[00:00:01] Speaker 01:
The next case for argument is 22-2232, Ryzen Farmong versus Alastair.

[00:01:16] Speaker 01:
You're ready whenever you are, sir.

[00:01:32] Speaker 02:
Good morning, your honor.

[00:01:34] Speaker 02:
May it please the court, Mark Tong, for the appellant, Ryzen Suzo Pharmatech.

[00:01:40] Speaker 02:
So before us today, there are two issues.

[00:01:43] Speaker 02:
One is whether the PTAB erred in failing to properly apply the lead compound test.

[00:01:49] Speaker 02:
And the second issue is whether the PTAB violated the APA in citing the Costanza reference for the first time in the final written decision.

[00:01:56] Speaker 02:
I'll proceed first with the first issue, which I think will take most of the time.

[00:02:00] Speaker 02:
But I would like to address the second issue as well.

[00:02:03] Speaker 02:
So on the first issue, on the lead compound test, it's our position that the lead compound test is what the parties agreed should be the right standard.

[00:02:14] Speaker 02:
And while the final written decision mentions the test, it does not actually apply the first step in that test, which is the identification of a lead compound, the selection process.

[00:02:25] Speaker 01:
As noted, I mean, I guess I was very

[00:02:28] Speaker 01:
taken aback by blue, because taking it at base value, when I turned to the board decision, I didn't expect to find anything about Lee Kampong.

[00:02:37] Speaker 01:
And frankly, there are at least six or seven pages that talk about Lee Kampong.

[00:02:41] Speaker 01:
I didn't see any problem with their articulation of what the test is.

[00:02:46] Speaker 01:
They cited up Takeda.

[00:02:48] Speaker 01:
They cited the other case.

[00:02:50] Speaker 01:
And then your answer in gray, once red pointed that out, seemed to be, well, they were just taking snippets.

[00:02:58] Speaker 01:
see where they were not developing a fulsome argument.

[00:03:02] Speaker 01:
Now, the board did talk about Dillon, but they didn't talk entirely about the so-called Dillon test as opposed to the Decatur test.

[00:03:10] Speaker 01:
So what's wrong with what the board did?

[00:03:13] Speaker 01:
Are you saying there's legal error here in something the board said about lead compound?

[00:03:18] Speaker 02:
Um, yes.

[00:03:19] Speaker 02:
So the lead compound test, um, from what we see in the case law has three steps.

[00:03:24] Speaker 02:
The first step is the selection of a lead compound.

[00:03:27] Speaker 02:
This is what one or more, one or more.

[00:03:30] Speaker 00:
Yes.

[00:03:34] Speaker 02:
That's correct.

[00:03:35] Speaker 02:
Right.

[00:03:35] Speaker 02:
So the Takeda says that it's the, um, a compound in prior art that would be most promising to modify.

[00:03:41] Speaker 02:
So that's step one.

[00:03:42] Speaker 02:
That's actually where the criticism is.

[00:03:44] Speaker 02:
It's not on the remaining steps, which is the motivation to modify.

[00:03:47] Speaker 01:
Well, how many compounds did they pick here?

[00:03:50] Speaker 02:
So they picked two compounds.

[00:03:51] Speaker 01:
Two.

[00:03:52] Speaker 01:
OK.

[00:03:52] Speaker 01:
As the most promising.

[00:03:54] Speaker 02:
That's right.

[00:03:54] Speaker 01:
Too very closely related compounds as it happens.

[00:03:58] Speaker 02:
Yes, but I guess here's really where our dispute is.

[00:04:03] Speaker 02:
Those two compounds are the only two compounds they considered.

[00:04:06] Speaker 02:
There was never a comparison done to select the most promising.

[00:04:10] Speaker 02:
And the word most is important here, as well as the word lead in lead compound test.

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Because the entire purpose of the test is to help prevent hindsight bias, where you look at the patent at issue.

[00:04:24] Speaker 02:
With that in front of you, you go select the prior art references.

[00:04:27] Speaker 01:
And, you know, we give some deference.

[00:04:29] Speaker 01:
I'm not sure on this issue exactly.

[00:04:31] Speaker 01:
Your deference lies.

[00:04:32] Speaker 01:
But the board had quite a bit of discussion in terms of why these were promising candidates.

[00:04:39] Speaker 01:
So what do I miss?

[00:04:41] Speaker 01:
I mean, where is the clear error here in what the board did or did not do with respect to picking another compound?

[00:04:48] Speaker 02:
That's exactly right.

[00:04:50] Speaker 02:
Because the word most, just like more or most, is a comparative term.

[00:04:55] Speaker 02:
It's not just finding a promising compound.

[00:04:58] Speaker 02:
It's finding the most promising.

[00:04:59] Speaker 02:
That's what the case law says.

[00:05:01] Speaker 02:
And that word alone suggests there's a comparison.

[00:05:05] Speaker 01:
If you look at the cases that follow the... So what are you saying under the analysis that Takeda requires that a fact finder do?

[00:05:14] Speaker 01:
you see, you've acknowledged, Judge Bryson, that most promising doesn't need to be just one, it can be two.

[00:05:21] Speaker 01:
So does the back-finder have to dismiss or compare everything else out there in order to establish that these were promising compounds to pick as the lead compound?

[00:05:32] Speaker 02:
No, this is not, I mean, we're still under a KSR framework, which everyone knows is a flexible framework.

[00:05:39] Speaker 02:
So we're not saying it's such a rigid test that it's a rigorous compare every single compound in the prior art.

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But we are saying that there needs to be some basis for selecting these two and not just looking at these two alone in isolation.

[00:05:54] Speaker 02:
You have to look at the prior art because, again, trying to avoid hindsight, at this time there were other candidates.

[00:06:00] Speaker 04:
How much prior art do you have to look at?

[00:06:02] Speaker 04:
The board looked at quite a lot of prior art here, didn't it?

[00:06:06] Speaker 04:
Thirteen studies of these particular compounds that they started with.

[00:06:12] Speaker 02:
Yes, but the board did not do a comparison.

[00:06:14] Speaker 02:
For example,

[00:06:17] Speaker 02:
are we raised at least five other compounds that were potential candidates.

[00:06:22] Speaker 02:
They were not discussed in the final decision.

[00:06:24] Speaker 02:
Why pick the candidates that the only compounds that are raised?

[00:06:30] Speaker 00:
You raised those before the board.

[00:06:32] Speaker 00:
What is that?

[00:06:33] Speaker 00:
You raised those other five compounds before the board.

[00:06:35] Speaker 00:
Yes, it was in the briefing.

[00:06:36] Speaker 00:
That's right.

[00:06:36] Speaker 00:
So the board was aware of those other five compounds, at least, and discussed them, I guess.

[00:06:41] Speaker 01:
Can we discuss them in the decision itself?

[00:06:43] Speaker 01:
When they decide the patent owner's argument, do they just ignore it?

[00:06:47] Speaker 01:
Do they just not put the stuff in, or do they articulate what the... I thought they typically articulate what the patent owner's arguments are.

[00:06:55] Speaker 02:
Yeah, they lay out the arguments, but they don't actually do a comparison.

[00:07:00] Speaker 02:
And I think that's really where the crux of the matter is.

[00:07:03] Speaker 02:
In order to say that these two compounds that the board did look at are the most promising, you have to look at the other compounds that have been raised and say, well, these are better.

[00:07:15] Speaker 02:
These are somehow more promising than the other ones that are raised.

[00:07:18] Speaker 02:
Otherwise, there isn't a step one.

[00:07:21] Speaker 02:
There isn't a comparison to select the most promising.

[00:07:25] Speaker 01:
So can you point me in the board decision, whether at least, I'm looking at what they, when they were citing what happened on their side.

[00:07:32] Speaker 01:
So it seems like they're putting in your arguments about why they wouldn't have selected these compounds.

[00:07:41] Speaker 02:
I'm looking for... Sorry, excuse me, you're looking for where the board talks about the... Where do they talk about the five compounds you asked them to compare to?

[00:08:38] Speaker 02:
I apologize.

[00:08:40] Speaker 02:
I actually don't see that the march through the other five.

[00:08:44] Speaker 02:
I know they were raised in the briefing.

[00:08:46] Speaker 04:
Is it your contention that the board entirely overlooked the comparisons that you asked it to make?

[00:08:52] Speaker 02:
Yes, certainly I don't see the comparisons in the final written decision and I think more importantly I don't, I mean there's one thing whether it lists it or not and that one I don't see here looking over the opinion.

[00:09:06] Speaker 02:
But more importantly in the analysis portion there is no analysis between which one is better.

[00:09:15] Speaker 02:
That's really where the crux of our issue is.

[00:09:19] Speaker 04:
On the lead compound, is it your contention that the board was required to apply lead compound analysis because that's what our case law requires?

[00:09:32] Speaker 04:
Or is the error simply that you think the parties agreed they should apply lead compound and somehow the board didn't go along with your agreement?

[00:09:47] Speaker 02:
I think the answer is both.

[00:09:50] Speaker 04:
Where have we said that lead compound analysis is required, even if the parties don't agree to it?

[00:09:58] Speaker 02:
So when there is a new chemical compound, and I'll give you the citations, I think Daiichi 619F3 at 1352.

[00:10:15] Speaker 02:
Here in the case it says, proof of obviousness based on structural similarity requires clear and convincing evidence that a medicinal chemist of ordinary skill would have been motivated to select and then to modify a prior compound, e.g.

[00:10:31] Speaker 02:
a lead compound.

[00:10:33] Speaker 02:
So that's one site.

[00:10:36] Speaker 02:
The next site is at the PSI 533 F3RD F1357.

[00:10:47] Speaker 04:
And what was the name of that second case?

[00:10:49] Speaker 02:
I'm sorry.

[00:10:50] Speaker 02:
It's a side.

[00:10:52] Speaker 02:
Sorry.

[00:11:01] Speaker 04:
Sorry.

[00:11:02] Speaker 04:
You also contend that what if the parties, even if our case law doesn't require lead compound in a case like this,

[00:11:10] Speaker 04:
if the parties agree to a legal standard, then the board is compelled to apply that legal standard?

[00:11:16] Speaker 04:
Is that part of your argument as well?

[00:11:18] Speaker 02:
I think that, I mean, unless it's such a clearly erroneous matter of law to apply the standard, because the briefing was done with that standard in mind.

[00:11:34] Speaker 01:
At bottom, is it your argument and is your challenge to what the board did predominantly its failure to discuss or to analyze your argument that there were other compounds that were more promising than the ones that selected?

[00:11:57] Speaker 02:
I think that's basically right.

[00:11:59] Speaker 02:
I mean, I think that the test is a little broader than just the compounds that the party's raised, but I think as a practical matter, the argument was raised and it was not considered by the state.

[00:12:13] Speaker 01:
You want to turn to the other issue now?

[00:12:14] Speaker 02:
Sure, so the other issues that the board cited a reference Eco stands up in its final written decision for a important proposition in fact the board cited it for And here here's the quote from waste the patient a PPX 70 which is the final written decision page 70 it says the board said it was generally known in the art and

[00:12:42] Speaker 02:
at the time of invention that when deuterium is incorporated into molecules in place of hydrogen, in most respects, the deuterated compound is very similar to the all-natural abundance hydrogen compound.

[00:12:54] Speaker 04:
And isn't that just a simply, wasn't Costanza just cumulative of lots of places in the record?

[00:13:03] Speaker 04:
I acknowledge the board didn't point to it, but

[00:13:05] Speaker 04:
On that almost undisputed fact about deuterium, I think the experts talked about it, Morgan talks about it.

[00:13:16] Speaker 04:
Isn't this just cumulative of what's already in the record?

[00:13:20] Speaker 02:
It's not for one important reason, and I didn't get to raise this earlier, but for example, Morgan was cited in our opening brief, in the appellate brief which cited to our POPR, our patent owner, preliminary response for the fact that the

[00:13:39] Speaker 02:
deuterated or isotopically modified compounds may have very, very different biological properties when they're actually used.

[00:13:48] Speaker 02:
And so there is actually a dispute on this point.

[00:13:50] Speaker 02:
This is not a given, generally known point.

[00:13:53] Speaker 02:
We certainly dispute it.

[00:13:55] Speaker 02:
We're not able to make a specific criticism on decastanza on that point.

[00:13:59] Speaker 02:
And so on the one hand, we don't dispute that this issue is raised.

[00:14:05] Speaker 02:
In fact, it's a pretty central issue to the IPR.

[00:14:09] Speaker 02:
But we do dispute that, given that Costanza was raised for the first time,

[00:14:13] Speaker 02:
in the final written decision, there was no chance to criticize it.

[00:14:16] Speaker 02:
I mean, even all we have is the title.

[00:14:18] Speaker 02:
We don't even have the reference.

[00:14:20] Speaker 00:
But Morgan cites De Costanzo for this proposition, if I recall correctly, and the first clip that includes the reference to De Costanzo.

[00:14:32] Speaker 00:
So the question is really, going back to Stark's question,

[00:14:37] Speaker 00:
Let me put it this way.

[00:14:38] Speaker 00:
Had the board put in a citation to Morton instead of a citation to de Costanzo, you wouldn't have any argument on this point, right?

[00:14:47] Speaker 02:
That's right.

[00:14:48] Speaker 02:
The point is really on de Costanzo.

[00:15:17] Speaker 03:
Please proceed.

[00:15:17] Speaker 03:
Thank you, Your Honor.

[00:15:18] Speaker 03:
May it please the court?

[00:15:19] Speaker 03:
Mark Feldstein on behalf of Appellee Alcyon, Inc.

[00:15:24] Speaker 03:
There were great questions raised during the questioning of Pied Owners Council.

[00:15:30] Speaker 03:
And I can answer one of them in terms of the five compounds.

[00:15:35] Speaker 03:
I think on appendix page 40 in the final written decision.

[00:15:38] Speaker 01:
So you're talking about his criticism of the board to be able to

[00:15:41] Speaker 01:
contrast or compare or deal with the compound.

[00:15:47] Speaker 03:
Appendix 40 addresses patent owner's argument that there are these other compounds that should be compared and I think what's important to recognize here is this is not a case like Daiichi where in Daiichi you had a metric potency

[00:16:02] Speaker 03:
And the court was looking at comparative potency.

[00:16:05] Speaker 03:
In Daiichi there was a second generation of compounds that had 100, 180 times greater potency.

[00:16:10] Speaker 03:
And the court there said, if we're going to measure potency, the second generation compounds are the starting point, not the ones that are proffered by the challenger.

[00:16:21] Speaker 03:
what patent owners puts in says, hey, there are these five other compounds, do some sort of mechanical comparison to them.

[00:16:29] Speaker 03:
But there's no evidence, there was no argument on why these five compounds would be like Daiichi chosen over

[00:16:37] Speaker 03:
the compounds tramiprosate and valAPS.

[00:16:42] Speaker 03:
And so there's nothing mutually exclusive about the idea that there were other compounds out there.

[00:16:47] Speaker 03:
There are other compounds that may even lead for other direction.

[00:16:50] Speaker 01:
But there's- Let me ask you.

[00:16:51] Speaker 01:
So you pointed out, and the board every summarizes what the Patnona argues.

[00:16:57] Speaker 01:
In the citations that are here or whatever, was there a fulsome argument in comparison in what the Patnona submitted as to why these would have been preferable from one selected?

[00:17:06] Speaker 03:
no your honor they're just proffered as here are other compounds I think maybe some there may be an argument that no they're not argued as

[00:17:18] Speaker 03:
why they'd be chosen over tramiprosate and valAPS.

[00:17:24] Speaker 03:
They're presented as other things that some mechanical comparison should be made against.

[00:17:29] Speaker 03:
There is no requirement for this mechanical comparison.

[00:17:32] Speaker 03:
There is no requirement for a side-by-side.

[00:17:34] Speaker 03:
It happens in some cases where you have a metric that you're doing

[00:17:37] Speaker 03:
comparison on, and the challenger says, hey, I'm going to pick this compound because it's potent, that doesn't apply here.

[00:17:43] Speaker 03:
Those are the cases where you have some list, some mass of compounds, and you're trying to filter through them.

[00:17:50] Speaker 03:
Here the facts are that the ART had already identified trami-prostate and valp APS as literally, quote, promising candidates.

[00:17:59] Speaker 03:
You don't need more evidence to know that they're promising candidates.

[00:18:03] Speaker 03:
Your Honor, Judge Stark, you brought it up.

[00:18:05] Speaker 00:
It would be a difference, I would think, if you had maybe the fact that there are two promising candidates out of a group of seven.

[00:18:14] Speaker 00:
Maybe that is enough to make them lead compounds for purposes of analysis.

[00:18:18] Speaker 00:
But if you had two promising candidates among a group of 100 other promising candidates,

[00:18:26] Speaker 00:
You really couldn't say at that point that aha, these are the two that should be identified as a lead compound, could you?

[00:18:32] Speaker 03:
Perhaps, but it's not the evidence we have here.

[00:18:34] Speaker 03:
We have two promising compounds.

[00:18:36] Speaker 03:
We have their patent admitting that tramiprostate is a promising compound consistent with the art.

[00:18:42] Speaker 03:
And we have.

[00:18:42] Speaker 03:
five other compounds that they said hey you should have made a comparison to and then we have this massive chart that's quoted copied in the final written decision I think appendix 69 or 70 that shows just this massive universe and the implication yeah

[00:19:00] Speaker 03:
and that they're rejecting the idea that we have to go and do and select out the most promising candidate out of this entire mass, out of this entire universe.

[00:19:11] Speaker 03:
There's no need for that where the art, including the admissions from the patent owner, already point to and are already using the compound as a lead.

[00:19:20] Speaker 03:
That happened in the BMS case that we cite, where the compound that was presented as the lead compound was already being used as a lead compound for further development.

[00:19:30] Speaker 03:
The hindsight issue that the lead compound analysis is preventing is going back in time to a retrospective analysis of the art.

[00:19:39] Speaker 03:
What would someone have thought if they would look back at all this massive data?

[00:19:43] Speaker 03:
That's not an issue here where the art

[00:19:46] Speaker 03:
like in BMS says, here is something that people have to consider promising.

[00:19:50] Speaker 03:
Here's something that people are continuing to develop.

[00:19:52] Speaker 03:
Here is something that continues to show interest.

[00:19:55] Speaker 03:
Here is something that is being used as a lead compound already.

[00:19:58] Speaker 04:
To the extent that comparison is required by the law, you would say that comparison had already been done before this case even arose.

[00:20:06] Speaker 04:
It had been done in the prior art.

[00:20:09] Speaker 04:
And that should be sufficient under the law.

[00:20:11] Speaker 03:
Correct, Your Honor.

[00:20:11] Speaker 03:
Here, the recognition in the art is a comparison on how did it bubble to the top?

[00:20:17] Speaker 03:
How did it bubble to the top of people's interest?

[00:20:19] Speaker 03:
How did it bubble to the top of the admitted promising compound candidate that is recognized in the pad?

[00:20:25] Speaker 04:
So what is your view of the legal

[00:20:28] Speaker 04:
situation here is a lead compound analysis sort of in quotes.

[00:20:34] Speaker 04:
Is that required in a case like this or particularly in this case?

[00:20:39] Speaker 03:
I think it's one way to establish, it's clearly one way to establish obviousness and I think like I think it's in Altana where they are addressing the idea that like the teaching suggestion motivation test

[00:20:52] Speaker 03:
It's informative, post-KSR, of a way to find obvious, but it's not a rigid rule, and the bottom line is recent identification for the lead compound starting point.

[00:21:04] Speaker 04:
And what about the two cases that were cited to us, ISI and... Did we not require, as a matter of law, a lead compound analysis in those cases?

[00:21:19] Speaker 03:
No, there's not a requirement as a matter of law for a lead compound with a comparative analysis.

[00:21:25] Speaker 03:
They were certainly applying.

[00:21:28] Speaker 01:
We're not talking about a comparison anymore, we're just talking about the requirement for the lead compound.

[00:21:34] Speaker 03:
So, Takeda, if I can answer from Takeda, Takeda is clear, if your honor is asking, could Dylan still apply?

[00:21:42] Speaker 03:
That's the context.

[00:21:43] Speaker 03:
That would be another way to put it.

[00:21:46] Speaker 03:
Is that what Takeda says, Dylan's an en banc decision, I believe, and Takeda says,

[00:21:52] Speaker 03:
This law still applies it makes sense to have to look for structural similarity in certain cases where things are so close Homologues isomers analogs.

[00:22:02] Speaker 03:
There's nothing closer than the two neutron difference We have here and what Takeda says is Dylan's good but you still have to then have a reason to make this modification and so you don't have to in some circumstances where the structure is so close and

[00:22:20] Speaker 03:
a homolog, an isomer, an analog.

[00:22:24] Speaker 03:
And in this case, the PTAP found that the same elements, hydrogen and deuterium, two neutron difference, that Dillon is the most applicable analysis.

[00:22:35] Speaker 03:
But they did Dillon Plus.

[00:22:36] Speaker 03:
They did Dillon Plus Takeda, where they then looked at, are there specific reasons to modify trimiprosate or valAPS to make the modifications

[00:22:47] Speaker 03:
They found there were that's similar to this essentially the second part of the compound.

[00:22:51] Speaker 04:
So I'm hearing that as you read our case law is not absolutely requiring a quote lead compound analysis in this case.

[00:23:00] Speaker 04:
Right.

[00:23:01] Speaker 04:
That's right.

[00:23:02] Speaker 04:
You're right.

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

[00:23:03] Speaker 04:
So putting aside our case law for the moment what about was there not an agreement

[00:23:08] Speaker 04:
in this case to do it and Relatedly if you wouldn't mind If we said lead compound for whatever reason is required here Are we allowed to pick and choose through what the board found?

[00:23:21] Speaker 03:
To come up with our own lead compound analysis when they say they're not doing it I don't think you need to pick and choose they did both analyses.

[00:23:28] Speaker 03:
They said Dylan's the most applicable We're going to tell you why it's true under Dylan and then at appendix 60

[00:23:38] Speaker 03:
Exactly, 65 to 66.

[00:23:41] Speaker 03:
They say, here are the two-part tests.

[00:23:45] Speaker 01:
Do you think the board of opinion has applied the Takeda lead compound analysis?

[00:23:50] Speaker 01:
Because I did.

[00:23:51] Speaker 03:
I did, absolutely.

[00:23:52] Speaker 03:
They cite SUCA citing Takeda on 65 to 66, and they say it's got two parts.

[00:23:58] Speaker 01:
So they did both.

[00:23:59] Speaker 01:
They did both.

[00:24:00] Speaker 01:
You're right.

[00:24:01] Speaker 01:
I read it as certainly applying the compound analysis of Takeda.

[00:24:05] Speaker 01:
It may have been a different

[00:24:06] Speaker 01:
So different because the universe here is so much more limited.

[00:24:10] Speaker 01:
But you agree that they apply to me.

[00:24:14] Speaker 03:
They absolutely apply to me.

[00:24:16] Speaker 04:
Whether or not sorry because I threw a lot I whether or not they did both.

[00:24:20] Speaker 04:
Did you, in fact, agree in front of the board that they had to do a lead compound analysis?

[00:24:26] Speaker 03:
The argument that was presented by Petitioner was a lead compound analysis, and we agreed it was applicable.

[00:24:32] Speaker 03:
I don't think that we agreed that we made any commitment or any position that Dylan couldn't also apply.

[00:24:37] Speaker 03:
But clearly, Petitioner's argument was that it was a lead compound.

[00:24:42] Speaker 03:
The board, in its institution decision, raised Dillon pretty much on its own, and then the parties addressed it.

[00:24:50] Speaker 03:
But I don't think that the agreement or the common proffering of lead compound was to the exclusion of alternatives.

[00:24:58] Speaker 03:
We just proved our case below.

[00:25:00] Speaker 03:
Under lead compound, the board said, you know what?

[00:25:04] Speaker 03:
Dillon plus Takeda is the closest case law and analyzed under that also.

[00:25:15] Speaker 00:
to these doctrines, which I think can be mischievous in and of itself.

[00:25:19] Speaker 00:
But is there any fundamental difference between Lee compound or Dylan?

[00:25:25] Speaker 00:
Aren't they doing the same thing?

[00:25:26] Speaker 00:
You look for a starting point that makes sense and that a poser would look at.

[00:25:32] Speaker 00:
And then you ask, how should I or could I modify this in a way that a poser would have expectation?

[00:25:40] Speaker 00:
It works.

[00:25:41] Speaker 00:
Isn't that what we're talking about, whether we call it lead compound or whether we call it filling?

[00:25:46] Speaker 03:
I think that's correct, Your Honor.

[00:25:48] Speaker 03:
I think that the one piece to add to what the cases are saying in terms of the first step, it needs to be a non-hindsight reason.

[00:25:55] Speaker 03:
It needs to be a reason from the art.

[00:25:56] Speaker 00:
Right.

[00:25:56] Speaker 00:
And it's something that is out there that we oppose or would understand to be a good starting point.

[00:26:03] Speaker 03:
Exactly, Your Honor.

[00:26:05] Speaker 00:
All right.

[00:26:05] Speaker 00:
Sometimes I think that we create opinions for these doctrines, and then we silo them.

[00:26:11] Speaker 00:
out there and there's no reason to do that.

[00:26:14] Speaker 00:
It seems to me the fundamental element of what's going on is the same across these various stuff.

[00:26:21] Speaker 03:
And that's what your case is recognized as well.

[00:26:22] Speaker 03:
They recognize especially, you know, trying to rationalize post-KSR.

[00:26:26] Speaker 03:
They say it's a flexible test.

[00:26:28] Speaker 03:
Bottom line is you need a reasoned identification in a certain point.

[00:26:35] Speaker 01:
specifically to Costanza?

[00:26:37] Speaker 03:
Sure.

[00:26:38] Speaker 03:
So Costanza is irrelevant to leap compound analysis.

[00:26:44] Speaker 03:
If the court agrees that the board did a leap compound analysis, Costanza only comes up in the context of Dillon.

[00:26:51] Speaker 03:
So Costanza is just completely irrelevant.

[00:26:54] Speaker 00:
It's decostanza, right?

[00:26:55] Speaker 03:
It is decostanza.

[00:26:57] Speaker 03:
It was brief as Costanza.

[00:26:58] Speaker 03:
I don't know how that started.

[00:27:00] Speaker 00:
Senator Fielder, one of the Yankees, goes, not Joe Maggio.

[00:27:04] Speaker 03:
It is DeConstanza, Your Honor, absolutely.

[00:27:07] Speaker 03:
And the reliance, where DeConstanza is cited, it's cited in the context of why the board thinks that Dylan Perticata is a relevant legal analysis.

[00:27:22] Speaker 03:
And the first thing that they address on why do they think Dylan's relevant is on page

[00:27:29] Speaker 03:
64, appendix 64, that it's undisputed that deuterium is the same element as hydrogen.

[00:27:36] Speaker 03:
And then they go on that it's a two-neutron difference.

[00:27:39] Speaker 03:
So in terms of whether there's structural similarity, even before the paragraph that's addressing decastanza, they've already identified undisputed evidence, undisputed positions that

[00:27:50] Speaker 03:
that there's structural similarity.

[00:27:52] Speaker 03:
They're the same element, two new ton difference.

[00:27:54] Speaker 03:
I haven't heard an argument from Ryzen that there is not structural similarity between trimiposate and deuterate trimiposate, valAPS and deuterate valPS.

[00:28:07] Speaker 03:
So I haven't heard that that even matters, that you get to deconstanza, that it even matters any of this because there doesn't seem to be a substantive dispute that there is structural similarity here.

[00:28:19] Speaker 01:
So your position is there was no error even if you were harmless.

[00:28:22] Speaker 03:
At best, it's harmless error, because there's a standalone paragraph already addressing the premise, sufficient premise to find structural similarity.

[00:28:31] Speaker 01:
But the same statement, essentially, was in Morgan.

[00:28:33] Speaker 03:
It absolutely was, Your Honor.

[00:28:35] Speaker 03:
And Dika Stanz has cited there as a C-site.

[00:28:38] Speaker 03:
It's a C-site for the proposition that, in most respects, it's similar.

[00:28:44] Speaker 03:
And what comes up in Reisen's briefing is they talk about property differences.

[00:28:49] Speaker 03:
There may be property differences.

[00:28:51] Speaker 03:
They may speak to unexpected results.

[00:28:53] Speaker 03:
But the differences in properties aren't differences in structures.

[00:28:57] Speaker 03:
And so there's really no reason to dispute here that there's a difference in structure.

[00:29:02] Speaker 03:
And so deConstanza is cumulative on an undisputed finding from the board that there's the same elements, two-newton difference, and the general knowledge that they're similar in most respects.

[00:29:14] Speaker 04:
It may well be a harmless error, but I'm

[00:29:19] Speaker 04:
clear on how it's not error.

[00:29:21] Speaker 04:
I mean, why go to all the trouble of putting together a record and requiring the board to consider things on the record if they can just go ahead and pull things off a shelf that counsel didn't even know about and start relying on it as the basis for its findings.

[00:29:37] Speaker 03:
It is not clear to us, Your Honor, why Dee Costanza was cited and not Morgan.

[00:29:41] Speaker 03:
It seems to be that the board was paraphrasing Morgan's citation of Dee Costanza.

[00:29:46] Speaker 04:
There's a speculation, I'm sure you saw it, that maybe the patent owner beat back Morgan in an earlier stage of the proceeding because it said something about unpredictability.

[00:29:56] Speaker 04:
And the board was scared about that, so they just skipped over Morgan.

[00:30:00] Speaker 03:
But there's subsequently no dispute that the structure is similar.

[00:30:05] Speaker 03:
So it's at best a harmless error because it's a tertiary point on structural similarity and it's an immaterial point on structural similarity because there's no subject dispute, they're not structurally similar.

[00:30:20] Speaker 03:
One could take a marker and cross off, the DECA stands a paragraph, and the decision would stand, the analysis on why Dylan makes sense would stand, and the entirely separately compound analysis would stand.

[00:30:36] Speaker 03:
Thank you, Your Honor.

[00:30:59] Speaker 02:
Hi.

[00:31:00] Speaker 02:
If you have any questions for me, please ask them.

[00:31:06] Speaker 02:
Otherwise, I have two points to make.

[00:31:08] Speaker 02:
One is that Council for Appellee said several times that there is no dispute, that there is no structural similarity.

[00:31:16] Speaker 02:
But the point here is it's not just, is it structurally similar?

[00:31:19] Speaker 02:
The question is, is it obvious in light of the prior art?

[00:31:23] Speaker 02:
And as we noted in our briefing,

[00:31:26] Speaker 02:
there's a site to Morgan at page 230 on how different the properties could be.

[00:31:31] Speaker 02:
In fact, the fact that the hydrogen and deuterium differ by a neutron could make all the difference in the world in terms of how it reacts in the body.

[00:31:40] Speaker 02:
And that has certainly patentability effects.

[00:31:43] Speaker 02:
And so I don't think that structural similarity is the end of the inquiry.

[00:31:47] Speaker 02:
In fact, if you look at the citation in Daiichi,

[00:31:52] Speaker 02:
This is at 1354.

[00:31:54] Speaker 02:
It says that the attribution of a compound as a lead compound must avoid hindsight bias.

[00:32:01] Speaker 02:
It must look at the state of the art at the time of the dimension was made to find a motivation to select.

[00:32:08] Speaker 02:
And then it goes on to say, accordingly, proving a reason to select a compound as a lead compound depends on more than just structural similarity.

[00:32:16] Speaker 02:
So structural similarity doesn't get you there.

[00:32:18] Speaker 02:
You need something more.

[00:32:20] Speaker 02:
And that's what the case law says.

[00:32:22] Speaker 02:
This diache is a different part than what I quoted in the beginning of my opening argument.

[00:32:30] Speaker 02:
And so I think that there is still error in the application of the compound test.