[00:00:00] Speaker 04:
We will hear argument next in case number 232173, i-therapies against Slaback Pharma.

[00:00:10] Speaker 03:
Good morning, your honors.

[00:00:10] Speaker 03:
May I please the court?

[00:00:12] Speaker 03:
The board made a number of errors that independently warrant reversal or remand, and I'd like to begin with the board's construction of consisting essentially of, which cut a wide swath through the board's obviousness analysis.

[00:00:25] Speaker 03:
Now, on this issue, the parties agree on two things.

[00:00:27] Speaker 03:
First, that consisting essentially of was an important issue during prosecution because the applicant used it to distinguish the prior art.

[00:00:35] Speaker 03:
And second, the scope of consisting essentially of can be narrowed during prosecution through lexicography or disclaimer.

[00:00:42] Speaker 03:
And that's what happened here.

[00:00:44] Speaker 03:
During prosecution, to distinguish the combination therapy disclosed in Dean, the applicant amended the claims to add consisting essentially of and argued

[00:00:54] Speaker 03:
that this language excluded any other active ingredients besides low-dose bromonidine.

[00:00:59] Speaker 03:
Now, the applicant made that point several times, including two.

[00:01:02] Speaker 04:
Just to be clear, so the claim construction that you think is correct is one that excludes all active ingredients except the low-dose bromonidine.

[00:01:17] Speaker 04:
Correct, Your Honor.

[00:01:18] Speaker 04:
OK.

[00:01:18] Speaker 04:
That's the formulation.

[00:01:20] Speaker 04:
Correct, Your Honor.

[00:01:20] Speaker 04:
And that formulation of your construction

[00:01:25] Speaker 04:
had some importance to your response to footnote 24 of the board's decision.

[00:01:30] Speaker 04:
Right.

[00:01:32] Speaker 03:
I think that would be fair.

[00:01:33] Speaker 03:
Yes.

[00:01:33] Speaker 04:
OK.

[00:01:36] Speaker 03:
Now the applicant made the point several times including defining

[00:01:40] Speaker 03:
on two occasions, consisting essentially of using the definitional clause, i.e., as not including other active ingredients.

[00:01:48] Speaker 03:
So the board erred in failing to give effect to these clear statements of definition and disclaimer in the prosecution history.

[00:01:55] Speaker 03:
Now, the board was apparently concerned that construing consisting essentially of as excluding other active ingredients would give it the same scope as consisting of, but that's incorrect.

[00:02:06] Speaker 03:
742 patent explains, and there's no dispute about this, that various inactive ingredients can be included in the inventions such as preservatives and buffers.

[00:02:16] Speaker 03:
And these inactive ingredients would also be included under eye therapy construction, even though they're not expressly claimed.

[00:02:23] Speaker 04:
Is there case law or established practice

[00:02:28] Speaker 04:
one way or the other for the meaning of a consisting of X and whether that precludes inactive ingredients, excipients, and whatever.

[00:02:45] Speaker 03:
If we're talking about consisting of, I believe the case law generally says consisting of is a close-ended preamble.

[00:02:52] Speaker 03:
And so it would exclude anything that's not specifically listed in the claim.

[00:02:57] Speaker 00:
So the only way to get this construction, that is, what is in the parenthetical, for example, to A1055, is by using consistent essentially of so that you can include inactive ingredients but not active.

[00:03:12] Speaker 03:
Correct, Your Honor.

[00:03:13] Speaker 03:
Consisting essentially of, as this Court has held, is a basically in-between transition clause that can include other components that do not materially affect the basic and novel properties.

[00:03:25] Speaker 03:
But with respect to these inactive ingredients, like excipients and buffers and so forth, the applicant made that very point during prosecution by pointing to example 10 of Dean and conceding that example 10 of Dean does meet the consisting essentially of requirement

[00:03:42] Speaker 03:
even though it includes inactive ingredients in addition to bromonadine.

[00:03:46] Speaker 00:
Where's that?

[00:03:47] Speaker 03:
So that would be at appendix 1058, where the applicant said that Dean discloses only one composition consisting essentially of bromonadine.

[00:04:04] Speaker 03:
And this composition has bromonadine at a concentration of 0.2%, citing example 10.

[00:04:10] Speaker 03:
An example ten has an experience and whatnot.

[00:04:13] Speaker 03:
Correct.

[00:04:14] Speaker 03:
So my point here, and I don't believe there's been a dispute about this in the briefing, my point here is that the board simply got it wrong.

[00:04:20] Speaker 03:
Our construction does not conflate consisting essentially of with consisting of.

[00:04:24] Speaker 04:
So can I ask you this question?

[00:04:25] Speaker 04:
Suppose we were to agree with you about that, then the decision of the board has to be vacated.

[00:04:33] Speaker 04:
What else

[00:04:35] Speaker 04:
is important for, in your view, for us to say to make sure that the board not only reconsiders its particular judgments to the extent that those judgments are affected by the claim construction, but anything else in the board's decision that might be worth if not deciding

[00:05:04] Speaker 04:
by us now, flagging.

[00:05:07] Speaker 03:
Understood, Your Honor.

[00:05:09] Speaker 03:
The claim construction enough would be enough to warrant at least a remand.

[00:05:12] Speaker 03:
But to your question, what else was there?

[00:05:15] Speaker 04:
But you don't want to go back and say, and the board say, footnote 24 makes all of that irrelevant, for example.

[00:05:22] Speaker 03:
Let me I want to make sure I'm answering your question I would say that the the it would be very helpful if the court could address the closest prior art issue because that was another area with every deal was the right and that actually does intermesh with the claim construction issue as well and I can explain that in a moment and I think it would be also helpful if the board could could excuse me if the if the court could address the the teaching away or the the alphagans studies that we presented as evidence of

[00:05:50] Speaker 03:
of both teaching away and as a rebuttal to expectation of success.

[00:05:54] Speaker 03:
So those are two major areas where it would be helpful to have guidance from the court so that we don't end up on a round trip here on these same issues.

[00:06:02] Speaker 03:
But I would like to, if I may, address footnote 24, because you've brought it up a couple times, and I want to make sure I do address that.

[00:06:09] Speaker 03:
So footnote 24 is where the board prophylactically tried to apply a narrower construction.

[00:06:16] Speaker 03:
And Slaback has incorrectly stated that this was basically the board saying even under i-therapy's construction, it would still reach the same result.

[00:06:26] Speaker 03:
But the problem is Footnote 24 doesn't use i-therapy's construction.

[00:06:30] Speaker 03:
Footnote 24 still relies on a construction that allows other active ingredients, like in Norden.

[00:06:35] Speaker 03:
And that was not how the applicant defined consisting essentially of during prosecution.

[00:06:40] Speaker 03:
So we don't believe Footnote 24 can salvage the board's opinion under the correct construction.

[00:06:46] Speaker 03:
As I was mentioning, this construction also infected

[00:06:50] Speaker 03:
I should say this claim construction error also infected the board's determination of the closest prior art for comparative purposes.

[00:06:58] Speaker 03:
Eye therapies presented clinical data showing unexpected results of the claimed invention versus Visine, which at the time was the prevailing gold standard eye redness reliever on the market.

[00:07:10] Speaker 03:
And this testing showed that Brahmonidine, low dose, was five times more effective than Visine in reducing eye redness and without any side effects.

[00:07:18] Speaker 03:
The board rejected those results and held that eye therapies should have tested against .03-baronidine, which is found only in GIL example 1.

[00:07:27] Speaker 03:
Now, first of all, GIL example 1 isn't a method of reducing redness, and so it shouldn't have been even considered as part of the closest prior art, because the most important limitation in our claims is a method of reducing redness.

[00:07:43] Speaker 03:
But even putting that aside,

[00:07:45] Speaker 03:
under the proper construction.

[00:07:47] Speaker 03:
Remember, Gill example one is a combination therapy, not a monotherapy.

[00:07:51] Speaker 03:
And so under the proper construction, the board certainly could not have pointed to Gill example one as the closest prior art.

[00:07:56] Speaker 03:
What do you think is the closest prior art?

[00:07:59] Speaker 03:
We believe that Visine is the closest prior art under this court's rationale set forth in Inray Merchant.

[00:08:05] Speaker 03:
Whenever you're dealing with closest prior art, by definition, there's going to be at least one limitation missing.

[00:08:12] Speaker 03:
And so the question is, what are the important limitations?

[00:08:15] Speaker 03:
And here, the important limitations in these claims is that it's a method of treating eye redness, that it's a monotherapy, that it's an ocular drop that's applied for that purpose.

[00:08:29] Speaker 03:
and it's a low concentration.

[00:08:31] Speaker 03:
And on all of those limitations, Visine is the closest prior art.

[00:08:35] Speaker 03:
Now, we can see that it doesn't have Brahmonidine, but as an alternative argument, we also pointed to the AlphaGAN studies to say, well, if you want to look at something with Brahmonidine, the AlphaGAN studies would be the closest prior art.

[00:08:48] Speaker 03:
And again, our clinical data showed unexpected improvement over the .5 and .2 percent AlphaGAN studies, which showed

[00:08:57] Speaker 03:
some blanching or whitening of the eye, but with side effects.

[00:09:01] Speaker 03:
And that blanching or whitening fell off dramatically below .2% concentration.

[00:09:10] Speaker 03:
So we think there was an error there.

[00:09:11] Speaker 03:
If the board under the correct construction was still to insist on using 0.03 percent bromonidine from GIL example 1, it would have to extensively modify that in order to make it essentially the closest prior arc.

[00:09:26] Speaker 03:
It would have to get rid of all of the other active ingredients, and it would have to completely change the protocol to make it a method of reducing eye redness instead of a method for basically treating pain or preventing pain.

[00:09:39] Speaker 03:
And that would run headlong into this court's ruling in Millennium that the applicant is not required to test against a hypothetical compound or treatment method that's actually not disclosed in the prior art or not tested in the prior art.

[00:09:52] Speaker 01:
I'm going back to footnote 24.

[00:09:55] Speaker 01:
It seems like the board's suggesting almost a middle ground claim construction, where consisting essentially of means consisting essentially of only one active component for eye redness.

[00:10:08] Speaker 01:
But it can include other active components, which seems like that's what footnote 24 is referring to.

[00:10:15] Speaker 01:
your statement with respect to DEAN, i.e.

[00:10:19] Speaker 01:
methods which should not include administering other active agents, why couldn't that mean that the board's construction in footnote 24 is correct?

[00:10:30] Speaker 01:
That essentially what you're consisting essentially of means only one whitening agent or only one anti-redness agent, but it can include other active ingredients.

[00:10:41] Speaker 03:
Well, I think the problem with that is DEEN, the other active agent in DEEN, is brazolemide.

[00:10:47] Speaker 03:
And brazolemide was not there as either a redness-reducing agent or any other reason.

[00:10:53] Speaker 03:
It was a treatment for glaucoma.

[00:10:56] Speaker 03:
And so when the applicant argued that DEEN is distinguished because of this consisting essentially of, and the board, excuse me, the examiner accepted that argument,

[00:11:05] Speaker 03:
That was basically saying no other active ingredients, regardless of what they're there for.

[00:11:09] Speaker 03:
No other active ingredients.

[00:11:10] Speaker 03:
It's a monotherapy, which, by the way, is fully consistent with if you take a step back and look at what this invention is all about, and you look at the Federal Register, these are monotherapies for treating essentially minor eye redness.

[00:11:22] Speaker 03:
That's what the applicant was trying to convey during prosecution and did so with this definitional language.

[00:11:27] Speaker 03:
So I do agree with you that the board was trying to reach some sort of middle ground in footnote 24.

[00:11:34] Speaker 03:
But even that middle ground is not what the applicant was arguing during prosecution.

[00:11:41] Speaker 03:
I would just like to make one last point.

[00:11:43] Speaker 03:
I've eaten into my rebuttal time here.

[00:11:46] Speaker 03:
But on the AlphaGAN studies, we also think there is a legal error there, especially when you look at what the board accepted as evidence

[00:11:56] Speaker 03:
expectation of success, which is an entirely prophetic hypothetical rabbit study that wasn't even capable of measuring eye redness and had no data whatsoever versus actual human clinical data showing a clear dose response with the whiteness or the blanching dropping off below 0.2%.

[00:12:14] Speaker 03:
When you put those two on the scale, the idea that the board essentially elevated the prophetic rabbit example and I'm going to say gave the back of the hands of the human clinical data we think is both a

[00:12:24] Speaker 03:
an error of substantial evidence as well as a legal error under this court's cases such as University of Strathclyde and OSI pharmaceuticals.

[00:12:34] Speaker 03:
And I'd like to reserve the rest of my time.

[00:12:35] Speaker 01:
Thank you.

[00:12:42] Speaker 02:
Good morning, Your Honors, and may it please the Court, Kevin Martin on behalf of Sleighback.

[00:12:47] Speaker 02:
Your Honors, this case involves one straightforward claim construction question and an application of the substantial evidence standard to the Board's factual findings concerning the prior art.

[00:12:56] Speaker 02:
I'll start with claim construction as my brother did.

[00:12:59] Speaker 02:
On claim construction, i-therapies doesn't argue that the board really got the law wrong in considering the claim construction issue.

[00:13:06] Speaker 02:
It just argues that the board misread the prosecution history.

[00:13:09] Speaker 02:
And the board clearly did not.

[00:13:11] Speaker 02:
If you look at the arguments that they fronted today, those arguments were being raised for the first time in a reply brief and an old argument.

[00:13:19] Speaker 02:
And if they were right, they would have been raised before.

[00:13:21] Speaker 02:
Let's take the IE argument, for example.

[00:13:24] Speaker 02:
which was a major focus of their reply brief and a major focus of the argument today.

[00:13:28] Speaker 00:
When you say the reply brief, you mean the reply brief on appeal?

[00:13:31] Speaker 02:
To this court, right.

[00:13:32] Speaker 02:
If you look at their opening briefs of this court, they never argued that IE was a definitional term in the prosecution history.

[00:13:40] Speaker 02:
They actually referred to that.

[00:13:42] Speaker 00:
They did argue, though, that this was the proper construction, and they relied on the prosecution history, including those pages, right?

[00:13:48] Speaker 02:
It's really interesting though, because every place that they refer to those pages, they surgically excise the IE.

[00:13:55] Speaker 02:
except for one place in the background section.

[00:13:58] Speaker 02:
They have a long block quote where they include the IE, but in the introduction and in the argument, every time they talk about the parenthetical, they don't include the IE.

[00:14:06] Speaker 02:
They are certainly not arguing that IE are magic definitional words the way they are in their reply brief to this court and the way that they did this morning.

[00:14:15] Speaker 02:
The same thing happened below before the board.

[00:14:18] Speaker 02:
They referred in a couple of places once in their supplemental opening brief, once in their supplemental reply brief,

[00:14:23] Speaker 02:
to the parenthetical.

[00:14:25] Speaker 02:
Both times, they left out the word IE.

[00:14:27] Speaker 01:
I'm sorry.

[00:14:28] Speaker 01:
If I'm looking at the opening, maybe I just want to make sure I'm not confused.

[00:14:31] Speaker 01:
If I'm looking at the opening green, looking at the blue green, it's 13 to 14.

[00:14:39] Speaker 01:
There's the quote there with the IE.

[00:14:42] Speaker 01:
Right.

[00:14:42] Speaker 01:
That's the block quote where it appears.

[00:14:44] Speaker 01:
But then when you look at that there.

[00:14:46] Speaker 01:
I'm sorry.

[00:14:46] Speaker 01:
And the IE is bolted.

[00:14:48] Speaker 02:
That's in the original.

[00:14:50] Speaker 02:
I believe it's bolded.

[00:14:51] Speaker 02:
So they're not really calling attention to it.

[00:14:53] Speaker 02:
If you look at the introduction.

[00:14:54] Speaker 00:
It's actually not in the original.

[00:14:56] Speaker 02:
Oh, it's not?

[00:14:57] Speaker 02:
OK.

[00:14:57] Speaker 00:
No, and it says emphasis added.

[00:14:59] Speaker 02:
So I apologize for that, Your Honor.

[00:15:01] Speaker 02:
But if you look at the introduction and if you look at the argument section, when they start talking about this language, they never refer to the IE.

[00:15:07] Speaker 02:
And their argument now is that IE.

[00:15:09] Speaker 00:
So you're arguing waiver?

[00:15:11] Speaker 02:
I'm arguing waiver and forfeiture, because it was never argued to the board that IE is a definitional term of art that requires this use.

[00:15:17] Speaker 00:
But they did argue that they defined it in the prosecution history through these three pages, right?

[00:15:23] Speaker 02:
I don't dispute that, Your Honor.

[00:15:24] Speaker 02:
What I dispute is that it was your argument that IE is definitional.

[00:15:27] Speaker 00:
Well, why don't you just tell us why it is?

[00:15:29] Speaker 00:
Why don't you go to the mayor and explain why it is that this isn't definitional?

[00:15:34] Speaker 02:
It was wrong, Your Honor.

[00:15:35] Speaker 02:
Rembrandt, which is their leading case, says that IE is not always definitional.

[00:15:39] Speaker 02:
You have to look at the context.

[00:15:40] Speaker 00:
Well, setting that aside, why wouldn't a person of ordinary film and art reading YouTube pages, looking at Dean, understanding, you know, the claims and reading the specification, why wouldn't this youth, they think,

[00:15:53] Speaker 00:
that this is defining, consisting essentially of, to mean Ramonidine and not other active ingredients.

[00:16:01] Speaker 02:
Because if they wanted to say that, Your Honor, I think they would have said that in as many words as Your Honor just did.

[00:16:05] Speaker 02:
What they consistently told the examiner was not that consisting essentially of forecloses, the word they use today is excludes, other active ingredients.

[00:16:15] Speaker 02:
What they said was not good.

[00:16:16] Speaker 00:
But what about the language?

[00:16:17] Speaker 00:
It says, A, pharmaceutical composition, which does not include any other active ingredients.

[00:16:22] Speaker 00:
That's at page A, 1055.

[00:16:24] Speaker 00:
Whether it uses IE, and that was pointed out or not.

[00:16:28] Speaker 00:
Yep.

[00:16:29] Speaker 00:
How do you respond to that?

[00:16:30] Speaker 00:
It seems to me like a really hard thing for you to respond to.

[00:16:33] Speaker 02:
Because, Your Honor, if you look at the full context of the prosecution history, what they are consistently arguing is that, indeed, the branzolomide was an essential or required ingredient, and that without that additional ingredient, there would not be treatment of an ocular condition.

[00:16:51] Speaker 02:
For example, if you look at 1054 through 1055, Dean only can be fairly read to stand for the conclusion

[00:16:59] Speaker 02:
that the administration of brimonidine alone is not sufficient to treat an ocular condition.

[00:17:04] Speaker 02:
1055, the methods of dean, the administration of brimonidine and the methods of dean is a necessary but insufficient part of the Todd methods.

[00:17:13] Speaker 02:
Again and again and again, we have all the examples in our briefing.

[00:17:17] Speaker 02:
They're pointing out that what the applicant told the examiner was that without the branzolomide,

[00:17:24] Speaker 02:
Dean is not teaching how to treat inocular condition, and they aren't teaching how to treat inocular condition using just, just barmonidine.

[00:17:33] Speaker 02:
At no point, though, did they ever tell the examiner that it was, it was important and part of their invention that no other active ingredients be present.

[00:17:42] Speaker 02:
And the examiner clearly understood this.

[00:17:44] Speaker 02:
When the examiner and the reasons for allowance explained

[00:17:47] Speaker 02:
Their understanding of what was being argued by the applicant.

[00:17:51] Speaker 02:
They didn't say the applicant Argued that other active ingredients were excluded or foreclosed or prohibited They said and this is at 1082

[00:18:00] Speaker 02:
As amended and set forth in the arguments, applicants specifically states that the presently claimed methods do not require the use of any other active ingredients, in addition to barmonidine, thereby instating the consistent essentially-of language.

[00:18:15] Speaker 02:
So the examiner clearly thought that what they were arguing

[00:18:18] Speaker 02:
was that other active ingredients are not required, not that other active ingredients are forbidden.

[00:18:24] Speaker 02:
Again, if this were part of the invention, if making sure no other active ingredients were there was something that was important for this invention, you would expect there to be discussion of it in the specification.

[00:18:35] Speaker 02:
No one's specification, do they say, ever, that it's important to have no other active ingredients be present when the barmonite is there.

[00:18:43] Speaker 00:
They do have embodiments in which there are no other active ingredients, right?

[00:18:47] Speaker 02:
No, Your Honor.

[00:18:48] Speaker 02:
They have ingredients which are.

[00:18:49] Speaker 00:
I mean, no other active ingredients.

[00:18:52] Speaker 00:
Not a single embodiment, you say.

[00:18:54] Speaker 02:
No, that would be.

[00:18:55] Speaker 02:
And there was a question about how you would frame this, right, if you wanted to have no other active ingredients.

[00:19:00] Speaker 02:
And what they could say, and I'm sure Your Honors have seen claims like this all the time, would be a composition consisting of bironidine, maybe a carrier, maybe an antibiotic.

[00:19:12] Speaker 02:
But you would have a consistent claim which lists what you want in there.

[00:19:17] Speaker 02:
You could say consisting of vermonidine is the only active ingredient plus non-active ingredients.

[00:19:23] Speaker 02:
And they've actually gone out and gotten other claims like that.

[00:19:27] Speaker 02:
So there are ways to do this, to get to what they're now arguing this was supposed to be.

[00:19:33] Speaker 02:
But that's not this.

[00:19:34] Speaker 02:
When they say that there are claims which are monotherapy claims, monotherapy that never appears in the prosecution history, doesn't appear in the spec, I think what they're talking about are the embodiments

[00:19:45] Speaker 02:
which are consisting essentially of brimonidine, and they don't mention another active ingredient.

[00:19:49] Speaker 02:
But of course, the typical meaning of consisting essentially of is open to other active ingredients, so long as they do not, in the words of this court's precedence, materially affect the basic and novel properties of the invention.

[00:20:05] Speaker 02:
That typical meaning under this court's precedence of consisting essentially of is what they told the examiner consisting essentially of meant.

[00:20:13] Speaker 02:
If you look at page 1050 community appendix, the applicant referred to the legal standard and said, you know, that is the standard.

[00:20:24] Speaker 02:
He then went on to distinguish the branzolomide, both by saying it was required and by saying, and this is at 1054, for example, they say branzolomide was found to be effective in increasing blood flow in ocular tissues.

[00:20:39] Speaker 02:
So it's vasodilative.

[00:20:41] Speaker 02:
Thus, it is clear that Brunzolomide is an essential active ingredient, and including Brunzolomide would necessarily materially affect the basic and novel characteristics of the invention.

[00:20:51] Speaker 02:
Now, how did they characterize that portion of the prosecution history when they were before the board?

[00:20:56] Speaker 02:
What they told the board was, as the patentee – this is at page 429 in the appendix – as the patentee argued during prosecution

[00:21:04] Speaker 02:
Dean teaches only that branzolomide lowers intraocular pressure and actually increases blood flow in ocular tissue, inconsistent with the vasoconstrictive effect.

[00:21:14] Speaker 02:
Right?

[00:21:14] Speaker 02:
So they were below, both before the examiner and before the board, identified the correct legal standard

[00:21:23] Speaker 02:
and argued that branzolamide was inconsistent with the invention under a consisting essentially only of test because it is vasodilative.

[00:21:34] Speaker 02:
It's inconsistent with the vasoconstructive effect that is the point of the brimonidine.

[00:21:40] Speaker 02:
And under this court's precedence, the board correctly discussed cases like Ecolab and AK Steel.

[00:21:47] Speaker 02:
If you have other active ingredients that will serve the same purpose, that's OK.

[00:21:53] Speaker 02:
It's when you get into a case like AK Steel, where the active ingredient, the additional ingredient in AK Steel would be inconsistent with the purpose of the invention, then you run into trouble.

[00:22:03] Speaker 02:
And that's the way they distinguish Dean.

[00:22:05] Speaker 02:
I do want to make the point, Dean example 10 is something else that was not ever raised to the board or raised in the opening brief to this court.

[00:22:12] Speaker 02:
They have two pages of it in their reply brief.

[00:22:15] Speaker 02:
They mentioned it again today.

[00:22:16] Speaker 02:
If Dean Example 10 had the weight they say it did, then they would have raised it before.

[00:22:20] Speaker 02:
The way we understand what the board meant when it said, you're effectively turning this into a consisting of claim rather than consisting only of, is that they were saying, consisting only of has the ordinary meaning that you can have other active ingredients.

[00:22:33] Speaker 02:
You're effectively trying to treat this like a consisting only of claim to the extent you would leave other ingredients out.

[00:22:39] Speaker 01:
Let's go back to the quote on 1061.

[00:22:44] Speaker 01:
Dean teaches away from methods consisting essentially of administering Griminidon, i.e.

[00:22:51] Speaker 01:
methods which do not include administering other active agents.

[00:22:55] Speaker 01:
Looking at that, it looks like a definition, consisting essentially of administering permanent IE methods which do not include other active agents.

[00:23:08] Speaker 01:
Looks like a definition, looks like the parenthetical is trying to describe that consisting essentially of phrase.

[00:23:14] Speaker 01:
If that's a clear, at least it seems like a clear definition, where is the clear statement that defines it in a different way?

[00:23:23] Speaker 02:
It would be every other place in the prosecution history, Your Honor.

[00:23:26] Speaker 01:
What made it a clear statement that defines it in a different way?

[00:23:29] Speaker 02:
I would say, for example, on 1083, when the applicant was defining the basic and novel characteristics of the invention, what the applicant said was, one of the basic and novel characteristics of the presently claimed methods.

[00:23:43] Speaker 02:
Sorry, you're right.

[00:23:44] Speaker 01:
1083?

[00:23:44] Speaker 02:
1053, Your Honor.

[00:23:45] Speaker 02:
1053, sorry.

[00:23:47] Speaker 02:
Is that they do not require the use of every other – of any other active ingredients in addition to bicarbonate.

[00:23:53] Speaker 01:
So when they said – Why isn't that statement consistent with this definition?

[00:23:56] Speaker 02:
Because this is require.

[00:23:58] Speaker 02:
And every other place that they talk about this, they say require, or they say that the bronzolamide, the bronzolamide, indeed, was essential, right?

[00:24:08] Speaker 02:
So this is all about required, essential, needed.

[00:24:11] Speaker 02:
Without the bronzolamide, the method was insufficient.

[00:24:15] Speaker 02:
You cannot – I'm sorry, Your Honor.

[00:24:18] Speaker 02:
I'm sorry.

[00:24:19] Speaker 01:
What I'm wondering is why he isn't not requiring other active agents.

[00:24:24] Speaker 01:
consistent with this definition that says it doesn't include other ingredients.

[00:24:27] Speaker 02:
Like, we gave the example in our brief of a requirement is not required, but it's allowed, right?

[00:24:32] Speaker 02:
So when they say required, that's consistent with the ordinary meaning of consisting essentially of, in which you have to have at least the listed ingredient, but you could have others if they're not inconsistent.

[00:24:42] Speaker 00:
What is the scope of a claim that allows but does not require other ingredients?

[00:24:49] Speaker 00:
I mean, it seems like it's kind of

[00:24:52] Speaker 00:
not very valuable if that's how it's interpreted.

[00:24:56] Speaker 02:
I'm not sure I understand the question.

[00:24:59] Speaker 02:
You get to include other active ingredients as long as they're not, for example, vasoconstrictive, which is the way that, as we pointed out, they distinguished Dean both before the examiner and the board.

[00:25:11] Speaker 02:
They pointed to the fact that it had this vasoconstrictive effect.

[00:25:15] Speaker 02:
Again, pages 4 to 29.

[00:25:19] Speaker 02:
And 254.

[00:25:20] Speaker 00:
So for example, would the claim then cover something that has two active ingredients, both of which reduce eye redness?

[00:25:30] Speaker 02:
You would have to look at the facts of the particular case.

[00:25:32] Speaker 00:
I gave you the facts.

[00:25:33] Speaker 00:
That's my hypothetical.

[00:25:35] Speaker 02:
So please answer it.

[00:25:37] Speaker 02:
So that's often the case, Your Honor.

[00:25:38] Speaker 02:
And if you look at this court's decisions, like Echolab and Corning.

[00:25:42] Speaker 00:
It's a yes or a no.

[00:25:44] Speaker 00:
Could you answer my question?

[00:25:45] Speaker 02:
I will say yes.

[00:25:47] Speaker 02:
I think why I'm hesitating is maybe you have too much of a good thing, and then it becomes a bad thing.

[00:25:53] Speaker 02:
But I think in the ordinary circumstance under this court's precedence, like Ecolab and Porti, you are allowed to have other ingredients that serve the same purpose.

[00:26:01] Speaker 02:
Well, let's get to the alternative claim construction as well.

[00:26:05] Speaker 04:
Can I just ask one more question on the basic thing?

[00:26:09] Speaker 04:
And I'm not sure I'm going to get the wording right, but the board seemed to say, I think this is at page 14 of the appendix, the claim methods cannot include additional active ingredients that are required to perform the method.

[00:26:23] Speaker 04:
And I think

[00:26:26] Speaker 04:
i-therapies argues that actually because they figured out that the benefit can be had with the verminidine alone, nothing would ever be required.

[00:26:41] Speaker 04:
And so the board's view makes a nullity of the change of the transitional phrase to consisting essentially of communism.

[00:26:51] Speaker 02:
So I think there are two ways that would not be the case.

[00:26:54] Speaker 02:
One would be if you just had

[00:26:55] Speaker 02:
Too little brimonidine.

[00:26:57] Speaker 02:
There's not enough brimonidine.

[00:26:58] Speaker 02:
It's not enough to have a whitening effect.

[00:27:00] Speaker 02:
Therefore, you need a second ingredient to get you there.

[00:27:02] Speaker 02:
That would not infringe.

[00:27:04] Speaker 04:
The second- But I thought the discovery here was with the amount of brimonidine claimed, you do get that effect.

[00:27:13] Speaker 02:
Right.

[00:27:13] Speaker 02:
So this is now getting- Nothing else would ever be required.

[00:27:18] Speaker 02:
No, this is getting to infringement, Your Honor.

[00:27:20] Speaker 02:
So if you had not points- Isn't it the scope of the claim?

[00:27:25] Speaker 02:
What's that, Your Honor?

[00:27:26] Speaker 00:
It's low dose, right?

[00:27:27] Speaker 00:
So it's a scope of the claim?

[00:27:29] Speaker 02:
It's low dose, but there's a specific range claimed.

[00:27:30] Speaker 02:
And so I suppose if you were below the dose, you would no longer have enough brimonidine to.

[00:27:37] Speaker 02:
And actually, the claim doesn't even require a redness reduction at the end of the day.

[00:27:40] Speaker 02:
It just requires giving the ocular drop in a method.

[00:27:46] Speaker 02:
It does not require success according to the board's claim instruction.

[00:27:49] Speaker 02:
But you know what, I do want to get to the alternative construction issue, because I realize I'm running out of time here.

[00:27:56] Speaker 02:
In addition to the footnotes that your honors have focused on,

[00:28:02] Speaker 02:
I want to point to another finding.

[00:28:04] Speaker 02:
This is also on page 54 of the appendix.

[00:28:07] Speaker 02:
And it's a finding that they have not addressed, even though we raised it in our response brief, and it goes directly to this point.

[00:28:14] Speaker 02:
This is the finding where the board says, we credit the testimony of Dr. Scher, who explains that a post-so would have been motivated to use a single active ingredient to avoid possible negative side effects from the second drug.

[00:28:28] Speaker 02:
Right?

[00:28:28] Speaker 02:
So there's a factual finding that

[00:28:31] Speaker 02:
a POSA would look to use a monotherapy because you would potentially have side effects from a second drug.

[00:28:38] Speaker 02:
So if their argument is that this claim only covers monotherapy, only covers a single drug, the board found that a POSA would have been nominated to use just the vermonidine to treat eye redness, and they have not challenged the factual basis for that finding in their appeal.

[00:28:57] Speaker 02:
Thank you.

[00:29:10] Speaker 03:
Just a few points on the rebuttal, if I may.

[00:29:13] Speaker 03:
First, on the waiver point, we did raise this below.

[00:29:18] Speaker 03:
I would point your honors to appendix page 13, which is room.

[00:29:27] Speaker 03:
Can you get more to the merits?

[00:29:28] Speaker 03:
OK.

[00:29:30] Speaker 03:
Let me also address, there was a question about whether the specification discloses any embodiments that use only Brahmanidine by itself.

[00:29:37] Speaker 03:
And of course, it does.

[00:29:39] Speaker 03:
examples one, four, and five, which are set forth in appendix 164 through 65.

[00:29:44] Speaker 03:
Each of those examples is bemonadine alone.

[00:29:47] Speaker 03:
And as we explained in our brief at appendix page 162, when the patent specification transitions to a discussion of combination therapies, it prefaces that by saying, in addition to using bemonadine by itself, you can also use it in combination.

[00:30:03] Speaker 03:
So clearly, there is a disclosure

[00:30:05] Speaker 03:
uh... it uh... for monitoring by itself and that is what is being claimed in these claims uh... with respect to ecolab which my colleague uh... pointed to ecolab as we explained in our brief is a fully distinguishable case uh... it does not stand for the blanket proposition that consisting essentially of always allows the use of other active ingredients uh... instead it was a fact intensive case where the prosecution history an argument was made during prosecution history during prosecution

[00:30:34] Speaker 03:
that the consisting essentially of excluded other active ingredients.

[00:30:38] Speaker 03:
The examiner disagreed.

[00:30:40] Speaker 03:
The applicant changed course and never made that argument again.

[00:30:43] Speaker 03:
So that is factually distinguishable from our case.

[00:30:45] Speaker 03:
We don't believe Ecolab is on point here.

[00:30:49] Speaker 03:
With respect to Judge Scarcy's question about the comment about required

[00:30:56] Speaker 03:
Uh, we agree with, I believe what you were saying, just as far as he is from a pharmaceutical context and the context of what this invention is all about.

[00:31:06] Speaker 03:
When the applicant said a basic and novel property of our invention is that it does not require any other active ingredients, in the pharmaceutical context, that's understood to mean you're not including other active ingredients.

[00:31:18] Speaker 03:
It's not a combination therapy.

[00:31:19] Speaker 03:
Because in pharmaceuticals, the only reason you would ever include another active ingredient is because it's required.

[00:31:26] Speaker 03:
And I think that was made further clear through the discussion and distinguishing.

[00:31:30] Speaker 04:
Does that point, what you just said, align with

[00:31:34] Speaker 04:
with what Mr. Martin said I think really on a motivation piece of the obviousness analysis that what you just said is in fact a motivation to start shedding

[00:31:52] Speaker 04:
members of a, you know, set more than one active ingredient because you never know what the second one might do.

[00:32:01] Speaker 03:
Sure.

[00:32:01] Speaker 03:
I think he was pointing to a statement in the board's opinion.

[00:32:07] Speaker 03:
basically referring to their expert, Dr. Scherer, who said there would be a motivation to use only one active ingredient so that you don't have to risk the side effects from other active ingredients.

[00:32:17] Speaker 03:
The problem is the board never actually used that.

[00:32:20] Speaker 03:
It cited Dr. Scherer's comments on that point, but that wasn't what the board did.

[00:32:24] Speaker 03:
If you read the board's obviousness analysis, it did not modify example one of GIL by getting rid of all the other active ingredients.

[00:32:31] Speaker 03:
If it had tried to do that, it would have then had to explain how you're not destroying

[00:32:35] Speaker 03:
the basic intended use of Gill example one.

[00:32:40] Speaker 03:
What the board did instead was cite its own claim construction and say, it's okay that there's these other active ingredients because we don't read consisting essentially of as excluding other active ingredients.

[00:32:51] Speaker 03:
And then they dropped footnote 24 as a prophylactic and said,

[00:32:54] Speaker 03:
Even if some active ingredients are allowed that basically aren't needed for redness reduction, the claim is still obvious.

[00:33:04] Speaker 03:
But it was basically relying on Norton, which still includes other active ingredients.

[00:33:09] Speaker 03:
That wasn't our claim construction.

[00:33:11] Speaker 04:
Thank you.

[00:33:11] Speaker 04:
Thanks to all counsel.

[00:33:12] Speaker 04:
Case is submitted.