[00:00:48] Speaker 02:
If we're ready, then you are.

[00:01:01] Speaker 01:
Mr. O'Connor, a little housekeeping question.

[00:01:04] Speaker 01:
Yes.

[00:01:04] Speaker 01:
Is claim one of the 453 patent representative of the claims on appeal?

[00:01:11] Speaker 03:
I'm sorry, is claim one of the 453 representative of the claims on appeal?

[00:01:18] Speaker 03:
I think, generally speaking, it is, Judge Wallach.

[00:01:20] Speaker 03:
There are some minor differences between the claims of the 453, the 801, and the 802, going principally to how many wherein clauses they have contained within them.

[00:01:30] Speaker 03:
But I think, generally speaking, it's fair to treat the 453 as being representative.

[00:01:36] Speaker 03:
And with that, on their face, the claims at issue here look virtually indistinguishable from those

[00:01:41] Speaker 03:
at issue in Bristol Myers or Copaxone or other cases where this court has held that the recitation of results in wherein clauses or preambles was not limiting.

[00:01:52] Speaker 03:
Much like those cases, the asserted methods here... But wherein clauses can be limiting.

[00:01:58] Speaker 03:
They can be, just like language in a preamble can be limiting.

[00:02:01] Speaker 03:
And the question really here is when is that the case?

[00:02:05] Speaker 03:
Like those cases, the asserted methods here involve a single manipulative step that is administering a fixed composition of bromonadine and timolol twice daily.

[00:02:16] Speaker 03:
And this is not a case where Allergan used its results to delineate between compositions that were claimed

[00:02:25] Speaker 03:
and compositions that were not claimed based on whether they achieve those results.

[00:02:30] Speaker 03:
There's no evidence of any such distinction anywhere in the intrinsic record.

[00:02:35] Speaker 03:
And the intrinsic record does not reflect.

[00:02:38] Speaker 02:
If the test is, if we all agree that the test is whether or not it makes a manipulative difference, and if on the face of the claim, we're reading the claim and

[00:02:50] Speaker 02:
That phrase that we're deciding whether is limiting or not differentiates between which formulations would be covered by the claims and which would not.

[00:03:02] Speaker 02:
Doesn't it?

[00:03:03] Speaker 02:
I mean, I don't understand what more you have to prove.

[00:03:06] Speaker 02:
That's what the claims say.

[00:03:08] Speaker 02:
Claims that do not meet the efficacy and safety limitations would not be covered by the claims, right?

[00:03:16] Speaker 03:
Well, Chief Judge Pross, respectfully, I think that is really the question here, is whether or not the compositions that would not meet the efficacy

[00:03:26] Speaker 03:
and the adverse results turns would be excluded by these claims.

[00:03:35] Speaker 03:
And you won't find anywhere in the intrinsic record where they suggested that the use of such terms was drawing a distinction.

[00:03:43] Speaker 03:
Because otherwise, the point that you're making, Chief Judge Crost, could have been made in Copaxone.

[00:03:47] Speaker 03:
It could have been made in Bristol Myers, where you could say, well.

[00:03:50] Speaker 02:
Well, there were other factors in that that you could differentiate those cases.

[00:03:53] Speaker 02:
They may not be outcome determinative.

[00:03:55] Speaker 02:
But in Copaxone, for instance, wasn't there

[00:03:58] Speaker 02:
Was that the one where the court relied on the fact that it was redundant of other language?

[00:04:05] Speaker 02:
So it didn't serve the purpose of being a manipulative difference because it was already included in other portions of the claims.

[00:04:12] Speaker 02:
So wasn't that a basis for differentiating that case from this one?

[00:04:16] Speaker 03:
Well, respectfully, Chief Judge Proce, I don't think that that's true with respect to all of the terms that were at issue in Copax.

[00:04:22] Speaker 03:
And for example, there were terms that required that it achieve the same efficacy

[00:04:27] Speaker 03:
as 20 milligrams being administered daily, or the same reduction in adverse events as 20 milligrams being administered daily, this court found that those were not limiting.

[00:04:38] Speaker 03:
And I think that there's really no difference here.

[00:04:41] Speaker 03:
The question on whether something is a manipulative step goes to whether or not it changes the method.

[00:04:47] Speaker 03:
So whether or not a patient experiences a reduction in adverse events in this case

[00:04:53] Speaker 03:
The steps are going to be performed the same way.

[00:04:57] Speaker 03:
That's exactly what Bristol-Meyer says is not a limiting term.

[00:05:02] Speaker 03:
And the only reason that it would be limiting is if it would be, quote, material to patentability.

[00:05:08] Speaker 03:
That is, this court said it's either got to be manipulative, it's got to be structural, or it's got to be manipulative to, excuse me, material to patentability.

[00:05:15] Speaker 03:
And so the question is, what has this court meant when it has said material to patentability?

[00:05:21] Speaker 03:
It can't just be,

[00:05:22] Speaker 03:
oh, well, it's not obvious, or it wasn't in the prior art, because this is claim construction we're talking about.

[00:05:28] Speaker 03:
It's got to be that it's being used to draw a line, to exclude material, in the words of Georgetown Rail, that it reflects a, quote, intent to exclude, in this case, compositions of 0.2 Brahmanadine and 0.6A Timlaugh.

[00:05:43] Speaker 03:
And I think that Allergan actually basically agrees with that in this appeal, because if you look at their brief

[00:05:50] Speaker 03:
at page 31, their position is now that, quote, any Brahmanadine-Timmer law formulation that does not meet the recited results terms is not covered by the claims.

[00:06:01] Speaker 03:
And they reiterate this at pages 4, 37, and 40 of their brief.

[00:06:07] Speaker 03:
The problem for them, though, is that before this litigation, they never took the position that the recitation of results was

[00:06:15] Speaker 03:
was used to mean some compositions of Brahman and Dien and Temelol, 0.2 Brahman and Dien and 0.68 Temelol were in.

[00:06:22] Speaker 03:
And some were out.

[00:06:23] Speaker 03:
In fact, their position was exactly the opposite.

[00:06:25] Speaker 02:
But now we're in claim construction.

[00:06:28] Speaker 02:
In order to reach the conclusion that he or she, I don't know who the district court was, reached, they concluded that this was a distinction.

[00:06:37] Speaker 02:
In other words, under the claim construction, no matter what they said before or after, under this claim construction, certain claims who don't meet this efficacy and safety limitation would not be covered by the claims under this claim construction, correct?

[00:06:52] Speaker 03:
That is the conclusion, I think, that would come from their construction.

[00:06:56] Speaker 03:
The question is whether that construction is right, which, of course, this court reviews de novo.

[00:07:00] Speaker 02:
That's what I mean.

[00:07:01] Speaker 02:
It's not a question of what they said before or what they argued before.

[00:07:05] Speaker 02:
The question is whether or not this claim construction is right.

[00:07:08] Speaker 02:
And I don't see how using statements they made before are probative on that issue.

[00:07:13] Speaker 03:
Well, the reason I think they're not only probative but honestly dispositive, Chief Judge Prost, is because we're trying to answer the question,

[00:07:20] Speaker 03:
of whether or not something that is recognized as being exceptional, that is a results term, and for 70 years the jurisprudence has been results are not claimable.

[00:07:30] Speaker 03:
They don't add anything that's limiting.

[00:07:33] Speaker 03:
And the only exception to that is have they used their results to basically engage in functional claim drafting.

[00:07:40] Speaker 03:
Then instead of claiming... Right.

[00:07:41] Speaker 02:
And we have a lot of these kinds of claims, and if they're challenged and go down, typically it's on the validity side, right?

[00:07:49] Speaker 02:
Right.

[00:07:49] Speaker 02:
With prescription and enablement, that's where we see with some frequency challenges to these types of claims.

[00:07:55] Speaker 03:
Sure.

[00:07:56] Speaker 03:
And in other cases, like Bristol Myers, like Copaxon, like Minton, like Lockheed Martin, and Texas Instruments,

[00:08:03] Speaker 03:
The recitation of results has been recognized by this court as not being limiting.

[00:08:08] Speaker 03:
And the question is, do they fit the exception of when it would be?

[00:08:11] Speaker 02:
This is really a question.

[00:08:12] Speaker 02:
I don't know.

[00:08:13] Speaker 02:
Is the differentiation to be made between whether they were intended results or whether they were unexpected results?

[00:08:20] Speaker 02:
Can't you claim unexpected results, isn't that?

[00:08:24] Speaker 03:
Chief Judge Prost, I think the question is whether or not they are recited as intended results.

[00:08:32] Speaker 03:
And part of how you know that that's all they are here is that when you look at what they say that they have to prove for purposes of infringement, they don't have to prove that these results occur in any particular given individual person.

[00:08:44] Speaker 03:
And that is exactly what this court has recognized is the kind of indicia that it's not limiting.

[00:08:53] Speaker 03:
And that gets back to when you look at Georgetown Rail and Symantec and Catalina,

[00:08:59] Speaker 03:
In every one of those cases, in deciding whether or not a result or a term in a wherein clause was actually limiting, the court looked at the intrinsic record and looked and asked, was it being used to draw a line?

[00:09:14] Speaker 03:
Was it being used to define?

[00:09:16] Speaker 03:
Was it, in the words of Biosig versus Nautilus, was it about ascertaining the boundaries?

[00:09:22] Speaker 03:
And to just simply say, the only reference in the intrinsic record to these so-called unexpected results

[00:09:28] Speaker 03:
was in supporting arguments about non-obviousness or why there wouldn't have been a motivation to combine.

[00:09:32] Speaker 02:
Well, there's also prosecution history.

[00:09:34] Speaker 02:
You're right.

[00:09:34] Speaker 02:
It may have been in the prior obviousness context that the patent examiner relied heavily on this differentiation of allowing claim.

[00:09:43] Speaker 03:
Well, relied on it in differentiating other compositions that were not compositions of Brahmanidine and Temelol to show that these were unexpected results because it performed differently than Brahmanidine alone administered twice a day.

[00:09:58] Speaker 03:
or Temelol alone twice a day.

[00:09:59] Speaker 03:
But if you look at the intrinsic record, and you look particularly at appendix 943 to 948, you'll see statement after statement in the prosecution of these claims, where they say that treatment with the composition claimed herein is what unexpectedly resulted in reduced side effects.

[00:10:17] Speaker 03:
That's at 946.

[00:10:20] Speaker 03:
that the twice daily administration in a single composition, as presently claimed, eliminates the afternoon trough.

[00:10:29] Speaker 03:
That's an unexpected result, 945.

[00:10:30] Speaker 03:
Those are all attributes that they are giving to the composition of 0.2-Bermanadine, 0.68-Timalal, not drawing lines between some 0.2-Bermanadine, 0.68-Timalal compositions that do work and others that don't.

[00:10:46] Speaker 03:
And if it's not being used to draw a line, I don't think this court's cases

[00:10:51] Speaker 03:
allowing them to then say, oh, well, this result in a wherein clause is limiting.

[00:10:56] Speaker 03:
Because it's not doing any work to distinguish what's in and what's out.

[00:10:59] Speaker 03:
And if you say, well, they can just write it in the claim.

[00:11:02] Speaker 03:
and then argue after the fact.

[00:11:04] Speaker 02:
What about if the claim construction then says, whether or not we think that we would have read this, but if there's a claim construction that says this does differentiate, it only covers what's in and it excludes what does not achieve safety.

[00:11:23] Speaker 03:
Sure, so Chief Judge Percival, I mean, I agree with the comment you made earlier that if you, I guess it's construed that way, sure, that introduces all sorts of potential 112 problems for them.

[00:11:36] Speaker 03:
But what I would say, more foundational, is they shouldn't be allowed to have the choice.

[00:11:42] Speaker 03:
They shouldn't be allowed to write these types of things into their claims.

[00:11:45] Speaker 03:
Just simply go out and test, do their testing and write the results they observe.

[00:11:52] Speaker 03:
That's literally what they did here.

[00:11:53] Speaker 03:
You can see it Appendix 388 and Appendix 566 and just write the observed results into the claim and be able to then decide when we get to actual litigation

[00:12:02] Speaker 03:
Well, I think I have a stronger infringement case and a weaker invalidity case, so I want to rely on these as being limiting.

[00:12:10] Speaker 03:
Or I think we have a situation where I have a tougher infringement case, but I feel okay about invalidity, so I'm going to say they're not limiting.

[00:12:17] Speaker 03:
They don't get to make the choice after the fact.

[00:12:20] Speaker 03:
The question is, did they argue, either in the specification,

[00:12:25] Speaker 03:
or in the prosecution history that this was being used to draw a line, just like was in Georgetown Rail where there was no suggestion.

[00:12:36] Speaker 01:
It sure does look, though, that they did with the examiner.

[00:12:40] Speaker 03:
Well, respectfully, Judge Wallach, I think what they were doing was telling the examiner that, yes, these are attributes

[00:12:48] Speaker 03:
that different prior art compositions didn't have.

[00:12:51] Speaker 03:
These are results that made their composition not obvious.

[00:12:58] Speaker 03:
And it's very clear.

[00:12:58] Speaker 03:
If you look at appendix 943, they say the presently claimed methods are not directed to the use of prior art compositions, but rather to new compositions not found in the prior art.

[00:13:12] Speaker 03:
So they were distinguishing their new composition from prior art compositions.

[00:13:17] Speaker 03:
And yes, they were extolling the virtues of their new composition.

[00:13:21] Speaker 03:
And in fact, they were extolling the virtues of the new composition in a way in which they said, all such

[00:13:27] Speaker 03:
0.2-Bermanadine, 0.68-Timelaw compositions are going to achieve these results, not to draw the line that they are now trying to draw for the first time in this litigation.

[00:13:37] Speaker 02:
So what is your citation for where they said this, that all of these combinations will achieve these results?

[00:13:43] Speaker 03:
Yeah, well, I'd point you to at least four places, Chief Judge Prost.

[00:13:47] Speaker 03:
The first that I've already mentioned are appendix 945 and 946, referring to the composition as presently claimed

[00:13:54] Speaker 03:
And they can't say, well, that includes the efficacy, because the whole point that they're saying is that the composition is what achieves the efficacy.

[00:14:01] Speaker 03:
And I'll also point you to the earlier prosecution of the composition patent, which shares, for all practical purposes, a common specification with these patents, where if you look at appendix 1351 and 1326, they said the presently claimed composition, in that case, the composition again, there were no efficacy limitations.

[00:14:21] Speaker 03:
It was just the composition.

[00:14:23] Speaker 03:
was non-inferior to that of concurrent treatment.

[00:14:26] Speaker 03:
I see that I'm thinking to my rebuttal time, but I'm happy to take further questions from the court.

[00:14:32] Speaker 03:
Thank you.

[00:14:33] Speaker 03:
Thank you very much.

[00:14:43] Speaker 00:
May it please the court, Jonathan Singer for Allergan.

[00:14:47] Speaker 02:
Could you just pick up where your friend left off?

[00:14:49] Speaker 00:
Sure.

[00:14:50] Speaker 00:
I'll go right there.

[00:14:50] Speaker 00:
We've traveled a long road in this case.

[00:14:52] Speaker 00:
And the issue of what's in and what's out, that is what is defined by the where in clause.

[00:15:01] Speaker 00:
We litigated this in the first case, we litigated this in the second case, and now here we are at claim construction.

[00:15:06] Speaker 02:
Yeah, but he's citing to stuff in the record, which suggests or states that you didn't make this differentiation earlier.

[00:15:14] Speaker 02:
There was no such differentiation made in the intrinsic record.

[00:15:19] Speaker 00:
We told the examiner that the Temoptic reference does not teach or suggest that the claimed fixed combination of vermonity and tar trade in Timahal

[00:15:29] Speaker 00:
would be as effective as the administration of 2.2% weight by volume for monitoring tar trade three times per day.

[00:15:37] Speaker 00:
So it's right there.

[00:15:38] Speaker 00:
That's page 944.

[00:15:39] Speaker 00:
It's also at the Zabo reference at 944.

[00:15:43] Speaker 00:
The same place telling the examiner that the prior art does not teach that you would yield this combination that would have these results.

[00:15:51] Speaker 00:
And that's the dividing line that you're looking for.

[00:15:54] Speaker 00:
between those combinations that achieve the results and those that do not.

[00:15:59] Speaker 02:
What about the references your friend made to whether or not this was an intended result?

[00:16:04] Speaker 02:
I mean, is your read of the law that if it's an unexpected result, it's kosher to have the wear-in clauses, and if it's an expected result, then it's not?

[00:16:16] Speaker 00:
Well, if it were an expected result, it'd be an obvious.

[00:16:19] Speaker 00:
It would still be an OK, I think, to answer your question directly, Chief Judge Prost.

[00:16:24] Speaker 00:
I think it'd be an OK claim limitation, but it'd be an obvious claim limitation.

[00:16:29] Speaker 00:
And it might go down on inherency because it's inherent in the obvious subject matter.

[00:16:34] Speaker 00:
But in this case, we've already adjudicated that these are not obvious results.

[00:16:38] Speaker 00:
They're not inherent in the adjudicated as obvious subject matter.

[00:16:43] Speaker 00:
And fundamentally, their position asks this court to rule that Allergan, with all the record

[00:16:48] Speaker 00:
that we've made in this case over a decade went back to the patent office to cure some claiming defects about the salts and secured claims on the already adjudicated obvious subject matter.

[00:17:00] Speaker 00:
It doesn't make sense.

[00:17:01] Speaker 00:
Of course Allergan in the intrinsic record in the file history described these as effects that are required and it is even in the specification describing the need

[00:17:12] Speaker 00:
for these compositions that achieve these results.

[00:17:14] Speaker 02:
The key question is whether or not some would not.

[00:17:18] Speaker 02:
Some of these compositions achieve this versus others that don't.

[00:17:22] Speaker 02:
Where is that laid out in the record?

[00:17:23] Speaker 00:
And that is laid out.

[00:17:24] Speaker 00:
We actually tried that issue.

[00:17:26] Speaker 00:
That was the trial.

[00:17:27] Speaker 00:
If you remember, Your Honor, you were on the first panel in this case, and it's a long road, as I said.

[00:17:32] Speaker 00:
And there was the debate between the majority and the dissent as to whether or not the

[00:17:36] Speaker 00:
I in the majority?

[00:17:38] Speaker 00:
You were in the majority.

[00:17:39] Speaker 00:
But the debate was under the Bristol Myers case.

[00:17:45] Speaker 00:
I mean, it's very interesting we have the Bristol Myers case referred to by the examiner, by all the parties, and even in the first opinion as to whether or not this was an inherent result.

[00:17:53] Speaker 00:
And the court concluded, on the record, in the first case, we couldn't conclude one way or the other whether it was inherent and therefore the claim stood.

[00:18:00] Speaker 00:
We then went and had a trial.

[00:18:02] Speaker 00:
about the second case.

[00:18:03] Speaker 00:
That was the trial of the second case where Sandoz attempted to marshal evidence to prove it was inherent, and the court ruled that it failed.

[00:18:12] Speaker 00:
And in fact, their expert in that case admitted that the concentration of preservative, in this case, BAK, would have an effect on the result of adverse events in that case.

[00:18:25] Speaker 02:
Yeah, but they're suggesting, and I'm not sure I disagree with them, that inherency shouldn't be the only way to get there.

[00:18:31] Speaker 02:
Inherency is really hard.

[00:18:32] Speaker 02:
So they are looking for an alternative way.

[00:18:35] Speaker 02:
They cite in gray the Copaxon case.

[00:18:41] Speaker 02:
And when I mentioned to your friend that I read some of the decision there being based on the redundancy, he seemed to disagree with me and said other aspects of it don't rely on redundancy.

[00:18:53] Speaker 00:
In the decision itself, it's redundancy.

[00:18:56] Speaker 00:
The claim both said,

[00:18:58] Speaker 00:
that it had to be the regiment being sufficient to reduce the frequency of relapses.

[00:19:02] Speaker 00:
That was the wear-in clause.

[00:19:03] Speaker 00:
But it also required the claim be therapeutically effective.

[00:19:07] Speaker 00:
And it was that redundancy between therapeutic effect and the regiment being sufficient to reduce.

[00:19:13] Speaker 00:
So that was a redundancy.

[00:19:14] Speaker 00:
Bristol Myers, it was a redundancy between anti-neoplastic and the actual claimed amounts.

[00:19:20] Speaker 00:
And so those cases, it's about redundancy.

[00:19:23] Speaker 00:
In this case, it's the opposite.

[00:19:24] Speaker 00:
It's about non-redundancy.

[00:19:26] Speaker 00:
It's about drawing the dividing line

[00:19:28] Speaker 00:
between those formulations that do have the efficacy and safety of CombiGAN, which was proven to do this.

[00:19:37] Speaker 00:
And by the way, CombiGAN is specifically claimed in the later claims, and those that do not.

[00:19:42] Speaker 00:
And we tried the issue.

[00:19:44] Speaker 00:
Their expert admitted on the stand that things like the preservative, excuse me, the preservative, the way it was admitted, the preservative BAK would affect the end results that you would get from a clinical trial.

[00:19:57] Speaker 00:
It's particularly, in this case, whether or not Inherency is a good standard or a bad standard or too difficult standard doesn't matter.

[00:20:06] Speaker 00:
They did not meet it, and their expert admitted it, that it wasn't met.

[00:20:10] Speaker 00:
And so we have in this kind of a rare circumstance where the record that went before that we can bring into the claim construction addresses the issue of Inherency, which I agree with you.

[00:20:22] Speaker 00:
is an exacting standard.

[00:20:24] Speaker 02:
Can I just ask you a kind of housekeeping question?

[00:20:27] Speaker 02:
Sure.

[00:20:28] Speaker 02:
Just tagging on to what Judge Wallach asked your friend at the outset, which is, other than claim one of the 453, other claims asserted or relevant here?

[00:20:38] Speaker 02:
Or is that fairly relevant?

[00:20:40] Speaker 00:
I think the 453 is representative of the other two patents, Judge Wallach.

[00:20:44] Speaker 00:
The only relevance, Your Honor, is that the later claims

[00:20:48] Speaker 00:
add the actual specific formulation of Combaghan itself.

[00:20:54] Speaker 00:
So the first claim is to the Bermanite and Timalol.

[00:20:59] Speaker 00:
Those are the only recited ingredients.

[00:21:01] Speaker 00:
And the later claims, the dependent claims, I don't know which number he

[00:21:05] Speaker 00:
they recite the specific ingredients, so additional specific ingredients to the formulation.

[00:21:12] Speaker 02:
But is any of that relevant to the issue we're deciding here?

[00:21:16] Speaker 00:
Is it relevant?

[00:21:17] Speaker 00:
I do not think it's relevant to claim construction as to whether or not this is a limitation or not.

[00:21:25] Speaker 00:
I do not think so.

[00:21:28] Speaker 00:
That's the distinction between the claims.

[00:21:32] Speaker 00:
I'm more interested in answering your questions than I am in making arguments.

[00:21:36] Speaker 00:
We've laid out our position, and as I said, we have traveled a long, long road.

[00:21:42] Speaker 00:
I will simply add, this case is not the first time that we've advocated.

[00:21:46] Speaker 00:
And I heard that from counsel.

[00:21:47] Speaker 00:
I'm surprised.

[00:21:48] Speaker 00:
This is not the first time we've advocated this.

[00:21:50] Speaker 00:
We advocated back in the very first case.

[00:21:53] Speaker 00:
And in the second case, it was the determinate feature.

[00:21:56] Speaker 00:
And this case, that claim construction is what?

[00:21:58] Speaker 02:
When does this patent expire?

[00:22:00] Speaker 00:
2022.

[00:22:00] Speaker 00:
2022.

[00:22:03] Speaker 00:
So and if there are if there are no further questions, then I don't have anything further to add.

[00:22:10] Speaker 00:
Thank you.

[00:22:15] Speaker ?:
Okay.

[00:22:21] Speaker 03:
Thank you.

[00:22:27] Speaker 03:
Thank you, Chief Judge Prost.

[00:22:28] Speaker 03:
This case, of course, presents the first time this court has been asked to address the issue of claim construction in between these parties.

[00:22:36] Speaker 03:
And this case addresses new patents that didn't exist at the time of any of the prior litigation.

[00:22:42] Speaker 03:
And I think the parties agree that the issue here really should be whether or not these terms were being used to delineate what's in and what's out.

[00:22:51] Speaker 03:
And the question that's really before the court is,

[00:22:54] Speaker 03:
How do you decide whether particular terms were being used that way?

[00:22:59] Speaker 03:
And I think the answer that you find consistently from the case law is that you look to the intrinsic record.

[00:23:04] Speaker 03:
Because again, if you allow it to come from the litigating positions after the fact, it's subject to manipulation.

[00:23:12] Speaker 03:
And I think if you look at appendix 945, 946,

[00:23:16] Speaker 03:
1351, 1326, and 4363.

[00:23:18] Speaker 03:
You will see that in the intrinsic record, they weren't using these results to draw a line between compositions.

[00:23:26] Speaker 03:
They weren't saying some compositions work and some compositions don't, and giving any indication as what the special sauce is for knowing which it's going to be.

[00:23:36] Speaker 03:
No.

[00:23:36] Speaker 03:
What they were doing was they were claiming all compositions, and they were including these as statements of intended results.

[00:23:42] Speaker 03:
Now, coming back to questions that you had about Chief Judge Prost, I think you identified the key question is whether there are some examples that don't achieve these results.

[00:23:54] Speaker 03:
They don't identify any such examples in the intrinsic record.

[00:23:58] Speaker 03:
They don't identify any such examples in the specification.

[00:24:01] Speaker 03:
And if this was genuine functional claim drafting, well, this court's decisions in cases like Halliburton

[00:24:06] Speaker 03:
514F3 at 1256 tell you that if these were being used to draw lines, you would expect to see examples of what's in and what's out.

[00:24:15] Speaker 03:
You would expect to see examples that don't work.

[00:24:17] Speaker 03:
And the fact that they're there, that they're not there, is what shows you that these were not being used to draw lines.

[00:24:24] Speaker 03:
Instead, what they rely on now are hypotheticals.

[00:24:27] Speaker 03:
Maybe if you added so much of something else, then the thing wouldn't work.

[00:24:32] Speaker 03:
There were no admissions from our expert.

[00:24:34] Speaker 03:
What there was was a hypothetical question.

[00:24:36] Speaker 03:
in which the experts said, well, maybe.

[00:24:39] Speaker 03:
And that's what they rely on is hypotheticals.

[00:24:41] Speaker 03:
And if hypotheticals were good enough, then I respectfully submit that Bristol Myers was wrong.

[00:24:46] Speaker 03:
Copaxone was wrong, because I could come up with hypotheticals there, too.

[00:24:50] Speaker 03:
And then lastly, Chief Judge Brooks, if I could point you

[00:24:52] Speaker 03:
in Copaxone at page 1023, I think the court makes a couple points that are relevant here.

[00:24:58] Speaker 03:
One is it says there's no meaningful difference between the claims in Bristol Myers and here, and it shows how there it isn't being used to make a manipulative difference, even though the claims look a lot like the ones here.

[00:25:09] Speaker 03:
And second, if you look at claim 12, which is referenced on page 23, I don't think there's any basis for saying redundancy was an issue there, because it was a method for improving the tolerability

[00:25:21] Speaker 03:
of glutamate or acetate treatment of a human patient suffering from relapses, which is as effective as the administration of 20 milligram GA daily.

[00:25:31] Speaker 03:
That's exactly like the kind of limitations we have here.

[00:25:33] Speaker 03:
There's no redundancy.

[00:25:34] Speaker 03:
The court said it wasn't limiting.

[00:25:36] Speaker 03:
The same results should apply here.

[00:25:38] Speaker 03:
The court has further questions?

[00:25:39] Speaker 02:
Thank you.

[00:25:40] Speaker 02:
Thank you very much.

[00:25:41] Speaker 02:
Thank you.

[00:25:41] Speaker 02:
We thank both sides in the case.