[00:00:00] Speaker 04: The case is Epicon versus the ITC, 2022-11-11. [00:00:05] Speaker 04: Mr. Desai, is it? [00:00:06] Speaker 04: Yes, Your Honor. [00:00:08] Speaker 04: Please proceed. [00:00:11] Speaker 04: Good morning, Your Honors. [00:00:18] Speaker 01: May it please the Court? [00:00:19] Speaker 01: I'll start with the 369 patent. [00:00:21] Speaker 01: The ITC's claim construction incorrectly excluded curved surfaces. [00:00:26] Speaker 01: The ITC's mistake [00:00:28] Speaker 01: was limiting the structure to the illustrated flat surface and disregarding the broader linkage to ramp surfaces and otherwise sloped surfaces in the text. [00:00:37] Speaker 04: This is means for guiding. [00:00:39] Speaker 01: That is correct, Your Honor. [00:00:41] Speaker 01: A ramped surface is a structure that is clearly linked to the function. [00:00:45] Speaker 01: This is a separate disclosure that is linked by a dependent claim that is part of the specification by virtue of being an original claim in the application. [00:00:57] Speaker 01: Ramps can be curved like a skateboard ramp. [00:01:00] Speaker 01: They can be flat like a ramp used to bring furniture up a moving truck. [00:01:05] Speaker 01: The 369 pattern uses the words ramp surface in exactly that way to mean both flat and curved surfaces. [00:01:13] Speaker 01: At appendix three. [00:01:14] Speaker 02: What if we were to read the relevant passage and specification when it talks about, as shown in figures 40 and 41, to be referencing [00:01:27] Speaker 02: the actual illustrated straight ramps in those figures. [00:01:34] Speaker 02: And then if we look at it like that and narrow on the background principle that the patent drafter has a duty to clearly link the structure with the recited function and the means plus function limitation, why shouldn't that be pretty much the end of the story on what is [00:01:54] Speaker 02: the corresponding structure for a means for guiding. [00:01:56] Speaker 01: Two reasons, Your Honor. [00:01:57] Speaker 01: First, ramp surface is separately linked from that passage you referred to. [00:02:01] Speaker 01: It is separately linked by a dependent claim in the original application. [00:02:04] Speaker 01: It is part of the specification, and that is a clear link. [00:02:08] Speaker 01: A clear link of ramp surface as a structure performing the function. [00:02:12] Speaker 01: Second reason. [00:02:13] Speaker 01: I'm sorry, what claim are you referring to? [00:02:16] Speaker 01: Dependent claim 23 was an original claim. [00:02:20] Speaker 01: in the application. [00:02:21] Speaker 01: As we pointed out in our brief, an original claim in an application is part of the specification. [00:02:26] Speaker 01: But claim 23 doesn't say curved surface. [00:02:31] Speaker 01: It says ramped surface. [00:02:32] Speaker 01: And ramped surfaces, there is no dispute and there is no evidence [00:02:36] Speaker 01: There is no dispute that ramp surfaces are both flat and curved. [00:02:40] Speaker 02: Maybe in the most general sense, but in the context of a means for guiding, maybe not. [00:02:47] Speaker 01: In the context of this patent, the words ramp surface are used to include both flat and curved surfaces. [00:02:53] Speaker 01: At appendix 392, column 26, the words ramp surface are described as comprising one or more flat surfaces, curved surfaces, concave surfaces, [00:03:03] Speaker 01: and or convex surfaces. [00:03:04] Speaker 01: The word ramp surface means the same thing. [00:03:06] Speaker 02: That's a reference to a different element of this overall assembly, of this overall tool, right? [00:03:14] Speaker 01: It is a reference. [00:03:15] Speaker 02: It has nothing to do with the means for guiding [00:03:20] Speaker 01: It is a reference to Ridge 615 can comprise a ramped surface, and it says ramped surfaces are these things. [00:03:27] Speaker 01: The words ramped surface mean the same thing. [00:03:29] Speaker 02: But what element is it talking about in that college 25? [00:03:33] Speaker 02: It is talking about Ridge 615, which I agree... What is Ridge 615? [00:03:38] Speaker 01: Ridge 615, I agree, Your Honor, is not... What is that? [00:03:41] Speaker 01: It is not the structure for performing... What is it? [00:03:45] Speaker 01: It's on the cartridge. [00:03:49] Speaker 01: It is not part of the guiding function. [00:03:53] Speaker 01: The purpose of that passage is to understand that ramp surface is used consistently throughout this patent. [00:04:00] Speaker 01: And ramp surface means both flat and curved surfaces. [00:04:03] Speaker 01: There are other examples of the words ramp being used. [00:04:06] Speaker 02: Is there something in the specification that says, hey, when we say ramped, we're talking about it in the broader, casual sense and not [00:04:14] Speaker 02: just a straight edge sense. [00:04:17] Speaker 01: That paragraph that I just read says ramp surface. [00:04:20] Speaker 02: That's what I just said. [00:04:21] Speaker 02: It just describes element 615, ridge 615 on the cartridge. [00:04:26] Speaker 01: Well the exact language is ridge 615 can comprise a ramped surface which can comprise one or more flat surfaces, curved surfaces, or concave surfaces. [00:04:35] Speaker 01: So it is saying that ramped surfaces are these things. [00:04:39] Speaker 01: There are other examples of ramps that are both flat and curved and described as such in the patent. [00:04:43] Speaker 01: But I get to the other point, which is the language, the separate language, which is chamfer or otherwise sloped as shown. [00:04:50] Speaker 01: A chamfer, the word otherwise there is critical, and it means in a different way or manner. [00:04:56] Speaker 01: A chamfer is a constant slope surface, a flat surface. [00:05:02] Speaker 01: A flat surface, as the ITC construed the term, [00:05:06] Speaker 01: is exactly like a chamfer, sloped exactly like a chamfer. [00:05:10] Speaker 01: It is not sloped in a different way than a chamfer. [00:05:13] Speaker 01: The language is otherwise sloped. [00:05:15] Speaker 01: It's not likewise sloped. [00:05:17] Speaker 01: To be sloped in a different way than a chamfer is a variable slope, which would be a curved surface. [00:05:23] Speaker 01: Including curved surfaces gives meaning to otherwise. [00:05:27] Speaker 01: Limiting to flat surfaces does not. [00:05:29] Speaker 01: And the ITC makes two arguments in that respect. [00:05:32] Speaker 01: One is they're saying, well, otherwise refers to bevels or inclined planes. [00:05:38] Speaker 01: That does not give meaning to otherwise. [00:05:41] Speaker 02: Bevels and inclined planes are constant sloped flat in the same- So there's a strong statutory interpretation principle that we're not supposed to read statutory language in a way that renders it superfluous. [00:05:55] Speaker 02: I don't know if there's a principle quite like that when it comes to reading a patent specification. [00:06:01] Speaker 02: I mean, this wouldn't be the first patent out there ever in the history of patents where a patent drafter spoke redundantly in describing something. [00:06:12] Speaker 01: Your honor, I don't see that there's any justification here to render the word otherwise superfluous. [00:06:18] Speaker 01: We can give meaning to otherwise and we can give meaning to as shown. [00:06:23] Speaker 01: In a claim term, you wouldn't give a claim term, you wouldn't render that superfluous. [00:06:26] Speaker 01: Here in a means plus function term, we are taking the specification language, which we agree is linked and making that the claim language. [00:06:34] Speaker 01: There is no reason why you would take that language and say this is what's being claimed and say let's render otherwise superfluous. [00:06:42] Speaker 01: There's no basis for that and it follows because you wouldn't render a claim language superfluous for a means plus function if you're taking the specification language and making it part of the claim. [00:06:52] Speaker 01: You wouldn't render that language superfluous either. [00:06:54] Speaker 01: And otherwise under the ITC's construction does not have any meaning because bevels and inclined planes, as they're saying, are exactly the same as a chamfer. [00:07:05] Speaker 01: They are not sloped in a different way. [00:07:07] Speaker 01: And I think the other point is, Ethicon, we are not ignoring the words as shown. [00:07:13] Speaker 01: As shown refers the reader to the figures that show you where the structures are located and how they perform the function. [00:07:20] Speaker 01: In other words, see the figure, it shows you chamfer 6133, that's what's actually shown, and it also shows you where the otherwise sloped surface would be located. [00:07:36] Speaker 01: Your Honor, if I may move on to the 969 patent. [00:07:40] Speaker 01: For the validity of the 969 patent, the ITC failed to address the evidence that the Prior Art PMI device was subject to a safety-related recall. [00:07:50] Speaker 01: A POTSA would not be motivated to combine an unsafe surgical device with a robotic system. [00:07:58] Speaker 01: At appendix 3043, Ethicon's expert identified the FDA recall [00:08:02] Speaker 01: as a key reason why a poster would not combine it with the robotic system. [00:08:06] Speaker 01: At appendix 2524, the recall notice itself states, [00:08:21] Speaker 01: that the action is being undertaken due to certain products potentially exhibiting compromised stable formation. [00:08:27] Speaker 02: Recall was recalled the following year, right? [00:08:30] Speaker 02: It was terminated in 2010. [00:08:31] Speaker 01: That is the argument and we agree that there was a determination. [00:08:35] Speaker 01: The problem there is that it was automatically terminated as we pointed out [00:08:40] Speaker 01: with the CFR in our brief, because PMI Sapler was never put back on the market. [00:08:45] Speaker 01: That's confirmed by the testimony of Intuitive's own witness, appendix 2752. [00:08:49] Speaker 02: That statement, I read that statement, it seemed rather equivocal. [00:08:55] Speaker 02: I mean, there was no proclamation that, yes, this was terminated and, yes, that this [00:09:03] Speaker 02: staplers off the market now and no longer will ever be on the market. [00:09:08] Speaker 02: It's less than clear about saying that. [00:09:11] Speaker 01: That was the intuitive witness most knowledgeable about the PMI staplers. [00:09:14] Speaker 01: There is no evidence in the record whatsoever that the PMI stapler was ever put back on the market. [00:09:19] Speaker 01: That is the only evidence, and the evidence shows that according to intuitive's most knowledgeable witness, the PMI staplers were never put back on the market. [00:09:29] Speaker 02: You pointed to that testimony in your gray brief. [00:09:31] Speaker 02: It wasn't in your blue brief. [00:09:33] Speaker 02: Was it ever presented to the ALJ or the ITC in the briefing below? [00:09:40] Speaker 01: Absolutely, Your Honor. [00:09:40] Speaker 01: That testimony was designated as part of the hearing. [00:09:44] Speaker 02: And the issue here is, Your Honor, the ITC... Was it in your brief when you said, oh no, claim 24 of the 969 could never be obvious? [00:09:51] Speaker 02: Because not only was there a safety recall, but when the safety recall was terminated, the stapler was never put back on the market. [00:09:59] Speaker 02: See what this one witness said who [00:10:02] Speaker 02: kind of equivocally suggests that. [00:10:04] Speaker 01: Our expert pointed to the testimony of the intuitive witness. [00:10:09] Speaker 01: The argument was made to the ALJ in our briefs. [00:10:13] Speaker 01: Was it stated the way I just stated it? [00:10:15] Speaker 01: The argument was presented that the staples were recalled and they were never put back on the market. [00:10:21] Speaker 01: And the problem here is that the ITC did not ever even address this issue. [00:10:26] Speaker 01: There is no discussion of the recall in the ITC's decision. [00:10:29] Speaker 01: And the ALJ summarily dismissed the recall for the wrong reason, because he was relying on this 2008 agreement and was of the view that the poster would not be aware of the recall in 2008 when that agreement was signed. [00:10:43] Speaker 01: The commission struck the reliance on that agreement in its decision. [00:10:48] Speaker 01: And the relevant date here for the obviousness question is 2011, so the only reasoning in the ALJ's decision and by virtue of the Commission's opinion is wrong. [00:11:01] Speaker 02: By 2011, wasn't it pretty established and conventional to connect surgical tools to robots and have robots control surgical tools? [00:11:12] Speaker 01: respectfully I disagree as evidenced by the IPRs in this case where there were seven grounds presented that went to final written decision where robotic tools the argument was being made for this particular claim that certain handheld tools would be combined with a robot those were all rejected seven different grounds this is the eighth ground involving a different tool that had a safety problem [00:11:35] Speaker 01: And that issue was never considered by the ITC. [00:11:39] Speaker 02: Well, you're not suggesting that your inventor was the first one to connect a surgical tool to a robot, right? [00:11:45] Speaker 01: That is not what we've claimed either. [00:11:47] Speaker 01: The claim is not to any tool. [00:11:48] Speaker 01: There are particular elements of this tool. [00:11:51] Speaker 02: There were, in fact, other tools that had been connected to a robot. [00:11:55] Speaker 01: But the relevant question for obviousness is whether you would be motivated to combine that tool with the robotic system, which is what was being argued by the other side. [00:12:05] Speaker 04: Counselor, you're well into your rebuttal time. [00:12:07] Speaker 04: Do you want to save it or continue? [00:12:11] Speaker 01: I will save the rebuttal time here. [00:12:12] Speaker 02: Thank you. [00:12:12] Speaker 02: Just one quick question. [00:12:15] Speaker 02: The first 35 pages of the 369 patent is a very long list of prior art documents that were cited in the record. [00:12:28] Speaker 02: Is this standard practice for your client to submit, I don't know, [00:12:35] Speaker 02: 2,000 references to a patent examiner? [00:12:38] Speaker 01: Your Honor, in this particular instance, with these robotic tools, I believe there are a substantial number of patents out there on robotic tools and staplers and prior art. [00:12:47] Speaker 01: And I don't know if it's standard practice for every patent, but I believe in this situation, there are a number of patents covering staplers. [00:12:55] Speaker 01: And the client believes it's prudent to disclose those. [00:12:59] Speaker 04: How does that enable the examiner to determine what is most relevant? [00:13:07] Speaker 01: In this case, in the prosecution, this particular... On your answer, I'm not sure I have an answer to that. [00:13:16] Speaker 01: I don't think there's an issue on this appeal. [00:13:18] Speaker 01: And in this case, to be fair, the 369 patent was put through IPR and the claim survived the IPR. [00:13:25] Speaker 04: Thank you. [00:13:26] Speaker 04: We'll save the rest of your time. [00:13:29] Speaker 04: Mr. Richards. [00:13:38] Speaker 03: Thank you, Your Honors. [00:13:39] Speaker 03: May it please the court? [00:13:42] Speaker 03: This case is essentially about three commission findings that are unremarkable applications of settled patent law, and we would request that they be affirmed as such. [00:13:50] Speaker 03: I'll start in the same order as my friend so I can address the same points. [00:13:54] Speaker 03: With the 369 patent and the means for guiding, there's no dispute here as to what the function is. [00:14:01] Speaker 03: It's a guiding the at least one lower foot on the firing element out of the proximal channel opening and into the internal passage [00:14:08] Speaker 03: The Commission then did exactly what it was supposed to do. [00:14:11] Speaker 03: It looked through the specification for structure that was clearly linked. [00:14:15] Speaker 03: I don't believe there's actually any dispute that that structure is at column 77, lines 24 through 44. [00:14:22] Speaker 03: And it's what we've already talked about. [00:14:24] Speaker 03: There's a chamfer on the lower foot of the firing element, of which there's no dispute that the chamfers are flat. [00:14:30] Speaker 03: And then there is a portion of the elongate channel 6122, defining the proximal end 6131, [00:14:37] Speaker 03: of the internal passage 6030 that can either have a chamfer, again flat, or otherwise be sloped as shown in figures 40 through 41. [00:14:50] Speaker 03: What's shown in figures 40 through 41 when you look to the portion of the elongate channel defining the proximal end of the internal passageway is a flat slope. [00:15:01] Speaker 03: Now my friend mentioned that there are ramps claimed in dependent claim 23. [00:15:05] Speaker 03: I don't think there's any dispute there. [00:15:07] Speaker 03: I don't think there's any dispute that in a general sense, a ramp could be curved. [00:15:12] Speaker 03: And there's also no dispute that this was an original claim. [00:15:16] Speaker 03: But the original claim was also dependent on the independent claim reciting means for guiding. [00:15:23] Speaker 03: As a statutory matter, we know that means it must be an additional limitation on the means for guiding. [00:15:30] Speaker 03: The argument that Ethicon is making instead is that the disclosure of this additional limitation actually wipes out the corresponding structure limitations on the independent limitation from which it depends. [00:15:43] Speaker 03: That's the problem with the ramps answer. [00:15:46] Speaker 03: It's not an issue of whether ramps are flat or narrow. [00:15:48] Speaker 03: It's an issue of the fact that claim 23 depends and therefore by statute must be an additional limitation. [00:15:56] Speaker 03: The court has seen this before. [00:15:58] Speaker 03: The Safran case is remarkably on point. [00:16:01] Speaker 03: So is the Lytrem case. [00:16:03] Speaker 03: Both of those were the exact same argument where a party looked to a dependent claim essentially to wipe out limitations that were in the independent claim. [00:16:12] Speaker 03: And I want to be clear, there's no conflict between 23 and how the commission construed this claim, right? [00:16:19] Speaker 03: As we heard my friend mention, a ramp can be flat and thus a flat ramp as an additional limitation on the means for guiding. [00:16:28] Speaker 03: is entirely consistent with the commission's construction that the means for guiding via the corresponding structure is flat. [00:16:37] Speaker 03: Turning to otherwise float, this is just a matter of misconstruing what otherwise is referring to. [00:16:44] Speaker 03: Otherwise in that sentence refers to something other than a chamfer. [00:16:49] Speaker 03: I think I heard an assertion that a chamfer is any flat surface, but that's not what the evidence shows here. [00:16:56] Speaker 03: The testimony from Dr. Howe that's at appendix page 3485, question answer 62, explains that a chamfer is a specific type of sloped surface where a corner is removed to leave a flat surface. [00:17:10] Speaker 03: He then goes on to give two other examples in bevels and in-kind planes. [00:17:14] Speaker 03: So here otherwise is simply saying it can be a chamfer or it can be something other than a chamfer as long as it is also sloped as shown in figures 40 through 41. [00:17:26] Speaker 03: With that understanding, there's nothing redundant about the Commission's construction. [00:17:30] Speaker 03: There's no superfluity in the Commission's construction. [00:17:35] Speaker 02: I don't understand. [00:17:35] Speaker 02: Why isn't what is being illustrated in Figures 40 and 41 the definition of a chamfer? [00:17:43] Speaker 03: Why isn't it? [00:17:44] Speaker 02: Yeah. [00:17:45] Speaker 02: You're cutting off a corner and with a straight line. [00:17:48] Speaker 03: I wouldn't disagree with you, Your Honor. [00:17:50] Speaker 03: What's being shown there is a chamfer. [00:17:53] Speaker 02: Right. [00:17:53] Speaker 02: So that leads us right into the point that the other side's trying to make, which is, well, we want to assume the patent drafter wasn't being redundant. [00:18:02] Speaker 02: And so maybe, as otherwise shown, should make us think a little harder about whether it has to only be a straight line because it says chamfer or otherwise shown. [00:18:18] Speaker 03: So the problem with that reading, your honor, is that would actually require rewriting the corresponding structure. [00:18:24] Speaker 03: To achieve that reading, what you have to do is essentially move that as shown clause earlier in the sentence. [00:18:30] Speaker 03: So the sentence would then read, champ for 6133 as shown, or be otherwise sloped. [00:18:37] Speaker 03: That is essentially the reading that Ethicon is pushing for. [00:18:40] Speaker 03: And the commission isn't able to rewrite the corresponding structure in a patent to achieve that. [00:18:46] Speaker 02: I guess what I'm saying is it seems unnecessary to try to bend over backwards to try to find meaning in this extra phrase if it turns out that what the extra phrase is really getting at through the illustration figures 40 and 41 is actually a chamfer. [00:19:02] Speaker 03: That's certainly true, Your Honor. [00:19:04] Speaker 03: If all that phrase was saying is just a chamfer, that again is still consistent with the Commission's construction, right? [00:19:10] Speaker 03: The Commission's construction merely resolved the dispute that was before it. [00:19:14] Speaker 03: whether or not curved surfaces fall within the scope of the means for guiding. [00:19:20] Speaker 03: And it resolved that by saying, no, they don't. [00:19:23] Speaker 03: As you point out, [00:19:24] Speaker 03: If that extra verbiage simply is another way of saying a chamfer, the Commission's construction is still correct. [00:19:31] Speaker 02: Before you sit down, you're running out of time. [00:19:33] Speaker 02: Can we talk a little bit about SunTiger, which is the infringement argument on 369? [00:19:39] Speaker 03: Sure. [00:19:39] Speaker 02: And whether SunTiger permits the other side [00:19:44] Speaker 02: to the plaintiff to make the argument that all they have to do is look at one piece of the corresponding ramp in the sure form stapler and find a straight line and therefore that's good enough for infringement purposes. [00:20:00] Speaker 02: They don't need a ramp from top to bottom to be straight and flat. [00:20:05] Speaker 03: Of course. [00:20:07] Speaker 03: So SunTiger is inapplicable here, and I'm not sure that this has been caught on Ethicon's side. [00:20:13] Speaker 03: In SunTiger, the claims were to sunglass lenses, but the actual claim limitations simply specified you've got to have a plastic matrix that has to have certain light transmission characteristics. [00:20:24] Speaker 03: And so they were orange lenses, they had a gray gradient coating on them, and it essentially said, so there might be a spot down in the lower right-hand corner that's going to meet these transmission characteristics. [00:20:36] Speaker 03: This court held that that portion of the lens met every single limitation of the claim at issue. [00:20:43] Speaker 03: That's very different from the infringement argument here, where we're talking about a portion of a sloped surface. [00:20:49] Speaker 03: That portion of the sloped surface definitely doesn't meet every limitation of this claim. [00:20:55] Speaker 03: This claim, for instance, has a firing element limitation. [00:20:58] Speaker 03: The portion of the sloped surface is clearly not the firing element. [00:21:03] Speaker 03: Sun Tigers were dealing with a very different problem [00:21:07] Speaker 02: Can you get to the FDA recall? [00:21:10] Speaker 03: Yes. [00:21:10] Speaker 03: So the FDA recall, I want to make a particular point. [00:21:13] Speaker 03: The commission didn't address it, right? [00:21:15] Speaker 03: The commission did not write about it. [00:21:17] Speaker 03: I understand there's been an assertion the commission didn't consider it. [00:21:20] Speaker 03: That's not true. [00:21:22] Speaker 03: The ALJ considered it. [00:21:23] Speaker 03: The commission specifically reviewed that portion of the ALJ's findings and upon reviewing them concluded that on balance the other substantial evidence still supported a motivation to combine and a reasonable expectation for success. [00:21:38] Speaker 03: I'd like to point out the expert testimony from Ethicon's side. [00:21:41] Speaker 03: I'm sorry, I see my time has expired. [00:21:44] Speaker 03: May I finish my answer? [00:21:45] Speaker 03: Ethicon's expert has a single line, quite literally one sentence pointing this out. [00:21:54] Speaker 03: I'm not aware of anywhere in the record before the commission, before the ALJ, where Ethicon ever even acknowledged that the recall had been terminated. [00:22:03] Speaker 03: I'm sorry, yes, that the recall had been terminated. [00:22:06] Speaker 03: I think what my friend said is true. [00:22:10] Speaker 03: They pointed out there had been a recall and the products hadn't been put back on the market. [00:22:15] Speaker 03: But when I pulled the CFR section that was cited in their reply brief for the first time, it says to me that the recall will be terminated when reasonable efforts have been made to remove or correct the product in accordance with the recall strategy. [00:22:31] Speaker 03: So I don't know how that leads to the conclusion that the recall was terminated because the product was never put back on the market. [00:22:39] Speaker 03: If there is a lack of writing on this topic in the Commission's opinion, it's because it is consistent with the amount it was treated below. [00:22:48] Speaker 03: We have expert testimony that is a single sentence. [00:22:53] Speaker 03: With that, Your Honors, I'll sit down. [00:22:54] Speaker 03: Thank you for allowing me to answer your question. [00:22:57] Speaker 04: Thank you, Chancellor. [00:22:57] Speaker 04: Mr. Denning, intuitive. [00:23:04] Speaker 04: I assume your arguments will be expressed, not intuitive. [00:23:08] Speaker 00: They will be, Your Honor. [00:23:11] Speaker 00: Good morning. [00:23:12] Speaker 00: Roger Denning of Fish & Richardson on behalf of the intervener, intuitive. [00:23:16] Speaker 00: I want to touch on just a couple of the things that have already been discussed this morning, and then I want to move to something new that hasn't been talked about. [00:23:24] Speaker 00: First, on the issue of the otherwise sloped as shown, there's testimony from Dr. Howe, who is an intuitive expert in this case, that otherwise sloped as shown would be understood by one of skill and the art to mean other flat surfaces. [00:23:41] Speaker 00: So we've seen in the patent, it shows a chamfer, a corner that's been cut off. [00:23:47] Speaker 00: Dr. Howe testified there are also bevels, and there are also inclined planes. [00:23:54] Speaker 00: All of those are surfaces that are otherwise sloped as shown in figures 40 and 41. [00:24:00] Speaker 00: They're all flat surfaces. [00:24:02] Speaker 00: So they support the commission's construction. [00:24:04] Speaker 04: I don't mean to nitpick, but I don't know that what you just showed is in the record. [00:24:10] Speaker 04: Would you just point it toward Mr. Desai so he sees what it is? [00:24:15] Speaker 00: Thank you, Your Honor. [00:24:16] Speaker 00: Happy to do so. [00:24:17] Speaker 00: And I will note, for the record, Dr. Howe's testimony is at 3485 and 3486 of the appendix, and also 1603 and 1604. [00:24:34] Speaker 00: With regard to the point about infringement in SunTiger, this is a means plus function limitation. [00:24:40] Speaker 00: What you need to identify is the function in the claim. [00:24:44] Speaker 00: and then the structure in the accused product that supposedly practices that function, and then match up that structure with the corresponding structure in the specification and see if they match. [00:24:56] Speaker 00: Here, the only structure that Ethicon or its expert, Dr. Franzak, identified as performing the function of the means for guiding is that entire sloped surface, the curve and the straight line. [00:25:11] Speaker 00: You look at that entire surface, the curve and the slope line, and compare that to the flat surfaces in figures 40 and 41, they're not the same. [00:25:21] Speaker 00: They're not identical. [00:25:23] Speaker 00: And they need to be. [00:25:24] Speaker 00: Ethicon has not made any equivalence argument here. [00:25:27] Speaker 00: So that disposes with infringement of the means for guiding limitation. [00:25:33] Speaker 00: One brief point on the recall testimony. [00:25:37] Speaker 00: This is on the 969 validity point. [00:25:41] Speaker 00: and the motivation to combine. [00:25:43] Speaker 00: The initial determination below addressed the recall, and I'll point the court to Appendix 525, where the chief judge [00:25:54] Speaker 00: said, finally, Ethicon makes several arguments as to why a person of ordinary skill in the art would not, in fact, combine the references. [00:26:02] Speaker 00: And there's actually a footnote shortly after that talking about the recall. [00:26:07] Speaker 00: And then the chief judge said, additionally, Dr. Vita Kunis's testimony shows that these concerns are unfounded. [00:26:15] Speaker 00: and gives a site to Dr. Vitacunis' testimony. [00:26:18] Speaker 00: So absolutely, the chief judge considered the recall, considered the testimony from Dr. Vitacunis who said, one of skill in the art would not be deterred by this FDA recall. [00:26:30] Speaker 00: Dr. Vitacunis also testified, this wasn't something wrong with the product. [00:26:34] Speaker 00: It wasn't as if all staples were found to be defective. [00:26:39] Speaker 00: it was a manufacturing issue with this particular stapler. [00:26:42] Speaker 00: And Dr. Vitacuna said one of scale would not be deterred by that, even if there was a recall. [00:26:48] Speaker 00: Of course, the recall was terminated. [00:26:51] Speaker 00: There is no evidence in the record. [00:26:53] Speaker 00: The recall was in effect for six months. [00:26:56] Speaker 00: And there was three and a half years from the I-60 device being cleared by FDA before the priority date of the 969 patent. [00:27:06] Speaker 00: So for three of those three and a half years, there was no recall on the PMI stapler. [00:27:12] Speaker 00: The recall was terminated. [00:27:13] Speaker 00: There's no evidence in the record that it was terminated because of removing the PMI stapler from the market. [00:27:20] Speaker 00: The testimony they rely on is from an intuitive engineer, not a PMI engineer. [00:27:26] Speaker 00: who said, to my knowledge, they didn't put it back on the market. [00:27:29] Speaker 00: But that is certainly not evidence that that was the reason for the recall. [00:27:35] Speaker 00: There is so much other substantial evidence in the record to support the commission's finding of motivation to combine here. [00:27:43] Speaker 00: And the commission cites to the initial determination and page after page from the chief judge talking about how [00:27:52] Speaker 00: One of Skill in the Art knew that robotic instruments offered benefits over handheld instruments, that you would combine a stapler with the robotic instrument, and that one of Skill in the Art would know how to make the adjustments to do that. [00:28:08] Speaker 00: There's overwhelming evidence of a motivation to combine, let alone substantial evidence. [00:28:15] Speaker 00: The new issue that I referenced earlier that I want to raise with the court is the alternative grounds for non-infringement on the 369 patent. [00:28:24] Speaker 00: And that's the proximal channel opening. [00:28:28] Speaker 00: We submit that there's an issue of law here in that in making its infringement determination, the commission looked at the wrong product. [00:28:37] Speaker 00: The commission did not look at the product as imported by intuitive into the United States, but instead looked at a sub-assembly that is altered before it is ever entered into the United States. [00:28:49] Speaker 00: The commission looked at the channel, which is one sub-component, [00:28:54] Speaker 00: and identified an opening in the bottom of that channel and said that must be the proximal channel opening and it meets these limitations. [00:29:04] Speaker 00: The problem is that that opening is covered by a welded-on cover before it's ever imported, before it's ever sold, before it's ever used, and that cover cannot be removed. [00:29:16] Speaker 00: That cover is a permanent part. [00:29:18] Speaker 00: of the bottom of the stapler. [00:29:20] Speaker 00: Does it completely cover the proximal channel opening? [00:29:24] Speaker 00: There is a small oval that's left uncovered. [00:29:28] Speaker 00: There's an opening in the cover. [00:29:29] Speaker 00: That's right. [00:29:30] Speaker 00: The commission pointed, actually, to that opening and said, well, that meets the one limitation that says you need to be able to see the firing elements through that hole. [00:29:40] Speaker 00: The problem is that hole doesn't meet the limitation requiring that it be sized to receive the laterally extending lower foot. [00:29:49] Speaker 00: The lower foot of that eye beam, no way can fit through that hole. [00:29:54] Speaker 00: And I would direct your attention to, in intuitive's brief at page 25, we show those two things juxtaposed across each other. [00:30:05] Speaker 00: And you can see there's no way that the lower foot would fit through that hole. [00:30:09] Speaker 00: It's only by using the hole in the channel, the sub-assembly, that is never actually part of the product, and then using the hole in the cover that the commission can find that it meets all the limitations. [00:30:22] Speaker 00: And we will submit that that's inappropriate. [00:30:24] Speaker 00: You should look at the product as imported into the United States. [00:30:28] Speaker 00: I see that I'm into the red mic time. [00:30:32] Speaker 04: You are outside of your allow time. [00:30:35] Speaker 04: Do you have a final thought? [00:30:36] Speaker 00: I would just encourage the courts to confirm the findings of non-infringement and invalidity for the 969 patent and non-infringement for the 369 patent. [00:30:49] Speaker 04: Thank you, Your Honor. [00:30:50] Speaker 04: Thank you, Mr. Denning. [00:30:51] Speaker 04: Mr. Desai, we'll give you three minutes for butter. [00:30:55] Speaker 01: Thank you, Your Honor. [00:30:56] Speaker 01: Let me start with the 369 patent again and the ramped surface and the argument that that would wipe out the independent claim. [00:31:03] Speaker 01: The independent claim cannot exclude [00:31:05] Speaker 01: ramp surface. [00:31:07] Speaker 01: The dependent claim specifically says that that is structure for performing the guiding. [00:31:11] Speaker 01: The independent claim cannot remove ramp surface, and the question is, do ramps include curves? [00:31:18] Speaker 01: And the Saffron case was the case that my friend relied on. [00:31:21] Speaker 01: That was a claim differentiation case. [00:31:24] Speaker 01: This is different. [00:31:25] Speaker 01: This is an original claim in the application. [00:31:29] Speaker 01: It is part of the specification. [00:31:30] Speaker 01: That was not an issue in Saffron. [00:31:32] Speaker 01: Second point, [00:31:33] Speaker 01: In saffron, the specification specifically limited to hydrolyzable bonds, and that's why they ended up limiting the claim to that. [00:31:41] Speaker 01: Here, ramped surface is not limited in the 369 specification to flat surfaces. [00:31:50] Speaker 01: The opposite is true. [00:31:52] Speaker 01: The patent uses the word ramped surface broadly to cover both flat and curved surfaces, which is the ordinary meaning of ramped surface. [00:32:02] Speaker 01: going to the otherwise language, the only argument they have is that otherwise is referring to bevels or inclined planes. [00:32:12] Speaker 01: And the issue is those are sloped in the same way. [00:32:17] Speaker 01: as a chamfer. [00:32:17] Speaker 01: They are not sloped in a different way than a chamfer. [00:32:20] Speaker 01: They do not give meaning to otherwise. [00:32:22] Speaker 01: Two places that were pointed to was 3485, which is Dr. Howe's testimony. [00:32:28] Speaker 01: He was distinguishing chamfers, bevels, and inclined planes from curved surfaces. [00:32:35] Speaker 01: His testimony there is that bevels, inclined planes are the same type of sloped surface, not different types of sloped surfaces. [00:32:43] Speaker 01: They are not otherwise sloped. [00:32:45] Speaker 01: So in other words, a chamfer, a bevel, and an incline plane are not otherwise sloped, they're sloped the same. [00:32:51] Speaker 01: And at 1603, which was the other citation, this was even more clear that the error that was being made. [00:32:57] Speaker 01: Dr. Howe said a chamfer in that testimony is a constant sloped surface. [00:33:02] Speaker 01: He then said otherwise sloped is a constant sloped surface, if you read that testimony. [00:33:07] Speaker 01: So he was reading the phrase as constant sloped surface or otherwise constant sloped surface, which makes no sense. [00:33:15] Speaker 01: And that is what you will see at 1603. [00:33:16] Speaker 01: Let me turn to the validity, the 969, the recall issue. [00:33:22] Speaker 01: The only place in the ALJs and the commission's opinion was a footnote on the recall, and it was dismissed because the recall was in 2009, and the intuitive PMI agreement was in 2008. [00:33:35] Speaker 01: That reasoning does not hold. [00:33:37] Speaker 01: So effectively, the recall was unaddressed by the commission and the ALJ. [00:33:44] Speaker 01: Dr. Vita Kunis' testimony at 3348 does not address the statement in the recall about compromised staple formation. [00:33:53] Speaker 01: So he talks about other parts of the recall, but he doesn't address the part that talks about the safety issue, and that's how he offers the opinion that it wasn't a safety issue, because he doesn't address the part of the recall that was saying it was a safety issue. [00:34:04] Speaker 01: The recall and the termination. [00:34:07] Speaker 01: The only evidence in the record is that the PMI staples were never put back on the market. [00:34:12] Speaker 01: There is no testimony from anyone that they were ever put back on the market. [00:34:16] Speaker 01: And the recall notice itself states that Covidian, which bought PMI, was planning to introduce unique powered products to replace the PMI staples. [00:34:26] Speaker 04: Thank you, Council. [00:34:28] Speaker 04: We thank both Council and cases submitted.