[00:00:00] Speaker 02: The United States Court of Appeals for the Federal Circuit is now open and in session. [00:00:06] Speaker 02: God save the United States and this honorable court. [00:00:11] Speaker 00: Good morning, ladies and gentlemen. [00:00:13] Speaker 00: We have five cases on the calendar this morning, three being argued, two from the PTO and one from the claims court. [00:00:23] Speaker 00: The veterans and an employee case are submitted on the briefs and will not be argued. [00:00:29] Speaker 00: Our first case is Almirall, LLC, versus Amnial Homosuticals, 2020-23-31. [00:00:39] Speaker 00: Please proceed, Mr. Treanor. [00:00:43] Speaker 03: Good morning, Judge Chen, Judge Laurie, Judge Cunningham. [00:00:46] Speaker 03: And may it please the court, James Treanor, on behalf of the Patent Owner Appellant, Almirall. [00:00:53] Speaker 03: And it's a privilege to have your time today to be heard. [00:00:57] Speaker 03: Your Honours, the board's decision below cannot be sustained as it is infirmed on at least three matters that I'd like to speak about today. [00:01:07] Speaker 03: The treatment of the facts and the law with regard to the so-called doctrine of interchangeability. [00:01:18] Speaker 03: Similarly, the legal conclusions and the underlying factual findings concerning the doctrine of overlapping ranges [00:01:28] Speaker 03: and the treatment of the patent owner's evidence of unexpected results below. [00:01:34] Speaker 00: Mr. Treanor, it seems to me this case isn't about overlapping ranges at all. [00:01:41] Speaker 00: I would agree with you. [00:01:42] Speaker 00: We're not talking about ranges of the same material. [00:01:48] Speaker 00: We're talking about different materials. [00:01:51] Speaker 00: We're talking about a primary reference garris, which describes a composition [00:01:58] Speaker 00: with a thickening agent, which has certain disadvantages to it. [00:02:03] Speaker 00: And there are other references, like Nadeau and I think it's Borna Kuchina, that describe other thickening agents and show the interchangeability between carbamers and ASA agents. [00:02:25] Speaker 00: And so why isn't it [00:02:26] Speaker 00: a simple question of exchanging one interchangeable thickener for another. [00:02:36] Speaker 03: I see. [00:02:38] Speaker 03: Yes, well, I think the two issues are blurred at times. [00:02:42] Speaker 03: Let me address interchangeability. [00:02:45] Speaker 03: As far as the law of interchangeability goes, the authority of this court has been limited to facts that are not present here. [00:02:55] Speaker 03: In all of the cases where the court found obviousness, and in this case, according to the petitioner, a account that is based upon interchangeability relieves any need to show a motivation to combine, all of the authority of this court stands for the proposition that in order to deem a [00:03:24] Speaker 03: asserted prior art reference to be interchangeable with the claim, the interchangeability has to be shown inside of the asserted reference or combination of references. [00:03:40] Speaker 03: So in this case, what we would need to have is some disclosure, some teaching somewhere with regard to the novel ASA copolymer [00:03:54] Speaker 03: together with the active ingredient Bapzone here, or the very critical solvent that is used, which we call DGME. [00:04:04] Speaker 03: But that is among the counts. [00:04:06] Speaker 00: That would be in anticipation, wouldn't it, if the substituted material were in Garrett itself? [00:04:15] Speaker 03: It could be in anticipation if it were in Garrett itself, I suppose, but that would also depend upon [00:04:23] Speaker 03: if that disclosure in Garrett itself also met the specific concentration limitations of that particular claim element. [00:04:35] Speaker 03: To give you an example, Your Honor, if we look at the two cases that the board cited and that were in turn relied upon by the appellees, they're principally the Omeprazole case, [00:04:50] Speaker 03: which I believe Judge Rader wrote, and the Wrigley case. [00:04:55] Speaker 03: And here's how those cases are quite different. [00:04:58] Speaker 03: In the Omeprazole case, the element that was deemed to be interchangeable in the challenged claim was an element that had existed in disclosures and teachings in the prior art alongside Omeprazole. [00:05:14] Speaker 03: Similarly, in the Wrigley case, you didn't have what we have here. [00:05:19] Speaker 03: which are prior art disclosures of simply the missing claim element itself. [00:05:25] Speaker 03: There, in Wrigley, you had the missing claim element together with menthol. [00:05:32] Speaker 03: So in the art, there had been some discussion, some teaching, some showing of how the component that you're trying to plug in to meet your obviousness case relates to [00:05:46] Speaker 03: the whole of the formulation that's claimed or disclosed in the prior art reference. [00:05:50] Speaker 03: In this case, none of the references of the counts say anything about the active ingredient Dapsone. [00:05:57] Speaker 03: They don't say anything about the DGM e-solvent, which is really sort of critical to the unique nature of the formulation design that is called out as critical not only in Garrett, but in all of the prior art from 2006 to 2011. [00:06:15] Speaker 03: all of it is consistent in saying that the specific design where you have not all the drug dissolved in the topical, but you purposefully keep two-thirds or some significant portion of that drug undissolved for reasons that go to the unique delivery mechanism and the delay and the desire to keep the treatment, this is a method of treatment claim, local, there's no [00:06:45] Speaker 03: There's no discussion whatsoever about any of the other components, aside from water, I suppose, that are in the formulation as a whole, that is the lead formulation, that is the starting point, that is the reference here. [00:07:00] Speaker 03: All you have are two isolated references that discuss this novel thick in the agent and not anything about how they might relate [00:07:11] Speaker 03: or whether they might actually function to perform a method of treating acne, because there's just nothing. [00:07:20] Speaker 03: There's nothing in those references, in those secondary references. [00:07:24] Speaker 03: So unlike, this case is very much, sorry. [00:07:27] Speaker 00: They don't seem to be novel thickening agents. [00:07:30] Speaker 03: Which, the ASA copolymer, which in this case has been probably loosely interchanged with the brand name Sopinio, which is an embodiment [00:07:42] Speaker 03: of that particular claim limitation. [00:07:44] Speaker 03: Yes, that was a novel thickening agent. [00:07:47] Speaker 03: That was admitted many times over by the petitioner's expert. [00:07:54] Speaker 03: That was acknowledged by the board itself during the trial. [00:07:59] Speaker 03: Two judges separately made the point that this was a novel thickening agent. [00:08:05] Speaker 03: This was a novel excipient that had just entered the market. [00:08:12] Speaker 03: It hadn't been approved or argued. [00:08:14] Speaker 03: There wasn't evidence that it had been approved, but we think it had been approved in just one drug product, not a cosmetic, one drug product by the FDA prior to that time, prior to the invention date. [00:08:25] Speaker 03: Even, even judge, even judge Flax at the trial said, this is not new. [00:08:31] Speaker 03: Where is the evidence that this was popular? [00:08:33] Speaker 03: No one had used this before. [00:08:34] Speaker 03: In fact, if you look at the face of the on a Coutinho reference, which is the secondary reference in count two, [00:08:41] Speaker 03: It clearly shows that it's an investigation of this novel polymeric thickening agent. [00:08:49] Speaker 02: But we have references. [00:08:51] Speaker 02: This is Judge Chen. [00:08:52] Speaker 02: We have references in this record that say, well, if we were to agree with the board that this particular thickener, ASA, is interchangeable with carbamer, or ASA is a particularly desirable thickener to use. [00:09:11] Speaker 02: So, I mean, you didn't invent ASA. [00:09:15] Speaker 02: You didn't invent this particular thickener. [00:09:17] Speaker 02: So, I mean, it's a little strange to hear you say that it's novel. [00:09:22] Speaker 02: So, if you want to say it hadn't been commercially used, fine. [00:09:27] Speaker 02: But we have other references that make it clear that at least certain authors [00:09:35] Speaker 02: prior art references believe them to be interchangeable or ASA with carbomer and ASA in particular to be a very desirable thickener. [00:09:43] Speaker 02: And then we have this other reference in the record called Guo, which shows an example of using ASA with Dapsone with this particular active ingredient in this claimed invention. [00:09:56] Speaker 02: So, I mean, the problem here is that we're looking at a very fact-bound case [00:10:03] Speaker 02: And this is something, as you know, that the tribunal, the first instance gets to make the call and we have to defer to that call unless it's really unreasonable. [00:10:15] Speaker 02: And it's hard for me to understand why the board was so off the rails that it was unreasonable to find that ASA is interchangeable with Carbomer on this record. [00:10:27] Speaker 03: I don't know why they were off the rails, but I can tell you [00:10:30] Speaker 03: that those findings are absolutely unsupported in the record. [00:10:34] Speaker 03: Not only that, they're absolutely explicitly contradicted in the record. [00:10:39] Speaker 03: The portions in the excerpted appendix that you should have have a fairly short section of the two depositions of the expert who carried all of this evidence, whose testimony and evidence was credited on every score in this case. [00:10:58] Speaker 03: That expert admitted, in no uncertain terms, when asked, what do you mean interchangeable? [00:11:06] Speaker 03: And she says, well, it all depends. [00:11:09] Speaker 03: And that's the point. [00:11:11] Speaker 03: What is it interchangeable for? [00:11:13] Speaker 01: Council, you indicated that it's contradicting the record. [00:11:17] Speaker 01: Do you have specific page sites for us? [00:11:20] Speaker 01: Because my take right now is similar to my colleague's here. [00:11:24] Speaker 03: Sure, I do. [00:11:25] Speaker 03: Just give me one moment. [00:11:27] Speaker 03: Pull that up. [00:11:28] Speaker 03: OK. [00:11:29] Speaker 03: So for example, and this is the expert. [00:11:32] Speaker 03: OK. [00:11:34] Speaker 03: We could say, all right. [00:11:39] Speaker 03: Let me take this here. [00:11:41] Speaker 03: First of all, this expert is conceding, as was clear from the petition as it was filed, that even though we're talking about Garrett, and even though we're making use of prophetic broad disclosures there, truly, [00:11:56] Speaker 03: the lead prior art reference is the preferred embodiment, which happened to be a commercial embodiment, which was a 5% dab zone. [00:12:07] Speaker 03: And that expert agrees that that is what we start with and we do not want to abandon that design because that design is well known in the prior art to be intentional. [00:12:19] Speaker 03: because it is what serves the purpose of making it a good medicine. [00:12:23] Speaker 03: And that is the design that I follow. [00:12:24] Speaker 01: Council, do you have the page number so that I can also follow along with you? [00:12:28] Speaker 01: I want to be able to read the stuff myself directly. [00:12:32] Speaker 03: Sure. [00:12:32] Speaker 03: OK. [00:12:32] Speaker 03: So if we look at appendix page 7832, just as one example, OK? [00:12:40] Speaker 03: And there's a couple of pages here. [00:12:44] Speaker 03: And then there's four pages of deposition on 7832. [00:12:47] Speaker 03: Are you there, Doug? [00:12:49] Speaker 03: You can keep going. [00:12:54] Speaker 03: OK. [00:12:58] Speaker 03: So the question goes back a page, but then it says, the answer carrying over says, so this may be generally useful, but not particularly relevant to the problem. [00:13:09] Speaker 03: Now, she's talking about the problem that the secondary reference mid-alfalcuta is trying to solve, which is to get rid of any undissolved drug particles in a formulation, because that's sometimes what you want to do with the drug. [00:13:22] Speaker 03: And she recognizes that that is not just disclosed there. [00:13:26] Speaker 03: That is explicitly the invention. [00:13:29] Speaker 03: Here is what you do. [00:13:30] Speaker 03: Here are the teachings when you want to get rid of any undesired, undissolved particles in your topical. [00:13:38] Speaker 03: That is antithetical to the teaching of Gary. [00:13:43] Speaker 03: Gary is teaching the importance of maintaining that, so she continues. [00:13:46] Speaker 03: He says, so this may generally be useful, but not particularly relevant to the problem. [00:13:52] Speaker 03: That's 251, continuing over. [00:13:54] Speaker 03: Again, as I state the importance of Nadal Foucault for a person of ordinary skill in the art, [00:14:00] Speaker 03: Number one, it's not the only reference they're looking at. [00:14:02] Speaker 03: I need to restate. [00:14:03] Speaker 03: But they're looking for alternative gelling agents in water and soluble drugs. [00:14:07] Speaker 03: And among them, Melissa Sopinio, including being a preferred gelling agent. [00:14:12] Speaker 03: So then I asked the question, well, if your opinion is that ASA and Sopinio 600 or not, and Carbomer are known to be interchangeable, then what explains the variation in the concentration [00:14:24] Speaker 03: of these interchangeable thickeners, as described across these examples. [00:14:28] Speaker 03: And now we're looking at the secondary reference of count one. [00:14:31] Speaker 03: And her answer, depends on what you mean by interchangeable. [00:14:36] Speaker 03: Okay, so now we know that that's a very, a term that has many meanings, even to the one expert who's marshaling all of the evidence that allowed this petition to succeed. [00:14:48] Speaker 03: And then it continues. [00:14:50] Speaker 03: Well, that's the word you're using in your declaration, so maybe you can tell me [00:14:54] Speaker 03: Does interchangeable have a different definition depending on context? [00:14:59] Speaker 03: Answer. [00:15:00] Speaker 03: See that? [00:15:01] Speaker 00: You have virtually used up all your time. [00:15:04] Speaker 00: OK. [00:15:04] Speaker 00: OK. [00:15:04] Speaker 00: I'll let you hear from the other side, and we'll give you your full three minutes of rebuttal. [00:15:09] Speaker 03: Sure. [00:15:10] Speaker 03: Thank you. [00:15:11] Speaker 00: Mr. Vergis, is it? [00:15:14] Speaker 04: Yes, it is, Your Honor. [00:15:16] Speaker 00: Please proceed. [00:15:18] Speaker 04: Thank you, Judge Laurie. [00:15:19] Speaker 04: Good morning, Your Honors. [00:15:21] Speaker 04: Dennis Vergis for Appellee Edmiel may please the court. [00:15:24] Speaker 04: In a detailed and thorough 79-page decision, the board below carefully analyzed the party's arguments, weighed all the evidence, made credibility determinations, and resolved, in annual's favor, all key factual questions underlying the issues on appeal, finding all claims Valmaral's patent unpatentable as obvious in view of not one, but two separate and distinct grounds of obviousness. [00:15:47] Speaker 04: The first ground was the Garrett reference combined with NADU-Fourcade, both prior art published patent applications, and the second [00:15:54] Speaker 04: The teachings of Garrett combined with Bonacuchina, a scientific review article about Cepineo, which is synonymous with A-slash-F-A. [00:16:04] Speaker 04: Almirall on appeal raises a slew of factual issues that it hopes to re-litigate under the guise of purported legal errors. [00:16:11] Speaker 04: The board committed no such legal errors or any factual errors for that matter. [00:16:15] Speaker 04: But each of the grievances that Almirall raises on appeal reflect near disagreement and dissatisfaction with the board's factual findings [00:16:24] Speaker 04: which were all supported by substantial evidence. [00:16:26] Speaker 04: The board carefully considered all the arguments Almalal raises on appeal here and explained why each of them were unpersuasive or not credible. [00:16:35] Speaker 04: Only then did the board make the ultimate legal conclusion of obviousness. [00:16:38] Speaker 04: Board findings were correct and respectfully I submit the board should, this court should affirm. [00:16:45] Speaker 04: Now if it pleases the court, I'd like to pause right there before going into specific arguments about some of the points that Almalal raised [00:16:53] Speaker 04: and address any questions that your honors might have. [00:16:57] Speaker 00: Well, what about this argument of overlapping percentage? [00:17:04] Speaker 04: The overlapping ranges? [00:17:06] Speaker 04: Yes. [00:17:06] Speaker 04: Your honor? [00:17:06] Speaker 04: Yes. [00:17:08] Speaker 04: The board here relied on well-settled law from this court, including the E.I. [00:17:12] Speaker 04: Dupont case, that finds that when you have a prior art numerical range for a claim parameter that overlaps with the claimed ranges [00:17:21] Speaker 04: it renders those claimed ranges prima facie obvious. [00:17:25] Speaker 04: And the board applied that jurisprudence to the facts of this case and made multiple factual determinations, some of which I'll highlight, and found that the claimed range of the ASA or SEPINAO thickener were rendered obvious. [00:17:38] Speaker 04: Now, the board relying on E.I. [00:17:40] Speaker 04: Dupont and decades-long precedence, after finding prima facie obviousness based on overlapping ranges, invited Almaral to come forward with evidence of criticality or unexpected results [00:17:52] Speaker 04: hitching away, or evidence that the parameter in question, the claim thickener here, was not a result-affected variable. [00:17:59] Speaker 04: ALMRAW could not meet that. [00:18:01] Speaker 04: Now, the challenge claims recite a range of 2% to 6% of SEPINAO, or ASA, which serves as a gelling agent, also known as thickener. [00:18:11] Speaker 04: The board specifically found the NATO 4K disclosure of 0.2% to 5% of SEPINAO, which is at appendix 36, [00:18:21] Speaker 04: and Bona Kachina's disclosure of 0.5 to 5% of sepinaeum at appendix 45 to 46 rendered the claimed range prima facie obvious. [00:18:32] Speaker 04: And if that wasn't enough, the board also found that the Garrett reference disclosed 0.2% to 4% of carbapol, another hydrophilic thickener that is closely related to sepinaeum structure and function. [00:18:47] Speaker 00: But of course, these are different materials and different materials [00:18:51] Speaker 00: to be effective in a particular formulation may well have different percentage amounts. [00:19:01] Speaker 00: So it's not overlapping ranges of the same material. [00:19:08] Speaker 00: It doesn't necessarily they will be different percentage amounts. [00:19:16] Speaker 04: I apologize for interrupting, Your Honor. [00:19:18] Speaker 04: Judge Laurie, the native 4K reference [00:19:21] Speaker 04: discloses both materials, Carbapol, which is a thickener in Garrett, and Cepineo, which is the claimed thickener, side by side in a short list of hydrophilic preferred thickeners. [00:19:34] Speaker 04: And Native Forkade says that both of those materials should be used at a preferred concentration of 0.2 to 5%. [00:19:43] Speaker 04: So we are talking about the identical thickener that is recited in the challenge claims, Cepineo. [00:19:49] Speaker 04: That's exactly what Native4K discloses. [00:19:52] Speaker 04: And to go beyond that, Bonacachina also identifies the exact same claimed ASA Cepineo thickener and identifies that the preferred range or concentration is 0.5% to 5%. [00:20:04] Speaker 04: So we're talking about PriorArt disclosing exactly the same thickener that's recited in the claims. [00:20:13] Speaker 04: And the board went on to find that even though Garrett, Garrett, the first reference, didn't teach the specific sepinaeum that is claimed, Garrett nevertheless disclosed the use of various hydrophilic thickeners and that the teachings of native 4K provide the missing claim sepinaeum, which is hydrophilic. [00:20:31] Speaker 04: These are all detailed factual determinations that the board made below. [00:20:35] Speaker 04: And I respectfully submit that I think this court should defer to the board's fact findings there. [00:20:43] Speaker 04: Next, to address, unless Your Honors have any questions about overlapping ranges, I'd like to... Yeah, this is Judge Chen. [00:20:50] Speaker 02: Just getting back to a question Judge Lurie had asked your opposing counsel earlier. [00:20:56] Speaker 02: What's the right way to think about this case? [00:21:01] Speaker 02: Is this just a straight-ahead substitution case or is this an overlapping ranges case or is it some hybrid of the two? [00:21:11] Speaker 04: So with the grounds, the board treated ground one as an interchangeability case and treated ground two as motivation to combine, reasons to combine, identify different ones. [00:21:25] Speaker 04: I think the overlapping range jurisprudence of this court applies to both grounds. [00:21:30] Speaker 04: Because there's not an identical disclosure of the range themselves. [00:21:33] Speaker 04: There's no disclosure of 2% to 6% as claimed. [00:21:36] Speaker 04: So the parties need to rely on this court's extensive jurisprudence about overlapping ranges. [00:21:42] Speaker 04: So the overlapping range jurisprudence applies to both grounds. [00:21:45] Speaker 04: But ground one is an interchangeability case, and ground two is reason to combine. [00:21:50] Speaker 04: But because this is all prior art, I think there's some sort of overlap in terms of the ideology there. [00:21:58] Speaker 04: Also, to address my esteemed colleague, Mr. Treanor's comment about Seponeo being novel, I strongly disagree with that. [00:22:06] Speaker 04: no less than four different references are in the record showing that Cepineo was not novel. [00:22:12] Speaker 04: Native Fourcase, Bonacachina, there was an FDA approved product out of 2008, four years before the priority date here called EpiDuo that used Cepineo as the thickener. [00:22:23] Speaker 04: And as Your Honor Judge Chen noted, the rule of reference, this wasn't a prior art that Cepineo was perfectly compatible with Dapsone. [00:22:31] Speaker 04: And Dapsone, there's a footnote in the board's decision where [00:22:35] Speaker 04: Both parties agree there's no dispute that Daphnone is a well-known water insoluble or water sensitive drug. [00:22:41] Speaker 04: And Native Forkate specifically says that Cepineo is a preferred candidate for water sensitive drugs like Daphnone. [00:22:54] Speaker 04: And in terms of interchangeability, just a few other points to highlight of the board's fact finding. [00:22:59] Speaker 04: The board specifically said at appendix 38, we find [00:23:03] Speaker 04: that Native Forkade and Garrett disclosed the same classes, same types, and same specific gelling agents in their topical pharmaceutical formulations for water and soluble drugs in overlapping concentrations. [00:23:16] Speaker 04: And the board also noted, citing Guo, that the combined Cepineo and Dapstone specifically confirmed that ASA and Dapstone were compatible, thus supporting interchangeability. [00:23:30] Speaker 04: And the board concluded at appendix 40, 41, and 42, citing KSR and some of this court's cases, including Omeprazole, that interchangeability is a perfectly fine rationale to support obviousness. [00:23:44] Speaker 04: Now, I know Almaral has complained on appeal that the board somehow didn't also analyze motivations to combine or reasons to combine that a postman has. [00:23:55] Speaker 04: That's not true. [00:23:57] Speaker 04: The board did not rest simply on interchangeability in its analysis, which it could have, but rather expressly found that APOSTA would have been motivated with a reasonable expectation of success to incorporate NADU-4K's ASA gelling agent into Garrett's Daphnum formulations for treating acne. [00:24:14] Speaker 04: And the board noted that Almaral treats both grounds together. [00:24:18] Speaker 04: The board credited ABNEIL's expert, Dr. Mishniak Cohn, that the overlapping characteristics of Garrett's gelling agent and NADU-4K's [00:24:26] Speaker 04: would be a reason that a post-sub would have looked to native forkade for additional thickening agents for water-insoluble drugs like Gapsone. [00:24:34] Speaker 04: Here are some of the factors that the board found factually. [00:24:38] Speaker 04: Both were hydrophilic, both were known to be good for water-insoluble drugs, commonly used in topical formulations, and both were grouped in a short preferred list together. [00:24:50] Speaker 04: All of these factors would have been reasons that a post-sub would have found it not obvious [00:24:55] Speaker 04: to use Cepineo in Garrett's formulation instead of cardamom to arrive at the claimed formulation. [00:25:03] Speaker 04: And then in analyzing the second reference, the reference of the second ground, Bona Kachina, the board found additional reasons that APOSA had to combine Cepineo with Garrett. [00:25:15] Speaker 04: For example, Bona Kachina specifically teaches that Cepineo is a prime candidate for use in topical formulations. [00:25:24] Speaker 04: also, in contrast to carbapol, did not require a neutralization step, which provided efficiencies that the board found provided additional motivations for a person to use Cepanaio. [00:25:35] Speaker 04: The board also found that Cepanaio has self-gelding and thickening properties, which make it easy to use in the formulation of gel and emulsion gels. [00:25:43] Speaker 04: And again, not to belabor the point, but these are all factual findings that the board made after looking at a wholesome record. [00:25:51] Speaker 04: These additional motivations identified by the board negate any suggestion by Almaral that the board somehow abdicated the requirement to show a reason to combine the teachings of Garrett and Native Forkade. [00:26:04] Speaker 04: And then finally, I'll spend just a few minutes addressing the Warner Declaration and unexpected results. [00:26:12] Speaker 04: Almaral tried to argue unexpected results in this case, but its only evidence was the 132 declaration [00:26:19] Speaker 04: submitted by Dr. Warner during prosecution. [00:26:22] Speaker 04: However, based on the motion to exclude as impermissible hearsay, Almaral and its counsel distance itself from Warner, both at the oral hearing and in writing. [00:26:33] Speaker 04: Almaral escapes, and I'm quoting. [00:26:36] Speaker 04: Almaral, moreover, is not relying on the Warner declaration for its truth. [00:26:41] Speaker 04: Almaral is not relying on it as proof of unexpected results. [00:26:45] Speaker 04: And based on that, the board rightfully accorded [00:26:48] Speaker 04: any reliance by Almirall's expert in this proceeding, Dr. Osborne, any reliance by Dr. Osborne on the Warner Declaration, little late. [00:26:56] Speaker 04: But beyond that, the board still considered the Warner Declaration for completeness. [00:27:01] Speaker 04: The board said, even if statements set forth in the Warner Declaration were considered and assumed to be truthful, they do not demonstrate unexpected results that are commensurate in scope with the claimed invention. [00:27:13] Speaker 04: So Alma can't say that the board did not give the Warner declaration due consideration. [00:27:19] Speaker 04: In fact, I would submit that the board actually gave it more consideration than it deserved. [00:27:25] Speaker 04: So with that, your honors, I'm happy to rest on the papers for the rest of the argument, unless your honors have any question or points that you would like for me to specifically discuss. [00:27:34] Speaker 00: Counsel, no one ever loses points by not using up all of their time. [00:27:40] Speaker 04: Thank you, your honor. [00:27:41] Speaker 00: Mr. Treanor has three minutes for rebuttal. [00:27:53] Speaker 00: Mr. Treanor, are you there? [00:27:55] Speaker 03: I'm sorry, Your Honor, I was on mute. [00:27:58] Speaker 03: There's only one case in this record, and as far as I'm aware, only one case out there, where overlapping late ranges gave rise to a rebuttable presumption [00:28:10] Speaker 03: a prima facie obviousness, and that's the iron grip case, which this court made clear was a very narrow exception to what is already an exception. [00:28:19] Speaker 03: What ends up happening in this case is, whether you call it interchangeability or not, the presumption operates to essentially resolve the case to our burden of production to show unexpected results. [00:28:36] Speaker 03: And it absolves [00:28:37] Speaker 03: the petitioner, the challenger of a presumed valid patent, not to have to show motivation to combine, and not to have to show reasonable expectation of success. [00:28:48] Speaker 03: And that's why if you read the board's decision, there's almost no mention of any of the competing expert testimony that's offered on all that you would consider in the prima facie case. [00:28:58] Speaker 03: It's just ignored because obviousness is presumed. [00:29:01] Speaker 03: But it is not interchangeable. [00:29:03] Speaker 03: There is no case where overlapping ranges has been found [00:29:08] Speaker 03: where the entire claim subject matter is not in the reference and that's where you get the overlapping ranges from. [00:29:15] Speaker 03: Not just one single limitation. [00:29:17] Speaker 03: Iron grip is the one exception and it makes sense. [00:29:21] Speaker 03: The problem with that is if you were to offer what is the basis for saying [00:29:28] Speaker 03: you should have that presumption. [00:29:31] Speaker 03: They say, well, they're in a team. [00:29:32] Speaker 01: Do you have some sort of distinction you want to make with iron grip? [00:29:36] Speaker 01: You're mentioning a few times. [00:29:37] Speaker 03: Do you have iron grip? [00:29:39] Speaker 03: Iron grip is a case where they actually found overlapping ranges using multiple or two references, three references for a bar and one disclosure that had three plates and another disclosure that had one. [00:29:52] Speaker 03: And they said they overlap. [00:29:54] Speaker 03: to give a rebuttable presumption of two, and I may have the facts wrong, but it's that simple. [00:29:59] Speaker 03: All of the technology was the same. [00:30:01] Speaker 03: All of the elements were discussed. [00:30:03] Speaker 03: It was the same exact bundle as you would have, for example, in this case, if the proxy was the full claimed formulation or the full claimed method of use. [00:30:14] Speaker 03: So every other case requires that the entire formulation be in the single prior art reference and then [00:30:23] Speaker 03: you can get the overlapping ranges presumption. [00:30:26] Speaker 03: And it's appropriately narrow, because the law of the land is you have to show up some reason why you'd actually combine these references, which is highly difficult in this case for the petitioners to do, because they know that any reference concerning ASA, if there's any at all that combines with any of the components of that formulation, they do and operate the opposite [00:30:51] Speaker 03: of what that formulation design was in the prior art, that they're experts. [00:30:56] Speaker 02: This is Judge Chen. [00:30:57] Speaker 02: Can you speak to the valiant opinion from this course? [00:30:59] Speaker 03: Yes, absolutely. [00:31:01] Speaker 03: The valiant opinion, excuse me, the valiant opinion actually makes... It's a summary doesn't case, but in the valiant opinion, you have structural similarity. [00:31:14] Speaker 03: Okay, so that's an interchangeability or overlapping range case or whatever gave rise to the presumption. [00:31:21] Speaker 03: And there you had three derivatives of a compound where there was art, there was testimony, and there was admission by the patent owner that these things were all structurally similar and were known in the art to function in the same way. [00:31:39] Speaker 03: That was not the case here. [00:31:41] Speaker 03: There was nothing in the art. [00:31:43] Speaker 03: about a comparison between carbon restructure, it's never been offered in this record, and there is none, about carbon restructure and ASA structure. [00:31:52] Speaker 03: In any event, the result, Your Honors, is that the case resolves to unexpected results, where we offer the 132 declaration that was submitted and over which the claims were allowed. [00:32:07] Speaker 03: And if you look at the decision, this is very, very troubling. [00:32:11] Speaker 03: They asked for a deposition of that inventor. [00:32:14] Speaker 03: The inventor was one month before the trial when they noticed the deposition. [00:32:19] Speaker 03: The inventor couldn't be available for one week past the deadline. [00:32:23] Speaker 03: We got on the phone with the board. [00:32:25] Speaker 03: We asked to extend the time so he could be deposed. [00:32:29] Speaker 03: It was the petitioners who avoided that and then took the position. [00:32:35] Speaker 00: Please do not talk over the court, counsel. [00:32:38] Speaker 00: As you have heard, your time has expired. [00:32:44] Speaker 00: We've given you quite a bit of time. [00:32:46] Speaker 00: We appreciate the arguments from both sides, and the case is submitted.