[00:00:08] Speaker 05:
The next case for argument is 151802, Storer versus Clark.

[00:01:01] Speaker 05:
You ready?

[00:01:08] Speaker 03:
If you're ready.

[00:01:09] Speaker 03:
Thank you, Your Honors, and may it please the court.

[00:01:12] Speaker 03:
There are two principal issues in this appeal, which is from an interference judgment of the board.

[00:01:18] Speaker 03:
The first one is jurisdictional.

[00:01:20] Speaker 03:
Identics believes that notwithstanding this court's decision in Biogen, it should be able to proceed in district court under section 146.

[00:01:28] Speaker 03:
And secondly, on the merits,

[00:01:29] Speaker 03:
which presents this court with a question of law, asks the ultimate legal question of whether the patent disclosure, the disclosure, allows a person of ordinary skill to practice the invention.

[00:01:41] Speaker 03:
Here, the arguments that were offered by Mr. Clark and the board's decision fail to engage the patent disclosure of identics.

[00:01:52] Speaker 03:
Let me start very briefly with two points on the jurisdictional issue.

[00:01:57] Speaker 03:
We are aware

[00:01:58] Speaker 03:
of the Biogen decision and the limits that that places on a panel in deciding that the case was wrongly decided.

[00:02:05] Speaker 03:
We're not asking the panel to do that.

[00:02:07] Speaker 03:
There are, however, two issues that we think the panel could reach.

[00:02:11] Speaker 03:
First is the rule that repeals of jurisdictional provisions must be expressed and not implied.

[00:02:19] Speaker 03:
That's reflected in the Rosecrans decision of the Supreme Court in 1897, continuing through cases into the present day.

[00:02:27] Speaker 03:
Under footnote two of the Atlantic thermoplastics decision, this issue should be open to the court because that footnote says a decision that fails to consider Supreme Court precedent does not control if the court determines that the prior panel would have reached a different conclusion if it had considered control of precedent.

[00:02:46] Speaker 03:
And we think that the rule that repeals of jurisdictional provisions must be expressed was not briefed by the parties.

[00:02:54] Speaker 03:
We've looked at the briefs that were presented to the panel in the Biogen case.

[00:02:58] Speaker 03:
And that is an issue that is open to this panel to decide under footnote two of Atlantic thermoplastics.

[00:03:04] Speaker 03:
That construction, if the Rosencrantz line of cases is followed, will then allow the court to avoid the constitutional issue that we present also under the equal protection clause.

[00:03:17] Speaker 03:
Those are the two issues with regard to jurisdiction.

[00:03:19] Speaker 03:
And unless the court has questions on that, I will turn to the merits of the case.

[00:03:27] Speaker 03:
The board's enablement decision in this case was simply not supported by substantial evidence.

[00:03:32] Speaker 03:
It wasn't supported by substantial evidence because it never answered the proper legal enablement inquiry.

[00:03:37] Speaker 03:
Can a person of ordinary skill make or use the invention from the disclosures in the patent without undue experimentation?

[00:03:46] Speaker 03:
Clark's, our friend's evidence of undue experimentation was completely untethered to the identics disclosure.

[00:03:53] Speaker 00:
And the board's decision was- Are you sure that I understand the issue?

[00:03:56] Speaker 00:
We're talking entirely about the provisional specification.

[00:04:00] Speaker 00:
Is that right?

[00:04:01] Speaker 00:
And whether that specification adequately discloses your neighbors?

[00:04:10] Speaker 03:
We are talking about the provisional.

[00:04:12] Speaker 03:
And the court has been, I think, supplied with a couple of visual aids, which we submitted earlier.

[00:04:18] Speaker 03:
And there's no objection from the other side to use them.

[00:04:24] Speaker 03:
The one that is oriented, Judge Newman, horizontally, like this, contains on the left side the actual target compound.

[00:04:36] Speaker 03:
And it shows not only that the target compound was disclosed, but also tells the artisan to look to the materials or the steps on the right-hand column, which are the steps for, as it says, the heading is,

[00:04:52] Speaker 00:
Well, I do think that was helpful, because I was looking particularly at the two prime position and the fluoro down methyl up at that stage of the proceeding, and I couldn't find it.

[00:05:07] Speaker 00:
Well, OK.

[00:05:07] Speaker 00:
If you look at the provisional specification and then all of the alternatives listed there, you can perhaps find it, although even there, I'm not so sure about the steric structure.

[00:05:22] Speaker 00:
I didn't see it in the visual aids that you provided.

[00:05:25] Speaker 03:
Well, what I will tell you is that if you follow the left-hand column, and I confess that I'm not a chemist, but I think I know enough to be dangerous here.

[00:05:35] Speaker 03:
If you follow the left-hand column and follow each of the steps that are listed, including the underlined materials, you will draw this, which you see on my post-it note here, with the fluoro down.

[00:05:47] Speaker 03:
You will get to that.

[00:05:48] Speaker 03:
So it discloses.

[00:05:49] Speaker 03:
the end product.

[00:05:50] Speaker 03:
And that really has not been a point of great dispute in this case.

[00:05:54] Speaker 03:
The board certainly didn't find that it failed to disclose it.

[00:05:57] Speaker 00:
Where is it disclosed?

[00:05:58] Speaker 03:
You said generically.

[00:05:59] Speaker 03:
Yes, absolutely.

[00:06:00] Speaker 03:
But if you follow the specific things that are underlined here, you get to the specific 2-methyl-up, 2-fluorodown nucleoside.

[00:06:10] Speaker 03:
Then what you have is a disclosure, and on the cardstock handout that we've handed out,

[00:06:17] Speaker 03:
to you, there's another side to our visual aid, which is this vertically oriented one, which has two columns.

[00:06:25] Speaker 03:
One is our patent and the application, and the other is Clark's enabling conception doctrine.

[00:06:31] Speaker 03:
There are only two differences between the disclosures.

[00:06:34] Speaker 03:
Clark's is admittedly enabling.

[00:06:35] Speaker 03:
They have not argued that their own reference isn't enabling.

[00:06:38] Speaker 03:
We certainly haven't.

[00:06:39] Speaker 03:
There are only two differences.

[00:06:41] Speaker 03:
One is the presence of this arrow at the top.

[00:06:45] Speaker 03:
boxed in in red and highlighted in yellow.

[00:06:48] Speaker 03:
And the other is the explicit reference to DAST, the fluorination reagent.

[00:06:54] Speaker 03:
Those were found by the board in, I believe, 823 to be well within the ordinary skill of one in the art.

[00:07:03] Speaker 03:
And that brings us back to the failure of the board's decision and ultimately of Clark's arguments.

[00:07:09] Speaker 03:
One would expect in a case like this, where

[00:07:13] Speaker 03:
Those are the differences between the supposedly enabling junior party and the supposedly non-enabling senior party.

[00:07:20] Speaker 03:
The focus of the board's decision would be on those differences.

[00:07:23] Speaker 03:
But that couldn't be the difference.

[00:07:26] Speaker 03:
That couldn't be the focus of our friends on the other side or the board, because those were well within the knowledge of one ordinary skill in the art.

[00:07:35] Speaker 03:
And the record is replete and undisputed with regard to that aspect of the case.

[00:07:38] Speaker 04:
But what is it that the Montpelier people who tried and failed to do this for?

[00:07:43] Speaker 04:
period of years that they would have learned, according to you, that they didn't want from the application.

[00:07:55] Speaker 03:
Well, the Montpelier people, and we're talking about Dr. Griffin and usually one research assistant at a time, what he was doing was completely untethered to the specification.

[00:08:07] Speaker 03:
It was as though he was sent out into the woods without a map.

[00:08:11] Speaker 03:
He never had the specification.

[00:08:12] Speaker 03:
There's no evidence that he did.

[00:08:14] Speaker 03:
And the evidence that he didn't is profound because... But wasn't he trying to synthesize a specific compound?

[00:08:20] Speaker 03:
Yes, but he was trying to do it without the aid of the specification.

[00:08:24] Speaker 03:
So my question is, how would the specification have aided him?

[00:08:27] Speaker 03:
Well, I'll give you specific examples in response to your question with specific record citations.

[00:08:35] Speaker 03:
If you look at page A41-278 and A41-280,

[00:08:39] Speaker 03:
You will see that he started with entirely different starting materials.

[00:08:43] Speaker 03:
He started with a two-prime-anhydro-two-iodomethyl derivative.

[00:08:48] Speaker 03:
That's nowhere set forth here.

[00:08:51] Speaker 04:
When he goes on, in the next few months, A41278... Was there expert testimony that he would have learned something from the specification that he didn't learn from talking to the inventors?

[00:09:05] Speaker 04:
Was there testimony...

[00:09:07] Speaker 04:
You can talk all the chemistry you want, but our job is not to be chemists.

[00:09:11] Speaker 04:
It's to judge this case based on the record.

[00:09:14] Speaker 04:
What does the record show about what he would have learned that he didn't know?

[00:09:20] Speaker 03:
Well, the record doesn't show anything that he would have learned.

[00:09:22] Speaker 03:
What it does show is that he did have some discussion with the inventors, but there is no testimony, not to my knowledge and not brought up by our friends on the other side, suggesting that the inventors gave him this path.

[00:09:34] Speaker 03:
And in fact, if the inventors gave him this path, then there's no rational explanation for him to have started in an entirely different direction and taking entirely different routes of synthesis.

[00:09:45] Speaker 03:
And that ultimately brings up the reason why the Griffin evidence is not relevant here.

[00:09:51] Speaker 03:
And I want to direct the court's attention to its prior decision in the Johns Hopkins case, which is cited in both parties' briefs.

[00:09:58] Speaker 03:
In Johns Hopkins, one of the questions at issue was whether the summary judgment, district court case in that one,

[00:10:04] Speaker 03:
of enablement was proper.

[00:10:08] Speaker 03:
And there was a claim made on appeal that an expert's testing program had shown failures.

[00:10:14] Speaker 03:
This is what the court said, and if you'll indulge me with two sentences from the decision.

[00:10:19] Speaker 03:
A party who wishes to prove that the claims of a patent are not enabled by means of a failed attempt to make the disclosed invention must show that the patent's disclosure was followed.

[00:10:30] Speaker 03:
Because Sutherland, the expert in that case, deviated from the teachings of the patent in his failed attempts to make the claimed antibodies, his testimony is insufficient to disprove enablement as a matter of law.

[00:10:43] Speaker 00:
Let's assume that the synthesis of the specific compound, which is now at issue, was not so complex that the basic chemistry couldn't have been found somewheres or other, whether in the provisional specification or in the prior

[00:10:59] Speaker 00:
Here we have a use claim to a specific compound used to treat hepatitis C. That is the issue that must be founded in the provisional, is it not, in order to have the benefit of that date.

[00:11:18] Speaker 00:
There's a big gap there that I haven't been able to fill and that I haven't seen filled in this presentation.

[00:11:24] Speaker 00:
Well, I'm sorry, Judge Newman, but I think I'll turn you back to... You want us to talk about enablement of the synthesis, I gather.

[00:11:32] Speaker 00:
There is nothing in the provisional to say that you must select this particular compound out of the several thousand that are disclosed.

[00:11:41] Speaker 03:
And I think this court's decision in Alcon, for example, says that that's not a requirement that there be a

[00:11:47] Speaker 03:
a teaching that you have to select the specific things.

[00:11:50] Speaker 03:
In fact, Alcon says that it's irrelevant whether you even know in the original application that you've actually invented the target.

[00:11:59] Speaker 03:
But here, again, I bring the court back to this vertically oriented visual aid, which is the comparison between our disclosure and the Clark disclosure.

[00:12:10] Speaker 03:
There's only two differences.

[00:12:13] Speaker 03:
One is that arrow, and the other is the disclosure of DAST.

[00:12:16] Speaker 00:
That wasn't focused on by the board.

[00:12:18] Speaker 00:
I'm not sure I understand this comparison.

[00:12:20] Speaker 00:
Their disclosure is not an issue.

[00:12:23] Speaker 00:
If the provisional, the store provisional, does not support one way or another the count of the interference, then you may have additional questions as to whether Clark does or does not.

[00:12:37] Speaker 00:
But you're asking us to say that because Clark may be viewed as having enabled the specific compound

[00:12:45] Speaker 00:
This then reflects backward to the earlier provisional?

[00:12:50] Speaker 03:
I perhaps have put too much weight during this argument on that.

[00:12:53] Speaker 03:
That really, for us, I think, is further proof.

[00:12:56] Speaker 03:
It is what you see in our disclosure in the first instance, which is on the other side of our card stock handout that demonstrates that the invention was enabled.

[00:13:08] Speaker 03:
But Judge Newman, go back to the board's decision here.

[00:13:11] Speaker 03:
The board's decision contains a healthy discussion

[00:13:14] Speaker 03:
of the undue experimentation requirement of the wants factors.

[00:13:19] Speaker 03:
And most of it is rehearsal of the party's various arguments.

[00:13:23] Speaker 03:
Clark says, store, response, that sort of thing.

[00:13:27] Speaker 03:
I urge the court to look at the findings and look at the summary of what Clark's arguments were.

[00:13:33] Speaker 03:
Clark's arguments didn't have anything to do with the specification.

[00:13:36] Speaker 03:
They had everything to do with the Griffin project taking place in Montpellier.

[00:13:43] Speaker 03:
And that wasn't tied to the specification.

[00:13:45] Speaker 03:
And when you look at the conclusion of the court, it's all based on the Griffin work.

[00:13:50] Speaker 03:
It's not tied.

[00:13:51] Speaker 04:
Well, that's not quite true, because at page 23, they say that the application provides no explicit explanation or guidance as to how to synthesize.

[00:14:02] Speaker 03:
Well, there is one sentence at page 23, which, by the way, goes to one's factor number two, I think.

[00:14:09] Speaker 03:
rather than number one, which is the undue experimentation.

[00:14:12] Speaker 03:
This is under the amount or direction of guidance presented.

[00:14:15] Speaker 03:
And we admit there is a gap.

[00:14:17] Speaker 03:
There is the gap between what is shown, the end product, and the precursor that hasn't been fluorinated.

[00:14:25] Speaker 03:
But look at what the board says right after that, Judge Dyke.

[00:14:29] Speaker 03:
Moreover, we have related SUPRA, how the IDENTX team identified such a molecule as a high-priority target, but failed to synthesize such a compound.

[00:14:38] Speaker 03:
Again, it goes back to

[00:14:39] Speaker 03:
the same flawed, undue experimentation ruling that it made.

[00:14:45] Speaker 03:
And if there's any doubt about the board's failure to focus on the specification, you can look, compare pages 8 and pages 35 of the board's decision.

[00:14:54] Speaker 03:
In page A8, the board states the rule correctly.

[00:14:58] Speaker 03:
It states the rule that we're looking to the specification.

[00:15:01] Speaker 03:
When you get to page 835, the board's ultimate conclusion is, we therefore find that Wands Factors 1, 2, 3, 5, and 7

[00:15:08] Speaker 03:
strongly indicate that a person skilled in the art would not arrive at the claimed invention without undue experimentation.

[00:15:14] Speaker 03:
There's no reference there whatsoever to the specification.

[00:15:18] Speaker 03:
And if you'll note, it's factors 1, 2, 3, 5, and 7 that are called out by the board as being particularly relevant.

[00:15:24] Speaker 03:
And 1, 2, and 7 were all infected by the Griffin testing and the failure to arrive at

[00:15:33] Speaker 03:
the invention or at least knowingly arrive at the invention.

[00:15:36] Speaker 04:
So the burden of proof to show that the provisional was enabling was on you?

[00:15:44] Speaker 03:
I don't think that's right because we were designated as the senior party in the first instance.

[00:15:48] Speaker 03:
So I think that the burden was on my friends on the other side.

[00:15:51] Speaker 03:
And ultimately our point with regard to remedy here is that it's not just that the board failed to do enough work like in Cutsworth or Garth's side, Chief Judge Prost, but

[00:16:02] Speaker 03:
It's also that their evidence ultimately failed to engage the specification in the same way that the court's decision failed, and that the enablement decision we should be restored as the senior party.

[00:16:13] Speaker 03:
That should be the end of enablement, and the case should be sent back for further proceedings on the other issues.

[00:16:18] Speaker 03:
And I'll return on rebuttal if the court will have me.

[00:16:21] Speaker 05:
Good morning.

[00:16:27] Speaker 02:
May it please the court.

[00:16:29] Speaker 02:
Let me start first with this visual aid, because it's got a lot of air time here.

[00:16:34] Speaker 04:
Who asked the burden of proof, Bob, to show that provisional was enabled?

[00:16:38] Speaker 02:
We were initially the junior party, and we had the burden to show that they could not claim it.

[00:16:44] Speaker 02:
Provisional was not enabled?

[00:16:45] Speaker 02:
Yes.

[00:16:46] Speaker 02:
Yes.

[00:16:46] Speaker 02:
I think that is correct, what Council said.

[00:16:49] Speaker 02:
And we carried that burden, as the board explained at length in its decision.

[00:16:53] Speaker 02:
which I want to get to, but this visual aid, I really want to talk about because I know Judge Newman, you had some questions about it.

[00:17:01] Speaker 02:
This does not reflect the 350 specification really even closely of what the specification actually shows.

[00:17:09] Speaker 02:
And in particular, I'd like to talk about, counsel spent a lot of time on what he called the vertically oriented sheet.

[00:17:16] Speaker 02:
And what they have done here is what they did in front of the board, and the board saw through it.

[00:17:21] Speaker 02:
They have hunted through this 2,000 page patent specification, because that's what we're talking about here.

[00:17:27] Speaker 02:
You have the appendix up there.

[00:17:30] Speaker 02:
Two of the four volumes are this gigantic specification that has something for everybody in there.

[00:17:37] Speaker 02:
And what they have done is they have picked one compound from column A161, which describes the Scheme 3.

[00:17:46] Speaker 02:
And they have juxtaposed it in their visual aid

[00:17:50] Speaker 02:
with a formula that is 1,000 pages later in the specification.

[00:17:56] Speaker 02:
That formula is one that happens to show fluorine down at the 2 prime position.

[00:18:02] Speaker 00:
But they did eventually settle, as did you, on the compound with the 2 prime fluoromethyl configuration.

[00:18:13] Speaker 02:
If your question is, is there disclosure of two prime methylfluoro somewhere in this specification among the potentials of compounds?

[00:18:23] Speaker 02:
Yes.

[00:18:24] Speaker 00:
You can find it there.

[00:18:25] Speaker 00:
I mean, this is the question, is it not?

[00:18:27] Speaker 02:
Yes, yes.

[00:18:28] Speaker 02:
You can find it there.

[00:18:29] Speaker 02:
But really, the question on this appeal is not just can you see it drawn on a sheet of paper?

[00:18:35] Speaker 02:
Can you make it?

[00:18:36] Speaker 02:
Is there any teaching in this specification of how someone of scale and the art could actually synthesize that compound?

[00:18:42] Speaker 04:
If I understand correctly, it's not so much identifying the compound that's the issue, because the Montpelier people were looking for a specific compound, right?

[00:18:51] Speaker 04:
Yes.

[00:18:51] Speaker 04:
The question is whether it was the original enabling to make that specific compound.

[00:18:59] Speaker 02:
Precisely.

[00:19:01] Speaker 02:
Correct.

[00:19:02] Speaker 02:
And here you had a group that, with all due respect, counsel says there's no link between Dr. Graffan and his failures in the specification.

[00:19:10] Speaker 02:
Dr. Grafon was working with two of the inventors on the specification, who, if they had thought they had come up with an enabling way to make the compound, certainly would have, working with Dr. Grafon, told him.

[00:19:23] Speaker 04:
I guess the problem is they didn't actually, the Montpelier people didn't actually have the specification or the provision, right?

[00:19:29] Speaker 02:
Well, actually, certainly they had it in the sense that, because again, two of the authors of this specification that

[00:19:36] Speaker 02:
that Agenix tries to rely on, we're working with Dr. Grafon.

[00:19:40] Speaker 02:
Dr. Storer is the person to whom Dr. Grafon reported.

[00:19:44] Speaker 02:
So in that way, they had access to this presentation?

[00:19:47] Speaker 02:
Absolutely.

[00:19:47] Speaker 02:
And indeed, some of the key evidence the board relied on involved Dr. Grafon reporting directly to Dr. Storer, an inventor on this application, saying, I cannot make this thing.

[00:19:59] Speaker 02:
I've tried every way we can think of.

[00:20:01] Speaker 02:
We've consulted the experts.

[00:20:03] Speaker 02:
They made suggestions.

[00:20:04] Speaker 02:
That didn't work either.

[00:20:05] Speaker 02:
Nothing has worked.

[00:20:06] Speaker 02:
And Dr. Storer, does he think for a moment to say to Dr. Garfand, gee, all you got to do is go to my specification.

[00:20:12] Speaker 02:
It's all laid out there.

[00:20:14] Speaker 02:
Why don't you try that?

[00:20:15] Speaker 02:
No, he never does that.

[00:20:17] Speaker 00:
But actually, more than that, I believe I heard... Well, just because a particular scientist went down the wrong path and wasn't able to achieve the synthesis doesn't necessarily say that it's not enabled if, in fact, it was readily enough synthesized.

[00:20:35] Speaker 00:
when identified that this is the compound that's needed.

[00:20:39] Speaker 02:
In the abstract, I agree with you, Your Honor, but there are two very important distinguishing characteristics here.

[00:20:45] Speaker 02:
Number one, Dr. Grafon was working, again, with the scientists who are named on this application.

[00:20:53] Speaker 04:
To synthesize a specific compound.

[00:20:55] Speaker 02:
Trying to synthesize a specific compound.

[00:20:57] Speaker 02:
And the board found he tried seven different routes.

[00:21:02] Speaker 02:
Ultimately, he did try the route which Idenex's expert says would have been apparent to somebody of skill in the art from this Scheme 3.

[00:21:13] Speaker 02:
So he did ultimately try the very thing that Idenex says the spec taught, and that failed too.

[00:21:21] Speaker 02:
And so it isn't correct.

[00:21:23] Speaker 02:
The suggestion was made to you that Grafon's work was completely untethered to the spec.

[00:21:28] Speaker 02:
It was not.

[00:21:29] Speaker 02:
In fact, one of his seven failures

[00:21:31] Speaker 02:
was to try this so-called Scheme A. It's referred to as Scheme A in the briefing.

[00:21:36] Speaker 02:
The very thing their expert says is suggested by the spec, and that failed too.

[00:21:40] Speaker 02:
And again, to come back to, but Scheme A isn't in the spec.

[00:21:44] Speaker 02:
This is my last point, really, on this Visual A, Judge Newman.

[00:21:49] Speaker 02:
They reproduce Scheme 3, which is not remotely Scheme A. And they juxtapose it with this formula that comes 1,000 pages later in the specification.

[00:22:00] Speaker 02:
And so the board said,

[00:22:01] Speaker 02:
I see the argument you're trying to make.

[00:22:03] Speaker 02:
I see the argument your expert is trying to make.

[00:22:06] Speaker 02:
But the specification shows no synthesis route at all for a 2-prime methyl up fluoro down.

[00:22:13] Speaker 02:
Indeed, the board found there's no synthesis route suggested for fluorinating any kind of nucleoside at all, period, in the specification.

[00:22:23] Speaker 02:
So you don't have a starting compound.

[00:22:26] Speaker 02:
You don't have reagents.

[00:22:27] Speaker 02:
You don't have reaction conditions.

[00:22:29] Speaker 02:
You don't have a route that's disclosed.

[00:22:31] Speaker 02:
So the spec doesn't have any of that.

[00:22:33] Speaker 02:
Then you look at the prior art.

[00:22:35] Speaker 02:
Well, gee, and there are some cases of this court that say, in a situation where the specification doesn't have it, but if the prior art shows it, and everybody knew it was in the prior art, maybe you have enablement.

[00:22:49] Speaker 02:
Here it's undisputed.

[00:22:50] Speaker 02:
The prior art didn't have it either.

[00:22:52] Speaker 02:
The board made specific findings on that.

[00:22:55] Speaker 02:
This compound had never before been synthesized, a nucleoside with a two prime

[00:23:00] Speaker 02:
Methyl upslerodone had never before been made until Clark made it.

[00:23:05] Speaker 00:
What was the use claim, the claim in interference?

[00:23:08] Speaker 00:
Was that a count of the interference?

[00:23:10] Speaker 00:
I thought it was curious at who we were arguing about enablement and that the question of priority, when we were talking about priority, didn't seem to involve the testing and the development and verification of the use.

[00:23:29] Speaker 02:
Well, I think the reason for that was just practical, Your Honor.

[00:23:32] Speaker 02:
And that was you don't even really have to get to the question of how the compound could have been used or might have been used because no one had been able to even make the compound or test the compound for activity.

[00:23:43] Speaker 02:
So I mean, on this record, it's undisputed that Clark, my client, was the first person to make it in 2002, 2003.

[00:23:52] Speaker 02:
And ultimately, when his work was published,

[00:23:57] Speaker 00:
But apparently a lot of these compounds of this general structure, as it was observed that it had potential value, were synthesized and tested.

[00:24:07] Speaker 02:
Not this compound.

[00:24:08] Speaker 02:
There were other compounds.

[00:24:09] Speaker 00:
Related compounds within the generic structure of the 2000 listed in the provisional.

[00:24:15] Speaker 02:
Yes.

[00:24:16] Speaker 02:
There were other compounds.

[00:24:17] Speaker 02:
Yes, there were.

[00:24:18] Speaker 02:
And in fact, that really is, I think, an important point.

[00:24:20] Speaker 02:
The only thing that identics had ever in store, had ever successfully synthesized

[00:24:25] Speaker 02:
was a two prime methyl up OH down.

[00:24:29] Speaker 02:
That is what they thought conferred activity.

[00:24:31] Speaker 02:
That is really what drove their patent application.

[00:24:34] Speaker 02:
That, of course, is not at all a two prime methyl up fluoro down.

[00:24:38] Speaker 02:
A, B, it's not even a compound.

[00:24:41] Speaker 00:
But fluoro is listed among the 2,000, nonetheless.

[00:24:45] Speaker 00:
So it isn't as if a scientist might not have considered that these are paths to be explored.

[00:24:52] Speaker 02:
I agree with you in the sense that there are many, many, many thousands of compounds disclosed.

[00:24:58] Speaker 02:
A scientist could have looked at that and thought, maybe that's one that I could try or should try.

[00:25:03] Speaker 02:
And then the scientist says, he asks himself two questions or herself two questions.

[00:25:08] Speaker 02:
Does the specification tell me how I can synthesize it so I can even get the compound and see what it is, what it does?

[00:25:15] Speaker 02:
The answer to that is no.

[00:25:16] Speaker 02:
The board found resoundingly that was no.

[00:25:18] Speaker 00:
You're talking about conception, not reduction to practice, right?

[00:25:22] Speaker 02:
Actually, I'm talking about both, because I believe in this field, in the chemical art, it's not enough for conception to be able to draw a compound on a piece of paper.

[00:25:34] Speaker 02:
You have to either disclose a viable synthetic route to make that compound, or, again, to go back to my other exception that's recognized under the case law, if the prior art already told you how to make it, well, then drawing it

[00:25:47] Speaker 02:
could be conception.

[00:25:49] Speaker 02:
But they don't have either thing here.

[00:25:51] Speaker 02:
And the board made multiple findings on both of those issues.

[00:25:55] Speaker 02:
So the person of skill looks at these many, many thousands of compounds, could see that one of them is a two prime methyl up fluoro down.

[00:26:02] Speaker 02:
Yes.

[00:26:03] Speaker 02:
Specification doesn't tell me how to make it or how to make anything that's fluorinated at all full stop.

[00:26:10] Speaker 02:
I look at the prior art.

[00:26:11] Speaker 02:
Does the prior art tell me how?

[00:26:13] Speaker 02:
Absolutely not.

[00:26:14] Speaker 02:
Also undisputed, there is no synthetic route

[00:26:17] Speaker 02:
in the prior art for this compound.

[00:26:19] Speaker 02:
And in fact, no synthetic route in the prior art that could be modified to make this compound.

[00:26:27] Speaker 02:
So there we are.

[00:26:27] Speaker 02:
I have two minutes left.

[00:26:31] Speaker 02:
I wanted to discuss one other aspect of the argument of counsel, which was the teachings of the specification.

[00:26:42] Speaker 02:
So the board, as I already said, found that the spec doesn't disclose any fluorination of any kind.

[00:26:50] Speaker 02:
There's a lot of focus on this one compound in Scheme 3, this so-called two prime ketone compound.

[00:26:58] Speaker 02:
And Identix says, well, if you take that as a starting point and you make a bunch of subsequent choices, you can ultimately get to something that works.

[00:27:07] Speaker 02:
In that respect, two points.

[00:27:10] Speaker 02:
The ketone shown in the patent application is never described as being useful for synthesizing the two prime methyl fluoro.

[00:27:19] Speaker 02:
By any route, indeed, it is used to arrive at something else entirely, which is this methyl up hydroxy down compound, not the claimed compound or the compound of the count, I should say.

[00:27:31] Speaker 02:
And in fact, and this again is undisputed, it has the stereochemistry

[00:27:36] Speaker 02:
that is exactly the opposite of what you want, that we later learn from Mr. Clark, works.

[00:27:44] Speaker 02:
So it's not only that it's not something that itself could be used, it actually leads affirmatively to a dead end.

[00:27:51] Speaker 02:
And so you can look in the specification, at the specification, and you won't find what you need.

[00:27:58] Speaker 02:
Last point, unless there are questions, there was a suggestion made that

[00:28:04] Speaker 02:
Griffon's failures are not relevant because he's not tied closely enough to the 350 specification and to the route and the specification.

[00:28:13] Speaker 02:
I already addressed that.

[00:28:15] Speaker 02:
I just want to point out that we cited in our brief a couple of this court's cases, the Alza case and the Ormco case, both of which say it is, in fact, highly relevant when the patentee's own efforts at trying to synthesize a disclosed compound fail.

[00:28:34] Speaker 02:
That is highly relevant evidence on the enablement question.

[00:28:48] Speaker 05:
Thank you.

[00:28:49] Speaker 05:
Thank you.

[00:28:52] Speaker 01:
That's correct your honor.

[00:28:53] Speaker 01:
Good morning Joe Buce on behalf of the government.

[00:28:55] Speaker 01:
The United States intervened solely to address one issue that is the issue of the constitutionality

[00:29:01] Speaker 01:
of several acts of Congress as interpreted by this court in Biogen.

[00:29:05] Speaker 00:
I believe... Rather than the threshold of the constitutionality, are you also prepared to discuss section 146?

[00:29:14] Speaker 01:
We are definitely prepared to discuss how phasing out 146 review for newly declared interferences.

[00:29:19] Speaker 00:
But what is the government's position?

[00:29:21] Speaker 00:
If you read the legislative history of the statute,

[00:29:26] Speaker 00:
doesn't say anything about section 146 and yet logically it doesn't fit with the change to refers to file.

[00:29:35] Speaker 00:
So what is the position of the government on the viability of section 146?

[00:29:39] Speaker 01:
Well I think the position of the government is that the panel opinion in Biogen definitively settled the question of whether section 146 review is still available for newly declared interferences and that you know the full

[00:29:52] Speaker 01:
court having denied unbanked rehearing, and the Supreme Court having denied cert on this question, that it's a binding decision that applies to this panel.

[00:30:01] Speaker 00:
You're saying it's decided, and therefore the government takes that position?

[00:30:04] Speaker 01:
That's correct, Your Honor.

[00:30:05] Speaker 01:
We don't feel the need to take it.

[00:30:06] Speaker 00:
And if for some reason, many of you can't say it's decided?

[00:30:11] Speaker 01:
Well, we do.

[00:30:12] Speaker 01:
I'm not in the habit of questioning binding circuit precedent.

[00:30:17] Speaker 01:
So I apologize, Your Honor.

[00:30:18] Speaker 01:
I am here only to defend the constitutionality of the statutes.

[00:30:21] Speaker 01:
as interpreted in Biogen.

[00:30:23] Speaker 01:
And if there are no further questions on that simple issue, we believe that our brief lays out the relevant facts and the law.

[00:30:32] Speaker 01:
And so we're happy to rest on that brief.

[00:30:34] Speaker 01:
I would only emphasize the simple question that is before this court.

[00:30:39] Speaker 01:
And that is to decide the question of whether any conceivable set of facts could support a rational basis for the classifications drawn.

[00:30:47] Speaker 01:
Under Beach Communications, a Supreme Court case

[00:30:50] Speaker 01:
It is irrelevant whether Congress actually had that rational basis in mind when it enacted the statute.

[00:30:57] Speaker 01:
There only must be a conceivable set of facts that would make it rational for Congress to have drawn the lines that it did.

[00:31:03] Speaker 01:
Here, we provide at least four reasons why Congress could have rationally devised the lines that Storer now complains of.

[00:31:10] Speaker 01:
And unless there are further questions, we are happy to rest on the briefs.

[00:31:16] Speaker 01:
Thank you.

[00:31:16] Speaker ?:
Thank you.

[00:31:27] Speaker 03:
I have one point on jurisdiction and I think five points with regard to the merits.

[00:31:31] Speaker 03:
On jurisdiction, simply point out that the Rosencrantz rule regarding an express repeal of a jurisdictional provision was never addressed by the United States in its brief and never addressed by our friends at Gilead in their brief either.

[00:31:47] Speaker 03:
With regard to the merits, also bridging the two points,

[00:31:51] Speaker 03:
This 15-minute argument, or 20 minutes probably by the time we're all done here, is the only hearing we're ever going to get on this.

[00:31:58] Speaker 03:
The board never heard argument in this, and if the jurisdictional challenge that we have is rejected, then this is it for us.

[00:32:06] Speaker 03:
That's why we think we should get the 146 action, but it also really points out why the board went astray and didn't focus on the right thing here.

[00:32:15] Speaker 03:
My friend said you have to hunt through this huge patent disclosure.

[00:32:18] Speaker 03:
You don't have to.

[00:32:19] Speaker 03:
The heading of the left-hand column on one of our visual aids tells you it's headed, general synthesis of two prime C branch nucleosides.

[00:32:30] Speaker 03:
If that wouldn't direct an ordinary skilled artist in where to start reading, then nothing would.

[00:32:35] Speaker 03:
The second point is, Judge Newman, just to clarify from our earlier colloquy, there's no meaningful difference for purposes of this case between the 350 and the 600, the provisional and the actual patent.

[00:32:48] Speaker 03:
We included the entire patent in the record.

[00:32:50] Speaker 03:
That's the first two volumes, but only excerpts of the provisional.

[00:32:55] Speaker 03:
Third, the issue here is enablement, not written description.

[00:32:58] Speaker 03:
And enablement does not require working examples.

[00:33:00] Speaker 03:
That's what I've been hearing repeatedly from the other side.

[00:33:03] Speaker 04:
So what is it that the specification taught that they didn't try?

[00:33:09] Speaker 03:
It taught the starting materials, and it taught the routes of synthesis.

[00:33:14] Speaker 03:
And neither of those were the ones that Griffin

[00:33:17] Speaker 03:
in his work followed.

[00:33:19] Speaker 03:
And to that point, Judge Dyke, there's a lot of speculation going on about what Griffon did or did not know when he was doing his testing.

[00:33:27] Speaker 04:
Were the roots that you're talking about the ones followed by Clark?

[00:33:31] Speaker 03:
Yes.

[00:33:32] Speaker 03:
And if you look at the parallels between the Clark disclosure and our disclosure, you'll see that everything except the explicit disclosure of the fluorination step.

[00:33:40] Speaker 04:
Did you have testimony by somebody that

[00:33:42] Speaker 04:
If they tried this approach that you say was disclosed in the specification, they would have easily come to the synthesis?

[00:33:51] Speaker 03:
Well, not only did we put in testimony of that, but we even have, from their own expert's mouth, Dr. Marquez at 39.523 and 24 said that you will get this particular compound if you apply the fluorination agent to it.

[00:34:08] Speaker 03:
The Clark patent of course shows the same thing, but out of the balance of their own expert.

[00:34:13] Speaker 03:
They say that it will happen It's not there's no experimentation to that one missing step, but I want to point out Judge Dyke on this point They deposed dr. Griffin didn't ask him about the specification didn't ask him if he had it didn't ask him if he followed it maybe strategically

[00:34:28] Speaker 03:
They followed the OTM rule of one too many questions, because they didn't want to know the answer.

[00:34:33] Speaker 03:
But as the party with the burden, that's chargeable to them.

[00:34:36] Speaker 03:
And their strategic choices should not deprive us of the opportunity to have proper finding.

[00:34:45] Speaker 03:
The finding of the board with regard to what the specification taught is that the specification did not

[00:34:56] Speaker 03:
specifically teach how to fluorinate a two-primed-down tertiary fluorine.

[00:35:01] Speaker 03:
So that was not taught or suggested by the prior art.

[00:35:04] Speaker 03:
But it's undisputed on this record that fluorination agents, the DAS or deoxofluor that are disclosed here, are well-known.

[00:35:11] Speaker 03:
They're within the ordinary skill of one in the art.

[00:35:14] Speaker 03:
And there's no finding that that would have required undue experimentation.

[00:35:17] Speaker 03:
Quite the contrary, the Marquez testimony that I just mentioned to you says that if you do that, which will be the natural thing that

[00:35:24] Speaker 03:
person of ordinary skill would look to, you will get the targeted compound.

[00:35:29] Speaker 03:
And one final comment, your honor, with regard to the comment about maybe Dr. Griffin didn't have the specification, but he actually took the route in 2003 that we say should have been done, which is reacting the Matsuda compound 17 with DEST.

[00:35:44] Speaker 03:
Yes, he did do that.

[00:35:46] Speaker 03:
And he got six products, and he analyzed one of them.

[00:35:50] Speaker 03:
And you can't square that with

[00:35:52] Speaker 03:
their experts' own testimony that if you react Metsuda 17 with DAS, you will, not may, not might, not subject to a whole lot of things, you will get the target compound.

[00:36:04] Speaker 03:
Thank you.