[00:00:00] Speaker 02: We appreciate your cooperation. [00:00:07] Speaker 02: As you know, for purposes of argument, we've consolidated the first three cases this morning, 16.1814, 16.1815, and 17.1051, soft gel technologies versus JARO formulas. [00:00:24] Speaker 02: You're going to have to help me pronounce your name, but why don't you come up? [00:00:28] Speaker 02: Good morning, please. [00:00:49] Speaker 01: May I please the court? [00:00:51] Speaker 01: The board's inconsistent decisions in these three related cases highlights its legal error as well as the lack of substantial evidence to support its findings. [00:01:03] Speaker 01: As such, the board's conclusion that the claims of these three patents are unpatentable should be reversed. [00:01:10] Speaker 01: First, I'm going to address the board's analysis of anticipation. [00:01:15] Speaker 01: The discovery in this case for all three patents is [00:01:19] Speaker 01: basically that CoQ10 can be dissolved in D-limonene. [00:01:26] Speaker 01: The claims in all three cases, in 1814, the claims are directed to the final formulation. [00:01:33] Speaker 01: So they're directed to a soft gel capsule or a packaged nutraceutical formulation. [00:01:40] Speaker 01: Same thing in 1815. [00:01:42] Speaker 01: The claims are to the final formulation. [00:01:45] Speaker 01: The claims are directed to a solubilized CoQ10 formulation or a packaged nutraceutical formulation. [00:01:53] Speaker 01: And in 1051, the claims are directed to making the soft gel capsule. [00:02:00] Speaker 01: In each of these claims, you'll see that the claims require that the CoQ10 be dissolved in D-limonene and that in the final product, there's not an emulsion. [00:02:13] Speaker 01: And that's where I want to start first. [00:02:15] Speaker 01: In the 1051 case, the patent, the board specifically found that the Nizal or Khan reference only teaches use of an emulsion. [00:02:29] Speaker 01: If you read the reference itself, it's always the same approach. [00:02:34] Speaker 01: They take CoQ10, they put it in lemon oil, then they melt it. [00:02:40] Speaker 01: And when it's melted, they add a [00:02:44] Speaker 01: emulsifier plus one other ingredient. [00:02:46] Speaker 01: It cools, it becomes solid, and then they can load it in a soft gel capsule or wherever they want. [00:02:52] Speaker 01: But the fact that they always emulsify and make it an emulsion gets it outside the scope of the claims that are in all three patents. [00:03:01] Speaker 04: Now, the con patent recites both in the specification and the claims that the melting occurs and that the process results in thereby solubilizing [00:03:14] Speaker 04: i.e. [00:03:15] Speaker 04: dissolving. [00:03:16] Speaker 04: You agree that solubilizing and dissolving mean the same thing? [00:03:20] Speaker 01: In our patent, that's true. [00:03:22] Speaker 01: Solubilizing and dissolving mean the same thing. [00:03:24] Speaker 01: But just in chemistry, generally. [00:03:25] Speaker 01: That's certainly undeniable, correct? [00:03:29] Speaker 01: Well, it may be undeniable in chemistry, Your Honor, but in the con patent itself, when they were saying solubilize, what the con patent was doing was talking about melting. [00:03:40] Speaker 01: Every aspect of the con patent, in fact, [00:03:43] Speaker 01: The reason in the con patent solubilize can't mean dissolve is there's a sentence in column six where it says, due to limited solubility of the CoQ10 and fixed oils. [00:03:53] Speaker 01: If you read the background section of the contract in column two or column one, they specifically highlight the problems in the prior art regarding being able to dissolve CoQ10. [00:04:04] Speaker 04: But now Nassau's declaration seems to me to address this issue. [00:04:09] Speaker 04: And Nassau's declaration states, [00:04:12] Speaker 04: that there is liquefying or dissolving, as well as the melting. [00:04:18] Speaker 04: In other words, the melting then facilitates the solubilization. [00:04:22] Speaker 04: So it seems to me that for purposes of what the evidence shows as to the relationship between the melting and the solubilization, Nassau's declaration is quite important. [00:04:34] Speaker 01: Nassau's declaration is important, but it actually goes in the other direction. [00:04:37] Speaker 01: So if you focus in on paragraph four of Nassau's declaration, [00:04:40] Speaker 01: And I think that's where everybody's focused, is if you look at those sentences, what he's saying is you've now got CoQ10 and lemon oil, say, and you then melt it. [00:04:53] Speaker 01: At that point, you've got a liquid CoQ10 with lemon oil. [00:04:58] Speaker 01: That liquefaction is not dissolving, that's melting. [00:05:01] Speaker 04: You think that Nassal doesn't understand the difference between dissolving and melting? [00:05:06] Speaker 04: Because he says in paragraph six, he's quite explicit, [00:05:10] Speaker 04: in saying that the higher amounts of the molten, i.e. [00:05:15] Speaker 04: already melted, CoQ10 can be dissolved or solubilized. [00:05:21] Speaker 04: Now, he seems clearly to distinguish between melting and solubilization there. [00:05:27] Speaker 01: At that point, you've already got the CoQ10 and the oil in a liquid state. [00:05:34] Speaker 04: Right. [00:05:35] Speaker 01: And then all they're doing is then adding the emulsifier to it, [00:05:39] Speaker 01: to make an emulsion. [00:05:40] Speaker 01: That is all Nizal ever does. [00:05:42] Speaker 01: And there's nothing, there's no evidence. [00:05:44] Speaker 01: If you look at the DSC charts that they've used in there, both in the application and in the PhD thesis, it's all the interpret melting. [00:05:52] Speaker 01: There is not a single, there's nothing anybody points to to say there's some additional energy change that causes this immiscibility where now there's a dissolution on top of that. [00:06:04] Speaker 01: The only evidence you have is really in con [00:06:09] Speaker 01: or Nassau, they're actually trying to figure out what they can do as an alternative to dissolving. [00:06:17] Speaker 01: And so what they focus in on is melting the CoQ10 with oil. [00:06:23] Speaker 01: And they've got the CoQ10 in the oil, they melt it. [00:06:27] Speaker 01: And after they melt it, they add an emulsifier to it and one other ingredient. [00:06:31] Speaker 01: It cools, it becomes a solid emulsion. [00:06:34] Speaker 01: If you look at in column six, [00:06:36] Speaker 01: They call that the resultant emulsion. [00:06:38] Speaker 01: In column 11, in every instance, it's the same approach. [00:06:42] Speaker 01: And in every instance where they end up is an emulsion. [00:06:46] Speaker 01: Never, and certainly not in the final time. [00:06:49] Speaker 04: Not a solution, you think. [00:06:50] Speaker 04: I'm sorry? [00:06:50] Speaker 04: And not a solution. [00:06:51] Speaker 04: Not a solution. [00:06:52] Speaker 04: Well, and yet we have on column two of the con patent at lines 58 through 60, [00:07:02] Speaker 04: the SEDS improves the dissolution of poorly soluble compounds such as the CoQ10. [00:07:10] Speaker 04: That is to say that the process that is used in Kahn results in an improvement in dissolution. [00:07:20] Speaker 04: Why is that not saying exactly what the board found, which is that there is solubilization? [00:07:28] Speaker 01: That SEDS is different from [00:07:31] Speaker 01: What's going on here where that? [00:07:33] Speaker 04: Take that sentence just by itself. [00:07:35] Speaker 04: Reading that sentence, for the moment, let's just read it in itself. [00:07:39] Speaker 04: That sentence seems to me to support the board's finding. [00:07:43] Speaker 01: I'm sorry, Your Honor. [00:07:43] Speaker 01: Which sentence are you on? [00:07:44] Speaker 04: This is at column two, lines 57, 58 through 60, through 61, actually. [00:07:57] Speaker 04: And it seems to me your argument is ultimately that Khan and Nassau were saying solution, but they meant emulsion. [00:08:19] Speaker 01: No. [00:08:19] Speaker 01: So if you read those sentences that you have there, [00:08:23] Speaker 01: It's exactly what I'm saying. [00:08:25] Speaker 01: So what they do is they have the drug, when they say in this case the oil phase containing the drug itself, there they've already made that process that I just walked you through, which is they've got, they had the oil, the lemon oil, they had the CoQ10, they put the two together, they melted it, they added an emulsifier and one other ingredient, it cooled. [00:08:48] Speaker 01: They've got now what they call the SNEDs. [00:08:52] Speaker 01: In the body, it's going to heat up again. [00:08:54] Speaker 01: It's going to melt. [00:08:55] Speaker 01: You're going to have those fine emulsion droplets. [00:08:58] Speaker 01: And it's a way to make it available to the body. [00:09:01] Speaker 04: But that would not be what you would define as dissolving, correct? [00:09:07] Speaker 04: That is not dissolving in this. [00:09:09] Speaker 04: And notwithstanding that they use that term. [00:09:12] Speaker 01: Because it is clearly melting. [00:09:14] Speaker 01: It's the application of heat. [00:09:15] Speaker 04: I want you to tell me if, in fact, what you're saying is, [00:09:20] Speaker 04: that Kahn and Nassau used the term dissolving, but they didn't mean dissolving as it is uniformly used. [00:09:27] Speaker 04: In the chemical arts, they meant melting and emulsifying. [00:09:32] Speaker 01: Your Honor, in that sentence, I would agree with you that they are not using dissolving in the way it's being defined for the patents at issue. [00:09:39] Speaker 01: In the patents at issue, it is dehyminin is being used as a solvent to dissolve the solute being co-cutene. [00:09:47] Speaker 04: Now, with reference to the obviousness, [00:09:50] Speaker 04: question, would you agree that Motoyama does talk about dissolving in the same sense that the patents do? [00:09:59] Speaker 01: Yes, I would agree with that. [00:10:00] Speaker 04: And so the only problem with Motoyama as a reference is that it refers to solubilizing in carvone. [00:10:10] Speaker 04: Yes, carvone continuous. [00:10:12] Speaker 04: But it definitely includes, you're not suggesting that Motoyama is not solubilizing in the conventional sense. [00:10:19] Speaker 01: I agree with that. [00:10:20] Speaker 01: I agree. [00:10:20] Speaker 01: So Modayama clearly does disclose dissolving or solubilizing in the same sense as our patent. [00:10:28] Speaker 04: And one more question, and then I will let you go. [00:10:33] Speaker 04: Modayama talks about the particular essential oils that are referenced in Modayama as including terpenes. [00:10:42] Speaker 04: So why is that not very close, at least, to specifically identifying limonene, which is a monoterpene? [00:10:50] Speaker 01: And the reason there, Your Honor, is two or threefold. [00:10:54] Speaker 01: But let me start with, in Motoyama, what Motoyama came up with was an understanding that CoQ10 may be dissolved, or as you put it, solubilized in carbon containing oils. [00:11:09] Speaker 01: And so the component that he's focused in on for his invention is the carbon containing portion of those oils. [00:11:18] Speaker 01: Now, for [00:11:20] Speaker 01: D-limonene is not a carbone-containing oil. [00:11:23] Speaker 01: So to make that leap that D-limonene now would be used for dissolution, there is no suggestion, therefore, for a couple of reasons. [00:11:34] Speaker 01: One is even Dr. Khan, in his application for the 786, told the Patent Office, and this is Appendix 1212 of the 1051, told the Patent Office this is an unpredictable area. [00:11:46] Speaker 01: You need empirical evidence to be able to know if something is going to work like this. [00:11:51] Speaker 01: There is absolutely no suggestion anywhere that you would be able to dissolve CoQ10 in D-limonene. [00:12:01] Speaker 01: Because the only source, there's not even a mention of D-limonene in Conronazole. [00:12:07] Speaker 01: But even if you take lemon oil to have a component of limonene, and then you say somehow, they would still understand that the component that we're looking at is not [00:12:15] Speaker 01: L but d-limonene, even if you get that far, what Nizal and Khan teach is a melting point reduction method that's an alternative to dissolving. [00:12:27] Speaker 01: So for someone skilled in the art to all of a sudden say, I will take the lemon oil, I will then intuit that I can get to d-limonene as opposed to any other enantiomer. [00:12:42] Speaker 01: I will take that. [00:12:43] Speaker 04: Well, there are only two enantiomeres. [00:12:45] Speaker 01: But still, you'd have to know that that's the one that's out there. [00:12:48] Speaker 01: It's got to be one or the other. [00:12:49] Speaker 01: But if you look at the evidence... That's right, isn't it? [00:12:51] Speaker 01: That is right. [00:12:52] Speaker 01: There's two enantiomeres. [00:12:53] Speaker 01: But if you look at the evidence even, Dr. Kahn himself in 2004 had a study to see if either of those enantiomeres would help in the melting point reduction method, not in dissolving. [00:13:04] Speaker 01: Just what is the effect? [00:13:06] Speaker 01: Even if you look at Dr. Nizal's thesis, he specifically says he doesn't understand [00:13:11] Speaker 01: why, what components of lemon oil may be helping with the melting point reduction method. [00:13:16] Speaker 01: No one is talking about dissolving there. [00:13:18] Speaker 01: They're just talking about their method of the, of the melting point. [00:13:21] Speaker 01: So they reduce the melting point, they make, they melt it, and then they're able to add the emulsifier, make that solid emulsion, and then be able to make their drug of some kind. [00:13:31] Speaker 01: And so in each instance, there is nothing in the art that would [00:13:37] Speaker 01: suggest to one skilled in the art that what you can do is all of a sudden dissolve in d-limonene, much like Motoyama did in dissolving CoQ10 in carbone-containing oils. [00:13:51] Speaker 04: What do you make of Motoyama's statement that, and this is at 183, that the oils used in the first and second inventions, which he refers to earlier, [00:14:05] Speaker 04: Specific examples of such oils, the essential oils that he's talking about, include, and then he has a list, a long list, include terpenes. [00:14:15] Speaker 04: That would seem to include limonene. [00:14:18] Speaker 01: But I think in the context of Motoyama... That's right, isn't it? [00:14:23] Speaker 01: If it's a terpene, it would include limonene. [00:14:26] Speaker 01: Or limonene, I agree with that. [00:14:28] Speaker 01: But the problem is, in the context of Motoyama, where he's focused on all those oils, [00:14:34] Speaker 01: is really the selection he's making for his invention, where he's saying it's dissolvable, is with carbone. [00:14:43] Speaker 01: It's the carbone portion of it. [00:14:44] Speaker 04: But certainly, d-lemonine doesn't contain carbone. [00:14:48] Speaker 04: I don't know how many of those other oils, and there are many, many in that list, how many of those contain carbone. [00:14:54] Speaker 04: But it doesn't sound like he's focusing exclusively on carbone-containing oils. [00:15:01] Speaker 01: I believe he is, Your Honor. [00:15:02] Speaker 04: Turpenes as a whole are [00:15:04] Speaker 04: include... Can you tell me where you see that sentence on the terpenes? [00:15:10] Speaker 04: That do not have carvone, correct? [00:15:14] Speaker 01: Yep. [00:15:14] Speaker 01: And so can you show me where that sentence is? [00:15:19] Speaker 04: Yeah. [00:15:20] Speaker 04: It's at 183, starting at about line 10 of Moriyama [00:15:26] Speaker 04: Although the oils used in the present, first, and second inventions were mentioned previously, specific examples of such oils will be further listed. [00:15:33] Speaker 04: And then he has a very long list. [00:15:35] Speaker 04: And about halfway through the list, you'll see the word terpenes. [00:15:42] Speaker 01: What book are you in? [00:15:43] Speaker 04: I'm sorry. [00:15:44] Speaker 04: I'm in the 1814 appendix. [00:15:48] Speaker 04: One of the problems with having three different appendices is the same material appears at different pages. [00:15:53] Speaker 04: Sorry. [00:15:58] Speaker 04: It's in the right-hand column. [00:16:00] Speaker 04: And the reference to terpenes is almost halfway done. [00:16:23] Speaker 01: And that teaching is too broad. [00:16:26] Speaker 01: There's nothing in the art. [00:16:28] Speaker 01: given his focus on Carvone-containing oils, even the next sentence where he says, among these oils, Carvone is particularly preferred oil due to the good solubility of ubiquinone. [00:16:38] Speaker 01: And given just the general understanding and the arc, not just the predictable nature, but even in that same office session that I was talking about in Appendix 1213, Kahn even says, CoQ10 known not to be [00:16:52] Speaker 01: dissolvable. [00:16:53] Speaker 04: But he says carvone is particularly preferred, but that means that the patent covers non-carvone oils. [00:17:00] Speaker 04: Correct. [00:17:01] Speaker 04: Particularly preferred, the implication is it's not, the patent is not limited to those. [00:17:08] Speaker 01: And that would be, that would be one read, but there's no evidence that anybody skilled in the art would read it. [00:17:13] Speaker 04: It's pretty much the only read as far as I can see. [00:17:15] Speaker 01: But no one skilled in the art would read Modayama to understand that it would cover d-limonene. [00:17:21] Speaker 01: I don't believe [00:17:21] Speaker 01: I don't believe that there's evidence to that fact. [00:17:26] Speaker 01: And the fact of mentioning terpenes is too broad. [00:17:30] Speaker 04: I mean, I can understand your argument that it's too broad. [00:17:32] Speaker 04: But to say that it isn't covered seems to me to be outside the battle. [00:17:38] Speaker 01: And when I say it's not covered, it's not going to be something. [00:17:40] Speaker 01: It's not explicitly called out by name. [00:17:43] Speaker 04: But it's called out by category. [00:17:44] Speaker 01: It's called out by category. [00:17:46] Speaker 01: But it's a forest for a tree where the invention here is very specific. [00:17:51] Speaker 01: to something that the inventor discovered. [00:17:54] Speaker 04: But the point that I'm trying to get at, and I think you would agree with me, that, well, maybe you wouldn't. [00:18:02] Speaker 04: But it does look like what Motoyama is saying here is that I'm not limiting my invention to carvones. [00:18:10] Speaker 04: Would you agree with that? [00:18:11] Speaker 01: And he's trying to say that. [00:18:12] Speaker 01: But I think one skill in the art would not give him d-limonene based just on that sentence, because he would not possess it. [00:18:18] Speaker 04: That's a different point. [00:18:19] Speaker 04: That's the overly broad point. [00:18:20] Speaker 01: Right. [00:18:21] Speaker 04: The question that what this seems to go to me is to say Modayama is not limited to car phones. [00:18:30] Speaker 01: And, Your Honor, I mean, there's a way to read that. [00:18:32] Speaker 01: I mean, that's what he's trying to do. [00:18:33] Speaker 01: But I think one's killed in the arc. [00:18:35] Speaker 01: When they read it, I don't think it would. [00:18:36] Speaker 01: All right. [00:18:37] Speaker 01: I understand your argument. [00:18:43] Speaker 01: I'm just going to touch on a couple more things, and then I'll do the rest on rebuttal. [00:18:48] Speaker 03: Can I just, before you move on from obviousness, do I understand it correctly that if we agree with the board on obviousness, that resolves all three cases? [00:18:57] Speaker 03: Yes, it will. [00:18:59] Speaker 01: So on obviousness, we've hit Moriyama. [00:19:03] Speaker 01: But on the con basis for obviousness, again, in 1051, the board found that con is not a good basis for obviousness. [00:19:15] Speaker 01: And for the same reason that I've mentioned before, [00:19:17] Speaker 01: In Kahn, every embodiment, always the same. [00:19:20] Speaker 01: They make an emulsion, and then that's what's used. [00:19:23] Speaker 01: And in Kahn, there's no mention of D-limonene. [00:19:25] Speaker 01: In fact, in Morayama, there's no mention of D-limonene. [00:19:28] Speaker 01: The fact that our claims are very specific to being able to be dissolved in D-limonene, and the fact that Kahn does not actually teach dissolution, but rather a melting point reduction method, which is the alternative to dissolution, [00:19:45] Speaker 01: shows that it's actually a teaching away and can't be combined. [00:19:49] Speaker 01: And for all those reasons, the board's finding of no obviousness based on Khan should foreclose the board from being able to use it in the other two cases. [00:20:01] Speaker 01: What about with that? [00:20:03] Speaker 04: Go ahead. [00:20:03] Speaker 04: The Motoyama obviousness rejection was Motoyama combined with Khan and other references, I think, right? [00:20:12] Speaker 01: Yes. [00:20:13] Speaker 01: And the problem, other than [00:20:16] Speaker 01: They're using CON. [00:20:18] Speaker 01: None of them actually mentioned d-limonene specifically. [00:20:21] Speaker 04: Not d-limonene, although Nassau mentions limonene. [00:20:25] Speaker 01: Nassau only mentions limonene in this context. [00:20:27] Speaker 01: When he's suggesting this would be a subject for investigation at the end of his thesis. [00:20:32] Speaker 01: Exactly, but not something that can be used. [00:20:35] Speaker 01: And in fact, when they did study it, they only studied it with regard to seeing if it can further help on the melting point reduction method, not as [00:20:43] Speaker 01: a substance that can then dissolve CoQ10. [00:21:01] Speaker 00: Okay. [00:21:06] Speaker 00: Good morning. [00:21:06] Speaker 00: May it please the court? [00:21:07] Speaker 00: Mark Girotin with McCarter in English for the UPELLI JAR Formulas. [00:21:14] Speaker 00: First, with respect to melting versus dissolving, the only evidence of record on melting, the only evidence of record on what is really happening here is set forth in Khan and Nassau. [00:21:27] Speaker 00: Khan and Nassau, they set forth really in ad nauseum detail exactly what's occurring when you put CoQ10 in a volatile essential oil like lemon oil or like peppermint oil or spearmint oil as disclosed in Moriama. [00:21:42] Speaker 00: And what Kahn and Nassau show is that when you put a sufficient amount of volatile essential oil in the presence of the CoQ10, it reduces the melting point of the CoQ10 such that it liquefies the CoQ10. [00:21:55] Speaker 00: It turns it from a solid crystal into a liquid. [00:21:59] Speaker 00: And now you have two liquids that form a solution. [00:22:02] Speaker 00: They dissolve. [00:22:04] Speaker 00: And Kahn explicitly states this. [00:22:06] Speaker 00: Kahn explicitly states at column [00:22:10] Speaker 00: Well, first I should explain. [00:22:11] Speaker 04: Well, what is the mechanism? [00:22:13] Speaker 04: You agree that they are first turned into an emulsion, right? [00:22:18] Speaker 00: No, I do not. [00:22:19] Speaker 04: You don't agree. [00:22:19] Speaker 04: They never turn into an emulsion? [00:22:20] Speaker 00: Absolutely not. [00:22:21] Speaker 00: Absolutely not. [00:22:22] Speaker 04: There is never an emulsion until... Notwithstanding that Kahn refers to the emulsion. [00:22:27] Speaker 00: Yes, he does, Your Honor. [00:22:29] Speaker 04: So the peculiar thing about this case is each of you has to argue. [00:22:33] Speaker 04: It seems to me that Kahn doesn't really understand chemical terminology. [00:22:38] Speaker 04: You're saying Khan didn't understand the term emulsion, and your opposing counsel is saying that Khan didn't understand the term solution. [00:22:48] Speaker 04: Is that really where we are? [00:22:51] Speaker 00: Let me try to clarify, Your Honor. [00:22:52] Speaker 00: Let me try to clarify, because what Khan is very clear on is that he first dissolves, he first melts and thereby solubilizes the CoQ10 in the essential oil. [00:23:06] Speaker 00: And he's very clear on that. [00:23:08] Speaker 00: He explains Nizal in the dissertation thesis. [00:23:11] Speaker 00: Nizal and Khan are one and the same, essentially. [00:23:13] Speaker 00: And Nizal explains in his dissertation thesis that the SNEDs, which is the self-nano-emulsifying drug delivery system, that's what Khan invented, a self-nano-emulsifying drug delivery system. [00:23:29] Speaker 04: Emulsifying, being the word that [00:23:31] Speaker 04: catches one's attention. [00:23:33] Speaker 00: Yeah, of course, your honor. [00:23:34] Speaker 00: And so let me try to clarify that. [00:23:35] Speaker 00: So what he does first is he mixes the CoQ10 with the volatile essential oil when he creates his formulation. [00:23:41] Speaker 00: Why does he do that? [00:23:42] Speaker 00: He does that because he wants to melt the CoQ10 and liquefy it. [00:23:47] Speaker 04: Both are incontrovertible. [00:23:50] Speaker 04: So we get to liquid. [00:23:51] Speaker 04: But the question is, what's the nature of that liquid? [00:23:54] Speaker 00: Well, that liquid is once you, by definition in this case, once you solubilize, which means dissolve, [00:24:00] Speaker 00: You have a solution. [00:24:02] Speaker 04: Well, yes, but we haven't gotten there yet, right? [00:24:04] Speaker 04: All we've done is we've melted the CoQ10. [00:24:09] Speaker 04: And then we have the lemon oil around the limonene or whatever essential oil is used to reduce the melting point. [00:24:18] Speaker 04: Yes, Your Honor. [00:24:19] Speaker 04: But the next question, the critical question to me at least, is what is it that tells us that that melted CoQ10 and the essential oil [00:24:29] Speaker 04: turn into a solution as opposed to an emulsion. [00:24:34] Speaker 04: So walk me through that. [00:24:35] Speaker 00: Yeah, let me take you to at least two places. [00:24:38] Speaker 00: The two places I'm going to go is I'm going to go to the con pattern of column 19. [00:24:42] Speaker 00: And then I'm going to go to the Nassau declaration. [00:24:44] Speaker 00: I'm going to start there. [00:24:45] Speaker 00: And then I'm going to explain to you about emulsions. [00:24:49] Speaker 00: So let's start with con of column 19. [00:24:51] Speaker 00: This is where he's claiming his SNED. [00:24:53] Speaker 04: Yeah, I discussed this with your opponent counsel, the claim language about solubilization. [00:24:59] Speaker 00: Yeah, so he says, you have a sufficient amount of volatile essential oil to solubilize the ubiquinone. [00:25:05] Speaker 00: So this essential oil solubilizes it, and then he says, your honor, to thereby solubilize the ubiquinone. [00:25:12] Speaker 00: So you melt, what he says is, he says, wherein the volatile essential oil is present in a sufficient amount [00:25:19] Speaker 00: to reduce the melting point of ubiquinone to 37 degrees C or below. [00:25:23] Speaker 00: 37 degrees C is the human body temperature. [00:25:27] Speaker 00: So what he wants to do is when this is ingested into the body, he wants it to melt. [00:25:32] Speaker 00: Of course. [00:25:32] Speaker 00: OK, so it turns into a liquid and forms a solution with the lemon oil. [00:25:36] Speaker 04: Forms a solution. [00:25:37] Speaker 04: That's the critical question, because your opposing counsel says he misused the term solubilize at that point in the claims and in the rest of the patent when the term is used. [00:25:48] Speaker 04: He says the rest of the patent makes clear that what he's creating is an emulsion, not a solution. [00:25:54] Speaker 04: Now again, I want you to show me why that's not true. [00:25:58] Speaker 00: Okay. [00:25:59] Speaker 00: So, well, number one, he says that you melt in there by soluble ice. [00:26:02] Speaker 00: Okay. [00:26:02] Speaker 00: So when, first of all, if we look at the definition of dissolve that was adopted by the board in this case. [00:26:09] Speaker 04: Well, I know the board and probably any first year chemistry student except apparently [00:26:15] Speaker 04: Mr. Kahn, Dr. Kahn probably, was absent that day. [00:26:20] Speaker 04: But any first year chemistry student would say dissolve means turn it into a solution, not an emulsion. [00:26:26] Speaker 04: But the problem is we have to grapple with the argument that this was a misuse in light of everything else we have about Kahn talking about emulsions. [00:26:35] Speaker 04: This is a misuse of the term solidization. [00:26:37] Speaker 04: Why is that true? [00:26:39] Speaker 04: or why is that not true? [00:26:40] Speaker 00: Okay, well I'm going to get to that sentence that they're hinged at, they're latching on to. [00:26:43] Speaker 00: Before I get there, let me try to explain physically what's happening with his, with Khan's formulation. [00:26:48] Speaker 00: What he does is he takes the CoQ10 essential oil, and when he creates his SNEDs, he combines it with what's called a surfactant and a co-surfactant. [00:26:56] Speaker 00: Surfactants and co-surfactants are emulsifiers. [00:27:00] Speaker 00: Right. [00:27:00] Speaker 00: Emulsifiers allow you to maintain an emulsion. [00:27:03] Speaker 00: What's key though, [00:27:04] Speaker 00: is that it does not form an emulsion until it is put into an aqueous environment. [00:27:10] Speaker 00: And that is very clear throughout his patent. [00:27:13] Speaker 00: So what he's saying is his whole goal here is to create a capsule. [00:27:17] Speaker 00: The capsule has in it a formulation. [00:27:20] Speaker 00: That formulation has no water. [00:27:22] Speaker 00: That formulation has CoQ10, essential oil, surfactant, and co-surfactant. [00:27:29] Speaker 00: Then what he says is when this is ingested into the gut at 37 degrees C, [00:27:35] Speaker 00: Now, I'm going to reduce the melting point of the CoQ10 so it becomes liquid. [00:27:39] Speaker 00: I'm going to create a solution and it's going to disperse because it's in the presence of water and it's going to create an emulsion inside the gut. [00:27:49] Speaker 00: And that is when he creates an emulsion. [00:27:51] Speaker 00: Why does he want an emulsion? [00:27:53] Speaker 00: He wants an emulsion when it's in the gut because he wants to disperse these micro droplets throughout the aqueous environment of the gut. [00:28:01] Speaker 00: The surfactant and the co-surfactant is what enables him to do that. [00:28:06] Speaker 00: So he's not in emulsion, Your Honor, until he puts it in the presence of water. [00:28:11] Speaker 00: And I will submit to you that his disclosure is very clear on that. [00:28:15] Speaker 04: Well, let's look at example two, and particularly column 12. [00:28:20] Speaker 04: Help me with this. [00:28:21] Speaker 04: Yes. [00:28:25] Speaker 04: The first sentence on the top of column two, the SNEDs, was then allowed to cool at ambient temperature for 24 hours until a viscous paste was obtained. [00:28:34] Speaker 04: Nanoemulsion absorbed granular material was obtained from the mixture. [00:28:39] Speaker 04: Isn't that referring to an emulsion? [00:28:48] Speaker 00: This is the embodiment. [00:28:49] Speaker 00: Let me say two things here. [00:28:51] Speaker 04: But that's an emulsion, right? [00:28:52] Speaker 00: Well, let me see. [00:28:55] Speaker 00: He uses the term self-nano-emulsifying drug delivery system. [00:28:59] Speaker 00: Right. [00:29:00] Speaker 00: So he's a little loose at times, I will admit, with how he describes the self-nano-emulsifying. [00:29:05] Speaker 00: But I will submit to you that when he describes his, here he's making a dry paste, OK? [00:29:12] Speaker 04: Without an aqueous, the aqueous, you say emulsifying aqueous environment is not present. [00:29:19] Speaker 00: That's right. [00:29:20] Speaker 04: So according to you, this should be a solution at this point. [00:29:24] Speaker 00: Well, no, it's not a solution because it's at room temperature. [00:29:26] Speaker 04: Well, OK, but if it were raised, if you raised it to 37C, it would be, right? [00:29:30] Speaker 00: Yeah, it can't be an emulsion there, Your Honor, because it's solid. [00:29:34] Speaker 04: Well, it's solid because it's at room temperature. [00:29:37] Speaker 04: But if you raised it, it would become liquid. [00:29:40] Speaker 04: And you say it would be soluble. [00:29:41] Speaker 00: At that point. [00:29:42] Speaker 04: Is that right? [00:29:43] Speaker 00: Yes, at that point. [00:29:44] Speaker 04: And not an emulsion? [00:29:45] Speaker 00: Not an emulsion until you put it into the gut. [00:29:48] Speaker 00: So it simultaneously becomes a solution and an emulsion in this embodiment. [00:29:52] Speaker 00: Because what's happening is, first of all, this can't be an emulsion. [00:29:56] Speaker 00: Why? [00:29:56] Speaker 00: Because an emulsion is defined as when you've got two liquids that are immiscible. [00:30:01] Speaker 00: Here you've got solids. [00:30:02] Speaker 00: It's a powder. [00:30:03] Speaker 00: What he's doing is he's... See, what Kahn wants to do in this particular embodiment is he wants to create a dry, powdered snet, and he wants to compress it so that when you ingest it, then it will become a nanomic emulsion. [00:30:20] Speaker 00: It doesn't become an emulsion though, Your Honor, because it's a solid one. [00:30:24] Speaker 00: As described right there, it's a solid. [00:30:26] Speaker 00: So by definition, it cannot be an emulsion. [00:30:30] Speaker 00: OK? [00:30:30] Speaker 04: It's not until... So his use of the term emulsion is explained by what? [00:30:35] Speaker 04: Well, how do you explain the fact that he refers to it as an emulsion? [00:30:40] Speaker 04: He just made a mistake? [00:30:40] Speaker 04: You said he used a loose language. [00:30:43] Speaker 04: Is that what's going on? [00:30:44] Speaker 00: Well, in that particular, I haven't studied that sentence, your honor, but I think when you look at this reference as a whole, I think he's very clear when he's talking about emulsions, he's saying the resultant emulsion after you put it in water and you stir it. [00:31:00] Speaker 00: I mean, he also goes on to, he explains elsewhere, unambiguously, that the SNEDS is not an emulsion. [00:31:08] Speaker 00: And it doesn't become an emulsion until it's put into an aqueous environment. [00:31:13] Speaker 00: If we look, for example, at Nassau at his dissertation thesis, and by the way, I'm in the appendix. [00:31:32] Speaker 00: I apologize from a different one than you. [00:31:33] Speaker 00: I'm in 1051. [00:31:34] Speaker 04: All right, I'll use it. [00:31:37] Speaker 00: OK. [00:31:57] Speaker 00: Okay, so he, at appendix 849, which is page 19 of his thesis, under the heading SEDS and SMEDS. [00:32:07] Speaker 00: SEDS is self-emulsifying drug delivery system. [00:32:10] Speaker 00: SMEDS is self-micro-emulsifying drug delivery system. [00:32:16] Speaker 00: Then he uses SEDS later in that paragraph, SELS, nano-emulsifying drug delivery system. [00:32:21] Speaker 00: Micro versus nano just depends on the size of the droplet when it's in the gut. [00:32:26] Speaker 00: So he says in the first sentence, he says self-emulsifying drug delivery systems, SEDs, and self-micro-emulsifying drug delivery systems, SMEDs, are not micro-emulsions. [00:32:39] Speaker 00: He says they're not emulsions. [00:32:40] Speaker 00: Then he explains, if we go down to the end of that paragraph on the top of the next page, he explains that on the last sentence, he says SEDs and SMEDs, [00:32:53] Speaker 00: I'm sorry, SEDS and SNEDS with an N, which is the term he uses in the 786. [00:32:57] Speaker 00: Nano emulsion. [00:32:58] Speaker 00: Nano. [00:32:59] Speaker 00: Can therefore be defined as isotropic solutions of oil, surfactant, co-surfactant, and drug, which form O slash W, which means oil in water, microemulsions, when introduced into aqueous phases under gentle agitation. [00:33:21] Speaker 00: What he's saying here is it becomes a micro emulsion when it's introduced into an aqueous environment under general agitation. [00:33:29] Speaker 00: He then goes on, your honor, and when we look at the examples where soft gel argues, he's always saying it's an emulsion. [00:33:36] Speaker 00: What he's saying in each of those cases is that, that they point to, is that when you stir it, he says there is a resultant emulsion because you put it in water and now it results in an emulsion. [00:33:48] Speaker 00: And we submit that's clear. [00:33:49] Speaker 00: There is one very clear ambiguity in this case with use of the word emulsion. [00:33:55] Speaker 00: And that's in connection with example two in the 786. [00:33:58] Speaker 04: That's the one we were just looking at. [00:34:00] Speaker 00: Yes. [00:34:00] Speaker 00: Well, not that exact language. [00:34:03] Speaker 00: But I'll say the language that was latched onto by Softgel and initially relied upon by the board in reaching its decision to reverse the obviousness rejection based on con. [00:34:14] Speaker 00: The board then, that was the first case the board handled. [00:34:18] Speaker 00: We then had oral argument on the other two cases, where we clarified with the board this issue. [00:34:24] Speaker 00: The board then went back and reversed itself and said, uh-uh, there is no evidence that Kahn has an emulsion, that the snedge is an emulsion, until it's introduced into water. [00:34:34] Speaker 04: Well, they came out differently in those two cases. [00:34:37] Speaker 04: They didn't reverse their position in the first case. [00:34:39] Speaker 00: Yeah, I apologize. [00:34:40] Speaker 00: Yeah, poor you, sir. [00:34:43] Speaker 00: And so if we look at example two, which is, and if we look at line [00:34:49] Speaker 00: This is the line that Softgel will point to, which is column 11, this is a page 804 of the appendix we're referring to. [00:34:58] Speaker 00: Column 11, line 65. [00:35:03] Speaker 00: And he explains here that, first of all he explains in the beginning of that paragraph how he creates the SNEDs. [00:35:09] Speaker 00: Essentially it's oil, CoQ10, it's lemon oil, CoQ10, surfactant, co-surfactant. [00:35:15] Speaker 00: And then what he explains here is he says, [00:35:17] Speaker 00: The resultant emulsion was mixed with a stirring bar until a transparent solution of sneds was obtained. [00:35:26] Speaker 00: So Softgel has grabbed onto that to argue that, OK, he says it's an emulsion. [00:35:31] Speaker 04: Sounds like it's exactly the opposite of the mechanism that you've just been describing. [00:35:36] Speaker 00: This is the one sentence, Your Honor, that is ambiguous. [00:35:40] Speaker 00: It's internally inconsistent and, quite frankly, makes no sense. [00:35:43] Speaker 04: So he should have said, [00:35:45] Speaker 00: uh... was mixed with a stirring bar the resultant solution yet not emotion was used for the stirring bar until a transparent sort of you know also where the resulting formulation the resulting formulation right but it is a very starkly put he's gotten both of the terms wrong as you in your view well i i did not the transparent solution part uh... well yeah i mean uh... i mean i think that is the one mistake in the in the sentence doesn't make sense by by [00:36:13] Speaker 00: By definition, an emulsion cannot be a solution. [00:36:17] Speaker 00: One cannot be the other. [00:36:19] Speaker 00: So by saying that the emulsion became a solution, it's a physical impossibility. [00:36:24] Speaker 04: But you're saying that the solution became an emulsion when it was added, when it was put in an aqueous environment. [00:36:32] Speaker 00: Yes. [00:36:33] Speaker 00: Well, the solution itself is emulsified in the water. [00:36:37] Speaker 00: Right. [00:36:37] Speaker 00: So the CoQ10 in oil doesn't [00:36:41] Speaker 00: itself, that still remains a solution. [00:36:43] Speaker 00: It's a micro-droplet. [00:36:45] Speaker 00: There's micro-droplets of oil and water, which themselves are little micro-solutions of oil and water. [00:36:52] Speaker 00: Those are suspended in, I'm sorry, wrong word. [00:36:55] Speaker 00: Those micro-droplets of Ococutinin oil are in solution as micro-droplets. [00:37:01] Speaker 00: They are suspended in water. [00:37:04] Speaker 00: And that's how they create an emulsion. [00:37:07] Speaker 00: The water and the oil are immiscible. [00:37:09] Speaker 00: They cannot dissolve one in the other. [00:37:13] Speaker 00: And that's why it becomes an emulsion in water. [00:37:17] Speaker 00: But when you've got the oil and the CoQ10, those are two liquids. [00:37:21] Speaker 00: And they are. [00:37:22] Speaker 00: They become a solution. [00:37:23] Speaker 00: So they're a solution. [00:37:24] Speaker 00: And those micro droplets of solution are suspended in the water. [00:37:28] Speaker 04: And you say that the nano droplets, if you will, of CoQ10 and limonene [00:37:38] Speaker 04: are in solution in the micro droplets. [00:37:42] Speaker 00: In the micro droplets. [00:37:44] Speaker 00: And then the surfactants, they surround the micro droplets and they help maintain the suspension of the micro droplets in the water because they're emulsifiers. [00:37:53] Speaker 00: That's by definition what an emulsifier does. [00:37:56] Speaker 00: So we submit, Your Honor, physically that is what's happening here. [00:38:02] Speaker 04: And where's the best description anywhere in this record of that process that you've just laid out? [00:38:11] Speaker 04: Because that goes beyond anything that I saw in the records. [00:38:18] Speaker 00: Yeah, I would submit, Your Honor, that the, you know, I think the best description that helps us, you know, understand that, I mean, the best description, I think, to start with is in Nassau at 849, 850 in the appendix, because that's where it tells us it's not. [00:38:37] Speaker 04: But that doesn't go as far as your description of the methods. [00:38:40] Speaker 00: No, and you know, Your Honor, [00:38:42] Speaker 00: I'm sorry, wait a minute. [00:38:46] Speaker 00: Where is it? [00:38:49] Speaker 00: He does explain in his patent, and I just can't right now. [00:38:54] Speaker 03: Kahn? [00:38:55] Speaker 00: Kahn, yeah. [00:38:56] Speaker 00: Kahn does explain in his patent how, let's see, could be in a summary. [00:39:14] Speaker 00: Okay, here's a pretty good sentence, Your Honor. [00:39:17] Speaker 00: Let me go to the summary of the invention in Con 786, Appendix 799. [00:39:20] Speaker 00: Okay, and if we go down to line 55, this is the summary of the invention. [00:39:29] Speaker 00: He states, column 2, line 55, he says, in a eutectic-based SNEDs, the melting point depression method allows the oil phase containing the drug itself to melt at body temperature. [00:39:43] Speaker 00: from its semi-solid consistency and disperse to form emulsion droplets in nanometer size range. [00:39:53] Speaker 00: Okay, so he's saying that when it gets into the gut, it disperses in these emulsion droplets, which are in nanometer size range. [00:40:02] Speaker 00: And then if you go to the latter part of his spec, he conducts a series of turbidity measurements because he's very focused on evaluating how this emulsion is created [00:40:13] Speaker 00: So when he's talking about, if we go to page 802 at column 7, he explains visual observations. [00:40:26] Speaker 00: He's trying to evaluate how this emulsion looks when you put it in water and whether it creates a transparent emulsion or not. [00:40:36] Speaker 00: And so, for example, at [00:40:40] Speaker 00: at column seven, line 100. [00:40:44] Speaker 00: He said, or 99, he has visual observations. [00:40:47] Speaker 04: Whoa. [00:40:47] Speaker 04: Line 100, there are 100. [00:40:48] Speaker 00: Oh, I apologize. [00:40:50] Speaker 00: You know, these are printed so small, I left my reading glasses in the thing. [00:40:53] Speaker 00: I think it's 80, roughly. [00:40:54] Speaker 00: 80. [00:40:55] Speaker 00: No, I'm sorry. [00:40:56] Speaker 04: There's no 80s. [00:40:56] Speaker 00: They only go up to 67. [00:40:58] Speaker 00: Yeah. [00:40:59] Speaker 00: Boy, my eye doctor would be embarrassed right now. [00:41:01] Speaker 00: OK. [00:41:02] Speaker 00: So where it says visual observations. [00:41:05] Speaker 00: It says to assess the self-emulsification properties [00:41:08] Speaker 00: formulation, 50 milligrams pre-melted at 37 degrees C, was introduced into 100 ml of water in a glass flask at 25 degrees C. And the contents were gently stirred manually. [00:41:26] Speaker 00: The tendency to spontaneously form a transparent emulsion was judged. [00:41:32] Speaker 00: So what he's trying to do there is he's trying to assess, OK, when you put this snit in water and I stir it gently, [00:41:38] Speaker 00: does it spontaneously form the transparent emulsion? [00:41:43] Speaker 00: Which he's trying to emulate. [00:41:45] Speaker 04: And you say that it's converting the solution into an emulsion. [00:41:51] Speaker 00: Yeah, well what it's doing is, to be a little bit more precise, Your Honor, he's not converting those micro droplets themselves. [00:41:56] Speaker 04: No, no, I understand that. [00:41:57] Speaker 00: What he's doing is he's creating this nano emulsion, he calls it, which is nano-sized droplets of solution [00:42:05] Speaker 00: suspended in water. [00:42:07] Speaker 00: Right. [00:42:07] Speaker 04: But before the water arrived, it was, you say, a solution. [00:42:12] Speaker 00: Yes. [00:42:13] Speaker 00: Yes. [00:42:13] Speaker 04: So the water converts the solution into an emulsion. [00:42:17] Speaker 00: Yes. [00:42:17] Speaker 00: OK. [00:42:18] Speaker 00: Yes. [00:42:30] Speaker 00: So a couple things, Your Honor. [00:42:32] Speaker 00: While we're on example two. [00:42:34] Speaker 00: You know, we submit that the only evidence, well, first of all, as I indicated, the board reversed, the board reversed in the H-26 case, or 10-51 appeal, the board reversed the examiner's rejection, obviousness rejection, based on Khan-Nazal without mode ama. [00:42:55] Speaker 00: And the reason for reversing the examiner was really based on that one sentence that I pointed to in connection with example two, [00:43:02] Speaker 00: where he said the result in emulsion became a transparent solution. [00:43:07] Speaker 00: And we submit that, first of all, the board very carefully went through that, reconsidered it in the other two cases, and issued a different opinion. [00:43:18] Speaker 00: We submit that there is no substantial evidence in this patent to support the conclusion that CONS SNEDS is an emulsion. [00:43:26] Speaker 00: The only evidence that Softgel has pointed to to support that is that sentence. [00:43:32] Speaker 00: That sentence we submit is not evidence. [00:43:34] Speaker 00: That sentence is internally inconsistent and ambiguous and is no evidence at all. [00:43:39] Speaker 00: And therefore, we submit that there is an alternative ground for affirmance here based on the obviousness rejection over comp. [00:43:48] Speaker 04: Now, with respect to- And I take it that you think it's an appropriate setting for an alternative basis as opposed to a cross-appeal? [00:43:57] Speaker 00: Yes, Your Honor. [00:43:58] Speaker 00: The reason being, we couldn't cross-appeal on that issue because it wouldn't have enlarged the relief zone. [00:44:03] Speaker 04: It wouldn't have changed. [00:44:04] Speaker 00: It wouldn't have changed. [00:44:09] Speaker 00: So with respect to obviousness and Moriyama, and Moriyama combined with Khan Nassau, we agree, first of all, with your honor's view that Moriyama does teach [00:44:26] Speaker 00: that you can use any of a number of different oils. [00:44:28] Speaker 00: It lists a long laundry list of oils, including terpenes. [00:44:33] Speaker 00: Modayama also very clearly says that you can dissolve CoQ10 in an equal amount of, you can dissolve CoQ10 in an equal amount of carvone. [00:44:45] Speaker 00: And it also says that carvone containing oils, experimental peppermint oil are highly preferred. [00:44:52] Speaker 00: Kahn, on the other hand, tells us that lemon oil [00:44:55] Speaker 00: peppermint oil and spearmint oil also melt and thereby solubilize or dissolve the CoQ10. [00:45:03] Speaker 00: And so we submit that there were any of a number of bases to motivate the person of ordinary skill in the art to substitute Kahn's lemon oil for Moneama's carbon containing oils. [00:45:17] Speaker 00: Several, several bases. [00:45:19] Speaker 00: Number one, there's Nizal's statement [00:45:23] Speaker 00: at the end of his dissertation, where he explicitly states that, and this is at page 1076 of the appendix, he says, based on the present investigation, the following studies may be pursued, among others. [00:45:42] Speaker 04: Yeah, right. [00:45:42] Speaker 04: That's his final conclusion. [00:45:44] Speaker 00: Yeah. [00:45:44] Speaker 00: Chemical components of essential oils, such as limonene, menthol, and carbon, can be evaluated for their potency. [00:45:51] Speaker 00: So we submit that right there, [00:45:53] Speaker 00: That's a motivation of the person of ordinary skill in the art to say, hey, I think I'll try limonite instead of the carvone in Moriama's reference. [00:46:03] Speaker 00: Secondly, if we look at Kahn, Kahn tells us that lemon oil is actually better than peppermint oil and spearmint oil. [00:46:12] Speaker 00: So if we go to Kahn at column seven, Kahn runs a test. [00:46:17] Speaker 00: This is Kahn on page 802 of the 1051 appendix. [00:46:23] Speaker 00: In table two, Kahn says, okay, I appreciate that when you put this in the body, you're not gonna have just a binary mixture of CoQ10 essential oil. [00:46:33] Speaker 00: You're gonna combine it with other stuff, formulation excipients, okay? [00:46:37] Speaker 00: And so he wants to evaluate what happens when you combine CoQ10 essential oil with other excipients, and how does that affect the melting point depression and the solubilization that results? [00:46:49] Speaker 00: And so he combines CoQ10 with spearmint oil, [00:46:53] Speaker 00: peppermint oil, lemon oil, and anis oil. [00:46:56] Speaker 00: And he combines them with different amounts of cremophore L, which is a surfactant and emulsifier. [00:47:05] Speaker 00: And so what this table shows is that as you put increasing amounts of cremophore L in that formulation, it doesn't melt the co-cutanin any longer for peppermint oil and spearmint oil. [00:47:17] Speaker 00: So it shows that peppermint oil and spearmint oil, although they work, [00:47:22] Speaker 00: they don't work necessarily for real high concentrations of surfactant. [00:47:27] Speaker 00: Lemon oil, on the other hand, melted everything, okay? [00:47:32] Speaker 00: And so lemon oil worked with all levels of Cremoforal. [00:47:35] Speaker 00: And so what the, what Kahn says here at column seven, line 29, he concludes essentially, the use of lemon oil appears reasonable and attractive. [00:47:47] Speaker 00: I submit, Your Honors, that that is [00:47:49] Speaker 00: A statement that will provide the person with ordinary skill and motivation to try lemon oil over peppermint oil or spearmint oil. [00:47:57] Speaker 00: He even goes further because he says he provides one other benefit of lemon oil. [00:48:01] Speaker 00: He says furthermore, lemon oil has been used internally as herbal medicine for acidic disorders such as arthritis and rheumatism with great benefit in liver congestion. [00:48:17] Speaker 00: So he tosses in one more reason why you want to use lemon oil over the other oils. [00:48:22] Speaker 00: Again, providing a motivation to the person of ordinary skill. [00:48:26] Speaker 00: Then we've got as another reason, another motivation to make the combination. [00:48:31] Speaker 00: We've got Softgel's own expert witness in a federal litigation involving the con patent where Softgel's own expert said that the substitution of, and this is by the way, [00:48:46] Speaker 00: page 1,200 of the intent. [00:48:48] Speaker 04: Yeah, that wasn't cited in your brief. [00:48:50] Speaker 04: You cited something that didn't have any of that material. [00:48:52] Speaker 00: I apologize. [00:48:53] Speaker 00: I caught that yesterday. [00:48:54] Speaker 00: We had a typographical error. [00:48:57] Speaker 00: And we had the wrong site for this. [00:48:59] Speaker 00: All right. [00:48:59] Speaker 04: Well, that's OK. [00:49:00] Speaker 00: We have it. [00:49:00] Speaker 00: I wanted to make a point. [00:49:01] Speaker 04: It's on page 1,200. [00:49:03] Speaker 00: To say it's 1,200. [00:49:04] Speaker 04: That's the district court's quoting Dash. [00:49:07] Speaker 00: Yes. [00:49:08] Speaker 00: Yeah, he's quoting Dash. [00:49:10] Speaker 00: And so Dash says that the substitution of lemon oil for other essential oils [00:49:14] Speaker 00: is a predictable variation that will be known to one of ordinary skill. [00:49:18] Speaker 00: At a minimum, be obvious to use or obvious to try lemon oil based on the teachings of the prior art. [00:49:25] Speaker 00: So he was saying, and he was speaking there with reference to Moriyama. [00:49:29] Speaker 00: Okay, it would be obvious to use or obvious to try lemon oil in Moriyama. [00:49:32] Speaker 04: So on top of that now, you've got- Was that Moriyama or was it, there's a reference in the next line to the Shuck patent. [00:49:40] Speaker 00: Yes, the Shuck patent. [00:49:41] Speaker 04: Was he talking about shuck or was he talking about modayama? [00:49:45] Speaker 00: Well, what he's saying is, if we look up above, Your Honor, in the middle of the paragraph above, it says, Dr. Dash opines that shuck may be combined with modayama. [00:49:55] Speaker 00: So what he's talking about there is combining the teaching of shuck with modayama. [00:50:00] Speaker 00: So what he's saying is, based on those teachings in the yard, it would have been obvious to substitute lemon oil for the oils of modayama. [00:50:08] Speaker 04: But the essential oils that he refers to in that quote [00:50:11] Speaker 04: are the essential oils of what? [00:50:14] Speaker 00: Of Morayama? [00:50:18] Speaker 04: Morayama. [00:50:20] Speaker 00: Morayama was the primary 103 reference. [00:50:25] Speaker 00: And so they were talking about modifying Morayama to arrive at the issue in this case, by the way, and this sort of touches on their collateral estoppel argument. [00:50:35] Speaker 00: We submit there is no collateral estoppel. [00:50:37] Speaker 00: They're not the same issues here. [00:50:39] Speaker 00: But the issue in this case of this opinion [00:50:41] Speaker 00: at 1,200 was whether or not Khan's claimed invention was obvious over Morayama. [00:50:49] Speaker 00: And so what Dash was arguing was that it would have been obvious to modify Morayama in view of Shuck to use lemon oil and Morayama. [00:51:01] Speaker 00: And therefore, you'd have claim one of the Khan patents. [00:51:08] Speaker 00: And then on top of that, back to motivation to combine, you've got both soft elements in their patent that both carvone and limonene are monoterpenes. [00:51:24] Speaker 00: They're the same class of molecule. [00:51:26] Speaker 00: They can be expected to behave similarly. [00:51:28] Speaker 00: And therefore, when you make the motivation, there's clearly a reasonable expectation of success for that additional reason. [00:51:33] Speaker 00: So we submitted there multiple reasons why it would have been there was a motivation to combine with a reasonable expectation of success. [00:51:42] Speaker 02: Your time has expired. [00:51:44] Speaker 00: Thank you. [00:51:45] Speaker 00: I appreciate it. [00:51:47] Speaker 00: It's at 38 seconds, so I could confuse me. [00:51:49] Speaker 00: Thank you. [00:51:49] Speaker 00: We're over the red line. [00:52:14] Speaker 01: Your Honor, I'm going to hit dissolution. [00:52:16] Speaker 01: I understand now, I think, where there may be confusion between what I'm saying and what we were talking about before. [00:52:23] Speaker 01: So let me be clear, at least, as to what I think is going on. [00:52:27] Speaker 01: So there's a timing difference. [00:52:29] Speaker 01: If you look at what's in column two in the lines we were reading for dissolution. [00:52:33] Speaker 01: Now, which appendix are you using? [00:52:36] Speaker 01: I'm using 1814, because that's the one I'm using. [00:52:39] Speaker 01: That's fine. [00:52:41] Speaker 01: So it's appendix 493. [00:52:44] Speaker 01: And Mr. Giotana said this, and I just want to make sure we're all talking about the same thing. [00:52:50] Speaker 01: When I talk about the process of making SNEDs, and that's in the patent, and I don't think it's really disputed, the process of making SNEDs has no water in it. [00:53:01] Speaker 01: What they have is Cocutane lemon oil. [00:53:04] Speaker 01: They melt it. [00:53:05] Speaker 01: Then they add the emulsifier. [00:53:08] Speaker 01: At that point, they have an emulsion. [00:53:10] Speaker 01: And then that's what's either put in the soft gel capsule [00:53:13] Speaker 01: or in the powdered form, they do something to make it a tablet. [00:53:17] Speaker 01: And that's fine. [00:53:18] Speaker 01: But regardless, the starting point for making that, where now you have an emulsion, that paste or whatever that, when you have the CoQ10 that you've melted in with the lemon oil, you've now added the emulsifier. [00:53:29] Speaker 01: At that point, you have an emulsion. [00:53:31] Speaker 01: And that paste is either going to go into the soft gel, or it's going to be in a powdered form. [00:53:36] Speaker 04: Now, once that final- I don't think your opposing counsel would agree with that proposition, though. [00:53:41] Speaker 01: And that's clearly what's in this patent. [00:53:44] Speaker 01: I mean, we can go through sentences in column six, they say the resultant emulsion in column 11 that you walked through with them. [00:53:50] Speaker 01: That's the same process. [00:53:52] Speaker 01: It's the process of making the product. [00:53:54] Speaker 01: When we're in column two and we're talking about dissolution here, it's the next step. [00:53:59] Speaker 01: Now you've got this product. [00:54:01] Speaker 01: Let's do the capsule version. [00:54:03] Speaker 01: And you've got what is the SNED, which is the four things that are listed in column two. [00:54:11] Speaker 01: Oil, the surfactant, the drug, and the co-surfactant, which is the beginning. [00:54:17] Speaker 01: He read that in line 52. [00:54:19] Speaker 01: It contains the oil, the lemon oil, the surfactant and the co-surfactant. [00:54:23] Speaker 01: I'm just calling those emulsifiers. [00:54:25] Speaker 01: And then the drug is CoQ10. [00:54:27] Speaker 01: So that's the final product that is now that we use the process I went through. [00:54:33] Speaker 01: They melted it. [00:54:34] Speaker 01: They added it. [00:54:35] Speaker 01: They've now made that emulsion. [00:54:37] Speaker 01: They've loaded it into the capsule. [00:54:40] Speaker 01: somebody takes it. [00:54:42] Speaker 01: And the dissolution there now that we're talking about, because the body now melts it at 37 degrees, you've got fine emulsion droplets. [00:54:53] Speaker 01: And the dissolution there that we're talking about is bioavailability to the body. [00:54:59] Speaker 01: It's at a different time. [00:55:02] Speaker 01: Because when I was first talking to you about the manufacturer, at the manufacturer, there's no water. [00:55:08] Speaker 01: All there is is that four steps I said, you have the lemon oil, you have the CoQ10, you put them together, you melt it. [00:55:17] Speaker 01: Now you have a solution of lemon oil and CoQ10 that was based on that melting. [00:55:23] Speaker 01: You add the emulsifier. [00:55:26] Speaker 01: surfactant coaster back and there was a solution well when I say it's the melting is the resulting of the melting right but but you said it's a solution right and and yeah can we agree that that is it is dissolved in addition to being melted no when I say well you said solution yeah when I say so you have oil and you have lump you have coke you tan you melt it it's a liquid [00:55:50] Speaker 01: So it's a liquid ending, and that's a solution, but it didn't dissolve there. [00:55:53] Speaker 04: They melted it and get there. [00:55:55] Speaker 04: Not all liquids are solutions. [00:55:57] Speaker 04: So is it a solution in the chemical sense? [00:56:00] Speaker 01: Your Honor, all I meant was now you have CoQ10 from solid form to liquid form. [00:56:04] Speaker 04: You meant liquid, not solution. [00:56:06] Speaker 04: You meant not to say solution. [00:56:07] Speaker 01: I didn't mean to say solution. [00:56:09] Speaker 01: So they're in liquid, and then you add the emulsifiers, and then they stir it. [00:56:16] Speaker 01: But at the end of the day, that becomes the paste [00:56:18] Speaker 01: that is now in the tablet or the soft gel capsule, when he's talking about them, that is then ingested. [00:56:25] Speaker 01: That is what the sentences that we've all focused in on from line about 50 to 60 in column two is talking about. [00:56:34] Speaker 01: So that dissolution that we're talking about there is after you take that tablet, what happens in the gut. [00:56:42] Speaker 01: But for purposes of our claim, where we're talking about how you make the product, [00:56:48] Speaker 01: At the product level, what Khan teaches in every instance is that process where you end up with an emulsion that you then form into a tablet or you form into a capsule. [00:57:00] Speaker 04: Now, does it form a solution when it gets into the gut and it's in an aqueous environment? [00:57:10] Speaker 01: I don't know for sure. [00:57:11] Speaker 01: Well, that's what Khan thinks. [00:57:13] Speaker 01: Well, I think at that point, though, it's not the final product. [00:57:16] Speaker 01: It wouldn't even be related to the claims anymore. [00:57:19] Speaker 01: Because the claims are to that soft gel capsule. [00:57:25] Speaker 01: The claims aren't to what happens to the soft gel capsule after it's ingested. [00:57:31] Speaker 01: The claims are to making that soft gel capsule. [00:57:34] Speaker 01: And the way we make our soft gel capsule, and that's why I said that's the discovery, is we've got in the patents, somebody takes D-limonene, [00:57:43] Speaker 01: and dissolves it in, I'm sorry, somebody takes CoQ10, dissolves it in D-limonene, and it excludes any emulsion, and then they put that in the soft gel capsule. [00:57:55] Speaker 01: And that's the product. [00:57:57] Speaker 03: If you compare that to what Khan does, Khan- I'm a little confused because you seem to be positing some kind of distinction between dissolving something and melting something. [00:58:09] Speaker 03: Yes. [00:58:11] Speaker 03: If your patent says you take CoQ10 and you add D-limonide and it dissolves, and Kahn says you take CoQ10 and it is melted by the addition of D-limonide, I don't understand how those two things, which are the same actions, work differently. [00:58:33] Speaker 03: Is it that you use more D-limonide, which dissolves rather than just melts? [00:58:38] Speaker 03: Does the D-limonide and [00:58:41] Speaker 03: and CoQ10 stay somehow, even though it's in liquid form, stay somehow separate in Khan and in yours, it's dissolved together? [00:58:49] Speaker 01: That's a great question. [00:58:51] Speaker 01: So Khan doesn't actually say take CoQ10 and put it in d-limonene. [00:58:59] Speaker 01: What Khan says is take CoQ10 and put it in lemon oil. [00:59:02] Speaker 01: And what Khan found is whatever he did when he put those two together, [00:59:07] Speaker 01: He couldn't get those to dissolve. [00:59:09] Speaker 01: That is what he teaches you. [00:59:10] Speaker 01: He specifically says, due to the lack of solubility in fixed oils like this, he actually cannot get them to dissolve. [00:59:18] Speaker 01: So what he saw in the lab, when he put that together, when he put lemon oil and CoQ10 together, by his own words is not dissolution. [00:59:26] Speaker 01: So then he applies heat. [00:59:29] Speaker 01: In this case, he's going to body temperature. [00:59:31] Speaker 01: He's trying to get to a point where he says, if you put enough lemon oil there, you can get the melting point of CoQ10 down to 98 degrees or so. [00:59:39] Speaker 01: So your body temperature can melt it for the bioavailability piece. [00:59:43] Speaker 01: That's his goal. [00:59:44] Speaker 01: But to get there, the way he does that is he's got CoQ10 in lemon oil. [00:59:49] Speaker 01: He observes those not to have dissolved. [00:59:52] Speaker 01: So he applies heat. [00:59:54] Speaker 01: Wait, when does he apply heat? [00:59:55] Speaker 01: When he's making that formulation. [00:59:57] Speaker 03: When he's making his formulation, he puts... And your patent, sorry, just to make clear, when your patent does it, you don't need heat to dissolve it? [01:00:05] Speaker 03: Nope. [01:00:05] Speaker 01: In our patent, the way it happens is you just, you have, it's just like salt and water, except the water is D-limonene and the salt is CoQ10. [01:00:14] Speaker 01: You put it in there, it now dissolves. [01:00:17] Speaker 04: No matter what the temperature? [01:00:19] Speaker 01: No matter, at least there's no limitation on the patent on that. [01:00:21] Speaker 01: There's no discussions at room temperature is the example, I think. [01:00:25] Speaker 01: So at room temperature, it just dissolves. [01:00:27] Speaker 01: Whereas in Khan, to be very specific, what he has to do is he takes that CoQ10, puts it in lemon oil. [01:00:36] Speaker 01: He observed that he cannot dissolve it. [01:00:38] Speaker 01: And so he then applies heat to melt it. [01:00:42] Speaker 01: And that liquid, he then adds the emulsifiers to, which then is the resultant emulsion [01:00:50] Speaker 01: that he then forms into whether it's a soft gel capsule or whether it's a tablet. [01:00:55] Speaker 01: That's why it's excluded from all the claims. [01:00:58] Speaker 01: Our claims are very specific to say that final product is that d-limonene solvent in which you put the CoQ10 in, solute, it's now dissolved, that is in the final tablet. [01:01:14] Speaker 01: It is not then an emulsion and we exclude emulsions [01:01:18] Speaker 01: specifically in the claims, all the claims. [01:01:21] Speaker 01: And when they're talking about dissolution, at least in column two, it's about bioavailability once you've ingested it. [01:01:28] Speaker 01: That's a different time than what's in the claims. [01:01:33] Speaker 01: And that would be also true when you look at the claim of cod, because that claim is to the dietary supplement itself. [01:01:41] Speaker 01: It's post-manufactured. [01:01:43] Speaker 01: We're talking about that. [01:01:45] Speaker 01: Once it's in, the body's going to melt it. [01:01:46] Speaker 01: You're going to have something available to the body in those micro emulsion droplets. [01:01:51] Speaker 01: It's not talking about it at the time you're manufacturing it. [01:01:54] Speaker 01: At the time you're manufacturing it, what they're doing is taking that CoQ10, adding it to lemon oil, melting it, because they're not seeing a dissolution. [01:02:08] Speaker 01: And that's why they're telling you, due to the problems with this solution, we can't get CoQ10 to dissolve. [01:02:15] Speaker 01: So here's our other approach. [01:02:17] Speaker 01: We're going to melt it, put an emulsifier in. [01:02:20] Speaker 01: It becomes solid. [01:02:21] Speaker 01: We can load it. [01:02:22] Speaker 01: And then in the body, those little emulsion droplets gives you more bioavailability in whatever happens in your gut. [01:02:36] Speaker 01: The one other [01:02:41] Speaker 01: I just want to mention a couple other things that Council mentioned. [01:02:45] Speaker 01: One is con, and this goes more to the obviousness side. [01:02:51] Speaker 01: The one thing that's clear from Nassau is they really didn't understand what value, what any component of lemon oil could or could not do. [01:03:03] Speaker 01: And they are very skilled people in the art. [01:03:05] Speaker 01: They are professors. [01:03:07] Speaker 01: They were at Texas Tech. [01:03:08] Speaker 01: They had post-docs working on the 2004 study. [01:03:11] Speaker 01: to figure out what, if any, any effect that these chiral components can have. [01:03:18] Speaker 01: And so it would be impossible to say Khan himself studied or taught anything with regard to those specific components, in particular D-limon. [01:03:30] Speaker 01: And then lastly, he brought up Dr. Dach, and I'll just mention this. [01:03:33] Speaker 01: In Dr. Dach, at the time we were putting those in, there was a big debate at the district court [01:03:39] Speaker 01: And the construction that they were propounding at that time was melting and dissolving were the same. [01:03:46] Speaker 01: So we didn't have this distinction that we're talking about here. [01:03:49] Speaker 01: And the district court did find that melting and dissolving were different. [01:03:52] Speaker 04: Would you agree that the quote from the district court's opinion on app 1200 from the 1051 appendix is both accurate as quoting Dr. Dasch and also referencing [01:04:08] Speaker 04: the essential oils of Moriyama? [01:04:10] Speaker 01: I believe he was referencing the essential oils of Moriyama, Your Honor. [01:04:17] Speaker 01: OK. [01:04:17] Speaker 01: Thank you. [01:04:18] Speaker 02: We thank both sides.