[00:00:04] Speaker 01: May it please the Court, Lauren Degnes-Demoskowitz. [00:00:07] Speaker 01: The District Court here erred by construing the term universal in the preambles as limiting. The default rule that preambles are non-limiting governs here. When we look at each of the guideposts this Court has provided for conducting this inquiry, I'll start with universal is not described as a fundamental characteristic in the specification. In fact, it appears only once in the entire specification in the background of the invention. [00:00:40] Speaker 01: where it says the present invention relates to a unique, universal, bidirectional system. And this sort of limited, distinctly limited description and the use of the word universal tells us it's not a fundamental characteristic. [00:00:55] Speaker 03: Ms. Duggan, do you know how the patent examiner treated the preamble during prosecution? I don't think we have the prosecution history. I don't think any party has made any argument based on that, but I think it would be could be insightful to know how it was treated. [00:01:11] Speaker 01: You're right. No one has made any arguments about how that came to be in the briefing. [00:01:16] Speaker 03: That's not what it came to be, but when the examiner looked at prior or maybe applied it to the claim, did it consider the preamble part of the claim or not? [00:01:26] Speaker 01: So I'm not aware that the examiner did, in fact, rely on universal and the preambles in order to assess patentability. I may be able to confer with counsel when I sit down just to provide more detail on that point for you, Your Honor. [00:01:44] Speaker 04: Your argument that it's not limiting, is that made assuming we accept the district court's claim construction? [00:01:52] Speaker 01: It is not limiting under the district court's claim construction or under the construction that we advanced. It's not limiting in any way in these preambles, regardless of the claim construction. [00:02:02] Speaker 04: If the claim construction requires that it can be inserted in any region using any surgical approach, how would that not be limiting? [00:02:13] Speaker 01: Okay, I'll say two things in response to that, Your Honor. First, I think that distal cork construction in particular describes sort of a statement of intended use in that it can be in any part of the spine used through any possible implementation, surgical approach. But secondarily, I think when we go to the guidepost about does the body describe – a structurally complete invention, it certainly does in both Claim 47 and Claim 1. The body has a structurally complete invention, so even under the district court's construction of universal, the preamble does not have essential structure. [00:02:52] Speaker 01: We could still remove the word universal from the preambles, and we would see in Claim 47 a very detailed structure description of the intervertebral cage. And we would see in claim one a complete tool for inserting such a cage. And so in particular, if I talk about claim one under the district court's construction, even grafting all those requirements onto universal, we still have kind of the quintessential recitation of of a statement of intended use. [00:03:28] Speaker 01: It's still a tool for manipulating and inserting this very detailed universal intervertebral bone fusion spacer. So in particular claim one, under the district court's construction, we have one of the most straightforward statement of intended uses that I think we can see. [00:03:47] Speaker 03: One thing I'm struggling with is when is it that part of the preamble has weight and part of it doesn't? And I think part of the rule with that is that you have to be able to separate out the language, be able to see different parts within the preamble. What is your view of that rule under our precedent? [00:04:12] Speaker 01: Certainly, Your Honor. So there's not going to be one test. That's not how our precedent works. But the way I would look at it, first, you're right, is it neatly packageable? Can you cut it up in manageable pieces? Here, universal is an adjective, and so it's the sort of thing that can be cleaved off, just like space efficient in the Nimble Inc. case that we gave you. And if we contrast that with the Bio-Rad case, where this court said we could not really slice and dice it the way that the litigants there wanted, the preamble was quite different. [00:04:45] Speaker 01: The method was for conducting a reaction in plugs in a microfluid system comprising, and the part they wanted to cleave out was the conducting in. So it was sort of two different parts of a very long clause, where in a case like this, we have universal in the front end of a structure that is then defined as in the body and used in the body. And so I wouldn't say every adjective can be cleaved off. I don't think we can just use that as a talisman. [00:05:16] Speaker 01: But given the kind of work the universe is doing in this claim, given the other guideposts, I think it is something we can, you know, The case you're referring to is the nimble link case that you provided? Yes, Your Honor. [00:05:31] Speaker 04: Quite a system we've created, haven't we? I mean, claim construction in and of itself is difficult and contentious enough, and now we've got the additional question of whether the preamble is limiting, and then the sub-question of what portion of the preamble, because under your theory you can slice and dice. [00:05:51] Speaker 04: That's not a pejorative term, but quite a system, isn't it? [00:05:59] Speaker 01: But I remind us all that the overlay on that system is the default presumptive rule that the preambles are not limiting. [00:06:08] Speaker 04: But you're even acknowledging that some of the preamble could be limiting and some other portions of it not be limiting, right? In this case in particular, in claim one, don't you concede that some of it is limiting? [00:06:21] Speaker 01: So I don't think we can see that any of it is limiting. What we said was really the slots and the screw guides, they serve as reference points, and then CR-BAR just serving as reference points didn't require them to be limiting. However... If anything, in the preamble of Claim 1 were to be considered limiting, it would be those slots and the screw guides, the integral screw guides. But I think if you look very closely, they're more reference points. [00:06:52] Speaker 01: They're not like Bicon, where the abutment had a very specific structure, and you had to contour and follow that abutment. Here, the slots and the screw guides are more reference points. [00:07:09] Speaker 03: Is there something to be said about how this preamble might be different from that in New Belink? Because the preamble here is, frankly, just really long. I mean, I'm looking at claim one of the 913 patent, and the preamble itself, might be longer, might have more words than the body of the claim. [00:07:31] Speaker 03: In that circumstance, it's hard to imagine, in some respects, an inventor wouldn't expect that candle to have some length. [00:07:39] Speaker 01: Well, I have two responses for that. First, I actually think length often would cut in our favor. If it's very long, it's easier to parse out into discrete subparts. [00:07:50] Speaker 01: So I would say the length, I wouldn't hang my hat on length as always being something that shows it is limiting. I think in our case it shows it's not. But again, claim one is interesting in that it is a tool for manipulating and inserting this universal intervertebral bone fusion spacer. That is quintessential youth function. And then it describes a thing that's going to be inserted. the context, the use of the intended use of the tool that's being claimed, and then it reinforces right before comprising that the body is going to be describing the actual affirmative limitations of the tool. [00:08:29] Speaker 01: It says the tool comprising. You're talking about the tool comprising. That's right. [00:08:32] Speaker 03: So you would say you would – we should ignore everything – that comes from universal and beyond, including the two wearing clauses, and then give weight to the tool comparison. [00:08:47] Speaker 01: That's exactly right, Your Honor. Those wearing clause, again, the second wearing clause sort of, those wearing clause describe some of the reference points that are used later, but the entire preamble, and in particular, the reference points are related to the cage, the intervertebral cage. Those are reference points of the caged. not the universal intervertebral bone fusion spacer. The spacer includes the cage, and then the cage is described, but ultimately, the body of the claim is all about the tool. [00:09:20] Speaker 04: Before your time runs out, do you want to touch briefly on the second issue of cooperating? [00:09:28] Speaker 01: Yes, Your Honor. Did you have questions on the actual construction of universal? Because we could talk about that I mean, it does exclude every single embodiment in the claim. In the press specification, there's not a single embodiment that is described as being used in each and every location of the spine. I would draw your attention at column two. It says, herein we describe multiple device embodiments. It talks predominantly about an embodiment, a physical device that goes in the lumbar region of the spine. [00:10:03] Speaker 01: And when it goes on to talk about how it might be modifiable is talking about the teachings to be modifiable. It talks about extraordinary screw box and those teachings could be then modified so that the screw box could be used in a different portion of the spine. Those are teachings about the invention. They're not saying there's any one device that can be itself changed and I would draw your attention to claim 38 which talks about selecting the bone fusion spacer based on the measured dimensions of the disk space, selecting something that already exists, not modifying the spacer so that it can be put into a different part based on dimensions of the disc space. [00:10:49] Speaker 01: So I think when we look very closely at the specification, there's no embodiment that a physical device is modified so it can go into lumbar versus cervix. Instead, the teachings are there. The innovative screw box is able, those teachings are able to be incorporated into an appropriately sized spacer for the neck and one that's sized for the lumbar. [00:11:13] Speaker 04: Let's see what it means. [00:11:18] Speaker 04: which supported his name. [00:11:19] Speaker 01: Well, respectfully, the district court is misreading the specification, and in particular, if you wanted to look at Appendix 197 at Column 3 down around Line 51, where it talks about the expendable embodiment of the sprue box can also be enlarged and modified to be suitable for cervical, thoracic, and lumbar vertebral body replacement. A body replacement means you take out the vertebrae itself. Not the disc. So most of what the specification talks about, you stick the spacer between two vertebrae. [00:11:54] Speaker 01: And here, it's not saying you could place it anywhere between two vertebrae. It's saying you would actually replace and remove the vertebrae and use the cage instead. And that is the teaching about how broad the invention is. You use these... [00:12:14] Speaker 01: the cage with the two screw guides, it has a lot of applicability, but no one physical device itself is modified to go into any portion of the spine. [00:12:26] Speaker 01: I am in my rebuttal time. I certainly want to answer questions you might have on cooperating, but I want to be respectful of time. [00:12:34] Speaker 01: Okay, thank you. [00:12:44] Speaker 00: Good morning. John Lahat of Sussman Goffrey for the Appellee Globus Medical. So plaintiff's arguments are divorced from the intrinsic record, the claim language, the spec, and how they, how Moskowitz, applied the claims in this litigation. Let's start with this argument that claim 1 of the 913 is directed solely to the tool. [00:13:06] Speaker 00: We know that can't be right. [00:13:12] Speaker 00: First, there are... I'm sorry. [00:13:13] Speaker 04: Just... [00:13:15] Speaker 04: what points to that conclusion is the first word, which says a tool, and then even before comprising, it says the tool comprises. [00:13:26] Speaker 04: Right? [00:13:26] Speaker 00: Yes, but there are dependent claims that don't say anything about the tool. There are dependent claims that describe just the cage, claims 10 through 14. [00:13:37] Speaker 00: Those claims describe attributes of the cage. So if claim 1 says, is all about the tool, then what are we doing with claims 10 through 14? What work do they do? They have to do some work. They're not just there for garnishment or surplusage. [00:13:53] Speaker 03: What about the argument that, true, and the page was recited in the body of the claim, but it's other parts of the preamble that our law would require us to not give way to it? [00:14:09] Speaker 00: So it sounds like Your Honor is asking about splitting or slicing and dicing. Yeah, that is exactly what I'm asking about. [00:14:14] Speaker 03: I'm just imagining what the response is from opposing counsel to your argument based on what we've heard argued to us, which is that either one way to look at it under our precedent is that an adjective like universal should not be given weight under the case that was cited in the 28J letter. So what is your response to that? [00:14:38] Speaker 00: So... [00:14:40] Speaker 00: While it is true that this court has, if I can borrow your phrase, sliced and diced the preamble before, it has cautioned against doing that in situations where you can't neatly package the preamble. And in this case, well, let's go back to TomTom. In TomTom, the portion of the preamble deemed non-limiting was superfluous or redundant, giving that the quote-unquote generating and updating appeared in the body. [00:15:07] Speaker 00: That's not the case here. The universal screw guide and fixation apparatus, or the universal intravertebral bone fusion spacer, is the invention. [00:15:18] Speaker 00: And it's used and referenced in the dependent claims. And if you were to take TomTom as a blueprint and say, we're going to try to slice and dice this preamble as TomTom. [00:15:30] Speaker 03: I just want to understand, what is your basis for saying it is the invention? I can see you saying it's part of the invention, but How do you say it is the invention? Are you saying the tool is not the invention? [00:15:42] Speaker 00: The tool is part of the invention. The cage is just as part of the invention as the tool. And it's the only invention. [00:15:48] Speaker 02: Take that from the fact that it's in the preamble, or do you take it from the fact that it's in the specification? [00:15:53] Speaker 00: Both. It's in the preamble. It's in the claims. In the 913 patent, every time you see spacer in the claims, it's preceded by universal intervertebral bone fusion spacer. As the district court found, not just any spacer, but a universal spacer. And it's in the specifications. [00:16:13] Speaker 00: I understand that universal is not used with frequency in the specification, but all you've got to do is read the spec to see what the inventors are talking about. Right? If we start... [00:16:27] Speaker 00: I think it is in the embodiments. There's no differentiation between embodiments based on certain features, and one of those features would be used in certain regions of the spine. [00:16:40] Speaker 03: What is your best place in the specification to support what you just said? [00:16:44] Speaker 00: Sure. I've got a few, if I can get a few in. [00:16:49] Speaker 00: This is the nine-month respec. [00:16:51] Speaker 00: Column one, lines 35 through 43, talks about a posterior lumbosacral and thoracic spine, and then these are posteriorly and anteriorly placed, may obviate the need for supplemental screw fixation. If we go on to, we stay in column one, the problem that is identified by the patentees is a problem they see with fusion techniques in all regions. [00:17:25] Speaker 00: I am still in column 1, yes, Your Honor. It's going to be lines 53 to 57. Let me make sure I'm giving you the right size. [00:17:37] Speaker 03: So that's page A250. You said the 913 column. [00:17:40] Speaker 00: Yes, it's going to be in the spec at 250. [00:17:56] Speaker 00: Right, and this is right about, this is in the appendix at 250. [00:18:01] Speaker 00: This is line, column one, line 54. [00:18:05] Speaker 00: The problem is currently the majority of posterior cervical and almost all anterior and posterior lumbosacral and thoracic fusion techniques are supplemented with pedicle screw placement. That's the problem. We have these fusions in all three regions. [00:18:21] Speaker 03: It doesn't say the problem, right? It doesn't use that word. I just want to make sure because you're not quoting it correctly. If you're going to be quoting something, make sure you quote it accurately, please. [00:18:32] Speaker 00: And so the reason why I refer to that as a problem is if you fast forward to column 12, it goes back to that problem, and it uses the word problem. If you can go to column 12 at lines 16 through 20, that's going to be in the appendix at 255. [00:18:54] Speaker 00: The present inventions may provide effective and safe techniques that overcome the problems of associated with current transpedicular-based cervical, thoracic, and lumbar function technology, and for many, degenerative-stable and unstable spine disease. So that's why I phrase it as the problem identified, I think. [00:19:14] Speaker 00: And then we look in column 11 as well, where you've got lines. This is also on Appendix 255. Lines 29 through 33 and 49 to 54 say, which talk about using that construct in the anterior thoracic and lumbar spine. It also talks about the posterior placement of the constructs. [00:19:38] Speaker 03: So these things that you're referring to, these are talking about the idea that these cages, lack of a better word, can be used in all the different ways in which they're placed in and different places in the body in which they can be inserted. [00:19:56] Speaker 00: Yes, and without changing the allegedly inventive aspects of the cages or the spacers. [00:20:03] Speaker 03: There's only two things... They just have to change the size and things. [00:20:07] Speaker 00: That seems to be... There's two ways... I'm sorry. [00:20:11] Speaker 00: There's two ways to use... The specification says to use these implants in different regions. Neither of them have anything to do with the inventive aspects of it. Change the size... [00:20:26] Speaker 00: And use two. This is in Figure 4. You can change the size, which is immaterial to the inventive aspects, or you can just use two, which is what we see in Figure 4, and that's described as the lumbosacral implementation. Nothing changes about the cage or the spacer. The screw guides are the same. The ridges are the same. The slots are the same. The method of expansion, if it's expandable, is the same. They're just using two, which makes sense. You've got a larger disk space down there, you can just use two. [00:20:57] Speaker 00: Those are the only two ways that the spec discusses how the embodiments would differ in various regions of the spine. [00:21:06] Speaker 03: And I take it then that the accused device doesn't operate that way? It can only be used to be put in certain parts of the body? [00:21:14] Speaker 00: Correct. [00:21:14] Speaker 03: Never change the size and things like that? [00:21:16] Speaker 00: It can change the size a touch, but they're indicated for use in certain approaches and in certain regions. So you can't take, so yes, the answer to your question is yes. [00:21:29] Speaker 00: I want to go back to the tool the argument that it's just a tool or it's just intended use. [00:21:37] Speaker 00: We know that's not right because of the claim language. Like I said, claims 10 through 14 of the 913 are not directed to the tool. [00:21:47] Speaker 00: They're directed to the cage. [00:21:51] Speaker 00: And also, if claim 1 was directed to just the tool, then Moskowitz would not have accused the implants of infringement as it did. [00:22:01] Speaker 00: And If claim one is just the tool, then how are they accusing the implant of infringement of claim one, which is what they did below? You can see that in the district court referred to it, Appendix 29. Their plaintiff's damages report discusses this at Appendix 3096. It's in our statement of undisputed facts below at 3132. Moskowitz's response... 3132. [00:22:31] Speaker 00: Moskowitz's response to our statement of undisputed facts, where they acknowledge this, is at 3717. And our expert report discussing this is at 3151 through 57. And of course, they needed to accuse the implants because that's where the damages are. We don't sell the tools. [00:22:55] Speaker 00: The tools are consigned. They're loaned out. We don't sell them. The only thing that is sold is the implants. [00:23:04] Speaker 00: You can see some factual background about us not selling the tools at Appendix 3278 to 79, and then in some discovery responses in the Appendix 3585. [00:23:17] Speaker 00: So, patentee's interpretation of Claim 1 says, throughout most of this litigation, including for purposes of damages and infringement, was that claim one was drawn to the implant as well. [00:23:31] Speaker 00: And that distinguishes what we have here from Moskowitz's favorite case, C.R. Bard. [00:23:39] Speaker 00: In C.R. Bard, the claimant issue was directed to the biopsy needle with a tissue sampling device There's some language regarding the biopsy gun in that device. [00:23:54] Speaker 00: That gun language was held as not part of the separate claims to the needles. But in that case, the plaintiff limited its interpretation of claim 21 to the needle and then argued that language about the gun was not limiting. In our case, as I said, Moskowitz accused the implants as well as the instruments of infringing. It didn't limit interpretation. the infringement allegation to the tool. So I don't think it can be heard now to say that the claim is limited to just the tool. [00:24:25] Speaker 00: And again, this is not to mention that there are dependent claims that have nothing to do with the tool. [00:24:31] Speaker 00: Now, if I can go back to Your Honor's question about splitting the claim limitation or the preamble, if we want to go back to the TomTom case, which they hinge this idea on... [00:24:47] Speaker 00: In TomTom, the language at issue involved generating and updating, and the court held, well, generating and updating, that's intended to use, that's not limiting. [00:25:02] Speaker 00: In our case, if we want to do it using TomTom as a blueprint, what we could do is say, okay, manipulating and inserting may not be limiting, that's akin to generating and updating, but the remainder is, right? In TomTom, the court held that, or actually commented that the district court correctly held that the device was limited because the claim was not directed to just any mobile unit. It was a specific type of mobile unit in TomTom. [00:25:32] Speaker 00: Likewise, in this case, we're not talking about just any spacer. It is a universal one. [00:25:46] Speaker 03: What about the decision that was cited in the 2018 letter? Did you address that? That's a different kind of... That case involved a different kind of parsing of the language, pulling out an adjective. [00:26:03] Speaker 00: Yeah, and I don't think adjective... I don't think... [00:26:08] Speaker 03: saying that it was an intended use, right? So this would be an intended use of the device that the school was inserting. [00:26:17] Speaker 00: Yeah, I think the Nimble Link case is just an opposite. In that case, the court held that space-efficient devices was not limiting, but the court held that space-efficient doesn't extol the virtues or benefits of the invention. In this case, universal does. It is the invention. It's unlike a nimble link where the panel noted that the specification discussed various design choices that could achieve these space savings. [00:26:50] Speaker 00: That's not the case here. [00:26:51] Speaker 03: It's a hard thing to pass, to be honest with you, for you to say it is the invention. is the hard thing for me to know. I do think it's hard to parse, but don't get me wrong. [00:27:02] Speaker 00: I agree. [00:27:02] Speaker 03: But I'm just saying that your distinction of the case isn't doing it for me because it's hard, as I sit here and you say universal is the invention, I just don't know how I'm supposed to know that in an objective way. [00:27:18] Speaker 00: I think the claim language and the specification get you there. [00:27:22] Speaker 03: I think the repeated use of – and taking a look at the court – So how are we able to look at that other case, and how are we able to see that in that patent specification? [00:27:33] Speaker 03: it's not in the claim, the language, and it's not mentioned or emphasized in the specification. Not in the same way. I bet it's in the claim, and I bet it's in the specification. It's clearly in the claim. So there needs to be, I don't understand that as a basis for distinguishing [00:27:49] Speaker 00: I want to reiterate that it's not just an issue of fundamental characteristic. There's also the notion of antecedent basis. I don't know if space efficient was provided any kind of antecedent basis in that claim, whereas in this case it does. Again, you've got universal preceding interval T of a bone fusion spacer in every case. You've got claims five and nine, which... [00:28:16] Speaker 00: rely on claim 1 for antecedent basis. You've got claims 49, 55, and 57 of the 022, which rely on the preamble to claim 47 for antecedent basis. So there are multiple guideposts, as counsel noted, and I think that all of them militate in favor of finding the preamble limiting in this case. I don't think you can slice and dice it, certainly not with any kind of clarity or fairness, and in a manner that provides sufficient notice to the public about what's claimed and what's not. [00:28:51] Speaker 00: So while I agree that slicing and dicing the preamble is possible, I don't think it's possible accurately in this case. [00:29:00] Speaker 03: Thank you. [00:29:02] Speaker 00: Unless there are any questions on the J-Mall, happy to rest in the papers on that. [00:29:17] Speaker 01: Thank you. Thank you. So let me address a couple of things. First, I would say it is not the invention. And I'll introduce you to two places that I think really bring this part home in appendix A. Unfortunately, my sites are usually 022, so Appendix 197, Column 3, around Line 34, starting at Line 31, it says... You've got to give me... We're talking about which patent? [00:29:40] Speaker 04: This is the 022, Appendix 197, Column 3, starting at Line 31. And it says... [00:29:58] Speaker 01: The novelty of this design is the built-in prescribed angles of the integral screw guides, which allow the posterior transvertebral penetration into the vertebral bodies. This is a truly amazing feat. [00:30:16] Speaker 01: accomplished in the posterior lumbar spine is fitting the anatomy. They're saying the pedicle screws were a problem, and this screw box, this cage, was very useful. And in column 12 of the 022 patent, at the very end, in appendix 201, line 64, to our knowledge, there have not been any previously described similar posterior lumbar And thoracic combined spacer and construe constructs. [00:30:49] Speaker 01: The novelty is the screw box, the dual function in nature. It has nothing to do with using the same physical device and moving it from location to location. [00:31:02] Speaker 01: If I can have just a couple of your other questions. [00:31:06] Speaker 01: The... [00:31:08] Speaker 01: With respect to claims 49 and 57 of the 022, all that says there is the apparatus of claim 47. It doesn't even repeat the universal aspect of it, showing intentionality for the preamble not to be providing an incident basis. [00:31:27] Speaker 01: In terms of why did we accuse the implants when we were going after the tool, Appendix 3132 is not in the joint appendix, but I think he's confusing a damages model construct with what the claim actually is about. [00:31:43] Speaker 03: And I think we can see claim one is about the tool, and the rest of it is... What was the damages model to get the device that's inserted using the tool? [00:31:54] Speaker 01: I don't have the details at my fingertips, but you can certainly envision that the value of the tool might have something to do with how often it is used to actually implant these implants into people. And so I think that's sort of a diversion. But again, not selling the tool, it could be that the value of using the tool that is in an indirect infringement model could be tied to how many... [00:32:31] Speaker 01: I don't actually have all those details, and it's not in the joint appendix. I was just trying to address this portion of the appendix that's literally not in the joint appendix, and so I'm providing kind of little context. [00:32:43] Speaker 03: It's hard to know, honestly, assess the value of that argument. [00:32:48] Speaker 01: And then to answer the question you raised earlier, Judge Stoll, universal did not come up during the regular prosecution. During the IPR, there was some IPRs that failed, and in our response to the IPR, we point out a procedural flaw, and this is at Appendix 3699, describes in background. [00:33:06] Speaker 03: Is it during the original prosecution? [00:33:08] Speaker 01: Universal never came up. The preambles and universals did not come up during the ordinary prosecution. [00:33:16] Speaker 03: So universal was added later. [00:33:18] Speaker 03: That is what I am told. [00:33:23] Speaker 01: It was not relied upon to get over prior art during the original prosecution. Did not mention it, as far as I know. Did not mention it. But I do want to, if you want to talk about the IPRs, Appendix 3699 explains that When they put in their petition, they put forth their construction that the district court adopted, but then they made no effort to meet it at all. And based on that procedural flaw, we pointed that out. And so we didn't rely on Universal to get over prior art in the IPR. [00:33:53] Speaker 01: It was purely their petition was defective. [00:33:57] Speaker 04: Thank you. Thank you.