[00:00:00] Speaker 00: The first case for argument this morning is 16-2616, Praxair versus Malencroft. [00:00:07] Speaker 00: And we've got a cross-appeal here too. [00:00:08] Speaker 00: Mr. Peterson, whenever you're ready. [00:00:21] Speaker 03: Mr. C. Thank you. [00:00:22] Speaker 03: May it please the court. [00:00:24] Speaker 03: Your Honor, William Peterson on behalf of the appellant to cross up the Praxair distribution in corporate [00:00:29] Speaker 03: In the main appeal which concerns only claim nine, the board erred in three respects. [00:00:35] Speaker 03: First, dependent claim nine was not briefed separately by Malancrot and should not have been addressed separately by the board. [00:00:43] Speaker 03: Second, the board failed to give the phrase in accordance with its broadest reasonable interpretation. [00:00:48] Speaker 03: And third, even under the board's construction, the board incorrectly analyzed obviousness. [00:00:52] Speaker 00: Would you mind going to the third point first? [00:00:55] Speaker 00: Because that's the one I think has most heft to it. [00:00:58] Speaker 03: Thank you, your honor, very gladly. [00:01:02] Speaker 03: It's recognized in specification and in the board's opinion, page 40 of the joint appendix, that pulmonary edema was a known life-threatening side effect that could occur when patients with left ventricular dysfunction were treated with inhaled nitric oxide. [00:01:20] Speaker 03: So claim nine consists of a recommendation and under the board's construction, a based on that recommendation step, [00:01:29] Speaker 03: which involve instructing a doctor to discontinue a known treatment when a known life-threatening side effect of that treatment results. [00:01:40] Speaker 02: And discontinuing the treatment is the only distinguishing factor over claims that have been held invalid. [00:01:48] Speaker 03: Yes, Your Honor, that's correct. [00:01:50] Speaker 03: And really, from our perspective, this is simply common sense. [00:01:53] Speaker 03: It's the first principle of medicine. [00:01:55] Speaker 03: First of all, do no harm. [00:01:57] Speaker 03: when a life-threatening treatment results, doctors don't need to be instructed, or life-threatening side effect results, doctors don't need to be instructed that one of the options available to them is to discontinue that treatment. [00:02:10] Speaker 00: Well, what was the board's conclusion with respect to why this was non-obvious? [00:02:14] Speaker 00: Because there was nothing in the prior art that suggested discontinuance under these circumstances? [00:02:21] Speaker 03: Well, I think that's right, but we actually think the board misread some of the art [00:02:27] Speaker 03: that it discussed, both the Barnasconi reference and the I-022 study. [00:02:31] Speaker 02: Did the board find a functional relationship between discontinuing and the other steps? [00:02:38] Speaker 03: The board found a functional relationship between the recommendation to discontinue treatment and the discontinuing of the treatment based on its construction of in accordance with as requiring a causal link between the two. [00:02:50] Speaker 03: And so for that reason, it gave patentable weight to the recommendation. [00:02:54] Speaker 03: But again, we think discontinuing is obvious, and recommending discontinuance is obvious for the very same reasons. [00:03:01] Speaker 03: The evidence the board pointed to in the prior art, the I022 study, the Bernis-Cote, the board said that those references didn't teach excluding patients from treatment with inhaled nitric oxide when they had left ventricular dysfunction. [00:03:16] Speaker 03: But that's simply not what clean 9 requires. [00:03:20] Speaker 01: I'm not sure I understand. [00:03:21] Speaker 01: How would this patent be enforced? [00:03:24] Speaker 01: Is it a matter of putting on the label of the competing product the mode of use, that is, to discontinue treatment? [00:03:32] Speaker 01: Is that where the infringement would arise? [00:03:37] Speaker 03: Well, this is a method claim. [00:03:40] Speaker 01: But the physicians are practicing the method, so they discontinue treatment. [00:03:45] Speaker 01: How does that benefit your client? [00:03:48] Speaker 01: I mean, how would it be implemented? [00:03:53] Speaker 01: You can't license every physician in the nation or every pediatrician, so is it a matter of the label on the product? [00:04:01] Speaker 03: Yes, I believe that's the case. [00:04:02] Speaker 03: It would be the label on the product being the providing the recommendations. [00:04:06] Speaker 00: So it would be an inducement or contributory theory? [00:04:09] Speaker 00: Yes, Ron. [00:04:09] Speaker 00: And the direct printer would be the doctor, the physician, who discontinues treatment, right? [00:04:14] Speaker 03: Yes, Ron. [00:04:16] Speaker 03: But from our perspective, if you look at the Idomax label, what you'll see is it actually recommends discontinuing treatment based on another known side effect of inhaled nitric oxide therapy. [00:04:29] Speaker 03: So under KSR, when a physician's looking at the options available to them when a known side effect of inhaled nitric oxide therapy occurs, one of the options available to them already in the prior art was the discontinuance of treatment. [00:04:43] Speaker 00: You're into your rebuttals, which I know you want to save for the cross field. [00:04:48] Speaker 00: So let's hear from the other side. [00:04:53] Speaker 04: May it please the court. [00:04:54] Speaker 04: Ken Schuller on behalf of Malincrot. [00:04:57] Speaker 04: This court should affirm the board's determination that claim nine is patentable, and with it enter judgment that claim 11, which is dependent upon claim nine, is likewise patentable. [00:05:07] Speaker 04: The board's determination that the Berness-Goney reference, which is the loan reference that was cited by Praxair below, [00:05:12] Speaker 04: does not teach or suggest the discontinuing step is supported by substantial evidence. [00:05:16] Speaker 00: Well, if there's a life-threatening event, so what this patent adds, the added limitation is if there's some life-threatening occurrence based on the dosage, then you discontinue. [00:05:29] Speaker 00: I mean, I know common sense has been somewhat of a controversial notion in some of our case law here with regard to KSR. [00:05:37] Speaker 00: But isn't this really a common sense, common occurrence? [00:05:42] Speaker 04: I think not for four reasons. [00:05:43] Speaker 04: And if the court will indulge me, the first, the most important, might be the specification itself. [00:05:49] Speaker 04: In the I-022 study, if you look at table 7, there were two instances of pulmonary edema during the course of the study. [00:05:56] Speaker 04: The table 7 indicates in neither instance was the treatment discontinued. [00:06:00] Speaker 04: So it was not common wisdom or common sensical to these physicians to discontinue the treatment. [00:06:06] Speaker 04: The second point is this is a life-threatening condition that it's indicated. [00:06:10] Speaker 04: neonates that have hypoxic respiratory failure. [00:06:12] Speaker 04: And so a position, it's not common sense to discontinue something that's saving the neonate. [00:06:19] Speaker 04: Third, the board looked at all the evidence and said they concluded that Bernisconi does not teach or suggest discontinuing inotreatment in neonates. [00:06:29] Speaker 04: It merely says that there's a need for monitoring during inotreatment in adults. [00:06:35] Speaker 04: There's two important things there. [00:06:37] Speaker 04: The first is [00:06:38] Speaker 04: Our expert explained, Dr. Rosenthal explained, that urnascone is a study involving adults. [00:06:43] Speaker 04: That is not applicable to neonates who are not little adults. [00:06:48] Speaker 04: They have fundamentally different pulmonary vasculature systems. [00:06:51] Speaker 02: Mr. Scholar, I'd like to interrupt your four points and get to the cross appeal. [00:06:58] Speaker 02: I think your argument is that the board should not have discarded the steps of providing information and recommendation [00:07:07] Speaker 02: as printed matter. [00:07:13] Speaker 02: Isn't printed matter simply an abstract idea reduced to writing? [00:07:21] Speaker 04: That's one potential way to look at it. [00:07:23] Speaker 04: I think that in this instance, we know that there's a functional relationship between that printed matter and the remaining steps of the method for a multitude of reasons. [00:07:33] Speaker 02: Well, what's a functional relationship? [00:07:36] Speaker 04: That's a very good question, Your Honor. [00:07:38] Speaker 02: I think a functional relationship is one that's called... Making a recommendation doesn't make something happen. [00:07:43] Speaker 02: They don't work together. [00:07:45] Speaker 04: Well, they do have to work together. [00:07:46] Speaker 04: I think that there's two interesting examples in the specification that establish that there is a functional relationship. [00:07:52] Speaker 04: In other words, a causal functional relationship between the information of Clause 2 and the remaining steps of the method. [00:07:59] Speaker 04: And the first of those examples is the I-022 study. [00:08:02] Speaker 04: As the court may recall, the study protocol originally indiscriminately allowed for the administration of the nitric oxide gas to the patients, regardless of whether they have left ventricular dysfunction. [00:08:16] Speaker 02: As a matter of law, does the functional relationship test, if we can call it that, survive ALICE? [00:08:23] Speaker 02: Because abstract subject matter is abstract subject matter, and printed matter is [00:08:30] Speaker 02: Is mental steps abstract, subject matter reduced to writing? [00:08:34] Speaker 02: So does that survive Alice? [00:08:36] Speaker 04: I think it does because if there's a functional relationship with physical steps, and here there is even with claim one, remember claim one specifies that the information has to be sufficient to cause a physician who's otherwise considering using the nitric oxide gas to elect not to treat one or more of the neonates. [00:08:55] Speaker 04: That sufficient to cause means that it's specifying a reaction by the physician in one [00:09:00] Speaker 04: that is causally related, sufficient to cause. [00:09:04] Speaker 04: In the IDON-22 study, that's exactly what happened. [00:09:06] Speaker 04: The information that was provided to the physicians, they were given the gas and one set of exclusion criteria. [00:09:13] Speaker 04: After the protocol was revised, they were given the gas with a different set of exclusion criteria. [00:09:18] Speaker 04: And there was an empirical benefit in terms of substantial increase in safety. [00:09:24] Speaker 04: There was a reduction in the number of adverse events. [00:09:26] Speaker 04: That was set forth in our declarant Dr. Rosenthal's declaration, explaining that empirically, the information caused a benefit in terms of a reduction in adverse events. [00:09:38] Speaker 04: So I don't think that Alice would implicate the doctor in that fashion. [00:09:43] Speaker 04: So long as there's a functional relationship with other physical steps, then it is patentable subject matter. [00:09:53] Speaker 04: The board also, I think, missed [00:09:55] Speaker 04: read the specification in a second respect. [00:09:58] Speaker 04: There's additional evidence of a functional relationship, and that is that the information at issue in clause two empirically led the FDA to change the labeling. [00:10:06] Speaker 04: The information that patients with LBD could suffer from pulmonary edema led to the labeling revision, and that's explained in the specification as well. [00:10:16] Speaker 04: The other error, I really think the most apt case for the court to consider is the Levin case. [00:10:23] Speaker 04: There, the court found a functional relationship between [00:10:26] Speaker 04: color coding for expiration dates on a pharmaceutical product and the product itself. [00:10:33] Speaker 02: Which case is that? [00:10:34] Speaker 04: In Ray Levin. [00:10:37] Speaker 04: That's 1997 Westlaw 44797. [00:10:40] Speaker 04: So the court explained the color coded expiration edition provides information about the drug, i.e. [00:10:47] Speaker 04: the substrate. [00:10:48] Speaker 04: And the same is true here. [00:10:50] Speaker 04: The information in the clause provides information. [00:10:54] Speaker 00: Did you cite that case in your brief? [00:10:56] Speaker 04: It's in our reclibrary. [00:10:57] Speaker 04: Not in the red. [00:10:58] Speaker 04: I think it's in both reclibraries. [00:11:01] Speaker 04: I think it was originally cited by Praxair, and we cited it as well. [00:11:05] Speaker 04: And so there's information that tells the physician information about the drug, i.e. [00:11:11] Speaker 04: who it can be safely administered to. [00:11:13] Speaker 04: The court found a functional relationship. [00:11:14] Speaker 00: Well, what about AstraZeneca and King? [00:11:17] Speaker 00: Didn't at least one of those cases deal with instruction or information? [00:11:20] Speaker 04: Yeah. [00:11:21] Speaker 04: I think it's distinguishable on multiple grounds. [00:11:22] Speaker 04: The first is there was nothing really tying [00:11:25] Speaker 04: the instructions to the method. [00:11:26] Speaker 04: It was just give the drug. [00:11:29] Speaker 04: Here, claim one again explicitly says that the information has to be sufficient to cause a reaction by a physician. [00:11:37] Speaker 04: So claim one itself recites a functional relationship. [00:11:40] Speaker 04: I think in AstraZeneca, there was really no tie between the kit and the beauty side. [00:11:49] Speaker 02: You say there's a functional relationship between [00:11:52] Speaker 02: providing information or recommendation between that and the physical steps. [00:11:59] Speaker 02: But what are the physical steps providing nitric oxide? [00:12:05] Speaker 02: This almost sounds like mayo. [00:12:10] Speaker 02: Minor physical steps and abstract ideas. [00:12:14] Speaker 04: Respect to this, Your Honor, I think that they're supplying the INO, they're obtaining the INO, and they're supplying to the physician [00:12:21] Speaker 04: And again, claim one recites that there has to be information sufficient to cause a reaction by the physician. [00:12:27] Speaker 04: In other words, the physician who is otherwise considering giving the drug to a patient with LVD elects not to treat them. [00:12:34] Speaker 04: So that's a physical reaction. [00:12:37] Speaker 04: And I think that that's not abstract at all. [00:12:39] Speaker 04: I think that's that's. [00:12:40] Speaker 02: You're not claiming a method of treatment of this ailment with nitric oxide. [00:12:47] Speaker 04: Not in this pad, other than claim not. [00:12:50] Speaker 02: That's in the prior op. [00:12:51] Speaker 04: I think claim nine does involve treatment. [00:12:55] Speaker 04: But with regard to our cross appeal, I think you're correct, Your Honor, that claims one through eight are not explicitly a method of treatment. [00:13:02] Speaker 04: They're a method of supplying the nitric oxide gas. [00:13:04] Speaker 02: So what you've added to the prior art is providing information and a recommendation, abstract ideas. [00:13:12] Speaker 04: Well, I don't agree in the sense that if you look at the study, [00:13:18] Speaker 04: You might call it an abstract idea, but it resulted in a physical change of multiple steps. [00:13:23] Speaker 04: In other words, the physician stopped treating those patients that had pre-existing LVD. [00:13:28] Speaker 04: And, as Dr. Rosenfall explained, it led to a substantial improvement in the safety attributes. [00:13:34] Speaker 04: Now, the board made an observation, Your Honor, that the drug inherently causes this effect. [00:13:40] Speaker 04: Well, if that's true, the only way to make it safer is to change physician behavior with information. [00:13:45] Speaker 04: You can't make the drug itself any safer. [00:13:48] Speaker 04: And so in a real world sense, not an abstract sense, the way that safety gets implemented in the medical field is by educating physicians about things like that. [00:13:57] Speaker 00: So what is it in the claims other than claim nine? [00:13:59] Speaker 00: So they say providing information, and then where is the language about what they're going to do with this information? [00:14:05] Speaker 04: In which claim? [00:14:06] Speaker 00: I'm asking you. [00:14:07] Speaker 00: I mean, claim one. [00:14:08] Speaker 00: I mean, what I said is other than claim nine, because we've already dealt with that. [00:14:12] Speaker 04: Sure. [00:14:12] Speaker 04: In claim one, there is the clause. [00:14:16] Speaker 04: Claim one mandates that the information in clause two be, quote, sufficient to cause a medical provider considering inhaled nitric oxide treatment for a plurality of neonatal patients who are, A, suffering from a condition for which inhaled nitric oxide is indicated and, B, have preexisting left ventricular dysfunction to avoid treating one or more plurality of patients with inhaled nitric oxide to avoid putting them at risk for pulmonary edema. [00:14:46] Speaker 00: So the action it causes is to allow the physician to consider doing this? [00:14:52] Speaker 04: To elect, not to treat those patients. [00:14:55] Speaker 00: So it doesn't say you have to do it or this is necessarily required. [00:14:59] Speaker 00: It says to elect to avoid treatment. [00:15:02] Speaker 04: I think sufficient cause is both causal and establishes a functional relationship. [00:15:08] Speaker 04: The information has to be sufficient to cause every action by the physician, and we think that that [00:15:13] Speaker 04: is exactly what a functional relationship is. [00:15:15] Speaker 04: And the claim recites it. [00:15:17] Speaker 04: And the specification supports that there's a functional relationship between the specific information at issue and the safe and effective administration of nitric oxide. [00:15:31] Speaker 04: Just very briefly, and I'll save the rest of my time, there was also a procedural error by the board. [00:15:35] Speaker 04: They adopted a construction of pharmaceutically acceptable in its final decision that neither party had [00:15:42] Speaker 04: promulgated or proffered under SAS. [00:15:45] Speaker 04: That's plain error. [00:15:47] Speaker 04: We never got an opportunity to argue to the board non-obviousness under the construction that neither party had offered. [00:15:53] Speaker 02: How can there be a real question about what pharmaceutically acceptable means? [00:15:57] Speaker 04: Well, neither party thought that there was, Your Honor. [00:15:59] Speaker 04: And the board adopted a construction that neither party had proffered. [00:16:03] Speaker 04: And frankly, we don't see in any case law. [00:16:05] Speaker 04: More interestingly, the board didn't cite any affirmative evidence for its construction. [00:16:09] Speaker 04: It dealt with our evidence, intrinsic and extrinsic, and said they dismiss it. [00:16:13] Speaker 02: It almost seems like whoever raised it. [00:16:15] Speaker 02: It almost seems like a silly question to me. [00:16:18] Speaker 02: And it either is physically capable of being administered to a person and is acceptable in terms of toxicity, efficacy. [00:16:33] Speaker 02: It's an established term. [00:16:34] Speaker 04: We thought it was too, Your Honor, and that's [00:16:38] Speaker 00: construction we proffer, the board came up with a different... But the difference is you were proffering the inclusion of the word safe. [00:16:44] Speaker 00: And there was evidence, I think, even by your expert that the board pointed to, that that would be kind of a roving term that could be changed just based on the science and the information. [00:16:54] Speaker 00: And that's what was troubling about adding that particular term, right? [00:16:58] Speaker 04: I think that was the reason. [00:17:00] Speaker 04: I think it's misguided because the construction never changes. [00:17:04] Speaker 04: Pharmaceutical acceptable has the same meaning. [00:17:07] Speaker 04: what might be in an FDA label, he admitted, does change over time. [00:17:10] Speaker 04: But remember, the information is already specified in the claim. [00:17:13] Speaker 04: So the claim's not going to change, right? [00:17:16] Speaker 04: The clause two specifies what information would be. [00:17:18] Speaker 00: So what is the import of the difference? [00:17:20] Speaker 00: They said, pharmaceutically acceptable. [00:17:22] Speaker 00: You said, pharmaceutically safe and acceptable, or safe? [00:17:26] Speaker 04: We said, suitably safe for pharmaceutical use. [00:17:28] Speaker 04: They said, suitably pharmaceutical. [00:17:30] Speaker 00: So what's the difference between the two, in your view? [00:17:32] Speaker 04: I think that Praxair's construing it to be that it's pharmaceutical grade. [00:17:37] Speaker 04: I don't think that that's a reasonable construction. [00:17:41] Speaker 04: Morphine, you know, I can hand somebody morphine and it might be pharmaceutical grade morphine. [00:17:45] Speaker 04: That doesn't make it pharmaceutical acceptable without information about its safe and effective administration and its addictive properties. [00:17:54] Speaker 04: I don't think anybody would think that that's reasonable to just hand somebody some morphine and say it's acceptable because it's pharmaceutical grade. [00:18:00] Speaker 04: It doesn't have any undue toxicity and there's not lace with fentanyl. [00:18:04] Speaker 04: suitable for pharmaceutical use. [00:18:06] Speaker 04: The procedural point, though, is the board never gave us a chance to argue under its construction for the patentability of claims one through eight. [00:18:14] Speaker 01: So did you request rehearing from the board either side? [00:18:18] Speaker 04: We did not. [00:18:19] Speaker 04: Given that Praxair was appealing claim nine, we decided to appeal to this court in cross-appeal. [00:18:27] Speaker 00: So with that, I'll reserve it. [00:18:28] Speaker 00: OK, we want to save your rebuttal time on your cross-appeal. [00:18:38] Speaker 03: Thank you. [00:18:39] Speaker 03: Your Honor, what I heard from my friend, an argument about sufficient to cause actually requiring the result to actually take place in claim one, is I think a claim construction that I certainly didn't see in Malincrot's brief. [00:18:54] Speaker 03: And it's certainly a claim construction that was never argued to the board. [00:18:57] Speaker 03: Today is the first time that Malincrot has suggested that the language of claim one, that the information must be sufficient to cause a medical provider to like to avoid treating [00:19:08] Speaker 03: must actually require a medical provider to elect to avoid treating. [00:19:12] Speaker 03: But when you look at the language of claim one, the steps there are simply obtaining a cylinder containing compressed nitric oxide, supplying the cylinder, and providing information. [00:19:23] Speaker 03: There's no requirement in claim one that actually requires a patient to be treated, much less a provider to actually make a decision [00:19:32] Speaker 03: to treat or not to treat based on the information. [00:19:35] Speaker 03: You need to provide information that is sufficient to cause that result. [00:19:39] Speaker 03: But claim one doesn't actually require that result. [00:19:42] Speaker 03: And until today, Malibu has never argued that it has. [00:19:46] Speaker 03: Now, the other argument I heard from my friend is that a functional relationship can be shown empirically. [00:19:52] Speaker 03: That is, you can look at how patent is actually practiced and see whether information in practice [00:19:58] Speaker 03: changes the results of one step, changes decisions that are made by physicians. [00:20:03] Speaker 03: This court rejected that in in-rate cow. [00:20:06] Speaker 03: That's 639 F3, 1057. [00:20:08] Speaker 03: It's a case the board relied on. [00:20:11] Speaker 03: And we think it's the right guidance for how this court and the board should conduct a functional relationship analysis. [00:20:18] Speaker 02: If the functional relationship relates to information, does that survive, Alice? [00:20:25] Speaker 03: If the information [00:20:26] Speaker 03: has a functional relationship actually causes a physical change in the active steps of the patent. [00:20:32] Speaker 02: How does information change a physical step? [00:20:38] Speaker 03: Well, I think the board's construction of Claim 9 is probably one in which the functional analysis was correct. [00:20:46] Speaker 03: Again, we think the board erred in its obviousness under Claim 9, and we think the board erred in its construction of in accordance with. [00:20:52] Speaker 03: But under the board's construction, [00:20:54] Speaker 03: the physician actually has to make a decision to treat or not treat as a result of its consideration of information. [00:21:02] Speaker 03: And at least in this court's precedent, when you have that link between the information and the accomplishment of physical steps. [00:21:08] Speaker 00: So that's another additional limitation. [00:21:11] Speaker 00: It's not just providing the information, but it's compelling or requiring some action as a result of the information. [00:21:18] Speaker 00: And that's the difference, in your view, I assume, between claim nine and the other claim two. [00:21:22] Speaker 03: Absolutely. [00:21:23] Speaker 03: And at least on the board's, again, what we think is an erroneous construction of claim nine. [00:21:27] Speaker 03: And when you look at COW, that's what this is. [00:21:28] Speaker 00: So going back to claim nine just briefly, I know you want to respond to the other thing. [00:21:31] Speaker 00: So your view of claim nine is, so let's assume there is a functional relationship. [00:21:36] Speaker 00: And we're not talking about excluding that. [00:21:38] Speaker 00: But your argument would be, nonetheless, it's obvious. [00:21:41] Speaker 03: Yes, both the information and the discontinuance as a result of that information. [00:21:45] Speaker 03: But turning to the other claims, we think that causal relationship between the physical steps and the information is what's lacking from the claims. [00:21:53] Speaker 03: We were talking about this in respect to Mao. [00:21:55] Speaker 03: Mao says you can't take a law of nature and patent the claims that simply say apply the law of nature. [00:22:01] Speaker 03: This is frankly a claim that says tell someone about a law of nature and keep on doing what you were doing anyway without it actually affecting you. [00:22:09] Speaker 03: So when you look at the cow case, that's another case where [00:22:14] Speaker 03: The claims required providing information and providing a therapeutically effective amount of an oral release dosage form, in that case of oxymorphone. [00:22:25] Speaker 03: And the patent owner there made arguments that were remarkably similar to Malamvrat's empirical arguments here. [00:22:31] Speaker 03: They said, well, look, in practice, having that information changes what the therapeutically amount of the dose is. [00:22:38] Speaker 03: And therefore, you can come up with some sort of functional relationship, even though there's not really one in the claims. [00:22:43] Speaker 03: And this court rejected it. [00:22:44] Speaker 03: actually emphasized in the opinion was nothing in the claims requires that the dosage be adjusted in response to the providing of information. [00:22:54] Speaker 03: So Malincourt hasn't claimed any sort of change in what the physician does. [00:22:59] Speaker 00: So help us out a little because our cases and even one of our cases may be King where the case initially went down by the district court on a one-on-one analysis. [00:23:07] Speaker 00: Our court changed the analysis. [00:23:10] Speaker 00: I think it was King. [00:23:11] Speaker 00: and went into an obvious analysis. [00:23:13] Speaker 00: And obviously, Judge Lurie and I agree with him. [00:23:15] Speaker 00: There's a feel of a 101 here and a Mayo claim with respect to information. [00:23:20] Speaker 00: So how would you recommend that we resolve this on the traditional printed matter functional relationship? [00:23:27] Speaker 00: Or necessarily, because of Mayo and recent Supreme Court cases, we should add in a mental step analysis? [00:23:35] Speaker 03: Well, I think you should resolve it as a form of printed matter. [00:23:37] Speaker 03: And it's well within the printed matter doctrine. [00:23:41] Speaker 03: that steps under DeStefano, which claim the content of information, are not given patentable weight, can't be used to distinguish claims from the prior audit, unless that information, whether it's provided, evaluated, received, considered, is functionally related, has some physical effect on one of the active physical steps of the patent. [00:24:07] Speaker 03: And in that regard, let me actually turn [00:24:10] Speaker 03: my friend's discussion of pharmaceutically acceptable, because Judge Laurie, we agree wholeheartedly with the construction that you suggested, which is what we think the board construed it as. [00:24:20] Speaker 03: Now, obviously we don't believe pharmaceutically acceptable is limiting at all, but if it's going to be limiting, the board construed it the right way, which is simply a physically safe, physically non-toxic substance. [00:24:31] Speaker 00: Well, is that the, I mean, your friend is making it first, in the first instance, a procedural argument, a process argument with respect to [00:24:38] Speaker 00: they're not having had the opportunity to respond. [00:24:41] Speaker 00: So you weren't proposing the construction that the board ultimately adopted, were you? [00:24:46] Speaker 03: We didn't propose that construction. [00:24:47] Speaker 03: What we have done is consistently opposed the limitation that Malinckrodt seeks to impose through pharmaceutically acceptable. [00:24:55] Speaker 03: And when they say pharmaceutically acceptable must be safe, what they don't mean is physically safe. [00:25:00] Speaker 03: What they don't mean is nontoxic. [00:25:02] Speaker 03: You'll see this on page 3962 of the appendix. [00:25:05] Speaker 03: They agree that [00:25:07] Speaker 03: Pharmaceutically acceptable, the actual content of the cylinder never changes. [00:25:11] Speaker 03: So pharmaceutically acceptable has nothing to do with physically what the inhaled nitric oxide is. [00:25:16] Speaker 03: Instead, Mr. Shuler was asked on page 3975 by the board, I'm trying to figure out how pharmaceutically acceptable makes your canister different than any other canister that's out there. [00:25:26] Speaker 03: And what he answered was, it's the information that goes with it. [00:25:30] Speaker 03: So what Mallenkraut's been saying is, pharmaceutically acceptable doesn't mean physically safe. [00:25:34] Speaker 03: It means safe. [00:25:35] Speaker 03: because you are given information that allows it to be used safely. [00:25:39] Speaker 03: Prexer has consistently opposed that, primarily by arguing that the preamble is not limiting. [00:25:48] Speaker 03: And critically here, this is not a situation in which the board adopted a construction, a pharmaceutical acceptable, in its institution decision, and then, without notice, the parties changed that construction in its final written decision or at the hearing. [00:26:04] Speaker 03: what we think happened with respect to Clayton Heine, where both parties agreed with the construction and the institution decision. [00:26:11] Speaker 03: And then at the hearing, the board proposed a new construction without notice. [00:26:16] Speaker 03: There was no construction of pharmaceutically acceptable in the institution decision. [00:26:19] Speaker 03: Malinprot briefed its arguments about the meaning of pharmaceutically acceptable at length in its patent owner's response. [00:26:26] Speaker 03: Malinprot knew going into the hearing that the correctness of this construction and the limitations imposed by pharmaceutically acceptable were in dispute. [00:26:34] Speaker 03: The board considered those arguments and simply found them wanting. [00:26:37] Speaker 03: In that regard, we do think this is perhaps most similar to the intellectual ventures to versus Erickson case. [00:26:43] Speaker 03: This court's May 17th, or sorry, May 8th decision from 2017. [00:26:47] Speaker 03: So we don't see any procedural issues here with the construction of pharmaceutically acceptable. [00:26:52] Speaker 03: But let's assume Malancrot's right. [00:26:54] Speaker 03: If you accept Malancrot's construction of pharmaceutically acceptable, it still doesn't create the sort of functional relationship between the informational steps [00:27:02] Speaker 03: and the active steps of the claims, Malincrot's construction simply transforms pharmaceutical acceptable itself into a printed matter limitation. [00:27:11] Speaker 03: Because under Malincrot's construction, pharmaceutical acceptable is claiming the content of information. [00:27:16] Speaker 03: It's pharmaceutical acceptable depending on whether or not there's particular information that goes along with the inhaled nitric oxide. [00:27:23] Speaker 03: So with claim one, for example, Malincrot would then need to show a functional relationship between the pharmaceutical acceptable nitric oxide [00:27:31] Speaker 03: and the physical steps of obtaining and supplying nitric oxide. [00:27:35] Speaker 03: And Mallinprod hasn't attempted to make that link. [00:27:37] Speaker 03: So in our view, however you end up ensuring pharmaceutical acceptable, if you accept the board's view, it's not a printed matter limitation. [00:27:44] Speaker 03: It's a physical limitation. [00:27:46] Speaker 03: But there's no functional relationship between that physical limitation and the informational steps. [00:27:51] Speaker 03: If you accept Mallinprod's construction, well, printed matter becomes an informational step. [00:27:55] Speaker 03: And there's no functional relationship between that informational step and the physical steps of obtaining and supplying [00:28:01] Speaker 00: Although the board obviously never had to reach that analysis because they construed it differently, right? [00:28:07] Speaker 03: No, Your Honor, I didn't need to go down that route. [00:28:09] Speaker 03: Unless the panel has further questions, I think I've made the points I'd like to make. [00:28:12] Speaker 03: Thank you. [00:28:13] Speaker 04: Thank you. [00:28:26] Speaker 04: Briefly, I think that there was some suggestion that we had not argued [00:28:30] Speaker 04: the sufficient to cause language. [00:28:32] Speaker 04: That's a page 38 of our brief appeal. [00:28:35] Speaker 04: I think it's clear what the plain language of the claim means. [00:28:41] Speaker 04: The council made a point about not transforming the canister or the cylinder of gas, and I think that's a misguided point. [00:28:48] Speaker 04: This was not a product claim. [00:28:49] Speaker 04: The printed matter doesn't have to transform the product. [00:28:52] Speaker 04: It's a method claim. [00:28:53] Speaker 04: And so the question is whether [00:28:55] Speaker 04: the information, the printed matter, transforms the known method of supplying the gas. [00:28:59] Speaker 04: And we know that it did. [00:29:01] Speaker 04: Because prior to the transformation, the printed matter being given to the physicians in the study, they were indiscriminately giving the drug to patients whether or not they had left ventricular dysfunction. [00:29:12] Speaker 04: There were a series of adverse events that were substantially higher than expected. [00:29:17] Speaker 04: The printed matter went with the gas, with the revision, supplied the gas to the same physicians, [00:29:23] Speaker 04: with the printed matter that said, don't give it to people with LBD. [00:29:26] Speaker 04: And there was a substantial reduction in the number of severe adverse events. [00:29:31] Speaker 04: That is an empirical and functional relationship between the printed matter and the supply of the gas. [00:29:38] Speaker 04: The same gas, but the information changed how the physicians acted, and it changed the safety profile of the drug. [00:29:46] Speaker 04: And that is the paradigmatic example of a functional relationship. [00:29:50] Speaker 00: Thank you. [00:29:50] Speaker 00: We thank both sides and the case is submitted.