[00:00:00] Speaker 00: The case for argument this morning is 21-1969, University of Massachusetts versus L'Oreal. [00:00:06] Speaker 00: Mr. Lampkin, whenever you're ready. [00:00:08] Speaker 00: Nice to see you again. [00:00:11] Speaker 02: Good morning. [00:00:11] Speaker 02: May it please the court? [00:00:13] Speaker 02: Despite the patent's expressed definition of skin enhancement, which is a noticeable decrease in the amount of wrinkling, dryness, or other listed conditions, and recitation of a specific effective dermal adenosine concentration, the district court held [00:00:29] Speaker 02: the phrase amount effective for enhanced skin condition is indefinite because the patent supposedly allows for purely subjective determinations of whether there was a decrease in the amount of a listed condition. [00:00:40] Speaker 00: Well, you may be right that it supposedly allows for [00:00:45] Speaker 00: a purely subjective, but it explicitly allows for subjective evaluations, right? [00:00:52] Speaker 00: And that word must mean something. [00:00:53] Speaker 00: They could have said evaluations by patients and doctors. [00:00:56] Speaker 00: They said subjective evaluations. [00:00:59] Speaker 00: So I don't know how to parse the difference between subjective and purely subjective. [00:01:05] Speaker 00: We've got dictionary definitions for subjective. [00:01:08] Speaker 00: So the question, for me, it comes down to what does subjective mean? [00:01:12] Speaker 00: and who gets to decide that, and how is that decided? [00:01:17] Speaker 00: And your suggestion there that it's a jury is also one that I'd like to get into with you. [00:01:22] Speaker 00: So if you could start there for me. [00:01:23] Speaker 02: So I think we'll start with the patent, because the patent says that subjective evaluations are permitted in the art. [00:01:29] Speaker 02: They're well known in the arts. [00:01:30] Speaker 02: You would look at the ones that are permitted in the art. [00:01:33] Speaker 02: And immediately after that statement, it cites a study, Olson. [00:01:37] Speaker 02: And if you look at Olson, Olson is a study of 296 patients. [00:01:42] Speaker 02: double-blind study, it has dermatologist assessments, subjective, they're looking at the patients. [00:01:47] Speaker 02: It has patient questionnaires, potentially subjective as well. [00:01:51] Speaker 02: But when you have a study, you eliminate that subjectivity being random because you do a properly controlled study. [00:01:57] Speaker 02: And in this art, that's permitted. [00:01:59] Speaker 02: And if you look at the next thing that's recited, it's also a study. [00:02:02] Speaker 02: And it is Olson again, it's a 1997 Olson study, again a study. [00:02:07] Speaker 02: And when you look again at the next one, or actually it proceeds a little bit, Grove, Grove is once again a study of 24 individuals. [00:02:13] Speaker 02: And it's just well accepted in the art that when you are looking to see whether or not you have improvement or something's effective, [00:02:19] Speaker 02: at improving a particular condition, lessening them out. [00:02:22] Speaker 02: You have objective criteria, lessening them out. [00:02:24] Speaker 02: You're allowed to have these subjective criteria. [00:02:26] Speaker 02: But you use a study in order to do that. [00:02:28] Speaker 00: And there's a reason for that. [00:02:29] Speaker 00: But what does subjective mean? [00:02:31] Speaker 00: I mean, it can mean one of two things. [00:02:34] Speaker 00: But I think the definition is relation to judgment and peculiar to a specific particular individual or modified or affected by personal views, experience, or background. [00:02:47] Speaker 00: Do you accept that as the definition of subjective? [00:02:49] Speaker 02: I think subjective means that you are using your judgment and the evaluation and skilled artisans like people who are looking at skin all the time, they are going to be deciding based on their judgment. [00:03:00] Speaker 00: What about patients though? [00:03:00] Speaker 02: Let's talk about patients. [00:03:02] Speaker 02: You can also do patient questionnaires, but no one would say, gee, one patient has decided that this has improved her skin, therefore it is an effective amount to reduce the fine lines and wrinkles. [00:03:14] Speaker 02: you would have to do a study because that's what effective mounts are about. [00:03:18] Speaker 02: They're about whether or not it works across a population. [00:03:21] Speaker 02: And that's how the art works. [00:03:22] Speaker 02: It looks at effects across a population. [00:03:25] Speaker 02: And when you look across a population, you can do a proper controlled study to eliminate that. [00:03:29] Speaker 02: You have the same observer before and after. [00:03:31] Speaker 02: You have placebo effect. [00:03:32] Speaker 02: You have a double-blind study. [00:03:34] Speaker 02: These are all things that are accepted in the art to reduce it. [00:03:37] Speaker 02: So let me move on to the second part of my question, because I don't want to monopolize this too much. [00:03:43] Speaker 02: If you couldn't have some element of subjectivity in there, [00:03:47] Speaker 02: You couldn't have a patent, for example, for applying an effective amount of a pain reliever because the patient's the one who feels the pain. [00:03:54] Speaker 02: And that's certainly much more subjective how much pain you feel than the externally observable criteria of lessening of amount, reduction in quantity of observable things on somebody's face. [00:04:05] Speaker 02: I'm sorry, Judge. [00:04:05] Speaker 00: But it does use the word subjective, and subjective has to mean something. [00:04:09] Speaker 00: They could have just said evaluation by patients, and I'm not sure we would be here. [00:04:13] Speaker 02: Yeah, certainly if they left out that word, but that word is modified by what follows. [00:04:18] Speaker 02: It says, in the art, and the art accepts people looking at skin. [00:04:22] Speaker 02: and doing an evaluation without actually counting, but saying, yes, that looks like it's an improvement. [00:04:27] Speaker 02: And as long as you're doing it as part of a study, as long as you're doing it across the population, that's how people determine therapeutically effective amounts. [00:04:34] Speaker 02: And that's how it's done in vaccines. [00:04:36] Speaker 02: You wouldn't just ask one person, did you have less symptoms because you had the vaccine? [00:04:40] Speaker 02: You'd ask a whole group and you properly control, and you would determine, yes, indeed, this does reduce the symptoms, even though to some degree people are saying subjectively, I felt better, I did not. [00:04:49] Speaker 00: Who makes the decision? [00:04:51] Speaker 00: I mean, there's a suggestion in your brief in a number of places that we're looking at a juror. [00:04:57] Speaker 00: And could a juror do this? [00:04:59] Speaker 00: And I'm not seeing what the role of the juror would be here. [00:05:03] Speaker 00: This, to me, seems quite parallel. [00:05:05] Speaker 00: And I think the cases support that this is parallel to claim construction. [00:05:09] Speaker 00: So you can have extrinsic evidence. [00:05:11] Speaker 00: but that that's for the judge and not a jury. [00:05:14] Speaker 02: So why am I wrong about that? [00:05:22] Speaker 01: Doesn't that case merely say that it's okay to give it to the jury? [00:05:27] Speaker 02: Yes, it says it is at least permitted. [00:05:29] Speaker 01: You're arguing that you have an entitlement to a jury to determine, if not, certainly not the claim construction aspects, but it's several real world what would scientists know about consistency or methodology questions that go into reasonable certainty. [00:05:49] Speaker 01: Like Judge Prost, I've had some trouble trying to figure out why [00:05:54] Speaker 01: whether there is controlling precedent on whether those aspects, which are not really claim construction aspects, are jury questions. [00:06:03] Speaker 02: Right. [00:06:03] Speaker 02: And you're correct that Bombardier says to the extent you're looking at claim construction, that's not going to the jury. [00:06:08] Speaker 02: It's only when you're looking at extrinsic facts. [00:06:11] Speaker 02: And it lists some of the extrinsic facts here. [00:06:12] Speaker 00: And you have extrinsic facts. [00:06:13] Speaker 00: Well, we can have extrinsic facts under TEVA and in claim construction. [00:06:17] Speaker 00: And there's no suggestion, and I think we all accept, I can't pinpoint who said what when, that that's not an issue that goes to the jury. [00:06:25] Speaker 00: That's for the judge. [00:06:26] Speaker 00: And even in TEVA, on remand here, where we talked about what the Supreme Court said about standards of review, yadada, they are talking about a judge making that determination just like in claim construction. [00:06:38] Speaker 00: So where is the juror involved? [00:06:40] Speaker 02: So we believe that the juror would be involved, that if the court, it would be at least permissible for the court to allow the jurors to determine those extrinsic facts and make a determination indefinite, as happened in Bombardier. [00:06:51] Speaker 02: But even if we're talking about the court making the determination, it's still subject to the clear and convincing evidence standard, and the court is still going to have to account for the evidence on both sides. [00:06:59] Speaker 02: And in this case, the court didn't look and say, you know, under the methods in the art, [00:07:04] Speaker 02: these types of studies. [00:07:05] Speaker 02: Studies at Morialius as well, it's not you can't actually determine whether there is this. [00:07:10] Speaker 02: They simply said well there's subjectivity here and therefore I'm going to throw it out. [00:07:13] Speaker 02: But the art allows for that degree of subjectivity because it has studies. [00:07:17] Speaker 02: Well, where's the evidence? [00:07:19] Speaker 00: I mean, you had your chance, right? [00:07:22] Speaker 00: I mean, what can you point me to in the record where this is the argument that your experts pointed to and that your expert talked about these studies and talked about subjectivity? [00:07:33] Speaker 02: So if you turn to page 1200, 478 of the record. [00:07:36] Speaker 02: Wait, I'm sorry. [00:07:39] Speaker 02: Are we in the second book? [00:07:42] Speaker 02: It's 12,478. [00:07:43] Speaker 02: It's paragraph 185. [00:07:50] Speaker 02: And it says, here's the methods. [00:07:52] Speaker 02: And it says, comparative studies have shown correlation between assessments performed using different metrics. [00:07:57] Speaker 01: Can I just double check something? [00:07:58] Speaker 01: I think in your response to the summary judgment, you have to file some here, the facts that we just read. [00:08:03] Speaker 01: You cited 186, but not 185. [00:08:07] Speaker 01: Is that just the typo? [00:08:08] Speaker 02: I think that's just a typographical error, Your Honor. [00:08:10] Speaker 02: And it's very clear because it goes on and says, numerous publications and other patents describe compositions that are directed toward enhancing the condition of skin. [00:08:18] Speaker 02: And a skilled artisan would have well understood that the efficacy of this method could be evaluated in a similar way. [00:08:23] Speaker 02: And then it cites some of the studies that are in the patent and additional studies in that footnote. [00:08:27] Speaker 02: And then if you turn to page 15176 and 15522, these are actually L'Oreal studies. [00:08:36] Speaker 02: And what does L'Oreal look at? [00:08:37] Speaker 00: You've got to give me a chance. [00:08:40] Speaker 02: 176-15522. [00:08:43] Speaker 02: These are L'Oreal studies, and they're under SEAL, so I'm not going to go into detail on them. [00:08:48] Speaker 02: But L'Oreal itself relies on patient questionnaires and dermatologist assessments in determining whether or not its products are effective for its advertise purposes, subject to an FTC injunction that says you have to have support for your assertions that this does reduce fine lines, wrinkles, or whatever the condition. [00:09:05] Speaker 01: So on the assumption that [00:09:08] Speaker 01: Accepted methodologies can include subjective self-assessment as data. [00:09:14] Speaker 01: It would remain the question whether the various methodologies produce sufficiently inconsistent results, inconsistent in a way material to whether something is in or out. [00:09:31] Speaker 01: Did you really create a triable issue in your summary judgment papers about the question of consistency? [00:09:37] Speaker 02: Oh, I think so. [00:09:37] Speaker 02: This just comes down to the credibility of the experts. [00:09:40] Speaker 02: And I don't think there's evidence from the other side that in the context of adenosine, in the context of the types of studies one runs, according to the patent itself and the specification, you're going to get such varying results that you can't tell whether you're in the patent or out. [00:09:54] Speaker 02: But I also think that it doesn't matter because the patent actually tells you the effect of the therapeutically effective amount. [00:10:00] Speaker 02: You don't need to go to those studies because the patent tells you the therapeutically effective amount. [00:10:05] Speaker 02: at the dermal layer is specifically, let me try the page, 10 to the negative third to 10 to the negative seven molarity, which is 10 to the negative third to the negative seven moles per liter. [00:10:17] Speaker 02: If you have that molarity at the dermal layer, you are applying the effective amount. [00:10:22] Speaker 00: Can I ask you just one basic question before we get into the details of that. [00:10:27] Speaker 00: Is there anything in the spec that tells us what the amount [00:10:32] Speaker 00: that is put on the epidural layer of the skin gets you. [00:10:36] Speaker 00: I mean, what is in the claim language, I understand, is the concentration that is measured at the dermal layer. [00:10:43] Speaker 00: Am I right about that? [00:10:44] Speaker 00: That's correct. [00:10:46] Speaker 00: Do we know anything about what the amount that is administered on the epidural layer to get that amount on the dermal layer? [00:10:53] Speaker 02: So the patent does not tell you that answer, except in one respect. [00:10:57] Speaker 02: So first, the evidence showed on page 12,474 of the record now [00:11:02] Speaker 02: that a skilled artisan would know how to prepare a composition that would deliver the recited concentrations to the dermal cells. [00:11:08] Speaker 00: Hold on. [00:11:08] Speaker 00: You have to be patient with me. [00:11:09] Speaker 00: Okay. [00:11:10] Speaker 00: Give me the site first and let me get to it. [00:11:11] Speaker 02: 12,474. [00:11:12] Speaker 02: I believe it's the top. [00:11:14] Speaker 00: I'm reading through my notes. [00:11:16] Speaker 02: It says a skilled artisan would have known how to prepare a composition that would deliver the recited concentrations to the dermal cells. [00:11:23] Speaker 02: So we have a record that shows that skilled artisans know how to do this. [00:11:26] Speaker 00: But on top of that, the paragraph... I'm sorry, I'm on 12474, and what paragraph are you looking at? [00:11:32] Speaker 00: 172. [00:11:33] Speaker 00: Oh, what? [00:11:35] Speaker 01: There's the paragraph. [00:11:36] Speaker 00: Oh, okay, okay. [00:11:40] Speaker 02: Okay, thank you. [00:11:42] Speaker 02: But in addition, Patton also gives you the information about if you're looking for an absolute number. [00:11:47] Speaker 02: If I get to ask the court, and I will go slow this time, Judge Prost, I apologize. [00:11:51] Speaker 02: to go to column five of the patent, which is on page 69 of the appendix. [00:12:00] Speaker 02: And it says, for example, and this is line 35, dosages for a therapeutically effective amount for topical application. [00:12:07] Speaker 02: So this is talking about in the composition that goes on your skin, not what penetrates the dermal layer. [00:12:13] Speaker 02: for topical application would be in the range of 100 nanograms to 10 milligrams per treated surface area per day. [00:12:19] Speaker 02: So you have an amount there. [00:12:21] Speaker 02: And the key to the whole thing is that when the patent says this, the patent's very clear about distinguishing between the topical composition, what's topically applied, and the concentration of the dermal layer. [00:12:31] Speaker 01: For the topical composition... I'm sorry, when you say the patent is clear... The patent claims. [00:12:36] Speaker 01: The claim, right. [00:12:37] Speaker 01: The patent is, I think, about as far from clear about that distinction as it is possible to get. [00:12:42] Speaker 02: No, I think it's relatively clear, especially after you've amended the claims, because you look at the data and the data is talking about the molarity. [00:12:48] Speaker 01: Can I ask you about the wherein clause? [00:12:51] Speaker 01: What thing is the thing measured in leaders in the denominator when measuring the molarity figures in the wherein clause? [00:13:02] Speaker 02: That's the dermal layer. [00:13:03] Speaker 02: So you're looking at the concentration at the dermal layer. [00:13:07] Speaker 02: So it's the walls per liter of derma. [00:13:08] Speaker 01: And that's, I think, pretty obviously different from what the concentration is in, which is the denominator is the solution of the composition. [00:13:20] Speaker 01: So we're not talking about a composition put on the skin. [00:13:28] Speaker 01: in which there's a certain amount of adenosine measured in molarity with the number of liters of the solution, mainly the composition being the denominator. [00:13:37] Speaker 01: All of that going down through the epidermis to reach the dermal cell, and some of it is adenosine, some of it is the solution, and you're now applying that solution with adenosine in it, measured as a concentration, to the dermal cells. [00:13:55] Speaker 01: you want to translate the wherein clause into an amount of adenosine gets to the cells forming a concentration in the dermal cells of those amounts. [00:14:07] Speaker 02: So I think that's mostly right if I'm understanding correctly, Your Honor. [00:14:11] Speaker 02: I think the wherein clause is very clear. [00:14:13] Speaker 02: It says wherein the adenosine concentration applied to the dermal cells. [00:14:16] Speaker 02: So when you're looking at the dermal cells from one layer to the next for example. [00:14:20] Speaker 01: It's a very strange use of the word concentration. [00:14:23] Speaker 01: No, because I think that is... You mean the adenosine, what's applied to the dermal cells is the adenosine. [00:14:29] Speaker 01: It's not a molarity, it is the actual moles of adenosine. [00:14:34] Speaker 02: No, your honor, because at that point it's absorbing through the layers of the dermis. [00:14:38] Speaker 02: And so the concentration is going to be the concentration in the dermis, like you would talk about the concentration in a bloodstream. [00:14:44] Speaker 01: You're looking at it's diluted to some degree, but it's actually... Why would you use the language of concentration applied to language that I would think means you have to measure the concentration before it gets to the thing? [00:15:02] Speaker 02: Well, you certainly would measure concentration before it gets there. [00:15:05] Speaker 02: So maybe I should talk about the contradistinction between the topical composition and what happens at the dermal layer. [00:15:12] Speaker 02: The wearing clause, you have a very specific, it says, when the adenosine concentration, so you have a specific one, applied to the dermal cells, so it's reaching the dermal cells. [00:15:20] Speaker 02: And it gives you a specific number. [00:15:21] Speaker 01: That suggests that it's actually the concentration, namely a number of adenosine moles in the leader of the composition. [00:15:28] Speaker 01: That's the antecedent, isn't it? [00:15:32] Speaker 02: It says we're in the concentration applied to the dermal cells. [00:15:35] Speaker 02: But when you go up and you're talking about the topical application, it says comprising topically applying to the skin, a composition comprising [00:15:43] Speaker 02: a concentration of adenosine. [00:15:45] Speaker 02: So it is agnostic. [00:15:46] Speaker 02: It's not specific about how much adenosine is in there. [00:15:50] Speaker 01: I would think that the definite article V, which is a reference back to the antecedent, would be to the solution, namely the adenosine in composition. [00:16:02] Speaker 01: I don't know what else is in solid, right? [00:16:06] Speaker 01: In the solution. [00:16:07] Speaker 02: So it has to be measured at the dermal layer. [00:16:10] Speaker 01: You have to see what's reaching the dermal layer because it says... But you don't want to do that because you don't want to measure a concentration until it's in the dermal layer and you're using the dermal layer as the denominator. [00:16:23] Speaker 02: Remember, the dermal layer isn't just sort of a sudden event. [00:16:26] Speaker 02: You have, as it goes through, it's going through the dermal layer, through the epidermis to the dermal layer and through different layers of the dermal layer. [00:16:34] Speaker 02: And our understanding is that when you're looking at measuring that concentration at the dermal layer, you would include the dermal cells as the denominator and you will include the adenosine as the numerator. [00:16:45] Speaker 02: When you're talking about the topical composition though, the language is very different. [00:16:49] Speaker 02: It uses a concentration of adenosine, an amount, so it uses nonspecific generic terms. [00:16:55] Speaker 02: Well, how do you know? [00:16:56] Speaker 02: How much do you put in the topical composition that goes on the skin? [00:17:00] Speaker 02: You put the amount in the topical composition that will achieve the adenosine concentration at the dermal layer. [00:17:06] Speaker 02: So how much do you put in? [00:17:07] Speaker 02: You put in enough to get to those concentrations in the dermal layer. [00:17:11] Speaker 02: And it's very clear from the science that was there, they were looking at what reaches these dermal cells, what's reaching the fibroclasts. [00:17:18] Speaker 02: And if you look at pages 69 to 71 of the appendix, they're looking at what's touching the fibroclasts, and it's a concentration. [00:17:25] Speaker 01: It's not going to be touching the fibroclasts if it were... I'm sorry, you were referring to... [00:17:30] Speaker 01: the experiments. [00:17:32] Speaker 01: But there isn't the concentration measured as a certain amount of adenosine in a liquid that is then being put into the little petri dish or something with the fibroblasts. [00:17:43] Speaker 01: The fibroblasts are not the part, are not themselves the denominator. [00:17:48] Speaker 02: I think the measurement there is the concentration sitting in that vial as it's applied, not a concentration just superficially. [00:17:55] Speaker 02: And the evidence showed that when you're doing that number and then [00:17:58] Speaker 02: And if the fibroblasts count for anything, remember we're in a petri dish, so that's going to be a very, very small number. [00:18:03] Speaker 02: When you're trying to penetrate the dermis, and you're trying to reach all those cells in the dermis to enhance all the things that are getting enhanced here, you're going to want to put a concentration in that dermis. [00:18:12] Speaker 02: It's going to be applied to the dermis, the entire layer. [00:18:15] Speaker 02: That's going to be the concentration all the way through, not just a concentration at the top layer. [00:18:18] Speaker 02: And I think that both the PTAP and the district governor understood that the dermis is a layer including that dermal layer, that concentration there. [00:18:26] Speaker 02: When you're talking about the topical concentration, [00:18:28] Speaker 02: that isn't specified because it says a concentration and I'm out. [00:18:32] Speaker 01: Right, so in a way that I think is probably obvious, if we were to conclude that the district court was wrong on this threshold claim construction question and that the wherein clause actually does refer to the concentration of adenosine in the composition, what do we do here? [00:18:57] Speaker 02: Well, so if that were the case, then this would have to be remanded, because the district court didn't evaluate it under that standard. [00:19:03] Speaker 02: But I think that's quite clearly wrong, because it really does very clearly distinguish between two things. [00:19:09] Speaker 02: A topical composition. [00:19:10] Speaker 00: What is quite clearly wrong? [00:19:11] Speaker 00: The claim. [00:19:13] Speaker 00: Claim one. [00:19:13] Speaker 02: Claim one says, applying to the skin a composition [00:19:16] Speaker 02: comprising a concentration of adenosine in an amount, so it is very nonspecific, it's very general, some concentration, some amount is going to be applied. [00:19:27] Speaker 02: And then what do you have to do? [00:19:29] Speaker 02: You have to make sure that the adenosine concentration applied to the dermal cells, when you get down to that dermal layer, you have this concentration. [00:19:37] Speaker 01: Right, I guess my problem, and I just could be failing to understand this, it seems to me that [00:19:42] Speaker 01: that it would be one thing to say something that you don't say. [00:19:46] Speaker 01: And that thing would be, take the cream, which is a composition containing adenosine and other stuff. [00:19:54] Speaker 01: And that has a certain concentration, the adenosine over the volume of the rest of the cream. [00:19:59] Speaker 01: You see how much of that whole thing hits the dermal cells. [00:20:05] Speaker 01: And you measure that concentration in that whole [00:20:11] Speaker 01: amount of cream that is going through and that's because that's what applied to seems to me to mean as a matter of playing language You don't want to do that. [00:20:22] Speaker 01: You want to take the adenosine molecules Measure them a certain number of moles over the leaders of the dermal cells which seems to me [00:20:33] Speaker 01: not at all what the language says. [00:20:35] Speaker 01: And if the language isn't clear, then it seems to me the spec and the prosecution history push really, really strongly in favor of saying the 10 to the minus third to 10 to the minus seven molarity is all about the composition, the thing put on the skin. [00:20:55] Speaker 02: No, Your Honor, I think that all points the opposite way. [00:20:58] Speaker 02: Because remember, the wearing clause was added at the examiner's request. [00:21:03] Speaker 02: And the wearing clause was very clear and added no new, because it said, we're in a normal layer. [00:21:08] Speaker 01: You said when you added it that all we're doing here is putting basically the limitation of what defendant claims three into claim one. [00:21:18] Speaker 01: You never called any attention. [00:21:20] Speaker 01: until after the fact, after the allowance, to the idea that this addition of the dermal cell language was radically changing everything about the measurement being done. [00:21:31] Speaker 01: And you never said, here's how we're going to measure that. [00:21:33] Speaker 01: Suddenly the denominator is no longer the composition. [00:21:36] Speaker 01: It's something else. [00:21:39] Speaker 01: That's why I think, am I right in thinking that remembering that the board said, this prosecution history may not be quite strong enough, but boy does it look like this sort of favored L'Oreal's voice. [00:21:52] Speaker 02: It's certainly not enough to show that there's a disavowal where you would say that the concentration- Why would you need a disavowal? [00:21:58] Speaker 01: This is not narrowing. [00:22:00] Speaker 01: This is a changing of meaning. [00:22:02] Speaker 02: Well, you'd need a disavowal because the language [00:22:04] Speaker 02: And the district court thought the language was very, very clear. [00:22:07] Speaker 02: And the PTAB understood the language was very, very clear, that the measurements at the dermal layer are not the topical composition. [00:22:12] Speaker 01: Did the PTAB understand how you measured this concentration in the wherein clause? [00:22:18] Speaker 02: Yes. [00:22:18] Speaker 02: There were extensive affidavits about how you measure the wherein clause. [00:22:23] Speaker 01: Including the fact that the denominator there had nothing to do with the solution. [00:22:27] Speaker 02: Exactly. [00:22:28] Speaker 02: And there were arguments from my colleagues that [00:22:30] Speaker 02: It is indefinite because those measurements don't work. [00:22:33] Speaker 02: A skilled artist can't make that measurement. [00:22:35] Speaker 02: On the other hand, we relied on from cell diffusion testing saying, oh no, you can make that measurement. [00:22:39] Speaker 02: You go measure it and you measure how much has gotten through. [00:22:42] Speaker 02: And that is the same debate that's actually occurring here. [00:22:45] Speaker 02: PTAB ultimately didn't decide it because it decided the text was absolutely clear. [00:22:49] Speaker 02: There's one composition that's topically applied. [00:22:53] Speaker 02: It can have a quantity of adenosine, an amount, [00:22:58] Speaker 02: And then when you get down to the dermal layer, it says wherein the amount applied to the dermal layer, the dermal cells, so you're reaching and penetrating the dermal cells, that's the amount. [00:23:08] Speaker 02: If you imagine the second layer of dermal cells, not the first, the second layer is only going to get the concentration of what's up there with the first. [00:23:14] Speaker 02: The third layer of dermal cells, it's only going to get what's up there with the first two layers. [00:23:17] Speaker 02: And so when you're trying to figure out what's reaching all the dermal cells in that layer, that's the concentration that's there in the dermal layer. [00:23:24] Speaker 02: If the court, I think I'm well past my time at the moment, if the court has no other questions, I'd say one minute perhaps on jurisdiction, which is simply to say that it was, excuse me, jurisdiction over L'Oreal SA, that it was error to require us to try this on affidavits when we're just simply strangers to the corporation. [00:23:43] Speaker 01: Can I just, what difference, if any, to any substantive issue in the case would it make if SA is here? [00:23:51] Speaker 02: So it's simply a matter of who's liable. [00:23:53] Speaker 02: In terms of the substantive issues of the case, it doesn't make any. [00:23:56] Speaker 02: So we were assuming that we would get, we're asking for that relief, but if we are going to lose on indefiniteness, it doesn't really matter anymore. [00:24:02] Speaker 02: But we're hoping we're not going to lose on indefiniteness. [00:24:05] Speaker 01: Right, but I guess maybe I was asking if you were going to win on indefiniteness, would other issues in the case be affected? [00:24:14] Speaker 01: Assuming USA is not insolvent or something? [00:24:16] Speaker 02: Yeah, I don't think so, Your Honor. [00:24:18] Speaker 02: I think it's simply a matter of who's liable and who we can get discovery from and things like that. [00:24:22] Speaker 02: Thank you, Your Honor. [00:24:22] Speaker 02: Thank you. [00:24:26] Speaker 03: Good morning. [00:24:29] Speaker 03: Good morning, Your Honors. [00:24:29] Speaker 03: May it please the Court? [00:24:31] Speaker 03: Unless Your Honors would like to direct me otherwise, I will begin by addressing plaintiff's contention that the skin enhancement language does not limit the claims beyond the required concentration. [00:24:41] Speaker 03: The skin enhancement limitation appears twice in the claims, in the preamble as well as the body. [00:24:47] Speaker 03: The preamble was added to the claims in response to an examiner rejection and was specifically relied upon to avoid an anticipation rejection over the Kronstein reference. [00:24:57] Speaker 03: That's 2689 in the appendix. [00:24:59] Speaker 03: And regardless, the body of the claims require an amount effective to enhance the condition of the skin. [00:25:06] Speaker 03: In column two, lines 38 to 40 of the specification states that this term means an amount that enhances skin condition when applied to skin. [00:25:16] Speaker 03: This is a functional definition that avoids something like a minuscule amount of adenosine at the required concentration being there only briefly and having no effect. [00:25:27] Speaker 03: Perhaps more importantly, concentration and amount are separate claim terms. [00:25:31] Speaker 03: And there really can't be a debate that they mean different things. [00:25:35] Speaker 03: Now, Dr. Dobson was plain as 30b6 witness with respect to the topic of the effect of adenosine on the concentration. [00:25:44] Speaker 01: Can I just move closer to what I think we were focusing on when talking about the indefiniteness aspect? [00:25:56] Speaker 01: which I think centers around this column five language and the reference to subjective evaluation, subjective evaluations either by the patient or by an individual physician. [00:26:12] Speaker 01: Mr. Lamkin says, look at that language from the point of view of what you agree to be the relevant skilled artisan, which is a science type. [00:26:22] Speaker 01: And science types in this field know what to do with essentially individual reports. [00:26:29] Speaker 01: They don't take anyone as gospel. [00:26:31] Speaker 01: They factor them in looking at a global population, not global, global, but a [00:26:38] Speaker 01: a large sample population to figure out what to make, what conclusions to draw from a variety of evidence, some of which are individual self-assessments, and that that, in this field, provides enough reasonable certainty. [00:26:54] Speaker 01: What's wrong with that view of this quite central language? [00:26:59] Speaker 03: I'll respond to that in two ways. [00:27:01] Speaker 03: First, the specification is very purposeful. [00:27:04] Speaker 03: in referring to this as subjective evaluations by a patient. [00:27:08] Speaker 03: This is talking about who's receiving the composition. [00:27:10] Speaker 03: The claims say you're going to give this to a mammal having skin containing dermal cells and see if it enhances their skin. [00:27:17] Speaker 03: That's what's required by this method. [00:27:19] Speaker 03: That is subjectively performed. [00:27:22] Speaker 03: An individual who receives the cream will decide based on their judgment or opinion whether or not they think, for example, there's a noticeable decrease in their wrinkles. [00:27:30] Speaker 03: And the record is replete with the problems with that. [00:27:33] Speaker 01: That is true. [00:27:35] Speaker 01: But the question for reasonable certainty is whether a relevant skilled artisan would face unreasonable uncertainty. [00:27:47] Speaker 01: And the reasonable, the relevant skilled artisan is not the patient. [00:27:52] Speaker 01: It's not even the individual doctor. [00:27:54] Speaker 01: It's this person that you defined. [00:27:56] Speaker 01: as having certain kind of scientific credentials and experience, who would not, the argument goes, take any individual patient's word as gospel, but use it as part of a data pool. [00:28:12] Speaker 03: Well, I think the pose is being told, instructed by the specification to use subjective evaluations by patients. [00:28:18] Speaker 03: They were told that that's how you do it. [00:28:23] Speaker 03: Even if you look at subjective self-assessments, and I'm going to go to the second part of the answer to this question, the Olson reference was brought up, for example. [00:28:31] Speaker 03: If you look at the 0.05% concentration that was found, supposedly to be effective in that study, [00:28:38] Speaker 03: The global response, overall assessment for skin, was different. [00:28:41] Speaker 03: The patient's self-assessments, the overall questionnaires found no effect, which was different than clinicians. [00:28:46] Speaker 01: Is that the one where the p-value was so high that you wouldn't deem it statistically significant? [00:28:51] Speaker 03: It was outside the statistical significance. [00:28:53] Speaker 03: But when you look at the individual results, even for roughness, the patients thought that there was no improvement in roughness. [00:28:58] Speaker 03: Clinicians felt otherwise. [00:29:00] Speaker 03: And this is what Dr. Casting, L'Oreal's expert, if you look at the appendix starting at 12.331, [00:29:06] Speaker 03: He goes through the problems of these subjective assessments, including the Olson article. [00:29:11] Speaker 03: And he talks about that they produce these conflicting results, even if you're using assessments. [00:29:15] Speaker 03: And putting aside that I still submit that these are specifications calling for subjective evaluations by individual patients, even if you accept that it's an assessment. [00:29:25] Speaker 03: There is no response from plaintiff's expert, Dr. Michniak-Kohn. [00:29:29] Speaker 03: She talks about objective methodology. [00:29:31] Speaker 03: She never takes on subjective assessments. [00:29:34] Speaker 03: She never takes on what Dr. Casting says about Olson. [00:29:36] Speaker 03: or any other reference that Dr. Casting explained in detail? [00:29:40] Speaker 00: Can you turn to paragraph 185, the one that we focused on on the briefs and that we talked about today, and respond to what Mr. Lampkin said about why that is so helpful to him? [00:29:53] Speaker 03: Yeah, and I think this is, when you look at that paragraph, [00:29:58] Speaker 03: Dr. Mishnyakone talks about the second sentence. [00:30:01] Speaker 03: These methods could include objective clinical evaluation scales or tests. [00:30:05] Speaker 03: And she goes on to list a number of computerized objective tests. [00:30:10] Speaker 03: And then she talks about correlations. [00:30:12] Speaker 03: And she never, though, talks about the problems of subjective assessments. [00:30:16] Speaker 03: Dr. Casting walked through that for pages. [00:30:18] Speaker 03: And she simply did not take issue and did not address subjective assessments at all. [00:30:23] Speaker 03: She focused on objective methodologies. [00:30:25] Speaker 03: And that's been the thrust of her opinion, that you could use objective. [00:30:28] Speaker 03: The specification tells you, you can't. [00:30:31] Speaker 03: And this is not disputed. [00:30:32] Speaker 00: Again, doctors... The specification doesn't say you can't use objective methods. [00:30:36] Speaker 03: No, no, of course. [00:30:37] Speaker 03: The specification says you can't ignore subjective. [00:30:40] Speaker 03: Unless the claim... These claims, of course, could have been written to pick a methodology and could have said, we're going to assess it this way, this objective method to assess enhancement of the skin condition. [00:30:50] Speaker 03: It doesn't do that. [00:30:51] Speaker 00: Well, if the spec had just referred to there are methods of measuring improvements in skin conditions are well known in the art and cited a couple, that would have been sufficient too, right? [00:31:02] Speaker 00: What gets you into trouble here is the shout out to including subjective evaluation. [00:31:10] Speaker 00: Am I wrong? [00:31:11] Speaker 00: No. [00:31:11] Speaker 00: If this had just said, and it had hit it full stop, dryness, [00:31:17] Speaker 00: methods of measuring improvements in skin condition are well known in the arts. [00:31:21] Speaker 00: CEG, Olson, and blah, blah, blah. [00:31:24] Speaker 03: That would certainly be a very different situation. [00:31:26] Speaker 03: But to your point, Dr. Dobson, again, he was a 36 witness from plaintiffs on effects of adenosine on the skin. [00:31:34] Speaker 03: And he unequivocally testified that these claims involve subjective assessment. [00:31:38] Speaker 03: So there's no dispute on that. [00:31:39] Speaker 03: That's part of these claims. [00:31:40] Speaker 03: You can't erase that. [00:31:41] Speaker 03: And adding objective methodologies can't save a subjective assessment. [00:31:45] Speaker 00: So Mr. Lannkin's other argument is even if you accept the word subjective, however grudgingly, there's still that the case law says purely subjective. [00:31:56] Speaker 00: And there's a distinction I think perhaps he is trying to draw between the use of subjective in this context and purely subjective, which is what our cases call out as being improper and indefinite. [00:32:09] Speaker 03: Yes, the cases talk about you have to have objective boundaries. [00:32:12] Speaker 03: And you can't have objective boundaries when there's subjectiveness in the claims. [00:32:16] Speaker 00: So do you think any minimal amount of subjective, I mean, purely subjective, we might have said it because that's what we thought, doesn't rule out something less than that explicitly. [00:32:26] Speaker 00: But if it was two out of 100 things that you look at, I mean, if it was a little bit of subjectivity possibly entered into some phase [00:32:39] Speaker 00: of the fact finding, does that make the claim indefinite? [00:32:43] Speaker 00: I'm asking you, is there some point in which it's de minimis? [00:32:47] Speaker 03: Certainly, I wouldn't say that there couldn't be some set of facts in which that's possible. [00:32:51] Speaker 03: But here, 100% of this assessment, whether you're looking at dryness, roughness, wrinkles, laxity, they all are subject to the subjective evaluation. [00:32:59] Speaker 03: So this is permeates the claim scope. [00:33:01] Speaker 03: And you can't have objective boundaries when it's infected with a subjective evaluation. [00:33:04] Speaker 00: But there's nothing specific. [00:33:08] Speaker 00: It was up to the parties to ask below. [00:33:10] Speaker 00: But none of it were the experts asked the frequency with which subjective. [00:33:14] Speaker 00: One, what subjective evaluations really mean, because there seems to be some dispute about that. [00:33:20] Speaker 00: And two, the frequency with which these methods are used to make these assessments. [00:33:27] Speaker 00: You had a chance to make your record. [00:33:28] Speaker 00: I don't know who that cuts against. [00:33:30] Speaker 00: But is there anything on the record that talks about that? [00:33:32] Speaker 03: in the prosecution here is no i'm talking about the record before the district court told the expert testimony itself yes yet again if you look at the appendix twelve three three one doctor casting spends a number of pages talking about the problems with subjective assessments in the conflicting results and that again is not responded to but the frequency of use uh... the frequency of use i think that is not that is that is conceded again doctor dobson says these claims are assessed involving subjective assessments he never said that [00:34:01] Speaker 03: It's only sometimes, only for certain conditions. [00:34:05] Speaker 03: He's unequivocally admitted. [00:34:06] Speaker 01: What about frequency of use among artisans in the field at L'Oreal's labs and other people's labs? [00:34:12] Speaker 01: Do they get patient self-assessments as part of their evaluation? [00:34:18] Speaker 03: Again, that was an argued summary judgment, but what the record shows is that certainly patient self-assessments are looked at for informational marketing purposes. [00:34:26] Speaker 03: There is nothing in the record [00:34:28] Speaker 03: that's suggesting that you're making a decision about whether a patent claim is satisfied or not using subjective evaluations, and this court's law says that you can't do that. [00:34:36] Speaker 03: So again, L'Oreal, of course, the art looks at what patients think is useful information, but it's not what is required for reasonable certainty in a patent claim. [00:34:45] Speaker 00: What about, I mean, the other side rests a lot on Sonic. [00:34:49] Speaker 00: And Sonics, I think, was the case where the district court did say, this is subjective, this visually negligible, or something like that. [00:34:58] Speaker 00: And our court said, no, it's not subjective. [00:35:02] Speaker 00: And it distinguishes between something just because an individual is looking at it and can see it versus something like using judgment or opinion, like aesthetically pleasing. [00:35:17] Speaker 00: I think the other side is suggesting that subjective in this context might mean the former, that it's something visible to the naked eye and not necessarily exclusively this opinion, you know, subjective stuff. [00:35:30] Speaker 00: What do you say to that? [00:35:31] Speaker 03: I think Sonics is dramatically different in the sense that [00:35:34] Speaker 03: there the evidence was undisputed that it was a single objective baseline, the normal human eye, what can be seen. [00:35:41] Speaker 03: Could these microscopic images be seen or not by the normal human eye? [00:35:45] Speaker 03: Opposed would apply that single objective standard to decide what is infringing or not. [00:35:50] Speaker 00: Not this case. [00:35:51] Speaker 00: Well, why isn't that what this case is talking about, though? [00:35:53] Speaker 00: If you're talking about a patient assessment, a patient has a normal eye, presumably, and they're looking at their skin. [00:36:00] Speaker 00: and they're saying, is it dry or did the wrinkle go away? [00:36:04] Speaker 00: Why isn't that what's normally visual? [00:36:08] Speaker 03: Because again, it's in the evidence of record that I pointed to from Dr. Cassing and otherwise shows that patients when they look at themselves in the mirror and say, have my wrinkles decreased? [00:36:19] Speaker 03: There are things like lighting and amount of sleep and mood and facial expressions can [00:36:25] Speaker 03: alter the perception. [00:36:27] Speaker 03: It comes down to it's a judgment or opinion of whether someone thinks I detect a difference in my skin. [00:36:32] Speaker 03: And that's the same for patient self-assessments. [00:36:35] Speaker 03: That's how they [00:36:35] Speaker 03: provide results like I think it's a little bit improved, I think it's better, I think it's good. [00:36:40] Speaker 03: It's all subjective opinion, which is why if you are talking about a claim scope that can be determined using the subjective opinions of just one person, which can vary from person to person, that's the common thread amongst datamize, interval licensing, intellectual ventures, all those cases. [00:36:58] Speaker 03: focus on that and that's what's involved here because again what the specification teaches tells opposed to what to do and again it's not disputed in this case that it applies to these claims these claims could have been written differently. [00:37:10] Speaker 01: So your argument sounds like it depends on the assertion that this half sentence in column five tells a POSA that the POSA must make its determination on the basis of a single patient's self-assessment. [00:37:30] Speaker 01: Why would you read the sentence to say that? [00:37:32] Speaker 01: That's ridiculous. [00:37:33] Speaker 03: I think that the specification tells a POSA how to conduct a test. [00:37:37] Speaker 03: It's told many different ways. [00:37:39] Speaker 03: One of the ways is you evaluate it by subjective assessments by a patient. [00:37:43] Speaker 01: By an individual patient, even though the citations and everything else makes the common sense point that, of course, a POSA would use a pool of patient self-assessments to make an evaluation. [00:37:57] Speaker 01: This POSA is a lab person who's trying to decide whether [00:38:03] Speaker 01: the product to the normal human eye, let's call it, would produce a decrease, a noticeable decrease in wrinkles. [00:38:16] Speaker 03: Yeah, and again, I think that's what Dr. Dobson testified to. [00:38:22] Speaker 03: It's not disputed, but I would again go back to even if it's patient self-assessments. [00:38:27] Speaker 03: Dr. Casting pointed out the problems. [00:38:28] Speaker 01: It's a general conflicting result. [00:38:31] Speaker 01: That's a completely different story. [00:38:34] Speaker 03: The second basis would be Dr. Casting's pointing out that even subjective self-assessments provide conflicting results, was not responded to. [00:38:43] Speaker 03: As a district court found, Dr. Michniak Cohen did not even address subjective evaluations. [00:38:48] Speaker 03: So that's an independent second basis. [00:38:50] Speaker 01: But I would like to spend. [00:38:51] Speaker 01: And you don't think the paragraph 185 citations to Grove and Grove, and is it Olson also in there? [00:38:57] Speaker 01: I guess just Grove and Grove, which do talk about self-assessments by patients as part of the evaluation in Grove and Grove. [00:39:07] Speaker 03: I think the context of that paragraph is objective and that's what she states. [00:39:11] Speaker 03: I would like to move to the claim construction issue, Your Honor. [00:39:15] Speaker 00: What you said was just really an exaggeration of the words in it. [00:39:18] Speaker 00: It says it can include. [00:39:20] Speaker 00: In other words, it doesn't say it must include. [00:39:23] Speaker 00: And the number is unknown. [00:39:27] Speaker 00: I mean, it could be it can include it, but I don't know who it hurts. [00:39:32] Speaker 00: It helps. [00:39:32] Speaker 00: It doesn't cap it. [00:39:34] Speaker 00: So I think your view would be, well, it's indefinite. [00:39:36] Speaker 00: We don't know if it does include subjective evaluations. [00:39:41] Speaker 00: and the portion of the evaluation that is based on these subjective evaluations. [00:39:46] Speaker 00: I thought that was in the midst of your argument, nothing more. [00:39:50] Speaker 03: And it goes to the fact that what does Opposa do? [00:39:52] Speaker 03: He's told, one thing is look at subjective evaluations by patients. [00:39:55] Speaker 03: Then look at computer topography. [00:39:57] Speaker 03: It's done completely differently. [00:39:58] Speaker 03: Then ask what the doctors think, clinical scales, et cetera. [00:40:01] Speaker 03: Opposa doesn't know what to do, what to use to assess, and the record is clear. [00:40:05] Speaker 03: They provide conflicting results. [00:40:07] Speaker 03: I would like to spend just a few minutes on the claim construction issue. [00:40:10] Speaker 03: Of course, if Your Honors have questions, I want to address them first. [00:40:14] Speaker 00: Well, that goes to the standard review, right, on the claim construct. [00:40:16] Speaker 00: Oh, I'm sorry. [00:40:17] Speaker 00: No. [00:40:17] Speaker 03: Go ahead. [00:40:18] Speaker 03: Just because there are some very good questions asked about that. [00:40:22] Speaker 03: I want to focus, of course, I'm happy to address any questions. [00:40:25] Speaker 03: We brief the ordinary meaning, the language of the claims that we think supports our construction, but at a minimum raises ambiguities. [00:40:31] Speaker 03: I want to focus on the specification [00:40:33] Speaker 03: first, which I think is clear and is positive, and then briefly talk about the prosecution history. [00:40:38] Speaker 03: This specification never once talks about a concentration in terms of a volume of dermis. [00:40:43] Speaker 03: Never once. [00:40:44] Speaker 03: Instead, the summary of the invention, six different times, talks about the invention as concentrations in therapeutically effective amounts. [00:40:54] Speaker 03: And those therapeutically effective concentrations are described, and they correspond exactly with what's in each of the asserted claims, and each time they are said [00:41:03] Speaker 03: that they're applied to the skin containing dermal cells. [00:41:07] Speaker 03: That's our construction taken directly from the summer of the invention. [00:41:11] Speaker 00: Now, plaintiffs pointed to- Wait, are we talking about the district court accepted, I thought, their construction, not your construction? [00:41:19] Speaker 03: Yes, we're talking about the plaintiff's construction issue that my friend, Mr. Lamkin, addressed. [00:41:25] Speaker 03: So you're defending the district court's plaintiff's construction. [00:41:28] Speaker 03: I'm suggesting the district court's and plaintiff's construction was wrong in that this is an alternative basis where we would prevail. [00:41:33] Speaker 03: based on plane construction. [00:41:34] Speaker 03: I apologize, Your Honor. [00:41:36] Speaker 00: There are too many plane constructions. [00:41:40] Speaker 03: Understood. [00:41:40] Speaker 03: Thank you. [00:41:41] Speaker 03: So I want to also briefly mention in column two, lines 14 to 17, that's what Mr. Lamkin referred to when he was trying to say that, well, the patent tells you it's the concentrations that get to the dermis. [00:41:53] Speaker 03: That's wrong. [00:41:54] Speaker 03: That sentence, when you look at it, it says it refers to the concentrations used in the above described methods. [00:41:59] Speaker 03: And again, [00:42:01] Speaker 03: Every one of those methods is talking about applying to the skin containing dermal cells. [00:42:06] Speaker 03: We also talked about the claim language and when this wearing clause got added to the claims. [00:42:10] Speaker 03: As a baseline, the numerical concentration ranges in the original claims indisputably were applied to skin. [00:42:18] Speaker 03: And the only cited support was again the summary of the invention passage I just referred to. [00:42:23] Speaker 03: When the wearing clause was added to the claims, [00:42:25] Speaker 03: They again cited the summary of the invention, same passage, but more than that, and this is at Appendix 2702, this is important, the applicant stated that the pending claims, quote, all are based on the application of certain concentrations of adenosine to the skin. [00:42:41] Speaker 03: They represented when they added this language in, the wearing clause, that its concentrations apply to the skin. [00:42:48] Speaker 01: I thought that, I don't know, there's another quote on that page when the applicant says, this amendment would add no new matter as it merely includes a range of concentrations of adenosine recited in dependent claims in the specification. [00:43:06] Speaker 01: In the specification, I don't know. [00:43:08] Speaker 01: And that's an excellent point, yes. [00:43:09] Speaker 01: But was it claim three, which had this range, I think, the dependent claim, said nothing about dermis or dermal cells. [00:43:19] Speaker 01: I guess I had read this to be a pretty clear declaration that all that was going on in this amendment was to move into the independent claim, the 10 to the minus 3 to 10 to the minus 7 or 6 or whatever it was, that was in the dependent claim, not to change the location of a measurement. [00:43:42] Speaker 03: I think that's exactly right, Your Honor. [00:43:43] Speaker 03: And the claims, the concentration ranges, again, in the original claims were indisputably all applying to the skin. [00:43:49] Speaker 03: So to your point, this one was moved into the claim. [00:43:52] Speaker 03: It wasn't some dramatic shift to say, I'm going to look at this totally differently. [00:43:54] Speaker 00: But I guess, I mean, we can look at prosecution history and so forth. [00:43:57] Speaker 00: But I'm just looking at the language of the claim. [00:43:59] Speaker 00: It isn't the language of the claim explicit. [00:44:02] Speaker 00: It says more than three says. [00:44:05] Speaker 00: It says concentrations applied to the germ cells. [00:44:11] Speaker 03: And how do you apply a concentration to dermal cells and unbroken skin that this claim requires? [00:44:17] Speaker 03: It's impossible to do it other than indirectly. [00:44:19] Speaker 03: And that's the sense of apply being used here, that you apply it to skin and it gets to the side of acne. [00:44:24] Speaker 00: Yeah. [00:44:24] Speaker 00: So, okay, so it's applied indirectly, but it's still applied to the derma cells and that's where the measurement occurs. [00:44:31] Speaker 03: No, the key is that when it's applied and it has to be a concentration as a solution, when it's applied [00:44:37] Speaker 03: That's the concentration that matters. [00:44:38] Speaker 03: And it eventually gets to the dermal cells. [00:44:40] Speaker 03: That's the site of action. [00:44:41] Speaker 03: But that's entirely consistent with the specification talks about. [00:44:45] Speaker 00: I'm getting confused on what your point is and how it differs from the other point. [00:44:49] Speaker 00: You're saying that the numbers here are the concentration when it's applied in the first instance and not after it reaches the derma cells? [00:45:00] Speaker 03: 100% correct. [00:45:01] Speaker 03: And that's consistent with the summary of the invention. [00:45:03] Speaker 03: It's consistent with the fact that that's how solutions are applied. [00:45:06] Speaker 03: There is not a single instance in the specification, not even one time, of a concentration being expressed in terms of some volume of skin or dermis. [00:45:14] Speaker 03: It never once appeared in the specification. [00:45:16] Speaker 00: But don't you agree that the words of the claim say something more explicit and say something different, that the best reading of words is when the concentration applied to the dermis cells is? [00:45:27] Speaker 03: And it's not saying applied. [00:45:29] Speaker 03: applied directly. [00:45:30] Speaker 03: Again, the only way you apply... Oh yeah, I was going to ask you, how would you say it more clearly? [00:45:34] Speaker 03: I would say that it's applied in the sense that it's an indirect, that you apply it to the skin, it gets to the dermal cells. [00:45:40] Speaker 03: Just like, for example, the specification talks about patches. [00:45:43] Speaker 03: It's one way to apply this is to first put it in the patch, and then it's still applied topically, and then it gets to your skin through indirect. [00:45:50] Speaker 03: So it's the sense of the word applied, and we have evidence of record, Dr. [00:45:54] Speaker 03: explain that dermal administration in the art, this is at 2872 to 73, that means the same thing is applied to the skin. [00:46:01] Speaker 03: And plaintiff's IPR paper is at 2864, equated, applied to dermal cells with topical applications. [00:46:08] Speaker 03: This is how it works when you have unbroken skin. [00:46:10] Speaker 03: You can't apply it to dermal cells directly. [00:46:12] Speaker 03: It doesn't work. [00:46:13] Speaker 03: Right. [00:46:13] Speaker 00: No, no, no. [00:46:14] Speaker 00: We all agree with that. [00:46:15] Speaker 00: And we talked to Mr. Lamkin about what's the initial concentration of the application. [00:46:22] Speaker 00: And how does that differ? [00:46:23] Speaker 00: And he said, well, it's known in the art or whatever what that number needs to be. [00:46:27] Speaker 03: Yeah, I would disagree with that. [00:46:29] Speaker 03: And the patent says nothing about it. [00:46:31] Speaker 03: And that's for a reason. [00:46:31] Speaker 03: There is only this, there is a dermal cell experiments with specific concentrations. [00:46:36] Speaker 03: that were lower, 10 to the minus 4, 10 to the minus 6. [00:46:39] Speaker 03: The specification is very clear that based on those experiments, they disclose applying solutions of higher concentrations, 10 to the minus 3, to the skin to achieve those effects. [00:46:49] Speaker 03: This is very straightforward. [00:46:51] Speaker 03: This is all being invented after the fact by the plaintiffs to say this is how we should read our claims because they know our products don't infringe under the proper construction. [00:47:00] Speaker 01: What do you make of the applicant's comment on reasons for allowance that, as far as I can tell, for the first time tries to call some attention to this dermal cell language that was added by amendment? [00:47:21] Speaker 03: Yeah, I think what's interesting about that comment, in addition to the fact that it came after all the prosecution activities and the examiner saying expressly [00:47:29] Speaker 03: I understand the concentrations to be applied to the skin. [00:47:32] Speaker 03: They say that the examiner's reasons are not the only reasons for allowing the claims. [00:47:36] Speaker 03: That's not disagreeing with the examiner. [00:47:38] Speaker 03: That's saying that there might be more reasons why I should get a patent. [00:47:41] Speaker 03: But everything you said is correct, examiner. [00:47:43] Speaker 03: So to include this sort of additional remark of just repeating the claim language, [00:47:47] Speaker 03: after all the clear, not only representations of what the claim language meant when it was added, but here we have the prior art being distinguished, multiple prior references, based on the composition concentration applied to the skin, including, by the way, the 0.1% concentration that L'Oreal's products use, and to say that somehow now [00:48:08] Speaker 03: We always meant something completely different about some concentration in skin that doesn't scientifically make sense. [00:48:13] Speaker 01: Do you agree with, I think, if Lampkin said this, that if we were to reverse Judge Connolly's claim construction on this point, that the right disposition in this appeal is to vacate the indefiniteness ruling and remand full stop? [00:48:32] Speaker 03: It would end up in the same place, Your Honor. [00:48:34] Speaker 03: There's the Durell case, the Sinovian case. [00:48:36] Speaker 03: There are examples of this court, given the admission on page 20, footnote 6, that L'Oreal's products exceed the claim range. [00:48:44] Speaker 03: You have the power, of course, to make a decision based on the record, but if it goes back... It would end up in the same place. [00:48:51] Speaker 03: It would end up in the same place, Your Honor. [00:48:53] Speaker 03: If you get sent back on a claim construction, this case would be over. [00:48:57] Speaker 03: Because there'd be no infringement. [00:48:58] Speaker 00: There'd be no infringement. [00:48:59] Speaker 01: But then you would have to drop your invalidity counterclaim. [00:49:03] Speaker 01: A non-infringement judgment would not by itself, without further words, end the case. [00:49:09] Speaker 01: We certainly believe that there's invalidity shown, but we think that... If you plan to do that, that's one thing, but that's not before us. [00:49:16] Speaker 03: And just very briefly on, of course, any other questions, but on the alternative, you don't have to reach it, the alternative indefinite grounds on the concentration limitation. [00:49:26] Speaker 03: I just want to point to a few places in the appendix first. [00:49:31] Speaker 03: Can you say exactly what you're talking about now? [00:49:33] Speaker 01: This is the alternative indefinite grounds. [00:49:37] Speaker 00: There's no specific way to measure it. [00:49:39] Speaker 00: Precisely. [00:49:40] Speaker 00: It was addressed briefly. [00:49:41] Speaker 00: I think we'll take it on the briefs. [00:49:42] Speaker 00: We're way ahead of our time. [00:49:44] Speaker 03: OK. [00:49:44] Speaker 03: Thank you, Your Honor. [00:49:45] Speaker 00: All right, so somehow I think this gets evened out if we give you about three minutes. [00:49:59] Speaker 02: Thank you. [00:50:00] Speaker 02: I'd like to make just two points, one on indefiniteness and the other on claim construction. [00:50:06] Speaker 02: On indefiniteness, this is at least as definite as sonics, where the phrase is visually negligible. [00:50:11] Speaker 02: This is an amount of criteria, more or less, that are actually concrete. [00:50:16] Speaker 02: And the fact that the studies can include, meaning you are allowed to rely in part on subjective evaluations, doesn't make it indefinite, because the art knows how to deal with that subjectivity to make sure that you get consistent results. [00:50:31] Speaker 02: And there's just simply no finding by the district court that the results are going to be in conflict. [00:50:35] Speaker 02: That's something the district court didn't address. [00:50:37] Speaker 02: The experts disagree. [00:50:39] Speaker 02: Our expert says that they correlate. [00:50:40] Speaker 02: Their expert says you get conflicting results. [00:50:43] Speaker 02: But there's no finding that by clear and convincing evidence, no reasonable fact finder could determine that these are so disparate in terms of whether it's going to infringe or not that you cannot have reasonable certainty as to whether you infringe. [00:50:57] Speaker 02: The type of subjectivity here is simply subjective evaluation like a doctor listening to your heart. [00:51:02] Speaker 02: Yes, he uses his judgment to account, but he uses objective criteria to make that determination. [00:51:07] Speaker 02: Turning to the claim construction, I think the basic problem with taking the concentration at the dermal layer and making it the concentration for the topical solution is that it's actually scientifically impossible. [00:51:20] Speaker 02: It wouldn't be the same concentration in the dermal layer because even their expert concedes [00:51:25] Speaker 02: I'll point out at 2877. [00:51:27] Speaker 02: The topical agents permeate at different rates. [00:51:30] Speaker 02: So the topical solution isn't going to be at the same concentration when it reaches the dermal layer. [00:51:36] Speaker 02: It's just not possible to have both the same concentration in the topical solution and in the dermal layer. [00:51:40] Speaker 01: So what permeates at different rates, the adenosine and the other stuff in the composition? [00:51:44] Speaker 02: Other things. [00:51:45] Speaker 02: And in fact, the amount of the adenosine, their experts said, [00:51:47] Speaker 02: that has to be applied to the skin is much greater than the amount that permeates to a particular layer of the skin, often by large amounts, and that's Appendix 2877. [00:51:56] Speaker 02: Because the skin acts as a barrier, it keeps a lot of the things out, including some adenosine. [00:52:00] Speaker 02: So when you're trying to figure out how to reach the dermal layer with the protective concentration, scientifically you can't say, I'll apply this amount, and that same concentration is going to be at the dermal layer. [00:52:09] Speaker 02: You have to apply more at the topical, [00:52:12] Speaker 02: in order to reach that concentration at the dermal layer. [00:52:15] Speaker 02: I think that's undisputed by everybody that they cannot be the same thing because things permeate at different rates and not everything goes through. [00:52:22] Speaker 01: Although just I guess to go back to the thing that I guess I've been hung up on, that would be an argument for [00:52:33] Speaker 01: saying, look at a concentration in two different places, which aren't going to be the same where the denominator is the same. [00:52:40] Speaker 01: It's the other stuff in the composition. [00:52:43] Speaker 01: They, it'll change because there's different permeability of the adenosine and the other stuff, but you're doing something completely different. [00:52:51] Speaker 01: You're now forgetting about all of them. [00:52:54] Speaker 01: non-adenosine parts of the composition and using as your denominator something else, namely the dermis. [00:53:01] Speaker 02: So you would look at the concentration at the dermal layer and it would include additional things and some things that aren't there because you're doing a concentration. [00:53:08] Speaker 02: Some things are flowing into the fluid from parts of the skin. [00:53:12] Speaker 02: Some things are not making it all the way down there. [00:53:14] Speaker 02: So yes, your enumerator is going to change, the adenosine is going to change, and your denominator is going to change because other things are probably going to be diluting it and other things will be falling away and possibly be replaced. [00:53:23] Speaker 02: You would look at a concentration [00:53:24] Speaker 02: at the dermal layer, but it doesn't, they're not gonna match. [00:53:27] Speaker 02: It cannot be. [00:53:28] Speaker 02: that the topical layer, the topical concentration, is the same as the concentration of the dermal layer. [00:53:33] Speaker 02: And if we read it that way, we would be reading the phrase, at the dermis, right out of the patent. [00:53:38] Speaker 02: The patent starts out by saying there's the skin, and it's got a dermis. [00:53:42] Speaker 02: But two separate things, and the amount topically applied is on your surface, and what reaches the dermis is a different amount. [00:53:48] Speaker 02: I don't think it's scientifically permissible, and even at, in terms of, as you noticed, when they got the notice of allowance, they responded and said, oh, correction, [00:53:56] Speaker 02: you have to submit concentrations measured at the dermal layer. [00:54:00] Speaker 02: That's not necessary to preserve your reading, but it certainly is consistent with the reading. [00:54:06] Speaker 02: And finally, just one final act. [00:54:10] Speaker 02: I think when you're measuring the fibroblasts and you're looking at the tests, and this would be appendix 2721, and you're looking at that concentration, the concentration [00:54:19] Speaker 02: at most because you have your cells floating in like sort of a sea of the fluid. [00:54:24] Speaker 02: That's basically going to be the concentration surrounding those fibroclasts. [00:54:27] Speaker 02: It's exactly like looking at the dermal layer and says, what's surrounding these fibroclasts? [00:54:30] Speaker 02: Well, it's a dermal layer with a concentration of adenosine in it. [00:54:33] Speaker 02: So if there's no further questions, I appreciate the court's indulgence. [00:54:36] Speaker 02: Thank you very much. [00:54:37] Speaker 02: Thank you both very much. [00:54:38] Speaker 02: And the case is submitted. [00:54:39] Speaker 00: That concludes our proceeding for this morning.