[00:00:00] Speaker 04:
District Court, case number 151881, MIT versus Shire Pharmaceuticals, the appeal from a judgment of the district court in the District of Massachusetts.

[00:00:24] Speaker 04:
All right, you're going to have to help me with your pronunciation.

[00:00:27] Speaker 04:
Kuzmich?

[00:00:28] Speaker 04:
Kuzmich?

[00:00:29] Speaker 04:
Kuzmich?

[00:00:30] Speaker 04:
OK.

[00:00:32] Speaker 04:
And you want five minutes for rebuttal?

[00:00:34] Speaker ?:
Yes, please, Your Honor.

[00:00:35] Speaker 04:
You'll be the first person who's managed to save for a full five minutes, but we'll see.

[00:00:47] Speaker 01:
May I please the court?

[00:00:48] Speaker 01:
Yes.

[00:00:49] Speaker 01:
Good morning, Judge O'Malley and Judge Chen and Judge Stoll.

[00:00:53] Speaker 01:
This case, probably like the last one, is about disclaimer.

[00:00:58] Speaker 01:
And it's our position that it is clear and unequivocal that the claimed terms, vascularized organ tissue and cells derived from the vascularized tissue, were disclaimed and that cells derived from the vascularized tissue must require parenchymal cells and vascular organ tissue must be limited or must not include skin.

[00:01:21] Speaker 01:
And I think we can begin by looking at what does this invention... You have really two different points, right?

[00:01:28] Speaker 04:
There was a disclaimer of skin generally.

[00:01:30] Speaker 01:
Yes, Your Honor.

[00:01:31] Speaker 04:
And then there was a disclaimer of these types of cells.

[00:01:34] Speaker 01:
Yes, the requirement to use those cells.

[00:01:35] Speaker 01:
The requirement to use them.

[00:01:36] Speaker 01:
Yes.

[00:01:37] Speaker 01:
OK.

[00:01:37] Speaker 01:
And so I think both tie into what is actually the invention here.

[00:01:41] Speaker 01:
The invention here is making organs or organ equivalents that are supposed to supplement lost organ function.

[00:01:48] Speaker 01:
How does that actually happen?

[00:01:50] Speaker 01:
That happens by using the cells that have the function that are specific to the organ they're trying to replace.

[00:01:57] Speaker 01:
And those are parenchymal cells.

[00:02:00] Speaker 01:
It's a standard definition, a dictionary.

[00:02:02] Speaker 01:
It's the functional cells of the organ.

[00:02:05] Speaker 01:
And what we find, and I'll begin with the cells and our position on specification disclaimer, is that even at the outset, at the summary of the invention, it states the invention uses functional cells.

[00:02:21] Speaker 01:
They're placed on a polymer.

[00:02:23] Speaker 01:
And then they're grown.

[00:02:25] Speaker 01:
It's implanted.

[00:02:26] Speaker 02:
The spec also talks about skin, though, right?

[00:02:29] Speaker 01:
Yes, it does.

[00:02:30] Speaker 02:
Therefore, an object of invention to produce organs, including skin, et cetera, et cetera.

[00:02:37] Speaker 01:
And so going to the issue of vascular organ tissue and skin, I think that is different than the cells, because the skin was actually included in the specification.

[00:02:51] Speaker 01:
And I think that you might more consider a classic prosecution history disclaimer, because the applicants started thinking skin could be an organ of the invention.

[00:03:01] Speaker 01:
What I think is important is that if you fast forward to the prosecution history, they actually state later on when they disclaim skin, they say, look back to our application.

[00:03:13] Speaker 01:
we distinguish skin from organs and identify that.

[00:03:17] Speaker 03:
They tried to actually expressly claim non-skin.

[00:03:22] Speaker 03:
They tried to actually expressly have their claims say that skin wouldn't be an organ or wouldn't be something that was within the scope of the claims.

[00:03:31] Speaker 03:
And the examiner did not allow them to do so.

[00:03:35] Speaker 03:
Why doesn't that undercut your disclaimer argument?

[00:03:38] Speaker 01:
Absolutely.

[00:03:39] Speaker 01:
And I think what that is is

[00:03:42] Speaker 01:
The examiner wasn't looking at how it was characterized, how skin was characterized in the specification.

[00:03:49] Speaker 01:
And at that point in time, the inclusion of non-skin cells that you refer to was 1989.

[00:03:56] Speaker 01:
Fast forward in 1995 is when the applicant said, take a look at our specification.

[00:04:03] Speaker 01:
Skin is distinguished from organs.

[00:04:06] Speaker 01:
And if you look at the specification where they refer you to,

[00:04:10] Speaker 01:
there's quotes around organ when it refers to skin.

[00:04:14] Speaker 01:
And they're differentiating.

[00:04:15] Speaker 04:
Well, because that's because there are vascularized, that there is vascularized skin, correct?

[00:04:20] Speaker 01:
There is vascularized skin.

[00:04:22] Speaker 01:
I think, but the issue at that point in time was organs as opposed to skin.

[00:04:28] Speaker 01:
They said that the prior art was good for making skin as opposed to organs.

[00:04:34] Speaker 01:
And so I think

[00:04:36] Speaker 01:
the examiner didn't recognize that there is a distinction in the specification although skin is an organ and we don't dispute that but the fact is that it has differences and that was what allows the applicants to distinguish skin over other organs and so going to your point Judge there is a basis to say that skin is not an organ

[00:05:02] Speaker 01:
of the invention.

[00:05:03] Speaker 02:
Why wouldn't it be just a helpful organizing principle to understand everything that happened in prosecution history?

[00:05:12] Speaker 02:
Every time the Africans were referring to skin, they were really referring to the epidermis.

[00:05:19] Speaker 01:
I don't think a person of ordinary skill in the art looks at skin as just the epidermis.

[00:05:25] Speaker 02:
In fact, in the tutorial that was submitted... But I guess we're trying to understand if it's even possible.

[00:05:31] Speaker 02:
to draw a straight line through everything that happened in the prosecution history.

[00:05:35] Speaker 02:
One possible way to achieve that would be that, in context, what the applicants were talking about when they were talking about skin and everything they were trying to overcome was just in reference to the epidermis portion of the skin.

[00:05:54] Speaker 01:
Your Honor, I don't think that there's any evidence in the record to tell you that.

[00:05:59] Speaker 01:
maybe stepping back now 30 years later, possibly.

[00:06:03] Speaker 01:
Every time they talked about skin, it was about the skin, the skin equivalence.

[00:06:11] Speaker 01:
The prior art makes skin equivalence as opposed to our invention, which is organs.

[00:06:19] Speaker 04:
When you keep saying every time, part of me looks at this and I see someone who kept trying to disclaim skin.

[00:06:26] Speaker 04:
and then ultimately wasn't allowed to, so they went back and essentially withdrew that disclaimer.

[00:06:35] Speaker 01:
Well, I don't think that they withdrew this disclaimer because the final disclaimer, what we're talking about, where the term in 1997, vascularized organ tissue, which is the term in dispute today, that was in the claims.

[00:06:52] Speaker 01:
And at that point in time,

[00:06:53] Speaker 01:
there was still the statements made by the applicants saying, for example, at A1772-71, the prior art, while suitable for skin repair or for regeneration of nonvascular tissues, cannot without serious modification be applied to the purposes of the presently claimed invention for producing functional vascularized tissues and organs.

[00:07:20] Speaker 01:
So throughout the prosecution history,

[00:07:23] Speaker 01:
No matter what the claim language was, these statements were being made.

[00:07:28] Speaker 01:
And then even at the end, when we're talking about the absolute language that's in dispute here, there is a disclaimer.

[00:07:36] Speaker 01:
It's distinguishing what the prior art can make as compared to what is being claimed.

[00:07:42] Speaker 01:
And it wouldn't make sense if skin was an organ in this statement.

[00:07:49] Speaker 01:
It just wouldn't.

[00:07:50] Speaker 03:
Didn't they amend their claim to say it has to be a vascularized organ and then there was a distinction between the dermis and the epidermis?

[00:07:58] Speaker 01:
What happened in that response to the office action was that the prior art that was stumping the applicants for so long, they recognized or identified a paper that said that prior art could only

[00:08:16] Speaker 01:
make epidermis and some part of the dermis.

[00:08:20] Speaker 01:
It can only regenerate the dermis partially.

[00:08:23] Speaker 01:
But they never said anywhere here in the prosecution history, in any, I'm going to say, there was no retraction of now, OK, well, our invention encompasses dermis.

[00:08:35] Speaker 01:
That's not the case.

[00:08:36] Speaker 01:
They didn't say that.

[00:08:37] Speaker 01:
They said they continued to call the prior art skin, and they contrasted it from their vascularized organs.

[00:08:46] Speaker 02:
Even at that point... They didn't say something about the vascularized component of the skin?

[00:08:51] Speaker 01:
They talked about the vascularized dermis.

[00:08:54] Speaker 01:
Dermis being the component of the vascular part of the skin.

[00:08:58] Speaker 01:
But that statement is... And I think that all the disclaimers that we've identified in our briefing before that we consider those disclaimers.

[00:09:09] Speaker 01:
We don't... I don't think the public or a person of ordinary skill in the art can read those last statements

[00:09:16] Speaker 01:
as any kind of retraction.

[00:09:18] Speaker 04:
Wait, it says the prior art, while suitable for skin repair or for regenerating non-vascular tissues cannot without serious modification be applied to the purposes of the presently claimed invention for producing functional vasculized tissues and organs.

[00:09:33] Speaker 04:
So they are distinguishing between non-vascular and vascular tissues.

[00:09:41] Speaker 01:
Right, they're distinguishing between vascular and non-vascular.

[00:09:45] Speaker 01:
There's no distinguishing between the skin being vascular and the different parts of the skin of the prior art in contrast to the invention.

[00:09:56] Speaker 01:
There was never a statement here where, OK, now our invention covers the dermal part of the skin.

[00:10:03] Speaker 01:
This does not rise to the level of a retraction.

[00:10:08] Speaker 03:
But once they amended their claims,

[00:10:11] Speaker 03:
They amended their claims.

[00:10:12] Speaker 03:
They tried to claim non-skin.

[00:10:14] Speaker 03:
They were told they couldn't do that.

[00:10:16] Speaker 03:
Why didn't that in itself retract the disclaimer that you are speaking of?

[00:10:22] Speaker 01:
Because I think what you're talking about is when they added the non-skin cells to the claim.

[00:10:30] Speaker 01:
Correct.

[00:10:30] Speaker 01:
Right.

[00:10:31] Speaker 01:
And then the examiner said there wasn't support for that.

[00:10:33] Speaker 03:
Right.

[00:10:33] Speaker 03:
So why doesn't that?

[00:10:35] Speaker 03:
I mean, you're saying that there's some disclaimer by having statements in the prosecution history where they distinguished the prior art

[00:10:41] Speaker 03:
based on it being for skin.

[00:10:45] Speaker 03:
And then they try to claim that our invention just relates to organs that are not skin.

[00:10:51] Speaker 03:
And the examiner says, no, you can't do that.

[00:10:54] Speaker 03:
Why isn't that enough to retract any alleged disclaimer?

[00:10:59] Speaker 01:
Because I think after that, there were multiple other statements that once again said, our invention is organs

[00:11:09] Speaker 01:
as opposed to skin.

[00:11:10] Speaker 01:
For example, in 1995, years after the statement or the insertion of the non-skin cells was, it is clear from the foregoing excerpts from the patent application that construction of matrices for implantation of cells forming organs as opposed to skin is intended.

[00:11:31] Speaker 01:
So even if one could consider

[00:11:35] Speaker 01:
that insertion of non-skin cells into the claims in 1989 as an attempt, which I think it was, to disclaim skin, they couldn't do it that way.

[00:11:47] Speaker 01:
So they continued to try to make these arguments.

[00:11:50] Speaker 04:
But I mean, this was going back and forth with the examiner.

[00:11:52] Speaker 04:
I think the examiner was getting educated about the distinctions between types of skin.

[00:11:58] Speaker 04:
I mean, maybe this is where the phrase comes from.

[00:12:00] Speaker 04:
But wasn't there a distinction between thin skin and thick skin?

[00:12:04] Speaker 01:
And I think there was.

[00:12:06] Speaker 01:
Yes, you're absolutely right.

[00:12:07] Speaker 01:
But again, many of those statements, Your Honor, were made in the context of discussing the summary of the invention in addition to various other statements.

[00:12:18] Speaker 01:
I think these statements were clear and unequivocal as you walk through the whole file history that they were facing this prior art.

[00:12:27] Speaker 01:
Their colleagues, the Yanis prior art,

[00:12:29] Speaker 01:
that really focused on making skin equivalents, and that's what was done.

[00:12:34] Speaker 03:
So they were distinguishing skin, but then they had to amend the claims to say vascularized organs to try to distinguish that prior, because the examiner wasn't buying their argument based on just distinguishing skin, right?

[00:12:48] Speaker 01:
I'm not sure if the examiner wasn't buying that, possibly, but we still have to rely, the public has to rely, this is notice, it's clear that

[00:12:58] Speaker 01:
For 10 years, these applicants said, this is not skin.

[00:13:03] Speaker 01:
Skin is not an organ of the invention.

[00:13:06] Speaker 03:
The examiner kept saying skin is an organ.

[00:13:08] Speaker 03:
And so then they had to say, well, what we mean is vascularized organs in order to be able to distinguish that prior art.

[00:13:17] Speaker 01:
That's right.

[00:13:17] Speaker 01:
That's a way that they distinguish the prior art.

[00:13:19] Speaker 01:
But the other distinguishing feature that they made throughout, which I think that a person of ordinary skill in the art and the public needs to rely on,

[00:13:28] Speaker 01:
are those multiple times that they have said, skin is not an organ of this invention.

[00:13:34] Speaker 03:
What if the examiner says, I think skin is an organ of this invention?

[00:13:39] Speaker 03:
Does that, even hypothetically, let's just say that somebody has a disclaimer.

[00:13:45] Speaker 03:
They try to say, my invention's not X. And the examiner comes back multiple times and says, your invention covers X. I read your claims, and they cover X. And so then they go ahead and they take a different approach.

[00:13:56] Speaker 03:
Is that a disclaimer?

[00:13:58] Speaker 01:
That is still a disclaimer because the examiner is going to be using the broadest reasonable interpretation of the invention, of the claims.

[00:14:07] Speaker 01:
And so as we discussed earlier, the specification calls skin an organ, even though it differentiates it from others.

[00:14:16] Speaker 01:
So the examiner, even though the applicants can say that skin is not an organ, the examiner can look at the claim language and say, from the broadest reasonable interpretation,

[00:14:27] Speaker 01:
this could cover skin.

[00:14:29] Speaker 01:
And I think we cited in our brief the cases for that and went to Spring's window and said, Spring's window teaches us that even if you have narrowing statements, the examiner, it's not good enough for the examiner because the examiner takes the broadest reasonable interpretation.

[00:14:47] Speaker 01:
What happens is that you're still going to be held to that later on in terms of claim construction.

[00:14:53] Speaker 04:
OK.

[00:14:53] Speaker 04:
You pretty much used up your rebuttal.

[00:14:55] Speaker 04:
I'll give you two minutes for rebuttal.

[00:14:57] Speaker 01:
Thank you, Your Honor.

[00:15:05] Speaker 00:
Good morning, Your Honors.

[00:15:06] Speaker 00:
Gerald Wiesen on behalf of Appellee's MIT and Boston Children's Hospital.

[00:15:10] Speaker 04:
Can we start where your friend on the other side finished, which is what about the fact that we're supposed to be using a different construction now than the examiner uses during the course of the examination?

[00:15:24] Speaker 00:
Your Honor, I think that the question that's raised here is whether there's a clear and unmistakable disclaimer.

[00:15:30] Speaker 00:
And when you rely on prosecution history disclaimer, the questions are, what are the statements that we've relied on?

[00:15:36] Speaker 00:
We have pointed to, at A, I think it's 9065 of the record.

[00:15:42] Speaker 00:
Judge Dole, it's not a hypothetical whether the examiner said skin is part of the invention at 9065.

[00:15:47] Speaker 00:
I believe the examiner said that.

[00:15:50] Speaker 00:
But that's not the only thing we're relying on.

[00:15:52] Speaker 04:
Who cares if the examiner buys your

[00:15:54] Speaker 04:
If you disclaimed it, you disclaimed it, right?

[00:15:57] Speaker 00:
Certainly true, Judge O'Malley.

[00:16:00] Speaker 00:
Whether it is the basis for allowable or not, there can be a disclaimer if there is a clear and unmistakable statement in the prosecution history or in the specification.

[00:16:10] Speaker 00:
Here there is not, quite frankly.

[00:16:12] Speaker 04:
The 1995 statement is the one that gives me the most pause with respect to your arguments.

[00:16:17] Speaker 04:
It says, skin is differentiated from organs.

[00:16:21] Speaker 04:
and then you go on later and you actually talk about cells forming organs as opposed to skin.

[00:16:26] Speaker 04:
I mean, that's pretty clear, right?

[00:16:29] Speaker 00:
If I recall that one correctly, Your Honor, that's at A1645.

[00:16:34] Speaker 00:
That specifically refers back to the specification earlier on in that passage.

[00:16:40] Speaker 00:
If we look back at the specification and we see how skin is distinguished from other organs, it is certainly true that skin is distinguished, but not because it's not an organ.

[00:16:50] Speaker 00:
As Judge Chen was pointing out, the specification is explicit that skin is an organ.

[00:16:54] Speaker 00:
It just has some different issues.

[00:16:57] Speaker 00:
And I think Judge Chen's also correct that it's fair that what we're talking about really is the difference between the dermis and the epidermis.

[00:17:03] Speaker 00:
That becomes clear in the 1997 amendment at the very end of the prosecution.

[00:17:07] Speaker 04:
Right.

[00:17:09] Speaker 04:
But in 1995, it doesn't look like that's the distinction you're making.

[00:17:12] Speaker 04:
It looks like you're making the distinction between organs and skin organs.

[00:17:20] Speaker 00:
In context, because it refers back to the specification explicitly, we believe that a person of ordinary skill reading the record as a whole would understand by referring back to the specification, we're not saying skin is not an organ.

[00:17:34] Speaker 00:
Because explicitly in the specification we say skin is an organ.

[00:17:37] Speaker 00:
What we're saying is skin as an organ raises some different issues.

[00:17:41] Speaker 00:
And it does.

[00:17:41] Speaker 00:
The epidermis especially raises different issues.

[00:17:45] Speaker 00:
Council for Shire suggested that this was a situation where

[00:17:48] Speaker 00:
there was some unexpected art that forced us to narrow the claims.

[00:17:52] Speaker 00:
That's incorrect.

[00:17:53] Speaker 00:
The art that was relied on for skin, the Yannis art, is actually the art that's disclosed and discussed in the specification in column four.

[00:18:01] Speaker 00:
It was the same art back and forth entirely throughout the prosecution that we knew about when we filed the application.

[00:18:09] Speaker 00:
And despite knowing about that art, we said that skin is an organ of the invention.

[00:18:13] Speaker 00:
Why?

[00:18:14] Speaker 00:
because you can't make the thicker skin with the vascularized dermal tissue with the Janus Prior Art.

[00:18:21] Speaker 00:
They use a different three-dimensional, they use a different scaffold.

[00:18:24] Speaker 04:
The real invention here is... Is there such a thing as a scaffold that's not three-dimensional?

[00:18:31] Speaker 04:
I mean, it seems a little redundant to call it a three-dimensional scaffold.

[00:18:35] Speaker 00:
What happened in this art, Your Honor, is people would grow cells on a flat surface, or a basically flat surface, a petri dish, a gel.

[00:18:44] Speaker 00:
A three-dimensional scaffold is one in which the cells can grow in all three dimensions.

[00:18:52] Speaker 00:
And the scaffold is the supporting structure.

[00:18:55] Speaker 00:
So what's critical here for this invention is that you have a structure that spaces the cells from each other.

[00:19:01] Speaker 00:
I got that.

[00:19:03] Speaker 04:
I guess maybe I was just being flip.

[00:19:05] Speaker 04:
But I just don't understand how a scaffold could picture a scaffold that's anything other than three-dimensional.

[00:19:11] Speaker 00:
I haven't thought about the question, Your Honor.

[00:19:13] Speaker 00:
I'm not sure I can identify one.

[00:19:15] Speaker 00:
I think a person of ordinary skill in the art would understand what the three-dimensional scaffold was, whether or not the three-dimensional was sort of a necessary part of the term.

[00:19:24] Speaker 00:
I took you off your argument.

[00:19:25] Speaker 02:
Can you go back to the organs as opposed to skin comment in the prosecution history?

[00:19:30] Speaker 02:
You were saying or suggesting, intimating, that skin has some different issues, some unique issues.

[00:19:38] Speaker 02:
But you didn't explain what you meant by that.

[00:19:41] Speaker 00:
So if you look in column four of the patents at A44, I'm referring to the 830 patent.

[00:19:47] Speaker 00:
Because there was a continuation in part, there are different specifications, but the 830 is the most comprehensive.

[00:19:53] Speaker 00:
It talks about starting about line seven, although different from organs such as the liver and interesting in a number of ways, skin is also an organ subject to damage by disease or injury which performs the vital role of protecting the body from fluid loss and disease.

[00:20:10] Speaker 00:
So what we see throughout column four of the 830 patent is that there is a distinction that's discussed here with skin.

[00:20:18] Speaker 00:
That's partially because the applicants are aware of the Janus art.

[00:20:23] Speaker 00:
They know that there are some artificial skin references available in the prior art, and they want to acknowledge that's there, but our invention is still different from that.

[00:20:32] Speaker 00:
It's different not because we're not skin.

[00:20:34] Speaker 00:
It's different because our three-dimensional scaffold is different than

[00:20:38] Speaker 00:
the collagen gel that Yannis and Burke and Green use.

[00:20:42] Speaker 00:
And if you get to column five, they're explicit about that starting at line 10.

[00:20:46] Speaker 00:
It is therefore an object of the present invention to disclose a method and means for creating a variety of organs, including skin.

[00:20:54] Speaker 00:
And so what they're pointing out is although there are some differences, and really Judge Chen, I think you hit on it, that the difference they're talking about is the epidermis versus the dermis.

[00:21:04] Speaker 02:
Right.

[00:21:04] Speaker 02:
But I guess what I'm trying to figure out is up until 1997,

[00:21:08] Speaker 02:
it looked like the applicants were ready to throw skin writ large out the window.

[00:21:15] Speaker 02:
Is that fair to say?

[00:21:16] Speaker 00:
I think, Your Honor, that what's fair to say is that there was a lot of back and forth with the examiner.

[00:21:22] Speaker 00:
This was a groundbreaking invention that they were having trouble explaining to the examiner what it was and getting the examiner to understand the scope of the invention.

[00:21:31] Speaker 02:
I guess if the examiner had allowed any version of the claims throughout the prior 10 years

[00:21:38] Speaker 02:
then wouldn't it be fair to say that your claims would have been limited to non-skin organs?

[00:21:44] Speaker 00:
There were times, certainly, when the non-skin limitation was added, that the claims would have been limited.

[00:21:50] Speaker 00:
That would not have prevented the applicants from going back with a continuation application.

[00:21:54] Speaker 00:
It's not an unusual strategy for a prosecutor.

[00:21:57] Speaker 00:
If you're offered half a loaf or 7 eighths of the loaf of bread, to take that piece, file a continuation,

[00:22:04] Speaker 00:
and go back and see whether you can get the last piece of it.

[00:22:07] Speaker 02:
So what's the best way to look at all of these statements?

[00:22:09] Speaker 02:
Is it that there was a last second, just in time, Harry Houdini moved to save themselves from all the disclaiming statements that had happened by going in a different direction with vascularized organ tissue?

[00:22:25] Speaker 02:
Or is it that, well, no, we were always talking about epidermis.

[00:22:29] Speaker 02:
We just never said the magic word epidermis until the last second?

[00:22:33] Speaker 00:
I think what was actually going on is that they were trying to distinguish the prior art in a variety of different ways.

[00:22:37] Speaker 00:
What we didn't hear about from Council for Shire is what claims were pending during these different amendments and different arguments.

[00:22:45] Speaker 00:
The claims kept shifting.

[00:22:46] Speaker 00:
And one of the things that was added repeatedly was a thickness requirement, that the organ had to be greater than 300 microns.

[00:22:56] Speaker 00:
Generally speaking, it was viewed that the skin was going to be narrower than that.

[00:23:00] Speaker 00:
And so for many of the amendments that they're talking about, when they talked about thick versus thin, it may have been the case, certainly with the Janus art, with the epidermis, it would have been thinner than that.

[00:23:11] Speaker 00:
And so they were trying a variety of ways to get around the prior art.

[00:23:16] Speaker 00:
It was not by disclaiming all skin.

[00:23:19] Speaker 00:
It was not by disclaiming any of the particular specific disclosed vascularized organs.

[00:23:24] Speaker 00:
Instead, it was different claims.

[00:23:26] Speaker 00:
That's how I pronounce it.

[00:23:30] Speaker 00:
I'm not sure whether that's correct.

[00:23:33] Speaker 00:
So that's the second issue that was raised in the brief, was to focus on whether we disclaim the parenchymal cells.

[00:23:40] Speaker 00:
For that one, they rely on some statements in the specification, some statements in the prosecution history.

[00:23:45] Speaker 00:
But like the case we heard, you just heard, there are specific dependent claims to non-parenchymal cells.

[00:23:53] Speaker 00:
And there's really no dispute about that.

[00:23:55] Speaker 00:
Their expert below, Dr. Badalak, conceded in his declaration that the bone-forming cells are not parenchymal cells.

[00:24:03] Speaker 00:
And in fact, the proposed construction from Shire is that would be parenchymal cells and bone-forming cells.

[00:24:10] Speaker 02:
And mouse fibroblasts?

[00:24:12] Speaker 00:
Mouse fibroblasts would also not be, would be stromal, not parenchymal.

[00:24:17] Speaker 00:
That's a critical one for Shire because their product uses fibroblasts.

[00:24:21] Speaker 00:
You won't be surprised to know the reason this matters to them is that

[00:24:24] Speaker 00:
Their claim, at least, is that they don't use parenchymal cells.

[00:24:27] Speaker 00:
And they're trying to draw this bright line between parenchymal and stromal and functional and non-functional.

[00:24:33] Speaker 00:
But that ignores that, especially for an organ like the skin.

[00:24:36] Speaker 00:
The structure is part of the function.

[00:24:39] Speaker 00:
There are some references, in fact, in the prosecution history to the fact that structure is a function.

[00:24:43] Speaker 00:
There's no sort of bright line between them.

[00:24:46] Speaker 00:
And the line that Shire is trying to draw in this disclaimer

[00:24:50] Speaker 00:
is one that's artificial and not contained when you read the specification and prosecution history as a whole.

[00:25:05] Speaker 00:
I think it's also fair to say that focusing on the parenchymal limitation, there's no dispute that the claims as drafted and as issued are simply cells derived from a vascularized tissue.

[00:25:17] Speaker 00:
There's no limitation on which cells,

[00:25:20] Speaker 00:
They need to find, again, a clear and unmistakable disclaimer.

[00:25:24] Speaker 00:
And when they point even to the summary of the invention, what we see is even the summary of the invention in column six lists these nonparenchymal cells as examples of the invention.

[00:25:37] Speaker 00:
And that means that the logic that they're applying, that every time we, because we use the word parenchymal sporadically throughout the specification, we must be limited to that, is incorrect.

[00:25:48] Speaker 00:
It's inconsistent with both the specification and the dependent claims.

[00:25:54] Speaker 00:
And with that, it's impossible to find a clear and unmistakable surrender.

[00:25:59] Speaker 04:
Right.

[00:25:59] Speaker 04:
Well, the district judge actually, for some reason, I thought it was parenchymal.

[00:26:03] Speaker 04:
But the district judge actually did say that the use of the word functional and parenchymal were used interchangeably.

[00:26:12] Speaker 00:
He suggested it was used interchangeably in one paragraph of the specification.

[00:26:16] Speaker 00:
but not throughout the entirety of the specification.

[00:26:19] Speaker 00:
And we had a day and a half Markman hearing with Judge Wolff, as well as a half day tutorial.

[00:26:24] Speaker 00:
So he was very up to speed on these issues.

[00:26:27] Speaker 00:
And his point was, in the summary of the invention, it refers to function and then parenchymal.

[00:26:33] Speaker 00:
But he did not have any observations or make any findings concerning whether functional was used interchangeably throughout, or whether structure could or could not be a function.

[00:26:45] Speaker 04:
OK, so the bone-forming cells, those are the stromal cells, right?

[00:26:49] Speaker 00:
They are nonparenchymal.

[00:26:50] Speaker 00:
I believe they are stromal, yes.

[00:26:51] Speaker 00:
As are the smooth muscle cells, as are the bovine endothelial cells.

[00:26:56] Speaker 00:
The smooth muscle cells are claimed in one of the dependent claims in the 193 patent.

[00:27:00] Speaker 00:
The bone-forming cells are claimed in a dependent claim of the 830.

[00:27:05] Speaker 00:
The bovine endothelial cells are disclosed in the 830 patent and is discussed in a specification, but they are not actually claimed in any of the dependent claims.

[00:27:13] Speaker 00:
They were used as a model.

[00:27:15] Speaker 02:
So is our case law so clear that, hypothetically, if there were very clear what would be otherwise clear disclaimer statements in the prosecution history, that can somehow be undone or washed clean by the end of the prosecution?

[00:27:36] Speaker 02:
That maybe in 1993, one of skill in the art would see a very clear statement

[00:27:42] Speaker 02:
but there's still a way to escape that very clear statement by the applicants and patent owners?

[00:27:50] Speaker 00:
I think, Judge Chen, the key here is that there are amendments of the claims and that the language changes.

[00:27:56] Speaker 00:
At one point, we actually used the word parenchymal or parenchymal.

[00:27:59] Speaker 00:
Other times, we've changed, and what was issued just had cells derived from vascularized tissue.

[00:28:06] Speaker 00:
And having made that change,

[00:28:08] Speaker 00:
It's impossible to say there's a clear and unmistakable surrender of the claim language as issued when that language wasn't even in the claims at the time the statements were made that they're pointing to, and when, moreover, there's no language in that final amendment that limits the claims in that way.

[00:28:27] Speaker 00:
And it's at that point in that Council for Shire referred to that passage at 1770 and 1771

[00:28:34] Speaker 00:
That's the passage where there's the very explicit distinction between dermis and epidermis.

[00:28:39] Speaker 00:
And I think that's a good example where when the claim language changes, you get the explanation.

[00:28:45] Speaker 00:
And if there had been a disclaimer, and I don't think there was when you look in context, but it's the reason your case law suggests you have to read the entire prosecution history.

[00:28:55] Speaker 00:
I wouldn't suggest that here.

[00:28:56] Speaker 00:
It was thousands of pages over 12 years.

[00:28:59] Speaker 00:
But you need to look at the entire context.

[00:29:01] Speaker 00:
And when you see that context, it's clear that by the end,

[00:29:05] Speaker 00:
We wanted the broad scope.

[00:29:06] Speaker 00:
There was an interview between the applicants and the examiner, and I believe the examiner's supervisor, where they sat down and said, look, let us try one more time to explain to you why this is a groundbreaking broad invention.

[00:29:19] Speaker 02:
And then by the end, though, the applicants were still loosely talking about skin with respect to Janus, right?

[00:29:26] Speaker 00:
Well, there's where they were talking about the dermis versus epidermis.

[00:29:30] Speaker 00:
And what they were talking about with Janus was, by that time,

[00:29:33] Speaker 00:
Janus actually had post-art that he had published explaining that his method did not work for dermis, and you needed the spacing of the invention to make it work for the vascularized dermis.

[00:29:44] Speaker 00:
It's not prior art, but they were pointing to it as an example that, in fact, what we've been telling you all along is correct, that Janus does not work for the vascularized portion of skin, the dermis, and he now himself acknowledges that.

[00:30:01] Speaker 04:
OK.

[00:30:02] Speaker 04:
We've got three seconds.

[00:30:03] Speaker 04:
You want to wrap up?

[00:30:05] Speaker 00:
Your Honor, we think that Judge Wolf did an excellent job considering this, and we'd ask you to affirm the finding of infringement and validity based on the stipulation from the Jire.

[00:30:15] Speaker 04:
Thank you.

[00:30:21] Speaker 04:
And how do you pronounce it?

[00:30:23] Speaker 01:
I was pronouncing it parenchymal.

[00:30:25] Speaker 04:
OK.

[00:30:26] Speaker 04:
I have no idea.

[00:30:28] Speaker 01:
I've heard it both ways.

[00:30:30] Speaker 01:
Thank you for these two minutes, Your Honors.

[00:30:33] Speaker 01:
Commenting on what my colleague said, I'd like to go to the parenchymal, the cells.

[00:30:39] Speaker 01:
It was a clear and unmistakable explanation of what the cells of the invention are in the 1996 response to the office action at A1579-80.

[00:30:51] Speaker 01:
The applicants expressly stated that the types of cells described in the application

[00:30:58] Speaker 01:
are defined in medical dictionaries and textbooks as parenchymal cells.

[00:31:04] Speaker 01:
And they go on and they say that the parenchymal cells applicants have repeatedly tried to use other words to describe the cells, in particular organ cells, and each examiner, of which there have been many or several, has objected to the language of his predecessor.

[00:31:21] Speaker 01:
Applicants will use appropriate language that this examiner prefers if necessary.

[00:31:27] Speaker 01:
And this only makes sense in that the parenchymal cells are the functional cells.

[00:31:32] Speaker 01:
If the object of the invention is to make an organ that supplements lost or supplements lost organ function, you need the parenchymal cells.

[00:31:42] Speaker 01:
This is a clear and unmistakable surrender of claim scope.

[00:31:47] Speaker 01:
The cells required are parenchymal.

[00:31:50] Speaker 01:
And yes, the language did change after, where now we have what happened about a year later.

[00:31:56] Speaker 01:
was the language we see now, cells derived from a vascularized tissue.

[00:32:01] Speaker 01:
But there's nothing that retracts this clear and unmistakable surrender.

[00:32:06] Speaker 02:
But the word parenchymal was no longer in the claim, right?

[00:32:09] Speaker 01:
That's correct, Your Honor.

[00:32:10] Speaker 02:
Whereas when there was all this conversation, the word parenchymal was in the claim.

[00:32:15] Speaker 01:
Right.

[00:32:15] Speaker 02:
And there was an indefiniteness rejection, and there was then all this back and forth about trying to figure out what is the meaning, what is the scope of parenchymal.

[00:32:23] Speaker 01:
Right.

[00:32:23] Speaker 01:
Right.

[00:32:24] Speaker 01:
But just taking out that language out of the claim is not a retraction.

[00:32:28] Speaker 01:
And this is the statement that I'm pointing to is not the only statement that we've seen about parenchymal.

[00:32:35] Speaker 01:
The specification teaches parenchymal.

[00:32:37] Speaker 01:
There was a prior Office Action response that teaches parenchymal.

[00:32:42] Speaker 01:
And so parenchymal was clearly required to make this invention work.

[00:32:47] Speaker 01:
I recognize I'm past time.

[00:32:49] Speaker 01:
So we would ask the court reverse the findings of claims instruction

[00:32:53] Speaker 01:
Judge Wolf found.

[00:32:56] Speaker 01:
And basically, as a matter of law, a demograph does not infringe based upon Shire's proposed constructions.

[00:33:04] Speaker 04:
Thank you.