mention that none of those embodiments support Blue Cat Bio's proposed construction.

[00:21:20] Speaker 00:
In none of those embodiments do you remove a de minimis amount of liquid from the wall.

[00:21:26] Speaker 03:
And is that, from your view, the real problem with Blue Cat's proposed construction is that it would allow just the removal of a small amount of water to still be within the scope of the claims?

[00:21:41] Speaker 00:
That's not the only reason, but that certainly is an important reason.

[00:21:44] Speaker 00:
That's one of them.

[00:21:45] Speaker 03:
What are some of the other problems with their construction?

[00:21:47] Speaker 00:
Well, another reason is that when you're construing claims, you start with the structural language of the claims, right?

[00:21:55] Speaker 00:
And we have the independent claims 1 and 12, and they talk about how you have a rotor and you centrifuge, you rotate the centrifuge and liquid from the microtiter plate that's in there.

[00:22:08] Speaker 00:
will expel liquid onto the inner surface of the housing.

[00:22:12] Speaker 00:
And you have a gap.

[00:22:14] Speaker 00:
And the gap is such that you generate a wind that drives that liquid to the drain.

[00:22:20] Speaker 00:
And so the structural language of the claim is it's driving the expelled liquid.

[00:22:27] Speaker 00:
Before, it's saying liquid from the microtiter plate.

[00:22:30] Speaker 00:
And reading that, you see that what they're doing is they're saying you're driving the expelled liquid.

[00:22:39] Speaker 02:
And as noted by the- That modifies previous language that says cause liquid.

[00:22:45] Speaker 00:
Liquid, right.

[00:22:46] Speaker 00:
It says liquid from the microtiter plate.

[00:22:49] Speaker 00:
And by the way, in the claim, it's in the context of a centrifuge for cleaning microtiter plates, which is where you remove all the liquid from, or as much as you can get out from the microtiter plates.

[00:23:03] Speaker 00:
OK?

[00:23:04] Speaker 00:
When you're looking at that claim, you certainly don't see it say some or at least some.

[00:23:12] Speaker 00:
So you have a problem with their construction just from the structure and language.

[00:23:18] Speaker 02:
It doesn't say all.

[00:23:19] Speaker 00:
It doesn't say all either.

[00:23:22] Speaker 00:
And then we get to the context also, reading it in the context of the patent prosecution.

[00:23:30] Speaker 00:
But then we have dependent claims seven and 17, which are discussed quite a bit in the party's briefs.

[00:23:37] Speaker 00:
So when you have a centrifuge, you run the rotor in one direction.

[00:23:42] Speaker 00:
And in this invention, the way they've constructed it, the rotation creates a wind in that direction.

[00:23:51] Speaker 00:
And so it's pushing the expelled liquid that's on the inner surface to the drain.

[00:23:57] Speaker 00:
And in claims seven and 17,

[00:24:00] Speaker 00:
What you see is the patent calls for, after you've completed the centrifuging step in the independent claims, you reverse the direction of the rotation to remove a residual liquid film on the rear side of the drain.

[00:24:20] Speaker 00:
Okay.

[00:24:20] Speaker 00:
So now, now we know, okay.

[00:24:24] Speaker 00:
So claims seven and 17, they depend from the independent claim.

[00:24:28] Speaker 00:
And they're saying we have to reverse rotation to remove this liquid film, which means, okay, we have to accommodate the possibility that there's this liquid film on the rear side of the housing, to the back of the drain, on the backside of the drain.

[00:24:46] Speaker 00:
And so now we know that claim one was not all.

[00:24:50] Speaker 00:
But we also know in context that,

[00:24:56] Speaker 00:
in the context of avoiding contamination, that this was all that was left.

[00:25:03] Speaker 00:
A person of ordinary skill in the art reading this.

[00:25:05] Speaker 02:
It must have been all or most.

[00:25:08] Speaker 00:
It depends what you mean by most, right?

[00:25:12] Speaker 00:
And that's one of the problems we've had here is that the patent talked about the main part.

[00:25:16] Speaker 00:
And we took the position that main part means the important part.

[00:25:19] Speaker 00:
Important in the context of avoiding contamination is removing nearly all.

[00:25:25] Speaker 00:
In other words, you could have this liquid film on the back side of the, you know, to the rear of the drain on the inner surface of the housing.

[00:25:34] Speaker 00:
And so why, right?

[00:25:35] Speaker 00:
Well, Blue Cat Bio didn't present expert testimony on contamination.

[00:25:41] Speaker 00:
We engaged an expert specifically on biochemical assays in the problem of contamination to advise our mechanical engineering expert who was a person of ordinary skill in the art.

[00:25:57] Speaker 00:
We're talking about a centrifuge.

[00:25:59] Speaker 00:
It's a mechanical device.

[00:26:00] Speaker 00:
So the person of ordinary skill in the art, and this is not disputed, was a mechanical engineer with a certain amount of experience who'd been informed about

[00:26:10] Speaker 00:
biochemical assays and the sensitivities of those.

[00:26:13] Speaker 00:
And that's what we presented.

[00:26:15] Speaker 00:
We presented Dr. Katz, who's a mechanical engineering professor at the Johns Hopkins University, and an expert on fluid mechanics drops, drops and things of that sort.

[00:26:27] Speaker 00:
And then we had

[00:26:28] Speaker 00:
another technical expert, Dr. Nissen, who is an expert in biochemical assays.

[00:26:36] Speaker 00:
And he explained in his declaration about problems relating to biochemical assays and contamination that Dr. Katz then, being a mechanical engineer and considering how the design of a centrifuge would take place, could opine then, OK, well, what's going on here?

[00:26:59] Speaker 00:
Dr. Nissen testified that, well, in a biochemical assay, even one drop getting into a drop from one well, these microtiter plates have multiple wells, typically, but a drop getting from one into another well of that plate or another well of a subsequent plate coming in is unacceptable.

[00:27:23] Speaker 00:
It'll ruin the test.

[00:27:25] Speaker 00:
And so the

[00:27:29] Speaker 00:
Dr. Katz, who's a person of ordinary skill in the art, with an understanding now of the sensitivities of biochemical assays, concluded that the expelled liquid, that the wind has to be such that the expelled liquid is either all or nearly all of that expelled liquid is removed by the wind.

[00:27:53] Speaker 00:
And that's what's required in the context of the claims

[00:27:58] Speaker 00:
and the patent.

[00:28:01] Speaker 00:
I think I'm out of time.

[00:28:06] Speaker 00:
So I'll wrap up here, but I'd like to thank the board.

[00:28:09] Speaker 02:
Thank you.

[00:28:10] Speaker 00:
Thank you, Your Honors.

[00:28:12] Speaker 02:
Mr. Rader has some rebuttal time, about three minutes.

[00:28:15] Speaker 01:
Yes.

[00:28:16] Speaker 01:
Judge Stark, you asked counsel whether the board's claim construction excludes the wind embodiments.

[00:28:22] Speaker 01:
So the question is, all or nearly all the board's construction, what does that mean?

[00:28:27] Speaker 01:
How much reduction in the possibility of cross-contamination is necessary?

[00:28:32] Speaker 01:
You just heard Mr. Shapiro say even one single drop remaining, as their expert testified, and they've endorsed on page 56 of the red brief, even one single drop remaining in that housing disqualifies the

[00:28:47] Speaker 01:
device from satisfying the wind limitation.

[00:28:50] Speaker 01:
That means that those first two embodiments, the aspiration pump embodiment and the reversal embodiment, are excluded.

[00:28:56] Speaker 01:
They can't have it both ways.

[00:28:57] Speaker 01:
It can't be that one drop is too much and these two embodiments that leave residual liquid behind that's removed by wiping it down or by reversing it somehow still satisfy the limitation.

[00:29:08] Speaker 01:
They can't have it both ways.

[00:29:10] Speaker 01:
The board applied its

[00:29:13] Speaker 01:
Claim construction, as I said, it's like an onion.

[00:29:16] Speaker 01:
All or nearly all doesn't really tell you anything.

[00:29:18] Speaker 01:
The question is, how low does the risk of cross-contamination have to go for a device to satisfy this limitation?

[00:29:26] Speaker 01:
The only perhaps slightly more objective view that was ever offered is this patent talks about certain assays, cellular assays and ELISA assays that the device can be used for.

[00:29:40] Speaker 01:
And the testimony was undisputed from Yagi-san.

[00:29:45] Speaker 02:
Counsel, isn't the issue here relating to priorat, which is not being argued, but the priorat device drove only a small amount of the liquid.

[00:29:57] Speaker 02:
And so you're arguing how much is how much, but you're not even close when the priorat got rid of only a small amount.

[00:30:04] Speaker 01:
No, that's not correct, Your Honor.

[00:30:06] Speaker 01:
So a number of tests were done.

[00:30:08] Speaker 01:
But in the simplest test to talk about, so the device was run.

[00:30:12] Speaker 01:
There was a pipe from the bottom of the device down to a bucket.

[00:30:16] Speaker 01:
And 73% of the liquid that started in the microplate made it not just to the drain, but all the way through the pipe and to the bucket.

[00:30:27] Speaker 01:
So something north of 73%, since some of the liquid remained in the hose, an indeterminate amount, something north of 73%

[00:30:34] Speaker 01:
of that liquid went down, went to the drink.

[00:30:38] Speaker 01:
And Yagi-san testified that his device is used for the very same assays that the patent describes, which their same expert, Dr. Nissen said at one point, that's the touchstone.

[00:30:48] Speaker 01:
Is it good for those assays?

[00:30:49] Speaker 01:
Yagi-san testified it is.

[00:30:51] Speaker 01:
And there's independent corroboration of that in

[00:30:53] Speaker 01:
Micronix's 2010 patent application from before all of this, that that's what its device is used for.

[00:30:59] Speaker 01:
The bottom line, Your Honors, is they were faced with an examiner that disagreed, said that the wind limitation was broad, just like we say it is.

[00:31:09] Speaker 01:
They have the opportunity to amend their claim.

[00:31:12] Speaker 01:
They could have written whatever they wanted in their claim, all or nearly all, no cross-contamination,

[00:31:18] Speaker 01:
Quantified however they wanted to.

[00:31:20] Speaker 01:
They chose not to amend their claim.

[00:31:21] Speaker 01:
Instead, they're arguing a construction that excludes two of the three embodiments.

[00:31:26] Speaker 01:
And I didn't have a chance to mention this, but the only embodiment it includes is the preferred embodiment with a gap of one millimeter or less.

[00:31:33] Speaker 01:
And we're not supposed to import limitations from a preferred embodiment.

[00:31:38] Speaker 02:
Thank you, counsel.

[00:31:38] Speaker 02:
Thank you, your honor.

[00:31:39] Speaker 02:
We'll take the case under submission.