[00:00:07] Speaker 04:
Our final case for today is 2019-1527, Bexalta versus Genentech.

[00:00:40] Speaker 01:
Mr.. Peterson Please proceed when you're ready May it please the court the district court heard by construing antibody inconsistently

[00:01:08] Speaker 01:
with how the word is used in the claims.

[00:01:11] Speaker 05:
Mr. Peterson, I have some questions.

[00:01:13] Speaker 01:
Yes, Your Honor.

[00:01:14] Speaker 05:
In the blue brief at 40, you argue that the district court characterized the PTO's office action as, quote, really confusing.

[00:01:23] Speaker 05:
That's in the last full paragraph on page 40.

[00:01:27] Speaker 05:
Yes, Your Honor.

[00:01:29] Speaker 05:
Isn't it true that the really confusing comment occurred early in the Markman hearing before a genetic oral argument?

[00:01:37] Speaker 01:
Yes, Your Honor, that's correct.

[00:01:39] Speaker 01:
And I apologize.

[00:01:39] Speaker 01:
I did not mean to mislead the court there.

[00:01:42] Speaker 01:
Certainly the district court, in his opinion, reflects what he believed to be a clear understanding of the office action.

[00:01:50] Speaker 01:
Although we certainly agree with the district court's earlier comment that it was really confusing.

[00:01:56] Speaker 05:
Well, you don't present it that way.

[00:01:59] Speaker 05:
I mean, how can a statement by a court about an office action at the start of a Markman hearing be evidence of the court's understanding at the end of the hearing?

[00:02:10] Speaker 05:
During the claim construction proceedings, the district court characterized this office action as really confusing.

[00:02:17] Speaker 05:
I don't think that's fair.

[00:02:20] Speaker 05:
In the red brief at 35, Genentech states that you assert for the first time on appeal that because the cited prior art describes IgM and IgA antibodies as having more than two identical heavy chains and two identical light chains,

[00:02:40] Speaker 05:
The prior contradicts the district court's construction.

[00:02:45] Speaker 05:
Is Genentech correct that you're raising this for the first time on appeal?

[00:02:50] Speaker 01:
No, Your Honor.

[00:02:51] Speaker 05:
Where'd you raise that below?

[00:02:56] Speaker 01:
Your Honor, I apologize.

[00:02:57] Speaker 01:
May I respond to that during rebuttal?

[00:02:59] Speaker 01:
It is in the record.

[00:03:00] Speaker 01:
I do not have a specific citation.

[00:03:02] Speaker 05:
In the red brief at 62 to 65, Genentech states that you never explained

[00:03:09] Speaker 05:
Your disclaimer of the claim scope, I'd like you to explain it now.

[00:03:14] Speaker 05:
Specifically, what did you disclaim to obtain the issuance of the patent?

[00:03:19] Speaker 01:
Your Honor, you'll see this on index pages 16040 to 16041, portion of the transcript of the Markman hearing.

[00:03:31] Speaker 01:
What we believe was disclaimed during prosecution related to two amendments that were made

[00:03:39] Speaker 01:
not with respect to the general change from derivatives to fragments, but with respect to modifications relating to original claim five, which originally read wherein said antibody derivative comprises a complement determining region, peptide.

[00:03:56] Speaker 01:
That was amended and issued claim 21.

[00:04:01] Speaker 05:
I'm sorry, did you say 16040?

[00:04:02] Speaker 05:
Yes, Your Honor.

[00:04:16] Speaker 01:
originally referred to any complementary determining region peptide, CDR peptide.

[00:04:22] Speaker 01:
As issued, the claims related only to CDR3 peptides.

[00:04:28] Speaker 01:
That was an amendment in the surrender that we acknowledge was made during the prosecution.

[00:04:32] Speaker 01:
The other surrender that we acknowledge related to an amendment in what was Claim 7 relating to derivatives comprising amino acids selected from the group with random or variable amino acid sequences.

[00:04:45] Speaker 01:
that was modified during the prosecution and the issued claims to list only specific amino acid sequences.

[00:04:54] Speaker 01:
So those are the only two surrenders that we see, clearly and unmistakably, in the file history.

[00:05:02] Speaker 01:
And you see that, I'm looking on appendix page 16041, page 37 of the transcript,

[00:05:09] Speaker 01:
The court asking Mr. Abernathy its lines 15 to 18.

[00:05:13] Speaker 01:
Are those the only two surrenders in your view, Mr. Abernathy?

[00:05:17] Speaker 01:
Yes, Your Honor.

[00:05:19] Speaker 01:
We certainly acknowledge there was an amendment from derivative to fragment, generally, during the prosecution of the patent.

[00:05:26] Speaker 01:
But it is ambiguous as to why that amendment was made.

[00:05:30] Speaker 01:
And certainly nothing in the file history clearly and unmistakably indicates that the examiner and the patentee understood that amendment to be surrendering all bispecific antibodies, all chimeric antibodies, all humanized antibodies.

[00:05:49] Speaker 01:
And in fact, we think the suggestion of a disclaimer of those antibodies is refuted by the claims that actually were allowed.

[00:05:57] Speaker 01:
As this court noted in the intellectual adventures versus T-Mobile case, a requirement in a dependent claim belies disclaimer in the independent claims from which those claims depend.

[00:06:10] Speaker 01:
Here, if you look at the face of the claim to the 590 act, claim 19 refers to an antibody that is a humanized antibody.

[00:06:19] Speaker 01:
Claim 4 refers to wherein an antibody or antibody fragment is a bispecific antibody.

[00:06:26] Speaker 01:
Just from English grammar, antibody is necessarily used broadly enough in the claims to include humanized antibodies, is used broadly enough to include bispecific antibodies.

[00:06:37] Speaker 01:
Under my friend's construction adopted by the district court, those phrases are oxymorons.

[00:06:43] Speaker 01:
an antibody by definition cannot be a humanized antibody, an antibody by definition cannot be a bi-specific antibody.

[00:06:50] Speaker 02:
What do you think the column five language in the specification, in your view, was seeking to do?

[00:06:59] Speaker 02:
Was it seeking to define antibody or was it seeking to define what antibodies are in the human body?

[00:07:05] Speaker 02:
There seems to be

[00:07:08] Speaker 02:
You know, that's one of the most important issues in this case, of course.

[00:07:12] Speaker 01:
So what's your view on that?

[00:07:18] Speaker 01:
But is it true that that's a description of how they would occur in the human body?

[00:07:29] Speaker 01:
It's a description of some naturally occurring antibodies in the human body.

[00:07:33] Speaker 02:
Are there naturally occurring antibodies that wouldn't fall within that?

[00:07:36] Speaker 01:
Yes, Your Honor.

[00:07:37] Speaker 01:
The vast majority of IgM antibodies are pentameters.

[00:07:41] Speaker 01:
They have more than two heavy chains and more than two light chains, although those heavy and light chains are identical.

[00:07:49] Speaker 01:
And with respect to lexicography and the definition, I'll note that this court has never suggested that a to be verb standing alone is enough to constitute lexicography.

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And certainly in Abbott Laboratories, this court rejected lexicography based solely on the use of a to be verb in specification.

[00:08:08] Speaker 01:
You don't see any other indicia here.

[00:08:10] Speaker 01:
You don't see as used herein.

[00:08:12] Speaker 01:
You don't see the word antibodies in quotation marks.

[00:08:15] Speaker 01:
You don't see antibodies of the present invention.

[00:08:19] Speaker 01:
And in fact, if you look just two columns later, column seven carrying over to column eight, what you'll see is a statement that the antibodies of the present invention can be prepared by means of phage display gene libraries or humanizing techniques.

[00:08:37] Speaker 01:
We asked their expert about that statement at his deposition, and he admitted that it couldn't be harmonized with treating column five as a definition.

[00:08:48] Speaker 01:
He said in his words, quote, I think there is a miswriting there in the specification.

[00:08:53] Speaker 01:
That refutes any suggestion that column five can be taken as definitional.

[00:08:58] Speaker 02:
Did anybody argue, you know, I'm looking at column five here, the definition comprises multiple sentences in the specification.

[00:09:08] Speaker 02:
Did anybody argue that additional sentences should be read in, like there's another sentence, at least one other sentence in this paragraph,

[00:09:17] Speaker 02:
that seems to be adding on to the definition that purportedly is provided here.

[00:09:25] Speaker 02:
Why the cutoff here at line 63?

[00:09:30] Speaker 01:
The parties focused on the portions of the definition that were material to the infringement contentions.

[00:09:37] Speaker 01:
Here, hemiCizumab, the accused product, is a humanized, bi-specific antibody, which would fall outside this narrow definition.

[00:09:48] Speaker 01:
narrow description because it has non-identical heavy and light chains and because its synthesis was not induced by an antigen.

[00:09:55] Speaker 02:
Sure, your view is that it could have been the whole paragraph, but there was no need to go on because this was enough to do distinguish the accused product.

[00:10:03] Speaker 01:
Yes, Your Honor, I think in the district court's reasoning it would have to be the whole paragraph.

[00:10:07] Speaker 01:
I point you to appendix page 39.

[00:10:09] Speaker 01:
Note 6, where there was some discussion of the synthesis requirement, which receives very little analysis in the district court's opinion.

[00:10:17] Speaker 01:
But the district court included that in the construction, saying because column 5 is definitional and this is part of column 5, it is necessarily part of the construction.

[00:10:27] Speaker 01:
Let me take you back, though, because I think the district court went astray.

[00:10:31] Speaker 01:
You've heard my argument about the usage of the word antibody in the dependent claims.

[00:10:35] Speaker 01:
The district court treated this as a claim differentiation argument.

[00:10:38] Speaker 01:
And that's not correct.

[00:10:41] Speaker 01:
The argument is not based on the scope of the claims.

[00:10:43] Speaker 01:
The argument is not that these dependent claims imply that there is not a limitation present in the independent claim from which they depend.

[00:10:52] Speaker 01:
Our argument is just based on the usage of the word antibody in the claims.

[00:10:57] Speaker 01:
If you took claim 19, struck out the dependents from claim 1, and just made it an independent claim that recited an antibody that is a humanized antibody, our argument would be exactly the same.

[00:11:09] Speaker 01:
that you should not adopt constructions of terms that render claims nonsensical on their face.

[00:11:15] Speaker 02:
Would you say that that applies to the specification as well?

[00:11:17] Speaker 02:
The specification teaches lots of different adjectives that precede the word antibody.

[00:11:23] Speaker 02:
Would you say that in each of those cases the word antibody

[00:11:27] Speaker 02:
should be inclusive of all those different kinds of antibodies.

[00:11:30] Speaker 02:
Like, I don't know, an example would be a nail.

[00:11:34] Speaker 02:
A nail is a nail, whether it's a rusty nail or a non-rusty nail, a steel nail, or an aluminum nail.

[00:11:41] Speaker 02:
Here you've got a lot of different kinds of antibodies, including bispecific, monospecific,

[00:11:48] Speaker 02:
different kinds, would they all still be antibodies?

[00:11:50] Speaker 02:
Is that your position?

[00:11:52] Speaker 01:
They're not all exclusively antibodies.

[00:11:54] Speaker 01:
If you look at claim four, I think here's probably the best thing to take a look at, because we do have four antibody fragments in there.

[00:12:02] Speaker 01:
So I realize this is a little bit counterintuitive, but to want of skill in the art, in our view, at least an antibody fragment can be a bispecific antibody.

[00:12:10] Speaker 01:
So if you can imagine the antibody is the Y with the ends of the Y that affect the antigens to which it binds,

[00:12:17] Speaker 01:
take that bispecific antibody, cut off the bottom piece, and you would still have an antibody fragment that would be bispecific and would bind to multiple antigens.

[00:12:26] Speaker 02:
But it wouldn't be an antibody?

[00:12:28] Speaker 01:
It would not be an antibody at that point.

[00:12:30] Speaker 02:
If it were cut off?

[00:12:31] Speaker 01:
Yes, if you cut off the bottom piece of it.

[00:12:33] Speaker 01:
In our view, it would be an antibody fragment.

[00:12:36] Speaker 04:
So an antibody fragment is a portion of an antibody, right?

[00:12:40] Speaker 01:
Yes, you're right.

[00:12:40] Speaker 04:
So like a chimeric antibody is not an antibody fragment, it's just a different

[00:12:47] Speaker 04:
kind of antibody from the one typically found in human beings?

[00:12:51] Speaker 01:
Yes, Your Honor.

[00:12:51] Speaker 01:
That's our view.

[00:12:52] Speaker 01:
Although to be clear, we think you could also have an antibody fragment that is a chimeric antibody if you took an antibody that was a chimeric antibody.

[00:13:00] Speaker 04:
Then it would be a chimeric antibody.

[00:13:02] Speaker 04:
It would be a chimeric antibody fragment, correct?

[00:13:05] Speaker 01:
Your Honor, as the terms are used to those of skill and the art,

[00:13:09] Speaker 01:
an antibody fragment that was derived from a chimeric antibody that is an antibody would be an antibody fragment that is a chimeric antibody.

[00:13:20] Speaker 01:
And I apologize.

[00:13:21] Speaker 01:
I realize that's contrary.

[00:13:22] Speaker 01:
Look, if you were going to hold simply that chimeric antibodies are antibodies and bispecific antibodies are antibodies, we would have very little quarrel with that.

[00:13:35] Speaker 01:
The main thing here is on the face of the claims.

[00:13:37] Speaker 01:
Not a claim differentiation argument, a usage argument.

[00:13:40] Speaker 01:
The word antibody is used in a way that includes humanized antibodies, includes bispecific antibodies.

[00:13:47] Speaker 01:
It would be an extraordinary thing to affirm a decision.

[00:13:49] Speaker 01:
that adopts a construction that renders these claims nonsense on their face.

[00:13:54] Speaker 01:
If the panel has no further questions, I'll reserve my remaining time for rebuttal.

[00:13:57] Speaker 04:
Very good.

[00:14:04] Speaker 00:
Thank you.

[00:14:05] Speaker 00:
Mr. Stone?

[00:14:06] Speaker 00:
May I please the court?

[00:14:07] Speaker 00:
I would like to begin with- Let me ask you a question.

[00:14:10] Speaker 05:
Regarding the disclaimer issue, if IGM and IGA remain in the claims, then they're not disclaimed, right?

[00:14:19] Speaker 00:
It is not our contention that IGMs or IGAs were disclaimed.

[00:14:22] Speaker 00:
No, Your Honor, derivatives were disclaimed.

[00:14:24] Speaker 00:
The question of whether IGMs and IGAs remain in the claim arises out of the language in column five that an antibody

[00:14:32] Speaker 00:
consists of two identical heavy chains and two identical light chains.

[00:14:36] Speaker 00:
I think there's a little gamesmanship going on there.

[00:14:38] Speaker 00:
IgM's and IgAs are created in our B cells as monomers that have two identical heavy chains and two identical light chains.

[00:14:47] Speaker 00:
Some of them, then, for IgA associate into pairs of two, and some of them for IgM associate into groups of five of those antibodies.

[00:14:55] Speaker 00:
Whether the pentameric form of an IgM

[00:14:58] Speaker 00:
and the dimeric form of an IGA are within the scope of that paragraph.

[00:15:03] Speaker 00:
I'm confident that if they ever accused this patent against someone who made a pentameric IGM, they would say you have five infringing products.

[00:15:10] Speaker 00:
But certainly the monomeric form is within the scope of the definition in column five, and it is not our position that those were disclaimed, derivatives were disclaimed.

[00:15:19] Speaker 00:
I would like to return to your honor's question about the disclaimer, if I may.

[00:15:25] Speaker 00:
What we say in the red brief is that they've never plausibly explained the disclaimer.

[00:15:28] Speaker 00:
They started by saying there was no.

[00:15:30] Speaker 04:
Let's just start with whether there is a disclaimer.

[00:15:33] Speaker 00:
Absolutely.

[00:15:33] Speaker 04:
The disclaimer has to be clear and unmistakable.

[00:15:36] Speaker 00:
Yes, Your Honor.

[00:15:36] Speaker 04:
They changed the word derivative to the word fragment.

[00:15:39] Speaker 04:
Yes, Your Honor.

[00:15:40] Speaker 04:
I will be honest.

[00:15:41] Speaker 04:
I'm having trouble completely understanding what that change impacted.

[00:15:47] Speaker 03:
Sure.

[00:15:49] Speaker 04:
But I'm really

[00:15:50] Speaker 04:
struggling with the idea that whatever it impacted amounts to a clear and unmistakable disclaimer.

[00:15:56] Speaker 04:
If I can't figure out and find it confusing, how is it clear and unmistakable?

[00:16:01] Speaker 00:
May I answer that question, Your Honor?

[00:16:02] Speaker 00:
I want to start with, I hear two questions.

[00:16:04] Speaker 00:
One, was there a disclaimer?

[00:16:05] Speaker 00:
And two, how do we know what it was?

[00:16:07] Speaker 00:
The district court began the Markman hearing by asking the following question, coincidentally in the Surrey courtroom, at page A16034 of the record.

[00:16:17] Speaker 04:
Why would you point that out?

[00:16:19] Speaker 00:
for no reason other.

[00:16:20] Speaker 00:
I apologize, Your Honor.

[00:16:21] Speaker 00:
I intended no significance to it.

[00:16:23] Speaker 00:
I apologize.

[00:16:24] Speaker 04:
It was an entirely inappropriate thing to say.

[00:16:26] Speaker 00:
I'm terribly sorry, Your Honor.

[00:16:27] Speaker 00:
I did not intend it that way at all.

[00:16:30] Speaker 04:
We'll talk about that.

[00:16:30] Speaker 00:
I'm terribly sorry, Your Honor.

[00:16:31] Speaker 00:
I apologize.

[00:16:33] Speaker 00:
The district court asked question, and I think there's also agreement that there was a disclaimer in the prosecution as to derivatives, but there's no agreement as to what a derivative is.

[00:16:45] Speaker 00:
Is that a fair statement?

[00:16:47] Speaker 00:
The district court said, I take it that there's agreement that there was a disclaimer as to derivatives, but there's no agreement as to what a derivative is.

[00:16:54] Speaker 00:
Is that a fair statement?

[00:16:55] Speaker 00:
And both counsel answered, yes, Your Honor.

[00:16:58] Speaker 00:
And the district court was entitled to rely.

[00:17:00] Speaker 00:
I apologize, Your Honor.

[00:17:02] Speaker 00:
I truly do.

[00:17:03] Speaker 00:
I did not intend to suggest anything by that.

[00:17:06] Speaker 00:
And I ask that I apologize.

[00:17:08] Speaker 00:
I do not believe you.

[00:17:09] Speaker 00:
But go ahead.

[00:17:10] Speaker 00:
I truly didn't, Your Honor.

[00:17:11] Speaker 04:
Then you wouldn't have said it.

[00:17:12] Speaker 04:
What is your move on?

[00:17:13] Speaker 00:
But the point is this, Your Honor.

[00:17:14] Speaker 00:
I'm terribly sorry.

[00:17:17] Speaker 00:
The district court asked the parties, I think there was also agreement that there was a disclaimer in the prosecution as to derivatives.

[00:17:26] Speaker 00:
But there's no agreement as to what a derivative is.

[00:17:29] Speaker 00:
Is that a fair statement?

[00:17:30] Speaker 00:
And both parties agreed yes.

[00:17:32] Speaker 00:
And the district, yes, Your Honor, from Bexalta.

[00:17:34] Speaker 00:
Yes, Your Honor, from Genentech.

[00:17:36] Speaker 00:
The parties then and the district court then endeavored to figure out what is a derivative, because the parties both agreed that derivatives were disclaimed.

[00:17:45] Speaker 00:
That's the beginning of the markment transcript.

[00:17:47] Speaker 02:
So do I understand correctly that what happened was that then the court turned to the column five language and then looked at the language of top of column six and said, because column six uses the word

[00:17:59] Speaker 02:
derivatives and says it includes bispecific antibodies.

[00:18:03] Speaker 02:
And the definition of antibodies in column five doesn't include bispecific antibodies.

[00:18:08] Speaker 02:
It must be that bispecific antibodies are in fact not antibodies, but in fact are fragments.

[00:18:16] Speaker 00:
Well, are derivatives.

[00:18:17] Speaker 00:
But I don't think that's quite right, Your Honor.

[00:18:19] Speaker 00:
I think that what the district court said was first, when the patent was filed, it referred to antibodies and antibody derivatives.

[00:18:26] Speaker 00:
And in each of the instances in columns 5, 6, and 7, with the exception of the one that I will come to at the bottom of column 7 into 8, in every other instance, it refers to antibodies and antibody derivatives as one term.

[00:18:38] Speaker 00:
And in fact, in column 6 refers to the term in the singular, factor 9, antibodies and antibody derivatives.

[00:18:45] Speaker 00:
The court said, how do I figure out what's an antibody?

[00:18:47] Speaker 00:
What's an antibody derivative?

[00:18:49] Speaker 00:
The patent, the court said, tells me what an antibody is.

[00:18:52] Speaker 00:
Because in column 5, it says antibodies are

[00:18:55] Speaker 00:
Immunoglobulins, et cetera.

[00:18:57] Speaker 00:
And then every instance thereafter where it refers to things that are inconsistent with that definition, chimeric antibodies, which are arguably inconsistent by specific antibodies, which are definitely inconsistent because they don't have two identical heavy chains and two identical light chains.

[00:19:14] Speaker 00:
In every instance where those embodiments are referred to, they are preceded by the phrase antibodies or antibody derivatives, including in the claim as initially filed.

[00:19:25] Speaker 00:
And so the question is, when Bexalta surrendered, antibody derivatives, which they conceded they did.

[00:19:32] Speaker 00:
They disclaimed antibody derivatives and replaced it with fragments.

[00:19:35] Speaker 00:
The question is, what is a derivative?

[00:19:38] Speaker 02:
And so the court, please.

[00:19:40] Speaker 02:
So he said this bispecific language in column five, for example, is one of those things that you're saying must be an antibody derivative.

[00:19:50] Speaker 00:
Well, in column seven, where it defines a bispecific antibody, Your Honor,

[00:19:54] Speaker 00:
It says bispecific antibodies are macromolecular, or heterobifunction, or cross-linkers.

[00:19:58] Speaker 00:
The district court found that that was within the scope of derivatives as initially filed, as did the examiner.

[00:20:06] Speaker 00:
And the examiner's rejection says you don't have support for antibody derivatives, including bispecific antibodies.

[00:20:12] Speaker 00:
And it's worth pointing out that the way that one makes a bispecific antibody is by taking two other antibodies, cutting them in half, combining them, and deriving a bispecific antibody from them.

[00:20:22] Speaker 00:
And so the record in this case is that a bispecific antibody is an artificially engineered product.

[00:20:30] Speaker 00:
In fact, the district court's construction of bispecific antibody, which Bexelta has not challenged on appeal, is that a bispecific antibody is an artificially engineered macromolecular, heterobifunctional cross-linker.

[00:20:44] Speaker 00:
There's no contesting in this courtroom that bispecific antibodies are artificially engineered.

[00:20:48] Speaker 00:
That's the construction below, and Bexelta hasn't challenged it on appeal.

[00:20:52] Speaker 00:
The question then for this court is, what's a derivative?

[00:20:56] Speaker 00:
And what the district court did is exactly what TEVA tells the district court to do.

[00:21:01] Speaker 00:
The district court looked first at the specification, found no definition there.

[00:21:06] Speaker 00:
then looked at the claims, found no clarity there, looked at the prosecution history, and then turned to expert testimony.

[00:21:15] Speaker 02:
Can I ask you something?

[00:21:16] Speaker 02:
Of course.

[00:21:19] Speaker 02:
How is that consistent, what you've said with claim four, that doesn't have derivative in it at all?

[00:21:25] Speaker 00:
Sure.

[00:21:25] Speaker 02:
Your Honor, there is no explanation.

[00:21:27] Speaker 02:
And it strictly defines or includes a bi-specific antibody.

[00:21:32] Speaker 00:
Your honor, I think that's the core question on the appeal.

[00:21:34] Speaker 00:
There is no set of facts or no explanation for either side that explains all of the facts.

[00:21:40] Speaker 00:
There is something missing from each side.

[00:21:42] Speaker 00:
For us, it is Claim 4 and 19.

[00:21:44] Speaker 00:
Claims 4 contain embodiments that the examiner rejected, and the district court concluded that Bexalta failed to conform those claims.

[00:21:54] Speaker 00:
That is the explanation that the district court concluded reviewing.

[00:21:57] Speaker 02:
That the examiner didn't catch that.

[00:22:00] Speaker 00:
That's correct, Your Honor.

[00:22:01] Speaker 00:
There's nothing in the prosecution history that suggests that the examiner changed his mind.

[00:22:06] Speaker 00:
There's no moment in the notice of allowance, for example.

[00:22:08] Speaker 02:
You don't think the issuance of these claims suggests anything?

[00:22:11] Speaker 00:
I don't think they can, Your Honor, because the district court, the patent office issues claims.

[00:22:16] Speaker 04:
But you're presuming that we think the word derivative included these terms.

[00:22:22] Speaker 04:
wherein the word fragment does not, you're starting from the premise that the prosecution history amounts to a relinquishment of bispecific, humanized, chimeric, and all of these other forms of antibodies, right?

[00:22:41] Speaker 00:
Yes, Your Honor.

[00:22:42] Speaker 00:
And the district court made a factual finding that in this court is reviewed for clear error under TEVA that a derivative

[00:22:49] Speaker 00:
is any significant change to a column five antibody.

[00:22:53] Speaker 00:
With that factual finding, which Bexalt did.

[00:22:55] Speaker 02:
Is that a fact finding?

[00:22:56] Speaker 00:
Because the district court relied on expert testimony.

[00:22:58] Speaker 00:
What the Teva case specifically said.

[00:23:00] Speaker 04:
So it's not a fact finding.

[00:23:01] Speaker 00:
I'm sorry?

[00:23:01] Speaker 04:
You're saying that expert testimony is a fact finding.

[00:23:04] Speaker 00:
No.

[00:23:04] Speaker 00:
No, I believe that the subsidiary fact finding based on expert testimony is a fact finding under Teva.

[00:23:10] Speaker 00:
Teva specifically actually, for what it's worth, the Supreme Court gave us two examples.

[00:23:15] Speaker 00:
This happens to be one.

[00:23:16] Speaker 00:
In some cases, the district court will need to look beyond the patent's intrinsic evidence and to consult extrinsic evidence in order to understand, for example, the meaning of a term in the relevant art during the relevant time period.

[00:23:29] Speaker 00:
That's exactly what the district court did here, was ask experts from both sides, what did the term antibody derivative mean?

[00:23:35] Speaker 00:
Because the parties agreed there was a disclaimer of antibody derivative, an agreement that is binding on both parties in this court.

[00:23:43] Speaker 00:
Antibody derivatives were disclaimed.

[00:23:45] Speaker 00:
The court then wanted to figure out what's an antibody derivative.

[00:23:48] Speaker 00:
The court looked at the intrinsic evidence and the extrinsic evidence and took testimony.

[00:23:52] Speaker 02:
It became a conclusion, right?

[00:23:53] Speaker 02:
I'm sorry?

[00:23:54] Speaker 02:
And developed a conclusion.

[00:23:56] Speaker 02:
But you just said that the court looked at the intrinsic evidence and the extrinsic evidence and then came up with a construction.

[00:24:04] Speaker 02:
I think that's kind of like obviousness.

[00:24:07] Speaker 02:
So the ultimate construction

[00:24:10] Speaker 02:
is legal, but there are underlying fact findings, including the crediting of the expert.

[00:24:15] Speaker 00:
I think that's 100% right.

[00:24:16] Speaker 00:
And I think the conclusion meant.

[00:24:17] Speaker 02:
I just want to make sure we're on the same page.

[00:24:18] Speaker 00:
Absolutely right.

[00:24:19] Speaker 00:
The ultimate construction is reviewed de novo.

[00:24:22] Speaker 00:
The subsidiary facts are reviewed for clear error, if but only if they rest on extrinsic evidence.

[00:24:28] Speaker 00:
This one does.

[00:24:29] Speaker 00:
What is a derivative rested on extrinsic evidence?

[00:24:32] Speaker 00:
The court looked to the experts and said, how was that term used in the art?

[00:24:36] Speaker 00:
Did it have a meaning?

[00:24:37] Speaker 00:
That's exactly what Teva then goes on in the next sentence to say is reviewed for clear error.

[00:24:42] Speaker 00:
So where we arrive in this courtroom is with an agreement that the district court elicited an agreement from the parties that there was a disclaimer of derivative, and then set out to figure out what is a derivative.

[00:24:58] Speaker 00:
And the conclusion that the court reached, which is a subsidiary fact finding to exclaim construction, is that as used in the art, the term antibody derivative

[00:25:07] Speaker 00:
meant any significant change to a column five antibody.

[00:25:11] Speaker 00:
Under that definition, it is undisputed that chimeric antibodies, humanized antibodies, and bispecific antibodies are antibody derivatives, because one makes each of them by making a material change to a column five antibody.

[00:25:25] Speaker 00:
That is completely consistent with every part of the prosecution history, but the part that your honors are struggling with, which is why are they still in the claim?

[00:25:33] Speaker 00:
And so the district court asked the question, why are they still in the claim?

[00:25:37] Speaker 00:
and concluded, which I believe is reviewed de novo to be clear, that Bexalta failed to conform the claims and that the examiner allowed them.

[00:25:46] Speaker 00:
And the question is, does the fact that the examiner rejected them, yet they're in the claim, yet they match what Bexalta concedes they disclaimed,

[00:25:56] Speaker 00:
allow them to recover the scope.

[00:25:58] Speaker 00:
And an unbroken line of cases.

[00:26:00] Speaker 04:
They don't match what Bexalta concedes they disclaimed.

[00:26:02] Speaker 04:
Bexalta does not concede they disclaimed the stuff that's in claim four or the stuff in claim 19.

[00:26:08] Speaker 00:
Bexalta concedes they disclaimed derivatives and doesn't challenge the finding of what a derivative is.

[00:26:14] Speaker 00:
I agree that they have not said, we disclaim by specific antibodies.

[00:26:16] Speaker 00:
We wouldn't be standing in front of your honor.

[00:26:18] Speaker 00:
But they have agreed they disclaimed derivatives and asked the district court, as did we, to figure out what is a derivative.

[00:26:24] Speaker 00:
and haven't challenged the fact finding of what is a derivative.

[00:26:29] Speaker 00:
So the district court found that a derivative is a significant change to an antibody from column five.

[00:26:36] Speaker 02:
I think that- And that's not challenged on appeal, you say?

[00:26:39] Speaker 00:
There is certainly no place where they say- I mean, it's based on their own expert's testimony.

[00:26:44] Speaker 00:
I'm not sure how they would mount a clear error or challenge to it.

[00:26:47] Speaker 00:
But there's certainly nowhere where they say that finding was wrong.

[00:26:50] Speaker 00:
I don't, I mean, we're here.

[00:26:53] Speaker 02:
Can you just point to me in the record where that is, that a derivative is anything that's changed from an antibody in page 5?

[00:27:02] Speaker 00:
Absolutely.

[00:27:03] Speaker 00:
On page A, 45, in the district court's opinion.

[00:27:22] Speaker 00:
The district court finds at the bottom, thus I find, that the term antibody derivative was used in the patent to denote antibodies within the column five definition that had been altered in some significant way.

[00:27:35] Speaker 00:
As initially drafted, there was no inconsistency between the dependent claims and the column five definition of antibody.

[00:27:42] Speaker 00:
That is a finding of what an antibody derivative is based on expert testimony.

[00:27:47] Speaker 00:
It's reviewed for clear error in this court.

[00:27:49] Speaker 02:
It's also based on the specification, right?

[00:27:51] Speaker 02:
It's not exclusively.

[00:27:54] Speaker 00:
I apologize.

[00:27:55] Speaker 00:
It's not exclusively based on expert testimony.

[00:27:57] Speaker 00:
But I believe it becomes reviewed for clear error because of the inclusion of expert testimony.

[00:28:02] Speaker 00:
I agree with you that it is not purely based on that.

[00:28:04] Speaker 00:
It's also based on the structure of the patent.

[00:28:06] Speaker 04:
But if we don't need expert testimony in order to review it, if the intrinsic record produces a result, then we don't have to look at the experts, right?

[00:28:15] Speaker 00:
I agree with that, Your Honor.

[00:28:16] Speaker 00:
If the court finds that the definition of antibody derivative were clear from the patent, it would not then need to look at the expert evidence on which the district court relied.

[00:28:24] Speaker 00:
Absolutely.

[00:28:25] Speaker 00:
And with that, I would actually like to talk about the language that, because I'm running out of time, on what the language that flows from column seven to column eight, where Mr. Peterson pointed out

[00:28:36] Speaker 00:
correctly that the carryover sentence says the antibodies of the present invention can be prepared by methods known from the art by conventional hybridoma techniques or means of phase display, which he says that sentence is inconsistent with the column five definition.

[00:28:51] Speaker 00:
I would point out that the next sentence says the production of the inventive antibodies and antibody derivatives may, for instance,

[00:28:59] Speaker 02:
I'm sorry to interrupt you.

[00:29:01] Speaker 02:
I know you have a point you want to make, but I have something that's bothering me, and I want to try and ask you.

[00:29:05] Speaker 00:
I'd love to be helpful.

[00:29:07] Speaker 02:
I'm a little troubled because the definition of antibody derivative seems to presume that the antibodies in the specification are limited to that, which is in column five.

[00:29:22] Speaker 00:
And so it feels a little circular.

[00:29:24] Speaker 00:
I don't think it presumes it, Your Honor.

[00:29:26] Speaker 00:
I think it starts by saying we have

[00:29:28] Speaker 00:
a term that originally was both antibodies and antibody derivatives.

[00:29:32] Speaker 00:
And we have a definition of what's an antibody in column five.

[00:29:35] Speaker 02:
So in other words, if I didn't agree that what was in column five is definitional, that I'm not limited to think that derivative means something that's based on that definition, right?

[00:29:48] Speaker 00:
Just so I understand.

[00:29:49] Speaker 00:
No, I think that's correct, Your Honor.

[00:29:51] Speaker 00:
OK.

[00:29:52] Speaker 00:
Right.

[00:29:53] Speaker 00:
The language in column five has all the indicia of a definition beyond merely the word is.

[00:29:58] Speaker 00:
And I just want to make the point that in the cases like Abbott, where you're applying the higher standard for lexicography, something that came up two arguments ago about more than one plain and ordinary meaning in the art and O2 micro, the parties agree that there's more than one definition of antibody known in the art.

[00:30:14] Speaker 00:
Here, the patentee specified one of them.

[00:30:16] Speaker 00:
No case has ever held that that's lexicography.

[00:30:19] Speaker 00:
Rather, what this court says is lexicography is defining this to mean a wedding ring.

[00:30:23] Speaker 00:
And so when looking at the language in column five, in addition to saying antibodies are, and Bexalto would like to read it to say antibodies include or some antibodies are, which it doesn't say.

[00:30:35] Speaker 00:
It says antibodies are.

[00:30:37] Speaker 00:
In Abbott and the other cases, rejecting is as sufficient.

[00:30:42] Speaker 00:
There are other definitions in the patent that say, as used herein, or adopt some different definitional format.

[00:30:48] Speaker 00:
There's nothing like that here.

[00:30:49] Speaker 02:
There is something else, though.

[00:30:50] Speaker 02:
Just again, make sure we're airing everything out.

[00:30:55] Speaker 02:
If you're going to say that antibody has different meanings in different contexts, why wouldn't you look at the entire specification, which has many different examples of antibodies, or the claims even, which are

[00:31:08] Speaker 02:
I think the original claims is they were originally presented.

[00:31:11] Speaker 02:
So they're actually part of the original specification, right?

[00:31:16] Speaker 02:
So why wouldn't you look at that and say the word antibody in the context of this entire specification has a broad meaning?

[00:31:23] Speaker 00:
Because in the original claims that claimed those embodiments, it said the antibody or antibody derivative of claim one that includes monospecific antibodies, chimeric antibodies humanized.

[00:31:34] Speaker 00:
It never said the antibody that is a bispecific antibody.

[00:31:37] Speaker 02:
What about the claims that said, I don't know if it's claim 19, but there are some claims that say

[00:31:43] Speaker 02:
the antibody derivative wherein the antibody is blah, blah, blah.

[00:31:48] Speaker 00:
There is one of them.

[00:31:49] Speaker 00:
It's claim 19.

[00:31:50] Speaker 00:
You're right.

[00:31:50] Speaker 00:
It's the antibody or antibody fragment wherein the antibody is humanized.

[00:31:53] Speaker 00:
And as we said at the district court, claims four and 19 are the two that are inconsistent.

[00:31:57] Speaker 00:
That one is inconsistent.

[00:31:59] Speaker 00:
Interestingly, in its initial iteration when filed, it said where the antibody derivative is humanized over the course of the prosecution, including after derivatives dropped out, that changed to where the antibody

[00:32:12] Speaker 00:
is a humanized antibody.

[00:32:13] Speaker 00:
And I can see that that claim and claim four are inconsistent with the notion that column five is a definition of antibody.

[00:32:22] Speaker 00:
That's the fact that doesn't fit from our end.

[00:32:25] Speaker 00:
The fact that doesn't fit from their end is what did they disclaim?

[00:32:28] Speaker 00:
Because what you just heard is that in changing the meaning of the word derivative to fragment in claim one, somehow the only thing that did was change claims seven, eight, and 21 and 22.

[00:32:39] Speaker 00:
But it somehow had no substantive effect

[00:32:42] Speaker 00:
in the claim in which it was made.

[00:32:44] Speaker 00:
And that is what the district court found was not a plausible explanation, that Bexalta, having been the party that prosecuted this, still can't say what the change from derivative to fragment meant.

[00:32:55] Speaker 00:
And so each of us stares at a part of it that we don't have a good answer for.

[00:32:58] Speaker 00:
My explanation for claim four and claim 19 is that those were rejected.

[00:33:03] Speaker 00:
And as the district court concluded, Bexalta failed to conform those claims.

[00:33:06] Speaker 00:
If the court starts with,

[00:33:08] Speaker 00:
whatever is in claim four has to be within antibody, then the court is quickly going to conclude that column five is not definitional.

[00:33:16] Speaker 00:
I concede that.

[00:33:17] Speaker 00:
However, this court's cases teach that you can't do that.

[00:33:20] Speaker 02:
The dependent claims don't look at the plain claim language first.

[00:33:23] Speaker 00:
First, but then the same case says, and then you look at the specification.

[00:33:27] Speaker 00:
And this court has said, forgive me for one moment, just so I can get the exact case.

[00:33:33] Speaker 00:
In North American vaccines, that the dependent claims are merely, quote, an aid to interpretation.

[00:33:39] Speaker 00:
In decocytomation, that the presumption that they're included is a rebuttable presumption.

[00:33:43] Speaker 00:
All of these things operate together.

[00:33:45] Speaker 02:
Yeah, but setting aside whether it's a claim dependency argument or not, or whether it's a look at the language of the claims to try to understand what the patent owner or inventor meant by that claim language,

[00:34:00] Speaker 02:
Then how does that affect whether we're allowed to look at dependent claims to see how the inventor used the words?

[00:34:07] Speaker 00:
I think you are allowed to look at dependent claims to see how the inventor used the words.

[00:34:11] Speaker 00:
I think you have to look at all of the claims for that purpose.

[00:34:13] Speaker 00:
I agree with that.

[00:34:13] Speaker 00:
But I don't think that that means that, I mean, to take the North American vaccines case, you have an independent claim to a conjugation of a sugar to a protein without significant cross-linking.

[00:34:26] Speaker 00:
And the question is, does that mean cross-linking on the same protein or between two proteins?

[00:34:30] Speaker 00:
and you have a dependent claim where everyone agrees, you would have cross-linking between two proteins.

[00:34:35] Speaker 00:
And yet the court says, that's not what claim one means.

[00:34:39] Speaker 00:
I'm not sure I have the number right.

[00:34:40] Speaker 00:
That's not what the independent claim means.

[00:34:43] Speaker 00:
And so we have dependent claims that give us evidence about what the term means.

[00:34:48] Speaker 00:
We also have a rather complicated history in which those embodiments were rejected.

[00:34:52] Speaker 00:
And there's no moment when the examiner says, you know what?

[00:34:55] Speaker 00:
You're right.

[00:34:56] Speaker 00:
I think you do have support for those.

[00:34:57] Speaker 00:
In fact, Baxalta's argument after the rejection of them wasn't about bispecific antibodies at all.

[00:35:04] Speaker 00:
And so we don't have an answer to why they're there, except that they stood rejected and somehow got allowed.

[00:35:11] Speaker 00:
And that happens.

[00:35:12] Speaker 00:
And this court's cases teach that sometimes this court invalidates patents that the examiners granted every day.

[00:35:18] Speaker 00:
Sometimes mistakes get made.

[00:35:20] Speaker 00:
And the answer cannot be that having failed to conform the dependent claim, they get to recover that scope.

[00:35:26] Speaker 00:
But I think that is the central issue.

[00:35:28] Speaker 00:
If you start there, you end with column five is not definitional.

[00:35:32] Speaker 04:
But what about column six?

[00:35:33] Speaker 04:
Do you think column six is at all definitional?

[00:35:37] Speaker 00:
Forgive me, Your Honor, which part of it?

[00:35:38] Speaker 00:
I'm happy to answer that.

[00:35:41] Speaker 04:
The inventive antibodies and antibody derivatives, which include bispecific.

[00:35:47] Speaker 00:
I'm not sure I think that that's definitional, but I think that that's completely consistent with our argument.

[00:35:52] Speaker 00:
Because what that says is the inventive antibodies

[00:35:55] Speaker 00:
and antibody derivatives and organic compounds derived from, there from, forgive me, comprise, and then there's a list of things.

[00:36:03] Speaker 00:
Our contention is and has always been, bispecific antibodies are antibody derivatives.

[00:36:08] Speaker 00:
They're also arguably compounds derived there from.

[00:36:11] Speaker 04:
Well, why then, though, when the patent actually calls out antibodies in some places and antibody derivatives, why then, when referring to humanized antibody, chimeric antibody, bispecific antibody,

[00:36:25] Speaker 04:
Do they not say derivatives?

[00:36:28] Speaker 00:
Because the term in the art for an antibody that contains the DNA sequence of more than one species is a chimeric antibody.

[00:36:37] Speaker 00:
The term in the art for an antibody that contains the binding sequences from one sequence and the rest is human is a humanized antibody.

[00:36:46] Speaker 00:
Those are antibody derivatives in that you derive them from other antibodies.

[00:36:51] Speaker 00:
But the term in the art for that is a chimeric antibody.

[00:36:54] Speaker 00:
In the same way, the dry ice isn't ice.

[00:36:56] Speaker 00:
In this patent, a chimeric antibody is an antibody derivative, but not an antibody.

[00:37:02] Speaker 02:
What about the language?

[00:37:03] Speaker 02:
And I think this was referred to below, and I know it was referred to in the briefs.

[00:37:07] Speaker 02:
At the bottom of column seven that says the antibodies of the present invention can be prepared by methods known in the prior, by conventional blah, blah, blah techniques.

[00:37:16] Speaker 02:
And I think that these techniques, including fake display gene, we are told that what

[00:37:23] Speaker 02:
this is referring to as something where you would probably classify it as a derivative.

[00:37:27] Speaker 00:
I think that's right, Your Honor, and that's actually the point I was trying to make earlier.

[00:37:30] Speaker 00:
I'm glad we came back to it.

[00:37:31] Speaker 00:
If Your Honor reads the next sentence, the next sentence says, the production of the inventive antibodies and antibody derivatives may, for instance.

[00:37:39] Speaker 00:
That paragraph is talking about both.

[00:37:42] Speaker 00:
The for instance in the second sentence makes that clear.

[00:37:45] Speaker 00:
I agree that the word derivative is not in the first sentence of the paragraph, but the whole paragraph is talking about both.

[00:37:51] Speaker 00:
That is the one moment in the patent when something that is inconsistent with column five being definitional is said, and the next sentence takes it back.

[00:38:01] Speaker 00:
That sentence should read the antibodies and derivatives of the present invention as all of the ones that preceded and follow it do.

[00:38:10] Speaker 00:
I hesitate to say that that's a typo, but the next sentence makes clear by virtue of the for instance that that sentence is talking about how to make both antibodies and antibody derivatives.

[00:38:22] Speaker 00:
And I simply don't think that the absence of the word derivative is from the first sentence of the paragraph.

[00:38:29] Speaker 04:
OK, thank you.

[00:38:30] Speaker 00:
Thank you, Your Honor.

[00:38:31] Speaker 00:
I appreciate it.

[00:38:31] Speaker 00:
Again, Your Honor, I apologize.

[00:38:41] Speaker 04:
Don't worry about the time.

[00:38:42] Speaker 04:
We went nine minutes over with him.

[00:38:44] Speaker 04:
So you talk as long as you feel like you need to, and I'll cut you off when it ceases to be helpful.

[00:38:48] Speaker 01:
Thank you, Your Honor.

[00:38:51] Speaker 01:
Judge Wallach, I owe you some citations.

[00:38:54] Speaker 01:
The discussion of IgM antibodies as being included or excluded by the construction was first raised at the preliminary injunction hearing.

[00:39:01] Speaker 01:
You find that on appendix pages 13918 to 13919.

[00:39:07] Speaker 01:
And the discussion was repeated at the Markman hearing.

[00:39:13] Speaker 01:
That is appendix page 16075.

[00:39:18] Speaker 01:
And you also see this in the district court's opinion, noting the dispute on appendix page 53, note 10, discussing the dispute between the parties over whether IgM antibodies would be included by the district court's construction.

[00:39:35] Speaker 01:
Thank you.

[00:39:36] Speaker 01:
You're welcome, Your Honor.

[00:39:38] Speaker 01:
In our view, this claim construction is resolved by the intrinsic evidence standing alone and the strongest possible intrinsic evidence, the language of the claims themselves.

[00:39:49] Speaker 01:
What this court said in Beckton Dickinson versus Tyco is that a construction that renders asserted claims facially nonsensical cannot be correct.

[00:39:58] Speaker 04:
What do you think the meaning of derivatives is?

[00:39:59] Speaker 04:
Sorry.

[00:40:00] Speaker 04:
Go ahead.

[00:40:00] Speaker 04:
What do you think the meaning of derivatives is?

[00:40:02] Speaker 01:
Your Honor, I believe it's ambiguous from the file history.

[00:40:05] Speaker 01:
But I believe it is likely coextensive with fragments.

[00:40:08] Speaker 01:
And the examiner suggested replacing a term that is not commonly used in the art with the term that is.

[00:40:14] Speaker 01:
What my friend didn't suggest was taking a look at how the word derivatives is used standing alone in the patent.

[00:40:19] Speaker 01:
And I do think that's helpful to look at.

[00:40:22] Speaker 01:
Column 20 is probably the best place to look to.

[00:40:28] Speaker 01:
And if you look, column 20, I believe it's lines 34 to 35.

[00:40:35] Speaker 01:
Therefore, an antibody, open parentheses, or an antibody derivative, e.g.

[00:40:42] Speaker 01:
SCFV, that's a single chain variable fragment, FAB, et cetera.

[00:40:51] Speaker 01:
FAB is where you've taken just one branch of this Y and broken it off of an antibody.

[00:40:57] Speaker 01:
An SCFV is where you've taken a variable region from a heavy chain and a variable region from a light chain and stuck them together using an artificial linker sequence.

[00:41:09] Speaker 01:
You see a similar reference to antibody derivatives in, so in our view of course, both of those are antibody fragments.

[00:41:16] Speaker 01:
They are pieces of antibody.

[00:41:18] Speaker 01:
You see a similar example

[00:41:19] Speaker 04:
Well, you actually say column 6 actually says that expressly, so you don't have to say in your view.

[00:41:24] Speaker 04:
Column 6 says, or antibody fragments, which partially or completely lack the consonant region, EG, FV, FAB, basically all the same things.

[00:41:32] Speaker 01:
Yes, Your Honor.

[00:41:33] Speaker 04:
Not all the same, because I guess S, to be clear, SC, FV, whatever the heck that is, ain't there, but the rest of them are.

[00:41:39] Speaker 04:
And so it defines antibody derivative in column 20 at line 35, and then has almost the exact same, almost the exact same definition.

[00:41:47] Speaker 04:
with the similar EG at column 6 for antibody fragment.

[00:41:51] Speaker 01:
Yes, Your Honor.

[00:41:52] Speaker 01:
You see something similar in column 30, actually.

[00:41:55] Speaker 01:
If you look at lines 15 through 18, again, that's a similar, though antibody derivatives such as FAB, FAB prime 2, I'm told is how that is said, SCFV, et cetera.

[00:42:14] Speaker 01:
Again, these are fragments.

[00:42:17] Speaker 01:
What you don't see is any reference in either the file history or in the specification to antibody derivatives such as... So nowhere in here does it say antibody derivatives, for example, a bispecific antibody.

[00:42:31] Speaker 01:
That's correct.

[00:42:32] Speaker 04:
Nowhere does it say antibody derivatives, for example, chimeric antibody.

[00:42:35] Speaker 01:
That's right.

[00:42:35] Speaker 01:
And nowhere in the specification.

[00:42:36] Speaker 04:
Or even humanized.

[00:42:37] Speaker 04:
Like it just said, antibody derivative dash humanized.

[00:42:41] Speaker 01:
That's correct, Your Honor.

[00:42:42] Speaker 01:
And nowhere does it say, either in the file history or in specification, that all bispecific antibodies are antibody derivatives.

[00:42:51] Speaker 01:
My friend says these claims were rejected.

[00:42:53] Speaker 01:
We disagree vehemently.

[00:42:56] Speaker 01:
The examiner never said, I reject antibodies that are bispecific.

[00:43:01] Speaker 02:
It's that I reject antibody derivatives that are bispecific.

[00:43:06] Speaker 01:
Some antibody derivatives that are bispecific.

[00:43:08] Speaker 01:
And again, it's undisputed.

[00:43:09] Speaker 02:
How do you interpret that?

[00:43:11] Speaker 02:
You interpret it as saying you have no enablement for antibody fragments that are made of bispecific antibodies.

[00:43:20] Speaker 02:
Is that how you're interpreting it?

[00:43:21] Speaker 01:
That's how we're interpreting it.

[00:43:22] Speaker 01:
And it's not all bispecific antibodies.

[00:43:25] Speaker 01:
It's a rejection, or not all,

[00:43:27] Speaker 01:
antibody derivatives, it's some bispecific antibodies with reference to different artificial linker sequences.

[00:43:33] Speaker 01:
Your Honor, I'll confess, the prosecution history is difficult to follow.

[00:43:38] Speaker 01:
I think the key, though, I go to appendix page 16021, because my friend's argument is that

[00:43:51] Speaker 01:
This amendment from derivative to fragment was the key that unlocked patentability, that by surrendering that swath of antibodies known to science, except for this basic description in column five, that that was what finally overcame this enablement projection.

[00:44:10] Speaker 01:
I'll point out, this is the response to the enablement rejection following the amendment.

[00:44:15] Speaker 02:
What language do you want us to focus on here on page 16021?

[00:44:19] Speaker 01:
What I want you to focus on is the absence of language.

[00:44:22] Speaker 01:
Because this is, so if you look just a couple of pages back, you'll see this is where we had a phone call with the examiner.

[00:44:28] Speaker 01:
The examiner suggested the amendment.

[00:44:30] Speaker 01:
And in my friend's view, the examiner suggested the amendment in order to overcome the enablement rejection.

[00:44:34] Speaker 01:
I think if that's correct, what this would say would be, as discussed on the call, we have given up the broad claim to antibody derivatives, and now, as you suggested, claim only antibody fragments.

[00:44:46] Speaker 01:
That overcomes the enablement problem.

[00:44:49] Speaker 01:
This is where, if you were looking for a clear and unmistakable disclaimer that said the change from derivative to fragment was a narrowing amendment to overcome the enablement rejection,

[00:44:59] Speaker 01:
This is where you would see it.

[00:45:01] Speaker 01:
If that was the impetus, the enablement rejection for the amendment, surely it would be referred to here.

[00:45:06] Speaker 01:
And I'll point out, even if it was a narrowing amendment, there is nothing in the file history that shows that all bispecific antibodies were understood to be antibody derivatives.

[00:45:16] Speaker 01:
Your Honor, I believe Judge Stoll, you are absolutely correct.

[00:45:18] Speaker 01:
But the district court's reasoning on this point is a bit circular.

[00:45:22] Speaker 01:
When the opinion is discussing antibody derivatives, both on appendix page 44 and on appendix page 45, the district court is relying on its already determined construction of antibody.

[00:45:36] Speaker 01:
So on appendix page 44, since bispecific antibodies are not within the definition of antibodies, they must be within the definition of antibody derivatives on appendix page 45.

[00:45:49] Speaker 01:
But the specification makes clear that an SCFV is not an antibody fragment using the definition of antibody from the specification.

[00:45:57] Speaker 01:
So the whole reading of the prosecution history is premised on the idea that this definition of antibodies is correct.

[00:46:08] Speaker 01:
As we see it, it's quite circular reasoning.

[00:46:09] Speaker 01:
And it's unclear to us why the district court continued on with the prosecution history when the reading of the prosecution history was premised.

[00:46:17] Speaker 01:
on a construction that the prosecution history was then being used to support.

[00:46:22] Speaker 01:
So yes, my friend and I do stand in different places here.

[00:46:25] Speaker 04:
What do we do with appendix page 15987, which amounts to the examiner's rejection?

[00:46:30] Speaker 04:
I think the one that preceded the page that you pointed us to.

[00:46:38] Speaker 04:
And in number 12, it seems that the examiner, at least,

[00:46:45] Speaker 04:
was it wherein said antibody derivative is chimeric antibodies, humanized antibodies, single-chain antibodies, bispecific, et cetera, et cetera.

[00:46:54] Speaker 04:
So is that not the examiner defining an antibody derivative as those types of antibodies?

[00:47:06] Speaker 01:
I don't believe so, Your Honor, because of the wherein.

[00:47:09] Speaker 01:
Wherein the antibody derivative is those.

[00:47:11] Speaker 01:
And again, in our view,

[00:47:13] Speaker 01:
We've always accepted that an antibody fragment, which everyone agrees is at least a subset of derivative, can be a chimeric antibody, can be a humanized antibody, can be a bispecific antibody.

[00:47:29] Speaker 01:
But our view is that the examiner didn't reject antibodies that were chimeric antibodies, humanized antibodies, and bispecific antibodies.

[00:47:38] Speaker 01:
My friend and I draw different inferences from that.

[00:47:41] Speaker 01:
He suggests that because there's no reference to the examiner rejecting antibodies that were by specific antibodies, that means they weren't claimed.

[00:47:49] Speaker 01:
We draw the inference that they were claimed and not rejected as not enabled.

[00:47:54] Speaker 01:
The prosecution history doesn't answer that, except for the fact

[00:47:57] Speaker 01:
that the claims were actually allowed.

[00:48:00] Speaker 01:
Yes, we have different arguments.

[00:48:02] Speaker 01:
I'll admit the prosecution history is ambiguous.

[00:48:05] Speaker 01:
He can make arguments based on it.

[00:48:06] Speaker 01:
But first, disclaimer's a high bar.

[00:48:09] Speaker 01:
It requires clear and unmistakable disclaimer.

[00:48:12] Speaker 01:
Our arguments on the face of the claims themselves.

[00:48:15] Speaker 01:
Phillips tells you that you look to the claims, and sometimes just how a word is used in the claims can be a strong basis for construing them.

[00:48:23] Speaker 01:
It's not a claim differentiation argument.

[00:48:25] Speaker 01:
My friend suggested it's just a usage on the face of the claims argument.

[00:48:29] Speaker 01:
And here, the district court found the construction we proposed was an ordinary meaning of antibody.

[00:48:35] Speaker 01:
It is an ordinary meaning that renders the claims sensible on their face, where their construction renders the claims nonsense on their face.

[00:48:46] Speaker 01:
Neither lexicography nor prosecution history disclaimer justifies adopting a construction that renders these claims nonsense on their face,

[00:48:55] Speaker 01:
And the claims should trump the prosecution history.

[00:48:57] Speaker 01:
There's a hierarchy here.

[00:48:59] Speaker 01:
And you cannot simply say these claims were issued in error, unless the court has questions.

[00:49:06] Speaker 04:
Thank you very much.

[00:49:07] Speaker 04:
This case is taken under submission.

[00:49:09] Speaker ?:
Thank you.