[00:00:01] Speaker 03: May it please the court Long ideas though a long ideas I'd like to address three issues today. [00:00:22] Speaker 03: The first two are claim construction issues review review de novo and [00:00:26] Speaker 03: And the third is a manifest failure by the board to assess a critical argument with respect to the feasibility of a proposed combination. [00:00:36] Speaker 03: I'd like to begin by addressing the claim limitation that's been identified as one i in the record, trigger a second alarm. [00:00:43] Speaker 01: Let me ask you a preliminary question. [00:00:46] Speaker 01: Is it your position that if the court agrees with the board's claim construction, [00:00:55] Speaker 01: of based on and predetermined that Bach does render the claims at issue obvious? [00:01:01] Speaker 03: There is also an issue of second alarm threshold, which is whether what Bach identified, sorry, what the board identified as the second alarm threshold in Bach, whether that is in fact a second alarm threshold. [00:01:18] Speaker 03: And that's exactly where I'd like to start, which is that the limitation is triggering a second alarm threshold based on exceeding a second alarm threshold. [00:01:34] Speaker 03: And if the court agrees with Massimo's proposed construction, the board made it clear at appendix page 17 that there would be no need for remand. [00:01:47] Speaker 03: The court could simply reverse because the board held patent owner's construction would differentiate claim one from buy. [00:01:54] Speaker 03: And that's why I'd like to start there. [00:01:58] Speaker 03: The board failed by failing to apply Phillips. [00:02:02] Speaker 03: And that the board conceded that Massimil was correct that the 218 patent does not disclose any embodiment in which the measured oxygen values exceed an additional and more extreme or lower alarm threshold than the alarm threshold AT, the adaptive threshold, to trigger an alarm. [00:02:27] Speaker 02: Let's just start with the first question on this term based on [00:02:32] Speaker 02: Are you reading based on to be based exclusively on or based only on? [00:02:39] Speaker 02: No, we are not. [00:02:40] Speaker 02: Okay, so that opens up limitation 1i to include other possible conditions that also must be met in order to trigger the alarm. [00:02:52] Speaker 03: That's correct. [00:02:53] Speaker 03: For example, in, I believe, the claim five. [00:02:55] Speaker 03: Right. [00:02:56] Speaker 03: The time delay. [00:02:57] Speaker 03: The time delay. [00:02:57] Speaker 03: Exactly. [00:02:58] Speaker 03: And that is consistent with the plain meaning of based on, which is that you could have it based on different criteria. [00:03:08] Speaker 03: A, B, C. But if it is based on exceeding a threshold, A, [00:03:14] Speaker 03: then it can't also be based on exceeding some other threshold, A' because then it's based on exceeding A'. [00:03:24] Speaker 03: And when the limitation is read together, [00:03:28] Speaker 03: triggering an alarm based on exceeding a second alarm threshold, that the specification makes clear that that's referring to the most extreme value. [00:03:41] Speaker 03: And the board conceded that every single time in the specification that there is a reference. [00:03:47] Speaker 02: What if we don't know that? [00:03:49] Speaker 02: What if we don't necessarily know from reading the patent that it has to be the most extreme value? [00:03:54] Speaker 02: And when we look at the prior art reference, [00:03:58] Speaker 02: we see that, OK, you have to exceed threshold 314 first in order to create limit 316. [00:04:09] Speaker 02: 316 doesn't exist until you meet and exceed threshold 314. [00:04:17] Speaker 02: And so in that way, 314 is [00:04:23] Speaker 02: the necessary condition before you're going to trigger that alarm, which only gets met after you meet condition 316. [00:04:30] Speaker 02: So why isn't that just a reasonable way of matching up what just happens to be happening in this prior art reference to understanding this claim limitation one eye, which we agree on that can be open to other conditions beyond the second alarm threshold being met? [00:04:53] Speaker 03: And that's exactly where I believe the board got hung up, which is the board construed it as a condition precedent, simply something that needs to happen before. [00:05:00] Speaker 03: And that's not what the limitation says. [00:05:02] Speaker 03: It's not the plain meaning of triggering an alarm based on exceeding a second alarm threshold. [00:05:08] Speaker 03: That doesn't mean just something that happens has to happen before. [00:05:12] Speaker 03: There has to be a causal connection. [00:05:14] Speaker 03: And in particular, it has to be exceeding that threshold. [00:05:18] Speaker 01: What's your source for this plain meaning? [00:05:23] Speaker 01: You're describing to us plain meaning. [00:05:26] Speaker 01: On what basis? [00:05:27] Speaker 03: So in the record, there was both a dictionary citation of base on as well as dictionary definitions of threshold. [00:05:36] Speaker 03: Although I think the far more important consideration is how the term was used in the patent. [00:05:43] Speaker 03: and that that's the basis of Phillips and claim construction, is how these terms would be read in the context of the patent. [00:05:51] Speaker 03: And the patent uses the term threshold, or alarm threshold, 40 times. [00:05:57] Speaker 03: And every single time in the specification, or maybe it's 39, it's approximately. [00:06:02] Speaker 03: And every single time, as the board conceded and as SOTERA conceded, [00:06:07] Speaker 03: it is referring to the most extreme value that needs to be exceeded in order to trigger the alarm. [00:06:15] Speaker 03: And you could also have a delay where it has to exceed that value for a certain period of time. [00:06:21] Speaker 03: But there is nothing disclosed in this specification where you have to exceed [00:06:27] Speaker 03: a threshold value, and then some more extreme threshold value. [00:06:30] Speaker 03: And so really, with the most important question being, how is this phrase used, how is this term used in the patent specification, there is no doubt about how it's used in the patent specification. [00:06:42] Speaker 02: But there's nothing lexicographic in the specification that says, when we say the term second alarm threshold, we mean the most extreme value that can be met in order to trigger the alarm. [00:06:57] Speaker 03: There is nothing that explicit. [00:06:58] Speaker 03: That is correct. [00:06:59] Speaker 03: So are there embodiments that are read out on your construction? [00:07:03] Speaker 03: No. [00:07:04] Speaker 03: No, every single embodiment, and the board specifically noted that, that the patent does not disclose any embodiment. [00:07:13] Speaker 03: Can you give me a page employee? [00:07:14] Speaker 03: Yes, that's appendix 25. [00:07:19] Speaker 03: And the board further conceded that the same is true of the fixed alarm thresholds D sub L and N D sub L of the prior art system illustrated in Figure 1 of the 218 patent, same citation, Appendix 25. [00:07:35] Speaker 03: So the board recognized that if one looks at the patent, this term, alarm threshold, is only used in one way. [00:07:43] Speaker 03: And it's used consistently and repeatedly in that one way when referring to the prior art [00:07:48] Speaker 03: and to the claimed invention. [00:07:50] Speaker 03: And Sotero further conceded that, and that's in their brief at page 28, and the quote is, the patent specification does not disclose an embodiment wherein the processor must determine that the measured SPO2 value exceeds an additional and more extreme threshold. [00:08:07] Speaker 03: And so, Your Honor, identify the issue correctly, but the positions are the reverse, which is that there is no embodiment or description of the prior art under Sotera and the board's proposed construction, whereas everything is consistent with Massimo's proposed construction. [00:08:24] Speaker 03: In addition, simply, there's only one place where the term based on appears in the specification. [00:08:32] Speaker 03: It's in the abstract. [00:08:34] Speaker 03: And if the court were to look at that, it further supports the argument, which is that it is used in the abstract to describe the first [00:08:47] Speaker 03: the first threshold, the first alarm threshold, and it highlights an important point which is that even there it's based on exceeding a first alarm threshold and it's tied to triggering a first alarm. [00:09:01] Speaker 03: And that makes sense because in every case the alarm threshold is tied to [00:09:07] Speaker 03: that specific alarm. [00:09:10] Speaker 03: And if it was simply a condition precedent, then triggering the second alarm would also be based on, for example, exceeding the first threshold, because that's simply something that has to happen first. [00:09:25] Speaker 03: The second claim construction issue, unless the Court has additional questions about that. [00:09:32] Speaker 03: The second claim construction issue I would like to address is predetermined. [00:09:37] Speaker 03: And sorry, before I do that, just to be clear, that first claim construction issue, in addition to not needing to be remanded, it addresses all the claims, because it addresses the Bach reference, which is part of ground one and ground two. [00:09:49] Speaker 03: So if the court agrees, with our construction, there would be a reversal as well. [00:09:54] Speaker 03: All claims, all grounds. [00:09:57] Speaker 03: The predetermined term [00:09:58] Speaker 03: is with respect to claims 7, 9, and 18. [00:10:03] Speaker 03: Again, the board erred in how it construed this term. [00:10:08] Speaker 03: Within the claim itself, element 1D uses the word determine to refer to a value. [00:10:18] Speaker 03: And I perhaps should back up, as you may recall, [00:10:22] Speaker 03: The disagreement is, does predetermined mean that value must be predetermined or that a formula for arriving at the value needs to be predetermined? [00:10:34] Speaker 03: What they call calculation. [00:10:35] Speaker 03: Calculation, yes, exactly. [00:10:38] Speaker 03: And if you look at how it's used in the claims, element 1D says, determine oxygen saturation values. [00:10:47] Speaker 03: So there we have the affirmative determine tied to values. [00:10:51] Speaker 03: Then we have claims 4 and 15, which use the word predetermined in describing the lower limit. [00:10:58] Speaker 03: That's the one that automatically assesses triggers and alarm. [00:11:02] Speaker 03: And those claims recite [00:11:04] Speaker 03: where the lower limit is predetermined. [00:11:07] Speaker 02: Could you address the board's reasoning? [00:11:09] Speaker 02: I mean, that's the thing I'm most interested in. [00:11:11] Speaker 02: OK. [00:11:11] Speaker 02: I understand the board's reasoning. [00:11:13] Speaker 02: They said, what's going on here is an adaptive threshold. [00:11:16] Speaker 02: We know from claim one that in order to get the second alarm threshold, you're replacing the first alarm threshold. [00:11:26] Speaker 02: And so at any given time, there's just one alarm threshold that is varying due to this adaptive threshold. [00:11:34] Speaker 02: I don't recall you responding to this. [00:11:40] Speaker 02: But assuming that's right, that there's an adaptive threshold in the claim, then what we're dealing with is some kind of dynamic threshold, not some preset fixed set of thresholds, which is, as I understand it, your argument. [00:11:56] Speaker 02: We know what your arguments are. [00:11:58] Speaker 02: Can you respond to the board's reasoning? [00:12:00] Speaker 02: Certainly. [00:12:01] Speaker 03: The board was simply confusing the first alarm threshold and the second alarm threshold in that the patent discloses different embodiments. [00:12:10] Speaker 03: In all of them, the second alarm threshold, or at least what's claimed the adaptive threshold, AT, is always a variable or adaptive threshold. [00:12:20] Speaker 03: But the first alarm threshold can either be variable or fixed. [00:12:26] Speaker 03: And the limitations in claims seven, nine, and 18 are referring to the embodiments where the first alarm threshold is fixed, predetermined before, and then the second alarm threshold is what varies. [00:12:44] Speaker 03: Or there could be embodiments where both are variable. [00:12:48] Speaker 03: And in the independent claims, claim one, [00:12:51] Speaker 03: it covers where the first alarm threshold is variable or fixed. [00:12:56] Speaker 03: And then in the dependent claims 7, 9, and 18, that's where the first alarm threshold is fixed and the second alarm threshold is variable or adaptive. [00:13:05] Speaker 02: And so the board simply got that wrong. [00:13:07] Speaker 02: How do we know that is what I'm trying to understand? [00:13:10] Speaker 02: Why isn't claim 7 in predetermined language open to the idea [00:13:16] Speaker 02: that the first alarm threshold, like the second alarm threshold, is open to being a variable threshold? [00:13:23] Speaker 03: Well, both from how it's used in the other claims, which is that in claims 4 and 15, the exact same word predetermined is used with regard to the lower limit, the absolute failsafe. [00:13:34] Speaker 03: And it specifically says the lower limit is predetermined. [00:13:38] Speaker 03: And so Tara concedes that. [00:13:40] Speaker 03: And so we have a situation where there's no doubt how the claims use determine. [00:13:44] Speaker 03: There's no doubt how the claims use predetermined, at least in some of the claims. [00:13:48] Speaker 03: And this assessment that somehow, but in other claims when it uses predetermined, it somehow meant something else. [00:13:54] Speaker 03: And there's a pretty strong presumption that claim terms mean the same thing, and throughout the claims. [00:14:00] Speaker 03: And there's no reason to give predetermined a different meaning in 7, 9, and 18. [00:14:08] Speaker 03: You're into your rebuttals. [00:14:09] Speaker 03: Yes, I realize that. [00:14:11] Speaker 03: I do want to save a minute. [00:14:13] Speaker 03: And so simply the final point was that there was, with regard to the ground two combination of adding Whirly to Bach, [00:14:23] Speaker 03: They made it very clear that they had changed their argument to not adding Whirly to Bach, but to removing Bach's 316, which is the alarm limit, and then introducing Whirly's delay. [00:14:35] Speaker 03: And when you do that, there is nothing in Bach to trigger an alarm. [00:14:40] Speaker 03: And therefore, the embodiment would be completely inoperative, and neither the board nor Sir Tara has ever explained how that would possibly work. [00:14:56] Speaker 00: Hello again, Your Honors. [00:14:57] Speaker 00: I'm going to limit my introductory comments to the two issues that you talked about in oral argument here, the claim constructions. [00:15:05] Speaker 00: I'm happy to answer any questions about the combination of Worley and Bach, of course. [00:15:11] Speaker 00: The triggering based on language [00:15:15] Speaker 00: At times, Massimo complains about how the board handled Based On, but they admit that Based On is open to other conditions. [00:15:23] Speaker 00: They admit that Claim 5 contemplates another condition, which is a time delay. [00:15:29] Speaker 00: So Claim 1 is open-ended. [00:15:31] Speaker 00: They concede that. [00:15:33] Speaker 00: This Court's precedent on negative limitations is exacting. [00:15:36] Speaker 00: They have to be their own lexicographer. [00:15:37] Speaker 00: There has to be a clear disavowal. [00:15:39] Speaker 00: None of that exists. [00:15:41] Speaker 00: What they're trying to do is add a negative limitation in. [00:15:43] Speaker 00: And I don't blame them. [00:15:44] Speaker 00: They're trying to add a negative limitation in. [00:15:46] Speaker 00: It carves around Bach, but leaves claim one open to any other condition under the sun other than Bach. [00:15:52] Speaker 00: And this court's precedent doesn't allow that. [00:15:54] Speaker 00: When we turn to the predetermined issue. [00:15:58] Speaker 02: I guess their argument, though, is that when the claim says second alarm threshold, that's the limit. [00:16:06] Speaker 02: That is the measured value that's [00:16:09] Speaker 02: going to trigger the alarm. [00:16:10] Speaker 02: And of course, you can add other conditions. [00:16:13] Speaker 02: But they've already defined in the claim itself what is the measured value that's going to be the triggering event or participate in the triggering event. [00:16:25] Speaker 02: And so it would be illogical to start creating other secret thresholds beyond the recited second alarm threshold. [00:16:37] Speaker 02: Instead of it being a negative limitation, it's more like a self-defining limitation as to what in terms of what is the criteria for a given parameter measurement before you trigger the alarm. [00:16:52] Speaker 02: So that's what we have to think through and correct your input on that. [00:16:57] Speaker 00: The starting point for any claim construction analysis would be the claim language, and the claim language doesn't carve out that exception. [00:17:04] Speaker 00: When you look to the specification, the specification contemplates other conditions, such as a time delay. [00:17:10] Speaker 00: Our expert Bergeron expressly testified, as adopted by the board, that they keep calling it more extreme threshold than Bach, that 316 alarm limit. [00:17:21] Speaker 00: It's a nuisance value eliminator. [00:17:25] Speaker 00: InBOK, when you cross 314, it triggers, right? [00:17:30] Speaker 00: I mean, it sets the alarm limit 316. [00:17:33] Speaker 00: So the processor is analyzing. [00:17:35] Speaker 00: Has the patient data fallen below 314? [00:17:38] Speaker 00: When it drops below 314, as Bergeron testified, and Yannuis as well, it's an effective time delay because it's going to give it a little more room to drop. [00:17:47] Speaker 00: If the transient drops too far, it sounds an alarm. [00:17:49] Speaker 00: If it doesn't, it gives it time. [00:17:51] Speaker 00: So here's 314. [00:17:52] Speaker 00: 316 decays to zero, and all it does is give, just like Whirly, just like 218, it gives the transient signal time to go back above 314 to eliminate nuisance value alarms. [00:18:05] Speaker 00: So Whirly shows one time, you know, time, nuisance value limit or time delay. [00:18:12] Speaker 00: 218 shows that. [00:18:14] Speaker 00: Bach shows it just in a different way. [00:18:16] Speaker 00: So the condition that Bach has is just 316 to case to zero. [00:18:21] Speaker 00: So it's just another condition that the language of claim one allows for. [00:18:26] Speaker 00: Does that answer the question? [00:18:29] Speaker 02: I understand your answer. [00:18:31] Speaker 00: OK, well, I know it means you don't agree with me, but I mean, it's I didn't say that either. [00:18:36] Speaker 00: All right. [00:18:37] Speaker 00: Fair enough. [00:18:38] Speaker 00: I'm hoping you agree with me. [00:18:39] Speaker 00: But yes. [00:18:40] Speaker 00: So and I'm happy to answer more questions on this or I was in my intro and I could go back to predetermined. [00:18:48] Speaker 00: Just go back. [00:18:50] Speaker 00: Go back to predetermined. [00:18:51] Speaker 00: So on predetermined, the board found below that the thresholds in claim one are adaptive thresholds. [00:19:00] Speaker 00: That was not disputed below that the thresholds are adaptive. [00:19:06] Speaker 00: Massimo, I think, disputes it on appeal, but they did not raise that argument below. [00:19:11] Speaker 00: We cite it to the spec. [00:19:12] Speaker 00: It's column four. [00:19:14] Speaker 00: It's like lines 30 to 50. [00:19:18] Speaker 00: What the 218 patent explains is that you have the prior art, level one and level two. [00:19:25] Speaker 00: Those were fixed thresholds in the prior art. [00:19:30] Speaker 00: In the 218 patent, [00:19:32] Speaker 00: all the thresholds in the claim are adaptive. [00:19:35] Speaker 00: And they model off of L1 and L2, the prior art. [00:19:39] Speaker 00: So if you read the spec at column four, it says that L1. [00:19:42] Speaker 02: Is there anything in the spec that shows an example where the first one threshold is not adaptive, but it's fixed? [00:19:50] Speaker 00: No, there is none. [00:19:51] Speaker 00: Not to our knowledge. [00:19:52] Speaker 02: There's none that has a set value? [00:19:55] Speaker 00: Not to our knowledge, no. [00:19:57] Speaker 00: I mean, the whole point of the patent, they criticize fixed thresholds. [00:20:00] Speaker 00: They say that fixed thresholds don't account for baseline drift. [00:20:05] Speaker 02: So if a normal patient... Their invention and Bach's invention was adaptive thresholds. [00:20:08] Speaker 00: They both are. [00:20:09] Speaker 00: 218 and Bach are both adaptive thresholds. [00:20:12] Speaker 00: And it accounts for... [00:20:13] Speaker 00: of just a physiological phenomenon in patients, right? [00:20:17] Speaker 00: I mean, if I have a normal patient has an SPO2 value of 98, but somebody else has one at 96, when they drop, you're going to be ringing alarms when they shouldn't be. [00:20:27] Speaker 00: So what both 218 and Bach account for is baseline drift. [00:20:32] Speaker 00: And so they measure the patient's actual value. [00:20:35] Speaker 00: That's the baseline. [00:20:37] Speaker 00: And then they drop the threshold lower to account for that. [00:20:41] Speaker 00: But the closer that that patient's data gets to the lower limit, where it's dangerous, we keep decreasing that adaptive threshold. [00:20:49] Speaker 00: So the threshold in the way you know in the claim language that it covers it is that the second adaptive threshold replaces the first. [00:20:57] Speaker 00: That's the exact language of claim one. [00:20:59] Speaker 00: And as I said below, [00:21:01] Speaker 00: the the uh... the board found that claim one only covers adaptive thresholds threshold one and threshold two uh... and the first replaces the second that's the claim language if you look at and we cited in our briefs it's in column four it says specifically that in the case of adaptive thresholds you can't use a fixed value turning to an argument that i found interesting claims four ten and fifteen [00:21:27] Speaker 00: refer to a predetermined value for the lower limit. [00:21:31] Speaker 00: The lower limit is, you got a serious problem. [00:21:34] Speaker 00: If you drop below that, there's no delay, you're sounding an alarm. [00:21:39] Speaker 00: In those claims, it says predetermined, and it's a value. [00:21:44] Speaker 00: So when Massimo used claim language in 4, 10, and 15, and they wanted to say predetermined meant value, those claims say value. [00:21:52] Speaker 00: When you look at 7, 9, and 18, it says predetermined. [00:21:55] Speaker 00: It doesn't use value. [00:21:56] Speaker 00: And when you tie that into the spec, the spec says for adaptive thresholds, you cannot use a fixed value. [00:22:02] Speaker 00: It would, of course, defeat the whole point of the invention. [00:22:08] Speaker 00: I don't have anything else unless you do. [00:22:10] Speaker 01: Thank you. [00:22:11] Speaker 01: Thank you your honor sir. [00:22:25] Speaker 03: Council mentioned that when in Bach it exceeds 314, it triggers. [00:22:32] Speaker 03: What he omitted was what is triggered. [00:22:34] Speaker 03: And what both Zotera and the board recognized is that to the extent it triggers anything, it triggers the creation or establishment of lower limit 316. [00:22:44] Speaker 03: It does not trigger an alarm. [00:22:46] Speaker 03: And that's why, when the limitation is read together and construed correctly, the board recognized, if construed that way, it's distinguished from Bach. [00:22:59] Speaker 03: With regard to the argument that Bach discloses an effective time delay, it's really the same thing. [00:23:04] Speaker 03: If that were true, Zotero would not have tried to make a three-way combination and add Whirly. [00:23:10] Speaker 03: They would have just tried to rely on [00:23:12] Speaker 03: the time delay in Bach, there is no time delay in Bach. [00:23:15] Speaker 03: And we know that because it's undisputed that if the level drops a little bit below 314 and then stays there for a really long time, even an infinite amount of time, no alarm is ever triggered. [00:23:28] Speaker 03: It's not a time delay. [00:23:29] Speaker 03: It's requiring a more extreme value. [00:23:34] Speaker 03: Council mentioned that [00:23:36] Speaker 03: The second adaptive threshold replaces the first is the claim language. [00:23:41] Speaker 03: That's not. [00:23:41] Speaker 03: I think it was corrected later. [00:23:43] Speaker 03: But I just want to make sure there's no reference in the claims to the first alarm threshold being an adaptive threshold. [00:23:52] Speaker 03: The claim language is alarm threshold. [00:23:55] Speaker 03: And that consistently ties the value being exceeded to the alarm being triggered. [00:24:01] Speaker 02: Are you saying that claim one doesn't encompass an adaptive threshold? [00:24:05] Speaker 03: No, claim one does encompass. [00:24:08] Speaker 03: Claim one, particularly for the first threshold, it can be either fixed or variable, whereas the second one is variable. [00:24:17] Speaker 03: And then finally, the statement characterizing claims for, et cetera, I believe was also incorrect. [00:24:23] Speaker 03: There's two limitations there. [00:24:24] Speaker 03: The first one is wherein the lower limit is predetermined and corresponds to a minimum parameter value for oxygen saturation. [00:24:33] Speaker 03: So I believe the argument was correct, that in each case, predetermined should be used at the same. [00:24:39] Speaker 03: Thank you. [00:24:40] Speaker 03: And thank both sides. [00:24:41] Speaker 03: The case is submitted.