[00:00:00] Speaker 02: ortho Excel technologies. [00:00:04] Speaker 02: I'm not saying you're appearing in front of me a lot, Mr. Carpenter, but I liked your tie better yesterday. [00:00:45] Speaker 04: Yes, please. [00:00:51] Speaker 00: Good morning. [00:00:52] Speaker 00: You may please report. [00:00:53] Speaker 00: I'm Paul Storm here on behalf of OrthoExcel. [00:00:57] Speaker 00: We are appealing the decision by Judge Seaborg to deny OrthoExcel's motion for plenary injunction on the basis that OrthoExcel had not established a likelihood of success on the merits with respect to validity. [00:01:11] Speaker 02: On page nine of the blue brief, [00:01:13] Speaker 02: You say that one of the issues in the case is whether Propel's expert impermissibly premised his testimony on only a portion of the relevant record and on false statements. [00:01:29] Speaker 02: What record evidence supports the statement that he based his testimony on false statements? [00:01:45] Speaker 01: It's on Appendix 1376. [00:01:51] Speaker 00: This is the second declaration. [00:02:04] Speaker 00: I'll let you get to it to give a little context. [00:02:07] Speaker 00: It's the second declaration by Dr. Yadav. [00:02:10] Speaker 00: It's in response. [00:02:11] Speaker 02: I meant lines one through [00:02:13] Speaker 02: Six, I have underlined. [00:02:15] Speaker 00: Right. [00:02:15] Speaker 00: It actually starts on 1375. [00:02:19] Speaker 00: At the bottom of 1375, Dr. Yadav says, as an initial matter, the priority documents do not disclose the combination of 20 minutes and 40 hertz, the first premise of Dr. Brunske's analysis. [00:02:31] Speaker 00: That statement is false. [00:02:35] Speaker 00: Now, I will point you to the basics. [00:02:37] Speaker 00: If you go to appendix page 590, [00:02:47] Speaker 00: Finish page 590 is a portion of the provisional application, which is the earliest document in the chain of priority. [00:02:58] Speaker 00: There's a full paragraph in the middle of the page. [00:03:03] Speaker 00: And the paragraph describes a device to apply cyclical forces and concludes with, the present invention embodied as the device described here repeats this cycle at a frequency of up to about 40 hertz. [00:03:18] Speaker 00: The next paragraph says, upon completion of one 20-minute duration of activation, the device automatically shuts off, clearly referring to the device in the previous paragraph indicated to operate at up to about 40 hertz. [00:03:32] Speaker 00: So when he says, when Dr. Yadav says the priority documents do not disclose the combination of 20 minutes and 40 hertz, that statement is false. [00:03:45] Speaker 00: on Appendix Page 1376. [00:03:47] Speaker 02: My recollection is that, in fact, there's something that says 1 to 20 minutes. [00:03:52] Speaker 02: Is that incorrect? [00:03:56] Speaker 00: The claim element at issue is 1 to 20 minutes daily. [00:04:01] Speaker 00: Uh-huh. [00:04:01] Speaker 00: Yes. [00:04:02] Speaker 00: These two sentences don't say 1 to 20 minutes daily. [00:04:04] Speaker 00: That's part of the issue in this appeal. [00:04:07] Speaker 00: These two statements say that there is an example at 20 minutes operating at 40 hertz. [00:04:13] Speaker 00: And Dr. Goddard said there is no [00:04:15] Speaker 00: example, 20 minutes at 40 hertz. [00:04:18] Speaker 00: So he's not correctly and in fact is falsely describing the priority documents, which goes to the question of whether Propel ever raised a substantial question of validity. [00:04:30] Speaker 00: The court's opinion does not cite to Dr. Yadav or in any way articulate that they did raise a substantial question of validity [00:04:39] Speaker 00: at that point the presumptive ability would prevail. [00:04:41] Speaker 04: You make some statements, so what's the case which says you need an expert? [00:04:48] Speaker 04: The other side would need an expert here? [00:04:51] Speaker 04: I think I said they need evidence. [00:04:53] Speaker 04: Is there a case that you can cite me that they need an expert? [00:04:57] Speaker 00: I don't think they have to have an expert. [00:04:59] Speaker 00: They have to have evidence outside the public record. [00:05:02] Speaker 00: But the presumption, because tight and tight. [00:05:03] Speaker 04: Okay, tell us why there has to be, I mean, what if we can decide the case based on reading the claims on the specification and the intrinsic record? [00:05:12] Speaker 04: Do you still need extrinsic evidence? [00:05:15] Speaker 00: I don't believe that you can decide the case based on just the intrinsic record, except in that narrow situation where you conclude that the claim element is totally absent from the specification. [00:05:26] Speaker 00: That's because, two things, the presumption of validity starts with [00:05:30] Speaker 00: The patent, when it issues, is presumed valid. [00:05:33] Speaker 04: So what is your statement? [00:05:34] Speaker 04: That you need extrinsic evidence in order to deal with the written description question in the context of preliminary injunction? [00:05:45] Speaker 00: Yeah, because the challenger, first off, it's clear. [00:05:49] Speaker 00: And I would cite the tightened tires again. [00:05:51] Speaker 00: Tightened tires specifically says, [00:05:53] Speaker 00: that unless there's a challenge, the presumption of validity is adequate. [00:05:58] Speaker 04: If they don't challenge it, it's a valid patent. [00:06:02] Speaker 04: How does that take us to the fact that they have to put on extrinsic evidence? [00:06:07] Speaker 00: Because the presumption of validity flows from the intrinsic record. [00:06:11] Speaker 00: So when the patent issues, we all know what the intrinsic record is. [00:06:15] Speaker 00: It's the claims, the specification, and the prosecution history, the priority leading up to those claims. [00:06:21] Speaker 00: That intrinsic record [00:06:22] Speaker 00: gets to the presumption ability. [00:06:24] Speaker 00: That's where the presumption ability comes from. [00:06:26] Speaker 00: And it's sufficient unless challenged. [00:06:29] Speaker 00: And the challenge has to be clear and convincing evidence. [00:06:31] Speaker 00: We all know that. [00:06:33] Speaker 00: So there has to be evidence other than the intrinsic record to raise that challenge. [00:06:40] Speaker 00: There was a couple of cases that were cited that we pointed out unless there's a claim element. [00:06:46] Speaker 00: It is totally absent, and that's not this case at all. [00:06:49] Speaker 02: Your expert is Dr. Brensky? [00:06:51] Speaker 02: Brensky, yes. [00:06:52] Speaker 02: He's not a person of skill in the art, correct? [00:06:54] Speaker 00: He is a person of skill in the art. [00:06:55] Speaker 02: Not by his definition. [00:06:57] Speaker 00: Well, if you look at his credentials, and I'll point you to... No, that's not what I'm asking. [00:07:02] Speaker 02: Not by his definition, is he? [00:07:04] Speaker 00: He is not an orthodontist. [00:07:06] Speaker 02: You're right. [00:07:07] Speaker 02: So he's not a person of skill in the art. [00:07:08] Speaker 00: I believe that he is a person of skill in the art, but not by his definition, and that's because of his background and training. [00:07:15] Speaker 02: So what you've answered, what you've answered me is, he's not a person of skill in the art by his definition. [00:07:22] Speaker 02: That's correct. [00:07:25] Speaker 00: But we didn't need to get to Dr. Bronski's testimony unless essentially a substantial question was raised. [00:07:33] Speaker 00: If you look at the court's opinion, the court does not cite to any of the evidence [00:07:39] Speaker 00: that Propell brought forward. [00:07:44] Speaker 00: In fact, I would point the Court's attention to the opinion because he doesn't give any credence to the presumption of validity on Appendix Page 25, which is where he really, the Court begins talking about the question in detail. [00:08:05] Speaker 00: For example, at the bottom of Page [00:08:07] Speaker 00: Pennings 25, of course, says, various references to the possibility of using time periods somewhat longer or shorter than 20 minutes carry no hint that time periods as short as a minute or two might suffice. [00:08:22] Speaker 00: Well, kind of mixing up two different things. [00:08:25] Speaker 04: This case is a little bit unusual only because the validity issue is tied to the priority question. [00:08:31] Speaker 04: So they come in and they say, there's prior art that anticipates. [00:08:37] Speaker 04: They've made a case of invalidity, which you don't even dispute. [00:08:42] Speaker 04: The only question is you come back and you say, well, no, no, no, no, no, that prior art doesn't invalidate because we've got a priority date, right? [00:08:51] Speaker 04: That's this case. [00:08:52] Speaker 00: That's close, but I believe that they have to carry the burden on the written description in order to meet that priority. [00:08:58] Speaker 00: So we don't stipulate that the priority documents fail the written description. [00:09:03] Speaker 00: Therefore, we are not stipulating that they are prior art. [00:09:06] Speaker 00: that invalidates these claims. [00:09:08] Speaker 00: They have the burden to show that there's a failure of written description in order to get into the challenge. [00:09:14] Speaker 04: So they have to show that there's no written description for the... In the priority document. [00:09:22] Speaker 00: So we don't dispute the dates and the filing dates and the other parts. [00:09:26] Speaker 00: But we obviously vigorously disputed the written description requirement. [00:09:32] Speaker 00: And you're right, I was somewhat pointing to another mistake that the court made. [00:09:36] Speaker 00: At the bottom of page 25, appendix page 25, where the court says there's no hint at these other times, he then cites to Purdue Pharma, a case I'm sure you're familiar with, that if you disclose a forest, you need something to point to the tree. [00:09:52] Speaker 00: That is a challenge to this written description not raised by Propel. [00:09:56] Speaker 00: If you read Dr. Yadav's testimony, he is very clear that in his view, the written description discloses about 20 minutes daily [00:10:05] Speaker 00: and nothing else. [00:10:06] Speaker 00: He disregards. [00:10:07] Speaker 00: So other points to your original question, he disregards the portion that says or longer or shorter or other frequency. [00:10:15] Speaker 00: That's repeated several times. [00:10:17] Speaker 00: He disregards the different frequencies. [00:10:19] Speaker 04: So your view is if you have an expert and he only deals with one aspect, one phrase in the written description, the district court judge can't read [00:10:30] Speaker 04: the other phrases in there and deal with them too or consider them? [00:10:33] Speaker 00: I don't understand the point you're making. [00:10:35] Speaker 00: This issue about Dr. Brunske goes straight to that question because the district court's not a person of ordinary skill. [00:10:40] Speaker 00: He's much farther afield from a person of ordinary skill than Dr. Brunske. [00:10:45] Speaker 02: Let me cut to, I think, is the chase. [00:10:47] Speaker 02: Sure. [00:10:47] Speaker 02: How does about 20 minutes, which is in the application of provisional application, support the range 1 to 20 minutes and claim 10? [00:10:57] Speaker 00: It does not. [00:10:58] Speaker 00: the two words or three words, about 20 minutes, taken in isolation, do not support one to 20 minutes. [00:11:05] Speaker 00: We haven't argued that they do. [00:11:07] Speaker 00: What we've argued is basically two-step analysis, if you will, that that is not remotely the limit of this disclosure. [00:11:15] Speaker 00: That this disclosure, when you read the entire disclosure, both patents, that is the provisional application and the utility application together, it is very clear that the inventor had a broad view of what they were up to. [00:11:27] Speaker 00: numerous broad statements about what it is they're trying to do. [00:11:30] Speaker 00: There's a statement about the fact that they're trying to do something that is shorter than what has been done before. [00:11:37] Speaker 00: There are specific statements that it's about 20 minutes or longer or shorter or other frequency, meaning it doesn't even have to be every day. [00:11:44] Speaker 00: They're clearly disclosing that they have a broader view than about 20 minutes. [00:11:50] Speaker 00: So step one of this inquiry is the disclosure as a whole [00:11:54] Speaker 00: That clearly shows that the inventor was not limiting themselves to about 20 minutes. [00:11:59] Speaker 00: And that's part of the challenge in Dr. Yadav. [00:12:01] Speaker 00: He just ignored all of that. [00:12:03] Speaker 04: Well, you're just saying that under Purdue Pharma, whatever, if the inventor thinks he wants to claim – he wants to get the whole forest, that somehow is sufficient. [00:12:12] Speaker 04: His intent is to get the whole forest because he has vague references to all of this. [00:12:17] Speaker 00: That doesn't do it under our case law, does it? [00:12:19] Speaker 00: It does not. [00:12:20] Speaker 00: That's why I said it's a two-step analysis. [00:12:21] Speaker 00: This is step one. [00:12:22] Speaker 00: Step one is we're talking about what are the edges of the forest, not the 20-minute tree that Dr. Yadkov sees. [00:12:29] Speaker 00: So the court only had the presumption of validity. [00:12:34] Speaker 00: So what's step two? [00:12:35] Speaker 00: Step two is Dr. Brunski's analysis that works through the entire disclosure that shows that in the provisional application, there is an exact [00:12:43] Speaker 00: sample that shows 40 hertz and 20 minutes. [00:12:46] Speaker 00: We just pointed to that directly. [00:12:48] Speaker 00: Then in the utility application, the inventors disclosed the use of 0.1 to 400 hertz. [00:12:54] Speaker 00: They disclosed it three different times. [00:12:55] Speaker 00: One of them is at 20 minutes. [00:12:57] Speaker 00: The other two times is not limited to any particular duration. [00:13:01] Speaker 00: And Dr. Brunske explains that when you look at the range of frequencies and the fact that it's a broad disclosure, what duration would you expect to come from those use of frequencies? [00:13:12] Speaker 00: And he explains how he gets to one minute from that. [00:13:14] Speaker 00: So he uses his skill in the bone reformation area to explain how the specific frequency ranges, examples, and broad disclosure taken together. [00:13:27] Speaker 02: What's the impact of concession that he's not a person of skill in the art? [00:13:35] Speaker 00: Then you would have to look at his disclosure and decide for yourself whether that evidence, if you conclude [00:13:41] Speaker 00: that you have to get there, that the presumptive village is not good enough, that a substantial question has been raised, then you have to look at the disclosure of his testimony itself to determine what the credibility to provide it. [00:13:53] Speaker 00: I think even though he's not an orthodontist, his testimony is quite useful as to how a person of ordinary skill would read these documents, even though he himself is not a person of ordinary skill by his definition. [00:14:06] Speaker 00: You're into your rebuttal, so why not get to the other side? [00:14:16] Speaker 03: May it please the Court and good morning, Your Honors. [00:14:18] Speaker 03: Christopher Schultz for the Appellee Propel. [00:14:22] Speaker 02: Tell us about Dr. Brunske. [00:14:24] Speaker 02: It's conceded he's not a person of skill in the arts. [00:14:28] Speaker 02: Is he an expert in the field? [00:14:30] Speaker 03: No, he's not, and that's an argument we made to the District Court and to Your Honors in this field. [00:14:35] Speaker 02: Why not? [00:14:37] Speaker 02: Because he defined... He's not a posita. [00:14:40] Speaker 02: Everybody agrees, not a person's skill in the art. [00:14:43] Speaker 02: But does he have general expertise? [00:14:45] Speaker 02: I mean, he's got a lot of stuff on his CV. [00:14:47] Speaker 03: He's a metallurgist, so I would say no. [00:14:50] Speaker 03: He has experience in dental implants, I believe, and the metallurgist background probably plays into that, what materials you use. [00:14:57] Speaker 03: But in terms of having... We're talking about braces, we're talking about aligners, we're talking about orthodontic treatment, in terms of skill in that area, [00:15:06] Speaker 03: I didn't see any of that, and that's why we made the point. [00:15:09] Speaker 03: So they say you need expert testimony, which to your honor's point, I'm not sure there is a case that says that, but if they're right about that, they have no expert, and I think you just heard counsel admit that. [00:15:20] Speaker 03: But the most compelling evidence in this case, and Ariad says you need to look within the four corners of the document, of the priority documents. [00:15:30] Speaker 03: The inventor in the provisional application said use zero to 40 hertz [00:15:36] Speaker 03: with about 20. [00:15:38] Speaker 03: When he filed the parent application, he apparently came to the realization that a broader range of frequencies was appropriate. [00:15:46] Speaker 03: He went from 0 to 40 to 0.1 to 400 times tenfold. [00:15:55] Speaker 03: Tellingly, what did he do with respect to duration? [00:15:58] Speaker 03: He again said, about 20. [00:16:02] Speaker 03: He demonstrated to one skilled in the hour reading these documents. [00:16:05] Speaker 03: Your learned opponent says, all through there, it says shorter periods. [00:16:11] Speaker 03: It does not say shorter. [00:16:12] Speaker 03: It says shorter or longer, and it says any suitable duration. [00:16:17] Speaker 03: That's all it says, isn't it? [00:16:20] Speaker 03: That's no better than the boilerplate in the D3 enterprise cases that their expert also relies on, which is the [00:16:27] Speaker 03: paragraph that's cut and pasted into virtually every patent application that we read and every issued patent, it provides no guidance to one skill in the art to one to 20 minutes. [00:16:42] Speaker 04: I don't want to make a big deal of this, but footnote five of your brief is quite unusual. [00:16:49] Speaker 04: Is it an intact case, Your Honor? [00:16:51] Speaker 04: Yeah, and that [00:16:54] Speaker 04: Yeah, you're asking us. [00:16:56] Speaker 04: I mean, there's nothing before us. [00:16:57] Speaker 04: There's no motion to resolve. [00:17:02] Speaker 04: I don't even understand how we would do that. [00:17:05] Speaker 04: We would say, this patent is invalid. [00:17:08] Speaker 04: And how did they have notice of that and the opportunity to argue that? [00:17:14] Speaker 04: It's a different issue, as we recognize here. [00:17:17] Speaker 04: Most of this stuff, rightly or wrongly, has been on what burdens [00:17:22] Speaker 04: exist in the preliminary injunction stage. [00:17:24] Speaker 04: So I don't understand what you're asking for or how we could do that. [00:17:28] Speaker 03: In the Genentech case, the authority of this court is cited, Judge Lurie reversed a preliminary injunction order and invalidated the patent, suesponte, because it did not enable the invention. [00:17:48] Speaker 03: So similar 112 first paragraph issue. [00:17:52] Speaker 03: The finding he made to do that was that there was no further evidence the parties could submit on the issue that could change it. [00:18:00] Speaker 03: And I submit that's where we are here. [00:18:03] Speaker 03: We've had depositions. [00:18:05] Speaker 03: We've had expert declarations. [00:18:06] Speaker 03: We've had a hearing. [00:18:07] Speaker 03: We have a parallel IPR. [00:18:09] Speaker 03: We have a federal circuit appeal. [00:18:13] Speaker 04: Well, at this point, we have an expert declaration that we're kind of questioning whether we ought to discount because it wasn't even a person skilled in the art. [00:18:21] Speaker 04: That doesn't mean that during a trial, look, I have absolute sympathy. [00:18:27] Speaker 04: I know you've got a client who is looking at, even if you prevail here, going through an entire trial. [00:18:33] Speaker 04: And your hope and probably your belief is at the end of the day, this case is going to go down on written description in any event. [00:18:41] Speaker 04: I just think it's quite a sort of exceptional ask on your part at this juncture. [00:18:47] Speaker 03: There's no doubt it is exceptional, extraordinary relief [00:18:51] Speaker 03: We did put it in a footnote and. [00:18:53] Speaker 04: Which I'm not sure how that, what, you know, we have a lot of, we have a lot of cases that talk about what footnotes mean and what they don't. [00:19:01] Speaker 04: But anyway, okay. [00:19:01] Speaker 04: Let me, I don't want to belabor this. [00:19:03] Speaker 04: I apologize. [00:19:04] Speaker 04: I just really was taken aback a bit. [00:19:08] Speaker 03: Yes, your honor. [00:19:09] Speaker 03: And the, the Purdue farmer case, which is discussed, I believe controls the issue, which is the forest they disclose is any suitable duration. [00:19:19] Speaker 03: The tree is one to 20 minutes. [00:19:22] Speaker 03: And they disclose no blaze marks to get you to one to 20 minutes. [00:19:27] Speaker 03: Well, the problem is it's a forest with only one tree in it. [00:19:32] Speaker 03: Well, they also rely on these catch-all statements, any suitable duration. [00:19:38] Speaker 03: And this court has repeatedly said... The increased megahertz and decreased megahertz, I suppose. [00:19:45] Speaker 04: What's the status of this case? [00:19:47] Speaker 04: Is it just stalled? [00:19:49] Speaker 04: in light of this preliminary injunction, or have things proceeded? [00:19:52] Speaker 03: It has stayed pending a parallel IPR, which we argued two weeks ago at the Board of Patent Appeals. [00:19:59] Speaker 03: Oh, OK. [00:19:59] Speaker 03: And it's the same issue, Your Honor. [00:20:02] Speaker 04: On an IPR written description? [00:20:04] Speaker 03: Yes. [00:20:05] Speaker 03: Well, it's a priority plan. [00:20:07] Speaker 03: Oh, I see. [00:20:08] Speaker 03: It's technically out of anticipation. [00:20:11] Speaker 03: But yes, the written description comes into it. [00:20:14] Speaker 03: And with that, Your Honor, the district court [00:20:17] Speaker 03: found that the priority documents carry no hint of one duration as low as one minute. [00:20:24] Speaker 03: And the appellant has done nothing to show that that's a clearly erroneous finding. [00:20:29] Speaker 03: And I have nothing further unless the court has questions. [00:20:33] Speaker 04: Thank you. [00:20:41] Speaker 00: It looks like I've got a minute 46. [00:20:42] Speaker 00: I'll be fast. [00:20:44] Speaker 00: With respect to the Genentech question, the party stipulated the record was closed. [00:20:47] Speaker 00: We don't stipulate to that, obviously. [00:20:49] Speaker 00: And with respect to this issue about Dr. Brunski, certainly the case is... Wait, I'm sorry. [00:20:54] Speaker 00: I didn't understand what you said. [00:20:55] Speaker 00: With respect to the issue about Dr. Brunski, as to whether he's a person or a nurse... No, no, no, no. [00:20:59] Speaker 04: You started by saying the party stipulated that the record is closed, but we don't stipulate? [00:21:04] Speaker 00: In the Genentech case where they... Oh, okay. [00:21:07] Speaker 00: Yes. [00:21:08] Speaker 00: That's the distinction between that case and this one. [00:21:11] Speaker 00: With respect to Dr. Brunski, we obviously, if there's any question about his ability to testify from the perspective of a person of ordinary skill, even though he's not himself an orthodontist, we certainly will get an expert that will not have that problem. [00:21:22] Speaker 00: That is not in this record. [00:21:26] Speaker 00: Mr. Schultz talked about other things in the record, like depositions have been taken. [00:21:29] Speaker 00: There are things that are in the IPR record that are not in this record that I haven't referred to, that we believe support our position, that there is written description support. [00:21:37] Speaker 00: I don't think it's proper for me to argue to you things not in this record, so I haven't. [00:21:41] Speaker 00: But certainly, there is a record to be developed. [00:21:45] Speaker 00: With respect to the question of blaze marks, I want to point your attention to appendix page 578 and 579, because this has been overlooked somewhat, the entire statement. [00:21:57] Speaker 00: The provisional application says in a paragraph, the proposed invention would be worn for approximately 20 minutes daily, but could be worn for longer or shorter periods of time, both more or less frequently, meaning not necessarily every day. [00:22:12] Speaker 00: It goes on to say, it represents the first time. [00:22:14] Speaker 02: How do we know it means that? [00:22:16] Speaker 00: It's just parsing the sentence. [00:22:18] Speaker 00: Proposed intervention could be worn for approximately 20 minutes daily. [00:22:22] Speaker 00: So there's a 20 minute duration of use and a daily frequency of use. [00:22:27] Speaker 00: Could be worn for longer, shorter periods of time. [00:22:29] Speaker 00: That refers to the 20 minutes. [00:22:31] Speaker 00: And both more or less frequently refers to the daily. [00:22:34] Speaker 00: So that's how you get that. [00:22:36] Speaker 00: If I can finish the sentence, then I'll be out of time. [00:22:39] Speaker 00: The point, the next sentence says, it represents the first time that medical device requiring such modest wear duration and related orthonic tooth movement and bone, et cetera, has been disclosed. [00:22:49] Speaker 00: So they're pointing to shorter rather than longer. [00:22:52] Speaker 00: And the rest of the discussion by Dr. Bronski explains the entirety into the 1 to 20 minutes. [00:22:58] Speaker 00: Thank you. [00:22:59] Speaker 00: We thank both sides. [00:23:00] Speaker 00: And the case is submitted.