[00:00:00] Speaker 01: First case is from the patent office shockwave medical versus cardiovascular systems 2023 1864 mr. McPhee It takes seven minutes Good morning, you can take 15 minutes I understood [00:00:26] Speaker 04: May it please the court. [00:00:28] Speaker 04: The board's finding of unpatentability in this case improperly relied upon AAPA as a basis. [00:00:35] Speaker 04: That's reversible legal error under this court's recent decision. [00:00:39] Speaker 03: Well, the first time they did, but not the second, right? [00:00:43] Speaker 03: Apologies? [00:00:44] Speaker 03: The first time they did, but not the second time. [00:00:48] Speaker 04: In fact, in the second time in the decision on rehearing, if you look at pages two to four of the decision, right there in the table, right up front, they include a table with a heading that lists out references slash basis, and they list AAPA for every single one of the grounds. [00:01:07] Speaker 02: How is AAPA defined here? [00:01:10] Speaker 02: Is it in patent admissions plus Healy and Hayes, or how is it defined for purposes of the petition here? [00:01:16] Speaker 04: It's a good question. [00:01:17] Speaker 04: So AAPA, there is a statement in the petition where CSI said, we're going to use AAPA to describe African-admitted prior art, figure one, from the patent, as well as, and then they used the words Healy and Hayes. [00:01:34] Speaker 04: That is the sum and substance of the analysis of Healy and Hayes in the petition. [00:01:39] Speaker 01: Well, isn't this statement, Levi, as modified by? [00:01:43] Speaker 01: That's the key language to determine [00:01:46] Speaker 01: what how AAPA was used here as modified by and is that the basis basis or not a basis that is a basis here and and I'll give a few reasons why you look at the petition the petition cites AAPA [00:02:05] Speaker 04: Not as evidence of background knowledge, but for every single one of the grounds, they cite AAPA as a reference. [00:02:12] Speaker 04: But they don't call it a basis, right? [00:02:14] Speaker 04: They call it a reference. [00:02:15] Speaker 04: They use it as a basis. [00:02:17] Speaker 04: They don't call it a basis. [00:02:18] Speaker 04: They do not call it a basis. [00:02:20] Speaker 04: The board understood use of AAPA as a reference to be equivalent to a basis, which is why they say reference slash basis. [00:02:29] Speaker 04: But even more than the labels, you look at how the petition actually uses AAPA. [00:02:35] Speaker 02: Wait, how do we know that the board thought reference was equivalent to a basis here? [00:02:40] Speaker 02: I don't think the slash between reference and basis means that's necessarily equivalent, because we've been finding two different things. [00:02:46] Speaker 04: Well, the reason I think that, Your Honor, I think it's the only possible understanding, because AAPA cannot be a reference. [00:02:53] Speaker 04: That was this court's decision in Qualcomm 1. [00:02:55] Speaker 04: So if AAPA is anything under that table, the board had to have understood it to be a basis. [00:03:01] Speaker 04: And that's consistent with the petition here. [00:03:04] Speaker 04: where if you look at each one of the challenged claims, every single one of the challenged claims includes at least one element where CSI said in its petition, we are relying exclusively on AAPA to satisfy that element. [00:03:19] Speaker 02: Do you agree that AAPA can satisfy the missing claim limitation? [00:03:26] Speaker 04: I would put it differently, Your Honor. [00:03:27] Speaker 04: I would say under this court's decision in Qualcomm 1, [00:03:32] Speaker 04: Background knowledge or general knowledge can satisfy an element, and background knowledge or general knowledge may rely on AAPA when presented properly as part of an expert opinion. [00:03:45] Speaker 04: So background knowledge, of course, is background knowledge of who? [00:03:49] Speaker 04: Of the person of ordinary skill in the art. [00:03:52] Speaker 04: And how do we present evidence of the understanding of the person of ordinary skill in the art? [00:03:57] Speaker 04: That's with an expert declaration. [00:04:00] Speaker 04: And that's the way it's always done. [00:04:01] Speaker 02: Does it have to require an expert declaration? [00:04:04] Speaker 02: Like, when I think of an expert, you could think of someone who is even greater skilled than a person of ordinary skills are. [00:04:11] Speaker 04: Yes, you're correct, Your Honor. [00:04:13] Speaker 04: But it is the expert who is at least of ordinary skill, who is opining on what the level of ordinary skill is. [00:04:21] Speaker 04: And that's what you have to have to establish background knowledge. [00:04:24] Speaker 04: And this is not something I'm just saying as a matter of practice. [00:04:28] Speaker 04: You can look at the statute itself. [00:04:31] Speaker 03: 311B says... It sounds as though what you're saying is that the petition and the board [00:04:39] Speaker 03: could properly have relied on applicants who had prior art, but they used the wrong language to describe what they were doing? [00:04:47] Speaker 03: Is that your theory? [00:04:49] Speaker 04: It's part of it, but it's more than that, Your Honor. [00:04:51] Speaker 04: So before we even get to that question, we look at what evidence did the petition actually present. [00:04:57] Speaker 04: Did the petition present evidence that this element was within the background knowledge? [00:05:03] Speaker 04: They didn't. [00:05:04] Speaker 04: The way you'd have to present that is with an expert declaration. [00:05:08] Speaker 04: You could maybe have done that. [00:05:09] Speaker 04: They maybe could have come in and said, so it's the absence of an expert declaration. [00:05:13] Speaker 03: That's the problem. [00:05:15] Speaker 04: It's the absence of an expert declaration or any other evidence that you could rely on to say this is background knowledge. [00:05:21] Speaker 03: I don't understand how, how, when you're trying to rely on. [00:05:25] Speaker 03: AAPA, you have to have an expert declaration. [00:05:28] Speaker 03: The whole point is it's in the patent itself. [00:05:32] Speaker 04: The reason is this, Your Honor, and this is why I was going to the statute. [00:05:35] Speaker 04: We know about 311B that says that the basis must be based on prior patents or written publications. [00:05:44] Speaker 04: If you go to 312A3, and you look at this, and this court has discussed this in yet a research case, it describes what kind of evidence can you rely on [00:05:55] Speaker 04: in an IPR proceeding. [00:05:57] Speaker 04: And there are two provisions there. [00:05:59] Speaker 04: The first is Priorit Patents Printed Publications. [00:06:01] Speaker 04: That can be the basis. [00:06:03] Speaker 04: What's the second one? [00:06:04] Speaker 04: The second one is declarations or affidavits with supporting evidence. [00:06:09] Speaker 04: Those are the two sources of evidence that you can use in an IPR proceeding. [00:06:13] Speaker 04: And it's different to say, here's an expert who is opining on background knowledge versus, I'm going to just skip the expert and go straight to the underlying material. [00:06:26] Speaker 04: How do we know that? [00:06:27] Speaker 02: That's the Phillips v. Google case. [00:06:29] Speaker 02: In your view, what is permissible use of AAPA in a petition? [00:06:34] Speaker 04: AAPA may be relied upon by an expert, for example, to show background knowledge or to show a motivation to combine or other reasons. [00:06:45] Speaker 02: What is your best case to say that an expert is required to rely on AAPA in an IPR petition? [00:06:53] Speaker 04: Well, so I would go to the statute number one, so 35 USC 312 A3, A and B, says you've got to either have... But what case? [00:07:03] Speaker 04: And the Yeta research case, which we cited in our opening brief, describes exactly that. [00:07:09] Speaker 04: It says, for example, you can have an expert present opinions based on evidence that is not prior art at all, or is not properly presented as a prior patent or printed publication. [00:07:23] Speaker 03: That's saying that you can have an expert. [00:07:25] Speaker 03: What case says you have to have an expert? [00:07:29] Speaker 03: To present opinions on background knowledge. [00:07:31] Speaker 03: To present opinions on AAPA. [00:07:37] Speaker 04: There's no opinion that I'm aware of that says that you have to have [00:07:40] Speaker 04: an expert to present opinions on AAPA. [00:07:43] Speaker 04: But if you look at the two categories of evidence that can be submitted in an IPR 312A3, AAPA has to fall under one or the other. [00:07:53] Speaker 04: So either it is a prior patent or printed publication. [00:07:57] Speaker 04: It can't be that under Qualcomm 1. [00:08:00] Speaker 04: It has to fall under the second category. [00:08:04] Speaker 04: And that is not what happened here. [00:08:06] Speaker 04: You can read the petition. [00:08:08] Speaker 04: You look at what they say. [00:08:09] Speaker 04: You look at the expert evidence they presented. [00:08:10] Speaker 04: There's no evidence. [00:08:12] Speaker 04: There's no citation to anything in Healy or Hayes that would support the finding of background knowledge. [00:08:21] Speaker 04: It simply isn't there. [00:08:23] Speaker 04: And I'd like to just present one other point before I sit down, which is this issue of motivation to combine. [00:08:30] Speaker 04: I'd just like to say if you look at appendix 836, [00:08:34] Speaker 04: which is a composite image of the various lithotrypter prior arc that's present, you'll see that this question of how to combine things is not a trivial one in this case. [00:08:45] Speaker 04: Every single one of the lithotrypter references that are presented on appendix 836 has a catheter with a balloon on the end. [00:08:52] Speaker 04: There was no way to use that with a guide wire without puncturing the balloon. [00:08:57] Speaker 04: And so whatever CSI has presented [00:09:01] Speaker 04: to say that these things should be combined, whether it's a catchphrase like design choice or conclusory statements. [00:09:08] Speaker 04: These are not sufficient to provide substantial evidence of combinability. [00:09:12] Speaker 04: That's not enough to say that a guidewire was well known. [00:09:14] Speaker 04: You have to show there was a reason to combine it. [00:09:17] Speaker 02: Do you agree that it's OK to rely on AAPA plus prior art in the form of pens or printed publications, but not AAPA alone as a basis for the IPR petition? [00:09:28] Speaker 04: I don't agree with that. [00:09:30] Speaker 04: That would just be the combination rule that was rejected in Qualcomm 2, which clearly said that's not sufficient. [00:09:38] Speaker 01: We will save the rest of your time. [00:09:40] Speaker 01: Mr. Bell. [00:09:54] Speaker 05: Good morning, Your Honor. [00:09:55] Speaker 05: May I please the court? [00:09:56] Speaker 05: Gabe Bell for the cross-appellant CSI. [00:09:59] Speaker 05: In this case, AAPA was properly relied on in the petition and by the board as evidence of background knowledge. [00:10:07] Speaker 02: Can you also define what AAPA meant in this particular case? [00:10:10] Speaker 05: Yes, Your Honor. [00:10:11] Speaker 05: And this is at page 355 of the appendix. [00:10:14] Speaker 05: We specifically defined it, so this kind of makes it an unusual case in this respect. [00:10:17] Speaker 05: The letters AAPA will include the admissions in the patent itself, including figure one and column three, about a typical over-the-wire angioplasty balloon. [00:10:26] Speaker 05: went on to say that same configuration is in numerous other prior art references, in particular, including Healy and Hayes. [00:10:35] Speaker 05: The petition then went on two pages later and said, it's the most widely used, most common and widely used configuration in the art. [00:10:44] Speaker 05: And this is what shows that it's used as background knowledge, not as the basis. [00:10:49] Speaker 05: Because if you're saying it's so pervasive in the art that everyone would know it, and in fact, patent owner itself, in this very [00:10:56] Speaker 05: proceeding at page 599 of the appendix said the following. [00:11:01] Speaker 05: This structure, talking about over the wire, is a standard structure for all angioplasty balloons and cited its expert for that proposition. [00:11:11] Speaker 05: So that's the defining line here between using something as background knowledge properly and in a case like Qualcomm 2 where it was used for an independent teaching. [00:11:22] Speaker 05: There was a power on-off system that was literally the basis of the combination, and another feature was engrafted in. [00:11:28] Speaker 05: That's not how the petition presented it here, and that's not how the board relied on it. [00:11:33] Speaker 05: The board recognized that this is a well-known configuration. [00:11:37] Speaker 05: As evidenced by, and it cited figure one, it cited numerous other references, it found that Healy and Hayes were specifically and sufficiently cited in the petition. [00:11:48] Speaker 05: It said, yes, you didn't point out [00:11:51] Speaker 05: any particular site, but it's apparent on the face, according to the board. [00:11:55] Speaker 05: And that's true. [00:11:56] Speaker 05: If you look at Healy and Hayes, on their face, very first page, they show over-the-wire configurations for good reason. [00:12:04] Speaker 05: Everyone knew that this is how you would do it in almost all cases. [00:12:07] Speaker 05: It would be like claiming a computer with a keyboard. [00:12:10] Speaker 05: Everybody knows it's background knowledge that a computer routinely often comes with a keyboard. [00:12:17] Speaker 05: And to the court's question about whether an expert declaration is required to show this, [00:12:21] Speaker 05: It isn't, but there is such a declaration here. [00:12:26] Speaker 05: We have Jensen, CSI's expert, paragraph 115 of his declaration, which was cited in the petition at page 357, and at paragraph 82 of Jensen's declaration, which is at appendix page 1622, commenting and explaining that over-the-wire systems go back as far as the 1980s. [00:12:46] Speaker 05: And that's borne out by the record. [00:12:48] Speaker 05: So an expert declaration isn't required here. [00:12:51] Speaker 05: And you can certainly rely on other sources besides that. [00:12:54] Speaker 05: And we know that from Konig League. [00:12:57] Speaker 05: In Konig League, this court held that the background knowledge provided a missing limitation. [00:13:04] Speaker 05: And that was the pipelining there. [00:13:06] Speaker 05: There's kind of an analogy here, because pipelining there kind of guided the download process. [00:13:11] Speaker 05: And here you have a guide wire guiding the insertion process, but there it relied on three different sources of evidence. [00:13:17] Speaker 05: It relied on an actual prior art reference, the WhoA reference, which disclosed pipelining. [00:13:22] Speaker 05: It relied on an expert declaration. [00:13:24] Speaker 05: And notably there, it also relied on the patent being challenged itself towards the end of that opinion. [00:13:30] Speaker 05: It noted that the patent and relied on this, that the patent said pipelining was common. [00:13:36] Speaker 05: Here we have a very similar thing. [00:13:38] Speaker 05: The patent here says, [00:13:39] Speaker 05: that the over the wire configuration was typical. [00:13:42] Speaker 05: In fact, the most typical. [00:13:44] Speaker 05: I would submit that if that isn't background knowledge, I'm not sure exactly what would be under the court's case law. [00:13:51] Speaker 05: And certainly, the clinic league supports that it can be used and presented in the way that it was here. [00:13:57] Speaker 02: Counsel, it seems like opposing counsel is trying to elevate form over substance a little bit in terms of the arguments they're being made. [00:14:05] Speaker 05: Yes, I think that's exactly right your honor and particularly relying on a passing reference in a table in the board's Decision and I'll just comment on that as kind of exemplary of their form over substance Argument the board didn't say that a APA was the basis In fact, it went on elsewhere in its opinion to specifically say it wasn't treating it as the basis So if there were any confusion from that table the board dispelled it later in its opinion [00:14:31] Speaker 05: And so I think what you need to do is look at what was dispositive in Qualcomm 2. [00:14:36] Speaker 05: It's how the petition presented. [00:14:38] Speaker 05: So even if you thought the board did somehow refer to it as the basis here, and I don't think that's a fair reading of the board's decision, it's ultimately the petition that governs. [00:14:47] Speaker 05: There, you had an express admission in the petition, which you don't have here. [00:14:51] Speaker 05: My friend acknowledged that the petition doesn't do that here. [00:14:54] Speaker 05: And instead, rather, what you have is the petition presenting it as common and well-known. [00:14:59] Speaker 05: exactly the sort of presentation you saw in Koneclik. [00:15:03] Speaker 01: It would have been helpful to have cited Healy and Hayes. [00:15:08] Speaker 05: So in the petition, Your Honor, we did point out the various exhibits. [00:15:11] Speaker 05: In the initial list, we say we're relying on the following prior art references. [00:15:16] Speaker 05: Healy and Hayes were listed in there. [00:15:18] Speaker 05: And then in defining it, again, at page 355, we said it's exemplary. [00:15:22] Speaker 05: And I think that's why it shows it's used as background knowledge, not for any one particular teaching. [00:15:27] Speaker 05: plucked out of one prior art that you're combining. [00:15:30] Speaker 05: You're saying it's so pervasive in the art. [00:15:32] Speaker 05: For example, Helian Hayes went on to say numerous other references. [00:15:36] Speaker 05: And the board of pages 39 to 41 found that it was, in fact, in numerous other references, including Lennox and O'Connor. [00:15:44] Speaker 01: It may be pervasive in the prior art, but it's also in the claim. [00:15:48] Speaker 05: It is. [00:15:49] Speaker 05: It is. [00:15:49] Speaker 05: And the fact that it's presented as pervasive in the prior art, I think. [00:15:53] Speaker 01: Which means that aspect of the prior art is important. [00:15:57] Speaker 05: It certainly means it's claimed. [00:15:59] Speaker 05: As to its importance, I think we can look at what the patentee itself said in bottom of column three. [00:16:05] Speaker 01: Every limitation in a claim is important. [00:16:08] Speaker 05: Every limitation certainly has to be shown for obviousness. [00:16:10] Speaker 05: That is undoubtedly correct. [00:16:12] Speaker 05: They are important to whatever degree the patentee intended it. [00:16:15] Speaker 05: And I think here, the patentee intended it to be the prior art. [00:16:19] Speaker 05: It said so in figure one. [00:16:21] Speaker 05: It said so in the bottom of column three. [00:16:24] Speaker 05: And ultimately, it presented not just AAPA as the reason to include a guide wire, but all of this other prior art, Healy and Hayes, let alone the admissions by their expert at page 599. [00:16:37] Speaker 05: Their expert also said, and this is Berger, quoting out. [00:16:42] Speaker 02: Does your argument change in any way if AAPA in the petition was just defined as the [00:16:48] Speaker 02: in patent admission and did not include helium haze? [00:16:53] Speaker 05: I think the way it would present in this petition, it wouldn't change the outcome. [00:16:58] Speaker 05: Because it was still presented as this is kind of exemplary of everything everybody knows. [00:17:03] Speaker 05: And again, at page 357, it was termed the most common and the most widely used configuration. [00:17:10] Speaker 05: We have the patent owner itself saying it's, in fact, in all angioplasty balloons. [00:17:15] Speaker 05: Again, if that's not background knowledge, which [00:17:18] Speaker 05: We know from cases like Conakley and Qualcomm 1 and 2, background knowledge can be used for a missing limitation. [00:17:24] Speaker 05: It can be used for a motivation to the mind. [00:17:26] Speaker 05: So the use of it certainly isn't a problem. [00:17:29] Speaker 05: It's just a question of how it was presented by the petition and how it was treated by the board. [00:17:33] Speaker 05: And we submit that both of those things are entirely appropriate here. [00:17:37] Speaker 03: Could you turn to Claim 5 before we run out of time? [00:17:40] Speaker 03: Yes. [00:17:40] Speaker 05: Thank you, Your Honor. [00:17:41] Speaker 05: I appreciate the prompt. [00:17:42] Speaker 05: Um, claim five, we think, is just as ineligible, excuse me, unpatentable as the other claims. [00:17:49] Speaker 05: It provides a nominal limitation for where to put the electrodes. [00:17:53] Speaker 05: And what we think the board went a little bit astray here is in looking at one reference in isolation rather than the combination. [00:18:01] Speaker 05: And that's the Uchiyama reference. [00:18:03] Speaker 03: Your expert, as I read the record, said that this is a common design choice, that it would have a benefit because it would reach [00:18:11] Speaker 03: further into the vessel wall, et cetera, et cetera. [00:18:15] Speaker 03: And if I read the patentee's expert, he really doesn't contest that, but says you wouldn't do it because of soft tissue damage. [00:18:25] Speaker 03: That's exactly right. [00:18:28] Speaker 03: There seems to be a dispute about whether, because of the risk of soft tissue damage, you wouldn't do this between the two experts. [00:18:37] Speaker 03: Am I correct about that? [00:18:39] Speaker 05: I think that's right. [00:18:40] Speaker 05: And the board resolved that dispute in the context of claim one. [00:18:45] Speaker 05: So the court would recall, claim one already required putting the electrodes in the balloon, but not in touching relationship with the balloon. [00:18:53] Speaker 05: So you're in the balloon to be in the liquid to provide the shockwave. [00:18:57] Speaker 05: That means you're already outside the guide wire limit by definition. [00:19:02] Speaker 05: So the only question then was, does it cause too much harm? [00:19:05] Speaker 05: And for purposes of claim one, this is at pages 32 to 35, the board rejected that exact argument that it would be too dangerous to put it too close to the balloon or too close to the edge because it would cause harm. [00:19:18] Speaker 05: So the board resolved that in our favor in claim one. [00:19:21] Speaker 05: That same reasoning we submit should apply to claim five because that was the only dispute. [00:19:27] Speaker 02: If you look at the patent owner's response... Can you also respond to the standing argument that was raised by opposing counsel? [00:19:33] Speaker 05: Of course, Your Honor. [00:19:34] Speaker 05: And just the site on that where you can see the patent owner's response was Appendix 658. [00:19:38] Speaker 05: That's where they dispute claim five. [00:19:40] Speaker 05: They just say it's not centered. [00:19:42] Speaker 05: The board, in fact, said it was centered. [00:19:44] Speaker 05: At page A69, the board found that it was off-center, and the board found elsewhere that it was not too dangerous. [00:19:51] Speaker 05: Those two findings, we think, show that the board improperly relied just on Uchiyama to reject the argument as to claim five. [00:19:59] Speaker 05: How about the standing question? [00:20:00] Speaker 05: Yes, Your Honor, thank you. [00:20:02] Speaker 05: So standing, we think this aligns very nicely with the GE2 decision. [00:20:07] Speaker 05: So the GE2 decision made clear that all you need to show is likely activity that's giving rise to a possible infringement suit. [00:20:15] Speaker 05: So it doesn't have to be an imminent. [00:20:16] Speaker 05: It doesn't have to be a definite. [00:20:18] Speaker 05: It's activity, possible infringement suit. [00:20:21] Speaker 05: And we think both of those are satisfied here. [00:20:23] Speaker 05: The activity when we submitted the Combrone Declaration at ECF 20-2 explains everything that happened up until the cross appeal. [00:20:32] Speaker 05: And it was substantial. [00:20:34] Speaker 05: There was a substantial investment. [00:20:35] Speaker 05: I won't say the number because it's confidential. [00:20:37] Speaker 02: Had any clinical trials occurred at the time the cross-appeal was filed? [00:20:40] Speaker 05: No. [00:20:40] Speaker 05: But it was in the process of talking with FDA. [00:20:43] Speaker 05: It's a long process, as the court is well aware. [00:20:45] Speaker 05: We were well into that process of back and forth at least. [00:20:49] Speaker 02: Was there a final product design at the time the cross-appeal was filed? [00:20:52] Speaker 05: It was close to final. [00:20:53] Speaker 05: And this is all public. [00:20:55] Speaker 05: It's close to a design freeze at that time. [00:20:57] Speaker 05: And we later pointed out in our apply that that design freeze had since happened. [00:21:02] Speaker 05: And then the progress has continued since. [00:21:04] Speaker 05: Clinical trials are currently ongoing, including in humans. [00:21:07] Speaker 02: Does Shockwave specifically threaten to sue CSI? [00:21:11] Speaker 05: Yes. [00:21:12] Speaker 05: I think even more so than other cases. [00:21:14] Speaker 05: Here's what Shockwave said. [00:21:15] Speaker 05: Quote, any viable IVL device must, end quote, read on claim five. [00:21:20] Speaker 05: This was right after they had managed to sneak claim five through the board. [00:21:24] Speaker 05: Excuse the pejorative language. [00:21:25] Speaker 05: Managed to uphold claim five through the board process. [00:21:29] Speaker 05: They came right out and said, we're going [00:21:31] Speaker 05: Anybody with a viable IVL device is going to infringe claim five. [00:21:35] Speaker 05: That's at page CSI appendix one. [00:21:38] Speaker 05: And Shockwave later said it will, quote, certainly sue anyone who does IVL. [00:21:44] Speaker 05: That's CSI appendix page 23. [00:21:46] Speaker 05: And at that time, recall, all they had was claim five. [00:21:49] Speaker 05: So that is a very clear and unmistakable threat that they intend to enforce this through claim five. [00:21:56] Speaker 05: And I see I'm almost out of time. [00:21:58] Speaker 05: Unless the court has further questions, I'll sit down. [00:22:00] Speaker 01: You are officially out of time, but you wanted to save two minutes for rebuttal. [00:22:06] Speaker 01: We'll give you a minute for rebuttal if there's something to rebut. [00:22:10] Speaker 05: I appreciate the court's consideration. [00:22:11] Speaker 01: Ms. [00:22:12] Speaker 01: Queller. [00:22:25] Speaker 00: Your Honors, it may please the court [00:22:27] Speaker 00: CSI's petition does not suffer from the same issues as the petition in Qualcomm 2, and therefore that case is not dispositive here. [00:22:36] Speaker 00: Additionally, because the board relied on two prior art references that we've already discussed here today, the Healy and Hayes reference, to establish what was well known in the art, the board's decision may be affirmed on the independent basis of Healy and Hayes without reaching the issue of the proper use of what's classically considered [00:22:56] Speaker 00: applicant admitted prior art, which here is figure one, just to make sure I'm clarifying Haley and Hayes versus figure one. [00:23:04] Speaker 00: With respect to the language of the petition, in Qualcomm 2, the court there relied on express statements that were unequivocally conceding that applicant admitted prior art was the basis. [00:23:18] Speaker 00: The petition here does not have any of those unequivocal or clear statements. [00:23:23] Speaker 00: They don't use the word basis at all. [00:23:26] Speaker 00: What has been relied on instead is the board's use of the words basis in one table at the beginning of the final written decision. [00:23:35] Speaker 00: But that does not align with the language of Qualcomm 2, because under SAS, we know that the board cannot rewrite the petition. [00:23:42] Speaker 00: So we can't assume that CSI was using it as the basis, because the board used that language in a table. [00:23:50] Speaker 00: And even if there was any inference that the board decided that figure one here was applicant admitted prior art, later they say at appendix 31 to 32, AAPA was not the basis. [00:24:04] Speaker 00: So that inference was later rebutted by the board. [00:24:06] Speaker 00: But even further, even if applicant admitted prior art was the basis, [00:24:12] Speaker 00: That is harmless error because the applicant admitted prior art was used as an umbrella term by CSI that included Healy and Hayes. [00:24:21] Speaker 00: Healy and Hayes are printed publications used as evidence of background knowledge. [00:24:26] Speaker 00: There's no dispute that that is proper under 311. [00:24:30] Speaker 00: So there's an independent reason to affirm. [00:24:33] Speaker 00: I do want to make one note with respect to Shockwave Council's reference to 312 that is not so limiting on the type of evidence that may be submitted in an IPR. [00:24:46] Speaker 00: You can also look at 314 and 316, which also talk about supplemental information and information the board can consider. [00:24:54] Speaker 00: And the language of 312 itself uses the word including, so it's not limiting. [00:24:58] Speaker 02: Do you have a response to opposing counsel's contention that an expert [00:25:03] Speaker 00: is required in using AAPA. [00:25:16] Speaker 00: the evidence of background knowledge, for example, helium haze. [00:25:20] Speaker 00: I don't think that aligns with the statute or has statutory basis there. [00:25:24] Speaker 00: And then finally, I guess, unless your honors have any questions, I'm happy to address any of the arguments with respect to notice or particularity of helium haze. [00:25:34] Speaker 00: But the PTO presents that that is an independent reason to affirm without reaching the use of figure one. [00:25:41] Speaker 01: Thank you, counsel. [00:25:42] Speaker 01: Mr. McPhee has five minutes plus. [00:25:52] Speaker 04: The defects here go to both form and substance. [00:25:55] Speaker 04: If you look at the substantive errors of the board's decision, appendix 31, relying on the wrong statutory interpretation rejected by Qualcomm 2. [00:26:04] Speaker 04: In the petition itself, look at it substantively what was presented, not just argument, but evidence. [00:26:10] Speaker 04: There is no evidence presented in the petition regarding Healy and Hayes whatsoever. [00:26:16] Speaker 04: It's completely absent. [00:26:18] Speaker 04: It's mentioned in the petition. [00:26:19] Speaker 04: It's not even mentioned by [00:26:21] Speaker 04: the expert. [00:26:22] Speaker 04: I understand CSI to say, well, it doesn't matter if you present a petition saying reference X in view of reference Y, or reference X in view of background knowledge based on reference Y. This court has rejected that concept. [00:26:40] Speaker 04: That's the Kunikla J. Phillips versus Google case where it says... What does they need to do here that they didn't do? [00:26:48] Speaker 04: At a minimum, they needed to present evidence of background knowledge presented through an expert. [00:26:53] Speaker 04: So it all turns on whether you have to have an expert. [00:26:56] Speaker 04: Not just whether to have an expert, but what did you present in your petition? [00:26:59] Speaker 04: The petition relied directly on AAPA as if it were a reference. [00:27:04] Speaker 04: It did not rely upon background knowledge. [00:27:06] Speaker 04: And under Philips versus Google, that's the theory. [00:27:08] Speaker 03: So they said in the petition, and you say they didn't, but there's an issue about that, if they said we're relying on this as background knowledge and they had an expert [00:27:18] Speaker 03: that relied on a P.A., that would be okay? [00:27:23] Speaker 04: We'd have a different story. [00:27:25] Speaker 04: That would be okay? [00:27:26] Speaker 04: I'd have to see what the expert did, but it would be a very different situation than we have here. [00:27:33] Speaker 04: Under the Phillips v. Google case, it does matter. [00:27:35] Speaker 03: Did you argue in your brief that you had to have an expert? [00:27:40] Speaker 04: We pointed to the Yetta research case that showed that it's a difference to have, to rely on something. [00:27:47] Speaker 03: My question is, did you argue in your brief that you had to have an expert? [00:27:52] Speaker 04: That was the intent. [00:27:53] Speaker 04: That was the argument that we made. [00:27:55] Speaker 04: You didn't actually say it. [00:27:56] Speaker 04: We made the point that there was no evidence and that they had relied improperly. [00:28:01] Speaker 03: But you did not argue that they had to have an expert. [00:28:04] Speaker 04: The argument was that they had improperly relied directly on the AAPA. [00:28:07] Speaker 03: No, no, no. [00:28:07] Speaker 03: To answer my question, did you argue they had to have an expert? [00:28:10] Speaker 04: We didn't have that exact statement. [00:28:12] Speaker 04: The point was that they had relied on it as if it were a reference. [00:28:16] Speaker 02: What is your response to the argument that there's an independent basis for informants here in light of the fact that AAPA was used as an umbrella term [00:28:26] Speaker 02: to include the classic AAPA, the in-patent admission, plus Healy and Hayes. [00:28:31] Speaker 04: So two problems there. [00:28:32] Speaker 04: Number one, even if you take that umbrella term, you look at what else was under the umbrella. [00:28:37] Speaker 04: Healy and Hayes, there was no evidence. [00:28:40] Speaker 04: there was no evidence presented in the petition regarding Healy and Hayes. [00:28:44] Speaker 04: They literally just said, Healy, Hayes. [00:28:46] Speaker 04: There was no citation to Healy or Hayes. [00:28:48] Speaker 04: There was no analysis. [00:28:49] Speaker 04: There was no expert who presented any information on Healy and Hayes. [00:28:52] Speaker 04: So it's impossible for that petition and the board's decision to have a basis in something that was completely absent from the petition itself. [00:29:03] Speaker 04: I'd like to go to the cross appeal, if I may. [00:29:07] Speaker 04: The question of standing is a fundamental jurisdictional defect, and it was CSI's burden to present evidence of concrete plans and that there was a substantial risk. [00:29:20] Speaker 03: So why isn't the Declaration of Carbon evidence of concrete plans? [00:29:26] Speaker 04: It actually shows the opposite of concrete plans. [00:29:28] Speaker 04: He concedes that design freeze had not yet happened. [00:29:31] Speaker 04: There could still be variance in the product. [00:29:34] Speaker 04: And so we don't know at the point that the cross-appeal is filed, we don't know what product we would evaluate for purposes of... So you have to have a specific product that's not subject to change to have standing? [00:29:45] Speaker 04: I'm not aware of a single case in which this course has found standing based on a product that was subject to change, that was [00:29:54] Speaker 04: internal that they were still working on. [00:29:57] Speaker 03: But on the other hand, there's no case that says you have to have a product. [00:29:59] Speaker 03: It's not subject to change. [00:30:00] Speaker 04: Every case at Platinum Optics, it was not fixed. [00:30:04] Speaker 04: JTEC case, it wasn't fixed. [00:30:06] Speaker 04: And moreover, you have the Fisher v. Pacl case, as well as the other ones I just mentioned, that said it's a problem if the product is a moving target. [00:30:15] Speaker 04: It's also a problem if you don't present evidence of what the product is. [00:30:20] Speaker 04: And there was virtually no evidence as to what the product is. [00:30:23] Speaker 04: I would submit virtually no evidence. [00:30:25] Speaker 04: Exterior photos of a product, no effort to say how the product related to any of the actual elements of claim five. [00:30:35] Speaker 04: We don't know whether the device uses electrodes or something else. [00:30:38] Speaker 04: If it does, what material the electrodes are made out of, where the electrodes are positioned, which is key for claim five, whether there will be a guide wire limit. [00:30:46] Speaker 02: What about the infringement threat that was made [00:30:48] Speaker 02: or at least described by opposing counsel in terms of what Shockwave said. [00:30:53] Speaker 04: Yes, so there were two statements generalized. [00:30:55] Speaker 04: One was made in response to a question at an investor conference. [00:31:00] Speaker 04: Neither of those rise to the level of a threat, nor could they have. [00:31:03] Speaker 04: The one that counsel relied on in particular was made in a general way before [00:31:10] Speaker 04: CSI had even announced that it was going to be introducing an IVL product. [00:31:15] Speaker 04: And this court has never found in any of its standing cases that I'm aware that was cited here has never found that a statement by a patentee can overcome [00:31:24] Speaker 04: the basic lack of evidence of a concrete product, something that is fixed in some way, and evidence of what that product actually looks like, how it maps to that. [00:31:35] Speaker 03: That seems to be a different question, but in terms of the threat, you agree that there was a sufficient threat? [00:31:41] Speaker 04: No, I don't believe it was a sufficient threat. [00:31:42] Speaker 04: I'm saying even if you take that as a threat of some sort, [00:31:46] Speaker 04: This court has never found that a threat is sufficient to show standing in the absence of evidence of something concrete and something where evidence is actually presented of how that product lines up. [00:32:00] Speaker 04: And in the GE2 case, which counsel relies on and says it's the closest, it's interesting. [00:32:05] Speaker 04: GE2 describes what happened in GE1 where standing was not found to exist. [00:32:12] Speaker 04: And in GE1, there were threats [00:32:14] Speaker 04: There was an understanding among the industry that the patentee was very aggressive, would enforce its portfolio, and yet it wasn't enough because there was no final concrete product. [00:32:26] Speaker 04: So even the very case they're citing, I think, demonstrates that the evidence, paltry as it is here, is not sufficient to show standing. [00:32:33] Speaker 04: And that's a fundamental defect. [00:32:35] Speaker 04: Of course, I'd submit, Your Honor. [00:32:37] Speaker 01: Your standing has ended here. [00:32:41] Speaker 01: And Mr. Bell can have a minute on the cross-appeal. [00:32:50] Speaker 05: Thank you, Your Honor. [00:32:52] Speaker 05: I don't know how to read those statements other than as a threat, and a threat against CSI. [00:32:56] Speaker 05: It was made after claim five was upheld here. [00:32:59] Speaker 03: What about the idea that there was a product that was subject to change? [00:33:03] Speaker 03: The design freeze hadn't happened yet. [00:33:06] Speaker 05: It was certainly very close, and it then happened imminently after that, as we predicted. [00:33:11] Speaker 05: So it was essentially final by the time the cross-appeal was filed. [00:33:16] Speaker 05: And I would like to note, even years before that, during the proceedings on rehearing, here's what Shockwave said. [00:33:21] Speaker 05: It's, quote, certainly reasonable to infer CSI's product will be covered. [00:33:27] Speaker 02: That's it. [00:33:27] Speaker 02: What is our best record evidence we could look at to see that it was essentially final in terms of the product? [00:33:34] Speaker 02: substantially final or use various words, but is there something we can look at in the record? [00:33:38] Speaker 05: Sure, sure. [00:33:38] Speaker 05: Cardone declaration, paragraphs 12 to 15. [00:33:42] Speaker 05: He was the vice president of research and development, so he would know. [00:33:45] Speaker 05: He said design freeze was imminent. [00:33:47] Speaker 05: And we know ultimately that it did happen shortly thereafter. [00:33:51] Speaker 05: In addition, we coordinated with the FDA to get the IDE approved. [00:33:55] Speaker 05: It's now in clinical trial. [00:33:56] Speaker 05: So it was clearly right on the cusp and essentially final by that point. [00:34:02] Speaker 05: And you look at a case like Moderna TX, where the patent owner there said, quote, extensive scope of its patent coverage over virtually all products was a type of statement that would indicate that it was a threat against a particular party. [00:34:18] Speaker 05: And indeed, there was no such threat. [00:34:19] Speaker 01: Thank you, counsel. [00:34:20] Speaker 01: Your time has ended. [00:34:22] Speaker 01: We appreciate both parties, and the case is submitted. [00:34:26] Speaker 05: Thank you, your honor.