[00:00:02] Speaker 01: Before we get to our business this morning, our scheduled business, we have other important business. [00:00:11] Speaker 01: Admission to the bar of our law clerks. [00:00:17] Speaker 01: I am the movement for two of them. [00:00:20] Speaker 01: And so Kevin and Angela, would you stand, please? [00:00:27] Speaker 01: First, I move the admission of Kevin Richards [00:00:31] Speaker 01: who is a member of the Bar and is in good standing at the highest court of Virginia. [00:00:36] Speaker 01: I have knowledge of his credentials and am satisfied that he possesses the necessary qualifications. [00:00:46] Speaker 01: I also move the admission of Angela Silverins, who is a member of the Bar and is in good standing with the highest court of Utah. [00:00:55] Speaker 01: I have knowledge of her credentials and I'm satisfied that she possesses the necessary qualifications. [00:01:02] Speaker 01: These are the statements that are standard and that I'm obligated to make. [00:01:07] Speaker 01: I'm not obligated to point out as I'm about to that they are both outstanding people. [00:01:15] Speaker 01: They have worked for me for one or two years, greatly assisted in the performance of my work. [00:01:24] Speaker 01: They are very smart, and they are hardworking. [00:01:29] Speaker 01: The commission on my wall says that I, just like my colleagues' commissions, have wisdom, uprightness, and learning. [00:01:39] Speaker 01: But whatever learning I have has been enhanced by working with them. [00:01:44] Speaker 01: I have no doubt that they will be successful in the future. [00:01:48] Speaker 01: So I move their admission to WABAR. [00:01:51] Speaker 05: Wait, that's a tough act to follow. [00:01:54] Speaker 05: That was really lovely. [00:01:55] Speaker 05: I move the admission of my clerk, Jessica DeLalio, who is a member of the barn, is in good standing with the highest court of Massachusetts. [00:02:04] Speaker 05: I have knowledge of her credentials, and I'm satisfied she possesses the necessary qualifications. [00:02:10] Speaker 05: Well, baby Jessica is all grown up. [00:02:13] Speaker 05: She has been our baby clerk. [00:02:14] Speaker 05: We call her that because she's the youngest clerk I've ever had. [00:02:16] Speaker 05: She's also incredibly accomplished for such a young age. [00:02:20] Speaker 05: And what I like best about her is the maturity with which she holds herself out and carries herself, the uprightness, the forthrightness, the morality. [00:02:31] Speaker 05: She wears her faith on her sleeve all the time and uses it in the thoughtful way in which she approaches everything she does and all the people she interacts with. [00:02:42] Speaker 05: She has been a wonderful law clerk to me over the last year, and I have no doubt that she's going to go on to [00:02:49] Speaker 05: a great and successful career. [00:02:51] Speaker 05: Hopefully someday she'll stand here in front of us and argue, but I've just really thoroughly enjoyed having your company over the course of the last year and having your help and support on the cases that we've worked on together. [00:03:07] Speaker 05: So thank you for doing that for me. [00:03:09] Speaker 05: And I'm happy to move your admission. [00:03:12] Speaker 05: Jojo Malley, what do you think? [00:03:14] Speaker 05: You going to let these kids in? [00:03:17] Speaker 04: I am the deciding vote here because they are both conflicted out. [00:03:21] Speaker 04: So I think after much deliberation, I accept the proposition that all of these children, not so children anymore, are wonderfully accomplished and that they will be a welcome admission to this bar. [00:03:37] Speaker 01: Would you all approach the well and be prepared to take the oath from the circuit executive? [00:03:46] Speaker 03: To our scheduled business. [00:04:08] Speaker 01: We have five cases on the calendar this morning, two patent cases, one from the Patent Office and one from the District Court, two cases from the Court of Federal Claims, and a government employee case. [00:04:23] Speaker 01: One of the federal claims cases is being submitted in the briefs and will therefore not be argued. [00:04:30] Speaker 01: First case is Inray Steppen Company, 2016, 1811, Mr. Wimbiskas. [00:04:42] Speaker 06: Good morning, your honor. [00:04:43] Speaker 06: May it please the court, counsel? [00:04:45] Speaker 06: This case proceeds from a decision of the Patent Trial and Appeal Board, rejecting all the pending application claims for obviousness. [00:04:53] Speaker 06: The board's decision we submit demonstrates the risks of assessing the issue of obviousness untethered to the constraints imposed by KSR and the decisions of this court. [00:05:02] Speaker 06: I'm going to focus on three errors that are briefed in further detail. [00:05:07] Speaker 06: First, the board erred by [00:05:09] Speaker 06: because there is no showing of a reasonable expectation of success, or a motivation to select and combine from amongst an infinite number of surfactants disclosed in the PALS specification. [00:05:23] Speaker 06: And further, the only examples using the recited amine oxide were failures at a less stringent cloud point test. [00:05:30] Speaker 05: Second. [00:05:31] Speaker 05: Just out of curiosity, before you go on, let's just start with this point. [00:05:36] Speaker 05: Your claims are so strikingly broad themselves. [00:05:40] Speaker 05: So your complaint is that the prior art discussed it. [00:05:45] Speaker 05: I mean, it's like what you get. [00:05:46] Speaker 05: There's two of 22 in the one case. [00:05:48] Speaker 05: That's one out of 231 possibilities. [00:05:50] Speaker 05: So that's not infinite. [00:05:51] Speaker 05: But then I realized there's the third element. [00:05:54] Speaker 05: But you certainly, if I were looking at your defendant claims, which you don't separately argue, there are some that are shockingly narrow in the world of possibilities and the prior art quite broad. [00:06:04] Speaker 05: But you don't separately argue those. [00:06:06] Speaker 05: Your claim one is immensely broad with [00:06:09] Speaker 05: 10 to 60 percent weight of, I'm going to call it DA, because I don't think I can say it, whatever it is. [00:06:16] Speaker 05: And then 5 to 30 percent of the water soluble plizers. [00:06:21] Speaker 05: And then 30 to 75 percent of the amine oxides. [00:06:23] Speaker 05: I mean, you see these percentages are so broad. [00:06:27] Speaker 05: And there's an admission in the Schreifer that a lot of the combinations would not produce the cloud point at 70 degrees Celsius as necessary. [00:06:38] Speaker 05: You're complaining the priority is so broad with so many possibilities, but so is your claim, your claim one. [00:06:42] Speaker 05: So what do you think about that? [00:06:44] Speaker 06: Yeah. [00:06:45] Speaker 06: Well, the response to that, Your Honor, is Steppen is the first to discover that a specific 5.5 component combination can yield these exceptional results, including a cloud point above 70 degrees Celsius. [00:06:59] Speaker 01: But it looks magical about 70 degree cloud point. [00:07:04] Speaker 01: If you're talking about making a new compound, say, [00:07:08] Speaker 01: Maybe it works. [00:07:11] Speaker 01: Maybe it doesn't. [00:07:12] Speaker 01: But here, you've got this broad prior art, and you've got broad claim. [00:07:17] Speaker 01: And what's so magical about 70 degrees? [00:07:19] Speaker 06: Well, first of all, if I may, Stepan has demonstrated by specific working examples that it has invented and has identified the specific combination that does provide these results. [00:07:31] Speaker 06: That's not in palace. [00:07:32] Speaker 06: So it's a completely different situation. [00:07:34] Speaker 06: It's a different disclosure. [00:07:35] Speaker 06: And it's a more limited invention. [00:07:37] Speaker 05: Let's take the dependent claims. [00:07:39] Speaker 05: The dependent claims reflect that. [00:07:41] Speaker 05: Some of your dependent claims are quite narrow. [00:07:43] Speaker 05: But this independent claim seems quite broad. [00:07:46] Speaker 06: Well, we do argue, first of all, dependent claims 26 and 27, I believe, which are PAG and PEG related. [00:07:53] Speaker 06: So we do call those out separately. [00:07:55] Speaker 06: But my point is, with respect to the broad claim, Stepan does have examples, working examples of success where the prior art failed. [00:08:03] Speaker 06: Priorit doesn't have that support. [00:08:04] Speaker 04: I think that's where we need to focus, and that's what I think Judge Laurie's question was really trying to get at. [00:08:09] Speaker 04: What is the magic of the above 70 cloud point? [00:08:14] Speaker 04: It's clear that in Pallas that they were hoping for higher cloud points, but they kept failing with the mean oxide combination. [00:08:24] Speaker 04: So why is that final requirement that you call out so critical? [00:08:30] Speaker 06: Well, the final requirement in Steppen's claims is it's a five-component composition made up of dihoxylated alkylamine, a first cationic, a water-missable solubilizer, and then an amine oxide, a second cationic, in combination with water and over 39% glyphosate salt. [00:08:49] Speaker 06: So it's that specific combination that is the subject of what's said to be a broad claim of Steppen, but it's supported by working examples [00:08:57] Speaker 06: that you can achieve that superior cloud point. [00:08:59] Speaker 04: And that's why I think you're missing. [00:09:00] Speaker 06: Oh, and what is the benefit of the cloud point? [00:09:02] Speaker 04: Yes. [00:09:03] Speaker 04: Because if I'm just looking at Pallas, there's lots of different things you can put together. [00:09:09] Speaker 04: And so maybe I can put these things together. [00:09:12] Speaker 04: And apparently, from what you're saying, is you don't think Pallas would teach that there'd be a reasonable expectation of succeeding with the cloud point. [00:09:22] Speaker 04: So what's the magic of that cloud point? [00:09:25] Speaker 06: OK. [00:09:25] Speaker 06: So if I understand you right, and I'm sorry, Your Honor, Judge Romali, the benefit is in the processing and handling of this material. [00:09:33] Speaker 06: It's touched upon in the briefs. [00:09:34] Speaker 06: It's also touched upon in the specification. [00:09:36] Speaker 06: But when you're manufacturing this, it's made at a high temperature. [00:09:39] Speaker 06: And if you have to wait for it to cool before you can add the surfactant component, that's a significant hindrance in the processing. [00:09:45] Speaker 06: Right. [00:09:45] Speaker 04: I got that. [00:09:46] Speaker 04: I got high cloud point. [00:09:48] Speaker 04: I got why that's important. [00:09:50] Speaker 04: Why 60 versus 70? [00:09:52] Speaker 06: why is 60 versus 70. [00:09:54] Speaker 06: Steppen had achieved a higher cloud point than anything in the prior art with a specific combination. [00:10:00] Speaker 06: And 70 degrees was a point deemed to be very pertinent for the processing benefits. [00:10:06] Speaker 06: And so it was 70 degrees was supported by the working examples, and 70 degrees ended up in the claims. [00:10:11] Speaker 04: So as I understand it, Pallas never even got to the 60 degree using intermine oxide. [00:10:17] Speaker 04: Is that right? [00:10:17] Speaker 06: True. [00:10:17] Speaker 06: Pallas never got any success [00:10:19] Speaker 06: He only had failures in terms of testings with the mean oxides. [00:10:23] Speaker 01: But Pallas was a disclosure of 60 degrees. [00:10:27] Speaker 01: It was a very broad disclosure with a lot of possibilities, as Judge Moore pointed out. [00:10:32] Speaker 06: Right. [00:10:32] Speaker 06: It's an infinite number of possibilities, and that was one of the main points. [00:10:35] Speaker 01: So Pallas wasn't a failed disclosure. [00:10:38] Speaker 01: It was a broad disclosure with mixed results. [00:10:42] Speaker 06: Right. [00:10:42] Speaker 06: limited results but a failure with the mean oxide. [00:10:45] Speaker 01: But it's a teaching of whatever it discloses. [00:10:48] Speaker 06: It's a teaching for whatever it discloses and what it discloses is that we tested a mean oxide for cloud point at a lower 60 degree cloud point test with a less than the claimed amount of glyphosate and we failed. [00:10:59] Speaker 06: That's the teaching that comes out of Palace. [00:11:02] Speaker 06: It also teaches failures with water miscible solubilizers, that's the polyethylene glycol, squarely within the claims of the step and combination [00:11:12] Speaker 06: failure. [00:11:12] Speaker 06: So we have this infinite number of surfactants disclosed in this catalogue, 14 page catalogue of the surfactants of the PALIS specification. [00:11:23] Speaker 06: Categories A through V and then additional paragraphs added on and we went through some math and we said each one of these classes could be quadrillions of possible surfactants and it goes on and on and there's no teaching of any predictability in the art. [00:11:40] Speaker 06: PALIS not only [00:11:41] Speaker 06: Proves that point because he tests up and down you can go through pages and pages of failures in Palace and then we've done some of that we paid point in our brief that appendix 778 and 780 and you can page on from there and you'll see failure after failure mixed with summary summary success But now with the mean oxide and not with it with the step in combination Palace didn't even test the three component surfactant system claimed by Stefan and [00:12:07] Speaker 04: What's your response to the argument that this would just be routine optimization? [00:12:12] Speaker 06: Routine optimization requires a reasonable expectation of success. [00:12:17] Speaker 06: It's in the case law. [00:12:18] Speaker 06: And here, there is no reasonable expectation of success. [00:12:22] Speaker 06: And one thing that's glaring in this case is that the board mistakenly took excerpts from two portions of the record, combined them in an error, and thought and believed that Pallas [00:12:37] Speaker 06: example 127 had no failures with amine oxide. [00:12:43] Speaker 06: That was, that, that was glaringly wrong. [00:12:46] Speaker 06: It's not disputed that the board's reasoning was, was wrong. [00:12:49] Speaker 06: But, but as your point, to your point, your honor, set aside that glaring error in reasoning, you need to have a reasonable expectation of success to rely upon routine optimization. [00:12:59] Speaker 06: And here, the record screams there is no reasonable expectation. [00:13:04] Speaker 04: call out in your application, you say, well, this is really unexpected that we've been able to put these things together and achieve this. [00:13:11] Speaker 04: But you didn't put in actual evidence of unexpected results, did you? [00:13:15] Speaker 06: We didn't put in declaration evidence, but we have our own specification which provides the teachings of what it shows. [00:13:23] Speaker 06: But we don't have to go there. [00:13:24] Speaker 06: Once you establish a prima facie case of obviousness, [00:13:28] Speaker 06: And we submit that the PTO did not come close to that threshold. [00:13:32] Speaker 06: So we have no obligation or burden yet. [00:13:33] Speaker 06: We did come in in our brief, and we said in our view that there was still unexpected results. [00:13:39] Speaker 06: And we went through some portion of the briefing on that. [00:13:41] Speaker 06: But that's really a backstop argument, because we have no burden. [00:13:45] Speaker 06: The burden is on the PTO in the first instance to show a reasonable expectation of success if you're going to rely upon a routine optimization argument. [00:13:58] Speaker 06: And here, I think this case is very much like the Atsuka Pharmaceuticals case. [00:14:02] Speaker 06: We put it in our brief in there. [00:14:04] Speaker 06: The court noted that the prior art reference, the 2, 3-dichloropropoxy compound is one of hundreds of examples that may be useful for the application. [00:14:13] Speaker 06: May be useful, but the court went on to say that the reference fails to tie 2, 3-dichloropropoxy to any meaningful suggestion of antipsychotic activity, desired activity. [00:14:23] Speaker 06: And that's similar to this case. [00:14:25] Speaker 06: Because Pallas fails to tie amine oxide to any meaningful suggestion of success or any desired activity. [00:14:32] Speaker 06: You need to have that reasonable expectation of success. [00:14:35] Speaker 06: And I think Atsuka Pharmaceuticals is very much on point. [00:14:39] Speaker 06: Briefly, I'll address the fact that the PTO has looked at the specification and said, look, they have to deal with the fact that it had disposed of an infinite number of surfactants and an infinite number of combinations. [00:14:53] Speaker 06: And how can we pare that down and make three pairing arguments [00:14:56] Speaker 06: and each of them are unsupported, they first argue that this 14, that column's classifications, maybe it's a dozen pages, classifications A through V, well, those are just effective, not preferred by Pallas. [00:15:08] Speaker 06: But that's not accurate. [00:15:09] Speaker 06: Pallas describes them all as both effective and preferred. [00:15:13] Speaker 06: The PTO then points to paragraph 130 and says, let's look at this paragraph to the exclusion of everything else in Pallas, which is improper. [00:15:20] Speaker 06: You can't pick and choose. [00:15:21] Speaker 06: You need to look at the reference as a whole. [00:15:24] Speaker 06: But even if you look at that, they say, it's only two of the four classes in that paragraph 130. [00:15:29] Speaker 06: But as you know, that's improper. [00:15:31] Speaker 06: But we called out, if you're going to look at specifically listed excipients, there are 100 others throughout the case, throughout the palace reference, 100. [00:15:39] Speaker 06: And none of those are amine oxide. [00:15:41] Speaker 06: So it shows that you can't make these arguments. [00:15:44] Speaker 06: They're trying very hard to make this paired down list. [00:15:48] Speaker 06: And in the case, the palace doesn't support it, they next argue that, [00:15:53] Speaker 06: Well, we only need to pick two out of 22 classifications. [00:15:55] Speaker 06: But that argument fails because, as we pointed out, one classification can contain quadrillions of members. [00:16:02] Speaker 06: And you need to test. [00:16:04] Speaker 06: And that's key. [00:16:04] Speaker 06: Palace says, I need to test to see what works, because there's no predictability in this art. [00:16:09] Speaker 06: There is none. [00:16:10] Speaker 06: You need to test from these quadrillions of potential surfactants. [00:16:14] Speaker 06: So you can't simply rely upon classifications. [00:16:18] Speaker 06: And the argument also ignores that the claimant invention here is [00:16:22] Speaker 06: multiple classes of surfactants in combination with the water-missable solubilizer, so I can't just pick a class. [00:16:27] Speaker 01: You know what your problem is? [00:16:28] Speaker 01: Even though you've got a very broad piece of prior art, you've got a very broad claim. [00:16:34] Speaker 06: Well, our claim is supported, though, by the working examples. [00:16:38] Speaker 06: That's why I would beg to be the difference. [00:16:41] Speaker 06: The palace has broad claims, but I don't think they're supported. [00:16:45] Speaker 06: But certainly the teaching of the palace doesn't teach the breadth of our claims. [00:16:49] Speaker 06: It's still picking and choosing. [00:16:51] Speaker 06: Hitting or miss, trial and error, with no predictability in the art. [00:16:54] Speaker 06: And Palace not only says there's no predictability, it demonstrates it. [00:16:58] Speaker 06: He demonstrates it by the tests he's done, where he looked at 1,200 formulations. [00:17:04] Speaker 06: He found there's no predictability. [00:17:06] Speaker 01: Would you like to save your rebuttal time? [00:17:09] Speaker 01: Yes, Your Honor. [00:17:10] Speaker 06: Thank you very much. [00:17:15] Speaker 01: Mr. Helm. [00:17:18] Speaker 02: Thank you, Your Honor. [00:17:19] Speaker 02: I may please the court. [00:17:21] Speaker 02: I think the prior art, the palace reference in this case, just reflects the fact that this is an incredibly crowded art field. [00:17:27] Speaker 02: It has to do with a well-known herbicide, which is the Monsanto Roundup product, in combination with a known quality, the Cloudpoint. [00:17:36] Speaker 02: All of these issues were known, including a wide range of surfactants that could be used in compatibility with that glyphosate herbicide. [00:17:49] Speaker 04: I'm with you on motivation to combine. [00:17:52] Speaker 04: Reasonable expectation of success is a bit of a problem for me, though, because then you understand you can't conflate the two concepts. [00:17:58] Speaker 04: They have to both be addressed and analyzed. [00:18:01] Speaker 04: And there is this issue of the 70-degree cloud point. [00:18:05] Speaker 04: And in Pallas, they never even got to 60 degrees using the amine oxide. [00:18:11] Speaker 04: So where is it in the opinion that the board says that there's a reasonable [00:18:18] Speaker 04: expectation of succeeding to that cloud point by coming up with some of the combinations in Pallas, or using the combinations in Pallas. [00:18:28] Speaker 02: Well, what the board did was they found that it would be a matter of routine optimization to take the disclosure of Pallas and then subsequently identify the 70-degree cloud point ones. [00:18:39] Speaker 04: They said that. [00:18:40] Speaker 02: That's right. [00:18:41] Speaker 04: But there's two problems. [00:18:42] Speaker 04: One is what they said is, well, Severn didn't [00:18:47] Speaker 04: disprove that it would be routine optimization. [00:18:50] Speaker 04: That's putting the burden in the wrong place, right? [00:18:54] Speaker 02: Yes. [00:18:55] Speaker 02: If it was that alone, then yes, that would be putting the burden in the wrong place. [00:18:58] Speaker 04: So what did the board rely upon? [00:19:00] Speaker 04: Was there anything in the record about what one of skill in the art would have understood about how routine optimization with this combination could get you to someplace where palace failed every time? [00:19:14] Speaker 02: Sure. [00:19:15] Speaker 02: And so in the palace art, [00:19:17] Speaker 02: when they discuss the preferred surfactants that they use, this is an A754 paragraphs 130 and 131, what they say is that the suitable cationic surfactants can be determined by those skilled in the art by routine experimentation. [00:19:31] Speaker 04: So Pallas... Well, they say that, but they couldn't get there. [00:19:34] Speaker 02: Did Pallas fail? [00:19:36] Speaker 02: Excuse me, Your Honor. [00:19:37] Speaker 01: Did Pallas fail? [00:19:39] Speaker 02: No, I don't think Pallas failed at all. [00:19:40] Speaker 02: I think those two questions are related. [00:19:43] Speaker 02: So what Pallas did was they took an under... [00:19:47] Speaker 02: What Pallas illustrates is that routine experimentation does have some failures involved. [00:19:52] Speaker 02: But it also is a matter of routine experimentation to test a very large number of combinations. [00:19:58] Speaker 02: and then find the ones that actually do work. [00:20:01] Speaker 05: But isn't it correct that the board aired, in fact misquoted them on page A9, regarding Pallas and whether or not the example 127 includes amine oxide. [00:20:14] Speaker 05: That's a failure. [00:20:15] Speaker 05: That was one of the failures in Pallas. [00:20:18] Speaker 05: And the board said, well, this failure isn't relevant because it doesn't include amine oxide, but it clearly does, doesn't it? [00:20:24] Speaker 02: Your Honor, the board [00:20:26] Speaker 02: Did misquote here. [00:20:27] Speaker 02: This was an incorrect quote. [00:20:28] Speaker 05: Well, it misquoted and resulted in inaccurate fact-finding on their point. [00:20:32] Speaker 05: Because to the extent that they found that this failure didn't have the amine oxide and the thing I'll call DA, because I can't figure out how to pronounce it. [00:20:41] Speaker 02: Yes. [00:20:42] Speaker 02: Feel free. [00:20:42] Speaker 05: That was a mistake by the board. [00:20:44] Speaker 05: So to the extent that they were going down the road of no, when they were talking about reasonable expectation of success, and they were looking at failures in Pallas, [00:20:52] Speaker 05: And they said, well, this is a failure, but it's not relevant, because it doesn't contain the claimed elements. [00:20:57] Speaker 05: They were incorrect. [00:20:57] Speaker 05: Now, I know it doesn't have the water missable thingy. [00:21:00] Speaker 02: That's right. [00:21:01] Speaker 05: But it does have the other two key claim elements. [00:21:03] Speaker 05: So I feel like that was a pretty big factual error by the board, because in the course of figuring out reasonable expectation of success, where there are a lot of disclosed possible combinations, they disregarded this failure as irrelevant when it actually is probably the most relevant example in the entire disclosure. [00:21:22] Speaker 02: I don't know that I would agree that's necessarily the most relevant portion of the disclosure. [00:21:27] Speaker 05: But it's highly relevant to the reasonable expectation of success analysis. [00:21:29] Speaker 02: It could be relevant, for sure. [00:21:30] Speaker 02: But I will say that the disclosure as a whole identifies to say that you would be led away from using the, what you term as the DA, in the... How do you actually pronounce it? [00:21:46] Speaker 02: That's the dialkoxylated alkylamine. [00:21:48] Speaker 01: Is that the one? [00:21:49] Speaker 01: Let's try dialkoxylated alkylamines. [00:21:52] Speaker 02: Yes. [00:21:53] Speaker 02: That sounds good to me. [00:21:55] Speaker 02: That's why we keep them around. [00:21:58] Speaker 02: Yes. [00:21:58] Speaker 05: I will continue to refer to it as DA, because that didn't actually help. [00:22:03] Speaker 02: Very good. [00:22:03] Speaker 02: But when there's four categories of preferred surfactants listed, and one of them is the thing that we're worried about is the amine oxide, the fact that some of those don't work [00:22:16] Speaker 02: Frankly, that's to be expected, that some of them will not work. [00:22:20] Speaker 04: Of course, in fairness, Palace says everything's preferred, right? [00:22:24] Speaker 04: You keep saying they're preferred. [00:22:26] Speaker 04: They list these preferred elements. [00:22:27] Speaker 04: I don't think that's the case. [00:22:29] Speaker 04: But they pretty much say everything's preferred. [00:22:32] Speaker 02: Their position is that this long list is all preferred. [00:22:37] Speaker 02: And what Palace actually says on A740 and then onto A741 is that they say, we're going to tell you what [00:22:45] Speaker 02: the preferred surfactants are listed below, then they say cationic surfactants effective if they have this long laundry list. [00:22:54] Speaker 02: And then on A754, which is below, they say some preferred cationic surfactants. [00:22:59] Speaker 02: And so here in paragraph 130, A754, they tell you four categories of the preferred surfactants. [00:23:06] Speaker 02: And so I don't actually think that's right that there's whatever it is, 22 categories of preferred surfactants. [00:23:12] Speaker 02: I think it's actually a much smaller [00:23:14] Speaker 02: smaller group. [00:23:15] Speaker 05: But did the board ever cite that paragraph or quoted or mention it in its opinion? [00:23:18] Speaker 05: I mean, it's actually not a good point by you, but I feel like it's a point by you. [00:23:21] Speaker 02: Well, thank you, Your Honor. [00:23:22] Speaker 05: I feel like it's a point by the Solicitor's Office and not a point that actually was identified or informed in the board's decision. [00:23:29] Speaker 02: I'm not sure that the board actually cited that paragraph, but all they... Not quoted or mentioned it? [00:23:35] Speaker 02: No, but they did find that this [00:23:37] Speaker 02: They found that these were the preferred surfactants. [00:23:40] Speaker 02: I think this is completely consistent with that. [00:23:41] Speaker 04: I feel like we're just completely ignoring the fact that no matter how broad this claim is, at the end of the day, the claim has a very express requirement that you have to be above 70 degree cloud point. [00:23:56] Speaker 04: And there's nothing in palace that talks about that or shows any combination that achieves that. [00:24:04] Speaker 02: Well, the way that I've looked at it is that what [00:24:07] Speaker 02: Palace discloses is a range, which is 60 or above. [00:24:12] Speaker 02: And then they're claiming a subset of that range, which is 70 or above. [00:24:16] Speaker 02: And so in that situation, typically you have to show some sort of criticality to moving that modest change in temperature. [00:24:22] Speaker 05: Except the problem was in Palace, the one, the example, what is it, 127, I think. [00:24:27] Speaker 05: I have to look at my little screen if you're up. [00:24:29] Speaker 02: That's right. [00:24:29] Speaker 05: Where they had the amine oxide and the DA stuff at 60 degrees didn't work. [00:24:34] Speaker 05: Even at 60. [00:24:35] Speaker 05: At 60, that's what I'm saying. [00:24:37] Speaker 05: So what would be the incentive to use these exact same ingredients, I'll call them, and then try to get it to be... Make sure I understand this. [00:24:47] Speaker 05: I don't fully understand this cloud point thing. [00:24:49] Speaker 05: So cloud point has something to do with the separation of the chemicals, right? [00:24:55] Speaker 02: Yes. [00:24:56] Speaker 05: And so you want it to have a cloud point above 70 degrees because you're combining these ingredients and the composition is hot when you're doing it. [00:25:06] Speaker 05: And so you want it to have this cloud point that doesn't occur until you're at least this certain point because that will be a more efficient manufacturing process. [00:25:14] Speaker 05: You won't have to cool it down before making certain combinations. [00:25:19] Speaker 05: Does that sound right? [00:25:20] Speaker 02: I think that's generally right. [00:25:22] Speaker 02: I think just simply it is because [00:25:24] Speaker 02: You want something that's clear, not something that's cloudy. [00:25:27] Speaker 02: I think that's maybe another way to put it. [00:25:29] Speaker 02: And what Pallas says is you can get things that are clear, which Pallas equates to storage stability at up to 60 and above is what's desirable. [00:25:41] Speaker 02: This is what you should screen for. [00:25:42] Speaker 02: And then they go, and they have many, many. [00:25:44] Speaker 05: But see, that goes again to Judge O'Malley's point, which I tend to agree with, which is I'm not surprised people might try. [00:25:51] Speaker 05: You know, Palace creates an obvious to try or a motivation to try. [00:25:55] Speaker 00: Right. [00:25:56] Speaker 05: But it's the success that I'm also in the same boat as she is, I think, with her questions, that I'm just wondering why, when the failure occurred with this combination and you had a cloud, you had a failure, [00:26:11] Speaker 05: You couldn't get the cloud point to even work at a 60 degree level. [00:26:15] Speaker 05: What's the expectation of success with the same compositions? [00:26:18] Speaker 05: I mean, yeah, it says try lots of different things, but I don't know. [00:26:23] Speaker 01: What is the role of reasonable expectation of success here? [00:26:28] Speaker 01: We're not talking about combining two references where reasonable expectation of success is really important. [00:26:36] Speaker 01: We're talking about taking a reference and varying it and moving on [00:26:42] Speaker 01: to not a particular target. [00:26:45] Speaker 01: Prior Art didn't say 70 degrees is a special goal, and no one has obtained it before. [00:26:52] Speaker 01: So where does the concept of reasonable expectation of success come in, if at all, when you have one reference? [00:27:01] Speaker 02: I'm not sure that it really makes all that much of a difference in the context of this reference. [00:27:08] Speaker 01: But is it a sound test? [00:27:11] Speaker 02: whether it's reasonable expectation of success. [00:27:13] Speaker 02: Is that correct? [00:27:14] Speaker 01: Is that a sound test for whether it is obvious to take a broad disclosure and move around and try to improve it? [00:27:25] Speaker 02: I think it would be in a case. [00:27:27] Speaker 02: I do think that it's a case-specific situation. [00:27:31] Speaker 02: So for example, if this was a pharmaceutical case where you were looking for something that had biological activity, [00:27:39] Speaker 02: reasonable expectations of success might be paramount because you really have, because it's so uncertain. [00:27:46] Speaker 02: And the difficulty in the optimization is so high in those cases. [00:27:53] Speaker 02: But in this situation, we're not dealing, it is a chemical art, but we're not dealing with that type of instance. [00:27:59] Speaker 02: And here what we're all looking at, and I talked about earlier, was whether the solution is clear or not. [00:28:05] Speaker 02: It's a test that can literally be run in thousand-fold. [00:28:09] Speaker 02: in short periods of time. [00:28:12] Speaker 02: So screening, just as Pallas did, screening many, many different combinations is simply what people in the art, in this particular art, could and did do. [00:28:22] Speaker 02: Whether there were failures doesn't enter into the equation, I think, in this type of situation where, yes, there will be failures, but we can test thousands. [00:28:33] Speaker 02: And so we can tell you what the failures are so quickly that whether or not it's [00:28:37] Speaker 02: We have an expectation that any particular one will work. [00:28:40] Speaker 02: We can tell you which ones will work. [00:28:42] Speaker 02: Just let us run the test. [00:28:43] Speaker 04: I guess I'm just having a hard time on this fallback of routine optimization. [00:28:49] Speaker 04: Because theoretically, the board could cite to that any time. [00:28:53] Speaker 04: Or our district court could cite to that any time and say, end of the inquiry. [00:28:57] Speaker 04: So we never got to this one admitted element of the claim. [00:29:03] Speaker 04: But we could just say they would routinely do it. [00:29:07] Speaker 04: And I just feel like there needs to be something more concrete to point us to something in the record that says that one of skill in the art would have understood that routine optimization. [00:29:22] Speaker 02: I know, I've already pointed out to you and I know it's, I can see from your question that you're skeptical of it, but that the art does say that this is routine optimization. [00:29:32] Speaker 02: It says that in those words. [00:29:33] Speaker 02: that it's routine optimization to pick out these surfactants. [00:29:37] Speaker 05: I mean, I'm just speaking off the cuff, but maybe the test isn't quite right. [00:29:45] Speaker 05: I guess Judge, you reframed it as, do we need a reasonable expectation of success in this scenario? [00:29:49] Speaker 05: And you, I think, very reasonably pushed back and said, yes, there's probably still a role for it. [00:29:55] Speaker 05: I'm kind of putting words in your mouth a little bit, but that's sort of what you said, and you explained it. [00:30:00] Speaker 05: But maybe the real answer is, [00:30:02] Speaker 05: When the experimentation is so simple and so easy to do, the fact that the art might discourage you from certain combinations wouldn't discourage a reasonable artisan in this field from trying them. [00:30:17] Speaker 05: But we need the board to say that. [00:30:18] Speaker 05: That has to be a fact-finding, right? [00:30:21] Speaker 05: That has to be a statement of, in this art, people are doing, like Pallas did, over a thousand experiments. [00:30:28] Speaker 02: Right, exactly. [00:30:29] Speaker 05: yes and so if the board could come along in a fact-finding I mean it might actually really helpful law because maybe reasonable expectation of success you know when you have to seek FDA approval on something right the the number of hoops you have to jump through the expense the difficulty of performing the test would discourage people in certain situations in this situation your argument which is actually really resonating with me as [00:30:51] Speaker 05: a meaningful tweak on the law, probably ought to take into account, in a way that I don't think we have in our case law, what would a skilled artisan do? [00:31:03] Speaker 05: How much failure would they tolerate? [00:31:04] Speaker 05: How easy is the testing? [00:31:06] Speaker 05: How cheap is the testing? [00:31:07] Speaker 05: All of that sort of thing. [00:31:08] Speaker 02: That's right. [00:31:08] Speaker 02: And I think even more, and just to add one additional thing onto that, with what Pallas, the type of thing that Pallas disclosed, where they disclosed glyphosate [00:31:20] Speaker 02: combinations with surfactants that achieve the higher cloud point, identify the higher cloud point. [00:31:25] Speaker 02: It's not just, there's not a motivation combined in the sense that it's a single prior art reference, but it does show you that people skilled in the art were looking at that variable and trying to optimize that variable. [00:31:39] Speaker 01: Let me ask you a related question, Mr. Helm. [00:31:41] Speaker 01: This is a composition claim. [00:31:43] Speaker 01: A, B, C, and D. Yes. [00:31:46] Speaker 01: The cloud point is a result [00:31:48] Speaker 01: Yes, Your Honor. [00:31:49] Speaker 01: It's not a component. [00:31:52] Speaker 01: All the components are in the prior op. [00:31:55] Speaker 02: That is absolutely right. [00:31:57] Speaker 02: And so to practice the claims, they're very broad. [00:32:00] Speaker 02: And I think you observed during the initial questioning, they're very broad. [00:32:05] Speaker 02: And so there is this kind of part and parcel of to practice those claims, you'd have to undergo the same routine optimization or routine experimentation. [00:32:12] Speaker 01: And to the extent that this result is considered to be important, [00:32:17] Speaker 01: There's been no showing that 70 percent is really good and 60 percent isn't good. [00:32:24] Speaker 02: Yes. [00:32:25] Speaker 02: Yes, Your Honor. [00:32:25] Speaker 02: That's what's missing. [00:32:26] Speaker 01: But the composition of the components are in the fire art together. [00:32:31] Speaker 02: That's right. [00:32:32] Speaker 02: That's what's missing from the rapid evidence is that there might be help. [00:32:35] Speaker 04: That routine experimentation language that you talk about from the palace, did the board ever cite to that language? [00:32:41] Speaker 02: No. [00:32:41] Speaker 02: I think Judge Moore asked that same question, Your Honor. [00:32:43] Speaker 02: And they just, all they said was that this, they identified [00:32:47] Speaker 02: these as preferred, and I don't think they, and found that would be routine optimization, but I don't think they said specifically to that language. [00:32:54] Speaker 02: And one last point, if I may, if that's okay, that this is the type of case where secondary considerations, I think, would be especially probative. [00:33:03] Speaker 02: Because the art's so crowded, and because it seems like everything is there, secondary considerations could make a huge difference in a case like this, but there aren't any secondary considerations in this case. [00:33:13] Speaker 00: Thank you very much, Your Honor. [00:33:17] Speaker 00: A few minutes. [00:33:18] Speaker 06: Thank you, Your Honor. [00:33:20] Speaker 06: A little half a minute. [00:33:20] Speaker 06: I'll be brief. [00:33:21] Speaker 06: I want to point out a couple of things. [00:33:22] Speaker 06: First of all, counsel referred to, and the court referred to paragraph 70 regarding the beginning of these categories, A through U or V. At Appendix 740, it says, preferred cationic and anionic surfactants effective in formulating. [00:33:39] Speaker 06: And it goes on from there. [00:33:41] Speaker 06: All of that catalog listing, 22 classifications deals with [00:33:46] Speaker 06: preferred, so-called preferred cationics. [00:33:49] Speaker 06: So there should be no question there. [00:33:51] Speaker 06: Secondly, Steppen's examples. [00:33:55] Speaker 06: Steppen provided 27 working examples that tested CloudPoint containing amine oxide, using five different amine oxides, and all met the greater than 70-degree CloudPoint test. [00:34:05] Speaker 06: That's at appendix 42 and 43. [00:34:08] Speaker 06: Steppen supported its claims, and they're narrowly tailored in the respect of this five-component surfactant combination. [00:34:16] Speaker 06: I want to, I want to make a point because I don't think it's clear. [00:34:18] Speaker 06: I've been hearing a lot about routine optimization and, and I think there's a confusion here about what, it might be routine to test, but that does not equate with routine optimization under the case law. [00:34:29] Speaker 06: Routine optimization under the case law requires a reasonable expectation of success. [00:34:34] Speaker 06: There's no car about that that we've seen and that nothing's been cited that says in a one, one reference case, I don't need to worry about a reasonable expectation of success. [00:34:43] Speaker 06: I think the law requires that. [00:34:44] Speaker 06: Otherwise, you're picking and choosing. [00:34:46] Speaker 05: And the law also requires... Well, I don't know that your argument is fair. [00:34:52] Speaker 05: I didn't understand the PTO to suggest that you should do away with the reasonable expectation of success. [00:35:00] Speaker 05: I think that what you need to address is Mr. Helm's point, which I think is a very good one, which is in a field like this, where you can, like Alice Palace did, [00:35:09] Speaker 05: actually test 1,000 different samples in the span of minutes. [00:35:13] Speaker 06: That's not in the record. [00:35:15] Speaker 05: Well, it is in the record that Pallas tested 1,000. [00:35:17] Speaker 06: But there's no span of minutes that's been cited that I've seen. [00:35:21] Speaker 06: I think that came from counsel. [00:35:23] Speaker 05: I see. [00:35:23] Speaker 05: So maybe that's exactly what I want you to do, maybe not quite as defensively as you just did, but maybe argue to me and explain why, even though he might have a point which is resonating with me because it is, the idea that reasonable expectation of success [00:35:38] Speaker 05: So what, the PALAS has one example, example 127, which actually failed. [00:35:44] Speaker 05: When you have something, if you do have something, that's easy and cheap to test, and if the kind of people who would be doing these tests would routinely test thousands of samples at once at low cost, maybe they're not dissuaded by example 127 in PALAS. [00:35:58] Speaker 05: So maybe your argument then is, go ahead. [00:36:00] Speaker 06: Yeah, well, the argument is that you need to have a basis to select and combine from amongst the others. [00:36:05] Speaker 06: And if it's just the fact that I have- None of this is in the record. [00:36:08] Speaker 06: Yeah, well, they have nothing in the record to say it's a matter of minutes to test thousands. [00:36:12] Speaker 06: I haven't seen that. [00:36:14] Speaker 06: That's pure naked unsupported argument. [00:36:16] Speaker 05: Well, I think it's actually me. [00:36:18] Speaker 05: I don't think he said matter of minutes. [00:36:19] Speaker 05: I think he said something like quickly or easily or something. [00:36:21] Speaker 06: Well, that's also unsupported and not in the record. [00:36:23] Speaker 06: But what is in the record is that the tests with the mean oxide were failures. [00:36:28] Speaker 06: And so no one's going to go to start with what's failed. [00:36:31] Speaker 06: They're going to go start with something that worked. [00:36:33] Speaker 06: And you can't undercut that. [00:36:35] Speaker 06: that prima facie requirement of the law by saying, well, you could run many tests in a short amount of time, that would undercut obviousness, and anyone could. [00:36:44] Speaker 01: Do you have a final thought, counsel? [00:36:47] Speaker 06: Yes, your honor. [00:36:56] Speaker 06: I'll just close with this. [00:36:58] Speaker 06: There's a glaring misunderstanding by the board. [00:37:00] Speaker 06: The board's reasoning was facially incorrect, and that's not disputed. [00:37:03] Speaker 06: And the board's errors are replete, including the failure to show reasonable expectation of success. [00:37:10] Speaker 06: And we submit that the case should be reversed. [00:37:12] Speaker 06: Thank you very much. [00:37:13] Speaker 01: Thank you. [00:37:13] Speaker 01: We will take the case under advisement. [00:37:15] Speaker 06: Thank you.