[00:00:00] Speaker 02:
In 1949, Mr. Halligan, no need to change.

[00:00:07] Speaker 03:
Thank you.

[00:00:07] Speaker 03:
That was my question.

[00:00:08] Speaker 02:
I just have to... You're going to stay where you are, but your colleagues are regrouping.

[00:00:52] Speaker 02:
If you're ready, Mr. Ellington, please proceed.

[00:00:55] Speaker 03:
Ellington.

[00:00:55] Speaker 03:
Thank you.

[00:00:57] Speaker 03:
So the district court again revised its claim-construction opinion and its post-trial opinion in the Alvagen case.

[00:01:06] Speaker 03:
It acknowledged that Alvagen used both conduction and convection bottom drying, that's at page 7, with the web dragging along hot metal plates and drag bars, but found

[00:01:23] Speaker 03:
that the drying was not substantial.

[00:01:26] Speaker 03:
And it found the process as a whole conventional.

[00:01:31] Speaker 03:
It then held that alvegene didn't infringe on that basis.

[00:01:35] Speaker 03:
So measured against the original disclaimer, these facts would have precluded a finding of non-infringement.

[00:01:43] Speaker 03:
There would be bottom drying, and therefore the product could not have been dried

[00:01:48] Speaker 03:
solely using conventional convection air drying from the top, and the bottom drying would have included conduction drying, and therefore would not have been accomplished using solely convection air drying from the top.

[00:02:05] Speaker 03:
Of course, the original articulation of the disclaimer didn't include any requirement of substantiality.

[00:02:12] Speaker 03:
It instead included the word solely.

[00:02:15] Speaker 03:
It had to do so, and it explained why.

[00:02:17] Speaker 03:
It had to do so because of embodiments showing top and bottom air being used together.

[00:02:26] Speaker 03:
The Court also departed from its focus on rippling.

[00:02:31] Speaker 03:
So it found that Alvagen designed its process to avoid the rippling effect, but then found that avoiding rippling wouldn't alone render the technique unconventional.

[00:02:44] Speaker 03:
That's at 13.

[00:02:45] Speaker 03:
This was the touchstone.

[00:02:47] Speaker 03:
in the claim construction opinion, the Alvigin case.

[00:02:51] Speaker 03:
It was treated, it was listed as being one factor, but there's no consideration given of that factor in the opinion.

[00:03:01] Speaker 03:
Instead, what was found was the entire process was conventional.

[00:03:07] Speaker 03:
The Court then examined the zone-drying process Alvigin used.

[00:03:11] Speaker 03:
And I think this is very important.

[00:03:13] Speaker 03:
You'll see at page 14 of the appendix

[00:03:18] Speaker 03:
the Court's discussion of zone drying.

[00:03:21] Speaker 03:
And what it says is the patent's mention of multi-zone drying does not alone render a process that employs multi-zone drying unconventional.

[00:03:33] Speaker 03:
So, again, that's at 14.

[00:03:35] Speaker 03:
Now, this analysis makes no sense.

[00:03:38] Speaker 03:
The patent doesn't just mention zone drying.

[00:03:44] Speaker 03:
It describes it as

[00:03:45] Speaker 03:
another method of controlling the drying process and is producing the controlled drying effect of the present invention.

[00:03:54] Speaker 03:
And this is at Appendix 348, column 32, lines 39 through 40, continuing with the present invention language at 63 through 64.

[00:04:07] Speaker 03:
It describes zone length, zone drying at length over two columns, 32 and 33, and states that it can be used

[00:04:16] Speaker 03:
to dry the film without surface skinning, which means rippling in this context.

[00:04:21] Speaker 03:
That's at 348, column 32, lines 49 through 50.

[00:04:26] Speaker 03:
And don't take my word for it being used interchangeably.

[00:04:29] Speaker 03:
I'm going to give you the sites for that.

[00:04:31] Speaker 03:
343 is the appendix page, column 22, line 51, and then 344 at column 23, line 2.

[00:04:42] Speaker 03:
The 514 patent teaches that zone drying

[00:04:45] Speaker 03:
the rippling effect by drying the film slowly at first and then more rapidly later on, what the 514 patent calls a stepped-up drying effect.

[00:04:57] Speaker 03:
That's at 348 in the appendix, column 32, lines 44 through 45.

[00:05:04] Speaker 03:
So it's not the case that zone drying was mentioned.

[00:05:08] Speaker 03:
This is described in the patent as a way to controllably dry film so as to maintain

[00:05:15] Speaker 03:
and avoid rippling.

[00:05:16] Speaker 03:
But the district court dismissed zone drying as conventional and therefore disclaimed because it found that zone dryers were conventional in 2001.

[00:05:28] Speaker 03:
That's at 14 of the appendix.

[00:05:31] Speaker 03:
But column 3 and column 28, they can't disclaim columns 32 and 33.

[00:05:37] Speaker 03:
That's a perversion of the exercise of looking at a patent as a whole

[00:05:43] Speaker 03:
and determining its meets and bounds, it can't possibly comport with a finding of disclaimer.

[00:05:51] Speaker 03:
That the claim construction.

[00:05:52] Speaker 01:
Kennedy Does that disclosure in 514 show that zone drawing is unconventional?

[00:06:00] Speaker 03:
I'm sorry, Your Honor.

[00:06:01] Speaker 03:
Does it show that it was unconventional?

[00:06:03] Speaker 01:
Kennedy Does it show that zone drawing is unconventional?

[00:06:06] Speaker 03:
I suppose that would be a way of looking at it.

[00:06:08] Speaker 03:
There isn't a definition in this patent of conventional or unconventional.

[00:06:14] Speaker 03:
For conventional, what we have is, and this is in column 3, a couple of times it refers to methods use, conventional drying methods use, generally use drying ovens, drying tunnels, and the like.

[00:06:29] Speaker 03:
The word unconventional is not distinguished from it.

[00:06:33] Speaker 03:
Instead, it's controlled drying methods.

[00:06:36] Speaker 03:
And we see in column 4, just bear with me one moment.

[00:06:47] Speaker 03:
In column four, what we see in the second paragraph under summary of the invention is a further aspect of the present invention.

[00:06:58] Speaker 03:
Methods of forming the films of this invention are provided by wet casting methods, and the next sentence refers to those wet casting methods.

[00:07:06] Speaker 03:
The film product is formed by combining a polymer,

[00:07:09] Speaker 03:
and a polar solvent forming the combination into a film and drying the film in a controlled manner.

[00:07:14] Speaker 03:
So that's the broad class, controlled manner of drying.

[00:07:19] Speaker 03:
And then it says, preferably, the film is dried initially only applying heat to the bottom side of the film.

[00:07:26] Speaker 03:
And that explains is done to avoid disuniformity.

[00:07:32] Speaker 03:
So that's one type of controlled drying.

[00:07:35] Speaker 03:
But all of controlled drying is separate and apart from

[00:07:39] Speaker 03:
the conventional drying techniques.

[00:07:41] Speaker 01:
If you look at the language in column 32, it says another method of controlling involved zone drying.

[00:07:48] Speaker 01:
That sounds conventional.

[00:07:52] Speaker 01:
Does the court make a finding of fact?

[00:07:54] Speaker 03:
It said on the next page in the opinion that multi-zone dryers were conventional because known in 2001.

[00:08:03] Speaker 03:
So here we are.

[00:08:05] Speaker 03:
The patent clearly says

[00:08:07] Speaker 03:
control drying methods can be used, okay?

[00:08:11] Speaker 03:
We would argue nowhere does it say you can't use conventional methods, but how do we read a patent that's recommended, that's touting control drying methods over multiple columns as somehow those are of no moment or are disclaimed by an earlier column in the patent?

[00:08:27] Speaker 03:
There's nothing like that in the law of disclaimer.

[00:08:30] Speaker 03:
We even see a couple of columns earlier, a reference to a different drying method

[00:08:36] Speaker 03:
that was spelled out in a patent to Magoon 14 years before.

[00:08:44] Speaker 03:
Let me find a place for this.

[00:08:45] Speaker 03:
It's at column 32.

[00:08:47] Speaker 03:
It's right above the zone drive.

[00:08:48] Speaker 03:
So it can't be that conventional means known or unknown.

[00:08:52] Speaker 03:
Instead, what a careful reading of the patent shows is there is some criticism of conventional techniques that don't control the parameters.

[00:09:02] Speaker 03:
And the patent over

[00:09:04] Speaker 03:
more than 30 columns describes those parameters, how to control them.

[00:09:09] Speaker 03:
It talks about the best way to mix, the best way to cast the film.

[00:09:14] Speaker 03:
It talks about controlling the thickness of the film.

[00:09:18] Speaker 03:
So all of that is expressly against the idea of there being any disclaimer here.

[00:09:25] Speaker 03:
I think an extraordinary thing when you look back at the PI opinion, I think it's on page 14 of the slip opinion,

[00:09:34] Speaker 03:
You'll see a bunch of block quotes of things that purportedly supported disclaimer.

[00:09:40] Speaker 03:
In most of those, it says things like, preferably, normally, tends to.

[00:09:45] Speaker 03:
One of those preferably references was the one to bottom drive that I just walked you through in Column 4.

[00:09:51] Speaker 03:
I know that that's consistent with the finding of disclaimer.

[00:09:55] Speaker 03:
The Simon case, for example, the disclaimer was largely based on a statement saying that

[00:10:03] Speaker 03:
All embodiments disclosed or contemplated herein will have a particular structure.

[00:10:10] Speaker 03:
The structure appears in drawing in the patent.

[00:10:13] Speaker 03:
We don't have anything like that here.

[00:10:17] Speaker 03:
The words present invention are used to describe all kinds of things, claimed and unclaimed.

[00:10:22] Speaker 03:
There are abundant descriptions of processes, including those purportedly disclaimed in a permissive way.

[00:10:31] Speaker 03:
None of this is consistent with the finding of disclaimer.

[00:10:34] Speaker 03:
And no finding of disclaimer could possibly embrace zone drawing.

[00:10:40] Speaker 03:
It just doesn't hold, ring true or hold together well.

[00:10:45] Speaker 03:
I talked before about the columns at war with each other, which I think is essentially the version of disclaimer that's posited here about zone drawing, that certain columns trump the zone drawing descriptions or the Magoon description.

[00:11:01] Speaker 03:
Something that I was struck by when I was looking at Alvigen's brief is they say they came upon their process, they changed their process after the DRL claim construction.

[00:11:15] Speaker 03:
And again, I would ask, why are sophisticated repeat litigants who are involved in litigation on a patent finding after a claim construction ruling

[00:11:28] Speaker 03:
that there was a clear and unmistakable disclaimer that was always present?

[00:11:34] Speaker 03:
This doesn't make sense.

[00:11:35] Speaker 03:
It doesn't hold true.

[00:11:37] Speaker 03:
This is no different.

[00:11:39] Speaker 03:
And I understand that the district court clearly struggled with articulating the scope of the disclaimer.

[00:11:45] Speaker 03:
But this is the same as having a claim construction that changes with each iteration to match an accused product.

[00:11:57] Speaker 03:
It can't be the case that we have a disclaimer of uncertain scope that yields non-infringement defenses time and again.

[00:12:11] Speaker 03:
Your Honor's have further questions about the specification, the prosecution, history of infringement?

[00:12:16] Speaker 02:
Well, let's hear from the other side, and we'll save you a ton of time.

[00:12:25] Speaker 02:
Mr. Schlar.

[00:12:27] Speaker 00:
Thank you, your honor.

[00:12:28] Speaker 00:
May it please the court.

[00:12:30] Speaker 00:
The inventors clearly and unmistakably disclaim films that are dried using solely conventional convection air drying from the top.

[00:12:37] Speaker 00:
The district court properly construed the asserted claims to give meaning to this disclaimer.

[00:12:42] Speaker 00:
After weighing competing testimony presented during a full trial on the merits, the district court correctly determined as a factual matter that Elvigen dries its films using a solely conventional convection air drying from the top process.

[00:12:55] Speaker 00:
This is precisely what the 514 patent disclaims.

[00:12:59] Speaker 00:
Indivier has not shown clear error in this finding.

[00:13:02] Speaker 00:
In some, the district court's judgment should be affirmed in all respects.

[00:13:06] Speaker 00:
Let's turn first to the claim destruction issue.

[00:13:10] Speaker 00:
The specification repeatedly disparages conventional convection air drying from the top.

[00:13:16] Speaker 00:
This method causes rippling and is not able to achieve drug content uniformity as required by the claims.

[00:13:23] Speaker 00:
There are no fewer than five separate and distinct portions of the specification where the inventor stated that conventional drying methods will not result in uniform films.

[00:13:32] Speaker 00:
These include columns 3, 8, 9, 22, and 28.

[00:13:37] Speaker 00:
The most telling of all of these provisions is in column 28 that we've heard something about this morning, lines 57 to 58.

[00:13:44] Speaker 00:
The specification states at that point, and I quote, conventional convection air drying from the top is not employed.

[00:13:53] Speaker 00:
This portion of the specification goes on to state that conventional top-only drying is disclaimed because it leads to non-uniform films due to a rippling problem.

[00:14:03] Speaker 00:
And there's another statement of disavowal in the specification.

[00:14:05] Speaker 00:
At column 22, lines 41 to 47, the specification provides that conventional drying techniques directed to the top surface of the film cause complications, including rippling, that leads to non-uniformity.

[00:14:18] Speaker 00:
There are other disclaimers in the specification as well.

[00:14:21] Speaker 00:
Columns 3,

[00:14:22] Speaker 00:
eight, nine, the specification further disparages conventional drying methods as unable to produce uniform films.

[00:14:29] Speaker 00:
Even in the description of the drawings in counts seven and eight, there's a clear distinction between films dried by the conventional drying processes and those dried by the inventive drying processes.

[00:14:40] Speaker 00:
Taken together, these statements establish that drying methods matter.

[00:14:44] Speaker 00:
The inventors told the public that conventional top air only drying processes will not work to produce uniform films.

[00:14:51] Speaker 00:
and this is exactly what Elvigen does.

[00:14:54] Speaker 00:
Elvigen does what is disclaimed.

[00:14:56] Speaker 00:
Importantly, the specification does not describe a conventional top air only drying process that is able to achieve... What drying method is being used?

[00:15:06] Speaker 02:
Is it the combination of top and bottom?

[00:15:08] Speaker 00:
In the Elvigen process it uses a top air only drying process.

[00:15:12] Speaker 00:
The air enters the oven from the top and that's the only source.

[00:15:16] Speaker 00:
It is not a combination of top and bottom air as

[00:15:19] Speaker 00:
suggested in an embodiment of the pen.

[00:15:21] Speaker 00:
So Elvigen only uses the top air only process, Your Honor.

[00:15:26] Speaker 00:
Does that answer your question?

[00:15:29] Speaker 02:
Well, that seems to be the question underlying the entire issue.

[00:15:33] Speaker 02:
There's a good deal of debate as to what's covered by the claims, but there's very little in terms of what's actually being used.

[00:15:42] Speaker 00:
There is no bottom air, bottom drying in Elvigen's process.

[00:15:47] Speaker 00:
The district court found as a factual matter that Elvigen does not affringe the asserted claims.

[00:15:53] Speaker 00:
The district court weighed testimony on this point, what was going on in the drying process.

[00:15:58] Speaker 00:
It heard testimony from both sides.

[00:16:00] Speaker 00:
And based on this record, it found that Elvigen uses a conventional convection air drying process, top only air drying process, to produce its film.

[00:16:08] Speaker 00:
The district court weighed that evidence and came to that conclusion.

[00:16:10] Speaker 00:
There is ample support in the record for that conclusion.

[00:16:13] Speaker 00:
In view of this testimony and evidence,

[00:16:15] Speaker 00:
The district court correctly concluded that Indivier failed to meet its burden of proof.

[00:16:20] Speaker 02:
Was it in combination with the viscosity of the system?

[00:16:24] Speaker 00:
I know that's been discussed at length.

[00:16:27] Speaker 00:
First, the claims.

[00:16:29] Speaker 00:
Claim 62 of the patent.

[00:16:31] Speaker 00:
Drawing, this is A369.

[00:16:34] Speaker 00:
Drawing is a required step in the patent.

[00:16:39] Speaker 00:
It's not an alternative in claim 62.

[00:16:41] Speaker 00:
Drawing is there.

[00:16:42] Speaker 00:
The viscosity alone

[00:16:44] Speaker 00:
cannot control uniformity for films that must be dried.

[00:16:47] Speaker 00:
It's not a substitute for films that must be dried.

[00:16:50] Speaker 00:
The patent does disclose certain procedures, methods, hot melt extrusion for one, that does not involve drying.

[00:16:57] Speaker 00:
Plaintiffs acknowledge that in their brief, reply brief at 15.

[00:17:01] Speaker 00:
But there are wet cast films described in the patent.

[00:17:03] Speaker 00:
That's what we're dealing with in this appeal.

[00:17:05] Speaker 00:
And that's what Elvigen's process is.

[00:17:07] Speaker 00:
And that's what the claim is.

[00:17:08] Speaker 00:
Those processes require drying.

[00:17:10] Speaker 00:
And for those processes that require drying,

[00:17:13] Speaker 00:
The specification is clear that that drying cannot be by a conventional top air only method.

[00:17:20] Speaker 00:
The fact that viscosity may be able to achieve uniformity in a set of processes that did not involve drying does not change the fact that for processes that do involve drying, the claim processes, there is a clear disclaimer of conventional convection air drying from the top.

[00:17:39] Speaker 00:
Does that get to your point, Your Honor?

[00:17:42] Speaker 02:
It's unclear.

[00:17:46] Speaker 02:
It's still, on the record, it's unclear, but I hear what you're saying.

[00:17:50] Speaker 00:
I'm not sure I call it unclear in the sense that certainly it's clear that Elvigen uses a conventional process.

[00:17:59] Speaker 00:
That's what the Court found.

[00:18:01] Speaker 00:
The Court actually found, as a matter of fact, that Elvigen's process, Elvigen uses his own drawing process, and that is a conventional process.

[00:18:07] Speaker 00:
That's part of the Court's opinion.

[00:18:09] Speaker 00:
So as a matter of fact,

[00:18:10] Speaker 00:
There is no dispute that alvegene uses a conventional top ear process that is a zone drawing process.

[00:18:15] Speaker 00:
Maybe at this point, let me turn to zone drawing for a second.

[00:18:18] Speaker 00:
There's certainly been a lot of discussion from my friend about that.

[00:18:22] Speaker 00:
The disclaimer that we've mentioned, that I mentioned in columns 28 and 22, is unequivocal.

[00:18:28] Speaker 00:
There is no zone drawing exception to this disclaimer.

[00:18:31] Speaker 00:
Maybe a bit about zone drawing might help.

[00:18:33] Speaker 00:
Zone drawing is not some magical, mystical thing.

[00:18:37] Speaker 00:
Zone drawing is simply just adding separate sections to a drawing process.

[00:18:42] Speaker 00:
You see this in the figures of the patent that show zone drawing.

[00:18:47] Speaker 00:
This is figures 35 and 36, Your Honor, at 329 and 330.

[00:18:52] Speaker 00:
They're just simply boxes.

[00:18:54] Speaker 00:
They're additional drawing zones.

[00:18:58] Speaker 00:
They meet the word.

[00:18:59] Speaker 00:
But the disclosure of zone drawing does not describe what type of air is used.

[00:19:03] Speaker 00:
It does not describe whether it's air or microwave.

[00:19:06] Speaker 00:
It does not describe whether it's on the top or on the bottom.

[00:19:10] Speaker 00:
There is nothing in the zone drying description in the patent that suggests that conventional convection air drying from the top will work in such a process.

[00:19:18] Speaker 00:
The disclaimer applies, this disclaimer in column 28, applies whether it's a single zone or multiple zones.

[00:19:26] Speaker 00:
It's not the case that there's some exception to zone drying for just

[00:19:31] Speaker 00:
for those situations involving a zone dryer.

[00:19:33] Speaker 00:
The disclaimer is not limited to zone drying.

[00:19:36] Speaker 00:
Zone drying doesn't solve the rippling problem independently.

[00:19:41] Speaker 00:
I think my friend mentioned that zone dryers somehow do that.

[00:19:45] Speaker 00:
Rippling exists with a solely conventional air drying process from the top, and it makes no sense to think that somehow when you do a process more, you would avoid rippling.

[00:19:55] Speaker 00:
You'd do more in more zones would avoid the rippling.

[00:19:57] Speaker 00:
If you have a rippling problem in a single zone,

[00:20:01] Speaker 00:
You'd have it in a multiple zone process.

[00:20:03] Speaker 00:
Therefore, it's appropriate in our view to read this discussion of zone drying consistent with the disclaimer in the specification.

[00:20:10] Speaker 00:
And the prosecution reinforces this point.

[00:20:12] Speaker 00:
I should make that clear.

[00:20:13] Speaker 00:
The prosecution distinguished a reference, the Chen reference, on the fact that it is a zone dryer.

[00:20:21] Speaker 00:
They distinguished based on the drying methods.

[00:20:23] Speaker 00:
But it's clear the plaintiffs acknowledge at page 35 of their opening brief that the Chen reference is a zone dryer.

[00:20:30] Speaker 00:
So to say somehow that zone drawing section in column 32 of the patent undoes the prosecution makes no sense.

[00:20:38] Speaker 00:
That they disclaim a process that involves zone drawing during prosecution and should not now be permitted to somehow bring back in zone drawing to something that's been disclaimed.

[00:20:50] Speaker 00:
There's been a discussion of Soli this morning.

[00:20:54] Speaker 00:
Let me touch on that, Your Honor.

[00:20:56] Speaker 00:
Soli was added to the claims during the DRL markman

[00:20:59] Speaker 00:
proceeding, and this is at A20514, to read out an embodiment of the claims where there is both drawing from the top and drawing from the bottom.

[00:21:08] Speaker 00:
It does not limit the disclaimer to those processes that have no bottom drawing whatsoever.

[00:21:13] Speaker 00:
The, the, the court found in, in, in its decision, the district court, that Elvin's drawing process is conventional.

[00:21:22] Speaker 00:
So, whether or not

[00:21:25] Speaker 00:
The court applied its claim construction, let me put it that way.

[00:21:28] Speaker 00:
The court applied its claim construction and said Elvigen is a conventional convection top air process.

[00:21:34] Speaker 00:
Plaintiffs are basically attempting to construe the construction with Soli to somehow focus on a bottom drying component that may or may not occur in Elvigen's process.

[00:21:44] Speaker 00:
But the fact is clear that the district court weighed that evidence about Elvigen's process and determined that it is a conventional convection top air drying process.

[00:21:56] Speaker 00:
I don't know if that makes sense, if you have a question on that point.

[00:22:08] Speaker 00:
The fact that Elvigen does not, the fact of the matter, I think Council mentioned that there's some amount of bottom drying that goes on in Elvigen's process.

[00:22:20] Speaker 00:
That hasn't, the district court specifically found that bottom drying has not been shown

[00:22:24] Speaker 00:
to be controlled or substantial.

[00:22:27] Speaker 00:
The district court, this is at A-17, said bottom drying is at most an insubstantial amount.

[00:22:33] Speaker 00:
So the fact that drying employs conventional convection air, any conventional convection air drying process will employ some drying from the bottom.

[00:22:43] Speaker 00:
That does not mean that we, the elegance process falls outside of the scope of the disclaimer.

[00:22:48] Speaker 00:
Certainly the claim construction can't be read to bring in those conventional processes where there is a conventional

[00:22:54] Speaker 00:
amount of bottom drying, if at all.

[00:22:56] Speaker 00:
And in fact, again, the district guard found the amount of bottom drying in Elvin's process, there has been not shown to be controlled or substantial.

[00:23:04] Speaker 00:
It's at most, at most insubstantial.

[00:23:09] Speaker 00:
Your Honor, we, we touched on the Indivier 1 decision, the prior DRL decision.

[00:23:14] Speaker 00:
Certainly, we believe that that decision supports disclaimer.

[00:23:18] Speaker 00:
In this, in this particular situation, there's no reason

[00:23:22] Speaker 00:
to on this specification, the same specification, to reach a different result.

[00:23:27] Speaker 00:
The zone drawing discussion doesn't change this panel's decision in that case.

[00:23:34] Speaker 00:
Let me briefly touch on our cross appeal at this point.

[00:23:38] Speaker 00:
Elvigen's cross appeal is relevant, and we discussed this in our brief at length.

[00:23:43] Speaker 00:
Elvigen's cross appeal becomes irrelevant only if this court adopts a different construction of the dry limitation.

[00:23:53] Speaker 00:
If the district court's construction is affirmed, there's no need to reach Alvagen's cross-appeal.

[00:23:57] Speaker 00:
Alvagen followed the roadmap of Lazar Kaplan to preserve its invalidity defenses in the event this court adopts a new and broadened construction of dried.

[00:24:05] Speaker 00:
As the court has observed in cases like Assist Technologies and Johns Hopkins, the rules of the game change when a new construction is adopted.

[00:24:12] Speaker 00:
I just want to make sure the court knows that in the event that there is a reversal on the claim construction that Alvagen is entitled to,

[00:24:19] Speaker 00:
at least some, present some invalidity offenses.

[00:24:23] Speaker 00:
Again, that doesn't detract in any way from the main point of our appeal and our, I believe, that the claims need to be construed in a way that's consistent with the disclaimer.

[00:24:35] Speaker 00:
So with that, let me reserve the rest of my time.

[00:24:38] Speaker 00:
I should say, if you have questions, I'll take them up.

[00:24:42] Speaker 02:
We'll save the rest of your time.

[00:24:51] Speaker 03:
I believe, Judge Newman, you asked whether alvegene uses bottom drying.

[00:25:01] Speaker 03:
Yeah.

[00:25:01] Speaker 03:
This is discussed at the appendix at page seven, and there was a finding that it does use bottom drying, that it was not substantial, but that there was bottom drying.

[00:25:13] Speaker 03:
Basically, what alvegene did, and this is not contested, it removed fuses from what's called a flotation dryer.

[00:25:21] Speaker 03:
where there's air that keeps the web afloat, the bottom of the oven.

[00:25:26] Speaker 03:
And as a result, the web drags along the bottom of the oven for certain periods of time and also touches hot drag bars.

[00:25:36] Speaker 03:
So there had to be bottom drying.

[00:25:38] Speaker 03:
The question is, the court said there's bottom drying below.

[00:25:42] Speaker 03:
The question is, is it finding that it's insubstantial?

[00:25:47] Speaker 03:
Does that matter given a claim construction?

[00:25:50] Speaker 03:
and the scope of a disclaimer that uses the word solely.

[00:25:55] Speaker 03:
So I think that that's, at the end of the day, the issue there.

[00:25:59] Speaker 03:
There's not an issue of fact.

[00:26:00] Speaker 03:
It has to do with the scope of the disclaimer and whether this Court gives meaning to the word solely, which the district court put in because of embodiments using both top and bottom air.

[00:26:14] Speaker 03:
I want to talk a little bit about rippling and zone drying.

[00:26:18] Speaker 03:
Rippling occurs when you dry the top of the film too quickly.

[00:26:22] Speaker 03:
This is explained in the patent, I believe, at Column 22.

[00:26:26] Speaker 03:
And there's also an earlier discussion, which would be referenced in our brief.

[00:26:31] Speaker 03:
It dries it too quickly.

[00:26:33] Speaker 03:
So a zone dryer allows you to step up the drying process by changing the temperature from zone to zone.

[00:26:40] Speaker 03:
So alveogen does that.

[00:26:43] Speaker 03:
It does it to avoid rippling.

[00:26:44] Speaker 03:
There was a finding that its process is designed to avoid rippling.

[00:26:49] Speaker 03:
And the column 32, in fact, says that this process avoids rippling.

[00:26:57] Speaker 03:
There it's called surface skinning.

[00:26:59] Speaker 03:
So all of this is explained clearly in the patent.

[00:27:03] Speaker 03:
I wanted to return to an issue of conventionality and this idea that if an old piece of equipment is used,

[00:27:11] Speaker 03:
then somehow it's part of something that's disclaimed.

[00:27:16] Speaker 03:
We heard that a strobush reference taught bottom drying.

[00:27:22] Speaker 03:
What exactly is it that would be within the scope of the claims if all you do is hunt for some prior use of a drying technique?

[00:27:32] Speaker 03:
When the patents are composition claims,

[00:27:35] Speaker 03:
There are composition claims that meet a need for a uniform film.

[00:27:40] Speaker 03:
There was no sublingual film before this point in time because particulate matter couldn't be dried and processed and cast in a way in which uniformity would be preserved.

[00:27:54] Speaker 03:
And dried in this composition claim, it's not even used in the claim as a process step.

[00:28:03] Speaker 03:
What it refers to, and you can see this when you look at claim 62, it talks about the state of the matrix before casting or drying.

[00:28:14] Speaker 03:
So it's not the case that there's even a step here of drying.

[00:28:18] Speaker 03:
It's true that final cast films will be dried, but these are composition claims.

[00:28:26] Speaker 03:
And you can see this very clearly in claim 62.

[00:28:30] Speaker 03:
which is the independent claim at issue.

[00:28:34] Speaker 03:
I want to just pose one question before my time is nearly up.

[00:28:41] Speaker 03:
Column four, I pointed to the language clearly identifying an alternative to any type of control drying.

[00:28:49] Speaker 03:
We don't hear an answer about that.

[00:28:51] Speaker 03:
It can't be referring to extruded films because they don't require additional solvent.

[00:28:58] Speaker 03:
They aren't dried.

[00:28:58] Speaker 03:
They're cooled.

[00:28:59] Speaker 03:
And in column three, which I heard a long list, most of it's discussed, I think all of it in our brief, about in column three, about all of the shortcomings of conventional drawing techniques, we didn't hear a word about what it says right below what was quoted to you.

[00:29:18] Speaker 03:
The conventional drawing methods themselves are unable to provide uniform films.

[00:29:23] Speaker 03:
Drop down four lines to column 20, to line 20 of column three.

[00:29:27] Speaker 03:
Uniformity is particularly difficult to achieve via conventional drawing methods with a relatively thicker film.

[00:29:36] Speaker 03:
This patent is focused on thin films.

[00:29:39] Speaker 03:
That's in the abstract.

[00:29:40] Speaker 03:
And there's a stated preference in column 22 of the thickness of the films is less than about 380 microns.

[00:29:50] Speaker 03:
For example, less than about 250 microns.

[00:29:53] Speaker 03:
And while the claim that I've been talking about,

[00:29:56] Speaker 03:
doesn't recite thin films, it doesn't use the word thin films, it provides that the micron size be small enough so you can make a thin film.

[00:30:06] Speaker 03:
All you've got to do is follow the teachings of the patent, whether it's choosing the right polymers, a thickness of the film that's appropriate, or the other many, many teachings in this patent about how to control viscosity, the mixing process, and drying, and you'll end up with a uniform film.

[00:30:25] Speaker 03:
So it can't be the case that this patent disclaims any particular drying methods.

[00:30:33] Speaker 03:
And I don't think that there's any coherent scope that we've heard about what it is that would have been disclaimed.

[00:30:42] Speaker 02:
If there's no drying method that can be controlled, what's the basis for unobviousness?

[00:30:52] Speaker 03:
I'm sorry, Your Honor.

[00:30:53] Speaker 02:
You're asking?

[00:30:54] Speaker 02:
the larger basis for the patentability of this film?

[00:31:00] Speaker 03:
This was the first time that anybody had been able to master all of the different parameters that go into making a film.

[00:31:08] Speaker 03:
Earlier I pointed to a passage talking about interaction.

[00:31:13] Speaker 03:
It's about interaction of all of the different process steps, finding the right viscosity, and then knowing what to do with it going forward.

[00:31:22] Speaker 03:
So there's a recommendation on how to cast the film.

[00:31:25] Speaker 03:
That's the reverse roll casting process is said to reliably deliver films that are of a uniform thickness, particularly if you use a doctor blade.

[00:31:36] Speaker 03:
There are all kinds of parameters set forth.

[00:31:39] Speaker 03:
And the secondary literature, this is something that's part of the other case that we pointed to, recites time and again the difficulties in obtaining uniform films.

[00:31:51] Speaker 03:
It has to do with particulate matter falling out.

[00:31:54] Speaker 03:
moving from side to side or from top to bottom.

[00:31:59] Speaker 03:
And this is particularly difficult if you're making a continuous sheet of film, and then subsequently the film is being cut after it's cast and dried.

[00:32:12] Speaker 03:
So it's an extremely difficult process, and it provides ways of drying the film that will get the job done, including zone drying.

[00:32:22] Speaker 03:
It talks about the advantages of bottom drying,

[00:32:24] Speaker 03:
But it also talks about the importance of having the right viscosity, how to mix the film.

[00:32:30] Speaker 03:
It mentions vacuum mixing.

[00:32:32] Speaker 03:
All of this isn't described in passing.

[00:32:35] Speaker 03:
It's described in column after column.

[00:32:37] Speaker 03:
And that's why, at the end of the day, what was invented here was a composition that is, shouldn't be limited to making it any particular way.

[00:32:48] Speaker 03:
That's the law of this Court in the Vanguard case.

[00:32:52] Speaker 03:
If you've got a composition claim,

[00:32:54] Speaker 03:
It's not limited to the way it's made.

[00:32:57] Speaker 03:
That's the by and large rule.

[00:32:58] Speaker 03:
It should be applicable here.

[00:33:00] Speaker 03:
There's no disclaimer.

[00:33:02] Speaker 03:
And any disclaimer couldn't possibly, couldn't possibly include a process that's recommended as a way to controllably dry.

[00:33:13] Speaker 03:
So if you're controllably drying, you're not going to have top air currents busting up the top level of the film.

[00:33:22] Speaker 03:
Zone drying is one of those ways to avoid that.

[00:33:25] Speaker 03:
So it couldn't possibly be the case that any disclaimer could provide a non-infringement defense to a company that follows the teachings of the patent and uses that zone drying process.

[00:33:43] Speaker 02:
Okay.

[00:33:43] Speaker 02:
Any questions?

[00:33:44] Speaker 02:
Any more questions?

[00:33:48] Speaker 02:
Any questions?

[00:33:48] Speaker 02:
Okay.

[00:33:48] Speaker ?:
Thank you.

[00:33:51] Speaker 03:
I didn't address the cross-appeal.

[00:33:54] Speaker 03:
I assumed if you had questions or something.

[00:33:56] Speaker 02:
You've got two minutes after we hear from.

[00:33:58] Speaker 02:
OK.

[00:34:01] Speaker 01:
Well, if Mr. Alcan didn't address it, then Mr. Speller has nothing to rebut.

[00:34:07] Speaker 03:
I suppose that's true.

[00:34:08] Speaker 03:
We think we've rebutted everything in our papers.

[00:34:12] Speaker 02:
I believe that.

[00:34:13] Speaker 02:
Do you want to hear on the cross-appeal?

[00:34:15] Speaker 02:
No, I think we have that.

[00:34:17] Speaker 02:
OK.

[00:34:17] Speaker 02:
In that case, the case is taken under submission.