Today, Council, prepared to go forward. Please proceed. You through on party? Yes, Your Honor. May I please the Court? The District Court erudists is a construction of two significant claim terms. In each instance, the District Court red language into the terms that not only is not present in the claims, but is not present in the specification. Let me ask you a question, Mr. Frank. In the joint appendix at 1021, you distinguish the side of the patent-directed ebric chain on the basis that it discloses controlled, related to polymer and capsulated formulations. But in the red brief, Selgin says, Accusphere is attempting to read its claims on Selgin's X-brain product, a product that consists of the same album, Bumin, polymer and capsulated formulations that you disclose during prosecution. Why should we not find that you are disclamed? Well, first of all, the first part of what Your Honor was referring to is a non-infringent argument, and we're not at that point. We did not, this is on the of a tax-state point, Your Honor, and there was no disclaimer because the ultimate reason that the District Court, that the Examinor allowed the claims and the basis, the argument that we made the Examinor, was on the speed of the dissolution. Now, controlled release and coding of particle may in some instances have some impact on that. I can see that. But that doesn't mean that in every instance that the albumin coded particles or that a coded particle is going to have an impact on the release rate, the dissolution release rate
. I mean, I suppose we could quibble about to what extent the Examinor relied on this particular distinction. But nevertheless, it is true that your client made these statements in the prosecution history. And I think the law is that any statements you make in the prosecution history as to what is the best understanding of the claim count and should be understood in terms of trying to find the best understanding of the claim. 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 given taken back and forth between the applicant and the Examinor. And so it is difficult at times to discern a precise and a clear and unambiguous disclaimer. And in this case, there is no clear and unambiguous disclaimer of the control release or the coded particles. Because in this case, in this case, they go on the way the applicant went about his amendments in this case was to have a paragraph that would describe the prior art and then would have a paragraph that distinguishes it. The statements that Your Honor is referring to come from the description paragraph. And a description is not the same thing as a disclaimer. It is the next paragraph where the distinction is actually made and in that paragraph where the distinction is being made, the distinction is based on dissolution rate and not specifically on the point that Your Honor has referred to from. So when I guess it's that J.A
. 1021, the applicant says, Haynes, and then says there are no nanoparticles nor is there a matrix formed of a hydrophilic recipient that dissolves upon contact with water to release nanoparticles and micro particles of the taxing. To me, the context is clear that the applicant is setting up a strong distinction between how it understands Haynes and likewise how it understands what's doing with its amendment. 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. And in that paragraph, the applicant makes very clear that no distinction is being made based on the size of the particles in Haynes and dissi as opposed to the invention. It specifically concedes that those references cover particles that are less than five microns in size. And so what the distinction was being made on with the patent office at that point in time was not a size. Are we flipping over to particle size now? I'm sorry, I showed your honor. I thought that's where you were going with that. I'm sorry, I was Judge Wallick led off with our right into taxane only. So I meant to try to stay there and I understood this portion of the prosecution history where the applicant was distinguishing its claim from Haynes and dissi. And as I read this excerpt on J.A. 1021, it really looks like the point to be made here is that you release taxane from the matrix
. So whatever is in that matrix, the remainder of the matrix dissolves and goes away leaving you taxane, resulting in taxane and Haynes and dissi nevertheless doesn't work that way. That's what I get from this portion. 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, which one? Accordingly or the accordingly paragraph at 81021. Farther down the paragraph, they say the distinction is that there is no immediate release upon dissolution of this rounding matrix that is taught in the dissi and Haynes references. And the patent examiner goes on to say, in fact in the notice of allowance when the patent examiner allows the patent, it's on the basis of the different dissolutionary. It's not on the basis of the size or on the basis of purity of particles. It's on the basis of the dissolution rate. And that's what the invention was. That's what they were telling what the applicant was telling the examiner the invention was during that period of time. So not the very end of 1021. I guess it's not a formulation having dispersed there in nanoparticles and micro particles of a drug released immediately upon dissolution of the surrounding matrix. Again, doesn't that reinforce the idea that these particles and these particles alone of taxing get freed up? It does add there's no question that the particles of taxing leave the matrix and get freed up
. Where is an issue between the parties about whether it's only the taxing particles that get freed up, which your honor I'm sure is aware of, but I'll pass that for right now. There's no question that that is the heart of the invention that that makes for dissolution rates to happen quicker. But the question I think your honor is asking me is did that 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 an instant instruction. And there is nothing like that that is given up in this statement. The term the claim was defined as being essentially pure taxing, formed of only taxing, essentially pure taxing. 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. It sure seems to say that the other step goes away. Well it says that it says and that's how it distinguishes. It distinguishes it by saying that there's a matrix and based on the use of that matrix you get a faster dissolution rate. It doesn't. It never says that everything goes away other than the taxing and in fact that's contrary to what the specification of the patent actually says. The specification of the patent says that you can have insoluble components that will be mixed in with the taxing. So those by definition wouldn't go away when you expose them to the equates media
. So that would be contrary to the way the invention is defined in the specification itself. There is nothing about purity of taxing or taxing being the only thing that's predisposed. But I guess we can all agree that both Haines and Decy have some kind of encapsulation of the taxing. That there's a surfact into something that's surrounding the taxing particles. There by leading to some kind of controlled release formulation. And now the applicant's goal here is to get away from Haines and Decy and distinguish over it the best way it thought it could. And the way that they ultimately did and so you're now saying whatever they gave up they didn't give up a version of taxing that still could be encapsulated by something but still somehow never left be a faster dissolution than the controlled dissolution of Haines and Decy. Yes and in fact that's the point. Do you understand why you're asking me to read something extra into the actual text of the prosecution history? Well I don't believe so you're honored because what it says is it describes Haines and Decy. I think Decy in particular is what your honors are referring to. Decy with control release and caps I've now lost the word but I believe it says encapsulated particles. And then goes on to say that the key fact is that it leads to dissolution faster dissolution in our product. The use of the matrix leads to faster dissolution and in fact in the specification of the patent it actually contemplates the use of particles that are coded
. Pegalated de-cipients are specifically disclosed in the patent. How do we know what pegalated de-cipients mean? Well I understand it that wasn't something that was debated evaluated. The experts did any treatment on below. Is that fair to say? It was not discussed below. It's not a waiver because it's not a different issue. It still goes to the same issue that we're talking about here which is the property. I understand but I don't know what pegalated de-cipient mean. And your honors... Right, it seems like you think you know what pegalated de-cipient means but it's just you unfortunately. Well but I point to the specification your honor at column five lines 52 to 62 where it's discussed and it says pegalated de-cipients are recipients that envelop the taxing. And so that by its nature means that you're talking about something other than just a pure taxing
. You're talking about something that envelops the taxing. So the fact that there is some kind of coded particle is not the basis for the distinct standard. The ultimate basis for the distinction is how fast it dissolves. 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. I'm sorry. Mr. Lambert, you're well within your rebuttal time. Do you want to devote any of your remaining three minutes to your tiny problem? To my your nanoversus micro. I'll just say I will just say that I think that the term is defined right there in the claims. The nanoparticles in my particle particles are set forth as being in a certain range. You say you're arguing is there's no universally accepted definition. And that's what the court found as well. And I tried
. I'd say that. But the judge did say that there was a definition. It's not just one that was universally accepted. Yeah, he found a definition, but he made that definition based on an unfortunate misunderstanding of the record. He thought that the inventor had written a particular chapter of a book that defines the term that ends up being not not true. And I will reserve your major of my time. Thank you. Good morning, Your Honours and May it please the court. There's much to say about the language of the claims here. We've said it in our brief. The I'll start with the nanoparticles issue and then turn to the other taxing issue. If you look at the claim language here, the nanoparticles and micro particles language shows up in the first clause as one or as two of the four components of the matrix. It then shows up again with an end
. I'm sorry. With an end as two different things. Yes, and it's two different things. And in Judge Wallach, you started the argument with the place that we could end the argument and that is the page 81021 of the record. If you look in that first paragraph where the applicant is talking about Haynes, they tell the world that Haynes is formed into micro particles by spray drying periods. There are no nanoparticles. What the applicant is telling the world here is that there are two different things. There is something called a micro particle and there is something called a nanoparticle. That cannot be reconciled with the position being brought here today by my friend on the other side. That is that they all mean something that's moshed together. It just means particles. If you take my friend's construction and apply it to the claim, what you really have would be a claim to say, the particle of a taxing, having these particular measurements that do not know what the claim says. Wherein clauses are supposed to bring further definition, they don't substitute for the separate clause
. I think one of their arguments though is that the specification appears to use the term micro particles interchangeably with the term nanoparticles and micro particles 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. We're just talking about really small particles that have this particular mean diameter range. There's no question that that is the limitation of the claim, but it's not the only limitation of the claim. If we're talking about what my friend has referred to in his briefs as the leclicography argument. Let's again step back and keep in mind that this court's precedent says that leclicography has to be what? It has to be, excuse me, clear. It has to be unmistakable. It has to be unquivocal. What you see in the specification is anything from that. For one, they did define terms in the specification. They defined two terms in particular, sprayed rye and patient. They did that in an ordinary definition mode. They said, as used here is, this is at the top of column 8 and 841, and the bottom of that same column on page 841. They didn't do that with nanoparticles and micro particles. In fact, the specification and the claim language are somewhat inconsistent because there's a place in the specification where they look to for their so-called definition that refers only to micro particles and they do not mention at all of nanoparticles. I guess that's they use that and rely on that to suggest that the terms micro particles and nanoparticles and micro particles are essentially the same thing. I think what thematically, that's what they're targeting throughout. What they're doing is they're lying on the fact that they were claim drafting and patent drafting, was left ambiguities and had some, as the district court mentioned, some inexplicable floppyness in terms of when they added nanoparticles to the claims, the insurgent nanoparticles in some places that not in others would have made sense. And certainly in the specification, that's not the way that the claims originally were. The claims did not include a nanoparticle limitation, but they had to add it in order to make the argument that they did at page A21 to get overhanged. 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. And there's another thing that's unclear about their lexicography. They take the wherein flux, which has both a mean diameter limitation and a total surface area limitation. And they decide, well, we're going to take half that. We're going to cherry pit that first half and say, well, that's our definition. But it doesn't take into account of all the surface area apartments. And that's not the sort of clarity and definitiveness that for an implied definition, one cell of lantic, you'd have
. In fact, the specification and the claim language are somewhat inconsistent because there's a place in the specification where they look to for their so-called definition that refers only to micro particles and they do not mention at all of nanoparticles. I guess that's they use that and rely on that to suggest that the terms micro particles and nanoparticles and micro particles are essentially the same thing. I think what thematically, that's what they're targeting throughout. What they're doing is they're lying on the fact that they were claim drafting and patent drafting, was left ambiguities and had some, as the district court mentioned, some inexplicable floppyness in terms of when they added nanoparticles to the claims, the insurgent nanoparticles in some places that not in others would have made sense. And certainly in the specification, that's not the way that the claims originally were. The claims did not include a nanoparticle limitation, but they had to add it in order to make the argument that they did at page A21 to get overhanged. 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. And there's another thing that's unclear about their lexicography. They take the wherein flux, which has both a mean diameter limitation and a total surface area limitation. And they decide, well, we're going to take half that. We're going to cherry pit that first half and say, well, that's our definition. But it doesn't take into account of all the surface area apartments. And that's not the sort of clarity and definitiveness that for an implied definition, one cell of lantic, you'd have. What are we supposed to make of dependent claim six? Is it your view that dependent claim six is invalid? Well, we haven't asserted in validity defense in this appeal with regard to driving the case. But it's following through on the logic of your position. What does that do to claim six? Why do claim six have some indefinite problems? I have no doubt about that. One of the problems with it, of course, is that it doesn't use the nanoparticles and micro particles when you would expect it in ordinary usage to have nanoparticles in there. The other is, of course, indefinite problem that we come to with regard to our cross appeal, having to do with the whole question of what does mean diameter and how to measure it. In any of that, the claim six arguments isn't really a pure claim differentiation argument that most their argument is, but there might be some under-tubberage at the lower level from 0.5 on, microns to one micron. 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. It's an estimation that takes place with a machine that may be analyzed using optical scanning and using calculations that are beyond my modest level of skill in this art. But the fact of the matter is that this is a desperate effort to say, well, mean here, just means average, and you can just figure out that that's inconsistent with that. And with when the score tolerates overlap, like that, it's sometimes even tolerates complete overlap and claim differentiation that the language allows for that, and that's what the language here does. With regard to the other tax-thing limitation, if I could turn to that, the language is in the claim again. It's other tax-thing
. What are we supposed to make of dependent claim six? Is it your view that dependent claim six is invalid? Well, we haven't asserted in validity defense in this appeal with regard to driving the case. But it's following through on the logic of your position. What does that do to claim six? Why do claim six have some indefinite problems? I have no doubt about that. One of the problems with it, of course, is that it doesn't use the nanoparticles and micro particles when you would expect it in ordinary usage to have nanoparticles in there. The other is, of course, indefinite problem that we come to with regard to our cross appeal, having to do with the whole question of what does mean diameter and how to measure it. In any of that, the claim six arguments isn't really a pure claim differentiation argument that most their argument is, but there might be some under-tubberage at the lower level from 0.5 on, microns to one micron. 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. It's an estimation that takes place with a machine that may be analyzed using optical scanning and using calculations that are beyond my modest level of skill in this art. But the fact of the matter is that this is a desperate effort to say, well, mean here, just means average, and you can just figure out that that's inconsistent with that. And with when the score tolerates overlap, like that, it's sometimes even tolerates complete overlap and claim differentiation that the language allows for that, and that's what the language here does. With regard to the other tax-thing limitation, if I could turn to that, the language is in the claim again. It's other tax-thing. Shrith Wollock said earlier in the colloquial group, 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. It's other tax-thing. It doesn't say, and this is important, substantially of a tax-thing. It doesn't say mostly of a tax-thing. It doesn't say a majority tax-thing. It's a tax-thing. I think the claim language itself is still open. This is the word comprising. So I don't necessarily see in just the claim language by itself in isolation. The conclusion of the tax-thing also being attached to something else is so long as the hydrophilic recipient and the wedding agent have been now separated and dissolved. Well, it's certainly true that it is a part of the composition comprising. But it is comprising a matrix
. Shrith Wollock said earlier in the colloquial group, 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. It's other tax-thing. It doesn't say, and this is important, substantially of a tax-thing. It doesn't say mostly of a tax-thing. It doesn't say a majority tax-thing. It's a tax-thing. I think the claim language itself is still open. This is the word comprising. So I don't necessarily see in just the claim language by itself in isolation. The conclusion of the tax-thing also being attached to something else is so long as the hydrophilic recipient and the wedding agent have been now separated and dissolved. Well, it's certainly true that it is a part of the composition comprising. But it is comprising a matrix. And then the matrix is comprising these four distinct elements. And one of them is of a tax-thing. And what is our nanoparticles for tax-thing? And microparticles of a tax-thing. Now, being an open claim doesn't mean that you can add something else to that tax-thing and still have it be of a tax-thing. If it were an open claim as the district court used the term un-dip, which I thought was a pretty interesting and useful way of thinking about how comprising my work in this claim. Does this un-dip of a tax-thing so that the microparticles and nanoparticles can be made of something else entirely in addition to tax-thing? No, what the comprising claim does, assuming even assuming that it's un-diped all the way down there. If it allows you to add a fourth element of the fourth limitation. So maybe the matrix is open that it has to have these four things, the hydrophilic recipient, the wedding agent, nanoparticles and microparticles. But it might also have some other exhibit. It's like a regulated exhibit, like the regulated exhibit that we were never able to develop the argument on in the trial court. What's your understanding of the regulated exhibit that surrounds the tax-thing particles? Well, it's hard to square with this patent, honestly. If it is indeed surrounding the tax-thing particles. Apparently, you could still potentially get a faster dissolution rate
. And then the matrix is comprising these four distinct elements. And one of them is of a tax-thing. And what is our nanoparticles for tax-thing? And microparticles of a tax-thing. Now, being an open claim doesn't mean that you can add something else to that tax-thing and still have it be of a tax-thing. If it were an open claim as the district court used the term un-dip, which I thought was a pretty interesting and useful way of thinking about how comprising my work in this claim. Does this un-dip of a tax-thing so that the microparticles and nanoparticles can be made of something else entirely in addition to tax-thing? No, what the comprising claim does, assuming even assuming that it's un-diped all the way down there. If it allows you to add a fourth element of the fourth limitation. So maybe the matrix is open that it has to have these four things, the hydrophilic recipient, the wedding agent, nanoparticles and microparticles. But it might also have some other exhibit. It's like a regulated exhibit, like the regulated exhibit that we were never able to develop the argument on in the trial court. What's your understanding of the regulated exhibit that surrounds the tax-thing particles? Well, it's hard to square with this patent, honestly. If it is indeed surrounding the tax-thing particles. Apparently, you could still potentially get a faster dissolution rate. So long, you could get a tax-thing particles are surrounded by something on a regulated exhibit that permits a faster dissolution. So the other way you could get a faster dissolution rate. Excuse me. However, here's what the language of the claim says. It says, it's artificially enveloped or shields the pack of tax from macrophage uptake. Now, as I understand it, a macrophage is a white blood cell that eats cellulose litter debris. And this is to keep those white cells in some fashion or another from eating the cellulose litter debris. Here's the problem with that. It actually keeps George Chen right into our indefinite mass argument with regard to this situation. Our friends, in their briefs, both in their opening brief of page 7 and their reply brief of page 52 and 53, show you the schematics that shows this bi-pathic dissolution. Well, the second speaker, 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 injected into an IV solution, an IV bag, say. That second solution shows the aqua-tactyl in solution. It's already dissolved
. So long, you could get a tax-thing particles are surrounded by something on a regulated exhibit that permits a faster dissolution. So the other way you could get a faster dissolution rate. Excuse me. However, here's what the language of the claim says. It says, it's artificially enveloped or shields the pack of tax from macrophage uptake. Now, as I understand it, a macrophage is a white blood cell that eats cellulose litter debris. And this is to keep those white cells in some fashion or another from eating the cellulose litter debris. Here's the problem with that. It actually keeps George Chen right into our indefinite mass argument with regard to this situation. Our friends, in their briefs, both in their opening brief of page 7 and their reply brief of page 52 and 53, show you the schematics that shows this bi-pathic dissolution. Well, the second speaker, 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 injected into an IV solution, an IV bag, say. That second solution shows the aqua-tactyl in solution. It's already dissolved. It's hard to see if there's a bi-pathic solution. How in the body this could guard those now-in-solution, now-aparticles, microparticles, whatever form they're in at that point, once they're now in solution. And of course, the problem, and let me just turn to indefiniteness to try to help answer this question. The basic indefiniteness problem we have with this is that let's assume, for sake of our arguments, that my friend is right, but the claim can be read to require the bi-pathic dissolution where the matrix dissolves first, and then there's a second dissolution where the nanoparticles, the microparticles go into solution. That's all well and good except that example 3 is the patent. Doesn't tell you that at point to exactly the opposite direction. Example 3 is describing a modified dissolution, a modified dissolution, excuse me. And even their own doctor langers said, that's what happens. It measures the example 3 is the test, and it measures when the taxing goes into solution and that's a page A3173 to A3175 of the record. So what you've got is at fast, giving my friend's claim instruction argument that I've been in the doubt, he said, it's claiming a bi-pathic dissolution. You've got example 3 that says it's a plain modified dissolution, which do we rely on? We don't know. We can't tell that in a definite, particularly after the law. You're in your cross appeal time, but 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
. It's hard to see if there's a bi-pathic solution. How in the body this could guard those now-in-solution, now-aparticles, microparticles, whatever form they're in at that point, once they're now in solution. And of course, the problem, and let me just turn to indefiniteness to try to help answer this question. The basic indefiniteness problem we have with this is that let's assume, for sake of our arguments, that my friend is right, but the claim can be read to require the bi-pathic dissolution where the matrix dissolves first, and then there's a second dissolution where the nanoparticles, the microparticles go into solution. That's all well and good except that example 3 is the patent. Doesn't tell you that at point to exactly the opposite direction. Example 3 is describing a modified dissolution, a modified dissolution, excuse me. And even their own doctor langers said, that's what happens. It measures the example 3 is the test, and it measures when the taxing goes into solution and that's a page A3173 to A3175 of the record. So what you've got is at fast, giving my friend's claim instruction argument that I've been in the doubt, he said, it's claiming a bi-pathic dissolution. You've got example 3 that says it's a plain modified dissolution, which do we rely on? We don't know. We can't tell that in a definite, particularly after the law. You're in your cross appeal time, but 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. Let me just make one other comment about the cross appeal with regard to the mean diameter limitation. Here's what we can all agree on. Everyone agrees that there are lots of different times with me in diameter, and everyone agrees that the patent does what they say, which one of these times with me in diameter is what the district court did, so it says, as well, the discussion of Hane that took place in the prosecution history says, well, that sounds mean it should be volume mean diameter, or mass mean diameter, which mean the same thing. Now, that can't be squared with 37 CFR 157, 1.57D2, which requires essential material for establishing the definiteness of a patent claim to be incorporated by reference. There is no argument and no possible argument that Hane was incorporated by reference. In fact, would be strange indeed for them to have incorporated by reference the reference they were trying to distinguish for reference. I've left a minute and a half, and I'll return. Thank you. Your honor, I would like to refer the court to the next amendment, the next communication between the examiner and the applicant's A1046, which I think illustrates precisely where this was going. You'll see that page, it's under, first is a head and a head and a head and a head and a middle page, there is a description of Hane's. Hane's discloses large diameter, i.e
. Let me just make one other comment about the cross appeal with regard to the mean diameter limitation. Here's what we can all agree on. Everyone agrees that there are lots of different times with me in diameter, and everyone agrees that the patent does what they say, which one of these times with me in diameter is what the district court did, so it says, as well, the discussion of Hane that took place in the prosecution history says, well, that sounds mean it should be volume mean diameter, or mass mean diameter, which mean the same thing. Now, that can't be squared with 37 CFR 157, 1.57D2, which requires essential material for establishing the definiteness of a patent claim to be incorporated by reference. There is no argument and no possible argument that Hane was incorporated by reference. In fact, would be strange indeed for them to have incorporated by reference the reference they were trying to distinguish for reference. I've left a minute and a half, and I'll return. Thank you. Your honor, I would like to refer the court to the next amendment, the next communication between the examiner and the applicant's A1046, which I think illustrates precisely where this was going. You'll see that page, it's under, first is a head and a head and a head and a head and a middle page, there is a description of Hane's. Hane's discloses large diameter, i.e. greater than 5 micron. Aristotle, Zybole, particles. Yes, and that's the paragraph that describes at your honor, and then below is where the distinction is made. The combination of design Hane's would not leave one skill in the art, and if you go, I won't read every word that you're honor, but most of those points that are made for the distinction is based on dissolution, and based on dissolution speed. It is clearly not based on size, and it's not based on whether there might be some coding there, which is your honor point out could be a coding that has no effect on the dissolution rate. So this is the way the file history goes about it. With respect to, with respect to the, whether this is bi-phasic or multi-phasic, example three makes very clear that this is a bi-phasic system. It talks about a 10 milliliter concentration that matrix is put in first, then the next is put into a 250 milliliter concentration of a aqueous medium. That's two phases, that's exactly what we have said throughout. As to the argument, my colleague said, I believe that there was an argument made to get over Hane's based on the fact, based on its size, and I think your honor might have been alluding to that when you point into the first line at A1046. Actually, there is no distinction based on size, and if A1021, the applicant specifically references the fact that there can be no distinction based on the size of the particles. At 1021, recognizes that the prior arts teaches that the drug formulation had a total particle size of less than five microns. That's what was claimed in the invention
. greater than 5 micron. Aristotle, Zybole, particles. Yes, and that's the paragraph that describes at your honor, and then below is where the distinction is made. The combination of design Hane's would not leave one skill in the art, and if you go, I won't read every word that you're honor, but most of those points that are made for the distinction is based on dissolution, and based on dissolution speed. It is clearly not based on size, and it's not based on whether there might be some coding there, which is your honor point out could be a coding that has no effect on the dissolution rate. So this is the way the file history goes about it. With respect to, with respect to the, whether this is bi-phasic or multi-phasic, example three makes very clear that this is a bi-phasic system. It talks about a 10 milliliter concentration that matrix is put in first, then the next is put into a 250 milliliter concentration of a aqueous medium. That's two phases, that's exactly what we have said throughout. As to the argument, my colleague said, I believe that there was an argument made to get over Hane's based on the fact, based on its size, and I think your honor might have been alluding to that when you point into the first line at A1046. Actually, there is no distinction based on size, and if A1021, the applicant specifically references the fact that there can be no distinction based on the size of the particles. At 1021, recognizes that the prior arts teaches that the drug formulation had a total particle size of less than five microns. That's what was claimed in the invention. So no distinction was being made that way, and the examiner didn't understand that that way. Brief ways to indefinite your NIS-Suron-R times up. That will be very brief on indefinite this year. Thank you. I expect to clarify, as my partner pointed out to me that when I refer to, in my discussion with Judge Chen, the test, I should have made clear that it was the test for determining whether the micro particles and nanoparticles had dissolved. That's what's in the example for other than that, I have nothing further. Thank you. Thank you, Council. Myter will stand submitted.
Today, Council, prepared to go forward. Please proceed. You through on party? Yes, Your Honor. May I please the Court? The District Court erudists is a construction of two significant claim terms. In each instance, the District Court red language into the terms that not only is not present in the claims, but is not present in the specification. Let me ask you a question, Mr. Frank. In the joint appendix at 1021, you distinguish the side of the patent-directed ebric chain on the basis that it discloses controlled, related to polymer and capsulated formulations. But in the red brief, Selgin says, Accusphere is attempting to read its claims on Selgin's X-brain product, a product that consists of the same album, Bumin, polymer and capsulated formulations that you disclose during prosecution. Why should we not find that you are disclamed? Well, first of all, the first part of what Your Honor was referring to is a non-infringent argument, and we're not at that point. We did not, this is on the of a tax-state point, Your Honor, and there was no disclaimer because the ultimate reason that the District Court, that the Examinor allowed the claims and the basis, the argument that we made the Examinor, was on the speed of the dissolution. Now, controlled release and coding of particle may in some instances have some impact on that. I can see that. But that doesn't mean that in every instance that the albumin coded particles or that a coded particle is going to have an impact on the release rate, the dissolution release rate. I mean, I suppose we could quibble about to what extent the Examinor relied on this particular distinction. But nevertheless, it is true that your client made these statements in the prosecution history. And I think the law is that any statements you make in the prosecution history as to what is the best understanding of the claim count and should be understood in terms of trying to find the best understanding of the claim. 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 given taken back and forth between the applicant and the Examinor. And so it is difficult at times to discern a precise and a clear and unambiguous disclaimer. And in this case, there is no clear and unambiguous disclaimer of the control release or the coded particles. Because in this case, in this case, they go on the way the applicant went about his amendments in this case was to have a paragraph that would describe the prior art and then would have a paragraph that distinguishes it. The statements that Your Honor is referring to come from the description paragraph. And a description is not the same thing as a disclaimer. It is the next paragraph where the distinction is actually made and in that paragraph where the distinction is being made, the distinction is based on dissolution rate and not specifically on the point that Your Honor has referred to from. So when I guess it's that J.A. 1021, the applicant says, Haynes, and then says there are no nanoparticles nor is there a matrix formed of a hydrophilic recipient that dissolves upon contact with water to release nanoparticles and micro particles of the taxing. To me, the context is clear that the applicant is setting up a strong distinction between how it understands Haynes and likewise how it understands what's doing with its amendment. 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. And in that paragraph, the applicant makes very clear that no distinction is being made based on the size of the particles in Haynes and dissi as opposed to the invention. It specifically concedes that those references cover particles that are less than five microns in size. And so what the distinction was being made on with the patent office at that point in time was not a size. Are we flipping over to particle size now? I'm sorry, I showed your honor. I thought that's where you were going with that. I'm sorry, I was Judge Wallick led off with our right into taxane only. So I meant to try to stay there and I understood this portion of the prosecution history where the applicant was distinguishing its claim from Haynes and dissi. And as I read this excerpt on J.A. 1021, it really looks like the point to be made here is that you release taxane from the matrix. So whatever is in that matrix, the remainder of the matrix dissolves and goes away leaving you taxane, resulting in taxane and Haynes and dissi nevertheless doesn't work that way. That's what I get from this portion. 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, which one? Accordingly or the accordingly paragraph at 81021. Farther down the paragraph, they say the distinction is that there is no immediate release upon dissolution of this rounding matrix that is taught in the dissi and Haynes references. And the patent examiner goes on to say, in fact in the notice of allowance when the patent examiner allows the patent, it's on the basis of the different dissolutionary. It's not on the basis of the size or on the basis of purity of particles. It's on the basis of the dissolution rate. And that's what the invention was. That's what they were telling what the applicant was telling the examiner the invention was during that period of time. So not the very end of 1021. I guess it's not a formulation having dispersed there in nanoparticles and micro particles of a drug released immediately upon dissolution of the surrounding matrix. Again, doesn't that reinforce the idea that these particles and these particles alone of taxing get freed up? It does add there's no question that the particles of taxing leave the matrix and get freed up. Where is an issue between the parties about whether it's only the taxing particles that get freed up, which your honor I'm sure is aware of, but I'll pass that for right now. There's no question that that is the heart of the invention that that makes for dissolution rates to happen quicker. But the question I think your honor is asking me is did that 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 an instant instruction. And there is nothing like that that is given up in this statement. The term the claim was defined as being essentially pure taxing, formed of only taxing, essentially pure taxing. 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. It sure seems to say that the other step goes away. Well it says that it says and that's how it distinguishes. It distinguishes it by saying that there's a matrix and based on the use of that matrix you get a faster dissolution rate. It doesn't. It never says that everything goes away other than the taxing and in fact that's contrary to what the specification of the patent actually says. The specification of the patent says that you can have insoluble components that will be mixed in with the taxing. So those by definition wouldn't go away when you expose them to the equates media. So that would be contrary to the way the invention is defined in the specification itself. There is nothing about purity of taxing or taxing being the only thing that's predisposed. But I guess we can all agree that both Haines and Decy have some kind of encapsulation of the taxing. That there's a surfact into something that's surrounding the taxing particles. There by leading to some kind of controlled release formulation. And now the applicant's goal here is to get away from Haines and Decy and distinguish over it the best way it thought it could. And the way that they ultimately did and so you're now saying whatever they gave up they didn't give up a version of taxing that still could be encapsulated by something but still somehow never left be a faster dissolution than the controlled dissolution of Haines and Decy. Yes and in fact that's the point. Do you understand why you're asking me to read something extra into the actual text of the prosecution history? Well I don't believe so you're honored because what it says is it describes Haines and Decy. I think Decy in particular is what your honors are referring to. Decy with control release and caps I've now lost the word but I believe it says encapsulated particles. And then goes on to say that the key fact is that it leads to dissolution faster dissolution in our product. The use of the matrix leads to faster dissolution and in fact in the specification of the patent it actually contemplates the use of particles that are coded. Pegalated de-cipients are specifically disclosed in the patent. How do we know what pegalated de-cipients mean? Well I understand it that wasn't something that was debated evaluated. The experts did any treatment on below. Is that fair to say? It was not discussed below. It's not a waiver because it's not a different issue. It still goes to the same issue that we're talking about here which is the property. I understand but I don't know what pegalated de-cipient mean. And your honors... Right, it seems like you think you know what pegalated de-cipient means but it's just you unfortunately. Well but I point to the specification your honor at column five lines 52 to 62 where it's discussed and it says pegalated de-cipients are recipients that envelop the taxing. And so that by its nature means that you're talking about something other than just a pure taxing. You're talking about something that envelops the taxing. So the fact that there is some kind of coded particle is not the basis for the distinct standard. The ultimate basis for the distinction is how fast it dissolves. 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. I'm sorry. Mr. Lambert, you're well within your rebuttal time. Do you want to devote any of your remaining three minutes to your tiny problem? To my your nanoversus micro. I'll just say I will just say that I think that the term is defined right there in the claims. The nanoparticles in my particle particles are set forth as being in a certain range. You say you're arguing is there's no universally accepted definition. And that's what the court found as well. And I tried. I'd say that. But the judge did say that there was a definition. It's not just one that was universally accepted. Yeah, he found a definition, but he made that definition based on an unfortunate misunderstanding of the record. He thought that the inventor had written a particular chapter of a book that defines the term that ends up being not not true. And I will reserve your major of my time. Thank you. Good morning, Your Honours and May it please the court. There's much to say about the language of the claims here. We've said it in our brief. The I'll start with the nanoparticles issue and then turn to the other taxing issue. If you look at the claim language here, the nanoparticles and micro particles language shows up in the first clause as one or as two of the four components of the matrix. It then shows up again with an end. I'm sorry. With an end as two different things. Yes, and it's two different things. And in Judge Wallach, you started the argument with the place that we could end the argument and that is the page 81021 of the record. If you look in that first paragraph where the applicant is talking about Haynes, they tell the world that Haynes is formed into micro particles by spray drying periods. There are no nanoparticles. What the applicant is telling the world here is that there are two different things. There is something called a micro particle and there is something called a nanoparticle. That cannot be reconciled with the position being brought here today by my friend on the other side. That is that they all mean something that's moshed together. It just means particles. If you take my friend's construction and apply it to the claim, what you really have would be a claim to say, the particle of a taxing, having these particular measurements that do not know what the claim says. Wherein clauses are supposed to bring further definition, they don't substitute for the separate clause. I think one of their arguments though is that the specification appears to use the term micro particles interchangeably with the term nanoparticles and micro particles 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. We're just talking about really small particles that have this particular mean diameter range. There's no question that that is the limitation of the claim, but it's not the only limitation of the claim. If we're talking about what my friend has referred to in his briefs as the leclicography argument. Let's again step back and keep in mind that this court's precedent says that leclicography has to be what? It has to be, excuse me, clear. It has to be unmistakable. It has to be unquivocal. What you see in the specification is anything from that. For one, they did define terms in the specification. They defined two terms in particular, sprayed rye and patient. They did that in an ordinary definition mode. They said, as used here is, this is at the top of column 8 and 841, and the bottom of that same column on page 841. They didn't do that with nanoparticles and micro particles. In fact, the specification and the claim language are somewhat inconsistent because there's a place in the specification where they look to for their so-called definition that refers only to micro particles and they do not mention at all of nanoparticles. I guess that's they use that and rely on that to suggest that the terms micro particles and nanoparticles and micro particles are essentially the same thing. I think what thematically, that's what they're targeting throughout. What they're doing is they're lying on the fact that they were claim drafting and patent drafting, was left ambiguities and had some, as the district court mentioned, some inexplicable floppyness in terms of when they added nanoparticles to the claims, the insurgent nanoparticles in some places that not in others would have made sense. And certainly in the specification, that's not the way that the claims originally were. The claims did not include a nanoparticle limitation, but they had to add it in order to make the argument that they did at page A21 to get overhanged. 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. And there's another thing that's unclear about their lexicography. They take the wherein flux, which has both a mean diameter limitation and a total surface area limitation. And they decide, well, we're going to take half that. We're going to cherry pit that first half and say, well, that's our definition. But it doesn't take into account of all the surface area apartments. And that's not the sort of clarity and definitiveness that for an implied definition, one cell of lantic, you'd have. What are we supposed to make of dependent claim six? Is it your view that dependent claim six is invalid? Well, we haven't asserted in validity defense in this appeal with regard to driving the case. But it's following through on the logic of your position. What does that do to claim six? Why do claim six have some indefinite problems? I have no doubt about that. One of the problems with it, of course, is that it doesn't use the nanoparticles and micro particles when you would expect it in ordinary usage to have nanoparticles in there. The other is, of course, indefinite problem that we come to with regard to our cross appeal, having to do with the whole question of what does mean diameter and how to measure it. In any of that, the claim six arguments isn't really a pure claim differentiation argument that most their argument is, but there might be some under-tubberage at the lower level from 0.5 on, microns to one micron. 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. It's an estimation that takes place with a machine that may be analyzed using optical scanning and using calculations that are beyond my modest level of skill in this art. But the fact of the matter is that this is a desperate effort to say, well, mean here, just means average, and you can just figure out that that's inconsistent with that. And with when the score tolerates overlap, like that, it's sometimes even tolerates complete overlap and claim differentiation that the language allows for that, and that's what the language here does. With regard to the other tax-thing limitation, if I could turn to that, the language is in the claim again. It's other tax-thing. Shrith Wollock said earlier in the colloquial group, 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. It's other tax-thing. It doesn't say, and this is important, substantially of a tax-thing. It doesn't say mostly of a tax-thing. It doesn't say a majority tax-thing. It's a tax-thing. I think the claim language itself is still open. This is the word comprising. So I don't necessarily see in just the claim language by itself in isolation. The conclusion of the tax-thing also being attached to something else is so long as the hydrophilic recipient and the wedding agent have been now separated and dissolved. Well, it's certainly true that it is a part of the composition comprising. But it is comprising a matrix. And then the matrix is comprising these four distinct elements. And one of them is of a tax-thing. And what is our nanoparticles for tax-thing? And microparticles of a tax-thing. Now, being an open claim doesn't mean that you can add something else to that tax-thing and still have it be of a tax-thing. If it were an open claim as the district court used the term un-dip, which I thought was a pretty interesting and useful way of thinking about how comprising my work in this claim. Does this un-dip of a tax-thing so that the microparticles and nanoparticles can be made of something else entirely in addition to tax-thing? No, what the comprising claim does, assuming even assuming that it's un-diped all the way down there. If it allows you to add a fourth element of the fourth limitation. So maybe the matrix is open that it has to have these four things, the hydrophilic recipient, the wedding agent, nanoparticles and microparticles. But it might also have some other exhibit. It's like a regulated exhibit, like the regulated exhibit that we were never able to develop the argument on in the trial court. What's your understanding of the regulated exhibit that surrounds the tax-thing particles? Well, it's hard to square with this patent, honestly. If it is indeed surrounding the tax-thing particles. Apparently, you could still potentially get a faster dissolution rate. So long, you could get a tax-thing particles are surrounded by something on a regulated exhibit that permits a faster dissolution. So the other way you could get a faster dissolution rate. Excuse me. However, here's what the language of the claim says. It says, it's artificially enveloped or shields the pack of tax from macrophage uptake. Now, as I understand it, a macrophage is a white blood cell that eats cellulose litter debris. And this is to keep those white cells in some fashion or another from eating the cellulose litter debris. Here's the problem with that. It actually keeps George Chen right into our indefinite mass argument with regard to this situation. Our friends, in their briefs, both in their opening brief of page 7 and their reply brief of page 52 and 53, show you the schematics that shows this bi-pathic dissolution. Well, the second speaker, 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 injected into an IV solution, an IV bag, say. That second solution shows the aqua-tactyl in solution. It's already dissolved. It's hard to see if there's a bi-pathic solution. How in the body this could guard those now-in-solution, now-aparticles, microparticles, whatever form they're in at that point, once they're now in solution. And of course, the problem, and let me just turn to indefiniteness to try to help answer this question. The basic indefiniteness problem we have with this is that let's assume, for sake of our arguments, that my friend is right, but the claim can be read to require the bi-pathic dissolution where the matrix dissolves first, and then there's a second dissolution where the nanoparticles, the microparticles go into solution. That's all well and good except that example 3 is the patent. Doesn't tell you that at point to exactly the opposite direction. Example 3 is describing a modified dissolution, a modified dissolution, excuse me. And even their own doctor langers said, that's what happens. It measures the example 3 is the test, and it measures when the taxing goes into solution and that's a page A3173 to A3175 of the record. So what you've got is at fast, giving my friend's claim instruction argument that I've been in the doubt, he said, it's claiming a bi-pathic dissolution. You've got example 3 that says it's a plain modified dissolution, which do we rely on? We don't know. We can't tell that in a definite, particularly after the law. You're in your cross appeal time, but 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. Let me just make one other comment about the cross appeal with regard to the mean diameter limitation. Here's what we can all agree on. Everyone agrees that there are lots of different times with me in diameter, and everyone agrees that the patent does what they say, which one of these times with me in diameter is what the district court did, so it says, as well, the discussion of Hane that took place in the prosecution history says, well, that sounds mean it should be volume mean diameter, or mass mean diameter, which mean the same thing. Now, that can't be squared with 37 CFR 157, 1.57D2, which requires essential material for establishing the definiteness of a patent claim to be incorporated by reference. There is no argument and no possible argument that Hane was incorporated by reference. In fact, would be strange indeed for them to have incorporated by reference the reference they were trying to distinguish for reference. I've left a minute and a half, and I'll return. Thank you. Your honor, I would like to refer the court to the next amendment, the next communication between the examiner and the applicant's A1046, which I think illustrates precisely where this was going. You'll see that page, it's under, first is a head and a head and a head and a head and a middle page, there is a description of Hane's. Hane's discloses large diameter, i.e. greater than 5 micron. Aristotle, Zybole, particles. Yes, and that's the paragraph that describes at your honor, and then below is where the distinction is made. The combination of design Hane's would not leave one skill in the art, and if you go, I won't read every word that you're honor, but most of those points that are made for the distinction is based on dissolution, and based on dissolution speed. It is clearly not based on size, and it's not based on whether there might be some coding there, which is your honor point out could be a coding that has no effect on the dissolution rate. So this is the way the file history goes about it. With respect to, with respect to the, whether this is bi-phasic or multi-phasic, example three makes very clear that this is a bi-phasic system. It talks about a 10 milliliter concentration that matrix is put in first, then the next is put into a 250 milliliter concentration of a aqueous medium. That's two phases, that's exactly what we have said throughout. As to the argument, my colleague said, I believe that there was an argument made to get over Hane's based on the fact, based on its size, and I think your honor might have been alluding to that when you point into the first line at A1046. Actually, there is no distinction based on size, and if A1021, the applicant specifically references the fact that there can be no distinction based on the size of the particles. At 1021, recognizes that the prior arts teaches that the drug formulation had a total particle size of less than five microns. That's what was claimed in the invention. So no distinction was being made that way, and the examiner didn't understand that that way. Brief ways to indefinite your NIS-Suron-R times up. That will be very brief on indefinite this year. Thank you. I expect to clarify, as my partner pointed out to me that when I refer to, in my discussion with Judge Chen, the test, I should have made clear that it was the test for determining whether the micro particles and nanoparticles had dissolved. That's what's in the example for other than that, I have nothing further. Thank you. Thank you, Council. Myter will stand submitted