[00:00:04] Speaker 02: I would ask them. [00:00:10] Speaker 04: Our next case is Gator Research and Development versus Abbott and GMBH consolidated. [00:00:23] Speaker 04: That's case 15-16-62 and we've consolidated for purposes of oral argument today [00:00:30] Speaker 04: That case was Abbott, GmbH versus leader research and development. [00:01:07] Speaker 04: Mr. Nelson, we've given you 20 minutes due to the consolidation. [00:01:11] Speaker 04: I understand that you're reserving five minutes of the 20 minutes for rebuttal. [00:01:15] Speaker 04: Is that correct? [00:01:15] Speaker 04: That's correct, Your Honor. [00:01:16] Speaker 04: And the other side has 20 minutes in total time. [00:01:21] Speaker 04: You may proceed. [00:01:22] Speaker 03: Thank you, Your Honor. [00:01:24] Speaker 03: Good morning. [00:01:24] Speaker 03: May it please the court? [00:01:26] Speaker 03: This case is unlike any of the inherency cases. [00:01:30] Speaker 02: OK, before you get to the merits, and I don't want to take up too much time because this is complicated, but I really don't understand why you have appealed [00:01:37] Speaker 02: separately from the 2008 order. [00:01:40] Speaker 02: It's an interlocutory order, and you're either out of time or it was an interlocutory order. [00:01:46] Speaker 02: It seems like you could have raised those arguments to Judge Collier and then appealed from that decision and included them all together, but I don't see how it's possible as a separate appeal. [00:01:56] Speaker 03: There were obviously two district court decisions in these proceedings, Your Honor. [00:02:01] Speaker 03: So the separate judgment from Judge Urbina and then the separate judgment. [00:02:04] Speaker 02: There's not a judgment from Judge Urbina that ever became final. [00:02:08] Speaker 02: You tried to appeal from that once and we said no. [00:02:11] Speaker 02: Correct. [00:02:11] Speaker 02: It went back to the board. [00:02:12] Speaker 02: The board adopted his reasoning with regard to the 089 application. [00:02:17] Speaker 02: You put that in your claim or your complaint when you went up to Judge Collier. [00:02:22] Speaker 02: I think there's references to that. [00:02:24] Speaker 02: But then you never argued anything about the 089 application to her. [00:02:30] Speaker 02: You didn't seem to me to preserve any arguments with regard to the 089. [00:02:35] Speaker 02: You can't appeal separately from a 2008 interlocutory order. [00:02:41] Speaker 03: Well, we were dismissed for lack of finality when we appealed the 2008 decision. [00:02:45] Speaker 02: Right. [00:02:46] Speaker 02: And so it went back to the board, the board issued a new decision, and a new action was instituted that involved that decision. [00:02:53] Speaker 02: And you actually went up to the district court again, but you didn't renew those arguments. [00:02:58] Speaker 03: There wasn't an opportunity to renew those arguments. [00:03:00] Speaker 03: The district court had already ruled on the 089 application. [00:03:03] Speaker 03: You still have to preserve them. [00:03:04] Speaker 03: All that remained to be decided was the 072 application. [00:03:08] Speaker 03: But it's still part of that case. [00:03:10] Speaker 02: It's not a separate case. [00:03:12] Speaker 02: So even if you hadn't waived it by not arguing it at Judge Collier, it is part of the 62 action. [00:03:18] Speaker 02: It's not a separate appeal. [00:03:20] Speaker 03: Well, it was a separate district court action which we had a right to appeal from. [00:03:23] Speaker 02: That's not the way things work. [00:03:25] Speaker 03: I'm sorry, Your Honor? [00:03:25] Speaker 02: I mean, basically you double your briefing pages by filing a separate appeal when it's all part of the same action. [00:03:34] Speaker 02: Let me ask you one more question and I'll let you go because I know you want to get to the merits and this is all kind of subsidiary. [00:03:39] Speaker 02: What does it matter to you about the 89 [00:03:43] Speaker 02: application and whether that makes their patent invalid if you don't win the 72. [00:03:48] Speaker 02: If Judge Collier is right that the 72 has sufficient written description and enablement and therefore gives them priority, does the 89 application matter at all? [00:04:01] Speaker 03: It should. [00:04:02] Speaker 03: There would have to be a chain of priority in order for Abbott to get the benefit of the 072 application. [00:04:09] Speaker 03: In order for the 915 patent to get the benefit of the 072 application, [00:04:12] Speaker 03: on paper, there would need to be a chain of priorities. [00:04:15] Speaker 02: So let's assume she's right about the 072 application providing written support and enablement and therefore gives them priority for the 915 application or the 915 patent. [00:04:27] Speaker 02: You know, I'm not saying that that's how I'm deciding, but just for purposes of trying to sort out these procedural issues, if she's right, then why would we need to reach whether Ingelman invalidates the 915 patent [00:04:43] Speaker 02: isn't the only reason to have the 89 application in there to address that, but the 72 would supersede that as well. [00:04:50] Speaker 03: My understanding is that there would still need to be a chain of priority. [00:04:53] Speaker 03: In order for Abbott and its 915 patent to get the benefit all the way back to the 072 application, the 089 application is intervening, and they would have to get the benefit of that as well. [00:05:05] Speaker 03: I might be able to help the court [00:05:08] Speaker 03: We'd like to focus today on the 072 application and Judge Collier's decision. [00:05:13] Speaker 03: I'm happy to answer more questions about Judge Urbina's decision and the 089 application. [00:05:19] Speaker 02: No, I mean, I think you've waived that. [00:05:22] Speaker 02: I don't think we have jurisdiction. [00:05:23] Speaker 02: My colleague might disagree, but why don't you get to the merits? [00:05:26] Speaker 03: OK. [00:05:27] Speaker 03: This case is unlike any of the inherency cases that Abbott relies on. [00:05:33] Speaker 04: Let me ask you a question. [00:05:34] Speaker 04: So Abbott's patent has expired, correct? [00:05:37] Speaker 04: Correct. [00:05:38] Speaker 04: And so you're pursuing an interference, and as a result of that, you're looking to get your own patent. [00:05:44] Speaker 04: Correct. [00:05:44] Speaker 04: Basically, and you want that to grant you 17 years of protection on a protein that's already in the public domain. [00:05:53] Speaker 04: Hasn't society already paid the price to keep that protein in the public domain? [00:06:01] Speaker 03: The way I'd respond to that question, Your Honor, is that it's not Yadav's fault that we're here [00:06:07] Speaker 03: in 2016 arguing about this. [00:06:10] Speaker 03: Yata tried to resolve this case a long time ago, tried to appeal directly to the Federal Circuit in 2008. [00:06:17] Speaker 03: It's unfortunate that the delay happened. [00:06:21] Speaker 03: The interference was declared in 1996. [00:06:23] Speaker 03: The board decided the interference fairly expeditiously in 2000. [00:06:28] Speaker 03: It wasn't Yata that appealed to a 146 action. [00:06:32] Speaker 03: So again, there's been some delay. [00:06:34] Speaker 03: We regret that. [00:06:36] Speaker 03: But it hasn't been of Yada's making. [00:06:38] Speaker 03: And Yada shouldn't be prejudiced. [00:06:40] Speaker 03: OK, that's fine. [00:06:40] Speaker 03: You've answered the question. [00:06:41] Speaker 02: Well, you have improperly tried to appeal interlocutory orders that delayed the proceedings. [00:06:47] Speaker 02: I mean, there's no doubt that 2008 order was interlocutory. [00:06:50] Speaker 02: I don't know why you ever filed an appeal on that. [00:06:53] Speaker 03: Well, in an abundance of caution, we were concerned that we might be deemed as having waived our right to appeal that decision at that point. [00:07:01] Speaker 03: So that's why we appealed. [00:07:03] Speaker 03: Federal Circuit disagreed with us, obviously, and here we are. [00:07:07] Speaker 03: What I'd like to direct the court's attention to, if possible, is on the merits, this case is unlike any of the inherency cases that Abbott relies on. [00:07:15] Speaker 01: Not the least, because in your reply brief in 1662, you use the term mischaracterized at pages 10, 12, 14, and 16 to describe what Abbott says. [00:07:32] Speaker 01: When somebody says something like that, I read it really carefully. [00:07:36] Speaker 01: And I'd be really careful of using that kind of language. [00:07:40] Speaker 01: It's clear you disagree, and you have reason to disagree with their interpretation of the euphonious wallet case. [00:07:47] Speaker 01: But despite that, I don't think it constitutes mischaracterization. [00:07:53] Speaker 03: OK, Your Honor. [00:07:54] Speaker 03: Well, we felt that the test that we had been articulating wasn't being stated fairly. [00:08:02] Speaker 03: by the other side, but so be it. [00:08:08] Speaker 03: If I could direct the court again, though, to the merits of the case, particularly on the 60-62... You argue that N. Ray Wallach favors your position. [00:08:18] Speaker 04: I'm sorry, Your Honor? [00:08:19] Speaker 04: You argue that N. Ray Wallach favors your position? [00:08:21] Speaker 04: That's right. [00:08:22] Speaker 03: Explain that. [00:08:28] Speaker 03: If the court had granted... I'm sorry. [00:08:32] Speaker 03: The fundamental holding in Wallach was that because the Wallach inventors, and those were Yeta inventors by the way, those were the same inventors in Wallach and that was dealt with a similar application or a related application to Yeta's application issue in this case, the court held essentially that because Yeta had only disclosed so much of the amino acid sequence of the protein that it wasn't in possession of [00:09:01] Speaker 03: the entire amino acid sequence of the protein, even though the claim certainly was directed to DNA. [00:09:07] Speaker 03: But the argument that we made there, which the court rejected, was that simply because you have possession of the protein doesn't mean you have possession of the protein's amino acids. [00:09:17] Speaker 04: But in Wallach, wasn't there evidence that the full amino acid sequence could be deduced from the partial sequence that was present? [00:09:28] Speaker 03: I don't think that that was the evidence, Your Honor. [00:09:30] Speaker 03: I don't think that that was the evidence in Wallach, and it's certainly not the evidence in this case, based on what was disclosed in the 072 application. [00:09:39] Speaker 03: Well, I'm quoting from that case of 1335. [00:09:42] Speaker 04: Anyway, go on. [00:09:46] Speaker 04: Okay. [00:09:47] Speaker 03: Okay. [00:09:49] Speaker 03: So Wallach does favor our position, but I'd like to focus on the facts [00:09:54] Speaker 03: in connection with the 072 application. [00:09:56] Speaker 03: And like I said, and this goes to the core of Abbott's inherency arguments, this case isn't like any of the inherency cases Abbott relies on. [00:10:06] Speaker 03: Unlike in all of those cases, no one could have gone back to any of the samples that Abbott had when they filed the 072 application and have identified any of the contiguous complete sequences of account. [00:10:19] Speaker 03: No one could have done that. [00:10:21] Speaker 03: What Abbott had when they filed the 072 application wasn't enough. [00:10:25] Speaker 03: They hadn't finished inventing. [00:10:27] Speaker 03: Later on, they finished inventing. [00:10:29] Speaker 03: They came close to it in the 089 application, for example. [00:10:32] Speaker 03: But when they filed the 072 application, they hadn't finished inventing. [00:10:36] Speaker 03: They actually had to develop an additional protocol that would yield a sample from which you could actually identify those sequences. [00:10:45] Speaker 03: You couldn't get to those sequences of account [00:10:48] Speaker 03: from anything Abbott had when they filed the 072 application? [00:10:52] Speaker 04: It was disclosed in the initial application. [00:10:54] Speaker 04: Wouldn't that have necessitated the existence of what we call, what we have here is a missing amino acid sequence? [00:11:06] Speaker 03: I'm sorry, I don't follow the question, Your Honor. [00:11:08] Speaker 04: Wasn't the sequence, the amino acid sequence that you say was not present in the original application, wasn't that inherent? [00:11:19] Speaker 03: No, it was not inherent. [00:11:21] Speaker 03: And it was not inherent because the sample wasn't purified and isolated. [00:11:25] Speaker 03: The test here, it's not, was the TBP2 protein in there? [00:11:31] Speaker 03: Did they have it in their sample? [00:11:33] Speaker 03: For example, they also had it in the urine that they started off with. [00:11:37] Speaker 03: But no one's saying that the complete sequence of the count was inherent in that urine. [00:11:42] Speaker 03: No, what they had to do was they had to purify and isolate the protein to a point [00:11:47] Speaker 03: where one of ordinary skill in the art, and this is inherency, one of ordinary skill in the art would necessarily see those sequences. [00:11:54] Speaker 03: And they didn't get to that when they filed the 072 application. [00:11:58] Speaker 03: And the only way that they did get to it, the only way that they got from point A to point B from the 072 application to any of the sequences of the count was they had to do further inventing. [00:12:10] Speaker 03: They weren't done inventing when they filed the 072 application. [00:12:13] Speaker 03: They completely changed their protocol. [00:12:16] Speaker 02: What was the further inventing? [00:12:18] Speaker 03: The further inventing was that they changed their protocol. [00:12:21] Speaker 02: The protocol of the 072 application... But the invention is not a method for purifying and isolating. [00:12:27] Speaker 02: It's the protein. [00:12:28] Speaker 03: It's a purified and isolated protein. [00:12:31] Speaker 03: And they hadn't gotten to that yet when they filed the 072 application. [00:12:36] Speaker 04: The additional... The court found that [00:12:40] Speaker 04: the seven characteristics of the amino acid that were disclosed in the specification identified the TBP2 protein as being present, as being subject to the O7-2 and O8-2 specifications? [00:12:57] Speaker 03: That was wrong, especially in the sense that the court seemed to think that what was in the O7-2 application was sufficient to distinguish the prior art. [00:13:07] Speaker 03: It wasn't sufficient to distinguish the prior art [00:13:09] Speaker 03: especially the second year reference that we've discussed in our briefs. [00:13:13] Speaker 03: In prosecution, when it came right down to it and when Abbott had to overcome the second year reference, they relied on one thing and one thing only, and it was a sequence that was found in the count. [00:13:24] Speaker 03: It wasn't a sequence from the 072 application. [00:13:27] Speaker 03: It wasn't anything else in the 072 application. [00:13:30] Speaker 03: When they had the chance to tell the examiner, [00:13:32] Speaker 03: and put it all on the line and say, here are all these characteristics that distinguish our protein from the protein of secondger. [00:13:39] Speaker 03: They relied on only one thing. [00:13:40] Speaker 02: Is the protein they discovered and described in the 072 application any different than the protein they discovered and described in the 915 patent? [00:13:53] Speaker 03: Yes, it is. [00:13:54] Speaker 03: They actually relied on a different form of the protein to get to the count. [00:13:58] Speaker 03: It's very odd. [00:14:00] Speaker 03: But when they changed their protocol, they used different chromatography columns, they even changed their source. [00:14:06] Speaker 03: They started working with a different source that they didn't report in the 072 application. [00:14:11] Speaker 03: And when they did all that, one of the sources... What's your support for that? [00:14:14] Speaker 02: I'm sorry? [00:14:15] Speaker 02: What's your support for that? [00:14:16] Speaker 02: Because that seems contrary to what the district [00:14:18] Speaker 03: Oh, there's no dispute about this, Your Honor. [00:14:23] Speaker 03: Even Abbott doesn't dispute it. [00:14:24] Speaker 03: We've discussed it extensively. [00:14:26] Speaker 03: The evidence was unrebutted on this. [00:14:32] Speaker 03: Some support can be found at A. So these are two entirely different proteins? [00:14:37] Speaker 03: The protein that was the basis for the count was a different form of the protein. [00:14:45] Speaker 03: They actually relied on, they actually started working with urine from people without fever. [00:14:51] Speaker 03: The 072 application says use urine from patients with fever. [00:14:55] Speaker 03: They started using ascites fluid later. [00:14:57] Speaker 03: This is all part of the additional inventing that they did. [00:14:59] Speaker 03: They weren't done inventing when they filed the 072 application. [00:15:02] Speaker 02: And they actually... So you're talking about different methods to reach this protein. [00:15:06] Speaker 03: Correct. [00:15:07] Speaker 02: But it was a different form of the protein. [00:15:10] Speaker 02: You're going to disagree that they claimed a different protein. [00:15:15] Speaker 03: There are some similarities but the fact remains and it's undisputed and it's unrebutted that they relied on a different protocol from different sources and even this different form of the protein and ultimately to get to the count. [00:15:30] Speaker 02: What do you mean when you say different form of the protein? [00:15:32] Speaker 02: I mean this discussion about different protocol and different methods seems [00:15:36] Speaker 02: not particularly relevant when we're not talking about a method claim. [00:15:40] Speaker 02: But if you're saying it's a different form, I don't know what that means. [00:15:43] Speaker 03: It doesn't meet their version of their parts of the count. [00:15:47] Speaker 03: Parts B and C of the count say a 42 kilodaltons protein. [00:15:50] Speaker 03: That's what they say that they invented by the time they filed the 072 application. [00:15:55] Speaker 03: Well, to get to the count, they were relying on, among other things, a 30 kilodaltons form of the protein. [00:16:02] Speaker 03: It wasn't the same form of the protein. [00:16:05] Speaker 03: And it doesn't matter that parts B of the count, for example, is directed to a protein. [00:16:13] Speaker 03: This is unlike any other case in that in order for Abbott to get from point A to point B, to get from the 072 application in order to the count, they had to do all this other stuff. [00:16:26] Speaker 03: They weren't done inventing. [00:16:27] Speaker 02: You seem to place some emphasis on this difference between the 42 whatever and the 30 whatever. [00:16:34] Speaker 02: If the 07-2 application had said 42, whatever that means, and had the complete amino acid sequence that was in the patent, would that be the same protein, even if it had a 30 count, whatever, in the application? [00:16:53] Speaker 03: I'm sorry, if the 07-2 application [00:16:56] Speaker 03: said 42 kilodaltons. [00:16:58] Speaker 02: I'm trying to figure out what the relevance of this difference between this 42 and 30 you're referring to is. [00:17:04] Speaker 03: The relevance is that they weren't done inventing when they filed the 072 application. [00:17:09] Speaker 03: If you take a look at any of the inherency cases they rely on, and I would submit even if you take a look at this course. [00:17:14] Speaker 02: Can you answer my hypothetical? [00:17:16] Speaker 02: Maybe you don't get it, because I don't quite, I'm not a, you know, I don't do this kind of stuff. [00:17:24] Speaker 02: as my day job. [00:17:25] Speaker 02: But both applications, the 72 application and 915, say it's this protein, this characteristics, both have the entire amino acid sequence. [00:17:39] Speaker 02: And the only difference is the 72 uses this 42 number and the PAT uses a 30 number. [00:17:45] Speaker 02: Are those the same protein? [00:17:47] Speaker 03: For purposes of the interference, they would [00:17:52] Speaker 03: The answer would be yes, and it's because yada's part of the count is to a 30 kilodalt form of the protein. [00:18:01] Speaker 03: So they have different molecular weights. [00:18:03] Speaker 03: I'm sorry. [00:18:05] Speaker 02: So that's what it is. [00:18:06] Speaker 02: You're talking about the 42 and 30 molecular weights. [00:18:09] Speaker 02: So if you think that's different, though, then why would the protein in the earlier application be the same protein if you think there's some relevance to the difference in molecular weights? [00:18:22] Speaker 03: The protein that they reported in the 072 application, it was a contaminated sample, but the protein that was in there, it's not the same protein. [00:18:33] Speaker 03: They didn't stick with just that in order to get to the count. [00:18:37] Speaker 03: They had to rely, like I said, [00:18:39] Speaker 03: on all this different stuff. [00:18:41] Speaker 03: They weren't done inventing. [00:18:42] Speaker 03: They had to develop a new protocol where they substantially changed their chromatography in order to get to a product. [00:18:51] Speaker 03: They also changed the sources that they worked with. [00:18:55] Speaker 04: Isn't it enough for the specification to identify the process that a protein can be obtained? [00:19:01] Speaker 04: You don't have to list all the proteins, not if your specification has described the process that you go to. [00:19:08] Speaker 04: obtain a particular protein? [00:19:10] Speaker 03: No, not across the board, Your Honor. [00:19:12] Speaker 03: That's a fact-specific scenario here. [00:19:15] Speaker 03: And I believe in Enroy Edwards, where the court reached such a result. [00:19:20] Speaker 03: The court was very particular in clarifying. [00:19:23] Speaker 03: This isn't a bright line rule here. [00:19:25] Speaker 03: But the evidence in this case shows that to one of ordinary skill in the art, viewing the 07-2 application, they hadn't gotten there yet. [00:19:34] Speaker 03: They had only identified a pur- I'm sorry, a significantly contaminated sample. [00:19:40] Speaker 03: I think one of the issues with this case is that- Your issue rebuttal time. [00:19:44] Speaker 03: You can continue if you want. [00:19:45] Speaker 03: Okay, if I could just finish this point. [00:19:47] Speaker 03: One of the issues with this case is that for lawyers looking at these documents and comparing the 072 application to the 915 patent, it's very tempting just to see some of the consistencies that there are between the [00:20:04] Speaker 03: between the two and say, well, it looks like that was close enough. [00:20:10] Speaker 03: But that's not the test. [00:20:11] Speaker 03: The test of written description is how the application would have been viewed by one of ordinary skill in the art at the time the application was filed. [00:20:18] Speaker 03: And there's extensive evidence in this case that one of ordinary skill in the art viewing the O7-2 application would not have viewed it as demonstrating a purified and isolated protein or a definitively identified protein, but instead would have considered it as evidence of [00:20:33] Speaker 03: considerable contamination that no single protein had been purified and isolated. [00:20:39] Speaker 04: Thank you. [00:20:39] Speaker 04: All right. [00:20:39] Speaker 04: Thank you, Mr. Nelson. [00:20:40] Speaker 04: We'll restore Mr. Nelson's rebuttal time back to three minutes, okay? [00:20:47] Speaker 04: Mr. Ferguson? [00:20:48] Speaker 00: Morning, Your Honor. [00:20:50] Speaker 00: May it please the Court, James Ferguson, on behalf of Abbott GmbH. [00:20:54] Speaker 00: I agree with counsel that this is a very unusual case. [00:20:57] Speaker 00: The Court has already noted [00:20:59] Speaker 00: that in this case, YADA is seeking in 2016 a patent to protect a protein that was discovered in 1989, a protein that has already been the subject of 17 years of patent exclusivity. [00:21:15] Speaker 02: Your patent's expired, right? [00:21:16] Speaker 00: Correct. [00:21:16] Speaker 02: Do you have any pending litigation asserting that patent? [00:21:19] Speaker 00: No. [00:21:19] Speaker 02: Do you have any other patents that rely on that patent? [00:21:22] Speaker 00: No. [00:21:22] Speaker 02: So there's nothing going to be from you ongoing on this. [00:21:26] Speaker 00: You're asking the question my client has been asking me. [00:21:29] Speaker 00: Your honor, we will gain absolutely or lose absolutely no patent protection as a result of the outcome of this litigation. [00:21:38] Speaker 00: We're in this litigation as a very reluctant defendant. [00:21:42] Speaker 00: The only reason we can't even settle the case because YADA is not seeking money damages or injunction. [00:21:49] Speaker 00: They're looking for a new claim relating to patent validity. [00:21:55] Speaker 00: And obviously, even if my client were willing to walk away from [00:21:58] Speaker 00: all the representations it's made to the PTO. [00:22:01] Speaker 02: Can I ask you this? [00:22:02] Speaker 02: I shouldn't, but I'm going to. [00:22:03] Speaker 02: Since you have no financial interest in this whatsoever, I know at the time you filed this patent, there may have been some question about patentability. [00:22:14] Speaker 02: I mean, is a purified protein even patentable any longer after the recent Supreme Court precedent? [00:22:20] Speaker 00: A very good question, Your Honor. [00:22:21] Speaker 02: You don't have to commit, but it seems to me that some of the recent Supreme Court cases [00:22:28] Speaker 02: make this highly suspect, highly suspect patent altogether. [00:22:32] Speaker 00: I wouldn't want to be quoted, Your Honor, so I'll simply say I agree that there are some questions about patentability in light of recent Supreme Court decisions. [00:22:39] Speaker 02: So could you address, I think I understand your friend's argument that because you claimed a purified and isolated protein in the 915 patent, that the 072 application has to provide written description and enablement for [00:22:57] Speaker 02: the purified and isolated protein and because it didn't describe the whole amino acid sequence, a person of an ordinary skill wouldn't see that application as showing the purified version of the protein but some other version of the protein. [00:23:11] Speaker 02: Why isn't he right about that? [00:23:15] Speaker 00: I understood his argument, Your Honor, to be focusing on Abbott's laboratory notebooks and what they revealed as opposed to the disclosure. [00:23:25] Speaker 00: in the 072 application and the 915 application. [00:23:29] Speaker 00: I was very surprised by some of the statements that I understood counsel to make. [00:23:34] Speaker 00: In light of concessions that Yada made before the district court and the district court recites at page 25 on her opinion, those concessions include the following. [00:23:46] Speaker 00: Number one, an amino acid is a unique and inherent characteristic of a protein. [00:23:50] Speaker 00: Number two, [00:23:52] Speaker 00: The full amino acid sequence is not necessary to identify unequivocally a protein. [00:23:58] Speaker 00: And number three, the nine amino acids that Abbott identified in its disclosure document, together with all the other biological data, including the 42 kilodalt molecular weight, unequivocally identified that protein as TBB2. [00:24:17] Speaker 00: What follows from that, [00:24:18] Speaker 00: The fourth conclusion, also an undisputed fact, is that the protein that was disclosed by the first filed application is the same protein as is recited in the count. [00:24:31] Speaker 00: You will search Yeda's briefs in vain for any statement that denies that what's the protein that's disclosed in the 072 application is not the same protein or is the same protein that's recited in the count. [00:24:47] Speaker 00: What they're saying is, notwithstanding that, there's not sufficient written disclosure because it doesn't contain these other amino acids. [00:24:56] Speaker 00: And as we lay out in greater detail in our brief, those amino acids are inherently disclosed. [00:25:02] Speaker 00: They meet the requirements of inherent disclosure cases because number one, the amino acids are inherent to the protein, no dispute. [00:25:11] Speaker 00: And number two, they're not material to patentability because they're not necessary to identify the protein. [00:25:17] Speaker 00: Again, Yata conceded, as recited in page 25 of the district court's opinion, that only one protein, one and only one protein, has the amino acids that are disclosed in the 072 application. [00:25:32] Speaker 04: So your opponent argues that we should reject the inherently arguments on the basis of our decision in Wallach. [00:25:39] Speaker 04: What's your response to that? [00:25:40] Speaker 00: I think my response is that my opponent, most respectfully, is mistaken. [00:25:46] Speaker 00: that both Wallach and Sanofi squarely hold that a partial amino acid sequence together with other biological data is sufficient to identify a protein. [00:25:58] Speaker 00: That's almost an exact quote from Sanofi and Sanofi cites Wallach for that proposition. [00:26:05] Speaker 00: And Your Honor, as we've argued at great length in our brief, that's exactly what we have here. [00:26:09] Speaker 00: A partial amino acid sequence together with other biological data [00:26:14] Speaker 00: that unequivocally established the protein that the Abbott inventors in 1989 had possession of the same protein that's now recited in the count. [00:26:25] Speaker 00: There are two other grounds that I just want to briefly touch on for sustaining the district court's opinion, a decision rather, and the first is judicial estoppel because Yada's current argument is directly contrary to representations that Yada successfully made to the [00:26:44] Speaker 00: Patent Office in the prosecution of the patent and in the interference. [00:26:50] Speaker 00: You may recall that Yada relied on the Engelman reference and persuaded the Patent Office that the Engelman reference, which contained only five amino acids, invalidated the Abbott patent on grounds of anticipation. [00:27:06] Speaker 00: Now, if the five amino acids in the Engelman reference are sufficient to invalidate on anticipation grounds, [00:27:14] Speaker 00: Abbott's patent containing 22 amino acids, that's pretty inconsistent in the district court so found with their current claim that our 072 application with nine amino acids is insufficient from a written description perspective. [00:27:31] Speaker 00: The last point I want to make is to remind the court, particularly in light of the challenge to the methodology that Abbott used in 1989, [00:27:43] Speaker 00: in identifying protein. [00:27:45] Speaker 00: In 2003, we replicated every step of the same methodology that's disclosed in the 072 application. [00:27:53] Speaker 00: And we did it in the presence of experts from YATA. [00:27:57] Speaker 00: That's not something you see all the time in patent law because it's high risk. [00:28:01] Speaker 00: If you make a mistake, the patent's gone. [00:28:04] Speaker 00: But we did it. [00:28:06] Speaker 00: There are experts who were there. [00:28:07] Speaker 00: And it resulted in TBB2. [00:28:10] Speaker 00: And so this was a compelling [00:28:12] Speaker 00: real-world demonstration that the method of purifying and isolating the protein that was disclosed in the 07-2 patent results in the protein, a separate ground for sustaining the district court's decision on written description. [00:28:30] Speaker 00: Unless the court has any questions, we'll rely on our brief. [00:28:35] Speaker 01: I just want to say the same thing I said to your opposing counsel, and that is you got stuck with the word [00:28:41] Speaker 01: which accused you, as far as I'm concerned, accused you of misconduct. [00:28:46] Speaker 01: And I couldn't find any. [00:28:49] Speaker 01: And I'll invite you to say anything else if you want to, but you don't have to. [00:28:53] Speaker 00: I appreciate your comments, Your Honor. [00:29:05] Speaker 03: Council for Abbott said that as of the filing of the 072 application that Abbott had possession of the protein. [00:29:12] Speaker 03: We're not disputing that. [00:29:13] Speaker 03: We're not disputing that a protein satisfying the limitations of the count was in their sample, but that's not the test. [00:29:21] Speaker 03: The test wasn't in there. [00:29:23] Speaker 03: It was also in the urine and that's not patentable. [00:29:26] Speaker 03: You had to purify and isolate the protein to the point where one of ordinary skill in the art would necessarily see the sequences. [00:29:34] Speaker 03: And that's why this case is different from all of this court's other cases that Abbott has cited. [00:29:41] Speaker 03: including recent cases like Cubist, which was decided after the briefs, where you couldn't necessarily, one of ordinary skill in the art, couldn't necessarily identify the sequences of the count from the sample that Abbott had, any of the samples that Abbott had when they filed the 072 application. [00:30:00] Speaker 03: Again, it's different from all of the, all of the, all of the inherency cases that Abbott has relied on, as well as this court's case, this court's decision in Sanofi, [00:30:12] Speaker 03: Council for Abbott referred to 2003 as well. [00:30:17] Speaker 03: The results of the 2003 experiments were disputed. [00:30:20] Speaker 03: Yata's experts took a look at the results and said they don't look any better to us than the 1989 results did. [00:30:27] Speaker 03: There's a genuine issue of material fact there that should have precluded summary judgment being entered in favor of Abbott. [00:30:35] Speaker 03: And no matter what the results of the 2003 experiments were, [00:30:39] Speaker 03: They don't negate the fact that in 1989, the one and only time that Abbott tried to practice the 072 protocol, it resulted in a complete failure. [00:30:49] Speaker 03: It didn't even result in the sequences that are disclosed in the 072 application itself. [00:30:54] Speaker 04: Did the experiments result in TBP2? [00:30:59] Speaker 03: It's not clear whether they had it in that sample, Your Honor. [00:31:04] Speaker 03: They may have. [00:31:05] Speaker 03: In the sample that's reported in the 072 application, [00:31:08] Speaker 03: There was some TBP2 in there, but again, that's not enough because the sequences weren't inherent in that sample. [00:31:15] Speaker 03: You had to do something more. [00:31:17] Speaker 03: Unlike all this court's other inherency cases, you had to do more inventing in order to get to those sequences. [00:31:24] Speaker 03: This is inherency. [00:31:25] Speaker 03: It can't be established by probabilities or possibilities. [00:31:29] Speaker 03: The same comment is applicable to the 2003 experiments when you compare those to what happened in 1989. [00:31:35] Speaker 03: They say they got it to work in 2003. [00:31:37] Speaker 03: They clearly didn't in 1989. [00:31:39] Speaker 03: They got something that was so bad they didn't even report it in the 072 application itself. [00:31:45] Speaker 03: They said it had very weak activity. [00:31:47] Speaker 03: Judge Collier noted that in her opinion. [00:31:49] Speaker 03: That's not sufficient for written description and it doesn't satisfy this court's test for inherency either. [00:31:56] Speaker 03: One last comment I would make is that [00:32:01] Speaker 03: on material to patentability. [00:32:04] Speaker 03: That was a burden that Abbott bore in this case. [00:32:07] Speaker 03: They had to show, in order to establish inherency, that the sequences of the count weren't material to patentability. [00:32:14] Speaker 03: There's no dispute that when it counted, when it actually mattered, that they relied on a sequence not in the 072 application to distinguish the prior art. [00:32:24] Speaker 03: And there's no evidence, including no evidence from their experts, that specifically addressed that second-year reference and said anything different. [00:32:31] Speaker 03: There's no evidence from their experts saying that second year could be distinguished on any other basis. [00:32:37] Speaker 03: We just have to go back to the objective record of the prosecution history. [00:32:41] Speaker 03: And you see from that, that they absolutely relied on a sequence of the count in order to get their claims issued. [00:32:47] Speaker 04: Do you have any concluding sentences or thoughts? [00:32:51] Speaker 03: Only that because the sequences of the count were material to patentability as a matter of law under this court's binding precedent, such as in Hitzeman, [00:33:01] Speaker 03: Abbott hasn't established inherent written description. [00:33:05] Speaker 04: Thank you, Your Honor. [00:33:06] Speaker 04: Thank you very much.