[00:00:00] Speaker 04:
The first case is Inrei Thirithiaram, 22-1346.

[00:00:05] Speaker 04:
Ms.

[00:00:07] Speaker 04:
Browning, whenever you're ready.

[00:00:14] Speaker 00:
Good morning, Your Honors.

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

[00:00:16] Speaker 00:
I've reserved five minutes for rebuttal.

[00:00:19] Speaker 00:
There are two issues that I want to focus on today.

[00:00:22] Speaker 00:
The first one is the lack of motivation, and the second one is the board's failure to consider the unpredictability of the art when evaluating the evidence.

[00:00:32] Speaker 00:
Before diving into those issues, however, I want to point to three aspects of the state of the art that the board failed to take into account, which we believe led to the

[00:00:43] Speaker 00:
errors, the legal and the factual errors.

[00:00:45] Speaker 00:
The first one is that the record evidence does not show that there was a problem to be solved, meaning that the commercial APOA1FC fusion protein, which had no linker, was not known to have low cholesterol efflux activity.

[00:01:04] Speaker 00:
The second one is

[00:01:06] Speaker 00:
The evidence shows that a person of skill in the art would not have believed a linker to be necessary for this type of fusion protein because it was recognized that the FC hinge region acts as a natural linker.

[00:01:20] Speaker 00:
The third is that the board failed to appreciate the unexpected nature of the invention because the board did not address or otherwise take into account the evidence that was submitted

[00:01:34] Speaker 00:
showing that the impact of linker length on the function of a fusion protein component was unpredictable.

[00:01:42] Speaker 03:
How do we know as a general matter what the board failed to consider?

[00:01:47] Speaker 03:
I mean, normally we assume that the tribunals we review have the evidence in front of them and that they consider it.

[00:01:54] Speaker 03:
We don't require them to go point by point and talk about every piece of evidence in order to assume that they factored it in.

[00:02:02] Speaker 03:
Yet your argument mostly is it's a pretty short opinion.

[00:02:06] Speaker 03:
And we threw in a lot of evidence that they don't specifically address.

[00:02:09] Speaker 03:
So we must assume that they didn't really evaluate it.

[00:02:14] Speaker 00:
I think there's two responses to that.

[00:02:15] Speaker 00:
The first is when you look at the motivation, they really only found, they used the claim as a map and they looked at the prior art to try to find the elements that were in that claim.

[00:02:28] Speaker 00:
There's no reason why anybody would have started adding a linker to the existing fusion protein, much less a longer linker.

[00:02:37] Speaker 00:
So what does the art that they used really show you?

[00:02:40] Speaker 00:
It points out that there are

[00:02:41] Speaker 00:
such a thing called linkers, and that you certainly can use a linker when you're modifying proteins, but they don't give you any reason for why you would start that process in the first place.

[00:02:55] Speaker 01:
Do you believe your argument is better on motivation to confine or on unexpected results?

[00:03:00] Speaker 01:
Which do you think is the better argument?

[00:03:02] Speaker 00:
I think they're equally strong, but I think as far as not addressing the evidence of record, the unpredictability of the art, that they clearly just did not address at all.

[00:03:12] Speaker 00:
And they relied on, for their references, they relied on, remember, Ledbetter as the sole reference to show reasonable expectation of success.

[00:03:23] Speaker 00:
This is a DNA protein.

[00:03:25] Speaker 00:
It's not related to the APOA1.

[00:03:28] Speaker 00:
That's one thing.

[00:03:29] Speaker 00:
But on top of that, they didn't address another art in the record, Dwyer, which is also related to the DNAs.

[00:03:38] Speaker 00:
And that particular reference, that study, showed

[00:03:42] Speaker 00:
no impact of linker link on the activity level of the fusion component.

[00:03:47] Speaker 00:
So I think that really highlights the inconsistency.

[00:03:51] Speaker 00:
On the one hand, the Patent Office wants to rely on these references that aren't necessarily related to the APOA-1.

[00:03:59] Speaker 00:
fusion protein and yet on the other hand when we show that the art was very unpredictable with respect to adding linker length and what impact the linker length might have on the activity level of the fusion protein

[00:04:13] Speaker 00:
then they discount and they don't even mention this reference.

[00:04:18] Speaker 00:
And Ledbetter itself, by the way, cited to Dwyer and in the very paragraph that are relied upon by the Patent Office and indicates that its own results are unexpected in view of Dwyer.

[00:04:36] Speaker 03:
If we agree with you that the board doesn't seem to have adequately considered or at least told us how it considered some of these references, for instance, the unpredictability, wouldn't that suggest that we should remand and have, I don't know, maybe the examiner resume the prosecution?

[00:04:56] Speaker 03:
Because you seem to ask us to just go ahead and grant your claims.

[00:04:59] Speaker 03:
But I'm a little concerned about the mismatch between your arguments and the relief you're requesting.

[00:05:05] Speaker 00:
I think that is a fair point with respect to the unpredictability of the art if you need to get to that point.

[00:05:11] Speaker 00:
But I think the failure to show even a motivation to begin the process, to even fail to show a motivation as to why you would start modifying the fusion protein in the first place, I think that is also something you could simply reverse on.

[00:05:27] Speaker 00:
They didn't even get to point one.

[00:05:34] Speaker 00:
So, I mean, turning to the motivation part, they did use the claims as simply a map.

[00:05:39] Speaker 00:
Let's look at Knutson, for example.

[00:05:41] Speaker 00:
That's the primary reference.

[00:05:42] Speaker 00:
It doesn't express a preference for using.

[00:05:45] Speaker 00:
It has one throwaway statement that just simply says,

[00:05:48] Speaker 00:
The APOA1 compounds described above may be fused directly or via a peptide linker.

[00:05:55] Speaker 00:
It doesn't have a preference for using a peptide linker over no linker.

[00:05:59] Speaker 00:
It certainly doesn't narrow the possible universe of linkers.

[00:06:02] Speaker 00:
It doesn't express any guesses on what activity level might or might not occur from using a linker.

[00:06:09] Speaker 00:
Nutsen has no data, right?

[00:06:11] Speaker 00:
It never did make an example.

[00:06:13] Speaker 00:
Whereas all the studies that we provided to the Patent Office were based on actual studies and real-life evidence and experimental evidence.

[00:06:22] Speaker 00:
So of course that should be more relevant to the determination.

[00:06:27] Speaker 00:
Same with Lagerstadt.

[00:06:29] Speaker 00:
Lagerstadt was really devoted to shortening

[00:06:32] Speaker 00:
the APOA1 peptide, and using just a very small snippet of that for a different functionality had to do with inducing glucose uptake into the cells.

[00:06:42] Speaker 00:
It has a very general discussion of the existence of numerous linkers, and I think you really need to look at that section of logger stat where it basically just says, you know, you can use no linker, you can use a short linker, you can use a linker of one to five, one to 10, one to 20, one to 100,

[00:07:02] Speaker 00:
And it has one in there that says 10 to 50, but it doesn't express any preference to use any one of those things, including no linger.

[00:07:10] Speaker 00:
And it certainly doesn't tell you what the results might be if you did.

[00:07:14] Speaker 00:
There's just no guidance to that whatsoever.

[00:07:18] Speaker 00:
Simply because one of skill in the art could do something is not sufficient.

[00:07:23] Speaker 00:
The patent office needs to show that they actually would have done that with some reasonable expectation of success.

[00:07:29] Speaker 00:
FACUS fares no better.

[00:07:30] Speaker 00:
FACUS is devoted to the ERBB-based ligand-binding molecules.

[00:07:37] Speaker 00:
It actually doesn't even say the linkers can be bound to the fusion protein.

[00:07:42] Speaker 00:
It has to do with fusion partners, fusion moieties.

[00:07:46] Speaker 00:
And again, it just has a throwaway statement that broadly refers to one or more linkers.

[00:07:52] Speaker 00:
It doesn't give any guidance.

[00:07:54] Speaker 00:
create or produce any of these linkers?

[00:08:01] Speaker 00:
And finally, what do they really add?

[00:08:05] Speaker 00:
They just tell you that there's a possibility out there that you could use a linker, but there's no reason to start using a linker.

[00:08:12] Speaker 00:
Finally, they add lead better to the mix.

[00:08:16] Speaker 04:
Are you saying that they had to show that somebody would be motivated because this would be an improvement over the prior art?

[00:08:24] Speaker 00:
Well, there could be multiple reasons, but there has to be some reason why you would be motivated to start modifying.

[00:08:30] Speaker 04:
Your precedent makes pretty clear that that doesn't have to be shown to have a motivation to combine, right?

[00:08:35] Speaker 04:
You don't have to show that because this may work okay, that the alleged combination would be an improvement.

[00:08:45] Speaker 04:
I think we just issued a decision on that within the last four or five months.

[00:08:50] Speaker 04:
So, I mean, they just have to show that there's a general motivation to combine these, which would be it works better, right?

[00:08:57] Speaker 00:
Well, they have to show at least a general motivation that somebody would take the existing protein and then start doing something to it for some reason.

[00:09:06] Speaker 00:
Start adding a linker, not adding a linker.

[00:09:08] Speaker 04:
There's no reason in the... Isn't the reason that it works better?

[00:09:12] Speaker 00:
Well, as it turns out, right, after a lot of experimentation.

[00:09:16] Speaker 04:
I mean, I'm having a little trouble separating your motivation to combine with your unexpected results argument.

[00:09:21] Speaker 04:
And your unexpected results argument, at least to the extent the board didn't really address them very well, or at all, I think has some fair

[00:09:31] Speaker 04:
points but I'm a little confused about why you could it doesn't seem like there's any well maybe there's a dispute but at least for purposes of this I don't see any contention that the prior art the more cited shows all the elements you're just arguing that there's no reason to combine it but

[00:09:47] Speaker 04:
When you say there's no reason to combine it, the board looked at all of this and said, sure, somebody would combine all these elements together because it would work better overall.

[00:09:58] Speaker 04:
You're saying, well, the references don't teach that.

[00:10:00] Speaker 04:
But I think we've said the references themselves don't have to teach that.

[00:10:05] Speaker 00:
The references.

[00:10:07] Speaker 00:
don't themselves maybe have to teach that if you did this, it would necessarily be better.

[00:10:13] Speaker 00:
But there has to be some reason to motivate, some reason to alter or change what the existing protein

[00:10:19] Speaker 00:
is, and even say you wanted just to change the protein because you just wanted to change the protein, why would you add linkers to it?

[00:10:29] Speaker 00:
There's really no motivation for why you would start adding linkers to this particular fusion protein.

[00:10:33] Speaker 00:
Maybe you would start modifying the different protein components.

[00:10:37] Speaker 04:
I think we have that argument.

[00:10:37] Speaker 04:
You're into your argument.

[00:10:38] Speaker 04:
Do you want to say the rest of it?

[00:10:40] Speaker 00:
Unless you have any questions, I will reserve the remainder.

[00:10:43] Speaker 03:
Is it correct that you concede that all the elements of your claim

[00:10:48] Speaker 03:
were known in the priority?

[00:10:52] Speaker 00:
Yes.

[00:10:53] Speaker 03:
Okay.

[00:10:53] Speaker 03:
Thank you.

[00:10:56] Speaker 02:
Good morning, Your Honor.

[00:10:57] Speaker 02:
Please support.

[00:10:58] Speaker 02:
The invention here is really much simpler than you might think, given the technology.

[00:11:04] Speaker 02:
We're talking about taking an APL01 protein and then

[00:11:10] Speaker 04:
fusing that to an FC fragment of an antibody to improve its blood... I think we understand the facts, or at least as much as I can ever understand these facts, but could you just get right to the unexpected results thing, because I think that's your most significant hurdle here.

[00:11:29] Speaker 02:
They allege unexpectedly superior results here.

[00:11:37] Speaker 02:
based on their findings that they have improved

[00:11:43] Speaker 02:
activity in their studies of APL-1 approaching the wild type and sometimes exceeding it when they have the FC fragment added.

[00:11:55] Speaker 02:
The board found that that was enough to provide a presumption of nexus, but the board found that that simply just wasn't enough to overcome the strong case of obviousness made out by the prior art.

[00:12:10] Speaker 04:
And what about the entire group of evidence that the board didn't address?

[00:12:15] Speaker 04:
I know you try to make a forfeiture argument, but I don't really see that as viable.

[00:12:23] Speaker 04:
And then you go on in your red brief, and I think make a very convincing argument about why none of those references are helpful.

[00:12:32] Speaker 04:
But you don't get to make that argument for the board.

[00:12:34] Speaker 04:
You don't get to save the board when they didn't write that into their opinion.

[00:12:39] Speaker 02:
I think in fairness, our red brief says that explains why they forfeited an argument based on those references.

[00:12:50] Speaker 02:
Their brief to the board cites the Ledbetter's second declaration.

[00:12:57] Speaker 04:
And then it cites a whole bunch of other studies.

[00:13:00] Speaker 02:
And then Ledbetter, if you look to Ledbetter's declaration, the paragraph they cite, it contains a string cite for a naked assertion that there's unpredictability in the art.

[00:13:12] Speaker 02:
That just should not be sufficient to raise an issue to the court.

[00:13:17] Speaker 04:
And then it follows with the sentences, in view of such studies, coupled with the lack of any relevant blah, blah, blah, a skilled artisan would not be able to reasonably predict.

[00:13:26] Speaker 04:
I mean, why isn't that enough?

[00:13:28] Speaker 04:
It's here's this declaration that includes a lot of studies.

[00:13:31] Speaker 04:
And by the way, it doesn't just site lead better and make you go look at that declaration.

[00:13:35] Speaker 04:
It includes it in their brief, all these studies, right?

[00:13:39] Speaker 02:
I don't believe that it did, but even if it... let's assume that... Let's assume it did.

[00:13:44] Speaker 02:
Let's assume that it had a street site.

[00:13:46] Speaker 04:
I can pull out the brief and look at it.

[00:13:47] Speaker 04:
I'm looking at my bench memo, which has the quote in it.

[00:13:51] Speaker 04:
And I assume it's accurate.

[00:13:52] Speaker 04:
But it cites all these studies, and then it follows with the sentence that says, these studies show unexpected results.

[00:13:59] Speaker 04:
And the board didn't address any of those studies.

[00:14:01] Speaker 02:
Well, what they're saying the studies show is an unpredictability in the art.

[00:14:07] Speaker 02:
but the board didn't buy into that argument because, for example... Where in the board's decision does it specifically address all of this?

[00:14:18] Speaker 02:
Again, Your Honor, the board does not specifically address wire and those other references, but... If we find that there, we have to send it back, right?

[00:14:27] Speaker 02:
No, I don't agree with that because the board said that they didn't find the board did not find the prior art to be as unpredictable as

[00:14:37] Speaker 02:
they're alleging.

[00:14:39] Speaker 02:
Whether they walk through all those references or not, they didn't agree with that.

[00:14:43] Speaker 02:
If you look at the claim.

[00:14:44] Speaker 04:
How do we know that when they didn't even discuss any of these?

[00:14:47] Speaker 04:
I know the board is not required to address every single piece of evidence.

[00:14:53] Speaker 04:
But it seems like there were two categories of evidence here.

[00:14:56] Speaker 04:
One category showing the studies that showed this was a good result.

[00:15:02] Speaker 04:
And then this other category that showed nobody would expect

[00:15:06] Speaker 04:
these things to accomplish this and they didn't address that second category at all.

[00:15:11] Speaker 04:
Why isn't that error?

[00:15:13] Speaker 02:
I don't believe that's error because what we're looking at here is just a simple optimization of linker length.

[00:15:20] Speaker 02:
If you look at the primary reference, Knudsen, which is also owned by Therippiad, you will see that Knudsen, these claims were specifically drafted to overcome Knudsen so that Knudsen wouldn't anticipate the claimed invention.

[00:15:37] Speaker 02:
So they've alleged that Knudsen's peptide linker, based on a definition of peptides being nine amino acids or shorter, that

[00:15:48] Speaker 02:
Knudsen's linker must be nine amino acids or shorter.

[00:15:53] Speaker 02:
So they specifically claim something that's 10 to 40 amino acids.

[00:15:57] Speaker 02:
But when you look to Lagerstad, Bacchus, and Leadbetter, you'll see that that's a typical link for a linker.

[00:16:07] Speaker 02:
It's in that 10, 14 range.

[00:16:08] Speaker 01:
Do you agree the board didn't discuss the comparative data in its decision?

[00:16:11] Speaker 01:
Do you agree with that premise?

[00:16:13] Speaker 01:
I'm sorry.

[00:16:14] Speaker 01:
Do you agree the board did not discuss the comparative data in its decision?

[00:16:17] Speaker 01:
Do you agree with that?

[00:16:18] Speaker 02:
Don't agree with that because if you look to the board's decision, they spent an entire page going through what The secondary consideration of evidence was If we If we look to page nine of the board's decision, which is a PPX 10 you'll see the board

[00:16:44] Speaker 02:
discusses what the evidence is that's found in the specification for the alleged unexpected results.

[00:16:51] Speaker 02:
And then you'll see in this second paragraph that follows the further studies that they've done where they've tested various linker links.

[00:17:05] Speaker 02:
And again, that's something people of ordinary skill and the art do.

[00:17:08] Speaker 02:
That's a results effective variable.

[00:17:11] Speaker 02:
Linkers perform two functions.

[00:17:14] Speaker 02:
Linkers bind two things together, and linkers also can be adjusted.

[00:17:20] Speaker 01:
So you're continuing the appendix page 11 as sufficient analysis on unexpected results.

[00:17:24] Speaker 01:
Is that what you're continuing?

[00:17:28] Speaker 02:
The board said that that data was not sufficient to overcome

[00:17:37] Speaker 02:
the expectation of success and the results shown, the strong case of obvious is shown in references like Bacchus or Ledbetter.

[00:17:49] Speaker 01:
I'm looking for a yes or no answer.

[00:17:52] Speaker 01:
on my question.

[00:17:53] Speaker 01:
Do you contend that this is sufficient analysis of unexpected results on the appendix page?

[00:17:57] Speaker 02:
Yes, I do.

[00:17:58] Speaker 02:
Because you don't read this page just in and of itself.

[00:18:02] Speaker 02:
This page must be read in context of the entire board's decision.

[00:18:10] Speaker 02:
And when you look at the entire board's decision and you look at their discussion of Leadbetter and Bacchus here,

[00:18:17] Speaker 02:
What they show is, particularly with Leadbetter, that as you adjust linker length, which is a results-effective variable, as you adjust that, you will see variations in the amount of activity of your protein interest.

[00:18:32] Speaker 02:
In this case, APOA1.

[00:18:35] Speaker 03:
So where, right, the board has a couple sentences about Leadbetter further down on A11.

[00:18:41] Speaker 03:
And they point out that it's Leadbetter's DNase enzyme.

[00:18:47] Speaker 03:
And then they just conclude that one of skill and the art would understand from that that there'd be a similar effect of the linker length on the biological activity we care about in APOA1.

[00:19:00] Speaker 03:
There's no explanation as to how they get from how one of skill and the art would take what they learn about DNase in Leadbetter

[00:19:09] Speaker 03:
to make it obvious that it would have the same impact in what we care about.

[00:19:13] Speaker 03:
Where's the explanation of that?

[00:19:17] Speaker 02:
I think that when, what they're talking about here is if you look at the sentence beginning with specifically, Leadbetter compares the activity of an FC fusion protein with a glyphosere 4 peptide linker, so that's a 20 amino acid linker, to the same

[00:19:38] Speaker 02:
protein lacking the FC linker, and they see that they have a dramatic increase when they've used a linker that's 20 amino acids long.

[00:19:51] Speaker 02:
And so the board relies on that.

[00:19:54] Speaker 02:
The board cites that as a basis for concluding that persons of ordinary skill in the art reasonably expect that as you adjust the linker length, as you optimize this result's effective variable, that you will find

[00:20:11] Speaker 02:
exactly what they've alleged to do here, which is you will find how to link them.

[00:20:16] Speaker 03:
But where's the analysis of the difference between DNAs and APOA1?

[00:20:22] Speaker 03:
Where's the analysis?

[00:20:23] Speaker 03:
And you've already admitted it's not there.

[00:20:25] Speaker 03:
Dwyer and the other prior art that suggests linker length effect is unpredictable.

[00:20:30] Speaker 03:
They just seem to leap from lead better to, well, one is still the art would think that that same principle would apply always.

[00:20:40] Speaker 02:
No.

[00:20:43] Speaker 02:
In fairness, what they said about Leadbetter and Bacchus as well is that

[00:20:53] Speaker 02:
When they raised similar arguments to the board, the board said, no, the difficulty here is that we're not talking about what the protein of interest is.

[00:21:04] Speaker 02:
We're just talking about using a linker to add an FC fragment to the protein of interest.

[00:21:10] Speaker 02:
Because FC fragments were known in the prior art to increase

[00:21:16] Speaker 02:
Stability in the bloodstream to increase half-life up and thereby increase bio Availability of your drug of interest and so this was a known thing to do and it was known to adjust linker link and I'd like to correct something that my friend across the aisle here said about Lagersted not providing any guidance or any reason why they would use the 10 to 40 amino acids and

[00:21:47] Speaker 02:
Leadbetter expressly states, if you look at the record at ACPX 2183, paragraph 266, that these linkers are typically, that's the word he uses, typically 1 to 50 amino acids.

[00:22:07] Speaker 02:
And then he talks about typically 1 to 40 amino acids.

[00:22:14] Speaker 02:
And so those are the words that are used, typically.

[00:22:17] Speaker 02:
It's not you're asked to pick this length of a linker from the air.

[00:22:23] Speaker 02:
You're being told that this is the typical length.

[00:22:27] Speaker 01:
Would you agree that your argument is better on motivation to combine than on unexpected results?

[00:22:37] Speaker 02:
I understand that the court believes that, but I think both arguments are strong.

[00:22:45] Speaker 02:
I concede that this court is concerned that the board didn't write more about the unexpectedly superior results and didn't go into each of these references.

[00:23:02] Speaker 02:
I don't believe the board was required to do that.

[00:23:07] Speaker 04:
Well, I'm still struggling with that a little bit.

[00:23:09] Speaker 04:
And I completely agree with you that we don't have a rule that the administrative agency has to discuss every single specific piece of evidence in support of arguments.

[00:23:21] Speaker 04:
But let's just draw this back from these specific references and think of it more general hypothetical.

[00:23:27] Speaker 04:
If there's two different categories of evidence and one supports

[00:23:32] Speaker 04:
shows why these superior results were sustained.

[00:23:37] Speaker 04:
And one shows that nobody thought these superior results could have been obtained.

[00:23:43] Speaker 04:
And it's a combination of those two things that suggests that, on the appellant side, that unexpected results occurred, because nobody thought this would have happened, and then it did happen.

[00:23:55] Speaker 04:
If the board only discusses the evidence showing it did happen, hasn't it made an error in not discussing the evidence showing nobody thought it would have happened?

[00:24:04] Speaker 04:
And again, divorce it from the facts of this case.

[00:24:06] Speaker 04:
Those are those two categories.

[00:24:08] Speaker 04:
They're not overlapping.

[00:24:11] Speaker 04:
Nothing in the evidence the board cited here I don't care about.

[00:24:15] Speaker 04:
If they failed to discuss one of those categories, haven't they made an error?

[00:24:22] Speaker 02:
I don't believe that they have under these circumstances.

[00:24:24] Speaker 02:
And here's why.

[00:24:25] Speaker 02:
Because they made arguments.

[00:24:29] Speaker 02:
They're chief arguments that they actually made before the board about why.

[00:24:33] Speaker 04:
I don't want to talk about the specifics of this case.

[00:24:36] Speaker 04:
This is why I asked it as I played it.

[00:24:38] Speaker 04:
If there's two categories of evidence, one category is skilled artisans wouldn't have expected this to happen because it's unpredictable and nobody would have known this.

[00:24:48] Speaker 04:
And then there's studies testing this out and saying, oh, this did happen.

[00:24:52] Speaker 04:
Here's why it does have these improved results.

[00:24:54] Speaker 04:
If the board only looks at the improved results and says, well, this shows that people would have expected this success, haven't they erred by not looking at the evidence that shows skilled artisans wouldn't have thought this would happen?

[00:25:06] Speaker 02:
Well, first of all, thank you for that clarification.

[00:25:09] Speaker 04:
I'm not asking you to concede your case.

[00:25:15] Speaker 04:
This is a hypothetical.

[00:25:16] Speaker 02:
No, I understand.

[00:25:17] Speaker 02:
And I would even say in that hypothetical, it would depend.

[00:25:20] Speaker 02:
And here's why.

[00:25:22] Speaker 02:
Because what you're in some sense making is a teaching away argument.

[00:25:28] Speaker 02:
You're saying that this is unpredictable.

[00:25:30] Speaker 02:
We wouldn't expect this to happen.

[00:25:32] Speaker 02:
And the board should have considered that.

[00:25:39] Speaker 02:
And whether the board errors by not going through that evidence, I think, turns on the facts of an individual case.

[00:25:46] Speaker 02:
But it can be error.

[00:25:47] Speaker 02:
I will concede that.

[00:25:50] Speaker 04:
OK, you're out of time.

[00:25:51] Speaker 04:
Do you have any last thoughts?

[00:25:53] Speaker 02:
No.

[00:25:54] Speaker 02:
Do your honors have any further questions?

[00:25:56] Speaker 02:
Thank you.

[00:25:57] Speaker 04:
Thank you.

[00:26:01] Speaker 04:
Ms.

[00:26:01] Speaker 04:
Browning, you have about four and a half minutes.

[00:26:05] Speaker 00:
Thank you.

[00:26:06] Speaker 00:
So we disagree that the...

[00:26:09] Speaker 00:
that the board analyzed the unpredictability aspect of the case, but if you don't have any more questions about that, I would like to address some of the motivation issues if that's okay.

[00:26:20] Speaker 00:
So the patent office said that adding a linker is routine, but that is already assuming that you have a reason to add a linker in the first place.

[00:26:30] Speaker 00:
So, and certainly they don't mention why it would be, you know, obvious to add a longer linker, right, to a fusion protein.

[00:26:37] Speaker 00:
So even the quotes pointed to in lead better going 1 to 50 or 1 to 40, that's a very broad range, right?

[00:26:44] Speaker 00:
That's certainly not the extended linker that was claimed.

[00:26:48] Speaker 00:
And many of the studies that we pointed to did tend to drift towards showing that shorter linkers would be better or adding no linkers at all, especially where there was the FC protein used.

[00:27:03] Speaker 00:
And as far as any kind of optimization argument, that was never raised or considered by the board below.

[00:27:11] Speaker 00:
So that would be, we would consider that to be a new argument as well.

[00:27:16] Speaker 00:
Any other questions?

[00:27:20] Speaker 04:
Thank you.