[00:00:25] Speaker 04:
OK, the next argued case is number 17-1333, or XOAB, against activist Elizabeth LLC, Mr. Taylor.

[00:00:37] Speaker 00:
Good morning, Your Honor.

[00:00:38] Speaker 00:
You may please the court.

[00:00:41] Speaker 00:
The main issue before this court is whether the claims should have been invalidated based on a few lines of conclusory expert testimony, testimony that is without support in

[00:00:54] Speaker 00:
the prior arc, and that contains factual assertions that, even if credited, do not lead to the key claim limitation at issue.

[00:01:06] Speaker 00:
If it is acceptable to the court, I want to spend most of my time discussing this issue and reserve a minute or two, if okay at the end, to discuss the second issue that we focused on in our briefs, which relates to

[00:01:24] Speaker 00:
question of whether a reference that teaches the way.

[00:01:27] Speaker 04:
Proceed as you see fit.

[00:01:30] Speaker 00:
Now, just to set the stage a little bit, the invention at issue is a structural arrangement of known ingredients.

[00:01:44] Speaker 00:
Now, this new structural arrangement of the ingredients in the prior art resulted in a surprising effect.

[00:01:54] Speaker 00:
The prior art disclosed materials such as the drug Suboxone.

[00:02:03] Speaker 00:
Suboxone included a number of ingredients, including citric acid and a number of other ingredients, along with the active ingredients.

[00:02:13] Speaker 03:
Did the record include any prior art at all that talked about using citric acid as a carrier?

[00:02:19] Speaker 00:
Not at all, Your Honor.

[00:02:21] Speaker 00:
In fact, citric acid had been known and used in pharmaceutical formulations for many, many years.

[00:02:27] Speaker 00:
And there was absolutely no reference that disclosed citric acid carrier.

[00:02:33] Speaker 00:
And in fact, the references that disclose this interactive mixture, which is the key claim component, including citric acid, a citric acid carrier particle with the buprenorphine active ingredient adhered to it,

[00:02:49] Speaker 00:
That's the key structural limitation in Claim 6 that was wholly missing from the prior art, from the interactive mixture prior art, like the 443 patent that relied on by the court, and the prior products, such as suboxone.

[00:03:06] Speaker 03:
Would it have been possible to micronize citric acid to put it in, and then it wouldn't be in the interactive mixture, but it still would be in the tablet?

[00:03:15] Speaker 00:
Absolutely.

[00:03:16] Speaker 00:
That's one of the reasons why it was

[00:03:19] Speaker 00:
we believe, ever for the court, to assume that just the combination of a reference that disclosed citric acid not in an interactive mixture in a totally different form, like the suboxone prior art with the 443 type prior art references that disclose other interactive mixtures that did not include suboxone, to presume that when you combine those references,

[00:03:48] Speaker 00:
you would get the specific claim structure.

[00:03:51] Speaker 00:
And again, when we talk about the specific same claim structure, it's not just a formulation that comprises an interactive mixture with citric acid.

[00:04:03] Speaker 00:
It's a formulation wherein the citric acid is a carrier particle for the bukinorphine in the interactive mixture.

[00:04:13] Speaker 00:
And we believe that's one of the ways that the court

[00:04:18] Speaker 00:
in that it glossed over this key claim limitation.

[00:04:22] Speaker 00:
The claim limitation isn't just an interactive mixture that has citric acid in it, a formulation with an interactive mixture that has citric acid in it.

[00:04:33] Speaker 00:
It is a formulation wherein the citric acid is a carrier particle for the buprenorphine.

[00:04:43] Speaker 00:
Now, that was a key limitation.

[00:04:45] Speaker 00:
in the claims.

[00:04:46] Speaker 00:
It's the reason why the invention has surprising activity, surprising bioavailability over the prior art.

[00:04:57] Speaker 00:
It's the reason why the claims were allowed over compositions such as suboxone, which included the same key ingredients, citric acid, buprenorphine, naloxone, and others, but in a different form.

[00:05:13] Speaker 03:
As I understood,

[00:05:15] Speaker 03:
the district court's analysis.

[00:05:17] Speaker 03:
The district court said one of ordinary spill-in-the-art would have been motivated to use citric acid as a carrier because it's a pharmaceutical acceptable substance that's water soluble and it's the appropriate size and therefore it meets the definition of what a carrier would be as provided by the specification.

[00:05:37] Speaker 03:
What's your response to that?

[00:05:38] Speaker 00:
Yeah, that is in fact based on this dire testimony

[00:05:44] Speaker 00:
Dyer was the expert by activists.

[00:05:47] Speaker 00:
And that testimony is wholly unsupported in the prior art.

[00:05:52] Speaker 00:
Two important things in that testimony, of the appropriate size.

[00:05:57] Speaker 00:
Now, there's no evidence in the prior art with regard to the size of any citric acid particles.

[00:06:06] Speaker 00:
None.

[00:06:07] Speaker 00:
The prior art references that included citric acid

[00:06:11] Speaker 00:
didn't have that citric acid in the particles.

[00:06:13] Speaker 03:
Let's say for a minute that I knew that I wanted citric acid to be the carrier.

[00:06:18] Speaker 03:
Let's just assume that.

[00:06:20] Speaker 03:
Then I could figure out what the right particle size would be, right?

[00:06:24] Speaker 03:
I understand that you don't agree with that assumption and that there might not even be record evidence to support it.

[00:06:32] Speaker 03:
But assuming for a minute that I did know that I wanted to use citric acid as a carrier, help me out.

[00:06:40] Speaker 03:
Would one of ordinary skill in the art know how to make a carrier, a particle size to make it a carrier?

[00:06:48] Speaker 00:
I absolutely do not disagree with that.

[00:06:51] Speaker 00:
You don't.

[00:06:51] Speaker 03:
You do not disagree.

[00:06:52] Speaker 00:
I do not disagree with that, but that's not, that's not the issue at all.

[00:06:57] Speaker 00:
The prior art was replete with disclosures of interactive mixtures.

[00:07:03] Speaker 00:
Interactive measures had been known for 20 years.

[00:07:06] Speaker 00:
The key is that there was no interactive mixture that disclosed citric acid as an interactive mixture.

[00:07:15] Speaker 00:
And the references that did disclose interactive mixtures disclosed other things as the core of the interactive mixture, not citric acid.

[00:07:32] Speaker 03:
Like something like mannitol or something?

[00:07:34] Speaker 00:
Like mannitol, like lactose, even like naloxone in the 443 patent.

[00:07:41] Speaker 00:
There's no disclosure of anything suggesting that citric acid would be used as a carrier particle.

[00:07:48] Speaker 00:
In fact, when you look at how citric acid was used in the prior audits, used for other reasons.

[00:07:54] Speaker 00:
And these references, like the 443 patent and suboxone, they suggest using

[00:08:01] Speaker 00:
citric acid in different ways.

[00:08:03] Speaker 00:
The 443 patent, for example, it also discloses that in these formulations, there is this interactive mixture.

[00:08:11] Speaker 00:
There are things in the mixture, but many, sometimes most of the ingredients in the formulation, they're not in the interactive mixture.

[00:08:20] Speaker 00:
So it was, in our view, error for the court to rely on this one unsubstantiated statement by

[00:08:31] Speaker 00:
Dr. Dyer for support for this critical claim limitation, especially when the prior art suggests that other materials, other ingredients, are much more likely to be used as a carrier particle than citric acid.

[00:08:57] Speaker 00:
I mean, that, Your Honor, is the heart

[00:09:00] Speaker 00:
of our concern with the court's decision and the reason why we believe whether you analyze it as an error of law or whether the factual findings were clearly erroneous, that the decision should be reversed.

[00:09:25] Speaker 00:
Now, you'll likely hear from activists

[00:09:31] Speaker 00:
that there are other evidence in the record to support this claim limitation.

[00:09:39] Speaker 00:
Now, the court did find that there was a motivation to reformulate suboxone as an interactive mixture.

[00:09:49] Speaker 00:
Now, when the court made this finding, it referred to, again, this 443 reference, reference that discloses interactive mixtures

[00:10:00] Speaker 00:
that don't have citric acid at all.

[00:10:03] Speaker 00:
Now, this finding as a general motivation to reformulate suboxone as an interactive mixture is not a finding of reformulating suboxone in the way that the citric acid is a carrier particle.

[00:10:20] Speaker 03:
And you don't challenge that finding on appeal.

[00:10:23] Speaker 03:
You don't challenge the finding that there was a

[00:10:26] Speaker 03:
general motivation to reformulate it into an interactive mixture.

[00:10:31] Speaker 03:
It's the particular way that you've claimed it that you're challenging, right?

[00:10:35] Speaker 00:
Our appeal on this issue assumes that fact that there was a motivation.

[00:10:43] Speaker 00:
And even if the court assumes that there was a motivation to combine these references, it still doesn't get to this claimed element.

[00:10:52] Speaker 00:
Now, we do have issues.

[00:10:54] Speaker 00:
with the court's analysis of motivation as it related to the A32 pattern.

[00:11:03] Speaker 00:
And that's the issue that I wanted to get to in a minute.

[00:11:06] Speaker 00:
But let me just finish on the points that activists made.

[00:11:10] Speaker 00:
Now, activists said this first one that there was motivation to reformulate suboxone.

[00:11:16] Speaker 00:
Now, that's not a substitute for a specific motivation to have a citric acid carrier with buprenorphine

[00:11:24] Speaker 00:
adhere to it.

[00:11:25] Speaker 00:
It's not.

[00:11:26] Speaker 00:
As we discussed before, the prior art didn't disclose a citric acid carrier at all.

[00:11:32] Speaker 00:
And in fact, the prior art that did suggest an interactive mixtures used other material.

[00:11:43] Speaker 00:
You'll likely hear activists say that citric acid would improve the bioavailability if it were to place into a

[00:11:53] Speaker 00:
interactive mixture.

[00:11:55] Speaker 00:
Well, the court relied on the A32 patent for that finding.

[00:12:03] Speaker 00:
Well, that patent doesn't mention interactive mixtures at all.

[00:12:11] Speaker 00:
And in fact, when the bioavailability was increased in that composition, it also resulted in an

[00:12:20] Speaker 00:
undesirable increase in the bioavailability of the second component in the composition.

[00:12:26] Speaker 03:
Would it make a difference in that bioavailability whether the citric acid was, or is there any evidence to show that it would make a difference when whether the citric acid was acting as a carrier or was micronized in the coating or elsewhere in the tablet?

[00:12:43] Speaker 00:
The A32 patent is not a tablet at all.

[00:12:46] Speaker 00:
It's a film.

[00:12:47] Speaker 00:
So there was, again, this is one of the references where the citric acid was not even in particular form.

[00:12:54] Speaker 00:
So for the court to have suggested that that reference is a suggestion of using citric acid in an interactive mixture is obviously something we have a real issue with.

[00:13:09] Speaker 00:
And again, even if that were correct, it didn't suggest the particular form

[00:13:16] Speaker 00:
that is in claim six, a claim that we're talking about now, where the citric acid is a carrier particle with the buprenorphine adhered to it in an interactive mixture.

[00:13:28] Speaker 00:
Another finding you might hear activists refer to is that a person of ordinary skill would have known how to form an interactive mixture.

[00:13:38] Speaker 00:
That's the question you asked earlier, Judge Stoke.

[00:13:42] Speaker 00:
Yes, that, again, is

[00:13:45] Speaker 00:
is true, but that says nothing about specifically forming this claimed structure that was key to the allowance of the claim and in fact is the thing that results in the unexpected bioavailability increase seen in the claimed product.

[00:14:06] Speaker 00:
So no amount of sort of creatively looking at the reference or

[00:14:14] Speaker 00:
or chopping or editing the court's opinion and the record will lead to a conclusion or evidence that the record suggests a citric acid carrier with a buprenorphine adhered to it.

[00:14:37] Speaker 00:
The only thing that the court relied upon to fill that hole

[00:14:42] Speaker 00:
was the dire testimony.

[00:14:45] Speaker 00:
And as we discussed, that testimony, one, does not lead to the claimed structure at all.

[00:14:52] Speaker 00:
All he said was that it was of the right size and that it would be a barrier particle.

[00:14:59] Speaker 00:
And it is totally unsupported by the prior art.

[00:15:03] Speaker 03:
So your point is that it's unsupported.

[00:15:06] Speaker 03:
And what's more, it doesn't explain why one of ordinary scale and the art would make

[00:15:11] Speaker 03:
the modification.

[00:15:13] Speaker 00:
Exactly.

[00:15:14] Speaker 00:
Exactly, Your Honor.

[00:15:16] Speaker 00:
And cases like Cephalon stand for the proposition that unsupported expert testimony should not be relied on to invalidate a patent, especially when that testimony is directed to the key claim element.

[00:15:36] Speaker 00:
Now, we had a discussion.

[00:15:39] Speaker 00:
in our briefs regarding this question of inherency.

[00:15:46] Speaker 00:
That was not an issue below, right?

[00:15:49] Speaker 00:
It wasn't an issue below.

[00:15:51] Speaker 00:
It was.

[00:15:52] Speaker 00:
But the way the court decided the case by reliance on this dire testimony that it, quote unquote, would form the interactive mixture is arguably

[00:16:09] Speaker 00:
and could only be an expression of an inherent formation, since none of the prior art that they relied on resulted in the claim structure.

[00:16:20] Speaker 00:
So there must be some assumption that when these things are combined, it would inherently form.

[00:16:27] Speaker 03:
I don't see where the district court said that, to be honest.

[00:16:30] Speaker 03:
I read the district court's opinion, and I don't see where she said that necessarily this is what would happen.

[00:16:37] Speaker 03:
Which is what's required.

[00:16:39] Speaker 00:
She absolutely did not.

[00:16:43] Speaker 00:
But in addressing one possible explanation for her reliance on Dyer for this important limitation when the prior art doesn't disclose it, we address the possibility that the court must have assumed that this thing was inherent, because it certainly isn't there in the prior art.

[00:17:04] Speaker 04:
Let's hear from the other side.

[00:17:06] Speaker 04:
We'll save you rebuttal time.

[00:17:15] Speaker 04:
Mr. Lombardi.

[00:17:17] Speaker 01:
May it please the Court.

[00:17:19] Speaker 01:
Your Honor, I'll take Council's lead and address the support for the use of citric acid as a carrier particle in this picture.

[00:17:28] Speaker 01:
Our position, as the Court knows, is that it was supported by

[00:17:33] Speaker 01:
the record not just by Dr. Dyer, but by the prior art references.

[00:17:37] Speaker 01:
And so here's the way it went in summary, and I'm happy to point you to specific references.

[00:17:44] Speaker 01:
There was art about interactive mixtures, which taught that an interactive mixture should be used with buprenorphine and naloxone in a sublingual tablet, which is precisely what we have here.

[00:17:55] Speaker 01:
That art makes clear that you must have a carrier particle.

[00:17:59] Speaker 01:
Carrier particles are essential to

[00:18:02] Speaker 01:
interactive mixtures.

[00:18:04] Speaker 01:
On the other hand, you have the citric acid art, which I call the citric acid art, but art which shows that citric acid should be used in any buprenorphine or buprenorphine and naloxone combination.

[00:18:19] Speaker 03:
Can I ask a question about that?

[00:18:20] Speaker 01:
Yes.

[00:18:22] Speaker 03:
I understand from reading all the briefs and the prior art that the citric acid could have been in the tablet

[00:18:32] Speaker 03:
as either a micronized particle or as part of the interactive mixture.

[00:18:36] Speaker 03:
Is that right?

[00:18:38] Speaker 01:
May I just ask which tablet are you referring to?

[00:18:41] Speaker 01:
Are you talking about the Suboxone tablet?

[00:18:43] Speaker 03:
I'm just asking about your combination.

[00:18:47] Speaker 03:
The problem I'm having is one where I understand you're saying, you know, it would have been obvious to have an interactive mixture.

[00:18:56] Speaker 03:
It would have been obvious that you'd want to have citric acid.

[00:19:00] Speaker 03:
And my stumbling block is

[00:19:03] Speaker 03:
Would you want to have citric acid as the carrier?

[00:19:05] Speaker 03:
Or would it be possible to have it as a micronized element?

[00:19:09] Speaker 03:
And excuse me, I have an electronic in the background.

[00:19:13] Speaker 03:
And that's my stumbling block.

[00:19:15] Speaker 03:
So could you address my just technical question?

[00:19:18] Speaker 01:
And I'll answer your question first, which is yes.

[00:19:20] Speaker 01:
Technically, it could be in as micronized or some other form than as a carrier particle.

[00:19:28] Speaker 01:
We believe it's taught that it should be a carrier particle in this instance.

[00:19:32] Speaker 01:
because an interactive mixture, the art strongly teaches use of an interactive mixture.

[00:19:38] Speaker 01:
Interactive mixtures must have carrier particles.

[00:19:41] Speaker 01:
Citric acid is taught to be used with buprenorphine and naloxone and meets the definition of a carrier particle.

[00:19:50] Speaker 01:
And Dr. Dyer testified that citric acid would help to enhance the bioavailability both by acting as a pH modifier

[00:20:01] Speaker 01:
which is how it was used in the art.

[00:20:03] Speaker 04:
But where is that in the prior art?

[00:20:05] Speaker 04:
I mean, this is the problem, isn't it?

[00:20:07] Speaker 04:
It turns out we're told, apparently undisputed, that there was, I think the words were surprising bioavailability.

[00:20:15] Speaker 04:
Where in the prior art are we led to understand that if you use citric acid in this form, you will get surprising bioavailability beyond what you had before?

[00:20:30] Speaker 04:
Other than a witness saying, well, I'm smarter than anybody, so it doesn't surprise me.

[00:20:37] Speaker 01:
Well, and that was not exactly what the witness said, Your Honor, but I take it you're going to the unexpected results question.

[00:20:44] Speaker 04:
Well, this is a factor in the overview to understand the correctness of the decision.

[00:20:51] Speaker 01:
Yes, Your Honor, that's absolutely correct.

[00:20:54] Speaker 01:
And the interactive mixture

[00:20:56] Speaker 01:
would have been expected to improve bioavailability.

[00:21:00] Speaker 01:
That's what the interactive mixture are taught and it taught that specifically about buprenorphine and naloxone combinations that you should use them in an interactive mixture in order to increase bioavailability.

[00:21:14] Speaker 04:
And that you'll do better with citric acid than any other of the standard

[00:21:18] Speaker 04:
Adjuvants?

[00:21:20] Speaker 01:
Your Honor, I will confirm what counsel said before and what we've said in our briefs.

[00:21:26] Speaker 01:
There is no piece of prior art that was presented that says citric acid is a carrier particle or should be used as a carrier particle.

[00:21:36] Speaker 01:
But I don't believe that's required under the law.

[00:21:39] Speaker 01:
We're not required to have a document that says everything in an obviousness case.

[00:21:44] Speaker 01:
Now, if this were anticipation,

[00:21:46] Speaker 01:
Clearly, we would.

[00:21:47] Speaker 04:
It's not required if it was obvious to do.

[00:21:50] Speaker 04:
This is what I'm trying to get to.

[00:21:52] Speaker 01:
Yes, and it was obvious, Your Honor, because the ARC teaches that you need carrier particles.

[00:21:59] Speaker 01:
Moreover, the ARC teaches, for instance, the 443 patent, that you're not limited to one carrier particle or any number of carrier particles.

[00:22:07] Speaker 01:
For instance, the 443 patent teaches multiple carrier particles can be used in this interactive mixture.

[00:22:15] Speaker 01:
So the idea that because we know in the art that particular substances were used as carrier particles doesn't mean that citric acid would not also be appropriate as a carrier particle in the same mixture.

[00:22:29] Speaker 01:
Citric acid becomes relevant because it's used in every single commercial formulation that uses buprenorphine.

[00:22:37] Speaker 01:
So when a person of skill in the art is looking at suboxone, the prior art tablet compound, and saying we're going to make

[00:22:45] Speaker 01:
an interactive mixture from the suboxone, the persiscome yard would see that citric acid was there, that it meets the definition of a carrier particle, and that therefore it can be used as a carrier particle and should be used because as... Where do you get the should be used?

[00:23:05] Speaker 03:
That's the part I'm having trouble with.

[00:23:08] Speaker 03:
I can follow you along to maybe it could be used

[00:23:11] Speaker 03:
but where you get to and it should be used.

[00:23:14] Speaker 03:
I don't see any evidence of the reference to support that.

[00:23:16] Speaker 03:
Not even your expert, to be honest.

[00:23:18] Speaker 01:
Well, just to go to the expert point, Your Honor, I'll just point you to A6684 of the appendix where he said that citric acid would help to enhance bioavailability acting both as a pH modifier and as a carrier.

[00:23:38] Speaker 01:
And so he's saying that

[00:23:41] Speaker 01:
You use citric acid because it helps to increase bioavailability in two ways.

[00:23:46] Speaker 01:
One way that had been specifically used by prior art combinations, which is as a pH modifier.

[00:23:52] Speaker 03:
I apologize.

[00:23:53] Speaker 03:
I didn't get there as quickly as you did.

[00:23:56] Speaker 01:
So what page are you?

[00:23:57] Speaker 01:
I'll be more specific.

[00:23:58] Speaker 01:
It's 6684.

[00:24:00] Speaker 01:
And I can give you the lines, page 427 within.

[00:24:11] Speaker 01:
line 23 to 428, line 2.

[00:24:17] Speaker 01:
And so what he's saying, Your Honor, is that citric acid, it's a person of skill in the art who's using an interactive mixture wants carrier particles.

[00:24:27] Speaker 01:
You want carrier particles because that's what makes an interactive mixture work.

[00:24:31] Speaker 01:
You look at suboxone, and it provides ingredients.

[00:24:35] Speaker 01:
You want to use those ingredients because you know they work together.

[00:24:38] Speaker 01:
And specifically, you want to use citric acid

[00:24:41] Speaker 01:
Because you know citric acid already has a positive effect on bioavailability because it's a pH modifier.

[00:24:50] Speaker 03:
Could it have been micronized and not been a carrier in the interactive mixture?

[00:24:56] Speaker 01:
Yes.

[00:24:56] Speaker 01:
I believe that was your honor's earlier question.

[00:24:59] Speaker 01:
If I wasn't clear, yes.

[00:25:01] Speaker 03:
Is there a testimony that explains why using it as a carrier over being micronized would have been advantageous

[00:25:11] Speaker 03:
for any reason?

[00:25:11] Speaker 01:
Well, it was the testimony that you'd want to use an interactive mixture, Your Honor.

[00:25:17] Speaker 01:
Really, the fundamental invention here, I would submit, is deciding to use an interactive mixture with buprenorphine and naloxone.

[00:25:26] Speaker 01:
That was the fundamental invention here.

[00:25:28] Speaker 01:
And that was the 443 patent, which taught that.

[00:25:32] Speaker 01:
Then once you had that fundamental idea, which is the structural arrangement in question,

[00:25:37] Speaker 01:
It is much less novel, it is not novel in our view, to say that citric acid should be the carrier particle.

[00:25:45] Speaker 01:
You were going to use, Opposa was going to use citric acid in any event.

[00:25:49] Speaker 01:
Can I ask you this?

[00:25:50] Speaker 02:
I'm not an economist, so I don't really get a lot of this stuff, but this notion of interactive mixtures, it's not confined to like opioid treatment substances.

[00:25:59] Speaker 01:
No, it's not.

[00:26:00] Speaker 02:
It's used throughout the pharmaceutical industry.

[00:26:02] Speaker 02:
It is, Your Honor.

[00:26:02] Speaker 02:
And the notion of using citric acid to

[00:26:05] Speaker 02:
to very pH balance, I assume is kind of widely accepted.

[00:26:09] Speaker 02:
It is, Your Honor.

[00:26:11] Speaker 02:
I mean, if both of those things are really well known, then one would think if citric acid were routinely, or it was obvious to use it as a carrier particle, you could have found some reference that used it.

[00:26:25] Speaker 02:
But Your Honor, the... Your expert didn't even testify that he was familiar with this industry and that citric acid

[00:26:33] Speaker 02:
was routinely used as a carrier particle in our active mixtures.

[00:26:36] Speaker 02:
He just said it's the right size and it could be used.

[00:26:40] Speaker 01:
Well, you're right, Your Honor, in terms of your characterization of the record.

[00:26:46] Speaker 01:
There was not citric acid used as a carrier particle that was in the record.

[00:26:51] Speaker 02:
How do we know, then, that this wasn't the first time ever somebody said, oh, we use citric acid to alter pH all the time, but if we also use it as a character,

[00:27:02] Speaker 02:
particle, it's going to have unexpected results, since all we have is your conclusory testimony from your expert.

[00:27:08] Speaker 02:
Or you can take out the word conclusory if you want to object to it.

[00:27:11] Speaker 02:
I mean, there's no single prior art reference that talks about citric acid as a carrier particle.

[00:27:16] Speaker 02:
And if it would have been so obvious to use it that way, you would think you would have found something.

[00:27:20] Speaker 01:
Well, the fact that citric acid had never been used as a carrier particle, I would submit, does not mean that it was not obvious to use citric acid as a carrier particle in this instance, Your Honor.

[00:27:31] Speaker 01:
And what makes this instance different is that citric acid is an ingrained part of all the suboxone, all the buprenorphine and naloxone combination products and the buprenorphine products that have ever been out on the market.

[00:27:48] Speaker 01:
So what you end up with is citric acid is part of a limited number, I believe 12 ingredients in suboxone.

[00:27:56] Speaker 01:
The person of skill in the art needs carrier particles.

[00:27:59] Speaker 01:
and is looking at suboxone to see what the carrier particle could be.

[00:28:04] Speaker 01:
That's why the definition of carrier particle is important and would lead the person's skill in the art to that carrier particle, the citric acid.

[00:28:13] Speaker 01:
And then using the definition of carrier particle is a broad one, Your Honor.

[00:28:19] Speaker 01:
And it's because this is a structural arrangement.

[00:28:22] Speaker 01:
This is not an interactive arrangement the way you may have issues in some pharmaceutical cases where

[00:28:29] Speaker 01:
There's concern about how things interact in the human body and what might happen in unpredictability.

[00:28:34] Speaker 01:
There's nothing in the interactive mixture art about that.

[00:28:38] Speaker 01:
The interactive mixture art simply says that if you're an appropriate size and you're water soluble and you're pharmaceutically acceptable, it will work as a carrier particle.

[00:28:50] Speaker 01:
And given that you want to have more than one carrier particle,

[00:28:56] Speaker 01:
the fact that citric acid is taught in the art, consistently taught in the art, as being in buprenorphine and buprenorphine.

[00:29:03] Speaker 02:
But never consistently taught in the art as being a carrier particle.

[00:29:07] Speaker 02:
Are you basically making some kind of argument that because there's a limited set of ingredients here, it would have been obvious to try all of the ingredients that could have been a carrier particle?

[00:29:17] Speaker 01:
No.

[00:29:17] Speaker 01:
My argument simply is that a person of skill in the art looking at the ingredients would want carrier particles.

[00:29:24] Speaker 01:
as many carrier particles as possible and would recognize that citric acid falls within that definition.

[00:29:30] Speaker 01:
And that was the position at trial.

[00:29:32] Speaker 01:
And Dr. Dyer, in addition, said that using citric acid as a carrier particle would improve bioavailability, both as a pH modifier and as a carrier.

[00:29:45] Speaker 01:
Now, in an obvious case, Your Honor, there are going to be, or frequently it's the case,

[00:29:52] Speaker 01:
that there are situations where there is a portion or a combination that has never existed before.

[00:29:59] Speaker 01:
And so you have to rely on, for instance, testimony in order to make your case.

[00:30:04] Speaker 01:
We're not required to have a document that says every aspect of the invention.

[00:30:09] Speaker 01:
What we're required to do is show that there would have been a motivation to combine, which I think the record does show.

[00:30:16] Speaker 01:
And that combination had a reasonable expectation of success.

[00:30:20] Speaker 01:
And we've also got testimony to that effect as well.

[00:30:25] Speaker 01:
I believe I've addressed the points that were raised by my colleague.

[00:30:30] Speaker 01:
If there are other questions, of course, I'm happy to answer them or delve into another topic.

[00:30:35] Speaker 04:
Any more questions?

[00:30:36] Speaker 04:
Any more questions?

[00:30:38] Speaker 04:
OK.

[00:30:38] Speaker 04:
Thank you, Mr. Lombardi.

[00:30:40] Speaker 04:
This is Mr. Leddy.

[00:30:42] Speaker 00:
Your Honor, I don't have much.

[00:30:48] Speaker 00:
I just wanted to address one point with the

[00:30:53] Speaker 00:
This whole definition of carrier particles, the definition of carrier particle is broad.

[00:31:00] Speaker 00:
But, and that is broad enough to encompass almost everything that were in these prior art compositions, such as suboxone.

[00:31:10] Speaker 00:
There's no suggestion in the prior art to use citric acid as the carrier particle in an interactive mixture in the manner that the inventors used it.

[00:31:22] Speaker 00:
In fact, if you look at what the interactive mixture art used, they used other materials that were in the suboxone type products as the carriers, mannitol and lactose.

[00:31:37] Speaker 00:
Those are the ordinary carrier particles that people use.

[00:31:42] Speaker 00:
It was on ordinary.

[00:31:43] Speaker 00:
It was special when the inventors decided to choose citric acid as a carrier particle.

[00:31:51] Speaker 00:
And doing that resulted in a surprising result.

[00:31:58] Speaker 00:
That's all I have, Your Honor.

[00:31:59] Speaker 00:
If you have any questions.

[00:32:01] Speaker 04:
Thank you, Mr. Taylor.

[00:32:03] Speaker 04:
The case is taken under submission.