[00:01:01] Speaker 00: Next case is Ethicon Endosurgery versus Covideen, if that's proper pronunciation, 2014-1370. [00:01:12] Speaker 00: Mr. Kavanaugh. [00:01:15] Speaker 03: Thank you, Your Honor. [00:01:20] Speaker 03: In each of the three issues Ethicon has raised on appeal, the district court erred by resolving disputed issues of fact rather than properly identifying such disputes [00:01:32] Speaker 03: which would necessitate a trial. [00:01:34] Speaker 03: Let me start with the issue of indefiniteness on the 501 patent. [00:01:39] Speaker 03: The district court granted summary judgment based on finding the claims indefinite because there were supposedly two ambiguities, what the distance should be between the blade and the clamp when force should be measured, and where along the length of the clamping arm the force measurement should be made. [00:02:02] Speaker 03: What the district court failed to recognize is that the specifications squarely answered that first question, what the distance should be between the blade and the clamp when force should be measured. [00:02:14] Speaker 03: And that, in turn, would inform a person of ordinary skill in the art where along the length of the clamping arm, the force measurement should be made. [00:02:22] Speaker 03: Let me start with the distance point. [00:02:25] Speaker 03: The specification says that the pressures discussed in the patent [00:02:31] Speaker 03: or when the entire clamping arm is in contact with the tissue. [00:02:37] Speaker 03: It then goes on to define the clamping surface area as where the blade and the tissue pad are in close proximity and the clamping arm is in a closed position. [00:02:52] Speaker 03: So that tells you that there's no angle you're dealing with. [00:02:56] Speaker 03: You're dealing with they're in close proximity. [00:03:00] Speaker 03: Once you know that, that answers the distance question. [00:03:07] Speaker 03: Once you've answered the distance question, you now know that you have a general linear surface and that the midpoint, and the claim says you're trying to determine the average. [00:03:25] Speaker 03: So with a general linear surface, well, some of the claims. [00:03:29] Speaker 03: some of the claims. [00:03:30] Speaker 03: But let me deal with the average claims first and then I'll turn to the other claims. [00:03:36] Speaker 03: The claim calls, claim 17, claim 1, call for an average. [00:03:40] Speaker 03: The midpoint is an appropriate point at which to measure the average. [00:03:46] Speaker 03: That's what our expert did. [00:03:48] Speaker 03: Our expert went on to confirm. [00:03:50] Speaker 02: Are there other points besides the midpoint that are also appropriate places to measure the average pressure? [00:03:57] Speaker 03: Our expert looked at the first and did it at one third and two thirds. [00:04:01] Speaker 03: Is the answer yes? [00:04:04] Speaker 03: Yes, there may well be. [00:04:06] Speaker 03: But what the district court and what Covidian did, they never did measurements when it was in a closed position. [00:04:13] Speaker 02: I guess I'm trying to understand why there's such a focus on the midpoint of the clamping arm as being the magical place to measure the average pressure. [00:04:23] Speaker 02: When, you know, I guess in this conversation, [00:04:27] Speaker 02: We appear to be agreeing that you could really measure pressure from any location on the arm for what the applied force is. [00:04:37] Speaker 03: You could, if you're trying to determine the average, the midpoint is certainly an appropriate point. [00:04:43] Speaker 03: What does average mean? [00:04:45] Speaker 03: Average means if you look at the entire surface area, you take the force and then you divide it by the entire surface area and that gives you the average. [00:04:55] Speaker 04: Well, but that gives you the average over the entire arm of the clamping arm. [00:05:01] Speaker 04: But it seemed to me that the focus of the patent is on that area of the clamping surface, that tiny piece of real estate at the very end of the arm, which is contacting the blood vessel. [00:05:13] Speaker 04: That's where the money, where the rubber hits the road, so to speak. [00:05:17] Speaker 03: I don't think that's correct, Your Honor, because the specification talks about the entire clamping surface area. [00:05:25] Speaker 03: where it's in contact with the tissue. [00:05:28] Speaker 03: So that occurs along the entire length. [00:05:32] Speaker 04: I thought the specification was clear, correct me if I'm wrong, that the clamping surface 24 or 26, right at the end of the clamping arm, figure two, is where the pressure is [00:05:55] Speaker 04: where the clamping occurs against the blood vessel. [00:05:58] Speaker 03: Is that right? [00:05:59] Speaker 03: The clamping occurs. [00:06:00] Speaker 03: There's a blade, and there's a tissue pad. [00:06:03] Speaker 03: The pivot arm comes down and closes it. [00:06:06] Speaker 03: The tissue runs along that entire clamping surface area. [00:06:12] Speaker 03: And that's why you're looking at the blade. [00:06:15] Speaker 03: It's about half an inch. [00:06:17] Speaker 03: The blade comes down on the tissue pad and cuts the tissue. [00:06:22] Speaker 03: Well, here's what. [00:06:24] Speaker 04: makes me uncomfortable with the midpoint argument, besides the fact that it shows up nowhere in the spec and only in your expert's report. [00:06:35] Speaker 04: If you look at the language of the patent that tells us that there's a force between, I think, it's two and seven pounds at the point of where the clamping surface is, [00:06:48] Speaker 04: and that you have a surface area on the clamping surface of 0.033 square inches, I think it is, that produces by the arithmetic exactly the pressure that you recite of 60 to 210, right? [00:07:04] Speaker 04: Yes. [00:07:04] Speaker 04: Right. [00:07:05] Speaker 04: So isn't that, isn't the patent telling us that's where you measure the, do the respective measurements and where you achieve [00:07:14] Speaker 04: And that's how you achieve the pressure between 60 and 210. [00:07:18] Speaker 03: Well, Your Honor, we're not saying... You understand what I'm saying. [00:07:21] Speaker 03: I think I do. [00:07:22] Speaker 04: Well, it's pretty simple. [00:07:24] Speaker 04: I mean, you've got a piece of real estate here, the clamping surface area. [00:07:30] Speaker 04: When you put the clamping surface down against the bottom of the clamp... Of the blade. [00:07:36] Speaker 04: Of the blade, what you're getting, according to the specification is, [00:07:40] Speaker 04: pressure between 2 and 7 pounds against the surface area right there of 0.033 square inches, which translates to 60 to 210 pounds per square inch. [00:07:52] Speaker 04: Yes. [00:07:53] Speaker 04: So far, so good. [00:07:54] Speaker 04: Why isn't that then what the patent is telling us about where to measure and how you determine whether the pressure is, in fact, between 60 and 210? [00:08:04] Speaker 03: And if you take the midpoint [00:08:06] Speaker 03: That is what you get. [00:08:07] Speaker 03: That is an appropriate point at which to do the measurement. [00:08:13] Speaker 03: You could take, as our expert did, our expert took a measurement at one-third and two-thirds along the length of the entire clamping surface and came up with the same number. [00:08:25] Speaker 04: But you're going to have a different force at those different points, I would assume, that would produce a different force to produce the same [00:08:37] Speaker 04: pressure. [00:08:39] Speaker 03: The differences are so minimal because it is generally linear. [00:08:47] Speaker 03: So the deviation is going to be minimal. [00:08:53] Speaker 03: And that's why it calls for an average. [00:08:57] Speaker 03: Now, all the testing that Covidian did, they always did it in an open position. [00:09:03] Speaker 03: They didn't do what the specification calls for. [00:09:06] Speaker 03: That's why they were getting deviations. [00:09:09] Speaker 03: They never said that our midpoint was not an appropriate average. [00:09:13] Speaker 03: They never challenged the fact that our experts took it at one third and two thirds and came up with the same number. [00:09:20] Speaker 02: That's fine. [00:09:21] Speaker 02: Right now, I think we're more concerned about trying to understand what the claim means. [00:09:25] Speaker 02: I mean, the claim talks about an average predetermined clamping pressure between and including 60 PSI and 10 PSI on tissue [00:09:36] Speaker 02: disposed between the tissue pad and the blade. [00:09:39] Speaker 02: So following up on Judge Bryson's question, it seems like the action of the claim is focused on the portion of the tissue that is disposed between the tissue pad and the blade and telling us that the pressure at that precise location [00:10:03] Speaker 02: has to be between 60 psi and 210 psi. [00:10:06] Speaker 02: Is that a correct reading of the clamp? [00:10:09] Speaker 03: That is a correct reading. [00:10:10] Speaker 02: Okay, but then now you're saying the force at that end of the clamping arm, that measurement of the force at the end of the clamping arm would have to be different than the measurement of the force at the midpoint of that same clamping arm. [00:10:27] Speaker 03: Am I wrong with that? [00:10:28] Speaker 03: There will be a slight difference, but [00:10:33] Speaker 03: it is because you're dealing with a generally linear surface at this point because it's not open it's closed it will be generally linear and the midpoint will give you an average just as taking it from one-third and two-thirds putting that together will give you an average. [00:10:55] Speaker 02: That's the average of the [00:10:59] Speaker 02: pressure that the tissue is experiencing all the way along the arm. [00:11:03] Speaker 02: And this claim is talking about the pressure on the specific part of the tissue that is between the tissue pad at the very end of the arm and the blade. [00:11:15] Speaker 03: No, the tissue pad runs along, Your Honor. [00:11:17] Speaker 02: The tissue pad is not on the very end of the clamping arm as illustrated in the figure? [00:11:23] Speaker 03: No, it runs along the clamping surface area. [00:11:27] Speaker 03: The clamping surface area constitutes the blade and the tissue pad. [00:11:34] Speaker 03: The tissue goes between it. [00:11:36] Speaker 02: Well, where's the tissue pad on your fingers? [00:11:39] Speaker 02: It runs from here to here. [00:11:42] Speaker 02: All the way down? [00:11:44] Speaker 05: Look at figure two. [00:11:53] Speaker 04: The tissue pad is 24. [00:11:57] Speaker 04: At least in the figure, that's just a tiny portion of the entire clamping arm. [00:12:05] Speaker 04: I'm reading this figure as being the same way that Judge Chen is, I think, which is 24 and 26, clamping surface, are just a small piece at the end of the clamping arm. [00:12:20] Speaker 04: Contrary to what you were saying. [00:12:22] Speaker 04: OK, go ahead. [00:12:26] Speaker 03: But the clamping surface area is that area defined by 26. [00:12:34] Speaker 03: That's what it's trying to get at. [00:12:36] Speaker 04: It's a very small piece at the end of the clamping arm, which is what I've been trying to explore with you. [00:12:43] Speaker 03: You're resisting that, which I don't understand. [00:12:45] Speaker 03: The entire clamping surface area is that tissue pad area. [00:12:50] Speaker 03: That's what they're talking about. [00:12:52] Speaker 03: I'm sorry, Ron, I must have misunderstood you, but that is [00:12:56] Speaker 04: To cut to the chase, if the measurement is done at the clamping surface area, then it seems to me your indefiniteness problem goes away. [00:13:11] Speaker 04: I don't understand why you're making this argument about the midpoint, because you've got elements in the patent that show us that if you measure at the clamping surface, you end up with the right [00:13:23] Speaker 04: the combination of force and pressure comes out right. [00:13:26] Speaker 04: Yes, and you run away from that. [00:13:30] Speaker 04: You have to measure the midpoint. [00:13:33] Speaker 03: I'm taking the midpoint, my colleague can correct me if I'm wrong, but the midpoint was taken along where the tissue pad was. [00:13:43] Speaker 03: That's the tissue pad and the clamping surface area. [00:13:46] Speaker 04: In that case, the drawing is very misleading because the tissue pad in the drawing is nowhere near the midpoint. [00:13:53] Speaker 04: Would you agree with me? [00:13:55] Speaker 03: Along the entire clamping arm? [00:13:57] Speaker 03: Correct. [00:13:58] Speaker 04: Okay. [00:13:58] Speaker 03: That is correct. [00:13:59] Speaker 04: What does the midpoint mean if it's not the midpoint of the entire clamping arm? [00:14:03] Speaker 03: It's the midpoint of the clamping surface area. [00:14:06] Speaker 03: And the area is the tissue pad and the blade when they are in close proximity. [00:14:12] Speaker 03: to one another. [00:14:13] Speaker 04: So are we talking about the midpoint of 26? [00:14:15] Speaker 04: Yes. [00:14:18] Speaker 03: That is what the expert did. [00:14:21] Speaker 02: All right. [00:14:22] Speaker 02: Well, it's not the midpoint of the arm 22? [00:14:25] Speaker 02: No. [00:14:26] Speaker 03: He took the midpoint of 26, the tissue pad, because that is the clamping surface area. [00:14:34] Speaker 00: Speaking of indefiniteness, [00:14:38] Speaker 03: But when it says, it says the clamping surface area and the tissue pad and the tissue pad are in close proximity. [00:14:48] Speaker 03: That's the language from... If you go to column four, line 25, as previously mentioned, a clamping surface area is the area where the blade and the tissue pad [00:15:07] Speaker 03: are in close proximity when the clamping arm is in a closed position. [00:15:13] Speaker 02: Right, and you're not teaching us anything. [00:15:15] Speaker 02: We knew that already. [00:15:17] Speaker 02: The question is, but what you are teaching us apparently is that we weren't, that your Dr. Schaefer was not talking about the midpoint of the clamping arm. [00:15:28] Speaker 02: He was talking about the midpoint of the tissue pad. [00:15:31] Speaker 02: Yes. [00:15:32] Speaker 02: And I apologize, I apologize if I was not clear. [00:15:35] Speaker 02: Can you point me to something that clarifies that? [00:15:38] Speaker 02: whether it's in his expert report or somewhere else. [00:15:41] Speaker 03: It is in his expert report where he did it because he showed, did he show figures where he did it? [00:15:51] Speaker 03: And I will find a site. [00:15:53] Speaker 04: Well, 4366 of the appendix is the paragraph in the middle of that page, I guess. [00:16:00] Speaker 04: It's the one place where he refers to the midpoint. [00:16:03] Speaker 04: He says that midpoint represents the average along the clamping surface, by which I guess he means the tissue pad. [00:16:09] Speaker 04: Is that right? [00:16:09] Speaker 03: Yes, because the patent refers to the... At least that's your understanding of what he says. [00:16:15] Speaker 03: Yes. [00:16:16] Speaker 03: By clamping surface area, that's what he was referring to. [00:16:21] Speaker 03: And I apologize if I wasn't clear on that point. [00:16:25] Speaker 03: I see that my time is... [00:16:28] Speaker 03: collapse, and I'll save my three minutes for a bottle. [00:16:31] Speaker 00: Well, you've used the three minutes, but we will give them back to you. [00:16:34] Speaker 03: Thank you, Your Honor. [00:16:36] Speaker 00: Mr. Winteringham. [00:16:40] Speaker 01: Thank you, Your Honors. [00:16:41] Speaker 01: May it please the Court. [00:16:42] Speaker 01: I want to make three general points, but then I think I'll focus on the 501 because that's what we've been focusing on. [00:16:49] Speaker 01: On the 501, even considering Dr. Schaeffer's opinion, which Ethicon says creates at least a question of material fact, [00:16:56] Speaker 01: fact remains that the 501 patent simply does not disclose a method for determining the pressure and force. [00:17:03] Speaker 01: And I'd like to address what Judge Bryson said about taking away the indefiniteness in a minute. [00:17:08] Speaker 01: As to the design patents, what Ethicon conveniently overlooks in his briefing is at least one major point, and that the judge did a side-by-side analysis, even considering the functional elements, and found that there was no infringement [00:17:24] Speaker 01: found them sufficiently distinct, so there was no need to consider a prior audit, and that's found at A135-43. [00:17:30] Speaker 01: And then at 275, putting aside the claim construction issues, putting aside the allegations of contact, you still, and I'm not saying there's not an answer to that, there is, but they have not shown there's any transverse vibration whatsoever in the sonic decision device. [00:17:47] Speaker 02: What about the droplet test that showed some splattering? [00:17:50] Speaker 01: The droplet test, which was conducted by [00:17:53] Speaker 01: Our, even though it's their obligation, their burden, was conducted by our experts. [00:17:58] Speaker 01: The droplet test, they don't contest. [00:18:01] Speaker 01: If there was no splattering, there's no transverse vibration. [00:18:04] Speaker 01: Every test but one showed no splattering. [00:18:07] Speaker 01: The test they turned to was a disassembled device that was not secured by O-rings at both ends, so it doesn't represent the actual device as it's sold. [00:18:16] Speaker 01: There's no support on that. [00:18:18] Speaker 02: Also, there wasn't a sleeve there, right? [00:18:20] Speaker 01: Correct. [00:18:21] Speaker 01: But the point is, if the device itself, absent the sleeve, has no transverse vibration, the sleeve isn't needed for damping out the transverse vibrations. [00:18:29] Speaker 01: But there was no support. [00:18:31] Speaker 01: So of course, the end is a very long wave guide. [00:18:34] Speaker 01: It's about that long. [00:18:35] Speaker 01: And there's no support at this end, so it doesn't reflect the normal vibration operation of the device. [00:18:42] Speaker 01: So turning to the 501, first of all, there's more than two aspects that can relate to pressure and force. [00:18:49] Speaker 01: But I just want to say, [00:18:50] Speaker 01: every asserted claim recites specific force and specific, or specific pressure. [00:18:57] Speaker 01: Some of them recite average. [00:18:59] Speaker 01: Some of them recite average, but they also have a specific force and pressure. [00:19:03] Speaker 01: So even if the argument was this is how you get average, there's no teaching whatsoever in the patent, and it doesn't teach average, I'll get to that, but it doesn't teach how to measure specific force. [00:19:13] Speaker 01: It's important to note that the undisputed evidence is that Ms. [00:19:19] Speaker 01: Noschang [00:19:20] Speaker 01: who is one of their inventors, testified there's at least four methods that they use to measure pressure and force. [00:19:29] Speaker 01: And she couldn't tell which one was used in the patent, and you get disparate results. [00:19:35] Speaker 01: That in and of itself says what the problem is. [00:19:37] Speaker 01: If they had put one of those methods into the patent, we wouldn't be here today. [00:19:42] Speaker 01: But there's simply no method disclosed how you measure the pressure and force. [00:19:47] Speaker 02: What's unreasonable about [00:19:49] Speaker 02: about thinking of the average pressure as being the midpoint of the tissue pad where the action is occurring? [00:19:59] Speaker 01: I have some very specific answers to that. [00:20:03] Speaker 04: The tissue pad, I gather, is quite small. [00:20:06] Speaker 04: Yes. [00:20:07] Speaker 04: So you would not expect the pressure to vary that much between one end of the tissue pad and the other. [00:20:13] Speaker 01: It actually does. [00:20:15] Speaker 04: How much does it vary? [00:20:16] Speaker 01: significantly. [00:20:17] Speaker 01: It's in, I can't tell you, it's in the appendix. [00:20:20] Speaker 01: We have recitations to some of the different measurements and it actually would take it out of the patent in some cases, in the patent in some cases. [00:20:27] Speaker 01: In fact, she also tests, both she and Mr. Hauser, who's the other inventor, testified that it depends on where you measure [00:20:39] Speaker 01: Ms. [00:20:40] Speaker 01: Noshank's testimony confirms that force values will vary depending on where along the jaw the measurement is taken. [00:20:45] Speaker 04: Along the jaw? [00:20:47] Speaker 01: And we're talking about it. [00:20:48] Speaker 01: Along the tissue pad. [00:20:49] Speaker 01: Right. [00:20:50] Speaker 01: That's the only place you measure it. [00:20:51] Speaker 01: There are a few different things. [00:20:52] Speaker 01: Yeah, no, I apologize. [00:20:53] Speaker 01: I don't want to get bogged up in that. [00:20:55] Speaker 01: It's where you measure it along where you're contacting the tissue. [00:20:58] Speaker 01: So that would be the tissue pad. [00:20:59] Speaker 04: So are we all on the same page here that the measurement, all the measurements we're concerned with have to do with just the tissue pad, the clamping surface, not the jaw? [00:21:09] Speaker 01: Correct. [00:21:10] Speaker 01: Okay. [00:21:10] Speaker 01: Now, if you look at the actual device, it's not like the patent where the tissue pad is just at the very, very tip. [00:21:18] Speaker 01: The jaw of the device is like this. [00:21:20] Speaker 01: Yeah. [00:21:20] Speaker 01: The tissue pad covers most of that open area because you're putting tissue into the jaw. [00:21:26] Speaker 01: And you don't want the surgeon to have to be able to just put it in a little way. [00:21:29] Speaker 01: So the blade in the jaw are basically the majority of that clamp. [00:21:33] Speaker 01: So it's, and it varies significantly along that. [00:21:36] Speaker 02: So you testify to- Is that the acute device? [00:21:38] Speaker 02: Yes. [00:21:39] Speaker 02: Okay. [00:21:39] Speaker 02: So maybe that's why in some circumstances we're talking about the midpoint of the arm versus when I look at figure two of the patent, we're I guess now looking at the midpoint of the tissue pad, right? [00:21:56] Speaker 02: Because you're saying you've got a tissue pad in your device that runs all the way along the clamping arm. [00:22:01] Speaker 01: Pretty much every device that is used to cut and coagulate tissue [00:22:06] Speaker 01: has an opening jaw, which you push into the tissue and you close. [00:22:10] Speaker 01: So you want the blade and the tissue pad to pretty much cover that open area. [00:22:14] Speaker 04: Well, that may be true in all the accused devices, but it doesn't appear to be true, at least in the figure that shows the jaw and the tissue pad in the patent. [00:22:26] Speaker 04: And therefore, what we're looking at is a question of indefiniteness of the patent, not whether the way that some of the accused devices are structured [00:22:36] Speaker 04: may make the patent difficult to apply. [00:22:38] Speaker 04: So the question is, if you look at the patent itself, which has a very small tissue pad displayed, why is it not accurate to say, why is it not sufficiently definite to say that the way you measure the pressure is that you take the force and you divide it by the surface area of the tissue pad. [00:22:59] Speaker 04: And you get, voila, you get [00:23:02] Speaker 04: 60 to 210 if you take two to seven pounds of pressure over the over the tissue pad. [00:23:08] Speaker 04: That seems very straightforward. [00:23:09] Speaker 01: And I said I would address that. [00:23:11] Speaker 01: Yes. [00:23:11] Speaker 01: That assumes that you've measured either the pressure or the force. [00:23:15] Speaker 01: You know this and there's no teaching whatsoever how to measure the pressure force. [00:23:20] Speaker 04: Do you think that it's necessary to measure force at a particular point? [00:23:24] Speaker 04: It would seem to me that's very easy to do. [00:23:27] Speaker 01: According to Ms. [00:23:28] Speaker 01: Nosheng and Mr. Hauser, [00:23:30] Speaker 01: It depends on at least three things. [00:23:33] Speaker 01: That is, where you measure it. [00:23:35] Speaker 04: That's the particular point. [00:23:37] Speaker 01: We know that. [00:23:38] Speaker 01: The distance or height that they're separated. [00:23:41] Speaker 04: Let's accept Mr. Kavanaugh's suggestion that the operation begins when the jaw is essentially closed. [00:23:48] Speaker 04: So the distance is going to be close to zero. [00:23:51] Speaker 01: Fine. [00:23:51] Speaker 01: That's what the specification says. [00:23:53] Speaker 01: I'll get that. [00:23:54] Speaker 01: Specification only talks about closure. [00:23:56] Speaker 04: So we've dealt with two of those variables. [00:23:58] Speaker 04: What's the third? [00:23:59] Speaker 01: We really haven't. [00:24:01] Speaker 04: I'm satisfied that the two are both out of the picture. [00:24:05] Speaker 04: So what have you got? [00:24:06] Speaker 04: What's your theory? [00:24:06] Speaker 01: Because Ms. [00:24:07] Speaker 01: Noshang admitted that the distance will depend on the thickness of the material in the jaw. [00:24:15] Speaker 01: That's one thing Mr. Kavanaugh conveniently overlooked is even if you're talking about closure, the pressure and force will also vary dependent upon the tissue [00:24:25] Speaker 01: that's in the jaw. [00:24:27] Speaker 04: Specification talks universally about the tissue being blood vessels. [00:24:32] Speaker 04: I don't see how the fact that it would be different pressure would be different if we were dealing with bone would make a difference. [00:24:38] Speaker 01: We don't deal with bone, and there's a great variance in the consistency of tissue that we are dealing with. [00:24:44] Speaker 01: In fact, Dr. Schaeffer agreed that the tissue characteristics such as compressibility vary depending on the type of vessel the surgeon encounters. [00:24:52] Speaker 01: Blood vessels can be six millimeters that can be [00:24:55] Speaker 01: half a millimeter, depending on the type of vessel you're dealing with. [00:24:58] Speaker 01: And the compressibility is different, and the pressure and force depends upon how much tissue you're actually compressing. [00:25:05] Speaker 01: It's not like a surgeon goes in there and can pick and choose, oh, I'll just clamp around this vessel. [00:25:10] Speaker 01: There's other stuff around it. [00:25:11] Speaker 01: Mist and terry, for example, is a whole conglomeration of vessels. [00:25:15] Speaker 01: So it depends on how much tissue, how many blood vessels, and the size of those vessels are in that clamp. [00:25:22] Speaker 01: And both inventors testified [00:25:24] Speaker 01: that these measurements of pressure and force depend upon the tissue. [00:25:28] Speaker 01: And indeed, as Mr. Kavanagh just recited, the pressures measured herein, or recited herein, are the pressures experienced by the tissue. [00:25:37] Speaker 01: And that's a conveniently overlooked factor. [00:25:39] Speaker 01: So there's where you measure it. [00:25:42] Speaker 01: And again, I say, it doesn't teach where you measure it, how far open it is, and that also depends on the type of tissue. [00:25:49] Speaker 01: Now, that's the average. [00:25:51] Speaker 02: Are you saying that if [00:25:53] Speaker 02: if the tissue is really thick. [00:25:57] Speaker 01: You're going to get higher pressures and forces because what you have to do is you have to clamp harder on the device. [00:26:02] Speaker 02: Then maybe you end up being just non-infringing. [00:26:05] Speaker 02: Then maybe you go outside the claim range. [00:26:07] Speaker 01: But the problem is if you have a device that it sometimes, and we of course think it's indefinite, but if you have a device that clamps on different tissues at different times, [00:26:19] Speaker 01: Are we saying sometimes we infringe, sometimes we don't? [00:26:20] Speaker 01: We have a problem with marketing the device. [00:26:22] Speaker 04: That's exactly the problem. [00:26:23] Speaker 04: It's frequently the case that one device can infringe in certain embodiments in certain instances and not in others. [00:26:30] Speaker 04: That wouldn't be shocking. [00:26:31] Speaker 01: And that doesn't cure the problem that we have. [00:26:33] Speaker 01: And that's why we're saying that the fact that this is indefinite and means it's invalid, we should not allow it. [00:26:39] Speaker 04: But as long as you know where the line is, then that solves the indefiniteness problem. [00:26:44] Speaker 01: But we don't know where the line is. [00:26:49] Speaker 01: I mean, first of all, when their own experts testify, there's at least three variables, where you measure and there's variance. [00:26:56] Speaker 01: And she could not say which method, there were four methods that they use at Ethicon. [00:27:01] Speaker 01: The testimony is that we use four methods at Ethicon and the results vary. [00:27:06] Speaker 02: What are those methods? [00:27:09] Speaker 01: I know of a couple of them. [00:27:10] Speaker 01: There's a pin method. [00:27:11] Speaker 01: I don't know all the methods because she didn't testify to the methods. [00:27:15] Speaker 01: The point is that she said we use four different methods. [00:27:16] Speaker 01: They're not disclosed. [00:27:19] Speaker 01: And that's the problem. [00:27:21] Speaker 01: If there's four methods and she testified, we get different varied results, and here's the three factors that can change the measurement, then we don't know reading the patent, how to get to those measurements. [00:27:33] Speaker 04: These are measurements of force? [00:27:35] Speaker 04: Is that what she's measuring? [00:27:37] Speaker 01: Yes. [00:27:37] Speaker 02: Force. [00:27:39] Speaker 02: Right. [00:27:40] Speaker 02: And some of those methods were that the jaw was partially open and not all the way closed. [00:27:45] Speaker 02: Is that right? [00:27:46] Speaker 01: But not open open. [00:27:47] Speaker 01: In other words, [00:27:48] Speaker 01: depending on the tissue, you can have, when you say open, you can have, it's not really open, it's a certain degree of separation. [00:27:56] Speaker 01: It could be where it's open, it could be where it's closed, but depending on the mass of tissue that's in there and type of tissue, closing can have different degrees of separation of the jaw. [00:28:05] Speaker 01: Again, just simple. [00:28:06] Speaker 01: You don't put this much tissue in, it's not gonna close as far. [00:28:10] Speaker 02: But I thought I read the patent just saying that you take these measurements when the jaw is closed. [00:28:18] Speaker 01: No. [00:28:18] Speaker 02: The clamping arm is in very, very close proximity to the underlying blade. [00:28:23] Speaker 01: The patent only says two things on that point. [00:28:26] Speaker 01: The pressures disclosed herein are pressures seen by tissue when the entire clamping surface area is in contact with tissue. [00:28:33] Speaker 01: When you first contact tissue, you're not nearly closed. [00:28:36] Speaker 01: So it doesn't teach there that it's closed. [00:28:39] Speaker 01: It then says, as previously mentioned, a clamping surface area where the blade and tissue pad are enclosed is [00:28:47] Speaker 01: The area where the blade and tissue had are in close proximity when the clamping arm is in a closed position. [00:28:52] Speaker 01: That just defines, if you look at the blades on these things, they're curved, they bend, and you have to actually close it to see what the cross section would be so that there would actually be mating. [00:29:03] Speaker 01: You can't tell just by having it open what would mate with the clamp. [00:29:07] Speaker 01: That only talks about the relationship of pressure equals force over surface area. [00:29:11] Speaker 01: So what is the surface area? [00:29:12] Speaker 01: The surface area is that much of the tissue pad that would actually come in contact with the blade if we closed it. [00:29:19] Speaker 01: That's defining the surface area. [00:29:20] Speaker 01: That's not defining when you measure. [00:29:24] Speaker 01: There's no talk about closure. [00:29:26] Speaker 01: And as far as average, first of all, as far as measuring the midpoint, the expert supported his opinion by nothing. [00:29:33] Speaker 01: There's no outside standard for measuring at the midpoint. [00:29:36] Speaker 01: None at all. [00:29:38] Speaker 01: He pointed to another patent. [00:29:39] Speaker 01: I think it's 874 and 974 patents. [00:29:41] Speaker 01: It's in his report. [00:29:42] Speaker 01: that talks about measuring at midpoint. [00:29:44] Speaker 01: He admitted at deposition that there was nothing in that patent-equating average with measuring at the midpoint. [00:29:51] Speaker 01: And indeed, that patent is not incorporated by reference or otherwise. [00:29:55] Speaker 01: Secondly, he admitted at his deposition that notwithstanding Mr. Kamino's saying it's a linear relationship, actually along the path he admitted at deposition that along that path it's absolutely hyperbolic. [00:30:05] Speaker 01: It's 1 over x. [00:30:07] Speaker 01: So it does vary greatly. [00:30:08] Speaker 01: It's not just minimal change along that path. [00:30:10] Speaker 01: It's 1 over x. That's what he said it is, deposition. [00:30:14] Speaker 01: And again, as I said, as far as average measurement, the claims call for not just average measurement. [00:30:20] Speaker 01: Every claim has a separately, either doesn't recite average or recite specific. [00:30:25] Speaker 01: For example, specific co-optation pressure. [00:30:30] Speaker 01: I'd like to turn to the design patents. [00:30:34] Speaker 01: The design patents cover three features. [00:30:37] Speaker 01: The U-shaped knob, which functionally is used to clamp the device, covers the design of three features. [00:30:44] Speaker 01: Theoretically, that's what it's supposed to cover. [00:30:48] Speaker 01: I apologize. [00:30:50] Speaker 01: You're right. [00:30:51] Speaker 01: It shows the design of a U-shaped figure, which in the device is used to clamp functionally the device. [00:30:58] Speaker 01: The design of the torque knob, which in the device is used to turn the clamp to align it with tissue. [00:31:05] Speaker 01: the design of the rounded button, which in the device is used to power the device. [00:31:10] Speaker 01: It's interesting to note that at the same time, in fact, they all claim priority back to a utility patent application that has the exact same elements and recites the functionality of these elements. [00:31:22] Speaker 01: For example, they talk about the ergonomically designed U-shaped trigger providing access to fingers with the longer lever allowing more figures to provide greater pressure and the shorter lever to allow [00:31:34] Speaker 01: the operator to use the fingers to open the device. [00:31:36] Speaker 01: The shape and location of the button is described as enabling access to shorter fingers. [00:31:40] Speaker 01: The shape and placement of the torque knob, as well as the number and size of the flutes, allows finger operation. [00:31:47] Speaker 01: Just by example, as far as whether these design elements are dictated by function or not and therefore invalid, the U-shaped trigger handle, and this is all from Essicon's testimony and documents, [00:32:02] Speaker 01: has a curvy device so it fits better in your hand. [00:32:04] Speaker 01: That's from Daniel Price, their lead design engineer. [00:32:08] Speaker 01: That's the curve. [00:32:09] Speaker 01: The open design provides easy access for the user. [00:32:12] Speaker 01: That's in their ad campaign. [00:32:13] Speaker 00: Mr. Winteringham, you're at the end of your time. [00:32:17] Speaker 00: You've gone over. [00:32:18] Speaker 00: Do you have any concluding comments on the design patent? [00:32:23] Speaker 01: I think that the point on the design patent is that putting aside Invalidi, which I was just talking about functionality on, [00:32:30] Speaker 01: As I noted at the beginning, there's a very detailed analysis at A135 to 43 of why there's no infringement and why the court found they were sufficiently distinct. [00:32:41] Speaker 01: Ethicon says, well, a error is they didn't consider the prior art. [00:32:45] Speaker 01: Under the Egyptian case, you don't have to consider the prior art if you found that they're sufficiently distinct. [00:32:52] Speaker 00: Thank you very much. [00:32:54] Speaker 00: Mr. Kavanaugh has a little rebuttal time if you want to take another minute, take four minutes. [00:33:01] Speaker 03: Thank you, Your Honor. [00:33:03] Speaker 03: Let me start again with 501 indefiniteness. [00:33:06] Speaker 03: Mr. Winterham is right. [00:33:07] Speaker 03: If you look at figure two, it is showing a very small tissue pad. [00:33:11] Speaker 03: It is somewhat longer in the accused product. [00:33:15] Speaker 04: What our expert did was... Well, it's not just the figure because the specification refers to that tissue pad as being very small. [00:33:23] Speaker 03: That's correct. [00:33:24] Speaker 03: It is, relatively speaking, all of these tissue pads are small in the accused product. [00:33:29] Speaker 03: But his point is correct. [00:33:31] Speaker 03: It's a little longer in the accused product here. [00:33:34] Speaker 03: And what our expert did was he took the midpoint of their tissue pad. [00:33:38] Speaker 03: Now, this issue of the thickness of the tissue [00:33:42] Speaker 03: is somewhat of a red herring, and the district court did rely on that. [00:33:48] Speaker 03: But if you take the measurement, as we believe the specification calls for, when the blade and the pad are in close proximity and the clamping arm is in the closed position, you're at the end of the cutting and sealing process. [00:34:05] Speaker 03: So whether you started with a thick vessel [00:34:08] Speaker 03: or a non-thick vessel, whether it was one millimeter, three millimeters. [00:34:13] Speaker 03: The patent only speaks about one to three millimeters, I believe. [00:34:17] Speaker 03: The measurement's going to come at the end of that process. [00:34:20] Speaker 03: You've already cut through the tissue. [00:34:23] Speaker 03: So you take that measurement at the end of that process. [00:34:27] Speaker 03: That's what the specification calls for. [00:34:30] Speaker 03: So the issue that there's great uncertainty created by virtue of the thickness of the tissue is [00:34:38] Speaker 03: is essentially irrelevant, just as the measurements they were talking about when it's in an open position are irrelevant. [00:34:47] Speaker 03: Yes, Ethicon has lots of ways to measure, but not measure for purposes of the patent derived at an average to determine whether you're in the claim. [00:34:57] Speaker 03: As an operating business and a technology company, yes, they're very interested in what's the force at the far end, the far distal end, [00:35:06] Speaker 03: Because that's where you go to grasp tissue sometimes. [00:35:09] Speaker 03: They have lots of issues. [00:35:12] Speaker 03: They're interested in what it looks like when it's open. [00:35:15] Speaker 03: But that has nothing to do with the purposes of this claim. [00:35:19] Speaker 03: On the design patents, this court has set a very stringent standard. [00:35:27] Speaker 03: Are there alternative designs that can provide these functions? [00:35:31] Speaker 03: Our expert laid out alternative functions, both with a U-shaped trigger [00:35:36] Speaker 03: and with a non-U-shaped trigger that can provide these basic functions and provide them comparably. [00:35:43] Speaker 03: They have a heavy burden of clear and convincing evidence with all inferences in our favor for them to get summary judgment on invalidity. [00:35:53] Speaker 04: Yes? [00:35:54] Speaker 04: Could you very briefly run through the four different methods that the [00:36:02] Speaker 03: I don't think she specified all four. [00:36:07] Speaker 03: I do know that some are when it's in the open position. [00:36:10] Speaker 03: I believe she mentioned the one that I just referred to that it's all the way at the end when they're interested in grasping tissue. [00:36:18] Speaker 03: But she did not relate any of those to the claim in an effort to determine an average when it's in a closed position. [00:36:28] Speaker 03: I believe I'm out of time. [00:36:29] Speaker 00: I was giving you another minute. [00:36:31] Speaker 03: So let me just say on the issue of infringement. [00:36:35] Speaker 03: Yes. [00:36:37] Speaker 03: Perhaps you don't need to look at the prior art when you're looking at the difference between an apple and a banana. [00:36:44] Speaker 03: But when you look at their design, their use of a U-shape, their configuration of our U-shaped handle, where they put their activation button, where they put their knob, [00:36:58] Speaker 03: It is sufficiently similar that you need to look at it in the context of the prior art. [00:37:04] Speaker 02: You have one design patent that's just devoted to the open trigger, right? [00:37:09] Speaker 02: Correct. [00:37:10] Speaker 02: Do you think that that design patent encompasses all U-shaped triggers? [00:37:15] Speaker 03: No, Your Honor. [00:37:16] Speaker 03: It would not. [00:37:17] Speaker 03: It would cover the ornamental aspects of our U-shaped trigger. [00:37:23] Speaker 03: The relative distance between the proximal and distal end. [00:37:27] Speaker 03: It's orientation. [00:37:31] Speaker 03: All of those things are ornamental aspects, and under this court's precedent, those ornamental aspects would make it... Curves, the tapering, the... Are all things that this court needs to take into consideration when it looks at the validity of the claim, but it is also something that the district court would need to look at in evaluating infringement. [00:37:54] Speaker 03: But it would need to do so in the context of the prior art [00:37:57] Speaker 03: which is very different. [00:37:59] Speaker 03: And they have adopted our look in comparison to the prior art. [00:38:07] Speaker 03: And that's why we believe there's infringement. [00:38:09] Speaker 04: Correct me if I'm wrong. [00:38:11] Speaker 04: The parties have waived the jury trial in this case. [00:38:14] Speaker 04: Yes. [00:38:14] Speaker 04: So if we were to reverse on the infringement, it would go back for a trial before the judge on the issue of infringement. [00:38:22] Speaker 03: That's correct. [00:38:23] Speaker 04: And the judge would look at the prior art and make a determination as to whether he was wrong in the first instance? [00:38:28] Speaker 03: Yes. [00:38:29] Speaker 03: I believe what this court needs to do is to advise the district court that it needs to look at this in the context of the prior art. [00:38:37] Speaker 00: Thank you, Mr. Cavanaugh. [00:38:38] Speaker 00: We'll take the case under review.