[00:00:00] Speaker 03:
23-2054 RESTEM versus JD Sell.

[00:00:18] Speaker 03:
Mr. Ricchetti, please proceed.

[00:00:22] Speaker 00:
Yes, may you please look forward.

[00:00:24] Speaker 00:
Joseph Ricchetti for RESTEM LLC.

[00:00:29] Speaker 00:
Your Honor, just based on the order that was provided, we could start with standing or go right to the merits.

[00:00:34] Speaker 00:
I just wanted to do whatever is best for the court.

[00:00:37] Speaker 03:
That'd be great.

[00:00:38] Speaker 03:
Why don't you start with standing?

[00:00:39] Speaker 00:
Great.

[00:00:39] Speaker 00:
So from our perspective, Your Honor, we submit that based on why we didn't have the benefit of the decision that was in the order at the time when we filed our opening brief following the precedent in LKQ and IBM in the General Electric case, we believe the jurisdictional statement set forth concrete plans

[00:00:59] Speaker 00:
for ReSTEM to bring their cells to the industry through that.

[00:01:05] Speaker 00:
And we believe that was sufficient to show that and to show the substantial risk of infringement.

[00:01:10] Speaker 00:
We believe that to be particularly true because of the public nature of the information we were relying on, namely the FDA filings.

[00:01:19] Speaker 00:
These are all public filings that are available on the website.

[00:01:22] Speaker 00:
The fact that ReSTEM is engaged in four FDA trials actively, working with universities,

[00:01:28] Speaker 00:
such as Stanford and the University of Florida, demonstrates a desire to bring their cells to people in the US.

[00:01:38] Speaker 03:
My question isn't your concrete plans to bring a product to market or your clinical trials.

[00:01:44] Speaker 03:
My only question of standing is whether there is, in fact, a substantial risk of infringement based on how you describe your own cells and, in particular,

[00:01:57] Speaker 03:
I mean, I think that you pretty strongly assert that your cells don't express N-A-N-O-G.

[00:02:08] Speaker 03:
Does that make sense?

[00:02:09] Speaker 03:
Am I saying that right?

[00:02:10] Speaker 00:
I don't know how to... You are, Your Honor.

[00:02:11] Speaker 00:
I guess the issue just is, it's just not that we're... I don't believe we're saying that.

[00:02:17] Speaker 00:
You know, how we would say is that we're using kind of the majority process, which is also described in the 176 patent specification, so the cells are all being created now.

[00:02:27] Speaker 03:
Again, the process is so broad and it could create a gazillion things.

[00:02:33] Speaker 03:
The question isn't that, the question is does it result in cells that fall within this

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narrow space.

[00:02:43] Speaker 03:
I mean, you've got a bunch of donut holes here, right?

[00:02:45] Speaker 03:
You've got a bunch of negatives in this claim, where the resulting cells don't express this, don't express that kind of thing.

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And so the question is, if your cells really don't express those things, then you can't fall within this claim.

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

[00:03:03] Speaker 00:
And I think there's a difference between whether or not these marker expressions have been identified, right?

[00:03:11] Speaker 00:
The marker expressions are a byproduct of the place in the umbilical cord that the cells are removed from.

[00:03:19] Speaker 00:
So when they're removed from the SL, the subethial layer, they're going to have these marker expressions.

[00:03:26] Speaker 00:
So it's not that the process creates the marker expressions.

[00:03:30] Speaker 00:
I'm sorry.

[00:03:31] Speaker 00:
It is that.

[00:03:32] Speaker 00:
It's not that the market expressions are different.

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It's just, where am I getting these cells from?

[00:03:38] Speaker 00:
And then the marker expressions tell you the location of where you got them from.

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And so when we look at this claim.

[00:03:44] Speaker 03:
I'm not entirely following you.

[00:03:46] Speaker 03:
But for standing purposes, I guess what I'm trying to figure out is, why is there any kind of substantial risk of infringement?

[00:03:54] Speaker 00:
Because we're all getting cells, at least in part, from the SL, from the subethial layer.

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And that's what drives the marker expression.

[00:04:03] Speaker 00:
So when you were taking cells from the SL,

[00:04:06] Speaker 00:
that's going to necessarily mean you're getting those marker expressions.

[00:04:11] Speaker 02:
No matter where in the SL you're taking them from?

[00:04:14] Speaker 00:
That's what the record shows you're on, yes.

[00:04:17] Speaker 00:
And that's an important part.

[00:04:19] Speaker 00:
The process is, there's different processes.

[00:04:22] Speaker 03:
I'm sorry.

[00:04:22] Speaker 03:
Is this going to your inherency argument?

[00:04:24] Speaker 03:
Is that why you think you're at substantial risk of infringement?

[00:04:28] Speaker 03:
This goes to inherency, doesn't it?

[00:04:31] Speaker 00:
Right.

[00:04:31] Speaker 00:
And I just think from our perspective, just because, whether it's Majuri or us, you test for different marker expressions based on what you're trying to investigate.

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And so from our perspective, if the cells are coming from the sub-ethio layer, it's an intrinsic quality of those cells.

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The marker expression is not something separate and distinct.

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from the process or from where you're getting it from.

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And that's what's key.

[00:04:57] Speaker 02:
This claim says you've got two actual process steps and then three properties, some of which are negative.

[00:05:07] Speaker 02:
And it seems to me, for your argument to work, either there has to be some prior art showing

[00:05:23] Speaker 02:
an isolated cell, whatever that might mean, that results from the two process steps and has all three properties.

[00:05:34] Speaker 02:
And the board said, you haven't shown me that.

[00:05:37] Speaker 02:
Or, and this is, in the end, what I thought your argument came down to, is an inherently argument.

[00:05:44] Speaker 02:
Any time you perform these two process steps, you will, with 100% certainty, get an isolated cell with these three properties.

[00:05:54] Speaker 00:
That's correct.

[00:05:55] Speaker 02:
And I'm not sure I saw the evidence for that.

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And I think the evidence is this.

[00:06:00] Speaker 00:
It's a product by process claim.

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And so we have a claim process that's defining the product.

[00:06:06] Speaker 02:
This is not helping.

[00:06:08] Speaker 02:
All of your discussion of this is a product by process claim does not help me at all.

[00:06:13] Speaker 02:
There are two steps in the process required, two process steps.

[00:06:18] Speaker 02:
And the result has to be a cell with three properties.

[00:06:21] Speaker 02:
For your inherency argument to work, it has to be the case that every time somebody performs the two processes, there will be a cell with the three properties.

[00:06:31] Speaker 02:
Where is the evidence that says that?

[00:06:33] Speaker 02:
Because you don't have any specific prior art that shows the presence of these three properties.

[00:06:41] Speaker 00:
And Your Honor, maybe the framework is what

[00:06:43] Speaker 00:
is confusing for us.

[00:06:45] Speaker 00:
We understand in a product by process claim that the claimed process defines and must result in the claimed product, the isolated cells.

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And so when Majore practices and discloses the claimed process, we believe it necessarily.

[00:07:04] Speaker 00:
What do you mean by you believe?

[00:07:05] Speaker 00:
I thought the board found that in Majore.

[00:07:08] Speaker 00:
Right.

[00:07:10] Speaker 00:
Perfect place to start, right?

[00:07:12] Speaker 00:
But the board found, and why we think there's an implicit construction, the board correctly expressly construed the claim limitations.

[00:07:19] Speaker 00:
The board expressly construed the two process steps, rejecting patent owners' requests to read in embodiments.

[00:07:26] Speaker 00:
That was good.

[00:07:28] Speaker 00:
That was OK.

[00:07:29] Speaker 00:
So we were OK at that point.

[00:07:30] Speaker 02:
The board expressed the constructions correct.

[00:07:32] Speaker 02:
That broadens the realm of the two process steps.

[00:07:38] Speaker 02:
So it's even harder to establish inherency, because now everything within the broader class, in your view, would have to produce these three properties.

[00:07:49] Speaker 00:
And we would suggest that it's in line with the teachings and the specification and prosecution history.

[00:07:53] Speaker 00:
So there's not broadening.

[00:07:55] Speaker 00:
It's just the proper interpretation of the claim, especially in light of the specification statements, which give alternative ways to do these two steps.

[00:08:05] Speaker 00:
And these two steps will result in the cells.

[00:08:08] Speaker 00:
No matter the alternative ways that you choose.

[00:08:11] Speaker 00:
And that's correct.

[00:08:12] Speaker 00:
Is that right?

[00:08:13] Speaker 00:
Well, and that's correct.

[00:08:14] Speaker 00:
And it's all because of the fundamental concept that when you extract the cells from the sub-ethial layer, that's what's driving the marker expression.

[00:08:23] Speaker 00:
There's no magic to this.

[00:08:26] Speaker 00:
You're getting it from a particular location.

[00:08:28] Speaker 00:
And that's why I think the file history is so instructive.

[00:08:32] Speaker 02:
Where is the evidence that every time you take a sub epithelial layer of the umbilical cord tissue and you put it on the required growth substrate that you will get one or more cells with all of these three properties?

[00:08:56] Speaker 00:
So in appendix 94 in the 176 patent in column 1,

[00:09:01] Speaker 00:
The specification goes on to explain, the isolated cell that is capable of self-renewal and cultural expansion and is obtained from the sub-ethial layer of a mammalian umbilical cord tissue is provided.

[00:09:14] Speaker 00:
Such an isolated cell expresses at least three cell markers, and dot dot dot, and does not express at least three cell markers.

[00:09:23] Speaker 02:
I guess I want to say two things about that.

[00:09:25] Speaker 02:
I'm not sure whether it counts.

[00:09:28] Speaker 02:
what is said in your specification as evidence.

[00:09:32] Speaker 00:
In the 176 pan.

[00:09:33] Speaker 00:
I'm talking about the pan and suit.

[00:09:35] Speaker 02:
That's right.

[00:09:36] Speaker 02:
Right.

[00:09:38] Speaker 02:
And second, what you just read does not say that whenever you do these two process steps, which are just where you're taking it from, the SL, as you say, you always get this.

[00:09:55] Speaker 02:
Those words that you read do not say that.

[00:09:58] Speaker 00:
I think it's just saying such an isolated cell that was taken from that is what it expresses.

[00:10:03] Speaker 02:
You got one.

[00:10:04] Speaker 00:
That doesn't mean you always get one.

[00:10:05] Speaker 00:
Right.

[00:10:06] Speaker 00:
And that's why I think, Your Honor, that maybe it's a disconnect in the record.

[00:10:10] Speaker 00:
I think what we're trying to demonstrate is that when the specification and the file history make clear that the process, the two-step process that they obtained a product by process claim on, when those two steps,

[00:10:26] Speaker 00:
And everything in the record demonstrates that those two steps create the isolated cells.

[00:10:32] Speaker 00:
That's what the specification supports.

[00:10:34] Speaker 00:
That's what the file history supports.

[00:10:37] Speaker 00:
In those situations, if Missouri is teaching and disclosing, and they didn't just say that Missouri is literally on 32 of the appendix.

[00:10:51] Speaker 00:
I mean, I think this is what is troubling for us, Your Honor.

[00:10:56] Speaker 00:
is that on page 32, the board finds that both Missouri and 176 patents disclose umbilical cord tissue cut into sections and placed into environments fostering cell culture

[00:11:19] Speaker 00:
and replication.

[00:11:20] Speaker 00:
And it goes on to 33.

[00:11:21] Speaker 00:
And this is the part that the board gets correct, which is, Missouri and the 176 teach the claimed process.

[00:11:30] Speaker 00:
And everything in the intrinsic record says that the claimed process yields the claimed isolated process.

[00:11:38] Speaker 02:
It always yields.

[00:11:39] Speaker 02:
Always is the crucial thing for you.

[00:11:41] Speaker 00:
And in a product by process claim, Your Honor, it has to.

[00:11:44] Speaker 00:
Right?

[00:11:44] Speaker 00:
It has to.

[00:11:45] Speaker 00:
That's not helpful.

[00:11:47] Speaker 02:
That's a conclusion.

[00:11:49] Speaker 02:
The words of the claim say, a process with the following property.

[00:11:55] Speaker 02:
You're telling me that the prior art, by showing a process, necessarily has the property, even though those cells did not show the property.

[00:12:08] Speaker 00:
I'm not sure about the last part of your sentence, the statement or the question.

[00:12:12] Speaker 00:
But what I guess I'm suggesting is, what we're arguing, Your Honor, is that in a product by process claim, the bargain between the patent owner and the patent office is that I'm not defining my product, my isolated cell, in structural recitation.

[00:12:30] Speaker 00:
They had a product claim in the file history, and they amended it to be a product by process, because the way they obtained the patent was saying, this process is different than the process in the prior art, and therefore we're entitled to this product by process claim.

[00:12:46] Speaker 00:
And under those circumstances, they're bound by those representations.

[00:12:50] Speaker 00:
To the point you're making, they're bound by the statement of, this process yields this.

[00:12:55] Speaker 00:
That's the relationship in a product by process claim.

[00:12:59] Speaker 00:
Here, it's even more than just that the nature of the claim suggested.

[00:13:02] Speaker 00:
It's because they changed it from a product by process claim.

[00:13:05] Speaker 00:
Then they argued the process, this ex plan process that's claimed, was different than the enzio-matic process that was in the prior art.

[00:13:12] Speaker 00:
And then the panel office and the examiner in the notice of allowance agreed and relied on it.

[00:13:19] Speaker 00:
And the specification is consistent, saying all you need to do is those two steps, and there's nothing contrary.

[00:13:27] Speaker 00:
There's nothing contrary in the record that suggests the claim process, which majority teaches, doesn't yield the isolated cell.

[00:13:37] Speaker 00:
And I would suggest, Your Honor, that was an argument they could have raised, because the board adopted our claim construction.

[00:13:43] Speaker 00:
that they're now suggesting are so broad.

[00:13:46] Speaker 00:
Those were our constructions down below.

[00:13:48] Speaker 00:
And so if their argument down below was, if you adopt these constructions, the claim process will not yield the claim product.

[00:13:57] Speaker 00:
And that's a problem.

[00:13:59] Speaker 00:
That wasn't argued, Your Honor.

[00:14:01] Speaker 00:
And what we would suggest and what we submit is that in this situation, the burden should be on us as petitioner.

[00:14:07] Speaker 00:
We've shown that in a product by process claim, the claim process was known, well known.

[00:14:14] Speaker 00:
And if the process is known, then the product's known.

[00:14:17] Speaker 00:
And I think there was confusion by the PTAB about Henry Thorpe and what Judge Newman was expressing.

[00:14:24] Speaker 00:
And all she was expressing was for a product by process claim, if you have a prior product, you don't have to have it use the same process as his claim.

[00:14:33] Speaker 00:
And that's understood.

[00:14:35] Speaker 00:
But when you do, you're not entitled to a process claim.

[00:14:39] Speaker 00:
You're not entitled to a product by process claim.

[00:14:41] Speaker 00:
You're out.

[00:14:42] Speaker 00:
I mean, King Pharmaceutical, there's many Federal Circuit decisions that demonstrate if you're relying on the process steps to demonstrate the patentability of the claim, much less define it.

[00:14:55] Speaker 00:
The burden should have been on them to show our claim process doesn't yield, even though we've told the Pat office it does, even though that's the reasons for allowance.

[00:15:06] Speaker 00:
And we can give appendix sites for all of this.

[00:15:12] Speaker 00:
You know, I think it's at appendix 909.

[00:15:17] Speaker 00:
Thank you.

[00:15:19] Speaker 00:
Right?

[00:15:19] Speaker 00:
This is what everything was based on, that this process yields this isolated cell with this marker expression.

[00:15:26] Speaker 00:
And after finding out, many years after the patent issues, patent owner says, oh, those two steps?

[00:15:32] Speaker 00:
Those two steps that we relied on to get the patent claim out?

[00:15:35] Speaker 00:
No.

[00:15:35] Speaker 00:
Now that we know those were in the prior audit, they're not sufficient to show.

[00:15:39] Speaker 00:
that the process discloses the claim.

[00:15:42] Speaker 00:
That's not appropriate.

[00:15:44] Speaker 00:
Everything in the intrinsic evidence supports it, and nothing is contradictory.

[00:15:48] Speaker 00:
And we have a product by process claim.

[00:15:49] Speaker 00:
It's the whole reason we have these claims.

[00:15:52] Speaker 00:
It's supposed to be when the product resists definition.

[00:15:57] Speaker 00:
And the only way you can produce, you know, to express it is through its process.

[00:16:02] Speaker 00:
That's what they chose.

[00:16:03] Speaker 00:
This was an intentional choice.

[00:16:04] Speaker 00:
They didn't need to do this.

[00:16:06] Speaker 00:
They have other patents with other types of claim types in it.

[00:16:09] Speaker 00:
But here they chose a product by process, and they're bound by it.

[00:16:12] Speaker 00:
And we believe the evidence is overwhelming that there's inherency.

[00:16:18] Speaker 00:
But it's inherency through the claim process now that the judge has found it.

[00:16:23] Speaker 00:
He found the claim construction was correct, and he found that the majority teaches the claim process.

[00:16:28] Speaker 00:
Once you get to that point, it necessarily follows because of the nature of the claim, but not only because of the nature of the claim, but because of the prosecution history, because of the specification, because they're clear and consistent that that claim process results in and yields the claimed isolated cell.

[00:16:48] Speaker 00:
And again, these are intentional choices.

[00:16:51] Speaker 00:
They had a product claim.

[00:16:52] Speaker 00:
They converted, right?

[00:16:54] Speaker 00:
They didn't have to argue the process creates it.

[00:16:56] Speaker 00:
They did.

[00:16:58] Speaker 00:
Down below, they could have raised this issue.

[00:17:00] Speaker 00:
Based on the board's, they could have raised the issue that our construction was so broad that it divorces the process from the claimed product.

[00:17:07] Speaker 03:
OK, well, we've used all your time in here at all time.

[00:17:09] Speaker 03:
Let's hear from the housing council.

[00:17:11] Speaker 00:
Thank you.

[00:17:12] Speaker 01:
May it please the court.

[00:17:18] Speaker 01:
As the appellant in the party seeking judicial review,

[00:17:21] Speaker 01:
It is RESTEM's burden to come forward.

[00:17:24] Speaker 01:
It is RESTEM's burden of production to come forward with evidence demonstrating that it has Article III standing to appeal the board's final written decision finding that RESTEM had not carried its burden of proof of trial.

[00:17:37] Speaker 01:
As this court found in Phigenics, the appellant must identify relevant evidence demonstrating it standing either at the board level or in response to a motion to dismiss or

[00:17:49] Speaker 01:
in its opening brief.

[00:17:50] Speaker 03:
Let me ask you a question.

[00:17:51] Speaker 03:
Does performing the two steps always result in the three properties?

[00:17:56] Speaker 01:
It does not, Your Honor.

[00:17:57] Speaker 01:
And in fact, the evidence that is on the record is... What is the best evidence on the record for that?

[00:18:03] Speaker 01:
KETA.

[00:18:04] Speaker 01:
KETA reference and the fan reference.

[00:18:06] Speaker 01:
Page slide.

[00:18:11] Speaker 01:
KETA reference is APPX1919.

[00:18:18] Speaker 01:
The key to reference, the board found that the key to reference disclosed the two steps, but it also found on APPX 1927, this is the key to reference, that a hundred percent of the cells expressed Nanog.

[00:18:34] Speaker 01:
And as this court knows, that is one of the negative limitations in the claim.

[00:18:38] Speaker 02:
And the board found that where, sorry?

[00:19:01] Speaker 01:
That is on APTX 70.

[00:19:04] Speaker 01:
70.

[00:19:04] Speaker 01:
The board says, while KETA cells are closer in that they satisfy limitation D, they strongly express NANOC.

[00:19:14] Speaker 01:
And KETA does not disclose non-expression of at least five of the markers in limitation P. The board goes on to say that if the petitioner had provided evidence that the process steps always result

[00:19:30] Speaker 01:
in the claim cells, well, then they might have an argument.

[00:19:33] Speaker 01:
But they didn't come forward with any of that evidence.

[00:19:36] Speaker 01:
And that's where Restem's argument falls apart.

[00:19:39] Speaker 01:
FAN is another reference.

[00:19:41] Speaker 01:
You're ours.

[00:19:42] Speaker 03:
FAN is... Well, just out of curiosity, help me understand how I should understand what the patentee's burden is in a product by process claim.

[00:19:56] Speaker 01:
The patentee's burden in demonstrating validity or invalidity rests solely on whether the product is new or not in the art.

[00:20:06] Speaker 01:
This court's long-standing precedent is that it looks only to whether the product is present in the prior art or not.

[00:20:15] Speaker 03:
Now, the inherent... When you say product is present in the prior art, I don't entirely follow.

[00:20:21] Speaker 03:
You mean as produced by the same process?

[00:20:25] Speaker 01:
No, whether it's there or not, regardless of the process, the process steps are ignored.

[00:20:31] Speaker 01:
That's very clear from this court's history.

[00:20:34] Speaker 01:
And that's the exact opposite of what ReSTEM would have this court do.

[00:20:38] Speaker 01:
ReSTEM is submitting to the board, hey, all you do is look at the process steps.

[00:20:42] Speaker 01:
And once the process steps are met, then as a matter of law, you must find that the product is also present.

[00:20:50] Speaker 02:
And just so I understand, your point is it is a matter of fact whether a process always produces or in any given case produces the actual claimed properties.

[00:21:04] Speaker 02:
And you can't ignore those, but you have to either show that here's something produced by the process that has those properties, or you have to show that everything produced by the process always has those properties.

[00:21:16] Speaker 01:
That is correct.

[00:21:18] Speaker 01:
And that's what the board found as well.

[00:21:20] Speaker 01:
And the board found that there were other factors and conditions that led to the resulting claimed sales.

[00:21:27] Speaker 01:
Restem on appeal says that those other factors and conditions are implicit claim constructions.

[00:21:33] Speaker 01:
But that only follows if you agree that as a matter of law, no matter what you recite in the process steps, then the product will always follow.

[00:21:42] Speaker 01:
And that is just not the law.

[00:21:54] Speaker 01:
I will note.

[00:21:56] Speaker 03:
Do you have either a written description or an enablement problem when you have a claim like this that basically claims a cell by virtue of what it expresses or doesn't express but doesn't tell you how to achieve that expression?

[00:22:14] Speaker 01:
Is your honor asking about the board's notice about how they're trying to construe the term express does not express?

[00:22:22] Speaker 03:
No, I'm not that specific.

[00:22:25] Speaker 03:
I'm just wondering, you have two steps that produce cell lines, but you're saying those steps themselves don't matter to how the scope of the claim should be construed.

[00:22:39] Speaker 03:
It's, in fact, the product that is the result.

[00:22:42] Speaker 03:
But you haven't explained how to create the product that is this resultant product.

[00:22:50] Speaker 01:
And those are separate analyses.

[00:22:52] Speaker 01:
The scope of the claim under Nautilus is based on a person of ordinary skills understanding of the art when they read the claim in the context of the specification.

[00:23:03] Speaker 01:
Does it teach the person of ordinary skill in the art how to make and use the invention?

[00:23:08] Speaker 01:
And the specification absolutely does.

[00:23:10] Speaker 01:
The claim doesn't have to do that.

[00:23:11] Speaker 01:
The claim doesn't have to teach you.

[00:23:14] Speaker 01:
Process A and Process B don't have to teach you.

[00:23:17] Speaker 03:
A dumb question.

[00:23:18] Speaker 03:
Does the specification in this case articulate the additional steps

[00:23:22] Speaker 03:
that are necessary to ensure you get the results in three properties?

[00:23:26] Speaker 01:
Yes, Your Honor.

[00:23:27] Speaker 01:
And I can cite you that.

[00:23:35] Speaker 01:
It is on APPX 97, column 8, lines 49 through 58.

[00:23:42] Speaker 01:
It's also in the examples, example number 2 on column 13.

[00:23:48] Speaker 01:
This is APPX 100.

[00:23:53] Speaker 01:
And that's the example two that the board presents.

[00:23:56] Speaker 01:
ReSTEM likes to make a big fuss over the different ways that you can.

[00:24:02] Speaker 03:
My only concern with example two

[00:24:06] Speaker 03:
is that example two is about umbilical cord tissue as opposed to SL, which is what the claim is directed to.

[00:24:13] Speaker 03:
And those are two different things.

[00:24:15] Speaker 03:
Umbilical cord tissue is a much broader thing and could, in fact, result in cell on cell impurities that cause it not to fall within this.

[00:24:26] Speaker 03:
So I don't think that example two actually is this claim at all.

[00:24:31] Speaker 03:
Am I missing something?

[00:24:32] Speaker 03:
Because this claim is about only using SL, right?

[00:24:35] Speaker 01:
column eight.

[00:24:36] Speaker 03:
Oh, I'm sorry.

[00:24:36] Speaker 03:
Did I miss something?

[00:24:38] Speaker 03:
You said example two.

[00:24:39] Speaker 01:
I did.

[00:24:39] Speaker 03:
Example two is in- But example two is in bilico cord tissue.

[00:24:42] Speaker 03:
Do you agree with me?

[00:24:43] Speaker 01:
Yes.

[00:24:43] Speaker 03:
It's a bilico cord tissue, which is a broader class of tissue than SL.

[00:24:47] Speaker 03:
Absolutely.

[00:24:47] Speaker 03:
So, okay.

[00:24:48] Speaker 03:
All right.

[00:24:48] Speaker 03:
So that's not relevant to claim one.

[00:24:49] Speaker 03:
It's not the same.

[00:24:50] Speaker 03:
Yes.

[00:24:51] Speaker 03:
So where else were you pointing me?

[00:24:53] Speaker 03:
Column eight.

[00:24:53] Speaker 03:
Yeah.

[00:24:54] Speaker 03:
Column eight.

[00:24:56] Speaker 01:
Lines 50 or 49 up above.

[00:25:02] Speaker 01:
Well, actually, let me

[00:25:03] Speaker 01:
Let me go up even a little bit above.

[00:25:05] Speaker 01:
43.

[00:25:06] Speaker 01:
There in one aspect, for example, umbilical cord tissue can be collected and washed to remove blood, Wharton's jelly, and any other materials associated with the SL or subepithelial layer.

[00:25:19] Speaker 01:
For example, in one laminate, well, I don't need to read it for the court.

[00:25:22] Speaker 01:
The court has it there.

[00:25:23] Speaker 01:
I'll just give you a quick rundown of what it means.

[00:25:27] Speaker 01:
I can imagine this.

[00:25:29] Speaker 01:
piece of paper is the umbilical cord, the outside layer is the epithelial layer, the inside layer is the sub-epithelial layer, and the material that's inside of it is the Wharton's jelly and the blood vessels.

[00:25:40] Speaker 01:
What Dr. Patel invented was he opened up that he removes all the Wharton's jelly and all the blood vessels, and he places it face down on the growth medium.

[00:25:51] Speaker 01:
And that's how he actually gets the results.

[00:25:54] Speaker 01:
Now, we argued to the board that the process steps should be construed narrowly to read on that embodiment.

[00:26:01] Speaker 01:
The board disagreed with us, and they read them more broadly.

[00:26:05] Speaker 01:
But that is the answer to your question, Your Honor, about enablement and written description.

[00:26:17] Speaker 01:
Does the court have any other questions for me?

[00:26:18] Speaker 01:
It's been a long day for you, and I'm happy to answer.

[00:26:20] Speaker 02:
We have not talked either with you or your opposite number about this question of whether an isolated cell can be a single cell or is instead limited to some collection of cells for which you can determine a registered

[00:26:46] Speaker 02:
amount of expression.

[00:26:49] Speaker 02:
Is that, are we not talking about it because it doesn't matter to the outcome here or what?

[00:26:54] Speaker 01:
Well, first, well I'll answer your second question first.

[00:26:59] Speaker 01:
It doesn't matter the outcome.

[00:27:01] Speaker 01:
There is no prejudice because there is no evidence that even whether it's a population of cells or a single cell, there's no evidence anywhere in the record of any single cell that has all these gene expression markers.

[00:27:14] Speaker 01:
None.

[00:27:15] Speaker 01:
So it's

[00:27:16] Speaker 01:
If it is error, it's harmless error.

[00:27:19] Speaker 01:
We would also submit that it is not error.

[00:27:22] Speaker 01:
There are many different canons of claim construction that litigants lean heavily on.

[00:27:26] Speaker 01:
And they certainly will lean on the one that favors them during their argument.

[00:27:30] Speaker 01:
This court has said that the claim construction is persuasive not because it follows a certain rule, but because it defines terms in the context of the whole patent.

[00:27:40] Speaker 01:
If one were to look at the term

[00:27:42] Speaker 01:
isolated cell in a vacuum as proposed by Restem, well then their argument might make sense.

[00:27:47] Speaker 01:
But the board looked at the intrinsic and the extrinsic record and found that, yeah, express does not express is understood in terms of cell populations, not cells all by themselves.

[00:28:08] Speaker 01:
Are there any other questions, Your Honors?

[00:28:12] Speaker 03:
Okay, thank you.

[00:28:24] Speaker 00:
So just working backwards, Your Honor, I mean we do feel that that issue about expression, non-expression, and population of cells does matter.

[00:28:32] Speaker 00:
You know, I think the

[00:28:34] Speaker 00:
Detailed description in Column 6 of Appendix 96 has it under a section called definitions.

[00:28:40] Speaker 00:
It has a definition for it that says one or more cells.

[00:28:44] Speaker 00:
Patent parlance, going back to Landis says A or N means one or more.

[00:28:50] Speaker 00:
So I don't think there could be any dispute.

[00:28:51] Speaker 00:
It's a clear error.

[00:28:53] Speaker 00:
We think it impacts the analysis potentially if the court was willing to remand it for the court to have the right constructions down.

[00:29:02] Speaker 00:
But we also think it's important because

[00:29:05] Speaker 00:
I think there's some confusion.

[00:29:06] Speaker 00:
I think Your Honor just mentioned this claimed process only takes the cells from the SL, from the subethial layer.

[00:29:16] Speaker 00:
And that's not what the board found.

[00:29:18] Speaker 00:
Their express construction was you could have a chunk of umbilical cord.

[00:29:22] Speaker 00:
And that's exactly what majority teaches.

[00:29:24] Speaker 00:
That was the part I read on 32 from the appendix.

[00:29:27] Speaker 00:
The board actually found that majority

[00:29:30] Speaker 00:
discloses the same embodiment as the 176-PAT does.

[00:29:36] Speaker 00:
And that's a slice of an umbilical cord where you have cells from a lot of different places.

[00:29:40] Speaker 00:
You're going to have them from the cell, and that's why it's going to necessarily produce these isolated cells with the marker expressions.

[00:29:49] Speaker 00:
But that's where the confusion comes in.

[00:29:51] Speaker 00:
When you start talking about populations of cells, it makes it sound like it has to be a heterogeneous situation where it can only produce cells with these markers.

[00:30:00] Speaker 00:
That's not what the claim process is about.

[00:30:02] Speaker 00:
The claim process, there's different embodiments.

[00:30:05] Speaker 00:
They make clear that you can use any of them.

[00:30:07] Speaker 00:
A variety of techniques can be used.

[00:30:08] Speaker 00:
The board expressly construed it properly.

[00:30:11] Speaker 00:
And what happens is, in the anticipation analysis, you see the board saying, well, comparing the prior art majority and saying, it doesn't disclose the interior side down embodiment.

[00:30:22] Speaker 00:
Well, that's not part of the express construction.

[00:30:24] Speaker 03:
OK, counsel, I think our time is up.

[00:30:26] Speaker 03:
I thank both counsels.

[00:30:27] Speaker 03:
This argument is taken under similar terms.