[00:00:53] Speaker 00: Okay. [00:00:54] Speaker 00: The next argued case is number 14, 1613, Ivera Medical Corporation against Husper Incorporated. [00:01:02] Speaker 00: Mr. Gross. [00:01:03] Speaker 03: Thank you, your honor. [00:01:04] Speaker 03: And may it please the court. [00:01:08] Speaker 03: Obviousness is a question of law, but it depends on underlying facts. [00:01:14] Speaker 03: And here, the record shows there are material factual disputes that precluded summary judgment. [00:01:21] Speaker 03: What we're asking this court to do [00:01:23] Speaker 03: is allow us to go to trial and have a jury decide the underlying facts, which is what should occur in an obviousness case when there's underlying factual review. [00:01:31] Speaker 04: Did the district court rely on the two declarations to deny summary judgment? [00:01:36] Speaker 03: The district court mentioned two declarations. [00:01:39] Speaker 03: It was interesting because the court said they were presented in a conclusory fashion. [00:01:44] Speaker 03: I believe what the district court was getting at, Your Honor, was that the briefing was very short, not that the declarations themselves were conclusory. [00:01:50] Speaker 03: The declarations actually have a fair amount of detail. [00:01:53] Speaker 03: So the district court was aware of two declarations. [00:01:55] Speaker 03: We put declarations in the record, Your Honor, but there wasn't a lot of... Was there any objection to the declarations? [00:02:00] Speaker 03: No, Your Honor. [00:02:01] Speaker 03: To the admissibility or anything like that? [00:02:04] Speaker 03: Not that I'm aware of. [00:02:05] Speaker 03: I don't think we're in a situation where there was sometimes in summary judgment, there's admissibility objections that the court rules on. [00:02:10] Speaker 03: But here the court did not throw those out on any admissibility issues. [00:02:15] Speaker 03: So they're in the record and they were before the court. [00:02:18] Speaker 03: And in fact, that raises the first material issue of fact [00:02:22] Speaker 03: which is KSR and the TriMED decision of the Federal Circuit make clear that when we're talking about whether there's an apparent reason to combine, two of the core fact questions are the following. [00:02:33] Speaker 03: Whether there's a trend in the relevant design community at the time of invention is a fact issue, and that's for the fact finder. [00:02:40] Speaker 03: Is there a trend in the relevant design community? [00:02:43] Speaker 03: Another one is what's the background knowledge of one of skill in the art? [00:02:45] Speaker 03: What's going on at the time? [00:02:47] Speaker 03: And here we have four declarants. [00:02:50] Speaker 03: four declarants presented to the district court that said the trend in the relevant design community was going away, away from venting of a disinfectant cap. [00:03:01] Speaker 03: That was the trend. [00:03:04] Speaker 02: I don't remember all of the details. [00:03:05] Speaker 02: I thought that some, at least, put aside, I guess, Mr. Huang, is that how one says it, his declaration for a minute, that the other ones [00:03:18] Speaker 02: pretty clearly about something different, not about cats, but about keeping a tight liquid seal on essentially fluid ducts. [00:03:30] Speaker 02: And that's not this. [00:03:32] Speaker 03: Your Honor, before the district court, and we talked in the oral argument for summary judgment at A1062, we made that point that the court is bringing up right now. [00:03:40] Speaker 03: We said, the testimony of the experts is that a person skilled in the art didn't want to vent at the time. [00:03:45] Speaker 03: That's what Lansing says. [00:03:46] Speaker 03: Buckman says, Morrison says, and Huang said. [00:03:50] Speaker 03: At least one of those was an actual disinfecting cap, Your Honor. [00:03:54] Speaker 03: The other one was art that was being considered. [00:03:55] Speaker 02: That's Huang. [00:03:56] Speaker 02: Yeah. [00:03:57] Speaker 02: And the other one was art that was being... And you say he just has sort of one sentence, right, that declares that. [00:04:03] Speaker 02: Is that right? [00:04:03] Speaker 03: Well, he says it was his understanding at the time of the invention that person of ordinary skill in the art wanted a fluid-tight seal. [00:04:09] Speaker 03: Mr. Linsing then raises that with the medical instruments that attach to people generally. [00:04:14] Speaker 03: And then we look at prior art references like Mr. Buckman, and Mr. Buckman says something similar. [00:04:19] Speaker 03: When you put it all together, Your Honor, and you... Well, the question... Go ahead, Your Honor. [00:04:24] Speaker 02: You know this prior art better than I, so my impression could be wrong. [00:04:28] Speaker 02: Tell me why this impression is wrong. [00:04:30] Speaker 02: That perhaps nothing but that Huang sentence is actually on point. [00:04:37] Speaker 02: That the other three are about a sufficiently different situation. [00:04:43] Speaker 02: keeping a line in which fluid is going to be flowing, tightly sealed. [00:04:50] Speaker 02: That's not what this is, in which case one can't put it all together. [00:04:56] Speaker 02: One would have to rely on the sufficiency of Mr. Huang's assertion alone. [00:05:04] Speaker 02: So tell me everything that's wrong with what I just described. [00:05:07] Speaker 03: Well, Your Honor, I guess we'd want to stay in the world of apples and apples. [00:05:10] Speaker 03: If we're going to say that the pertinent art is huang, because that's a disinfecting cap that has a sponge in it, and that's the art that we're talking about here, then the question is, how many concentric circles do you want to go away? [00:05:24] Speaker 03: We had four declarants who said, as you go away in concentric circles, you have a situation where the understanding of one of fill in the art with respect to seals is that it should be fluid-tight. [00:05:36] Speaker 03: And the court's question is, [00:05:37] Speaker 03: All right, well, what if we were to narrow the consensual circles down to just disinfecting caps like Hwang? [00:05:43] Speaker 03: Then we would say, understood. [00:05:45] Speaker 03: That's what we do. [00:05:46] Speaker 03: Then we would look to white, and white is a fluid seal, so that's also tight. [00:05:51] Speaker 03: And then the question would be, when we now talk about combining devices, what's the relevancy of chin loy? [00:05:57] Speaker 03: And the question would be none, because chin loy is not a disinfecting cap. [00:06:01] Speaker 03: Chin loy is sending gas into a machine. [00:06:04] Speaker 03: and has nothing to do with the disinfecting cap. [00:06:07] Speaker 03: So the point for the court is, if the court was going to have a narrow definition of what is the relevant art, then the court's point is well taken, Your Honor, that we have Wong and we have Linsing talking generally and other declarants talking more generally, Your Honor, but it would also then be not make any sense to say someone should look for Chin-Wai as a helpful reference. [00:06:30] Speaker 03: And I do want to say, go ahead, Your Honor, I'm sorry. [00:06:33] Speaker 02: Is it contested in the evidence that if somebody wanted to vent a catheter cap, that they would have looked to the combination of Huang and Chin-lui? [00:06:52] Speaker 03: It's absolutely contested in the sort of wall of pertinent art. [00:06:55] Speaker 03: Actually, going back to your court's original question, [00:06:59] Speaker 03: One would not look at chinloy because chinloy is not a medical cap that has a sponge or fluid. [00:07:05] Speaker 03: Chinloy is actually a completely different purpose. [00:07:07] Speaker 03: Chinloy has a torturous pathway where you inject gas inside a machine. [00:07:12] Speaker 03: You don't want to inject fluid inside a medical cap into the catheter. [00:07:16] Speaker 03: That's actually the opposite of what you want to do. [00:07:18] Speaker 03: And so we say, Mr. Lensing, Dr. Lensing, and also Mr. Huang says that's actually would frustrate the purpose to take chinloy. [00:07:25] Speaker 03: And going back to the court's original question, chinloy is [00:07:29] Speaker 03: farther away than Huang or the invention, just like the court's saying, well, where should we be drawing the line? [00:07:35] Speaker 03: Chin-Loi is far away. [00:07:36] Speaker 03: And our point is, if the convention from four witnesses is you don't want venting, you want a fluid-tight seal, understanding we're viewing the evidence in the light most favorable to us, that's where we are, because it's summary judgment, and it's a clear and convincing evidence standard, then the question is, all right, well, what if you have Chin-Loi, and we're saying, [00:07:56] Speaker 03: Chin-Loy, their channel or pathway, they go from the interior of the housing to the exterior of the cap. [00:08:02] Speaker 03: So they're not talking about trying to help out with the pressure buildup inside a cap. [00:08:07] Speaker 03: They have nothing to do with that. [00:08:09] Speaker 03: They're not talking about a fluid and trying to evaporate a fluid because it's a gas. [00:08:12] Speaker 02: Was the problem of pressure in a cap known before your invention? [00:08:21] Speaker 02: Your Honor... And is the pressure that occurs [00:08:26] Speaker 02: during the process of putting the cap on or is there pressure built up even once the cap is on? [00:08:32] Speaker 03: It's pressure putting the cap on creates the pressure and then you have to deal with it. [00:08:36] Speaker 02: So I mean you had, is it Mr. Rogers? [00:08:39] Speaker 02: I think he said something quite like this was a known problem. [00:08:45] Speaker 03: Your Honor, a person of ordinary skill in the art, if you are trying to figure out what was happening, what was happening is people were saying that [00:08:54] Speaker 03: understanding the skill, looking light and more stable than us, is the design community is saying, we want a fluid-tight seal. [00:09:02] Speaker 03: And they're not having success. [00:09:03] Speaker 03: It's been 20 years. [00:09:04] Speaker 03: There hasn't been any major success in the field. [00:09:06] Speaker 03: Our invention comes along and says, fluid-tight seal, no, we're going to have a vent. [00:09:11] Speaker 03: And what happens? [00:09:12] Speaker 03: Extreme success in the marketplace. [00:09:14] Speaker 02: So the question of the- I guess, at least for now, I'd like to keep the so-called objects of indicia separate from [00:09:24] Speaker 02: one sort of motivation to combine piece of logic. [00:09:30] Speaker 02: If it was true that there was a known problem of pressure with caps, and therefore a skilled artisan would have been motivated to look for a way to relieve the pressure using a cap, why isn't there a motivation to vent? [00:09:53] Speaker 03: Sure, thank you, and I'm sorry. [00:09:54] Speaker 03: If we look at whether there was a known problem of pressure in the cap, it's not the case that the prior art is identifying this known pressure, this known problem. [00:10:02] Speaker 03: So we're not looking at prior art and saying, we're not in a situation where the prior art is screaming out, there's this pressure problem. [00:10:07] Speaker 03: What are we going to do about it? [00:10:08] Speaker 03: That's not where we are, Your Honor. [00:10:09] Speaker 03: Where we are as a person of ordinary skill in the art was aware that this hadn't been working for years. [00:10:14] Speaker 03: I don't mean to suggest this is getting, I'm going ahead. [00:10:16] Speaker 03: I'm just saying that's what the situation was. [00:10:18] Speaker 03: So we're not in a situation where the prior art is screaming out, what are we going to do about this pressure buildup? [00:10:23] Speaker 03: Instead, we're in a situation where the invention was fluid-tight seal is now going to have this release of pressure, and it's going to allow this evaporation. [00:10:34] Speaker 03: And that was the inventive concept. [00:10:36] Speaker 03: And so now the court's asking, well, OK, let's say a person of ordinary standard was able to figure out that maybe the problem that it hasn't worked for so long has something to do with pressure buildup. [00:10:46] Speaker 02: And maybe even Mr. Rogers acknowledged that. [00:10:49] Speaker 03: Well, I think we're not, I can take a look at the record exactly, but I'm not comfortable saying Mr. Rogers has said that a person of ordinary skill in the art, specifically as an analyst, pressure buildup, I apologize, Your Honor. [00:11:02] Speaker 03: I'll take a look at that. [00:11:04] Speaker 03: But what I wanted to say, Your Honor, was even to the extent a person of ordinary skill in the art starts thinking about pressure buildup or evaporation, there are other means to address pressure buildup. [00:11:16] Speaker 03: that don't involve eliminating the fluid-type seal. [00:11:20] Speaker 03: And we have that in the record, that you could make the cap bigger on the inside, and that you could also have a certain type of material. [00:11:27] Speaker 03: There are other things you could do. [00:11:28] Speaker 03: And our point was, we want to go to the jury and argue that because chinloy has nothing to do with this art and is not helpful, and because white is a fluid-type seal, so white is not at all helpful, that a person of ordinary skill in the art would have nowhere to look, no answer to find, [00:11:46] Speaker 03: And so that person would do these other options that we have. [00:11:49] Speaker 03: And it's a clear fact dispute that experts should be able to fight over. [00:11:53] Speaker 02: Can I ask you a record question about the objective indicia matter? [00:11:58] Speaker 02: Was there evidence from either side about whether there were ventless caps on the market that were being used or that were tried and failed? [00:12:12] Speaker 02: Because obviously, you're [00:12:15] Speaker 02: product, I gather the evidence is at least clear enough for a tribal issue on the commercial success of the product. [00:12:23] Speaker 02: And the question is, what's it attributable to? [00:12:25] Speaker 02: And it might matter whether it's being compared to no caps versus ventless caps. [00:12:32] Speaker 02: And so I wanted to know what was the state of the record about the state of the world with respect to ventless caps. [00:12:40] Speaker 03: I believe, Your Honor, that there was some evidence in the record that there had been some caps that had not succeeded. [00:12:47] Speaker 03: There's an invention called Minnehay. [00:12:49] Speaker 03: I hope I'm not getting it wrong. [00:12:51] Speaker 03: Minnehay, I think, is the invention. [00:12:52] Speaker 03: I think it's the spelling right. [00:12:54] Speaker 03: But there was some prior art that didn't have the event, and nothing had been commercially successful. [00:13:01] Speaker 03: And, Your Honor, where we are in terms of moving on to, after we get past the fact that [00:13:05] Speaker 03: There's a raging debate about the state of knowledge of a person of ordinary skill in the art, which we've just talked about briefly, where we're saying the state of knowledge of person art was to go against venting in favor of a fluid-type seal, and we afford a clearance on that. [00:13:18] Speaker 03: The next point is there's a raging fight about what does the reference teach, which is a fact issue that should go to the jury, and we disagree with each other about what White teaches and what Chin-Loi teaches, and there's a raging fight about whether the function of Chin-Loi is relevant or not. [00:13:33] Speaker 03: So there's all these raging factual disputes that the district court resolved against us, even though it's summary judgment. [00:13:38] Speaker 03: When you get to secondary factors as a check on hindsight, it's clear that we are in danger of hindsight here, Your Honor. [00:13:45] Speaker 03: And the reason we're in danger of hindsight is that this commercial product that has the venting and has everything else, so the full breadth of the invention, the claimed product has every single feature of the claims, full breadth, went from zero to 300,000 to 10 million, [00:14:03] Speaker 03: to a hundred million in the first few years because it revolutionized how things were done in hospitals. [00:14:07] Speaker 03: Revolutionized. [00:14:08] Speaker 03: And to point your honest question, there's no evidence in the record that there was a successful, you know, very successful product that preceded it. [00:14:15] Speaker 03: It was really one of the cutting edge products. [00:14:17] Speaker 03: Whatever had happened before had failed. [00:14:19] Speaker 03: And under this court's precedent, if we can come forward and say we have an inventive product and it falls within the claim, then that creates [00:14:30] Speaker 03: a presumption that it's based on the product. [00:14:33] Speaker 03: In other words, Iberia's marketed product embodies the clean features of the invention. [00:14:37] Speaker 02: Well, our precedent is perhaps not quite as clear and uniform as it might be. [00:14:42] Speaker 02: There certainly are cases, as you say, that don't require the patent owner to come forward with affirmative evidence of what the success is attributable to, but at least like the Tokei case, [00:15:00] Speaker 02: points in the opposite direction. [00:15:03] Speaker 03: If I may quibble with Your Honor for just a moment. [00:15:05] Speaker 03: Please. [00:15:05] Speaker 03: Even when the Federal Circuit seems to be giving a little wiggle room, it still will usually cite this proposition from Brown and Williamson. [00:15:16] Speaker 03: It'll say that if a product is coincidental with the claim features, then the burden shifts to the defendant. [00:15:22] Speaker 03: In other words, that's a well-cited proposition. [00:15:24] Speaker 03: It's not one case that we kind of found in an attic somewhere. [00:15:27] Speaker 03: It's a well-stated proposition that if [00:15:29] Speaker 03: A marketed product embodies all the claimed features of the invention and its product is coextensive with the claimed features, the burden shifts the defendant. [00:15:36] Speaker 03: But Judge Toronto, what I do want to point out is in this case, the other side is not arguing nexus. [00:15:43] Speaker 03: In other words, they're not saying, we want to tell the court what the evidence is of what the alternative explanation is for this product, this exciting invention that revolutionized what happened in hospitals. [00:15:52] Speaker 03: Infections went down 85%. [00:15:55] Speaker 03: That's our unexpected result, 85% in one study that's in the record. [00:15:59] Speaker 03: based on this invention of blood infections. [00:16:01] Speaker 03: The reduction in blood infections was 85%. [00:16:03] Speaker 03: And this has been going on for 20 years that they've been studying what to do. [00:16:06] Speaker 03: They tried cap valves. [00:16:09] Speaker 03: They tried swabbing. [00:16:10] Speaker 03: That wasn't working. [00:16:11] Speaker 03: When this invention came, unexpected results. [00:16:13] Speaker 03: And your honor, to your point, nowhere did they come forward and say, I know that for 20 years they're having problems. [00:16:20] Speaker 03: And I know literally people were dying. [00:16:21] Speaker 03: And I know after this product came out, there was an 85% reduction in one study, which is in the record. [00:16:26] Speaker 03: And I know that this went from zero to a hundred million in a few years and basically has revolutionized the care of people and helped you with infections. [00:16:35] Speaker 02: You wouldn't kind of expect their declaration to say... Can I just make this point that on summary judgment... I thought that they were contesting that. [00:16:41] Speaker 03: They should be saying that, Your Honor. [00:16:43] Speaker 03: They should be saying in the light most favorable, all that's true. [00:16:45] Speaker 03: They should not be contesting what I just said. [00:16:48] Speaker 03: What I just said is in the record, and we get the entitlement of the light most favorable to us on summary judgment. [00:16:53] Speaker 03: They should be saying that's all true for purposes of summary judgment, but then they add this, we have another explanation, and it's this. [00:17:01] Speaker 00: And then they put it, no, and they don't do that. [00:17:03] Speaker 00: Sorry. [00:17:11] Speaker 00: Mr. Hess. [00:17:12] Speaker 01: Good morning, Your Honor. [00:17:15] Speaker 01: To address that last point that is being discussed, [00:17:20] Speaker 01: Prior to this invention, prior to the introduction of the churros cap by Ibera, there was no ventless cap, if you will, in the market. [00:17:30] Speaker 01: Where all the comparison is, and what it goes to, is the bare swabbing of the site on the end of the lower activated valve on the end of a catheter that goes into the body. [00:17:42] Speaker 02: Did anybody try to put a ventless cap on the market, even enough to see that after [00:17:49] Speaker 02: 10 uses, it was a bad idea? [00:17:52] Speaker 01: There was one ventless cap that was marketed several years before that. [00:17:56] Speaker 01: It had some problems with the design of the valve, though. [00:17:59] Speaker 01: The problems with that were not with the design of the cap itself. [00:18:03] Speaker 01: It was a bad valve. [00:18:05] Speaker 01: And so they stopped marketing that valve, and that company stopped marketing the cap that went with that valve. [00:18:10] Speaker 01: But all the studies that Ivera points to and all the comparisons they make are not with the cap that's shown in the Hong [00:18:19] Speaker 01: They're with simple wiping of the end of the valve that goes into the catheter that goes into your body. [00:18:26] Speaker 01: And when they talk about a fluid-tight seal, the fluid-tight seal is important on the end of the valve that's on the end of the catheter. [00:18:35] Speaker 01: The fluid-tight seal on the cap is not the issue. [00:18:37] Speaker 01: Whether the cap is ventless or whether it has a vent, there still will be a fluid-tight seal on the valve, even before caps were used. [00:18:47] Speaker 01: The valve just stuck out of your arm. [00:18:50] Speaker 01: It was a fluid-tight seal. [00:18:52] Speaker 01: And so this desire to have a fluid-tight seal is with regard to the valve, not with regard to the cap itself. [00:19:00] Speaker 04: Was there evidence presented to rebut the four declarations, the Han declaration, for example? [00:19:08] Speaker 01: There was evidence submitted by our expert, Mr. Sheehan, but with regard to the declarations, [00:19:14] Speaker 04: Not all of them were actually... What did your experts say with respect to the teaching away aspect of the Han declaration? [00:19:21] Speaker 04: I'm sorry? [00:19:22] Speaker 04: What did your experts say with respect to the teaching away aspect of the Han declaration? [00:19:27] Speaker 01: The Han declaration goes to an aspect of the cap that was not even contemplated by Han at the time. [00:19:35] Speaker 04: And that... That's what he's saying. [00:19:37] Speaker 04: He's saying at the time, we didn't contemplate this because [00:19:42] Speaker 04: the object was to prevent any type of, to have a tight seal. [00:19:47] Speaker 04: And it might, when I look at the Hong declaration, I just don't see a sentence, I see several paragraphs where he says that. [00:19:55] Speaker 01: Mr. Sheehan points out that the, in the Hong device, or in the Hong patent, to the extent there is a seal, the seal is, if you will, a face seal. [00:20:04] Speaker 01: The threads are not what the sealing device, the threads are not what seals the cap. [00:20:10] Speaker 01: And so, [00:20:11] Speaker 01: The Hong device or any of the caps, when you crank them down, there will be a seal on the face, but not on the threads themselves. [00:20:25] Speaker 01: What we need to look at here is what is not in dispute. [00:20:30] Speaker 01: What is not in dispute is that the Hong patent includes all the limitations except venting. [00:20:37] Speaker 01: What is not in dispute is the level of ordinary skill in the art. [00:20:41] Speaker 01: What's not in dispute is that the prior art contained disinfecting caps and venting caps. [00:20:48] Speaker 02: What's not in dispute is that... And by that, by prior art there, you mean documents. [00:20:52] Speaker 02: You don't mean, except for this one failed product, an actual product. [00:20:57] Speaker 01: Prior art patents and publications. [00:21:00] Speaker 01: It's not in dispute that the Chinloy reference discloses a vented cap. [00:21:05] Speaker 01: They may dispute that it goes to a different implement or it's a different type of medical device. [00:21:11] Speaker 01: But in doing so, Ivera focuses too narrowly on the preferred embodiment. [00:21:17] Speaker 01: Their commercial product relates to a lore-activated valve for an intravenous catheter. [00:21:23] Speaker 01: The claims, however, are not so limited. [00:21:26] Speaker 01: The claims don't go to a cleaning device for a medical implement. [00:21:30] Speaker 01: They're much broader than that. [00:21:32] Speaker 01: The title of the patent is a cleaning device for a medical implement. [00:21:35] Speaker 01: In fact, the specification describes medical implement [00:21:40] Speaker 01: as any tool or object that can be used in a medical setting. [00:21:44] Speaker 01: It gives numerous examples, including access ports on tubing, access ports on catheters, needle-free valves, stopcocks, lure connectors, and even stethoscopes. [00:21:57] Speaker 01: That's the area of the invention. [00:22:00] Speaker 01: That's the area of the prior art that we need to look to, not just the very narrow [00:22:05] Speaker 01: lower activated valves for intravenous catheters that is the subject of the commercial embodiment. [00:22:11] Speaker 00: What was the stage of the claim construction at the time of this motion? [00:22:16] Speaker 01: Claim construction was already resolved, Your Honor. [00:22:19] Speaker 00: And does it include all of the variables that you've just recited? [00:22:25] Speaker 01: Yes. [00:22:25] Speaker 01: My recollection is that the term medical implement was not a term that was construed specifically by the court or was not requested to be construed by the court, but the [00:22:35] Speaker 01: Patent specification very clearly states that that's what the term means. [00:22:40] Speaker 00: I wasn't asking about the specification. [00:22:42] Speaker 00: I was asking if there had been a formal claim construction as to what's meant by vent, the second thing. [00:22:48] Speaker 01: Oh, by vent. [00:22:49] Speaker 01: Yes, there was. [00:22:51] Speaker 01: The term vent does not actually appear in the claims. [00:22:54] Speaker 01: It's called second opening means. [00:22:55] Speaker 00: Or opening. [00:22:56] Speaker 01: And the judge determined that that means event. [00:23:03] Speaker 00: Well, you just recited a whole list of things, stop cops and so on. [00:23:07] Speaker 00: Are you saying that those were construed as included? [00:23:12] Speaker 01: Those were included in the term medical implement. [00:23:15] Speaker 01: The vent is in the cap that goes on to the medical implement. [00:23:19] Speaker 00: Okay. [00:23:20] Speaker 00: I'm trying to understand your argument about the breadth of the claim. [00:23:24] Speaker 01: The claims refer to a cleaning device for a medical implement. [00:23:30] Speaker 01: And then they go on to describe that the cleaning device has various features, including a first opening and a second opening. [00:23:38] Speaker 01: In making, in IVERA's making their argument about the prior art, they're trying to very narrowly focus on caps for lower activated valves with intravenous catheters. [00:23:51] Speaker 01: But the caps that are claimed go to a broader subject matter than just lower activated valves for intravenous catheters. [00:23:59] Speaker 01: the caps can go on any medical implement. [00:24:02] Speaker 01: And so when you interpret the term medical implement in the claim, to which the cap is applied, the term is much broader than the lure-activated vows of the commercial embodiment of the IVERA. [00:24:15] Speaker 00: Unlimited, you're saying, by any of the claim limitations? [00:24:19] Speaker 00: I'm sorry, I didn't. [00:24:21] Speaker 00: I'm really trying to understand this argument, which seems to be curious to me. [00:24:27] Speaker 00: that you're saying the claims are so broad that they are tainted? [00:24:33] Speaker 01: Well, they're not so broad that they're tainted. [00:24:35] Speaker 01: The issue is that IVARA seems to limit the relevant prior art or limit the analysis of the prior art to only that which is directed to lower activated valves or intravenous catheters. [00:24:48] Speaker 01: They ignore or want to disregard Chin-Loi, for example, because they say that it relates to a different medical implement. [00:24:56] Speaker 00: So are you saying that when the patentee says that the district court erred in not considering the secondary considerations that the breadth of comparison should have included all of these other medical devices? [00:25:13] Speaker 01: I was speaking more specifically about the basic obviousness issue, not getting into the secondary considerations. [00:25:20] Speaker 01: On secondary considerations, our argument is that the comparison [00:25:24] Speaker 01: is not with any of the prior art devices. [00:25:28] Speaker 01: The comparison that they're making and the comparison that they rely on is with regard to simple swabbing of the end of a device, not to a cap as that may have been. [00:25:40] Speaker 01: I'm sorry, I may not be following the argument of the question. [00:25:45] Speaker 00: I hear what you're saying, but I did not have the impression that there were caps [00:25:51] Speaker 00: to be compared with that were the same but for the second opening. [00:25:56] Speaker 00: For example, the comparison was interesting and if valid, quite powerful. [00:26:03] Speaker 00: If until this device came along, you had to swab these tips in order to disinfect them. [00:26:12] Speaker 00: And the difference now was as dramatic, to use the word, that we're told is shown [00:26:20] Speaker 00: by these data, then I'm trying to understand the contrary argument because, as you know, we have a fair number of cases which direct the decision maker to look and see how the device was received in the community as being, we have a case that says it can be the most powerful evidence of unobviousness. [00:26:45] Speaker 01: In this case, Your Honor, the cap sold well. [00:26:48] Speaker 01: There's no dispute about that. [00:26:50] Speaker 01: But what Iberra fails to do is to tie that, develop a nexus of that success to the claim features and specifically to the venting of the second opening meeting. [00:27:02] Speaker 00: Well, our cases, it's true that they are fact dependent, but the statute requires that the invention as a whole be considered. [00:27:13] Speaker 01: Yes, Your Honor. [00:27:14] Speaker 01: And even the invention as a whole, [00:27:17] Speaker 01: Ivera fails to make any connection between the invention as a whole and the commercial set of the unexpected results. [00:27:27] Speaker 04: I don't understand this argument. [00:27:29] Speaker 04: Now, are you saying that once the invention issue that there was more swabbing that happened in the industry and that's why there was less infections or that's why there was commercial success for the cab? [00:27:42] Speaker 01: No, that's not what I'm saying, Your Honor. [00:27:45] Speaker 01: What I'm saying is that [00:27:47] Speaker 01: prior to the invention being, prior to the CUROS cap being commercially introduced, swabbing was the primary method of cleaning the end of the lower activated valve. [00:27:58] Speaker 01: In fact, as of today, it still is the primary method of cleaning the end of a lower activated valve in hospitals. [00:28:06] Speaker 01: What they are saying is that the evidence shows that there is an increase, or rather a decrease, in bloodstream infections after the cap was used. [00:28:16] Speaker 01: That could be attributed to a lot of things. [00:28:18] Speaker 01: It could be attributed to... Isn't that a fact question? [00:28:23] Speaker 01: Is that a fact question? [00:28:24] Speaker 01: Yes. [00:28:24] Speaker 01: Yeah, the issue is a fact question. [00:28:27] Speaker 01: And they have not put in any evidence to show that it's not. [00:28:43] Speaker 01: With regard to [00:28:44] Speaker 01: secondary considerations and IVERA relies on so-called expert reports. [00:28:52] Speaker 01: Submitted two expert reports and relies on a number of other declarations. [00:28:58] Speaker 01: What IVERA fails to point out is that it devoted one sentence in its entire summary judge brief to the issue of secondary considerations. [00:29:08] Speaker 01: And that sentence was simply look to these two expert reports. [00:29:13] Speaker 04: The two expert reports were very conclusory and didn't cite to any... The district court, in deciding some judgment, looks at the evidence on the record, correct? [00:29:21] Speaker 04: Mm-hmm. [00:29:21] Speaker 04: Yes, ma'am. [00:29:22] Speaker 04: Not just decide based on argument made in a brief. [00:29:26] Speaker 04: No. [00:29:28] Speaker 04: Are you saying that the district court did not have to look at the declarations because counsel referred to them in one sentence? [00:29:35] Speaker 01: Well, no, Your Honor. [00:29:36] Speaker 01: There's two issues there. [00:29:37] Speaker 01: There are expert reports and there are declarations. [00:29:40] Speaker 01: There are several declarations that were [00:29:43] Speaker 01: originally filed in the patent office during re-examination of the patent. [00:29:49] Speaker 01: And those declarations were cited to the court with some other briefing prior to the summary judgment briefing, six months before any of the summary judgment briefs were filed. [00:29:59] Speaker 01: Those declarations were not referred to as part of the summary judgment briefing. [00:30:05] Speaker 01: They were not referred to in the expert reports and they were not referred to in IVERA's briefs. [00:30:11] Speaker 01: Only on appeal now [00:30:13] Speaker 01: has Ivera resurrected those, uh, declarations and said, your honor, the judge and district court should have gone back through the record, should have looked to some briefings six months ago. [00:30:24] Speaker 04: So the declarations are, they are part of the record. [00:30:28] Speaker 04: They're part of the record of the case. [00:30:30] Speaker 04: Yes. [00:30:30] Speaker 04: And as far as I can tell, you did not object to them when, when they were introduced into the record. [00:30:36] Speaker 01: When they were introduced into the record. [00:30:38] Speaker 01: That's correct, your honor. [00:30:40] Speaker 04: So you're stuck with them. [00:30:42] Speaker 04: Yes. [00:30:44] Speaker 04: Why don't those declarations raise a genuine issue of material fact? [00:30:49] Speaker 01: They don't raise a genuine issue of material fact because the basic evidence of obviousness is so strong. [00:30:58] Speaker 01: Even if you have a strong showing of secondary considerations of non-obviousness, a clear showing of obviousness cannot be overcome by that. [00:31:09] Speaker 01: Here, with what is admitted to be undisputed, [00:31:13] Speaker 01: in the record, there's a clear showing of obviousness. [00:31:18] Speaker 01: And no matter what is said in those declarations, we recognize that they're part of the record and we're not, you know, pointing them out that they're not. [00:31:29] Speaker 01: It's not enough to overcome the clear showing of obviousness. [00:31:33] Speaker 04: You've got four declarations and they all go to the issue of motivation. [00:31:40] Speaker 04: Isn't that part of a prime official case? [00:31:47] Speaker 01: It's part of a prima facie case, yes. [00:31:49] Speaker 01: It's just one of the many things that are considered as part of that case. [00:31:59] Speaker 02: Can you remind me, did you argue in your red brief that the declarations that were in the record but perhaps not referred to in IVERA's opposition to summary judgment [00:32:17] Speaker 02: cannot be relied on to defend, I'm sorry, to challenge the summary judgment ruling? [00:32:26] Speaker 02: That's essentially a procedural argument, that it's not enough for something to be in the record. [00:32:32] Speaker 02: It actually has to have been relied on by the opponent of summary judgment in the summary judgment opposition, and that was not done here. [00:32:40] Speaker 01: Is that an argument that's in your red brief? [00:32:42] Speaker 01: We did make that argument, yes, Your Honor. [00:32:46] Speaker 01: And I don't recall the page site, but I know that there were several cases where that has been the case where there was one case, I can't remember the name of it. [00:33:02] Speaker 01: There was one case where the declarations that were in a very similar situation were submitted four days from the time the summary judgment briefs were submitted. [00:33:14] Speaker 01: And in that case, this court found that they should not be relied upon as part of the analysis. [00:33:21] Speaker 01: And that is the Henry Blazo court case, where there was a four-day difference. [00:33:27] Speaker 01: Here we have six months difference from the time that the declarations were submitted to the court from when the summary judgment briefing occurred. [00:33:37] Speaker 01: And it's much more than the four days we saw in Blazo. [00:33:43] Speaker 00: Any more questions? [00:33:45] Speaker 00: Any more questions for Mr. Hess? [00:33:47] Speaker 00: Thank you. [00:33:47] Speaker 00: Thank you, Mr. Hess. [00:33:51] Speaker 03: Mr. Gross? [00:33:52] Speaker 03: Your Honor, if I may, I'm just going to give record time. [00:33:56] Speaker 03: That's all I'm going to do. [00:33:56] Speaker 03: I'm going to start with the four declarants. [00:34:00] Speaker 03: At A, 1062, B for the District Court, counsel below named names. [00:34:06] Speaker 03: Nate said, that's what Mr. Buckman says, Morrison says, Huang says, and Lansing says. [00:34:11] Speaker 03: So the District Court clearly had [00:34:13] Speaker 03: fully understood that the four declarants were part of that record with respect to motivation to combine. [00:34:18] Speaker 03: I now want to switch to secondary factors, and Judge Taranto, I was trying to find the Menehe site. [00:34:23] Speaker 03: I can't find it. [00:34:24] Speaker 03: I will just cite that in the record at A... Just spell that word. [00:34:28] Speaker 03: The answer is no, but I can find it for the court. [00:34:32] Speaker 03: It's M-E-N-Y-H-A-Y within a few letters. [00:34:38] Speaker ?: Okay. [00:34:38] Speaker 03: So, two other things quickly. [00:34:41] Speaker 03: The court asked about an example on page A5343. [00:34:47] Speaker 03: It talks about Mr. Buckman's cap and taking the court's point that it's not directly about a medical cap, but it's close. [00:34:53] Speaker 03: The phrase there is, Dr. Buckman's cap was never commercialized because it's extremely complex design and resulting high maintenance cost. [00:35:00] Speaker 03: And that's one of the references that they talk about in the briefing. [00:35:02] Speaker 03: So it's close, Your Honor. [00:35:03] Speaker 03: And then finally, this is very important. [00:35:06] Speaker 03: In terms of what was right before the court that the court referred to in the decision. [00:35:11] Speaker 03: So this was argued at the summary judgment and in the decision. [00:35:13] Speaker 03: There's two reports, Lansing and then also Kennedy. [00:35:17] Speaker 03: Kennedy at A5658 goes through the sales and talks about how it goes from zero to 300,000 to 10 million to a hundred million. [00:35:26] Speaker 03: So the sales of the claim of invention are in the record right before the court argued at the summary judgment hearing in the briefing and cited that there's no issue [00:35:35] Speaker 03: about whether that was cited to the district court. [00:35:37] Speaker 03: And then Lansing at page 5622 and 5623 discusses long felt need in detail and unexpected results in detail. [00:35:46] Speaker 03: So we're not in a situation where we're lost without the earlier declaration from Mr. Rogers. [00:35:51] Speaker 03: We're in a situation where even setting aside the Mr. Rogers declaration that was in the record and we think should be relied on, we had the core information. [00:35:58] Speaker 03: When you look at all that in the light from what's favorable to us, we believe it means that under the proper precedent of this court, [00:36:03] Speaker 03: We should have a chance to have a jury find all these disputed facts and not have the court throw the case out. [00:36:12] Speaker 00: Thank you, Your Honors.