[00:00:27] Speaker 00: May I please the court, Arlene Chao from Hogan Levels on behalf of Takeda. [00:00:32] Speaker 00: The intrinsic evidence does not support the district court's extraneous limitation that the entericote and sustained release agents must be chemically distinct. [00:00:42] Speaker 00: Let's first take the plain and ordinary meaning of the claim. [00:00:46] Speaker 00: It's clear. [00:00:47] Speaker 00: It does not require chemical distinctness. [00:00:50] Speaker 00: The claim recites two distinct components, but does not specify how the components are distinct. [00:00:57] Speaker 00: We submit that the court improperly conflated distinctness with chemical distinctness. [00:01:03] Speaker 00: There are different types of distinctness. [00:01:05] Speaker 00: What distinctness do you think the claim refers to? [00:01:09] Speaker 00: The claim is silent, and it captures all forms of distinctness. [00:01:12] Speaker 00: And in our briefs, we identified both physical and chemical distinctness. [00:01:16] Speaker 00: There certainly was no need, given the clear language, to import the requirement that that distinctness must be chemical. [00:01:25] Speaker 00: especially when there are different forms of distinctness, including physical distinctness, Your Honor. [00:01:31] Speaker 00: And Your Honor, so two components, they can be chemically the same and yet can be physically distinct. [00:01:37] Speaker 00: And the specification does not contradict the very clear claim language on this point. [00:01:43] Speaker 00: There's no definition. [00:01:45] Speaker 02: The claim language is hardly clear when it uses the word component as to whether that's a separate physical component or a distinct chemical component, right? [00:01:54] Speaker 00: Your Honor, the use of the term component goes to the fact that the two components are distinct. [00:01:59] Speaker 02: They said it was clear. [00:02:00] Speaker 02: I don't understand how you can argue that it's clear. [00:02:04] Speaker 00: Your Honor, there's no distinction being made between physical and chemical distinction. [00:02:12] Speaker 00: The use of the two components is referring to the enteric coding agent and the sustained release agent. [00:02:17] Speaker 00: And we do agree that they are distinct. [00:02:20] Speaker 00: But that does not necessarily mean that they are chemically distinct. [00:02:23] Speaker 00: which is what the district. [00:02:24] Speaker 01: In the specification, I didn't see any example in which the components were the same. [00:02:31] Speaker 01: Did I miss it? [00:02:34] Speaker 00: Your Honor. [00:02:34] Speaker 01: In terms of clarity or what one would ordinarily draw from the specification. [00:02:40] Speaker 00: So, Your Honor, the specification in referring persons of skill in the art to the enteric coding agents and the sustained release agents stated that they can both be methacrylic copolymers. [00:02:51] Speaker 00: And that is at column nine. [00:02:53] Speaker 02: But then it describes different copolymers, right? [00:02:58] Speaker 00: Your Honor, yes, but Your Honor, Your Honor, they are non-limiting. [00:03:02] Speaker 00: The examples are only, the list of enteric coding agents is the same. [00:03:06] Speaker 02: Well, I think Judge Newman's question was whether it ever shows using the same one, and the answer is no, it doesn't, right? [00:03:11] Speaker 00: But it does refer your, it does not specifically cite the specific copolymer as falling into both camps. [00:03:17] Speaker 00: However, persons of skill in the art, as made clear by the Eugerjet L30D55, [00:03:22] Speaker 00: would understand that there are methacrylate copolymers that fall in both camps. [00:03:27] Speaker 00: And there are sites within the record directly tailored towards oidrajet L30D55, which is a methacrylate copolymer. [00:03:35] Speaker 00: So from the perspective of a person of skill and ordinary skill in the art, they would understand that context matters. [00:03:42] Speaker 00: And the specification itself states that the enteric coding agents and sustain release agents can both be methacrylate copolymers. [00:03:50] Speaker 00: Sun must resort to the extrinsic evidence. [00:03:52] Speaker 00: must resort to the extrinsic evidence in order to undermine what is taught by the specification. [00:03:58] Speaker 02: The specification doesn't teach that component means physically separate, right? [00:04:04] Speaker 00: Nor does it teach that it's chemically separate. [00:04:07] Speaker 02: The answer is it does not teach that component means physically separate, right? [00:04:11] Speaker 00: It's silent on the issue, Your Honor. [00:04:13] Speaker 00: However, the claim is directed to two distinct components, Your Honor. [00:04:20] Speaker 00: Cornstarch, which was the cooking analogy, the direct correlation is shellac. [00:04:24] Speaker 00: Shellac, which is a very common pharmaceutical formulation, it's undisputed, is known by persons of skill in the art to be both enteric coding agents and sustained release agents. [00:04:34] Speaker 00: Lieberman, which is Sun's own treatise, which they cited as authoritative, stands for that proposition. [00:04:40] Speaker 00: It is cited as both an enteric coding agent and a sustained release agent. [00:04:44] Speaker 00: And your honor, this particular excipient is one of the most widely used excipients in pharmaceutical formulation. [00:04:50] Speaker 00: And the same also holds true with eutrogen L30D55, which is the specific excipient that Sun uses in its formulation. [00:04:58] Speaker 00: Persons of skill, it's known. [00:04:59] Speaker 00: I think the record is really replete with this knowledge of persons of skill in the art, that excipients, it matters what the context is, how it's being used. [00:05:09] Speaker 00: Now, the prosecution history doesn't contradict what we submit as the clear claim language. [00:05:16] Speaker 00: There was no clear and unmistakable disclaimer or disavowal as to chemical distinctness. [00:05:21] Speaker 00: Chemical distinctness was not discussed during prosecution. [00:05:25] Speaker 00: Neither the examiner nor Takeda stated that the enteric coding agents and the sustained release agents must be chemically distinct. [00:05:34] Speaker 00: Given the fact that the claim is very clearly just directing [00:05:38] Speaker 00: persons of skill and the art to the tarot-coding agent and the sustained-release agent, there is nothing in either the specification or the prosecution history that would require importing in the limitation that they must be technically distinct. [00:05:53] Speaker 02: We've got a potentially ambiguous term here that doesn't have to be a disclaimer to use specification to construe the term. [00:06:03] Speaker 00: Your Honor, we submit that the term is not ambiguous. [00:06:06] Speaker 00: It is very clear, and yet there is... How can a component be clear? [00:06:10] Speaker 00: A component is referring to the two different agents, enteric coding agents and sustained release agents. [00:06:15] Speaker 00: It's not stating that they must be chemically distinct. [00:06:18] Speaker 00: So I think the claim in and of itself is saying that there's two different things. [00:06:22] Speaker 00: And we're not walking away from that, Your Honor. [00:06:24] Speaker 00: However, the question is whether or not they must be chemically distinct, which is an additional requirement placed on top [00:06:31] Speaker 00: of the very clean language that is before the court today. [00:06:36] Speaker 00: And indeed, as I was stating, the examiner and Takeda, the point was not made. [00:06:44] Speaker 00: The argument was not raised that the two agents had to be chemically distinct. [00:06:50] Speaker 00: In terms of the prosecution history in relation to the 212 prior art reference, Takeda only stressed [00:06:59] Speaker 00: that there was no sustained release agent present. [00:07:02] Speaker 00: But they did not say anything about chemical distinctness, and nor did Takeda state that the oid-rigid L30D55, that it could not be a sustained release agent for the purposes of the patent, which would have been a very broad disclaimer, as opposed to just saying that in relation to the prior art, the oid-rigid was not behaving as a sustained release agent. [00:07:26] Speaker 00: There's really a question here of scope. [00:07:29] Speaker 00: And so, Your Honor, in terms of the extrinsic evidence standing for the proposition, again, I would just, again, cite to Shellac and the eutrogen L30D55 for the proposition that persons of skill in the art do understand that a particular chemical, a particular chemical component, depending on the context in which it's being used, can have two very different functions, both the [00:07:57] Speaker 00: our experts agreed on that point. [00:08:00] Speaker 00: And indeed, I think it's just understood as referred to by Sun's own authoritative treatise. [00:08:06] Speaker 00: This is something that really is consistent with our position as to the claim, the specification, and the prosecution history. [00:08:16] Speaker 00: In terms of the 212 reference, [00:08:23] Speaker 00: Actually, in terms of sun's formulation, I would like to stress this in terms of context. [00:08:28] Speaker 00: There are two distinct layers within sun's formulation. [00:08:33] Speaker 00: And I do want to stress that although there is an oedra that is appearing in both layers, the chemical composition... What does it take to be a separate component under your view? [00:08:43] Speaker 02: If you have a substance which acts both as an enteric coating layer and as a sustained release agent, [00:08:53] Speaker 02: and you put some of that in the pill or whatever it is, is that sufficient? [00:09:05] Speaker 00: So, Your Honor, the sustained release agent in the context of this invention is made clear by the Shimizu Declaration. [00:09:12] Speaker 00: It serves the purpose of... No, I don't think you're answering my question. [00:09:15] Speaker 02: My question is, you've got this compound in the pill. [00:09:22] Speaker 02: Yes. [00:09:23] Speaker 02: and it's just all mushed together. [00:09:27] Speaker 02: And because it, are you saying that because it acts both as an interior coating layer and as a sustained release agent, that it satisfies the claim? [00:09:38] Speaker 00: It does if they're in two different layers by way of example. [00:09:40] Speaker 02: It has to be two different layers? [00:09:42] Speaker 00: Yes, Your Honor. [00:09:42] Speaker 00: So that, a good example. [00:09:44] Speaker 00: Well, Your Honor, if you're doing an infringement analysis, and I will just take Sun's particular formulation as an example. [00:09:52] Speaker 00: There are two different enteric coding layers. [00:09:54] Speaker 02: How do we know it has to be two different layers? [00:09:56] Speaker 00: Your Honor, it can be plural. [00:09:58] Speaker 00: The specification allows for plural enteric coding layers as taught in column 16 of the patent. [00:10:04] Speaker 00: And that is undisputed by the parties, that the enteric coding layer can be plural. [00:10:08] Speaker 00: Now, in the context of the specific chemical. [00:10:11] Speaker 02: So it's all in a single layer. [00:10:12] Speaker 02: There's no infringement. [00:10:16] Speaker 00: So in the context of where there's... Wait, wait, try to answer my question. [00:10:19] Speaker 00: I will, Your Honor. [00:10:20] Speaker 00: If there's a single layer, a single chemical component, and you cannot distinguish its functions within that layer, there is no infringement. [00:10:26] Speaker 02: Well, suppose you can distinguish the functions. [00:10:28] Speaker 02: There's a single layer, but the thing acts both as an enteric coating agent and as the same release agent. [00:10:35] Speaker 02: Is there infringement or not? [00:10:37] Speaker 00: Only in the context where you would find that there's a distinct behavior by the chemical. [00:10:41] Speaker 00: I would submit that typically that would not be the case, Your Honor. [00:10:44] Speaker 02: So the answer is it could infringe? [00:10:47] Speaker 00: I find it unlikely. [00:10:47] Speaker 02: It's proclaiming both functions, but it's in a single layer. [00:10:50] Speaker 02: It could infringe. [00:10:51] Speaker 00: I say no, Your Honor. [00:10:52] Speaker 00: No. [00:10:53] Speaker 00: I'd say that what we would say is that there needs to be typically distinct layers. [00:10:57] Speaker 00: And in the context of distinct layers, you can point to the component. [00:11:00] Speaker 00: And in one layer, it's behaving as an enteric coding agent. [00:11:03] Speaker 00: In another layer, it's behaving as a sustained release agent. [00:11:05] Speaker 00: That works. [00:11:06] Speaker 00: If I could just return to Sun's formulation, because it would give some concrete context to this argument, Your Honor. [00:11:11] Speaker 00: The enteric coding layers are distinct. [00:11:13] Speaker 00: There are different amounts of eudrigets in both layers. [00:11:15] Speaker 00: The recipe for each layer, in instance sun's enteric coating agent, are different. [00:11:20] Speaker 00: There's two different recipes. [00:11:22] Speaker 00: One recipe with a substantial amount of eudriget and other excipients, which are different from the recipe for the second enteric coating layer, which has substantially less eudrigent and a different excipient mix. [00:11:35] Speaker 00: There, in that situation, same chemical, two different layers, behaving very differently, chemically distinct enteric coating layers. [00:11:43] Speaker 00: So, Your Honor, yes, in a situation where there is a single layer and there's a single eutrogen, and we can't distinguish what their behavior is, we would submit there is no infringement, yes. [00:11:54] Speaker 00: However, in this particular situation, where you have two distinct layers with two distinct chemical compositions, that's different. [00:12:02] Speaker 00: That's where we say that's different, Your Honor. [00:12:03] Speaker 00: So there, in our view, given the clear claim language saying that there must be an enteric coding agent and a sustained release agent in view of the specification, [00:12:13] Speaker 00: allowing for multiple enteric coding layers, we would say that that proclaim is being practiced, because there are chemical distinctions between the enteric coding layers. [00:12:24] Speaker 00: They're multiple, but they are not the same. [00:12:26] Speaker 00: They're behaving differently, Your Honor, and their makeup is different. [00:12:30] Speaker 00: One layer is very distinct from the other. [00:12:34] Speaker 00: Thank you. [00:12:46] Speaker 03: Good morning, Your Honors. [00:12:47] Speaker 03: Mark Schuman, representing the Sun at Belize. [00:12:51] Speaker 02: I don't want to take up too much of your time on this, but I find your confidentiality markings in your brief to be astonishing. [00:12:59] Speaker 02: I mean, you know, for example, on page six, you say, Decada needs the, and then you blank out and tear a coating agent, and then you block out sustained release agent. [00:13:09] Speaker 02: That's just a description of what's required. [00:13:11] Speaker 02: How could that, how could you mark that as confidential? [00:13:14] Speaker 03: What we're trying to do is prevent it as [00:13:16] Speaker 03: description or we have a certain component used for two different layers in our product. [00:13:22] Speaker 02: Look, that's what the whole argument is about here and you're marking it as confidential. [00:13:27] Speaker 02: It's ridiculous. [00:13:28] Speaker 03: We're trying to prevent our competitors from figuring out how we're doing our product. [00:13:31] Speaker 03: It doesn't describe your product, it describes what the claim requires. [00:13:34] Speaker 03: By understanding the argument that we're making you can understand. [00:13:37] Speaker 02: No, you're describing on this page what the claim requires and you're marking it as confidential. [00:13:43] Speaker 02: You cannot do that. [00:13:45] Speaker 03: I apologize, Your Honor. [00:13:47] Speaker 03: I do believe in my heart that you can read these briefs and understand what our product is if you understand what these two components are. [00:13:56] Speaker 02: I'm not saying there aren't some confidentiality markings here which are appropriate, but there are others which make no sense and are simply a description of the legal issue that's involved here. [00:14:10] Speaker 03: I apologize, Your Honor. [00:14:11] Speaker 03: I truly believe [00:14:13] Speaker 03: And I'm sorry that we disagree on that. [00:14:16] Speaker 03: And I'll try to do better in the future. [00:14:19] Speaker 03: Now, if I am right, Your Honor, I think that we talked about in the first talk with my friend here about the specification a little bit. [00:14:30] Speaker 03: And I'd like to turn to the prosecution history, if I could, because I think that's really where things crystallize for us as far as these two distinct components are concerned. [00:14:41] Speaker 03: There are, as you pointed out earlier, there are examples in the specification. [00:14:47] Speaker 03: There are descriptions at column nine of these excipients. [00:14:51] Speaker 03: And they don't overlap. [00:14:53] Speaker 03: But I think if you go to the prosecution history, that's really where one skill in the arts starts to get a crystallization, an understanding of what's happening and what this invention's all about. [00:15:04] Speaker 03: You heard my friend tell you that the function of the sustained release agent is to cushion. [00:15:10] Speaker 03: Now, if you read the patent, the 994 specification, you will not see a description in that specification of cushioning. [00:15:22] Speaker 03: Nowhere is the function of a sustained release agent described to one skilled in the art. [00:15:30] Speaker 03: You would think as one skilled in the art that a sustained release agent is going to function [00:15:35] Speaker 03: to sustain the release of the drug. [00:15:37] Speaker 03: That's typically what one skilled in the art thinks about when they think about a sustained release drug. [00:15:42] Speaker 03: It doesn't do that in this invention. [00:15:44] Speaker 03: It actually does something completely different, and the specification doesn't tell us that. [00:15:50] Speaker 01: I agree with that reading. [00:15:51] Speaker 01: At the same time, apparently there are two layers applied. [00:15:56] Speaker 01: What is the reason for using two layers? [00:15:59] Speaker 03: The two layers, typically these are very small, as I understand it. [00:16:03] Speaker 03: And it's hard to get a complete coating because of surface tension on these very small beads. [00:16:09] Speaker 03: So often you have to coat them twice. [00:16:12] Speaker 03: But you'll see in the patent, for instance, at example eight, you'll see whenever they coat them twice, they still use a two-component system where they have the sustained release agent and the enteric coating agent because they need to have that cushioning effect on that second coating. [00:16:31] Speaker 03: what they're trying to do is get a complete coating because you may get some air, not bubbles, but you may get some surface tension that creates an incomplete coating. [00:16:39] Speaker 03: So you want to coat it twice to get that coating on these very small beads. [00:16:44] Speaker 01: But you still have to dissolve the enteric coating after it passes through the stomach. [00:16:49] Speaker 01: Correct. [00:16:49] Speaker 01: And you still need some sort of surfactant or whatever, water soluble component. [00:16:56] Speaker 01: Exactly. [00:16:58] Speaker 01: It can't really be the same product. [00:17:00] Speaker 01: So it must be the additives. [00:17:02] Speaker 03: It's right. [00:17:02] Speaker 03: It's the additives. [00:17:03] Speaker 03: It's a sustain release product that's giving that cushion to the enteric coating product. [00:17:12] Speaker 03: Because the enteric coating agent is brittle. [00:17:16] Speaker 03: And it will crack if it's compressed. [00:17:19] Speaker 03: And so what they're doing is they're putting in the sustain release agent to give it some compressibility. [00:17:25] Speaker 03: But the specification doesn't tell us that. [00:17:27] Speaker 03: One skilled in the art doesn't recognize that really until you get into the prosecution history and you see what happens in the Shimizu Declaration, that 132 declaration that they put in during the prosecution. [00:17:39] Speaker 03: There, what they do is they compare the prior art in the Shimizu 122 European application to the claimed invention. [00:17:51] Speaker 03: And what they do is they say the prior art has a one-component layer. [00:17:57] Speaker 03: L30D55 enteric coat. [00:18:02] Speaker 03: And our invention has two components. [00:18:04] Speaker 03: It has L30D55 and N30D. [00:18:08] Speaker 03: And they compare the two in the Shimizu Declaration. [00:18:11] Speaker 03: And they conclude that their system has better acid resistance and better, they have another property, but it's all related to whether it cracks or not in the compression of the tablet. [00:18:27] Speaker 03: And they conclude that they get a better tablet. [00:18:29] Speaker 03: And one skilled in the art then begins to realize that what's happening here is it's not the sustained release aspect of this excipient, but it's this compressibility. [00:18:40] Speaker 03: And that's what's happening. [00:18:41] Speaker 03: So the examiner then is, here's what I want to get into the prosecution. [00:18:44] Speaker 03: When faced with this amendment or this... This compressibility relates to the tableting, doesn't it? [00:18:50] Speaker 01: Doesn't it relate to anything else? [00:18:51] Speaker 03: That's right. [00:18:52] Speaker 03: It's solely to the tableting, not to the... [00:18:54] Speaker 03: Not to the dissolving of the tablet or anything of that nature at all. [00:18:59] Speaker 03: Whether it cracks when it's tableted. [00:19:01] Speaker 01: So how does that affect the water dispersion? [00:19:06] Speaker 03: It only affects it if there's a crack in the tablet, in the layer. [00:19:10] Speaker 03: When it goes into your stomach, then the stomach acid can find its way into the crack, which is not good. [00:19:16] Speaker 03: You want to have a layer that's not cracked. [00:19:19] Speaker 03: So one skilled in the art would understand that if the layer is not cracked, [00:19:24] Speaker 03: then it's good. [00:19:26] Speaker 03: And so this addition of the sustained release agent, suddenly the lightbulb should go on to one skilled in the art. [00:19:33] Speaker 03: And the examiner recognizes that. [00:19:35] Speaker 03: If you look at his rejection, he says, at appendix page 927, he says that that declaration is not commensurate in scope with the claims. [00:19:47] Speaker 03: They had very broad claims at this point. [00:19:49] Speaker 03: Basically, they just claimed an enteric-coded tablet [00:19:53] Speaker 03: with a sustained release component. [00:19:56] Speaker 03: So he says, the declaration is not commensurate in scope with the claims. [00:20:01] Speaker 03: Your claims are too broad. [00:20:03] Speaker 03: He says, while the claims are very generic, the declaration is directed to, and this is important, a specific tablet having a specific acid labile drug or a specific acid labile physiological active ingredient. [00:20:21] Speaker 03: Specific tablet. [00:20:22] Speaker 03: specific drug, essentially. [00:20:24] Speaker 03: There is no claim present that is the scope of applicant's declaration. [00:20:29] Speaker 03: Again, he's iterating, your claims are too broad, given your declaration. [00:20:34] Speaker 03: The degree of hardness and acid resistance have not been claimed. [00:20:38] Speaker 03: Again, your claims are too broad. [00:20:42] Speaker 03: He's telling them how to narrow them. [00:20:44] Speaker 03: Further, the prior art does recognize [00:20:49] Speaker 03: a degree of acid resistance, an applicant's declaration admits that the prior art does have a degree of hardness. [00:20:56] Speaker 03: Hence, you haven't shown any unexpected results of the prior art. [00:21:01] Speaker 03: So he identifies three things. [00:21:04] Speaker 03: He says, your claim is too broad, given your declaration. [00:21:08] Speaker 03: He says, you've shown me a specific tablet, a specific drug, and specific hardness. [00:21:17] Speaker 03: Your claim's too broad. [00:21:18] Speaker 03: He's telling them, narrow your claim to a specific tablet, a specific drug, and a specific hardness. [00:21:25] Speaker 03: So what do they do? [00:21:26] Speaker 03: It's exactly what they do. [00:21:31] Speaker 03: If you look at the next amendment, on page 8-933, they narrow the claim to Lanzarpazol, to a specific hardness, and to the language that's here on appeal. [00:21:42] Speaker 03: A first component comprising the sustained release agent and a second component comprising [00:21:49] Speaker 03: I had those reversed, sorry. [00:21:53] Speaker 03: They did that specifically because the examiner said your claims were too broad. [00:21:57] Speaker 03: You need to essentially write a picture claim to get these things allowed. [00:22:02] Speaker 03: You need to narrow it down. [00:22:04] Speaker 03: And the remarks they made to the patent office were telling. [00:22:09] Speaker 03: They said on page 935 of the appendix, for purposes of advancing this prosecution, [00:22:17] Speaker 03: In the present case, applicants have amended claim one without prejudice to filing future applications. [00:22:24] Speaker 03: And now they recite the limitations, et cetera, that I just mentioned. [00:22:27] Speaker 03: What are they saying to the patent office? [00:22:30] Speaker 03: We don't like it that you've made us narrow the claim, but we narrowed the claim down to get something from you. [00:22:38] Speaker 03: And without prejudice, we're going to come back and try to get broader claims. [00:22:42] Speaker 02: All of this is interesting, but really doesn't address [00:22:46] Speaker 02: the central claim construction issue here, which is whether it has to be chemically distinct. [00:22:53] Speaker 02: And in the prior ARB, is there a disclosure of using, for example, this Urajet L30D55 as both an enteric coating agent and a sustained release agent? [00:23:11] Speaker 03: I don't think it does, no, Judge. [00:23:13] Speaker 03: There's no evidence of that in the record. [00:23:15] Speaker 03: and in fact i do think this prosecution is very important to that because the how to get out of the prosecution chemical chemically distinct the declaration that they filed the shimizu declaration, the 132 declaration only had a chemically distinct second component that's all there was and the examiner required them to claim the specific tablet that was in that declaration and that's what they did they narrowed it down to a two-component tablet that's what they did [00:23:46] Speaker 03: The declaration that Shimizu put in was not a multi-layered tablet, such as we're hearing about today with the appellants. [00:23:55] Speaker 03: They didn't put a multi-layered tablet in. [00:23:57] Speaker 03: They put a two-component. [00:23:58] Speaker 03: Where does the declaration address this? [00:24:00] Speaker 03: It's the Shimizu Declaration. [00:24:02] Speaker 03: Let's look at it. [00:24:03] Speaker 03: It's starting about 893. [00:24:15] Speaker 03: have two examples, Judge. [00:24:18] Speaker 03: Example A starts on A, 894, which is the prior art. [00:24:24] Speaker 03: And then the example from the patent starts on 896. [00:24:33] Speaker 03: And in fact, you can actually see... How does this help you? [00:24:38] Speaker 02: Explain to me how this helps you. [00:24:40] Speaker 02: How this declaration helps you. [00:24:42] Speaker 03: Because what they did is they put in [00:24:44] Speaker 03: a one-component prior art system versus a two-component system from their patent. [00:24:50] Speaker 03: And they explained to the examiner that the addition of the second chemically distinct component made it patentable. [00:24:58] Speaker 03: And the examiner said, yes, you're right. [00:25:00] Speaker 02: Where do they say that in this declaration? [00:25:02] Speaker 03: They don't. [00:25:03] Speaker 03: It's what one skilled in the art would take from that. [00:25:06] Speaker 03: Who said that? [00:25:09] Speaker 03: The examiner. [00:25:11] Speaker 03: the examiner rejected them and said you have to know who said you're construing this declaration is saying something which you say isn't here explicitly though one skilled in the art would understand it okay who told us that that's what this declaration means let's let's look at piqueta's own expert and what he said about this declaration which the district court had in front of him he's one skilled in the art at appendix 158 [00:25:50] Speaker 03: And I'm looking at paragraph 22 of Takeda's own expert. [00:25:56] Speaker 03: Further, during the prosecution, one of the co-inventors of the 994 patent, Dr. Shimizu, submitted a declaration showing that a tablet according to the 994 patent with an enteric coding agent and a sustained release agent in the enteric coding layer was superior to a prior tablet with just an enteric coding agent in the coding layer. [00:26:19] Speaker 03: That doesn't say chemically distinct. [00:26:21] Speaker 03: That's what was in there. [00:26:22] Speaker 03: There weren't anything else but two separate chemically distinct chemicals. [00:26:30] Speaker 03: If you look at the last sentence of page 23, the last sentence of paragraph 23, based on the Shimizu Declaration, a person of ordinary skill in the art would understand the inclusion of a sustained release agent prevented the enteric coat. [00:26:44] Speaker 03: The word inclusion [00:26:47] Speaker 03: He has to be talking about something chemically different. [00:26:49] Speaker 03: That's what was done there. [00:26:52] Speaker 03: This is what one skilled in the art, their own expert, says about this. [00:26:57] Speaker 03: These are chemically distinct. [00:26:59] Speaker 03: These are two chemicals, if you look at the Shimizu Declaration. [00:27:03] Speaker 03: How can they not be anything different than that? [00:27:09] Speaker 03: When their own expert says the same thing about it. [00:27:13] Speaker 03: You're supposed to interpret the claims as one skilled in the art would look at them. [00:27:18] Speaker 03: and be informed by the prosecution history, be informed by what's in the specification. [00:27:25] Speaker 03: There's nothing that would ever tell you that two components should be separated in a layer, as they suggest now on appeal. [00:27:37] Speaker 03: Nothing. [00:27:38] Speaker 03: Whenever two components are separated in a layer, or there's two layers in their patent, there's always two components in each layer. [00:27:46] Speaker 03: There's just no suggestion at all. [00:27:48] Speaker 03: One skilled in the art would never have thought of that, not even their own expert. [00:27:54] Speaker 03: How can that be error for the district court to have interpreted the claim consistent with the way every other person in the art has interpreted these claims? [00:28:04] Speaker 03: I'm coming up on my closing, Your Honor. [00:28:06] Speaker 03: Thank you very much. [00:28:20] Speaker 00: Your Honor, counsel just mentioned that he believed that the record was silenced on whether or not OIDRGIT L30D55 is a sustained release agent. [00:28:30] Speaker 00: I thought I'd provide some sites for you. [00:28:33] Speaker 00: At the appendix 405, there's a 475 patent which is referring to OIDRGIT L30D55 as a sustained release agent. [00:28:44] Speaker 00: At Appendix 733, Yvonnek, a manufacturer of oidrigid L30D55, is identifying it in relation to that function. [00:28:53] Speaker 00: And then, of course, there's also our experts, both his deposition at 2437 and his declaration in 162, which stands for L30D55. [00:29:04] Speaker 00: It can be both an enteric coding agent as well as a sustained release agent, depending on the context. [00:29:10] Speaker 00: So, Your Honor, in terms of Takeda's expert's declaration and his testimony, it stands for L30D55 in the Shimizu Declaration in that context for the 212. [00:29:24] Speaker 00: It was behaving as an enteric coding agent, but that's distinct from whether or not Eudred at L30D55 in proper context in other applications [00:29:34] Speaker 00: can be used as a sustained release agent. [00:29:37] Speaker 00: And that's precisely what our expert stated in his deposition at Appendix 2437, page 216, lines 1 through 16. [00:29:45] Speaker 00: So we submit the record does stand for that proposition. [00:29:50] Speaker 00: And Your Honor had correctly pointed in relation to the prosecution history, I just wanted to stress that, again, Takeda said nothing about chemical distinctness. [00:30:01] Speaker 00: between the tariff coding agent and sustained release agent. [00:30:05] Speaker 00: I did listen and hear you say that and I just did want to stress that again in my remaining time, Your Honor, unless there's additional questions. [00:30:28] Speaker 02: The honorable court is adjourned until tomorrow morning at 10 a.m.