[00:00:00] Speaker 01: 14-17-22 Medtronic Inc. [00:00:03] Speaker 01: vs. Novasiv Inc., Mr. Oliver. [00:00:22] Speaker ?: Go ahead. [00:00:28] Speaker 02: Good morning and may it please the court. [00:00:30] Speaker 02: This is an appeal of an inter-party re-examination from the Patent Office. [00:00:34] Speaker 02: The patent issued, the 058 patent, relates to minimally invasive spine surgery using well-known techniques and instruments such as dilators, stimulating electrodes, and retractable blades. [00:00:47] Speaker 02: All of the original claims of the 058 patent were found unpatentable below and subsequently canceled. [00:00:53] Speaker 02: That was also the fate of many of the other claims added during re-examination. [00:00:57] Speaker 02: However, one set remains anchored by independent claim [00:01:00] Speaker 02: The two issues on appeal are whether or not that set of claims was improperly broadened, and second, whether or not the Coros reference, which describes the use of fixation screws on a retractor blade, meets the limitation of a locking member on a retractor blade, both of which fix the retractor blades to the bone and spine. [00:01:22] Speaker 01: I think you've got an interesting argument that 32 in Coros satisfies the [00:01:29] Speaker 01: the limitations, but the problem is you don't have any expert who said that. [00:01:34] Speaker 01: You're asking us to review Coros and interpret it and interpret whether it satisfies the claim limitations. [00:01:43] Speaker 01: That's pretty difficult for us to do. [00:01:46] Speaker 01: What's your answer to that? [00:01:47] Speaker 02: Well, I don't know that an expert is needed based on the reference to Coros as a whole. [00:01:53] Speaker 02: What we're asking the court to do in this case is look at what is required, not just a particular embodiment of Coros. [00:01:59] Speaker 02: both of what the reference as a whole teaches. [00:02:02] Speaker 02: And if you look at the background and the objectives of the invention in this discussion, Coros, it describes the use of screws with retractor blades in general. [00:02:12] Speaker 01: Well, I don't think that's it. [00:02:13] Speaker 01: The screws is not the problem, because the screws do appear with respect to 32, what are called the distractor blades. [00:02:20] Speaker 01: The problem is with the locking member we recently received, et cetera. [00:02:27] Speaker 01: which the board said you hadn't established that those other aspects were satisfied with respect to 32, as I understand it. [00:02:38] Speaker 02: That's correct, but we did establish that they were shown with respect to blade 30, which is not distributed. [00:02:45] Speaker 02: What we've also argued, though, is it doesn't matter which blades the screws are put on, because the reference... I'm sorry, is your argument that the screws should be moved to 32? [00:02:55] Speaker 01: or that the locking mechanism should be moved to 32? [00:03:01] Speaker 02: The argument below is that it doesn't really matter what blades are used. [00:03:05] Speaker 02: The primary argument, however, in the claim charts and originally relied on blade 30 and the fact that Khoros discloses that screws may be used with retractor blades. [00:03:14] Speaker 02: The way these systems work is that these blades that have the screws are the ones that align with the spine. [00:03:21] Speaker 02: So it's a matter of disorientation. [00:03:23] Speaker 02: If you were to turn this thing 90 degrees, [00:03:25] Speaker 02: you would have to move which screws are on which blade. [00:03:29] Speaker 02: If you rotate it again, it would just have to be altered so that the blade aligned with the spine are the ones that have the screws. [00:03:37] Speaker 02: As far as the issue of whether or not blades 32 teach the other features, we think that's clear, but that obviously is not what was discussed in the record below. [00:03:47] Speaker 02: It was discussed in the record below with respect to retracting 30. [00:03:51] Speaker 02: we do agree that these retractors are basically almost mirror images of each other. [00:03:57] Speaker 02: They recite a lot of the same features. [00:03:59] Speaker 02: It just happened that for purposes of the claim chart, we pointed to the features relative to the retractors and we used the 30. [00:04:12] Speaker 02: With respect to the broadening issue, the original claim four recited the [00:04:21] Speaker 02: of sensing the response of a nerve depolarized by stimulation. [00:04:26] Speaker 02: However, the new claims that are issued here, starting with independent claim 10, change that sensing step. [00:04:32] Speaker 02: Instead of sensing the response of a nerve, it senses an electromyographic or EMG response of a muscle. [00:04:41] Speaker 02: It is undisputed in the record that EMG responses, which is basically just electrical activity, can come from a number of underlying causes. [00:04:49] Speaker 02: Those may be tremors, voluntary patient movement, as well as physical manipulation of the patient. [00:04:56] Speaker 02: So the issue here on the broadening question is whether or not claim 10 could potentially cover anything that claim four does not cover. [00:05:05] Speaker 02: We think this is the very definition of broadening because sensing EMG responses alone would sense electrical activity not caused by a nerve. [00:05:15] Speaker 02: And thus, you are no longer sensing just a nerve response. [00:05:19] Speaker 02: Now to overcome this problem, a new base of this asked this court and the board below to read into claim terms such as only and excluding, specifically to read the sentencing step, sentencing only EMG responses having a particular underlying cause. [00:05:35] Speaker 00: Well, there's plenty in the spec, isn't there, that would support that conclusion? [00:05:39] Speaker 00: I mean, look at column 11, lines 26 through 33. [00:05:44] Speaker 00: T-stimulation signals may cause nerves adjacent to or in the general proximity of the surgical access system to depolarize. [00:05:50] Speaker 00: This causes muscle groups to innervate and generate EMG responses. [00:05:55] Speaker 00: I mean, it's repeated throughout the spec that the point is that the detection of the muscles is for purposes of detection of sensing the response of the nerve depolarized. [00:06:08] Speaker 02: If you're talking about the intended infestation, I think you're exactly right. [00:06:11] Speaker 02: The question is whether or not we can read into the claim in the intended specification. [00:06:15] Speaker 02: What's described in the specification, as well as the prior art references of records such as Kelleher, are basically three distinct steps. [00:06:23] Speaker 02: Sensing electrical activity in a muscle. [00:06:26] Speaker 02: That electrical activity may come from any number of causes, one of which would be nerve decolorization. [00:06:32] Speaker 02: Since the idea is to look for a nerve, what the next step is is to determine or analyze causation. [00:06:39] Speaker 02: to make a determination or a filtering as to whether or not that particular EMG response likely came from electrical activity of the muscle. [00:06:47] Speaker 02: And to do that, there's multiple ways disclosed in the specification, the documents incorporated by reference and the prior reference in the record. [00:06:55] Speaker 02: That can be looking at the magnitude of the response, the size of the voltage. [00:06:59] Speaker 02: It can be done by looking at the shape of the voltage. [00:07:02] Speaker 02: But there has to be that next step of looking at what the causation is. [00:07:06] Speaker 02: Once you have filtered that down to what was likely a nerve response, that is then used to determine proximity. [00:07:13] Speaker 02: So we have in the specification, as your honor points out, three ideas here. [00:07:17] Speaker 02: Sensing an EMG response, determining causation, then determining proximity. [00:07:23] Speaker 02: And what claim four recited is sensing a nerve response, which could broadly be interpreted to cover all three of those. [00:07:31] Speaker 02: However, if you look at claim 10, it actually skips that middle step. [00:07:34] Speaker 02: It senses all EMG activity because the record establishes that EMG sensors must, by their very nature, sense all EMG activity. [00:07:43] Speaker 02: And then it uses that in the proximity determination. [00:07:46] Speaker 02: We don't disagree that the intent of specification includes more. [00:07:50] Speaker 02: We also don't disagree that to get a more accurate determination of proximity, it would be better to filter down all of the EMG responses. [00:07:59] Speaker 02: There's always going to be some issue of how accurate your determination of proximity is. [00:08:04] Speaker 02: the more filters you use, the more analysis of causation you provide, the better that determination will be. [00:08:11] Speaker 02: What we have here is a complete lack of the causation requirement in Claim 4. [00:08:16] Speaker 00: Instead, it's... But we can't ignore the fact that the specification repeatedly, and I cited you to one, but there's about six or seven other places where it makes it clear what it is that the relationship of the muscles must have to the nerve. [00:08:31] Speaker 02: But it also makes clear how to actually [00:08:33] Speaker 02: filter those out. [00:08:35] Speaker 02: And one of the examples they give at the bottom of column 11 is looking at the magnitude of the EMG response. [00:08:42] Speaker 02: How do we know that that EMG response was actually a nerve activity? [00:08:46] Speaker 02: Well, one way is we look at the voltage, and we're going to set a minimum voltage of, I think it is 100 microvolts in there. [00:08:54] Speaker 02: That is the next step that's needed to actually perform what is required by claim four, sensing a nerve response. [00:09:03] Speaker 02: If you simply sense, it would be like a step of detecting whether Judge O'Malley has turned on a light switch. [00:09:11] Speaker 02: And you do that by putting a light sensor in a room and then using some other next step as to determine who actually turned the light switch on. [00:09:19] Speaker 02: But if you change that to detecting whether Judge O'Malley turned on a light switch by just simply putting a light sensor in a room, you've only done part of the analysis needed to actually sense who turned on the light. [00:09:31] Speaker 04: Can I ask you this? [00:09:32] Speaker 04: Why, why doesn't the word response when it is not expressly followed by a word like to necessarily, nevertheless imply something about what it's a response to. [00:09:51] Speaker 04: And then the spec and the whole purpose here immediately tells you what that thing is, namely to depolarize nerds. [00:09:57] Speaker 02: Well, I think there's been no disagreement in the breathing back and forth that EMG responses are electrical responses. [00:10:04] Speaker 02: To what? [00:10:05] Speaker 02: To, you could poke a person's leg, you'll get an electrical response. [00:10:08] Speaker 02: You could have a voluntary muscle movement, you'll get an electrical response. [00:10:12] Speaker 04: So when this says sensing an EMG response of a muscle coupled to a nerve, you just don't think that there is implicit, given the purpose and everything, that it is a response to the [00:10:27] Speaker 04: nerve depolarized by stimulation. [00:10:30] Speaker 02: That is the argument that Nubase uses, that you should read couple two to be caused by. [00:10:35] Speaker 02: But as the dissent pointed out below using the correct analysis, the claims simply don't recite only sensing EMG responses having a particular underlying cause, or sensing EMG responses caused by this. [00:10:46] Speaker 00: Well, isn't the point that we're supposed to construe claim four, given it's brought us reasonable construction, in order to then measure that against claim ten? [00:10:54] Speaker 02: That's only part of the analysis. [00:10:58] Speaker 02: There were two different analyses used below. [00:11:00] Speaker 02: The majority did exactly that. [00:11:03] Speaker 02: They looked at claim four and said, well, if we're talking broadly about sensing a nerve, part of sensing a nerve, as described in the specification, can use EMG activity. [00:11:11] Speaker 02: We don't dispute that. [00:11:12] Speaker 02: But the proper test for broadening is not could claim four cover potentially EMG sensing. [00:11:18] Speaker 02: The question is using the broadest reasonable interpretation of the new claim, claim 10, [00:11:23] Speaker 02: could that potentially cover something else? [00:11:26] Speaker 02: And what the dissent did was a proper analysis, which is, if I broadly construe claim 10. [00:11:31] Speaker 04: Right. [00:11:31] Speaker 04: So let me just try to say the same thing again. [00:11:35] Speaker 04: It seems to me you are completely missing that when there is a word response, there is a suggestion of it being a response to something. [00:11:44] Speaker 04: And the suggestion is that it's a response to the thing that follows in the language. [00:11:50] Speaker 04: And that suggestion, I guess I want [00:11:53] Speaker 04: know why is it not compelling when that's the obvious thing that this whole device is supposed, that this element of the device is intended to do. [00:12:03] Speaker 04: Respond to the stimulation that depolarizes the nerve. [00:12:08] Speaker 02: I think the understanding from both sides has been that EMG responses is just a term of art that talks about muscle or electrical activity. [00:12:18] Speaker 02: There hasn't been a dispute on the other side. [00:12:20] Speaker 02: I think their brief actually acknowledges [00:12:23] Speaker 02: that it is undisputed that EMG responses can come from a number of sources. [00:12:28] Speaker 04: Of course they can. [00:12:29] Speaker 04: But this is a clause that says, response of a muscle coupled to a nerve depolarized by said stimulation. [00:12:37] Speaker 04: Why does not that tend to suggest that it's a response to the thing that follows, not compellingly, but then when you look at the spec and the whole purpose of this, it becomes compelling? [00:12:51] Speaker 02: I think the answer to that is this language was specifically changed to this instead of saying caused by, saying coupled to, which as the dissent acknowledges is just a physical connection. [00:13:02] Speaker 02: This was an amendment made in the re-examination. [00:13:07] Speaker 02: If the other side wanted it to be caused by, they could have recited caused by. [00:13:11] Speaker 02: And as the dissent noted, once the initial decision, which found broadening was issued, [00:13:17] Speaker 02: they could have gone back and actually corrected the language. [00:13:19] Speaker 02: This was not reliable. [00:13:20] Speaker 01: I guess my question is, do they have to actually correct the language? [00:13:23] Speaker 01: What they've said pretty much amounts to a disclaimer of the broader coverage, right? [00:13:29] Speaker 01: Can we pay attention to that? [00:13:32] Speaker 02: If it made sense. [00:13:33] Speaker 02: What they have argued is we should read that step as sensing only EMG activity that is caused by nerve depolarization. [00:13:46] Speaker 02: Now, that could be a proper construction if it had, well, first of all, under the broadest reasonable interpretation, the question is, why would you read only? [00:13:53] Speaker 01: No, but can we take account of a disclaimer? [00:13:55] Speaker 01: Suppose they'd said explicitly, your reading of the claim is incorrect. [00:14:01] Speaker 01: This is limited to muscle movement caused by electrical stimulation of the nerve, and that's all that this claim covers. [00:14:11] Speaker 01: That would be a disclaimer. [00:14:12] Speaker 01: Why wouldn't that be binding on that? [00:14:15] Speaker 02: It could potentially be binding one. [00:14:16] Speaker 02: The issue is if you do interpret the claim that way, sensing only EMG responses having a specific underlying causation, there would have to be support or enablement for that. [00:14:26] Speaker 02: And that requires some sort of sensor that can sense not only a voltage, but the underlying cause of the voltage. [00:14:32] Speaker 02: And as is described as the documents are corporate by reference, EMG electrodes conduct any electrical activity. [00:14:39] Speaker 02: These are just sensors that sense voltages. [00:14:41] Speaker 02: So the question is, if you're going to use that construction of sensing only voltages having a cause, there has to be enablement and support. [00:14:49] Speaker 02: And there's nothing here that describes a sensor or a sensing step that can determine a 60 microvolt voltage that came from one cause versus another. [00:14:58] Speaker 02: So how would we actually construe that outside of this if there's no sensor that can really do that? [00:15:04] Speaker 02: If the court is saying that, [00:15:06] Speaker 02: We're going to construe this to be sensors that sense EMG activity and can tell by the voltage alone what the cause is. [00:15:13] Speaker 02: That would be very narrowing, and that could be an issue here. [00:15:16] Speaker 02: But the question is, is there any support for that in the record? [00:15:18] Speaker 02: And I don't believe there is. [00:15:19] Speaker 02: And if there isn't, how do we come to that as being the correct claim construction? [00:15:26] Speaker 01: Okay. [00:15:26] Speaker 01: All right. [00:15:26] Speaker 01: Thank you, Mr. Holliver. [00:15:27] Speaker 01: We'll give you two minutes for rebuttal. [00:15:29] Speaker 01: Thank you. [00:15:32] Speaker 01: Mr. Rosano? [00:15:38] Speaker 03: Thank you, your honor, and may it please the court. [00:15:40] Speaker 03: I'd like to address the claim broadening issue first that was discussed. [00:15:44] Speaker 03: And there can really be no doubt here that the board got the claim construction analysis as well as the broadening analysis right. [00:15:54] Speaker 03: Their conclusion, a step forth in the decision on rehearing, was, and I quote, the language of claim 10 links the sensed EMG response of the muscle to the depolarization activity of the nerve [00:16:07] Speaker 03: and thus excludes other responses that are not the result of electrical stimulation of the nerve. [00:16:14] Speaker 03: So that is the correct interpretation. [00:16:19] Speaker 03: The process in getting to that conclusion was correct, and it flows naturally from a plain reading of the claim, claim 10. [00:16:28] Speaker 03: And I'd like to turn attention to that claim to support that argument. [00:16:33] Speaker 03: But looking at the sensing step, [00:16:36] Speaker 03: As Your Honor noted earlier, there is a response, an EMG response. [00:16:42] Speaker 03: And that sensing step links together the response, the depolarization of the couple nerve, and the electrical stimulation. [00:16:51] Speaker 03: And it's interesting that Your Honor noted the term response, because the dictionary's definition in the biological context is an action or movement due to the application of stimulus. [00:17:03] Speaker 03: So in the context of that limitation, it's virtually inconceivable that an EMG response has nothing to do with the depolarization of the nerve or the recite electrical stimulation. [00:17:17] Speaker 03: If there is any doubt as to that connection, that doubt is immediately resolved upon reading the very next limitation of the claim, which is the determining, which explicitly states that the EMG response is one evoked [00:17:34] Speaker 03: by the electrical stimulation. [00:17:37] Speaker 03: This is consistent with exactly how the board analyzed the claim and that construction is correct. [00:17:46] Speaker 00: Well, your friend on the other side argues that sensing a response of a nerve depolarized is different than sensing an EMG response of a muscle that happens to be coupled to the nerve depolarized, and that that is what broadened this claim. [00:18:02] Speaker 00: that you have to look at the fact that in claim four, there's a limitation that is expressly stated that is actually then arguably omitted from claim 10. [00:18:15] Speaker 03: I understand that the argument, the analysis there is faulty in the sense that it relies on an incorrect construction of original claim four. [00:18:26] Speaker 03: And this was noted in the fourth decision on rehearing when they went back and construed claim four [00:18:32] Speaker 03: and noted that CLAIM-4 does not require directly sensing the response of a nerve. [00:18:41] Speaker 03: And that interpretation was entirely consistent with the specification, which by no means would reasonably support such a limited construction of sensing a response of a nerve depolarized by said stimulation. [00:18:57] Speaker 03: A reasonable interpretation of that [00:18:59] Speaker 03: is that it would cover indirect sensing, including the very embodiments that are described in the specification. [00:19:08] Speaker 03: And those are sensing EMGs responsible muscle. [00:19:14] Speaker 01: So if I understand what they're saying, they're saying that claim 10 was amended during the course of the re-examination to change caused by to couple to. [00:19:24] Speaker 01: Is that correct? [00:19:25] Speaker 03: That's incorrect. [00:19:27] Speaker 03: There is no cause by what they're arguing is that there's no causal connection. [00:19:32] Speaker 01: But I thought they were talking about an amendment. [00:19:34] Speaker 01: Am I misunderstanding? [00:19:37] Speaker 01: Was there an amendment? [00:19:37] Speaker 03: There was an amendment during the course of reexamination. [00:19:40] Speaker 03: And what was the amendment? [00:19:42] Speaker 03: It's a new claim, kind of a new claim added in the reexamination. [00:19:47] Speaker 01: But it wasn't in the course of the reexamination amended? [00:19:51] Speaker 03: I don't believe it was, no. [00:19:53] Speaker 03: There was an amendment submitted. [00:19:56] Speaker 03: Maybe it's a matter of terminology. [00:19:58] Speaker 03: There's amendments submitted during the re-examination. [00:20:01] Speaker 03: That amendment did amend previously existing claims, but also added new claims. [00:20:09] Speaker 03: Actually, I'm sorry. [00:20:10] Speaker 03: I think claim 10 was amended. [00:20:14] Speaker 03: I'll have to look at the record. [00:20:15] Speaker 04: The earlier version said something like response to a nerve and what the change was was response to a muscle coupled to a nerve. [00:20:24] Speaker 03: Is that the gist of this? [00:20:27] Speaker 03: Claim limitation was Claim 4, right? [00:20:30] Speaker 03: This is an amended version of Claim 4. [00:20:32] Speaker 03: The original language was sensing a response of a nerve depolarized bicep stimulation. [00:20:39] Speaker 00: Okay. [00:20:40] Speaker 00: So Claim 10 is a new claim, and the only question is whether Claim 10 allows a broader, something broader than the original Claim 4. [00:20:50] Speaker 00: It wasn't that Claim 10 was amending Claim 4, it was adding Claim 10. [00:20:53] Speaker 03: It was adding Claim 10 as a, yeah. [00:20:56] Speaker 03: And the basis of comparison was Claim 4. [00:20:59] Speaker 00: And so what the board ultimately said is Claim 4 was broad enough to cover everything that's in Claim 10 now. [00:21:05] Speaker 03: They did say that. [00:21:06] Speaker 00: It's broad as reasonable construction. [00:21:08] Speaker 03: Among other things, yes. [00:21:09] Speaker 03: It was broad enough and then more pertinently if they analyzed and concluded that there was no subject matter that fell within the scope of Claim 10 that would not have fallen within the scope of original Claim 4. [00:21:25] Speaker 04: Can you switch to the other issue, the Coros question, and explain why terminology aside, Coros doesn't teach or suggest or motivate somebody to attach some kind of fixing device to what in your patent you call the retractor? [00:21:55] Speaker 03: We agree that the terminology issue is not the dispositive issue here. [00:22:00] Speaker 03: The dispositive issue, for one, is whether this argument was ever raised in the first place in a timely manner. [00:22:06] Speaker 03: And with years of reexamination and some 50-something grounds of rejection advanced, the one that's being argued in front of this court was not one of those grounds advanced. [00:22:18] Speaker 03: So this is a new argument presented in the context of a rehearing before the board. [00:22:23] Speaker 03: And one of the things the board noted was they could not possibly have overlooked an argument that wasn't made, that of course being the standard for granting a request for rehearing. [00:22:35] Speaker 03: So the issue on appeals was the board erred in making that decision, and they did not. [00:22:41] Speaker 03: It was a new issue, and it was appropriate under the board's rules to deny an issue that was newly raised because it was not in the context for rehearing something [00:22:52] Speaker 03: previously presented and therefore overlooked. [00:22:55] Speaker 03: Now, if this court is willing to entertain the merits of that new combination. [00:23:00] Speaker 04: And just to clarify, the board addressed this only on the ground of new issue, not on the merits of the Coros argument. [00:23:09] Speaker 04: Is that right or not? [00:23:10] Speaker 03: Well, reading your decision on a re-hearing, it does look like they considered the merits and made some commentary directed towards those. [00:23:22] Speaker 03: they did state to the extent this is new argument that is inappropriate. [00:23:28] Speaker 00: So it was an alternative analysis of the merits. [00:23:31] Speaker 04: I believe that's right. [00:23:33] Speaker 04: So now on the merits, why? [00:23:36] Speaker 04: You know the question about core. [00:23:38] Speaker 03: Yeah, so on the merits, let's be clear what is on the table here in terms of subject matter and what's being proposed. [00:23:46] Speaker 03: So the subject matter of the patent is trans so as [00:23:51] Speaker 03: minimally invasive surgery through a lateral approach. [00:23:55] Speaker 03: The COROS reference is a reference that's talking about open abdominal surgery, where a device is inserted in and the retractor blades are spreading apart organs and inwards to access the spine. [00:24:09] Speaker 03: And then the distractor blade, these distractor blades 32, are going in with the screws and distracting the vertebral body. [00:24:20] Speaker 03: Even the concept of making modifications or importing limitations is problematic from the sense that these components of COROS are not sized for a trans-SOS approach. [00:24:35] Speaker 03: They're not safe for a trans-SOS approach. [00:24:38] Speaker 03: And the very modification that's being proposed here, looking at the COROS reference itself would fundamentally alter that reference. [00:24:48] Speaker 01: You're talking about adding the screws to 30? [00:24:51] Speaker 03: Right, whether the screws are removed from 32 and placed on 30, either one of those steps is a fundamental alteration, if not destroying the Coros reference. [00:25:05] Speaker 03: Remember, the screws on blades 32 are there to help distract a part of the T-roll body. [00:25:13] Speaker 01: So what did the board say about why it wouldn't be obvious to add the screws to 30? [00:25:20] Speaker 03: Well, they said it was never presented in that way. [00:25:23] Speaker 03: And that's true. [00:25:24] Speaker 03: There was a citation of Blades 30 and a separate mention of Screws 32. [00:25:33] Speaker 03: And the board found that there is no argument in the record of removing components from one set of blades and putting them on the other. [00:25:45] Speaker 03: Now, with respect to the concept of adding- Where do they say that? [00:25:50] Speaker 03: I think it's 25 of the appendix. [00:25:55] Speaker 03: It's in the request for rehearing. [00:25:57] Speaker 03: 25 is where there are two Quoros references. [00:26:04] Speaker 00: Is it page 6 of the rehearing order? [00:26:15] Speaker 04: Do you have the rehearing opinion in front of you? [00:26:17] Speaker 03: It's not right in front of me at the moment, Your Honor. [00:26:25] Speaker 00: in the back of the blue group. [00:26:28] Speaker 04: Maybe you can at least cite the pagination from the original re-hearing number since you don't have JA numbers on your, or they don't have JA numbers on their addendum. [00:26:45] Speaker 03: Okay, so there are two grounds, ground A or ground 17 and then ground B. [00:26:53] Speaker 03: which is 18, so in 17. [00:26:57] Speaker 04: Page number please. [00:26:58] Speaker 03: This is page 4 of the rehearing and 21 of the appendix. [00:27:10] Speaker 03: Thank you. [00:27:10] Speaker 03: So the problem the board noted is that there's no site, what the requester did was site those blades 30, noting that those blades 30 included one of [00:27:23] Speaker 03: the features, which would be the proximal feature, the releasably lockable to a frame, and then referenced the screws as also being included. [00:27:35] Speaker 03: The board noted that those were not a component of the same blade. [00:27:40] Speaker 01: Well, they seem to reject that as a new argument now. [00:27:43] Speaker 03: Well, they rejected the simple citation as what seemed to be a misapprehension of the reference. [00:27:51] Speaker 03: Now, in rehearing, [00:27:53] Speaker 03: it was presented by the requester as a suggestion to essentially make a new modification, of course, to import the screw limitation into the blade limitation. [00:28:08] Speaker 03: That was rejected as a new argument. [00:28:11] Speaker 03: I think that is on page 23 of the appendix. [00:28:16] Speaker 03: Page six. [00:28:19] Speaker 03: Furthermore, in connection, I tried to not present a credible basis for concluding that it would have been obvious to implement courses locking mechanism 32 and tubular guide 32 into the retractable at 30, to the extent it now makes the connection untimely. [00:28:35] Speaker 03: And that's accurate. [00:28:44] Speaker 03: Now, there were, as to the [00:28:47] Speaker 01: Are 82 and 83 the screws? [00:28:49] Speaker 03: 83 are the screws, your honor. [00:28:54] Speaker 03: And 82, I believe, is the internal tubular guide. [00:29:00] Speaker 03: So the screws go through the interior of the blade through a tubular guide. [00:29:06] Speaker 03: So 83 is the screw. [00:29:10] Speaker 03: And with regard to the combination itself, even considering this new combination, [00:29:17] Speaker 03: argument was presented by the patent owner. [00:29:20] Speaker 03: It wasn't necessary for the board to ever get to this issue per se, because it was a new argument. [00:29:25] Speaker 03: But this idea of taking retraction screws off of one set of blades is meant to distract the vertebral bodies away from each other. [00:29:37] Speaker 03: Removing them no longer provides the functionality of that vertebral body distraction. [00:29:43] Speaker 03: putting those screws into different blades that are designed to hold vital organs apart in an open abdominal procedure, it's futile and there's no reason to do it. [00:29:58] Speaker 03: There's argument that it would be unsafe to do so. [00:30:02] Speaker 03: And that certainly makes sense because one of the key tissues being held away from the spine in an abdominal procedure is some of the vital arterial [00:30:13] Speaker 03: blood vessels, which obviously are next could be fatal. [00:30:18] Speaker 03: So adding screws to those components simply doesn't make sense. [00:30:23] Speaker 03: And I think there was a comment of whether there was any expert testimony on this. [00:30:28] Speaker 03: The answer is no. [00:30:30] Speaker 03: If there was expert testimony, certainly this would be an issue that would have to be explained, and I don't think it can be. [00:30:41] Speaker 01: Okay. [00:30:41] Speaker 01: Thank you, Mr. Rosano. [00:30:53] Speaker 01: Mr. Oliver. [00:30:55] Speaker 02: Thank you, Your Honor. [00:30:58] Speaker 02: First of all, I'd like to address that whether Corus was a new issue. [00:31:01] Speaker 02: The claim chart and original presentation of this proposed rejection referenced blade 30, but also stated separately that screws may be used with retractor blades, not retractor blades 30, not retractor blades 32. [00:31:15] Speaker 02: What seems to have happened below is it got off on a tangent of whether [00:31:18] Speaker 02: retractor blade and distractor blades, or retractor blade 30 and distractor blade 32 were different. [00:31:24] Speaker 02: And what we argued below was correctly that they're not different. [00:31:27] Speaker 02: If you look at Coros as a whole, which is what's required, in the background it describes that all of these are retractor blade. [00:31:33] Speaker 01: Why are we getting all of this as lawyer argument instead of putting in declarations from experts about how it would be feasible to modify Coros to add the screws to 30? [00:31:46] Speaker 01: Well, there are expert declarations that didn't address the specific issue. [00:31:50] Speaker 01: Well, but that's the point. [00:31:51] Speaker 01: I understand that, Your Honor. [00:31:53] Speaker 01: You don't bring the expert testimony before the board, and then you come up here and all you've got is lawyer argument asking us to make a decision about a technical subject that we're not expert about. [00:32:06] Speaker 02: Our argument on the appeal has been that there's no need to modify quorums because quorums describe that retractor blades may have scruples. [00:32:16] Speaker 02: And if it broadly discloses that retractor blades may have screws, you don't need expert testimony to say that that is what is part of the Coros disclosure. [00:32:25] Speaker 02: Now, there's been an attorney argument as to whether or not this would be dangerous. [00:32:29] Speaker 02: But I don't understand how that argument works, since Coros already described that you put these screws on blades. [00:32:35] Speaker 02: And they're saying if, for some reason, if they were on a different set of blades, it would suddenly become dangerous, because this is an abdominal surgery. [00:32:42] Speaker 02: to spine surgery. [00:32:44] Speaker 00: The claims of the patent clearly differentiate between the retractor blades and the distractor blades. [00:32:49] Speaker 00: And you're asking us to say that they can be completely interchangeable without giving us any expert testimony as to why that's so. [00:32:59] Speaker 02: Well, we don't think you need expert testimony if the background describes as a whole that these are all retractor blades and that the blades may include screws. [00:33:09] Speaker 02: And as we said in our brief, that was even claimed [00:33:11] Speaker 02: by a pilot of the course patent that you can use screws on retractor blades. [00:33:16] Speaker 02: This argument that it's only somehow limited to distractor blades sort of looks at the preferred embodiment. [00:33:23] Speaker 02: We don't disagree that preferred embodiment gives names and numbers to particular blades. [00:33:27] Speaker 02: It could have been first blades and second blades. [00:33:31] Speaker 02: They're called distractor blades because the ones that happen to have the screws are what help pull apart bone because they screw in the bone. [00:33:38] Speaker 01: I think we're out of time, Mr. Oliver. [00:33:39] Speaker 01: Thank you. [00:33:40] Speaker 01: Thank both counsel, the cases.