[00:00:00] Speaker 02: Four arguments this morning. [00:00:02] Speaker 02: The first is number 21, 2138. [00:00:05] Speaker 02: Sunova AG versus Med-El Electro. [00:00:11] Speaker 01: Mr. Cernel. [00:00:12] Speaker 01: Go ahead. [00:00:15] Speaker 01: May it please the court. [00:00:16] Speaker 01: Mark Cernel on behalf of Sunova. [00:00:19] Speaker 01: This is an appeal about an invention whose novel feature was described as revolutionary. [00:00:26] Speaker 01: A fundamental design shift from all of the prior art [00:00:30] Speaker 01: a design approach that revolutionized cochlear implants at the time it was implemented. [00:00:36] Speaker 01: These were the words of Apple Lee Medell when they implemented the novel feature into their product. [00:00:43] Speaker 04: Can I just double check something? [00:00:44] Speaker 04: All of that language was about the product with the magnets in a casing that allowed the free rotation in an MRI. [00:00:54] Speaker 04: And the casing is not part of the claim here, right? [00:00:57] Speaker 01: I believe that the [00:00:59] Speaker 01: That language actually ties directly to the use of a diametric magnet. [00:01:05] Speaker 01: But if it's the diametric magnet plus the casing that allows the rotatability, right? [00:01:11] Speaker 01: Again, I think you'd have to have it inside the implant, inside a casing, to have it in the implant at all or have it rotate. [00:01:19] Speaker 01: But we can point to, and if you'd like me to just give a couple of examples now, when it talks about the fundamental design shift, this is appendix 1932. [00:01:28] Speaker 01: But it all has to do with rotatability, right? [00:01:31] Speaker 01: I don't think it does. [00:01:33] Speaker 01: And if, for example, appendix 1932, a fundamental design shift was the direction of the magnetization of the implant's internal magnet, diametric instead of axial. [00:01:46] Speaker 01: When they launched the product, [00:01:47] Speaker 01: They didn't call out rotatability. [00:01:50] Speaker 01: They said, unlike other cochlear implants, this is appendix 1928. [00:01:53] Speaker 01: It uses a diametric magnet. [00:01:57] Speaker 01: Appendix 1482. [00:02:00] Speaker 01: What makes the MED-EL SYNCHRONY cochlear implant design unique? [00:02:05] Speaker 01: And the first thing they say, they hit upon the idea of a diametric magnet. [00:02:10] Speaker 01: And so I think when you look carefully at all of this evidence, and again, it comes up in the secondary considerations, but I think it answers directly the question of whether a diametric magnet is obvious. [00:02:23] Speaker 01: It is specifically calling out diametric magnet, not just simply talking about the product, not talking just about rotatability, calling out the diametric magnet specifically. [00:02:34] Speaker 01: And there's more than that. [00:02:37] Speaker 01: So what I think happened here is that the board failed to faithfully follow this court's precedent, developed to guard against the temptation of using hindsight to find obvious, obviousness. [00:02:51] Speaker 01: The board made legal errors in both the prima facie analysis as well as the consideration of the secondary indicia, some of which we just talked about, and fell into the trap of using hindsight to construct an obviousness combination. [00:03:05] Speaker 01: So what was that combination? [00:03:07] Speaker 01: The dormer reference was the primary reference. [00:03:09] Speaker 01: That's a cochlear implant reference. [00:03:11] Speaker 01: We acknowledge that's [00:03:12] Speaker 01: That's analogous art to the Schmid patent. [00:03:15] Speaker 01: 1982 patent, what's important about that is one, where it uses its magnets, they're all axially aligned. [00:03:22] Speaker 01: And then two, the reason it's being used in the obviousness combination is they're relying on the ring embodiment. [00:03:31] Speaker 01: And as your honors know from looking at Dormer, there's a single sentence mentioning this ring. [00:03:36] Speaker 01: It talks about other things that might be feasible, mentions the ring embodiment. [00:03:40] Speaker 01: I thought the ring embodiment didn't show whether it was actually or diametrically magnetic. [00:03:47] Speaker 01: So the ring embodiment, again, is mentioned in a single sentence. [00:03:50] Speaker 01: Am I correct? [00:03:52] Speaker 01: What I would say is this court's case law suggests that we need to look at the reference. [00:03:56] Speaker 02: No, no, no. [00:03:57] Speaker 02: You're not answering my question. [00:03:59] Speaker 02: I ask you a simple question. [00:04:01] Speaker 02: The ring embodiment in Dormer doesn't show whether it's axially or diametrically magnetized. [00:04:08] Speaker 01: Correct. [00:04:08] Speaker 01: There are no details describing the ring embodiment. [00:04:11] Speaker 02: You have to answer the question, not some other question that you'd like to talk about. [00:04:14] Speaker 01: So I would agree with your honor. [00:04:16] Speaker 01: There is no discussion of the details of the magnetization of the ring embodiment. [00:04:20] Speaker 01: In fact, no details at all about that embodiment. [00:04:24] Speaker 01: But this court's case law tells us that we need to look at a reference as a whole. [00:04:27] Speaker 01: And when we look at the references as a whole, all of the embodiments where there is detail provided has that detail showing an axially aligned magnet. [00:04:38] Speaker 01: And in fact, when we look at the prior art as a whole, the entire landscape of prior art, all cochlear implants, all hearing implants, all implantable devices, according to Medel, [00:04:49] Speaker 01: all used axially aligned magnets for this transcutaneous communication function, for a holding function of an implant and then an external device that it's communicating with. [00:05:01] Speaker 01: And so to suggest that somehow this is a design choice type of situation where a person of skill in the art would have had multiple choices that they would have thought about and selected one [00:05:13] Speaker 01: as the preference for a particular situation is just totally inconsistent with the record of both Dormer as well as the entire landscape of prior art, which only used axially aligned magnets. [00:05:28] Speaker 01: And then, so what was the combination? [00:05:30] Speaker 01: The combination was looking at Dormer and then saying, okay, let's use the diametric magnet from Goldberg. [00:05:37] Speaker 01: But how does Goldberg, again, a 1970s reference, [00:05:41] Speaker 01: using a magnet for a completely different purpose than this transcutaneous communication function, this holding function to hold coils in place. [00:05:50] Speaker 01: It's using a magnet as essentially a wrench to turn a heart pacemaker potentiometer, and it's not sort of attached and then creating any kind of electrical signal or communication. [00:06:03] Speaker 01: It's simply a wrench that turns [00:06:05] Speaker 01: the potentiometer and changes something. [00:06:09] Speaker 01: So Goldberg is not solving any problem or even using the magnet in the same way that Dormer does. [00:06:17] Speaker 01: It is for a completely different purpose. [00:06:18] Speaker 01: And so what the board did is to say, okay, well, we take Goldberg's diametric magnet and then apply that to Dormer. [00:06:26] Speaker 01: I would suggest, again, this is not a design choice type of case. [00:06:30] Speaker 01: The ring embodiment is just simply a throwaway sentence at the end of the reference. [00:06:34] Speaker 01: Dormer teaches axial. [00:06:35] Speaker 01: The question is, would a person's skill in the art be motivated to change Dormer, change this axial alignment that, again, was universal throughout? [00:06:45] Speaker 04: Is that really the language? [00:06:47] Speaker 04: We wouldn't ordinarily use the language of picking one teaching of a single piece of prior art as changing the prior art. [00:06:59] Speaker 01: I think it's a modification. [00:07:02] Speaker 02: a modification if the actual body doesn't show the whether it's actually are diametrically magnetized it's providing uh... which affect station this again it's a single sense and correct i i would suggest that this court's case law says we look at your own about the case lawyers you it's applying [00:07:29] Speaker 02: a magnetization that's missing in Dormer. [00:07:32] Speaker 01: It is absolutely missing in Dormer. [00:07:35] Speaker 01: Dormer says nothing about diametric magnetization. [00:07:38] Speaker 01: uh... or actual for the for the ring about it but it certainly teaches axial like again for decades all cochlear implants used axial all hearing implants all implantable devices used axial create this alignment for transcutaneous communication device and so we're going against the entire grain [00:08:00] Speaker 01: of prior art. [00:08:02] Speaker 01: The board even found that it went against the conventional wisdom of using axially aligned magnets to then go to diametric with Goldberg. [00:08:11] Speaker 01: And again, Goldberg is not using in the same way. [00:08:14] Speaker 01: It's using it as a wrench. [00:08:16] Speaker 01: And so this combination that the board comes up with, we would suggest, is in fact all drawbacks and no benefits. [00:08:25] Speaker 01: And so this court's case law suggests that when we look at an obviousness combination, [00:08:30] Speaker 01: There needs to be motivation. [00:08:31] Speaker 01: There needs to be desirability shown in terms of why would someone have done this at the time. [00:08:37] Speaker 01: And with the ring embodiment, if we think about this, it's actually undisputed and the board found that to start with the ring, the ring is going to be outside the coils of the cochlear implant. [00:08:48] Speaker 01: And so just starting out with the ring, you're getting something that's bigger in terms of a footprint than when you put the magnet inside the coils. [00:08:58] Speaker 01: We would suggest the person's skill in the art wouldn't even be motivated to start with the ring and bottom. [00:09:02] Speaker 01: And I understand that this court's case law hasn't really answered that question of whether the starting point, you need to show motivation and desirability at the starting point. [00:09:11] Speaker 01: We would suggest the proper reading of the case law does support that, where you need to look at things, all steps of the obviousness analysis from the perspective of a person's skill. [00:09:22] Speaker 01: And this court's case will also says, and has reminded WBIP, personal web via Apple, saying that the motivation and desirability needs to be shown for picking out the references and combining them, selecting the references and combining them. [00:09:37] Speaker 01: I would suggest that a person's feeling the art would not have been motivated, not find it desirable to use this ring embodiment where you're starting out with something that's increasing the size. [00:09:47] Speaker 01: of something you're putting between the skin and the skull. [00:09:51] Speaker 00: Are you making an argument of teaching away here? [00:09:53] Speaker 01: Not a teaching away. [00:09:55] Speaker 01: And again, there's no teaching away evidence here because no one was thinking about diametric at the time. [00:10:02] Speaker 01: Again, we've got decades of prior art [00:10:04] Speaker 01: We've got 1970s, 1980s reference for a patent that's then 2002. [00:10:10] Speaker 01: No one is mentioning diametric as an option and so there's no teaching away of diametric because it wasn't even in anyone's mind. [00:10:18] Speaker 01: And so then this question of is it obvious, is it desirable to go from the ring in Dormer and supply the diametric of Goldberg [00:10:28] Speaker 01: And I would suggest that, again, that's just all drawbacks, no benefits, no showing of desirability by the board. [00:10:36] Speaker 02: What drawbacks? [00:10:37] Speaker 02: That sounds like teaching away. [00:10:39] Speaker 01: What's the drawback? [00:10:39] Speaker 01: Well, there's all drawbacks in terms of the motivation. [00:10:42] Speaker 01: And so, again, no one thought to do this. [00:10:45] Speaker 01: No one did it. [00:10:45] Speaker 01: What do you mean drawbacks? [00:10:47] Speaker 01: Drawbacks in terms of size. [00:10:49] Speaker 01: It was undisputed that, obviously, when you have an implant, you're putting it in someone's head. [00:10:53] Speaker 02: But drawbacks in terms of size, that doesn't have to do with drawbacks of diametric magnetization, right? [00:10:58] Speaker 01: So if you have something... No, no. [00:11:02] Speaker 01: Yes, no. [00:11:03] Speaker 01: Can you repeat the question, please? [00:11:05] Speaker 02: You really need to listen. [00:11:06] Speaker 02: The question is, there's no drawback to using diametric magnetization. [00:11:14] Speaker 01: I believe there is, and the reason is because you need a larger magnet to achieve the same holding strength of the diametric magnet as compared to an axial magnet. [00:11:24] Speaker 04: Wasn't there a factual dispute about, if not the existence of the greater strength, the significance in this particular context of the needed greater strength, because of the way the field lines are slightly different? [00:11:40] Speaker 01: I think there may have been some disagreement in the record. [00:11:45] Speaker 01: But we pointed to, and if you look at appendix. [00:11:47] Speaker 04: And didn't the board say, we just don't see that this is significant enough? [00:11:52] Speaker 01: I think what the board said, and I think you may be referring to appendix 31 footnote 10, where it talked about how the ring is going to already be creating a larger implant. [00:12:05] Speaker 01: Again, we would suggest that's showing there would be no motivation to do that. [00:12:09] Speaker 01: And then suggesting that there wasn't any evidence in the record as to exactly how much bigger it might need to be. [00:12:15] Speaker 01: Of course, we're doing a hypothetical combination here, and so there's no way to judge [00:12:20] Speaker 01: a particular hypothetical because there's no finite discussion of it. [00:12:25] Speaker 01: But if you look at, for example, appendix 1969, post the Schmid patent, Medel in its own patent talks about how diametric requires, quote, significantly greater size implant magnet to achieve the required amount of magnetic attraction. [00:12:42] Speaker 01: it was estimated, this is Appendix 1970 and then Appendix 1766 and 67, 30 plus percent greater size. [00:12:53] Speaker 01: And so we have something that's going to be significantly greater size. [00:12:56] Speaker 01: We're putting it inside a person's head. [00:13:01] Speaker 01: And there's no benefit, zero benefit. [00:13:03] Speaker 01: The one thing that the board mentioned as a possible benefit, and the way the board talked about it was potentially retaining the benefit [00:13:12] Speaker 01: a specific predetermined alignment of the external with the implant. [00:13:18] Speaker 01: And the point was there were other embodiments in dormer that already had that benefit. [00:13:23] Speaker 01: And so what we have here is we're making a choice to bring diametric in for the ring embodiment where there's no added benefits and only drawbacks. [00:13:32] Speaker 01: It's a bigger implant, which everybody agrees is undisputed in the record that bigger is worse in the context of putting an implant into a person's body with no benefits. [00:13:42] Speaker 00: That sounds like a classic teaching away argument. [00:13:46] Speaker 00: But you're not making that argument, perhaps, because you don't have any evidence of teaching away. [00:13:53] Speaker 01: Again, I think there's sort of a temporal difference there. [00:13:57] Speaker 01: Teaching away is, at the time... You're saying it's all drawback and no benefit. [00:14:02] Speaker 00: Right. [00:14:03] Speaker 00: Isn't that teaching away? [00:14:05] Speaker 01: I think it's the motivation to combine and whether there's motivation to combine and whether there's desirability of the combination. [00:14:13] Speaker 01: We say that is lacking. [00:14:15] Speaker 01: There is not substantial evidence and the board made legal errors in making the motivation to combine the desirability conclusion. [00:14:22] Speaker 01: I don't go the step of saying teaching away because teaching away would suggest there's an option that people are contemplating and it says don't go there. [00:14:32] Speaker 01: We don't have evidence of that. [00:14:33] Speaker 01: We just have evidence saying why no one was even thinking about going there at the time. [00:14:38] Speaker 02: Is it the case that if you're using the wing embodiment and you want to have predetermined alignment that you have to use diametric magnetization to do that? [00:14:51] Speaker 01: I don't think you need to, and in fact, the figure five embodiment in dormer is a way of doing it without having diametric. [00:14:57] Speaker 01: It's not a ring embodiment. [00:14:59] Speaker 01: Correct. [00:15:01] Speaker 02: So my question was, in order to have a ring embodiment and predetermined alignment, is it the case that you have to use diametric magnetization? [00:15:10] Speaker 01: I could probably imagine, I don't think there's any evidence in the record answering that question, I could imagine a way that I think you could probably put a ring together where you're sort of putting different pieces together where you create that benefit without having to go with diametrics. [00:15:25] Speaker 04: I thought the, I don't know, the handbook, the manual or something, the page that shows 12 or 13 different- 31, yeah. [00:15:33] Speaker 04: Even in at least one ring embodiment, it shows magnetization essentially. [00:15:40] Speaker 04: I don't know if you had a ring sitting like a disc, magnetization going this way rather than this way. [00:15:46] Speaker 01: I think that, again, in the general art of magnets, there are ways to do it. [00:15:51] Speaker 04: You mentioned one thing about size I just wanted to ask you about. [00:15:57] Speaker 04: Is it true that a [00:16:05] Speaker 04: might it be the case or is it necessarily the case that axially aligned linear things like this, that those would stick out more than discs that are essentially sitting flat on the surface or is that not? [00:16:18] Speaker 01: Well again, the way the prior art did it was axially aligned in a disc. [00:16:22] Speaker 01: It's just sort of two pancakes on top of one another as opposed to two slices of a pizza. [00:16:28] Speaker 02: So, just to quickly mention... I think you're out of time. [00:16:34] Speaker 02: Unless there are further questions, we'll give you two minutes. [00:16:36] Speaker 02: Okay, thank you. [00:16:43] Speaker 03: Mr. Timbers? [00:16:45] Speaker 03: Good morning, Your Honors. [00:16:46] Speaker 03: Kerry Timbers for MED-EL. [00:16:49] Speaker 03: May it please the Court. [00:16:50] Speaker 03: Your Honor? [00:16:50] Speaker 03: Take your mask off. [00:16:51] Speaker 03: Oh, I'm sorry. [00:16:54] Speaker 03: Thank you. [00:16:57] Speaker 03: This is a classic case of two experts disagreeing with each other and a classic case of a fact finder deciding that one expert was credible and that the other was not. [00:17:11] Speaker 03: One expert, Medells, said that this was desirable, it was effective, it was simple. [00:17:19] Speaker 03: The other expert said the opposite. [00:17:22] Speaker 03: The board was very clear [00:17:24] Speaker 03: and looking at the most most desirable why did he say combination he said it was desirable because uh... as as one of the questions from your honors pointed out the ring magnet would not uh... work with axial it would work [00:17:44] Speaker 03: with diametric magnetization. [00:17:48] Speaker 03: If the ring magnet had axial magnetization all the way through it, it does not achieve the ability to align the magnet in any way. [00:17:58] Speaker 03: It's just the same all the way around. [00:18:01] Speaker 03: The key to Dormer was that it would be different on one side than the other. [00:18:08] Speaker 03: And the diametric magnetization does that. [00:18:14] Speaker 04: Would one example listed in the handbook or otherwise have a ring in which, say, only 11 o'clock to 1 o'clock and 5 o'clock to 7 o'clock would be magnetized at all, but they would each be magnetized axially, not diametrically? [00:18:39] Speaker 03: In other words, if you had... Most of it is dead. [00:18:43] Speaker 03: Yes. [00:18:43] Speaker 03: You would have to have opposite axial on the ring. [00:18:47] Speaker 04: Isn't that one of the things shown? [00:18:48] Speaker 03: And that would work. [00:18:50] Speaker 03: I'm not so sure that would not work. [00:18:52] Speaker 03: No, I believe that would work if you only had two. [00:18:58] Speaker 03: If you have more than two, then you get into difficulty because you need one specific orientation. [00:19:07] Speaker 03: So axial could work in that way. [00:19:10] Speaker 03: One of the problems here is the pot core. [00:19:14] Speaker 03: And putting the axial magnetization on the outside of the pot core could cause problems with that. [00:19:21] Speaker 03: And that's why the expert for MED-EL said that the diametric magnetization was desirable. [00:19:28] Speaker 03: He actually used that term. [00:19:30] Speaker 02: Could you show us where he talked about that? [00:19:32] Speaker 03: Yes. [00:19:40] Speaker 03: So in appendix at 732 and 733, paragraph 76, which is cited by the board, it talks about Dormer teaching all the elements of the connecting device. [00:20:07] Speaker 03: And at the bottom of 732, [00:20:09] Speaker 03: It says the positive would have recognized the simplest configurations, such as shown in the first row of Moskowitz, are sufficient to hold one magnet to the second magnet. [00:20:21] Speaker 03: Of these, the across diameter configuration is the most desirable to a positive, since it provides angular orientation when paired, as in Goldberg figure five. [00:20:37] Speaker 03: And on this same page, he addresses something extremely important under KSR, because at the bottom of [00:20:48] Speaker 03: after explaining the diametrically magnetized ring magnets, he says a positive would have known from Goldberg and basic magnetics that the diametrically magnetized ring magnets were a known workable option from among a finite number of predictable solutions. [00:21:10] Speaker 03: Such product design is straightforward, following the teachings of Dormer and the knowledge in the art. [00:21:18] Speaker 03: not innovation. [00:21:20] Speaker 03: And this basically, I would argue, is KSR. [00:21:24] Speaker 03: There was a design need, as Your Honor's questions showed. [00:21:29] Speaker 03: Dormer talks about a ring magnet, but does not provide any magnetization for it. [00:21:36] Speaker 03: And the fact that the other embodiments, which are not a ring magnet, [00:21:41] Speaker 03: Our axial does not mean that inherently they're disclosing axial magnetization. [00:21:46] Speaker 03: They're not disclosing any magnetization. [00:21:50] Speaker 03: So the design need is, well, what magnetization should we use? [00:21:56] Speaker 03: And the expert is showing that given the knowledge and experience of a positive, this would be the obvious and desirable [00:22:08] Speaker 02: uh... option among a finite number of options this is exactly the language from case my problem is maybe expert said that i'm not sure that uh... or agreed with that they seem to have said there was a finite number of choices for simple design choice rather than being advantages [00:22:35] Speaker 03: Well, the board does cite paragraph 77 in its decision. [00:22:46] Speaker 03: It actually cites all of these paragraphs that I've pointed to, 76 and 77, and it says that the expert was credible and that it is making its decision for the reasons proposed by petitioner. [00:23:03] Speaker 03: Which page does that say that? [00:23:05] Speaker 03: All right. [00:23:08] Speaker 03: So your honors, at appendix 32, which is page 32 of the board's decision, at the top, it's about a third of the way down. [00:23:22] Speaker 03: It talks about petitioners' arguments based upon Dormer and Goldberg. [00:23:27] Speaker 03: and specifically cites paragraph 76 and 77 of exhibit 1002, which is Dr. Trumper's declaration. [00:23:36] Speaker 03: So those are the paragraphs that I've pointed you to, and it goes on down and cites paragraph 76. [00:23:46] Speaker 03: Again, it's talking about why we find petitioners' argument that the action and diametric options are the most practical here. [00:23:56] Speaker 03: uh... even twelve options represent a finite number of options and supports petitioners position that choosing one of the options must what's described as standard support his obviousness argument citing paragraph seventy six and then above was talking about paragraph seventy seven so and again uh... the board uh... more than once indicates that it's basing its decision [00:24:26] Speaker 03: on the credible expert testimony, which is a nice way of saying we are not crediting the testimony of Sanova's expert, who came in with evidence about it was undesirable. [00:24:43] Speaker 04: Mr. Sunnell emphasized, featured, [00:24:49] Speaker 04: a kind of long timelines narrative about how until your product came along, even though Dormer may have mentioned the possibility of a ring magnet, nobody had been using any. [00:25:08] Speaker 04: any such things. [00:25:11] Speaker 04: Did you have evidence that addressed the real world absence for a seemingly extended period of anybody proposing this before 2001 here is, I guess, the priority date? [00:25:31] Speaker 03: I don't believe there is any evidence of the record addressing that issue. [00:25:37] Speaker 03: What is different about, I'll just point out that what's different about Dormer than all of the other commercial cochlear implant systems is that Dormer uses a pot core, which is a piece of metal and something that conducts magnetism. [00:25:53] Speaker 03: So in that way, it's a bit different than what is being done commercially, what was being done commercially with cochlear implants. [00:26:04] Speaker 03: But also is, [00:26:05] Speaker 02: Is Dormer suggesting the use of a ring magnet in connection with cochlear implants? [00:26:13] Speaker 03: It is a cochlear implant. [00:26:16] Speaker 03: It is a cochlear implant piece of art. [00:26:20] Speaker 02: So it's suggesting that the use of a ring magnet in that context is an available option. [00:26:26] Speaker 03: Yes, absolutely. [00:26:28] Speaker 03: It is saying exactly that. [00:26:30] Speaker 04: I would also point out that [00:26:34] Speaker 04: Do you have any evidence or explanation without evidence would be a second best, but either one for why it took so long, like the cochlear implants, what came in about 20 years before this, 30 years? [00:26:49] Speaker 04: Late 70s, early 80s. [00:26:52] Speaker 04: Okay. [00:26:52] Speaker 04: So we're talking about a two decade period. [00:26:55] Speaker 04: And yet is there some intuitively understandable reason why nobody was doing this? [00:27:02] Speaker 03: Well, sometimes in a commercial setting... I'm not suggesting that makes a legal difference. [00:27:07] Speaker 04: I'm trying to understand that. [00:27:08] Speaker 03: Yes, absolutely. [00:27:09] Speaker 03: Yes, Your Honor. [00:27:09] Speaker 03: Sometimes in a commercial setting, if something works, you just stick with it until you realize that it's hindering you from solving a different problem. [00:27:18] Speaker 03: So I don't believe there's been problems with attachment and retention in the industry. [00:27:24] Speaker 03: What happened with MED-EL was there was a recognition, there was a problem with putting these [00:27:30] Speaker 03: patients into MRI machines. [00:27:33] Speaker 03: And what was the problem? [00:27:35] Speaker 03: It was the magnet. [00:27:36] Speaker 03: And if you put a magnet in the machine, it wants to twist it. [00:27:40] Speaker 04: Is that a newly recognized problem? [00:27:42] Speaker 04: MRIs aren't all that new, are they? [00:27:45] Speaker 03: Well, part of the question is, how common are the MRIs? [00:27:50] Speaker 03: Strong are the MRIs. [00:27:52] Speaker 03: MRIs have gotten much stronger over the years. [00:27:54] Speaker 03: There used to be 1.5 Tesla, and then they became 3 Tesla, and now there's 7 Tesla machines. [00:28:02] Speaker 03: That just means bigger magnetization. [00:28:05] Speaker 03: Also, the more common it is, it used to be, it took a while to get an MRI, and you didn't just get one automatically. [00:28:13] Speaker 03: Now MRIs are super easy to get, very common in many countries. [00:28:18] Speaker 03: So it's about just looking at the marketplace and looking at what customers might think is important. [00:28:26] Speaker 03: And that changes over time. [00:28:27] Speaker 03: Okay. [00:28:27] Speaker 03: Thank you. [00:28:28] Speaker 03: Yes. [00:28:29] Speaker 03: Um, I also wanted to point out that the patent here Schmidt is not a cochlear implant patent. [00:28:37] Speaker 03: In fact, it doesn't say anything ever about cochlear implants. [00:28:42] Speaker 03: It's about an implant. [00:28:44] Speaker 03: And it talks a lot about access ports. [00:28:47] Speaker 03: and inserting medicine and things like that, but it is not in fact a cochlear implant patent. [00:28:56] Speaker 03: So I wanted to address, I wanted to just come back to this idea of fact question. [00:29:02] Speaker 03: Some of the questions from your honors ask Mr. Sernell, isn't that a fact question? [00:29:08] Speaker 03: So I think the big issue here is the board had the responsibility to weigh [00:29:14] Speaker 03: the evidence. [00:29:15] Speaker 04: Can you address the evidence on the objective and vicious side of the analysis? [00:29:21] Speaker 03: Yes, absolutely. [00:29:22] Speaker 03: So the board paid a lot of attention to that evidence. [00:29:30] Speaker 03: The board did not discard it. [00:29:32] Speaker 03: And the evidence was that years later, after MED-EL developed this MRI safe magnet, the first one in the industry, MED-EL and lots of other people said, wow, this is great. [00:29:45] Speaker 03: and it was the case that it required rotation of the magnet and the rotation of the magnet in that embodiment was allowed to happen by diametrically magnetizing the disc magnet and letting it rotate in a case. [00:30:02] Speaker 03: You're absolutely right about that. [00:30:05] Speaker 03: That it actually requires a whole bunch of other things. [00:30:09] Speaker 03: The key thing here that the board noted and that Medel noted was that [00:30:15] Speaker 03: Sunova never actually mapped the claims of the patent to the MED-EL product and still hasn't. [00:30:25] Speaker 03: And MED-EL always has taken the position and takes the position today. [00:30:29] Speaker 03: That is their burden. [00:30:31] Speaker 03: They have not done that. [00:30:33] Speaker 03: And they don't get to just say on appeal, oh, well, MED-EL has never said otherwise. [00:30:37] Speaker 03: That's not our job. [00:30:39] Speaker 03: They have to do that. [00:30:41] Speaker 03: And what they haven't done, it's very clear, is show that [00:30:45] Speaker 03: That invention that is so revolutionary is not about diametric magnetization. [00:30:56] Speaker 03: It's about rotation. [00:30:57] Speaker 03: And think about this. [00:30:59] Speaker 03: Why does Schmidt have and why does Dormer have this particular type of magnetization taught? [00:31:09] Speaker 03: To achieve an alignment so that it stays where it's put [00:31:14] Speaker 03: And there's only one way you can put it. [00:31:18] Speaker 03: Rotation is antithetical to that. [00:31:22] Speaker 03: Rotation has to throw all that away and say, we are not going to achieve that result. [00:31:28] Speaker 03: Instead, we're going to do a trade-off. [00:31:32] Speaker 03: We're going to do something important. [00:31:34] Speaker 03: And so that led to the MRI safe magnet that spins. [00:31:40] Speaker 03: And now it's industry standard. [00:31:42] Speaker 04: Would I assume correctly that when the MRI is turned off, the spinning stops and the realignment occurs? [00:31:49] Speaker 03: The MRI isn't turned off, ever. [00:31:51] Speaker 03: But yes, when the patient is taken away, then yes, absolutely. [00:31:56] Speaker 03: It's really a matter of, I shouldn't say spinning. [00:31:59] Speaker 03: It's a matter of turning to align with a field. [00:32:03] Speaker 03: And then when that field disappears, it's not, it doesn't, isn't compelled to turn in that way. [00:32:09] Speaker 04: It's not moving in a single place. [00:32:11] Speaker 03: Yes. [00:32:13] Speaker 03: Yeah, it just turns in order to align. [00:32:17] Speaker 03: I see my time is up, Your Honors. [00:32:19] Speaker 03: Any other questions? [00:32:21] Speaker 03: Thank you. [00:32:22] Speaker 02: Thank you, Your Honors. [00:32:24] Speaker 02: Mr. Cernel, you've got two minutes. [00:32:32] Speaker 01: So Mr. Timber suggested, in response to Judge Taranto's question, that this decades-long no-one-using axia or diametric was just sort of a, well, they picked one and just stuck with it. [00:32:47] Speaker 01: But what happened when they actually finally did it? [00:32:49] Speaker 01: Did they say, well, we're just making a different choice now and no big deal? [00:32:53] Speaker 01: Was it a basic design choice? [00:32:55] Speaker 01: as the board found, absolutely not. [00:32:57] Speaker 01: And again, we've got extensive evidence in the record about this being revolutionary, a fundamental design shift, all describing the specific change, the specific question that the board was wrestling with, which was, is this adding of a diametric magnet to a cochlear implant obvious or not? [00:33:14] Speaker 02: So there's nothing in your patent about MRIs or rotatability in MRIs, right? [00:33:23] Speaker 01: Correct. [00:33:25] Speaker 01: It's all about transcutaneous connections. [00:33:28] Speaker 01: And the question is, was that obvious to someone of skill in the art in 2001? [00:33:33] Speaker 01: And when it was done more than a decade later, again, it was described [00:33:38] Speaker 01: in these glowing terms is fundamental design shift, fundamentally different, a big leap. [00:33:43] Speaker 01: There were, in addition to Medel's commentary, a peer-reviewed article talking about use of a diametric magnet, not talking about rotatability and how it positively impacts patient care. [00:33:55] Speaker 01: It's really hard to imagine any stronger or more direct secondary consideration evidence than what we have in this case. [00:34:02] Speaker 01: And in fact, this court's kinetic concepts v. Smith and Nephew case tells us that objective considerations like this are most important. [00:34:12] Speaker 01: When we're looking at simple technology and there's this possibility of lawyers looking at it in hindsight and saying, oh, this seems obvious to me, it's especially important to look at the objective of indicia. [00:34:23] Speaker 01: And I would suggest that here that tells us that this invention was the antithesis of something that was obvious. [00:34:29] Speaker 01: It was revolutionary, a fundamental design shift [00:34:32] Speaker 01: specifically tied to this use of a diametric magnet in the context of a cochlear implant, which was the core obviousness question the board wrestled with.