[00:00:00] Speaker 05:
Our final case for argument today is 23-1977, Azzurri Pharmaceutical vs. Alchem Laboratories.

[00:00:11] Speaker 00:
Good morning, Your Honors.

[00:00:11] Speaker 00:
May I please report T.O.

[00:00:13] Speaker 00:
Kong on behalf of Azzurri Pharmaceuticals, Inc.

[00:00:16] Speaker 00:
The district court determination that a clear and unmistakable disclaimer was made during prosecution was erroneous.

[00:00:24] Speaker 02:
It was a clear and unmistakable error, so to speak.

[00:00:27] Speaker 02:
All right.

[00:00:29] Speaker 02:
I got the veterans' law on the brain.

[00:00:32] Speaker 02:
Let me start you out with this basic question about how consisting of claims worked.

[00:00:37] Speaker 02:
for a mixture.

[00:00:38] Speaker 02:
If you have a consisting of claim, you have several items in the mixture that are listed A, B, and C, and then the accused infringer adds some D, thinking they're going to be off the hook, is it kind of a universally accepted approach to an infringement theory to say, well,

[00:00:58] Speaker 02:
Limitation C, whatever ingredient C is, that sometimes has D in it.

[00:01:02] Speaker 02:
So we'll just draw a little dotted line around the D and kind of tuck that in inside the C. I think the phrase Trojan horse was used.

[00:01:09] Speaker 02:
Is the Trojan horse theory of mixtures universally accepted as a fine approach?

[00:01:15] Speaker 02:
Because it seemed like Judge Goldberg, he accepted that and it's not being challenged.

[00:01:20] Speaker 00:
I just want to get your thoughts on that.

[00:01:29] Speaker 00:
And so if another ingredient functions as part of that flavoring agent, like it did here, then it is part of the listed ingredients.

[00:01:35] Speaker 00:
So yes, it is acceptable.

[00:01:36] Speaker 02:
And that was the premise of the fact-finder's effort at the bench trial.

[00:01:40] Speaker 02:
The premise was, we're going to find out what the propylene glycol is doing, what its function is.

[00:01:45] Speaker 00:
So that was how the analysis and the opinion started.

[00:01:49] Speaker 00:
But what distracted the court was this disclaimer argument.

[00:01:52] Speaker 00:
I understand.

[00:01:52] Speaker 02:
But I'm just going to get into the question of what was the purpose of the bench trial?

[00:01:55] Speaker 02:
That was one of the reasons.

[00:01:56] Speaker 00:
That was one of the purposes, yes.

[00:01:58] Speaker 00:
OK.

[00:01:58] Speaker 02:
OK.

[00:01:59] Speaker 00:
Returning to disavowal, there was no clear or unmistakable statement of disavowal in the prosecution history.

[00:02:07] Speaker 00:
A review of the entire scope of the prosecution history and its context that it provides to the alleged disclaiming statement shows that, at best, the alleged disclaiming statement was subject to multiple reasonable interpretations.

[00:02:20] Speaker 00:
I want to focus on two aspects of the prosecution history.

[00:02:22] Speaker 02:
What's the interpretation of the disclaimer that makes you win?

[00:02:25] Speaker 00:
That the use of propylene glycol in that sentence is a reference to the use of propylene glycol as a carrier.

[00:02:33] Speaker 00:
It was excluding that use only.

[00:02:34] Speaker 00:
Not any amount of propylene glycol, but the use of propylene glycol as a carrier.

[00:02:39] Speaker 02:
So that's a, in other words, one of the things you'd have to do as the fact finder is determine what the propylene glycol is being used for in order to assess a composition claim.

[00:02:51] Speaker 00:
what the propylene glycol is being used for in the prior art.

[00:02:54] Speaker 00:
Yes.

[00:02:54] Speaker 00:
So in the Palipu reference, it very clearly was being used as a carrier, as a solvent.

[00:02:59] Speaker 00:
It says so directly in the reference and the testimony at trial.

[00:03:02] Speaker 02:
Doesn't the ANDA say that the propylene glycol is a co-solvent?

[00:03:06] Speaker 00:
So now we're talking about the issue of infringement.

[00:03:08] Speaker 00:
So I'm talking about disclaimer.

[00:03:09] Speaker 00:
So if we shift to infringement.

[00:03:10] Speaker 00:
The whole purpose is... Fair enough.

[00:03:11] Speaker 00:
So the ANDA does describe the 0.1% PG as a co-solvent.

[00:03:17] Speaker 00:
Yes.

[00:03:17] Speaker 00:
But that's not the end of the analysis.

[00:03:19] Speaker 00:
That doesn't end the inquiry.

[00:03:20] Speaker 00:
And the district court found that as well.

[00:03:21] Speaker 00:
That's why you had a trial.

[00:03:23] Speaker 02:
Correct.

[00:03:23] Speaker 03:
The inquiry.

[00:03:24] Speaker 03:
Could you speak a little bit more about this theory of disclaimer is limited to using PG as a carrier?

[00:03:32] Speaker 03:
Because when I read through the prosecution history, I didn't see those words.

[00:03:36] Speaker 03:
What I saw were words more like the absence of propylene glycol from our claimed invention distinguishes our claimed invention from this.

[00:03:46] Speaker 03:
reference I would point so that that you know I've got a limited brain but that's very clear to me in understanding the scope of the disclaimer PG is out of this claim and we're making it super clear by not only telling you this mr. examiner but we're also going to convert our claim into a consistent up claim

[00:04:08] Speaker 00:
So earlier in prosecution, the very idea of using consisting of came from the examiner.

[00:04:14] Speaker 00:
This is recorded in the examiner interview summary, where the examiner says, use consisting of to exclude the glycol as a carrier or a solvent.

[00:04:22] Speaker 00:
So that was the purpose of using consisting of.

[00:04:24] Speaker 03:
What is your best statement in the prosecution history?

[00:04:29] Speaker 03:
I can see and understand clearly the narrative that the district court followed through with various quotes from the prosecution history to arrive at his understanding of the disclaimer.

[00:04:42] Speaker 00:
At the moment, I don't understand your opinion.

[00:04:44] Speaker 00:
2673 is the interview summary written by the examiner, where she said that the use of insisting... Hold on.

[00:04:50] Speaker 04:
Give us a second.

[00:04:50] Speaker 04:
I'll look at there.

[00:04:51] Speaker 04:
2673.

[00:04:58] Speaker 00:
So this is from the 717 application.

[00:05:01] Speaker 00:
There's a similar statement from the 059 application that is found on... I'm a little lost.

[00:05:07] Speaker 03:
The 717, that did not mature into the 948 patent, did it?

[00:05:12] Speaker 00:
It didn't.

[00:05:13] Speaker 00:
The 400 application did.

[00:05:14] Speaker 03:
Right.

[00:05:15] Speaker 03:
So what's the relationship of this application?

[00:05:18] Speaker 00:
So what the district court found was that the statements earlier in prosecution for related applications

[00:05:26] Speaker 00:
Okay.

[00:05:26] Speaker 00:
...relevant to the finding of disclaimer for the patent ensued.

[00:05:30] Speaker 00:
Okay.

[00:05:30] Speaker 00:
And so what the examiner here says, and I'm looking at, I'm on Appendix 2673, I'm on the fourth line down, and it says, the set starting, applicants could amend, and I'll wait for you to catch up, it says, applicants could amend using consisting of language for the solvent or carrier in order to explicitly exclude the glycol.

[00:05:51] Speaker 00:
And so the statement there is,

[00:05:54] Speaker 00:
was made in response to the examiner's rejection of the expressed negative limitation that would have excluded PG, any amount of PG, that was rejected on a 112 basis.

[00:06:06] Speaker 00:
The examiner suggested using consisting of language to expel the PG from the carrier.

[00:06:11] Speaker 00:
Not in its entirety, but from the carrier.

[00:06:13] Speaker 05:
I have a really, really dumb question.

[00:06:16] Speaker 05:
But looking at claim number five, OK,

[00:06:19] Speaker 05:
and I see A, a buffering agent, and then I see B, water, and C, sweetener, and D, preservative, and what is the carrier?

[00:06:27] Speaker 00:
Water.

[00:06:28] Speaker 00:
Water is the only ingredient that's suitable to be a carrier.

[00:06:31] Speaker 05:
Okay, so then why didn't you put consisting of before the word water?

[00:06:35] Speaker 05:
use it in the preamble the word consisting of applies to every single one of the things that follow

[00:06:50] Speaker 05:
You could have, and I often see pharma claims where there are elements that have subs that say, for element B, consisting of only this or this.

[00:07:02] Speaker 05:
So even if I were to understand that this related application

[00:07:10] Speaker 05:
which is not the application that matured in this patent.

[00:07:13] Speaker 05:
There was a statement by the examiner that suggested, hey, to make something clear, you can put consisting of to show that you're excluding PG from the carrier.

[00:07:24] Speaker 05:
But then a skilled artisan who actually read this claim wouldn't understand you to have done that, because you didn't choose to put consisting of before the carrier.

[00:07:33] Speaker 05:
You chose to put consisting of at the start of the claim, making it clear that you were eliminating PG from everything.

[00:07:39] Speaker 00:
I would disagree with that, Your Honor.

[00:07:40] Speaker 00:
I think there's more than one way to skin that cat in terms of how to draft that claim to use the consisting of language.

[00:07:45] Speaker 05:
I only think there's one way to skin a cat on consisting of.

[00:07:48] Speaker 05:
If you put it in a preamble, it's only the stuff after.

[00:07:51] Speaker 05:
And I will not allow you to infuse confusion to that part of our law.

[00:07:55] Speaker 05:
That has been clear for decades and decades.

[00:07:58] Speaker 00:
And we accept that, Your Honor, which is why we argued the 0.1% PG is part of the flavoring agent, a listed ingredient.

[00:08:06] Speaker 00:
So we were trying to go outside the list of ingredients.

[00:08:08] Speaker 00:
But because ALKIM manufactures its product in a way that utilizes PG as a subcomponent of a flavoring agent, the addition of 0.1% PG doesn't change that.

[00:08:18] Speaker 05:
I thought at the trial that this judge found that that was not accurate, that there is no PG in the flavoring agent of the accused product.

[00:08:24] Speaker 00:
What he found was that all the PG in the product, including the 0.1% PG, interacts with the artificial flavoring.

[00:08:32] Speaker 05:
No, but didn't he find it was not part of the flavoring agent?

[00:08:36] Speaker 05:
It's a yes or no question.

[00:08:37] Speaker 05:
I thought there was an express finding in this case by the district court that the PG was not part of the flavoring agent.

[00:08:43] Speaker 00:
He had a note which had three items to it, which he found that because it was separately added, it wasn't part of the flavoring agent.

[00:08:50] Speaker 00:
But that is a claim construction position that he adopted that is not consistent with the scope of the claims.

[00:08:56] Speaker 03:
But aren't we in an infringement fact-finding question?

[00:09:00] Speaker 03:
Because, I mean, one of the ANDA ingredients is grape flavor 501417C, right?

[00:09:07] Speaker 03:
Which is an off-the-shelf flavoring agent.

[00:09:09] Speaker 00:
Right, which contains 94 or 95% PG.

[00:09:11] Speaker 00:
93% PG.

[00:09:12] Speaker 04:
So it's a third-party product.

[00:09:14] Speaker 04:
Am I understanding that right?

[00:09:16] Speaker 04:
Third-party product.

[00:09:17] Speaker 03:
So why was it unreasonable for the district court to look at that ANDA ingredient and say, there's your flavoring agent.

[00:09:27] Speaker 03:
It's called Grape Flavor 501417C.

[00:09:31] Speaker 03:
This other thing that the ANDA also identifies

[00:09:35] Speaker 03:
I don't think it was reached as a matter of fact.

[00:09:50] Speaker 00:
I think it was reached as a matter of claim construction.

[00:09:52] Speaker 03:
Well, let's assume for the moment it's a fact finding.

[00:09:54] Speaker 03:
Why would that be unreasonable?

[00:09:56] Speaker 00:
Because all the ingredients, according to Alcom's manufacturing process, are added and then thoroughly mixed.

[00:10:02] Speaker 00:
And so, as I said, all of the artificial flavor must necessarily interact with all of the PG in the formulation.

[00:10:09] Speaker 00:
So all the PG in the formulation contains some amount of flavoring agent.

[00:10:13] Speaker 00:
It imparts flavor.

[00:10:14] Speaker 00:
It is an agent of flavor, and therefore is a flavoring agent.

[00:10:17] Speaker 02:
That's where the district court did make a fact-finding.

[00:10:19] Speaker 02:
The district court found, as a matter of fact, that the PG doesn't have a significant enough flavor for itself to be considered the flavoring agent.

[00:10:27] Speaker 00:
PG standing alone is not a flavoring agent.

[00:10:28] Speaker 02:
Yes.

[00:10:29] Speaker 02:
But it could be in a flavoring agent, and you could at least, the district court seemed to accept the premise you could draw a dotted line around the extra PG

[00:10:38] Speaker 02:
and included as part of the flavoring agent.

[00:10:40] Speaker 02:
That seemed to be the premise of the trial going into it.

[00:10:43] Speaker 02:
Correct.

[00:10:44] Speaker 02:
But the problem with doing so, I think it traces back to the disclaimer, and I hear what you're saying about the Palipu reference being referenced as a carrier, but isn't the PG in the flavoring agent a carrier?

[00:10:58] Speaker 02:
Isn't that what it's doing in the

[00:10:59] Speaker 02:
Flavoring agent?

[00:11:00] Speaker 00:
So a carrier and a co-solvent are two different things.

[00:11:04] Speaker 02:
Well, you called it a carrier when you were talking about Palipoo, isn't that?

[00:11:08] Speaker 00:
When I'm talking about Palipoo, yes, but you shifted to .1% PG, and that's the ANDA product, not Palipoo.

[00:11:14] Speaker 02:
Okay.

[00:11:15] Speaker 00:
Okay, so this report actually found that the terms carrier, solvent, and vehicle all mean the same thing, and there's something different than what they're characterizing as a co-solvent.

[00:11:25] Speaker 00:
That small amount of PG and the ANDA, those are two different things.

[00:11:28] Speaker 05:
Did the district court also find that the disclaimer of PG also applies to the co-solvent?

[00:11:37] Speaker 00:
He applied it to every amount of PG, including the PG that's in the flavoring agent purchase off the shelf.

[00:11:41] Speaker 00:
Yes.

[00:11:42] Speaker 05:
Because Palipu is the flavoring agent, but the co-solvent.

[00:11:44] Speaker 00:
Correct.

[00:11:44] Speaker 00:
Everything.

[00:11:45] Speaker 02:
Palipu goes down pretty low.

[00:11:47] Speaker 02:
It goes down to like 1%.

[00:11:49] Speaker 00:
Yes.

[00:11:49] Speaker 00:
So one of the formulations in Palipu goes down to 1.25%.

[00:11:52] Speaker 00:
But Palipu characterized that as a solvent, as a carrier.

[00:11:57] Speaker 00:
And the only testimony was that that characterization was accurate.

[00:12:01] Speaker 02:
Yeah.

[00:12:02] Speaker 02:
It's really tough with the claim on a composition where the issues are turning on what ingredients are functioning as.

[00:12:11] Speaker 00:
But at a chemical level, the testimony was uncontroverted.

[00:12:14] Speaker 00:
And as Your Honor pointed out,

[00:12:15] Speaker 00:
There was a factual finding that all of the artificial flavor must necessarily interact with all the PG, because all the PG is chemically identical.

[00:12:24] Speaker 00:
That means that all the PG must have some amount of flavoring agent in it, and therefore it is

[00:12:29] Speaker 03:
Is it your view that the PG, the .1 PG, is necessarily interacting with just the flavoring agent and not anything else like the preservative?

[00:12:40] Speaker 00:
No, it can certainly interact with the paraben preservative, but that doesn't mean it's not also a flavoring agent.

[00:12:44] Speaker 00:
It can be an agent for the paraben as well as an agent for the flavor.

[00:12:47] Speaker 00:
And that doesn't take it outside the scope of the claim.

[00:12:49] Speaker 03:
Does Azzurri have any continuation application claims pending where they're trying to get coverage for this same invention, but not using the consisting of?

[00:13:02] Speaker 00:
So there was a continuation application that attempted to claim PG in the formulation?

[00:13:06] Speaker 03:
I'm saying a current continuation pending continuation application.

[00:13:10] Speaker 03:
Not that I'm aware of, Your Honor.

[00:13:12] Speaker 02:
One question I had I couldn't quite piece out from the record You walked away at some point from a DOE argument, right?

[00:13:21] Speaker 02:
in the case?

[00:13:23] Speaker 02:
We did not pursue a DOE order.

[00:13:25] Speaker 02:
Right.

[00:13:25] Speaker 02:
And was it because there was argument-based prosecution history estoppel on the PG?

[00:13:30] Speaker 00:
No, Your Honor.

[00:13:31] Speaker 00:
It's because doctrine of equivalence in this context with consisting of is a narrower doctrine.

[00:13:36] Speaker 00:
And we didn't think it was fruitful to explore that, especially when flavoring agent is identified in the ANDA itself.

[00:13:42] Speaker 00:
I'm sorry, PG is identified in the ANDA itself as being a flavoring agent.

[00:13:46] Speaker 00:
There's no need to go to an equivalent analysis.

[00:13:48] Speaker 00:
Different PG.

[00:13:50] Speaker 00:
Well, chemically identical and functioning exactly the same, which is mixed into the product, yes.

[00:13:58] Speaker 05:
You want to save some time for a little?

[00:14:00] Speaker 00:
Certainly.

[00:14:19] Speaker 01:
Helen Pollack, Windows Marks on behalf of ALCHEM.

[00:14:23] Speaker 02:
Council, question I asked on the other side.

[00:14:28] Speaker 02:
Is it correct that the premise of this trial, and there's no dispute at least at a conceptual level, forget the disclaimer, that it would be possible with a claim like this to group the extra PG that's listed on the ANDA in with the flavoring agent?

[00:14:45] Speaker 02:
That was something that was accepted going into the trial?

[00:14:47] Speaker 01:
No, I don't think that's accurate.

[00:14:49] Speaker 02:
It's right in the beginning of the district court's opinion.

[00:14:51] Speaker 01:
I understand that.

[00:14:52] Speaker 02:
It didn't seem like it was disputed.

[00:14:54] Speaker 01:
Well, we certainly agree that the inclusion of the co-solver makes an infringement finding impossible.

[00:15:00] Speaker 01:
But I believe that the inclusion of purple and black hole within the flavoring agent itself should also take us out of these coins.

[00:15:05] Speaker 01:
I do agree that the co-solver was the focus of the trial.

[00:15:09] Speaker 01:
And that was a factual finding that the district court made that's not clearly erroneous.

[00:15:14] Speaker 01:
And I don't see how they get over that.

[00:15:17] Speaker 01:
But there are other issues involved.

[00:15:19] Speaker 01:
I just wanted to talk about this.

[00:15:20] Speaker 05:
I don't understand.

[00:15:21] Speaker 05:
If you think PG in the flavoring agent also takes you outside of the scope of these claims, then why did you stipulate to the contrary on page 1773?

[00:15:30] Speaker 05:
I understood your stipulation to be limited to PG in flavoring agents and saying that that has no impact on whether it's covered by the claim.

[00:15:39] Speaker 01:
uh... reinterpreted that different uh... the the situation that you're referencing i believe is paragraph sixty-four the pre-trial what it comes to.

[00:15:46] Speaker 01:
Paragraph ninety-two.

[00:15:47] Speaker 05:
Paragraph ninety-two on page one seven seventy-eight.

[00:15:50] Speaker 01:
That arose from a discovery dispute that began with request for admission number five that we drafted to try and circumvent an argument that we feared they would raise that would be used essentially from our perspective as an excuse to avoid what we think is the clear and unambiguous language in their

[00:16:07] Speaker 01:
many representations and arguments in the file history.

[00:16:10] Speaker 01:
It was solely written to address whether, in a commercial sense, whether a post could go and find, as available, flavoring agents that didn't have propylene glycol, had propylene glycol.

[00:16:24] Speaker 01:
In other words, the availability in a real world commercial sense would not play a role in how you could make this product.

[00:16:30] Speaker 01:
That was the sole focus of that request.

[00:16:32] Speaker 05:
But what you said, and what you stipulated to, is suitable

[00:16:36] Speaker 05:
flavoring agents for use in the asserted claims include flavoring agents with or without PG.

[00:16:44] Speaker 03:
That's correct.

[00:16:45] Speaker 03:
It's that phrase, in the asserted claim, that's very bothersome.

[00:16:49] Speaker 03:
And it sounds like you are conceding, as a matter of claim scope or as a matter of infringement, that that limitation, of course, can have PG in it.

[00:16:59] Speaker 01:
I accept that.

[00:17:00] Speaker 01:
That was not our intent, but I would also add that if it is true that that's to be construed as a claim construction point, I would also point out that the district court judge is free to reject that, which essentially he did.

[00:17:14] Speaker 02:
If you look at the district court opinion... And what is our standard of review on the district court's interpretation and application of a stipulation?

[00:17:21] Speaker 01:
That, I believe, would be reviewed de novo.

[00:17:24] Speaker 01:
The interpretation is de novo, I believe, but the application of it to the facts of the case, that would be clearer.

[00:17:29] Speaker 01:
I believe we have a case that states that in our brief.

[00:17:33] Speaker 01:
I can point it out if you'd like.

[00:17:35] Speaker 05:
Well, I mean, district court judges aren't bound by stipulations regarding legal questions, right?

[00:17:39] Speaker 01:
Of course.

[00:17:40] Speaker 05:
So this goes to claim construction.

[00:17:42] Speaker 05:
Yes.

[00:17:42] Speaker 05:
And it's not like an underlying factual part of claim construction.

[00:17:45] Speaker 01:
Exactly.

[00:17:46] Speaker 01:
That was my point.

[00:17:46] Speaker 01:
Even if this is to be considered, as they argue, essentially a joint claim construction position, the judge is free to reject that, which he essentially did.

[00:17:55] Speaker 01:
In the district court opinion, he talked about how

[00:17:58] Speaker 05:
For his own purposes to understand and resolve this case He had to construe flavoring agent and he was he would not do that in the way that they liked because he viewed that in conflict with the intrinsic record one problem I have is that if we construe consisting of in claim five as meaning no PG anywhere Not you want it to be nowhere not even in the flavoring agent, right?

[00:18:21] Speaker 05:
but I mean in the ANDA isn't it clear that the flavoring agent has a

[00:18:28] Speaker 05:
PG in it?

[00:18:29] Speaker 01:
Yes, 92.5%.

[00:18:32] Speaker 01:
There's never any dispute about that.

[00:18:35] Speaker 05:
Don't most flavoring agents have?

[00:18:37] Speaker 01:
Well, that was the very issue we were trying to resolve in the request for admission, because we were concerned that if it is, in a commercial sense, impossible, at least with artificial flavors, to go out and make a product like this without propylene glycol, we were quite concerned that they would argue that, well, you know, all of our comments regarding propylene glycol in the file history

[00:18:57] Speaker 01:
They all come essentially with an asterisk.

[00:18:59] Speaker 01:
that says, well, you know, a poster would understand, you really can't make this kind of a product with a flavoring agent that doesn't have propylene glycol.

[00:19:08] Speaker 01:
We couldn't possibly have been referring to the flavoring agent.

[00:19:11] Speaker 03:
You wanted to cut that argument off.

[00:19:12] Speaker 01:
That is exactly what we tried to do.

[00:19:15] Speaker 01:
I do agree with the wording that ultimately ended up in a trouble where perhaps not ideal.

[00:19:19] Speaker 02:
So the way the appellant uses that stipulation and the other infringement stipulations is they say, those cut off the disavowal argument and disrecord

[00:19:29] Speaker 02:
Disagree with that and and use the disavow approach but the question came up in my mind is sometimes with disavowals It's not always clear what claim terms the disavowals actually tied to What's your position on which claim terms if any the disavowals tied to here?

[00:19:43] Speaker 01:
I think that's a that's a very important question to address in this type of claim a consisting of claim because I will can see that I think there was some confusion about the

[00:19:51] Speaker 01:
Interplay between claim construction and disclaimer and claims scope this came up in the first case we heard from this morning where I like Chief Judge more and Judge Murphy I also agree that claim scope is claimed construction that was discussed this morning I believe Council for outcomes said that very same thing in the 12 C and

[00:20:12] Speaker 01:
argument phase of this case as well.

[00:20:16] Speaker 01:
But I think because we're focusing on a consisting of claim and specifically something that's cut out of a consisting of claim, what you're actually construing is not as clear as it might be in a comprising claim.

[00:20:30] Speaker 01:
That's one of the reasons why we asked the court, even after we said we didn't think we needed claim construction,

[00:20:36] Speaker 01:
We ask the court to do claim construction, because one way to look at that is in a consistent claim where you're focusing on the things that are not there.

[00:20:44] Speaker 01:
One way to do that is to construe the limitations that are there, not to permit the thing that's excluded.

[00:20:50] Speaker 01:
It's essentially the same thing.

[00:20:52] Speaker 01:
But I do agree it's a little... OK.

[00:20:56] Speaker 05:
I'm struggling just a little bit.

[00:20:57] Speaker 01:
Sure.

[00:20:57] Speaker 05:
So if I were just reading this claim, and I didn't pay any attention to the prosecution history at all.

[00:21:03] Speaker 04:
Right.

[00:21:03] Speaker 05:
would think consisting of means limited to these items right and if flavoring agents include PG then you know it could

[00:21:15] Speaker 05:
be in there, but you couldn't put PG in there in a different capacity, right?

[00:21:19] Speaker 05:
That's the way I would think of it, consisting of claims.

[00:21:22] Speaker 05:
So now we pivot to the disclaimer and the prosecution history, and they say, no PG.

[00:21:29] Speaker 05:
And the question is, does that mean no PG anywhere, or does that mean no PG in some particular place?

[00:21:35] Speaker 05:
Which is, I'm getting at the same thing that Judge Murphy was trying to get at, which is trying to understand

[00:21:40] Speaker 05:
what the scope of the disclaimer precisely is, because if it's no PG anywhere, then it means you can't even have PG in a flavoring agent.

[00:21:49] Speaker 01:
Right.

[00:21:50] Speaker 01:
That's right.

[00:21:50] Speaker 01:
And that was the concern.

[00:21:52] Speaker 05:
Yeah, go ahead.

[00:21:53] Speaker 01:
That was the concern that causes the draft request for admission number five.

[00:21:57] Speaker 01:
But I would say that perhaps the simplest way to address this claim, which of course is a consistent claim, is to recognize that there is no co-solvent limitation in the claim.

[00:22:07] Speaker 01:
as long as the factual finding that our co-solvent is indeed a co-solvent, which we believe is correct and certainly not clearly erroneous, there's no way for them to make out an infringement of our part in this case.

[00:22:21] Speaker 02:
The district court said that the

[00:22:24] Speaker 02:
The ANDA characterizes the extra propylene glycol as a co-solvent.

[00:22:30] Speaker 02:
The district court said that's not controlling.

[00:22:32] Speaker 02:
Do we all agree on that?

[00:22:34] Speaker 01:
Yes, that is what the district court said.

[00:22:35] Speaker 01:
We did disagree with that.

[00:22:37] Speaker 02:
But not here on appeal?

[00:22:38] Speaker 01:
No, I think that's wrong.

[00:22:39] Speaker 01:
We did disagree with that in a fitment in our brief.

[00:22:43] Speaker 02:
That doesn't count.

[00:22:46] Speaker 01:
I do case law that says that doesn't count.

[00:22:50] Speaker 01:
The issue is that the resolution of what our co-solvent is was resolved in our favor.

[00:22:56] Speaker 01:
So there's nothing for us to appeal.

[00:22:57] Speaker 01:
That's why I understand it.

[00:22:59] Speaker 01:
We offer two reasons why the co-solvent was a co-solvent.

[00:23:02] Speaker 01:
One, it says it's a co-solvent.

[00:23:03] Speaker 01:
That's the PAR case.

[00:23:05] Speaker 01:
Judge didn't accept that, so we went for a factual finding where the judge allowed them to put on whatever evidence they liked to try and demonstrate that the co-solvent was something other than a co-solvent, or at least other than a co-solvent in part.

[00:23:16] Speaker 01:
I'm not sure what their aim was, but any found in our favor there.

[00:23:21] Speaker 01:
So that's an issue that we won, so there's nothing for us to appeal.

[00:23:23] Speaker 01:
So I'm not sure where that fits in, frankly.

[00:23:25] Speaker 02:
Well, it's just which ground of affirmance makes more sense to you.

[00:23:29] Speaker 01:
Right.

[00:23:29] Speaker 01:
Well, the simplest one, I guess, is the factual finding.

[00:23:34] Speaker 03:
The addition of 0.1 PG takes the and a product outside the claim?

[00:23:38] Speaker 03:
Yes.

[00:23:39] Speaker 03:
And then the alternate ground of affirmance would be the prosecution disclaimer is so extreme that it excludes PG anywhere, including any of the claim ingredients.

[00:23:53] Speaker 03:
Yes.

[00:23:54] Speaker 03:
And then we would have to somehow deal with

[00:23:57] Speaker 03:
What's the best understanding of the so-called suitability stipulation?

[00:24:01] Speaker 01:
Correct.

[00:24:02] Speaker 01:
I would also answer that the district court judge anticipated this very issue and made an observation that even if he were to accept that the suitability stipulation had some applicability to the flamering agent, the disclaimer would still apply to the consul.

[00:24:17] Speaker 01:
So he's already anticipated.

[00:24:21] Speaker 01:
There are a few other points I could happily go through.

[00:24:26] Speaker 01:
But if you have any other questions, I'm happy to push on and just mention a few other points that I thought are pertinent.

[00:24:34] Speaker 01:
This case went through a lot of different phases.

[00:24:36] Speaker 01:
At one point, we were talking about the Norian case from this court.

[00:24:39] Speaker 01:
Equivalence was a big issue early in the case.

[00:24:42] Speaker 01:
Of course, there were two other patents that were asserted against us.

[00:24:47] Speaker 01:
They were both dropped.

[00:24:48] Speaker 01:
The case had gone through a lot of changes on a different basis.

[00:24:52] Speaker 01:
But one part of this case that has never changed, has been continually fought up to this day, is their effort to avoid looking at the prosecution history.

[00:25:04] Speaker 01:
They went through a lot of hoops to try and make sure or try to try and have the court not look at the prosecution history.

[00:25:11] Speaker 03:
What about that one statement in the examiner summary of the 717 application about the carrier business?

[00:25:18] Speaker 01:
Well, first of all, I have a couple things to say about that.

[00:25:21] Speaker 01:
They are the party that said at the trial that the examiner comments don't matter.

[00:25:24] Speaker 01:
Now all of a sudden, the examiner comments are critical.

[00:25:28] Speaker 01:
So I think that's somewhat inconsistent with the position they argued before.

[00:25:31] Speaker 01:
That, of course, is the 717 application, which is not a direct end sensor to the 400 application, which is the application initiative as the 940 patent.

[00:25:39] Speaker 01:
But certainly, we relied on the 717, so that's fair.

[00:25:42] Speaker 01:
But I don't see how that comment helps them.

[00:25:47] Speaker 01:
It's not just that comment.

[00:25:49] Speaker 01:
There are a legion of comments and amendments that talk about the absence of Brooklyn's rightful without qualification.

[00:25:56] Speaker 01:
There may be some others that talk about

[00:26:00] Speaker 01:
Procling glycol and combination of lactic acid.

[00:26:02] Speaker 03:
We're not we're not discounting those but they don't undo the application I guess what I'm wondering is do you understand that's examiner summary statement to be talking about the usage of the term consisting of With respect to the carrier element alone as opposed to consisting of for the entire claim.

[00:26:20] Speaker 01:
No, I do not I

[00:26:21] Speaker 01:
I think it's very clear that the consisting of, as Chief Judge Point pointed out, was putting a preamble and applies to all the limitations of the plane, not just the carrier.

[00:26:30] Speaker 01:
At many, actually at several points... Was that an examiner summary?

[00:26:33] Speaker 03:
What was the examiner trying to get at?

[00:26:36] Speaker 03:
Was it trying to get at, hey, you could, you know, add a consisting of to the carrier limitation to make it clear that the carrier...

[00:26:47] Speaker 03:
excludes PG and so therefore that examiner statement isn't suggesting that the purpose of getting rid of PG for all pending claims is simply just for the carrier alone, not for the claim convention as a whole.

[00:27:08] Speaker 01:
No, I think the part of I'd have to check the exact claims that were at issue prior to that But there were some iterations of the claims that did talk about a carrier and the examiner was not happy with Representations about what the carrier had as opposed to the whole formulation.

[00:27:24] Speaker 01:
They took out the word carrier.

[00:27:26] Speaker 01:
It's not in any of the issued claims But it might have been at this point.

[00:27:30] Speaker 01:
I'd have to check I don't know that there were many different file action office actions and amendments throughout the

[00:27:36] Speaker 01:
I think there were a dozen between the first two applications.

[00:27:40] Speaker 03:
We don't happen to know whether Missouri has any pending claims in the continuation that are going after the same invention without the consisting of an agreement.

[00:27:48] Speaker 01:
None that are public that I'm aware of.

[00:27:50] Speaker 01:
OK.

[00:27:50] Speaker 01:
But one other issue I would point out that they do try and make something of one statement

[00:27:58] Speaker 01:
application, I believe it's the 421 application, where they told the examiner, first just to warn ourselves, the 421 application is not a descendant of the 400 application, which issued with this patent.

[00:28:10] Speaker 01:
It is related, but I guess it's in essence like a cousin, second, two times removed or something like that.

[00:28:17] Speaker 01:
After the notice of allowance issued in the 400 application, after we had sent the notice letter in this case, they wrote to the patent office and that application, the 421 application,

[00:28:28] Speaker 03:
Say oh by the way, you know their attempted take back occurred a month after that notice of allowance in this patent Right.

[00:28:35] Speaker 03:
And so the blue brief got that wrong.

[00:28:37] Speaker 03:
They switched it.

[00:28:37] Speaker 01:
Well, yeah a couple of things I just wanted to add about that first of all, they never that application that Statement was never made in the 400 application or any ancestor of the four applications a downstream statement and

[00:28:51] Speaker 01:
that I don't think is the type of statement this court normally relies on.

[00:28:54] Speaker 03:
But there are a couple of other... They're trying to cancel out what they conceded earlier.

[00:28:58] Speaker 03:
Exactly.

[00:29:00] Speaker 01:
But even in that statement, they don't even make the arguments that they've made in litigation.

[00:29:04] Speaker 01:
The big argument they have, and it's pretty much the only response that I can tell they've made to the statements that they are trying to walk away from in the prosecution history, is every time we spoke about propylene glycol, what we were really talking about is using it as the primary solvent and in combination with lactic acid.

[00:29:22] Speaker 01:
Neither those criteria are even in that back-to-back statement.

[00:29:25] Speaker 01:
And I think I'm nearly out of time, but I'm happy to address anything else that remains.

[00:29:29] Speaker 05:
Thank you.

[00:29:30] Speaker 05:
Counsel?

[00:29:41] Speaker 00:
Thank you, Your Honor.

[00:29:41] Speaker 00:
There's four points on rebuttal.

[00:29:42] Speaker 00:
The first has to do with the disclaimer argument.

[00:29:45] Speaker 00:
So I'll refer to Appendix 2554.

[00:29:48] Speaker 03:
And this is- You believe that in the 421 application, you're attempting to take back in an office action response that came in a month after, not before the notice of allowance in this patent.

[00:29:59] Speaker 00:
I trust Your Honor's conclusion on that.

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

[00:30:04] Speaker 00:
So Appendix 2554, this is where the examiner responded to the alleged disclaimer remark.

[00:30:11] Speaker 00:
And before I get to that point, we have never said the examiners' statements don't count.

[00:30:16] Speaker 00:
We said they can't be a disclaimer.

[00:30:18] Speaker 00:
But they certainly provide context that is worth considering for one of skill in the art to ascertain what these statements in the prosecution history actually mean.

[00:30:26] Speaker 00:
So 2554, this is claim 16, this is rebutting the alleged disclaiming statement.

[00:30:32] Speaker 00:
It says that the way that claim is written, it does not exclude the presence of the polar solvents, the carrier of palipule, referring to propylene glycol.

[00:30:42] Speaker 00:
So the examiner interpreted the literal statement that did not say propylene glycol as a solvent.

[00:30:48] Speaker 00:
but understood it meant as a solvent, because that was the context for this conversation using consisting of to get rid of PG as a solvent.

[00:30:56] Speaker 00:
And so here, the examiner says, no, it actually doesn't exclude propylene glycol as a solvent because of the way that it's drafted.

[00:31:02] Speaker 00:
So again, there's more context here that leads to the interpretation of this alleged disclaimer as being at least subject to multiple interpretations.

[00:31:10] Speaker 00:
But perhaps more importantly, what the examiner says, that claim 16 as written is rejected over Palipu.

[00:31:16] Speaker 00:
because of its scope, the way it was written.

[00:31:19] Speaker 00:
Now, to contrast that with claim 20, which was issued at, that was a formulation claim that is much more akin to the claims that eventually issued, including the claims asserted in this case.

[00:31:27] Speaker 00:
Claim 20, the description of the claim, but they- You said you had four points.

[00:31:31] Speaker 05:
You are 35 seconds over your time.

[00:31:33] Speaker 05:
How many of your points have you gotten through?

[00:31:35] Speaker 00:
I apologize.

[00:31:35] Speaker 00:
I'll finish this one.

[00:31:36] Speaker 05:
Okay.

[00:31:37] Speaker 05:
Go for it.

[00:31:38] Speaker 00:
Claim 20, the claim was characterized, it consisted of claims, as excluding the glycol, the glycol solvent of Palipute.

[00:31:47] Speaker 00:
And because Claim 16 was rejected into getting Claim 16 where this alleged disavow occurred, and Claim 20 eventually went on to get issued, as written at that time, with a minor amendment.

[00:31:56] Speaker 05:
If you want to say one sentence about each of the other three points, go.

[00:32:00] Speaker 00:
Sure.

[00:32:01] Speaker 00:
Point two, had ALKIM used any other flavoring agent that did not use PG as part of it, we wouldn't have a case.

[00:32:09] Speaker 00:
We agree.

[00:32:09] Speaker 00:
But because they did, the inclusion of the additional PG is a flavoring agent.

[00:32:15] Speaker 00:
That's how the molecule behaves.

[00:32:19] Speaker 00:
Last point, the co-solvent is a co-solvent finding.

[00:32:21] Speaker 00:
That's not inconsistent with the notion that the .1 PG does other things in the formulation as well, including act as a failing flavoring agent.

[00:32:28] Speaker 00:
Thank you.

[00:32:28] Speaker 05:
I thank both counsel for their arguments in this case to take another submission.