[00:00:00] Speaker 01:
Today, Council, prepared to go forward?

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

[00:00:05] Speaker 01:
Please proceed.

[00:00:09] Speaker 01:
Mr. Lombardi?

[00:00:10] Speaker 01:
Yes, Your Honor.

[00:00:14] Speaker 02:
May I please support?

[00:00:15] Speaker 02:
The district court erred as to the construction of two significant claim terms.

[00:00:21] Speaker 02:
In each instance, the district court read language into the terms that not only is not present in the claims,

[00:00:29] Speaker 02:
but it's not present in the specification.

[00:00:32] Speaker 01:
Let me ask you a question, Mr. Murray.

[00:00:35] Speaker 01:
In the joint appendix at 1021, you distinguish the side, the patent-directed abroxane, on the basis that it discloses controlled release, polymer-encapsulated formulation.

[00:00:50] Speaker 01:
But in the red brief, Celgene says, AcuSphere is attempting to read its claims on Celgene's X-Brain product

[00:00:57] Speaker 01:
a product that consists of the same albumin polymer encapsulated formulations that you disclosed during prosecution.

[00:01:08] Speaker 01:
Why should we not find that you disclaimed?

[00:01:12] Speaker 02:
Well, first of all, the first part of what Your Honor was referring to is a non-infringement argument, and we're not at that point.

[00:01:19] Speaker 02:
We did not, this is on the of a taxing point, your honor, and there was no disclaimer because the ultimate reason that the district, excuse me, that the examiner allowed the claims and the basis, the argument that we made to the examiner was on the speed of the dissolution.

[00:01:36] Speaker 02:
Now, controlled release and coating of particle may in some instances have some impact on that, I concede that.

[00:01:44] Speaker 02:
But that doesn't mean that in every instance that the albumin coated particles or that a coated particle is going to have an impact on the release rate, the dissolution release rate.

[00:01:56] Speaker 00:
I mean, I suppose we could quibble about to what extent the examiner relied on this particular distinction.

[00:02:02] Speaker 00:
But nevertheless, it is true that your client made these statements in the prosecution history.

[00:02:09] Speaker 00:
And I think the law is that

[00:02:12] Speaker 00:
any statements you make in the prosecution history as to what is the best understanding of the claim counts and should be understood in terms of trying to find the best understanding of the claim?

[00:02:25] Speaker 02:
Well Your Honor, I would say that there are various types of statements that are made in the prosecution history and one of the lessons of the law with respect to the prosecution history is that there's give and take and back and forth between the applicant and the examiner

[00:02:39] Speaker 02:
And so it is difficult at times to discern a precise and a clear and unambiguous disclaimer.

[00:02:45] Speaker 02:
And in this case, there is no clear and unambiguous disclaimer of the control release or the coded particles.

[00:02:54] Speaker 02:
Because in this case, the way the applicant went about his amendments in this case was to have a paragraph that would describe

[00:03:07] Speaker 02:
the prior art, and then would have a paragraph that distinguishes it.

[00:03:10] Speaker 02:
The statements that Your Honor is referring to come from the description paragraph, and a description is not the same thing as a disclaimer.

[00:03:18] Speaker 02:
It is the next paragraph where the distinction is actually being made, and in that paragraph, where the distinction is being made, the distinction is based on dissolution rate, and not specifically on the points that Your Honor has referred to from that statement.

[00:03:35] Speaker 00:
I guess it's at JA 1021.

[00:03:42] Speaker 00:
The applicant says, Hanes, and then says, there are no nanoparticles, nor is there a matrix formed of a hydrophilic excipient that dissolves upon contact with water to release nanoparticles and microparticles of the taxane.

[00:04:01] Speaker 00:
To me,

[00:04:03] Speaker 00:
the context is clear that the Africans setting up a strong distinction between how it understands Haynes and likewise how it understands what it's doing with its amendment.

[00:04:15] Speaker 02:
And I understand, I believe what your honor is pointing out, if you go a paragraph down at the same place in the appendix, 1021, there's a paragraph that begins with the word accordingly.

[00:04:25] Speaker 02:
And in that paragraph, the applicant makes very clear that no distinction is being made based on the size of the particles in Hanes and Desai as opposed to the invention.

[00:04:36] Speaker 02:
It specifically concedes that those references cover particles that are less than five microns in size.

[00:04:45] Speaker 02:
And so what the distinction was being made on with the patent office at that point in time was not size.

[00:04:51] Speaker 00:
Are we flipping over to particle size now?

[00:04:54] Speaker 00:
I'm sorry.

[00:04:56] Speaker 00:
I understood, Your Honor.

[00:04:57] Speaker 02:
I thought that's where you were going with that question.

[00:04:59] Speaker 00:
I'm sorry.

[00:05:00] Speaker 00:
Judge Wallach led off right into taxing only.

[00:05:04] Speaker 00:
So I meant to try to stay there.

[00:05:06] Speaker 00:
And I understood this portion of the prosecution history where the applicant was

[00:05:14] Speaker 00:
distinguishing its claim from Haynes and Desai.

[00:05:18] Speaker 00:
And as I read this excerpt on JA 1021, it really looks like the point to be made here is that you release taxane from the matrix.

[00:05:30] Speaker 00:
So whatever is in that matrix, the remainder of the matrix dissolves and goes away, leaving you taxane, resulting in taxane.

[00:05:43] Speaker 00:
pains in design, nevertheless, doesn't work that way.

[00:05:47] Speaker 00:
That's what I get from this portion.

[00:05:49] Speaker 02:
Well, what it says, again, and again, I'll try to address your honor's question more specifically this time, in that same paragraph I referred to, the applicant... Wait, which one?

[00:05:59] Speaker 02:
The accordingly or the...?

[00:06:01] Speaker 02:
The accordingly paragraph, at 81021.

[00:06:04] Speaker 02:
Farther down the paragraph, they say the distinction is that there is no immediate release

[00:06:12] Speaker 02:
upon dissolution of the surrounding matrix that is taught in the Desai and Hanes references.

[00:06:19] Speaker 02:
And the patent examiner goes on to state, in fact, in the Notice of Allowance, when the patent examiner allows the patent, it's on the basis of the different dissolution rate.

[00:06:30] Speaker 02:
It's not on the basis of the size or on the basis of purity of particles.

[00:06:35] Speaker 02:
It's on the basis of the dissolution rate.

[00:06:38] Speaker 02:
And that's what the invention was.

[00:06:42] Speaker 02:
they were telling what the applicant was telling the examiner the invention was during that period of time.

[00:06:50] Speaker 00:
So the very end of 1021, I guess it says, not a formulation having dispersed therein nanoparticles and microparticles of a drug released immediately upon dissolution of the surrounding matrix.

[00:07:05] Speaker 00:
Again, doesn't that reinforce the idea that these particles

[00:07:10] Speaker 00:
and these particles alone of taxane get freed up?

[00:07:18] Speaker 02:
There's no question that the particles of taxane leave the matrix and get freed up.

[00:07:22] Speaker 02:
Whereas an issue between the parties about whether it is only the taxane particles that get freed up, which Your Honor I'm sure is aware of, but I'll pass that for right now.

[00:07:32] Speaker 02:
There's no question that that is the heart of the invention and that makes for dissolution rates to happen quicker.

[00:07:38] Speaker 02:
But the question I think Your Honor is asking me is, did the applicant here give up in the course of making that statement the idea that taxing could be something more than the pure taxing that the district court required in its construction?

[00:07:54] Speaker 02:
And there is nothing like that that is given up in this statement.

[00:08:01] Speaker 02:
The claim was defined as being essentially pure taxing, formed of only taxing, essentially a pure taxing.

[00:08:09] Speaker 02:
There's nothing in the paragraph we've been looking at that says that it has to be that our invention is only a pure taxing, and that that's what distinguishes it from the prior art.

[00:08:20] Speaker 01:
But it sure seems to say that the other step goes away.

[00:08:23] Speaker 02:
Well, it says that it says that... And that's how it distinguishes it.

[00:08:26] Speaker 02:
It distinguishes it by saying that there's a matrix,

[00:08:29] Speaker 02:
And based on the use of that matrix, you get a faster dissolution rate.

[00:08:34] Speaker 02:
It doesn't, it never says that everything goes away other than the taxane.

[00:08:38] Speaker 02:
And in fact, that's contrary to what the specification of the patent actually says.

[00:08:43] Speaker 02:
The specification of the patent says that you can have insoluble components that will be mixed in with the taxane.

[00:08:49] Speaker 02:
So those, by definition, wouldn't go away when you expose them to the aqueous media.

[00:08:55] Speaker 02:
So that would be contrary to the way the invention is defined in the specification itself.

[00:09:00] Speaker 02:
There is nothing about purity of taxane, or taxane being the only thing present.

[00:09:06] Speaker 00:
But I guess we can all agree that both Haynes and Desai have some kind of encapsulation of the taxane, right?

[00:09:15] Speaker 00:
That there's a surfactant or something that's surrounding the taxane particles, thereby leading to some kind of controlled release formulation.

[00:09:25] Speaker 00:
And now the African's goal here is to get away from Haynes in design and distinguish over it the best way it thought it could.

[00:09:37] Speaker 02:
And the way that they ultimately did that.

[00:09:38] Speaker 00:
And so you're now saying whatever they gave up, they didn't give up a version of taxane that still could be encapsulated by something, but still somehow nevertheless be a faster dissolution than

[00:09:54] Speaker 00:
the controlled dissolution of Haynes and Desai?

[00:09:57] Speaker 00:
Yes.

[00:09:58] Speaker 00:
And in fact, that's important.

[00:09:59] Speaker 00:
But do you understand why you're asking me to read something extra into the actual text of the prosecution history?

[00:10:08] Speaker 02:
Well, I don't believe so, Your Honor, because what it says is it describes Haynes and Desai.

[00:10:13] Speaker 02:
I think Desai in particular is what Your Honor's referring to.

[00:10:16] Speaker 02:
Desai with controlled release,

[00:10:21] Speaker 02:
I've now lost the word, but I believe it says encapsulated particles.

[00:10:26] Speaker 02:
And then it goes on to say that the key fact is that it leads to dissolution, faster dissolution in our product.

[00:10:33] Speaker 02:
The use of the matrix leads to faster dissolution.

[00:10:35] Speaker 02:
And in fact, in the specification of the patent, it actually contemplates the use of particles that are coded.

[00:10:44] Speaker 02:
Pegolated excipients are specifically disclosed in the patent specification.

[00:10:50] Speaker 00:
pegalated excipients means?

[00:10:52] Speaker 00:
Because as I understand it, that wasn't something that was debated, evaluated, the experts did any treatment on below.

[00:10:59] Speaker 00:
Is that fair to say?

[00:11:00] Speaker 02:
It was not discussed below.

[00:11:03] Speaker 02:
It's not a waiver, because it's not a different issue.

[00:11:06] Speaker 02:
It still goes to the same issue that we're talking about here, which is the proper difference.

[00:11:10] Speaker 02:
I understand, but I don't know what pegalated excipient means.

[00:11:13] Speaker 00:
And your honor is right.

[00:11:14] Speaker 00:
It seems like you think you know what pegalated excipient means,

[00:11:17] Speaker 00:
It's just you, unfortunately.

[00:11:19] Speaker 02:
Well, but I point to the specification, your honor, at column five, lines 52 to 62, where it's discussed.

[00:11:26] Speaker 02:
And it says, pegalated excipients are excipients that envelop the taxing.

[00:11:31] Speaker 02:
And so that, by its nature, means that you're talking about something other than just a pure taxing.

[00:11:37] Speaker 02:
You're talking about something that envelops the taxing.

[00:11:40] Speaker 02:
So the fact that there is some kind of coded particle is not

[00:11:45] Speaker 02:
basis for the distinction here.

[00:11:47] Speaker 02:
The ultimate basis for the distinction is how fast it dissolves.

[00:11:51] Speaker 02:
And it's made very clear, I think, in the prosecution history, as well as in the patent, that what makes this a faster dissolving situation is the use of the matrix and the matrix that parts of which dissolve.

[00:12:05] Speaker 02:
I'm sorry.

[00:12:06] Speaker 01:
Mr. Lombardi, you're well within your rebuttal time.

[00:12:10] Speaker 01:
Do you want to devote any of your remaining three minutes to your tiny problem?

[00:12:15] Speaker 01:
Your nano versus micro?

[00:12:19] Speaker 02:
Your Honor, I will just say that I think that the term is defined right there in the claims.

[00:12:24] Speaker 02:
The nanoparticles and microparticles are set forth as being in a certain range.

[00:12:29] Speaker 01:
Your argument is there's no universally accepted definition.

[00:12:33] Speaker 02:
And that's what the court found as well.

[00:12:35] Speaker 02:
And I say that.

[00:12:37] Speaker 01:
But the judge did say that there was a definition.

[00:12:40] Speaker 01:
It's not just one that was universally accepted.

[00:12:43] Speaker 02:
Yeah, he found the definition, but he made that definition based on an unfortunate misunderstanding of the record.

[00:12:50] Speaker 02:
He thought that the inventor had written a particular chapter of a book that defined the term.

[00:12:56] Speaker 02:
That ends up being not true.

[00:12:57] Speaker 02:
And I will reserve the remainder of my time.

[00:13:00] Speaker 02:
Thank you, Your Honor.

[00:13:19] Speaker 03:
Good morning, your honors, and may it please the court.

[00:13:22] Speaker 03:
There's much to say about the language of the claims here.

[00:13:27] Speaker 03:
We've said it in our brief.

[00:13:31] Speaker 03:
I'll start with the nanoparticles issue and then turn to the other taxane issue.

[00:13:38] Speaker 03:
If you look at the claim language here, the nanoparticles and microparticles

[00:13:44] Speaker 03:
language shows up in the first clause as one or as two of the four components of the matrix.

[00:13:51] Speaker 03:
It then shows up again.

[00:13:52] Speaker 01:
With an and.

[00:13:53] Speaker 03:
I'm sorry?

[00:13:54] Speaker 01:
With an and as two different things.

[00:13:56] Speaker 03:
Yes, and as two different things.

[00:13:57] Speaker 03:
And Judge Wallach, you started this argument with the place that we could end this argument, and that is at page 81021 of the record.

[00:14:06] Speaker 03:
If you look in that first paragraph where the applicant is talking about Haynes, they tell the world.

[00:14:14] Speaker 03:
that Hanes is formed into microparticles by spray drying, period.

[00:14:19] Speaker 03:
There are no nanoparticles.

[00:14:22] Speaker 03:
What the applicant is telling the world here is that there are two different things.

[00:14:28] Speaker 03:
There is something called a microparticle, and there is something called a nanoparticle.

[00:14:32] Speaker 03:
That cannot be reconciled with the position being brought here today by my friend on the other side.

[00:14:38] Speaker 03:
And that is that they all mean something that's mashed together.

[00:14:43] Speaker 03:
It just means particles.

[00:14:44] Speaker 03:
And if you take my friend's construction and apply it to the claim, what you really have would be a claim that says particles of a taxane having these particular measurements.

[00:14:57] Speaker 03:
That's not what the claim says.

[00:14:59] Speaker 03:
Wherein clauses are supposed to bring further definition, they don't substitute for a separate clause.

[00:15:06] Speaker 00:
I think that- I guess one of their arguments though is that the specification appears to

[00:15:13] Speaker 00:
use the term microparticles interchangeably with the term nanoparticles and microparticles to a point where what they're really talking about, what the patent is really focused on, is that the mean diameter has to be somewhere between 10 nanometers and 5 micrometers.

[00:15:32] Speaker 00:
So we're just talking about really small particles that have this particular mean diameter range.

[00:15:41] Speaker 03:
There's no question that that is the limitation of the claims.

[00:15:44] Speaker 03:
But it's not the only limitation of the claims.

[00:15:46] Speaker 03:
And if we're talking about what my friend has referred to in his briefs as the lexicography argument, let's again step back and keep in mind that this court's precedent says that lexicography has to be what?

[00:15:58] Speaker 03:
It has to be clear.

[00:16:03] Speaker 03:
It has to be unmistakable.

[00:16:05] Speaker 03:
It has to be unequivocal.

[00:16:07] Speaker 03:
What you see in the specification is anything from that.

[00:16:10] Speaker 03:
For one, they did define terms in the specification.

[00:16:15] Speaker 03:
They defined two terms in particular, spray dry and patient.

[00:16:19] Speaker 03:
And they did that in an ordinary definitional mode.

[00:16:21] Speaker 03:
They said, as used here is.

[00:16:23] Speaker 03:
This is at the top of column eight at A41 and the bottom of that same column on page A41.

[00:16:31] Speaker 03:
They didn't do that with nanoparticles and microparticles.

[00:16:33] Speaker 03:
In fact, the specification and the claim language are somewhat inconsistent because there's a place in the specification

[00:16:40] Speaker 03:
where they look to for their so-called definition that refers only to microparticles and makes not mention at all of nanoparticles.

[00:16:51] Speaker 00:
I guess they use that and rely on that to suggest that the terms

[00:16:58] Speaker 00:
microparticles and nanoparticles and microparticles are essentially the same thing.

[00:17:03] Speaker 00:
Thematically, that's what they're targeting throughout.

[00:17:06] Speaker 03:
What they're doing is they're relying on the fact that their claim drafting and patent drafting left ambiguities and had some, as the district court mentioned, some inexplicable sloppiness in terms of when they added nanoparticles to the claims, they inserted nanoparticles in some places but not in others where it would have made sense.

[00:17:26] Speaker 03:
And certainly in the specification, that's not the way the claim was originally worth.

[00:17:30] Speaker 03:
The claim did not include a nanoparticle limitation, but they had to add it in order to make the argument that they did at page 821 to get over Haynes.

[00:17:41] Speaker 03:
And with regard to a couple of other comments about lexicography, if you apply a lexicography here, it would collapse and make redundant those limitations, as I said before.

[00:17:53] Speaker 03:
And there's another thing that's unclear about their lexicography.

[00:17:57] Speaker 03:
They take the wherein clause, which has both a mean diameter limitation and a total surface area limitation.

[00:18:05] Speaker 03:
And they decide, well, we're going to take half of it.

[00:18:07] Speaker 03:
We're going to cherry pit that first half and say, well, that's our definition.

[00:18:11] Speaker 03:
But it doesn't take into account at all the surface area apartment.

[00:18:14] Speaker 03:
And that's not the sort of clarity and definitiveness that for an implied definition like South Atlantic, you'd have.

[00:18:22] Speaker 00:
What are we supposed to make

[00:18:23] Speaker 00:
Dependent Claim Six.

[00:18:25] Speaker 00:
Is it your view that Dependent Claim Six is invalid?

[00:18:30] Speaker 03:
Well, we haven't asserted in validity defense in this appeal with regard to Dependent Claim Six.

[00:18:35] Speaker 00:
Right, but just following through on the logic of your position, what does that do to Claim Six?

[00:18:40] Speaker 03:
Well, I think Claim Six has some indefinite problems.

[00:18:42] Speaker 03:
I have no doubts about that.

[00:18:45] Speaker 03:
One of the problems with it, of course, is that

[00:18:48] Speaker 03:
It doesn't use the nanoparticles and microparticles when you would expect it in ordinary usage to have nanoparticles in there.

[00:18:58] Speaker 03:
The other is, of course, this indefinite misproblem that we come to with regard to our cross-appeal having to do with the whole question of what would mean diameter and how do you measure it.

[00:19:08] Speaker 03:
In any event, the claim 6 argument isn't really a pure claim differentiation argument.

[00:19:12] Speaker 03:
At most, their argument is that there might be some under-coverage

[00:19:16] Speaker 03:
at the lower level from 0.50 microns to 1 micron.

[00:19:22] Speaker 03:
But in point of fact, depending on how you measure and which measurement method you use for mean diameter, even a volume mean diameter isn't just an arithmetic mean.

[00:19:35] Speaker 03:
It's an estimation that takes place with a machine that may be analyzing using optical scanning.

[00:19:46] Speaker 03:
and using calculations that are well beyond my modest level of skill in this art.

[00:19:52] Speaker 03:
But the fact of the matter is that this is a desperate effort to say, well, mean here just means average.

[00:20:00] Speaker 03:
And you can just figure out that that's inconsistent with that.

[00:20:04] Speaker 03:
And when this court tolerates overlap like that, it sometimes even tolerates complete overlap in claim differentiation if the language allows for that.

[00:20:13] Speaker 03:
And that's what the language here does.

[00:20:16] Speaker 03:
With regard to the of a taxing limitation, if I could turn to that, the language is, in the claim, again, it's of a taxing.

[00:20:25] Speaker 03:
Just while I said earlier in the colloquy with my friend, the language of the claims says there's a matrix that includes nanoparticles and microparticles, and the whole point of the invention is to make the nanoparticles and microparticles separate away from the matrix.

[00:20:43] Speaker 03:
It's of a taxing.

[00:20:44] Speaker 03:
It doesn't say, and this is important

[00:20:46] Speaker 03:
substantially of a taxing.

[00:20:48] Speaker 03:
It doesn't say mostly of a taxing.

[00:20:51] Speaker 03:
It doesn't say a majority taxing.

[00:20:54] Speaker 03:
It says of a taxing.

[00:20:56] Speaker 00:
I think the claim language itself is still open.

[00:20:59] Speaker 00:
This is the word comprising.

[00:21:01] Speaker 00:
So I don't necessarily see just the claim language by itself in isolation.

[00:21:08] Speaker 00:
A little collusion of the taxing

[00:21:12] Speaker 00:
also being attached to something else is so long as the hydrophilic excipient and the wetting agent have been now separated and dissolved.

[00:21:22] Speaker 03:
Well, it's certainly true that it is a pharmaceutical composition comprising, but it is comprising a matrix.

[00:21:30] Speaker 03:
And then the matrix is comprising these four distinct elements.

[00:21:36] Speaker 03:
And one of them is of a taxing.

[00:21:38] Speaker 03:
Is our nanoparticles of a taxing?

[00:21:41] Speaker 03:
and microparticles of a taxane.

[00:21:42] Speaker 03:
Now, being an open claim doesn't mean that you can add something else to that taxane and still have it be of a taxane if it were an open claim, as the district court used the term unzip, which I thought was a pretty interesting and useful way of thinking about how comprising might work in this claim.

[00:21:59] Speaker 03:
Does it unzip of a taxane so that the microparticles and nanoparticles can be made of something else entirely in addition to taxane?

[00:22:06] Speaker 03:
No.

[00:22:06] Speaker 03:
What the comprising claim does

[00:22:08] Speaker 03:
even assuming that it's unzipped all the way down there, if it allows you to add a fourth element, a fourth limitation.

[00:22:15] Speaker 03:
So maybe the matrix is open, that it has to have these four things, the hydrophilic excipient, the wetting agent, nanoparticles and microparticles, but it might also have some other excipient.

[00:22:29] Speaker 03:
It's like a pegalated excipient?

[00:22:31] Speaker 03:
Like the pegalated excipient that we were never able to develop the argument on in the trial court.

[00:22:35] Speaker 00:
What's your understanding of the pegalated excipient that surrounds the taxane particles?

[00:22:40] Speaker 03:
Well, it's hard to square with this patent, honestly, if it is indeed surrounding the taxane particles.

[00:22:48] Speaker 00:
Right, necessarily.

[00:22:48] Speaker 00:
You could still potentially get a master dissolution rate.

[00:22:51] Speaker 00:
So long as the taxane particles are

[00:22:54] Speaker 00:
surrounded by something called a peggalated excipient that permits a faster dissolution than otherwise.

[00:22:59] Speaker 03:
In theory, you could get a faster dissolution rate.

[00:23:05] Speaker 03:
However, here's what the language of the claim says.

[00:23:08] Speaker 03:
It says, beneficially envelops or shields the paclitaxel from macrophage uptake.

[00:23:13] Speaker 03:
Now, as I understand it, a macrophage is a white blood cell that eats cellular debris.

[00:23:19] Speaker 03:
And this is to keep those white cells, in some fashion or another, from eating the cellular debris.

[00:23:25] Speaker 03:
a problem with that.

[00:23:26] Speaker 03:
And it actually feeds Judge Chen right into our indefinite misargument with regard to this patient.

[00:23:32] Speaker 03:
Our friends in their briefs, both in their opening brief at page seven and their reply brief at page 52 and 53, show you the schematic that shows this biphasic dissolution.

[00:23:43] Speaker 03:
Well, in the second beaker, which is filled with a lot more liquids, I guess that's supposed to indicate what the drug is like when it's in the body after it's been

[00:23:54] Speaker 03:
injected into an IV solution, an IV bag, say.

[00:24:00] Speaker 03:
That second solution shows the back of the tactile in solution.

[00:24:07] Speaker 03:
It's already dissolved.

[00:24:08] Speaker 03:
So it's hard to see, if there's a bitanus solution, how in the body this could guard those now in solution nanoparticles, microparticles, whatever form they're in at that point, once they're now in solution.

[00:24:24] Speaker 03:
And of course, the problem, and let me just turn to indefiniteness to try to help answer this question.

[00:24:30] Speaker 03:
The basic indefiniteness problem we have with this is that let's assume, for sake of argument, that my friend is right, that the plane can be read to require the biphasic dissolution where the matrix is off first, and then there's a second dissolution where the nanoparticles and microparticles go into solution.

[00:24:47] Speaker 03:
That's all well and good, except that example three of the patent

[00:24:51] Speaker 03:
doesn't tell you that it points in exactly the opposite direction.

[00:24:54] Speaker 03:
Example three is describing a monophasic solution, a monophasic dissolution, excuse me, and even their own Dr. Langer said that's what happens.

[00:25:04] Speaker 03:
It measures, example three is the test, and it measures when the taxane goes into solution, and that's at page A3173 to A3175 of the record.

[00:25:16] Speaker 03:
So what you've got is at best,

[00:25:18] Speaker 03:
giving my friend's claim construction argument the benefit of the doubt, he says it's claiming a biphasic dissolution.

[00:25:24] Speaker 03:
You've got example three that says it's claiming a monophasic solution.

[00:25:27] Speaker 03:
Which do we rely on?

[00:25:29] Speaker 03:
We don't know.

[00:25:29] Speaker 03:
We can't tell.

[00:25:30] Speaker 03:
That's indefinite, particularly after Nautilus.

[00:25:35] Speaker 01:
You're in your cross-appeal time.

[00:25:37] Speaker 03:
I'm trying to make sure that I lay the groundwork for any rebuttal that I need to do with regard to the cross-appeal.

[00:25:44] Speaker 03:
Let me just make one other comment about the cross appeal with regard to the mean diameter limitation, Judge Pollack.

[00:25:51] Speaker 03:
Here's what we can all agree on.

[00:25:53] Speaker 03:
Everyone agrees that there are lots of different kinds of mean diameter.

[00:25:56] Speaker 03:
And everyone agrees the patent doesn't say which one of these kinds of mean diameter you use.

[00:26:00] Speaker 03:
What the district court did, though, is say that, well, the discussion of haze that took place in the prosecution history says

[00:26:13] Speaker 03:
Well, that tells me it should be volume mean diameter or mass mean diameter, which means the same thing.

[00:26:21] Speaker 03:
Now, that can't be squared with 37 CFR 157 1.57 D2, which requires essential material for establishing the definiteness of a patent claim to be incorporated by reference.

[00:26:40] Speaker 03:
There is no argument and no possible argument that Haynes was incorporated by reference.

[00:26:44] Speaker 03:
In fact, it would be strange indeed for them to have incorporated by reference a reference they were trying to establish around.

[00:26:51] Speaker 03:
So I've left a minute and a half, and I'll return.

[00:26:54] Speaker 03:
Thank you.

[00:27:02] Speaker 02:
Your Honor, as to the tax aim point, I would like to refer the court to the next amendment, the next communication between the examiner and the applicants at A1046, which I think illustrates precisely where this was going.

[00:27:21] Speaker 02:
You'll see at that page, it's under, first is a heading, Haynes.

[00:27:24] Speaker 02:
In the middle of the page, there is a description of Haynes.

[00:27:28] Speaker 00:
Haynes discloses large diameter, i.e., greater than five microns.

[00:27:32] Speaker 00:
aerosol-zibol particles, right?

[00:27:36] Speaker 02:
Yes, and that's the paragraph that describes it, Your Honor, and then below is where the distinction is made.

[00:27:42] Speaker 02:
The combination of design Hanes would not leave one skilled in the art, and if you go, I won't read every word of that, Your Honor, but each of those points that are made for the distinction is based on dissolution, and based on dissolution speed.

[00:27:55] Speaker 02:
It is clearly not based on size,

[00:27:58] Speaker 02:
And it's not based on whether there might be some coding there, which, as your honor pointed out, could be a coding that has no effect on the dissolution rate.

[00:28:08] Speaker 02:
So this is the way the file history goes about it.

[00:28:12] Speaker 02:
With respect to whether this is biphasic or multiphasic, example three makes very clear that this is a biphasic system.

[00:28:25] Speaker 02:
It talks about a 10 milliliter.

[00:28:27] Speaker 02:
concentration that the matrix is put in first, then the next is put into a 250 milliliter concentration of aqueous medium.

[00:28:37] Speaker 02:
That's two phases.

[00:28:38] Speaker 02:
That's exactly what we have said throughout.

[00:28:42] Speaker 02:
As to the argument, my colleague said, I believe that there was an argument made to get over Hanes based on its size, and I think

[00:28:53] Speaker 02:
Your Honor might have been alluding to that when you pointed to the first line at A1046.

[00:28:58] Speaker 02:
Actually, there is no distinction based on size.

[00:29:01] Speaker 02:
And it's A1021.

[00:29:03] Speaker 02:
The applicant specifically references the fact that there can be no distinction based on the size of the particles.

[00:29:11] Speaker 02:
at 1021 recognizes that the prior arts teaches that the drug formulation had a total particle size of less than five microns.

[00:29:20] Speaker 02:
That's what was claimed in the invention.

[00:29:22] Speaker 02:
So no distinction was being made that way, and the examiner didn't understand that way.

[00:29:28] Speaker 02:
Brief ways to indefiniteness, Your Honor.

[00:29:31] Speaker 02:
Time's up.

[00:29:32] Speaker 02:
Time's up.

[00:29:33] Speaker 02:
Then we'll be very brief on indefiniteness, Your Honor.

[00:29:36] Speaker 02:
Thank you.

[00:29:41] Speaker 03:
I expect to clarify, as my partner pointed out to me, that when I referred to, in my discussion with Judge Chen, the test, I should have made clear that it was the test for determining whether the microparticles and nanoparticles had dissolved.

[00:29:56] Speaker 03:
And that's what's in example three.

[00:29:58] Speaker 03:
Other than that, I have nothing further.

[00:30:00] Speaker 03:
Thank you.

[00:30:01] Speaker 01:
Thank you, counsel.

[00:30:02] Speaker 01:
The matter will stand submitted.