[00:00:02] Speaker 03: The United States Court of Appeals for the Federal Circuit is now open and in session. [00:00:07] Speaker 03: God save the United States and this honorable court. [00:00:12] Speaker 03: The first case for argument this morning is 191566, Clarice Therapeutics versus Lipocene. [00:00:20] Speaker 03: Ms. [00:00:21] Speaker 03: Borg-Green, whenever you're ready. [00:00:23] Speaker 02: Thank you, Your Honor. [00:00:24] Speaker 02: Good morning to all of you, Your Honors, and may it please the court. [00:00:28] Speaker 02: Clarence respectfully requests that this court reverse the board's ruling that the Clarence Common Specification lacks a written description of an embodiment of the account. [00:00:39] Speaker 02: We request this reversal because the board's decision is rooted in legal error and is unsupported by substantial evidence. [00:00:48] Speaker 02: Your Honors, we submit that in this case the facts are very straightforward. [00:00:52] Speaker 02: The board found and licensing did not contest in its appeal that the Clarence Common Specification [00:00:58] Speaker 02: in particular, Table 1, describes to a person of ordinary skill in the arts a composition including the specific drugs recited in the count, testosterone and decanoate, together with the specific lipophilic and hydrophilic surfactants of the count. [00:01:12] Speaker 02: So the only issue on appeal is whether the CLARIS common specification further sets forth a written description of the inclusion of one co-solvent, polyethylene glycol, while excluding another, ethanol. [00:01:25] Speaker 02: But in this case, Your Honor, the party's experts agree that a person of ordinary school in the arts reviewing the CLARIS Common Specification would understand that the inventor has contemplated that one or more co-solvents could optionally be included in the compositions of the invention, including those exemplified compositions in Table 1. [00:01:44] Speaker 02: Indeed... Excuse me. [00:01:48] Speaker 03: I'm going to interrupt for a moment. [00:01:50] Speaker 03: This is on the substantial evidence point. [00:01:52] Speaker 03: I mean, the board went through the specification carefully and just said, hey, look, there's too much picking and choosing going on here. [00:02:01] Speaker 03: And that seemed to have been confirmed by the Lipocene's expert, which the board credited. [00:02:09] Speaker 03: So how do you transcend that on a substantial evidence review? [00:02:14] Speaker 02: Your Honor, it's our view that Lipocene never made the argument, this expert never presented the argument [00:02:22] Speaker 02: before the board that a person of ordinary skill in the arts would find that the number of selections to be made among co-solvents was too numerous to permit the person of ordinary skill in the art from being able to understand the inventors had possession of an embodiment of account. [00:02:37] Speaker 02: While licensing did present a sort of blaze marks argument to the board, that argument was exclusively related to the selection of testosterone and decanoate as the drug. [00:02:47] Speaker 02: And that argument was considered and rejected by the board. [00:02:51] Speaker 02: With respect to the selection of the co-solvent, Leipzig's only argument was that a person of ordinary skill in the art, while recognizing that a co-solvent could be included and that there were only eight, would choose to prefer to include ethanol over polyethylene glycol. [00:03:07] Speaker 02: And it's our position that the evidence of which co-solvent a person of ordinary skill in the art would believe would be superior or would be more effective in the composition is not relevant to whether or not there's a written description. [00:03:21] Speaker 02: Because in this case, we have a clear statement from the inventors that co-solvents can be included. [00:03:27] Speaker 02: There's a clear recitation among the eight listed that polyethylene glycol and ethanol are alternative options for co-solvents to be included. [00:03:35] Speaker 02: And that by itself conveys to the person of ordinary skill in the art that the inventors included as part of their invention compositions such as the ones in table one, which could include any one or more of those optional co-solvents. [00:03:51] Speaker 00: Well, that may be, but your problem is that you have here a negative claim limitation. [00:03:58] Speaker 00: And while the written description may have been adequate for something that was not a negative claim limitation, here you have a negative claim limitation and there's nothing in the specification that tells you to avoid using alcohol, nor is there a description of a combination which excludes alcohol. [00:04:22] Speaker 02: So Your Honor, I have two points to respond to that. [00:04:24] Speaker 02: One is that the example compositions in table one all are without ethanol. [00:04:29] Speaker 02: So we submit that there are examples which exclude ethanol. [00:04:32] Speaker 02: But this court's precedent in the Sinteras and Infi cases expressly states that in order for there to be a written description of a negative claim limitation, there is no requirement that the specification provide [00:04:46] Speaker 02: some rationale for contraindication or reason to exclude one alternative embodiment in favor of another, that it's sufficient where the, in this case, eight co-solvents are described as alternative embodiments that can be included in the compositions of the invention, that that can alone provide the reason to exclude. [00:05:06] Speaker 02: And if we go back to the CCPA's earlier cases, there's a lot of discussion about cautioning against putting form over substance. [00:05:15] Speaker 00: It's not that... Well, the way I read the NC case, it at least requires that you have identified the specific combination that satisfies the negative claim limitation. [00:05:29] Speaker 00: And as I understand it, in Table 1 does not disclose the specific claim limitation. [00:05:35] Speaker 00: There may be items listed in there that exclude ethanol, but it's not the combination we're dealing with here. [00:05:44] Speaker 02: Well, in Table 1, we have the combination of the drug T-beu, together with the specific lipophilic and hydrophilic surfactant, in the absence of ethanol. [00:05:54] Speaker 02: And in the specification, the inventors state that co-solvents are optional. [00:05:59] Speaker 02: They're not required, but they can be included. [00:06:01] Speaker 02: And then there's a clear indication of eight different co-solvents that can be selected from. [00:06:06] Speaker 02: They're presented as alternative [00:06:09] Speaker 02: Dr. Elder and his deposition testimony as a glyphosate expert agreed that this language would mean that you could select only one to be included. [00:06:17] Speaker 02: And so in this type of situation where you have a small number of optional co-solvents that are given, we submit that that is sufficient to provide a written description of the composition of the count where you have three of the elements in the absence of ethanol already set forth by the inventors as their preferred combination. [00:06:38] Speaker 02: together with the clear statement that an additional co-solvent such as polyethylene glycol can be optionally included in that composition? [00:06:48] Speaker 03: What's your response to the argument that the specification expressly says that they can be used in combination? [00:06:57] Speaker 03: In other words, it doesn't say pick one of these co-solvents and exclude others. [00:07:01] Speaker 03: It says you can use them all in combination. [00:07:04] Speaker 02: Well, that's correct, Your Honor, that when the inventors identify the use of co-solvents, they indicate that you can use them individually or in combination. [00:07:14] Speaker 02: And so I think the fact that they permit combinations doesn't negate the fact that it's clear to a person of ordinary skill in the arts that the inventors were in possession of each one of those embodiments. [00:07:26] Speaker 02: And the fact that they've identified them as alternatives tells the person of ordinary skill in the arts that you can pick one or you could choose to pick more than one [00:07:34] Speaker 02: But each of those embodiments is something that the inventors were in possession of. [00:07:39] Speaker 02: And the fact that the inventors chose to claim the embodiment where they selected polyethylene glycol without including ethanol is within their choice because they had set forth a written description of all of them. [00:07:52] Speaker 02: And they're free to claim less than what they've described in their specifications. [00:07:57] Speaker 02: There shouldn't be a requirement that they set forth every single permutation of every combination in order to show that they have possession. [00:08:04] Speaker 03: The requirement that excluding one of those is a preferred method? [00:08:17] Speaker 02: I'm sorry, Your Honor, I just couldn't hear the question. [00:08:20] Speaker 03: No, there's nothing in the specification that says to exclude any one of those co-solvents. [00:08:25] Speaker 02: And that's correct, Your Honor. [00:08:26] Speaker 02: There's not an expressed statement that ethanol should be excluded. [00:08:30] Speaker 02: However, there is a statement in the specification that none of the co-solvents are required. [00:08:36] Speaker 02: There are examples which don't include ethanol, which would tell the person with ordinary skill in the arts that ethanol is not required. [00:08:42] Speaker 02: And then there's the affirmative statement that these compositions can optionally include any one of the eight listed co-solvents. [00:08:50] Speaker 02: And under this court's prior decision, [00:08:53] Speaker 02: We submit that that disclosure is sufficient to support a finding that there is a written description. [00:08:58] Speaker 03: What's your response to the argument that I know your opponent is going to make, which is that our prior case law actually says you have to disclose them as mutually exclusive co-solvents in order for the mere reference to them to be enough. [00:09:19] Speaker 02: Well, Your Honor, I read those cases differently. [00:09:21] Speaker 02: When I look at the Santeros case, in that specification, there was a disclosure of three alternative antacids, but in the claims, they claimed two and excluded a third. [00:09:31] Speaker 02: So, that's not mutual exclusivity. [00:09:34] Speaker 02: That's them affirmatively claiming two in combination while excluding a third. [00:09:39] Speaker 02: And similarly, in the ENTI decision, [00:09:42] Speaker 02: In that case it was clear in the specification and the court cited this in its opinion that there were embodiments which described circuits that received two chip select signals. [00:09:53] Speaker 02: So while the court there wanted to confirm that these different chip select signals could be used in the alternative, the fact that it also disclosed that they could be used in combination didn't defeat support for the negative claim limitation. [00:10:11] Speaker 02: So I read those cases differently. [00:10:13] Speaker 02: There's no discussion of mutual exclusivity, and indeed the facts support that in those cases, the alternatives that were disclosed were not mutually exclusive. [00:10:30] Speaker 02: I think that the CCPA's prior cases are also instructive in this regard. [00:10:35] Speaker 02: If we turn our attention to the Smith v. Essel case, [00:10:39] Speaker 02: In that instance, it's similar in that there's a small number of options for the laser ion. [00:10:44] Speaker 02: There's also a list of different options for the laser matrix material. [00:10:50] Speaker 02: In that case, the argument was made that there were too many combinations and that it was impossible to envision that the inventors had possession of what they were claiming. [00:10:59] Speaker 02: But in that case, the CCPA held that when you disclose only 14 options, [00:11:05] Speaker 02: that a person of ordinary skill in the art can readily envision that any one of those options can be used. [00:11:11] Speaker 00: Well, your problem with that is that you might well be correct if there were no negative claim limitation here. [00:11:21] Speaker 00: But the problem is there is a negative claim limitation and something more is required than merely the disclosure of the possibility of a particular combination. [00:11:34] Speaker 02: Well, Your Honor, just two points there. [00:11:36] Speaker 02: In the Snitzer case, actually, that claim was directed to a consisting, essentially, of style of claim. [00:11:42] Speaker 02: And so by structure, it actually did exclude certain embodiments. [00:11:46] Speaker 02: And to the extent that those claims would have included a combination of another laser ion, I submit that that would have materially affected the basic and novel properties. [00:11:56] Speaker 02: So there is an element of a negative claim limitation in the Snitzer case. [00:12:01] Speaker 02: But I also would direct your attention to the court's discussion in Inchi where the court emphasizes that there is no requirement that you provide some reason to exclude. [00:12:12] Speaker 02: There's no requirement that there be evidence of contraindication of the excluded element. [00:12:18] Speaker 02: All that's required is that you positively set forth the alternative embodiment and then you can claim one and exclude the other. [00:12:26] Speaker 02: And that's exactly what the inventors did in this case. [00:12:29] Speaker 02: I see that I'm out of time. [00:12:32] Speaker 03: Yes. [00:12:32] Speaker 03: We'll reserve your rebuttal time and let's hear from the other side. [00:12:37] Speaker 02: Thank you, Your Honor. [00:12:38] Speaker 03: Thank you. [00:12:41] Speaker 03: Ms. [00:12:41] Speaker 03: Fiorella, are you with us? [00:12:44] Speaker 01: I am, Your Honor. [00:12:46] Speaker 03: Good morning. [00:12:47] Speaker 01: Good morning, Your Honor. [00:12:50] Speaker 01: Thank you. [00:12:50] Speaker 01: Good morning, Your Honor. [00:12:51] Speaker 01: It's Natika Fiorella on behalf of the appellee you like to be in state police, the court. [00:12:56] Speaker 01: Your Honors, there are two distinct but related reasons that the Board's decision should be affirmed. [00:13:02] Speaker 01: The first is because substantial evidence supports the Board's finding that a skilled artisan would have to do too much picking and choosing from the specification to get to the composition that's embodied in the interference count. [00:13:17] Speaker 01: The second reason, Your Honors, is because CLARIS simply failed to show [00:13:21] Speaker 01: that just by listing a class of possible ingredients as options, that that alone is enough to require, under the law, a finding of written description for a composition that expressly includes one of those options, here PEG, and expressly excludes another, here ethanol. [00:13:43] Speaker 01: I'll begin with the first task to affirmance, Your Honors. [00:13:49] Speaker 03: the arguments that you waived that because you never made that argument to the board that your argument about picking and choosing only related to the TU? [00:13:59] Speaker 01: Certainly, Your Honor. [00:14:00] Speaker 01: With that, I would say that there really can't be any waiver here because the board itself based its decision here on the fact that there were too many selections to be made. [00:14:12] Speaker 01: Now that's at A21 and at A31. [00:14:17] Speaker 01: The concept of waiver assumes that the board wasn't able to consider an argument in the first place, that we didn't make an argument to the board so they couldn't consider it. [00:14:27] Speaker 01: That's clearly not the case here, because the rationale of the board was, in fact, that there were too many selections. [00:14:34] Speaker 01: But even beyond that, Your Honor, we then repeatedly make arguments that are listed in our red brief at 22 to 23 before the board. [00:14:43] Speaker 01: And I can point, Your Honor, to the pages in the record [00:14:47] Speaker 01: that show each one of those arguments. [00:14:50] Speaker 00: So for example... Where in the court, in the board's opinion, does it address this first argument, the blaze marks argument, if we can call it that, as opposed to the negative claim limitation argument? [00:15:05] Speaker 01: Your Honor, I would point you to A21. [00:15:08] Speaker 00: Where? [00:15:10] Speaker 01: In A21, the board specifically says [00:15:15] Speaker 01: While there is testimonial evidence on both sides of the issue, on balance, given the selections needed to be made within the 646 application, types of testosterone esters, presence and absence of ethanol, type of co-solvent, we are not persuaded that Clarice was established for purposes of Clarice motions two and three, entitlement to priority benefit by demonstrating an anticipatory embodiment. [00:15:43] Speaker 00: Okay, but that's a conclusion. [00:15:46] Speaker 00: addressing specifically the blazemarks argument as opposed to the negative claim limitation argument? [00:15:53] Speaker 01: Your Honor, I would say that the board's opinion starts by looking at whether or not you would pick TU. [00:15:59] Speaker 01: It does find enough blazemarks to direct a skilled artisan at least to TU. [00:16:05] Speaker 01: But what this conclusion tells us is that the board then looked to what other selections needed to be made. [00:16:12] Speaker 01: One of those questions is what type of co-solvent. [00:16:15] Speaker 00: Have you got anything better than this language on 21? [00:16:20] Speaker 01: I would say that the language on page 31 also supports this idea that there was simply too much picking and choosing that needed to be done. [00:16:28] Speaker 01: And that's when the board is addressing Dr. Imigi's testimony and says that his testimony expects one of still in the arts to choose various combinations and prescriptions. [00:16:41] Speaker 01: to come up with the subject matter of the count, which is insufficient to establish a constructive reduction to practice of the subject matter of the count. [00:16:50] Speaker 01: So again, Your Honor, I would say that what the board is saying here is there are simply too many decisions to be made, and there are not enough dipos, and there's not enough in the specification itself to tell a skilled artisan that, yes, this is what the inventor has invented. [00:17:07] Speaker 01: Instead, a skilled artisan would need to go and [00:17:10] Speaker 01: try and figure out what they could make or what they could arrive at based on the teaching. [00:17:15] Speaker 01: And that's more of obviousness, not of written description. [00:17:19] Speaker 01: So both of those conclusions of the board suggest that the board understood that part of the issue here is, are there disclosures in the specification that would guide a skilled artisan to make all the decisions necessary to arrive at the count? [00:17:35] Speaker 03: And again, we need to consider the only [00:17:38] Speaker 03: decisions were which co-solvents to include and which to exclude. [00:17:45] Speaker 03: In other words, the chief was disclosed. [00:17:51] Speaker 01: Yes, Your Honor. [00:17:51] Speaker 01: The board did eventually find that there were enough blaze marks to direct a field artisan to select PU. [00:17:59] Speaker 01: But I would not say that that means that the only decision that needs to be made is whether one would include PEG and exclude ethanol. [00:18:07] Speaker 01: Instead, that's, I guess I would say using the analogy just because a split artisan would have enough blazemarks to get them somewhere into the middle of the forest doesn't mean that you can just ignore the fact that they have to follow blazemarks to get there in the first place. [00:18:23] Speaker 01: And to get out of the forest or get to the specific tree in the forest, you need more and more blazemarks than at some point [00:18:30] Speaker 01: what the board seems to recognize is it just becomes too much. [00:18:34] Speaker 01: So what I would say is you still need to consider the fact that there is not one single embodiment that expressly says use TU, then add something, even though the specification actually teaches that with this invention, you don't need to add any kind of solvent. [00:18:50] Speaker 01: So, okay, then you have to add something. [00:18:52] Speaker 01: Then you take a co-solvent instead of a digestible oil, which is also disclosed, 21 of them, [00:18:59] Speaker 01: And the examples actually at least include an example of an oil, never a co-solvent. [00:19:04] Speaker 01: But okay, then you have to pick a specific co-solvent. [00:19:08] Speaker 01: And then when you get to the co-solvent, the only description in the specification is one paragraph that says eight of these can be optionally included alone or in combination. [00:19:20] Speaker 01: And there's no teaching as to why one would or that one would pick PEG [00:19:27] Speaker 01: But importantly, that you would pick one of the listed eight and then based on the exact same teaching that says you can use ethanol too, expressly exclude ethanol. [00:19:37] Speaker 01: So to get back to your question, Your Honor, certainly one of the decisions that needs to be made is do you take PEG from that list and expressly exclude ethanol. [00:19:47] Speaker 01: But I would say that before you get to that point and starting at that point, ignore the fact that a skilled artist would have to make a number of decisions before they got to that point. [00:19:56] Speaker 01: And again, I'm happy to point out in the record where we need each of the arguments that I just reiterated about why one would pick you, why one would not understand to pick to you, why one would not understand to add any kind of solvent and so forth, which I'm happy to provide right now if Your Honor would like. [00:20:24] Speaker 03: I think we've got the record. [00:20:26] Speaker 03: But what's, so what is your, what do you think the law requires before you can support the negative limitation? [00:20:36] Speaker 01: Your Honor, I would say that NC does require providing a reason to exclude. [00:20:42] Speaker 01: It just found that in NC you didn't need to specifically say one is better than the other, which is what happened in Centaurus. [00:20:50] Speaker 01: So there is still a requirement to find a reason to exclude the negative limitation. [00:20:55] Speaker 01: In INPE, that was found because the specification repeatedly treated the different DDR signals as alternatives, not options, not that one would understand you could pick both or you should pick both. [00:21:08] Speaker 01: And in fact, there were tables that identified and distinguished between the different signals, suggesting again to the skilled artists that they would understand to pick one. [00:21:19] Speaker 01: So the INPE court found that that was enough in affirming the board. [00:21:22] Speaker 01: They found that that was enough [00:21:25] Speaker 01: to find written description support and a reason to exclude. [00:21:30] Speaker 00: So I would say... Suppose we were to read NFE as requiring only that there be a specific disclosure of a particular combination rather than leaving the skilled artisan to make choices. [00:21:50] Speaker 00: Would that [00:21:51] Speaker 00: standard be satisfied here? [00:21:53] Speaker 00: Does this specification disclose the particular combination excluding alcohol that we're talking about? [00:22:02] Speaker 01: No, Your Honor. [00:22:03] Speaker 01: I would say that it does not. [00:22:05] Speaker 01: As the board found, there is not a single embodiment or a single example that includes each one of the claimed limitations. [00:22:14] Speaker 01: My colleague on the other side points to table one. [00:22:18] Speaker 01: The table one does not include PEG. [00:22:21] Speaker 01: So based on the argument that, well, just because it doesn't expressly list ethanol, that means a skilled artisan would understand you don't add ethanol. [00:22:31] Speaker 01: Well, that logic follows for PEG, too. [00:22:33] Speaker 01: If it doesn't show any PEG, a skilled artisan doesn't understand that the table or the 48 formulations in that table also include PEG. [00:22:43] Speaker 01: So to the extent NPSA, you do need to actually show [00:22:48] Speaker 01: an example or any disclosure of the limitations together, I would say that that standard is certainly not satisfied with the specification. [00:23:02] Speaker 01: Your Honor, I'd also like to talk a little bit about SNPSR. [00:23:06] Speaker 01: That has been a focus of the brief and was also brought up here at argument [00:23:11] Speaker 01: And I would just like to reiterate that that case is also different. [00:23:16] Speaker 01: As Dr. Scheck, I believe that you mentioned, it's certainly different because there is no negative limitation in that case. [00:23:23] Speaker 01: And more importantly, there's no mutual exclusivity. [00:23:27] Speaker 01: So there is not saying, and sister, here is a glass laser. [00:23:32] Speaker 01: Now you need to pick an ion that activates it of this 14. [00:23:37] Speaker 01: But you also need to expressly not pick another one of those 14 ions. [00:23:42] Speaker 01: So right off the bat, I think that that makes this case different. [00:23:46] Speaker 01: But beyond that, coming back to kind of the pick and choose argument, the invention in SISTER was a laser ion that activated the laser. [00:23:56] Speaker 01: So you had to pick. [00:23:58] Speaker 01: It's good that I've been reading it, would know that they had to pick one of those 14. [00:24:03] Speaker 01: And there was a line in the opinion that basically said the specifications [00:24:09] Speaker 01: suggested or emphasized that one of skill of yours would just pick one of those 14 even though it said the in combination language. [00:24:16] Speaker 01: Here we don't have either of those situations. [00:24:19] Speaker 01: The specification in fact tells you you don't need to pick any solvent. [00:24:23] Speaker 01: One of the good things about this invention, the specification says, is that it can solubilize the PU or the testosterone ester because of the drug delivery system and you don't need to add anything else. [00:24:36] Speaker 01: But fine, if you are going to add something else, then again, there's levels of decision-making that need to be done. [00:24:41] Speaker 01: And that simply wasn't the issue in sister, because the skilled artist knew you had to pick one. [00:24:46] Speaker 01: And I do think that that makes a difference, because again, these are very factually intense inquiries. [00:24:52] Speaker 01: And they're very dependent on exactly what the specification says and exactly what the claim requires. [00:24:58] Speaker 01: And particularly here on a substantial evidence standard, where the board did look through the specification [00:25:05] Speaker 01: did comment on the expert testimony and ultimately found that substantial evidence did not, that there was evidence in the record that suggested a skilled artist who would not understand the claimed composition to be disclosed is fully supported by the points and the passages of the board site. [00:25:32] Speaker 01: Finally, Your Honors, I'd just like to take [00:25:35] Speaker 01: a few minutes to discuss the remand versus reversal. [00:25:40] Speaker 01: If this court should side with Claris and find written description support, this case should still be remanded back to the board to determine priority. [00:25:49] Speaker 01: We've discussed in the red brief why that is. [00:25:51] Speaker 01: I'm happy to answer any questions on that. [00:25:54] Speaker 01: But in a nutshell, we presented evidence that we needed to present to get before the date that the board afforded Claris. [00:26:02] Speaker 01: We specifically said, and the board specifically found, that we showed no later than October 2005. [00:26:10] Speaker 01: We had created a composition that met all of the limitations. [00:26:15] Speaker 01: But in our priority statement, we actually preserved an earlier date. [00:26:20] Speaker 01: So at its very minimum, the case should be remanded for the board to hear that in the first instance. [00:26:27] Speaker 01: And I'd just like to address Clarissa's suggestion [00:26:30] Speaker 01: that this court should affirm the board's other ruling. [00:26:34] Speaker 01: We disagree with that. [00:26:36] Speaker 01: The board's other rulings have not been fully briefed here. [00:26:40] Speaker 01: Clerics lost on its motion to accord benefits, and it appealed on that basis. [00:26:46] Speaker 01: We believe, as we've explained, that the board was correct in its decision on those motions, so we defended that ruling. [00:26:53] Speaker 01: And because we wanted the board, we didn't need to defend any other ruling. [00:26:57] Speaker 01: But should this court [00:26:59] Speaker 01: decide that the board was wrong on that point, remained as appropriate, and the court should not affirm on other grounds that have not been fully briefed here. [00:27:10] Speaker 03: Thank you very much, Counsel. [00:27:13] Speaker 03: Thank you. [00:27:20] Speaker 03: Ms. [00:27:20] Speaker 03: Borg-Breen, you have three minutes remaining for rebuttal. [00:27:25] Speaker 02: Thank you, Your Honor. [00:27:26] Speaker 02: I'd like to first address counsel for Lipstein's argument that they didn't waive the argument that there was too much picking and choosing. [00:27:33] Speaker 02: The fact that the board references some discussion about picking and choosing doesn't mean that Lipstein presented that argument to the board. [00:27:41] Speaker 02: And in fact, when you look at the evidence that is in this record, [00:27:46] Speaker 02: there is nowhere that Liposine or its expert Dr. Elder ever took the position or offered the opinion that a person of ordinary skill in the art would believe that there was too much picking and choosing to select polyethylene glycol and exclude ethanol. [00:28:02] Speaker 02: There's never any blaze marks argument presented by Liposine or Dr. Elder. [00:28:07] Speaker 02: There's never any discussion [00:28:09] Speaker 02: that a person of ordinary skill in the art would find there to be too much thinking and choosing. [00:28:13] Speaker 02: And we know from this court's decisions that we must look at written description as a question of fact from the perspective of a person of ordinary skill in the art. [00:28:21] Speaker 02: And the board is not permitted to substitute their own judgment in favor of, in lieu of what a person of ordinary skill in the art would think. [00:28:28] Speaker 02: In this record, the only evidence of what a person of ordinary skill in the art would think about the selection of co-solvents comes from Dr. Oniji. [00:28:35] Speaker 02: who offered his opinion that a person of ordinary skill in the art would readily understand that any one of those co-solvents could be included to the exclusions of others. [00:28:44] Speaker 02: So we submit that Leipzig did waive this argument before the board because they never presented any evidence to support it. [00:28:52] Speaker 02: And moreover, to the extent that the board's decision is based on some, you know, some evidence of too much picking and choosing, [00:28:59] Speaker 02: there is no evidence, there is no substantial evidence to support that opinion because that evidence was simply never part of the record. [00:29:08] Speaker 02: Similarly, the argument about no blaze marks was never made, so that can't be part of the record. [00:29:14] Speaker 02: There cannot be substantial evidence to support that. [00:29:17] Speaker 02: I also want to point out that in the ENFEDE decision, this course clearly says that they hold that Santa Rita did not create a heightened written description standard for negative claim limitations. [00:29:28] Speaker 02: and their properly described alternative features are sufficient to satisfy the written description standard of section 112 paragraph 1 for negative claim limitations. [00:29:37] Speaker 02: And so, we submit that based on that statement of the holding and the infee case, that the record in CLARIS' common specification [00:29:46] Speaker 02: is sufficient to provide a written description of the claimed polyethylene glycol in the exclusion of ethanol. [00:29:54] Speaker 02: There is no requirement, and ENFIE did not find that there was a requirement of evidence of a reason to exclude. [00:30:00] Speaker 02: Indeed, in this case, when we look at the actual evidence, Dr. Elder agreed in his deposition that when you read this language that the inventor set forth in their specification, [00:30:13] Speaker 02: that you would understand that you can pick just one of those eight co-solvings. [00:30:18] Speaker 02: There's no need to have a teaching to exclude one because Dr. Elder agreed that there would be at the amount of time. [00:30:30] Speaker 02: Thank you. [00:30:31] Speaker 02: Dr. Elder agreed that a person with an ordinary skill in the art would understand that language [00:30:36] Speaker 02: to mean that you could pick one and that selection by itself would exclude the rest. [00:30:41] Speaker 02: There was no requirement to pick a combination. [00:30:43] Speaker 03: Okay. [00:30:46] Speaker 03: We thank both counsel. [00:30:48] Speaker 03: We realize this is a challenge for all of us and we appreciate your cooperation. [00:30:52] Speaker 03: The case is submitted.