[00:00:11] Speaker 05:
Okay, the next argued case is number 16-2116, ABT Holding Company against Garnet Biotherapeutics, Incorporated.

[00:00:27] Speaker 05:
When you're ready, Mr. Huntington.

[00:00:48] Speaker 01:
Morning, Your Honors.

[00:00:51] Speaker 01:
Excuse me.

[00:00:52] Speaker 01:
This interference that's involved in this appeal had two patents and an application for FERC and two applications for HO.

[00:01:01] Speaker 01:
And it relates to cell populations that co-express two markers, 49C and 90.

[00:01:08] Speaker 01:
And there were two issues, root description and interference in fact.

[00:01:12] Speaker 01:
And the two HO specifications are intrinsic evidence in this case.

[00:01:18] Speaker 01:
And they contain two definitions, two different definitions of co-express.

[00:01:24] Speaker 01:
The broader definition states that the two markers can be identified.

[00:01:29] Speaker 02:
Let me ask you a question that bothers me quite a bit.

[00:01:33] Speaker 02:
In the red brief, Appellee states that Dr. Verphi's publication in blood experimental hematology was retracted.

[00:01:47] Speaker 02:
which is a significant event for a scientist.

[00:01:50] Speaker 02:
And in your gray brief, you say, Ho argued at numerous instances in its brief, in particular with regard to a lack of written descriptions, support for FERC 118, and so on, such that data presented in two research publications by the FERC inventors had been falsified.

[00:02:11] Speaker 02:
Such allegations of inequitable conduct by Ho in its original list of proposed motions

[00:02:16] Speaker 02:
were expunged by the board as improper.

[00:02:18] Speaker 02:
Indeed, the board did not allow Ho to submit such a motion and made no findings regarding the issue.

[00:02:24] Speaker 02:
That statement doesn't resolve Appellee's statement for me.

[00:02:28] Speaker 02:
I want to know whether Dr. Verfy's publication in Blood and Experimental Hematology was retracted.

[00:02:35] Speaker 01:
It was retracted, yes, Your Honor.

[00:02:36] Speaker 02:
Because it's never discussed.

[00:02:38] Speaker 01:
It was not discussed because the board didn't decide that issue.

[00:02:42] Speaker 01:
The board specifically said at the very end of the decision that the whole question of inequitable conduct or all of that was not a decision that they made.

[00:02:51] Speaker 01:
And so we didn't discuss it.

[00:02:52] Speaker 01:
I will tell you that all of that information was given to the examiner.

[00:02:56] Speaker 01:
It was all reviewed.

[00:02:58] Speaker 01:
And these cases were allowed and issued over that.

[00:03:03] Speaker 02:
Is that incorrect?

[00:03:05] Speaker 02:
Yeah.

[00:03:05] Speaker 02:
It looked like it was obfuscation.

[00:03:07] Speaker 02:
And that's why it was concerned.

[00:03:09] Speaker 01:
That's a fair answer.

[00:03:10] Speaker 01:
Nothing that's important to this particular piece.

[00:03:12] Speaker 02:
Fair answer.

[00:03:14] Speaker 01:
So going back to this question of co-expression, when you look at the decision, it talks about just on a cell, whereas that definition says that it would be an expression in a collection of cells.

[00:03:33] Speaker 01:
So the board's decision, by not considering that second definition,

[00:03:39] Speaker 01:
was wholly defective, and it should be remanded so that they look at both definitions and not just the narrow one.

[00:03:46] Speaker 01:
And the reason why that is important is because it- Now where's the narrow definition found?

[00:03:53] Speaker 01:
The narrow definition is in the 244 application of hope.

[00:03:59] Speaker 01:
It is in the appendix.

[00:04:10] Speaker 01:
page 119, I believe.

[00:04:20] Speaker 01:
So the narrower definition.

[00:04:23] Speaker 03:
And so where is it 119?

[00:04:24] Speaker 01:
Yeah, it's the appendix page 119, which is page 12.

[00:04:30] Speaker 01:
And it talks about

[00:04:42] Speaker 01:
At the very bottom of the page, it says, actually, this is the broader definition.

[00:04:50] Speaker 01:
It says co-express or co-expresses.

[00:04:53] Speaker 01:
And then at the top of page 13, appendix page 120, it says, on or in a single cell or alternatively on or in a collection of cells.

[00:05:06] Speaker 01:
In the other application, the 244 application, this is the 685, it stops.

[00:05:13] Speaker 01:
before that semicolon, and it simply says on the single cell.

[00:05:18] Speaker 01:
Where is that?

[00:05:21] Speaker 03:
That is... I have the 244, Appendix 7, I guess it is.

[00:05:30] Speaker 01:
Yes, it's Appendix page 57, and it's line 19 and 20.

[00:05:40] Speaker 01:
It says,

[00:05:41] Speaker 01:
that's used here again refers to the simultaneous detection of two or more molecules on or in a single cell.

[00:05:55] Speaker 01:
So as you can see, the definition that the board used is the one that's on Appendix Page 57 that talks about a single cell.

[00:06:04] Speaker 01:
They never looked at the one that's on Appendix Page 120 that talks about

[00:06:11] Speaker 01:
on or in a collection of cells.

[00:06:14] Speaker 01:
And because of that mistake, it permeates the entire decision with respect to the 037 patent and the 256 application.

[00:06:23] Speaker 01:
Now, the 118 patent, I want to talk about separately.

[00:06:26] Speaker 03:
Why is that a mistake?

[00:06:27] Speaker 03:
They chose a definition.

[00:06:29] Speaker 03:
They chose a definition from the 244, right?

[00:06:34] Speaker 01:
They took that definition, but they never even acknowledged the fact that there was a different definition.

[00:06:39] Speaker 01:
If they had said, Your Honor,

[00:06:41] Speaker 01:
There are two definitions, and we choose this one, not this other one, then that would have been different.

[00:06:45] Speaker 01:
But that's not what they did.

[00:06:46] Speaker 01:
They took the narrower one, and they never acknowledged that there was a broader definition that they could have looked at.

[00:06:55] Speaker 01:
And that's the point.

[00:06:55] Speaker 03:
We think they should have looked at the broader definition because it would have made a difference in terms of their... You're saying if they looked and said, here's this, here's A, here's B, we choose A, instead of just choosing A, there wouldn't be a problem.

[00:07:11] Speaker 01:
There might still be a problem, but that's not the problem here.

[00:07:15] Speaker 01:
The problem here is there's a broader definition, and we explain in here why it would make a difference if you use the broader definition.

[00:07:22] Speaker 01:
And the only way to fix that is to send it back to the board to have them look at it and reconsider the evidence with the broader definition.

[00:07:32] Speaker 01:
And the reason is when you look at the Dean's Declaration and how this whole definition of what you have to show in terms of

[00:07:40] Speaker 01:
being expressed on cells, it's the position of Ho that you have to show that do simultaneous detection on a single cell, whereas what was done in the Dean's experiment is he had two aliquots.

[00:07:55] Speaker 01:
He tested for one marker, the first aliquot, then he tested on the second aliquot, and then he said because it tested both of those, that means that it satisfies the limitation with respect to co-expression.

[00:08:07] Speaker 05:
But you're saying on the narrower definition is no interference in fact, and on the broader definition you would want to remand?

[00:08:15] Speaker 01:
For the broader definition with respect to determining interference in fact, yes, Your Honor.

[00:08:22] Speaker 01:
So I also want to just point out a second thing with respect to that.

[00:08:30] Speaker 01:
And that is that it shouldn't make a difference

[00:08:35] Speaker 01:
whether they decide no interference in fact first, or they decide written description first.

[00:08:40] Speaker 01:
You should get the same result with respect to the patentability of these particular claims.

[00:08:45] Speaker 01:
But that's not what happened here.

[00:08:47] Speaker 01:
Here, the board first went through and analyzed written descriptions.

[00:08:50] Speaker 01:
So they said, we're going to look at written description of the FERC claims using the whole specifications, and that's appropriate.

[00:08:56] Speaker 01:
That's what the law says.

[00:08:57] Speaker 01:
So they went through that, and they said, well,

[00:09:00] Speaker 01:
you don't have written description under that.

[00:09:02] Speaker 01:
Now, if they had used the correct definition, we think they would have.

[00:09:06] Speaker 01:
But under the definition they used, they said, you don't have that.

[00:09:10] Speaker 01:
Then they went forward and said, nevertheless, we're going to look at the no interference in fact.

[00:09:17] Speaker 01:
And then when they went through and did that, they still continued using that definition rather than looking at what is the... Did FERC copy the definition of co-express from the 244?

[00:09:29] Speaker 01:
We did not copy any definition of co-expression.

[00:09:32] Speaker 01:
In fact, Your Honor, we didn't even ask for the interference.

[00:09:35] Speaker 01:
We put in a claim that was a broader claim in a sense.

[00:09:39] Speaker 01:
It doesn't recite the 91% we're talking about here.

[00:09:43] Speaker 01:
And the patent office decided to take not only the application where we had copied that, the 256 application, and put it into interference, but they brought in the 037 patent, which it issued several years before, that had no limitation with respect to percentage.

[00:09:58] Speaker 01:
And they brought in the 118 patent that doesn't even recite these two markers.

[00:10:04] Speaker 01:
So it was not something that we asked for.

[00:10:09] Speaker 01:
It was kind of thrust upon us.

[00:10:11] Speaker 01:
And that's part of my point here.

[00:10:13] Speaker 01:
When you look at the 118 patent, it was judged on the specification of the 118 patent.

[00:10:21] Speaker 01:
They looked at the claims, and they said, OK, we're going to judge those that way.

[00:10:25] Speaker 01:
But with respect to the 037,

[00:10:27] Speaker 01:
And the 256 cases, they looked at it and they said, well, because you asked for an interference, we're not going to look at your specification.

[00:10:36] Speaker 01:
We're going to look at the specification of ho and figure out what your claims are.

[00:10:41] Speaker 01:
If there's no interference, there's no reason to continue looking at the ho application.

[00:10:46] Speaker 01:
You look at the FERC application.

[00:10:47] Speaker 01:
What does the FERC application say?

[00:10:49] Speaker 01:
And what do those claims say?

[00:10:50] Speaker 01:
They don't have a percentage.

[00:10:52] Speaker 01:
The application does say that it's

[00:10:57] Speaker 01:
that you co-expressed, that you have both markers.

[00:10:59] Speaker 01:
So if you were only looking at the FERC applications and the FERC specifications, then there wouldn't be a problem with respect to these claims.

[00:11:06] Speaker 01:
It's only because of how they did the analysis, the order they did them, that issue arises.

[00:11:15] Speaker 03:
Now, one of the problems the board had was with the deans.

[00:11:20] Speaker 03:
Didn't give a lot of credibility, saw problems in the deans' analysis.

[00:11:24] Speaker 03:
Is that correct?

[00:11:25] Speaker 01:
They looked at Dean's, first of all, let me be clear that the Dean's application was, or declaration was not done for purposes of starting an interference.

[00:11:34] Speaker 01:
It was work that had been done before.

[00:11:37] Speaker 01:
But when you look at the Ho application, all six of these factors, they have a very broad range.

[00:11:43] Speaker 01:
And they say, you can vary this, you can vary this, you can vary this, and yet you still get our claim sells.

[00:11:49] Speaker 01:
That's what they say in Ho.

[00:11:50] Speaker 01:
And what FERC did was,

[00:11:52] Speaker 01:
Rather than repeating the experiment, for example, one, he had done experiments in which he had done things that were within FERC, but also within HOE.

[00:12:04] Speaker 01:
And he said, here are the results.

[00:12:07] Speaker 01:
And the results show greater than 91% of both of these markers being expressed.

[00:12:12] Speaker 01:
But because of the definition that had been used, the board said, first, both that it wasn't inherent and that

[00:12:21] Speaker 01:
that it didn't satisfy the definition.

[00:12:24] Speaker 05:
OK.

[00:12:24] Speaker 05:
Let's hear from the other side, and we'll save you rebuttal time.

[00:12:28] Speaker 01:
OK, Your Honor.

[00:12:29] Speaker 05:
Is there any other point you want to raise?

[00:12:32] Speaker 01:
Well, there was.

[00:12:33] Speaker 01:
I just wanted to, I didn't get a chance to talk at all about the 118 claims because you were asking about the 118-17.

[00:12:39] Speaker 01:
But I can do that during my rebuttal time if you prefer, Your Honor.

[00:12:43] Speaker 01:
But I couldn't give them a chance to.

[00:12:43] Speaker 05:
Well, no, I think maybe take another minute and outline what you want to tell us.

[00:12:46] Speaker 01:
OK.

[00:12:46] Speaker 01:
All right.

[00:12:46] Speaker 01:
With respect to the 118 claims,

[00:12:48] Speaker 01:
The literal words of the claim are in the FERG specification.

[00:12:52] Speaker 01:
Ariad and AbbVie are not applicable, because those claims in those other cases were directed to a large genus, and those claims didn't have the structural and functional limitations that we have here.

[00:13:04] Speaker 01:
We have that we cite the claims are multipotent, that they're non-embryonic, that they're non-germ cells, that they can differentiate into various cell types, that they've undergone 10 to 40 cell doublings, and they recite the expression of

[00:13:18] Speaker 01:
on telomerase.

[00:13:20] Speaker 01:
So they have all of those things.

[00:13:23] Speaker 01:
And the other point that I want to make, your honor, is Hose says you can get it from any tissue.

[00:13:29] Speaker 01:
Why should it not be true that we can get it from any tissue?

[00:13:32] Speaker 01:
And the last one is just the board goes to a particular passage and they say, yes, you show mouse brain, liver, bone marrow, but you only show human bone marrow.

[00:13:44] Speaker 01:
And here's one passage that shows that mouse doesn't

[00:13:47] Speaker 01:
act the same way human does.

[00:13:49] Speaker 01:
Well, that's at zero days.

[00:13:51] Speaker 01:
But there's a passage.

[00:13:52] Speaker 01:
The very next sentence says, at 14 days, they do act the same.

[00:13:57] Speaker 01:
And if you used for the human cells to isolate brain and liver in the same way that you did for the bone marrow, you would expect it to work the same way, in exactly the same way that for mouse the procedures used work for all three tissues.

[00:14:14] Speaker 01:
Thank you.

[00:14:14] Speaker 05:
OK.

[00:14:14] Speaker 05:
Thank you, Mr. Huntington.

[00:14:24] Speaker 05:
OK, Mr. Dowd.

[00:14:25] Speaker 00:
Good morning, Your Honor.

[00:14:27] Speaker 00:
May it please the court, Matthew Dowd for the appellee garnet about therapeutics.

[00:14:31] Speaker 00:
I'd like to pick up right where my colleague left off with the 118 patent, but also directly address your question, Judge Wallach, about our comment about verified and falsified data.

[00:14:42] Speaker 00:
I want to clarify that, because I think it's important, particularly for the 118 patent.

[00:14:46] Speaker 00:
We're not raising the inequitable content issue.

[00:14:48] Speaker 00:
That issue is still alive and goes back down.

[00:14:51] Speaker 00:
But the falsification of data is directly applicable to the written description analysis of the 118 claim.

[00:15:00] Speaker 00:
Both experts acknowledge that.

[00:15:01] Speaker 00:
We have expert testimony on that.

[00:15:03] Speaker 00:
And it all goes to the predictability of the field and of the art.

[00:15:07] Speaker 00:
And so we have a situation where a university researcher published articles in Nature, in Blood, some of the top journals.

[00:15:19] Speaker 00:
They're retracted.

[00:15:20] Speaker 00:
Both experts on both sides say this is a significant event.

[00:15:24] Speaker 00:
The university said this was falsified.

[00:15:26] Speaker 00:
So it all goes to the predictability and the state of the art.

[00:15:30] Speaker 00:
And it sort of turns me to another issue I'd like to just raise very briefly, is when if you look at the blue brief in this case, and this is how we responded with the red brief, they're almost all factual issues that were raised.

[00:15:43] Speaker 00:
And we responded in kind.

[00:15:45] Speaker 00:
And as the court knows well, the court

[00:15:49] Speaker 00:
excuse me, the standard of review, substantial evidence.

[00:15:52] Speaker 00:
And this is a battle of the experts for a lot of those factual issues.

[00:15:58] Speaker 00:
There's testimony on both sides.

[00:16:00] Speaker 00:
There are five volumes of joint appendix.

[00:16:03] Speaker 00:
I counted last night.

[00:16:03] Speaker 00:
We have 50 articles, 50 peer-reviewed articles that are cited.

[00:16:07] Speaker 00:
So we think that in almost every issue that was raised, there's substantial evidence supporting the board's conclusion.

[00:16:14] Speaker 00:
Now with that being said, I'd like to turn back

[00:16:18] Speaker 00:
the issue about claim construction.

[00:16:20] Speaker 00:
Now, again, the appellant rests a lot of their appeal, at least in the blue brief, about factual issues.

[00:16:28] Speaker 00:
But I'll pause it for a second, but I'll turn back to it.

[00:16:33] Speaker 00:
The claim construction issue is a red herring.

[00:16:36] Speaker 00:
And to the extent that we didn't make that as clear as possible in the brief, I apologize to the court.

[00:16:41] Speaker 00:
But let me explain why.

[00:16:44] Speaker 00:
And it goes back to two reasons.

[00:16:48] Speaker 00:
With respect to your comment, Judge Schall, FERC did copy these claims.

[00:16:54] Speaker 00:
They said they're copying the claims.

[00:16:56] Speaker 03:
They said 2597, FERC asked that an interference be declared between the above-captioned application, its application, and the HO244 application.

[00:17:08] Speaker 03:
Doesn't that necessarily bring in the definition or the discussion about

[00:17:16] Speaker 03:
code expression in HO244.

[00:17:20] Speaker 00:
Correct, HO244.

[00:17:22] Speaker 03:
But this has been... Where it has to be on one cell.

[00:17:27] Speaker 00:
Let me step aside for a second.

[00:17:29] Speaker 00:
I think if you look at the data, we don't dispute that the distinction between one cell testing versus a population cell testing, it doesn't matter in terms of the conclusion of the board.

[00:17:42] Speaker 00:
And again, perhaps I didn't make that as clear as possible in the red brief.

[00:17:46] Speaker 00:
But what makes the difference with respect to the claim construction is what FERC was arguing was that you have to look at the 6.85 pattern.

[00:17:54] Speaker 00:
And there, there's some discussion, and my colleague didn't really get into this on opening, is that there's discussion about, does protein expression mean the same thing as mRNA transcripts?

[00:18:09] Speaker 00:
Both experts on both sides acknowledge that they're not equivalent.

[00:18:12] Speaker 00:
And so just because you show mRNA

[00:18:16] Speaker 00:
expression doesn't necessarily mean that you get protein expression.

[00:18:20] Speaker 00:
Now that brings us back to whether there's written description support in FERC's application for its claim.

[00:18:30] Speaker 00:
I'll admit this is a confusing case because we have a number of applications depending on what issue you're looking at.

[00:18:36] Speaker 00:
You look at different specifications for the claim construction.

[00:18:39] Speaker 00:
So let's walk through this.

[00:18:41] Speaker 00:
With the written description of the FERC claim,

[00:18:46] Speaker 00:
We look at the host specification and say, well, how is co-expressed defined?

[00:18:51] Speaker 00:
There's nothing in the specifications that says, when you're analyzing expression of the protein, mRNA is sufficient to show expression of the protein.

[00:19:00] Speaker 00:
I mean, that's our ultimate point here with respect to the claim construction.

[00:19:06] Speaker 00:
So then you go back.

[00:19:07] Speaker 00:
With that claim construction, you say, well, claim construction for co-expressed, you have to demonstrate expression of the protein

[00:19:15] Speaker 00:
So then we go back to the first specification and look at what's disclosed in that specification.

[00:19:21] Speaker 00:
So either the 037 patent or the 256 application.

[00:19:26] Speaker 00:
They're both the same specifications.

[00:19:29] Speaker 00:
Nowhere in that specification do the inventors ever state that expression of mRNA is the same as expression of a protein.

[00:19:40] Speaker 00:
Dr. Keating, first expert,

[00:19:43] Speaker 05:
That's the only way proteins is expressed from the RNA or the DNA.

[00:19:49] Speaker 05:
So why do you have to say so?

[00:19:51] Speaker 00:
Your Honor, I would respectfully disagree with that premise, both from a scientific perspective, but also based on the evidence in this record.

[00:19:58] Speaker 00:
Because this is exactly what I was saying.

[00:20:00] Speaker 00:
Dr. Keating, for its own expert, acknowledged that showing mRNA transcripts in a cell is not enough to show protein expression.

[00:20:10] Speaker 05:
Well, then you have no interference in fact.

[00:20:13] Speaker 00:
Correct, John.

[00:20:14] Speaker 00:
There is no interference in fact here.

[00:20:16] Speaker 00:
Now, let me bring you to a second point, though.

[00:20:19] Speaker 00:
And this goes to really what this case is about in terms of both written description and interference in fact.

[00:20:26] Speaker 00:
And this is how it's been presented from day one.

[00:20:28] Speaker 00:
And this is going back to 2005.

[00:20:29] Speaker 00:
This is how long this case has been going on.

[00:20:33] Speaker 00:
FERC has always argued that the cell population that is disclosed in the FERC specification 037

[00:20:43] Speaker 00:
inherently expresses both CD90 and CD49C.

[00:20:49] Speaker 00:
We acknowledge that the specification demonstrates that it expresses CD90.

[00:20:57] Speaker 00:
The specification doesn't say that the sales express CD49C.

[00:21:01] Speaker 00:
Our experts support that conclusion.

[00:21:04] Speaker 00:
Now, if you go back and you look at every publication that Dr. Fervai, one of the inventors, published, not a single time

[00:21:14] Speaker 00:
Did she or her group ever identify CD49C as a protein associated with this particular stem cell population?

[00:21:23] Speaker 00:
So that's one point.

[00:21:24] Speaker 00:
That by itself is substantial evidence.

[00:21:26] Speaker 00:
Second, though, and this gets to our broader argument about the dean's declaration, and I think this is to your question, Judge Schall, is that, and this is really what the board picked up on, is that, and it gets to the inherency argument.

[00:21:42] Speaker 00:
They've always argued that,

[00:21:44] Speaker 00:
their cells inherently express these two protein markers.

[00:21:48] Speaker 00:
Now, to demonstrate that, as was discussed in the case prior to ours, for inherency, you have to show that the invention necessarily leads to whatever your conclusion or facts that you want to show.

[00:22:00] Speaker 00:
To do that, FERC was obligated to show that the method and the cells described in the FERC specification produce

[00:22:11] Speaker 00:
the co-expression of CD49C and CD90.

[00:22:15] Speaker 00:
They never did that.

[00:22:15] Speaker 00:
They never tested.

[00:22:17] Speaker 00:
I was about to say that they never tested the FERCT cells, but I caught myself.

[00:22:23] Speaker 00:
Because if you go back and you look at the cross-examination testimony at, I can pull this up in a second, but if you look at the cross-examination of Dr. Deans, he acknowledges that they did in fact make FERCT cells according to the single method

[00:22:40] Speaker 00:
disclosed in the first specification.

[00:22:44] Speaker 00:
They had that data.

[00:22:45] Speaker 00:
They never presented it in this case.

[00:22:48] Speaker 00:
So what did we do in kind?

[00:22:51] Speaker 00:
Well, we looked at the method used.

[00:22:53] Speaker 00:
We looked at the science.

[00:22:55] Speaker 00:
We have testimony, documents, evidence demonstrating that when you don't use the same methods, you won't necessarily get the same cells.

[00:23:06] Speaker 03:
They used different oxygen levels in a different sort of

[00:23:10] Speaker 03:
A culture.

[00:23:11] Speaker 03:
And a different shape.

[00:23:14] Speaker 02:
Yeah.

[00:23:14] Speaker 02:
Class.

[00:23:14] Speaker 00:
Correct.

[00:23:14] Speaker 00:
Correct.

[00:23:16] Speaker 00:
And again, these are all factual questions.

[00:23:19] Speaker 00:
They're all supported by substantial evidence.

[00:23:21] Speaker 00:
But I'll focus on the two.

[00:23:23] Speaker 00:
And so the oxygen levels.

[00:23:27] Speaker 00:
In the first specification, it's silent on oxygen.

[00:23:31] Speaker 00:
But Dr. Deans, Dr. Keating, and our expert Dr. Finney all say that when a reference is silent about oxygen,

[00:23:39] Speaker 00:
what they call normoxia, 20%, 21%, is what we're breathing right now.

[00:23:45] Speaker 00:
In the HOPE specification, they're specific.

[00:23:48] Speaker 00:
The method used to make the spell sells 5%.

[00:23:51] Speaker 00:
In the Dean's declarations, 5% oxygen.

[00:23:57] Speaker 00:
And I suspect part of that is because, and this is consistent with the other evidence in the record, is that

[00:24:05] Speaker 00:
There's this long history of no one being able to reproduce these so-called map C cells that are disclosed in the FERC specifications but could never be reproduced and that were subject to the retracted articles and the falsified data.

[00:24:23] Speaker 00:
Again, I'm not bringing up an ethical conduct.

[00:24:25] Speaker 00:
It all goes back to a factual dispute that appellants raised in their blue brief saying that

[00:24:31] Speaker 00:
This was not an unpredictable feeling.

[00:24:33] Speaker 02:
Is there evidence about that 5%?

[00:24:35] Speaker 02:
I mean, I think I see where you're going with that.

[00:24:38] Speaker 02:
But is there evidence that they were manipulating it for that purpose?

[00:24:42] Speaker 00:
No, Your Honor.

[00:24:43] Speaker 00:
I didn't mean to say that that's why they did that.

[00:24:47] Speaker 00:
But it's an inference that I'm just talking off the top of my head.

[00:24:51] Speaker 00:
I don't want the court to rely on that.

[00:24:53] Speaker 03:
But you could just ask the court to rely on the fact that a different oxygen level was used.

[00:24:58] Speaker 00:
Yes, Your Honor.

[00:25:00] Speaker 00:
consistent testimony by both experts acknowledging that when you change the oxygen level, you don't know how that will affect.

[00:25:10] Speaker 00:
I'm being generous here when you say you don't know, because I also believe that there's evidence saying that with respect to certain markers, you know for a fact that protein markers will change.

[00:25:21] Speaker 00:
And in fact... It's in there.

[00:25:26] Speaker 00:
So it's in Keating's testimony, there's a profile reference that specifically states it's a 2005 reference.

[00:25:34] Speaker 00:
And in 2005, they changed the oxygen levels.

[00:25:37] Speaker 00:
So ultimately, in a broad picture, this is a question about, with respect to the written description analysis, is whether there is written description support, inherent support, that the cells disclosed in the FERC specification made by a single method

[00:25:55] Speaker 00:
inherently express the two markers that they now claim in their patent.

[00:26:00] Speaker 00:
Now, we're not saying that they didn't invent certain types of cells.

[00:26:04] Speaker 00:
But what we're saying is that there's no evidence to demonstrate that they had possession of a population of cells that co-express these two markers.

[00:26:14] Speaker 00:
And I acknowledge that.

[00:26:15] Speaker 00:
I think our argument was primarily based on the 91% limitation.

[00:26:20] Speaker 00:
But I think when you analyze the dean's

[00:26:23] Speaker 00:
declaration, you understand that they're not representative of what's in the FERC specification.

[00:26:28] Speaker 00:
The actual limitation of the co-expression doesn't matter, because they haven't demonstrated 70%.

[00:26:36] Speaker 00:
They haven't demonstrated any co-expression.

[00:26:40] Speaker 00:
Now, one last thing.

[00:26:41] Speaker 00:
I have a couple more minutes.

[00:26:42] Speaker 00:
In addition to the oxygen level, we have the media that's different.

[00:26:46] Speaker 00:
And in fact, in the second Dean's declaration, Dr. Dean's never even specified what media he used.

[00:26:54] Speaker 00:
And Judge Wallop, to your point earlier, it's the shape of the cell, the density.

[00:27:00] Speaker 00:
I think they're tied together.

[00:27:01] Speaker 02:
It's the shape of the flask, wasn't it?

[00:27:03] Speaker 00:
It is, Your Honor.

[00:27:05] Speaker 00:
And to be specific, so in the dean's declaration, they use what's called a T75 flask.

[00:27:11] Speaker 00:
And it's sort of like a rectangular flask.

[00:27:15] Speaker 00:
In the FIRT application specification, they use 96 well plates.

[00:27:20] Speaker 00:
And if you've ever seen those, they're smaller.

[00:27:23] Speaker 00:
And really what that gets to, and the experts explain this in their declarations and in their testimony, is that it affects cell density, it affects how the cells interact with other cells, and all of these factors go into what types of cells you will get.

[00:27:35] Speaker 00:
And this could have been a very simple case for FER, for ABT.

[00:27:41] Speaker 00:
I mean, all they had to do was produce the evidence that they already have, produce

[00:27:46] Speaker 00:
the evidence relating to the cells that they made according to the first method that Dr. Deans admitted that they had made at some point in the past.

[00:27:54] Speaker 00:
But they never did that.

[00:27:55] Speaker 05:
Because they had copied the claims.

[00:27:58] Speaker 00:
Yes.

[00:27:59] Speaker 05:
And so the board ordered that the copied claims be canceled.

[00:28:03] Speaker 05:
Does that take us, again, to the no interference in fact conclusion?

[00:28:09] Speaker 00:
Your Honor, let me address that, I think, two ways.

[00:28:12] Speaker 00:
First, with respect to the no interference in fact, and this goes, again, if you look at the blue brief, my job here is to respond to the arguments that the appellant has raised.

[00:28:24] Speaker 00:
And if you look at the blue brief, every single argument that they put forth with respect to the no interference in fact conclusion by the board relies on arguments and evidence presented with respect to the 037 and 118 pattern.

[00:28:42] Speaker 00:
stand and fall together in a way.

[00:28:44] Speaker 00:
Now, I suspect that my colleague could have presented another argument or could have disputed other things.

[00:28:50] Speaker 00:
For example, as the court probably knows, when you do a no interference, in fact, you have to demonstrate two-way anticipation and non-obviousness.

[00:28:59] Speaker 05:
Our expert... But it was a board conclusion.

[00:29:03] Speaker 05:
Correct, Your Honor.

[00:29:04] Speaker 05:
And it's before us.

[00:29:05] Speaker 00:
Yes, Your Honor.

[00:29:06] Speaker 00:
Yes.

[00:29:07] Speaker 00:
Right.

[00:29:08] Speaker 00:
But my point being is that my colleagues don't demonstrate the underlying...

[00:29:12] Speaker 00:
differentiate between any underlying facts or subsidiary facts upon which that conclusion may lie.

[00:29:19] Speaker 00:
They tie them all together.

[00:29:20] Speaker 03:
Stan, let me ask you one thing.

[00:29:22] Speaker 03:
If one were to conclude that there's a lacking of written description support, which you're asking us to do, how can there be an interference?

[00:29:34] Speaker 03:
It's a good question, Your Honor.

[00:29:36] Speaker 03:
If a patent isn't valid because there's no written description support, how can

[00:29:42] Speaker 03:
you get to interference?

[00:29:44] Speaker 00:
Your honor, I think it's a good question.

[00:29:45] Speaker 00:
And I think it's not exact.

[00:29:47] Speaker 00:
The board doesn't really state or explain why.

[00:29:50] Speaker 00:
And it's a little confusing in that respect.

[00:29:52] Speaker 00:
But again, I think the point being is that there is no interference, in fact, because there's no written description.

[00:30:00] Speaker 00:
And there's no written description because the cell populations are different.

[00:30:04] Speaker 00:
And that's really, whether it's Rulon as lack of written description or lack of interference in fact,

[00:30:10] Speaker 00:
It ultimately comes down to the single linchpin that the appellants have presented, basically that the dean's declaration inherently shows that the FERC cells are the same as the host cells.

[00:30:21] Speaker 00:
And it doesn't demonstrate that.

[00:30:22] Speaker 00:
And one last quick point, Your Honor.

[00:30:25] Speaker 00:
With respect to the 118 claims, again, these are claims that are trying to claim a adult human cell, any type of cell from any type of organ,

[00:30:38] Speaker 00:
that can differentiate into any other type of cell.

[00:30:43] Speaker 00:
The record is clear that no one has ever even proven that, or even done that, to date.

[00:30:49] Speaker 00:
But on top of that, we have our expert testimony, both in the declaration and the cross-examination, and we have testimony from the other side, acknowledging that the disclosure that's in the FERC specification is much, much narrower than what's described and claimed in the 118 patent.

[00:31:07] Speaker 00:
Okay.

[00:31:08] Speaker 00:
No further questions?

[00:31:09] Speaker 05:
Thank you, Mr. Dowd.

[00:31:10] Speaker 00:
Thank you, Your Honor.

[00:31:15] Speaker 05:
Mr. Huntington, full rebuttal.

[00:31:23] Speaker 01:
Your Honor, the first thing I want to address is this idea about whether message is an appropriate, message RNA, measuring for that, is an appropriate way of detecting expression.

[00:31:34] Speaker 01:
If you look at appendix page 57,

[00:31:38] Speaker 01:
This is the 685 application, and it specifically says, this is the whole application, techniques to detect the molecules of interest can also include quantitative PCR.

[00:31:50] Speaker 01:
Quantitative PCR detects message.

[00:31:54] Speaker 01:
It does not detect protein.

[00:31:56] Speaker 03:
What page is that again?

[00:31:57] Speaker 01:
Appendix page 57.

[00:31:58] Speaker 03:
What line are you on?

[00:32:00] Speaker 01:
Line 28, the very last line, the last two lines there.

[00:32:06] Speaker 01:
So the point is, Hull agrees with that.

[00:32:09] Speaker 01:
We say that in our application.

[00:32:12] Speaker 01:
It is unreasonable and contrary to the intrinsic evidence to go and say, well, the experts say this when the intrinsic evidence says that you can detect message.

[00:32:25] Speaker 01:
So that's why that's just completely wrong.

[00:32:31] Speaker 01:
The second thing that I want to say is this whole idea that somehow

[00:32:37] Speaker 01:
this falsification of evidence comes into this case is absolutely false.

[00:32:43] Speaker 01:
I realize that's probably a plan of words, but what they're trying to do is throw mud on this and say this, there is nothing in that decision that says anything that they considered about that at all.

[00:32:54] Speaker 01:
It is unreasonable to look at that and consider that as a part of anything on this decision.

[00:33:00] Speaker 01:
That was not evidence they considered.

[00:33:03] Speaker 01:
With respect to these six differences,

[00:33:05] Speaker 02:
It can still be relevant, though.

[00:33:08] Speaker 01:
It could be relevant if the board had considered it.

[00:33:11] Speaker 01:
But you're reviewing this board's decision.

[00:33:14] Speaker 01:
The board did not decide anything about it.

[00:33:16] Speaker 01:
It expressly said, we did not decide it.

[00:33:19] Speaker 03:
Well, he's saying it's representative of the uncertain state in the art.

[00:33:25] Speaker 01:
He's saying that, but that's not what the board said.

[00:33:28] Speaker 01:
He's trying to bring new arguments in.

[00:33:30] Speaker 01:
He's trying to put on this by saying, oh, it's uncertain, et cetera, for reasons that the board didn't adopt.

[00:33:36] Speaker 01:
With respect to the question of whether you look at both applications, the 685 and the 244, I refer you to the Tobenic decision, where it refers to the fact that you look at both specs.

[00:33:54] Speaker 01:
With respect to the question of whether the FERC application discloses the 49C,

[00:34:04] Speaker 01:
I would refer you to page 220 of the appendix page 220.

[00:34:15] Speaker 01:
This is the 037 pattern, column 17, line 7, where it specifically says CD49C.

[00:34:26] Speaker 01:
So it is clear that it also

[00:34:33] Speaker 01:
that 49C is, CD49C is in the HO, I'm sorry, is in the FERC patent application.

[00:34:49] Speaker 01:
The other thing I want to say with respect to these differences, yes, they are differences, no question, but they are differences that are within the scope of the HO,

[00:35:02] Speaker 01:
application, and then within the scope of the FERC application or the skill in the art.

[00:35:06] Speaker 01:
There is a second Dean's declaration in the case, in the 256 case, that goes through and details all of the knowledge and the art about oxygen levels.

[00:35:18] Speaker 01:
And the last thing I want to leave you with is, Hose says that none of those six things make a difference with respect to their getting their cells.

[00:35:29] Speaker 01:
There's no process limitations in their claims.

[00:35:33] Speaker 01:
And yet, now they're saying, oh, you have to do all of these things to get our cells.

[00:35:37] Speaker 01:
Well, if that's the case, this court should say that so that the public is on notice of the fact that they have an extremely limited claim and not one that just has two markers and a double print.

[00:35:49] Speaker 01:
If their cells can be produced this broadly, why wouldn't an experiment, the dean's experiment, go through and

[00:35:58] Speaker 01:
be sufficient as long as it follows within those same parameters.

[00:36:07] Speaker 05:
Thank you.