[00:00:01] Speaker 03:
The first case for argument this morning is 20-2334, Cornell Research versus Vidal.

[00:00:08] Speaker 03:
Ms.

[00:00:08] Speaker 03:
Goldenberg, whenever you're ready.

[00:00:15] Speaker 00:
Good morning.

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

[00:00:16] Speaker 00:
Thank you, Your Honor, and may it please the Court.

[00:00:19] Speaker 00:
This case relates to the solution of a major thermal stability problem in the agricultural food pellet industry and the cancellation of six groundbreaking patents.

[00:00:29] Speaker 00:
There are three main issues in this appeal.

[00:00:32] Speaker 00:
The first issue involves annotation, and the record demonstrates that Dr. Lee's testimony is sufficiently corroborated by both his contemporaneous manuscript and by circumstantial evidence, including expert testimony.

[00:00:47] Speaker 00:
The board's contrary finding is not supported by substantial evidence.

[00:00:51] Speaker 00:
Further, at minimum, Dr. Lee conceived of at least as much as CRUTS prior to CRUTS's priority date.

[00:00:58] Speaker 00:
which is all that is required for annotation.

[00:01:01] Speaker 04:
Do I understand right that we do not have to reach the whole CRETS issue if we agree with the board on the rest?

[00:01:09] Speaker 00:
If you agree on the other combinations, that would be correct.

[00:01:13] Speaker 00:
The CRETS issue only relates to the 300 patent.

[00:01:16] Speaker 00:
But turning to that second issue, which involves motivation to combine, mostly references that were already considered by the patent office.

[00:01:24] Speaker 00:
The record demonstrates an unpredictable art at the time of the invention.

[00:01:29] Speaker 00:
In view of such uncertainty, a skilled artisan would have had no reasonable expectation of success in combining various disclosures from Dasa and Greener with either Chang or Romanos and Van Gorka.

[00:01:41] Speaker 03:
I understand what you're going to say, and we read it all in the brief.

[00:01:44] Speaker 03:
The concern I have for this, so I don't know if you have a response, which is that whether you're right or wrong, this is clearly substantial evidence applies here, right?

[00:01:52] Speaker 03:
And there was conflicting testimony by the experts.

[00:01:57] Speaker 03:
And there's detailed discussion by the board explaining which expert they credited and why.

[00:02:02] Speaker 00:
How do you get around that on appeal?

[00:02:05] Speaker 00:
Certainly, substantial evidence isn't a mere scintilla.

[00:02:07] Speaker 00:
It has to be adequate for a

[00:02:10] Speaker 00:
for a reasonable mind to accept.

[00:02:12] Speaker 00:
And if you look at the evidence here, it simply is not adequate.

[00:02:15] Speaker 00:
Specifically, all the experts agree that it was an unpredictable field, and they admitted that whether any given bacterial phytase could successfully be expressed in a fungal host was a case-by-case basis.

[00:02:29] Speaker 00:
This is also shown by ABF's own expert, Dr. Robertson.

[00:02:33] Speaker 00:
In 2004, he made a statement

[00:02:35] Speaker 00:
that thermal tolerance was not necessarily predictable based on a sequence or structure analysis.

[00:02:40] Speaker 00:
Of course, Cornell's expert also agreed, Dr. Benedict.

[00:02:44] Speaker 00:
And then you have the testimony from Dr. Hahn, who was a researcher.

[00:02:47] Speaker 01:
Why is that not substantial evidence?

[00:02:50] Speaker 01:
It seems to me you're arguing more of the weight of the evidence than whether it's substantial evidence or not.

[00:02:56] Speaker 00:
It's because everybody's in agreement of this evidence, which is we've got an unpredictable field.

[00:03:01] Speaker 00:
Once again, it has to be adequate for a reasonable mind.

[00:03:05] Speaker 00:
here, that simply isn't true.

[00:03:07] Speaker 00:
You look at all the evidence here and you're only left even after crediting the testimony of AVS expert.

[00:03:14] Speaker 00:
The record at most shows that while Pichia's yields can be high, we learned that E. coli's phytase yields are low, and that teaches away from the motivation to combine.

[00:03:25] Speaker 00:
That's from the prior Wodzinski reference.

[00:03:29] Speaker 00:
And there's no correlation between a higher yield of Pichia

[00:03:32] Speaker 00:
in a cheaper production, the economics, which is what the board relied on.

[00:03:36] Speaker 00:
If you look at the evidence behind what the board relied on, it was testimony from Dr. Robertson that PGE had high yields, and that would provide an economic incentive to combine.

[00:03:48] Speaker 00:
But there's also testimony that high yields require more culture supernatant, which is expensive.

[00:03:53] Speaker 00:
And there's no record evidence here showing which outweighs which one.

[00:03:57] Speaker 00:
Are you really saving money here?

[00:03:59] Speaker 00:
And that testimony about culture supernatant went unrebutted.

[00:04:04] Speaker 03:
KSR clearly teaches us that it doesn't have to be the best choice.

[00:04:11] Speaker 03:
It just has to be in the range of acceptable choices.

[00:04:14] Speaker 03:
though, and to judge Raina's point about the weight.

[00:04:20] Speaker 03:
I mean, certain weight was ascribed to certain of the testimony.

[00:04:23] Speaker 03:
And you mentioned it was clear that this was an unpredictable field.

[00:04:27] Speaker 03:
Well, that's not enough.

[00:04:29] Speaker 03:
The board analyzed.

[00:04:30] Speaker 03:
I mean, Robertson said what he said, the other experts said, and they credited certain portions of his testimony over the others.

[00:04:39] Speaker 03:
And you also mentioned the Witzowsky teaching away.

[00:04:43] Speaker 03:
Well, if one reference teaches away, that's not dispositive of the issue.

[00:04:48] Speaker 03:
The board understood what Wasinski said and considered that and weighed it as it thought it should.

[00:04:53] Speaker 03:
And that's a substantial evidence review.

[00:04:55] Speaker 03:
I grant you it's more than a scintilla.

[00:04:58] Speaker 03:
But substantial evidence based on a record that's very fact-based and based on testimony of experts is a really hard thing to overcome, right?

[00:05:08] Speaker 00:
I recognize it is a difficult standard to overcome.

[00:05:11] Speaker 00:
But I think in this case, it is met.

[00:05:13] Speaker 00:
And if you look at it, you mentioned the choices that were available.

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There is no record evidence indicating that there were only a few limited choices of phytase and host.

[00:05:22] Speaker 00:
In fact, it's the opposite.

[00:05:24] Speaker 00:
If you look at appendix page 15206, you'll see testimony from Dr. Robertson explaining that there were over 10,000 E. coli enzymes alone available to choose from.

[00:05:38] Speaker 00:
And if you look at the director's brief on page 40, the director says,

[00:05:43] Speaker 00:
Reiner discusses just two phytases from E. coli.

[00:05:47] Speaker 00:
Dasa narrows that down to just the APA gene.

[00:05:50] Speaker 00:
Cheng discloses a few examples of well-characterized industrial microbial production hosts.

[00:05:55] Speaker 00:
That's cherry picking.

[00:05:56] Speaker 00:
That's using the patent as a roadmap and using hindsight bias to build a story of how you could build this invention based on picking and choosing things from the prior art.

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And we know under KSR and this court's jurisprudence that that is insufficient.

[00:06:13] Speaker 03:
Can I move you back to where you started, which is the Kretz issue?

[00:06:16] Speaker 03:
And I think I heard you say here, argue substantial evidence with respect to the boy's determination.

[00:06:22] Speaker 03:
And I thought in your brief you were trying to make more of a legal argument than a substantial evidence argument.

[00:06:28] Speaker 00:
Yeah, I don't think I said substantial evidence with respect to Kretz.

[00:06:31] Speaker 00:
And if I did, I apologize.

[00:06:32] Speaker 00:
It was a slip of the tongue.

[00:06:34] Speaker 00:
So whether or not a reference is annotated as a question of law, there are underlying factual findings with that.

[00:06:40] Speaker 00:
And then the other standard that's involved here is the rule of reason standard for corroboration, which is a standard that this court developed over the years to ease the requirements of corroboration.

[00:06:51] Speaker 00:
So we have three standards at play when looking at CRETS.

[00:06:54] Speaker 00:
And a lot of things are certainly disputed with regards to CRETS, but much is not.

[00:07:00] Speaker 00:
It is undisputed from this court's jurisprudence that a few species can cover an entire genus.

[00:07:06] Speaker 00:
It is undisputed that Dr. Lee testified that he envisioned the genus

[00:07:10] Speaker 00:
it is undisputed that corroboration only requires this easier-to-meet rule of reason standard.

[00:07:15] Speaker 00:
So let's look at what was corroboration evidence here.

[00:07:19] Speaker 00:
You've got the April 16, 1997 manuscript, which is contemporaneous, and it's where Dr. Lee recognized that because it is a eukaryote, PCIA has many of the advantages of higher eukaryotic expression systems.

[00:07:32] Speaker 00:
You've got

[00:07:33] Speaker 00:
Dr. Robertson's own testimony that a skilled artisan at that time would have understood that successful expression in a yeast species would indicate successful expression in the broader genus.

[00:07:45] Speaker 00:
You've got Dr. Benedict, who's Cornell's expert, also agreeing with that.

[00:07:49] Speaker 00:
And then you have CRETS, which is a very interesting contemporaneous reference that was written to a skilled artisan and assumes that finger cells, such as yeast, can produce this E. coli phytase.

[00:08:03] Speaker 00:
Now, CRETS doesn't tell you how to do it.

[00:08:05] Speaker 00:
CRETS doesn't say it did it.

[00:08:07] Speaker 00:
But CRETS clearly thinks that it's within the mind of a skilled artisan.

[00:08:11] Speaker 00:
that this could be done once you accomplish certain things, which Dr. Lee did accomplish.

[00:08:17] Speaker 00:
Further, the only thing to meet the corroboration standard, or to annotate the reference that Cornell needs to show is that Dr. Lee disclosed at least as much as cruts, not actually the whole breadth of the claim.

[00:08:32] Speaker 00:
The whole breadth of the claim, we can talk about an enablement, written description.

[00:08:35] Speaker 00:
That's a different challenge.

[00:08:36] Speaker 00:
But here, all we have to do is beat cruts.

[00:08:38] Speaker 00:
And all Kretz did is said one line.

[00:08:41] Speaker 00:
It's a reference to fungal cells, with a typo, meaning fungal cells, such as a yeast, as an example of an appropriate host.

[00:08:49] Speaker 00:
So all that Cornell was required to show to meet its corroboration under this rule of reason standard was that Dr. Lee disclosed expression in fungal cells such as yeast.

[00:08:59] Speaker 00:
Well, he clearly did that.

[00:09:00] Speaker 00:
He did that in two different species.

[00:09:02] Speaker 01:
If we find that Kretz was prior to the 300-pound

[00:09:07] Speaker 01:
Does that anticipate or render obvious all the claims of the patent?

[00:09:11] Speaker 00:
So it's just for the 300 patent, and it was an obviousness.

[00:09:16] Speaker 00:
I believe it was an obviousness argument there.

[00:09:20] Speaker 00:
But the court considered Kretz, but if that's annotated, the combinations that include Kretz would go out.

[00:09:28] Speaker 03:
In other words, so the answer is yes to him.

[00:09:31] Speaker 03:
that would cover everything.

[00:09:32] Speaker 00:
For the 300 patents.

[00:09:33] Speaker 00:
Now there's five other patents that didn't involve CRETS, so the only issue for them is the motivation to combine on the other combination.

[00:09:41] Speaker 00:
So the last issue in this appeal relates to thermal stability of the claims 10 through 12 and 21 through 23.

[00:09:48] Speaker 03:
And there's a waiver issue involved in that.

[00:09:51] Speaker 00:
Yeah, but that's pretty baseless in our opinion.

[00:09:53] Speaker 00:
The waiver issue seems to be based on the fact that in the motivation to combine section we say

[00:09:59] Speaker 00:
All of these arguments apply to the combinations with Olson, too.

[00:10:02] Speaker 00:
That statement is limited in the motivation to combine section.

[00:10:06] Speaker 00:
The thermal stability section, if you look at our table of contents, is a separate section.

[00:10:10] Speaker 00:
It's combination agnostic.

[00:10:14] Speaker 00:
It's making arguments based on any combination that the board's findings related to thermal stability are not supported.

[00:10:22] Speaker 00:
The waiver argument doesn't really make sense to me.

[00:10:24] Speaker 00:
I think the director just misread our brief on that issue.

[00:10:29] Speaker 03:
Well, as I understood it, the argument is you're only arguing in herency.

[00:10:36] Speaker 00:
Yes.

[00:10:36] Speaker 03:
And the board relied as an alternative, I guess, on Olson.

[00:10:40] Speaker 03:
And you never attacked that or rebutted that or argued that.

[00:10:46] Speaker 03:
Is that the way you're understanding what the argument is?

[00:10:49] Speaker 00:
Well, it's that these arguments apply equally to Olson, just as they do every other combination.

[00:10:55] Speaker 00:
Because these arguments, like I said, are not directed to any particular reference.

[00:10:58] Speaker 00:
It's simply a lack of proof argument.

[00:11:01] Speaker 00:
If you look at the record, there's no data or analysis of the experts, other than the quotations that the board cited relate to the actual invention, not any combination.

[00:11:11] Speaker 00:
No expert said you take Olson, and you'll get these thermal stability ranges.

[00:11:16] Speaker 00:
And at least the board didn't rely on that.

[00:11:18] Speaker 00:
Of course, you can only affirm based on what the board relied on under SEC versus Chenery.

[00:11:25] Speaker 00:
So the board only relied on expert testimony about the invention.

[00:11:30] Speaker 00:
And there's insufficient evidence here on the record to show that these specific combinations would result.

[00:11:36] Speaker 00:
You take these combinations, not the invention, but these combinations that you're cherry picking, and you'd result in the actual thermo-stability ranges.

[00:11:43] Speaker 00:
There's no data.

[00:11:44] Speaker 00:
There's no analysis.

[00:11:45] Speaker 00:
There's just statements about the invention.

[00:11:48] Speaker 00:
So there's a mismatch there in the evidence.

[00:11:51] Speaker 00:
And if you compare this case to Haspera, which is the court's preeminent case on inherency.

[00:11:56] Speaker 01:
I thought your argument with respect to the thermal stability is that the board's finding isn't supported by substantial evidence because it doesn't disclose the specific claim temperatures.

[00:12:09] Speaker 00:
Correct, none of the combinations do.

[00:12:11] Speaker 01:
Does it have to disclose the specific range temperature or can it just disclose an increase in the temperature and thereby meet the thermal stability claim?

[00:12:24] Speaker 00:
So an increase in the temperature in your hypothetical would not be sufficient.

[00:12:27] Speaker 01:
You have to actually disclose... In an inherency inquiry.

[00:12:32] Speaker 00:
Yeah, you would have to show that the result of combining these references

[00:12:36] Speaker 00:
would inherently have this feature.

[00:12:39] Speaker 01:
Okay, and it appears to me that the evidence shows that.

[00:12:42] Speaker 01:
But I thought your argument was that there's no disclosure in the evidence as to a specific claimed temperature.

[00:12:50] Speaker 00:
Exactly.

[00:12:51] Speaker 00:
So you'd have to show that this specific claimed temperature, that's the feature I was talking about, is the temperature, because that's what's in the claim.

[00:12:58] Speaker 01:
So for inherently purposes, it's not enough to show just a rise in the temperature?

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

[00:13:05] Speaker 00:
Because that's not what the claims say.

[00:13:06] Speaker 00:
The claims have a specific range.

[00:13:09] Speaker 00:
So you have to meet the range.

[00:13:10] Speaker 00:
And if you can't show, in here there's just a failure of proof on the evidence.

[00:13:14] Speaker 00:
If the evidence doesn't show that you're going to hit that range, they don't have expert testimony saying that.

[00:13:19] Speaker 00:
They have expert testimony on the invention.

[00:13:21] Speaker 00:
And then the only other evidence that they relied on was an unsupported examiner statement that the thermal stability of the phytase would be an inherent characteristic of an phytase expressed in the yeast host cells.

[00:13:33] Speaker 00:
But he cited nothing and then withdrew that rejection.

[00:13:36] Speaker 00:
And then a statement from the applicant during prosecution history about similar properties.

[00:13:41] Speaker 00:
But we know from this court's jurisprudence that similar does not get us to inherency.

[00:13:47] Speaker 00:
Go ahead.

[00:13:48] Speaker 03:
No, you're into your rebuttal.

[00:13:50] Speaker 03:
So finish your statement and maybe you want to sit down.

[00:13:53] Speaker 00:
Yes.

[00:13:54] Speaker 00:
The last thing I was just going to note is that we're not in an inherency in an anticipation analysis.

[00:13:59] Speaker 00:
We're in an inherency in an obviousness analysis, which is a higher standard.

[00:14:03] Speaker 00:
And the board found no inherency with anticipation, but yes, with obviousness, which just further underlies the sort of confusing way that the board treated this issue.

[00:14:14] Speaker 00:
I'll reserve the rest of my time for rebuttal.

[00:14:15] Speaker 00:
Thank you.

[00:14:31] Speaker 03:
Good morning.

[00:14:31] Speaker 02:
Good morning.

[00:14:33] Speaker 02:
Your honors, and may it please the court.

[00:14:35] Speaker 02:
I'll start with obviousness, because that will dispose of all of the claims in the six patents in this consolidated appeal.

[00:14:42] Speaker 02:
With respect to obviousness, there's substantial evidence support for the board's finding of a motivation to combine with a reasonable expectation of its success of expressing the E. coli ap a phytase from Grineer and Dassa in either the fungal host of Chang or Romanos and Van Gorkum.

[00:15:00] Speaker 02:
With respect to Cornell's arguments that the experts agree upon unpredictability, that there's an wildly unpredictable field, we respectfully dispute that.

[00:15:13] Speaker 02:
And as Your Honors recognized, the board weighed the credibility of both experts and found that Dr. Robertson's testimony that there was a motivation to express this was credible.

[00:15:25] Speaker 02:
And with respect to the specific deposition testimony that counsel pointed out with respect to Dr. Robertson, he did not testify that you wouldn't expect bacterial phytase enzyme to work.

[00:15:38] Speaker 02:
He said you wouldn't expect all bacterial enzymes to work.

[00:15:42] Speaker 02:
And that's the 10,000 number that counsel

[00:15:45] Speaker 02:
represented, and that's at appendix 15206.

[00:15:49] Speaker 02:
If you continue on and read his deposition testimony at 15207, in addition to saying he would expect that bacterial phytases would work, he gives you a reason why, and that's because they have this cofactor in them that explain why he would expect the bacterial phytase to work when perhaps he wouldn't expect all bacterial enzymes, you know, all 10,000 of them in E. coli to work.

[00:16:13] Speaker 02:
And that's at 15207, but he also explains that in his appendix or his second declaration at appendix 5855.

[00:16:22] Speaker 02:
With respect to- Can you just clarify something?

[00:16:25] Speaker 04:
What are the bacterial enzymes that are different from phytanes that were the subject of the testimony you're just describing?

[00:16:34] Speaker 04:
So he doesn't list them- Stuff to get phosphorous out or stuff to get something else out?

[00:16:39] Speaker 02:
Basically, I think the best analogy would be to think of a human, and we have tons of enzymes.

[00:16:45] Speaker 02:
Now, obviously, a bacteria itself has many fewer enzymes, but there's still 10,000 that do a host of things to break down all sorts of different chemicals, to metabolize all different sort of things.

[00:16:59] Speaker 02:
Dr. Robertson did not go through all of

[00:17:02] Speaker 02:
the different various types of bacterial enzymes that are in E. coli.

[00:17:07] Speaker 02:
But I think a good analogy is just as we ourselves have thousands of different types of enzymes that do different things and make different proteins that we need to survive, so a bacteria does.

[00:17:17] Speaker 02:
This particular type of phytase in E. coli, there's a number of different ones.

[00:17:23] Speaker 02:
And Dr., you know, you can screen to find out which type of bacteria, which type of E. coli has different types of phytase.

[00:17:32] Speaker 02:
So, Kretz talks about the E. coli B phytase.

[00:17:35] Speaker 02:
There's also, as we know from Grenier and Dassa, the E. coli APA phytases.

[00:17:41] Speaker 02:
Those are just different types of phytase that do, as your honor recognized.

[00:17:44] Speaker 04:
What was the appendix page for this testimony that you're discussing?

[00:17:47] Speaker 02:
For the testimony about the... Well, I'll put your honors to the board decision where the board in talking about

[00:17:58] Speaker 02:
the obviousness of the phytases in view of pretz.

[00:18:03] Speaker 04:
And that is... I apologize.

[00:18:09] Speaker 04:
You don't actually have the appendix page for the testimony.

[00:18:12] Speaker 02:
Your Honor, I do not have that at hand just because that wasn't at issue in this court, so I do not have it, but I'm happy to supplement later if that's necessary.

[00:18:21] Speaker 02:
I can find it.

[00:18:22] Speaker 02:
Okay.

[00:18:24] Speaker 02:
With respect to counsel's discussion of the Wodzinski reference and teaching away, first I'd like to point out that the reply brief counsel argues, Cornell argues in the reply brief at 18 and 20, that Wodzinski teaches away from

[00:18:41] Speaker 02:
using hosts, that bacterial hosts or fungal hosts, that's simply not correct throughout the course of this proceeding.

[00:18:49] Speaker 02:
The entire focus on is whether Wodzinski teaches away from using bacterial phytases.

[00:18:55] Speaker 02:
That's the thing you put in the host.

[00:18:58] Speaker 02:
And so with respect to whether Wodzinski teaches away from bacterial phytases, the board looked, as they're supposed to do, at all of the statements in the art and the expert statements

[00:19:09] Speaker 02:
and found that when they looked at Dr. Robertson's testimony, that was not negated by Woodzinski's statement.

[00:19:17] Speaker 02:
At Appendix 84, the board said they looked at Dr. Robertson's testimony and decided whether or not it was still credible with the fact that he said Woodzinski itself does talk about some negative things about bacterial phytases.

[00:19:34] Speaker 02:
But the citations to their testimony that they have there say that

[00:19:39] Speaker 02:
go on to reflect that Dr. Robertson explained that despite Wodzinski's statement, one of Warnier's familiar would still have motivation because Wodzinski was, A, wrong about the pH of a bacterial phytase.

[00:19:53] Speaker 02:
He said it would be neutral to alkaline.

[00:19:55] Speaker 02:
And in fact, as Warnier says,

[00:19:57] Speaker 02:
It's a pH of 2.5, which is highly acidic.

[00:20:01] Speaker 02:
And also that one of ordinary skill in the art would know how to design around Woodzinski's problems.

[00:20:07] Speaker 02:
And so the board looked at all together in totality and found that the Woodzinski did not destroy the credibility of Dr. Robertson's statement.

[00:20:15] Speaker 02:
that Wooden Board Day skill in the art would be motivated to express the bacterial phytase.

[00:20:20] Speaker 02:
Notably, we don't have Woodzinski in the record, so that's an initial problem in finding that Woodzinski teaches away.

[00:20:27] Speaker 02:
The whole discussion before the board was whether or not Woodzinski

[00:20:33] Speaker 02:
causes a problem with the credibility of Dr. Robertson.

[00:20:37] Speaker 02:
So we have Dr. Robertson's deposition testimony and some prosecution statements.

[00:20:41] Speaker 02:
The board looked at all that and found, made a credibility determination based on that.

[00:20:47] Speaker 02:
With respect to counsel's discussion of an allegedly not rebutted economic argument, I'd like to point out that the board at appendix 81

[00:21:00] Speaker 02:
specifically credits Dr. Robertson on his experience with costs of production, specifically addresses the arguments of Dr. Benedict that Cornell relies on.

[00:21:12] Speaker 02:
They addressed paragraph 73 on this appendix 81, and they find that Dr. Robertson was more credible, that his discussion at appendix 5847 rebuts Dr. Benedict over whether E. coli is more cost-efficient.

[00:21:28] Speaker 02:
Just a few more points with respect to the... Can you just address Ms.

[00:21:34] Speaker 04:
Goldenberg's point about your sentences or sentence on page 40 of your brief that this kind of... I think she used the word cherry picking of going from Griner to DASA to Chang as I take it kind of infected by hindsight use of the patent itself.

[00:21:59] Speaker 02:
Yes, your honor.

[00:21:59] Speaker 02:
So this is with respect to the finite number of predictable solutions.

[00:22:03] Speaker 02:
And as we pointed out in our brief at page 40, Chang only discloses a few examples of well-characterized industrial microbial production hosts.

[00:22:13] Speaker 02:
And Dr. Robertson has a detailed discussion of that

[00:22:16] Speaker 02:
at appendix 5904.

[00:22:18] Speaker 02:
So it's not the board doing a cherry picking.

[00:22:21] Speaker 02:
It's that Dr. Robertson looked at the art and said, if I'm going to take Vernier, who says, I have this apé fine taste, I need to express it.

[00:22:31] Speaker 02:
I'm going to look to see where can I express it.

[00:22:33] Speaker 02:
And Chang tells me, I have a few well-recognized industrial production hosts.

[00:22:38] Speaker 02:
That is sufficient to narrow down the number of hosts that we're looking at.

[00:22:43] Speaker 02:
Now, when counsel mentioned that there's 10,000 out there, or in the reply brief, they talk about a million hosts out there, those are different considerations.

[00:22:52] Speaker 02:
With respect to the 10,000, as I already mentioned, that was discussion of how many E. coli enzymes are out there, not how many phytases were disclosed as having benefits, like Renear tells you that it's at...

[00:23:09] Speaker 02:
E. coli ap a phytase has these benefits.

[00:23:13] Speaker 02:
It is known for the feed industry, so we're also narrowing it down by the feed industry.

[00:23:17] Speaker 02:
Grenier talks about the feed industry.

[00:23:19] Speaker 02:
Chang talks about the feed industry.

[00:23:21] Speaker 02:
Then you have Chang telling you, this is an off-the-shelf kit.

[00:23:25] Speaker 02:
Romanos repeats that as well.

[00:23:27] Speaker 02:
You can buy this pichia from Invitrogen and use it.

[00:23:31] Speaker 02:
I'm going to tell you exactly how to do that.

[00:23:33] Speaker 02:
That is not telling one of ordinary skill in the art.

[00:23:36] Speaker 02:
Just figure it out, go out there in an art that's completely unpredictable and I'm not giving you any guidance.

[00:23:42] Speaker 02:
It's saying, here's the host, here's where you can buy it, here's exactly how to use it.

[00:23:50] Speaker 02:
millions of hosts that they discuss in the reply brief.

[00:23:55] Speaker 02:
I think it's important to distinguish between what we're looking at in obviousness, which is how many hosts were out there in the art to choose from versus what they're trying to claim in the broad scope of their claim with respect to all fungal hosts.

[00:24:10] Speaker 02:
So there's a difference.

[00:24:11] Speaker 02:
One would not have considered all fungal hosts because all fungal hosts weren't known in the art at the time to be used as industrial bacterial

[00:24:20] Speaker 02:
production host.

[00:24:21] Speaker 02:
That's a different question.

[00:24:22] Speaker 02:
That's the scope, the extremely broad scope of the claim that they're trying to get in the 300 patent.

[00:24:28] Speaker 02:
That is this 1 million number of fungal hosts out there.

[00:24:35] Speaker 02:
Finally, with respect to obviousness and thermostability, Your Honor, we would say it's pretty clear if you look at the opening brief at 44 to 48, despite counsel saying

[00:24:47] Speaker 02:
that they've discussed the Olson reference or they've argued the merits of the Olson reference.

[00:24:53] Speaker 02:
It simply does not mention Olson.

[00:24:55] Speaker 02:
It doesn't mention any of the arguments or citations of the board's discussion of why Olson found these thermostability arguments or why one would have been motivated to get these thermostability limitations with a reasonable expectation of success based on Olson.

[00:25:11] Speaker 02:
It only talks about inherently.

[00:25:13] Speaker 02:
So for that reason, they've waived any arguments.

[00:25:16] Speaker 04:
But what about the challenge to the sufficiency of the board's inherency finding?

[00:25:21] Speaker 04:
Put aside Olson.

[00:25:22] Speaker 02:
Certainly.

[00:25:23] Speaker 02:
So if this board forgives the waiver, we'd also argue that Olson by itself stands.

[00:25:28] Speaker 02:
And that's discussed at appendix 140, and then 93 to 100, which does not rely on inherency.

[00:25:33] Speaker 02:
That is a separate argument from inherency.

[00:25:36] Speaker 02:
The board found, based on Olson.

[00:25:38] Speaker 04:
Right.

[00:25:38] Speaker 04:
I'm sorry.

[00:25:39] Speaker 04:
I was asking, but put aside Olson, why did the board

[00:25:43] Speaker 04:
Why was the board's inherency without Olson finding sufficiently supported for the pretty high inherency standard?

[00:25:53] Speaker 02:
Yes.

[00:25:53] Speaker 02:
So with respect to the support, both experts agreed thermostability is the inherent result of expressing the same enzyme in the same phytase.

[00:26:04] Speaker 02:
So you have Dr. Robertson saying that at appendix 5820.

[00:26:07] Speaker 02:
Then you have Dr. Benedict saying that a defendant's 76, 95.

[00:26:13] Speaker 02:
That alone is enough to support the fact that when you have the same enzyme, app A, and the same phytase, fisha, you will get the same thermostability results.

[00:26:23] Speaker 02:
That is ample, we'd say, substantial evidence support.

[00:26:26] Speaker 04:
Would I be thinking about this wrong if I asked the question, aren't there other variables for

[00:26:33] Speaker 04:
that go into exactly how you express the same phytase and the same host that could actually change the thermostability properties of what comes out?

[00:26:46] Speaker 02:
Your honor, I'd say that could have been an argument that Cornell could have made.

[00:26:50] Speaker 02:
But the point is that neither expert said that.

[00:26:53] Speaker 02:
They said, yes, it is inherent.

[00:26:55] Speaker 02:
The examiner also said that.

[00:26:56] Speaker 02:
It is inherent when you express this aphephytase in this production host.

[00:27:01] Speaker 02:
I agree that in this art it seems like it may be likely, but that does not seem to be an argument that was made before the board pointing to any reason that you would have a different number come out.

[00:27:13] Speaker 02:
And one kind of, I think, good way to show how carefully the board thought about this is that you'll see that they did not find that Kretz anticipated the thermostability limitations

[00:27:26] Speaker 02:
because CRETS was a different E. coli.

[00:27:30] Speaker 02:
It was an E. coli B. phytase.

[00:27:33] Speaker 02:
And it was only a few amino acids different than E. coli app A. But the board recognized that that's not enough for an inherently.

[00:27:41] Speaker 02:
We need the same enzyme and the same phytase

[00:27:44] Speaker 02:
And E. coli B is not the same phytase.

[00:27:48] Speaker 02:
And therefore, it's not anticipated.

[00:27:50] Speaker 02:
So the board did a very thorough job consisting with this court's precedent in finding support for the inherency merits.

[00:27:57] Speaker 01:
With respect to the priority issue, can you address your opponent's arguments regarding corroboration?

[00:28:04] Speaker 02:
Yes, Your Honor.

[00:28:04] Speaker 02:
We believe that the board's finding of no corroboration for Dr. Lee's testimony that he conceived of using non-yeast fungal hosts is supported by substantial evidence.

[00:28:15] Speaker 02:
The board poured into a number of supports for a decision, including the document's entire focus on yeast hosts.

[00:28:25] Speaker 02:
Dr. Lee's testimony that his documents were silent as to any non-yeast fumble hosts.

[00:28:33] Speaker 03:
There's no- Well, just to save a little time, their argument seems to be more of a legal argument than a substantial evidence argument.

[00:28:40] Speaker 03:
And they cite some cases.

[00:28:42] Speaker 03:
there as they talk about the rule of reason.

[00:28:44] Speaker 03:
So why don't you address focus on that?

[00:28:46] Speaker 02:
Certainly.

[00:28:47] Speaker 02:
So the rule of reason importantly does not dispense with the requirement for corroboration.

[00:28:51] Speaker 02:
And here corroboration is judged by substantial evidence.

[00:28:54] Speaker 02:
So I'd say while it sounds like it's something different, because the rule of reason does not dispense with corroboration and whether or not there's substantial corroboration, which is the board found there is not, that is judged by substantial evidence.

[00:29:08] Speaker 02:
And here

[00:29:09] Speaker 02:
the substantial evidence overwhelmingly supports the board's finding of no corroboration.

[00:29:14] Speaker 02:
The expert testimony that Cornell points out is what Dr. Robertson and Dr. Benedict thought well later on in this timeline of this case, what they would have thought.

[00:29:25] Speaker 02:
That does not support that Dr. Lay himself thought that or disclosed it to others, which is what the corroboration requires.

[00:29:35] Speaker 04:
And Ms.

[00:29:35] Speaker 04:
Goldenberg also made the point that the

[00:29:38] Speaker 04:
crucial thing is to compare what Lay thought with a pretty slight commentary, let's call it, of Kretz in referring to a broader group of fungi.

[00:29:56] Speaker 02:
Yes, so they are correct that

[00:29:58] Speaker 02:
You need to only show prior invention of what the reference shows.

[00:30:03] Speaker 02:
However, as the board found, the reference shows more.

[00:30:07] Speaker 02:
They say, fungal hosts as a broad category, use them.

[00:30:11] Speaker 02:
That's important, use fungal hosts.

[00:30:13] Speaker 02:
And then yeast... The reference here being crits.

[00:30:15] Speaker 02:
Correct, correct.

[00:30:17] Speaker 02:
And then yeast as a non-limiting category there.

[00:30:20] Speaker 02:
Dr. Lay, on the other hand, said, just use yeasts.

[00:30:23] Speaker 02:
He didn't say use broader fungal hosts.

[00:30:25] Speaker 02:
And Kretz did say he used yeast.

[00:30:28] Speaker 02:
One of the ways we know that is that Cornell has not disputed Kretz's anticipation of disclosing filamental fungus hosts.

[00:30:37] Speaker 02:
So the board found that Kretz anticipates the disclosure of, or the claims that are directed to filamentous fungal hosts, and that's Appendix 53, and that's not disputed by Cornell.

[00:30:52] Speaker 02:
So Cornell is broader.

[00:30:53] Speaker 02:
They're saying use fungal hosts and in fact use filamental fungal hosts at minimum, which is broader than what Dr. Lay said, which is just use yeasts.

[00:31:03] Speaker 02:
I'm focused on yeasts, non-yeast fungal hosts.

[00:31:06] Speaker 02:
I've done it in these two.

[00:31:08] Speaker 02:
There's no documents talking about anything else.

[00:31:11] Speaker 02:
Dr. Lay's testimony said

[00:31:13] Speaker 02:
The documents are silent.

[00:31:15] Speaker 02:
And so any attempt to kind of change what the document says in this particular manuscript later on just doesn't match up, as the board found, with what Dr. Lay actually said.

[00:31:29] Speaker 02:
And so I see the amount of time.

[00:31:30] Speaker 02:
Unless your honors have any other questions, we ask that you reject Cornell's attempt to reweigh the evidence both for obviousness and anti-dating.

[00:31:41] Speaker 03:
Seeing no questions, thank you.

[00:31:42] Speaker 03:
Thank you.

[00:31:43] Speaker 03:
We went a little over, so Ms.

[00:31:45] Speaker 03:
Goldberg, will we store your remarks or rebut?

[00:31:57] Speaker 00:
Thank you, Your Honor.

[00:31:58] Speaker 00:
Three main brief points to make on rebuttal.

[00:32:01] Speaker 00:
The first is there's no record evidence of how many industrial posts were available at that time to choose from.

[00:32:08] Speaker 00:
Chang discusses a couple, but there's no record that those were the only ones.

[00:32:12] Speaker 00:
And once again, it was their burden to prove obviousness.

[00:32:15] Speaker 00:
And without a record to show, and there's agreement that there were millions of possible combinations and many possible hosts in general.

[00:32:22] Speaker 00:
So the director's attempts to sort of limit that to just the few that are in Chang is classic hindsight bias.

[00:32:30] Speaker 00:
The second issue is that

[00:32:34] Speaker 00:
regards Olson.

[00:32:36] Speaker 00:
And I heard the argument again on waiver.

[00:32:39] Speaker 00:
We believe that the Olson findings were based on inherency only, but to the extent the court does want to review our opening brief, we did address Olson separately on page 31, where we reference it that the board actually miscites Olson.

[00:32:55] Speaker 00:
And if you go to appendix page 63, you'll see the quote

[00:32:59] Speaker 00:
where the board says that Olson discloses that a bacterial cellulose synthesized in yeast was found to be heavily glycosylated and that the thermostability was improved relative to the native form.

[00:33:10] Speaker 00:
The board ends the citation there.

[00:33:11] Speaker 00:
Olson goes on to say, but the increase was moderate.

[00:33:14] Speaker 00:
Olson does not disclose the thermostability claims.

[00:33:17] Speaker 00:
And you can also look at Olson on appendix page 10740.

[00:33:21] Speaker 00:
Opposing counsel mentioned that

[00:33:27] Speaker 00:
Dr. Lee said just use yeast.

[00:33:30] Speaker 00:
I heard that during argument.

[00:33:31] Speaker 00:
He never said that.

[00:33:33] Speaker 00:
If you look at his manuscript, he clearly references why the fungal hosts that he chose are successful and why he doesn't think that the invention is limited to the yeast.

[00:33:44] Speaker 00:
And the testimony that they relied on in their brief, which is on appendix page 8729 at page 359, doesn't say that he never thought about using broader fungal hosts.

[00:33:55] Speaker 00:
It just says that his own experimental records don't show that he successfully expressed it in the broader fungal host.

[00:34:06] Speaker 00:
That's one last point I want to make as well, is that the analysis on motivation to combine for the 300 patent mentions cruts and relies heavily on cruts in the other combinations, which makes it much more difficult for this court to understand exactly why it found motivation to combine.

[00:34:22] Speaker 00:
There's a lot of citations back to the analysis in cruts

[00:34:25] Speaker 00:
a lot of citations to CRETS.

[00:34:26] Speaker 00:
So if CRETS is indeed anodated, then at minimum, this court should consider reversing or vacating the findings as to the 300 patent and sending that back so that we can get clear findings on the motivation to combine.

[00:34:40] Speaker 00:
I know Judge Sharonto asked me earlier about motivation to combine.

[00:34:43] Speaker 00:
Now, if you affirm across the board, my answer still stands, but if you affirm across the board on motivation to combine, you don't need to address the CRETS reference.

[00:34:52] Speaker 00:
You can also look specifically at the 300 patent and see how CRETS infected the analysis.

[00:34:57] Speaker 00:
And then I wouldn't affirm across the board and would reverse on that.

[00:35:00] Speaker 00:
So I just wanted to clarify that.

[00:35:02] Speaker 03:
Thank you.

[00:35:03] Speaker 03:
Thank you.

[00:35:03] Speaker 03:
We thank both sides and the case is submitted.