[00:00:00] Speaker 02: It may please the court. [00:00:02] Speaker 02: This is a pretty complex case, but I think it boils down, really, to three issues. [00:00:07] Speaker 02: One is the claim construction. [00:00:08] Speaker 02: Two is the prosecution history estoppel. [00:00:11] Speaker 02: And number three is one factual issue. [00:00:13] Speaker 02: And it has to do with the binder on the annual product. [00:00:17] Speaker 02: And I think all of those can really resolve every issue. [00:00:20] Speaker 02: Everything is before the court. [00:00:22] Speaker 05: But the meaning of a Marquish group within a comprising claim [00:00:29] Speaker 05: It's key here, isn't it, to your PD or appeal? [00:00:32] Speaker 02: It is. [00:00:33] Speaker 02: It is key. [00:00:35] Speaker 02: The difference between many cases and this case is the specific language that's in Nismark's group. [00:00:43] Speaker 02: And this goes to Judge Toronto, your dissent in multi-layer, where you have to look at the specific words. [00:00:50] Speaker 03: Right, but the particular ground of that dissent is not an issue here. [00:00:54] Speaker 03: That was about a question whether [00:00:56] Speaker 03: genus-species relation was a necessary part of this, and we don't have that. [00:01:00] Speaker 02: Correct, correct. [00:01:01] Speaker 02: But I took the point from your dissent that you really need to look at the words, and the words here are different than in multi-layer and in other Marcouche cases. [00:01:09] Speaker 02: The words here are similar to the in-rate Krish case. [00:01:13] Speaker 05: Some judges think that dissents don't count. [00:01:17] Speaker 02: Well, that may or may not be, Your Honor, but I'm just taking some guidance. [00:01:24] Speaker 02: But I think it's a good one in that you need to look at the words, and the words are important. [00:01:28] Speaker 02: And the words that are important here are the at least ones. [00:01:31] Speaker 02: So if you look at that claim in its totality, you have comprising, which is open-ended. [00:01:36] Speaker 02: You have at least one [00:01:39] Speaker 02: which Krish and Manisman say, suggests that there's something else that's in that group or something else you can have that serves that function. [00:01:48] Speaker 05: And then you have the... And does at least one override the two cases which are Multilayer and Shire? [00:02:05] Speaker 02: Yeah, well, I don't know about that. [00:02:07] Speaker 05: That's your problem, multilayer and Shire. [00:02:09] Speaker 05: But does at least one override those holdings? [00:02:13] Speaker 02: Yes, it does, Your Honor. [00:02:14] Speaker 02: And the difference is the existence of the language at least one. [00:02:19] Speaker 02: So that language, if you look at Krish, what Krish says is that that implies that there's something else. [00:02:25] Speaker 02: And so that language is not in multilayer, and it's not in Shire. [00:02:30] Speaker 02: Shire, for example, uses two. [00:02:32] Speaker 02: It nests. [00:02:34] Speaker 02: consists of and consisting of. [00:02:38] Speaker 02: So that's a double in there. [00:02:40] Speaker 02: Here, if you look at the language, you have the comprising which is open-ended, the at least one which is not either in multilayer or Shire, and then on top of that you have the end mixtures thereof at the end of the binder term. [00:02:55] Speaker 02: And so, and also the disintegrate term. [00:03:00] Speaker 02: And so what that means is, according to multilayer, multilayer determined this, is that the mixtures refer to the excipients that's within that Marcouche group, which leaves the at least language having to have a different meaning than the end mixtures thereof. [00:03:16] Speaker 02: And the only meaning it can have in this context consistent with the Krish case and the management case is that something else is allowed. [00:03:25] Speaker 03: It is your view and important to your view that while, let's just think about binders, while other unlisted binders are permissible, the percentage ranges have to be met only by the listed ones. [00:03:45] Speaker 03: Correct. [00:03:46] Speaker 03: So that you could have, I forget what the, is this the one to five or is that the other one? [00:03:50] Speaker 02: Yeah. [00:03:52] Speaker 02: I have it. [00:03:53] Speaker 02: Yeah, one to five percent. [00:03:54] Speaker 02: The binder is the one to five. [00:03:55] Speaker 03: So that you could have 20 percent of binders, but as long as 15 percent of that, 15 percent was made up of unlisted ones, that would be met. [00:04:08] Speaker 02: uh... that would be technically correct i think your honor but there is it but there is an element of claim and i'm i'm sorry i hope i didn't cut you off there there's an element of the claim it's gotta be useful to treat the disease right yeah yeah right right right but here's i guess why why i'm why i'm asking it seems to me that [00:04:27] Speaker 03: the origin story of this claim where C and D get content filled in after an initial version, not quite initial but almost initial, version of the claim that in which the diluent has listings but the other two do not, that I'm finding it hard to read that initial version as saying something other than all the binders together must be between one and five percent. [00:04:58] Speaker 03: And yet your view is that when the specificity was added by the examiner's amendment, [00:05:09] Speaker 03: that principle, that interpretation, that understanding fell away. [00:05:15] Speaker 03: And suddenly, the totality of binders could be more than 5%. [00:05:20] Speaker 03: That seems problematic to me. [00:05:23] Speaker 03: So I guess I'd like to hear about that. [00:05:24] Speaker 02: Well, you can't go above 100%. [00:05:26] Speaker 02: I think really what you need to look at, though, is if you go back to what the nature of the invention is, and I think this is one thing that the district court did not do, if you look at what happened here, this was considered to be, the FDA called it, [00:05:39] Speaker 02: a magic bullet drug, right? [00:05:41] Speaker 02: And this act of syncalcet was notoriously difficult, in fact a nightmare to formulate. [00:05:48] Speaker 02: And so what happened here is they came up with the active, they came up with the salt version of it, and they came up with these excipient classes. [00:05:58] Speaker 02: And the way the classes are divided is by their common characteristics. [00:06:03] Speaker 02: And so what made this work was having those particular classes, which are embodied by the Mark Kusch group, in those percentages. [00:06:15] Speaker 02: And so if somebody came along and added 1% of something else, is it fair that they can defeat the patent that way when it makes absolutely no difference in terms of what makes this invention what it is, right? [00:06:27] Speaker 02: This magic bullet drug. [00:06:29] Speaker 02: And so it was that unique formulation that made this work that hadn't worked previously before. [00:06:36] Speaker 02: And so, Your Honor, you mentioned 20%. [00:06:39] Speaker 02: I could say half a percent of something else. [00:06:43] Speaker 02: And so should somebody be permitted to beat the patent by putting in a half a percent of something that doesn't make any difference to the invention at all? [00:06:53] Speaker 05: That's what comprising is for. [00:06:56] Speaker 02: Yes, it is. [00:06:56] Speaker 02: But that's also why the at least is there as well. [00:06:59] Speaker 02: And so it's intended to cover those circumstances where somebody's trying to do that. [00:07:07] Speaker 05: In other words, the at least. [00:07:09] Speaker 05: exacerbates the stringency of the maqush, the usual stringency of the maqush. [00:07:17] Speaker 02: Yes, exactly. [00:07:17] Speaker 02: That's exactly right, Your Honor. [00:07:20] Speaker 02: The other point I want to make here, too, is that where the district court erred is in, Judge Stroner, you bring up the unlisted excipients, and I interpreted that as being something that's not disclosed in the patent. [00:07:33] Speaker 03: But when you have this formulation... What I meant by unlisted is not in the claim. [00:07:38] Speaker 02: Okay. [00:07:39] Speaker 02: Well, yeah. [00:07:40] Speaker 02: All right. [00:07:41] Speaker 02: So maybe we should clarify this so that we're talking about the same thing. [00:07:46] Speaker 02: One thing that district court did is- I'm remembering right. [00:07:49] Speaker 03: I mean, the list in the claim matches the list in the spec. [00:07:54] Speaker 02: It does. [00:07:55] Speaker 02: But what the district court did is it was determining that one of the listed excipients, if it had a secondary function, was considering that to be an unlisted excipient. [00:08:05] Speaker 02: And that to me is particularly difficult in terms of the reasoning here. [00:08:09] Speaker 02: And looking at the global, how you look at this invention in its totality and what it was intended to accomplish. [00:08:16] Speaker 02: And so if I have a pre-gelatinized starch, which is a diluent, and it happens to have a secondary function as a binder, he was calling that to be... This is the issue in the zidus clay. [00:08:30] Speaker 02: Yes, that's right. [00:08:32] Speaker 02: He was considering that to be an unlisted binder and that would defeat the infringement claim. [00:08:37] Speaker 02: But that's supposed to be in there. [00:08:39] Speaker 02: The pre-gelatinized starch was supposed to be in the composition and so because it was actually operating to have a secondary function, should not disqualify it or take it outside the scope of the claim as something that's unlisted. [00:08:54] Speaker 02: Now if somebody comes along [00:08:56] Speaker 02: and comes up with a different binder that's nowhere disclosed or isn't supposed to be in there. [00:09:02] Speaker 02: I still think that's included by the claim, but that's different. [00:09:08] Speaker 02: But he has even excluded excipients that serve secondary functions. [00:09:13] Speaker 02: And that's not fair. [00:09:15] Speaker 02: And that's not consistent with the patent teaching. [00:09:17] Speaker 02: What the patent teaching is about is you take one excipient, at least one, from each of those categories. [00:09:26] Speaker 02: And it forms the formulation with the active. [00:09:31] Speaker 02: And that's what's important. [00:09:32] Speaker 02: And if it serves a secondary function, it doesn't matter. [00:09:35] Speaker 02: I think one thing the district court found was that there was wild agreement that all of these excipients have secondary functions, or they can have secondary functions. [00:09:45] Speaker 02: And so everybody knew that. [00:09:46] Speaker 02: And people of skill in the art would read the patents that way. [00:09:49] Speaker 02: And so to call that an unlisted, an unlisted exhibit, I think just turns logic on its head. [00:09:58] Speaker 02: So that can't be the right interpretation. [00:10:00] Speaker 05: I think I misspoke. [00:10:02] Speaker 05: I got mixed up with my four syllable words. [00:10:06] Speaker 05: I think I said exacerbates, ameliorates is the point. [00:10:12] Speaker 05: Simpler is better. [00:10:14] Speaker 02: OK. [00:10:14] Speaker 02: Yes, I agree. [00:10:21] Speaker 02: So I think you have to look at the invention. [00:10:23] Speaker 02: That's something that the district court did not do. [00:10:26] Speaker 02: It didn't really look at the invention here. [00:10:29] Speaker 02: The other thing that district court didn't do, just getting back to this at least one language, district court never addressed that. [00:10:35] Speaker 02: During the trial, it was attempted to be brought in, this issue. [00:10:39] Speaker 03: And the trial council- But this is part of a claim construction argument. [00:10:42] Speaker 02: No, it was after the claim construction. [00:10:45] Speaker 03: But you are now making this as part of a claim construction. [00:10:48] Speaker 02: Yes, I am. [00:10:49] Speaker 03: So why would that be brought in at trial? [00:10:53] Speaker 02: Well, because the judge never considered the at-least language. [00:10:57] Speaker 05: Well, that almost doesn't need to be construed. [00:10:59] Speaker 05: It's sitting right there. [00:11:00] Speaker 05: It has plain meaning. [00:11:02] Speaker 02: Well, I guess so, but there was a disagreement which came up about a week and a half before trial as to that language. [00:11:11] Speaker 02: In fact, Amniel, I mean, there was a claim construction proceeding about a year or nine months before trial. [00:11:15] Speaker 02: This issue never came up. [00:11:17] Speaker 02: Amniel brings this up a few weeks before trial. [00:11:21] Speaker 03: The district court judge is now... The whole issue of the closed versus open. [00:11:25] Speaker 03: That's what you mean by this issue. [00:11:26] Speaker 02: Yes, yes, that's exactly right. [00:11:28] Speaker 02: This only was resolved a week and a half before trial. [00:11:30] Speaker 02: And the district court judge said, even after trial, he said, well, my ruling apparently caused confusion at trial. [00:11:36] Speaker 02: And there did, to me at least, seem like a lot of confusion at trial. [00:11:40] Speaker 02: And that he was not going to proceed with the case until this issue was resolved by the federal circuit. [00:11:45] Speaker 02: And so there was a little bit of confusion or maybe a lot of confusion on this issue. [00:11:51] Speaker 02: And the issue really is the closed versus open. [00:11:54] Speaker 02: And that's really driven by the at least one, which is not in multi-layer and it's not in Shire. [00:12:01] Speaker 02: And so that issue should have been addressed. [00:12:03] Speaker 02: I think this court can address this de novo if you look at the language. [00:12:08] Speaker 02: Because it can only mean that at least one can only mean one thing in the context of that claim. [00:12:14] Speaker 02: And that means that the rest of that element is open. [00:12:20] Speaker 02: It can include unlisted. [00:12:22] Speaker 02: And the unlisted can be something that's not supposed to be in there, but it especially includes excipients that are supposed to be in there anyway, according to the patent. [00:12:33] Speaker 02: And they just serve a secondary function. [00:12:40] Speaker 02: Okay, so I've got two more issues I want to cover really quickly. [00:12:45] Speaker 02: One of them is the binder in the amnyl product, this HPMC versus opadry. [00:12:54] Speaker 02: One thing that the district court did is it decided that this opadry [00:12:59] Speaker 02: which is 92% HPMC, which is a listed excipient. [00:13:04] Speaker 02: District court said, no, this opidry is something different because it's in this, because it's combined with polyethylene glycol, a PEG, which is a plasticizer, it's not a binder. [00:13:14] Speaker 02: Yet, he concluded that it's, that the HPMC is a distinct chemical entity. [00:13:24] Speaker 03: so what he said is opa dry is not the part that i guess i'm remembering that he said that seems to me to go beyond that was that with the plasticizers the nature of opa dry as a binder as a binder is different from the nature of the ninety two percent [00:13:43] Speaker 03: HPC as a binder. [00:13:47] Speaker 03: And so you would, in fact, it's not like Funk Brothers where you just put a couple of things in the package and they have nothing to do with one another. [00:13:55] Speaker 03: The district court found that when you put a couple of plasticizers with the HPC, the mixture is now a different binder from what HPC was alone. [00:14:06] Speaker 02: Well, that's inconsistent with his determination that the HPMC is a distinct chemical entity in overdrive. [00:14:16] Speaker 02: What I would say about what you just said, Judge Naranjo, is that what he was doing there was more of a DOE analysis rather than a literal infringement analysis. [00:14:28] Speaker 02: When you determine that HPMC is a distinct chemical entity in the overdrive, and it constitutes 92% [00:14:36] Speaker 03: of the opa dry and the other 8% has nothing to do with being a binder it may be that the plasticizer the district court did not the district court found the opposite of the 8% has nothing to do with it being a binder the district court said once you have that other stuff it does have something to do with it being a binder [00:14:56] Speaker 02: Well, it may have enhanced effects, but again, I think that's more of a DOE concept, right, in terms of a function-way result. [00:15:03] Speaker 02: Maybe you get a somewhat different result. [00:15:05] Speaker 02: That does not mean that the HPMC is not in the solution. [00:15:10] Speaker 02: it may have an enhanced binder function because of the peg and just accepting that as true for the purposes of this argument. [00:15:20] Speaker 02: That does not mean that the HPMC is not there and that was his factual ruling. [00:15:27] Speaker 02: If we have to go by clear error, when it comes to the clear error standard, when it comes to fact finding, we should also be able to get the benefit of his other rulings, which is that HPMC is a distinct chemical entity in the open dry, which means it's a distinct chemical entity in the AND solution. [00:15:47] Speaker 02: Unless there's questions on that, I just want to move on to prosecution history estoppel because this is an important issue for us. [00:15:53] Speaker 04: Well, if you could be brief because we're running out of time. [00:15:56] Speaker 02: Oh, I'm sorry. [00:15:57] Speaker 02: All I want to say is that the one thing that made a difference and the one claim element that made the difference in the allowance [00:16:09] Speaker 02: was the narrowing of the range of the active. [00:16:12] Speaker 02: If you look at the excipient elements, they were never changed. [00:16:17] Speaker 02: All that happened was that the [00:16:19] Speaker 02: Claims six and eight which were the Marcuse groups were moved into the independent claim But there was no no narrowing in response to the prior art The only thing that was narrowed was the range of the active and that's why the claims are allowed So we don't even get to the issue of there may have been narrowing, but it certainly wasn't with respect to the binder Marcuse group It was not for the purposes of patentability and in any event [00:16:44] Speaker 02: The narrowing of the binder was tangential, which is similar to the Lillard case. [00:16:53] Speaker 04: Before you sit down, we have a question about the cross appeal. [00:16:58] Speaker 04: We noticed that there are three of you on that side of the table. [00:17:03] Speaker 04: Were you planning on raising the cross appeal as a principal argument? [00:17:07] Speaker 04: Because I note that Mr. Maddox, you actually reserved a minute of rebuttal. [00:17:12] Speaker 04: which implies an opportunity for the other side to respond. [00:17:17] Speaker 04: Does that make sense as a way to approach the cross-appeal? [00:17:22] Speaker 03: Are you speaking first? [00:17:24] Speaker 03: I'm going to ask you a question about jurisdiction, so you should have that in mind. [00:17:28] Speaker 04: Okay. [00:17:33] Speaker 03: Is it ready to go? [00:17:34] Speaker 04: Well, in that case, all right, then we'll proceed. [00:17:37] Speaker 04: Now, you planned to [00:17:43] Speaker 04: Well, I'm not sure how you plan to organize this, but you'll tell us as you go along. [00:17:48] Speaker 00: We divided the 15 minutes we have among us. [00:17:51] Speaker 00: I did file it as a separate appeal. [00:17:53] Speaker 00: We were consolidated by the court, and so we do the best we can with what the court has given us. [00:17:58] Speaker 03: OK. [00:17:59] Speaker 03: So you represent Zydus, and you have a judgment of infringement against you. [00:18:04] Speaker 03: That's correct. [00:18:05] Speaker 03: I'm concerned about whether we have jurisdiction over the appeal from that. [00:18:10] Speaker 03: Not about the other one, right? [00:18:12] Speaker 03: The other one is the amnial pyramal one. [00:18:15] Speaker 03: That one, there's a judgment in the district court of non-infringement. [00:18:21] Speaker 03: And we've had a bunch of cases that say, in that circumstance, the defendant can say, as long as this judgment sticks, we're happy litigation over. [00:18:31] Speaker 03: If it doesn't, we've got some invalidity defenses and counterclaims we're going to come back with. [00:18:37] Speaker 03: You're in the opposite position. [00:18:39] Speaker 03: You have a judgment. [00:18:40] Speaker 03: that says you infringe. [00:18:44] Speaker 03: I can't quite and I don't know of any cases where we have said there is a final judgment or what we don't have here but even that there could be a rule 54b judgment that allows you to say [00:18:59] Speaker 03: what happened here as to Zydus. [00:19:02] Speaker 03: We're going to put the invalidity claims. [00:19:04] Speaker 03: We're going to dismiss them without prejudice. [00:19:08] Speaker 03: But if that judgment, the one you actually have in front of you, is affirmed, I assume you're not going to stand here and say, we hereby forego our invalidity defenses and counterclaims. [00:19:20] Speaker 03: You're going to want to raise them, right? [00:19:27] Speaker 00: I don't know. [00:19:29] Speaker 00: My client is right there. [00:19:30] Speaker 00: I could ask him. [00:19:31] Speaker 03: In any event, are you aware of any precedent that allows a judgment that on its face, infringement, doesn't end the dispute because that judgment could be undone by the invalidity defenses? [00:19:52] Speaker 03: If you're prepared to say they're gone with prejudice, then that's one thing. [00:19:58] Speaker 03: You shouldn't have to decide this by, you know, by a 30-second conversation. [00:20:02] Speaker 04: Do you need help from a colleague to come forward? [00:20:06] Speaker 00: May I? [00:20:13] Speaker 00: I'm sorry, as you know, jurisdiction wasn't raised on the brief. [00:20:15] Speaker 03: I know, but we're obliged to address it. [00:20:18] Speaker 00: I appreciate that. [00:20:19] Speaker 00: I'm just saying we're caught a little bit. [00:20:22] Speaker 00: Even if infringement is a firm Okay, so [00:20:40] Speaker 00: Clean construction. [00:20:43] Speaker 00: This case is just like Multilayer and Shire. [00:20:46] Speaker 00: They come in, and the arguments keep shifting. [00:20:49] Speaker 00: In the briefs, it was there's stuff in the specification that seems to indicate other things can be used. [00:20:54] Speaker 00: This is exactly what we had in Multilayer, and it's exactly what we had in Shire. [00:21:00] Speaker 00: The words at least one are not magical, and they do not exacerbate nor ameliorate. [00:21:07] Speaker 00: Marcuse group in 2003 this court told told patentees that if they wanted in Abbott If they wanted to cover a combination of mixtures in their Marcuse groups They should use language like and mixtures thereof or in at least one member of the group. [00:21:23] Speaker 05: This is but why why doesn't at least Keep you in the Marcuse group [00:21:32] Speaker 05: So it basically enlarges the Marcoosh group because it's part of it. [00:21:39] Speaker 00: No, at least one tells you that you can have multiple members of the Marcoosh group. [00:21:46] Speaker 00: And mixture tells you you can have mixtures of those ingredients. [00:21:51] Speaker 00: And that's what you asked for in 2003 in the advocacy. [00:21:54] Speaker 05: So you're saying at least one must be at least one of those recited? [00:21:57] Speaker 00: Yes. [00:21:58] Speaker 00: Now, as for why this doesn't really mean comprising, Judge Toronto, you put your finger on it. [00:22:05] Speaker 00: We started this as a claim of limited to 1% to 5% binders. [00:22:10] Speaker 00: Then the patent examiner said, you've got problems with the prior art. [00:22:14] Speaker 00: Creekmore, I believe. [00:22:16] Speaker 00: How about you do this? [00:22:17] Speaker 00: You put this Marquise group in limited to these things. [00:22:22] Speaker 00: And now the result of that limiting amendment, according to Amgen, would be to have basically opened the amount of binder to anything you want. [00:22:34] Speaker 00: It doesn't have to be only up to 5%. [00:22:35] Speaker 00: This, by the way, also runs into the science [00:22:40] Speaker 00: that Amgen gave to the US examiner, as well as the European examiners, and reporting their experiments about how the limitations on amounts of weight were what was critical to getting the desired effect. [00:22:53] Speaker 00: So the real thing that's going on in Krish, first of all, we're putting aside the different standard. [00:23:00] Speaker 00: In Krish, this court said, listen, the language requiring, quote, at least a portion, and that was in the claim language there. [00:23:09] Speaker 00: of nucleotides implies that the pending claims contemplate additional nucleotides. [00:23:14] Speaker 00: And the language back in Madison, it had one part that was at least one, but it had at least a portion. [00:23:21] Speaker 00: It's the portion that's causing the problem there. [00:23:24] Speaker 00: And I would suggest that this court has never said that using the signposts for mixtures and multiple combinations that the court gave it back in 2003 [00:23:40] Speaker 00: has never held that that means consisting of, with respect to a Marcuse group, turns into comprising. [00:23:46] Speaker 00: It sort of defies common sense that it would, especially given this prosecution history. [00:23:52] Speaker 00: Now, turning to the errors here, yes, we put all our arguments in there. [00:23:58] Speaker 00: He did seem to change the burden of proof. [00:24:01] Speaker 00: All of a sudden, it became Zydus's job to rebut allegations. [00:24:05] Speaker 00: But mostly, in ante cases, you have many of them before you. [00:24:10] Speaker 00: These are consolidated trials. [00:24:13] Speaker 00: The judge basically said, OK, Andin, you didn't meet your burden of proof, but I'm going to go find evidence from some other defendant in this trial I've consolidated for my convenience. [00:24:25] Speaker 00: I'm going to apply that expert opinion in a way that that expert himself refused to do and in a way that contradicts my own finding of fact that you cannot determine the function of PGS based on weight percent alone. [00:24:40] Speaker 00: and then I'm going to find you infringed. [00:24:43] Speaker 00: Now this is going to lead to a bunch of very interesting consolidated trials because we, at this table, are competitors. [00:24:51] Speaker 00: Consolidation of trials is for the court's convenience. [00:24:54] Speaker 03: But doesn't that fact that your competitors put you on notice that you cannot rely on the other people at your table as your friends for purposes of immunizing you from the effect of evidence that they put on? [00:25:13] Speaker 00: So let the word go out that if you're in a consolidated trial, you are now litigating against the patent holder who has a burden of proof, and you've been through in discovery. [00:25:25] Speaker 00: But don't worry, the patent holder doesn't have to worry about the burden of proof so much, because afterwards, if he can find other stuff from other people said about you. [00:25:33] Speaker 03: But plaintiffs all the time get to rely, unless there's some sort of procedural objection or something, to meet their burden by, among other things, evidence that the defendant puts on. [00:25:47] Speaker 00: Against that defendant, yes. [00:25:49] Speaker 03: but why not by any other evidence? [00:25:51] Speaker 00: Why not by any other defendants? [00:25:53] Speaker 00: And the litigation is going to change, because we're going to start litigating against each other. [00:25:58] Speaker 00: And frankly, there should be a point at which consolidation doesn't affect [00:26:03] Speaker 00: the burden and quantum of proof you have to refute. [00:26:06] Speaker 00: And it shouldn't affect the patentee's burden of actually proving infringement. [00:26:10] Speaker 00: But even if you were going to say, great, open season, sorry, generics, you're going to be fighting each other as well for the court's convenience, even if you're going to say that, then when the court does reach out to grab some evidence, at least let's make it evidence that's not clearly erroneous. [00:26:29] Speaker 03: Well, that's a different argument. [00:26:31] Speaker 00: Well, but it's happened here. [00:26:34] Speaker 00: The judge said, well, I see from this expert, over 20%, it won't be a binder, and so you're free. [00:26:42] Speaker 00: And so you have failed to rebut the allegations. [00:26:48] Speaker 00: The actual expert refused to do that, said you can't do that. [00:26:52] Speaker 00: And even the fact that the court elsewhere had found us fact. [00:26:56] Speaker 00: that you cannot tell from just the weight. [00:26:58] Speaker 00: And then it turned around and said, hey, I can tell from just the weight. [00:27:02] Speaker 00: The court got lost on this. [00:27:04] Speaker 00: It lost the forest for the trees. [00:27:06] Speaker 00: The court got the claim construction right. [00:27:09] Speaker 00: It's black litter law. [00:27:10] Speaker 00: It's straightforward. [00:27:10] Speaker 00: There's nothing magical about at least one. [00:27:13] Speaker 00: And then the court lost the forest for the trees, and my client suffered. [00:27:17] Speaker 00: Court got confused, made some errors of law, and fact. [00:27:20] Speaker 00: Thanks. [00:27:21] Speaker 04: So you're sharing your time with your colleagues. [00:27:25] Speaker 04: OK, next is Mr. Barkoff. [00:27:26] Speaker 00: I have a minute reserved for rebuttal. [00:27:28] Speaker 00: I cede that. [00:27:28] Speaker 04: Well, I saw you were saving a minute. [00:27:31] Speaker 04: It depends on what there is to rebut, I suppose. [00:27:33] Speaker 00: If you allow me more, but I know I've done before, and I certainly don't want to short my analysis. [00:27:38] Speaker 04: OK, Mr. Barkoff. [00:27:43] Speaker 01: May it please the court. [00:27:44] Speaker 01: My name is Aaron Barkoff. [00:27:46] Speaker 01: I represent Parimal Health Care in this case. [00:27:48] Speaker 01: One of the two defendants who prevailed below with the judgment of non-infringement. [00:27:55] Speaker 01: Council for Amgen said this is a complicated case. [00:27:58] Speaker 01: That may be true because there are three defendants here and one is a cross-appellant, but for Paramo, this is a very simple case. [00:28:08] Speaker 01: This case is a textbook example of prosecution history estoppel. [00:28:14] Speaker 01: Amgen filed broad claims to a formulation comprising at least one binder. [00:28:20] Speaker 01: The examiner rejected the claims as obvious over prior art disclosing the active ingredient and formulations comprising binders and disintegrants. [00:28:31] Speaker 01: Amgen then amended the claims to recite a specific amount of synicalcite from about 20 milligrams to about 100 milligrams. [00:28:41] Speaker 01: The examiner maintained the rejection even in the face of that narrowing of the amount of synicalcite. [00:28:50] Speaker 01: The examiner suggested adding a Marcouche group of four binders and another Marcouche group of three disintegrants. [00:28:58] Speaker 01: Amgen agreed to that examiner's amendment. [00:29:01] Speaker 01: Then the claims were allowed. [00:29:03] Speaker 01: And in allowing the claims, the examiner stated, the closest prior art fails to specifically disclose or render obvious the combination of components and in the amounts thereof set forth in claim two. [00:29:19] Speaker 01: there can be no credible dispute that the amendment adding the Marcoosh group to the Marcoosh groups to the claims was made for a substantial reason of patentability. [00:29:33] Speaker 03: Amgen relies heavily on their own... Can I just ask you, I think you said that after the absolute weight as opposed to the percentage weight of Senecausa was added, the examiner rejected the claims again. [00:29:44] Speaker 03: Can you just [00:29:46] Speaker 03: Give me the joint appendix page where that happened. [00:29:48] Speaker 01: Yes, Your Honor. [00:29:49] Speaker 01: It's 9457 through 9458. [00:30:16] Speaker 01: That's the examiner's amendment. [00:30:20] Speaker 03: I think I heard you say that before the examiner's amendment the absolute weight was added and nevertheless the examiner again rejected it. [00:30:32] Speaker 03: I was not remembering that. [00:30:35] Speaker 01: There was not a formal office action per se but if you look on appendix 9457 you'll see under examiner's amendment [00:30:45] Speaker 01: An examiner's amendment appears below authorization to the examiner's amendment was given in a telephone interview with Alicia Russo on March 12, 2015 before the mailing of this examiner's amendment on March 25th. [00:31:03] Speaker 01: So there was an examiner-initiated interview where the examiner maintained the rejection [00:31:09] Speaker 01: and proposed a claim amendment, adding the Marcouche groups. [00:31:14] Speaker 03: I'm sorry. [00:31:15] Speaker 03: I just want to be a little picky here. [00:31:18] Speaker 03: Where the examiner maintained the rejection. [00:31:21] Speaker 03: Show me where that is. [00:31:23] Speaker 01: Perhaps I shouldn't have used those words. [00:31:26] Speaker 03: Well, you know, it does make a difference. [00:31:28] Speaker 03: Their whole point is that the only important part of the amendment was the absolute weight of cynicalis. [00:31:35] Speaker 03: This is what this debate is about. [00:31:38] Speaker 01: That is their point. [00:31:40] Speaker 03: And one of the things they say is that the prior art that had been invoked had the same, or at least one of the same, maybe more than one, but at least one is probably all that matters, of the excipients. [00:31:57] Speaker 03: So the addition of the specificity as to excipients could not have mattered. [00:32:05] Speaker 01: Well, I disagree with that, Your Honor. [00:32:07] Speaker 03: The prior art. [00:32:08] Speaker 03: Oh, it doesn't? [00:32:10] Speaker 01: There were three pieces of prior art. [00:32:12] Speaker 01: One disclosing the active ingredient. [00:32:14] Speaker 01: That was van Weggenen. [00:32:16] Speaker 01: That's Amgen's patent on the molecule, Cynicalcid. [00:32:19] Speaker 01: The examiner combined that with two other articles disclosing pharmaceutical formulations that did not include Cynicalcid. [00:32:27] Speaker 01: There were other pharmaceutical formulations disclosing compositions comprising [00:32:33] Speaker 01: a long list of binders and a long list of disintegrants. [00:32:38] Speaker 01: And the examiner in this examiner-initiated interview proposed amending narrowing the claims dramatically from at least one binder and at least one disintegrant [00:32:52] Speaker 01: to market groups comprising the specific binders and specific disintegrants that were disclosed in the specification and in the examiner's i think i now understand what i understood before you [00:33:07] Speaker 03: said something, I don't think your argument depends on what you asserted about how there was a rejection even after an initial addition of the absolute weight of the cynical set. [00:33:21] Speaker 03: So I took it that the record showed that the examiner rejected the original claims, post preliminary amendment claims. [00:33:32] Speaker 03: The only thing we know is that the examiner said, [00:33:36] Speaker 03: I want not only [00:33:39] Speaker 03: I now see there's an absolute weight of cynical set and I would like to add the identification of particular excipients and with that, that whole combination, it's enough. [00:33:54] Speaker 01: Yes, and Your Honor, if I may, I believe reasonably inferred that he maintained the rejection because if he had not, he would have allowed the claims without those additional Marquish claim amendments. [00:34:08] Speaker 01: He would have said, yes, the narrowing of the amount of cynicality is sufficient to overcome the prior arc. [00:34:14] Speaker 01: He didn't do that. [00:34:15] Speaker 01: He made very substantial narrowing claim amendments that Amgen agreed to. [00:34:20] Speaker 01: Amgen says that wasn't for reasons of patentability because we later put in this. [00:34:24] Speaker 01: Right. [00:34:25] Speaker 03: I think, I mean, their problem is that the record [00:34:28] Speaker 03: doesn't really tell you that it wasn't for reasons, that these pieces weren't for the reasons, with one possible exception, and that is their argument about how the three pieces of prior art contained all of these, so this part could not possibly be, this part, the addition of the identity of binder and disintegrant excipients, could not possibly have been part of the reason to overcome [00:34:57] Speaker 03: the prior art rejections. [00:34:59] Speaker 01: That is Amgen's argument. [00:35:00] Speaker 03: Right, so can you tell me why they're wrong about that? [00:35:03] Speaker 01: Yes, they're wrong because the prior art, one [00:35:07] Speaker 01: leaving aside the van weggen in reference, which disclosed Cynicalcid. [00:35:11] Speaker 01: Going to the Sioux reference, HSU, that reference disclosed 10 binders and 12 disintegrants. [00:35:18] Speaker 01: You multiply those together, you get 120 binder-disintegrant combinations. [00:35:24] Speaker 01: The other reference, Creekmore, disclosed 19 binders and 8 disintegrants. [00:35:29] Speaker 01: And I'm not going to try the math in my head, but it's around 140 [00:35:36] Speaker 01: binder-disintegrant combinations. [00:35:39] Speaker 01: The claims, Amgen's claims, were narrowed to recite three binders and four disintegrants. [00:35:45] Speaker 01: That's 12 combinations with Cynicalcid. [00:35:50] Speaker 01: And the examiner said in his statement of reasons for allowance, the prior art does not disclose these specific combinations. [00:35:58] Speaker 03: Help me unravel the confusion. [00:36:01] Speaker 03: Tell me why it would be wrong to say as long as any one of the ultimately selected binder disintegrants appeared in the prior art, the prior art would stand as an objection to these claims. [00:36:20] Speaker 01: Well, because the prior art also disclosed hundreds of other combinations and [00:36:29] Speaker 01: a separate reference disclosed Cynicalcid. [00:36:32] Speaker 01: So there was no anticipation rejection here. [00:36:35] Speaker 01: It was an obvious disrejection that relied upon combining disparate references. [00:36:42] Speaker 05: Was there any evidence to show that this particular formulation has properties unexpected over the formulation of this compound? [00:36:53] Speaker 05: These are all standard ingredients. [00:36:57] Speaker 01: no your honor because the parties agreed to bifurcate the trial into infringement and then validity later the parties agreed that the court would try infringement first so we didn't reach questions of validity and evidence of unexpected results therefore wasn't presented to the court all right thank you [00:37:32] Speaker 04: Thank you, Your Honor. [00:37:35] Speaker 06: Yes, I'm going to address the finding by the district court that there is no listed binder present in Amniel's proposed formulation. [00:37:44] Speaker 06: There was an entire failure of proof on that element. [00:37:47] Speaker 06: I'm Jake Holdreth. [00:37:48] Speaker 06: I represent Amniel. [00:37:50] Speaker 06: The Amniel case was decided, among other things, on a non-infringement finding that opadry is not HPMC, the listed binder to which Amgen equated it. [00:38:02] Speaker 06: They are different molecular entities with different functions. [00:38:06] Speaker 06: And just as salt. [00:38:08] Speaker 05: What do you mean different molecular entities? [00:38:11] Speaker 05: HPMC is HPMC, right? [00:38:17] Speaker 06: Correct, your honor. [00:38:18] Speaker 06: And open drive. [00:38:19] Speaker 05: That's the same molecular entity. [00:38:21] Speaker 05: The presence of 8% something else is different. [00:38:25] Speaker 05: But HPF hydroxypropyl methyl cellulose is just that, right? [00:38:30] Speaker 06: Well, Your Honor, this is a fact issue. [00:38:33] Speaker 06: It was hotly disputed. [00:38:34] Speaker 06: What the district court found is that OPA dries a molecular dispersion of HPMC with two grades of polyethylene glycol. [00:38:42] Speaker 06: And if you were to simply mix PEGs and HPMC, you would get a slurry. [00:38:48] Speaker 06: They're miscible, but they don't form a solution. [00:38:50] Speaker 05: A physical slurry. [00:38:51] Speaker 06: Correct. [00:38:52] Speaker 05: Not a chemical reaction. [00:38:53] Speaker 06: Exactly. [00:38:54] Speaker 06: opa dry is made by a proprietary process which creates a molecular dispersion of those three ingredients and that molecular dispersion has completely different properties different functions from HPMC that were just mixed with PEG and that was the subject of extensive testimony and factual findings what the district court found was and it is [00:39:21] Speaker 06: at page 14 of his decision in appendix 16, the excipients have different chemical structures, physical characteristics, binding mechanisms, and commercial sources. [00:39:36] Speaker 06: HPMC is a single molecule, whereas opidry is a molecular dispersion of three distinct chemical ingredients. [00:39:44] Speaker 06: The testimony on that was really the subject of both experts, almost their entire testimony that's found in the cross-examination of Amgen's expert in the appendix at 3610 to 3652, direct examination of Ann Meals' expert, [00:40:02] Speaker 06: at the appendix of 3955 to 4027, and there was testing from Amnil's product development that showed that HPMC as a binder in Amnil's formulation did not release the drug in a satisfactory release curve on dissolution, but that opidry did, so that they fundamentally behaved differently with respect to a critical function of the final formulation. [00:40:28] Speaker 06: This really is just a fact dispute that was resolved in Amniel's favor on substantial evidence your honors one last quick point Council said that where a single excipient like PGS has a quote-unquote secondary function It should count as for both functions for example binder and a disintegrant That's a fact issue whether it has a secondary function [00:40:53] Speaker 06: What the trial court found here with respect to AMUEL as a separate independent ground of non-infringement is that PGS in AMUEL's formulation, in the ratio that it's found, functions only as a disintegrant, not that that is its secondary function. [00:41:10] Speaker 06: And so that too is a fact finding that should not be disturbed on appeal. [00:41:15] Speaker 06: Thank you very much, Thomas. [00:41:18] Speaker ?: OK. [00:41:18] Speaker ?: Thank you. [00:41:19] Speaker 04: So let's give five minutes of rebuttal to start. [00:41:24] Speaker 02: Thank you, Your Honor. [00:41:25] Speaker 05: Counsel, we were talking earlier about at least one, and whether that gets out from under the Malkush limitation. [00:41:33] Speaker 05: But it's at least one selected from the group. [00:41:38] Speaker 05: So why isn't that governed by the Shire and multi-layer cases? [00:41:46] Speaker 02: No, because the at least one has to mean something, right? [00:41:49] Speaker 02: And so if you look at the end of that. [00:41:51] Speaker 05: But it doesn't allow for something outside of the group. [00:41:55] Speaker 05: It's from that group. [00:41:56] Speaker 02: OK, so then you also have to, in considering that question, you have to consider what does it mean at the end of that clause and mixtures thereof, right? [00:42:05] Speaker 02: And so mixtures thereof, just grammatically, would mean combinations of the excipients in the Marcouche group. [00:42:14] Speaker 04: But I gather you always have one anyway from the group. [00:42:20] Speaker 04: And the question is whether also something from outside of the group does destroy compliance. [00:42:29] Speaker 02: Right, that's correct. [00:42:30] Speaker 02: And so what I'm saying is that the mixtures thereof and at least one cannot mean the same thing. [00:42:35] Speaker 02: They have to have different meanings. [00:42:36] Speaker 02: They have to be presumed to have different meanings. [00:42:39] Speaker 02: And what we're saying, what our position is that the mixtures thereof take into account where you can have more than one of the listed excipients. [00:42:47] Speaker 02: But at least one was intended to imply that you can have something else in there in addition to what's listed in the Marcouche group. [00:42:57] Speaker 02: Because otherwise, you'd have to conclude that both of those terms mean exactly the same thing. [00:43:04] Speaker 02: We should not be doing that because that's not proper claim construction. [00:43:10] Speaker 02: The at least one in the mixtures thereof, you can't say that they mean the same thing. [00:43:14] Speaker 02: And so they have to be different. [00:43:16] Speaker 02: And so when you look at the case law, the two cases that we cite, and there's no cases to the contrary on this, the cases that we're aware of, wherever it says at least something, a portion, at least one, in a Marquish setting, that means that you're entitled to have unlisted excipients. [00:43:36] Speaker 03: What is your view of the pre-examiner amendment claims where it says, for example, from about 1 percent to about 5 percent by weight of at least one binder? [00:43:53] Speaker 02: I think that actually supports our position. [00:43:54] Speaker 02: What does that mean? [00:43:56] Speaker 02: Well, to me, that means that you need that percentage of at least one binder, but that there's other binders because of the at least language that you can have in there. [00:44:04] Speaker 03: So you do not read that as saying the sum total of binders must be between 1% and 5%. [00:44:12] Speaker 02: Correct. [00:44:14] Speaker 02: Now, let me just make one point that I think is an important one. [00:44:19] Speaker 02: I think a lot of this dispute centers around unlisted binders being something that's nowhere disclosed in the patent. [00:44:28] Speaker 02: That, as I said earlier, is different than the situation where you have a listed binder from another group. [00:44:35] Speaker 02: that people are saying is an unlisted binder and that I think takes care of the percentage question Judge Taranto that you're raising because as long as with respect to anything that's listed it has to be governed by those percentages and I think that the secondary function of a listed binder should not fall into the same category as [00:45:02] Speaker 02: unlisted binders that are nowhere disclosed in the patent. [00:45:05] Speaker 02: And really, by the teachings of the patent, don't necessarily need to be in... This goes to the starch issue of phrasitis. [00:45:11] Speaker 02: Yes. [00:45:12] Speaker 02: Yes. [00:45:13] Speaker 02: Yes. [00:45:14] Speaker 02: And so I think the district court really went too far in a couple of different ways. [00:45:18] Speaker 02: Number one, by calling a listed binder, for example, saying a listed binder, if it has a secondary function, then it's outside the scope of the claim. [00:45:30] Speaker 02: So that was too far. [00:45:32] Speaker 02: And it was also too far to say that, well, you can't have anything else in there either, whether it's another listed binder or whether it's an unlisted something. [00:45:41] Speaker 02: And so those are two different issues. [00:45:43] Speaker 02: I think the result is the same in terms of the claim construction. [00:45:47] Speaker 02: But certainly the court's claim construction is wrong. [00:45:51] Speaker 02: And so this, it's just way too broad. [00:45:54] Speaker 03: Can I just double check? [00:45:56] Speaker 03: Amniel's argument about opidrai stands, whether right or wrong, it stands independently of this claim construction issue. [00:46:06] Speaker 03: Is that right? [00:46:07] Speaker 02: That's correct. [00:46:08] Speaker 02: That's correct. [00:46:09] Speaker 02: So with respect to that, and I'll just jump to that if I may, one thing that we cannot ignore is the fact, and I think Judge Lora, you're touching on this a little bit, right? [00:46:19] Speaker 02: Opidry contains 92% HPMC. [00:46:22] Speaker 02: This court decided after all of this fact finding that it was a distinct chemical entity. [00:46:29] Speaker 02: And you can take any substance and throw some distilled water in there and create a slurry, right? [00:46:35] Speaker 02: And yeah, it looks different. [00:46:37] Speaker 02: It's not the original form, which may be a powder or something like that, but this is just what chemical formulations are about. [00:46:43] Speaker 02: So I don't think the question is whether they look different. [00:46:46] Speaker 02: It's whether HPMC is in the anda formulation, and it definitely is, because opadry is 92% and it's a distinct chemical entity. [00:46:56] Speaker 02: That's what the court found. [00:46:57] Speaker 02: And look, we're not raising other factual issues here, right, because it's difficult on appeal to deal with those, but this is one where the court committed clear error and it came out the wrong way, notwithstanding his factual finding on that. [00:47:17] Speaker 02: Council for Amniel talked about the secondary functions being irrelevant and all of this fact finding on the secondary functions. [00:47:24] Speaker 02: And again, I think that's where the district court went wrong, because the secondary functions should be irrelevant, especially on literal infringement. [00:47:33] Speaker 02: It may be appropriate to get into that issue on doctrine of equivalence, but not on literal infringement. [00:47:42] Speaker 02: One thing I want to do is just touch a little bit on the prosecution history of Staple, if I may. [00:47:48] Speaker 02: And so we don't have to guess as to what the examiner and the applicant were up to. [00:47:54] Speaker 02: And so in the preliminary amendment, Amgen talked about how the rejections were made to place the claims in proper format and to better define the claim subject matter, including equivalence. [00:48:05] Speaker 02: The examiner did not come back and dispute that despite the fact that there were [00:48:10] Speaker 02: at least three contacts between the examiner and the applicant after that. [00:48:15] Speaker 02: There were two notices of allowances and one interview. [00:48:19] Speaker 02: And so the examiner never disputed that. [00:48:21] Speaker 02: And then when we get to the end of this, and if you look very closely through the prosecution history, you follow what happened there. [00:48:28] Speaker 02: Specific excipients were never an issue. [00:48:31] Speaker 02: And in fact, [00:48:32] Speaker 02: All of those excipients, in response to Judge Toronto to your question, all of the excipients that are in each of those Marquish claim elements were in the prior art. [00:48:42] Speaker 02: In fact, Creekmore, example number two, has at least one from each of the categories of the Marquish groups of the claims. [00:48:52] Speaker 02: So all of those were in the claims. [00:48:55] Speaker 02: There was no change to the content of the Marcouche groups in response to the rejection. [00:49:01] Speaker 02: There was no narrowing of those Marcouche groups. [00:49:03] Speaker 03: Did the priority have them in these percentages? [00:49:06] Speaker 02: No, they didn't. [00:49:07] Speaker 03: Oh, so doesn't that somewhat weaken your point that these listings [00:49:15] Speaker 03: couldn't really distinguish the prior art. [00:49:17] Speaker 02: No, but there was no change in the claim. [00:49:19] Speaker 02: There was no change whatsoever. [00:49:20] Speaker 02: I mean, the claims included the percentages from the beginning. [00:49:24] Speaker 02: And there was no change whatsoever. [00:49:27] Speaker 02: And again, we don't have to guess as to why the examiner allowed the claims, right? [00:49:30] Speaker 02: Because I'm referring to page A6, or appendix 1643. [00:49:36] Speaker 02: And so what the examiner there said is, claim compositions are distinguished from the closest prior art by incorporating precise amounts of calcium-receptive active [00:49:45] Speaker 02: Compound, cynical set HCL, right? [00:49:47] Speaker 02: So this is the narrowing of the active. [00:49:50] Speaker 02: The nature of the excipients, and previously when the examiner during the office action, he called them ingredients. [00:49:57] Speaker 02: He didn't call them, he didn't talk about the nature. [00:49:59] Speaker 02: He repeatedly, though, during the prosecution, after the rejection, called the excipients, he referred to the nature. [00:50:05] Speaker 02: And then he says it's the nature of the excipients and their respective combinations. [00:50:10] Speaker 02: So what he's talking about there is the three categories, the combination of that and the nature of these excipients. [00:50:18] Speaker 02: And so he's not talking about individual excipients. [00:50:20] Speaker 02: He's not talking about pre-gelatinized starch, which is the issue for Pyramol. [00:50:25] Speaker 02: And whether there was a specific narrowing of the claims based on starch being in the prior art, that never happened. [00:50:37] Speaker 02: And so there's no narrowing due to patentability. [00:50:40] Speaker 02: And at a minimum, at a minimum, [00:50:43] Speaker 02: It was tangentially related to the equivalent, any amendment. [00:50:47] Speaker 02: But we're not even saying that. [00:50:48] Speaker 02: We're saying that this was not narrowed for the purposes of patentability with respect to that particular element. [00:50:57] Speaker 04: OK. [00:50:57] Speaker 04: OK. [00:50:58] Speaker 04: Thank you. [00:50:59] Speaker 04: Now, Mr. Maddox, you asked for one minute on the cross-appeal. [00:51:02] Speaker 00: We haven't really gotten into it. [00:51:05] Speaker 00: Well, I just watched him do seven. [00:51:06] Speaker 00: But yeah, that was one. [00:51:10] Speaker 00: Right. [00:51:13] Speaker 00: This is not the case to rewrite Marcuse Group law. [00:51:18] Speaker 00: He lied it over, well, when it says at least one or at least a portion. [00:51:21] Speaker 05: Is that the cross-appeal Marcuse Law? [00:51:24] Speaker 00: Well, yeah. [00:51:25] Speaker 00: Our cross-appeal depends on affirming the claim construction. [00:51:29] Speaker 00: And what they are arguing is going to change Marcuse Law [00:51:32] Speaker 00: tremendously because any time according to them, if you use the phrase at least one of, which this court said you gotta use otherwise we're gonna limit you to just one in Abbott in 2003, you've opened up Marcuse Group. [00:51:47] Speaker 00: The cases Krish and Manisman back in 1986, that's your case. [00:51:53] Speaker 03: The claim language was at least a portion of, and it was that particular claim language. [00:52:06] Speaker 03: The combination of at least one and mixtures changes the rule of how you interpret these things. [00:52:12] Speaker 03: Everything else, I mean, I think that's their one point. [00:52:15] Speaker 03: Why shouldn't it? [00:52:16] Speaker 00: Why shouldn't it? [00:52:17] Speaker 00: Because they're using the flags that this court told the drafters to use, but you can have more than one thing in a composition without having a mixture of those two things. [00:52:30] Speaker 00: That doesn't follow that a combination of things is always a mixture. [00:52:36] Speaker 05: Isn't your answer that at least relates to what was recited the same things? [00:52:42] Speaker 05: It's not outside of that. [00:52:45] Speaker 00: Yes, that would be my answer to a slightly different question, but yes, that would be my answer to your question, but I also gave you another answer. [00:52:56] Speaker 00: If the rule is going to be [00:52:58] Speaker 00: You want to cover having more than one and having mixtures of one. [00:53:02] Speaker 00: But if you put language of both the at least one and the mixture, you lose it all, then I guess we should make that rule and tell everyone about it very loudly because it would be so new and so different. [00:53:16] Speaker 00: There are times when you could take construction and say at least a portion of it. [00:53:19] Speaker 04: We're going to have to wrap it up. [00:53:22] Speaker 04: I think we will have to figure it out. [00:53:24] Speaker 04: Thank you all. [00:53:25] Speaker 04: The case is taken under submission. [00:53:27] Speaker 04: That concludes our arguments for this morning and afternoon.