1093, Farma Resources versus Roxane Laboratories All at the very least we can recognize that we have highly experienced counsel before us. We're ready to hear your argument, sir. We're going to honor for the visit work and your how-for the appalling planage park on municipal resources as a board is aware this is an appeal from the summary judgment decision of in validity of the claims in the suit as the two patents for lack of an appeal. Namely, this is about a pharmaceutical composition in which a steroid, in this case, magesco acetate, is combined with a number of other ingredients, surfactant, wedding agent. And this steroid is used to treat hate's patients. The steroid has great difficulty being the stylized name, it's insoluble and that's why you need this to fabricate. I'm just going to jump right into my questions. I'm worried your time is going to run out and I won't get them out. The claims are just incredibly broad. A lot of your brief I construed as argument about your three examples and how they enable. And I absolutely agree with you and I don't think district court disagreed. I don't think the district court suggested a complete and utter lack of an ablement. I think that his focus or her focus I'm not sure was on the breadth of the claims because you would agree that an ablement has to exist for the breadth of claim. These are the broadest claims I could possibly imagine except for the doughnut hole that is at singers. I certainly agree with you. I'm sorry. Go ahead. I certainly agree with your broad claims. I don't know that the broadest claim that can match. In regard to this invention. How many surfactants are there out there in the known chemical world that are pharmaceuticals using? There are 20-some law that are listed in the USP and the next one. Is your claim in any way limited to that? Is your claim in any way limited to the 24 surfactants listed? So there are at least 24 surfactants that would be candidates? In fact there would be hundreds that are candidates. There are 24 that are listed in a recommendation
. Hundreds, maybe thousands, be appropriate or hundreds, be more appropriate. The professor of Vermont says in her report that she is the one that says that one of what are your skill in the law? And that's the key here. Is how are these claims we looked at by one of what are your skill in the law? A formula later. How do a key or a sheet look at these claims and this law? And what professor of Vermont said is they would see this universe of surfactants that are well known in the first place. And they would specifically name you go to the USP, the US Department could pick up with a national formula where they say what are suitable pharmaceutical surfactants. And that's what one of what are your skill in the law will probably start and look at those. Are there other ones? Of course there are other ones. The key to this invention is what one of what are your skill in the law understands here. The prior art before at center, which was the key piece of prior art, that was the Bristol Mars pattern. The prior art before at center was Nash, which was decided in the patent specification. That you could have a surfactant from 0.05% to 0.5%. Very, you know, it's a narrow range. I mean, no one's ever talking that these claims could have a surfactant in 20, 34%. The prior art says when you have a surfactant that you're using with a steroid, which is what I'm just saying. Now you're getting a concentration argument as opposed to the number of surfactants. I'm just trying to think, that's a whole different dimension upon which the claims could be construed broadly, because there's no concentration limitation. But the wrong number of surfactants, it's just so large and then you have a number of wedding agents, and it just gives such an enormous population to choose from. There are four wedding agents that you can use as specified in the client. On a surfactant side, we also have to appreciate the claim is a claim directed to an oral composition, an oral pharmaceutical formulation that forms a stable flocculation suspension. Is that a claim limitation? It's got to be a formal pharmaceutical
. I might be understanding you to say that the preamble is a claim limitation in this case. Yes, I think so. So it has to be compound ultimately that is useful in treating AIDS patients. Yes, we'll go on the plan. There for it has to have at least three months stability. No, that is an FDA requirement that it may have to have. But that is really a depends answer because the three months stability, which does appear in the number of the claims in the three-way patent itself, some of the claims are limited by that three months stability, limitation, and others are not. However, the FDA requires bioavailability, biohubless, and that does not necessarily mean three months stability. It depends on the drug that you're talking about, the depends on the dosage form, depends on the method of administration, so on and so forth. Are you suggesting there's no timing component to the word stability? And don't we have to construe? I assume this term in order to possibly reach a conclusion about the Femia, I'm saying his name right, Dr. Femia. We have to reach a conclusion about whether it's three of seven or seven of seven requires an understanding of what the word stable means in the claim. Because he clearly delineates between long term stability, i.e. longer than three months, and short term stability, I guess, is the way he sort of delineates it in his testimony. Because your contention is the district court got it wrong when they said only three of seven, in fact, all seven of his. I think the Femia testimony is the exchange of evidence, and so to the extent that it's the exchange of evidence, I don't think you should look at it for purposes of claim construction. And in fact, down the law of Judge Debra, who hasn't didn't. No, no, I'm not mean we suggest we look at this for purpose of claim construction, but you want us to look at this for purposes of enablement. And how we interpret Mr. Femia's testimony depends on whether the word stable means three months or longer. The problem with the Femia testimony is I'm not expecting this for to look at that testimony and make a decision on whether or not you agree or disagree with the arguments that are being made here
. That's the whole point here. This is a summary judgment. The judge down below did that. And I think that's one of the errors that he made. What he did is he looked at this testimony of Femia. He also looked at the child testimony, which is another inventor, and he interpreted it, the way Roxanne urged that he should. But he made a determination that this is what the testimony is, and this is what it means. And therefore, as a matter of law, it supports a non-namalment position because I'm finding that from this testimony, there are inoperative formulations. Can I talk about Femia and interpret the testimony? I mean, there's no need for interpretation. The testimony is unequivocally clear. I mean, that doesn't involve a matter of interpretation. Three of seven worked, and Di-E4 of seven didn't work. If you're looking for three months or longer stability, three of seven of seven worked, if stability is instantaneous as a concept. I mean, that part of the Femia testimony, I don't understand to be an interpretation issue or in dispute in any way. I respectfully disagree because first off, that testimony comes from not this lawsuit. It comes from the prior lawsuit where Mr. Femia was being asked about the research and development of PAR. But this is your evidence to avoid some re-judgment of not a freshman. This is the evidence that you rely upon to argue on appeal, isn't it? That there's a disputed issue of fact here. Yes, it is. It is disputed. It's disputed, well, first off, to answer your question
. This testimony, but Mr. Femia is talking about an ad-singer pattern, comparing the PAR formulations with the ad-singer pattern as the prior one. In this case, we've also cited to testimony from Mr. Femia, where he clearly explains that testimony, and he said, this is on page 181, it's actually, the panic said, A421. The one thing you need to recall, the definition of stability was always versus the brand product. If it appeared as flocculated as the brand product, it was deemed stable. If it was less flocculated, but still flocculated, it would still be deemed less stable, but not necessarily unstable. I'm sorry, what are you reading from? I'm reading from the Deposition transcript. This is on A421. And I apologize. The Deposition transcript of who? I'm hoping that you can read what you have in your head. Oh, by the way, these appendices were absolutely horrendous. I mean, I had to, I'm not old, and I had to plot my magnifying glass to figure out what some of this stuff says. I am older, and I am definitely having to then. I apologize sincerely to the poor for that. It's on page 181 of the Deposition transcripts in the upper left hand corner, which should be A421 and B421. And any of that, what he's doing here is, in Vemia Femia, that is explaining what he was saying in that prior definition, which is what you were inquiring, and he's saying that I was talking about stability in the context of preparing it to a commercial product that they were then focused on. The claims, of course, in this case, claim 19 and claim 41, do not have a stability limitation of three months. That, of course, is a argument that Roxanne has made it in this appeal. But they say stable. Yes. So stable for how long? Three seconds
. Three days. I think, again, it's a moral form suitable formulation. If it's three seconds, it is useless. It's not going to do anything for any reason. Council, is there anything in the spec that lends insight into the definition of the word stable? When you need us to define this claim term in order to figure out the breadth of this claim, and to consider your evidence, and whether it creates a dispute effect. So is there anything in the specification that you think is up to inform or... The root definition of the word stable. Let me give you a little help. How to line 49. I have a brilliant law clerk that brought this to my attention. And she said, look here, concentrations as indicated are not stable in that defloculation and caking occur. Would that possibly support your argument that stability could be instantaneous? It's not certainly what I would think the ordinary meaning of the word would be. That is, I believe, how the word stable is defined. We'll look at it by the district court and urged by asking the Indian to prevent defloculation or caking. Whether that takes one month, one week, or six months, I would not think of the context. In the context of what this invention is addressed to, and the specification discussion of the disease and the need to get nutrition and stimulate appetite into these seriously ill patients, so you're talking about a large population of patients in the United States who need this assistance during their treatment. And so you're talking about something that has to be commercially viable and have widespread availability throughout the United States. Can stability in that context mean anything less than three months? What measurement can there be for a successful treatment, which is what this invention reports to be, for this problem? If you have stability that lasts for something less than the shelf life that is expected? The answer to that is twofold. How do the FDA answer that? Namely, is this an approval product that's safe and an efficacious for patient administration? Namely, if it's only stable for a month, could that be enough? I think there are probably drugs where the answer is yes, but I don't know. Well, I'm trying to say it on as I'm trying to answer your question
. It requires an FDA-based answer, although the particular drug, what are you doing with it? And similarly, there's a commercial answer. When you say shelf life, shelf life is not three months, shelf life could be two years. And so, quite frankly, there are. So that suggests that perhaps stability should be judged in the range of three months to two years. If it's put in the context of what would be a commercially viable product that has a shelf life of two years, then the answer is yes. There are many paths that claim just that. They claim shelf life of two years. So, Council, you've got to decide it in this case. We've got to construe this for its stability, and you're giving us any help. I mean, how do we define the word stability? Are you suggesting there's no timing component to it whatsoever? The chief asked you that and I didn't get your answer. I think there is no timing component on it. I don't, there is no timing component. How could it be stable? Look, the claim, Crayamble, says, a stable, flock-shielded, flock-related suspension. So clearly, if it's flock-shielded, that doesn't define stable, right? That's campy, because otherwise those two words will be redundant. Stable has to imply flocculated for some period of time. What, how else could we conclude? I think you're on a point into one part of the specification that doesn't answer the question. Floculated meaning is stable, as long as it is in the flocculated suspension state. Once it becomes deflockulated meaning that it settles down in the cakes, so you can now won't reuse this solution, it's no longer stable. That's how, that's what stable really means to you. And, and for purposes, I mean, it's dangerous. I think the mix, to mix that up as an argument, which is when we're talking about what's required for commercial purposes with the FDA, versus what's required under the pandemic. No, I'm, I'm referring to your own specification, and the problem that you're attempting to address with this invention
. Clearly, your specification talks in terms of three months, and you have dependent claims that focus in on the 40 degrees Celsius, 75% humidity, three months. And, and so I could imagine from a claim differentiation standpoint, you're going to suggest to me, therefore claim 19 should not be limited that way, right? Right. Without what you're saying. But then I just don't know how to read the word stable. I mean, because it seems to me, it's redundant if it simply means flocculated. It doesn't mean flocc, well, it means, because that's what I mean. Because that's what I mean. It doesn't deflock, it doesn't start to fall apart, doesn't, you know, one could look at it as saying, so that's a deterrent column. But it doesn't deflock, once it deflockulates, it's finished. In other words, the patient can't use it anymore. It's sitting in the medicine cabinet, it's sitting in the bottle of the thing, when you shake it, nothing happens. It's, it's gone, it's finished. It's deflockulated. That would be unstable at that point. All I'm saying is within the context of these paths, there is no time limit. It doesn't have to be three months. The 45 degrees, 75% relative humidity for three months, is a well-known kind of state-of-the-art measurement for stability, in this area, when people are filing drug proofs. It doesn't mean that, you know, most of these drugs are far more stable than three months, obviously. So once killed in the art would understand and really the word stable, it would be to them, it would be meaningful in terms of three months. If it, if the claim, your honor, if the claim said a commercial formulation of a gestural acetate, or it had a limitation as to the shelf life, the usable shelf life, or if it had some other limitation like that, the answer to your question would be absolutely correct. Yes. But that, those limitations are not in these plans
. The, the Nairobi's plans in this invention was the discovery that accident, the piece of prior art, was wrong. And what it said you had to do to make a stable, blocked rate of suspension in the gestural acetate. And you proved it was wrong by being able to recreate that effect with one other, or, um, surficant. Proved by using other surfactants, yes, and also using other wedding engines, and using them in completely different concentration ranges, outside of the specified ranges of the prior art answer, and others below and above. Now that's really the, the essence of the key here. And by frankly, once part did this, so that a lot of other people in the industry. And so that was the discovery, is that what AdSinger said was the problem in the prior art, mainly, you could not use more than a certain amount of surfactant with a, with a stiroidal compound. That's what AdSinger said to the patenters, and that's how they got their package to it. And particularly surfactant with a particular wedding agent at a particular concentration, far and designing around that pattern, discovered. So there are indeed that that was not the case. Let me just make sure I understand. You're not going to be disclosed to the public. Because I've made just so much of your time on clean construction. I'm going to let you know. With the chiefs indulgent, let me make sure I just understand the evidence that you say creates the dispute effect. Okay. It's the two declarations, extra reports that were coming. The problem I have with those is having looked at them. It's incredibly conclusive, what they say. Let's quickly just look at. They don't give any detail. They reach a very conclusive confusion
. Look at the one on page A268 of your appendix. The only testimony at all that Dr. Pramar presents with regard to this issue appears, as I understand it really, in paragraph 14, where she just says, or she, she, she, she, okay, where she just says, it would not be under experimentation, period. Correct. That's all she says. There's no analysis. There's no articulation of how one would come to it quickly. Professor Pramar, paragraph 9 on A267 talks about pharmaceutical formulas that is rely on compounds whose standards are adopted by the US biomew and the P.A. etc. That's where the basis for the statement, you are going to have one of the skill in the art. Would immediately look at what may be first or early on, would look at what is known in the industry to you. It was namely what's in the US being the national formula. And the point here at Professor Pramar is that her opinion is that one of ordinary skill in the art would be looking at those things and would know what's the fact that it's to try. Would you know what a surfactant works before you, before you experiment with it? It depends how much experience they have, I suppose. But I think that is really the key to Professor Pramar's expert report, similarly with Professor Cleveland, who is the other one. He talks about, in quite detail, about paris discovery and its R&D efforts to determine that you could have anionic, cationic, nionic, surfactants, long chain, short chain. All of those were discoveries that were made after that sentence, out there as part of it. That's what he's talking about. And so really the questions of fact that I believe the district court decided, I mean, I'm not, you know, obviously the district court had views of how he viewed this evidence, but that's not what this appeal is about. The appeal here is whether or not it's appropriate and proper to make a legal finding, and be non-amidant, based on these factual assumptions and findings that I believe the district court made. I look here from the other side
. Mr. Pramar. Thank you. If the court's permission elected is to address the points that were raised by the panel, and if there are any other questions, I'll be happy to answer them. First, I'd just like to mention that there's no support in the record for the fact that other people came into the market, and they were not really copying what part of it. The reality shows, the evidence shows that everybody, after the answer that came out with their invention, all the generics wanted to come in and make a generic, and they all did the same thing. But Council, there are two extra facts. There are two extra facts. The court reports here that say it would not require undue experimentation, point to the 24 listed surfact, and there is Dr. Femmya's testimony that in his belief, or not in his belief, but that seven of all seven that he tried were, in fact, stable, if we interpret the claim term stable the way a peasant would like us to. So, I mean, not a lot of evidence for the district court to say as a matter of law, there's no disputed issue of fact, whether or not undue experimentation is required. Okay. You're on, firstly regarding the declarations. As you pointed out, I think as we made the exact same point in our briefs, these declarations are conclusive. They simply say somebody would look at it, and they would know how to do it. With respect, for example, to the going... Somebody would look at it, and they would know how to do it. What exactly is the test from doing experimentation then? Because if somebody would look at the patent claim and know how to do this, then there is an undue experimentation. What's that? Why wouldn't that be enough? Because you have to take into account on the facts of this case exactly what the intrinsic record tells us about whether you can do it or not. And I don't think an expert can simply say, oh, well, despite all of what that says, you can absolutely do it. By that I specifically mean the specification, in this case, says, and I'm reading now from column three of the 318 patent on page A39 at the bottom. It says, the surfactants and the stable flocculid suspension need to be selected carefully and used within a critical concentration range, because even minor changes can have an effect on the properties of such a stable formulation. This is particularly true for majestial acetate, and that's the act of here, because predictability based on prior teachings does not apply. So they ought to be telling you in their effort to avoid an obvious rejection. Then hey, we have a completely unpredictable regime here. There's no way you can predict what's going to happen if you change the amount of this infection. And by the way, it's got to be used in some critical concentration range, but that's unpredictable. You make a slight change, you go to a different surfactant. We don't know what's going to happen. Now, do they tell us what's going to happen? And is there guidance as to how to go about finding what's going to happen? The argument, by the way, that a person of ordinary skill, I think it's in Dr. Pramar's declaration that you brought up, that you would go to the 24 surfactants in the USP, because those are suitable for oral pharmaceutical formulations again. Look at the specification. And by the way, below my opposing counsels specifically arguing that there is no limitation on the type of surfactant that can be used in the claims. And I honestly don't believe him to be saying anything different here. I think he's conceding that. But I don't see how you can flip flat back on those two points. The law is that the enablement must be recently commenced with a full scope of the claim. The full scope of the claim encompasses any surfactant. I don't think anybody disbures that. You know, but it doesn't necessarily enable for every possible variation. I mean, I agree. It's really broad
. By that I specifically mean the specification, in this case, says, and I'm reading now from column three of the 318 patent on page A39 at the bottom. It says, the surfactants and the stable flocculid suspension need to be selected carefully and used within a critical concentration range, because even minor changes can have an effect on the properties of such a stable formulation. This is particularly true for majestial acetate, and that's the act of here, because predictability based on prior teachings does not apply. So they ought to be telling you in their effort to avoid an obvious rejection. Then hey, we have a completely unpredictable regime here. There's no way you can predict what's going to happen if you change the amount of this infection. And by the way, it's got to be used in some critical concentration range, but that's unpredictable. You make a slight change, you go to a different surfactant. We don't know what's going to happen. Now, do they tell us what's going to happen? And is there guidance as to how to go about finding what's going to happen? The argument, by the way, that a person of ordinary skill, I think it's in Dr. Pramar's declaration that you brought up, that you would go to the 24 surfactants in the USP, because those are suitable for oral pharmaceutical formulations again. Look at the specification. And by the way, below my opposing counsels specifically arguing that there is no limitation on the type of surfactant that can be used in the claims. And I honestly don't believe him to be saying anything different here. I think he's conceding that. But I don't see how you can flip flat back on those two points. The law is that the enablement must be recently commenced with a full scope of the claim. The full scope of the claim encompasses any surfactant. I don't think anybody disbures that. You know, but it doesn't necessarily enable for every possible variation. I mean, I agree. It's really broad. And there's a lot of possible combinations. But, you know, I'm not one of ordinary skill in the art. And if one of ordinary skill in the art can focus in on the combinations that make sense, for example, maybe they've never put this wedding agent with this surfactant because it's known in the art bad things would happen. You know, I don't know because I'm not going to skill in the art. But one skill in the art could make those sort of determinations. And the same thing with regard to concentration. I mean, why haven't they at least raised a genuine issue of fact? I don't think that raises a genuine issue of fact. First, you know, in the spec, by the way, when they list all the surfactants and they tell everyone if you look at the beginning of each sentence where they have these launch releases of surfactants, it says, quote, column four, line 32. Suitable cationic surfactants are launch relist. Column four, line 15. Suitable anion surfactants are launch relist. Column four, line 30. Suitable nonion surfactants are launch relist. Every surfactant they identify in the spec, which as you pointed out, and in true, it's literally hundreds and hundreds, but several of these are genesis of compounds. Are identified as suitable for the invention. And if you're going to claim that if you want to cover the waterfront and stop everybody else from trying anything else, you've got to give a corresponding enabling disclosure, and this does not come close to doing that. Now, not only with respect to the identification of the surfactant, but one of your orders pointed out that there's a separate basis, there's no identification in these broad claims of any range limitation on these surfactants. And Dr. Climinoff, the other expert report that the, excuse me, declaration that they put in to create a quote unquote, initial effect, he specifically says that you wouldn't go reading the spec beyond .03.03 percent surfactant because above that, you're going to get problems of caking. He says that, he tells us that, that's a person of ordinary skill
. And there's a lot of possible combinations. But, you know, I'm not one of ordinary skill in the art. And if one of ordinary skill in the art can focus in on the combinations that make sense, for example, maybe they've never put this wedding agent with this surfactant because it's known in the art bad things would happen. You know, I don't know because I'm not going to skill in the art. But one skill in the art could make those sort of determinations. And the same thing with regard to concentration. I mean, why haven't they at least raised a genuine issue of fact? I don't think that raises a genuine issue of fact. First, you know, in the spec, by the way, when they list all the surfactants and they tell everyone if you look at the beginning of each sentence where they have these launch releases of surfactants, it says, quote, column four, line 32. Suitable cationic surfactants are launch relist. Column four, line 15. Suitable anion surfactants are launch relist. Column four, line 30. Suitable nonion surfactants are launch relist. Every surfactant they identify in the spec, which as you pointed out, and in true, it's literally hundreds and hundreds, but several of these are genesis of compounds. Are identified as suitable for the invention. And if you're going to claim that if you want to cover the waterfront and stop everybody else from trying anything else, you've got to give a corresponding enabling disclosure, and this does not come close to doing that. Now, not only with respect to the identification of the surfactant, but one of your orders pointed out that there's a separate basis, there's no identification in these broad claims of any range limitation on these surfactants. And Dr. Climinoff, the other expert report that the, excuse me, declaration that they put in to create a quote unquote, initial effect, he specifically says that you wouldn't go reading the spec beyond .03.03 percent surfactant because above that, you're going to get problems of caking. He says that, he tells us that, that's a person of ordinary skill. He's opining on that. But then is any saying one of ordinary skill would know not to do that? And therefore it's not necessary for the spec to tell you not to do that. It's not necessary for the spec to say, don't go above point whatever, because want to steal the art knows not to do that. And that satisfies, could arguably satisfy a naval one, because this is some rejudgment. I don't agree. I don't agree for two reasons. One, firstly, if the spec is clear, as Dr. Climinoff is telling it is, that you can't go above .03. The spec says it's unpredictable, it's a critical concentration range. How can you then put in a claim that prevents anybody from ever trying to find out if there's a way to go above what you've found to be the limit of .03? And isn't that directly analogous to the courts ruling in the NK steel case? And also in the NRA Fisher case where they said, look, if you're teaching away, if you're telling us there's a range outside of which this doesn't work, we're not going to let you claim that. You can't stop everybody else from practicing beyond what your contribution is to the art. And that's exactly what's happened here. They're trying to cover the waterfront, block everybody else as you start this argument today. These are incredibly broad claims. They block competition, they block other generics from coming out. What they want to do, obviously, is being the market by themselves with Bristol Myers-Grid, who has the brand name product, so that they can keep the price up high and stop everybody else from using any other way to create a suspension. I can't help with that. Prope's not really relevant to what we have to figure out. Do you agree that we need to interpret the word stable? No, I don't think you have to, but I think it helps my position if you do. And I want to be clear on it
. He's opining on that. But then is any saying one of ordinary skill would know not to do that? And therefore it's not necessary for the spec to tell you not to do that. It's not necessary for the spec to say, don't go above point whatever, because want to steal the art knows not to do that. And that satisfies, could arguably satisfy a naval one, because this is some rejudgment. I don't agree. I don't agree for two reasons. One, firstly, if the spec is clear, as Dr. Climinoff is telling it is, that you can't go above .03. The spec says it's unpredictable, it's a critical concentration range. How can you then put in a claim that prevents anybody from ever trying to find out if there's a way to go above what you've found to be the limit of .03? And isn't that directly analogous to the courts ruling in the NK steel case? And also in the NRA Fisher case where they said, look, if you're teaching away, if you're telling us there's a range outside of which this doesn't work, we're not going to let you claim that. You can't stop everybody else from practicing beyond what your contribution is to the art. And that's exactly what's happened here. They're trying to cover the waterfront, block everybody else as you start this argument today. These are incredibly broad claims. They block competition, they block other generics from coming out. What they want to do, obviously, is being the market by themselves with Bristol Myers-Grid, who has the brand name product, so that they can keep the price up high and stop everybody else from using any other way to create a suspension. I can't help with that. Prope's not really relevant to what we have to figure out. Do you agree that we need to interpret the word stable? No, I don't think you have to, but I think it helps my position if you do. And I want to be clear on it. I don't think they can rely on experiments from their notebooks to support an enabling disclosure. The case law seems pretty clear that on the issue of an enablement, if you're going to, for an able to, you have to show that the experimentation that you're relying on is in the specs only. I can rely on it to show that they have an operating environment. That's different. But the law seems to be clear that there's that demarcation they've got to rely on what's in their spec to show an enabling. Why? Why? Why can't they show? Look, we did an experiment. Our lab notebooks show that we chose seven different combinations of surfactants and wedding agents, and all of them resulted in stability as the way we define stability. And why wouldn't that be evidence that might create a question of fact with regard to the scope of their enablement? Well, I believe you're, first of all, even if it seems relevant, I mean, it doesn't seem like it's irrelevant evidence. So where is this demarcation that you say exists? Well, I have specific reference to the Genentech case, notebook notebooks. It's a 108F31361. And they have a note there and footnote for, I believe it's on page 1368 of the case. And they discussed evidence that's put forward by the patent T. And they make the point, quote, but none of the necessary experimentation is described in the specification. Which is where it should be if it is to contribute to an enabling disclosure. And the court seems to say that if you're going to rely on something, it has to be in respect. No, if you're going to rely on something to claim you need this disclosure, but what about the fact that somebody tried? Okay, so suppose it wasn't Dr. Femier. Suppose it was, it was you all. Suppose there was evidence in, you know, your client's lab notebooks, which was discovered during discovery, that you randomly tried 25 different surfactants and wedding agents and every one of them worked and met the definition of stable, whatever that is. Are you suggesting that evidence would be irrelevant for determining whether these specification is enabling? I don't think that would be relevant to whether the specification is enabling. But why isn't the specification doesn't provide the guidance of how to go about finding what the correct concentration is? If, to, to not provide it would result in undue experimentation. And if there is sufficient extrinsic evidence that there wouldn't be undue experimentation because the experimentation readily brought you to the answer, why doesn't that bring us back to the idea that the spec is enabling? Because again, I believe it again
. I don't think they can rely on experiments from their notebooks to support an enabling disclosure. The case law seems pretty clear that on the issue of an enablement, if you're going to, for an able to, you have to show that the experimentation that you're relying on is in the specs only. I can rely on it to show that they have an operating environment. That's different. But the law seems to be clear that there's that demarcation they've got to rely on what's in their spec to show an enabling. Why? Why? Why can't they show? Look, we did an experiment. Our lab notebooks show that we chose seven different combinations of surfactants and wedding agents, and all of them resulted in stability as the way we define stability. And why wouldn't that be evidence that might create a question of fact with regard to the scope of their enablement? Well, I believe you're, first of all, even if it seems relevant, I mean, it doesn't seem like it's irrelevant evidence. So where is this demarcation that you say exists? Well, I have specific reference to the Genentech case, notebook notebooks. It's a 108F31361. And they have a note there and footnote for, I believe it's on page 1368 of the case. And they discussed evidence that's put forward by the patent T. And they make the point, quote, but none of the necessary experimentation is described in the specification. Which is where it should be if it is to contribute to an enabling disclosure. And the court seems to say that if you're going to rely on something, it has to be in respect. No, if you're going to rely on something to claim you need this disclosure, but what about the fact that somebody tried? Okay, so suppose it wasn't Dr. Femier. Suppose it was, it was you all. Suppose there was evidence in, you know, your client's lab notebooks, which was discovered during discovery, that you randomly tried 25 different surfactants and wedding agents and every one of them worked and met the definition of stable, whatever that is. Are you suggesting that evidence would be irrelevant for determining whether these specification is enabling? I don't think that would be relevant to whether the specification is enabling. But why isn't the specification doesn't provide the guidance of how to go about finding what the correct concentration is? If, to, to not provide it would result in undue experimentation. And if there is sufficient extrinsic evidence that there wouldn't be undue experimentation because the experimentation readily brought you to the answer, why doesn't that bring us back to the idea that the spec is enabling? Because again, I believe it again. I don't think it matters which way you decide that question. I don't think it affects the outcome of the case one bit. But I don't believe based on my understanding that you can supplement the disclosure of the specification to show that you've enabled the full scope of the claim by going to experiments that are hidden in your notebook. And even today are unknown to the public. The public has no knowledge. Those documents are still confidential. Has no idea what they did, how they did, how they achieved that. And as the court pointed out, the district court, excuse me, and it's opinion below that par took, by its own admission, several months to come up even with its own one commercial. So no one knows how that was achieved. But can I speak just briefly to the question and stability that you raised during argument earlier? Let's not lose sight of the fact that the whole point of this invention is not the idea of just slapping together with the fact that a wedding agent putting it together with magestial acetate. That was known. As the pattern here and the spec points out, the whole point is to be able to create a stable, flocculated suspension. Anybody can put the things together and mix it. The idea is to get it to remain stable. And of course you're right that there's got to be some limitation on what stable means. It can't mean two seconds. That makes absolutely no sense. Now here, I must tell you that when I think the district court judged it and I think he was corrected. Nobody basically in a way, hung them by their own authority, saying, look, you're saying it has no meaning. I'll go along with that. I agree that that's the correct plan for destruction here. I have been personally disagreeing
. I don't think it matters which way you decide that question. I don't think it affects the outcome of the case one bit. But I don't believe based on my understanding that you can supplement the disclosure of the specification to show that you've enabled the full scope of the claim by going to experiments that are hidden in your notebook. And even today are unknown to the public. The public has no knowledge. Those documents are still confidential. Has no idea what they did, how they did, how they achieved that. And as the court pointed out, the district court, excuse me, and it's opinion below that par took, by its own admission, several months to come up even with its own one commercial. So no one knows how that was achieved. But can I speak just briefly to the question and stability that you raised during argument earlier? Let's not lose sight of the fact that the whole point of this invention is not the idea of just slapping together with the fact that a wedding agent putting it together with magestial acetate. That was known. As the pattern here and the spec points out, the whole point is to be able to create a stable, flocculated suspension. Anybody can put the things together and mix it. The idea is to get it to remain stable. And of course you're right that there's got to be some limitation on what stable means. It can't mean two seconds. That makes absolutely no sense. Now here, I must tell you that when I think the district court judged it and I think he was corrected. Nobody basically in a way, hung them by their own authority, saying, look, you're saying it has no meaning. I'll go along with that. I agree that that's the correct plan for destruction here. I have been personally disagreeing. But the judge said, I find that that's the case. And since you're saying it can mean anything, it's got to also be stable for three months. And you haven't shown that. And so the Femme and Testimonium becomes relevant. And therefore it shows they've failed experiments. That's what I think he did. I don't think he was, he was out of his mind and concluded that it has no limitation. And then he found the Femme experiments were relevant. Of course he concluded that since it has no limitations, it's got to be stable for some reason. But the reality is, you are, is that I believe that the prosecution history establishes beyond doubt here what stable means. Firstly, you're on a point that's something in column two. There's a clear statement in column four of the specification where the patent talks specifically about suspension's stability. And it identifies that very test of the three months of the column four and have been spoke by the column. I'm sorry, it's example for in column seven, my apologies. Under the heading, suspension's stability. Yeah, but this is one of the embodiments. Well, multiple embodiments. I mean, that's not a definition of the word stability. That is maybe a further limitation of the word stability. I'll allow the dependent claims, but I don't see how we can extrapolate from that definition. I was going to go a little further. Okay, good
. But the judge said, I find that that's the case. And since you're saying it can mean anything, it's got to also be stable for three months. And you haven't shown that. And so the Femme and Testimonium becomes relevant. And therefore it shows they've failed experiments. That's what I think he did. I don't think he was, he was out of his mind and concluded that it has no limitation. And then he found the Femme experiments were relevant. Of course he concluded that since it has no limitations, it's got to be stable for some reason. But the reality is, you are, is that I believe that the prosecution history establishes beyond doubt here what stable means. Firstly, you're on a point that's something in column two. There's a clear statement in column four of the specification where the patent talks specifically about suspension's stability. And it identifies that very test of the three months of the column four and have been spoke by the column. I'm sorry, it's example for in column seven, my apologies. Under the heading, suspension's stability. Yeah, but this is one of the embodiments. Well, multiple embodiments. I mean, that's not a definition of the word stability. That is maybe a further limitation of the word stability. I'll allow the dependent claims, but I don't see how we can extrapolate from that definition. I was going to go a little further. Okay, good. Bring me further. Okay, let me bring it a little further. Then during the prosecution of the first application, the two four one application, the very first application in the chain, they go through the application, it gets rejected on 112 from 103. Respond, make all the arguments that point out it's unpredictable. They reiterate that any change in types of amounts of ingredient, unpredictable, same rejection from the examiner. Then they come back and they amend the claims in that patent to limit to a very narrow concentration range. And both of the claims will limit it to the specific suspension's stability, but not all of them. The specific suspension's stability, the example for and they get that patent. And of course, they have a suit also that happens. We go to fringe that patent. And now they say in their remarks to the examiner, and I quote from page a 301 in the many of the claims to obtain their allowability, they say surprisingly, the present invention provides for a stable, flocculated suspension. And again, the present invention, no specific reference to a claim, of a gestural acetate by using different ingredients than adsinger. And then there's a parenthetic, we're not using polysolvatin, PEG, simultaneously the same composition, they don't have that, they're on invention. Then they go on to say, I quote, this stability of the suspension of the present invention is described on page 13 of the specification as the ability of the ability to be reviewed. You're building to be re dispersed after being allowed to settle at 40 degrees centigrade and 75% relative humidity for a period of three months. Now, this court has said, when you talk in your prosecution history about the present invention, make broad sweeping statements, you're going to be stuck with that, that you're bound by that. And in the LK case, they're... Okay, hold on, I'm just a little bit confused about where you are. It's kind of hard to read, but on 301, it says in response, applicants is here in amended claim. I assume that's one, it might be three, I can't tell
. Bring me further. Okay, let me bring it a little further. Then during the prosecution of the first application, the two four one application, the very first application in the chain, they go through the application, it gets rejected on 112 from 103. Respond, make all the arguments that point out it's unpredictable. They reiterate that any change in types of amounts of ingredient, unpredictable, same rejection from the examiner. Then they come back and they amend the claims in that patent to limit to a very narrow concentration range. And both of the claims will limit it to the specific suspension's stability, but not all of them. The specific suspension's stability, the example for and they get that patent. And of course, they have a suit also that happens. We go to fringe that patent. And now they say in their remarks to the examiner, and I quote from page a 301 in the many of the claims to obtain their allowability, they say surprisingly, the present invention provides for a stable, flocculated suspension. And again, the present invention, no specific reference to a claim, of a gestural acetate by using different ingredients than adsinger. And then there's a parenthetic, we're not using polysolvatin, PEG, simultaneously the same composition, they don't have that, they're on invention. Then they go on to say, I quote, this stability of the suspension of the present invention is described on page 13 of the specification as the ability of the ability to be reviewed. You're building to be re dispersed after being allowed to settle at 40 degrees centigrade and 75% relative humidity for a period of three months. Now, this court has said, when you talk in your prosecution history about the present invention, make broad sweeping statements, you're going to be stuck with that, that you're bound by that. And in the LK case, they're... Okay, hold on, I'm just a little bit confused about where you are. It's kind of hard to read, but on 301, it says in response, applicants is here in amended claim. I assume that's one, it might be three, I can't tell. And that's when it says about the limitation of 40 degrees and 75. Is there another place where they're making this in regard to the invention generally? I believe this... No, there is not, but I believe this statement I've read is about the invention generally. It says, it's called out claim, I believe it's one, it might be three, I can't read the number. It's one. But it calls out a particular claim. And then... Well... And it says this claim was amended to include this limitation. So I don't see how you extrapolate from that that they were giving it up with regard to the invention generally. Because I think they clearly say in the present invention, by the way, in the paragraph right above where you're looking at, they point that the examiner rejected claims 1 to 22 as allegedly own pattern. So they are there talking about generally all the claims. Then they do talk about the amendment they claim, which of course is logical, because that's the only amended claim. But then the next paragraph, I don't see how it can be read, is anything that can be about the invention, the entire invention. And again, if it doesn't mean that, what does it mean? What does stable mean? As one of you are on this pointed out, it's got to mean something. And it can't be that all I have to do is formulate it, see that it's stable for three seconds, five seconds, ten minutes
. And that's when it says about the limitation of 40 degrees and 75. Is there another place where they're making this in regard to the invention generally? I believe this... No, there is not, but I believe this statement I've read is about the invention generally. It says, it's called out claim, I believe it's one, it might be three, I can't read the number. It's one. But it calls out a particular claim. And then... Well... And it says this claim was amended to include this limitation. So I don't see how you extrapolate from that that they were giving it up with regard to the invention generally. Because I think they clearly say in the present invention, by the way, in the paragraph right above where you're looking at, they point that the examiner rejected claims 1 to 22 as allegedly own pattern. So they are there talking about generally all the claims. Then they do talk about the amendment they claim, which of course is logical, because that's the only amended claim. But then the next paragraph, I don't see how it can be read, is anything that can be about the invention, the entire invention. And again, if it doesn't mean that, what does it mean? What does stable mean? As one of you are on this pointed out, it's got to mean something. And it can't be that all I have to do is formulate it, see that it's stable for three seconds, five seconds, ten minutes. That's not useful. It wouldn't be beneficial anyway. Is there evidence about one of what ordinary skill in the art, how they would interpret the word stable? Was there any such evidence? It'd probably be useful in this case. I don't believe that in this case, the parties relied on the intrinsic record in supporting the arguments. And if I'm not, I don't want to speak to my closing counsel if you may, but on our side, I believe we did. All right, thank you. You only have a minute. You only have a minute. The question about whether or not parking rely on experiments outside of the specification for purposes of establishing a settlement, the answer is yes. I would go to the site, the analyst, Howard Case, which is cited in page 10 of our brief. And again, it's about the determinations that were made by the district court in order to get to the finding of one label. That's what we're feeling here. That's what we think is Tara. This court ultimately did look at that same evidence where you and the judge down below. As a trial, if this court assess the case back there. Did you all just find out who's answer the question? Is there any extrinsic evidence about stable? Any experts that said stable means to me blank? I don't believe so because I think the mark here and here we have in this case did not go back to. And so the warning answers that occurred in connection with the mark. It was oral argument that that did affect the area of the basketball back. That's a shame. I should see it helpful. All right. We think all counsel will take this a few longer advice