[00:00:01] Speaker 05:
Final case for argument this morning is 15-2-0-2-9 Purdue Pharma versus Ditman.

[00:00:26] Speaker 00:
Good morning.

[00:00:27] Speaker 00:
Good morning, Your Honors, and may it please the Court.

[00:00:29] Speaker 00:
The board in this case had before two very close references, the Beveja reference and the 837 patent.

[00:00:36] Speaker 00:
Those two references fit tightly together and taught all the limitations of the Challenge-Depamid patents.

[00:00:42] Speaker 00:
The board found three things that are important.

[00:00:45] Speaker 00:
One, that all of the limitations of the Challenge-Depamid patents and claims were present in the prior art references.

[00:00:52] Speaker 00:
Two, that there was no teaching away, contrary to an argument Depp and Mett had made and re-urges here.

[00:01:00] Speaker 00:
And three, that the two references may, and that's the board's turn, may be interrelated.

[00:01:05] Speaker 00:
And in fact, they are.

[00:01:06] Speaker 00:
And we'll see that in a moment.

[00:01:07] Speaker 03:
Mr. Costanious, the Patent Office has confirmed and quotes this patent multiple times.

[00:01:16] Speaker 03:
It issued it.

[00:01:19] Speaker 03:
I think there was an endo action.

[00:01:23] Speaker 03:
It confirmed the patentability.

[00:01:25] Speaker 03:
And it's done so here.

[00:01:28] Speaker 03:
Are they wrong all those times?

[00:01:31] Speaker 00:
Yes.

[00:01:32] Speaker 00:
And here's why.

[00:01:34] Speaker 00:
Despite the three findings that I just laid out for you, Judge Lurie, the board stopped short of an obviousness holding in this case and instead held that Purdue had failed, perhaps as an evidentiary matter.

[00:01:46] Speaker 00:
We're not entirely sure.

[00:01:48] Speaker 00:
But we had failed to show motivation to combine these references with a reasonable expectation of success.

[00:01:53] Speaker 00:
The board got to where it did by applying a rigid and highly formalistic version of KSR that can't be squared with KSR itself or its progeny from this court.

[00:02:05] Speaker 00:
Now pages 826 to 29, Your Honor, the board gave- I thought you were listening to the last argument.

[00:02:10] Speaker 00:
I was indeed.

[00:02:12] Speaker 00:
And we find ourselves, I think, on the other side of the coin here.

[00:02:16] Speaker 00:
But I don't think we have any holes to fill here.

[00:02:19] Speaker 00:
And I'll tell you why.

[00:02:20] Speaker 00:
If I could go through the three reasons that the board ruled against us, and those appear at pages 826 to 29, at the first of the three decisions that they're replicated in the other decisions.

[00:02:32] Speaker 00:
First, the board ruled that Perdue had not persuasively explained, quote, how or why.

[00:02:38] Speaker 00:
How or why a person of ordinary skill would have combined the swelling and substantially intact features of the 837 patent with Beveja.

[00:02:48] Speaker 00:
Now, if that how or why ruling is understood as meaning that Perdue's evidence was conclusory or vague, as my friend on the other side says in his red brief, that's not supported by substantial evidence.

[00:02:59] Speaker 02:
No, they really said it was unpredictable.

[00:03:02] Speaker 02:
Isn't that the core of what we're talking about?

[00:03:05] Speaker 00:
I think that is the third argument that was offered by the board in opposition.

[00:03:11] Speaker 00:
And that is that there wouldn't have been a reasonable expectation of success.

[00:03:14] Speaker 00:
And I'll go through very quickly, Judge Newman, what the preaching board's three rulings were.

[00:03:19] Speaker 00:
One, that we failed to show how or why.

[00:03:21] Speaker 00:
Two, that the nature of the problem to be solved was contrary to their decision.

[00:03:26] Speaker 00:
I appreciate that.

[00:03:26] Speaker 02:
Where did they say it was predictable that this particular

[00:03:31] Speaker 02:
Modification.

[00:03:32] Speaker 00:
Right.

[00:03:32] Speaker 00:
Judge Newman, what the board did in that regard was to look to the expert testimony and say, well, formulation is inherently unpredictable.

[00:03:41] Speaker 00:
There are a whole lot of factors to be used.

[00:03:44] Speaker 00:
But all of that testimony that was relied upon by the board, both Dr. Bodmeier's, our expert's testimony, as well as Hoppenberg and Helen, which were their witnesses,

[00:03:54] Speaker 00:
That testimony was given in the abstract.

[00:03:57] Speaker 00:
It was given without any reference to Beveha or 837 as the starting points.

[00:04:02] Speaker 00:
When you start Judge Newman with Beveha, we've got admittedly everything except

[00:04:09] Speaker 00:
the swelling and the substantially intact limitations expressly on that reference.

[00:04:16] Speaker 00:
Now, we've made an anticipation argument in our petition.

[00:04:20] Speaker 00:
But the petition was not initiated on that ground.

[00:04:24] Speaker 00:
And so unfortunately, because of the strange procedures of the PTAB, we can't come here and urge anticipation as an alternative ground for a furnace, because it wasn't addressed

[00:04:33] Speaker 00:
in the final decision.

[00:04:34] Speaker 05:
Referring back to the earlier case that we all just sat through, I mean the main complaint there, whether legitimate or not, we have yet to decide, is that the lack of discussion by the board, the lack of analysis.

[00:04:46] Speaker 05:
Here it seems to me that whether you like it or not, we've got a deferential standard of review

[00:04:53] Speaker 05:
We had witnesses, the experts, their testimony was discussed in detail by the board, explained by the board why they rejected one and not another.

[00:05:02] Speaker 05:
Even the point you just made, they dealt with that point and they said they're not persuaded that you've shown sufficiently that, however you pronounce the reference, bah bah bah, inherently teaches the entirety of the swelling limitation.

[00:05:17] Speaker 05:
And then they go on to explain their results.

[00:05:21] Speaker 05:
I mean, we've got some deference here we have to show.

[00:05:24] Speaker 05:
There were experts on both sides of the issue.

[00:05:27] Speaker 05:
This is a complex field.

[00:05:29] Speaker 05:
This is tough.

[00:05:31] Speaker 05:
And the fact that your expert came and said, I could do it in a week, the board just discounted that.

[00:05:38] Speaker 00:
But that's not the critical aspect.

[00:05:40] Speaker 00:
We're not arguing evidence here.

[00:05:41] Speaker 00:
And we're not saying, well, gee, you should take into account my guy's evidence versus their guy's evidence, because it's better.

[00:05:47] Speaker 00:
That's not the point.

[00:05:48] Speaker 00:
All of the evidence that the board relied upon with regard to the unpredictability issue was evidence in the abstract.

[00:05:55] Speaker 00:
We're not riding on a blank slate here, though.

[00:05:57] Speaker 00:
And that's what KSR reminds us.

[00:05:59] Speaker 00:
We're not taking a blank piece of paper and saying, OK, design something that has all the limitations of the challenge definite patterns.

[00:06:05] Speaker 00:
What we're doing is we're taking the VEHA and 837, parts of the prior art, which a person of ordinary skill is presumed that objective hypothetical construct

[00:06:15] Speaker 00:
That person is presumed to know that Beveha and 837 exist.

[00:06:19] Speaker 00:
Dr. Helen, one of their co-inventors, said she didn't even know about them.

[00:06:23] Speaker 00:
She didn't do any prior research.

[00:06:25] Speaker 00:
It took her a really long time.

[00:06:26] Speaker 00:
That's what the board relied upon.

[00:06:27] Speaker 00:
That's evidence, but it's not evidence of what a person of ordinary skill would have done with Beveha and 837 sitting in front of them.

[00:06:35] Speaker 00:
But the burden is on you.

[00:06:37] Speaker 00:
And I'm trying to carry out that burden here on appeal.

[00:06:40] Speaker 00:
as well, because what the board did was not address that argument, the board addressed a different argument, which is the argument that if you were writing on a blank slate, it would be very difficult to formulate.

[00:06:52] Speaker 00:
And formulations, I admit, can be unpredictable.

[00:06:55] Speaker 00:
We're not talking unpredictability here.

[00:06:57] Speaker 00:
Beveha tells you one polymer, HPMC.

[00:07:01] Speaker 00:
It doesn't just tell you HPMC, it tells you where to get it and what city to get it from.

[00:07:07] Speaker 00:
That's right on the face of the Beveha reference.

[00:07:09] Speaker 00:
Then it discloses two high-solubility drugs.

[00:07:15] Speaker 00:
Viveja, those are the only formulation requirements aside from the ratios, which were also disclosed in figures one and figure two.

[00:07:24] Speaker 00:
The swelling and substantially intact limitations are not, judge, further ingredients or further components that have to be added.

[00:07:34] Speaker 00:
They're simply qualities.

[00:07:36] Speaker 00:
And what 837 adds to the mix is it tells us that if you take HPMC and you take the high-solubility drug and you put it together in the ratios that Beveha discloses in figures one and two, you will get swelling and substantially intact.

[00:07:57] Speaker 00:
Those limitations will be met.

[00:07:58] Speaker 00:
And remember, the board said all the limitations are present in the prior arc.

[00:08:02] Speaker 00:
There was nothing absent, no hold of them.

[00:08:06] Speaker 00:
So to recap, with regard to the board's first ruling against us, which is now- Was anticipation raised in the petition for IPR?

[00:08:17] Speaker 00:
It was raised in the petition, and the board did not initiate on that ground.

[00:08:22] Speaker 00:
So under their procedures, they don't issue a final decision on it.

[00:08:26] Speaker 00:
We would be under the accusation that we were asking to have a non-reviewable initiation decision reviewed here if we were arguing anticipation.

[00:08:35] Speaker 00:
But we did the next best thing.

[00:08:36] Speaker 00:
We said 837 answers any questions you've got with regard to the two supposedly inherently present, or now we have to pretend that they're missing elements from the Beveja.

[00:08:48] Speaker 00:
But just to recap, the board's three rulings against us.

[00:08:52] Speaker 00:
On how or why, that's not the legal standard.

[00:08:55] Speaker 00:
If it was meant to be a ruling that our evidence was inadequate, insufficient, vague, or conclusory, as my friend says, that can't be supported by substantial evidence.

[00:09:06] Speaker 00:
If you look at Dr. Bodmeier's declaration from A 1955 to A 1962, paragraphs 121 to 133, 13 detailed paragraphs with extensive reasoning supported by pinpoint citations,

[00:09:19] Speaker 00:
to the two pieces of prior art and detailing two distinct reasons why a person of ordinary skill would have combined 837 with the Veja, their interrelated teachings, and the nature of the problem to be solved.

[00:09:34] Speaker 00:
That's a far cry from the only cases that we've been able to find from this court that use the term how or why in a genetics in its footnote three, an early post-KSR decision,

[00:09:44] Speaker 00:
in which it said that in that case, there was a complete absence of proof as to the motivation to combine.

[00:09:50] Speaker 00:
But that's the only way that how or why could be understood as a factual, substantial evidence failure on our part.

[00:09:57] Speaker 00:
And that holding itself is not judging and supported by substantial evidence.

[00:10:01] Speaker 00:
What we do think the board did instead was to turn that how or why into something resembling the rigid teaching suggestion motivation test that the Supreme Court emphatically rejected in its KSR decision.

[00:10:14] Speaker 00:
What the board did without any really prior reference to this standard is to hang this up for failing to satisfy a legal standard which doesn't appear in any case that they sign, or anywhere in the initiation decision, or was even raised at the argument.

[00:10:34] Speaker 00:
And the way it was applied against us, we think, made the obviousness tested to a rigid and mandatory formula.

[00:10:42] Speaker 00:
What was once supposed to be a helpful insight became rigid and mandatory.

[00:10:46] Speaker 00:
That takes care of the first reason.

[00:10:48] Speaker 00:
The second reason was the argument that Purdue's recitation of the problem to be solved was essentially a recitation of definite challenge claim.

[00:10:57] Speaker 00:
That was the ground on which review was instituted.

[00:11:02] Speaker 00:
And that can be found in the institution decision.

[00:11:04] Speaker 00:
The board reversed course in its final decision and said, no, that's just the claim.

[00:11:08] Speaker 00:
We've showed on page 44 of the blue brief why that's wrong.

[00:11:11] Speaker 00:
And you can find every single aspect of the problem to be solved right on the face of the 837 patent, including the addition of high-solubility drugs, which are right there.

[00:11:23] Speaker 00:
Finally, and this goes back to my discussion with Judge Newman earlier,

[00:11:27] Speaker 00:
The board's holding that a person of ordinary skill would not have had a reasonable expectation of success.

[00:11:32] Speaker 00:
We're not drawing a blank piece of paper.

[00:11:34] Speaker 00:
We start with Beveja.

[00:11:36] Speaker 00:
Beveja tells us one polymer.

[00:11:38] Speaker 00:
It tells us two high-solubility drugs.

[00:11:41] Speaker 00:
It gives us two figures, one and two, that show the polymer to drug ratio.

[00:11:47] Speaker 00:
Then all you need to do is go to Beveja to learn quite clearly and unmistakably that when you do Beveja, you will get

[00:11:57] Speaker 00:
swelling and substantially intact.

[00:11:59] Speaker 00:
Those of the court has further questions for me.

[00:12:01] Speaker 00:
I'll reserve the remainder of my time.

[00:12:12] Speaker 05:
Mr. Andre.

[00:12:13] Speaker 01:
May I please report Paul Andre and Hannah Lee for defamed.

[00:12:19] Speaker 01:
The board, in this case, made extensive factual findings that Purdue did not provide substantial evidence to support three very important legal principles, any one of which would be enough to defeat their petition.

[00:12:36] Speaker 01:
The first, as my friend has talked about, is the reason to combine these references.

[00:12:45] Speaker 01:
There was no reason at all

[00:12:47] Speaker 01:
given by Petitioner, in this case Purdue, to combine these references.

[00:12:52] Speaker 01:
There was a general conclusory statement by their expert that said, well, of course you'd look at these two references, because they're both in the same general field of polymer science.

[00:13:04] Speaker 01:
That's not enough.

[00:13:06] Speaker 01:
The burden on Petitioner is to provide the glue.

[00:13:10] Speaker 01:
the holds, these references together.

[00:13:11] Speaker 01:
Why do you put these references together?

[00:13:13] Speaker 01:
The how and why question, based on the FAR, the part of our suit case, is just that.

[00:13:22] Speaker 01:
Why would you do this and how would you do it?

[00:13:24] Speaker 05:
But your friend is right, is he not, that we've all read KSR to not require any rigidity or any specific disclosure in that regard.

[00:13:34] Speaker 01:
And the board was very clear on it.

[00:13:35] Speaker 01:
They did not put that rigid standard in.

[00:13:38] Speaker 01:
In fact,

[00:13:40] Speaker 01:
It was a very flexible standard.

[00:13:42] Speaker 01:
They just looked for evidence.

[00:13:43] Speaker 01:
They said, give us evidence as to just something.

[00:13:45] Speaker 05:
Let me ask you something.

[00:13:49] Speaker 05:
It raised my eyebrows a bit when I read a red brief when the board clearly concluded here that all of the claim limitations existed in the prior art and that there was no teaching away.

[00:14:01] Speaker 05:
It rejected your arguments in that regard.

[00:14:03] Speaker 05:
It doesn't give me a lot of comfort

[00:14:06] Speaker 05:
that the board is right when you choose to spend a lot of your defense of the board arguing a theory that the board rejected?

[00:14:15] Speaker 01:
Well, the point that we argued that the board rejected was the teaching away.

[00:14:21] Speaker 01:
Yeah.

[00:14:22] Speaker 01:
And I think that is an issue of law.

[00:14:23] Speaker 01:
There's no dispute of fact.

[00:14:25] Speaker 01:
The reference says what it says.

[00:14:26] Speaker 01:
It says that the first formulations are a major disadvantage.

[00:14:30] Speaker 01:
That's factual.

[00:14:31] Speaker 01:
There's no dispute.

[00:14:31] Speaker 05:
OK, so let's assume that we disagree with you and we agree with the board on teaching away.

[00:14:36] Speaker 05:
What are we left with here?

[00:14:38] Speaker 01:
Well, we would also say that, as the KSR court said, all inventions are made up of known components.

[00:14:48] Speaker 01:
And going back to the priority of picking shoes of those components is not enough.

[00:14:53] Speaker 01:
That's where you have protections in for the obvious and standards.

[00:14:55] Speaker 01:
So we're not contesting the board's factual findings as to whether or not they're all there.

[00:15:03] Speaker 01:
We disagree with it, but we're not here to contest that.

[00:15:07] Speaker 01:
This appeals about whether or not

[00:15:10] Speaker 01:
The petitioner put substantial evidence in to support the obvious determination, and the board determined they didn't.

[00:15:17] Speaker 05:
So how much more?

[00:15:17] Speaker 05:
What was missing?

[00:15:19] Speaker 05:
I mean, they did have a witness.

[00:15:21] Speaker 05:
Now, the board, I guess, criticized their witness for having said, it would take me five days, and that doesn't deal with the time of the invention.

[00:15:29] Speaker 01:
Yeah, I actually took that deposition where he said that.

[00:15:31] Speaker 01:
And when this witness was testifying in deposition and his declaration, he gave very general, broad conclusions.

[00:15:41] Speaker 01:
He went back and shared his prior art based on complete hindsight.

[00:15:47] Speaker 01:
What you would require here is something in the teachings that would tell those who are at the time, as the other criticism the board had of their expert,

[00:15:56] Speaker 01:
He said they did not use one skill in the art at the time of the invention.

[00:16:00] Speaker 01:
He was looking at one skill in the art as of today.

[00:16:03] Speaker 01:
Another criticism.

[00:16:04] Speaker 01:
So the fact of the matter is we didn't have the burden of proof.

[00:16:08] Speaker 01:
We put forward two declarations that contradicted the legal arguments and the factual arguments that counsel is making.

[00:16:16] Speaker 03:
Mr. Andre, what's your answer to the assertion that the VAHA is missing only the two qualities or results of the formulation?

[00:16:32] Speaker 01:
I would disagree with that determination.

[00:16:34] Speaker 03:
But they don't differ structurally.

[00:16:36] Speaker 01:
Yeah.

[00:16:37] Speaker 01:
And pharmaceutical formulations, they're missing two qualities.

[00:16:44] Speaker 01:
That could mean 10 different components that could actually attribute those qualities.

[00:16:50] Speaker 01:
That's the big issue here.

[00:16:52] Speaker 03:
In our inventor's declaration... If, in fact, your invention structurally contains the materials that produce those qualities, are they simply unrecognized in the earlier reference?

[00:17:08] Speaker 01:
No, I would say not, because... Or unstated.

[00:17:12] Speaker 01:
Well, I would say not.

[00:17:15] Speaker 01:
And the reason being is because the fact that the polymer happens to be there, a given polymer, HPMC polymer, just because it happens to be there doesn't mean it's going to give the qualities.

[00:17:27] Speaker 01:
It has to be there in certain ratios and certain proportions.

[00:17:30] Speaker 01:
And this was the three years of experimentation that took DEPMA-MAD to do to get to this dimension.

[00:17:35] Speaker 01:
Three years of trial and error, going through and testing different concentrations.

[00:17:42] Speaker 01:
There are at least 10 different factors, 10 different components that the inventor testified to that took this three years of full-time work.

[00:17:53] Speaker 01:
And if you look at all the possibilities, how you would mix and match those, they come well over a million.

[00:18:00] Speaker 01:
As the petitioner's own expert said, it could be in the millions, plural.

[00:18:07] Speaker 01:
But not only did that show the reason to combine,

[00:18:09] Speaker 01:
But there's no evidence for the reasonable expectation of success, as Judge Newman asked about earlier.

[00:18:16] Speaker 01:
The fact of the matter is, here in this case, every declarant, ours and theirs, said there were numerous possibilities.

[00:18:27] Speaker 01:
Without any kind of certainty, what was going to work?

[00:18:31] Speaker 01:
In fact, like I said, it took three years for it to work.

[00:18:35] Speaker 00:
Ms.

[00:18:36] Speaker 01:
Helms, the inventor, talked about

[00:18:39] Speaker 01:
The amount of work it took to get the release of the drug, over the rate, the swelling, at the size, and without restriction, and having the type of drug that would be loaded into the formulation was very unpredictable.

[00:18:59] Speaker 01:
The fact that one of the largest pharmacies that comes in the world, BMS, Bristol Myers Squibbs, came to them and said, can you do this?

[00:19:05] Speaker 01:
We can't.

[00:19:07] Speaker 01:
It tells you something right there.

[00:19:08] Speaker 01:
And that's what this invention was about.

[00:19:11] Speaker 01:
The third issue that council brings up is the looking at hindsight.

[00:19:20] Speaker 01:
Using our patent as a template or a recitation of the problem to be solved.

[00:19:29] Speaker 01:
Nowhere in the prior art were people trying to solve this problem.

[00:19:32] Speaker 01:
There's no recitation.

[00:19:34] Speaker 01:
So what the petitioner did improperly was take our claim language, almost verbatim, that's what the board found once again, and said, that's the problem to be solved.

[00:19:44] Speaker 01:
Now, go back with hindsight and see if you can find the article.

[00:19:48] Speaker 01:
In our red brief, we give a chart of all the different references that the board actually instituted on.

[00:19:55] Speaker 01:
And the board instituted on, it looked like a poster child for hindsight reconstruction.

[00:20:01] Speaker 01:
there were numerous references.

[00:20:03] Speaker 01:
And the board has a pretty low standard on instituting these trials, as I think this court is very well aware, almost 9% at the time this one was filed.

[00:20:14] Speaker 01:
And also, the PTAB is not shy about invalidating claims.

[00:20:20] Speaker 01:
In fact, in pharmaceutical science, once a trial is instituted, over 90% of the times, the board invalidates claims.

[00:20:29] Speaker 01:
In this case, the board instituted

[00:20:32] Speaker 01:
We came through and showed them that there was no evidence to support this finding.

[00:20:37] Speaker 01:
And they flipped.

[00:20:39] Speaker 01:
I feed them to itself.

[00:20:43] Speaker 01:
Now, when we talk about the reference, you asked about Beveha and the teaching of white.

[00:20:50] Speaker 01:
I worked in science for years.

[00:20:52] Speaker 01:
And when I would read a reference, and they'd say, this is a major disadvantage of this formulation.

[00:20:57] Speaker 01:
As one skill they are at the time,

[00:21:01] Speaker 01:
That would tell you not to go there.

[00:21:02] Speaker 01:
It's a major disadvantage.

[00:21:03] Speaker 01:
It's discouraging my use of that formulation, regardless of how you read it.

[00:21:09] Speaker 01:
The board found it was in our law that it was not a teaching away, but the facts are not disputed.

[00:21:14] Speaker 01:
But even if you were to agree with the board that this is not a teaching away, which is hard to imagine, this is not a teaching away, even if you agree with them, the fact that the primary reference lacked so many different elements, we argued they lacked four elements, the board agreed to them.

[00:21:29] Speaker 01:
But those two elements could lead to a vast amount of uncertainty that you just couldn't account for.

[00:21:35] Speaker 01:
The last thing I want to talk about, if you have any questions, is the secondary considerations.

[00:21:44] Speaker 01:
It's not an issue upon appeal, but the mere fact that you can judge the merits of this appeal brief by the fact that they've asked this court to invalidate these claims.

[00:21:56] Speaker 01:
But you read the board's decision, we put in an amazing amount of secondary considerations for non-obviousness.

[00:22:02] Speaker 01:
Everything from commercial success, unexpected results, licensing, et cetera.

[00:22:07] Speaker 01:
The board did not address those.

[00:22:09] Speaker 01:
So at the very least, the best that petitioner could ask for would be remanded back for further findings.

[00:22:18] Speaker 01:
That's not what they did.

[00:22:19] Speaker 01:
They actually wanted this court to invalidate the claims without even looking at the secondary considerations.

[00:22:26] Speaker 01:
I think that goes to really telling this court what this appeal is about.

[00:22:32] Speaker 01:
The attorney held Mary past because they went to the PTAB.

[00:22:37] Speaker 01:
They lost.

[00:22:38] Speaker 01:
And now they're trying to make this a legal argument instead of what it really is, a factual argument where the board decided their facts, chapter, and version.

[00:22:48] Speaker 01:
Any questions?

[00:22:49] Speaker 01:
Thank you for your time.

[00:22:58] Speaker 00:
Be very brief.

[00:23:03] Speaker 00:
I think teaching away is regarded as a question of fact, and that fact's been found against them.

[00:23:07] Speaker 00:
I think it's inappropriate, as we pointed out in our gray brief, for that to be re-urged here.

[00:23:12] Speaker 00:
With regard to secondary considerations, which we just heard about, that wasn't briefed either by my friend on the other side.

[00:23:18] Speaker 00:
The request for a remand in lieu of a reversal comes a little late when he had the opportunity to put that in his red brief.

[00:23:26] Speaker 00:
In fact, the ruling here was made not only on the independent claims, but the dependent claims as well, based on the same rationale that we discussed, the three points made by the board in its opinion.

[00:23:42] Speaker 00:
And you can find that with regard to the dependent claims at pages A32, A34, A70, and A105.

[00:23:50] Speaker 00:
Finally, with regard to the claim of years of experimentation, I think I've already answered this point, but I'm going to underscore it here.

[00:23:56] Speaker 00:
The years of experimentation took place with DEPIMED because they weren't aware of the BEHA.

[00:24:01] Speaker 00:
They weren't aware of the prior art.

[00:24:04] Speaker 00:
Their co-inventor, Helm, testified that she wasn't even aware of her co-inventor's 837 patent.

[00:24:10] Speaker 00:
Remember, 837 is a DEPIMED patent.

[00:24:13] Speaker 00:
The Dr. Shell is the loan-named inventor on, and he is also an inventor on the two challenge patents in this case.

[00:24:19] Speaker 00:
The person of ordinary skill is an objective, hypothetical construct.

[00:24:24] Speaker 00:
It's not subjective, so in terms of secondary considerations, whether it took three days, three months, three years, or three centuries for Depamed to make

[00:24:35] Speaker 00:
What it made is not relevant.

[00:24:37] Speaker 00:
What is relevant is what a person of ordinary skill would have done with Beveha on one hand and 837 on the other.

[00:24:43] Speaker 00:
And the answer is very clear.

[00:24:45] Speaker 00:
It was an extraordinarily limited universe of possible options.

[00:24:49] Speaker 00:
It is not the formulator's nightmare of millions and millions of possible options.

[00:24:55] Speaker 00:
When I read Beveha, I see basically two options.

[00:24:58] Speaker 00:
It's one polymer.

[00:24:59] Speaker 00:
It's two high-solubility drugs.

[00:25:03] Speaker 00:
And the ratios are overlapping in figures 1 and 2, with the ratios that are in 837, and the ratios claim that's in a chart that's on page 14 of our reply brief.

[00:25:14] Speaker 00:
And that yields us at least a presumption of obviousness, which has not been rebutted, and that ought to be conclusive in this case.

[00:25:21] Speaker 00:
So if the court has further questions for me, I thank you for your time.

[00:25:25] Speaker 04:
Thank you.

[00:25:25] Speaker 04:
We thank both counsel when the case is submitted, and that concludes our proceedings for this morning.

[00:25:31] Speaker 03:
All rise.