[00:00:49] Speaker 04: Okay, the next case is number 15, 1957, UCB Incorporated Against Yetter Research and Development. [00:00:57] Speaker 04: Mr. Groombridge. [00:00:58] Speaker 00: Thank you, Your Honor. [00:00:59] Speaker 00: I feel like I can't resist saying I have a sense of deja vu as I stand here, but hopefully this case will be less of an enigma than one we heard a while back. [00:01:10] Speaker 00: What I wanted to do was begin with the District Court's claim construction, which was with respect to the term monoclonal antibody. [00:01:19] Speaker 00: which was a homogeneous population of a single type of antibody produced by a hybridoma and not including chimeric and humanized antibodies. [00:01:30] Speaker 00: And I think we can split that into three parts. [00:01:33] Speaker 00: The first part, a homogeneous population of a single type of antibody, is undisputed. [00:01:38] Speaker 00: And everybody agrees that that's appropriate. [00:01:40] Speaker 00: Then what I would like to do is talk about the second part, produced by a hybridoma, and then move to the third part, what I would think of as a negative [00:01:49] Speaker 00: limitations saying not including chimeric and humanized antibodies. [00:01:53] Speaker 02: Now with respect to the first, with respect to the portion that says produced via hybridoma... Mr. Grimbridge, just for clarification, are you saying that produced via hybridoma, does that by itself necessarily exclude the chimeric antibodies? [00:02:10] Speaker 02: Are you saying that language by itself is still open-ended enough? [00:02:15] Speaker 02: that if there's some mix of where it can be produced by hybridoma, yet still be a chimerical? [00:02:20] Speaker 00: We think it, Your Honor, we think that as a practical matter, produced by hybridoma would necessarily exclude chimerical. [00:02:27] Speaker 00: There's some things with the word in the record below that said potentially there might be some kind of chimerical. [00:02:32] Speaker 02: So it's a little bit redundant, the negative limitation that was added to the claim construction. [00:02:37] Speaker 00: Right. [00:02:38] Speaker 00: That's correct, Your Honor. [00:02:39] Speaker 00: And so the produced by hybridoma, the way we would look at that is to say what has been done here is to read in [00:02:45] Speaker 00: a method of making to a composition of matter claim. [00:02:50] Speaker 00: There's no dispute that the claim to a monoclonal antibody. [00:02:54] Speaker 03: But the issue was claim construction with respect to whether it includes humanized and chimeric materials. [00:03:03] Speaker 03: And those aren't anywhere in the specification. [00:03:06] Speaker 00: Your Honor, that's correct. [00:03:07] Speaker 00: And I think that that leads us to what I was planning to get to second, but I'll happily talk about it now, which is I think the biggest single issue in this case. [00:03:15] Speaker 00: boils down to this. [00:03:17] Speaker 00: Whether a genus claim, otherwise properly supported, can validly cover species that are not disclosed or described within the patent document. [00:03:30] Speaker 00: I think that's where the court is disputed. [00:03:32] Speaker 04: You mean properly construed, and to be construed to be unlimited. [00:03:37] Speaker 00: Yes, Your Honor. [00:03:38] Speaker 00: And in our view, that brings us back to the law of this court since Henry Ruchig. [00:03:43] Speaker 00: It has been abundantly clear. [00:03:45] Speaker 00: that it is possible to have written description for a genus and yet not have written description for every species within that genus. [00:03:54] Speaker 00: And that's what we're looking at here. [00:03:55] Speaker 03: That's not the issue. [00:03:57] Speaker 03: To encompass chimeric and humanized, there's got to be something in the specification. [00:04:05] Speaker 03: There's nothing. [00:04:06] Speaker 03: And as a matter of fact, as you know, in our Chiron case, we determined that the term monoclonal antibody in 1984 [00:04:15] Speaker 03: was not broad enough to encompass Chiron. [00:04:18] Speaker 00: I think about this. [00:04:21] Speaker 00: Your Honor, I would respectfully disagree with that. [00:04:22] Speaker 00: First of all, I would say that following Ariad, and indeed before Ariad, going back to Enzo, it is abundantly clear that one way in which a genus may be supported is by a written description of the structural features common to the genus. [00:04:36] Speaker 00: And that's exactly what we find in the 923 pattern. [00:04:39] Speaker 00: With respect to Chiron, to the extent that I [00:04:42] Speaker 00: would submit your honor very respectfully, Chiron is talking about whether there was substantial evidence to support a jury verdict following the 13-day jury trial. [00:04:51] Speaker 00: Now, to the extent that Chiron, and Chiron in this case, both by the district court and by UCB, has, I submit, been used primarily for the factual premise about what those of skill in the art did and didn't know in 1984. [00:05:06] Speaker 00: Now, I think there's two things wrong with that. [00:05:08] Speaker 00: One is that our [00:05:11] Speaker 00: Chiron is a case about whether there was substantial evidence to support a jury verdict. [00:05:16] Speaker 00: It's on an entirely different record, a record that yetta here has never had a chance to make. [00:05:21] Speaker 00: Secondly, there is a 10-month difference in the priority dates between the patent in Chiron and the patent here. [00:05:27] Speaker 00: That 10 months turns out to be of vast importance with respect to this question, because as the Chiron case. [00:05:32] Speaker 03: Are you saying that the humanized chimeric antibodies [00:05:37] Speaker 03: bind to a human cytotoxin having a molecular weight of 17,500, et cetera? [00:05:43] Speaker 03: Is that supported by the record? [00:05:46] Speaker 00: Your Honor, what I would say when we look at the 923 pattern, what we see is this is an example of an antibody pattern. [00:05:58] Speaker 00: There is written description for the genus of antibodies by virtue of describing the antigen. [00:06:05] Speaker 00: a novel antigen not previously characterized. [00:06:07] Speaker 00: That's what these inventors contributed and described. [00:06:10] Speaker 00: And the way we would look at that, Your Honor, is to say that in Ariad, the court expressly endorses the principle that there can be written description by virtue of describing the structural features common to the genus. [00:06:23] Speaker 03: In the case of an antibody... What are the structural features here? [00:06:26] Speaker 00: The CDRs, the Complementarity Determining Regions, which are what confer the specificity for this antigen, TNF. [00:06:34] Speaker 00: And that seems to be undisputed. [00:06:37] Speaker 00: For example, in the record at 1429, we have UCB's experts saying the CDRs are the portion that confer specificity for the antigen. [00:06:46] Speaker 00: What we have here then, Your Honor, is following the principle that this court adopted from the written description guidelines in Enzo. [00:06:53] Speaker 00: And again, referenced in Noel versus Lederman and in Center Court. [00:06:59] Speaker 00: right, that there can be a situation in which when the contribution of the patent is a novel antigen, newly characterized... The Center Core went the other way. [00:07:08] Speaker 00: It did, because in Center Core, the contribution precisely was not a novel antigen. [00:07:12] Speaker 00: It was in fact this antigen, TNF, previously characterized first of all by these inventors. [00:07:17] Speaker 00: And therefore, there was no way that Center Core could come into this court and say, we were the first to characterize this antigen. [00:07:24] Speaker 00: What these inventors contributed to the art was not a way of making antibodies. [00:07:29] Speaker 00: wasn't an improvement in the other regions of the antibody. [00:07:35] Speaker 00: It was a showing that it was possible for the first time to make antibodies against TNF and to characterize TNF in such a way that others in the field could then make such antibodies. [00:07:47] Speaker 00: That was what they brought to the party, if you will. [00:07:50] Speaker 00: And it precisely falls within the category of cases that Center Core did not [00:07:56] Speaker 00: Right. [00:07:57] Speaker 00: Wherein the contribution is the novel antigen, not any method of making. [00:08:02] Speaker 00: And indeed everyone concedes here that the hybridoma technique was well known and routine in 1984. [00:08:08] Speaker 00: And therefore novelty could not possibly have resided in that technique. [00:08:13] Speaker 00: And so, your honor, what we would say here is this is a case in which we take two principles and bring them together. [00:08:20] Speaker 00: The first principle is the principle of Ariad, that one way properly to describe a genus [00:08:26] Speaker 00: is to identify the structural features common to that. [00:08:30] Speaker 02: I guess that's a concern I have with your case is that your premise is that the claim for a monoclonal antibody is a broad genus claim that covers any possible way to make this particular antibody that's monoclonal that binds to this cytotoxin. [00:08:51] Speaker 02: But what if monoclonal antibody [00:08:55] Speaker 02: one of skill in the art at the time of 1984, understood monoclonal antibody, not to be any antibody that happens to be monoclonal, but had some different technical understanding of monoclonal antibody. [00:09:09] Speaker 02: That being the very definition that our opinion in Chiron cited to several treatises and dictionary definitions. [00:09:20] Speaker 02: And to mean antibody that's monoclonal, [00:09:25] Speaker 02: that's produced by hybridoma. [00:09:26] Speaker 02: In fact, if you go back and look at the Coombs definition that your client sided to in the prosecution history, it's a very long definition that goes through punishing detail about how such monoclonal antibodies are produced by hybridomas. [00:09:42] Speaker 00: I think you're on the answer to that now view would be that monoclonal antibody is not a product by process definition. [00:09:49] Speaker 00: Monoclonal antibody is a thing. [00:09:51] Speaker 00: It's a population of antibodies that are all identical. [00:09:54] Speaker 00: And therefore, what we're talking about here, we know that the law of this court is that a composition of matter is not otherwise novel, is not limited by the method of making. [00:10:05] Speaker 00: That's, for example, the Vanguard case. [00:10:07] Speaker 02: I think as a general matter, that's true. [00:10:09] Speaker 02: I'm asking on the facts of this case, what if all the dictionaries and treatises that discuss and define the term monoclonal antibody go a different way and specifically call out that what that term means to [00:10:24] Speaker 02: people in this art is an antibody that's made a particular way, i.e. [00:10:31] Speaker 02: produced by hybridoma. [00:10:33] Speaker 00: But again, I think I would come, and maybe the answer is that I just misunderstand, or that I have a different view of that, Your Honor, but I would say that the answer is that we're talking about a thing. [00:10:43] Speaker 00: And even if people understood at the time that it was made by a particular process, if later in time a new process to make the same thing was invented, it would still be covered. [00:10:54] Speaker 00: And so as for example, this court's decision in MGen versus Oaks Marion Roussel, where you have a later arising way of making a composition of matter not known at the time, right? [00:11:05] Speaker 00: Even if at the time everybody would say, well, I know there's only one way to make that, right? [00:11:09] Speaker 00: The point is still that the claim is to a thing. [00:11:13] Speaker 00: And if later in time, clever people come up with a new way of making that same thing, then it would be covered. [00:11:18] Speaker 00: And that these are not in essence product by process claims. [00:11:21] Speaker 04: So you're telling us that it's to be defined as literally covering. [00:11:27] Speaker 04: Are you also still arguing the doctrine of equivalence? [00:11:30] Speaker 00: Yes, Your Honor. [00:11:31] Speaker 00: And I'd be happy to turn to that. [00:11:33] Speaker 00: Who's turned to that? [00:11:34] Speaker 00: So the first question then with respect to the doctrine of equivalence is whether there's a narrowing amendment here. [00:11:40] Speaker 00: And in our view, there is no such narrowing amendment. [00:11:43] Speaker 00: This brings us to the place where claim 41 in the application, which issued as claim one, was never changed. [00:11:49] Speaker 00: And the narrowing amendment then is purportedly the cancellation of dependent claims that are, according to the district court, then operated, if you will, as a way of carving out the subject matter of the dependent claims from the scope of the independent claims. [00:12:08] Speaker 04: Isn't that a different question from equivalency? [00:12:10] Speaker 04: Let's assume that that's a pretty weak argument. [00:12:15] Speaker 04: Cancelling the dependent claims says something. [00:12:19] Speaker 04: that we need to take cognizance of. [00:12:22] Speaker 04: But does that affect your argument of equivalency? [00:12:26] Speaker 04: Let's say that it does narrow the claim. [00:12:29] Speaker 04: Equivalency is actually intended derived from a narrowed claim rather than your initial argument that the claim is board enough. [00:12:42] Speaker 04: to be literally infringed, is that correct? [00:12:44] Speaker 00: I'm not sure that I fully understand the question, but as much as I do, I don't think it's correct, Your Honor. [00:12:49] Speaker 00: In other words, I think the first question here is whether the scope of what is issued as claim one was changed. [00:12:59] Speaker 04: Well, assume it's changed. [00:13:02] Speaker 04: For the sake of this argument, let's assume that you don't have the better of that argument. [00:13:08] Speaker 04: So it's changed. [00:13:10] Speaker 04: does or doesn't that still entitle you to argue equivalency? [00:13:14] Speaker 04: Perhaps not successfully. [00:13:16] Speaker 00: I think it conceivably does. [00:13:18] Speaker 00: In other words, I think, Your Honor, at that point we have to look at the reasons for the change and the fact then, and I think this brings us then back to this question of written description, right? [00:13:28] Speaker 00: And the fact that what happened here was the office subjected to or rejected the dependent claims on the basis that they were not described, right? [00:13:37] Speaker 00: But in our view, Your Honor, [00:13:40] Speaker 00: This, again, is the same question that we come back to, is what was the reason for which Yeda was not entitled to these claims? [00:13:49] Speaker 03: John Bridge, if you need to be administered an antibody for some reason, would you be just as happy to get a murine mouse antibody as a human antibody? [00:14:01] Speaker 03: In other words, their equivalent? [00:14:03] Speaker 00: I personally would not, Your Honor, and I make no dispute that there is a contribution. [00:14:07] Speaker 00: There are many contributions of people after this. [00:14:10] Speaker 00: But we have a situation here. [00:14:11] Speaker 00: Would I be happy to be administered an antibody against TNF? [00:14:14] Speaker 00: Absolutely. [00:14:15] Speaker 00: Before this patent, that did not exist. [00:14:17] Speaker 00: These inventors showed the art that it was possible to make that. [00:14:21] Speaker 00: And, Your Honor, in this regard, they made a contribution. [00:14:27] Speaker 00: It is absolutely clear that there were later contributions, many of which were patentable in their own right. [00:14:32] Speaker 00: But the premise of the district court seems to be that absent description of the accused embodiment, there could be no infringement. [00:14:39] Speaker 03: But where is the enablement in this specification with respect to humanized chimeric? [00:14:47] Speaker 00: I think, Your Honor, the question is not enablement of humanized and chimeric. [00:14:50] Speaker 00: The question, and in our view... Well, you want the claim to cover it. [00:14:54] Speaker 00: We certainly do. [00:14:56] Speaker 00: In our view, and by the way, [00:14:58] Speaker 00: There was no question that there was not a motion for summary judgment of invalidity below. [00:15:02] Speaker 00: We were talking about claim construction. [00:15:04] Speaker 00: So had there been a motion for summary judgment of invalidity, we would have made a record on these things. [00:15:10] Speaker 00: But enablement, there is certainly even in this record enough to show that chimeric antibodies were perfectly well enabled by the end of 1984. [00:15:17] Speaker 00: Humanized antibodies were not invented until 1986. [00:15:22] Speaker 00: No dispute about that. [00:15:23] Speaker 00: Notably, [00:15:24] Speaker 00: In the very first publication, the Jones paper, they are already described as monoclonal antibodies. [00:15:28] Speaker 03: You just said humanized antibodies were not invented until two years later. [00:15:32] Speaker 03: Correct. [00:15:33] Speaker 03: Yet this claim covers them. [00:15:36] Speaker 00: In our view, Your Honor, this claim covers, this is a genus. [00:15:40] Speaker 00: Broad or otherwise, I'm not sure. [00:15:41] Speaker 00: It's a genus of antibodies that specifically bind to TNF. [00:15:46] Speaker 00: And the reason for that is because those antibodies have, like the accused product here, CDRs. [00:15:51] Speaker 00: that recognize, and in the accused product here, they're murine CDRs. [00:15:56] Speaker 00: So if we got the accused product, Your Honor, an answer to Your Honor's question, we would be getting a mouse antibody to the extent that it actually interacts with the antigen. [00:16:08] Speaker 00: And so in this instance, Your Honor, what the accused product is is the precise thing that the applicant said it wished to cover, a humanized derivative of a mouse antibody. [00:16:21] Speaker 00: When we look at what the invention was here, in our view, it is clear that it is the portion of the antibody that recognizes human TNF, and that that is the CDRs, and that's what these inventors contributed. [00:16:35] Speaker 00: That's the common structural feature of the genus, and that's described and enabled. [00:16:39] Speaker 04: Okay, thank you. [00:16:40] Speaker 04: We'll save everybody a little time. [00:16:42] Speaker 02: I just want to ask one more question about the prosecution history. [00:16:45] Speaker 02: The dependent claims, 45 to 52, those were all dealing with chimeric, humanized, genetically engineered antibodies. [00:16:55] Speaker 02: In the face of a written description rejection, the applicant canceled all of those claims. [00:17:01] Speaker 02: And so I didn't see you citing in your gray brief our builder's concrete opinion, which talks about the idea that when you cancel subject matter, [00:17:15] Speaker 02: you know, claim subject matter from your application, you can't try to recapture that cancelled subject matter through an allowed claim that was unamended, but nevertheless, you can't try to recapture that subject matter. [00:17:33] Speaker 00: The claim set, though, in Builders Concrete is very different. [00:17:37] Speaker 00: So the asserted claim there was already a dependent claim, claim 10. [00:17:42] Speaker 00: which already and all along included the limitation that had to be added to the independent claim, claim one, in order to gain allowance. [00:17:50] Speaker 00: Here the converse is true. [00:17:52] Speaker 00: The independent claim was never amended and that's the claim that's asserted. [00:17:56] Speaker 00: These dependent claims were cancelled and the only way then that narrow scope is if the otherwise properly described and enabled dependent claim now has a carve out, some Swiss cheese style, that where these [00:18:11] Speaker 00: independent of these dependent claims were canceled. [00:18:13] Speaker 00: And in our view, Your Honor, it's just not reasonable to read it that way. [00:18:16] Speaker 00: One of those claims that was canceled for lack of written description was to non-murine antibodies. [00:18:25] Speaker 00: No one would seriously contend that claim one cannot cover non-murine antibodies in view of this prosecution. [00:18:33] Speaker 00: And yet the examiner was of the view there was no written description of that. [00:18:36] Speaker 00: It was enabled. [00:18:37] Speaker 00: It was properly within the scope of the broad claim one. [00:18:40] Speaker 00: It wasn't described. [00:18:41] Speaker 00: And we can have cancellation of claims for lack of written description, which in no way suggests of species, which in no way suggests that the genus itself is undescribed. [00:18:52] Speaker 00: And indeed, I would go all the way back to Ruchik and say that was the situation in Ruchik. [00:18:56] Speaker 00: There's a validly described genus claim, but a lack of description of a particular species. [00:19:02] Speaker 00: That is an absolutely common situation. [00:19:04] Speaker 03: That's the question, validly described genus claim. [00:19:08] Speaker 00: Yes, Your Honor. [00:19:09] Speaker 00: With that, I'm way past my time and I will yield the podium here unless there are further questions. [00:19:19] Speaker 04: Okay, no, we'll save you some rebuttal time, Mr. Greenbridge. [00:19:22] Speaker 04: We'll hear from Mr. Treanor. [00:19:34] Speaker 01: May it please the court. [00:19:38] Speaker 01: The issue before the panel is not whether later arising technology can in some instances be covered by the scope of a broadly drafted claim. [00:19:51] Speaker 04: Isn't that probably the most significant issue before us because we know that the doctrine of equivalence can reach later arising technology. [00:20:02] Speaker 04: We also know that a generic claim can cover later arising technology. [00:20:08] Speaker 01: It is a significant issue. [00:20:10] Speaker 04: It hasn't been argued that this technology existed before the filing date. [00:20:15] Speaker 01: That's correct. [00:20:17] Speaker 01: But that is a question, as you pointed out, of written description or enablement. [00:20:23] Speaker 01: And that is an analysis that is, as you pointed out, follows claim construction. [00:20:31] Speaker 04: For the literal claim construction, yes. [00:20:35] Speaker 04: Let us, perhaps in your cases, [00:20:38] Speaker 04: reasonably strong, that there is neither written description nor enablement of the human chimeric antibody. [00:20:47] Speaker 04: But if in fact it's equivalent under the law, you don't, it's assumed that it's not literally covered or else you wouldn't have to resort to equivalency, which is not so easy to demonstrate in any case. [00:21:06] Speaker 01: I would agree with that, Your Honor. [00:21:08] Speaker 01: The issue here is the threshold question of how, in 1984, a person of ordinary skill would understand the term monoclonal antibody. [00:21:21] Speaker 01: And independently dispositive, the question is whether that person could possibly define monoclonal antibody as encompassing chimeric or humanized antibodies. [00:21:35] Speaker 04: Because that's later arising technology. [00:21:38] Speaker 04: We know it's monoclonal, but it is prepared differently. [00:21:41] Speaker 01: That's correct. [00:21:42] Speaker 01: It may be a close case in some situations, but in this case, the prosecution history compels affirmance of the district court's construction, at least insofar as it excludes chimeric and humanized. [00:21:57] Speaker 04: How is that? [00:21:57] Speaker 04: 11 years later, they attempt literally to cover the technology that ensued after the initial filing date. [00:22:06] Speaker 04: The examiner didn't let them do it. [00:22:08] Speaker 01: That's correct. [00:22:09] Speaker 01: And there are two clear and unambiguous instances of disclaimer. [00:22:13] Speaker 04: That's literal infringement we're talking about. [00:22:15] Speaker 04: But let's talk about the terms of equivalency. [00:22:18] Speaker 01: OK. [00:22:19] Speaker 01: I would say that in terms of equivalency, whatever equivalents are available under the doctrine of equivalence, they cannot include the precise subject matter that was disclaimed. [00:22:34] Speaker 01: So there may be instances [00:22:36] Speaker 01: Maybe even here, where there are equivalents of chimeric and humanized. [00:22:40] Speaker 01: But one thing is for certain, and that is that chimeric and humanized cannot be equivalents. [00:22:47] Speaker 04: And there is- Are you saying that canceling the dependent claims was a disclaimer? [00:22:52] Speaker 04: Maybe they just were worn out? [00:22:54] Speaker 04: It was pending for 11 years. [00:22:55] Speaker 01: In this case, they are. [00:22:57] Speaker 01: In this court's decision in re-arcs, that is exactly what happened. [00:23:01] Speaker 01: In builders concrete as well, although they weren't dependent claims. [00:23:05] Speaker 01: And the most comprehensive analysis, at least in my reading, of the disclaimer issue is the Omega case. [00:23:13] Speaker 01: And the Omega case, this court exhaustively goes through where disclaimers started, starting with Shriver-Shroth, our main case from the Supreme Court. [00:23:22] Speaker 03: Is this, in fact, after acquired technology? [00:23:26] Speaker 03: Wasn't something described in November at the month before the priority date? [00:23:31] Speaker 01: That's correct, Your Honor. [00:23:32] Speaker 01: And what was that? [00:23:33] Speaker 01: That's what's referred to as the Morrison paper. [00:23:36] Speaker 01: It's not of record. [00:23:39] Speaker 01: It was the subject of the district court's opinion, but the appellant elected not to include that in the appendix. [00:23:46] Speaker 03: That doesn't mean it's not of record. [00:23:48] Speaker 01: Pardon me? [00:23:49] Speaker 01: That doesn't mean it's not of record. [00:23:51] Speaker 01: The reference itself is not in the record. [00:23:53] Speaker 01: That's all I was saying, Your Honor. [00:23:54] Speaker 01: The Morrison paper is the very first disclosure of chimeric [00:24:01] Speaker 01: So it doesn't speak to humanized antibodies. [00:24:03] Speaker 01: It's the very first disclosure ever, a few weeks before the filing date. [00:24:09] Speaker 01: And it does not, even if the Morrison paper discloses how to make, theoretically, a chimeric antibody, two things are important. [00:24:21] Speaker 01: Number one, Morrison and colleagues are, even as Yada points out, this is a landmark publication. [00:24:32] Speaker 01: They are people of extraordinary skill in the art, not ordinary skill in the art. [00:24:36] Speaker 01: To draw from that that ordinarily skilled artisans in a few weeks all know how to make a chimeric antibody is unreasonable. [00:24:46] Speaker 01: And in any event, just disclosing how to make a chimeric antibody is a different question from how did one [00:24:56] Speaker 01: understand the term monoclonal antibody more specifically. [00:25:00] Speaker 03: Did that mean? [00:25:01] Speaker 03: You're then arguing lack of enablement. [00:25:05] Speaker 03: But I was asking the question in the context of after arising technology. [00:25:10] Speaker 03: Okay. [00:25:10] Speaker 03: And you've essentially said it was not, chimeric was not after arising technology that had been described among earlier. [00:25:18] Speaker 01: I think to ordinarily skilled artisans, it certainly was later arising technology. [00:25:25] Speaker 01: There's nothing other than that first publication in November of 1984. [00:25:29] Speaker 03: A publication is a publication, isn't it? [00:25:31] Speaker 01: Pardon me? [00:25:32] Speaker 03: A publication is a publication. [00:25:34] Speaker 03: That is correct. [00:25:35] Speaker 03: It wasn't enabling? [00:25:38] Speaker 01: I don't believe it was enabling. [00:25:42] Speaker 01: But I think the question is, even if it enables, does that mean, does it follow that those of ordinary skill now associate the term monoclonal antibody [00:25:54] Speaker 01: with chimeric antibodies. [00:25:55] Speaker 01: And I will point out that in that paper, the authors distinguish between monoclonal antibodies and chimeric antibodies. [00:26:04] Speaker 01: Even in 1986, when the winter paper comes and discloses humanized antibodies, and I wanted to address that point, they don't call humanized antibodies monoclonals. [00:26:18] Speaker 01: In fact, they do the opposite. [00:26:20] Speaker 01: I think it's in the record at page 333. [00:26:24] Speaker 01: where in the summary of that paper, Winter and colleagues, Jones rather, Winter's the last author in the paper, discuss monoclonal antibodies and in the same breath, separately, their new chimeric antibodies. [00:26:40] Speaker 01: So, sorry, they address chimeric antibodies separately from monoclonal. [00:26:45] Speaker 01: So even in 1986, two years after Morrison, those in the art are still distinguishing between monoclonal antibodies on the one hand, [00:26:55] Speaker 01: and these other genetically engineered antibodies on the other. [00:27:00] Speaker 01: So that continues beyond 1984. [00:27:02] Speaker 02: Let me try a different way of getting at maybe some of the same issues we're talking about here. [00:27:11] Speaker 02: Let's assume for the moment that humanized antibodies, chimeric antibodies, weren't described or enabled as of December 1984, and the claim [00:27:23] Speaker 02: as best construed is restricted to antibodies produced by hybridoma across any species. [00:27:33] Speaker 01: Assuming they were enabled? [00:27:35] Speaker 01: Assuming they were enabled? [00:27:37] Speaker 02: For rabbits, rats, mice, et cetera, but not for chimeric or humanized. [00:27:46] Speaker 02: So let's assume also that [00:27:48] Speaker 02: all these genetically engineered antibodies are later-arising technology, after-arising technology. [00:27:55] Speaker 02: Classically, you can go through doctrinal equivalence to try to reach people that are practicing the invention using after-arising technology. [00:28:06] Speaker 02: So you have to then establish, saying your side has to establish that there was some kind of prosecution history estoppel, that they're barred from doing this. [00:28:17] Speaker 02: Throughout the prosecution, they seem pretty clear that they want coverage of chimeric antibodies, humanized antibodies, that they're not giving it up. [00:28:28] Speaker 02: And towards the tail end, January 2000, they proclaim that their claims are covering antibodies per se. [00:28:38] Speaker 02: So that suggests that they aren't looking to restrict their claim to just hybridoma-produced antibodies. [00:28:47] Speaker 02: So why is there a disclaimer under those circumstances? [00:28:50] Speaker 01: Because the focus is not on what the applicant wants or intends. [00:28:55] Speaker 01: It's on the impact that the prosecution history has on the public and the competitors. [00:29:02] Speaker 01: So no competitor or other member of the public could reasonably read the record any other way. [00:29:10] Speaker 01: There are two clear disclaimers. [00:29:14] Speaker 01: 12 years into the patent is the first time we ever see the word genetically engineered antibodies. [00:29:21] Speaker 01: It's 14 years in where we start to have an exchange about the breadth of a claim that was claim 31 that was originally to, with reference only to the antibody, the single antibody described in the patent, which is called CT1. [00:29:39] Speaker 01: In 1988, four years in, [00:29:42] Speaker 01: They had added that claim and added the language and derived there from. [00:29:46] Speaker 01: The examiner repeatedly rejected it nine times over nine years. [00:29:50] Speaker 01: And then we get to 1996 and the examiner's point and the inventors do as you suggest. [00:29:56] Speaker 01: They let the examiner know, we think this should cover chimeric and humanized and genetically engineered antibodies. [00:30:02] Speaker 01: He says, you have no support for that. [00:30:04] Speaker 01: That claim is amended. [00:30:06] Speaker 01: That's prosecution history is stopped to delete that language. [00:30:11] Speaker 01: Between the time that amendment was made and the time that the applicants received the examiner's notice of allowance, Remicade is approved by the FDA. [00:30:22] Speaker 01: That's the first, that's the chimeric anti-TNF antibody. [00:30:26] Speaker 01: So the applicants appear to have tried again, this time through the dependent claim route. [00:30:31] Speaker 01: The fact that they're dependent claims still means that the term monoclonal antibody is carried into that claim. [00:30:39] Speaker 01: disclaimer, prosecution disclaimer, prosecution history, estoppel are not anchored to any particular claim. [00:30:47] Speaker 01: They're anchored to the claim term. [00:30:49] Speaker 01: So wherever that term is used, the estoppel or the disclaimer would apply. [00:30:53] Speaker 04: I thought they canceled dependent claims and what's now claim one were added at the same time. [00:31:02] Speaker 04: And then the dependent claims were canceled when the examiner wouldn't allow them. [00:31:07] Speaker 04: Is that an incorrect [00:31:09] Speaker 01: They were added at the same time, Your Honor, and it's... Claim 41 also received enablement and written description rejections and also received the same comments from the examiner that there is no support in the specification for genetically engineered antibodies. [00:31:31] Speaker 01: What the applicants did in response was to say, we're concerned with limiting that claim [00:31:38] Speaker 01: to mouse monoclonal antibodies, because we're not sure if you limit it that way, whether it'll cover chimeric or human eyes. [00:31:48] Speaker 01: And we're particularly interested in achieving coverage for those types of antibodies. [00:31:54] Speaker 01: And the examiner said, no. [00:31:56] Speaker 01: The dependent claims are explicit to those types of antibodies. [00:32:00] Speaker 01: The examiner rejected them on the same basis, and those claims were canceled. [00:32:05] Speaker 04: For lack of enablement. [00:32:06] Speaker 04: Pardon me? [00:32:07] Speaker 04: For lack of enablement. [00:32:08] Speaker 04: But the new generic claim that included them was not rejected for lack of enablement. [00:32:15] Speaker 01: Claim 41? [00:32:15] Speaker 04: 41. [00:32:16] Speaker 01: It was rejected for both. [00:32:18] Speaker 01: But it was allowed. [00:32:18] Speaker 01: It was allowed in response to a declaration where the examiner noted in allowing the claim, I'm withdrawing the rejection on the basis of the Engelman declaration, which made two points. [00:32:33] Speaker 01: One is, [00:32:34] Speaker 01: The claim was enabled at the time, it was within the skill of those in the art, to make antibodies from more than just the mouse species. [00:32:44] Speaker 01: The second point that Engelman made was, because of the Morrison paper, I believe one of ordinary skill in the art would have been enabled to make chimeric antibodies. [00:32:56] Speaker 01: So two things on that. [00:32:58] Speaker 01: One, if you look at the Engelman Declaration, he himself distinguishes the meaning of that term. [00:33:03] Speaker 01: uses monoclonal separate from chimeric. [00:33:06] Speaker 01: Number two, the point that he made on Morrison and the enablement for genetically engineered antibodies as distinguished from the species of origin was not the base. [00:33:19] Speaker 01: The stated allowance and withdrawal of that rejection was simply was limited to the species of origin. [00:33:25] Speaker 02: Right. [00:33:26] Speaker 02: I think you want to be careful about how you're characterizing [00:33:29] Speaker 02: the grounds of the examiner's rejection of application claim 41. [00:33:34] Speaker 02: The examiner, she never relied on a written description theory for chimeric antibodies. [00:33:41] Speaker 02: It was solely a scope of enablement 112 rejection based on her view that a claim for monoclonal antibody couldn't enable antibodies across all species. [00:33:59] Speaker 02: And I think [00:34:00] Speaker 02: this is maybe helping you, that's important because it reveals the examiner never thought application 41 covered chimeric antibodies. [00:34:11] Speaker 02: And so, therefore, when she allowed the claim, it was purely after being convinced that such a claim across all hybridoma, you know, source from different animals was enabled. [00:34:29] Speaker 01: I think that is the takeaway from the prosecution, Your Honor. [00:34:32] Speaker 02: And so therefore, allowing that claim was not a commentary that she thought potentially that chimeric antibodies were either supported or enabled by this patent? [00:34:43] Speaker 01: At least with respect to prosecution history estoppel, I'm not sure that the basis for the amendment would change the fact that there's an estoppel. [00:34:51] Speaker 01: The exchange, the long-term, years-long discourse between the applicant and the examiner about [00:34:58] Speaker 01: wanting to cover these antibodies in any number of claims, which other broad claims were rejected on the same basis that just had different language, like inhibited by the reference monoclonal. [00:35:11] Speaker 01: That was a 112 written description rejection of 41. [00:35:14] Speaker 01: And there's a very consistent pattern of we'd like to get coverage, and the examiner's saying you're not entitled to it. [00:35:22] Speaker 01: You have a cancellation of claims in the second instance. [00:35:24] Speaker 01: You have a narrowing amendment in the first instance. [00:35:28] Speaker 01: As I suggested, the impact on the public is what matters. [00:35:32] Speaker 01: I think as a competitor, you read that and say, they tried to get these claims. [00:35:37] Speaker 01: They couldn't get them. [00:35:39] Speaker 01: That is outside the boundaries of their intellectual property. [00:35:42] Speaker 01: And that fact implicates all of the issues on appeal. [00:35:47] Speaker 01: My time is up. [00:35:49] Speaker 01: Do I have any other questions? [00:35:50] Speaker 01: Any more questions? [00:35:51] Speaker 01: Thank you, Mr. Treiner. [00:35:52] Speaker 01: Thank you, Your Honor. [00:35:52] Speaker 01: Thank you for your time and consideration. [00:35:54] Speaker 04: Mr. Greenbridge, you have three minutes. [00:35:56] Speaker 00: Thank you very much, Your Honor. [00:35:59] Speaker 00: So I would just like to say that, looking at the doctrine of equivalence, if, in fact, the claims are construed so that monoclonal antibody only means the product of a hybridoma, then claim 41, by definition, was not narrowed. [00:36:16] Speaker 00: It never covered the things that the dependent claims purported to cover, and cancellation of those claims could not have affected the scope of claim 41. [00:36:25] Speaker 00: And they were, if you will, improperly dependent, if that's what monoclonal antibody is construed to mean. [00:36:30] Speaker 00: And therefore, the cancellation of them should not be a bar to have claim 41 having some scope of equivalence with respect to after arising technology. [00:36:39] Speaker 03: Does that argument help you if you state that they were improper, dependent claims? [00:36:48] Speaker 00: I think certainly the applicant's view at the time was that they were not improperly dependent claims. [00:36:53] Speaker 00: And the applicant made clear [00:36:55] Speaker 00: in this is with reference to the exchanges that Judge Chen mentioned, we are taking out the reference to the method of making and we believe that monoclonal antibody is covered even by genetically engineered techniques and so on. [00:37:10] Speaker 00: So the applicant I think certainly didn't think they were improperly dependent. [00:37:13] Speaker 00: If looking back at this one says, well monoclonal antibody at the time and now only meant things produced by hybridoma, then in that case claims that reach [00:37:25] Speaker 00: matter that isn't produced by Iberdoma would have been improperly dependent. [00:37:29] Speaker 00: And cancellation of those claims would not have operated to carve anything out, if you will, from claim 41. [00:37:35] Speaker 02: Why isn't that something of a wooden understanding of prosecution history is toppled? [00:37:40] Speaker 02: Because if application claim 41 had said a monoclonal antibody, including chimeric antibodies, that claim certainly would have been rejected for [00:37:51] Speaker 02: encompassing chimeric antibodies, you would have had to delete that for lack of written description. [00:37:56] Speaker 02: And then you're saying, OK, that application claim would be barred from pursuing doctrine of equivalence under a prosecution history estoppel. [00:38:04] Speaker 02: But because that very same claimed subject matter for chimeric antibodies was in the dependent claim, the improperly drafted dependent claim, that claimed subject matter, which was ultimately canceled for lack of written description, cannot be used [00:38:20] Speaker 02: as a bar to stop? [00:38:24] Speaker 00: I think you're on the way. [00:38:25] Speaker 00: I would look at that as to say that all of this is not the correct reading of the prosecution history, that the dependent claims were never rejected for being improperly dependent. [00:38:34] Speaker 00: They were never rejected. [00:38:36] Speaker 00: And so if you assume the examiner is hearing the applicant say, I think claim 41 includes genetically engineered antibodies, the examiner [00:38:48] Speaker 00: In that, if the examiner disagreed, the examiner should have come back and said, then I reject claim 41 as embracing subject matter for which there is neither written description nor enablement. [00:38:57] Speaker 00: That never happened. [00:38:59] Speaker 00: And in fact, in our view, the correct reading of this is the examiner said you are entitled to a broad generic claim. [00:39:06] Speaker 00: What you're not entitled to are species claims that go to our undescribed species within that genus and that that's the proper reading of the exchange. [00:39:16] Speaker 00: I'm saying if we read it differently, [00:39:18] Speaker 00: and say monoclonal antibody never embraced genetically engineered species in the examiner's mind, then we, in that case, there would be no narrowing of claim 41. [00:39:27] Speaker 00: Either way, you can get to a place, and you should get to a place where there can be some form of coverage of this type of embodiment, namely a humanized derivative of a mouse antibody. [00:39:40] Speaker 00: The one last point I would like to make is that I think Mr. Treanor misspoke when he said there was no disclosure other than the [00:39:46] Speaker 00: November 1984 Morrison paper. [00:39:49] Speaker 00: There is in the record, and this is at 2441 to 45, the Kabili paper published in June of 1984, which describes our chimeric monoclonal antibodies. [00:40:01] Speaker 00: And it specifically says in the last paragraph, talks about expression, in other words, genetic engineering. [00:40:08] Speaker 00: And then it's... Published in 1984? [00:40:09] Speaker 00: Published in June of 1984. [00:40:11] Speaker 00: and it's in the proceedings of the National Academy of Science, and it specifically says these approaches, genetic engineering, could lead to alternative ways of preparing stable human monoclonal antibodies. [00:40:22] Speaker 00: It's an explicit reference using monoclonal antibody to refer to genetically engineered material. [00:40:27] Speaker 00: It's in the record, and it's in combination with the statements of our experts [00:40:35] Speaker 00: And the other things referred to in the record about the state of the art make it clear in our view that as of December 1984, the term monoclonal antibody did include genetically engineered material. [00:40:45] Speaker 02: Could you give me the JA site one more time? [00:40:47] Speaker 00: Yes. [00:40:47] Speaker 00: The paper as a whole is JA2441. [00:40:53] Speaker 00: And the portion that I quoted is JA2445. [00:40:58] Speaker 00: And it is the very final paragraph of the text before the acknowledgments and references. [00:41:05] Speaker 04: Thank you, Mr. Groombridge, and thank you, Mr. Treanor. [00:41:08] Speaker 04: The case is taken under submission.