[00:00:00] Speaker 00: We will hear argument next, case number 23-2357, aniline pharmaceuticals against Moderna. [00:00:13] Speaker 00: Mr. Hughes. [00:00:15] Speaker 01: May it please the court, Paul Hughes, for appellant aniline. [00:00:19] Speaker 01: This is a claim construction dispute. [00:00:21] Speaker 01: And as always, the court should start with the language of the claims. [00:00:25] Speaker 01: Here, the claim language read with the whole specification [00:00:29] Speaker 01: makes abundantly clear that the heartland of these claims encompasses branched alkyls with two carbon bonding because the branching occurs at the alpha position. [00:00:40] Speaker 02: The specification contains... If that's true, what is that definition doing in the specification? [00:00:46] Speaker 01: You know, the definition, what it's doing in the specification is it's talking about the underlying science. [00:00:51] Speaker 01: It functions as a textbook. [00:00:53] Speaker 01: And the vast majority of times when you have a branched alkyl and an alkyl chain, you have three-carbon bonding. [00:01:00] Speaker 01: Let me explain just for a moment the science behind that. [00:01:03] Speaker 01: When you have a branched alkyl that's within an alkyl chain, the thing that's coming into the branch, that central carbon, is a carbon. [00:01:09] Speaker 01: And then it branches to two carbons. [00:01:11] Speaker 01: So you necessarily have three-carbon bonding. [00:01:14] Speaker 01: When you look at the patent, I will acknowledge the vast majority of examples, the overwhelming majority of examples, describe a branched alcohol where the branching occurs within the alcohol chain. [00:01:28] Speaker 01: And in all of those circumstances, you have at least three-carbon bonding. [00:01:32] Speaker 01: What we are dealing with, though, in claims 18 and 20 is what I think is an exception to how branched alcohol usually operates. [00:01:39] Speaker 01: And it's where it's in the alpha position. [00:01:41] Speaker 01: And the only way you can have a branched alkyl that has two carbon bonding, it can't be one because you have two branches. [00:01:47] Speaker 01: The only way that you can have a branched alkyl when you have two carbons. [00:01:51] Speaker 01: is where the branching occurs in the alpha position, because since it's not in the chain. [00:01:56] Speaker 03: So then just going back to the definition of column 412. [00:02:00] Speaker 03: And when I say definition, I'm kind of previewing what I think about column 412. [00:02:06] Speaker 03: What work is problem one of that definition doing when it says where the carbon atom [00:02:12] Speaker 03: is connected to at least three carbons. [00:02:16] Speaker 03: I mean, you just all agreed that in every other position, it's always going to be at least three carbons. [00:02:23] Speaker 03: And so the only work that that prong one is doing in the definition is excluding the possibility of three carbons at the alpha position, where normally at the alpha position, you could have two carbons or three carbons. [00:02:39] Speaker 01: Your honor, I think a couple of points about that. [00:02:41] Speaker 03: When you look at the definitional section as a whole... Is it right, though, that that is the only work that prong one of the definition in column 412 is doing? [00:02:50] Speaker 03: No, your honor, I think the upshot is... What's the purpose of adding prong one to that definition? [00:02:56] Speaker 03: I guess that's really what I'm trying to get at. [00:02:58] Speaker 01: What this is doing is this functions as a textbook. [00:03:00] Speaker 01: This is giving organic chemistry terms and saying how those terms are meant to be understood and usually used. [00:03:07] Speaker 01: What's important in the definitional section of columns 411 and 412, sometimes the patentee says, this is what this term means in all places. [00:03:15] Speaker 01: But for branched alcohol, what the patentee said was, unless otherwise specified, which means the patentee knew that there would be times where there's not three-carbon branching. [00:03:25] Speaker 01: The only time that can exist is when you have it in the alpha position. [00:03:29] Speaker 01: I acknowledge, Your Honor, the majority of the time when you have a branched alkyl, what that term means is three-carbon bonding. [00:03:36] Speaker 01: And that's what 412 is telling you, just as a textbook would inform you how terms often operate. [00:03:41] Speaker 03: I guess just to put a finer point on it, wouldn't a skilled artisan reading that prong one of the definition say, OK, this prong one is here. [00:03:51] Speaker 03: And because they want to exclude two carbons at the alpha position, unless otherwise specify it. [00:03:59] Speaker 03: Because otherwise you could just completely remove prong one and there wouldn't be any other difference to the basic background understanding of a branched out kill. [00:04:08] Speaker 01: Well, you know, I don't think that these broad definitions are meant to have a strictly limiting sense. [00:04:14] Speaker 01: What they're designed to do is provide base understanding of what these terms mean as a general matter. [00:04:20] Speaker 01: And let me, I think if I can [00:04:21] Speaker 01: point the court to Formula 2. [00:04:23] Speaker 01: Formula 2, I think, is very helpful to illustrate the point, if I may, Your Honor. [00:04:27] Speaker 01: Formula 2 is at the very beginning of the specification. [00:04:30] Speaker 01: It begins at the bottom of column 3, and the formula is at the top of column 4. [00:04:36] Speaker 01: What's really important about Formula 2 to start with, at the column 3 lines 64 and 65, it describes a branched alkyl at the alpha position. [00:04:46] Speaker 01: So this is our unique circumstance here. [00:04:48] Speaker 01: It's using the language branched alkyl. [00:04:50] Speaker 01: It's in the alpha position. [00:04:52] Speaker 01: And then if you turn to column five, first line, column five says M1 and M2 are each independently a biodegradable group. [00:05:01] Speaker 01: And the second listed example is COO. [00:05:05] Speaker 01: Now COO is what is required by our dependent claim 20. [00:05:09] Speaker 00: Just one thing. [00:05:11] Speaker 00: acknowledge, I think, that Formula 2 is not within the claim, right? [00:05:14] Speaker 00: Let me be precise about that. [00:05:15] Speaker 00: Why is that? [00:05:16] Speaker 01: Well, two responses, Your Honor. [00:05:19] Speaker 01: That's actually, I think, a little inaccurate, and let me be very precise about this. [00:05:23] Speaker 01: There is overlap of things that are within Formula 2 are within the claim, but there are things that are within Formula 2 which are outside the claim, and there are things that are in the claim that are outside Formula 2. [00:05:34] Speaker 01: The distinction is the carbon weight, and I can talk about the carbon weight between the R-13 [00:05:39] Speaker 01: and then the whole tail, the R12, the M, and the R13. [00:05:43] Speaker 03: Let's try it a different way then. [00:05:45] Speaker 03: I heard a lot of some parts inside, some parts outside. [00:05:48] Speaker 03: There's no embodiment of formula two that you could create based on all of these different variables that would fall within the scope of any of the assertive claims. [00:06:00] Speaker 01: No, absolutely there is. [00:06:01] Speaker 01: There is. [00:06:02] Speaker 01: There are many, probably most of the, well, many of the embodiments that you would claim, that you would create from formula two, [00:06:08] Speaker 01: fall within. [00:06:08] Speaker 01: So if you have a branched alkyl, you know everything in Formula 2 is branching at the alpha position. [00:06:14] Speaker 01: You have a COO. [00:06:15] Speaker 01: The two biodegradable groups that are claimed in 18 are OCO and COO, which are the first two that are described. [00:06:23] Speaker 01: The distinction, Your Honor, is the [00:06:25] Speaker 01: carbon weight for the R-13 and the tail. [00:06:28] Speaker 03: Why does your footnote nine at blue brief 18 say, while formulas one and two fall outside the asserted claims? [00:06:36] Speaker 01: I think that was a bit imprecise because there are aspects of formula two that fall outside if it has too many or too few carbons, but much of what's in formula two is within claim scope. [00:06:48] Speaker 01: But my second point is even if the court [00:06:51] Speaker 01: I'm proffering that's correct, and I can provide a letter to the court if it would be helpful as to more explanation as to why that's correct. [00:06:58] Speaker 01: But my second point, which is sort of independent from that, is what formula two is doing is using the term branched alkyl in a specific context. [00:07:07] Speaker 01: That's the alpha position. [00:07:08] Speaker 01: And the point I really want to clearly make for the court is when you look at the formula that's at the top of column four, here are the things that are true about this and are identical to our patent. [00:07:20] Speaker 01: where you have, if you look at the top right portion, the M1, that's the biodegradable group, that's the ester. [00:07:27] Speaker 01: We know from lines two of column five that that ester includes a COO. [00:07:33] Speaker 01: That means the last atom of the ester is an oxygen. [00:07:37] Speaker 01: Then when we look to see where that branches, you have the branching to the R and to the Z. Those are the two carbons. [00:07:43] Speaker 01: Now, my friend, when he talks about what claim 20 does or the possibility of [00:07:48] Speaker 01: how you have three carbon branching in the context of COO, the sole argument they have is, well, there could be three branches, and that's how you get to the three carbons. [00:07:56] Speaker 01: But this figure actually draws in the hydrogen. [00:08:00] Speaker 01: It draws in the hydrogen to say it's just two branches, and usually when you don't have, as the court knows, and this is, my friend agrees at footnote five of his brief, and this is at the appendix page 4,949, [00:08:13] Speaker 01: Usually in these drawings, if you don't have a bond that's drawn, you assume it's a hydrogen. [00:08:17] Speaker 03: Let's just take your footnote in your blue brief at its word that this formula, you know, versions, all versions of this formula fall outside the scope of the asserted claims. [00:08:31] Speaker 03: And let's also [00:08:33] Speaker 03: except that what is being disclosed here in this formula, at least for purposes of just narrowly spotlighting the alpha position, is something that encompasses a secondary carbon. [00:08:47] Speaker 03: I guess the question still remains, why would it be wrong to look at this patent as saying, OK, at 412, it's making a [00:08:59] Speaker 03: proclamation of what branched alkyl means. [00:09:02] Speaker 03: And it is saying, in all contexts, branched alkyl requires three carbons at the alpha position unless otherwise specified. [00:09:12] Speaker 03: And then here, we can deduce that formula two can encompass a branched alkyl at the alpha position that's a secondary carbon. [00:09:23] Speaker 03: two carbons, but because formula two is outside the scope of the asserted claim, it only changes the meaning of branched alkyl for purposes of formula two. [00:09:37] Speaker 03: For that particular instance in this endlessly long spec, that [00:09:43] Speaker 03: Branched alkyl can include a secondary carbon. [00:09:45] Speaker 03: But in all other instances, unless, again, further specified in some other part of the spec, you have to go with the three carbon. [00:09:54] Speaker 01: Well, I think I agree with most everything of what you said, Your Honor. [00:09:58] Speaker 01: Other, let me just posit. [00:09:59] Speaker 01: I don't disagree that this is outside. [00:10:01] Speaker 01: And again, if the court would permit, I may want to submit a letter on that. [00:10:04] Speaker 01: But separately, even if you would take that as assumed, when [00:10:09] Speaker 01: What this shows is how you otherwise specify. [00:10:13] Speaker 01: You don't look at one sentence of the specification and read it in isolation. [00:10:17] Speaker 00: This is, I guess, a version of what Judge Chen said, which doesn't need to assume that your footnote on page 18. [00:10:32] Speaker 00: And I think this is probably how Chief Judge Connolly viewed this. [00:10:37] Speaker 00: The definition is really a definition. [00:10:39] Speaker 00: Seriously, really a definition. [00:10:41] Speaker 00: It has an exception. [00:10:43] Speaker 00: It doesn't apply where it is otherwise specified. [00:10:46] Speaker 00: There are various ways to otherwise specify. [00:10:49] Speaker 00: In the claim, you'd need language or necessity [00:10:54] Speaker 00: that that claim has to cover something. [00:10:58] Speaker 00: You don't have that. [00:10:59] Speaker 00: You don't have that even if Formula 2 sometimes would come within the claim, but it doesn't have to, and therefore no necessity in the context of the claim. [00:11:12] Speaker 01: If I may respond to both of your points there. [00:11:14] Speaker 01: I mean, I agree that Judge Connolly would have us shoot off a cannon down the middle of Fifth Avenue for us to say otherwise specified, and he rests on [00:11:21] Speaker 01: My friends rest on a dictionary definition of the word specified that has more and broader capacious meanings, but that's not how we narrowly look at specifications. [00:11:29] Speaker 01: The critical question is, what would a person of ordinary skill in the art understand the claim language to do? [00:11:35] Speaker 01: And to get back to Judge Chen's question, the reason Formula 2 is so important is because it uses branched alcohol, and from the context in which it's used, a person of ordinary skill in the art would know what immediately occurs there is two-carbon bonding. [00:11:49] Speaker 01: What are the two salient attributes of this? [00:11:52] Speaker 01: It's first, bonding in the alpha position, and second, an ester, where the last atom of the ester is something other than a carbon, COO. [00:11:58] Speaker 01: Those are the exact two attributes that we have spelled out in claims 18 and 20, and that is why a person of ordinary skill in the art would know this. [00:12:06] Speaker 01: Every other piece of evidence here in the specification when it talks about alpha branching, talks about two-carbon bonding, not three-carbon bonding. [00:12:13] Speaker 01: My friend has drawn various diagrams in their brief where they show the possibility of three carbon ranching. [00:12:20] Speaker 01: Those are all made up for litigation. [00:12:22] Speaker 01: None of them actually come from the specification. [00:12:25] Speaker 01: This is important because it shows the context of what a person of ordinary skill in the art would appreciate is that all of the examples, and I point the court to tables 2D and 2E, for example, and if I may just turn to 2E briefly for a moment, what 2E shows is there's only one [00:12:42] Speaker 01: example of alpha branching. [00:12:44] Speaker 01: This is at column 74, line 55. [00:12:48] Speaker 01: And what my friend says about this is, well, in column 2e, there are 15 examples of hydrophobic tails, 12 of which have branching, and only one has alpha branching. [00:12:57] Speaker 01: And so I'm accused of cherry picking this from a long list. [00:13:01] Speaker 01: That is my point, though. [00:13:02] Speaker 01: This is a unique context, a unique setting, where what 2e shows right here is that you have two carbons, not three carbons, [00:13:10] Speaker 01: in this context, because again, you don't have the triple branching, you have the dual branching. [00:13:15] Speaker 01: That's the context by which a person with an ordinary skill in the art would know that we're talking about something else. [00:13:19] Speaker 03: Just to be clear, in this section of the patent, which talks about all these different tables and then you're adding all these groups together, there's no combination of [00:13:31] Speaker 03: 2B, 2C, 2D, 2E that would result in something that comes within the claims. [00:13:36] Speaker 03: Is that right? [00:13:37] Speaker 01: No, Your Honor. [00:13:38] Speaker 01: It's the first example of 2D. [00:13:39] Speaker 01: So 2D column 72. [00:13:40] Speaker 03: I know, but none of the table 2B linkers is a single central carbon or nitrogen atom. [00:13:48] Speaker 03: Is that right? [00:13:51] Speaker 01: Your Honor, I'd have to consult on that. [00:13:53] Speaker 01: I'm not sure if there's a 2B problem. [00:13:55] Speaker 01: But I can tell you that 2D and 2E, which is what we're focused on in this claim language, combine exactly [00:14:00] Speaker 01: for what the claim says. [00:14:02] Speaker 01: For that isolated part of the claim. [00:14:06] Speaker 01: And again, this is why Formula 2 I think is helpful. [00:14:08] Speaker 01: Formula 2 does not shoot the cannon off and say, here, it's two carbons. [00:14:14] Speaker 01: It is directly known to a person of ordinary skill because of the attributes of alpha branching and the COO as the ester. [00:14:22] Speaker 01: That is the context that the patentee has made clear. [00:14:24] Speaker 00: that you know when you're in... Just to get back, why doesn't Formula 2, what does your expression shoot the cannon off, whereas the claim doesn't? [00:14:33] Speaker 01: Because I think the only distinction is Formula 2 has the drawn-in hydrogen, but the point is everything else that we have here shows that there's only two branches. [00:14:42] Speaker 01: Their theoretical possibility for claim three is that there are three branches, not two branches, has no support in the specification. [00:14:50] Speaker 01: They can't point to anywhere in the specification [00:14:52] Speaker 01: where in the context of alpha branching with a COO ester, there's ever been contemplation that there is three branching to meet the three carbon limitation that they would impose on this. [00:15:03] Speaker 01: Every piece of evidence in the specification shows that one skilled in the art would know otherwise specified. [00:15:08] Speaker 01: And just to close on this last point, we know that the patentee did not intend for it always to mean three carbons because it used the language unless otherwise specified. [00:15:17] Speaker 01: That means there have to be circumstances of two carbons. [00:15:19] Speaker 01: The circumstances, as figure two makes clear, [00:15:22] Speaker 01: unless otherwise is alpha branching in with the right answer. [00:15:24] Speaker 03: Just real quick, you have another later continuation patent, do you not, that claims that the alpha position just branching, and doesn't use the term branched alkyl? [00:15:37] Speaker 01: I would have to confirm that, Your Honor. [00:15:39] Speaker 01: I'll discuss that in a bit, if I may. [00:15:40] Speaker 03: That you're suing Moderna at in Delaware? [00:15:44] Speaker 01: Let me confirm that, Your Honor. [00:15:46] Speaker 01: OK. [00:15:46] Speaker 01: Thank you. [00:15:46] Speaker 00: Thank you. [00:15:57] Speaker 03: Mr. Lampkin, do you know the answer to my question? [00:16:00] Speaker 04: I do not, whether I know exactly what you're saying. [00:16:03] Speaker 03: Someone was nodding. [00:16:04] Speaker 04: The other case I know about uses the phrase where there is branching at the alcohol position or something like that, but doesn't use the term branched alcohol. [00:16:13] Speaker 04: It says branching at the alcohol branches at the alcohol position, something along those lines. [00:16:18] Speaker 04: May I please the court? [00:16:20] Speaker 04: The patent's definition of branched alcohol is unmistakable like psychography. [00:16:24] Speaker 04: It not only appears in the dictionary section, [00:16:26] Speaker 04: It not only says branched alcohol and sets it off in quotation marks. [00:16:31] Speaker 04: It uses definitional phrasing. [00:16:32] Speaker 04: It says refers to, which is typically something that means it's definitional. [00:16:37] Speaker 04: And then it provides a clear definition. [00:16:38] Speaker 04: Two components, one you have to have one carbon bonded to three others, and an exclusion as well. [00:16:44] Speaker 04: And the qualifier, unless otherwise specified, tells the skilled artist on how to recognize any exceptions. [00:16:50] Speaker 04: They will be specified, which means it's specific, clear, unambiguous, [00:16:56] Speaker 04: The type of thing you look at and say, aha, I've been told that the definition doesn't apply here. [00:17:00] Speaker 04: And they knew how to make something non-definitional, because if you looked at, for example, appendix 257, column 411, lines 4042, that one says that some groups contain a biodegradable include, include, not refers to, for example, illustrative, but not limited to. [00:17:16] Speaker 04: So it's clear that the artisans, excuse me, the patent draftsman knew how to make something non-definitional, but instead here said refers to. [00:17:24] Speaker 04: And it's important to stick to that definition, because it serves a critical notice function. [00:17:29] Speaker 04: The skilled artisan is entitled to look at that definition and knows it applies, and knows that if there's going to be exception, something will specify otherwise, tell them otherwise. [00:17:39] Speaker 04: And it's very important, especially in this type of claim, because these claims are quite unusual, frankly, [00:17:44] Speaker 04: Usually when you see this type of claim, you would see a structure, a diagram, and tell you what the substituents can be. [00:17:50] Speaker 04: But in this one, they chose to describe it using words. [00:17:53] Speaker 04: But if you're going to use words in the claim to describe a chemical structure, you're going to have to define the words. [00:17:58] Speaker 04: You're going to have to give them meaning. [00:18:00] Speaker 04: And the specification here [00:18:02] Speaker 04: goes and gives us a definition that's absolutely clear beyond doubt, which is you've got to have three carbons to have your balance. [00:18:08] Speaker 00: I guess one thing that counts against that, and I don't mean to draw a conclusion of whether it sufficiently counts against it, [00:18:19] Speaker 00: There really isn't anything in this massive spec that shows triple branching at the alpha, just nothing at all. [00:18:28] Speaker 00: There are a few triple branches down further in the chain in a few columns. [00:18:34] Speaker 00: Why wouldn't that, together with what the claim makes absolutely clear, which is that the biodegradable group can have the connector with the oxygen and without the carbon, [00:18:47] Speaker 00: signal sufficiently to a skilled artisan that the branched alkyl here, you know, doesn't have to be tertiary. [00:18:55] Speaker 04: Well, critically, of course, even if you have branching at the alpha position, you can still have a branched alkyl with three carbons. [00:19:02] Speaker 04: The skilled artisan would know. [00:19:03] Speaker 00: That's what I was at least trying to refer to as completely missing from anywhere in this 500-column. [00:19:11] Speaker 04: The carbon has four bonds, and if you don't dedicate one of those bonds to an oxygen because you have the COO position, [00:19:17] Speaker 04: in your biodegradable group. [00:19:18] Speaker 04: There's three bonds left, each of which can be occupied by a carbon. [00:19:22] Speaker 04: But it shouldn't be surprising that we don't have a diagram or an example here, because we have a clear definition. [00:19:28] Speaker 04: We have something better. [00:19:29] Speaker 04: We don't need an illustration, because we know what the words on the page mean. [00:19:32] Speaker 04: It says you have a carbon, and it's attached to three other carbons. [00:19:36] Speaker 04: If I can turn for a minute to formula two, which my colleague here refers to extensively, when you have lexicography that's so unmistakable, and it tells you definition, it tells you [00:19:46] Speaker 04: that it equals, it goes through it with one exception and two clear terms. [00:19:51] Speaker 04: When you have that and you need to specify otherwise, a formula like formula two can't come close and does not come closer to it. [00:19:59] Speaker 04: And it doesn't come close for three reasons. [00:20:01] Speaker 00: The first... So you're saying formula two itself doesn't otherwise specify. [00:20:06] Speaker 00: It does not otherwise specify. [00:20:07] Speaker 00: Even though it shows all the carbons filled and with only two carbons connected. [00:20:15] Speaker 02: I think that's correct and I think there's... What if there was a claim that said whatever else it requires as referenced by formula two? [00:20:24] Speaker 02: In the actual claim language, not just an embodiment, would that be otherwise specified? [00:20:31] Speaker 04: So that would not be otherwise specified, but I'd be down to two reasons rather than three, because the first reason is it doesn't fall within the claims, that's the concession. [00:20:39] Speaker 04: But it's not just the concession in the blue brief. [00:20:41] Speaker 04: If you look at appendix 4496, note 26, this concession as well, formula two is not the cationic lipids claimed in the aesthetic claims. [00:20:49] Speaker 04: And that's what we've relied on in all our briefing. [00:20:51] Speaker 04: I think that we should, frankly, be stuck with that. [00:20:54] Speaker 04: But second, if you look at formula two, it allows, but it doesn't require you to have a secondary rather than tertiary carbon at that M1 or M2 position. [00:21:05] Speaker 04: It's going to be important that you have an M1 and M2 position, two different biodegradable groups. [00:21:10] Speaker 04: The fact that you can come up with an example where it would be secondary, and therefore fall out of the definition, doesn't tell disk load ours and the definition doesn't apply. [00:21:17] Speaker 04: It just means that you could come up with an example. [00:21:19] Speaker 02: So your view is that embodiment itself is not clear enough to be a two. [00:21:24] Speaker 00: Yeah. [00:21:24] Speaker 00: And that's what you're saying. [00:21:25] Speaker 00: I'm sorry. [00:21:26] Speaker 00: Just say that again. [00:21:27] Speaker 00: M1 clearly can be in the COO configuration. [00:21:31] Speaker 00: That's right. [00:21:31] Speaker 00: So it's possible. [00:21:32] Speaker 00: And the H is an H, not a carbon. [00:21:35] Speaker 00: And that leaves two. [00:21:37] Speaker 04: More right, but you wouldn't have you couldn't just stop there your honor because there's two biodegradable groups There's an M1 and an M2 so to place this Figure outside of the claims you'd have to first say I'm going to choose a biodegradable group COO for M1 and Then that will give me two carbons there and so that's but then you have a second chance. [00:21:58] Speaker 04: There's an M2 and [00:22:00] Speaker 03: i guess it would have and to his office you know you have exactly as you have to do this pick pick and choose we start and say i'm the first one to do is i guess what you're must be trying to say is that four twelve dominates on over formula too and so you have to read and understand what's disclosing formula to through the funnel of [00:22:19] Speaker 03: the definition of 412. [00:22:21] Speaker 04: I think that's right. [00:22:21] Speaker 04: And this field artisan would have to go and say, look, I'm going to check. [00:22:24] Speaker 03: But I guess the question is, why is that right? [00:22:27] Speaker 03: Because formula two says what it says with 100 different variable offerings. [00:22:31] Speaker 04: Right. [00:22:31] Speaker 04: So what you'd have to do in order to get formula two outside of what is a branched out within definitions, you'd have to do two things. [00:22:38] Speaker 04: First, for the first one, M1, you'd have to go to that list of non-exclusive list of 22 different biodegradable groups. [00:22:45] Speaker 04: And you might choose COO. [00:22:46] Speaker 04: Then you'd have to do that again for M2. [00:22:50] Speaker 04: A skilled artist in saying, oh, gee, I can jerry it. [00:22:52] Speaker 04: If I jerrymandered a bit, get away. [00:22:53] Speaker 00: If I do a double bit and two. [00:22:55] Speaker 00: I guess I just want to push back on that. [00:22:57] Speaker 00: So just at the bottom of column three, this is all the descriptions, right? [00:23:04] Speaker 00: And it says in further abiding, it's M1 and M2 are each independently. [00:23:08] Speaker 00: They're OCO or COO. [00:23:10] Speaker 00: For example, they're both COO. [00:23:12] Speaker 04: Ah, that's a very important point, Judge Taranto. [00:23:14] Speaker 04: Because when it says right below it says in another embodiment. [00:23:18] Speaker 04: Yeah, that's the reference to formula 2 that reference in a further embodiment That's talking about formula 1. [00:23:24] Speaker 04: Okay, if you back up the formula 1 which is on column 2 [00:23:28] Speaker 00: It's actually the reverse. [00:23:30] Speaker 00: So for formula two, you've got to go to column five and say M1, M2 are each, and now there's a larger numbers. [00:23:36] Speaker 04: Well, it's not a larger numbers. [00:23:37] Speaker 04: It never tells you go ahead and make COO, your choice. [00:23:40] Speaker 00: That's what I mean. [00:23:41] Speaker 00: There's now a list of many different possibilities, not just the two that are exactly. [00:23:46] Speaker 04: Now, if you flip back to formula one, it actually has the reverse structure so that you have your M, your biodegradable group on the right, and you have your [00:23:57] Speaker 04: alpha carbon on the left. [00:23:59] Speaker 04: In that case, COO would produce a tertiary carbon. [00:24:04] Speaker 04: And so it's actually quite telling that when you have formula one, where COO produces a tertiary carbon, it says it's permissible to have both of them COO. [00:24:13] Speaker 02: But when you get to Formula 2... Can I go back to my question about Formula 2? [00:24:18] Speaker 02: Let's just assume... I understand you don't think Formula 2 actually shows it. [00:24:22] Speaker 02: Let's just say in some universe it actually does just show the 2. [00:24:27] Speaker 02: I assume you would say if it actually shows and is an example of [00:24:35] Speaker 02: an exception to the definition, and there's a claim that specifically says, this claim relates to Formula 2, that would be good enough to show an exception to the definition. [00:24:47] Speaker 02: Because it is something that's not covered by the definition explicitly, and the claim is explicitly incorporating that. [00:24:54] Speaker 04: I think your honor, that was certainly a closer case because it has features that are absent here. [00:24:58] Speaker 04: One, it has something in the claim itself. [00:24:59] Speaker 02: We can stop that. [00:25:00] Speaker 02: I'm going to assume that that's the best you can get to a yes. [00:25:05] Speaker 02: So my next question is, because I'm trying to understand it is, [00:25:11] Speaker 02: What happens if a claim doesn't explicitly incorporate in Formula 2, which satisfies the exception requirement, but by necessary inference has to because of the structures and stuff? [00:25:26] Speaker 02: If the answer to the first one is yes, if it's also a necessary inference, even though it doesn't use explicit language, [00:25:33] Speaker 04: Is that good enough? [00:25:35] Speaker 04: I don't think so your honor because I think comes from the terms specify otherwise it has to specify it has to make clear if it's an inference for an implication or Suggestion where you're kind of drawing a chain of inferences that doesn't otherwise specify. [00:25:48] Speaker 02: Okay, but I think we're fine Can I just because you know, I don't mean to cut you off, but I understand what you're answering Are there any claims here? [00:25:59] Speaker 02: in your view, that at least by inference incorporate Formula 2? [00:26:05] Speaker 04: No, I don't think so, Your Honor. [00:26:06] Speaker 04: I don't think there are. [00:26:07] Speaker 02: Is there any way to distinguish? [00:26:08] Speaker 02: Because obviously, it can't be all of them. [00:26:14] Speaker 02: Or at least, I don't think it can be all of them. [00:26:15] Speaker 02: So the only way we could get to somehow Formula 2 [00:26:20] Speaker 02: relating to specific claims, which none of them say is incoherent to me. [00:26:23] Speaker 02: It is the only way to read those claims, those specific ones that they referred for me to. [00:26:30] Speaker 02: Honestly, I don't follow the science extremely well. [00:26:33] Speaker 02: I do my best. [00:26:34] Speaker 02: I thought I heard Mr. Hughes suggesting that there might be specific claims, but I could have got that wrong. [00:26:40] Speaker 04: So specific claims in this patent that I know of, no. [00:26:44] Speaker 04: But it's important to keep in mind that this is a continuation of a continuation of a continuation with a shared specification. [00:26:51] Speaker 04: So when it says things like the present invention or when it talks about it has these formulas in it, that does not mean that Claim 18 in particular or its dependent claims necessarily incorporate or necessarily refer to or necessarily reflect anything else in the patent. [00:27:06] Speaker 04: Those may be in an earlier claim to another patent. [00:27:09] Speaker 04: They may be later for a continuation patent. [00:27:11] Speaker 04: But it doesn't mean that claim 18 in particular is going to incorporate formula two. [00:27:15] Speaker 02: Is the logic of their argument that every single claim in this patent would cover the two and the three? [00:27:22] Speaker 04: I think that's absolutely right, Your Honor. [00:27:24] Speaker 04: Or at least everything with alpha position branching, as I understand their argument. [00:27:28] Speaker 04: And I think the real problem with the argument is this. [00:27:30] Speaker 04: It makes the definition largely irrelevant. [00:27:33] Speaker 04: Because if the claim itself is narrow enough that it requires tertiary carbon, you don't need the definition. [00:27:41] Speaker 04: And I think I heard the argument, in essence, that because the claims are broad enough to incorporate a two carbon, a secondary carbon, that specifies otherwise. [00:27:50] Speaker 04: Well, that makes the definition irrelevant a second time. [00:27:53] Speaker 04: It just reads it out, which is why the court's precedents, like Thornor, are pretty clear that when a definition, and I'm quoting, makes clear that the invention does not include a particular feature, that feature is deemed outside the claims of the patent, even though the language of the claims [00:28:10] Speaker 04: read without reference to the specification might be broad enough to encompass the future in question. [00:28:14] Speaker 04: The whole purpose of that definition is to narrow the claims so that you know you just punch in the definition unless otherwise specified. [00:28:22] Speaker 04: And there's simply nothing here that otherwise specifies. [00:28:26] Speaker 04: If I can turn very briefly to section, I guess it's 2D and 2E. [00:28:33] Speaker 04: Again, I think there's two real problems with 2D and 2E, those two tables, and they appear on page 70. [00:28:39] Speaker 04: Whoops, I'm sorry about that. [00:28:40] Speaker 04: It's actually pages, appendix 88 to 89. [00:28:44] Speaker 04: The first is that we still have clear lexicography. [00:28:46] Speaker 04: None of this is gonna contradict the clear lexicography, but it's especially uninformative for two reasons. [00:28:52] Speaker 04: First, if you look on page 88 for the appendix, and look at the examples for 2D. [00:28:59] Speaker 04: Excuse me. [00:29:00] Speaker 04: under table 2e, if you look at the very first one, right below at the bottom of the page, that's not even arguably branched. [00:29:07] Speaker 04: So there's no way in which this is saying, when you see things in this table, assume that they're branched alcohols. [00:29:13] Speaker 04: It's simply saying, oh, here's a bunch of representative tales for a very broad invention, not necessarily named here. [00:29:20] Speaker 04: And the second problem is to come up with a branched alcohol that only has two carbons, and I [00:29:27] Speaker 04: use that loosely because it's outside the definition, it wouldn't be a branched alcohol. [00:29:31] Speaker 04: You have to do a pick and choose, again, and try and combine from 19 possible biodegradable groups and 15 tails and come up with one that doesn't work. [00:29:42] Speaker 04: And that's just not something that tells a skilled artisan what a branched alcohol means, especially since table 2e isn't labeled branched alcohol. [00:29:49] Speaker 04: There's lots of things in there, the vast majority of things in there, that aren't branched alcohols at all. [00:29:54] Speaker 04: And finally, I think one thing that's overlooked in the presentation [00:29:57] Speaker 04: is previously is that the term alcohol itself has an important role. [00:30:03] Speaker 04: And alcohol is a hydrocarbon. [00:30:04] Speaker 04: It means carbon and hydrogen only. [00:30:07] Speaker 04: So if you're trying to ask if something's branched and it's a branched alcohol, you would only look at the alcohol. [00:30:13] Speaker 04: You'd only look at the carbons and hydrocarbons, excuse me, only look at the carbons. [00:30:18] Speaker 04: And so if what you get when you do that and you sort of trace your finger through it is sort of a continuous line where you don't have a branching point where you have to split off, that's not a branched alcohol. [00:30:27] Speaker 04: If there's an oxygen there, you don't count that. [00:30:30] Speaker 04: That doesn't count. [00:30:31] Speaker 04: It's just a continuous line. [00:30:32] Speaker 04: So a branched alkyl is carbons only. [00:30:35] Speaker 04: And you have to find a place where the carbons flick. [00:30:37] Speaker 04: They split off. [00:30:38] Speaker 04: And to get that kind of fork, you need a tertiary carb. [00:30:41] Speaker 04: You need a carbon attached to three other carbons. [00:30:43] Speaker 04: Otherwise, you actually just have a chain of carbons, maybe attached to an oxygen in the middle. [00:30:47] Speaker 04: But that doesn't count. [00:30:48] Speaker 04: It's just a chain of carbons. [00:30:49] Speaker 04: It's linear. [00:30:50] Speaker 04: It's not a branched alkyl. [00:30:52] Speaker 04: If the court has no further questions, I will surrender the room by remaining 10 seconds for the court. [00:30:58] Speaker 04: Thank you. [00:31:06] Speaker 01: Thank you, your honor. [00:31:07] Speaker 01: I'll be brief. [00:31:13] Speaker 01: Thank you, your honor. [00:31:14] Speaker 01: I'll be brief. [00:31:15] Speaker 01: As Moderna sees it, the only work that claim 20 can do is this hypothetical triple branching. [00:31:22] Speaker 01: But as the court pointed out, there's a lot in the specification. [00:31:26] Speaker 01: but there is no indication of triple branching at the alpha position. [00:31:30] Speaker 01: Rather, the patentee made clear throughout, this is in Formula 2, and I think as the Court appreciates, Formula 2 can only be fairly read as showing that you can have two carbon bonding at the alpha position when you have the COO as the ester. [00:31:44] Speaker 01: Tables 2D and 2E. [00:31:45] Speaker 01: that we describe in our brief of that combination, the only thing that shows alpha branching connected to the COL. [00:31:51] Speaker 00: Just to see if I'm getting closer to understanding this, I think Mr. Lampkin was concentrating very much on the fact that the biodegradable group [00:32:02] Speaker 00: the pool of possible biodegradable groups is quite a large pool for Formula 2. [00:32:10] Speaker 00: And that is a real problem for reading into Formula 2 something that rises to the level of specifying, which it might not be if there were only two possible biodegradable groups. [00:32:26] Speaker 01: Well, I don't think COO can work in Formula 2 under their [00:32:30] Speaker 01: definition. [00:32:31] Speaker 01: COO would not be available as an ester under formula two given their understanding of this. [00:32:40] Speaker 01: So I don't think that argument works for him because the patentee put in COO and it's the same with 2D and 2E. [00:32:47] Speaker 01: The first example under 2D is COO and the only example of a branched alkyl in the alpha position in the menu from 2E is exactly what we've shown where it's two carbons. [00:32:57] Speaker 01: Then look to the prosecution history. [00:32:59] Speaker 01: The prosecution history, the patentee gave one very clear example, which he expressly said was within what the invention, this particular invention, was to overcome the allowance. [00:33:09] Speaker 01: The one diagram shows COO with two carbons. [00:33:13] Speaker 01: Every piece of evidence about what the patentee understood when there are two ingredients. [00:33:17] Speaker 01: The first ingredient is alpha positioning and the branching of the alpha position. [00:33:21] Speaker 01: The second ingredient is the COO ester. [00:33:24] Speaker 01: Every piece of specification evidence we have [00:33:26] Speaker 01: shows that that is a context that indicates two-carbon branching is appropriate and what the patentee had in mind. [00:33:32] Speaker 01: We think that's how branched alcohol should be understood. [00:33:35] Speaker 01: Yes, generally, most of the drawings, it is three bonds because that is typically how branch works in an alcohol chain, but the situation is different when you are at the start of when it's in the alpha position and you're bonded to something that is not carbon. [00:33:50] Speaker 01: It is [00:33:51] Speaker 01: That is the circumstance. [00:33:52] Speaker 03: Mr. Lampkin cited a page in the JA saying that your side conceded Formula 2 doesn't come within the scope of the claims. [00:34:01] Speaker 01: Do you agree with that understanding of the JA side? [00:34:06] Speaker 01: I don't agree with that understanding, Your Honor. [00:34:08] Speaker 01: And again, what I'd like to do is take a look at that JA side and perhaps give the court a letter if we think we disagree with that on that point. [00:34:14] Speaker 01: Because I don't think we agree that Formula 2 is wholly outside the scope. [00:34:18] Speaker 01: But if we've made a concession otherwise, [00:34:20] Speaker 01: We'll indicate that. [00:34:21] Speaker 01: All right. [00:34:23] Speaker 03: You don't need to send a letter unless we ask for it. [00:34:25] Speaker 03: OK. [00:34:28] Speaker 01: Ultimately, the claim language is what matters. [00:34:30] Speaker 01: The claim language here has two really important features. [00:34:33] Speaker 01: The claim language is it's branching at the alpha position, and it is the COO is the ester. [00:34:38] Speaker 01: Every piece specification makes apparent when those things are present. [00:34:41] Speaker 01: One skilled in the art would know that two carbon bonding is appropriate. [00:34:45] Speaker 01: That's the context that specifies here, and we urge the court to reverse.