[00:00:00] Speaker 02:
Next case is number 22-1165, Medi-Tox Inc.

[00:00:06] Speaker 02:
vs. Gelderner SA.

[00:00:11] Speaker 02:
Mr. Gupta?

[00:00:13] Speaker 00:
May please the court, Vishal Gupta, for Mehdi Talks.

[00:00:16] Speaker 00:
Your honors, the PTAB aired by concern 50% or greater as a range instead of a threshold.

[00:00:22] Speaker 00:
And that error infected the board's analysis with respect to its new matter determinations, written description, and enablement.

[00:00:29] Speaker 02:
OK, so let me ask you a question.

[00:00:31] Speaker 02:
Suppose a competitor achieves 95%.

[00:00:40] Speaker 02:
Could you sue for infringement?

[00:00:44] Speaker 00:
Your honor, that would fall within the scope of the claims.

[00:00:46] Speaker 00:
And this is the reason why.

[00:00:48] Speaker 02:
OK, so how can you have a different construction for infringement and invalidity?

[00:00:54] Speaker 00:
Your honor, it would not be a different construction.

[00:00:56] Speaker 00:
The evidence points in one way for the construction.

[00:00:59] Speaker 00:
And that's that 50% or greater is a threshold.

[00:01:03] Speaker 02:
And the reason- I don't think you're answering my question.

[00:01:05] Speaker 02:
You say that if somebody achieves 95%,

[00:01:09] Speaker 02:
he's infringing, so it has to be within the scope of the claim, so the claim has to reach 95%.

[00:01:15] Speaker 00:
Yes, your honor.

[00:01:16] Speaker 00:
And this is the reason why.

[00:01:18] Speaker 00:
Because any responder rate in the context of these claims, any responder rate above 50% is essentially the same.

[00:01:26] Speaker 00:
So 52 in the context of these claims would be the same as 95.

[00:01:29] Speaker 00:
And the reason why is because a POSA would see 50% or greater as a test for greater length of effect.

[00:01:37] Speaker 02:
I don't understand what you're saying.

[00:01:38] Speaker 02:
How could it be?

[00:01:40] Speaker 02:
that if it infringes at 95%, that we don't consider that the claim encompasses 95% primitivity purposes.

[00:01:49] Speaker 00:
Your Honor, the claim would encompass a responder rate of 95%.

[00:01:55] Speaker 00:
And the reason why is because of the threshold construction.

[00:01:58] Speaker 00:
It should not be construed as a range construction.

[00:02:00] Speaker 00:
And if I can just go into the reasons why.

[00:02:02] Speaker 01:
Well, maybe you could help us.

[00:02:04] Speaker 01:
What is the difference between the range and the threshold of 95%

[00:02:08] Speaker 01:
is within the scope either way, right?

[00:02:11] Speaker 01:
Well, Your Honor, this leads to... Is that right, that 95% is within the scope under your construction or under their construction?

[00:02:19] Speaker 00:
Yes, but the construction is still a threshold.

[00:02:24] Speaker 00:
And the reason why that matters is because a person of already skill in the art

[00:02:28] Speaker 00:
would look at 95 or 52, for example, as the same, as a demonstration of sustained clinical effect or greater length of effect in the context of these claims.

[00:02:39] Speaker 00:
And that's widely in the extrinsic evidence.

[00:02:42] Speaker 00:
It's widely used as a test for sustained clinical efficacy.

[00:02:46] Speaker 00:
And in the intrinsic evidence, in the specification, 50% or greater is used as a test for sustained clinical efficacy.

[00:02:54] Speaker 01:
And so how, even if you're right,

[00:02:58] Speaker 01:
I'm not sure what you mean by I suppose it would look at it the same, but even if you're right, how is that implicated by the claim construction dispute?

[00:03:05] Speaker 01:
What is actually in dispute between the two parties as to whether it's a threshold or a range?

[00:03:10] Speaker 00:
Well, Your Honor, I think this gets into the 112 analysis.

[00:03:13] Speaker 00:
The PTAP improperly was looking at whether the disclosures of the specification enable or describe very specific responder rates above 50%.

[00:03:27] Speaker 00:
When it should have just been looking at whether sustained clinical efficacy was demonstrated or not.

[00:03:32] Speaker 00:
It's a yes, no test.

[00:03:34] Speaker 02:
We're talking about claim construction.

[00:03:36] Speaker 02:
You're suggesting that it makes a difference whether it's a range or a threshold.

[00:03:40] Speaker 02:
We're suggesting to you it seems to make no difference at all because no matter what the specific point is above 50%, you believe that competitors achieving that is infringement and is within the scope of the claims.

[00:03:58] Speaker 02:
So that means that for infringement, it goes up to 100.

[00:04:03] Speaker 02:
If it goes up to 100 for infringement, it has to go up to 100 for invalidity.

[00:04:07] Speaker 02:
What's the difference?

[00:04:09] Speaker 00:
Well, Your Honor, this is the difference, is that as a range, again, a POSA would look at both of those values as a demonstration of clinical efficacy, whether it's 100 or whether it's above 50.

[00:04:23] Speaker 02:
That doesn't seem to me to be a claim construction issue.

[00:04:26] Speaker 02:
That may be a different issue.

[00:04:28] Speaker 02:
There may be a relevant difference between a range and a threshold.

[00:04:36] Speaker 02:
But for purposes of claim construction, there's no difference.

[00:04:39] Speaker 00:
Well, Your Honor, respectfully, we do believe it's a claim construction issue that infected the downstream analysis on 112.

[00:04:47] Speaker 00:
And again, in the context of these specific claims, it's a demonstration or a test for clinical efficacy or greater length of effect.

[00:04:58] Speaker 00:
The claim was not directed to a range of specific responder rates.

[00:05:04] Speaker 00:
And so if I could direct you to the evidence with respect to claim construction, specifically, the claims don't recite 2 100.

[00:05:16] Speaker 00:
They say 50% or greater.

[00:05:18] Speaker 00:
That's explicitly a threshold.

[00:05:19] Speaker 00:
That's how one of ours still in the art would use it.

[00:05:22] Speaker 00:
But further, the Glasgow article at appendix 61, which is cited within the specification,

[00:05:30] Speaker 00:
the specification discusses it and says that sustained clinical effect

[00:05:36] Speaker 00:
was observed by applying a threshold test of more than 50 percent of responders.

[00:05:40] Speaker 00:
So that is how this term is used in the specification.

[00:05:45] Speaker 00:
And then the extrinsic evidence is also in accord.

[00:05:48] Speaker 00:
There are various references that use greater than 50 percent as a threshold to determine sustained clinical efficacy.

[00:05:56] Speaker 00:
So again, it should not be looked at as a constellation of specific responder rates, but rather

[00:06:03] Speaker 00:
as an on-off binary test, as a demonstration of greater length of effect.

[00:06:09] Speaker 00:
That is how a postal would view the term.

[00:06:12] Speaker 00:
And so getting to the enablement and written description analyses, the board specifically aired by requiring possession and enablement of specific responder rates above 50%.

[00:06:25] Speaker 00:
It should have instead been focusing on whether any responder rates above 50% exist without

[00:06:31] Speaker 00:
emphasis on the magnitude, without regard to the magnitude.

[00:06:34] Speaker 01:
I guess I'm lost at just the common sense question.

[00:06:38] Speaker 01:
If 95% to take Judge Dyke's hypothetical, if it infringes, then don't you have to show you had possession of it to satisfy the written description, and don't you have to show that one of skill in the art could look at your patent and without undue experimentation achieve 95%?

[00:06:54] Speaker 00:
Sure, Your Honor.

[00:06:55] Speaker 00:
That's a good question.

[00:06:56] Speaker 00:
And what would support 95% as an example would be the disclosures that show efficacy greater than 50%.

[00:07:06] Speaker 00:
And the reason why is because it's an on-off switch.

[00:07:11] Speaker 00:
When greater length of effect is demonstrated by the robust clinical trials.

[00:07:14] Speaker 02:
That's a different issue.

[00:07:14] Speaker 02:
That's not complete construction.

[00:07:16] Speaker 02:
That's a different issue.

[00:07:18] Speaker 00:
Your Honor, with respect to support of written description and enablement, that's a question of whether there's enough support in the specification.

[00:07:29] Speaker 00:
And the specification here is rife with support, and you don't have to look at- Do you believe this is an unpredictable art?

[00:07:37] Speaker 00:
When you have the guidance, the right guidance of the specification, which has robust clinical trials, which discloses the concentrations of the different formulation ingredients, which has an example formulation of MT-119.

[00:07:50] Speaker 02:
There's a lot of testimony here.

[00:07:51] Speaker 02:
It's unpredictable.

[00:07:52] Speaker 02:
Your Honor.

[00:07:53] Speaker 02:
And you'd have to run the clinical trials to figure out whether a particular compound or whatever it is would achieve greater than 50%.

[00:08:04] Speaker 00:
Your Honor, with the guidance of the spec, it's not unpredictable.

[00:08:09] Speaker 00:
And secondly, any testing that would have to be taken would be routine.

[00:08:14] Speaker 02:
Why is it not unpredictable under the spec?

[00:08:17] Speaker 00:
Well, Your Honor, the reason why it's not unpredictable is because many talks disclosed exactly how to get to the narrow circumscribed claims here.

[00:08:25] Speaker 00:
And it tells you exactly how to run a clinical trial.

[00:08:29] Speaker 00:
It tells you the formulation ingredients.

[00:08:31] Speaker 00:
It tells you the active ingredient type.

[00:08:34] Speaker 00:
It tells you add polysorbate.

[00:08:36] Speaker 00:
It says add a stabilizer.

[00:08:38] Speaker 02:
It also... Do you mean if the specification tells you how to run a test, it doesn't make any difference whether you can brick the test results in advance or not?

[00:08:48] Speaker 00:
Your Honor, any testing that would have to occur would be routine in view of the specification.

[00:08:58] Speaker 02:
It might be routine.

[00:08:59] Speaker 02:
The testing methodology might be routine, but the predictability is absent.

[00:09:04] Speaker 02:
We can't figure out which products are going to achieve 95% under my house.

[00:09:14] Speaker 00:
Well, Your Honor, specifically in this case, as discussed on page 39 of our brief, that gives enough guidance for APOSTA to make formulations that would fall within the scope of these narrow circumscribed method of treatment.

[00:09:33] Speaker 00:
It gives the ingredients and their amounts, the composition.

[00:09:36] Speaker 00:
It even discloses MT-10109L at appendix page 61, which specific ingredients and amounts.

[00:09:44] Speaker 00:
and many times expert doctors saying testified at appendix four two five nine this uh... forty five nine to sixty and four to six six that also would expect similar variations of empty one oh one oh nine l to work in the clean method of treatment after becoming aware of the disclosure of the seven to eight patent in any event the reason the board found otherwise right or credit their expert review that

[00:10:12] Speaker 00:
Well, Your Honor, that's not substantial evidence.

[00:10:14] Speaker 00:
And that's why the board erred.

[00:10:16] Speaker 00:
The body of evidence points in one direction of sufficient support.

[00:10:21] Speaker 00:
And the reason why is because there are robust clinical trial disclosures.

[00:10:26] Speaker 00:
And there are also robust formulation disclosures here.

[00:10:29] Speaker 01:
How do we just light the side of their expert?

[00:10:33] Speaker 01:
I think it was Dr. Singh.

[00:10:35] Speaker 01:
But whoever their expert was and the board's crediting of their expert, we can't just ignore that, can we?

[00:10:42] Speaker 00:
uh... your honor respectfully there wasn't substantial evidence for the board's determination and the court should follow its decisions in alergan and alcon here those are those are very instructive in those specific cases your honor the the the board held adequate written description

[00:11:04] Speaker 00:
and enablement based on far less disclosure.

[00:11:06] Speaker 00:
And if I could just briefly go over Allergan, for example, the claims there involve the composition that lowers interocular pressure with less hyperemia as compared to a second composition.

[00:11:18] Speaker 00:
And it was unbounded in terms of the amount of hyperemia that was lessened.

[00:11:23] Speaker 00:
In other words, the clinical effect was either achieved or it wasn't, just like here, and the claims were held to be adequately described despite no clinical data.

[00:11:33] Speaker 00:
Similarly, in ALKON, claims directed to enhancing chemical stability without an upper limit, by adding a certain stabilizer held to be adequately described despite no data in the specification on chemical stability.

[00:11:47] Speaker 00:
And as this court has noted, working examples of every embodiment

[00:11:52] Speaker 00:
are not required.

[00:11:55] Speaker 03:
When did you make your claim construction arguments before the board?

[00:11:59] Speaker 03:
It seems to me that your case rests on claim construction.

[00:12:05] Speaker 03:
And you're arguing here, no, I'm not arguing claim construction, but it seems to me that you are.

[00:12:10] Speaker 03:
You're making claim construction arguments that I don't think you made before the board.

[00:12:14] Speaker 03:
Am I correct?

[00:12:16] Speaker 00:
your honor we this I am I the claim construction is still dispute we're saying that it's arranged we made those arguments before we consistently argued below that the threshold construction should be should be used for 50% or greater did you argue that it should be that it's a range or did you argue simply that

[00:12:37] Speaker 03:
the claim term should be given the Plain and Ordinary Mealing.

[00:12:40] Speaker 00:
We argued that it should be given the Plain and Ordinary Mealing as a threshold and specifically not a range.

[00:12:45] Speaker 00:
So that was, that's present at the Singh Declaration of Appendix 2802 to 2805 and also Appendix 4256 to 5757.

[00:12:54] Speaker 00:
That argument was presented before the PTAB at oral hearing and the recon motion or the director review motion also raised that specific issue.

[00:13:03] Speaker 00:
And so the claim construction here is important because that is how one of our skill in the art would view the claim term.

[00:13:12] Speaker 00:
And then similarly, that interpretation would then be taken into how the guidance of the specification would be interpreted.

[00:13:21] Speaker 00:
And there are multiple responder rates above 50%, which would support the full scope of the threshold limitation.

[00:13:28] Speaker 00:
And one last point that I'd like to make before sitting down.

[00:13:32] Speaker 00:
This is not a claim the world scenario.

[00:13:34] Speaker 00:
If you look at the first page of the brief, Romanet 1, which details the claim, there are many limitations here.

[00:13:41] Speaker 00:
This is a specific circumscribed claim for a method treating globular lines using specific formulation and specific amounts, specific ingredients, then it outlines a specific test in terms of how to carry out a comparison.

[00:13:54] Speaker 00:
These claims have continually been narrowed.

[00:13:57] Speaker 00:
during the PGR proceedings.

[00:13:59] Speaker 00:
So there was no introduction of new matter, and these claims are circumscribed in nature, which highlights how robust the written description and specification support is for the claims at issue.

[00:14:14] Speaker 02:
Okay, you want to save the rest of your time?

[00:14:16] Speaker 02:
Yes, thank you, Your Honor.

[00:14:17] Speaker 02:
We'll give you two minutes.

[00:14:18] Speaker 02:
Thank you.

[00:14:19] Speaker 02:
Mr. Jordan.

[00:14:22] Speaker 05:
Good morning.

[00:14:22] Speaker 05:
May it please the Court, Joe Mahoney on behalf of Caldera.

[00:14:27] Speaker 05:
And I'll start with addressing, first, Meditoxic Council's argument about... I'm sorry, you're Mr. Mahoney, right?

[00:14:36] Speaker 05:
Yes, Mr. Mahoney.

[00:14:37] Speaker 05:
Joe Mahoney.

[00:14:38] Speaker 05:
Pleasure to be here.

[00:14:40] Speaker 05:
So the on-off switch, OK?

[00:14:43] Speaker 05:
The yes or no test.

[00:14:46] Speaker 05:
Their substitute claim 19

[00:14:51] Speaker 05:
according to its expressed words, it has two requirements.

[00:14:58] Speaker 05:
One is that the animal protein free composition has a greater length of effect compared to Botox 20 units.

[00:15:06] Speaker 05:
And then the second part is that that animal free composition has a responder rate at 16 weeks of 50% or greater.

[00:15:18] Speaker 05:
But if you look at their construction under their yes or no median construction, what about an instance where Botox 20 units has the claimed responder rate that's higher than 50%?

[00:15:35] Speaker 05:
There's literature that shows that that actually happens.

[00:15:39] Speaker 05:
The woo paper that we cite to at appendix 2546.

[00:15:42] Speaker 02:
What's the print that you're making?

[00:15:44] Speaker 05:
Well, what I'm trying to point out is, if it's yes or no, and if both the animal protein-free and the Botox exceed this 50% or greater, that makes no sense.

[00:16:01] Speaker 05:
There's no way to differentiate

[00:16:05] Speaker 05:
the two to see which one of those lasts longer.

[00:16:09] Speaker 05:
And that's why a range makes sense.

[00:16:11] Speaker 02:
In other words, I think what... Do you think there's a difference between a range construction and a threshold construction?

[00:16:19] Speaker 05:
Well, no.

[00:16:20] Speaker 05:
Not based on, you know, what they've said.

[00:16:25] Speaker 05:
What their expert said was that 70%, 80%, 90%.

[00:16:28] Speaker 02:
It's not a question of what the expert said.

[00:16:30] Speaker 02:
It's a question of what the patent says, what the claim says.

[00:16:35] Speaker 05:
Yeah.

[00:16:36] Speaker 02:
And they admit that for infringement, they can sue up to $100.

[00:16:41] Speaker 05:
Right.

[00:16:43] Speaker 05:
That's right.

[00:16:43] Speaker 05:
And we agree.

[00:16:44] Speaker 05:
We think that that 50% or greater goes between 50% and 100%.

[00:16:49] Speaker 05:
And 100% is the inherent upper limit of the responder rate.

[00:16:56] Speaker 01:
So what if anything turns on the claim construction dispute?

[00:16:59] Speaker 05:
I'm sorry.

[00:17:00] Speaker 01:
What if anything turns on the claim construction dispute that's before us?

[00:17:04] Speaker 05:
Well, nothing, because whether it's a threshold or a range, you still, for the purposes of written description, you have to show possession for the full scope of the claim.

[00:17:19] Speaker 05:
So between 50 and 100.

[00:17:21] Speaker 01:
And your argument is the same whether we go with their construction or yours.

[00:17:26] Speaker 01:
Is that right?

[00:17:26] Speaker 05:
Well, in terms of requiring

[00:17:34] Speaker 05:
That claim would require, for the purposes of 112 written description, possession of the full scope of the claim.

[00:17:42] Speaker 05:
So they've only shown with two examples, 52% and 62%.

[00:17:48] Speaker 05:
They've not shown possession of compositions that exceed that.

[00:17:58] Speaker 05:
And therefore, that's why there's no written description.

[00:18:03] Speaker 01:
But okay, but if I if I say it's a threshold is your argument any different?

[00:18:10] Speaker 05:
Well as long as you win under their construction well as long as that threshold means From 50 to 100 percent we do and then there is a difference Okay And I want to address

[00:18:30] Speaker 05:
Yes, it is an unpredictable art.

[00:18:34] Speaker 05:
Certainly, the patent talks about botulinum A toxin compositions.

[00:18:42] Speaker 05:
That's very broad because it's a protein.

[00:18:45] Speaker 05:
It may exist in many different forms.

[00:18:50] Speaker 05:
These botulinum A complexes have molecular weights of 900, 500, 300 kilodaltons.

[00:18:58] Speaker 05:
That's at appendix 54.

[00:19:01] Speaker 05:
And what that means is all these different type A toxins, they have different molecular weights.

[00:19:08] Speaker 05:
They have different activities, different doses, different efficacy, different duration, different immunogenicity.

[00:19:16] Speaker 05:
And that's why they all have different names.

[00:19:19] Speaker 05:
Botox is onobotulinum toxin.

[00:19:22] Speaker 05:
Dysport is ABO botulin.

[00:19:25] Speaker 05:
They're all these different names, and it's due to the variations in the proteins, due to the different manufacturing processes, different purification, different formulations, all this unpredictable.

[00:19:38] Speaker 02:
What's the point?

[00:19:39] Speaker 05:
All this is very unpredictable art.

[00:19:41] Speaker 02:
Okay.

[00:19:42] Speaker 05:
Very unpredictable art.

[00:19:44] Speaker 05:
And these type A toxins are not interchangeable.

[00:19:49] Speaker 05:
The

[00:19:53] Speaker 05:
And then, to that point, our expert, Dr. Ash Ramzan, he opined to the unpredictability and the undue experimentation on the enablement side.

[00:20:06] Speaker 05:
But significantly, meditoxas expert Dr. Singh said that it's impossible to speculate whether new formulations would meet the 50% or greater limitation.

[00:20:23] Speaker 05:
On judging your question about whether the claim construction arguments were made before the board, we acknowledge that many talks they did say to the board that 50% or greater was a threshold.

[00:20:39] Speaker 05:
But they didn't cite to any intrinsic evidence to support that.

[00:20:47] Speaker 05:
Okay.

[00:20:48] Speaker 05:
And so, for example, their argument as to the patent's reference to GloGao, that's new.

[00:20:57] Speaker 05:
That's a new argument for the purpose of this appeal.

[00:21:01] Speaker 05:
But that argument doesn't, that point about the GloGao reference, which is at column 22 of the patent, that doesn't save many talks.

[00:21:11] Speaker 05:
I mean, the whole point of GloGao's reference in the patent

[00:21:17] Speaker 05:
why it was cited was to simply point out that larger, longer studies are necessary to confirm Medutox's result.

[00:21:27] Speaker 01:
But the construction was requested, the argument was made, and the intrinsic evidence didn't change, right?

[00:21:34] Speaker 01:
The intrinsic evidence was in the record.

[00:21:36] Speaker 01:
You're just faulting them for not pointing to certain parts of that intrinsic evidence?

[00:21:40] Speaker 05:
Correct.

[00:21:43] Speaker 05:
But that glugal reference, it's about Botox and how in the glugal study

[00:21:50] Speaker 05:
the responder rate for Botox was greater than 50 percent, and that was at odds with metatoxic study.

[00:22:00] Speaker 05:
But the glugal reference, it's not talking about a threshold test.

[00:22:06] Speaker 05:
As claimed here, it doesn't involve an animal protein-free composition or any comparison with any other botulinum toxins.

[00:22:19] Speaker 05:
So unless there's any further questions.

[00:22:21] Speaker 01:
Can I just ask you, your counsel for MediTox repeatedly said that a person with skill in the art would view 52% efficacy the same as 95%, essentially.

[00:22:33] Speaker 01:
Is there evidence in the record to support that?

[00:22:38] Speaker 05:
No.

[00:22:40] Speaker 05:
No, there's not.

[00:22:41] Speaker 05:
They only studied specific compositions where they got 52% and a 62% and that was it.

[00:22:50] Speaker 05:
And there's no evidence that any other composition

[00:22:59] Speaker 05:
would be better than that.

[00:23:01] Speaker 01:
I probably wasn't clear.

[00:23:05] Speaker 01:
Is there evidence as to whether a person of skill in the art would see all those different formulations essentially as the same?

[00:23:12] Speaker 01:
If you could do 95%, if you could do 85%, you could do 62%.

[00:23:17] Speaker 01:
The argument seems to be a person's skill in the art would see those all as the same thing.

[00:23:21] Speaker 01:
Is there evidence for that proposition?

[00:23:24] Speaker 05:
There's no evidence for that.

[00:23:26] Speaker 05:
And in fact, our expert Dr. Ramson says the opposite.

[00:23:30] Speaker 05:
You would not see that.

[00:23:32] Speaker 05:
That there's no structure, function, relationship established

[00:23:36] Speaker 05:
by their specific formulations where they found 52 and 62%.

[00:23:43] Speaker 05:
And you can't extrapolate that to any other botulinum toxin.

[00:23:49] Speaker 05:
And so for example, there's ABO botulinum toxin, the Asher reference, where

[00:24:01] Speaker 05:
It's an animal protein-free composition.

[00:24:06] Speaker 05:
So it meets the limitations of the claim, except the responder rate was below 50%.

[00:24:13] Speaker 05:
So it didn't work.

[00:24:17] Speaker 03:
In your view, what's the scope that is captured by the written description?

[00:24:23] Speaker 03:
In the upper limit terms, is it 62%?

[00:24:28] Speaker 05:
Well, I'm saying that's the only examples that they have are a 52% and a 62%, but those are for specific formulations they have.

[00:24:43] Speaker 05:
The claim is broader than that.

[00:24:45] Speaker 05:
As I was saying, the claim is to a type A botulinum toxin, where even the data that they got is only specific to a single one of those type A's.

[00:24:59] Speaker 02:
Would you agree that there's written description support and enablement for 50 to 62%?

[00:25:04] Speaker 05:
No, I do not agree with that.

[00:25:06] Speaker 02:
Why not?

[00:25:07] Speaker 05:
Because, again, because the different botulinum type A toxins, they all work differently.

[00:25:16] Speaker 05:
They have different molecular weights, different potencies, and all of that.

[00:25:23] Speaker 05:
You can't even say that any other would work.

[00:25:27] Speaker 02:
And in fact, as I was mentioning, that Asher 28- Somebody has to have hundreds of examples before there's written description support and enable

[00:25:40] Speaker 02:
I don't know where that argument carries.

[00:25:44] Speaker 05:
Well, I'm saying what they've claimed is far more than what they invented.

[00:25:50] Speaker 05:
They're not claiming the specific formulations that they study and that they achieve those amounts.

[00:25:58] Speaker 05:
They're claiming all type A toxins with any polysorbate, any stabilizer.

[00:26:07] Speaker 05:
And they haven't possessed that.

[00:26:10] Speaker 02:
Okay.

[00:26:11] Speaker 05:
All right.

[00:26:12] Speaker 05:
All right.

[00:26:12] Speaker 04:
Thank you.

[00:26:14] Speaker 02:
Mr. McFly.

[00:26:16] Speaker 04:
Good morning, Your Honors.

[00:26:16] Speaker 04:
May it please the Court.

[00:26:18] Speaker 02:
I represent Intervenor, the United States... Do you agree that there's no written description, support, or enablement for 50 to 62 percent?

[00:26:29] Speaker 04:
I don't have an opinion on that particular question.

[00:26:31] Speaker 04:
It wasn't addressed by the PTO in our brief.

[00:26:36] Speaker 04:
on whether there's written description support for 52 to 62%.

[00:26:41] Speaker 04:
Yeah.

[00:26:42] Speaker 04:
I don't have a view to express on behalf of the agency on that particular issue.

[00:26:51] Speaker 04:
I think here the board found that under the construction of the range is 50 to 100%, there wasn't written description support.

[00:27:00] Speaker 04:
It'd be a different question about that narrower range.

[00:27:05] Speaker 02:
OK.

[00:27:06] Speaker 03:
But is the question here one of enablement or restriction, or does it matter?

[00:27:13] Speaker 04:
Well, I think there's they're both requirements and the board found here that under that construction of the 50% or greater limitation as a range of 50 to 100% there was both lack of written description and lack of enablement the board went through the wands analysis factors and found that there basically wasn't any disclosure of how to

[00:27:38] Speaker 04:
make and use that range of responder rates having 80 to 100%.

[00:27:42] Speaker 03:
Does a written description disclose a range up to 62%, a responder rate of 62%?

[00:27:50] Speaker 04:
I mean, I believe there's three examples in the specification that have responder rates of 52, 61, and 62%.

[00:27:57] Speaker 03:
I'm talking about 62%.

[00:28:00] Speaker 04:
My understanding is there was a disclosure of one formulation that had a response rate of 62%.

[00:28:05] Speaker 03:
I believe so.

[00:28:07] Speaker 03:
So that's not a problem in your view.

[00:28:10] Speaker 04:
I mean, if there was a claim just claiming that 62%, that formulation having a response rate of 62%, it seems like they had described that.

[00:28:21] Speaker 01:
Let's give out one of the APA arguments.

[00:28:23] Speaker 01:
The board seems to have changed its mind on claim construction and new matter between the preliminary guidance and the final decision.

[00:28:31] Speaker 01:
If we say that that's OK, wouldn't that raise a concern about whether there's

[00:28:39] Speaker 01:
any use to this preliminary guidance if the board can just change its mind after the patentee relies on it?

[00:28:45] Speaker 04:
Yeah.

[00:28:46] Speaker 04:
Well, I mean, the preliminary guidance was designed to be an initial discussion of whether the patent owner has shown there's a reasonable likelihood that the proposed motion to amend meets the statutory and regulatory requirements.

[00:29:02] Speaker 04:
at the final written decision stage based on a preponderance of the evidence and the The notice in the Federal Register before this pilot program began said that it was going to be a preliminary Initial nine non binding view of the board is there really any value to the preliminary guidance then there is actually If you I actually found some some statistics summarizing

[00:29:25] Speaker 04:
the grant rate of motions to amend before the pilot program and after the pilot program was instituted.

[00:29:32] Speaker 04:
And it shows that 84% of patent owners that file motions to amend request preliminary guidance.

[00:29:39] Speaker 04:
And then in response to that preliminary guidance, 49% of patent owners file a revised motion to amend.

[00:29:46] Speaker 03:
Well, all you need is just one instance to upset those statistics.

[00:29:50] Speaker 03:
This may be it.

[00:29:51] Speaker 03:
Is there no integrity to a preliminary guidance?

[00:29:55] Speaker 03:
Is there no structural integrity?

[00:29:58] Speaker 04:
I think there needs to be integrity.

[00:30:00] Speaker 04:
And here, in this case, I think the board was simply following the evidence as it came in.

[00:30:04] Speaker 02:
I mean, the patent- So ordinary guidance suggests that they're going to potentially change their minds, right?

[00:30:10] Speaker 04:
Right.

[00:30:11] Speaker 04:
But the key there is that it provides the patent owner with an opportunity to respond by filing a revised motion to men, providing additional evidence, arguments, which was done in this case.

[00:30:22] Speaker 03:
And if you look at the statistics... The argument is they were denied that opportunity.

[00:30:28] Speaker 04:
I don't think they were denied any opportunity in this case, because first of all, the preliminary guidance, it's an optional program.

[00:30:34] Speaker 04:
You have to request it.

[00:30:36] Speaker 04:
If you're not happy with the chance that the preliminary guidance may change, you don't have to request that they give preliminary guidance.

[00:30:43] Speaker 04:
And in this case, it provided more process and more opportunities to be heard.

[00:30:48] Speaker 04:
MediTox was able to provide a revised motion to amend, provide additional evidence.

[00:30:53] Speaker 04:
Their expert provided additional evidence.

[00:30:55] Speaker 04:
Their counsel was able to make additional arguments.

[00:30:58] Speaker 04:
So there was more process here, not less.

[00:31:03] Speaker 03:
And I don't think it was arbitrary.

[00:31:04] Speaker 03:
Is it fair after all that process, the provision of argument and the provision of evidence to sue a sponsor to adopt a different path?

[00:31:14] Speaker 03:
A different path.

[00:31:16] Speaker 04:
I mean, if it's supported by the evidence as it came in, in this case, after the board had issued its preliminary guidance that it was a threshold, appellant's argument, I'm sorry, appellant's expert, Dr. Singh, conceded at his deposition that that threshold actually encompassed responder rates of 70%, 80%, 90%, and appellant's counsel at the oral hearing seemed to say that the upper limit was 100% and the range

[00:31:45] Speaker 04:
or the threshold was really, in all practical aspects, the same as arranged.

[00:31:49] Speaker 04:
And I think faced with that evidence and those arguments, the board made a reasonable decision to change its mind.

[00:31:56] Speaker 04:
And this court has actually encouraged the board in FanDuel, for example, if it's convinced that its initial decision was incorrect based on the record, it should change its mind on issues if it thinks it was incorrect.

[00:32:07] Speaker 04:
And that's what happened here.

[00:32:09] Speaker 04:
So I don't think there's any due process violations.

[00:32:12] Speaker 02:
Okay.

[00:32:12] Speaker 02:
Thank you.

[00:32:13] Speaker 02:
Thank you.

[00:32:14] Speaker 02:
Mr. Gaffney, you have two minutes.

[00:32:17] Speaker 00:
Thank you, Your Honors.

[00:32:18] Speaker 00:
I just wanted to raise a few points.

[00:32:21] Speaker 00:
Starting with Mr. Mahoney's argument, as to Glasgow, that's always been in the intrinsic record and in the briefing and even in the argument, they don't dispute that Glasgow uses 50% as a threshold to do their analysis.

[00:32:36] Speaker 00:
uh... and uh... as to some other specific issues that he raised were fifty percent of the make sense in the in the concept claim doctors and address that at appendix two eight one five to one six that the analyzed rates in blackout were actually on less than fifty percent

[00:32:52] Speaker 00:
Another point that I'd like to make is under either construction, the Allergan and Alcon cases control, because there's right guidance in the specification really to making animal protein-free compositions that fall within the scope of these claims.

[00:33:07] Speaker 00:
In response to the variables that Galderma raised, there's sufficient guidance in the spec, as I pointed out in my opening argument.

[00:33:16] Speaker 00:
As this court has held, you don't have to disclose 100% of the working examples.

[00:33:22] Speaker 00:
The Bayer case says that, the Alcon case says that, the Allergan case says that.

[00:33:29] Speaker 02:
With respect to the functional claim, structure function claim issue that... You don't have to have work examples, but there has to be some communication that you're in possession of.

[00:33:43] Speaker 02:
I mean, take Novo, for example.

[00:33:45] Speaker 00:
Sure.

[00:33:46] Speaker 00:
There has to be some communication.

[00:33:47] Speaker 00:
And here we have more than ample support for the narrow claims at issue here.

[00:33:51] Speaker 00:
We have the animal protein-free composition, their ingredients, their ratios, as well as all of the other additional method of treatment limitations.

[00:34:01] Speaker 00:
We are disclosing robust advanced clinical trials in this patent specification.

[00:34:06] Speaker 01:
What is the evidence in the record that a person of skill in the art would see the 52% and the 95% embodiments as the same thing?

[00:34:14] Speaker 00:
there's there's a replete testimony regarding the the threshold element and and that That more the the clinical trials sufficiently support though the full scope of the threshold range as claimed between 62 and 100

[00:34:37] Speaker 00:
Well, Your Honor, again, the clinical trials that are disclosed, that disclose 52, 61, and 62, they would support the whole range.

[00:34:44] Speaker 00:
And the reason why is because the greater length of effect is demonstrated by those specific clinical trials.

[00:34:52] Speaker 01:
Does your expert say 52, 62, and 95 are all the same thing to a person skilled in the art?

[00:35:00] Speaker 00:
Yeah.

[00:35:01] Speaker 00:
Dr. Singh says that within the context of his overall testimony at the lower court.

[00:35:06] Speaker 00:
Can you give me an idea of where I would find that?

[00:35:11] Speaker 00:
Yes, Your Honor.

[00:35:14] Speaker 00:
Sorry, if you could just give me one second.

[00:35:18] Speaker 00:
It's at the Third Singh Declaration Appendix 4256 to 577.

[00:35:23] Speaker 00:
There, Dr. Singh's testifying about 50% being... Hold on a second.

[00:35:31] Speaker 02:
4256?

[00:35:33] Speaker 00:
Okay.

[00:35:34] Speaker 00:
There, Dr. Singh, that's just one example, but there, Dr. Singh is talking about how 50% is a clinically meaningful threshold.

[00:35:43] Speaker 02:
Tell us what language you're relying on, where it is.

[00:35:49] Speaker 00:
I'm basically relying on the testimony where he said that 50% is a clinically meaningful threshold.

[00:35:59] Speaker 01:
Just because it's clinically meaningful doesn't mean that a person of skill in the art would see an embodiment that's 100% effective the same as one that's only 52% effective, does it?

[00:36:10] Speaker 01:
Those seem like different things.

[00:36:12] Speaker 00:
Well, that's why the threshold construction is important, Your Honor, because both of these values would be the same in the context of these claims.

[00:36:22] Speaker 01:
But it's that point that I'm not seeing the evidence for.

[00:36:24] Speaker 01:
You've insisted repeatedly that a person of skill in the art would see them as the same.

[00:36:28] Speaker 01:
I get that that's your argument, but where's the evidence for that?

[00:36:32] Speaker 00:
Your Honor, it's the intrinsic evidence as well as all the testimony related to the threshold limitation.

[00:36:41] Speaker 00:
and the threshold limitation disclosing the wide range of responder rates.

[00:36:49] Speaker 00:
Once you have responder rates above a certain amount,

[00:36:52] Speaker 00:
above 50 to a post that would enable the full scope.

[00:36:56] Speaker 00:
But even under the ALKON and Allergan case, which had less disclosure, to hold otherwise here would be inconsistent with those decisions.

[00:37:05] Speaker 00:
Also, there's something called the Kaplan-Meier test that's within the context of the intrinsic evidence that we cited, for example, the Bertucci reference.

[00:37:16] Speaker 00:
And that's in the briefing.

[00:37:19] Speaker 00:
That also shows how 50% is a threshold.

[00:37:23] Speaker 02:
May I just make one more point related to the EPA?