[00:00:00] Speaker 01:
It is number 17-1043, MyMedics Group Inc.

[00:00:07] Speaker 01:
versus Musculoskeletal Transplant, Mr. Flint.

[00:00:12] Speaker 03:
Good morning, Your Honors.

[00:00:14] Speaker 03:
May it please the Court?

[00:00:15] Speaker 03:
I would like to devote the principal amount of my time opening here on the fact that the claim construction that was proposed by the Board here, found by the Board, is unreasonable

[00:00:29] Speaker 03:
in light of the intrinsic record.

[00:00:32] Speaker 03:
And the intrinsic record, we believe, and the specification alone, we submit, compels the conclusion that the construction was unreasonably broad.

[00:00:42] Speaker 01:
Why does the specification putting aside the prosecution history lead to that conclusion?

[00:00:48] Speaker 03:
If you look at column one, lines 33 to 39, Your Honor, the patent says that the amnion consists of four things.

[00:00:58] Speaker 03:
the epithelium cells, the reticular fibers, the compact layer, and the fibroblast layer.

[00:01:05] Speaker 03:
And those are four layers.

[00:01:09] Speaker 03:
In question, we exclude the spongy layer.

[00:01:12] Speaker 03:
And there is art of record that some people include the spongy layer as part of the amnion.

[00:01:21] Speaker 03:
It's not unlike, by way of a somewhat frivolous analogy,

[00:01:26] Speaker 03:
Some people, most people would probably say there are only four members of the beetle.

[00:01:32] Speaker 03:
Other people will refer to various people as a fifth beetle.

[00:01:35] Speaker 01:
The inventor here... I don't think you're answering the question.

[00:01:38] Speaker 01:
Where is it in the specification that it teaches removing the spongy layer?

[00:01:44] Speaker 01:
I don't see... I mean, I understand there's significant prosecution history which

[00:01:52] Speaker 01:
have to address, but the specification standing alone, where does it say you have to remove the spongy layer?

[00:01:57] Speaker 03:
You start with the fact that the specification tells you there are only four layers of the amnion.

[00:02:03] Speaker 03:
The specification then tells you that you separate the amnion from the corium, and the boundary of that separation is the spongy layer, and the spongy layer, the integrity of the spongy layer, is destroyed by the separation process.

[00:02:19] Speaker 03:
You have remnants

[00:02:20] Speaker 03:
of the spongy layer on the amniote side and you have remnants of the spongy layer on the corian side.

[00:02:26] Speaker 03:
And then at page, at column 6, lines 42 to 45, you are told, and this is explicitly, that you remove blood clots and other extraneous tissue from each layer of tissue until the amniotic membrane tissue and the corian are clean.

[00:02:48] Speaker 03:
Now, because the first part of the patent defines only four layers of the ambion, anything that isn't one of those four layers is, by definition, extraneous tissue.

[00:02:59] Speaker 03:
And that was what the inventor is making clear here.

[00:03:04] Speaker 03:
And the fact that you separate and destroy the integrity of the spongy layer means that it is, in fact, the remnant of this destruction.

[00:03:14] Speaker 03:
It is debris.

[00:03:15] Speaker 03:
And what the patent goes on to say... But the patent doesn't specifically say the spongy layer is the strangest issue.

[00:03:23] Speaker 02:
It doesn't specifically say it's debris.

[00:03:26] Speaker 02:
This is your problem, and then your expert is all over the place on this issue.

[00:03:31] Speaker 03:
With all due respect, the expert isn't, and I can get to that.

[00:03:35] Speaker 03:
But the point is, it does not use the word spongy layer.

[00:03:39] Speaker 03:
But a person of ordinary skill in the art knows that what is left when you separate the am, the un, and the chorion

[00:03:45] Speaker 03:
besides blood clots, all that's there to be removed is, the only extraneous tissue to be removed is the spongy layer.

[00:03:55] Speaker 03:
The step, the patent goes on to refer to, at line 55 of column 6, residual debris.

[00:04:05] Speaker 03:
Now what residual debris could there be but the leftover pieces of the spongy layer caused by the separation of the chlorine and the ambient?

[00:04:12] Speaker 03:
When you look at the layers

[00:04:14] Speaker 03:
that all the textbooks provide, that's all there is to be removed.

[00:04:18] Speaker 03:
Now this is done in a sterile environment.

[00:04:20] Speaker 03:
We're not talking about somebody's lunch crumbs left on this.

[00:04:23] Speaker 01:
Let's talk about the prosecution history.

[00:04:26] Speaker 01:
Sure.

[00:04:27] Speaker 01:
The prosecution history... What you have is a situation in which the examiner's statements are clear, but that the spongy layer should be removed.

[00:04:38] Speaker 01:
But I think what's missing

[00:04:41] Speaker 01:
is any amendment to the claim limiting it that way or any clear statement by the applicant that the applicant agrees with the examiner.

[00:04:55] Speaker 01:
And in fact, at the end of the day, the applicant says, you know, without agreeing with the examiner, et cetera, et cetera.

[00:05:08] Speaker 01:
Why should that

[00:05:10] Speaker 01:
prosecution history lead to the conclusion that under the BRI standard, the claim should be limited to a situation where the spongy layer is removed?

[00:05:22] Speaker 03:
Sure.

[00:05:24] Speaker 03:
The first answer is that the prosecution history explanation that makes clear that this debris is, in fact, the spongy layer was a result of an interview in which there were a number of participants from the inventor side as well as the examiners.

[00:05:39] Speaker 03:
And when you read the results of the interview, it's very clear that's where the examiner got the notion, OK, what you mean by substantially cleaning is you're removing the spongy layer.

[00:05:51] Speaker 01:
Where is there a statement by the applicant that there's agreement with the examiner when, at the end of the day, in the same memorandum, it says, without acquiescing in the examiner's stated rationale, blah, blah, blah.

[00:06:07] Speaker 03:
I recognize that when you're talking about the examiner's amendment, there is that language.

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But if you look earlier at the description of the interview, the examiner is not recounting simply his statement.

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He's recounting what was accepted and agreed to in the interview.

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And we submit that it is the interview results that make it very clear explicitly what was necessarily implicit in the

[00:06:36] Speaker 03:
written description already, that the only thing left to be removed was the spongy layer.

[00:06:40] Speaker 01:
Where's the language you're relying on?

[00:06:44] Speaker 03:
For the interview.

[00:06:52] Speaker 03:
It's in the appendix at page 1059.

[00:06:56] Speaker 03:
It's the second paragraph that appears.

[00:06:59] Speaker 01:
Hold on, hold on.

[00:07:05] Speaker 03:
1059?

[00:07:05] Speaker 03:
1051, excuse me.

[00:07:06] Speaker 03:
No.

[00:07:08] Speaker 03:
1051 and 1059.

[00:07:11] Speaker 03:
Which page?

[00:07:13] Speaker 03:
1059 is the interview summary.

[00:07:16] Speaker 01:
What part do you want?

[00:07:18] Speaker 01:
Sure.

[00:07:18] Speaker 03:
The paragraph that reads, applicants did point out.

[00:07:21] Speaker 01:
What page?

[00:07:22] Speaker 03:
I'm sorry.

[00:07:23] Speaker 03:
Application page 1059.

[00:07:24] Speaker 03:
OK.

[00:07:27] Speaker 03:
It's page 60 of exhibit 1002 from the hearing.

[00:07:32] Speaker 01:
And where do you want us to look?

[00:07:33] Speaker 03:
Second paragraph begins, applicants did point out

[00:07:36] Speaker 03:
that they were intending to claim a tissue graft, wherein both the amnion and corian layers were present, but at least a portion of the intermediate layer naturally present between the amnion and corian, i.e.

[00:07:47] Speaker 03:
the spongy layer, has been removed.

[00:07:49] Speaker 01:
Well, that talks about a portion of the intermediate layer.

[00:07:52] Speaker 01:
It doesn't say the whole thing.

[00:07:55] Speaker 03:
Of course, but they were claiming substantially cleaning, and that's... Well, it doesn't say substantially removed.

[00:08:00] Speaker 01:
It just says a portion of the intermediate layer.

[00:08:02] Speaker 03:
I agree with that, Your Honor.

[00:08:05] Speaker 03:
Get to another point as well.

[00:08:06] Speaker 03:
The point of that is, that is not an examiner's statement of, oh, I think what you're doing is removing the spongy layer.

[00:08:19] Speaker 03:
The examiner is documenting that the applicant said, what we're removing is the spongy layer.

[00:08:23] Speaker 03:
No, that doesn't say that.

[00:08:25] Speaker 03:
It says, at least a portion is removed.

[00:08:29] Speaker 03:
I understand that.

[00:08:30] Speaker 03:
The claim itself defines how much of it you remove.

[00:08:35] Speaker 03:
What my point is, is that that clearly discloses the applicant is... Is that the best you have in terms of the applicant's account?

[00:08:45] Speaker 03:
No.

[00:08:45] Speaker 03:
I would also call your honor's attention to the file history and starting at page 1050 and specifically 1051.

[00:09:03] Speaker 03:
It starts at 1050, and it refers to it during a follow-up conversation with Examiner Ford and the applicant's representatives.

[00:09:11] Speaker 03:
That's when the applicant, the examiner recommended that they amend by resetting a product by process.

[00:09:16] Speaker 03:
And then it reads, starting at page 1050 and then going on to 1051, it was discussed that the intact amnion layer and the corian layer were isolated and substantially clean.

[00:09:29] Speaker 03:
As such, the tissue graft was substantially free from blood clots

[00:09:33] Speaker 03:
and an intermediate layer, but a small amount of blood and intermediate layer might remain in the tissue graft as one skill in the art would understand.

[00:09:41] Speaker 03:
So you have an explicit reference in the interview to the applicant saying we're talking about the spongy layer, and we have an explicit statement in the remarks submitted by the applicant that we're talking about substantial removal of that intermediate layer.

[00:09:54] Speaker 03:
We submit that in light of those unequivocal statements in the intrinsic record,

[00:10:01] Speaker 03:
that you don't need to look at the statements of the experts.

[00:10:07] Speaker 03:
The intrinsic record provides the answer here.

[00:10:10] Speaker 03:
The evidence, in fact, that the board cited.

[00:10:13] Speaker 04:
What's your explanation of the fact that your expert was a little bit all over the place and at one point testified that when you separate these two layers some spongy tissue is

[00:10:30] Speaker 04:
removed and some spongy tissue adheres to each one of those layers?

[00:10:37] Speaker 03:
There's no question that everybody agreed that when you destroy the spongy layer by removing it, some stays on one side, some stays on the other.

[00:10:46] Speaker 03:
Everybody agreed to that.

[00:10:47] Speaker 03:
The reason you have different- The testimony is that- That is the testimony.

[00:10:51] Speaker 04:
In effect, the spongy tissue that remains affixed to each layer becomes sort of a part of that layer.

[00:10:58] Speaker 03:
No, no, just the opposite.

[00:11:00] Speaker 03:
The patent is clear, and the final history is clear, that you don't stop there.

[00:11:05] Speaker 03:
That you not only just remove the blood clots, but remove the intermediate layer.

[00:11:09] Speaker 03:
You remove that extraneous tissue.

[00:11:11] Speaker 03:
That's very clear from the teaching.

[00:11:13] Speaker 03:
And the problem was caused by the fact that all... That's clear, but where is the... What is your expert's comment on that?

[00:11:20] Speaker 03:
The expert was comment... The two cases that are cited by the board, one was the expert simply describing the separation process.

[00:11:28] Speaker 03:
Which doesn't mean that you stop there.

[00:11:30] Speaker 03:
In fact, the patent is clear that you do.

[00:11:33] Speaker 03:
The expert, in fact, testified.

[00:11:41] Speaker 03:
And this is the appendix at 3023.

[00:11:45] Speaker 03:
Do you consider spongy connective tissue to be extraneous material?

[00:11:48] Speaker 03:
Hang on a second.

[00:11:50] Speaker 03:
What is it?

[00:11:50] Speaker 03:
3023?

[00:11:51] Speaker 03:
3023, Your Honor.

[00:11:59] Speaker 03:
This is line 16.

[00:12:02] Speaker 04:
This is Dr. Bergen.

[00:12:03] Speaker 03:
I believe so, yes.

[00:12:05] Speaker 03:
Do you consider spongy connective tissue to be extraneous material?

[00:12:09] Speaker 03:
Answer.

[00:12:10] Speaker 03:
Well, this is part of what's clean.

[00:12:12] Speaker 03:
Well, you know, whether you call it extraneous or not, I think that that's kind of moot.

[00:12:17] Speaker 03:
For the purposes of washing and substantially cleaning, it includes blood clot, extraneous tissue, and some spongy connective tissue.

[00:12:25] Speaker 02:
So she specifically calls spongy tissue different than extraneous tissue.

[00:12:30] Speaker 02:
This is what's the problem with your expert testimony.

[00:12:33] Speaker 02:
It's not clear on anything.

[00:12:36] Speaker 02:
What you just read us doesn't specifically say spongy tissue is extraneous tissue.

[00:12:41] Speaker 03:
You don't need to just rely on our expert.

[00:12:44] Speaker 03:
Their expert described the spongy tissue as extraneous.

[00:12:47] Speaker 03:
In fact, their theory going clear.

[00:13:12] Speaker 03:
If you look at the appendix at page 1709 and 10, paragraph 98 on page 1709, moreover, because the spongy layer is attached to the separated amniotic corian loosely and unevenly, it is debris-like, wherein numerous random pieces of spongy layer dangle or hang loosely from the amniotic corian.

[00:13:40] Speaker 03:
Paragraph 99.

[00:13:42] Speaker 03:
Given that it is debris-like and not necessary for at least certain medical applications, a posa, person of skill in the art, would understand that the spongy layer constitutes, quote, extraneous tissue, close quote.

[00:13:57] Speaker 03:
In such circumstances, it is my opinion that, quote, washing and substantially cleaning the amni on, karma.

[00:14:04] Speaker 02:
Isn't all of this, what you're citing to us, an explanation of why, if the claim construction does include

[00:14:11] Speaker 02:
spongy, should include spongy tissue removal that Klein still anticipates?

[00:14:17] Speaker 02:
It's not agreeing that it does, it's just saying Klein anticipates if it does.

[00:14:23] Speaker 03:
That was the legal argument was Klein anticipates.

[00:14:26] Speaker 03:
This testimony by the expert is their expert's testimony.

[00:14:29] Speaker 02:
Which is all of their, the testimony is all under headings of why Klein invalidates, right?

[00:14:37] Speaker 03:
I understand.

[00:14:38] Speaker 02:
And it's conditional.

[00:14:39] Speaker 03:
That point, I don't think that it, she's not saying

[00:14:42] Speaker 03:
If the claim is construed in a certain way, spongy layer is extraneous tissue.

[00:14:51] Speaker 03:
But if it's proved differently, it's not spongy layer.

[00:14:54] Speaker 03:
This part of the testimony is unequivocal, unconditioned statements drafted with the help of their lawyers defining the spongy layer as, quote, extraneous tissue.

[00:15:04] Speaker 03:
Can you look at 1703?

[00:15:05] Speaker 02:
Sure.

[00:15:06] Speaker 02:
Paragraph 82.

[00:15:10] Speaker 02:
In the event that element D is construed to require that Washington and substantially cleaning stuff includes sponge material, Klein satisfies this.

[00:15:20] Speaker 02:
And then it goes on to talk about Klein on the pages you discuss.

[00:15:26] Speaker 02:
I mean, that clearly seems to be conditional on 1703, that she's not agreeing with that construction, but is just explaining why Klein still invalidates based upon that construction.

[00:15:37] Speaker 03:
I understand that point.

[00:15:41] Speaker 03:
Two things.

[00:15:41] Speaker 03:
One, in that written testimony, that actual explanation of what a person would understand to be extraneous tissue is not conditioned.

[00:15:51] Speaker 03:
And in her deposition, she was specifically asked, not in any condition, and this is in the appendix at 4706, line 12 question, what do you mean there by, quote, extraneous tissue, close quote?

[00:16:05] Speaker 03:
Answer.

[00:16:05] Speaker 03:
So, for example, you can have dead bits of tissue attached in there.

[00:16:08] Speaker 03:
You can also have other bits of tissue that have come out in delivery stuck to the membrane.

[00:16:12] Speaker 03:
In the case you are separating, you get bits of spongy layer hanging off, for example, and then could also represent extraneous tissue.

[00:16:20] Speaker 03:
Question, are there other types of extraneous tissue?

[00:16:23] Speaker 03:
A, not that I can think of.

[00:16:24] Speaker 03:
Now, what was going on at the time?

[00:16:26] Speaker 01:
OK, I think, Mr. Flynn, we're out of time here.

[00:16:29] Speaker 01:
We'll give you two minutes for a bottle.

[00:16:32] Speaker 01:
Thank you.

[00:16:32] Speaker 01:
Mr. Nicodemus?

[00:16:34] Speaker 00:
Yes, sir.

[00:16:34] Speaker 00:
Good morning, Your Honor.

[00:16:35] Speaker 00:
I would please report.

[00:16:38] Speaker 00:
If I may first address this argument that the inventor defined Amnion in the specification as not to include the spongy layer.

[00:16:45] Speaker 00:
I have two responses.

[00:16:47] Speaker 00:
One, that's incorrect.

[00:16:48] Speaker 00:
And two, even if he did, it doesn't matter.

[00:16:50] Speaker 00:
So in the background of the invention, the inventor was just giving a background of the technology, of the field of endeavor.

[00:17:00] Speaker 00:
He wasn't saying, in the claims, Amnion means this.

[00:17:03] Speaker 00:
or in the present invention, amnion means that.

[00:17:06] Speaker 00:
Because if he did, the claims wouldn't make sense.

[00:17:10] Speaker 00:
If you look at the claims, every time the word amnion appears, if he was defining it that way, it would mean it didn't have the spongy layer.

[00:17:18] Speaker 00:
So when you separated the amnion from the corion, nothing would be there, even though they concede that the spongy layer is there.

[00:17:25] Speaker 00:
It doesn't make sense.

[00:17:26] Speaker 00:
If there was no spongy layer to begin with, you wouldn't need a washroom cleaning step.

[00:17:31] Speaker 00:
Now, they do concede

[00:17:32] Speaker 00:
that during the separation step, there is spongy layer, and some of it goes on the chorion, some of it goes on the amniion.

[00:17:40] Speaker 00:
Now the question becomes, is that the type of material that should be cleaned?

[00:17:45] Speaker 00:
Is it debris?

[00:17:46] Speaker 00:
Is it contamination?

[00:17:47] Speaker 00:
Is it blood clots?

[00:17:48] Speaker 00:
And the answer is no to each and every one of them.

[00:17:51] Speaker 00:
They talk about Dr. Bergen.

[00:17:53] Speaker 04:
Well, isn't that residual spongy material extraneous to both the amniion and chorion layer?

[00:18:00] Speaker 00:
But that isn't what extraneous means.

[00:18:02] Speaker 00:
There's no evidence from any skilled artisan that extraneous means a separate layer.

[00:18:09] Speaker 00:
Extraneous means things.

[00:18:11] Speaker 04:
What do you think that extraneous means?

[00:18:13] Speaker 00:
Just what the board said, things that can, based on Bergen's testimony, things that can compromise the safety of the graph, debris, contamination.

[00:18:20] Speaker 00:
If you look in this patent, it's all about what you have to clean.

[00:18:24] Speaker 00:
In the summary of the invention, column three, it says in the cleaning step,

[00:18:29] Speaker 00:
you clean blood clots and other contaminants.

[00:18:32] Speaker 00:
In the chemical decontamination step in columns 6 and 7, it says you further clean bacteria and other contamination.

[00:18:40] Speaker 04:
But it's talking about cleaning from the... From the amnion and chorion layers.

[00:18:46] Speaker 04:
From those two layers.

[00:18:48] Speaker 00:
There's no evidence in this record that spongy layer is a bacteria, it's debris.

[00:18:53] Speaker 00:
In the context of the patent,

[00:18:56] Speaker 00:
You know, they talk about Dr. Jones.

[00:18:57] Speaker 04:
Is it your position then that the spongy layer residue is part of the amnion or corian layer?

[00:19:07] Speaker 00:
Yes.

[00:19:08] Speaker 00:
Dr. Bergen, for a variety of reasons.

[00:19:12] Speaker 00:
Dr. Bergen said it was.

[00:19:14] Speaker 00:
Dr. Jones said many people consider it.

[00:19:16] Speaker 00:
And we submitted lots of articles and book citations, including articles and books written by my medics, where they say,

[00:19:25] Speaker 00:
The spongy layer is part of the amnion.

[00:19:29] Speaker 00:
Now, I want to address for two seconds this prosecution history.

[00:19:34] Speaker 00:
I think Your Honor is pointing to appendix page 1059.

[00:19:37] Speaker 00:
This was the interview summary.

[00:19:41] Speaker 00:
And look what the examiner said.

[00:19:42] Speaker 00:
The examiner offered a suggestion to write a claim to distinguish over natural placenta.

[00:19:51] Speaker 00:
And she said, when you write this claim, include in it

[00:19:55] Speaker 00:
that at least a portion of the intermediate layer is removed.

[00:19:57] Speaker 00:
That's a spongy layer.

[00:19:59] Speaker 00:
And that would distinguish over natural percenta because the product would then lack the natural intermediate layer.

[00:20:06] Speaker 00:
They never wrote that claim.

[00:20:10] Speaker 00:
All they have is washing and substantially cleaning.

[00:20:13] Speaker 00:
Now, what the board did is comply with the BR bystander from top to bottom.

[00:20:18] Speaker 00:
You look to the specification.

[00:20:21] Speaker 00:
It says what to clean.

[00:20:24] Speaker 00:
Even at the final hearing, the oral argument, my medics counsels conceded that the specification and claims make no reference to removing the spongy layer.

[00:20:37] Speaker 00:
Dr. Bergen, she was asked in the related litigation to define what extraneous tissue means.

[00:20:45] Speaker 00:
Because if you look in column six, it says blood clots and other extraneous tissue.

[00:20:49] Speaker 00:
That's part of what the board relied on.

[00:20:51] Speaker 00:
They said extraneous tissue means debris and contamination.

[00:20:55] Speaker 00:
She was asked, what does it mean?

[00:20:57] Speaker 00:
In her declaration, she could have said the spongy layer.

[00:21:00] Speaker 00:
No.

[00:21:01] Speaker 00:
What she said was blood clots.

[00:21:03] Speaker 00:
What she said was remnants of tissue of various pathological states.

[00:21:07] Speaker 00:
And what she said was dead tissue.

[00:21:10] Speaker 00:
Now, my medics tries to say, well, that's all illustrative.

[00:21:13] Speaker 00:
But everybody knew what this case was about.

[00:21:15] Speaker 00:
What prevented her from saying it included the spongy layer?

[00:21:19] Speaker 00:
In the IPR proceeding, I took her deposition.

[00:21:23] Speaker 00:
I asked her about extraneous tissue.

[00:21:24] Speaker 00:
First, she said, look, my medics' counsel gave me this construction that has the spongy layer removed.

[00:21:31] Speaker 00:
I have no opinion on whether it's right or not.

[00:21:34] Speaker 00:
Then I asked her, what about extraneous tissue?

[00:21:36] Speaker 00:
You know what she says?

[00:21:37] Speaker 00:
It's ENR brief.

[00:21:38] Speaker 00:
That's beyond the scope of my opinions.

[00:21:41] Speaker 00:
Because in the litigation, she said what it was, and she didn't say it included the spongy layer.

[00:21:47] Speaker 00:
So she may have been all over the place on a lot of things.

[00:21:51] Speaker 00:
But she was right on when she was defining extraneous tissue.

[00:21:54] Speaker 00:
And she didn't define it as including the spongy layer.

[00:21:58] Speaker 00:
Now, one last point I'd like to make.

[00:22:00] Speaker 00:
It's true that when Dr. Jones' declaration was talking about the spongy layer and extraneous tissue, that was the alternative obviousness argument.

[00:22:10] Speaker 00:
Those citations that they talk about, they didn't present to the board in their brief.

[00:22:16] Speaker 00:
And that's what the board has to go on, what's in your briefs.

[00:22:18] Speaker 00:
What they did present

[00:22:21] Speaker 00:
is the last page of the appendix, 5343 at the final hearing.

[00:22:31] Speaker 00:
The title of this slide that they presented is that Dr. Jones agrees the spongy layer is extraneous tissue.

[00:22:38] Speaker 00:
But now look at what she testified to.

[00:22:40] Speaker 00:
Extraneous doesn't appear anywhere in there.

[00:22:44] Speaker 00:
And when I gave my rebuttal before the board, I said that.

[00:22:46] Speaker 00:
Where does she say it's extraneous tissue?

[00:22:48] Speaker 00:
None of those other citations

[00:22:50] Speaker 00:
were brought to the board's attention because they knew it was based on an alternative obvious in this argument.

[00:22:58] Speaker 00:
Look what Joan said in this PowerPoint slide.

[00:23:01] Speaker 00:
Some people think it's part of the amnion.

[00:23:03] Speaker 00:
Some people don't.

[00:23:05] Speaker 00:
But it's generally an intermediate layer.

[00:23:06] Speaker 00:
If it's intermediate, that doesn't mean it's debris or contamination.

[00:23:10] Speaker 00:
That doesn't mean it's something you have to clean because the specification doesn't say that.

[00:23:17] Speaker 00:
Unless your honors have any other questions, I'm finished.

[00:23:20] Speaker 00:
Thank you very much for your time.

[00:23:27] Speaker 03:
Very briefly, I'd like to address very specific three points about the characterization of the extrinsic record.

[00:23:34] Speaker 03:
First of all, my colleague said that Dr. Bergen testified in her declaration that the

[00:23:46] Speaker 03:
This bunch of layer was part of the amnion.

[00:23:47] Speaker 03:
That's not true.

[00:23:48] Speaker 03:
At paragraph 118, at appendix 1453, and this is what's cited by the board for this proposition, ironically, she says, quote, histologically, some have classified this layer as part of the amnion, while others have classified it as part of the choreo.

[00:24:07] Speaker 03:
And as I submit, the inventor of Mr. Daniel was very clear as to which side of that he was on.

[00:24:13] Speaker 03:
The second point on this that was made

[00:24:16] Speaker 03:
was that in Dr. Bergen's other statement, she listed various things like blood clots and dead tissue and did not list spongelayer.

[00:24:28] Speaker 03:
She didn't, but the period, the sentence appears in front of EG, not IE.

[00:24:34] Speaker 03:
She was not being exclusive.

[00:24:35] Speaker 03:
She was using examples of kinds of things that could be dead tissue.

[00:24:40] Speaker 03:
The final point I want to make is going back to, and I think the most important place is the

[00:24:45] Speaker 03:
specification where the layers of the amnion, as the inventor saw them, are set out.

[00:24:51] Speaker 03:
And it is somehow suggested that he's not defining what he understands the amnion to be for purposes of his invention, because it's in some background statement.

[00:25:00] Speaker 03:
It's in the background of the invention.

[00:25:03] Speaker 03:
That's the part that this occurs in.

[00:25:05] Speaker 03:
And that's the reason why the specification itself makes clear that if it's not one of those four layers, and the spongy tissue clearly isn't,

[00:25:15] Speaker 03:
it has to be extraneous tissue.

[00:25:17] Speaker 01:
Thank you.