[00:00:00] Speaker 03:
Good morning, ladies and gentlemen.

[00:00:02] Speaker 03:
Please be seated.

[00:00:03] Speaker 03:
We have four cases on the calendar this morning.

[00:00:13] Speaker 03:
Two from the PTAB, one from the Veterans Court, and one from a district court.

[00:00:21] Speaker 03:
First case is Matt Therapeutics versus Ocular Therapeutics.

[00:00:29] Speaker 03:
2020-2176.

[00:00:29] Speaker 03:
Mr. Huynh.

[00:00:48] Speaker 04:
Good morning.

[00:00:49] Speaker 04:
May it please the court.

[00:00:51] Speaker 04:
The central issue on this appeal is the lack of substantial evidence to support the board's obviousness determination in this case.

[00:00:57] Speaker 04:
for two specific issues.

[00:00:59] Speaker 04:
The first is a reason to select dexamethasone as the active ingredient in the challenge claims.

[00:01:05] Speaker 04:
And the second is a motivation or reason to combine the coloring agents from the Gillespie reference with the dexamethasone plug from the Pritchard reference.

[00:01:14] Speaker 04:
It's apparent from looking at the final written decision that there's insufficient evidence based on the portions of the record that the board cited.

[00:01:20] Speaker 04:
There's really only two pages from the final written decision that address these two specific issues.

[00:01:26] Speaker 04:
And the cited portions of the petition and the two expert declarations that the petitioner ocular submitted in this case show that there's a lack of substantial evidence on those issues.

[00:01:36] Speaker 03:
Well, Council, Prichard mentions dexamethasone specifically.

[00:01:42] Speaker 03:
And so what's so obscure about that?

[00:01:44] Speaker 03:
Putting a well-known anti-inflammatory in the eye seems pretty obvious.

[00:01:51] Speaker 04:
Well, Judge, there's several reasons why, even though there's a literal disclosure of dexamethasone in the Prichard reference,

[00:01:57] Speaker 04:
That's not enough evidence to show that there would be a reason to choose that drug out of all the hundreds that are shown, and they are.

[00:02:03] Speaker 04:
First of all, we can go straight to the Pritchard reference.

[00:02:06] Speaker 04:
Pritchard doesn't really teach the selection of dexamethasone specifically.

[00:02:10] Speaker 04:
And as we explain in the briefs, a person of ordinary skill has to go through a very complicated chain of incorporation by reference to even find dexamethasone in the reference.

[00:02:19] Speaker 02:
But aren't you confusing written description concepts with obviousness concepts?

[00:02:25] Speaker 02:
I mean, with respect, I understand we've got

[00:02:27] Speaker 02:
lays marks and it says if there's a whole bunch of things, you can't just say that one is disclosed.

[00:02:32] Speaker 02:
But when you're talking about obviousness, it's in there and you don't have to have the same kind of emphasis on what's disclosed.

[00:02:42] Speaker 04:
Well, reasonably, Judge Amali, I believe the law still says that there still has to be a reason to choose the active ingredient, especially when there's a large number that are disclosed in a particular reference.

[00:02:52] Speaker 04:
It is in the same reference within Pritchard, technically, through the incorporation by reference.

[00:02:56] Speaker 04:
So it is all within a single reference.

[00:02:58] Speaker 04:
But there still has to be a reason under this court's precedence to choose that particular ingredient.

[00:03:03] Speaker 04:
For example, the impacts case, there's a prior rod reference where there are 25 different examples.

[00:03:08] Speaker 04:
and categories of drugs that are disclosed.

[00:03:11] Speaker 04:
But the court still said that's insufficient to show why that particular active ingredient, zomotriptan in that case, would have been chosen by a person of ordinary skill.

[00:03:18] Speaker 02:
But isn't dexamethasone, wasn't it, well known at the time for use with respect to pain, post-surgical, for instance?

[00:03:27] Speaker 04:
It was a known anti-inflammatory and it was a known corticosteroid.

[00:03:32] Speaker 04:
So it was known for treating pain.

[00:03:33] Speaker 04:
That's correct.

[00:03:34] Speaker 04:
But one point about Pritchard, for example, is that if you look at the totality of the disclosure, it's not really about treating that particular indication.

[00:03:42] Speaker 04:
The 360 provisional by itself is about chelation-resistant materials for implantation in the patient.

[00:03:49] Speaker 04:
It's not specific to pump of plugs, for example.

[00:03:51] Speaker 04:
So there's no reason a person, even looking at the 700 examples of drugs and the 130 categories of drugs in those two separate lists, would have seized upon that particular reference.

[00:04:01] Speaker 04:
Richard itself, the published application, is primarily about treating dry eye, not really about treating pain or inflammation.

[00:04:08] Speaker 04:
So an anti-inflammatory like dexamethasone doesn't naturally lend itself to a person of ordinary skill when they're trying to find an active ingredient for the claimed invention.

[00:04:18] Speaker 02:
Well, you say Richard is primarily about dry eye, but it also references post-surgical uses, right?

[00:04:25] Speaker 04:
That's correct.

[00:04:25] Speaker 04:
And in some of the claims, so I think, for example, claim 77 of the published application, there's a reference to some of those other indications.

[00:04:32] Speaker 04:
And those are cited in other grounds or for other claims, I should say for other claims by the board and by the petitioner in this case.

[00:04:39] Speaker 04:
But it is primarily about treating dry eye.

[00:04:42] Speaker 04:
If you look at, I think, the initial parts of the specification of Pritchard,

[00:04:46] Speaker 04:
It talks mostly about treating dry eye.

[00:04:49] Speaker 04:
And so that's where the indication to use dexamethasone is not really indicated by Pritchard.

[00:04:56] Speaker 03:
What about the Gillespie reference?

[00:04:59] Speaker 04:
Well, so then it gets to the issue about motivation to combine the coloring agents in that reference, the Gillespie reference, even if you have a dexamethasone plug that's disclosed by Pritchard.

[00:05:09] Speaker 04:
And there, there's still insufficient evidence to show a reason to combine in that particular case.

[00:05:14] Speaker 02:
But that's a factual finding that the board made.

[00:05:16] Speaker 02:
I mean, they cited Dr. Lohman's testimony and actually found that there was a motivation to combine.

[00:05:25] Speaker 02:
That's a tough road for you to climb in terms of convincing us that that factual finding was not supported by substantial evidence.

[00:05:34] Speaker 04:
Well, that's correct, Judge Malley.

[00:05:36] Speaker 04:
It is a factual finding.

[00:05:37] Speaker 04:
The standard reviews, of course, substantial evidence.

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But it's meant in this case based on what the board cites about Dr. Lohman's testimony in this case.

[00:05:45] Speaker 04:
So if you look at that portion of the final written decision, and that's really just the bottom of page 62 to 63 that talks about the motivation to combine choosing colors and adding them to dexamethasim, there it really only cites three parts of Dr. Lohman's declaration.

[00:06:01] Speaker 04:
The first is paragraph 89, and that's at appendix 2898.

[00:06:06] Speaker 04:
And there, Dr. Lohmann simply says that dexamethasone and other therapeutic agents are generically available.

[00:06:12] Speaker 04:
So he's done no more than what was in the petition in Dr. Dana, the first expert's declaration, simply saying that dexamethasone is known as an anti-inflammatory.

[00:06:21] Speaker 04:
Then on motivation to combine, the board cites paragraphs 92 and 93 of Dr. Lohmann's declaration, and that's at appendix 2899.

[00:06:30] Speaker 04:
And there, all he says is that a formulator whose experience could add color, just generally coloring agents, to a known drug delivery device.

[00:06:39] Speaker 04:
It's not specific to dexamethasone.

[00:06:41] Speaker 04:
It's not specific to punctal plugs.

[00:06:43] Speaker 04:
And it mostly says could, right, a person of ordinary skill could take coloring agents in general, add them to a plug that has a drug in it.

[00:06:52] Speaker 04:
And the squirt is said repeatedly that that's not enough to establish a reason to comply.

[00:06:56] Speaker 04:
For example, the InTouch versus Vigo case

[00:06:58] Speaker 04:
It says there's a difference between would, what a post-doc would do, and what's possible.

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So even if everything Dr. Lerman says is correct, that's all the board relies on.

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And that's simply legally insufficient to establish motivation to comply in this case.

[00:07:12] Speaker 04:
It's just a statement about possibility.

[00:07:15] Speaker 01:
Do I remember correctly that the claims aren't limited to any particular treatment, that really it's directed to more of the device?

[00:07:23] Speaker 01:
Is that correct?

[00:07:24] Speaker 04:
That's correct, yes.

[00:07:25] Speaker 04:
Yes, the preamble to the claim is a drug delivery device.

[00:07:27] Speaker 04:
Yes, that's correct.

[00:07:28] Speaker 04:
That's correct.

[00:07:30] Speaker 04:
So to finish that thought, again, there's just insubstantial evidence, even on the motivation to combine.

[00:07:35] Speaker 04:
And that's why, to judge O'Malley's question, there's still a lack of substantial evidence to support that aspect of the obviousness to translation.

[00:07:41] Speaker 03:
Substantial evidence, of course, is not a preponderance.

[00:07:44] Speaker 03:
It's some reasonable amount of evidence.

[00:07:47] Speaker 03:
There is some evidence here.

[00:07:49] Speaker 04:
Well, yes, that's correct, Judge Durie.

[00:07:52] Speaker 04:
It doesn't have to be a preponderance.

[00:07:53] Speaker 04:
And there is some evidence.

[00:07:55] Speaker 04:
But as looking at the specific portions of the Lohman Declaration say, that's legally insufficient.

[00:08:02] Speaker 04:
There is some evidence, but it doesn't go to the legal question of a reason to combine, a motivation to combine.

[00:08:08] Speaker 04:
I notice that's a could.

[00:08:09] Speaker 04:
And again, that's similar to the in touch case where the court says, when an expert just says there's puzzle pieces, the pieces of a jigsaw puzzle,

[00:08:17] Speaker 04:
you try to put them together, it's possible to put them together.

[00:08:20] Speaker 04:
That's still not enough to show a reason to combine the particular pieces of an invention.

[00:08:25] Speaker 04:
So the evidence that's cited, those three paragraphs, are still legally insufficient to get to where the board wanted to go when it came to obviousness in this particular case.

[00:08:35] Speaker 04:
So another point about those portions of the Lohmann Declaration is that it's inconsistent with the way the board dealt with the handbook reference, which was used for a different ground.

[00:08:44] Speaker 04:
So the petitioner had tried to use this handbook reference, which lists a number of different coloring agents in connection with pharmaceuticals as a substitute for the Gillespie reference.

[00:08:54] Speaker 04:
And the board said that was insufficient to establish obviousness because there's no indication that using the coloring agents from the handbook reference could be done with the plug from Pritchard.

[00:09:05] Speaker 04:
But somehow when Dr. Lohman says essentially the same thing, that there's a large number of coloring agents and it's possible to use them

[00:09:12] Speaker 04:
with different active ingredients, that's enough for obviousness.

[00:09:15] Speaker 04:
That's inconsistent.

[00:09:16] Speaker 04:
And arguably, Dr. Lohman's opinion is actually less specific because it doesn't provide the kinds of examples that the handbook reference does.

[00:09:25] Speaker 02:
But doesn't Gillespie itself provide the motivation for having color in these plugs?

[00:09:37] Speaker 04:
Well, I say no for these two reasons.

[00:09:39] Speaker 04:
One is that Gillespie doesn't talk about using therapeutic agents.

[00:09:42] Speaker 04:
So it doesn't talk about using active ingredients.

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And certainly, for that reason, it doesn't talk about using dexamethasone.

[00:09:48] Speaker 04:
That's in the challenge plans.

[00:09:50] Speaker 04:
And the second thing is, if you look at that portion of the board's opinion that we were just discussing, 62 to 63, I believe there's no discussion there of Gillespie supplying that motivation.

[00:10:00] Speaker 04:
They rely exclusively on what Dr. Lohman says.

[00:10:03] Speaker 04:
He's not an ophthalmologist.

[00:10:04] Speaker 04:
He's not a person of skill in the art.

[00:10:06] Speaker 04:
And again, those side portions, taking the board at its word, don't support the legal conclusion that it's trying to reach in terms of obviousness.

[00:10:15] Speaker 02:
So what you're asking is that we send it back for the board to explain itself better?

[00:10:20] Speaker 04:
Well, no, we'd ask for a reversal, because as the court has said before, the evidence is in the record, what the expert said, what the petition said, and what the references said.

[00:10:29] Speaker 04:
And it's just legally insufficient to establish a reason to choose dexamethasone, and then also the motivation to combine in this particular case.

[00:10:36] Speaker 04:
This court has done that before.

[00:10:39] Speaker 04:
TQ Delta versus Cisco, one of the cases we cited, has a similar posture where the board reversed on obviousness, partly because of an up-inclusory expert opinion about motivation to comply.

[00:10:50] Speaker 04:
So there's no need for the board to explain itself, the evidence is in, and there's no indication that you could establish obviousness as a matter of law in this particular case.

[00:11:03] Speaker 04:
So I want to go back to the issue about choosing Dexamethasone and the evidence that's cited for that.

[00:11:10] Speaker 04:
So that portion of the final written decision is Appendix 62, page 62 of the opinion.

[00:11:16] Speaker 04:
And then the paragraph at the top of the page, the board really just relies on attorney argument from the petition, and then also paragraph 65 of Dr. Dana's declaration, which is Appendix 1465.

[00:11:29] Speaker 04:
And the statement there is just, quote, dexamethasone is an anti-inflammatory and can be used to treat pain and discomfort.

[00:11:37] Speaker 04:
That's it.

[00:11:38] Speaker 04:
That's all that's cited there.

[00:11:39] Speaker 04:
So it's a conclusory opinion, because there isn't really reasoning behind that.

[00:11:44] Speaker 04:
And second, it's a generic statement.

[00:11:46] Speaker 01:
Why is that conclusory of Dr. Dana, who was a person of ordinary skill in the art, right, an ophthalmologist, says that it's an anti-inflammatory and can be used to treat pain and discomfort, and that's one

[00:11:59] Speaker 01:
particular treatment for eyes, then why wouldn't that be sufficient under a substantial evidence standard?

[00:12:06] Speaker 04:
Well, it's just a statement that the drug is known and that it has certain properties.

[00:12:10] Speaker 04:
It's anti-inflammatory.

[00:12:11] Speaker 04:
It doesn't say why you'd want to necessarily use it in connection with the claimant invention.

[00:12:15] Speaker 01:
And as we discussed earlier... I would presume it's because you want to treat pain and discomfort, which is the express reason provided.

[00:12:21] Speaker 01:
Why isn't that enough?

[00:12:22] Speaker 04:
Well, a couple of reasons.

[00:12:24] Speaker 04:
One is that pre-treatment, again, is primarily about treating dry eye.

[00:12:27] Speaker 04:
It's not really about treating

[00:12:28] Speaker 04:
pain or inflammation, which is what dexamethasone is for.

[00:12:32] Speaker 04:
And then second, there's a large number of anti-inflammatories.

[00:12:34] Speaker 01:
So we're supposed to look at Prichard and say that that device in Prichard is only for treating dry eye.

[00:12:40] Speaker 04:
I wouldn't say it's only for that purpose, but it is the primary purpose that's discussed.

[00:12:44] Speaker 04:
And so looking at the reference as a whole, as a person of ordinary skill has to, that's the conclusion they would get, particularly given the chain of incorporation by reference and the huge number of drugs that are in those laundry lists.

[00:12:55] Speaker 04:
But to finish the answer to your question, the other thing is that there's a large number of anti-inflammatories.

[00:13:00] Speaker 04:
And for example, acetaminophen, Tylenol, it's an anti-inflammatory.

[00:13:04] Speaker 04:
But that fact by itself doesn't mean that I have a reason to stick it into my eye and add coloring agents to it.

[00:13:10] Speaker 04:
There has to be something more than that, as the cases say, to get to the point where you have a reason to choose that particular drug, particularly given just how many are disclosed in the pressure reference.

[00:13:21] Speaker 03:
So you went to your bottle, and you wanted to save some time.

[00:13:24] Speaker 04:
Yes, thank you.

[00:13:25] Speaker 04:
I'll say the rest of my time for rebuttal.

[00:13:26] Speaker 04:
Thank you.

[00:13:36] Speaker 03:
Also, could you pronounce your name for us?

[00:13:40] Speaker 00:
Yes, Your Honor.

[00:13:41] Speaker 00:
I'd be happy to.

[00:13:41] Speaker 00:
It's Sweezy.

[00:13:42] Speaker 03:
Sweezy.

[00:13:45] Speaker 03:
Good morning.

[00:13:46] Speaker 00:
Good morning.

[00:13:47] Speaker 00:
May it please the court.

[00:13:48] Speaker 00:
I'd like to address the substantial evidence that supports the board's decision.

[00:13:52] Speaker 00:
And I would like to start with a few

[00:13:54] Speaker 00:
Background principles, number one, why this case is different than impacts, the evidence will show.

[00:13:59] Speaker 00:
Number two, why there were not only two pages in the board's final written decision that support its determination that claims five, 14, and 20 were obvious.

[00:14:09] Speaker 00:
And all of the background principles that we use in evaluating obviousness, which is that the person of ordinary skill in the art looks at the reference for all that it teaches, and of course is a creative, practical person.

[00:14:21] Speaker 00:
So with all of those principles in mind,

[00:14:23] Speaker 00:
point that this is a fact-specific question, let me sort of both step back and jump into the evidence that supports the board's decision.

[00:14:31] Speaker 00:
And I'd really like to make two overarching points here.

[00:14:36] Speaker 00:
The board made numerous findings leading up to its determination that claims 5, 14, and 20 would have been obvious.

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And much of this was uncontroverted by Maddie.

[00:14:47] Speaker 00:
So the first of the two points, the board made determinations that

[00:14:51] Speaker 00:
the Pritchard reference taught a variety of categories of drugs, a breadth of categories.

[00:14:57] Speaker 00:
And this is a case where the large number certainly doesn't suggest non-obviousness, but it suggests obviousness.

[00:15:03] Speaker 00:
And the board made that finding, that's in Appendix 58, and noted that Matty did not contest these teachings in Pritchard across this breadth of categories.

[00:15:13] Speaker 02:
The second point... What about the fact that, as your friend on the other side points out, I mean, even from the

[00:15:20] Speaker 02:
starting point, you have to go back to the incorporated reference to even find dexamethasone.

[00:15:27] Speaker 00:
Judge O'Malley, it is not the situation that there's any sort of web or complexity here under this court's case law.

[00:15:32] Speaker 00:
In a legal matter, the Prichard 368 provisional is incorporated in full in the Prichard reference.

[00:15:39] Speaker 00:
This is in the Pace versus Ford Motor case.

[00:15:42] Speaker 00:
And that is treated as a singular document, one cohesive unitary document.

[00:15:47] Speaker 00:
So there's no sort of digging or complication

[00:15:49] Speaker 00:
the person of ordinary skill in the art would not be lost.

[00:15:52] Speaker 00:
That document is incorporated in reference in full, and it discloses drugs.

[00:15:57] Speaker 00:
Pritchard itself is not solely about non-drug delivery ocular devices, but also repeatedly refers to ophthalmic drugs to be used.

[00:16:08] Speaker 00:
That's at appendix 800, also has a section at appendix 801 that says,

[00:16:17] Speaker 00:
This drug device may further comprise a therapeutic agent.

[00:16:20] Speaker 00:
And so we treat Prichard and Preacher 368 as one singular document.

[00:16:25] Speaker 02:
Can you explain how the 368 provisional provides 112 support for Prichard?

[00:16:33] Speaker 00:
Your Honor, I might answer that this way.

[00:16:36] Speaker 00:
It is more disclosure than the 082 has for its claim to dexamethasone.

[00:16:42] Speaker 00:
So it doesn't do any less than the 08-2 patent in terms of providing support for choosing dexamethasone.

[00:16:48] Speaker 00:
And we have both the board's findings that these broad categories, including anti-inflammatories and corticosteroids, would have been obvious.

[00:16:56] Speaker 00:
And you also have the board's findings that Pritchard teaches a variety of conditions.

[00:17:00] Speaker 00:
Both of those were essentially uncontroverted by Matty at appendix 58 and 59.

[00:17:06] Speaker 00:
All of those background findings and extensive findings are more than when the board finally gets to the coda.

[00:17:12] Speaker 00:
claims 5, 14, and 20 in the fact that it recites one specific pharmaceutical agent that is expressly recited in the Prichard 368 provisional, which is incorporated into Prichard.

[00:17:25] Speaker 00:
This isn't any inventive leap to selecting one of the particular ingredients that is expressly recited on the face of Prichard 368.

[00:17:34] Speaker 00:
And that makes this case different than ones where you might have to modify or extrapolate

[00:17:38] Speaker 00:
or to take an inference from, it is expressly recited there.

[00:17:42] Speaker 00:
And the board made that determination that it would have been obvious to choose that within the category of anti-inflammatories and corticosteroids, which were obvious choices.

[00:17:54] Speaker 00:
Given Pritchard's disclosures, that was really all we needed.

[00:17:57] Speaker 00:
But we did put forth expert testimony, which was not conclusory, just because an expert is succinct and brief and in a well-known mature field, as the board found.

[00:18:07] Speaker 00:
Nothing more is required.

[00:18:09] Speaker 00:
The board credited our expert and credited the person of ordinary skill in the arts reading of Prichard, incorporating Prichard 368.

[00:18:17] Speaker 02:
But putting aside whether it's actually incorporated, because there's no dispute over that, but I am trying to talk about the 112 issue, the dynamic drinkware case or line of cases.

[00:18:31] Speaker 02:
Was that not an issue at all?

[00:18:33] Speaker 00:
That was not an issue.

[00:18:35] Speaker 00:
And what I would say, Judge O'Malley, is that, again, going back to the point that the person of ordinary skill in the art looks at a reference for all that it teaches.

[00:18:45] Speaker 00:
Pritchard teaches ocular devices.

[00:18:48] Speaker 00:
It specifically says that its devices can use a drug delivery agent.

[00:18:53] Speaker 00:
It teaches the types of materials, the hydrogel materials of the 082 patent claims, and it incorporates by reference the Pritchard 368.

[00:19:02] Speaker 00:
And the Prichard 368 lists the specific drug that, again, sort of down these chain of findings that is recited in claims 5, 14, and 20.

[00:19:12] Speaker 00:
So I think Maddie is sort of trying to treat Prichard and Prichard 368 as entirely unrelated and independent.

[00:19:18] Speaker 00:
Even if that were the case, it's in the art, but it actually isn't an accurate way to look at the art.

[00:19:23] Speaker 00:
Prichard and Prichard 368 are together.

[00:19:26] Speaker 00:
their one document.

[00:19:27] Speaker 00:
And so the only question then is would a person of ordinary skill in the art been motivated to add color, which is the other limitation.

[00:19:34] Speaker 00:
And the board again had substantial evidence to support its determination that yes, this was a mature art.

[00:19:40] Speaker 00:
The board said specifically that the maturity of the art included all of these different elements, materials, hydrogels, and color with a drug delivery agent.

[00:19:50] Speaker 00:
And that's at the board's decision at appendix 40 to 42.

[00:19:54] Speaker 02:
So what about the fact that the board was not exactly chatty when it came to the issue of Gillespie, all right?

[00:20:06] Speaker 02:
It is a very short and succinct statement that you would just do color.

[00:20:13] Speaker 02:
You would just add color.

[00:20:15] Speaker 00:
Your Honor, I don't think there's anything wrong.

[00:20:17] Speaker 00:
We should probably welcome succinct and efficient

[00:20:21] Speaker 00:
descriptions.

[00:20:22] Speaker 00:
There's certainly no legal error in being succinct and concise.

[00:20:26] Speaker 00:
But I would also point out that the determination that the board made at pages 62 to 63 that Maddie's counsel referenced, again, follows its determination of the combination of Pritchard and Gillespie, which is an appendix 40 to 42, and talks about why a person of ordinary skill would have been motivated to combine those two references.

[00:20:47] Speaker 00:
So it is more than what is at 62 to 63.

[00:20:50] Speaker 00:
I don't think brevity should be faulted here at all, but I did want to point to the other findings in the final written decision.

[00:20:56] Speaker 02:
Do you disagree with his characterization that really all the board said, or all Dr. Lohman said, was that someone could do this as opposed to someone would be motivated to do this?

[00:21:08] Speaker 00:
Dr. Dana's testimony and the references themselves, and of course the board,

[00:21:13] Speaker 00:
is an expert body and can look at the references themselves.

[00:21:16] Speaker 00:
And the board made a determination, a factual determination that a person of ordinary skill in the art looking at these two references would have been motivated on the face of Gillespie alone.

[00:21:25] Speaker 00:
Gillespie says these are small devices.

[00:21:27] Speaker 00:
It would be a good idea to color them.

[00:21:30] Speaker 00:
It would be an improvement on the art.

[00:21:32] Speaker 00:
And that is substantial evidence that supports the determination by the board.

[00:21:37] Speaker 02:
And where did the board make that finding?

[00:21:40] Speaker 00:
That finding is at appendix 40

[00:21:43] Speaker 00:
to 41 that the combination of guests Gillespie and Pritchard Gillespie provides an advantage to color punctal plugs.

[00:21:56] Speaker 00:
And it credits our expert Dr. Dana, which his opinion is at appendix 1468 to 1471.

[00:22:04] Speaker 03:
Would you say that Gillespie itself is almost in anticipation if it had disclosed dexamethasone?

[00:22:12] Speaker 03:
After all, it was a punctal plug, and it disclosed coloration.

[00:22:17] Speaker 00:
That might be.

[00:22:18] Speaker 00:
We did offer Pritchard as an anticipatory reference, but it also might be.

[00:22:22] Speaker 00:
But all the court has before it is the obvious determination.

[00:22:25] Speaker 00:
And certainly with the way a person of ordinary skill in the art would read the evidence, the decision is supported.

[00:22:32] Speaker 00:
And I would just, on the number of drugs, I think that is, Maddie has made an argument in its brief that there's some sort of legal rule or one way to look at the number of items that might be listed.

[00:22:44] Speaker 00:
Of course, that's not the case.

[00:22:45] Speaker 00:
That is not what impacts held.

[00:22:47] Speaker 00:
Impacts relied on additional findings such as that particular drug was unique, and it would have been counterintuitive.

[00:22:53] Speaker 00:
In this art, where it was mature in dexamethasone, as Maddie itself and its expert conceded were,

[00:22:59] Speaker 00:
known to be used as anti-inflammatories.

[00:23:03] Speaker 00:
We're not in the impact situation.

[00:23:04] Speaker 00:
We have mature, well-developed science that it would have been obvious to select X-medstone out of the categories that Maddie conceded were disclosed at Pritchard.

[00:23:20] Speaker 00:
If the court has no further questions, we will rest on our brief.

[00:23:24] Speaker 03:
Thank you, Ms.

[00:23:25] Speaker 03:
Sweezing.

[00:23:26] Speaker 03:
Thank you.

[00:23:26] Speaker 03:
Mr. Huang has a couple of minutes of rebuttal time.

[00:23:48] Speaker 04:
Thank you, Your Honor.

[00:23:49] Speaker 04:
I first want to address the incorporation by reference arguments that were just made, and then go back to motivation to comply.

[00:23:56] Speaker 04:
So an incorporation by reference, as the panel observed, it's not disputed that there is a quote unquote singular document, that as a legal and technical issue, that the 360 provisional is in there.

[00:24:06] Speaker 04:
At the end of the day, the question that matters, of course, is what the person of ordinary skill sees when looking at the reference as a whole.

[00:24:13] Speaker 04:
And as we explained, there's a complicated chain here that includes four different provisionals that are incorporated by reference.

[00:24:19] Speaker 04:
And even when you get to the section of Pritchard that talks about drug and therapeutic agent delivery, the part that talks about active ingredients, it cites a different provisional, the 132, not the 368 that actually has dexamethasone in there.

[00:24:32] Speaker 04:
And then the examples that are given in the Pritchard application itself

[00:24:36] Speaker 04:
are silver and triclosan, which are antimicrobials, and are not really related to dexamethasone at all.

[00:24:43] Speaker 04:
So a person of ordinary skill, yes, would find that that reference is literally in there.

[00:24:47] Speaker 04:
If you go and look at the eight pages of the 368 provisional that list all those hundreds of different categories and examples of drugs, it is literally listed there.

[00:24:56] Speaker 04:
But they would have to go through a lot to find it.

[00:24:58] Speaker 04:
And there's no indication to choose that particular drug out of all the ones there.

[00:25:02] Speaker 04:
And in that sense, it is like impacts, in that there's a large number to choose from, and that there has to be a reason to pick that particular one.

[00:25:09] Speaker 04:
Or like the legal pharmaceuticals case, where there are two active ingredients there, and then there are a number of choices.

[00:25:14] Speaker 04:
I think eight of one and 10 of another, from which a person of ordinary skill has to choose.

[00:25:19] Speaker 04:
So although it is one document, and maybe the incorporation by references is legally and technically correct, a postdoc is not going to seize upon dexamethasone as the choice for use

[00:25:30] Speaker 04:
with a punctal plug and with the coloring agents of Gillespie.

[00:25:35] Speaker 04:
And then second briefly in the remaining time on motivation to combine.

[00:25:39] Speaker 04:
So again, Gillespie does talk about using different coloring agents.

[00:25:43] Speaker 04:
But when we look at the specific claims, 5, 14, and 20, we're talking not just about a plug in general, but a plug that has dexamethasone.

[00:25:51] Speaker 04:
And again, the Gillespie doesn't talk about therapeutic agents.

[00:25:54] Speaker 04:
And if you look at what the experts say and what the board says, it's not just that it's succinct.

[00:25:58] Speaker 04:
It's that it's legally insufficient.

[00:26:00] Speaker 04:
There's no why or would that shows why the person of ordinary skill is going to do that.

[00:26:05] Speaker 04:
It's just that it's possible.

[00:26:07] Speaker 02:
Even if that's true within those two pages,

[00:26:12] Speaker 02:
friend on the other side just pointed out that there were numerous other pages in which the board expressly discussed why there would be a motivation.

[00:26:22] Speaker 04:
Yes, if I may, two quick points to that.

[00:26:23] Speaker 04:
One is that those two pages are about the dexamethasone claims, which is what's relevant to this appeal.

[00:26:29] Speaker 04:
And so even though there's some motivation to use color with plugs in general, the question is whether or not there's motivation to use those coloring agents with a dexamethasone plug, even if you arrive at that from reading Pritchard.

[00:26:41] Speaker 04:
And when you look at that and what the board said about that, that's legally insufficient for autism.

[00:26:46] Speaker 04:
If there are no further questions, I'll respectfully request reversal.

[00:26:50] Speaker 03:
Thank you, counsel.

[00:26:51] Speaker 03:
We appreciate both arguments.

[00:26:53] Speaker 03:
We'll take the case under submission.