[00:00:01] Speaker 05:
The first case for argument this morning is 16-1881 Enzo Biochem versus Athlera.

[00:00:08] Speaker 05:
Mr. Spears.

[00:00:10] Speaker 06:
Good morning, Your Honor, and may it please the Court.

[00:00:12] Speaker 06:
So we're back again for the third time in the 13-year history of this litigation.

[00:00:17] Speaker 05:
Is this it?

[00:00:19] Speaker 05:
Perhaps.

[00:00:19] Speaker 05:
You hope not.

[00:00:20] Speaker 06:
Perhaps.

[00:00:20] Speaker 06:
We'll see.

[00:00:22] Speaker 06:
A litigation that we believe the district court prematurely concluded as to claims one and eight

[00:00:28] Speaker 06:
That court granted summary judgment on an issue of technological equivalence, where the only evidence applying the function-of-way result test came from Enzo's expert.

[00:00:38] Speaker 06:
As to claims 67, 68, and 70, the district court denied those claims the scope they finally defined and indeed afforded the no scope whatsoever.

[00:00:50] Speaker 06:
The patented issue claims a composition.

[00:00:52] Speaker 02:
Do you understand the decision below?

[00:00:55] Speaker 02:
and the last Federal Circuit opinion to interpret 67, 68, and 70 as limited to only embodiments that are capable of indirect detection?

[00:01:09] Speaker 06:
No, I do not read the Court's prior opinion in that way.

[00:01:13] Speaker 02:
Are all indicator molecules capable of direct detection?

[00:01:19] Speaker 06:
Absolutely, and I would refer the Court to

[00:01:23] Speaker 06:
to column 18, lines 8 through 15, and column 1, lines 61 through 67 that describe direct detection of indicator molecules.

[00:01:32] Speaker 06:
That's exactly what they are.

[00:01:33] Speaker 02:
Are all fluorescent indicator molecules always capable of direct detection?

[00:01:38] Speaker 06:
Absolutely.

[00:01:38] Speaker 06:
And there's no evidence to the contrary.

[00:01:41] Speaker 06:
That's always been the assumption underlying this case.

[00:01:44] Speaker 02:
Is rhodamine as an indicator molecule always capable of direct detection when used as an A?

[00:01:50] Speaker 06:
As long as it's present in sufficient concentrations, then it can be directly detected, which is true in all of the accused products.

[00:01:59] Speaker 04:
Don't we have a problem in that?

[00:02:00] Speaker 04:
Our case law does say that a dependent claim can't actually contradict an independent claim, right?

[00:02:08] Speaker 06:
Respectfully, I disagree with that.

[00:02:10] Speaker 06:
This court has recognized that a dependent claim can have a scope entirely outside of an independent claim.

[00:02:17] Speaker 06:
This court first made that recognition in the FISA case in 2006, and more recently it was recognized in the multi-layer clean stretch bill.

[00:02:25] Speaker 04:
But in a way that actually contradicts the independent claim?

[00:02:31] Speaker 06:
Yes, absolutely.

[00:02:33] Speaker 06:
In the FISA case,

[00:02:37] Speaker 06:
The dependent claim claimed, I believe it was, an acid, whereas the dependent claim claimed an acid, whereas the dependent claims were limited to, no, it claimed to salt, whereas the claim it depended on was limited to lactones and acids.

[00:02:53] Speaker 06:
In multi-layer cling stretch, the dependent claim called out a polymer resin that wasn't listed in the claim from which it depended.

[00:03:03] Speaker 04:
But was that a situation in which

[00:03:07] Speaker 04:
claim construction said that the independent claim actually excluded the things that were then in the dependent claims.

[00:03:15] Speaker 06:
I don't read that this court's decision is affirmatively excluding that claim scope.

[00:03:20] Speaker 06:
The court said that A needs to be one component of a multi-component signaling system.

[00:03:27] Speaker 06:
And in the dependent claims,

[00:03:31] Speaker 06:
The dependent claims are an independent definition of A. Claim 67 tells you what A comprises.

[00:03:38] Speaker 06:
Claim 67 tells you A comprises an indicator molecule, and we all know that those are detectable directly.

[00:03:44] Speaker 06:
Claim 68 tells you that the indicator molecule is fluorescent, electron dense, or an enzyme that can cause a precipitate to form.

[00:03:52] Speaker 06:
All of that is directly detectable.

[00:03:54] Speaker 06:
Claim 70 tells you that the fluorescent indicator molecule can be fluorescent,

[00:04:00] Speaker 06:
Erotamine, we all know that those are directly detectable.

[00:04:05] Speaker 06:
For a long period of time, the claims of the United States patent have been understood to constitute separate definition and independent definitions of the invention.

[00:04:14] Speaker 06:
When you do that with claims 67, 68, and 70 on their own terms, each of those claims cover a directly detectable A. Did you ever dispute the Federal Circuit's use of claim one as representative for purposes of liability?

[00:04:28] Speaker 06:
There was no reason for us to dispute that because that came out in the court's opinion.

[00:04:33] Speaker 06:
We did move for reconsideration afterwards, and that motion was denied.

[00:04:38] Speaker 05:
Turning to claims... I'm sorry, can you clarify that?

[00:04:41] Speaker 05:
Wait, you moved for, after ENSO, the last ENSO opinion, you moved for reconsideration?

[00:04:46] Speaker 05:
Yes, we did.

[00:04:47] Speaker 05:
You moved for re-hearing, you mean re-hearing?

[00:04:49] Speaker 05:
Yeah, re-hearing.

[00:04:50] Speaker 05:
Okay, and in your re-hearing petition, did you call out the dependent claims, differentiate those from the independent claims, and so forth?

[00:04:58] Speaker 06:
Only to suggest that the panel's decision on the construction of Claim 1 was incorrect.

[00:05:05] Speaker 05:
Right.

[00:05:05] Speaker 06:
Right.

[00:05:06] Speaker 06:
That's right.

[00:05:06] Speaker 06:
As far as whether the panel's decision created a potential invalidity defense of improper dependency for Claim 67, 68, or 70, that wasn't our issue.

[00:05:19] Speaker 06:
That was a player's issue to raise, and they never raised it at any high.

[00:05:22] Speaker 04:
But you didn't, in your motion for rehearing, you did not say,

[00:05:27] Speaker 04:
and the court failed to rule separately on the scope of claims 67, 68.

[00:05:32] Speaker 04:
That's exactly right.

[00:05:35] Speaker 06:
Turning to claims one and eight, when we received the court's decision, we considered for the first time the possibility that they were infringed under the doctrine of equivalence.

[00:05:44] Speaker 06:
Spying the legal bar, like prosecution history is stumbling, we viewed this as purely an issue of technological equivalence, perhaps, by applying the function-of-way result test.

[00:05:54] Speaker 06:
So what is the first step of that analysis?

[00:05:57] Speaker 06:
you have to identify the function relevant to indirect detection of using an A that's a component of a multi-component signaling moiety.

[00:06:05] Speaker 06:
This court has indicated that when determining what the function of a limitation is, the best place to look is the patent itself.

[00:06:13] Speaker 06:
And when you look at the patent, the patent clearly tells us what the function is of using an A that's a component of a multi-component signaling moiety.

[00:06:23] Speaker 06:
That function is signal amplification.

[00:06:26] Speaker 04:
But this presupposes the conclusion that our prior opinion did not say that the claims don't support direct detection.

[00:06:37] Speaker 06:
That's exactly right.

[00:06:39] Speaker 04:
So you don't get there unless you went on the initial construction of that prior opinion.

[00:06:45] Speaker 06:
Well, as to claims 67, 68, and 70, I agree with that.

[00:06:50] Speaker 06:
As to claims 1 and 8,

[00:06:51] Speaker 06:
We are taking this court's construction of the definition of A as limited to direct detection, identifying a function of that limitation, which is stated in column 19 as one of signal amplification.

[00:07:07] Speaker 06:
The reason that you indirectly detect A by reacting it with something else is to substitute a stronger signaling source for A itself

[00:07:16] Speaker 06:
whose signal might be too weak to detect.

[00:07:18] Speaker 06:
And that's the function that Dr. Sendin identified in his declaration.

[00:07:24] Speaker 06:
The next step of that analysis is to take a look at the accused infringement and see if there's something in it that carries out the same function.

[00:07:33] Speaker 06:
The accused products in this case... I'm still not following.

[00:07:37] Speaker 04:
We said in the prior opinion that the claims do not, quote, support the inclusion of direct detection.

[00:07:43] Speaker 04:
And then we have multiple cases, including Dolly and others, that say that the concept of equivalency cannot embrace a structure that is specifically excluded from the scope of the claims.

[00:07:54] Speaker 06:
That's not how I see our equivalence theory.

[00:07:58] Speaker 06:
What this court did was to limit claim one to an A that has to be reacted with something else to detect it.

[00:08:08] Speaker 06:
The function of doing that is to amplify the signal.

[00:08:13] Speaker 06:
In the accused products, the signal of A is amplified by increasing their concentration through PCR enzymes.

[00:08:22] Speaker 06:
This is in no way the opposite of what is claimed and claimed one.

[00:08:27] Speaker 06:
In fact, these processes are complementary because you can do both of them, in theory.

[00:08:33] Speaker 06:
So this is not a case where we are advocating a scope of equivalence that is the opposite of what is being claimed.

[00:08:40] Speaker 06:
And more importantly... Where is that standard?

[00:08:42] Speaker 05:
I mean, okay, that's right.

[00:08:44] Speaker 05:
I mean, if you're not claiming the opposite, that doesn't mean that there's equivalence there.

[00:08:49] Speaker 05:
I mean, the definition of equivalence is it's not the opposite, right?

[00:08:53] Speaker 06:
That's exactly right.

[00:08:56] Speaker 06:
The evidence is our uncontroverted expert declaration that identifies the relevant function as the very function that is identified in the patent

[00:09:06] Speaker 06:
And this court precedent tells us that if you have a function identified in the patent, that's the function you run with.

[00:09:12] Speaker 04:
But what about the way?

[00:09:13] Speaker 04:
Even his, he said the difference is that increasing concentration versus increasing strength.

[00:09:19] Speaker 04:
Isn't that a different way?

[00:09:20] Speaker 06:
It is a different way.

[00:09:23] Speaker 06:
And under the doctrinal equivalence, as long as those ways are substantially similar, you can find infringement.

[00:09:29] Speaker 06:
Dr. Sinden declared.

[00:09:30] Speaker 04:
Did he say anything?

[00:09:32] Speaker 04:
I just couldn't find anything in his opinion where he said,

[00:09:36] Speaker 04:
that one of ordinary skill and art would understand those two things to be substantially equivalent.

[00:09:43] Speaker 06:
I refer the court to Appendix 855, paragraph 7 of Dr. Sandick's declaration.

[00:09:55] Speaker 06:
And keep in mind that what I'm about to read is not converted by any submission from ABI.

[00:10:03] Speaker 06:
It's Appendix 855.

[00:10:07] Speaker 06:
In the mid-1980s, a person of ordinary skill in the art of nucleotide analysis sequencing would have viewed as insubstantial the difference between PCR amplification in the accused products and the use of enzymes attached to Avidin to amplify the signal of a biotinylated nucleotide.

[00:10:25] Speaker 06:
That's the schematic in column 19.

[00:10:27] Speaker 06:
As to the indirectly detectable A of claim one, the use of PCR to amplify the signal of a DNA sequence is labeled by the fluorescent dye terminators in the accused products

[00:10:37] Speaker 06:
serves the same function to make the signal detectable by the methodology to be employed in ways that differ insubstantially, increasing concentration versus increasing strength, to yield the identical result, a detectable signal.

[00:10:50] Speaker 06:
So in claim one, we are amplifying the signal by associating a weakly signaling A with a stronger signaling source.

[00:10:59] Speaker 06:
In the accused products, we're doing that amplification by increasing the concentration of A to a point where it can be detected.

[00:11:06] Speaker 04:
But so that bold assertion without any kind of explanation as to how those two are effectively the same is supposed to be enough?

[00:11:17] Speaker 06:
And it is enough.

[00:11:18] Speaker 06:
And I refer to the court's decision in the Brilliant Instruments case, where there was an expert declaration of basically an identical scope to the one submitted by Dr. Senden

[00:11:33] Speaker 06:
and this court found that such a declaration raised a genuine issue of disputed fact and thereby vacated the summary judgment of non-infringement under the Doctrine of Law.

[00:11:42] Speaker 02:
I want to take you back to Pfizer.

[00:11:44] Speaker 02:
Okay.

[00:11:44] Speaker 02:
Your argument that Pfizer applies here hinges on a finding of improper dependence, which at least in that case meant that the two claims dealt with non-overlapping subject matter.

[00:11:55] Speaker 02:
Right.

[00:11:56] Speaker 02:
Why do you think that claim one and its dependent claims here do not have overlapping subject matter?

[00:12:02] Speaker 06:
Because claim one has been construed in a way that A cannot be the whole of the signaling moiety.

[00:12:08] Speaker 06:
Claim 67, 68, and 70 on their express terms define an A that can be the entire signaling moiety and expressly detected.

[00:12:17] Speaker 06:
Therefore, their scope is entirely outside of the scope of A as this court has construed A in claim one and Pfizer applies fully to this case.

[00:12:27] Speaker 06:
What ABI should have requested this court to do was to hold claims 67, 68, and 70 invalid for improper dependence.

[00:12:35] Speaker 06:
But ABI didn't do that.

[00:12:36] Speaker 06:
Instead, they asked this court to hold those claims not infringed, which is improper in light of Pfizer and in light of multi-layer stretch film.

[00:12:45] Speaker 06:
These claims have the scope that they define.

[00:12:48] Speaker 05:
You're into your rebuttal.

[00:12:49] Speaker 05:
OK.

[00:12:50] Speaker 05:
Save it.

[00:12:53] Speaker 05:
Thank you.

[00:13:04] Speaker 00:
Good morning, Your Honors.

[00:13:05] Speaker 00:
May it please the Court, Rob Hoffman, for a Clara.

[00:13:08] Speaker 00:
Judge Wallach, I'll pick up just where you left off.

[00:13:10] Speaker 00:
What I want to read is the second sentence of Section 112D of the patent statute.

[00:13:18] Speaker 00:
A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.

[00:13:28] Speaker 00:
What that means, in unambiguous terms, is that the limitations of the claim of an independent claim are automatically part of the dependent claim.

[00:13:38] Speaker 00:
So the limitation at issue in the prior appeal is still at issue when we're talking about claims of 60-70-60.

[00:13:45] Speaker 02:
Is it your understanding that the dependent claims recite structures that are always capable of direct detection?

[00:13:52] Speaker 00:
I don't know the answer to that.

[00:13:54] Speaker 00:
It may be that they are.

[00:13:56] Speaker 00:
But that doesn't preclude the need to claim an infringement, to have also the claim structure that is claimed in claim one.

[00:14:05] Speaker 00:
A has to be something that complexes with something else to form the signaling moiety.

[00:14:12] Speaker 00:
And there's no dispute that our products don't do that.

[00:14:15] Speaker 00:
That's the issue.

[00:14:17] Speaker 00:
And what Mr. Spears, I think, respectfully does is he gets away from the claim language and what the claim limitation really is.

[00:14:26] Speaker 00:
This is a modified nucleotide described to have a very particular structure.

[00:14:31] Speaker 00:
The structure is that it's been changed in such a way that it adds this part called, referred to as A. This A is a little molecule that is capable of complexing with something else.

[00:14:44] Speaker 00:
chemical reaction with something else to form a signaling moiety.

[00:14:49] Speaker 00:
Our products don't do that.

[00:14:51] Speaker 00:
Our products are modified in such a way that we have a very large molecule attached to our terminator molecules.

[00:14:58] Speaker 04:
But before we get to what your products do, we've got to conclude that the lower court's interpretation of our prior opinion was correct and that the claim construction that limits 67, 68, and 72 direct detection

[00:15:12] Speaker 04:
I mean, indirect detection only is correct, right?

[00:15:15] Speaker 00:
Agreed.

[00:15:16] Speaker 00:
And let's talk about that, the prior opinion.

[00:15:19] Speaker 00:
It begins by reciting all five claims at issue in the prior litigation, in the prior trial.

[00:15:25] Speaker 00:
It talks about the claims at issue throughout the appeal.

[00:15:28] Speaker 00:
It refers to claim one as representative of the claim limitations applicable to all for the obvious reason that claim one

[00:15:36] Speaker 00:
is the independent claim at issue and the claim limitations automatically pursuant to 112D apply.

[00:15:44] Speaker 00:
It then construes the critical language in the claim at least one component phrase and then also the linkage group that connects this A does not substantially interfere with formation of the signaling moiety and properly concludes

[00:16:01] Speaker 00:
that the claim does not cover a modified nucleotide that has a molecule attached to it that is itself the entire signaling moiety at issue.

[00:16:12] Speaker 00:
And then it concludes by saying it doesn't reach our enablement or written description arguments, which were expressly raised as alternative arguments

[00:16:22] Speaker 00:
If any claim, if you go back and you look at pages 50 and 59 of our prior briefing, where we begin both the written description and enablement arguments, we say if any claim at issue in this appeal is construed to cover direct detection, then it's invalid for lack of written description.

[00:16:41] Speaker 02:
Look, if we believe all the dependent claims have to be capable of indirect attention, everybody's going to agree that summary judgment was appropriate.

[00:16:50] Speaker 02:
In that case,

[00:16:51] Speaker 02:
do we need to get to the question of invalidity of the dependent claims?

[00:16:55] Speaker 02:
And I'm asking that because I'm looking at footnote two on page 29 and the prior oral argument.

[00:17:02] Speaker 02:
And you noted that your counsel at oral argument last time suggested that limiting the patent to indirect detection would probably leave claim 70.

[00:17:21] Speaker 02:
with no meaningful scope, but that 67 and 68 could probably be reconciled with the claims construction.

[00:17:29] Speaker 02:
How would you reconcile 67 and 68?

[00:17:31] Speaker 00:
Well, again, I don't see that primarily as my job.

[00:17:34] Speaker 00:
I don't know if it has any scope, but since you asked what I would say.

[00:17:37] Speaker 00:
Well, since it's in your footnote.

[00:17:39] Speaker 00:
I don't know what an indicator molecule means.

[00:17:42] Speaker 00:
That's the key term in claim 67.

[00:17:44] Speaker 00:
But what I do know is there's no logical reason why whatever that indicator molecule is,

[00:17:50] Speaker 00:
that it shouldn't have to complex with some other chemical.

[00:17:54] Speaker 00:
And remember, that's exactly what the claim requires.

[00:17:57] Speaker 00:
It shouldn't have to complex with some other chemical in order to form the signaling moly that is then used to enable detection.

[00:18:05] Speaker 00:
I don't know whether that's necessarily the way you would read it.

[00:18:08] Speaker 00:
I don't see that, again, as my job to try and fill content for a 13-year-later added dependent claim.

[00:18:16] Speaker 00:
that if it's given the scope that Enzo is asserting is, in our view, invalid to begin with anyway.

[00:18:22] Speaker 00:
And I want to just pause over our invalidity arguments.

[00:18:24] Speaker 00:
Not only did this court did not reach our prior invalidity arguments, which would be a very peculiar way to dispose of that prior appeal if the court did not construe all the dependent claims to be limited by the limitations of claim one, the representative claims.

[00:18:43] Speaker 00:
So that's one.

[00:18:44] Speaker 00:
And two, as for improper dependency under 112D, that was raised.

[00:18:49] Speaker 00:
They, for the first time, they did not say anywhere in the prior briefing, Your Honors, there's no reason for us to have an appeal here, because they've only challenged claims scope as to claim one.

[00:19:01] Speaker 00:
This is the last time around.

[00:19:02] Speaker 00:
They didn't say last time.

[00:19:03] Speaker 00:
The only challenge claims scope is to claim one.

[00:19:05] Speaker 00:
So even if you agree with them on the construction of claim one, well, the judgment's going to stand under the dependent claims.

[00:19:12] Speaker 00:
They never said that.

[00:19:13] Speaker 00:
So when they went back into the district court, and for the first time we saw this, said, what are they doing?

[00:19:19] Speaker 00:
First of all, we couldn't have imagined that.

[00:19:21] Speaker 00:
We didn't believe that that was a plausible reading of anything that had happened in the prior appeal.

[00:19:25] Speaker 00:
And then when they said it, we asserted it at the first opportunity.

[00:19:28] Speaker 00:
There's no waiver when the first time you're given an opportunity to raise an argument, you do.

[00:19:34] Speaker 00:
And so they've admitted improper dependency.

[00:19:37] Speaker 00:
So even if you think that the prior panel did not construe the claims,

[00:19:41] Speaker 00:
as limited by the indirect detection only limitations in the, in claim one.

[00:19:47] Speaker 00:
It's invalid for 112D.

[00:19:48] Speaker 00:
It's also invalid for written description.

[00:19:50] Speaker 00:
They're also invalid for written description enablement as well as we argued in the proper appeal.

[00:19:54] Speaker 00:
My own view is this is already done and tied up in a bow by the prior appeal.

[00:19:59] Speaker 00:
So I'll turn to the doctrine of equivalence.

[00:20:01] Speaker 00:
And Judge O'Malley, I think, I want to, I want to, I want to begin where you were used to, where you were as I understood your questions.

[00:20:08] Speaker 00:
Here's the problem.

[00:20:10] Speaker 00:
Did you notice that Mr. Spears started talking about signal amplification?

[00:20:16] Speaker 00:
But doctorate of equivalence is a claim limitation by claim limitation analysis.

[00:20:21] Speaker 00:
Signal amplification is not the claim limitation.

[00:20:24] Speaker 00:
Signal amplification is, in their view, the function of the indirect detection limitation.

[00:20:29] Speaker 00:
Now, we don't necessarily agree with that, but let's hold that.

[00:20:32] Speaker 00:
In terms of the way, what you were talking about,

[00:20:36] Speaker 00:
Go ahead and look through that Sinden declaration.

[00:20:38] Speaker 00:
I've read it over and over and over again.

[00:20:40] Speaker 00:
At no time does Dr. Sinden say, so I've looked at the way the indirect detection claim limitation, which requires the small molecule that's capable of complexing with something else, and I've looked at it and said, oh, that's the same way of accomplishing a signal amplification as having a large molecule

[00:21:02] Speaker 00:
attached to a modified nucleotide that you have to develop a special enzyme in order to enable it to hybridize effectively with an oligopoly.

[00:21:14] Speaker 00:
Well, he didn't explain it.

[00:21:15] Speaker 00:
He said it.

[00:21:17] Speaker 00:
I actually don't think he said that at all.

[00:21:20] Speaker 00:
He didn't talk about the underlying mechanisms that are really at issue.

[00:21:26] Speaker 00:
You're correct that he baldly asserted that PCR

[00:21:30] Speaker 00:
is insubstantially different from the avidin peroxidase reaction.

[00:21:34] Speaker 00:
But PCR isn't the feature of our claim, the direct detection feature of structure of our claim that corresponds to the claim limitation at issue, which again is not the avidin peroxidase reaction, but is this A, complexing with something else, structure of the claim.

[00:21:52] Speaker 01:
That's completely absent.

[00:21:53] Speaker 01:
And that's why we didn't put in an affidavit in response.

[00:21:56] Speaker 01:
We didn't have anything to respond to.

[00:21:58] Speaker 03:
I didn't want to break the thread of our argument

[00:22:00] Speaker 03:
counsel, but be careful about denigrating false assertions.

[00:22:03] Speaker 03:
Everything I say.

[00:22:04] Speaker 00:
Your Honor, I've been there.

[00:22:07] Speaker 00:
I'm right there with you.

[00:22:09] Speaker 00:
I'm right there with you.

[00:22:11] Speaker 04:
What impact does the recent Milan institutional case have

[00:22:18] Speaker 04:
where we say function way result isn't necessarily the end of the inquiry.

[00:22:22] Speaker 00:
Well, I don't know how you can get, whatever else there is to do, I don't see how you can get in this claim to this scope of equivalence.

[00:22:33] Speaker 00:
And let me explain why.

[00:22:34] Speaker 00:
If you have cases over and over and over again, the court has said doctrine of equivalence cannot be used to jettison structural limitations of claims.

[00:22:43] Speaker 00:
And it is repeatedly observed that a structural claim limitation may have little

[00:22:47] Speaker 00:
or no scope or range of equivalence.

[00:22:50] Speaker 00:
And let's look at the patent itself, or this.

[00:22:53] Speaker 00:
And if you look at column 6 of the patent, column 6, lines 30 to 38, and I'm going to start at line 30 and then jump down to line 36.

[00:23:04] Speaker 00:
Column 6 lists several quote, essential criteria, essential criteria of this invention.

[00:23:13] Speaker 00:
And the first one refers to the fact that the nucleotide is modified in such a way that it adds something normally not found, which it calls a probe.

[00:23:22] Speaker 00:
That's A. That's A. And then the second modification says the probe must react specifically with chemical or biological reagents to provide a sensitive detection system.

[00:23:35] Speaker 00:
That's what I'm talking about, the structure.

[00:23:37] Speaker 00:
This structure is essential.

[00:23:39] Speaker 00:
This structure is as important to the claimed invention as the ability to be detected itself.

[00:23:45] Speaker 00:
And your cases, over and over and over again, saying an essential feature of the patent like that, cannot be within the scope of equivalence, because that's the equivalent of saying that A is not A. Or as in more, that minority means majority.

[00:24:00] Speaker 00:
Or as in the more recent power integrations case, where you had an expert testimony saying, I worked on it.

[00:24:06] Speaker 00:
I couldn't get it to, there was a feedback signal issue.

[00:24:10] Speaker 00:
And he said, I couldn't get it to work with one, so I made multiple feedback signals.

[00:24:16] Speaker 00:
And the court said, well, and then when the patentee tried to cover a single feedback signal within the scope of equivalence, the court said, you can't do that.

[00:24:24] Speaker 00:
You can't do that.

[00:24:24] Speaker 00:
And this is just like that.

[00:24:26] Speaker 00:
You've got a claimed structure that clearly requires an additional chemical reaction.

[00:24:31] Speaker 00:
Again, earlier in the patent, it refers to summarizing the invention at the bottom of column two to the top of column three.

[00:24:39] Speaker 00:
these nucleotide derivatives, the modified nucleotide, as well as polynucleotides and coenzymes that will interact specifically and uniquely with proteins.

[00:24:50] Speaker 00:
The interaction is essential.

[00:24:52] Speaker 00:
And that's why, as a matter of law, there is simply no way to include our direct detection product, our product where there is no feature that interacts at all.

[00:25:04] Speaker 00:
Not interacting and interacting cannot be equivalent.

[00:25:07] Speaker 00:
and when interaction with some other chemical component, some other chemical, is essential to the claim, then whatever scope of equivalence these claims have, it can't cover that.

[00:25:17] Speaker 00:
I respectfully suggest that it has very little scope of equivalence, and there's nothing wrong with that.

[00:25:23] Speaker 00:
There's just nothing wrong with that.

[00:25:24] Speaker 00:
Unless your honors have further questions.

[00:25:26] Speaker 00:
Thank you.

[00:25:27] Speaker 00:
Thank you.

[00:25:38] Speaker 06:
This is not a case in which we are asserting a scope of equivalence that goes directly contrary to what is provided in claim one.

[00:25:46] Speaker 06:
Yes, the patent does describe, in very strong terms, how important it is to take weakly signaling A's and associate them with a strong signaling source to detect them.

[00:25:58] Speaker 06:
But doctrine of equivalence, you're starting with an assumption that there is no literal infringement.

[00:26:03] Speaker 06:
And while all those statements may be relevant to the construction of claim one,

[00:26:07] Speaker 06:
They are not relevant to adoption of equivalence analysis.

[00:26:09] Speaker 04:
Well, what about the last point that he made in column six where it talks about that it would be critical to have a reaction?

[00:26:18] Speaker 04:
How can you have something that's critical to the claims and yet, by way of equivalence, still be able to infringe?

[00:26:26] Speaker 06:
I'm going to quote from this court's decision in Cadence v. Excella Pharmaceuticals.

[00:26:31] Speaker 06:
In that particular case, the patent claimed a specific order of process operations, steps one, step two.

[00:26:38] Speaker 06:
And the accused infringement, they were carried out in the reverse order.

[00:26:42] Speaker 06:
So the infringer said, this is the very antithesis of what is being claimed, much like the argument that ABI is advancing here.

[00:26:51] Speaker 06:
The court did not find that at all relevant, noting that vitiation is not an exception or threshold determination that forecloses resort to the doctrine of equivalence.

[00:27:00] Speaker 06:
but instead is a legal conclusion of a lack of equivalence based on the evidence presented in the theory of equivalence asserted.

[00:27:07] Speaker 06:
In this particular case, the evidence presented is Dr. Sendin's function-way result analysis, where he takes as a starting point the function that's identified in the patent, signal amplification, finds the same function carried out by PCR enzymes in the accused infringement, and then goes on to say that these are substantially similar ways to yield an identical result.

[00:27:29] Speaker 06:
And that analysis was entirely proper and, at the very least, raised a disputed issue of material fact.

[00:27:36] Speaker 06:
I'd like to conclude by noting in response to a concern that Judge Wallach raised, Aplara has not cited a single case, nor is there a single case for them to cite, that has used an independent claim to claw back scope from a claim from which it depends.

[00:27:54] Speaker 06:
Instances of improper independence, such as Pfizer, such as multilayer stretch, such as this case, occur infrequently.

[00:28:02] Speaker 06:
But when they do, what the defendant has to advocate for is a finding of invalidity, which ABI never did before the prior panel that heard this case.

[00:28:12] Speaker 06:
Thank you.

[00:28:12] Speaker 06:
We thank both sides.

[00:28:13] Speaker 06:
The case is submitted.