[00:00:00] Speaker 01: Our last case this morning is United Therapeutics versus Liquidia Technologies, 2023, 1805. [00:00:09] Speaker 01: Mr. Koster. [00:00:11] Speaker 03: Good morning, Your Honors, and may it please the Court. [00:00:14] Speaker 03: The board below committed three independently reversible errors. [00:00:18] Speaker 03: First, under a de novo standard, the board substituted hypothetical not in evidence abstract books. [00:00:25] Speaker 03: in place of the Jesk and Jaha Journal article supplements identified as prior art in the petition. [00:00:32] Speaker 03: Second, the board used hindsight to determine a, quote, delivered dose based solely on express assumptions concerning fill volumes and prescribed volumes lacking substantial evidence of delivered dose. [00:00:46] Speaker 01: Counsel, there's prior art here. [00:00:50] Speaker 01: The 212 patent, it's your own patent. [00:00:55] Speaker 01: discloses essentially the same invention, including powder by inhalation. [00:01:05] Speaker 01: And the variations here would seem to be just within the normal skill of the art. [00:01:11] Speaker 03: No, Your Honor, we absolutely disagree with that. [00:01:13] Speaker 03: The 2-1-2 patent is a different patent which has no limitations pertaining to the dose regimen, the single event dose, the particular amount of the dose to be delivered, or in one to three breaths. [00:01:30] Speaker 03: All of the evidence that is contained in the disclosures in the patent itself, the 2-1-2 patent, are all solution-based. [00:01:38] Speaker 03: And there is one claim. [00:01:40] Speaker 03: that allows for inhalation of a dry powder with a certain limitation with respect to micron diameter, average micron diameter of the powder. [00:01:54] Speaker 03: We absolutely did present evidence of exactly that below to the board below with respect to the unexpected nature of dry powders. [00:02:08] Speaker 03: Dry powders, the only evidence that was presented to the board below are that dry powders are vastly different from solutions. [00:02:15] Speaker 01: Dry powders are mentioned in the 212 patterns. [00:02:18] Speaker 03: But they are, Your Honor. [00:02:20] Speaker 03: But again, at oral argument, we were asked specifically about that. [00:02:25] Speaker 03: And of course, we understand that the 212 patent is enabled. [00:02:29] Speaker 03: But as this Court has recognized, enablement does not forego a reasonable expectation of success [00:02:36] Speaker 03: in terms of an obviousness analysis. [00:02:38] Speaker 03: Moreover, Your Honor, there was evidence of unexpected results with respect to that specific dosage scheme. [00:02:46] Speaker 03: The enhanced relative amount of treprosynol, which is a highly potent compound, to be delivered by this dry powder in one to three breaths. [00:02:57] Speaker 03: That evidence was presented to the board below. [00:03:00] Speaker 03: and is vastly different and actually demonstrates the fundamental error that was committed by the board below in assessing those dry powder claims. [00:03:13] Speaker 03: The dry powder claims here, the board committed error by not evaluating the dry powder claims against [00:03:20] Speaker 03: the particular limitations from which those claims depend in violation of 112 section paragraph 4. [00:03:30] Speaker 03: Each claim is a separate invention. [00:03:32] Speaker 03: And so the way that the board actually went ahead and performed the analysis, and we can see this in APPX 34 and 35, is it just assumed based upon solution evidence only [00:03:45] Speaker 03: that the dosage regimen was found in the art, and then said, now all I need to do is to go ahead and find where's Waldo's style, any teaching of dry powder anywhere in the art. [00:03:59] Speaker 03: Divorced from the particulars of that particular dosage regimen and scheme, which is the heart of the invention here. [00:04:07] Speaker 03: That's the heart of what makes the 793 different from the 212, your honor. [00:04:12] Speaker 01: I want to talk about whether the [00:04:14] Speaker 01: Journal abstracts were prior of? [00:04:16] Speaker 03: Oh, absolutely, Your Honor. [00:04:17] Speaker 03: I'm happy to do that. [00:04:20] Speaker 03: The journal abstracts here, well, first of all, the thing that was presented in the petition were journal supplements, not abstract books. [00:04:30] Speaker 03: Abstract books is a fiction that came about during deposition of our expert. [00:04:36] Speaker 03: And only upon reply did these abstract books start to take on a bit of life of their own by virtue of a sentence or a section in the petitioner's reply. [00:04:51] Speaker 02: Your Honor? [00:04:51] Speaker 02: Abstract books are an abstract of a publication, correct? [00:04:58] Speaker 03: The abstract, an abstract is the front piece of a general larger publication, right? [00:05:05] Speaker 02: Generally, they define or give a road path as to where the publication is going to go. [00:05:11] Speaker 03: It talks about- Exactly right. [00:05:13] Speaker 02: Is it the case that in both of the prior arcs references that we have, that the abstract discloses the dosage limitation that we're addressing? [00:05:25] Speaker 03: No, we absolutely disagree with that, Your Honor. [00:05:28] Speaker 03: And in fact, we think there's no substantial evidence to support the notion that one can derive the dosage from that information. [00:05:38] Speaker 03: If we look to exactly that issue and go and track down and chase down the support, there are only essentially three [00:05:47] Speaker 03: There are only essentially two witnesses to sponsor that testimony. [00:05:52] Speaker 03: There's Dr. Gonda, who testifies that in one of the declarations says, [00:06:01] Speaker 03: Conventionally, it's understood to deliver of 1 to 5 milliliters. [00:06:07] Speaker 03: When you actually look at that conclusory statement and look to the materials upon which that depends, and he relies upon to support that statement, you only find that it's fill volumes of nebulizer. [00:06:21] Speaker 03: Again, solution, not dry powder. [00:06:23] Speaker 03: But it's fill volumes and prescribed volumes. [00:06:26] Speaker 03: He relies upon four or five [00:06:28] Speaker 03: approved product labels with respect to that. [00:06:32] Speaker 03: And as a result, that simply cannot hold as qualifying for substantial evidence. [00:06:41] Speaker 03: The other person who testified about this was Dr. Hill, and Dr. Hill relies on Dr. Donda. [00:06:49] Speaker 03: As a result, the entirety fails here because there is no substantial evidence [00:06:55] Speaker 03: to support the notion that the delivered dose here can be calculated based upon the information contained either in those journal article supplements or by virtue of the associated product labels that Dr. Gonda depends from. [00:07:10] Speaker 03: In fact, our expert, Dr. Waxman, specifically testified at APPX 3186. [00:07:17] Speaker 03: I don't know that we could really say for sure how much was delivered. [00:07:21] Speaker 03: So again, the claims require a particular dose to be delivered here. [00:07:27] Speaker 03: All the evidence that was presented in the petition and all the way through the proceeding had to do with how much volume you [00:07:35] Speaker 03: pour into the actual vessel that's going to nebulize or aerosolize the particular drug product. [00:07:46] Speaker 03: None of that has anything to do with the amount that actually gets to the patient that's actually delivered. [00:07:52] Speaker 03: And that's an utter failure of proof. [00:07:54] Speaker 03: And we submit [00:07:56] Speaker 03: supports the notion of an outright reversal, because there's no facts presented pertaining to delivered dose upon which you could support the conclusion that the claims that the prior art teaches delivered dose. [00:08:10] Speaker 03: And that's even assuming that the journal supplement abstracts are prior art in the first instance, your honor. [00:08:16] Speaker 03: Here we take grave issue with that. [00:08:18] Speaker 03: Those journal article supplements were the things that were relied upon in the petition as publications. [00:08:27] Speaker 03: And there was fighting back and forth about indexing and so on and so forth. [00:08:33] Speaker 03: Only after the board got smacked for having relied not upon publication, but rather a research aid theory, [00:08:43] Speaker 03: Did anything come up with respect to abstract books? [00:08:48] Speaker 01: Yes, Your Honor. [00:08:50] Speaker 01: The board said we find that both references were distributed sufficiently at professional conferences to be publicly accessible at the time of those conferences. [00:09:01] Speaker 01: By virtue of this public accessibility, both of them were printed publications early enough to qualify as prior art. [00:09:09] Speaker 01: Aren't those fact findings? [00:09:10] Speaker 03: Well, that's a determination of qualification as prior art under 102B, which is a question of law dependent upon underlying facts. [00:09:21] Speaker 03: We submit, Your Honor, that whether you consider this to be qualification of prior art as a question of law, which is subject to de novo review, or if you consider it to be a question of substantial evidence supporting underlying facts, we should win and the court ought to reverse. [00:09:38] Speaker 02: Well, there's two issues here. [00:09:39] Speaker 02: One is whether the abstract even discloses the dosage limitation at all. [00:09:46] Speaker 02: That's one. [00:09:46] Speaker 02: And the other is whether the abstract was accessible. [00:09:50] Speaker 03: Exactly right. [00:09:51] Speaker 03: Exactly right, Your Honor. [00:09:52] Speaker 03: And so for all the reasons I just went through with you, Your Honor, [00:09:55] Speaker 03: with respect to the lack of substantial evidence supporting delivered dose, we think that we get a reversal there. [00:10:03] Speaker 03: Secondly, and more importantly, though, these journal abstracts, these journal supplement articles, are not the basis upon which the panel below actually found public accessibility. [00:10:19] Speaker 03: Rather, it was dissemination of these phantom abstract books. [00:10:24] Speaker 03: There is no evidence whatsoever. [00:10:26] Speaker 03: There's no exhibit that they can say, here's the abstract book that was circulated. [00:10:31] Speaker 03: They don't have a witness. [00:10:32] Speaker 03: This is exactly the opposite of the Nobel BioCare case, where you had somebody who said, I went to the conference. [00:10:41] Speaker 03: I saw it. [00:10:42] Speaker 03: I can vouch and corroborate that this was disclosed. [00:10:51] Speaker 02: Our precedent would generally support that accessibility is determined on whether the [00:10:53] Speaker 02: publication was at and available at a conference, not whether somebody actually walked off with it. [00:11:00] Speaker 02: Though I think that's a tension. [00:11:02] Speaker 02: There's a tension there. [00:11:04] Speaker 02: But I'm more concerned in your claim that the abstract did not disclose the limitation to begin with. [00:11:14] Speaker 02: Well, we agree entirely that the other side's going to argue that, correct? [00:11:18] Speaker 02: That's going to make it a substantial evidence issue. [00:11:20] Speaker 03: That would be a substantial. [00:11:22] Speaker 03: That issue is a substantial evidence issue across the board. [00:11:25] Speaker 03: We agree. [00:11:26] Speaker 03: And as I've just walked through, Your Honor, I'm happy to walk through it in more detail if the Court has interest here. [00:11:31] Speaker 03: But at the red brief 43, there are essentially three bullet points that support this notion that there was a delivered dose. [00:11:38] Speaker 03: They cite to the Gonda. [00:11:40] Speaker 03: They cite to Hill. [00:11:41] Speaker 03: And they cite to Dr. Waxman, our expert. [00:11:45] Speaker 03: Dr. Gonda at APPX 1166 of paragraph 56 uses the word delivered. [00:11:50] Speaker 03: But for all the reasons I just walked through with, Your Honor, all of the supporting evidence says prescribed or dosage or filled. [00:11:59] Speaker 03: It has nothing to do with what's actually delivered. [00:12:02] Speaker 01: Counsel, you're into your rebuttal time, which you can save or use. [00:12:07] Speaker 03: Well, Your Honor, just let me summarize then very briefly and reserve some time for rebuttal. [00:12:15] Speaker 03: These abstract books never saw the light of day. [00:12:19] Speaker 03: There's no evidence that those abstract books even exist. [00:12:21] Speaker 03: And that's a proxy that's a fabrication by the board to support the notion that these journal supplement articles, which are different, and we don't know that they're the same because we don't even know if the abstract books exist, became public. [00:12:34] Speaker 03: And that's a fundamental foundational error, in addition to the issue that's troubling you, Judge Raina, which also troubles me. [00:12:41] Speaker 03: Thank you. [00:12:42] Speaker 01: We'll save the remainder of your time. [00:12:43] Speaker 01: And when you come back, perhaps you won't shout at us. [00:12:47] Speaker 03: Oh, I apologize. [00:12:51] Speaker 01: Mr. Suk Duong. [00:12:54] Speaker 00: Good morning, Your Honors. [00:12:55] Speaker 00: May it please the court. [00:12:56] Speaker 00: Sonia Suk Duong on behalf of Liquidea. [00:12:59] Speaker 00: I'd like to get to the issue with respect to the abstract books. [00:13:02] Speaker 00: The Liquidea's petition provided evidence of public accessibility. [00:13:05] Speaker 00: It's the same theory that was presented in the petition and the same theory that the board found public accessibility [00:13:11] Speaker 00: And as your honor had noted, the issue was whether they could access those. [00:13:17] Speaker 02: Yes, for both conferences, give or take. [00:13:32] Speaker 00: Yes. [00:13:35] Speaker 00: We have one, your honor. [00:13:38] Speaker 00: In the board's decision on rehearing, [00:13:40] Speaker 00: where they denied rehearing, they cited the two copies of the Jessk abstract. [00:13:47] Speaker 00: And if you look at page 58 of the rehearing decision. [00:13:52] Speaker 00: Somebody received them or had them? [00:13:56] Speaker 00: The copy that the board relied on is the abstract book. [00:13:59] Speaker 00: So if you go to appendix page 58, they cite a copy of Jessk, which is starting at appendix page 2681. [00:14:09] Speaker 00: And if you go to Appendix Page 2684, it says at the very bottom, this abstract book has been produced electronically by Alversier. [00:14:17] Speaker 00: This abstract book, that is the copy. [00:14:20] Speaker 00: The abstract in that copy was the exact same abstract that was cited in the petition and also relied on the hearing denial. [00:14:29] Speaker 00: With respect to JAHA, the board pointed in its rehearing denial [00:14:35] Speaker 00: When you look at the face of Jaha, it provides the date of the conference. [00:14:41] Speaker 00: The board also found in its rehearing denial at page 60 that when you go to the abstract itself for Jaha, that page, it tells you the date [00:14:52] Speaker 00: where that abstract is presented and tells you the hall. [00:14:55] Speaker 02: Do you have a declarant or something? [00:14:57] Speaker 00: We do not have a declarant, but we don't need a declarant here, Your Honor. [00:15:01] Speaker 02: You don't need one, but it's a big stretch. [00:15:04] Speaker 02: You've got 20,000 people that get these, and you can't produce a single person that says, I went, I received, I'm satisfied. [00:15:13] Speaker 00: This conference was in 2004. [00:15:18] Speaker 00: When you look at the documents that were submitted with the petition themselves, with the petition themselves that the board relied on, and these are factual issues, this is determined for substantial evidence, the faces of the documents themselves dictate that the copies presented at the petition were copies of the abstract book themselves. [00:15:39] Speaker 00: When you look at Jaha, [00:15:41] Speaker 00: Again, a copy that was submitted below before the board. [00:15:47] Speaker 00: There's another copy at appendix page 7606. [00:15:52] Speaker 00: When you go to that page in Jaha that was presented to the board and they accepted as evidence, there's an advertisement for a drug called Crestor and it says go to booth 2547. [00:16:03] Speaker 00: 2547, you don't need directions to go to a booth if it wasn't the abstract book. [00:16:10] Speaker 00: You don't need directions to go to Hall 12 on Wednesday if the copies that were submitted in the petition were not the copies originally at the conference. [00:16:21] Speaker 00: But we don't need a declarant to say, I've received it. [00:16:23] Speaker 00: In the Jazz Pharma case? [00:16:25] Speaker 02: Can you address the argument? [00:16:27] Speaker 02: from the other side, that even if the abstracts are publicly accessible, that they do not disclose the dosage limitation. [00:16:37] Speaker 00: Sure, yes. [00:16:38] Speaker 00: And that issue is determined by substantial evidence, and we believe the board's decision is amply supported by substantial evidence. [00:16:46] Speaker 00: The question is whether the Jessk abstract discloses 15 to 90 micrograms as claimed in the 793 patent. [00:16:54] Speaker 00: All of the experts agreed. [00:16:56] Speaker 00: Dr. Hill, Dr. Waxman, Dr. Gonda, and the board credited this testimony, which is that testimony which was given deference. [00:17:04] Speaker 00: All three experts concluded that at least one mil would be delivered. [00:17:12] Speaker 00: Dr. Hill said that. [00:17:13] Speaker 00: Dr. Gonda said that. [00:17:14] Speaker 00: And Dr. Waxman testified that he's never administered less than at least one mil. [00:17:19] Speaker 00: And I think the at least is critical. [00:17:21] Speaker 00: When you look at the, and counsel talked about fill volumes, [00:17:26] Speaker 00: The board considered the fill volume issue. [00:17:29] Speaker 00: And they specifically said in their final written decision that even if we consider all the factors presented by UTC in their response, substantial evidence, we still met our preponderance of the evidence standard in determining the dose. [00:17:46] Speaker 00: When you look at Jesk, it goes from 16 to 64 micrograms. [00:17:53] Speaker 00: At least one mil is going to give you at every single point within the 15 to 90 micrograms. [00:18:00] Speaker 01: And the issue is obviousness here, not anticipation. [00:18:03] Speaker 00: That's correct. [00:18:04] Speaker 00: And what the board determined is that a person of ordinary skill in the art, when you look at JESC, the person of ordinary skill in the art would determine, based on the evidence it presented and considering the alternative arguments on fill volume and patient [00:18:23] Speaker 00: characteristics that the person of skill in the art would still determine that Jesk teaches you delivery of at least one mil. [00:18:34] Speaker 00: And when you deliver at least one mil, you're going to fall within the scope of the 793 claims. [00:18:40] Speaker 01: What about unexpected results? [00:18:42] Speaker 00: Yes. [00:18:42] Speaker 00: And the board did consider that at appendix pages 22 to 23. [00:18:46] Speaker 00: The evidence that UTC presented below, [00:18:52] Speaker 00: And the evidence that they point to here, and it's a Seeger declaration, it's a Manion declaration, and a Waxman declaration, the board considered that evidence and determined that those declarations and the evidence that UTC presented talked about tripostinal versus ilipros, a completely different drug. [00:19:15] Speaker 00: And the board determined that UTC did not present evidence comparing tripostinal [00:19:22] Speaker 00: to the closest prior art, which would be inhalation of trapezoidal. [00:19:26] Speaker 00: That's disclosed in the 212 patent. [00:19:28] Speaker 00: That's disclosed in JESC. [00:19:30] Speaker 00: And that's disclosed in JAHA. [00:19:32] Speaker 00: UTC now argues here the same exact evidence they presented below that was disregarded, that was considered but not found sufficient by the board. [00:19:42] Speaker 00: And they argue here that they did talk about trapezoidal. [00:19:45] Speaker 00: But when you look at the citations that they point to, and again, it's appendix page 3983. [00:19:50] Speaker 00: Appendix page 5524, appendix pages 4795 to 4797. [00:19:55] Speaker 00: The word trapezoidal is mentioned there, absolutely. [00:19:59] Speaker 00: But that's talking about the 793. [00:20:01] Speaker 00: The comparator is illiprost in every single instance. [00:20:06] Speaker 00: So the board was correct in determining that the evidence of unexpected results did not compare [00:20:13] Speaker 00: tripostinal claim of the 793 patent against the closest prior art. [00:20:19] Speaker 00: Even the 212 patent, as your honors have pointed out, the 212 patent discloses inhalation of tripostinal. [00:20:27] Speaker 00: That's the claim. [00:20:28] Speaker 00: That's disclosure. [00:20:29] Speaker 00: They didn't even compare that against the 212 patent. [00:20:33] Speaker 00: So we believe substantial evidence supports the board's finding on the dosing. [00:20:37] Speaker 00: We believe that the board was correct in its consideration and decision not to rely on unexpected results with respect to the dosing issue. [00:20:47] Speaker 00: I want to go to the claims 4, 6, and 7 for a moment, if I can. [00:20:54] Speaker 00: With respect to claims 4, 6, and 7, the board did, in fact, determine [00:21:01] Speaker 00: the entirety, the claim as a whole, claim four as a whole, claim six as a whole, claim seven as a whole. [00:21:06] Speaker 00: When you look at the board's decision at appendix page 33 in the final written decision, they go and start at appendix page 31. [00:21:17] Speaker 00: They begin by talking about claims four, six, and seven. [00:21:23] Speaker 00: And the first part of the board's discussion in their final written decision regarding those claims at pages 31 [00:21:31] Speaker 00: to 33 address the combination of the 212 patent, Jesk, and Jaha. [00:21:40] Speaker 00: You only have to discuss, the board only had to discuss the combination of those three references if they were addressing the claim one limitations which are incorporated into claim four. [00:21:50] Speaker 00: There would be no need for the board to talk about the combination. [00:21:54] Speaker 00: Again, this is an obvious argument. [00:21:56] Speaker 00: The combination of those three references if they were not considering the claims as a whole. [00:22:00] Speaker 00: Then afterwards, starting at appendix page 34, they say, for all these reasons, we determine that the petitioner is shown by a preponderance of the evidence that a person of ordinary skill in the art would have a reason to combine the teachings of the 212 patent, Voswinkle-Jesk and Voswinkle-Jaha, and would have a reasonable expectation of success in doing so. [00:22:22] Speaker 00: And then after that, so that's the dosing and the breath issues. [00:22:26] Speaker 00: Then after that, they say, thus we move on. [00:22:30] Speaker 00: And that's at page 34 of the appendix. [00:22:33] Speaker 00: And that's where they start talking about the dry powder. [00:22:37] Speaker 00: They start talking about the inhalation device. [00:22:40] Speaker 00: And they start talking about the micron size, which are expressly disclosed in the 212 patent. [00:22:46] Speaker 00: So they did exactly what UTC says they didn't. [00:22:50] Speaker 00: They did exactly what UTC says they should have. [00:22:54] Speaker 00: Talk about the first part of the claim, which is the dosing and the inhalation. [00:22:59] Speaker 00: And then with respect to the additional limitations in those claims, they address those two in the 212 patent. [00:23:05] Speaker 00: And we believe that substantial evidence supports the board's finding with respect to the claims 4, 6, and 7. [00:23:15] Speaker 01: What if the 212 patent hadn't disclosed powder? [00:23:21] Speaker 00: If the 212 patent didn't disclose powder, they would have to find another reference out there that would disclose powder. [00:23:28] Speaker 00: Here, though, even if it didn't disclose powder, and it does, and the 212 patent is very interesting, it's UTC's own patent, and the disclosure is nearly identical to the patent that we're looking at, the 793. [00:23:43] Speaker 00: There's one sentence regarding powder and the particle size in the 212 patent, and the rest of the disclosure is solution. [00:23:52] Speaker 00: Council argues in their briefing that you can't bridge [00:23:57] Speaker 00: solution to powder, and the board didn't do that. [00:24:00] Speaker 00: Well, they did. [00:24:02] Speaker 00: If you look at the appendix, if you look at appendix page 33, the board said that the 212 patent provides enough information for a person of ordinary skill and they are to have made and used the invention defined by the claims of the 212 patent. [00:24:22] Speaker 00: They said the disclosure of the 212, which is solution, [00:24:26] Speaker 00: teaches you how to make a powder and use a dry powder inhaler. [00:24:31] Speaker 00: That is the bridge between a disclosure on solution on one hand in the 2-1-2 patent and how you get to dry powder, which they expressly claim. [00:24:41] Speaker 00: Council noted that the 2-1-2 patent doesn't talk about the dosing or the breaths, but it doesn't have to. [00:24:47] Speaker 00: That's Jesk and Jaha. [00:24:49] Speaker 00: Jesk and Jaha provide the dosing and provide the breath. [00:24:53] Speaker 00: 2-1-2 provides the dry powder. [00:24:56] Speaker 00: and provides the bridge between disclosures of solutions and disclosures of powders. [00:25:04] Speaker 00: And they argued, and there was quite a bit of argument in the oral hearing about enablement of the 212 patent. [00:25:11] Speaker 00: The point of that, and the reason why that came up, was UTC's only argument before the board was a credibility determination between Dr. Gonda's testimony at the district court and Dr. Gonda's testimony in the IPR. [00:25:26] Speaker 01: In other words, United got the 212 patent. [00:25:31] Speaker 01: And then it had these presentations, these lost-winkle presentations. [00:25:39] Speaker 01: And then after all of that, they still tried to get a patent with little refinements. [00:25:45] Speaker 00: Exactly. [00:25:45] Speaker 00: And those little refinements are obvious. [00:25:48] Speaker 00: If you look at the chronology of what went on, [00:25:51] Speaker 00: The 212 patent is earlier in time than Jeskin-Jaha. [00:25:55] Speaker 00: And as we argue in the petition, and as the board found, when you look at the 212 patent, it talks about administering a dry powder. [00:26:04] Speaker 00: And the board found, and this is supported by substantial evidence, and that is supported by Dr. Gonda, which is unrebutted. [00:26:11] Speaker 00: And the board found that. [00:26:12] Speaker 00: The motivation to combine was provided by Dr. Hill, and the board relied on that. [00:26:16] Speaker 00: He said that patients, [00:26:18] Speaker 00: When you take a nebulized solution, it takes a long time. [00:26:22] Speaker 00: There's adherence to the treatment protocol. [00:26:25] Speaker 00: And a person who already has skill in the gut will be motivated to get a more convenient mode of administration. [00:26:31] Speaker 00: That's Jesk and Jaha. [00:26:33] Speaker 00: That's the three breaths of Jaha. [00:26:36] Speaker 00: And that's the dosing provided in Jesk. [00:26:38] Speaker 00: And those references, time-wise, are after the 212 patent. [00:26:43] Speaker 00: So when you look at the chronology, [00:26:45] Speaker 00: In terms of obviousness, and what a person with already skilled in the art would do, they would see UTC as a patent to dry powder, the exact same patent that they're asserting here. [00:26:55] Speaker 00: And then a person of skill in the art looking at the 212 would say, how do I get this quicker? [00:27:00] Speaker 00: How do I make it more convenient to a patient? [00:27:03] Speaker 00: The board found that. [00:27:04] Speaker 00: And that's where you turn to Jessica and Jaha. [00:27:06] Speaker 00: Jessica and Jaha provide the dosing and the breaths. [00:27:10] Speaker 00: 212 does not need to provide that. [00:27:13] Speaker 00: It only needs to provide. [00:27:15] Speaker 00: the dry powder, and as the board found at appendix page 33, the bridge between solution and powder. [00:27:23] Speaker 01: If there were not the jest and the jaha, but only the 212 patent, it would be different? [00:27:31] Speaker 00: We believe no, but that issue is not before you. [00:27:35] Speaker 00: But I would argue that the 212 patent would maybe not anticipate, but you can rely a single piece of prior art for obviousness. [00:27:45] Speaker 00: And we would argue the 212 patent, if you look at the obvious context, that provides all the disclosure you need with respect to the 793 patent claim one. [00:27:55] Speaker 00: I see that I've got two seconds left. [00:27:56] Speaker 00: If you have any other questions, I'd be happy to address them. [00:27:58] Speaker 00: If not, with liquidity and myself, we appreciate your time. [00:28:01] Speaker 01: Thank you, counsel. [00:28:04] Speaker 01: Mr. Costin has some rebuttal time. [00:28:13] Speaker 03: Thank you, Your Honor. [00:28:15] Speaker 03: I'll try not to shout. [00:28:16] Speaker 03: I get kind of motivated when I see injustice below, and I think we've got that here. [00:28:23] Speaker 03: We appreciate motivation. [00:28:24] Speaker 03: Well, I hope you appreciate passion as well. [00:28:26] Speaker 03: I'd like to touch on a few points. [00:28:29] Speaker 03: One, Judge Raina, one of your questions to me was, do these articles even teach the delivered dose? [00:28:36] Speaker 03: There is a finding at APPX 15 that says, although this teaching [00:28:43] Speaker 03: shows administration to patients of inhaled solutions with particular concentrations of troprosanil. [00:28:49] Speaker 03: It does not disclose the amount of solution administered, which is necessary in order to calculate the amount of troprosanil administered. [00:28:57] Speaker 03: These articles did not teach any dose. [00:29:01] Speaker 03: Rather, you had to work through [00:29:05] Speaker 03: volumes and so forth with all those variables. [00:29:08] Speaker 03: And that is strikingly absent from the final written decision below. [00:29:14] Speaker 03: With respect to these abstract books, I've heard a lot from my friend that is not anywhere to be found in the record below or certainly not the basis that the final written decision either won or to relies upon. [00:29:31] Speaker 03: And obviously, since we're reviewing an administrative record here, [00:29:35] Speaker 03: We can't come up with alternative basis for affirmance. [00:29:37] Speaker 03: You have to look at what the board did. [00:29:41] Speaker 03: There's no evidence that the journal articles that were relied upon are the same thing that appeared in abstract books. [00:29:51] Speaker 03: Now, Mr. Suk Duong has made new arguments about why these journals may or may not have been the abstract books, but that's all supposition and was never raised. [00:30:02] Speaker 03: In fact, the Red Brief 27 talks about the journals and the abstract books as different things, and that's liquidity is own words. [00:30:10] Speaker 03: Moreover, Your Honor, this all came out down the road. [00:30:14] Speaker 03: We asked for approval to submit declarations pertaining to those conferences. [00:30:18] Speaker 03: You're right to question, why with 20,000 people couldn't you have a single person to corroborate any of this? [00:30:24] Speaker 03: We don't even know these abstract books exist. [00:30:26] Speaker 03: We asked for that. [00:30:27] Speaker 03: We were denied. [00:30:29] Speaker 03: And that's worthy of a remand and demands a remand. [00:30:32] Speaker 03: With respect to unexpected results, we did provide, in direct response to criticisms from Liquidia, the particular unexpected results comparison of treprosynil to other treprosynil prior art. [00:30:52] Speaker 03: That starts at the bottom of our patent-owner response, APPX 416, and also in surreply, in direct response, [00:31:00] Speaker 03: at pages APPX 584 to 585. [00:31:04] Speaker 03: The board's finding below that the patent owner does not ever allege unexpected results over this art is simply wrong. [00:31:15] Speaker 03: We know that the panel below overlooked certain evidence. [00:31:19] Speaker 03: That's the reason we have a final written decision too in this case. [00:31:23] Speaker 03: It's the same document that they overlooked here with respect to the unexpected results evidence. [00:31:28] Speaker 03: And that alone, as well, gives us the right to a remand. [00:31:32] Speaker 01: Thank you, counsel. [00:31:34] Speaker 01: The case is submitted. [00:31:35] Speaker 03: Thank you, Your Honor.