[00:00:23] Speaker 04: I think we're ready. [00:00:28] Speaker 01: Help me out with the pronunciation of your name. [00:00:30] Speaker 01: Bruce. [00:00:31] Speaker 01: Good morning. [00:00:32] Speaker 01: Good morning. [00:00:32] Speaker 01: May I please the court? [00:00:35] Speaker 01: The main issue in this case is obviousness. [00:00:38] Speaker 01: There's a single independent claim that was presented as amended in the re-examination proceeding the appeal. [00:00:49] Speaker 01: and a single prior reference that's still in the record, which is Bowery 188. [00:00:55] Speaker 01: Byron's position is that the Patent Office has failed to make a strong prima facie case of obviousness showing, primarily on the basis that the single prior reference, Bowery 188, does not teach the combination of features defined in Claim 1 as amended. [00:01:15] Speaker 04: Well, it includes a reference to two key [00:01:19] Speaker 04: T-P-T-S. [00:01:21] Speaker 04: Right. [00:01:21] Speaker 04: It's a soluble by whatever agent. [00:01:24] Speaker 04: Right. [00:01:25] Speaker 04: It does. [00:01:25] Speaker 01: OK. [00:01:26] Speaker 04: So why is that not enough? [00:01:28] Speaker 01: Well, Viren's position is that the reference, the single prior art reference, has a very broad chemical formula that covers many thousands of different possible compounds. [00:01:41] Speaker 01: The reference repeatedly suggests PTS, a different solubilizing agent, as the main [00:01:49] Speaker 01: I would say lead solubilizing agent of the reference. [00:01:53] Speaker 04: But it also calls out that TPGS, right? [00:01:56] Speaker 01: And the only way that it calls it out is to exclude it. [00:01:59] Speaker 01: And Byron's position is that this cannot be a motivation to select it. [00:02:05] Speaker 01: And there's no other evidence in the record that suggests a basis for substantially modifying PTS, which is chemically different. [00:02:14] Speaker 03: But it's well known in the art that TPGS [00:02:19] Speaker 03: It eliminates turbicity. [00:02:22] Speaker 01: But there was no evidence of any motivation in the record. [00:02:27] Speaker 03: But that's what the invention is all about. [00:02:31] Speaker 03: You're trying to get a liquid to go from a state where it's misty or obscured to where it's clear. [00:02:40] Speaker 03: And this compound, TPGS, is known in the art to produce that effect. [00:02:47] Speaker 01: And like I said, even with this knowledge, there wasn't anything in the record suggesting to modify the Bowery 188 composition to significantly chemically change PTS to use TPGS instead. [00:03:05] Speaker 03: But we're the ones with skill in the art, look at this and say, well, I think I'm going to try TPGS and see what it does. [00:03:13] Speaker 01: Well, and there's other evidence in the art that suggests that TPGS, even by Bowery himself, was considered to be toxic. [00:03:22] Speaker 01: There's not a teaching away here, is there? [00:03:25] Speaker 01: You're not arguing that there was a teaching away. [00:03:28] Speaker 01: We're not saying that it's a teaching away, but we're saying the only reference to TPGS and the only prior reference is not to use it. [00:03:37] Speaker 04: Doesn't our case law, though, Bristol Myers and other cases, talk about [00:03:41] Speaker 04: The difference in degree is not enough. [00:03:44] Speaker 04: There has to be a difference in kind. [00:03:46] Speaker 04: And this seems to me your argument is that, OK, people didn't necessarily know exactly how well TBDS worked. [00:03:55] Speaker 04: But that's a difference in kind for something that existed and was known in the prior art. [00:04:00] Speaker 04: So how does that get you above the hurdle you need to get over? [00:04:04] Speaker 04: I'm sorry. [00:04:04] Speaker 04: How does that get you over the hurdle? [00:04:06] Speaker 01: Yeah, so I think that we provided [00:04:10] Speaker 01: a lengthy discussion of the case law in the briefs. [00:04:14] Speaker 01: I don't think that there is a bar to patentability based on unexpected results of the degree, where the degree is significant. [00:04:24] Speaker 01: And I think here, if you read the inventor's two declarations and you study the data that's presented in the two tables, you will find that the results are significantly different. [00:04:35] Speaker 01: in terms of the clarity of the results. [00:04:38] Speaker 04: Well, there's a problem with those declarations, is there not? [00:04:40] Speaker 04: Or at least the board thought there was a problem because they spoke to dilutions and not to concentrates, right? [00:04:45] Speaker 01: Well, and again, I think that our position as presented in the briefs is that I think the criticism is unfair. [00:04:53] Speaker 01: I think that you can look at the properties of a composition, for example, a drug composition that is administered to a human subject. [00:05:02] Speaker 01: and to evaluate the properties of that composition when administered. [00:05:07] Speaker 01: That would not be evidence to not be considered, just because it wasn't claimed that way. [00:05:12] Speaker 03: It's been in the body. [00:05:14] Speaker 03: You say that the difference in degree was significant, but the board found that it wasn't anything more than what could have been expected under routine experimentation. [00:05:25] Speaker 03: In that situation, the board looks to see if there's a difference in kind. [00:05:30] Speaker 01: And there was no difference in kind here. [00:05:33] Speaker 01: I think that the Patent Office's decision unfairly dismisses the substantial nature of the differences and the turbidity that was measured. [00:05:47] Speaker 03: And that's a question of substantial evidence. [00:05:50] Speaker 03: We review that for substantial evidence. [00:05:54] Speaker 01: Right. [00:05:54] Speaker 01: And I think that if you look at the declarations and the detail that the inventor provided, it's pretty clear that he went out of his way [00:06:03] Speaker 01: to explain all of the different steps that he took in testing the different compositions of the prior reference, how they were diluted, why that's a fair way to evaluate turbidity of the concentrates. [00:06:21] Speaker 02: Well, speaking of clarity, as I was going to say previously, speaking of the briefs, you argue at 33 [00:06:33] Speaker 02: that the clarity of the concentrate is directly proportional to the clarity of the dilution. [00:06:41] Speaker 02: And you say the law of dilution is like any other established scientific principle which judicial notice should be taken. [00:06:51] Speaker 02: You don't cite any evidence to support the proposition, or at least I couldn't find any in the record, that the clarity is directly proportional [00:07:02] Speaker 02: And of course, lawyer argument and speculation don't equate to evidence. [00:07:08] Speaker 01: Right. [00:07:08] Speaker 01: And here, I guess I would say, we're relying on the inventor, who is an expert in this field. [00:07:14] Speaker 01: He had, at the time of his declarations, more than a decade of experience as a career chemist. [00:07:21] Speaker 01: Multiple inventions in the field that are in patents. [00:07:25] Speaker 01: And I think he said some 30 patents and patent applications. [00:07:29] Speaker 01: We did cite to the Beer Lambert. [00:07:31] Speaker 01: law. [00:07:34] Speaker 01: I don't think, on the other hand, that the Patent Office has raised a technical basis to challenge the validity of the scientific approach used by the inventor. [00:07:46] Speaker 01: It seems to be, to Viren and to us, an unfair criticism of an inventor who went to great lengths. [00:07:54] Speaker 02: So are you conceding that we can't take judicial notice? [00:07:57] Speaker 01: No, no. [00:07:58] Speaker 02: But I think that a Well, one in the record suggests [00:08:02] Speaker 02: that the purported scientific principle of which you're asking us to take judicial notice is of universal notoriety or generally known within our jurisdiction such that judicial notice is appropriate. [00:08:16] Speaker 02: I'm quoting, of course. [00:08:17] Speaker 01: Right. [00:08:17] Speaker 01: I think it's fair to take judicial notice of the existence of the Beer-Lambert principle, which is a well-known principle. [00:08:28] Speaker 02: I don't think that was the question. [00:08:29] Speaker 02: The question was, what in the record [00:08:32] Speaker 01: I guess just the reference to Beer Lambert and that formula, which is a well-known formula. [00:08:44] Speaker 01: So I would say, as we have stated in the briefs, we don't find that there was a very strong case of obviousness to begin with. [00:08:53] Speaker 01: The only mention of TPGS is to exclude it. [00:08:56] Speaker 01: There's nothing else in the record. [00:08:58] Speaker 01: that the patent office combines with the single prior art reference to make a case of obviousness. [00:09:05] Speaker 01: Even with that weak case, the inventor went to great lengths to provide direct comparisons with the closest prior art PTS compositions. [00:09:17] Speaker 01: I think when you study the data that's provided in the tables, it's impressive. [00:09:23] Speaker 01: And the differences are significant. [00:09:25] Speaker 01: And as the inventor stated repeatedly in the declarations, unexpected. [00:09:30] Speaker 01: And I think the fact that an anonymous competitor attacked the patent is also something relevant. [00:09:41] Speaker 01: Competitors are eager to enter this field. [00:09:45] Speaker 01: This is a big business worldwide. [00:09:49] Speaker 01: And the ability to get these [00:09:53] Speaker 01: non-polar active ingredients into sports drinks and other beverages in a way that is acceptable to the consumer is a big invention. [00:10:18] Speaker 00: May I please report? [00:10:19] Speaker 00: I'd like to begin by addressing the prima facie case, and then I'll discuss the unexpected results evidence. [00:10:26] Speaker 00: So with respect to the prima facie case, the board properly found that the examiner had established a strong prima facie. [00:10:32] Speaker 03: So is this your view when we look at secondary considerations? [00:10:35] Speaker 03: We're looking at a two-step process that first you must establish a prima facie case, and only then do the secondary considerations come into play. [00:10:48] Speaker 00: Well, that's certainly what the examiner does. [00:10:50] Speaker 00: The examiner has to establish, has the requirement to establish a prima facie case. [00:10:55] Speaker 03: And then the... What's the government's position on that? [00:11:00] Speaker 00: What the government's position here is that the examiner did. [00:11:04] Speaker 03: No, not what happened in the case. [00:11:06] Speaker 03: What's your position with respect to that process? [00:11:11] Speaker 03: Do we look at a two-step process? [00:11:14] Speaker 03: I mean, secondary considerations only come into play if you establish you make a prima facie case of Augustus? [00:11:22] Speaker 00: That's the way it works before the examiner. [00:11:24] Speaker 00: The examiner first has to establish a prima facie case, and then the applicant can come back in with rebuttal evidence of secondary considerations. [00:11:32] Speaker 00: Of course, once it gets to the board, and the board is looking at all of it together, essentially as is this court. [00:11:38] Speaker 04: And no determination is made on the final conclusion of obviousness before you look at the secondary considerations. [00:11:45] Speaker 00: Correct. [00:11:47] Speaker 00: So if I may, I'd like to discuss the prima facie case. [00:11:50] Speaker 00: And I think that there is evidence of a strong prima facie case. [00:11:54] Speaker 00: And that is in Borowski, which the examiner cites to. [00:12:03] Speaker 00: The first finding by the examiner is that formula 4, which is depicted on 1520 of the record, encompasses TPGS. [00:12:14] Speaker 04: In fact, it's quite a... I'm sorry to interrupt. [00:12:17] Speaker 04: But yeah, but that fact by itself doesn't help you that much, right? [00:12:20] Speaker 04: I mean, how many agents are included in formula 4, like gazillions, right? [00:12:25] Speaker 00: Let me explain. [00:12:26] Speaker 00: If you look to 1520, it's actually quite a simple formula. [00:12:30] Speaker 00: It's a Y, an L, and a Z. [00:12:33] Speaker 00: Y is a hydrophilic region. [00:12:37] Speaker 00: L is the linker. [00:12:38] Speaker 00: Z is a hydrophobic region. [00:12:40] Speaker 00: And that's what allows it to bridge between the polar solvent, which is, of course, the hydrophilic region would mix with the solvent. [00:12:47] Speaker 00: And hydrophobic region would basically mix with the active ingredient and allow it to sort of encapsulate the active ingredient and mix and then dissolve into the solvent. [00:12:59] Speaker 00: What is depicted and described here in 1520 [00:13:03] Speaker 00: is they recommend as the hydrophobic moiety or component, tosopherol. [00:13:11] Speaker 00: They recommend for the hydrophilic region, PEG, polyethylene glycol. [00:13:18] Speaker 00: So in paragraph 74, they talk about tosopherol and recommend that as the hydrophobic. [00:13:24] Speaker 00: In paragraph 75, they talk about PEG as the hydrophilic. [00:13:29] Speaker 00: Those are the two components of both PTS [00:13:33] Speaker 00: and TPGS. [00:13:34] Speaker 00: So it's directing you basically to those two components. [00:13:38] Speaker 00: Then the next remaining part of it is the linker and if you go to the next paragraph, 76, it talks about basically any kind of length of carbon chain including C4 or C10. [00:13:51] Speaker 00: C4 being what is present in TPGS and C10 being what is present in PTS. [00:14:00] Speaker 00: So that [00:14:01] Speaker 00: is really giving you a roadmap and directing you to those surfactants. [00:14:06] Speaker 00: In addition, there is the alternative embodiment, which is at 146, which excludes or says where the surfactant is not TPTS. [00:14:18] Speaker 00: That strongly implies that in other embodiments, it would be TPTS. [00:14:23] Speaker 00: And moreover, the final finding by the examiner is [00:14:29] Speaker 00: And the examiner's answer in several places, but most notably, at 10, I believe it's at 1199 of the record, the examiner says that TPGS is a well-known, if not one of the most well-known, solubilizing agents. [00:14:46] Speaker 00: And it cites as evidence of that Eastman and the AP6 patent. [00:14:51] Speaker 00: And that has actually never been disputed by Viren, that it is a well-known, solubilizing agent. [00:14:57] Speaker 00: The combination of all that evidence, I would submit, is almost close to an anticipation case, but certainly a very, very strong obviousness case. [00:15:05] Speaker 03: When you respond to your opponent that points out that in Borowski and the 826 patent, that there's an expression of concern that TPGS is toxic. [00:15:17] Speaker 03: That certainly seemed to me to kind of get a person of skill in the art to not consider that, waste their time to consider that if the result's going to be toxic. [00:15:28] Speaker 00: Well, I'm not quite sure how they're trying to use that piece of information. [00:15:32] Speaker 00: It's not something that's taught in Borowski. [00:15:34] Speaker 00: And this is an obviousness rejection based on Borowski. [00:15:37] Speaker 00: And there's nothing in Borowski that teaches away from it. [00:15:40] Speaker 00: And even then, when you look at the 826 patent, the language is actually not really. [00:15:49] Speaker 03: Was there an actual argument before the examiner on teaching away? [00:15:53] Speaker 00: Only to the extent that they said that in paragraph 146, [00:15:58] Speaker 00: that paragraph 146, because it excludes TPGS, is somewhat of a teaching away. [00:16:04] Speaker 00: But no. [00:16:05] Speaker 03: But not on toxicity. [00:16:06] Speaker 00: Not on toxicity. [00:16:07] Speaker 00: That came up later. [00:16:09] Speaker 00: Now if I may, I'd like to turn to the unexpected results evidence. [00:16:13] Speaker 00: And with respect to that, the board made several findings, which I think were quite proper. [00:16:19] Speaker 00: First, the board found that the evidence was not commensurate with what is claimed. [00:16:24] Speaker 00: And that is because what is claimed is a composition comprising three different components in particular amounts. [00:16:32] Speaker 00: There is the surfactant, which is at 16% to 30%. [00:16:36] Speaker 00: There's a polar solvent that's in 60% to 79%. [00:16:40] Speaker 00: And then there's the active ingredient that is 5% to 10%. [00:16:44] Speaker 00: The unexpected results evidence was done with a different composition, where they actually added in eight times more [00:16:54] Speaker 00: water, which is a polar solvent. [00:16:57] Speaker 00: So in effect, what you have and what the secondary consideration evidence was with was a completely different composition that had different amounts, closer to 99.9% of a polar solvent and appreciably less of both the surfactant and the active ingredient, something less than 1%. [00:17:17] Speaker 00: So the board properly found that the unexpected results evidence was not [00:17:25] Speaker 00: But there was no nexus between that and between the claimed. [00:17:29] Speaker 00: And moreover, they did not provide any evidence to show that similar results would be achieved with the concentrated or what is claimed, the compositions that are claimed. [00:17:42] Speaker 00: Secondarily, the board found that even if they were to accept this and consider it to be there to be a nexus and accept the evidence, there was additional problems with it. [00:17:52] Speaker 00: And that is, as Judge Prost indicated, this was more [00:17:55] Speaker 00: evidence of a difference in degree of a known and expected property, everyone based on Borowski knew turbidity and clarity were properties, desirable properties, not a difference in kind of a new property. [00:18:08] Speaker 04: But our case law does kind of open the door. [00:18:11] Speaker 04: If it's enough of a difference in degree, then maybe it's enough. [00:18:15] Speaker 00: Right. [00:18:15] Speaker 00: It does kind of open the door. [00:18:17] Speaker 00: But I don't think this, again, is still that kind of a case. [00:18:20] Speaker 00: Because as the examiner found in the second advisory [00:18:25] Speaker 00: action. [00:18:26] Speaker 00: I'm sorry, the first advisory action, which was after the 623 of the record, and that's after the second declaration was brought in by Bromley. [00:18:40] Speaker 00: What the examiner noted was that the values, the kind of values that were submitted in this declaration, were not appreciably different. [00:18:51] Speaker 00: In fact, there were actually lower values obtained by Borowski [00:18:55] Speaker 00: in figure two with PTS. [00:18:58] Speaker 00: So to the extent that they're showing this spectacular supposedly results with TPGS as compared to PTS, he said Borowski actually achieves comparable values and notably also says that there are comparable both in the declaration evidence and in Borowski they're usually in comparable ratio of the active ingredient and the surfactant. [00:19:25] Speaker 00: In addition, I will point the court to the examiner's answer at where it reproduces part of Borowski. [00:19:40] Speaker 00: And that's paragraph 30 of Borowski. [00:19:43] Speaker 00: So that's 1179 of the examiner's answer. [00:19:46] Speaker 00: And it reproduces Borowski paragraph 30, wherein it just defines [00:19:55] Speaker 00: essentially clear to when the turbidity is not more than about 500% higher. [00:20:00] Speaker 00: Again, suggesting that the kinds of values and differences in values are not really that significant, and even perhaps both would fall within what's considered to be essentially clear. [00:20:14] Speaker 00: Finally, as the board found, this was all well within routine experimentation. [00:20:22] Speaker 00: And I want to address the Beer-Lambert law. [00:20:25] Speaker 00: which was only raised in the reply brief before this court. [00:20:30] Speaker 00: So first off, the issue with the Beer-Lambert law is that it was not before the examiner or the board. [00:20:35] Speaker 00: It's effectively an argument that was waived. [00:20:38] Speaker 00: But I will address it because I think it's important. [00:20:41] Speaker 00: If you look into any chemistry textbook, you'll find that Beer-Lambert might hold up at very low concentration ranges. [00:20:47] Speaker 00: But here we're talking about a concentrate. [00:20:51] Speaker 00: you have a more concentrated solution, Beer-Lambert sort of falls apart because there are intermolecular actions between the molecules. [00:20:59] Speaker 00: And here it's simply not useful in terms of comparing the concentrates then to the dilutions. [00:21:06] Speaker 00: And significantly also in the examiner's answer at 1178, this is not, and another reason why Beer-Lambert is not likely to be applicable here, [00:21:17] Speaker 00: This is a more complicated, it's not like a simple sugar solution. [00:21:20] Speaker 00: Here we're talking about a different kind of a solution where you're forming these micelles. [00:21:26] Speaker 00: And 1178 to 79 of the record, Borowski talks about the fact that, first of all, there's a critical micelle concentration. [00:21:37] Speaker 00: In other words, there's a particular concentration for each surfactant. [00:21:41] Speaker 00: And until you reach that concentration, you're not going to get micelle formation. [00:21:46] Speaker 00: Further, it talks about if the micelles are too big, you start to get turbidity problems. [00:21:52] Speaker 00: So obviously, one of skill and the art with this would know that there is a range of the solvent that you have to use where you're going to have enough surfactant to get micelle formation but not too high that you start to get aggregates or large types of micelles that would cause turbidity. [00:22:11] Speaker 00: And that was well within the skill of the art. [00:22:13] Speaker 00: And simply, Beer Lampert does not change that. [00:22:18] Speaker 00: So I think the board's findings were simply completely defensible that this was well within what one of the skills of the art would be able to obtain these values submitted in the declarations were [00:22:34] Speaker 00: the kind of results that one would expect from routine optimization. [00:22:38] Speaker 00: And in fact, that is kind of the problem with them taking one slice at a particular dilution. [00:22:43] Speaker 00: Obviously, for each surfactant, you would have to sort of modify the amount of solvent to achieve the optimum clarity and turbidity. [00:22:52] Speaker 00: And one of skill and the art would know that. [00:22:54] Speaker 00: And therefore, in light of the strong prima facie case of obviousness, [00:23:00] Speaker 00: The secondary consideration evidence simply is insignificant to outweigh that. [00:23:07] Speaker 00: And therefore, I ask that this court affirm the board. [00:23:17] Speaker 01: Just a few quick points to close it out. [00:23:20] Speaker 01: I continue to have trouble understanding how the Patent Office can say it's a very strong case of prima facie obviousness when the reference [00:23:29] Speaker 01: identifies only CBUS8 solubilizing agents when TPGS is a succinate. [00:23:36] Speaker 01: The only reference to TPGS is that it be excluded and that there's not a single working example in the only prior art reference of a composition including TPGS. [00:23:46] Speaker 01: It seems hard for me to understand. [00:23:51] Speaker 01: On the subject of criticism of TPGS, I mean, the very inventor of the only prior art reference of record [00:23:59] Speaker 01: specifically states that TPGS is taxic. [00:24:03] Speaker 03: You didn't make this argument before the board did you? [00:24:06] Speaker 03: Did you make this argument? [00:24:08] Speaker 03: Was this argument made before the board? [00:24:10] Speaker 03: The taxicity argument? [00:24:11] Speaker 01: I don't recall. [00:24:12] Speaker 01: I don't recall it was part of the re-examination. [00:24:14] Speaker 03: The government is saying you waived it. [00:24:15] Speaker 03: You don't recall. [00:24:16] Speaker 03: I don't see it in the record. [00:24:20] Speaker 03: Pardon? [00:24:21] Speaker 03: I don't see it in the record that this argument was made below. [00:24:25] Speaker 01: I know it's part of our briefs. [00:24:28] Speaker 03: It's too late to bring it in your brief if you didn't make the argument before the board. [00:24:33] Speaker 01: Well, I think 826 was part of the record from the beginning. [00:24:37] Speaker 01: So as I was saying, example 14 basically calls out TPGS as the only solubilizing agent in that reference that was considered toxic and to be looked at with caution. [00:24:50] Speaker 01: So hardly a motivation to change from the PTS [00:24:54] Speaker 01: solulizing agents are the only prior art reference in this record. [00:24:58] Speaker 01: On the comments that counsel for the patent office made criticizing Beer Lambert, this is the first time we've heard any comment about it at all. [00:25:09] Speaker 01: So I don't think it's fair to. [00:25:11] Speaker 04: Well, I think that didn't explain. [00:25:13] Speaker 04: It's because you raised it for the first time and you read the ivory. [00:25:16] Speaker 01: Well, but it wasn't part of the record. [00:25:18] Speaker 04: How are they to respond before you raised it? [00:25:24] Speaker 04: If you only raised it in your reply group, this is their only opportunity to respond. [00:25:27] Speaker 01: Well, some technical basis for a reference or something that criticizes the applicability of Beer Lambert, I think, would be more persuasive than just an attorney argument. [00:25:41] Speaker 01: So in closing, I guess I would just say, Viren's position is [00:25:45] Speaker 01: There's not a strong prima facie case of obviousness. [00:25:48] Speaker 01: It's, in fact, totally deficient. [00:25:52] Speaker 01: The evidence of unexpected results is compelling. [00:25:57] Speaker 01: The inventor went to great lengths to describe the testing that was done. [00:26:01] Speaker 01: He tried to show that the dilutions were made consistently and that this is a sound scientific basis for measuring turbidity. [00:26:13] Speaker 01: I think it would be a dangerous precedent in the field of chemical patents to say that evidence like this is not sufficient to show patentability. [00:26:23] Speaker 01: But on the question of whether you even need to get to it, I don't think there's really a prima facie case of obviousness to begin with. [00:26:30] Speaker 01: But even if there was, the evidence here is quite compelling. [00:26:34] Speaker 01: And I would say if you consider this kind of evidence in the context of other inventions, these are the kinds of things that should be found patentable. [00:26:42] Speaker 01: If the inventor here had found this specific combination provided a substantially more effective treatment of cancer or Alzheimer's or HIV, these are the things that should be patented. [00:26:58] Speaker 04: Thank you.