[00:00:01] Speaker 03: The next argued case is number 161381, CDX Diagnostics Against U.S. [00:00:10] Speaker 03: Endoscopy. [00:00:11] Speaker 03: Mr. George. [00:00:17] Speaker 02: May it please the court. [00:00:18] Speaker 02: The issue on this appeal is whether the single prior reference, Parishure, anticipates the claims of the 044 patent. [00:00:28] Speaker 02: And to do that, it has to teach that the brush goes through the superficial, intermediate, and basal layers, as well as the basement membrane and the submucosa. [00:00:40] Speaker 02: So that's about five layers, and that's what claim three requires. [00:00:43] Speaker 02: Claim one requires two. [00:00:45] Speaker 02: And I'm going to refer to those as the five layers. [00:00:50] Speaker 02: We believe the board erred because it misread the Parisher reference. [00:00:55] Speaker 02: on this critical issue of going through the five layers. [00:00:57] Speaker 02: And it also misread the testimony of the patent owner's expert. [00:01:01] Speaker 02: And both errors are related. [00:01:03] Speaker 02: Let's go back to the decision to institute. [00:01:06] Speaker 02: The board looked at the Parish of Reference and said, OK, it does not expressly disclose that its brush goes through all five layers. [00:01:18] Speaker 02: And Petitioner realized this. [00:01:20] Speaker 02: And that's why they put in their expert witness, Dr. Kahela, [00:01:24] Speaker 02: to say that, well, when I read Parish and I see the word biopsy, it means all five layers. [00:01:31] Speaker 02: So based on that, they instituted the decision. [00:01:34] Speaker 03: Mr. George, you haven't talked about the standard of review. [00:01:37] Speaker 03: What the reference teaches is a fact question. [00:01:40] Speaker 02: It is. [00:01:41] Speaker 03: And we are quite deferential to the board's determination of what the reference teaches. [00:01:46] Speaker 02: Yes, Your Honor. [00:01:47] Speaker 02: But here, just as there was in the Institute-Pester case that I've cited in my brief, [00:01:53] Speaker 02: The board made a mistake. [00:01:55] Speaker 02: It's relying on a part of the reference that does not describe the invention. [00:01:59] Speaker 02: It's relying on a part of the reference that describes the prior art. [00:02:04] Speaker 02: And that really is the error here. [00:02:06] Speaker 02: That's how the board, they made a mistake there, and they made a mistake with Dr. Frommelitz's testimony as well. [00:02:13] Speaker 01: Well, you're discussing how, in the description of the prior art, it talks about gross tissue and then [00:02:21] Speaker 01: talks about to disclose a malignancy, for example. [00:02:25] Speaker 01: It may be appropriate to examine the mucus lining of the duct, the tissue duct, and even the adjacent tissue. [00:02:30] Speaker 01: But that same language, to some extent, parallels itself in the summary of the invention disclosure, which is undoubtedly referencing the puresh or brush. [00:02:44] Speaker 01: It talks about gross tissue again, right, at line 24? [00:02:48] Speaker 01: Yes, Your Honor. [00:02:50] Speaker 01: And then it also talks about the importance of more dependable diagnoses. [00:02:55] Speaker 01: And so in the background of the invention, it says to diagnose some malignancy, this is what you need to do. [00:03:03] Speaker 01: And then it says how this brush is going to result in more dependable diagnoses. [00:03:06] Speaker 01: So what's the problem with the board having looked to the definition given in the prior art description when it then used similar or identical terms in the description of the brush? [00:03:18] Speaker 02: That's because you won't find those terms. [00:03:21] Speaker 02: You will find gross tissue, Your Honor. [00:03:23] Speaker 02: You're absolutely right. [00:03:24] Speaker 02: But you don't find adjacent tissue. [00:03:27] Speaker 02: And that's the whole crux of the board's decision. [00:03:29] Speaker 02: The board gets to the five layers by saying that you get two adjacent tissues. [00:03:36] Speaker 01: But the adjacent tissue is what you need to reach to diagnose a malignancy. [00:03:41] Speaker 01: That's what it says in the background section. [00:03:44] Speaker 01: And then in the summary of the invention, it says this new brush is going to more dependably allow you to diagnose malignancies. [00:03:51] Speaker 01: Yes. [00:03:51] Speaker 02: Yes, Your Honor. [00:03:52] Speaker 02: There's one other point, though. [00:03:54] Speaker 02: At the very next column at two, it says column two, lines five, two to 10. [00:04:02] Speaker 02: It says, and it's talking about this diagnosis of malignancy. [00:04:06] Speaker 02: It's saying that what you don't want to do is risk perforating the duct. [00:04:13] Speaker 02: So this is in the back description of the prior art. [00:04:16] Speaker 02: It's talking about a cytology brush, and it's talking about that it doesn't give you enough. [00:04:20] Speaker 02: Then it's talking about the biopsy forceps technique. [00:04:24] Speaker 01: But the board has interpreted the language about reducing the risk of perforating the duct as equating to a non-lacerating brush, which means it wouldn't be a brush that lacerates the skin. [00:04:36] Speaker 01: That's the fact finding they made with regard to that language. [00:04:38] Speaker 01: I don't know how that has any impact on whether the brush scrapes [00:04:43] Speaker 01: adjacent tissue? [00:04:44] Speaker 02: To get to adjacent tissue, it has to perforate the duct. [00:04:48] Speaker 02: And that's the argument that they made. [00:04:50] Speaker 02: And that's what Dr. Fromwood's testified to. [00:04:53] Speaker 02: He talked about that the adjacent tissue could be the liver or the duodenum or something else. [00:04:57] Speaker 02: That's the whole problem here. [00:04:59] Speaker 02: You had two prior art techniques. [00:05:01] Speaker 02: The second one was a forceps. [00:05:03] Speaker 02: The forceps had a problem because you could perforate the duct. [00:05:06] Speaker 02: You could get to adjacent tissue. [00:05:08] Speaker 02: And that's [00:05:09] Speaker 02: That may be desirable, but in most instances, it's not. [00:05:12] Speaker 02: And it's not what Parisher wanted to do with his brush. [00:05:16] Speaker 02: We then go to the summary of the invention, and we never see that language again. [00:05:19] Speaker 02: We never see the language that you want to go perforate. [00:05:26] Speaker 02: They say don't perforate the duct, and they never say go to adjacent tissues. [00:05:31] Speaker 02: The only way you get to adjacent tissues is to perforate the duct. [00:05:34] Speaker 02: They don't want to do that. [00:05:36] Speaker 02: So this adjacent tissues, which is what everything is [00:05:39] Speaker 02: The whole board's decision is based on that language. [00:05:42] Speaker 02: They say, oh, if you get adjacent tissues, you're going through the submucosa. [00:05:46] Speaker 02: Well, yes, you're going through everything. [00:05:48] Speaker 02: You're perforating the duct, and you're coming out on the other side. [00:05:51] Speaker 02: And that is not what Parisher wants to do. [00:05:55] Speaker 02: And that's really the mistake here. [00:05:58] Speaker 02: And I think the petitioner realizes it's a mistake. [00:06:02] Speaker 02: They're not making these arguments. [00:06:04] Speaker 02: They're saying, oh, the board [00:06:06] Speaker 02: define gross tissue sample to include adjacent tissues. [00:06:10] Speaker 02: But the board never did that. [00:06:12] Speaker 02: The board defined gross tissue sample to say a sample you can see with the naked eye. [00:06:20] Speaker 02: That's all they said. [00:06:22] Speaker 02: And that doesn't tell you what's in that sample. [00:06:27] Speaker 02: So the issue really here is how do they get to all five layers? [00:06:33] Speaker 02: The only way they get there is by reading [00:06:36] Speaker 02: this adjacent tissue language in the background of the invention, where it's describing a prior forceps technique, and saying that, oh, the invention must go to adjacent, the parachute brush must go to adjacent tissues as well. [00:06:54] Speaker 02: And it's just not there. [00:07:01] Speaker 02: And when they went to Dr. Fromowitz's testimony, [00:07:05] Speaker 02: The testimony that they're relying on is, and this is at page 89, the main testimony, A89, the main testimony they're relying on is about this same language. [00:07:20] Speaker 03: But if Parisher describes taking a biopsy, doesn't that come within the claim to penetrate at least two layers of the epithelial tissue? [00:07:34] Speaker 02: No, Your Honor. [00:07:35] Speaker 02: And that's how this case started. [00:07:38] Speaker 02: They put a expert declaration to say biopsy means not only those two layers, but all five layers. [00:07:46] Speaker 02: And that was rejected because that's not what it means. [00:07:49] Speaker 02: And a biopsy can be one layer, two layers, three layers, four layers, five layers. [00:07:55] Speaker 02: And there's no teaching in Parisher of anything more than a gross tissue sample, a biopsy, [00:08:03] Speaker 02: They use a bunch of words, but it really comes down to the same thing, just to take a sample from the first layer. [00:08:11] Speaker 02: And that's what the board found in the other two IPRs where we've dropped the appeal. [00:08:17] Speaker 02: And to get past just taking it from that first layer and to go down into the five layers, to go to the second layer, the third, go all the way down to the fifth, the only difference between the decisions is they had to rely on this [00:08:33] Speaker 02: adjacent tissue language in the background of the invention that describes a biopsy forceps that Parishard tells you it doesn't want to do. [00:08:44] Speaker 02: So that's why, Your Honor, we're aware of the standard and the standard here is, we believe, this is just like the Institute Pasteur case where there is no evidence, where there's a misreading of the reference. [00:08:56] Speaker 03: How about the other cases? [00:08:56] Speaker 03: Why isn't there a stopple? [00:08:58] Speaker 02: Oh, there's not a stopple for many reasons. [00:09:00] Speaker 02: Number one, this isn't [00:09:02] Speaker 02: a second case. [00:09:03] Speaker 02: This is all the same case. [00:09:05] Speaker 02: We went below. [00:09:06] Speaker 02: We had three IPRs. [00:09:07] Speaker 03: Why isn't it law of the case? [00:09:10] Speaker 02: It's not law of the case because the issues are different. [00:09:12] Speaker 02: The issues in the other two patents had to do with just taking from the first layer. [00:09:20] Speaker 02: Claims 1 and 2 of the 913 patent and claims 1 and 2 of the 609 patent [00:09:27] Speaker 02: Those claims just say, I'm just going to take from the very top, the first layer, I'm just going to take a sample from that. [00:09:33] Speaker 02: And that's not the same issue as the claims in the crystal-4 pattern, where you're taking five layers. [00:09:40] Speaker 02: And claims three and four and claim three, those are a completely different kind of epithelium. [00:09:47] Speaker 02: They're in the bile duct. [00:09:49] Speaker 02: It's called glandular epithelium. [00:09:52] Speaker 02: It doesn't have the three layers. [00:09:54] Speaker 02: And I mean, there's multiple reasons. [00:09:57] Speaker 02: The other reason is for claims three and four, there were multiple grounds of rejection. [00:10:02] Speaker 02: And the case law says where there's multiple grounds, you don't have collateral estoppel as to any of them. [00:10:07] Speaker 02: So there's no collateral estoppel. [00:10:09] Speaker 02: There's no law of the case, because really the issues were different. [00:10:18] Speaker 02: I will save the rest of my time for a while. [00:10:20] Speaker 03: OK. [00:10:21] Speaker 03: Yes, let's hear from the other side. [00:10:30] Speaker 03: Mr. Tucker. [00:10:33] Speaker 00: May it please the court. [00:10:34] Speaker 00: I'm Todd Tucker, and I represent the United States Endoscopy Group. [00:10:39] Speaker 00: Based on the substantial evidence before us, it's clear that the board got the only contested issue, the only contested limitation, correct. [00:10:50] Speaker 00: And that is whether the pressure brush is capable of reaching the submucosa. [00:10:57] Speaker 00: Pressure expressly discloses [00:10:59] Speaker 00: throughout the entire specification, gross tissue sample or biopsy. [00:11:05] Speaker 00: And I know there's a lot of back and forth as to what biopsy means. [00:11:08] Speaker 00: But at the end of the day, as the record developed during the deposition of patent owner's own expert, Dr. Frommelitz, he indeed did say that he read Prasher to be capable of reaching that submucosa, reaching that fifth layer. [00:11:26] Speaker 00: And that's what the board relied on. [00:11:30] Speaker 00: In part, the board also relied on the fact that pressure expressly discloses that claim limitation of reaching the submucosa. [00:11:41] Speaker 00: What patent owner, what appellant would have us do is actually kind of apply the wrong test for anticipation. [00:11:49] Speaker 00: As the board noted, the patent owner would have, and I'm not sure if I'm going to say this right, [00:11:56] Speaker 00: a strict identity of words. [00:12:00] Speaker 00: Close enough. [00:12:01] Speaker 00: Thank you. [00:12:03] Speaker 00: A strict identity of words. [00:12:05] Speaker 00: And you've got to have those exact words. [00:12:07] Speaker 00: And that's the wrong test. [00:12:08] Speaker 00: The test for anticipation is what does one of skill and the art understand the disclosure to teach? [00:12:16] Speaker 00: And when you get through the deposition of Dr. Fraumowitz at several different points, he is [00:12:25] Speaker 00: testifying that as one of skill in the art, pathologists with about 35 years of practice, he understands that when they're using these terms of adjacent tissue, gross tissue sample, biopsy, the meaning of parashar is that the parashar brush is capable of reaching the submucosa. [00:12:48] Speaker 00: Now, a palant spends a lot of time trying to make hay [00:12:54] Speaker 00: out of this statement in column one that bleeds into column two, where it's description of the prior art. [00:13:00] Speaker 00: But as the court noted, as the board noted, that is a statement of ultimately the goal of the Parashar brush. [00:13:11] Speaker 00: And I've heard my friends say that this statement about not perforating the duct, that it only appears in column one as the description of the prior art, [00:13:24] Speaker 00: That's actually not true. [00:13:26] Speaker 00: And they're also saying that the invention of perashure isn't contemplating this not perforating the duct. [00:13:32] Speaker 00: And that's not true. [00:13:34] Speaker 00: Because when you shoot in column two, you shoot right down into the summary of the invention in the A571, which is the perashure reference. [00:13:44] Speaker 00: And I meant column two about line, I think, 11. [00:13:48] Speaker 00: It is an object of the invention to provide a method and apparatus that can better collect a tissue sample [00:13:54] Speaker 00: from a stricture in a duct or from another anatomical structure, preferably that can obtain a sufficient sampling of cells to assist in diagnosis more dependably. [00:14:05] Speaker 00: More particularly, there's a need to enable collection of a sample sufficient to qualify as a biopsy, but in a manner that reduces the risk of perforating the duct as compared with the known techniques. [00:14:16] Speaker 00: So there's a clear tie there of prerasure, of the goal and what's been done, [00:14:23] Speaker 00: in the prior art and how he's trying to improve upon that with the brush. [00:14:29] Speaker 00: And then on two separate instances, talking about column two, and then again in column three, Dr. Fraumowitz goes ahead and he confirms that it is capable, the pressure brush is capable of reaching the submucosa. [00:14:46] Speaker 00: And that's really important because there's also been a little bit of a battle over the application of the in-ray Schreiber case. [00:14:54] Speaker 00: Appellant has an argument that this was a finding of inherency. [00:14:57] Speaker 00: And indeed, it was not. [00:14:59] Speaker 00: The board simply found that under the classic test of anticipation, one of skill in the art read the Parashar patent to include all of the limitations at issue. [00:15:13] Speaker 00: And the board also noted that the way the claims of the 044 patent are written to penetrate, that is [00:15:24] Speaker 00: functional language. [00:15:26] Speaker 00: And I believe in Inrei Schreiber, they're quoting a well-established case from the CCPA, which is Inrei Schweinhart, that when you claim in functional language, you run this risk that a piece of prior art that shows it is capable of that function, now it anticipates. [00:15:51] Speaker 00: The limitation would read on that piece of prior art. [00:15:54] Speaker 00: So I think that that's rather important. [00:15:59] Speaker 00: And again, this issue, this issue of whether Parashar reaches the submucosa, that's the only contested issue. [00:16:07] Speaker 00: There's a lot of noise about other things in the brief, about sufficient stiffness. [00:16:14] Speaker 00: That wasn't arguable. [00:16:17] Speaker 00: Patent owner never presented that. [00:16:19] Speaker 00: The sites in patent owner's brief where they say, hey, we argued sufficient stiffness, [00:16:23] Speaker 00: Those are just quotes to where they're parodying the entire claim limitation. [00:16:27] Speaker 00: But that claim limitation from the 044 patent appears in claim 1, claim 12, claim 26. [00:16:36] Speaker 00: Excuse me, it's only in claim 1, the sufficient stiffness claim. [00:16:40] Speaker 00: Their whole argument was only about whether the submucosal was reached. [00:16:45] Speaker 00: They never argued whether sufficient stiffness was met. [00:16:49] Speaker 00: The board noted that. [00:16:50] Speaker 00: The board said it was admitted. [00:16:52] Speaker 00: And the board also noted on footnote 18, which is on page A84 of the appendix, it noted in footnote 18 that there were many, and I'll use plural, many new arguments were brought up at the oral hearing, and those were not being considered. [00:17:15] Speaker 00: And that's one of them. [00:17:16] Speaker 00: So the sufficient stiffness argument's not properly before us here. [00:17:22] Speaker 00: The court on A86 made a factual finding with regards to Parashar's teaching of sufficient stiffness. [00:17:29] Speaker 00: So the board went ahead and said it's admitted. [00:17:32] Speaker 00: And even though it's admitted, here's why it's there. [00:17:34] Speaker 00: So I think the case is closed on that. [00:17:38] Speaker 00: Finally, when it comes to the estoppel issue, if these are separate proceedings, it's collateral estoppel. [00:17:46] Speaker 00: If they're the same proceeding, then it's law, the case. [00:17:52] Speaker 00: grossly misstates the 609 patent. [00:17:55] Speaker 00: They keep talking about how the claims of the 913 in the 609 patent are only to glandular epithelial tissue. [00:18:02] Speaker 00: That's not quite right. [00:18:04] Speaker 00: In the 609 patent claim four, while it does say glandular epithelial tissue, it then states that the brush of claim four in the 609 patent must reach the submucosa. [00:18:19] Speaker 00: That's the exact language. [00:18:21] Speaker 00: That's in the 044 patent. [00:18:23] Speaker 00: And that's why the findings are the same. [00:18:27] Speaker 01: When we look... Is it your view, if we agree with you and find substantial evidence for the board's fact findings with regard to Parashar, that we don't have to reach the collateral estoppel issue? [00:18:39] Speaker 01: Or do you see that as a predicate? [00:18:40] Speaker 01: Do we have to reach it? [00:18:43] Speaker 00: No, Your Honor. [00:18:43] Speaker 00: If you reach that there's substantial evidence, the case is over. [00:18:51] Speaker 00: But again, I just want to point out that it's not correct to say that these are not identical findings that the issues were actually litigated because they were. [00:19:09] Speaker 00: Claim 4 of the 609 patent requires that you go to the submucosa. [00:19:14] Speaker 00: That's the same exact finding. [00:19:16] Speaker 00: that was used in the 044 patent. [00:19:22] Speaker 03: So it's estoppel rather than collateral estoppel? [00:19:27] Speaker 03: I mean, law of the case? [00:19:29] Speaker 00: I believe it's collateral estoppel, Your Honor, because there is a case, and it is escaping my memory right now, but there is a recent case that says consolidated hearings at the board [00:19:44] Speaker 00: are still considered to be separate cases. [00:19:46] Speaker 00: So that's why we believe it's collateral estoppel. [00:19:50] Speaker 00: If they were viewed as one case, then it would be law of the case. [00:19:57] Speaker 00: With that, Your Honors, I think at the end of the day, we need do nothing further than look at how one of skill in the art reads Parascher with the focus on the issue of whether Parascher is capable of reaching the semi-cosa. [00:20:15] Speaker 00: One scale in the art testimony confirms this. [00:20:19] Speaker 00: The way Parashar uses its terms confirms this. [00:20:22] Speaker 00: And so based on substantial evidence, the board got it right, and the claims under review are invalid, and the United States endoscopy requests affirmance of that finding. [00:20:34] Speaker 03: Thank you. [00:20:35] Speaker 03: Okay. [00:20:35] Speaker 03: Thank you, Mr. Tucker. [00:20:41] Speaker 02: Thank you, Your Honor. [00:20:41] Speaker 02: So my colleague takes me to task because he says that reducing the risk of perforating the duct was mentioned more than once. [00:20:51] Speaker 02: I agree. [00:20:52] Speaker 02: It was mentioned several times. [00:20:54] Speaker 02: It's mentioned in the abstract. [00:20:57] Speaker 02: Parisher says, I don't want to perforate the duct. [00:21:02] Speaker 02: It's mentioned in the head of column two, don't perforate the duct. [00:21:08] Speaker 02: And it's mentioned where my colleague said, don't perforate the duct. [00:21:12] Speaker 02: What does that mean? [00:21:13] Speaker 02: That means the brush doesn't go to adjacent tissue. [00:21:17] Speaker 02: That means that what they relied on, what the board relied on, the whole crux of the board's case at column one, line 61 to 64, is not describing Parrish's brush. [00:21:28] Speaker 02: It can't. [00:21:29] Speaker 02: It says go to adjacent tissue. [00:21:32] Speaker 02: And yet, as my colleague points out, you don't want to go to adjacent tissue. [00:21:37] Speaker 02: You don't want to perforate the duck, because that's how you're going to get there. [00:21:41] Speaker 02: This is not describing Parrish's brush. [00:21:43] Speaker 02: This is the linchpin of the board's decision that you get to five layers. [00:21:48] Speaker 02: And when Dr. Fromlitz's testimony, his only testimony where he really said, yes, you'll go through everything, was when they asked him about this same language, language that describes the prior art forceps technique that they were trying to improve on, not language that [00:22:06] Speaker 02: describes Parashar's brush. [00:22:07] Speaker 01: Can I ask you a factual question? [00:22:09] Speaker 01: Yes. [00:22:10] Speaker 01: Do you have to perforate the duct to be able to collect samples from the submucosa? [00:22:18] Speaker 02: You don't have to, but that was the argument that Petitioner made in their brief. [00:22:23] Speaker 02: They looked at this language. [00:22:24] Speaker 01: But it's possible, though, that Parashar discloses a brush capable of collecting cells from the submucosa [00:22:33] Speaker 01: consistent, though, with its goal of trying to avoid perforating the duck? [00:22:38] Speaker 02: The problem with that is that there's no teaching anywhere in Parasher. [00:22:43] Speaker 02: And the board went through this and tried to find it, where you could find that fact. [00:22:48] Speaker 02: And the only way they could find that fact was to go to the background of the invention. [00:22:53] Speaker 02: And that's the error. [00:22:56] Speaker 02: On Henry Schreiber, the case doesn't apply, because [00:23:00] Speaker 02: In reshriver to apply, you have to show that the prior art device is identical in construction, and therefore must function the same way. [00:23:10] Speaker 02: There's not evidence that it's identical in construction in this case. [00:23:14] Speaker 02: That was the whole argument in the case. [00:23:17] Speaker 02: And this argument about glandular epithelium, as our own expert admitted, glandular epithelium doesn't have five layers. [00:23:26] Speaker 02: So the fact that in the 609 claim three or four that he was talking about, that we went through glandular epithelium, that doesn't help. [00:23:35] Speaker 02: It's a different tissue. [00:23:36] Speaker 02: It doesn't have five layers. [00:23:38] Speaker 02: And their expert admitted that. [00:23:46] Speaker 02: Here, the board just made a mistake with the reference. [00:23:49] Speaker 02: The mistake was then compounded when they relied on Dr. Fromlitz's testimony. [00:23:55] Speaker 02: And they asked him about that same prior language. [00:23:58] Speaker 02: And that's where he said, yes, it would definitely go all the way through. [00:24:00] Speaker 02: And that's what they're hanging their hat on. [00:24:04] Speaker 02: You have no more questions? [00:24:07] Speaker 03: Thank you. [00:24:08] Speaker 03: Thank you. [00:24:08] Speaker 03: Thank you, Mr. George and Mr. Tucker. [00:24:10] Speaker 03: The case is taken on.