[00:00:00] Speaker 03:
versus Kumar, Biosciences 8.

[00:00:58] Speaker 03:
You have reserved three minutes just for your vote, correct?

[00:01:02] Speaker 03:
Yes.

[00:01:02] Speaker 03:
You may start shooting.

[00:01:33] Speaker 05:
Good morning and may it please the court.

[00:01:35] Speaker 05:
I'd like to begin by jumping into the board's motivation to combine in this case.

[00:01:42] Speaker 05:
We believe that the board both failed to support its motivation to combine with substantial evidence and made an error of law in doing that analysis.

[00:01:53] Speaker 05:
So how does the motivation to combine work in this case?

[00:01:57] Speaker 05:
Well, like IDT's patent, Gardner, the primary reference, describes a PCR method for amplifying target amino acid sequences.

[00:02:08] Speaker 05:
And those amino acid sequences are targeted with targeted primer pairs.

[00:02:14] Speaker 05:
And those targets overlap.

[00:02:16] Speaker 05:
And it's important that they overlap because in the area of the overlap, there is a danger of creating something that the patent claims call the third amplicon.

[00:02:26] Speaker 05:
It's also called a mini-amplicon, a short-amplicon, but it's the overlap region.

[00:02:31] Speaker 05:
And when those amplicons, the amplified regions, appear, they dominate the reaction, and you don't amplify your targets.

[00:02:39] Speaker 05:
Instead, you just get these short-amplicons that don't mean anything.

[00:02:46] Speaker 05:
Now Gardner, and we explain this in the patent, sort of how Gardner works, Gardner addresses this problem.

[00:02:53] Speaker 05:
by separating all the overlapping targets into two separate reactions.

[00:02:59] Speaker 05:
That's how Gardner does it.

[00:03:01] Speaker 05:
The board says that a person of ordinary skill in the art would be motivated to run Gardner's reaction in a single reaction vessel.

[00:03:10] Speaker 05:
and relies on Gardner for that purpose.

[00:03:13] Speaker 05:
But everyone agrees, then you have this problem of the third amplicon when you do that.

[00:03:20] Speaker 05:
And so how do you address that?

[00:03:22] Speaker 05:
Well, the board goes on.

[00:03:24] Speaker 03:
You have the problem of what?

[00:03:25] Speaker 05:
The third amplicon.

[00:03:26] Speaker 05:
OK.

[00:03:27] Speaker 05:
The board goes on and provides a second part of the motivation, and that is that

[00:03:33] Speaker 05:
Gardner also mentions one could run a step to remove the short amplicons from the reaction, and thereby avoid the need to.

[00:03:43] Speaker 03:
That seems to be a pretty clear invitation to a proposal to combine.

[00:03:52] Speaker 05:
Even accepting the board's work here, there's no evidence.

[00:03:57] Speaker 05:
The next step is the board says, and Lau, the secondary reference, provides such a step.

[00:04:04] Speaker 05:
And the problem is that Lao doesn't provide such a step.

[00:04:08] Speaker 05:
So the motivation to add Lao to Gardner fails.

[00:04:12] Speaker 05:
And the reason why Lao fails in this regard is when we talk about short amplicons, Gardner and Lao are talking about different sizes.

[00:04:23] Speaker 00:
Do you agree that Gardner discloses at least some amplicons that are within Lao's size limitations?

[00:04:32] Speaker 05:
Yes.

[00:04:33] Speaker 05:
So Gardner says, in his Gardner's design rationale for the primers, he says that the overlaps have to be a certain size.

[00:04:44] Speaker 05:
They have to be big.

[00:04:45] Speaker 05:
40 to 80 base pairs, that's not enough.

[00:04:50] Speaker 05:
It's got to be bigger than that.

[00:04:52] Speaker 05:
And so we asked the question, well, how much bigger?

[00:04:54] Speaker 05:
And we looked at Gardner's example, and 30 out of 36

[00:05:01] Speaker 05:
overlap regions were bigger than 100 base pairs.

[00:05:04] Speaker 03:
So when we say bigger, we're talking about 100 base pairs.

[00:05:08] Speaker 05:
Larger than 100 base pairs.

[00:05:10] Speaker 05:
Larger than.

[00:05:10] Speaker 05:
Some of them are more than 200 base pairs.

[00:05:13] Speaker 05:
And the problem when you say, well, the board does this, when you look at only the small ones and say, well, Lao would take those out, the first part of the motivation

[00:05:27] Speaker 05:
to run the reaction in a single tube, you need to get them all.

[00:05:37] Speaker 05:
Otherwise, you don't get it.

[00:05:40] Speaker 05:
You need to get them all.

[00:05:41] Speaker 05:
You need to get all of those overlap amplicons.

[00:05:44] Speaker 05:
Otherwise, you can't run it in a single vessel.

[00:05:47] Speaker 05:
Because what will happen is, for a few of the overlapping targets, you'll get your targets.

[00:05:54] Speaker 05:
But for the vast majority of your overlapping targets, you won't.

[00:05:58] Speaker 05:
You'll get the third amplicon.

[00:05:59] Speaker 05:
You'll get the overlap region.

[00:06:01] Speaker 05:
It will dominate the reaction for those targets.

[00:06:04] Speaker 05:
And you won't get those targets.

[00:06:06] Speaker 05:
So the idea that you would run Gardner in a single... The third amplicon you're talking about, that's a micro-amplicon.

[00:06:14] Speaker 05:
We don't call it micro, but it is short.

[00:06:18] Speaker 05:
We call it in the patent a mini-amplicon, but it's just the overlapping region.

[00:06:25] Speaker 05:
And so if you take the board's position that you don't need to get rid of all of them, then its motivation doesn't work.

[00:06:34] Speaker 05:
Because you still have, for Gardner's example, the vast majority of the targets won't get amplified.

[00:06:43] Speaker 05:
It won't run in one vessel.

[00:06:45] Speaker 05:
It won't run correctly.

[00:06:49] Speaker 00:
Are you contending that there can be no small applicants at all?

[00:06:53] Speaker 00:
I feel like that's what I'm hearing.

[00:06:54] Speaker 00:
But tell me if I'm accurate in what you're describing today.

[00:06:58] Speaker 05:
In order to meet the board's motivation, this two-part motivation that

[00:07:03] Speaker 05:
You run Gardner's reaction in one vessel and that you get there by running a step to take out the small amplicons.

[00:07:12] Speaker 05:
If you don't get them all, then in that one vessel, you won't amplify all your targets.

[00:07:16] Speaker 05:
You'll amplify some of your targets, but not others.

[00:07:19] Speaker 05:
And Gardner is left facing the problem that Gardner was facing all along and solved by separating the overlapping targets.

[00:07:31] Speaker 03:
But Lao teaches the problem, the gardener states.

[00:07:36] Speaker 05:
So Lao teaches a process for modifying the primers to remove some small amplicons.

[00:07:46] Speaker 05:
And Lao is very clear that his modification works at 100 base pairs and below.

[00:07:54] Speaker 05:
Above 100 base pairs, Lao preferentially amplifies

[00:08:01] Speaker 05:
And so for those bigger base pairs, the bigger amplicons and overlap amplicons in Gardner, Lao would amplify those, and you wouldn't get your targets.

[00:08:13] Speaker 00:
I thought in reading the briefs and the materials submitted that really the concern was more with having the small or many amplicons dominate the reaction as opposed to needing to eliminate them all.

[00:08:26] Speaker 00:
Am I misunderstanding what was previously presented?

[00:08:31] Speaker 05:
So we don't need the mini-amplicons to dominate the reaction.

[00:08:34] Speaker 05:
We want to stop the mini-amplicons from dominating.

[00:08:36] Speaker 00:
Yes, but I thought the concern was stopping dominating.

[00:08:39] Speaker 00:
I apologize.

[00:08:39] Speaker 00:
I thought the concern was stopping dominating as opposed to full-on elimination.

[00:08:43] Speaker 00:
I feel like those are two different things that you're saying.

[00:08:47] Speaker 05:
Thank you for asking that question.

[00:08:50] Speaker 05:
Let's back up and look at what I think one of the problems with the arguments are.

[00:08:54] Speaker 05:
So when we look at the amplicons in Gardner, there are 36 different overlaps.

[00:09:02] Speaker 05:
Each one of those is a different third amplicon.

[00:09:05] Speaker 05:
And I don't mean to suggest that for each individual overlap, you have to get rid of every single one of them.

[00:09:13] Speaker 05:
That's not what I'm saying.

[00:09:16] Speaker 00:
Okay, because we can use the word all.

[00:09:17] Speaker 00:
That implies we need to get rid of all of them.

[00:09:19] Speaker 05:
Okay, but you do need to reduce them, stop them from dominating the reaction for all 36, or you can't run them in the same vessel.

[00:09:31] Speaker 05:
You won't get your targets.

[00:09:34] Speaker 04:
You said that allow doesn't allow for that, but that's not what the board didn't make a finding on that.

[00:09:42] Speaker 04:
Well, the... I know that's your argument,

[00:09:45] Speaker 04:
But they didn't say that.

[00:09:47] Speaker 05:
What the board said about Lau that we disagree with is Lau provides such a step.

[00:09:55] Speaker 05:
And that such a step takes out the small amplicons from the gardeners.

[00:10:00] Speaker 04:
They didn't make a finding on a sufficient number.

[00:10:04] Speaker 05:
They didn't.

[00:10:06] Speaker 03:
So the question is, do you want us to construe the claim to mean that all applicants have to be removed, eliminated?

[00:10:16] Speaker 05:
Well, for the purposes of motivation, we don't think we need to talk about the claim construction at all.

[00:10:22] Speaker 03:
Yes, we're making this motivation, but really you're making a claim construction argument here.

[00:10:29] Speaker 05:
I'm happy to talk about the clang construction, but I don't think that's the argument here.

[00:10:33] Speaker 05:
So for example, the intelligent biosystems case.

[00:10:41] Speaker 05:
I think it has facts just like these.

[00:10:42] Speaker 05:
It doesn't depend on clang construction.

[00:10:44] Speaker 05:
It's a pure failure of evidence for motivation.

[00:10:47] Speaker 05:
And what happened there was it was another PCR reaction case.

[00:10:51] Speaker 05:
And there was a motivation to add, I believe it was an azido methyl group.

[00:10:58] Speaker 05:
for the purpose of improving the efficiency and reliability of the PCR reaction.

[00:11:08] Speaker 05:
And what actually happened was, it turns out that for doing that, to achieve that motivation, an important aspect is the part that you add, it has to perform quantitative de-blocking.

[00:11:20] Speaker 03:
And it turns out the evidence showed that- We're running out of time.

[00:11:25] Speaker 03:
I want to make sure that I understand.

[00:11:28] Speaker 03:
Is it your argument that the claims do not teach removal of all applicants?

[00:11:35] Speaker 05:
The claims do not teach removal of all applicants?

[00:11:41] Speaker 05:
It boils down to the construction issue.

[00:11:48] Speaker 05:
And the claims are a little different.

[00:11:50] Speaker 05:
They're the same, but they're different.

[00:11:52] Speaker 05:
So the claims actually say,

[00:11:55] Speaker 05:
You put all this stuff in one reaction.

[00:11:59] Speaker 05:
There is an overlap.

[00:12:00] Speaker 05:
It produces an overlap amplicon.

[00:12:03] Speaker 05:
And there is a way to treat it so that that third amplicon, the overlap amplicon, forms a stable secondary structure.

[00:12:12] Speaker 05:
And that structure is not further amplified.

[00:12:16] Speaker 03:
You could claim to require removal of all our amplifiers.

[00:12:25] Speaker 05:
in the sense that it uses comprising language, no.

[00:12:30] Speaker 05:
There could be other things in the reaction, and it's still part of the claims.

[00:12:34] Speaker 00:
Did you make a claim construction argument to the PTAB concerning whether claim one would require all short amplicons to be removed or just some of them?

[00:12:46] Speaker 00:
Was that ever made to the PTAB?

[00:12:48] Speaker 05:
No, and remember, we're not arguing for one given third amplicon that they all need to be removed.

[00:12:57] Speaker 05:
The court was correct about that.

[00:12:58] Speaker 05:
It just needs to be reduced to a level that it doesn't dominate.

[00:13:03] Speaker 05:
We didn't make a claim construction argument on this topic to the board because we thought the ordinary meaning suffice, that when it forms a stable secondary structure, stable means stable.

[00:13:16] Speaker 05:
So it isn't further amplified because it is a stable structure.

[00:13:21] Speaker 05:
And the board did something different than that.

[00:13:25] Speaker 05:
And that's why we have a problem with them there.

[00:13:27] Speaker 05:
And that impacts the reasonable expectation of success argument.

[00:13:31] Speaker 05:
But I don't think it impacts the motivation argument.

[00:13:35] Speaker 05:
The evidence doesn't support adding Lau to Gardner because Lau will not allow Gardner to run in a single PCR reaction.

[00:13:44] Speaker 05:
And that is the motivation that the board applied.

[00:13:48] Speaker 05:
The evidence isn't fair to support that.

[00:13:51] Speaker 05:
And I say that with such confidence because IDT's expert did this analysis, looked at Gardner, carefully calculated the size of the overlaps, and provided that analysis.

[00:14:06] Speaker 05:
Pilar's expert admitted on re-examination that she never considered the size of the overlaps.

[00:14:13] Speaker 05:
So we think the evidence only goes to one right here.

[00:14:31] Speaker 03:
That's correct.

[00:14:33] Speaker 01:
That's correct.

[00:14:33] Speaker 01:
Yes, Your Honor.

[00:14:35] Speaker 01:
May it please the court, Brian Matsui, for a pillar.

[00:14:38] Speaker 01:
Substantial evidence supports the board's findings that the claims would have been obvious.

[00:14:42] Speaker 01:
For reasonable expectation of success, IDT starts with the claim construction argument that it never made and demands more than its patent requires.

[00:14:51] Speaker 01:
And for motivation, IDT pivots to an argument that it made when contesting reasonable expectation of success.

[00:14:57] Speaker 01:
and asked the court to ignore findings or take undisputed facts that were found against it.

[00:15:02] Speaker 01:
So I think the best place to start is motivation, because that's where IDT spent most of its time arguing.

[00:15:10] Speaker 01:
The first issue I'd like to just point out is that they raised this issue really as motivation.

[00:15:14] Speaker 01:
as reasonable expectation of success.

[00:15:19] Speaker 01:
They had one sentence in their patented response at appendix 447 which said, as discussed in detail below in section 60, the record evidence demonstrates that the undesired overlap amplicons of Garner would have been too large for elimination by Lau's method.

[00:15:35] Speaker 01:
In section 60 is reasonable expectation of success.

[00:15:38] Speaker 00:
What appendix page did you just say?

[00:15:39] Speaker 00:
I apologize.

[00:15:39] Speaker 01:
Sure, it's appendix 447.

[00:15:44] Speaker 01:
And it's at the top, the first full sentence in there.

[00:15:51] Speaker 01:
And that's where they basically just cross-reference their reasonable expectation of success argument.

[00:15:59] Speaker 01:
And so that's why I think when we're looking at the board's decision, we're looking at reasonable expectation of success for this pivoted motivation argument that they're now presenting to this court.

[00:16:12] Speaker 01:
Judge Cunningham, I think that your point about the fact that even if you take sort of the most restrictive view of Lau, which is how the board described it, they still found that six of the 36 short amplicons would be removed.

[00:16:28] Speaker 01:
And that finding supports motivation right there because it's showing that a person of ordinary skill in the art would look at Gardner's invitation

[00:16:35] Speaker 01:
and it would see that even if you take this very restrictive view of Lao, you're still going to remove the third amplicon.

[00:16:44] Speaker 01:
Gardner's example that they're pointing to, that's not Gardner.

[00:16:48] Speaker 01:
Gardner is not an article about

[00:16:50] Speaker 01:
the genome sequence for this specific gene.

[00:16:53] Speaker 01:
It's a model.

[00:16:55] Speaker 01:
It explains that this is a model we're going to use.

[00:16:58] Speaker 01:
And the example has 53 different primers in it.

[00:17:02] Speaker 01:
And those 53 different primers create all these different amplicons.

[00:17:06] Speaker 01:
Gardner doesn't require you to have 53 primers, it just wants a multiplex reaction, and that only requires 4 primers, which happens to be the number of primers that the claim requires.

[00:17:17] Speaker 01:
If we look at claim 1, it requires a first forward primer,

[00:17:22] Speaker 01:
a second forward primer, a first reverse primer, and a second reverse primer.

[00:17:27] Speaker 01:
And from those primers, you're going to get three amplicons.

[00:17:31] Speaker 01:
A first amplicon, a second amplicon, and a third amplicon.

[00:17:35] Speaker 01:
So a person of ordinary skill in the art trying to achieve the claim of invention would not have to use 53 primers in Gardner's specific example.

[00:17:44] Speaker 01:
What we have here really is bodily incorporation.

[00:17:48] Speaker 01:
We have a patent owner taking

[00:17:51] Speaker 03:
A person would have to consider the size limitation elements that are cited in the map, correct?

[00:17:59] Speaker 01:
If the board actually found that that was, the board found that there was a teaching about 100 base pairs.

[00:18:05] Speaker 01:
But if we look at Lao itself, which again, the board said this was the most restrictive reading of Lao.

[00:18:13] Speaker 01:
If we look at Lao itself, for example, the 100 base pair

[00:18:18] Speaker 01:
example comes from Appendix 966 in paragraph 73, and it says in the middle of that paragraph, as noted below, in some embodiments, insert sections of at least 100 base pair are generally used.

[00:18:34] Speaker 01:
And so it's just talking about some embodiments.

[00:18:36] Speaker 03:
And then a little further down...

[00:18:41] Speaker 01:
Well, we didn't testify about amplicon size, because it's unnecessary.

[00:18:46] Speaker 01:
The teaching of Lao, which the board found in Appendix 22.

[00:18:51] Speaker 01:
Appendix 22.

[00:18:52] Speaker 02:
The board found that the teachings of Lao with the teaching size are immaterial?

[00:18:59] Speaker 01:
It says, first, as petitioner notes, this is the bottom of

[00:19:03] Speaker 01:
Appendix 22.

[00:19:04] Speaker 01:
First, as petitioner notes, Lau teaches that under its method, shorter amplicons will self-hybridize faster than longer amplicons, and that shorter amplicons thus take themselves out of the reaction.

[00:19:18] Speaker 03:
And that's the point here, is that you have a teaching... The issue here is not just with respect to shorter amplicons, or it's the size that we're talking about.

[00:19:31] Speaker 03:
That's what became

[00:19:33] Speaker 03:
relevant for

[00:19:35] Speaker 01:
I think only if you're looking at just combining the specific embodiment of Lau with the specific example of Gardner.

[00:19:45] Speaker 01:
And that's what this court has said, like in the axionics decision that we submitted in the 28-J letter, is that you don't do that.

[00:19:52] Speaker 01:
You don't try to see if by combining a first reference with a second reference, you're necessarily going to achieve the specific goal of the first reference.

[00:20:02] Speaker 01:
You're basing it upon what the claims require.

[00:20:05] Speaker 01:
And the claims require here only four primers and three amplicons.

[00:20:10] Speaker 01:
And the example in Gardner, which is just a specific example of the method, has 53 primers and it has 36 overlapping amplicons.

[00:20:22] Speaker 01:
None of that is required by the claims.

[00:20:25] Speaker 01:
In other words, if you were to take Gardner's method, which is what the authors were trying to show, this is the computational method they have to design primers.

[00:20:34] Speaker 01:
You could take those six amplicons and all the primers that basically form them and run that in a single reaction.

[00:20:44] Speaker 01:
But if you just use Gardner's method alone, you would have to use multiple reactions.

[00:20:49] Speaker 01:
And so that's why, even if we take the most narrow view of the art, so we're just incorporating one example into one embodiment, you still would have motivation from the teachings of these references that you would want to actually combine them

[00:21:08] Speaker 01:
giving gardeners express invitation, and allows teaching that you could actually eliminate shorter amplicons.

[00:21:17] Speaker 03:
So I'm going to ask you the same question I asked the other side.

[00:21:21] Speaker 03:
Do the claims here require the removal of all amplicons?

[00:21:26] Speaker 01:
No.

[00:21:26] Speaker 01:
All they require is the third amplicon.

[00:21:30] Speaker 01:
If we look at the claim language itself, at claim one.

[00:21:34] Speaker 03:
If they just require the removal, not all.

[00:21:38] Speaker 01:
So that's correct.

[00:21:40] Speaker 03:
Well, yes, that's right.

[00:21:44] Speaker 03:
So I think that there's nothing in the claims themselves.

[00:21:54] Speaker 01:
that require a specific size that gets removed.

[00:21:58] Speaker 01:
It just says the third amplicon is the amplicon that's removed.

[00:22:03] Speaker 01:
And it only requires, again, three amplicons here, not 36.

[00:22:10] Speaker 01:
like Gartner's method requires.

[00:22:15] Speaker 01:
And so I think what you're talking about, if you look at the claims themselves, they require the third amplicon.

[00:22:21] Speaker 01:
And we say the third amplicon is a category of amplicons.

[00:22:25] Speaker 01:
then yes, it requires the removal of basically all those amplicons.

[00:22:30] Speaker 01:
But that doesn't mean that if there were all these additional other amplicons that were in there, that those would also have to be removed, because the claim doesn't require that.

[00:22:40] Speaker 01:
The claim just says there's a third amplicon.

[00:22:44] Speaker 01:
So I think that that's...

[00:22:47] Speaker 01:
Perhaps the debate that's going on right now, it seems that the other side seems to be considering the claims to require more primers or more third amplicons than the claims actually state.

[00:22:59] Speaker 01:
Because they only require one third amplicon and four primers.

[00:23:04] Speaker 01:
Whereas if we look at Gardner's method, it's 53 primers and 36 amplicons.

[00:23:09] Speaker 03:
Well, I ask these questions because what's important to me here is with respect to this discussion we're having,

[00:23:21] Speaker 03:
evidence, and if there's no discussion as to that by the board, then I begin to have a hard time agreeing with him.

[00:23:33] Speaker 01:
Well, so I think that, Your Honor, I think that the board did have a discussion on that at Appendix 23, where it discusses, this is where it discusses the six of the 36.

[00:23:48] Speaker 01:
This is page 23, right?

[00:23:51] Speaker 01:
Page 23 where it says that

[00:23:59] Speaker 01:
This is where the board basically says that even under this restrictive reading of Lao, 30 of the 36 exceed the 100 nucleotides, but 6 don't.

[00:24:13] Speaker 01:
And so the board made this finding.

[00:24:15] Speaker 03:
When you say 100 nucleotides, you're referring to size.

[00:24:19] Speaker 01:
Size, 100 nucleotides.

[00:24:20] Speaker 01:
And I think that that's the argument that

[00:24:24] Speaker 01:
IDT is making is that 100 nucleotides is a cutoff in Lao, which that's not supported by any evidence because again, if you look at appendix 966 at paragraph 71, it says, remember the 101 said in some embodiments, now in appendix 96, it says at paragraph 71,

[00:24:47] Speaker 01:
In some embodiments, an insert that is short enough to reduce the likelihood that amplification will occur is between 1 and 200 nucleotides in length.

[00:24:56] Speaker 01:
So in this different embodiment, it's talking about a different size, 200 nucleotides.

[00:25:01] Speaker 01:
I think the point, though, is just to take a step back.

[00:25:05] Speaker 01:
This whole argument that they're making based upon amplicon size depends upon

[00:25:12] Speaker 01:
taking only narrow embodiments from the prior references and putting them together.

[00:25:19] Speaker 01:
Whereas an obvious analysis, and the one that we put forward in the board address, requires you to look at the teachings.

[00:25:26] Speaker 01:
And the teachings of Gardner are that you would have these multiplex reactions that would have a third amplicon, and that you would then have a method that could reduce the third amplicon, which is Lao.

[00:25:39] Speaker 01:
That doesn't mean that you need to

[00:25:40] Speaker 01:
stitch the two together from their specific examples.

[00:25:43] Speaker 01:
Because there are many examples that you could come up using Gardner's method that would meet even this 100 base pair requirement.

[00:25:52] Speaker 03:
For example, if it sounds now you're into reasonable expectation of success.

[00:25:56] Speaker 03:
Well, I mean, that's how they just find them.

[00:25:58] Speaker 03:
I want you to fully address that.

[00:26:00] Speaker 01:
Certainly.

[00:26:01] Speaker 01:
I mean, I think that the two issues are very tethered together here, just the way that it was presented to the board, and then the board then addressed it.

[00:26:11] Speaker 01:
I mean, they addressed this issue as reasonable expectation of success precisely because of the way that IDT framed it by just cross-referencing reasonable expectation of success.

[00:26:23] Speaker 01:
But on that, again, we're still in the situation where even if you look at

[00:26:28] Speaker 01:
the more narrow examples, you would have six of the 36 overlapping amplicons that still would be less efficiently amplified.

[00:26:39] Speaker 01:
But again, I think that that's the wrong analysis.

[00:26:41] Speaker 01:
And I think that at appendix 22, the board was recognizing more the teachings of Lao, which taught that there was short amplicons that would be removed.

[00:26:52] Speaker 01:
I would just like to also note

[00:26:54] Speaker 01:
At Gardner, when it discusses this, when the other side says there's just like 100 amplicon cutoff for, 100 nucleotide cutoff for Gardner, they mentioned that it's 40 to 80, and that's at appendix 1002 in the right-hand column.

[00:27:18] Speaker 01:
It says that

[00:27:20] Speaker 01:
Amplicons are allowed from anywhere in each region.

[00:27:23] Speaker 01:
Small overlaps, e.g.

[00:27:24] Speaker 01:
40 to 80, do not leave much room to find good priming regions.

[00:27:29] Speaker 01:
And then it goes down and says, and consequently, it may not be possible to find primers for all targets.

[00:27:35] Speaker 01:
When this happens, increasing the overlap and relaxing the primer specifications may be necessary.

[00:27:41] Speaker 01:
And so even Gardner itself is saying, 40 to 80 may not work, but you can still try it.

[00:27:47] Speaker 01:
And if it doesn't work, then you'd expand it.

[00:27:50] Speaker 01:
So there is no 100-amplicon cutoff in Gartner either.

[00:27:54] Speaker 01:
The only reason we get to the 100-amplicons is because we get to this specific example with respect to this one gene that Gartner put forward as an example.

[00:28:05] Speaker 01:
But that's not what Gartner is about.

[00:28:07] Speaker 01:
Gartner is about a model and how you would address these overlapping amplicons.

[00:28:12] Speaker 03:
What did the bloke say about reasonable education and success?

[00:28:17] Speaker 01:
I mean, the board found that once you get to the point that you don't have to remove all the short amplicons, because the claims don't require the removal of all short amplicons, then there is reasonable expectation of success.

[00:28:34] Speaker 01:
because Lao teaches that these short amplicons, the third amplicon, was self-hybridized and take itself out of the reaction.

[00:28:42] Speaker 01:
And then it looked at the example, even, of Gardner.

[00:28:48] Speaker 01:
And this is where it takes a restrictive reading of Lao and takes the Gardner example and says, you still remove six of the 36.

[00:28:56] Speaker 01:
And so you still would be removing some of the short amplicons.

[00:28:59] Speaker 00:
So you're again pointing to appendix page 23 for that.

[00:29:02] Speaker 00:
Yes.

[00:29:02] Speaker 01:
That's how this issue was completely framed to the board.

[00:29:06] Speaker 01:
So I don't think the board can be faulted for basically addressing this issue as reasonable expectation of success.

[00:29:13] Speaker 01:
And in this court precedent, like the intelligent biosystems case, of course, any findings that are made for reasonable expectation of success can still

[00:29:23] Speaker 01:
account for motivation and vice versa.

[00:29:26] Speaker 00:
Do you believe that opposing counsel is making a claim construction argument?

[00:29:29] Speaker 00:
It sounded like they might have backed away from that in their argument today, but I want to know your take on that.

[00:29:35] Speaker 01:
I think that they may have a new claim construction argument today that came up.

[00:29:39] Speaker 01:
I think the claim construction argument now today

[00:29:42] Speaker 01:
may be that the third amplicon doesn't mean the third amplicon from the first primer, the second primer, or the second verse, but it means that actually our method requires all these primers, and all these different third amplicons.

[00:29:58] Speaker 01:
And so I think that that may be the plan construction argument that they're making, that our method requires not three amplicons, but 36 amplicons.

[00:30:07] Speaker 01:
But there's nothing in the plain language that would support that at all.

[00:30:11] Speaker 01:
And I see my time has expired.

[00:30:13] Speaker 01:
You would ask the court to affirm.

[00:30:15] Speaker 03:
Thank you.

[00:30:22] Speaker 03:
We're going to restore you back to three minutes.

[00:30:25] Speaker 05:
Thank you.

[00:30:28] Speaker 05:
A couple of things that I want to take up.

[00:30:31] Speaker 05:
One thing I want to point out is Mr. Matsui had mentioned a 28-J letter.

[00:30:38] Speaker 05:
We filed a response to that letter this week.

[00:30:41] Speaker 05:
And we think that response is important.

[00:30:44] Speaker 05:
And we hope the court reads it before coming to a conclusion in this case.

[00:30:48] Speaker 05:
And it also addresses this issue of the 200 base pair citation from Plough, because they raised that footnote in their letter, and we couldn't find it anywhere in their briefing.

[00:31:00] Speaker 05:
Now, this was raised below, and it was vigorously attacked by our expert.

[00:31:08] Speaker 05:
And raising it now without the benefit of briefing leaves out all of that context as to why the 200 number is the wrong one to look at.

[00:31:17] Speaker 05:
So please don't accept that without looking deeper.

[00:31:24] Speaker 05:
One thing that I think is getting confused here is I stood up and started talking about motivation to combine.

[00:31:32] Speaker 05:
We don't make, our claim construction issue is on the reasonable expectation of success, error.

[00:31:40] Speaker 03:
But you're not making a claim construction issue.

[00:31:43] Speaker 03:
I mean, you are, but you didn't do that.

[00:31:47] Speaker 03:
And you can't make a claim construction issue in the forest.

[00:31:52] Speaker 05:
Well, Your Honor, one point I want to make is that our motivation to combine argument does not depend on any claim construction.

[00:32:01] Speaker 05:
We say the motivation fails because the board includes in its motivation must run in a single reaction.

[00:32:08] Speaker 05:
And a person of ordinary skill in the art would not run.

[00:32:11] Speaker 05:
I mean, let's find, call it an example.

[00:32:14] Speaker 05:
That example in Gardner.

[00:32:15] Speaker 05:
A person of ordinary skill in the art would not run that in a single reaction unless they could stop all 36 overlap implicons from dominating the reaction.

[00:32:27] Speaker 05:
Otherwise, Gardner wouldn't get Gardner's targets.

[00:32:30] Speaker 05:
You just wouldn't get them.

[00:32:31] Speaker 05:
And a person of ordinary skill would understand that and wouldn't make that combination.

[00:32:37] Speaker 05:
That's not a claim construction argument.

[00:32:39] Speaker 05:
That's an evidence argument.

[00:32:42] Speaker 05:
On claim construction.

[00:32:43] Speaker 03:
I guess what you're playing out is that Gardner deals with a standard PCR and now deals with a multiplex PCR?

[00:32:54] Speaker 05:
Well, multiplex just means more than one in a given reaction.

[00:32:59] Speaker 05:
So Gardner takes all of his and divides them into two so that there are no overlaps.

[00:33:05] Speaker 05:
Both of those are multiplex.

[00:33:08] Speaker 05:
But they're not a single reaction containing all of them.

[00:33:11] Speaker 05:
And the board's motivation expressly, the board says the motivation is to run Gardner in one reaction.

[00:33:19] Speaker 05:
And you can't run Gardner in one reaction unless you address all 36 overlaps.

[00:33:25] Speaker 05:
And Lau doesn't do that.

[00:33:26] Speaker 05:
And a person of ordinary skill in the art paying attention would know that.

[00:33:30] Speaker 05:
That's what we think the failure of evidence is.

[00:33:32] Speaker 05:
And that's not a claim construction.

[00:33:38] Speaker 03:
My time is up