[00:00:01] Speaker 03: The next case before the court is case number 151849 in Ray Rao. [00:00:10] Speaker 03: It is also an appeal from the Patent Trial and Appeal Board. [00:00:48] Speaker 03: All right, Mr. Kelver, you want to reserve five minutes for rebuttal? [00:00:51] Speaker 01: Yes, Your Honor. [00:00:52] Speaker 03: Okay. [00:00:54] Speaker 03: Are you ready? [00:01:00] Speaker 03: You ready? [00:01:01] Speaker 01: I'm ready, Your Honor. [00:01:02] Speaker 03: Okay. [00:01:02] Speaker 03: I want to make sure we can let everybody else exit before we... Okay. [00:01:09] Speaker 03: All right, you can begin. [00:01:10] Speaker 01: Your Honors, may it please this Court, I actually have a nice eight-minute story to tell you about this invention. [00:01:17] Speaker 01: But given this morning's oral argument, with your permission, I'm going to go to the four critical findings of fact that the board made that we submit are not supported by any evidence of record, and certainly not substantial. [00:01:33] Speaker 01: That's a good move. [00:01:33] Speaker 03: We would never get through the first minute of the eight minutes. [00:01:36] Speaker 03: OK. [00:01:38] Speaker 01: The principal reference the claims are rejected over is Ammon. [00:01:41] Speaker 01: Ammon is a topical disinfectant. [00:01:44] Speaker 01: You wash your hands with it. [00:01:45] Speaker 01: You wash the top of the hospital bench with it because it's applicable to patients with a rare bacterial infection where the bacteria, when they are exposed to excessively dry conditions, sporulate. [00:02:01] Speaker 01: Bacterial endospores, the most resistant form of life on earth, Emin calls them, they happen when it's dry. [00:02:11] Speaker 01: That's got nothing to do with oral care solutions, Your Honor. [00:02:15] Speaker 01: The board seized on paragraph 78, where in a flight of fancy Ammon says, you could administer this systemically. [00:02:23] Speaker 01: You could do it through the eyes. [00:02:26] Speaker 01: You could do it through the nose. [00:02:27] Speaker 01: You could do it through the mouth. [00:02:31] Speaker 01: Delivering a systemic medication by the mouth, whether it's a solution or a pill or a tablet or a capsule, is not administration. [00:02:41] Speaker 01: to the oral cavity. [00:02:43] Speaker 01: You're not delivering a functional ingredient to the oral cavity. [00:02:47] Speaker 01: That's non-analogous art, Your Honor. [00:02:50] Speaker 01: And there is no support in the record other than paragraph 78 to suggest anybody in the oral care solution business would ever look at a topical disease. [00:03:01] Speaker 02: What's the difference between administering through the mouth and delivering through the oral cavity? [00:03:08] Speaker 01: If you [00:03:10] Speaker 01: direct the solution in a mouthwash, for instance, to the tissues of the oral cavity, your honor, that's delivering a functional ingredient to the buccal cavity. [00:03:24] Speaker 01: If you just swallow something, if the presence in the mouth is evanescent, is temporally limited, not because you want to treat something in the mouth, but because you want to treat it in the liver or the kidneys, [00:03:40] Speaker 01: That's not an oral care solution. [00:03:42] Speaker 01: And that's what Ammon teaches. [00:03:45] Speaker 03: So there are two tests on what is relevant art for purposes of consideration. [00:03:53] Speaker 03: And the board never got to the second column. [00:03:56] Speaker 03: So even if we said that it wasn't in the same field of endeavor, wouldn't it be otherwise pertinent to the solution that you're trying to address? [00:04:06] Speaker 01: I don't think so, Your Honor, because the problem that was faced is how do you provide an aesthetically acceptable oral care solution? [00:04:16] Speaker 01: The answer is effervescence at a level below or not greater than 310 milliosmoles per kilogram. [00:04:25] Speaker 01: Above that, you kill the cells. [00:04:27] Speaker 01: I don't know why Ammon indicates a preference for low osmolality. [00:04:33] Speaker 01: That is the same in the reference and the claims. [00:04:36] Speaker 01: But the solution, the problem they're facing and the solution is totally unrelated. [00:04:43] Speaker 01: Effervescence does you no good in a topical disinfectant. [00:04:50] Speaker 01: It goes off to the air. [00:04:51] Speaker 01: You never notice it. [00:04:52] Speaker 03: No, but if you put it in the mouth, wouldn't it impact the ease of taking it orally or the taste or it wouldn't otherwise affect [00:05:03] Speaker 03: how it operates? [00:05:04] Speaker 01: We don't know what formulations they had in mind for oral administration, Your Honor. [00:05:08] Speaker 01: There is no disclosure in that at all. [00:05:10] Speaker 01: But typically, no. [00:05:12] Speaker 01: Typically effervescence is provided for an aesthetic purpose. [00:05:17] Speaker 01: Plop, plop, fizz, fizz. [00:05:19] Speaker 01: Typically effervescence doesn't impact the speed of anything. [00:05:25] Speaker 01: And if you're just swallowing it to ingest it, [00:05:29] Speaker 01: There's no taste associated with the tiny amounts of byguanide that are present in Ammon. [00:05:35] Speaker 01: So I don't think it's the same problem. [00:05:37] Speaker 01: I don't think it's the same endeavor. [00:05:41] Speaker 01: But if you do pick up Ammon and you want to figure out what solution to make, what buffer to use, Ammon tells you very explicitly in paragraph 19, use Tris. [00:05:55] Speaker 01: That's hardly a surprise. [00:05:56] Speaker 01: The entire world uses Tris. [00:05:58] Speaker 01: more than any other physiologic buffer. [00:06:01] Speaker 01: Ammon says, if you've got a particular purpose, you can use Tris and something else. [00:06:08] Speaker 01: You can use Tris and more than something else. [00:06:13] Speaker 03: It doesn't require Tris, though. [00:06:14] Speaker 01: Oh, it does require Tris, Your Honor. [00:06:17] Speaker 01: That's Ammon paragraph 19. [00:06:19] Speaker 01: The board interpreted it differently because there are four preparations in Ammon that appear to not include Tris. [00:06:28] Speaker 01: But the specification at paragraph 19 is totally clear. [00:06:34] Speaker 01: The specification, bear with me, the specification reads, as mentioned above, one or more buffers may be employed. [00:06:52] Speaker 01: Tromethamine, that's Tris, is a known buffer which is suitable for use. [00:06:57] Speaker 01: As an alternative, and this is what the board said was different than Tris, as an alternative, the subject solutions may include a supplemental buffering agent, meaning, and the patent is clear, meaning that the subject solutions may include a mixed buffer of tromethamine and one or more other buffering agents. [00:07:20] Speaker 01: You've got to have Tris present according to the teaching of Anna. [00:07:26] Speaker 01: 12 other classes of supplemental bottles. [00:07:29] Speaker 01: Hammond says you can use one or more. [00:07:31] Speaker 01: Certainly to get to citric acid and sodium bicarbonate, you have to use two out of that list. [00:07:39] Speaker 01: That's 12 factorial combinations. [00:07:43] Speaker 01: That's 475 million combinations. [00:07:47] Speaker 01: And out of that grouping, the board suggested, well, sodium bicarbonate and citric acid are an obvious choice, one out of a few. [00:07:57] Speaker 01: Why? [00:07:57] Speaker 01: Again, those of skill in the art would recognize that effervescence comes from sodium bicarbonate and citric acid in effective amounts and is of no utility in a topical disinfectant. [00:08:15] Speaker 01: The board went beyond that, however. [00:08:19] Speaker 01: They said, well, you could take out the seltzer, [00:08:25] Speaker 01: that sodium bicarbonate and citric acid and a lot of other things, and use that without tris. [00:08:35] Speaker 01: The problem with doing that is there's not a reference in the world that teaches that. [00:08:40] Speaker 01: Alka-Seltzer has a lot of other things in it. [00:08:43] Speaker 01: It's got aspirin, it's got dimethicone, it's got maltodextrin, which is important for the claims on appeal [00:08:53] Speaker 01: but is not important for Ammon, because Ammon is, after all, what's disclosed and enabled, is a topical disinfectant. [00:09:03] Speaker 01: How do you get to the combination of a vaccine preparation, which is what the Alka-Seltzer was used for, and Ammon? [00:09:13] Speaker 01: There's no teaching that leads you there. [00:09:15] Speaker 03: But they only cite to Alka-Seltzer for the osmolality, right? [00:09:20] Speaker 01: No, Your Honor. [00:09:20] Speaker 01: Alka-Seltzer has too high an osmolality. [00:09:23] Speaker 01: They seized, why Alka-Seltzer? [00:09:26] Speaker 01: Because there is no enablement, sorry, there's no exemplification in Ammon of Alka-Seltzer's bicarbonate and citric acid. [00:09:36] Speaker 01: That's why SAC, which says, here's a typical buffer, Alka-Seltzer is a record. [00:09:43] Speaker 01: That's the only reason it's a record. [00:09:45] Speaker 01: But without that, how on earth do you get to that one choice out of 475 million [00:09:53] Speaker 01: where that's the one choice that will do you absolutely no good in the preparation of Ammon. [00:09:59] Speaker 03: So you're saying that Ammon is not only not in the relevant art, but it also teaches a way. [00:10:08] Speaker 01: That's correct, Your Honor. [00:10:10] Speaker 03: And that's because you think that Ammon requires tris. [00:10:13] Speaker 01: That Ammon, sorry. [00:10:14] Speaker 03: Requires tris. [00:10:15] Speaker 01: Yes. [00:10:16] Speaker 03: The government argues that Ammon, by its own examples, doesn't require tris. [00:10:23] Speaker 01: There are four examples that do not include TRIS. [00:10:27] Speaker 01: Three of those examples have no buffer at all. [00:10:30] Speaker 01: The language of paragraph 19 is absolutely clear. [00:10:34] Speaker 01: That's the language we just visited. [00:10:37] Speaker 01: This is a government report, and dutifully they included every piece of data that they had. [00:10:44] Speaker 01: I don't know what those three examples are intended to prove, but there's worse to come. [00:10:50] Speaker 01: because the most important unsubstantiated finding comes from the fact that even if one of skill in the art makes this wild shot combination, sodium bicarbonate, citric acid, water, for an oral care solution using alka-seltzer, the osmolality is too high. [00:11:15] Speaker 01: That was proved by declarative evidence. [00:11:19] Speaker 01: The board said, [00:11:20] Speaker 01: No problem. [00:11:21] Speaker 01: You dilute it. [00:11:23] Speaker 01: Osmolality is complex stuff. [00:11:27] Speaker 01: Is that what your inventor said? [00:11:29] Speaker 01: I'm sorry? [00:11:29] Speaker 03: Is that what your inventor said? [00:11:30] Speaker 03: Didn't your inventor say? [00:11:32] Speaker 01: That's what my inventor said. [00:11:33] Speaker 03: I thought he said it was pretty easy, ultimately. [00:11:35] Speaker 01: No. [00:11:36] Speaker 01: My inventor said it's easy to measure. [00:11:39] Speaker 01: What Alan Rao said at 692 to 698 is that it's very easy to measure. [00:11:50] Speaker 01: It's complex and almost impossible to predict. [00:11:55] Speaker 01: That's why nobody predicts it. [00:11:58] Speaker 01: The USP, which outside of the patent world is the US Pharmacopia, absolutely says dilution is so complicated that you cannot, osmolality is so complicated, that you cannot calculate it by dilution. [00:12:17] Speaker 01: So that if you have an osmolality of 10, [00:12:20] Speaker 01: and you dilute it by 50%, you do not have an osmolality of five because the osmolar coefficient is a function of concentration. [00:12:33] Speaker 01: It changes as you dilute. [00:12:35] Speaker 01: The board said a college undergraduate chemistry student would know precisely how to do this. [00:12:48] Speaker 01: Your Honor, [00:12:50] Speaker 01: I don't know an undergraduate student that would know that. [00:12:53] Speaker 01: I don't know a graduate student that would know that. [00:12:57] Speaker 01: It's complicated. [00:12:59] Speaker 01: It's in the decoration. [00:13:00] Speaker 01: You have to know the molar coefficient. [00:13:03] Speaker 01: In order to know the molar coefficient, you have to know what your dilution is. [00:13:08] Speaker 01: The minute you change the dilution, and that's right in the formula, the minute you change that dilution, you're lost. [00:13:16] Speaker 01: You have to start all over again. [00:13:18] Speaker 01: It's not easy. [00:13:19] Speaker 01: It's very difficult. [00:13:21] Speaker 01: It's an invention. [00:13:22] Speaker 01: And that, Your Honor, we submit are four findings that are not supported by even a scintilla of Ammon. [00:13:30] Speaker 02: Your argument is that Ammon requires the presence of Tris. [00:13:35] Speaker 01: The specification of Ammon is non-compromising. [00:13:39] Speaker 01: It's got to be there. [00:13:41] Speaker 02: I'm looking at it on page 55. [00:13:43] Speaker 02: It says, preferably, solutions of the president [00:13:49] Speaker 02: include Tris. [00:13:51] Speaker 02: And another reference to Tris that uses it as an example, meaning that it's not required, but it can be. [00:14:00] Speaker 01: Where does it say it's not required, Your Honor? [00:14:02] Speaker 01: It says you can have Tris, or you can have Tris and something else. [00:14:09] Speaker 01: That's the limit of Ammon. [00:14:12] Speaker 01: If it's not a solution, Your Honor, it doesn't concern us, because then there's no osmolality at all. [00:14:17] Speaker 02: What about the Senate's preferably solutions of the President's invention include Tris? [00:14:23] Speaker 01: They do. [00:14:23] Speaker 01: It says that. [00:14:24] Speaker 01: That's a preference, but that's not a requirement. [00:14:27] Speaker 01: That's a different portion of the specification. [00:14:31] Speaker 01: You can use Tris, it says, or Tris in something else. [00:14:35] Speaker 01: There's no teaching to go to the other 12 and make your selection. [00:14:40] Speaker 01: And even if you do that, Your Honors, even if you say, forget Tris, now you're left [00:14:47] Speaker 01: with that same unbelievable number of possibilities. [00:14:52] Speaker 01: Out of that 475 million possibilities, there's one that's going to give you effervescence. [00:14:59] Speaker 01: And why do you want that one? [00:15:02] Speaker 01: That's the question the board couldn't answer because the evidence doesn't support it. [00:15:08] Speaker 03: All right. [00:15:09] Speaker 03: Thank you. [00:15:09] Speaker 03: Well, you pretty much used up your rebuttal. [00:15:11] Speaker 03: We'll give you three minutes. [00:15:13] Speaker 01: Thank you, Your Honor. [00:15:17] Speaker 00: Good afternoon. [00:15:19] Speaker 00: May it please the court? [00:15:20] Speaker 00: So first, I'll just point out that the claim is very broad. [00:15:24] Speaker 00: It's a very simple composition. [00:15:26] Speaker 00: It doesn't even say oral composition. [00:15:28] Speaker 00: It just says a composition comprising an effervescent combination of citric acid and sodium and bicarbonate, which are both two common components dissolved in water, wherein the composition has an osmolality of under 310. [00:15:43] Speaker 00: And it doesn't point to anything unique or special about that range. [00:15:47] Speaker 00: And in fact, that range is quite broad. [00:15:49] Speaker 00: It just says under 310. [00:15:52] Speaker 00: And then now respond to the four points that were made. [00:15:58] Speaker 00: With their analogous art point, first of all, it is a factual finding which is reviewed for substantial evidence. [00:16:05] Speaker 00: And Amman, it discloses at 78 that it is a topical [00:16:11] Speaker 00: It's not limited to a topical disinfectant that it can be used for, it can be used orally. [00:16:19] Speaker 00: And then if we turn to 63 and 80, it also discloses that it's a treatment for halitosis. [00:16:25] Speaker 00: And then if we compare that to, if we look at A79 to what applicant says is their summary of claimed subject matter, we say that it says that the composition [00:16:40] Speaker 00: can prevent tooth decay, clean teeth, reduce oral bacterial populations, freshen breath, and constitute a carrier for prescription medicine. [00:16:50] Speaker 00: So I submit that there is substantial overlap between the disclosures of Amon and what applicant has said is their invention. [00:16:58] Speaker 03: Is it your position that the claim had to have some kind of predicate preamble to say that it was for use in oral composition and that we ignore the fact that the specification [00:17:10] Speaker 03: only talks about an oral composition? [00:17:14] Speaker 00: It's my position that, in this case, it doesn't matter because Iman is speaking to oral compositions, but the fact that it just claims a composition, I think, I don't know that you would have to read into the claim the oral composition. [00:17:33] Speaker 03: Can we divorce the claim from the written description? [00:17:36] Speaker 00: No, we can't. [00:17:37] Speaker 00: But I do think that in the specification, there are broad disclosures about reducing bacterial population. [00:17:46] Speaker 00: There's a number of embodiments disclosed. [00:17:50] Speaker 00: But like I said, in this case, it doesn't matter because Ammon clearly is to oral care as well. [00:18:01] Speaker 00: It's not limited to a topical disinfectant. [00:18:04] Speaker 00: On the second point about Tris, as Judge Raina pointed out, it's hard to understand how it can be required when there are disclosures of a table that do not include Tris. [00:18:22] Speaker 00: And if we look at the claims on 63 of Amman, they also do not claim Tris. [00:18:27] Speaker 00: But again, the presence of Tris doesn't matter. [00:18:30] Speaker 00: The claim is open-ended. [00:18:32] Speaker 00: As was mentioned at oral argument at the PTO, the fact that you have or don't have Tris in the combination is irrelevant. [00:18:42] Speaker 03: I don't really completely understand that argument. [00:18:44] Speaker 03: I understand the argument that there are some combinations, or at least one, that doesn't require Tris and has a buffer. [00:18:53] Speaker 03: But if it did require Tris, if it only worked in the presence of Tris, [00:19:01] Speaker 03: then, or perhaps only worked for the oral composition or the sort of limited extent to which it applies orally, wouldn't that actually be a fair argument that it does teach away? [00:19:17] Speaker 00: I don't see that as a fair argument because when in 55 on, in period 19 of Amman, when it talks about Tris, it says it can be used in combination with other suitable buffers. [00:19:30] Speaker 00: So I don't see how a claim to, you know, if you're saying that Amman discloses Tris with also the use of citric acid and sodium bicarbonate, I don't see how that claim wouldn't meet the broad composition claim. [00:19:46] Speaker 00: And again, the number of combinations mentioned by opposing counsel is irrelevant because the board used the SAF reference, which specifically talked about the citric acid, sodium, bicarbonate, [00:20:01] Speaker 00: combination. [00:20:02] Speaker 00: The number of combinations is usually used, is attacked when, you know, the only, if Amman was the only reference being used, and then you might say, okay, yes, there's too many listed here to meet the claim. [00:20:16] Speaker 00: But here you're talking about alka-salter, which specifically shows those ingredients. [00:20:23] Speaker 00: So I don't think the number of combinations is relevant. [00:20:27] Speaker 00: And the last point about [00:20:30] Speaker 00: the osmolality and one of ordinary skill in the art, being able to make a composition with the required osmolality. [00:20:41] Speaker 00: I mean, everyone agrees that a mom does teach that the desired osmolality meets the claim limitation. [00:20:48] Speaker 00: And then if we look at 597 to the inventor's declaration, [00:20:56] Speaker 00: When he says that someone with an undergraduate degree in chemistry would have experience in the measurement of osmolality, it certainly is within the scale of one of ordinary skill in the art that they would. [00:21:09] Speaker 03: How do you respond to your friend on the other side? [00:21:12] Speaker 03: The argument that he made is that even if it's easy to measure it, it's not easy to determine the appropriate value for use in the invention. [00:21:21] Speaker 00: There's simply no evidence on the record that it's complicated beyond what one of ordinary skill in the art would be able to do. [00:21:33] Speaker 03: Can you explain that further? [00:21:36] Speaker 03: You don't see a difference between measuring a value and determining the appropriate value? [00:21:43] Speaker 00: A mom teaches that [00:21:46] Speaker 00: One of ordinary skill in the art would know how to vary osmolality. [00:21:51] Speaker 00: Imam teaches that they made various solutions of test solutions. [00:21:56] Speaker 00: They talk about osmolality adjusting agents. [00:22:03] Speaker 00: So I think one of ordinary skill reading the Imam reference would be able to know how to adjust the osmolality to be in [00:22:11] Speaker 00: the claimed range because a mom clearly discloses that they want the osmolality to be in the same claimed range. [00:22:20] Speaker 03: Okay, go ahead. [00:22:21] Speaker 00: If there's no further questions, I'll see you the rest of my time. [00:22:26] Speaker 03: Okay, thank you. [00:22:38] Speaker 01: There's nothing important about 310 milliosmoles per kilogram. [00:22:43] Speaker 01: That's where respondents started. [00:22:47] Speaker 01: That's where you start killing cells. [00:22:49] Speaker 01: That's what's wrong with Listerine, with Scope, with every dentiferous out there that's prepared in solution form. [00:22:57] Speaker 01: That's right in the specification. [00:22:59] Speaker 01: You can't miss it. [00:23:00] Speaker 01: That's the whole point of the invention. [00:23:02] Speaker 01: You've got to keep that osmolality low. [00:23:06] Speaker 03: But doesn't Amman disclose [00:23:08] Speaker 03: Low osmolalities? [00:23:10] Speaker 01: Sure, without functional agents, Your Honor. [00:23:13] Speaker 01: The problem is if you include Tris, if you say Tris is included, you never get to SAC because the whole point of SAC is to prove that you can do without a physiological buffer in a vaccine. [00:23:30] Speaker 01: There's no Tris there. [00:23:32] Speaker 01: SAC used Alka-Seltzer just for that purpose. [00:23:36] Speaker 01: You never get there. [00:23:37] Speaker 01: If you cut Tris out, there's no example within that. [00:23:43] Speaker 01: But if you cut Tris out, how do you go about preparing the solution of Ammon that's going to be given orally? [00:23:52] Speaker 01: What makes it acceptable? [00:23:55] Speaker 01: Ammon's not looking for effervescence because it's topical. [00:24:00] Speaker 01: There's just no way to get there. [00:24:04] Speaker 01: If Tris is not included, then you're [00:24:08] Speaker 01: in a situation where the application of Alka-Seltzer is something taken out of the air. [00:24:15] Speaker 01: Tris is a buffer, Alka-Seltzer is buffer. [00:24:18] Speaker 01: That's the connection. [00:24:20] Speaker 01: That's what the board relied on. [00:24:22] Speaker 01: So if you take Tris out and you're just combining at will those 12 supplemental, there's a reason why they're called supplemental, those 12 supplemental buffers, how on earth are you going to reach out to Alka-Seltzer? [00:24:40] Speaker 01: Nobody, nobody disputes that if you do that, if for some reason you combine Alka-Seltzer with Ammon, you have too high an osmolality. [00:24:53] Speaker 01: That's record evidence. [00:24:56] Speaker 01: So what are you going to do? [00:24:58] Speaker 01: Dilute it. [00:24:59] Speaker 01: That's the board's answer, without evidence of record. [00:25:03] Speaker 01: Dilute it? [00:25:05] Speaker 01: Ammon goes through 96 times 5, a lot of tests. [00:25:11] Speaker 01: testing each of its formulations at five levels of dilution, because Ammon is concerned that on dilution, it loses potency. [00:25:21] Speaker 01: And sure enough, that's exactly what Ammon found, that even at a two-to-one dilution, potency dropped off. [00:25:28] Speaker 01: You're not going to freely dilute Ammon. [00:25:32] Speaker 01: What about Alka-Seltzer? [00:25:35] Speaker 01: Alka-Seltzer is an OTC medication, just like [00:25:39] Speaker 01: A cold medication, just like aspirin. [00:25:43] Speaker 01: And we all know that all of those containers come with the words, use as directed. [00:25:49] Speaker 01: Why? [00:25:50] Speaker 01: Because bad things happen if you don't use them as directed. [00:25:54] Speaker 01: If you dilute it, and you have to dilute alpha-sulphur a lot because it's got all those non-ionic species present in it in order to get to the osmolality of 310 or less. [00:26:08] Speaker 01: The bad result is pain. [00:26:10] Speaker 01: It's ineffective. [00:26:11] Speaker 03: Well, that's the same problem with that. [00:26:13] Speaker 03: But the problem is, is that Alka-Seltzer is attempting to accomplish something different from what your inventors attempting to accomplish. [00:26:21] Speaker 03: But that doesn't mean that with respect to the ability to assess the possible osmolality range for an oral composition, that diluting Alka-Seltzer, it wouldn't have been obvious. [00:26:34] Speaker 01: It would have been desired, Your Honor. [00:26:36] Speaker 01: if for some reason that would be possible. [00:26:39] Speaker 01: But I would refer you as the final answer to that question to phase 692 to 698. [00:26:47] Speaker 01: Alan Rao never said this was easy. [00:26:49] Speaker 01: He said it's easy to measure. [00:26:51] Speaker 01: One of ordinary skill in the arc, he said, would know how to measure the osmolality. [00:26:56] Speaker 01: But at paragraph 9 of his declaration, which should be at 695, [00:27:04] Speaker 01: He tells you how complicated it is. [00:27:07] Speaker 01: The fact that it can be less than or greater than one makes it very difficult, if not impossible, to empirically determine a given solution, osmolality. [00:27:20] Speaker 01: Had this been raised in the normal course of these seven years of prosecution this case went through, we'd have submitted the evidence from the USP that says, you can't do it. [00:27:32] Speaker 01: You've got to measure it anon. [00:27:35] Speaker 03: I see that in this later declaration, but what about what he submitted during prosecution? [00:27:42] Speaker 03: He said, there's nothing at all complex or involved in determining osmolality. [00:27:47] Speaker 03: You make the solution and measure it with a meter. [00:27:49] Speaker 03: You start with a given combination as taught and alter it slightly. [00:27:53] Speaker 03: Test and alter. [00:27:54] Speaker 03: Soon, a veritable forest of compositions meeting the osmolality requirement comprising citric acid and sodium bicarbonate as the ester-vessin couple will be established. [00:28:04] Speaker 01: the variable forest. [00:28:06] Speaker 01: You've determined it in reverse. [00:28:08] Speaker 01: You don't know what you're going to get. [00:28:10] Speaker 01: You assemble it. [00:28:14] Speaker 01: Add fillers, lubricants, and the other elements of the oral care solution like claim A or the functional agents of claim 12. [00:28:26] Speaker 01: And it's a problem, your honor. [00:28:28] Speaker 01: These osmolality calculations [00:28:32] Speaker 01: You can measure solutions to your drop, but simply because you can measure 1,000 solutions without undue skill or undue experimentation doesn't mean you're going to get the combination of 310 or lower and effectiveness. [00:28:52] Speaker 01: That's the combination that's lost. [00:28:56] Speaker 03: Thank you, Your Honor. [00:28:57] Speaker 03: The case will be submitted.