[00:00:01] Speaker 02: Final case today, 2017-1798, Sumitomo versus Emker. [00:00:22] Speaker 04: Mr. Hugh, please proceed. [00:00:23] Speaker 04: Good morning. [00:00:24] Speaker 04: May it please the court, Christopher Hugh, blank, Rome, for repellence. [00:00:27] Speaker 04: This appeal involves the interpretation of a single claim of a 372 patent suit. [00:00:33] Speaker 04: That claim is the only one asserted in this litigation. [00:00:36] Speaker 04: And to put it in context, it's one of 20 claims in the patent suit. [00:00:41] Speaker 04: Other claims, and it's very narrow. [00:00:42] Speaker 04: It's claim 14. [00:00:43] Speaker 04: The other claims in the patent, including claims 1, 6, and 11, are very broad. [00:00:49] Speaker 04: And conservatively, they cover more than 2 billion compounds. [00:00:53] Speaker 04: So broad statements in this patent about the scope of the invention [00:00:58] Speaker 04: as a whole, really have very little pertinence to the interpretation of claim 14. [00:01:06] Speaker 02: Here's the thing that I, admittedly a non-chemical loving person, had with this. [00:01:15] Speaker 02: Is this the R or the S enantiomer in claim 14? [00:01:18] Speaker 02: Which one is it? [00:01:19] Speaker 04: It's the minus, I believe. [00:01:21] Speaker 02: What does that correspond to? [00:01:23] Speaker 04: R or S? [00:01:24] Speaker 04: Is it the R? [00:01:26] Speaker 04: The patent doesn't use RNS. [00:01:28] Speaker 00: Is it the same as lorazodone? [00:01:31] Speaker 04: I believe it is. [00:01:32] Speaker 04: But that term doesn't appear in the patent because that's the commercial embodiment that came out years later. [00:01:37] Speaker 02: This is Latuda. [00:01:38] Speaker 02: We're talking about Latuda. [00:01:39] Speaker 02: Yes. [00:01:40] Speaker 02: So this is the negative enantiomer depicted here. [00:01:44] Speaker 02: There's no positive enantiomer depicted here, correct? [00:01:47] Speaker 01: That's correct. [00:01:49] Speaker 02: But nobody is arguing to me that this claim is limited to the negative enantiomer, which would, in fact, cover the infringing product. [00:01:56] Speaker 04: That's correct. [00:01:57] Speaker 04: That's a very, very critical admission by the other side, that it doesn't cover the negative enantiomer alone, which is the one depicted. [00:02:05] Speaker 04: And there's a reason for that. [00:02:06] Speaker 04: And the reason is that the specific intrinsic evidence for claim 14 is so strong that there's no way to say it only covers the negative enantiomer. [00:02:16] Speaker 00: In your intrinsic evidence, [00:02:18] Speaker 00: I understand you to be saying that one of ordinary scalene art looking at what's depicted in claim 14 would understand that that's one way to indicate a racemic mix. [00:02:28] Speaker 04: Well, yes, and not just in the art in general, but in this specific patent, that's exactly the way to go. [00:02:33] Speaker 00: Can we stick for a minute just to plain claim language and how one of ordinary scalene art would understand it, setting the specification aside for a minute. [00:02:44] Speaker 00: Okay. [00:02:45] Speaker 00: Okay. [00:02:45] Speaker 00: So you have some [00:02:47] Speaker 00: intrinsic evidence, I mean, extrinsic evidence. [00:02:50] Speaker 00: No, we have intrinsic evidence. [00:02:51] Speaker 00: Well, just for a minute. [00:02:52] Speaker 00: Just for a minute. [00:02:54] Speaker 00: I want to talk about what is depicted in claim 14, and I want to specifically ask you. [00:03:00] Speaker 00: I understand you're saying that one of ordinary skeletal and yard would understand that this would at least encompass a racemic mix. [00:03:09] Speaker 00: Do you agree that one of ordinary skeletal and yard, looking at this, what's depicted in claim 14, would understand that it also depicts the negative enantiomer? [00:03:17] Speaker 00: Not in line with the specification. [00:03:19] Speaker 00: I understand your position is that in line with the specification, it should be limited to the racemic mix of compound 101. [00:03:26] Speaker 00: But I'm asking you, just looking at the plain claim, looking at that structural compound depicted there, would one of ordinary scale in the art understand that that's one way to depict the negative enantiomer? [00:03:40] Speaker 04: The way you phrased it, the answer is yes. [00:03:42] Speaker 04: It could, but not in this patent because of the intrinsic evidence that relates specifically to the claim. [00:03:49] Speaker 04: The answer is absolutely yes, because it could be used. [00:03:51] Speaker 04: That's how you would depict one enantiomer. [00:03:53] Speaker 04: But that's not how it's used here. [00:03:55] Speaker 02: And the reason is... I thought that if you were going to depict the negative enantiomer and the negative enantiomer only as opposed to the racemic mix, [00:04:02] Speaker 02: you would actually have a negative on the left before the whole depiction of the formula, like you do in some of your embodiments in the pictures. [00:04:08] Speaker 04: That's one way to do it, but the other way is the way they did it, which is to show the solid triangle and the dotted lines, which shows the, you know, those, what are they called, stereogenic carbons with something poking out and something going back. [00:04:20] Speaker 04: That's the other way. [00:04:21] Speaker 04: But the reason you can't interpret it that way in this patent is because [00:04:25] Speaker 04: The only person of ordinary skill would pick up the claim and look at it and say, there's a formula there. [00:04:30] Speaker 04: What does it mean in the context of this patent? [00:04:32] Speaker 04: The only other place this formula appears in the specification of the patent is at column 30. [00:04:38] Speaker 04: It's at the bottom. [00:04:40] Speaker 04: And there, this formula, the only place it appears is specifically labeled compound 101. [00:04:45] Speaker 04: There's a 101 under it. [00:04:48] Speaker 04: If you go to columns 31 and 32, [00:04:52] Speaker 04: It makes clear that compound 101 is the racemic mixture. [00:04:56] Speaker 04: So this pattern uses the structural formula as a shorthand for the racemic mixture, because compound 1 is separate and distinct from its individual constituent enantiomers. [00:05:07] Speaker 02: When you say the picture appears at the bottom of column 30, that's a salt. [00:05:11] Speaker 04: No, the salt is not what determines whether it's compound 101. [00:05:15] Speaker 04: It's the structure on the left. [00:05:16] Speaker 02: Yeah, but that is a salt, right? [00:05:18] Speaker 02: That's what the HCL is at the end of that. [00:05:21] Speaker 04: You're right. [00:05:21] Speaker 04: You can have compound 1, 101. [00:05:23] Speaker 02: I guess I just want to be clear that what is at the bottom of page 30 is not the same thing in column 14, and in claim 14, because at the bottom of column 30 is a salt, and what's at claim 14 is not a salt. [00:05:36] Speaker 04: Well, in claim 14 it says, or in acid addition salt thereof. [00:05:38] Speaker 04: So the structure is the same. [00:05:41] Speaker 04: It's not the salt that determines whether it's 101. [00:05:44] Speaker 04: It's whether you have the structure [00:05:45] Speaker 04: And the salt of the structure can appear in many forms of acid-additioned salts. [00:05:50] Speaker 04: And the patent has a tartrate salt that has hydrochlorite. [00:05:53] Speaker 04: So that's not what determines whether it's 101. [00:05:55] Speaker 04: That's clear in columns 31 and 32. [00:05:59] Speaker 04: So what's clear is that 101 itself is the racemic mixture. [00:06:03] Speaker 04: That's the intrinsic evidence. [00:06:04] Speaker 04: There's a direct link between claim 14 and compound 101, which is the racemic mixture. [00:06:09] Speaker 00: What about the existence of compound 105, which is the negative enantiomer? [00:06:13] Speaker 04: Yes. [00:06:14] Speaker 00: What about the existence of that? [00:06:15] Speaker 00: Why doesn't that provide support that if one of ordinary scleromia looking at claim 14 would understand that that kind of depiction is used to connote either the negative enantiomer or a racemic mix, why doesn't the existence of compound 105 make it so it wouldn't be appropriate for the claim to be limited to compound 101? [00:06:39] Speaker 00: All right, there are several reasons for that. [00:06:40] Speaker 04: First, compound 101 is [00:06:44] Speaker 04: There's no dispute that it's the racemic mixture. [00:06:46] Speaker 04: They don't dispute that. [00:06:48] Speaker 04: And it is the racemic mixture. [00:06:49] Speaker 04: Compound 101 then is described as being broken out into its constituent enantiomers. [00:06:53] Speaker 02: They don't dispute that the compound 101 is in fact a racemic mixture. [00:06:56] Speaker 04: I believe that's correct. [00:06:57] Speaker 02: There's no... Because even though it doesn't say it anywhere, and it doesn't give percentages or ratios anywhere, you think just the absence of the [00:07:05] Speaker 02: Polar light data or whatever is what would teach somebody that that's the reason we're not providing that data is because you don't have it for a racemic mix. [00:07:13] Speaker 04: Right, exactly. [00:07:14] Speaker 04: And that's one reason. [00:07:15] Speaker 04: But also when you look at the subsequent sub-examples, you can see that when they break 101 up, you get equal amounts of the two enantiomers, plus and minus, that have equal and opposite optical rotation, which tells you that 101 had to have them both, and you couldn't split it into two. [00:07:31] Speaker 02: No, it had to have them both, but didn't have to have them in equal amounts. [00:07:34] Speaker 04: That's the way they exist in nature. [00:07:35] Speaker 04: That's just the way it is. [00:07:37] Speaker 04: That's chemistry. [00:07:39] Speaker 02: But you can have a mixture that isn't equal amounts. [00:07:41] Speaker 04: Sure, but you have to create it out of the two constituents. [00:07:44] Speaker 04: These things are made naturally, and that's the way they exist. [00:07:47] Speaker 04: Because in nature, the two enantiomers generally exist in 50-50 mixtures, unless you take special steps to separate them, which they didn't do until after they made it. [00:07:55] Speaker 02: So let's assume that compound 101 is a racemic mix, and nobody disputes that. [00:08:01] Speaker 02: But I guess part of the problem is, [00:08:06] Speaker 02: A skilled artisan looking at claim 14 would understand that to depict the negative enantiomer. [00:08:13] Speaker 02: And I, at least, am having a little trouble getting over the idea that the racemic mix disclosed in compound 101 somehow narrows the plain meaning to a skilled artisan of claim 14. [00:08:27] Speaker 04: OK. [00:08:28] Speaker 04: But you can't read claim 14 in a vacuum. [00:08:30] Speaker 04: And when you look at column 30, where the structure [00:08:36] Speaker 04: that is depicted in Claim 14 is shown and labeled as compound 101. [00:08:39] Speaker 02: That's a really stupid question. [00:08:41] Speaker 02: Why do you want this? [00:08:43] Speaker 02: I mean, what if I just construe it as the negative enantiomer? [00:08:46] Speaker 02: Claim 14 is limited to the negative enantiomer. [00:08:49] Speaker 02: You still have the exact same judgment. [00:08:51] Speaker 02: Am I wrong about that? [00:08:53] Speaker 04: If it's just the negative enantiomer, I believe that's correct. [00:08:56] Speaker 02: OK, you're not at risk for a change to the validity of the patent. [00:09:00] Speaker 04: That's a different issue, Your Honor, that wasn't before the court. [00:09:04] Speaker 02: So if I were to hold this limited to the negative minimum, nothing about this judgment would change, correct? [00:09:09] Speaker 04: I believe that's correct. [00:09:10] Speaker 04: But that would be inconsistent with the intrinsic evidence. [00:09:13] Speaker 04: And I have more intrinsic evidence if I can get to that. [00:09:15] Speaker 04: So in columns 31 and 32, the patent makes clear that compounds 102, 103, 104, and 105, which are various salt forms with [00:09:26] Speaker 04: the enantiomers of compound 101 are separate and distinct compounds. [00:09:29] Speaker 04: They're numbered separately. [00:09:30] Speaker 04: The properties are given separately. [00:09:32] Speaker 04: And most importantly, at column two, lines nine through 12, the patent says there are two objects to the compounds of this invention. [00:09:41] Speaker 04: One, they have anti-psychotic activity. [00:09:43] Speaker 04: Two, they have reduced side effects. [00:09:45] Speaker 02: You're totally losing me. [00:09:47] Speaker 02: You're going really fast. [00:09:49] Speaker 02: And I don't understand what I'm supposed to take away from column 31 and 32 [00:09:54] Speaker 02: which tells me that claim 14 is limited to a racemic mixture only and does not include a product that is sold using exclusively the negative enantiomer. [00:10:06] Speaker 04: OK. [00:10:06] Speaker 04: Well, the issue there, Your Honor, is I think you're accepting the argument that somehow this claim was intended to cover the commercial product, which wasn't even known at the time. [00:10:17] Speaker 04: And we have to go on the intrinsic evidence. [00:10:19] Speaker 02: No, I'm not assuming anything. [00:10:22] Speaker 02: Claim 14 is a depiction of the negative enantiomer. [00:10:28] Speaker 02: And so I have to be honest, I was really confused when one side is arguing, no, it's a depiction of racemic mixture only, and the other side is arguing, no, it's a depiction of negative, positive, and everything in between. [00:10:40] Speaker 02: I was surprised that nobody was standing here arguing to me that claim 14 is depicting [00:10:45] Speaker 02: And claiming the negative enantiomer. [00:10:47] Speaker 04: Okay. [00:10:47] Speaker 04: Let me back up then. [00:10:48] Speaker 02: Do you believe that this patent doesn't disclose it? [00:10:50] Speaker 02: I think it discloses the negative enantiomer. [00:10:52] Speaker 04: Oh, I don't say it isn't disclosed. [00:10:55] Speaker 04: It's not within this claim properly construed in light of the intrinsic evidence. [00:10:59] Speaker 04: And then both sides agree on that. [00:11:01] Speaker 02: And the reason is... No, both sides don't agree on it. [00:11:03] Speaker 02: He thinks his claim construction includes all negative, all positive and everything in between. [00:11:08] Speaker 04: I'm sorry. [00:11:09] Speaker 04: I mean, as to the racemic mixture, there's no disagreement. [00:11:13] Speaker 04: that it covers the racemic mixture, which means they agree. [00:11:16] Speaker 02: But I don't have to accept a concession on a question of law. [00:11:20] Speaker 02: This is a question of law. [00:11:21] Speaker 02: You can both stand here and argue to me that a statute means X. And if I don't agree or if I think it means Y, guess what? [00:11:27] Speaker 02: It means Y. I don't have to accept some concession on a question of law. [00:11:31] Speaker 02: So I'm trying to figure out what this means. [00:11:34] Speaker 04: All right. [00:11:34] Speaker 04: So let me back up. [00:11:36] Speaker 04: To understand what the formula means, a person of ordinary skill would look at the specification and file history. [00:11:42] Speaker 04: understand what it means. [00:11:44] Speaker 04: That formula in claim 14 admittedly depicts the negative enantiomer, but the way it's used in this patent shows that it's labeled as compound 101, which is the racemic mixture. [00:11:58] Speaker 04: So the way it's defined in this patent, it's used as a shorthand. [00:12:03] Speaker 04: That's structural formula, which is the negative isomer. [00:12:06] Speaker 00: It sounds as if you're saying because it's an express definition of [00:12:10] Speaker 00: in the specification? [00:12:11] Speaker 04: I think that's fair. [00:12:12] Speaker 04: I think that's fair. [00:12:14] Speaker 04: It's labeled 101. [00:12:15] Speaker 04: And then the specification in columns 31 and 32 show that it's separated. [00:12:20] Speaker 04: And then the enantiomers are labeled as separate compounds. [00:12:23] Speaker 04: And they're treated as separate compounds. [00:12:25] Speaker 04: So this patent makes it clear that the racemic mixture is separate and distinct from its constituent enantiomers. [00:12:31] Speaker 04: That's what the intrinsic evidence says. [00:12:33] Speaker 04: And the data that I was referring to, which I started to get into, column 2, lines 9 through 12, it says, [00:12:41] Speaker 04: The compounds of this invention have two attributes, antipsychotic effect, reduced side effects. [00:12:47] Speaker 04: And if you look at the tables 2, 3, 4 on activity, diabetes, psychotic activity, and reduced side effects, tables 5 and 6, the only compound that shows up there is 101. [00:12:58] Speaker 04: That's the racemic mixture. [00:13:00] Speaker 04: Compound 105 appears only in table 2. [00:13:04] Speaker 04: So there's a little bit of data on activity, but not a lot. [00:13:08] Speaker 04: And there's no data on the reduced side effects. [00:13:10] Speaker 04: And notably, compound 104, which is the mirror image of 105, doesn't appear in any of the tables. [00:13:16] Speaker 04: So there's no teaching that somehow claim 14, which is directed to compound 101, somehow includes things that aren't even shown to be effective for the two objects of the invention. [00:13:31] Speaker 00: So it sounds as if what your argument is is because there's more data for 101 than 105 and all the other compounds. [00:13:37] Speaker 00: It must be that the inventor in writing this, or in presenting this claim, intended to limit it to 101. [00:13:45] Speaker 04: That's in addition to the fact that the structural formula that is in claim 14 is the one labeled as 101, which is the racemic mixture. [00:13:52] Speaker 04: So it's just piling on. [00:13:54] Speaker 00: Where is the formula for 105 depicted? [00:13:56] Speaker 04: There is none. [00:14:01] Speaker 04: There is none. [00:14:01] Speaker 04: Not 105, per se. [00:14:03] Speaker 04: No. [00:14:04] Speaker 04: And there's more. [00:14:05] Speaker 04: The file history is entirely consistent. [00:14:08] Speaker 04: cancelled all the original claims and added some new claims. [00:14:12] Speaker 04: They were faced with restriction requirements. [00:14:15] Speaker 04: The examiner said, too many different inventions, narrow it down. [00:14:19] Speaker 04: In at least two instances, the applicant said, we are electing the species of compound 101. [00:14:26] Speaker 00: I want to ask you a question about the technology. [00:14:29] Speaker 00: Why are there not four enantiomers given that there's two chiral carbons in what is depicted as what [00:14:38] Speaker 00: in the claim. [00:14:39] Speaker 04: I think because here, as I understand this, and again, my chemistry is a little rusty, it's because there are only two possible combinations. [00:14:47] Speaker 04: This won't show up too well on a date, but it's either this way or that way. [00:14:52] Speaker 04: So there are only two combinations. [00:14:54] Speaker 04: Those two carbons have only one. [00:14:57] Speaker 04: Each of them has only one thing that can be on there. [00:15:00] Speaker 04: And so it's either this way or that way, and the other one has to be the other way. [00:15:04] Speaker 04: So there are only two combinations. [00:15:06] Speaker 04: That's my understanding. [00:15:07] Speaker 02: Mr. Hugh, we have exhausted all of your time including rebuttal time. [00:15:10] Speaker 02: I'll restore two minutes. [00:15:12] Speaker 02: Let's hear from Mr. Ratliff. [00:15:14] Speaker 02: Is it Ratliff? [00:15:15] Speaker 03: Ratliff, Your Honor. [00:15:20] Speaker 03: Good afternoon. [00:15:21] Speaker 03: May it please the Court. [00:15:22] Speaker 03: My first point is that the clearly erroneous standard applies and my opponents have not and cannot overcome that standard. [00:15:31] Speaker 03: When you consider everything that my opponents have argued... I'm saying it clearly erroneously and it applies. [00:15:35] Speaker 02: This is claim construction. [00:15:36] Speaker 02: Claim construction is de novo. [00:15:38] Speaker 03: The ultimate question of claim construction is de novo. [00:15:41] Speaker 03: However, here, my opponent's argument is based upon two book excerpts. [00:15:47] Speaker 02: No. [00:15:48] Speaker 02: He argued two book excerpts. [00:15:50] Speaker 02: He also argued about ten other pieces of prior art and had an expert report as well. [00:15:55] Speaker 02: The district court, for whatever reason, decided not to consider any of that other extrinsic evidence. [00:16:00] Speaker 02: The district court did address those two book excerpts. [00:16:04] Speaker 02: And so I would have to use the district court's conclusion about what those two book excerpts tell me for clear error. [00:16:10] Speaker 02: But he hasn't said a word about those book excerpts as he stood up here today. [00:16:14] Speaker 02: Instead, we're all talking about claim construction. [00:16:16] Speaker 02: That's a question of law. [00:16:17] Speaker 02: What the court held on two book excerpts, that's a question of fact. [00:16:21] Speaker 02: But it didn't look at any of the other extrinsic evidence of which a mountain was presented. [00:16:25] Speaker 02: I don't understand why it chose to and none of the others to address. [00:16:30] Speaker 02: But I don't see how this could possibly be viewed as clear error standard of review. [00:16:34] Speaker 03: Well, Your Honor, it's because the book excerpts are foundational to my opponent's argument. [00:16:39] Speaker 03: That's how they make the leap from going from claim 14 depicting loracidone to excluding loracidone and limiting to a racemate. [00:16:47] Speaker 00: He said earlier that it's the specification that he's relying on to exclude the negative enantiomer. [00:16:55] Speaker 00: What I heard him to be saying was that the intrinsic evidence supports a construction that would cover both the negative enantiomer and the racemic mix. [00:17:07] Speaker 00: But it's the specification then, the intrinsic evidence that provides a special definition [00:17:13] Speaker 00: that in this case would make it so claim 14 is limited to the racemic mix. [00:17:18] Speaker 00: So that, I think, is a legal question because he's talking about interpreting the claim in light of the specification. [00:17:28] Speaker 03: Well, Your Honor, that's what he's trying to argue, but that's what... Let's assume that's what he's arguing. [00:17:33] Speaker 00: Do you think that's a legal issue that we review de novo? [00:17:37] Speaker 03: I think here to find for the appellants, [00:17:42] Speaker 03: It's based upon a clear error standard because of its foundational, their book excerpts to make that construction, to make the leap from going from depiction of a single enantiomer into a racemic mixture. [00:17:54] Speaker 03: My opponents actually agree that the claim depicts an enantiomer. [00:18:00] Speaker 03: They also agree that at page nine of their brief that the structure drawn for compound 101 is different. [00:18:09] Speaker 02: This is a real problem. [00:18:10] Speaker 02: I can't even believe you're standing here making this argument, because I don't understand how you don't see how it undermines your case. [00:18:18] Speaker 02: If you're telling me that the plain meaning of claim 14 to a skilled artisan as assessed by the district court was a negative enantiomer, then this district court absolutely erred in the construction he adopted to include everything, negative, positive, racemic, and all mixtures in between. [00:18:36] Speaker 03: Well, Your Honor, at the very least, the claim certainly... Do you not see that? [00:18:40] Speaker 02: Do you not see how your argument undermines your own construction? [00:18:44] Speaker 03: No, Your Honor, because our argument is informed by the intrinsic evidence. [00:18:49] Speaker 03: So the claim literally depicts an antimer, which is loracinone, that they agree. [00:18:55] Speaker 02: And then if you... Wait, what is your argument? [00:18:57] Speaker 02: What do you think the plain meaning to a skilled artisan of what is depicted in claim 14 is? [00:19:02] Speaker 02: What is your client's argument on that position? [00:19:04] Speaker 03: It depicts the enantiomer, which is... The negative enantiomer, correct? [00:19:09] Speaker 03: Yes, Your Honor. [00:19:10] Speaker 00: Forget about talking about the accused device. [00:19:13] Speaker 00: Just say a negative enantiomer, because we're not supposed to rely on the accused device to interpret a claim. [00:19:18] Speaker 03: Understood, Your Honor. [00:19:19] Speaker 02: So you're saying claim 14 depicts the negative enantiomer. [00:19:24] Speaker 03: It depicts the negative enantiomer, and when you read that claim in light of the specification, you understand from [00:19:31] Speaker 03: the specification in particular at column four, lines 51 through 53, that it talks about the invention including stereo and optical isomers and that this invention is intended to cover those anantamers as well as mixtures thereof. [00:19:53] Speaker 00: Why did you not argue that this claim covers the negative anantamer and nothing else? [00:19:58] Speaker 03: Because that's not the true spirit of the invention and what the specification teaches us. [00:20:04] Speaker 03: The specification teaches us that claim 14 is directed to a genus of compounds. [00:20:09] Speaker 03: So if you look, for example, at claim 14 and just looking at it, that picture, what is it associated with? [00:20:18] Speaker 03: Well, my opponents agree that's associated with compound number 105. [00:20:22] Speaker 03: They agreed to that in their brief at page 13. [00:20:26] Speaker 03: And then where do you see [00:20:28] Speaker 03: Compound 105, it's in the context of example one. [00:20:32] Speaker 03: In example one talks about a genus of compounds. [00:20:35] Speaker 03: It talks about a mixture. [00:20:37] Speaker 03: It talks about the plus and the minus enantiors. [00:20:41] Speaker 03: That's a self-described preferred example. [00:20:43] Speaker 00: Can you point me to where in the specification you're relying on where you say that compound 105 is in example one? [00:20:51] Speaker 03: Yes. [00:20:52] Speaker 03: So if we turn to the appendix at [00:21:02] Speaker 03: 86, if we look at 85 and 86, columns 30 of the patent, that's where we see the introduction to example one, and example one has various subparts, example 1A through example 1E, which ends on column 32. [00:21:22] Speaker 03: And so the introduction to this picture that's depicted here is the structure that's associated with [00:21:31] Speaker 03: all of these compounds that are example one, this subgenus, ending with compound number 105, which my opponents agree is literally depicted in the claim. [00:21:43] Speaker 03: And we know, Your Honor, that the construction that my opponents argue isn't a logical one because it would exclude the preferred embodiment that they say is literally depicted in the claim. [00:21:55] Speaker 03: And the only reason that they get there is because, again, they look at [00:22:01] Speaker 03: the claim, they recognize that it depicts the minus enantiomer, and then they argue based upon their book excerpts that a person of ordinary skill in the art would understand that to be a racemic mixture. [00:22:12] Speaker 03: The district court discredited that. [00:22:14] Speaker 03: That's foundational to their argument. [00:22:16] Speaker 00: What about their argument on appeal? [00:22:17] Speaker 00: They seem to have maybe modified it a little bit. [00:22:20] Speaker 00: As we hear today, it's that compound 101 is the only one that's depicted as being exactly what's shown in claim 14. [00:22:30] Speaker 03: Well, if they're arguing that, Your Honor, then that's inconsistent with the brief. [00:22:34] Speaker 03: Because they certainly say in their brief before this court at page 9, they recognize that there's a difference between compound 101 and D14. [00:22:44] Speaker 03: And they say the only difference between compound 101 and D14 is that compound 101 includes HCl, referring to the hydrochloride salt. [00:22:53] Speaker 03: And we also have their expert who has admitted that compound 101 [00:22:58] Speaker 03: includes the hydrochloride salt, and it is the hydrochloride salt. [00:23:02] Speaker 00: I know. [00:23:02] Speaker 00: Maybe I didn't ask my question. [00:23:04] Speaker 00: Which is that their argument seems to be that on the specification alone, they can limit the claim to the racemic mix. [00:23:16] Speaker 00: How do you respond to that argument, setting aside the extrinsic evidence? [00:23:22] Speaker 03: I respond, where does that come from? [00:23:24] Speaker 03: They're trying to import limitations from the specification into the claim? [00:23:29] Speaker 00: I think, as I understand it, is that the data is provided for compound 101. [00:23:35] Speaker 00: And so we should understand from that that that is the one compound that was intended to be claimed in claim 14. [00:23:46] Speaker 03: Your Honor, well, that's not how claim construction works. [00:23:48] Speaker 03: Certainly Compound 101 is featured. [00:23:51] Speaker 03: It's among the preferred, one of the preferred embodiments in the patent. [00:23:55] Speaker 03: But you don't read that limitation, an embodiment into the claim, particularly when we have a situation here where the enantiomer depicted, they want to read out of the claim. [00:24:07] Speaker 03: That doesn't make any sense. [00:24:08] Speaker 03: It's illogical. [00:24:09] Speaker 03: And they're arguing that the claim is limited to one compound. [00:24:14] Speaker 03: If you just look at [00:24:16] Speaker 03: If you just look at claim 14, again, you don't have to be an organic chemist to figure out that it actually claims a genus. [00:24:24] Speaker 03: It talks about a mid compound of a certain formula or an acid addition salt thereof. [00:24:29] Speaker 03: That's at least two compounds. [00:24:31] Speaker 03: But they're arguing that the claim is limited to compound 101, which is a hydrochloride salt. [00:24:36] Speaker 03: So you know right off the bat that their construction doesn't make sense. [00:24:39] Speaker 00: Mr. Hughes said that you had admitted that [00:24:44] Speaker 00: Compound 101 is a racemic mix. [00:24:47] Speaker 00: Is that true? [00:24:48] Speaker 03: That is not true, Your Honor. [00:24:49] Speaker 03: Compound 101 is certainly a mixture. [00:24:51] Speaker 03: There's no information in the patent that tells us if it's a racemic mixture or not. [00:24:57] Speaker 03: The specification actually doesn't use the term racemic mixture. [00:25:00] Speaker 03: But that's sort of besides the point, because it certainly is a mixture. [00:25:04] Speaker 03: But again, if you look at the claim and you understand that it does depict an enantiomer, their construction can't be right. [00:25:12] Speaker 03: because they're trying to exclude that particular enantiomer. [00:25:15] Speaker 03: And I submit again, it is foundational to their argument. [00:25:20] Speaker 03: They do argue in their briefs, and I know that they've only said part of their argument here. [00:25:25] Speaker 03: They do argue in their briefs that they're relying upon intrinsic evidence. [00:25:28] Speaker 03: That's how they get to actually limiting the claim to a racemic mixture. [00:25:34] Speaker 03: And that was discredited by the district court. [00:25:36] Speaker 03: And even if, and I do believe the clearly erroneous standards applies, [00:25:42] Speaker 03: Even if that doesn't apply, there's alternative. [00:25:44] Speaker 02: The most erroneous standard applies to a fact finding. [00:25:46] Speaker 02: The fact finding the district court made were specific to the organic chemistry book and the other organic chemistry book. [00:25:53] Speaker 02: That fact doesn't, it doesn't convert his claim construction in light of this specification into a fact finding. [00:26:00] Speaker 03: Well, your honor, I certainly, I certainly agree that that what the district court did applies to those particular facts, the book excerpts, but that's foundational to their argument. [00:26:12] Speaker 03: They never get to a racemic mixture otherwise. [00:26:15] Speaker 02: And if you also look at... Their argument is that compound 101 is a racemic mixture. [00:26:20] Speaker 02: That's how they get, that's how they claim they get to it. [00:26:23] Speaker 03: Yes, Your Honor, but they also agreed that at page nine of their brief, that the claim does not depict compound 101. [00:26:30] Speaker 03: So they say it's something different. [00:26:31] Speaker 02: So the only reason they... It depicts the salt, which is still a racemic mixture. [00:26:37] Speaker 03: Well, they don't argue that it depicts the salt. [00:26:41] Speaker 03: They say it depicts loracidone or compound 105. [00:26:45] Speaker 03: They actually say that in their brief. [00:26:46] Speaker 03: So that's their argument and the only reason that they get there is based upon those book excerpts. [00:26:51] Speaker 02: Why shouldn't I construe claim 14 is limited to the negative enantiomer? [00:26:55] Speaker 02: That's what's depicted. [00:26:57] Speaker 02: That's the plain meaning to a skilled artisan of that picture. [00:27:00] Speaker 02: Why don't I construe it as limited to a negative enantiomer? [00:27:03] Speaker 03: Your Honor, at the very least, it certainly does include the negative anathema because that's what's depicted. [00:27:09] Speaker 03: But we also don't read the claim in isolation. [00:27:11] Speaker 03: We read the claim in light of the specification. [00:27:14] Speaker 02: We read the claim in light of the specification to ascertain whether lexicography or disclaimer has occurred. [00:27:20] Speaker 02: But we give the claim its claim meaning to a skilled artisan outside of those circumstances. [00:27:24] Speaker 02: So where is there a definition? [00:27:26] Speaker 03: Well, Your Honor, the definition and what informs what's actually in claim 14 [00:27:32] Speaker 03: It is what you see at column four, column four lines 51 through 53. [00:27:38] Speaker 03: When you look at that, it's impactful language that the district court looked at in terms of coming up with its construction. [00:27:46] Speaker 00: Why do we need to resolve that issue? [00:27:49] Speaker 00: If by finding that this claim at least includes the negative enantiomer resolves the dispute between the parties, why do we need to go beyond that? [00:27:59] Speaker 03: Well, Your Honor, we don't need to go beyond that, but it certainly at least includes the enantiomer, the minus enantiomer. [00:28:08] Speaker 03: Absolutely. [00:28:09] Speaker 03: But if we're doing claim construction and actually looking at what a person of ordinary skill and the art would understand, it would encompass all of these other things. [00:28:18] Speaker 03: And that's the same thing that the defendants understood before they got in this litigation. [00:28:23] Speaker 02: Each of the three defendants... Why would it include all... You say a person under skill would understand this picture to include all those other things, all the possible combinations and mixtures. [00:28:32] Speaker 02: Why? [00:28:33] Speaker 03: Well, because that structure that's depicted in Claim 14 is associated with Example 1. [00:28:39] Speaker 03: Example 1 gives a subgenius of compounds. [00:28:42] Speaker 03: It gives the plus enantiomer, the minus enantiomer, as well as mixtures. [00:28:46] Speaker 03: And when my opponents study this claim and study [00:28:50] Speaker 03: the 372 pad before this litigation started, they all came to this conclusion that it covers loracidum. [00:28:55] Speaker 02: Did the district court reach the conclusion that you're advocating for, namely the specific conclusion that what is in Claim 14 is Example 1 with all of its relevant components? [00:29:08] Speaker 03: I believe so, yes, Your Honor. [00:29:09] Speaker 02: Where did the district court discuss Example 1? [00:29:13] Speaker 03: Well, Your Honor, the district court didn't discuss Example 1 specifically. [00:29:17] Speaker 03: But it certainly came to the conclusion. [00:29:19] Speaker 02: But it included everything. [00:29:20] Speaker 02: It backed into the conclusion. [00:29:21] Speaker 02: It included everything when it said it can't be limited to a racemic mixture because the picture is of a negative inanomer. [00:29:25] Speaker 02: But where did the district court conclude that the plain, ordinary meaning to a skilled artisan of Plane 14 in light of this specification is example one. [00:29:35] Speaker 02: And since example one includes negative, positive, and everything in between, it's all in there. [00:29:41] Speaker 02: I don't see the district court having adopted your logic at all. [00:29:46] Speaker 03: Well, Your Honor, and I'm not saying that the district court limited its analysis to the subgenus that's included in example one. [00:29:54] Speaker 03: What I'm saying is the district court looked at the intrinsic evidence, discredit their foundational extrinsic evidence, and found that consistent to have a claim that encompasses both the minus enantiomer, the plus enantiomer, and mixtures as well. [00:30:09] Speaker 03: So it didn't need to focus on example one, because again, if it just took example one and said that's all the claim covers, [00:30:15] Speaker 03: then that would also be the case. [00:30:16] Speaker 02: I'll tell you, if example one doesn't get you there, I don't think the column 14 statement gets you where you want it to go. [00:30:23] Speaker 02: That column 14 statement is extremely broad. [00:30:26] Speaker 02: It doesn't say the present invention. [00:30:28] Speaker 02: It doesn't say every compound. [00:30:29] Speaker 02: And this is the narrowest compound disclosed in this patent at claim 14. [00:30:33] Speaker 02: There are lots of broad claims in this patent. [00:30:36] Speaker 02: The one at 14 is the narrowest one. [00:30:39] Speaker 02: I certainly don't read the language in Column 4, 9, 51 to 54 to amount to a lexicography or disclaimer. [00:30:46] Speaker 02: I don't read it that way. [00:30:47] Speaker 02: So I don't get to where you want to go unless I'm going to say Claim 14 corresponds to Example 1, and Example 1 has all these subcomponents, all of which have to be read into Claim 14. [00:30:59] Speaker 03: Well, Your Honor, the picture that's depicted in Claim 14 is associated with Example 1. [00:31:06] Speaker 03: And my opponents agree with that. [00:31:08] Speaker 03: You can't dissociate that picture from example one. [00:31:11] Speaker 02: But your problem with then is, if we get to it, that picture isn't example one, right? [00:31:17] Speaker 02: It's example 1A. [00:31:20] Speaker 02: Example 1-A, production of compound number 101. [00:31:25] Speaker 02: So it doesn't say it's associated with all of example one, right? [00:31:29] Speaker 02: Do you have the picture in front of you? [00:31:30] Speaker 03: I do have the picture in front of me. [00:31:32] Speaker 02: Doesn't it say example dash 1A, production of compound 101? [00:31:36] Speaker 02: Why couldn't 1B, 1C, 1D, and 1E be different things other than this picture? [00:31:41] Speaker 03: Because we're talking about two different things. [00:31:43] Speaker 03: The picture that you see, the actual structure with the HCL, is compound 101. [00:31:48] Speaker 03: That's a different picture that's in claim 14. [00:31:52] Speaker 03: And my opponents admit that. [00:31:54] Speaker 03: So if the person of ordinary skill in the yard is reading example 1, [00:31:58] Speaker 03: They would understand. [00:31:59] Speaker 02: The only difference between the picture at the bottom of column 30 is the HCL label on the far end, which just means salt. [00:32:06] Speaker 02: And claim 14 includes the negative enantiomer, which this is a picture of, the negative enantiomer, and it's salt. [00:32:13] Speaker 02: So this is a picture of what's in claim 14. [00:32:16] Speaker 02: I don't understand your argument that it's not. [00:32:19] Speaker 03: I am arguing that the picture in claim 14 is associated with example 1. [00:32:25] Speaker 03: And I'm arguing that a person with a skill in the art... Compound 101. [00:32:29] Speaker 02: It's associated with Compound 101. [00:32:30] Speaker 03: It's associated with Example 1, which includes Compound 101. [00:32:34] Speaker 02: And then also includes other compounds. [00:32:36] Speaker 03: Correct, Your Honor. [00:32:39] Speaker 02: But how do I know those other compounds are meant to be encompassed by Claim 14? [00:32:43] Speaker 03: Well, these are self-described preferred embodiments of the patent. [00:32:47] Speaker 03: The patent says that. [00:32:49] Speaker 03: Inventors say that. [00:32:51] Speaker 02: Where? [00:32:51] Speaker 02: Wait. [00:32:52] Speaker 02: I'd like you to show her where. [00:32:54] Speaker 02: But is it your view that every preferred embodiment, especially in a case like this where there apparently are many, have to be included in every single claim? [00:33:02] Speaker 03: No, that's not my view, Your Honor. [00:33:04] Speaker 03: But this is a situation where you have a preferred embodiment that's specifically depicted in claim 14. [00:33:10] Speaker 03: So it can't be the situation. [00:33:11] Speaker 02: Right. [00:33:12] Speaker 02: It's not 101 that's specifically depicted in claim 14. [00:33:14] Speaker 03: No, Your Honor. [00:33:15] Speaker 03: As they agree, the minus enantiomer is specifically depicted [00:33:19] Speaker 03: in claim 14. [00:33:20] Speaker 02: So that's what compound 101 is. [00:33:21] Speaker 02: It's the minus enantiomer in salt form. [00:33:24] Speaker 03: No, Your Honor. [00:33:25] Speaker 02: They're arguing that... Look, it's got the little arrow above it. [00:33:27] Speaker 02: That's the negative enantiomer. [00:33:28] Speaker 02: No one has ever suggested anything otherwise. [00:33:31] Speaker 03: Your Honor, both parties agree that compound 101 is a mixture. [00:33:37] Speaker 03: Absolutely agree that it's a mixture and not the negative enantiomer. [00:33:40] Speaker 03: The negative enantiomer is compound 101. [00:33:42] Speaker 02: Well, what does that little arrow mean above compound 101? [00:33:46] Speaker 02: In compound 101, it's got that little [00:33:48] Speaker 02: thing above the H, I thought that was supposed to depict negative for me. [00:33:53] Speaker 02: That little triangle thing. [00:33:55] Speaker 02: I know I'm not being very technical, but geometric shapes are pretty straightforward. [00:34:02] Speaker 03: If you're talking about the two hydrogens that's depicting one coming into the page and out of the page, and that's not specifically directing whether or not [00:34:11] Speaker 03: it's negative or minus. [00:34:12] Speaker 00: Mr. Hugh has taken the position that what is shown in as compound 101 is a racemic mix, right? [00:34:19] Speaker 00: Correct. [00:34:19] Speaker 00: You're saying that you don't agree it's a racemic mix, but it's a mixture. [00:34:23] Speaker 00: Do I understand that correctly? [00:34:25] Speaker 00: Correct, Your Honor. [00:34:27] Speaker 00: Okay. [00:34:28] Speaker 00: And is it your view that compounds... Is it your position that compounds 105, which isn't depicted [00:34:41] Speaker 00: looks the same as compound 101. [00:34:44] Speaker 00: I'm trying to understand how you're saying that the compound that's designated as 101 is one of the only compounds in example one that's depicted. [00:34:57] Speaker 00: So why is that? [00:35:00] Speaker 03: Your Honor, my argument is that the structure that's depicted at the bottom of column 30 for compound 101 [00:35:10] Speaker 03: is associated with all the compounds in example one. [00:35:14] Speaker 00: Is one of the reasons why that's so is because none of the others are depicted separately as being something different? [00:35:19] Speaker 03: It would be absolutely redundant to draw the structure over and over again when the person of worrying skill in the art knows that they're associated with each other. [00:35:29] Speaker 03: If you look at the descriptions on column 31 and 32, you see that all of the other compounds, compounds 102, importantly compound 105, [00:35:38] Speaker 03: They're all described in the context of compound number 101. [00:35:42] Speaker 03: So a person of learning skill in the art knows that this is the structure. [00:35:45] Speaker 03: And so they'll be struck by that when they see claim 14. [00:35:49] Speaker 03: And they see that depiction. [00:35:51] Speaker 03: They'll be struck by the fact that this relates to the examples. [00:36:01] Speaker 03: And Your Honor, you asked a question. [00:36:04] Speaker 03: Where does it talk about environments of the invention and what's preferred? [00:36:08] Speaker 03: If you look at the appendix, page 77, column 14 of the patent, lines 56, it begins, practical and presently preferred embodiments of invention are illustratively shown in the following examples. [00:36:25] Speaker 00: Okay. [00:36:25] Speaker 00: Thank you. [00:36:25] Speaker 00: I think you answered my question that I had with your answer about how the example one is referring to all these different compounds based on compound 101. [00:36:39] Speaker 00: Is that, as I understand it, that's your basis for why it is that the claim one of ordinary scale in the art would read this portion of the specification at columns 30 through 32 to understand that the depiction of 101 is not limited to just 101. [00:37:00] Speaker 00: It also includes these other compounds 102 through 105. [00:37:04] Speaker 00: Do I understand that correctly? [00:37:06] Speaker 03: The only caveat, Your Honor, is that the depiction in Claim 14, it would plainly be associated with Example 1. [00:37:13] Speaker 03: It's not a depiction of Compound 101. [00:37:16] Speaker 03: And the parties agree on that. [00:37:18] Speaker 03: It's not a depiction of Compound 101. [00:37:21] Speaker 03: If anything, it's a depiction of Compound 105, the minus and antrimer. [00:37:25] Speaker 03: And a person who is still in the yard would understand that that's all associated with Example 1. [00:37:31] Speaker 02: Wait, why is compound 101 not a depiction of what's in claim 14? [00:37:35] Speaker 02: The picture looks exactly the same except DHCL at the end. [00:37:38] Speaker 03: And that's an important difference, Your Honor. [00:37:40] Speaker 02: No, it's just the salt form of the thing. [00:37:42] Speaker 02: You can have a salt form of a negative enantiomer. [00:37:44] Speaker 02: You can have a salt form of a positive or a salt form of a mixture. [00:37:46] Speaker 02: So what? [00:37:47] Speaker 03: It's important because, as my opponents argue, if claim 14 is limited to the hydrochloride salt and it's in fact compound 101, then the claim that terminal clause or an acid addition salt would have no meaning. [00:38:00] Speaker 03: It'd be superfluous. [00:38:02] Speaker 03: But we know the specification talks about there's several acid addition salts. [00:38:06] Speaker 03: So it can't be that this is just plug and play. [00:38:09] Speaker 02: They don't argue. [00:38:10] Speaker 02: The review of compound 101 is it's a racemic mixture or a salt thereof. [00:38:17] Speaker 02: And they claim that's what claim 14 is. [00:38:19] Speaker 02: They also claim that's what compound 101 is, a racemic mixture or a salt thereof, right? [00:38:24] Speaker 02: Am I wrong when I say that? [00:38:25] Speaker 03: That's what they argue, yes, Your Honor. [00:38:27] Speaker 02: So what is at the bottom? [00:38:29] Speaker 02: So if the picture at claim 14 looks exactly the same as compound 101, except that it has HCl on the end, and we all know claim 14 has a picture plus says or salts thereof, I don't understand the problem. [00:38:44] Speaker 03: Well, the problem is, Your Honor, because they say claim 14 covers only one compound. [00:38:48] Speaker 03: And that can't be right. [00:38:50] Speaker 03: And they agree and admit in their brief that compound 101 is the hydrochloride salt. [00:38:55] Speaker 03: But if you just look at the picture, it covers more than that. [00:38:58] Speaker 03: It's a genus. [00:38:59] Speaker 03: the compound of this formula or an acid addition of salt thereof. [00:39:03] Speaker 03: So that's at least too complex. [00:39:04] Speaker 02: Well, fine. [00:39:05] Speaker 02: But I have to decide this is a matter of law because there's nothing clearly erroneous about this claim construction. [00:39:10] Speaker 02: So what do I decide as a matter of law? [00:39:12] Speaker 02: Why don't I decide that claim 14 is limited to a racemic mixture or salts thereof? [00:39:17] Speaker 02: Because that's what the claim says. [00:39:18] Speaker 03: Well, the claim certainly doesn't talk about a racemic mixture. [00:39:22] Speaker 03: Nothing in the patent talks about a racemic mixture. [00:39:24] Speaker 03: The claims that the parties agree depicts [00:39:29] Speaker 03: the minus enantiomer. [00:39:32] Speaker 02: So if you look at the plain... It doesn't matter to me what you guys claim when it comes to claim construction or you agree to. [00:39:38] Speaker 02: Plus off, let's just be clear. [00:39:40] Speaker 02: Everything he said you agree to, you say you don't agree to. [00:39:42] Speaker 02: And I bet like anything, I got a lot of money that says when he stands up, he's going to say he doesn't agree with any of the things you claim he agrees with. [00:39:49] Speaker 02: So far, what I've found is neither of you actually agree with each other. [00:39:53] Speaker 02: So why isn't this a picture of the racemic mixture and salts thereof? [00:39:59] Speaker 03: Because when you look at it, it's depicting the minus enantiomer. [00:40:06] Speaker 03: And you can't say it's depicting compound 101, which is a mixture, because the picture for compound 101 is very different. [00:40:15] Speaker 03: So literally, when you look at claim 14, the plain meaning of it shows the minus enantiomer. [00:40:21] Speaker 03: And then you're informed by the specification. [00:40:23] Speaker 03: The specification informs you. [00:40:25] Speaker 03: This picture is associated with example one, which is a subgenus of compounds. [00:40:30] Speaker 03: We're not talking about a lot of compounds. [00:40:32] Speaker 03: We're talking about the enantiomer depicted, its opposite enantiomer, and mixtures. [00:40:37] Speaker 02: And all mixtures, no matter what the ratio. [00:40:39] Speaker 02: So you actually are talking about a lot of possible compounds. [00:40:43] Speaker 03: Your Honor, would you submit that that's still not a lot of compounds in the grand scheme of things of the patents and its compounds depicted? [00:40:52] Speaker 02: OK. [00:40:53] Speaker 02: You went over by 10 minutes, so Mr. Hugh, how much time did he have left? [00:40:59] Speaker 02: Thank you. [00:41:00] Speaker 02: He had none. [00:41:01] Speaker 02: So you get 10 minutes, Mr. Hugh. [00:41:02] Speaker 04: I don't need all of that, Your Honor. [00:41:04] Speaker 04: Thank goodness. [00:41:06] Speaker 04: I'm not going to live dangerous. [00:41:07] Speaker 04: I have to try to be equal. [00:41:09] Speaker 04: Thank you. [00:41:10] Speaker 04: I won't need it. [00:41:11] Speaker 04: First of all, [00:41:13] Speaker 04: Let's start with the books. [00:41:15] Speaker 04: It may not be the most important issue. [00:41:16] Speaker 04: The book excerpt argument was never the linchpin or foundation of our argument. [00:41:22] Speaker 04: We cited it simply to show that the intrinsic evidence here screams, I guess intrinsic evidence doesn't scream, it strongly states, indicates that the formula in claim 14 [00:41:35] Speaker 04: is compound 101, which is a restringent mixture. [00:41:38] Speaker 04: And we were citing the article simply to show that that usage is perfectly normal in the art, that the depiction of one enantiomer is used as a shorthand, for exactly the reasons he said, that you don't do it over and over again. [00:41:50] Speaker 02: The district court rejected, and I do have to review this clear error, whether or not your two organic chemistry books said that the plain meaning to a skilled artisan as they look at this negative enantiomer would be to understand it could be a negative enantiomer or a race [00:42:05] Speaker 04: I'm going to live dangerously, Your Honor, and I think you can disregard that issue because we don't need it. [00:42:12] Speaker 01: The intrinsic evidence says... Wait, wait, wait. [00:42:19] Speaker 02: Ten minutes. [00:42:19] Speaker 04: You don't need them all. [00:42:22] Speaker 02: So I guess one of the things that bothered me about this case was that you submitted an expert declaration [00:42:31] Speaker 02: along with citations to one, two, three, four, five, six, seven, eight, nine, 10, 10 different prior pieces of prior art or pieces of extrinsic evidence, 10 different things. [00:42:46] Speaker 02: The district court cherry plucked two and said neither of those two supported your argument, didn't consider any of the rest of them. [00:42:54] Speaker 02: So even if he's not clearly wrong, I saw those first two, I guess, [00:42:59] Speaker 02: Given how much you might have noticed, I am struggling to understand the technology. [00:43:04] Speaker 02: And having read his opinion and having seen that it sort of took a 10,000 approach level to the technology, I'm just wondering, I've never seen it happen before, but whether this is in a case where we vacate him or man and tell him, the Supreme Court said in Teva, extrinsic evidence can be used to help inform your understanding of the technology. [00:43:26] Speaker 02: I would like to know, I did not dig them up because they're not really relevant for appeal, but I'd like to know what all those other things you cited say about what the plain meaning to a skilled artisan of claim 14 is. [00:43:38] Speaker 02: Because you know what? [00:43:39] Speaker 02: You're both arguing the specification supports you, and I might as well flip a coin. [00:43:45] Speaker 02: So this seems like the kind of case where maybe extrinsic evidence would actually help inform us since we're not super skilled chemists in this field. [00:43:54] Speaker 02: I don't know. [00:43:54] Speaker 02: I mean, part of me thinks that that... And guess what? [00:43:57] Speaker 02: If the district court ever lied on extrinsic evidence for his basis, then it would be a clear error standard. [00:44:02] Speaker 02: And guess what? [00:44:02] Speaker 02: No matter how he comes out, that's going to be affirmed on appeal because this spec doesn't tell me for sure one thing or the other. [00:44:08] Speaker 02: So I don't know. [00:44:09] Speaker 04: Maybe tell him to go back and take some evidence and try to... I can say we did not rely on that in an argumentative or conclusory way. [00:44:18] Speaker 04: We cited it simply to try to give the district court comfort. [00:44:21] Speaker 04: that the construction dictated, in our view, by the intrinsic evidence was consistent with the usage in the art. [00:44:28] Speaker 04: And that's the only reason we did it. [00:44:29] Speaker 00: So we really- Those additional references that you cited, I looked at your expert's report citing those and describing those. [00:44:38] Speaker 00: Do I understand correctly that those additional nine references were being relied on to show that it is one convention for depicting a racemic mix [00:44:51] Speaker 00: is to depict one of the anatomers? [00:44:54] Speaker 04: Yes, for convenience. [00:44:55] Speaker 04: For exactly the reasons at police counsel said, you don't want to write them out over and over again when you're just making a little difference, a little change on whether it's in or out. [00:45:05] Speaker 04: You can use it as a shorthand. [00:45:06] Speaker 04: And that's the only reason. [00:45:07] Speaker 04: It was to give the district court some comfort that this result, which we say is dictated by the intrinsic evidence, both the specification and the file that was [00:45:16] Speaker 04: And incidentally, this notion that somehow compound 101 is a genus is just not correct. [00:45:21] Speaker 04: In the prosecution history, they repeatedly said in response to the restriction requirements, we elect the species of compound 101. [00:45:30] Speaker 04: Species of compound 101. [00:45:31] Speaker 04: And the salt doesn't make it a genus. [00:45:33] Speaker 04: What compound 101 is a racemic mixture of the two enantiomers, one of which is shown in the drawing. [00:45:38] Speaker 04: The salt is irrelevant. [00:45:40] Speaker 04: It doesn't make it a genus. [00:45:41] Speaker 04: You can have different salts. [00:45:42] Speaker 04: And the specification makes that clear. [00:45:44] Speaker 04: It says you can have the negative enantiomer of compound 101 in the form of a tartrate salt. [00:45:49] Speaker 04: It's not a different compound. [00:45:51] Speaker 04: And we're not limiting it to hydrochloride salt. [00:45:53] Speaker 04: We're saying it's this racemic mixture of these two enantiomers. [00:45:56] Speaker 02: Are you saying it wouldn't be a species if it was the negative, the positive, and the racemic mixture? [00:46:02] Speaker 02: That would be three species? [00:46:04] Speaker 04: That would be a genus, especially the way they've construed it, because I think, as your honor noted, it's a large number, because it's essentially infinite, depending on how finely you want to divide the [00:46:15] Speaker 04: You know, the 100%. [00:46:16] Speaker 04: So that's not what is meant here. [00:46:19] Speaker 04: 101, when they have activity for antipsychotic effect and lack of side effects in tables two through six, it has to be a specific compound. [00:46:29] Speaker 04: It's not some amorphous compound. [00:46:31] Speaker 04: Well, we don't know if it's 50% or 50.92% of one and the rest of the other. [00:46:35] Speaker 04: It's 50-50. [00:46:36] Speaker 04: It's a racemic mixture. [00:46:37] Speaker 04: It's a drug. [00:46:38] Speaker 04: It's got to be precise. [00:46:39] Speaker 04: That's why. [00:46:41] Speaker 00: Can't the claim be broader than... Sure. [00:46:44] Speaker 00: the specific compound that is... Sure. [00:46:48] Speaker 04: And claim one, for example, is an example. [00:46:49] Speaker 04: And that passage they like from column four that says... That passage actually says, the MI compound one is broad, to paraphrase. [00:46:59] Speaker 04: That formula appears in claim one. [00:47:01] Speaker 04: Conservatively, that's more than two billion compounds. [00:47:03] Speaker 04: So that really doesn't say anything about narrow claim 14. [00:47:07] Speaker 04: So can it be broad? [00:47:09] Speaker 04: Sure, but not this claim. [00:47:11] Speaker 04: This claim [00:47:12] Speaker 04: is specifically linked to a formula which is identified as 101. [00:47:17] Speaker 04: And these intrinsic evidence in columns 31, 32, and then the tables on activity would lead a person of ordinary skill to conclude that it's the racemic mixture, and it's separate and distinct from the constituent enantiomers. [00:47:28] Speaker 00: If claim 14 depicts much the same of what is shown as being compound 101, and compound 105 is the negative enantiomer, [00:47:39] Speaker 00: And claim 14 depicts the negative enantiomer. [00:47:44] Speaker 00: And there's nothing depicted in the patent for what compound 105 is, other than that it's based on compound 101. [00:47:51] Speaker 00: Why doesn't, you know, the figure that's shown in compound 101 depict compound 105? [00:47:58] Speaker 00: Why couldn't one of ordinary scalenia understand that? [00:48:01] Speaker 04: That would be kind of a hindsight leap to try to read it in, because the... I'm just saying in terms of how one of ordinary scalenia would understand this specification. [00:48:09] Speaker 04: Because the person of ordinary skill in the art here would look at the claim and say, OK, there are a number of ways of using this structural formula. [00:48:17] Speaker 04: How is it used here? [00:48:18] Speaker 04: And they would look at the specification. [00:48:19] Speaker 04: They would see column 30 and say, oh, they're saying it's compound 101. [00:48:24] Speaker 04: Then they would read the specification and say, what is compound 101? [00:48:28] Speaker 04: And you would conclude from this that it's a racemic mixture. [00:48:31] Speaker 04: and that it's separate from its constituent enantiomers. [00:48:34] Speaker 04: The activity data is reported separately. [00:48:36] Speaker 04: The physical properties are reported separately. [00:48:38] Speaker 04: They're numbered separately. [00:48:38] Speaker 04: Everything is different. [00:48:39] Speaker 04: They're not the same thing. [00:48:40] Speaker 00: So if compound 104 was depicted and it looked exactly the same as compound 101, that would undermine your argument? [00:48:48] Speaker 04: It would, but it also, there are other ways of claiming it where you could have made this clear. [00:48:53] Speaker 04: They could have said, [00:48:55] Speaker 04: You know, this compound, its mirror image, you know, mixtures there, it's very simple. [00:49:00] Speaker 04: They clearly meant 101, and that's what they said in the prosecution history. [00:49:04] Speaker 04: We elect the species of compound 101. [00:49:06] Speaker 04: It's a species. [00:49:07] Speaker 04: It's one compound. [00:49:08] Speaker 04: It's the racemic mixture of two enzymes. [00:49:10] Speaker 00: What if one were to say, well, 102, 103, 104, and 105 are all based and described in the specification as being based on compound 101. [00:49:17] Speaker 00: So why isn't that part of the species of 101? [00:49:21] Speaker 04: Because 101 is separate and distinct the way it's used in this patent. [00:49:24] Speaker 02: Do they say they elect the species of 101? [00:49:28] Speaker 02: Yes. [00:49:28] Speaker 02: Example one. [00:49:29] Speaker 02: Where do they say the species of 101? [00:49:31] Speaker 04: It's in the responses to the two- What page in the appendix? [00:49:51] Speaker 01: Oh, appendicle. [00:49:52] Speaker 01: Hang on a second. [00:50:07] Speaker 01: My law clerk says page 965. [00:50:12] Speaker 01: Why don't we turn there and see if that's what you're looking for. [00:50:20] Speaker 04: Yes, there are two responses to restriction requirements that are kind of back-to-back and they both say that. [00:50:31] Speaker 00: What about her? [00:50:32] Speaker 00: It says elect a group which encompasses compound 101. [00:50:35] Speaker 02: Yep. [00:50:36] Speaker 02: This is mainly example one in the application, which includes compound 105. [00:50:43] Speaker 04: I believe that reference is to the group of claims. [00:50:47] Speaker 04: They canceled all the original claims. [00:50:49] Speaker 04: And then just before these restriction requirements, they added a whole group of claims. [00:50:54] Speaker 04: And I believe they're referring to the group of claims, not a group of compounds. [00:50:58] Speaker 00: But they say, even down further, they say, [00:51:01] Speaker 00: then the applicant provisionally collect the species of compound number 101, namely example 1. [00:51:07] Speaker 00: They refer to example 1 twice on this page. [00:51:10] Speaker 00: Yes. [00:51:13] Speaker 02: Example 1 does include compound 105, doesn't it? [00:51:16] Speaker 04: Generically, if anything with a 1 in front of the ABC, yes. [00:51:21] Speaker 04: The answer is yes. [00:51:23] Speaker 02: Yes. [00:51:23] Speaker 02: All right. [00:51:24] Speaker 02: OK. [00:51:24] Speaker 02: This case is taken under submission. [00:51:26] Speaker 02: I thank both counsel for their arguments, or concluded.