Legal Case Summary

. And that is to describe the standard substantially pure regionalizer, the intermediate starting material, the PCK. It is pointedly never used to describe the purity of the end product in the claim line. In the claim line, in the claim line, in the specification, the term substantially pure regionalizer is only used in describing the invention of the applicant as attaining attaching to the intermediate. When the patent specification talks about the end products as related to the invention, it pointedly refers to them as PIPRA Dean derivative compounds, and sometimes refers to them as being substantially pure, sometimes not. But the important thing that I think distinguishes this case from thin control and some of the other cases of this court that have been cited, that you have to construe words in the claims of the given patent that the same does not apply here, because the words were worried about it. Stanchially pure regionalizer only occur with respect to the intermediate. But in the spec, it does refer to the specification to substantially pure end product, whatever. Yes, that's a good one. And would you construe substantially pure end product in the spec of this patent as referring to something other than greater than 95%. With all of the respect, I'm not sure we construe words in the specification, but does it have the same meaning? What does it mean? The meaning when they use the end product is substantially pure, and it may have the same meaning or not. That's going to depend on how many of these things are there. I'm not talking about the same as the intermediate. I'm just saying when it refers to substantially pure end product in the specification, is there any dispute that they're talking about over 95%. Yes, I believe there is dispute on that. So you've got to be skilled in the art would construe that as being could the construe substantially pure end product in the spec of this patent as being less than 95% online

. That is in dispute here. There is an argument in a different patent that actually claims the substantially pure end product, the 610 patent, that the particular prosecution history in that patent may have limited the scope of those claims under this courts law. Because it was an explicit disavowal or this claim or a claim. So let's assume hypothetically that we accept that. And so we would construe substantially pure in the spec, not a claim construction, just what the spec is talking about, substantially pure end product based on that prosecution history to being greater than 95%. We accept that hypothetically. How would we, wouldn't there be an assumption at least when construing substantially pure end claim that that two means over 95% and if not why not? It may be a starting point here, but that's all because the term to be construed is substantially pure regialisomer, the chemical intermediate. And one of ordinary stealing art would understand that the purity that needs to attach to an intermediate something that's going to be made into something else need not be as pure as a pharmaceutical grade product that's going to be administered to a patient. The important distinction in our case, you're on is the claim seven never requires the end product to be substantially pure or any particular level of purity. All you need to do to practice that claim is to make some effects of funding of whatever purity. And that claim could have been limited to use the same words substantially pure to define that product. And it wasn't the applicant could have done that, the examiner could have done that, but it is very clear that the only use of the term substantially pure in the claim is to define the purity level of the regialisomer intermediate. When we were talking about purity, that word itself talks in terms of something being 100%. Substantially is going to back off that at most a little bit, right? Well, back and off 100% a little bit. And that's the question

. Well, I understand that's the question, but now I'm just sticking right with the claim language and we're not even going to tinker around with the specification. And I'm saying pure is 100%. Now, you're going to back me off to 67% with the use of a weasel word? No, no, our belief is that one of the word there's still the argument read substantially pure regialisomer and understand it. And it's normal, ordinary and customary meaning. Substantially is a word that this coordinate is a number of its cases. Clearly we have, but when you put it in the context of purity, is one of you're telling me that one of skill in the art, what in the record would suggest to me that one of skill in the art would back that off by a third? We don't, it's not our position that would be back off by a third. There is evidence that people of ordinary skill in the art, can't let's just understand substantially pure regialisomer to me largely but not whole and pure. It still doesn't answer the question of a hard numerical limit. One of ordinary skill in the art would not put a hard numerical limit on those words. How far do you have to back it off in order to be able to alleged that the accused product is free? Well, in this case, you're on early evidence is that red back sees intermediate is either 88% or 92% pure. And they use that intermediate to make far and suitable grade effects of finity. So it's our position that it's clear that what they're doing is largely but not whole, substantially pure because they get to the preferred embodiment described in the past. They use that intermediate to make the very preferred embodiment the pure end product of the past, even though that's not required by the claim of issue in this case. So we believe our definition of largely but not fully pure is exactly what one of ordinary skill in the art would come to the conclusion that this is what it means and it would not put a hard numerical limit on the other. Would be anything over 51%

. Well, it clearly has to. You're out of refer to 67. Pure purity is pure that's 100%. I'm still troubled a little bit by with you back in the off. More than even isn't 10% already getting impure. It may in a given context. It may not. Okay, what is your best best record evidence that one of skill in the art would say even 90% is still pure. Our best record evidence would be from Professor Jack Baldwin, have you ever had a chemistry department at Oxford, a world renowned campus for the attitudes. And his view is that this term would mean largely but not fully. Not putting a hard numerical limit on it had the examiner or the applicant wish to put a hard numerical limit on the purity of the reach of ice. Well, not only almost me and definite. I mean, if assume that I'm presented with a patent that says the intermediate is largely but not fully pure. So I how do I know when I'm in trouble? If I want to design around your question. If that were that we of course don't believe the claim is indefinite or it's an issue

. But if that were the case, then the use of the terms of stanchology which by its nature means you don't have a hard precise limit on whatever the topic is. The judge there is not any kind of a suggestion that you do. If you say substantially pure, that means pure means pure and the driven is not dirty snow. You didn't claim largely, you claim pure. No, we claim substantially pure. And that makes it abundantly clear. Absolutely, but the main thing after the only percentage is clevengers points you could have claimed largely but not wholly. And then we would still get to the well, yes we would because they'd be saying they'd be prying because it's purity. It has to be it has to be. It might be saying your claim was indefinite and then you would be claiming why it's not. Yes. At this point of the case you are. We believe that the claim construction of the district court which imported a hard numerical limit into the claims from only one spot of the prosecution history. But you can't you can't quibble with the process right. I mean the manner in which the trial judge went about construing the claim

. And there's clear sensitivity to you're not supposed to import a limitation and there's clear sensitivity saying like I can't just sort of do this while in woolly. I'm marching through the sort of Phillips failings and I finally get to the point where I find this file history on with the 610 patent and I see a disclaimer. Saying at least within in product substantially cure me in north of 95% or get around a prior reference right. So assume for purposes of argument where the judge first started that we that we agreed that the trial judge made no error at least the data point of establishing that or an in product in this field substantially curious north of 95%. Once that happens then. Aren't you going to have a problem? No because the term to be construed here with with all respect. No because the term is substantially pure regional isomer defined in this claim in this patent as an intermediate right. And that's a different invention claim to a different patent with a different prosecution history in which claims code was disavowed specifically. It was not disavowed in this case and the district court aired in taking the 95% number from an amendments in the prosecution of the patent ensued and inserting it into the claim. And that was legal error. Well, it shouldn't be said that but at least we're talking about in that other prosecution the word purity and at least getting some idea of what they meant by purity. But pure and they were talking about 95%. Yes, actually in the 610 patent or under they were talking about 98% pharmaceutical grade purity for effects of fendivine the end product because that's what's required under FDA law for end product. There is no such requirement for a chemical intermediate that is only used inside of a chemical plant that that concept of it has to be pure enough to put into humans is completely absent and want to steal the art of building. So that's the only thing that I would like to say

. Thank you Mr. Progop. You know the dangers of trying to split time we're not going to tell you when to stop and him to win the start. You're going to have to sit down when you want your partner to start. And that would be a pro-favorite. Only the issue that I'm going to be addressed has been addressed for me for a larger. No, okay. In that case you're... I just like you're going to have all the time go ahead. I would be more than happy to see it sometime. Go ahead and record what? We may have to see. May please the court. I only have a few comments and then we'll be available to answer questions from the court

. As an initial matter Mr. Progop pointed out that the government case and its line of case is included in Bell and Hall. Explain that this area, this type of area is one with the court of real reverse on a preliminary juncture. And with respect, the air and the government and in Bell and Hall were a district court ignoring and express definition of specification. Still legal air as alleged, but it's qualitatively a different type of air. From the initial point you've gone from there. On the claim construction issue per se at the none of the issue, what event is asking is for this court to forgive its choice of using the same descriptive terms substantially purer to describe the purity of end products and the purity of intermediates. But there's no necessity that the two purity levels be the same. Absolutely. They could have clarified in the specific. Absolutely meaning what? Absolutely. You agree that there's no need to be a correct or not. They could have specified that the intermediates has a certain purity limit, certain purity standard and the end product. Why didn't they specify? Because one of skill in the art is certainly going to know the difference. They're going to know that an intermediate is not a final product

. In this case, axiomatic. No, no, no. In this case, the purity of one is not going to be the purity of the other reason. In the abstract, the purity of intermediates does not have to match the purity of the product. But I believe that was the question. In this case, the point that's repeatedly made in specification that's confirmed by the testimony of the inventor is that there was no mechanism, no, no method to increase purity or separate after the intermediate stage. So logically, from the description in the specification and particularly that appendix 334, column 4 in the background of the invention, it was made clear that there's no practical separation once you have the intermediate. So the level of impurities between the two regional isomers must remain constant in subsequent steps. So the logic of using the same descriptive phrase as purity is compelling. It fits with their decision, which is a clear decision. Another point that has to be addressed is that Mr. Berghof continually repeats here as he did the district court that the phrase substantially pure regional isomer is only used in the claim and only used to describe the intermediate. I must point the court to column 4, line 19, line 18 and 19, a practical separation to obtain grand quantities of substantially pure regional isomers has not been achieved. The reference there to the second and third mixtures, artifacts of anadone and effects of anadine. Those are the final products and there the precise phrase granted to the plural is substantially pure regional isomers

. They're properly described as regional isomers. In the claim, the regional isomer describes an intermediate but here it's a final product. Where does that get us? I mean, the claim language is talking about intermediate. Then why I mean, and you can see that you're not arguing that the claim language also covers end products because the why is the throughout what the argument is that the court was correct on the facts and based on the what he calls an assumption single single term will have a single meaning is that substantial purity substantially pure regional isomers is used to describe the end product in the specification. But you're not suggesting that the use of that term in the claim language is used to describe the substantial purity as as modifying regional isomers and as modifying piperding derivatives. And then you look and you say there's a single definition of substantially pure substantially pure piperding derivatives. That's the level of purity for final product substantially pure regional isomers. That's the level of as to the claims level of purity for the intermediate. Now when I was speaking with Mr. Burgoff, I said, give me your best record evidence that substantially pure has the meaning attributed to it. He spoke sir Baldwin and his expert testimony. Did your expert rebut that? Yes indeed. That's Dr. the expert testimony said a 54 and I mean three pointing out not only that every example in the patent has a substantially pure intermediate but that in the context of this patent, one would understand substantial purity has a single meaning. That expert testimony on claim structure or testimony on science. As I mentioned, he's a certified expert. Mr. Baldwin from Oxford University who said substantially pure means largely been not holy. He's a certified expert. He's a certified expert. He's a certified expert. He's a certified expert. He's a certified expert. He's a certified expert. He's a certified expert. He's a certified expert. He's a certified expert. He's a certified expert. He's a certified expert. He's a certified expert

. As I mentioned, he's a certified expert. Mr. Baldwin from Oxford University who said substantially pure means largely been not holy. He's a certified expert. He's a certified expert. He's a certified expert. He's a certified expert. He's a certified expert. He's a certified expert. He's a certified expert. He's a certified expert. He's a certified expert. He's a certified expert. He's a certified expert. He's a certified expert. He's a certified expert. He's a certified expert. He's a certified expert. He's a certified expert. He's a certified expert. He's a certified expert. He's a certified expert. He's a certified expert. He's a certified expert. He's a certified expert. He's a certified expert. He's a certified expert. He's a certified expert. He's a certified expert. He's a certified expert

. He's a certified expert. He's a certified expert. He's a certified expert. He's a certified expert. He's a certified expert. He's a certified expert. He's a certified expert. He's a certified expert. He's a certified expert. He's a certified expert. He's a certified expert. He's a certified expert. He's a certified expert. He's a certified expert. He's a certified expert. He's a certified expert. He's a certified expert. He's a certified expert. He's a certified expert. He's a certified expert. He's a certified expert. He's a certified expert. He's a certified expert. He's a certified expert. He's a certified expert Hippitynung. He's a certified expert. and stopped. I think there wasn't real intrinsic evidence here. Absolutely. So what says directly what we're supposed to do with this? What there is, and I would point the court to not only the 703 prosecution history at 845, 68, but also in the 610 prosecution history, one of the cores of a Ventus' claim construction position is that it's not permissible to separate substantially pure from the term it modifies, but throughout the 610 prosecution history, particularly at 842, 60, 42, 69, 42, 76, 42, 81, in every instance in their submissions in the 610 Sivling application, they define quote substantially pure

. He's a certified expert. He's a certified expert. He's a certified expert. He's a certified expert. He's a certified expert. He's a certified expert. He's a certified expert. He's a certified expert. He's a certified expert. He's a certified expert Hippitynung. He's a certified expert. and stopped. I think there wasn't real intrinsic evidence here. Absolutely. So what says directly what we're supposed to do with this? What there is, and I would point the court to not only the 703 prosecution history at 845, 68, but also in the 610 prosecution history, one of the cores of a Ventus' claim construction position is that it's not permissible to separate substantially pure from the term it modifies, but throughout the 610 prosecution history, particularly at 842, 60, 42, 69, 42, 76, 42, 81, in every instance in their submissions in the 610 Sivling application, they define quote substantially pure. And it's some of the claims that were issued in that case, intermediates were issued with respect to some of the prior art, which was at stake in, which was an issue in that appeal, or in that prosecution, a metabolite or intermediate based on synthesis, intermediates were an issue, and they repeatedly used substantially pure set aside from what it was modified. Why did they do that? Because in the 610, substantially pure is used to modify both regio-ICIers and end products. The logic is unassailable, even the assumption, but buttressed with the statements in the 7103 patent that separation is not possible after the intermediate stage. One would have to assume that the purity level at the intermediate stage would be retained at the final product. So there's a logical decision, and of course the same phrases are used as to the point of the same phrase as being used, in reference to the course to the black city or in the taxi case, in which the applicant laid out different levels of different degrees of purity in that case in an independent and dependent claim, and made it perfectly clear that while non-emorable limits were spelled out, that there were different degrees and different grades of purity. As patent drafters, we used words to build our claims. And that's an important decision. And if you're going to continually use the phrase substantially pure, and not use the myriad of other words that you might use to describe purity, you should be held to that decision. Well, except when you realize you're speaking to one of skill in the art, and you can assume that they're going to note the distinctions, and they didn't define substantially pure regio-ICI-Somer at any point in the specification we have before us. They defined it in a prostitution, history, and bigger corrector. They didn't define it, but they did link the purity of the intermeasant. They defined it, defined the term substantially pure regio-ICI-Somer. They expressly defined substantially pure in the context of the 6-10, they did not regio-ICI-Somer. No one is debating what regio-ICI-Somer is in this case. Obviously, the context of an end product

. And it's some of the claims that were issued in that case, intermediates were issued with respect to some of the prior art, which was at stake in, which was an issue in that appeal, or in that prosecution, a metabolite or intermediate based on synthesis, intermediates were an issue, and they repeatedly used substantially pure set aside from what it was modified. Why did they do that? Because in the 610, substantially pure is used to modify both regio-ICIers and end products. The logic is unassailable, even the assumption, but buttressed with the statements in the 7103 patent that separation is not possible after the intermediate stage. One would have to assume that the purity level at the intermediate stage would be retained at the final product. So there's a logical decision, and of course the same phrases are used as to the point of the same phrase as being used, in reference to the course to the black city or in the taxi case, in which the applicant laid out different levels of different degrees of purity in that case in an independent and dependent claim, and made it perfectly clear that while non-emorable limits were spelled out, that there were different degrees and different grades of purity. As patent drafters, we used words to build our claims. And that's an important decision. And if you're going to continually use the phrase substantially pure, and not use the myriad of other words that you might use to describe purity, you should be held to that decision. Well, except when you realize you're speaking to one of skill in the art, and you can assume that they're going to note the distinctions, and they didn't define substantially pure regio-ICI-Somer at any point in the specification we have before us. They defined it in a prostitution, history, and bigger corrector. They didn't define it, but they did link the purity of the intermeasant. They defined it, defined the term substantially pure regio-ICI-Somer. They expressly defined substantially pure in the context of the 6-10, they did not regio-ICI-Somer. No one is debating what regio-ICI-Somer is in this case. Obviously, the context of an end product. Yeah, so in other words, you're only definition is the end product, and we've already discussed one of skill in the art. Would know there's a distinction? No, based on Professor Schuster's testimony, and of course, a lot of it. Well, that gets us back to Sir Baldwin's testimony, which is a little bit different. So there is a relevance there, isn't it? You're ultimately building on that distinction. The distinction between what one of skill in the art would understand the difference between a regio-ICI-Somer and end product to be. Sir Baldwin says one thing, Schuster says something else. Frankly, what Mr. Baldwin says is they might be different. And seeing the same words, one skill in the art is not a blue. It's a little bit obvious to the use of the English language. But your trump card, oh, this minds all in the intrinsic evidence really kind of breaks down here. Clearly, it's in the intrinsic evidence. Well, and clearly what is in the intrinsic evidence is the end product. What we have is the intermediate. Now, we just went through the logic here

. Yeah, so in other words, you're only definition is the end product, and we've already discussed one of skill in the art. Would know there's a distinction? No, based on Professor Schuster's testimony, and of course, a lot of it. Well, that gets us back to Sir Baldwin's testimony, which is a little bit different. So there is a relevance there, isn't it? You're ultimately building on that distinction. The distinction between what one of skill in the art would understand the difference between a regio-ICI-Somer and end product to be. Sir Baldwin says one thing, Schuster says something else. Frankly, what Mr. Baldwin says is they might be different. And seeing the same words, one skill in the art is not a blue. It's a little bit obvious to the use of the English language. But your trump card, oh, this minds all in the intrinsic evidence really kind of breaks down here. Clearly, it's in the intrinsic evidence. Well, and clearly what is in the intrinsic evidence is the end product. What we have is the intermediate. Now, we just went through the logic here. We've got to get back to the point what would one of skill in the art to understand that distinction to be? One skill in the art would place reliance on the use of the same phrase. Why wouldn't they? First, because of the logic of the 703 patent that in turn between the intermediate stage and the final stage, no practical separation is possible. Now, is that, in that particular context, is significant to you if there had been no disclosure in column 4 that you couldn't purify? After the intermediate goes in, your case would be substantially weaker with a child. The case would rest as the district court's analysis would rest on the so-called assumption that the same words in the specification mean the same thing. Aventus makes much of that. Well, you'd have that on one side of the scale, and you'd have one of our nearest skill in the art, justifying the Oxford set on the other side. So what is intrinsic evidence? The same to me that the heart of your case, you hang on this disclosure in column 4 of this very embedder saying, once I throw the intermediate in, games over purification. That would be part of it. Obviously, the 610 prosecution history, which links the phrase substantial purity with the purity of the regialisomer. In that order, substantiality of regialisomer, is used in the claim that is at issue in the 610. And there, definitely. But definitely, one one, scale in the art probably would understand, or narrowly, you can have a 50% pure intermediate. That's correct. A series of 50% ingredients. That's correct

. We've got to get back to the point what would one of skill in the art to understand that distinction to be? One skill in the art would place reliance on the use of the same phrase. Why wouldn't they? First, because of the logic of the 703 patent that in turn between the intermediate stage and the final stage, no practical separation is possible. Now, is that, in that particular context, is significant to you if there had been no disclosure in column 4 that you couldn't purify? After the intermediate goes in, your case would be substantially weaker with a child. The case would rest as the district court's analysis would rest on the so-called assumption that the same words in the specification mean the same thing. Aventus makes much of that. Well, you'd have that on one side of the scale, and you'd have one of our nearest skill in the art, justifying the Oxford set on the other side. So what is intrinsic evidence? The same to me that the heart of your case, you hang on this disclosure in column 4 of this very embedder saying, once I throw the intermediate in, games over purification. That would be part of it. Obviously, the 610 prosecution history, which links the phrase substantial purity with the purity of the regialisomer. In that order, substantiality of regialisomer, is used in the claim that is at issue in the 610. And there, definitely. But definitely, one one, scale in the art probably would understand, or narrowly, you can have a 50% pure intermediate. That's correct. A series of 50% ingredients. That's correct. And you can do double, double, twilight trouble in the earth and throw some stuff in, and you can bring out a 99.9% pure improv. Yes, and again, I would turn it to the beginning of the art, which would be what they're asking for as forgiveness, that they use the term that they need not have used or should have used. Substantial purity is substantial purity. It's been clearly defined and explained in the specification. Now, did they have to use it? Obviously, the logic of column 4 is there. The logic compels the purity level of the intermediate to be akin to the purity level of the final product. And that's why the error, if there was an error made by the district court here, is certainly not akin to the error. But at some level, you're not dealing with an expert step. If the court has any questions. Thank you, Mr. Lee. Mr. Burgo, you have a couple of minutes remaining? I'd just like to come back to column 4 and address some missing questions that may. Let's begin the error here

. And you can do double, double, twilight trouble in the earth and throw some stuff in, and you can bring out a 99.9% pure improv. Yes, and again, I would turn it to the beginning of the art, which would be what they're asking for as forgiveness, that they use the term that they need not have used or should have used. Substantial purity is substantial purity. It's been clearly defined and explained in the specification. Now, did they have to use it? Obviously, the logic of column 4 is there. The logic compels the purity level of the intermediate to be akin to the purity level of the final product. And that's why the error, if there was an error made by the district court here, is certainly not akin to the error. But at some level, you're not dealing with an expert step. If the court has any questions. Thank you, Mr. Lee. Mr. Burgo, you have a couple of minutes remaining? I'd just like to come back to column 4 and address some missing questions that may. Let's begin the error here. Come 4 is referring to the prior heart car process. And it does use the term regiolicinous in its chemical correct sense that all of these compounds along the synthetic half regiolicinous. That's the prior art. When we turn to the rest of the specification, the inventor was meticulous. He was only using the word regiolicinous, substantial pure regiolicinous to refer to the intermediate and meticulous, in referring to end products as piper-D derivatives. Very clear and tensed by the applicant. The one he's referring in claims of, substantial pure regiolicinous, it's the enemy. And of course, it is, that's what's referred to. Secondly, much of the arguments by Appleese hinges on this idea that the regiolicinous are inseparable and what column 4 actually is referring to, a quote is that in the prior art, they have been unable to obtain a practical separation of random quantities. And that's column 4 in the paragraph 1st and 1st paragraph 1st. So that doesn't that mean the purity level at the regiolicinous, isomer level is going to be the same as the end product? No, no. What this is referring to is that in the prior art process, because you start in the prior art process with a different intermediate, a different intermediate, not the cycle intermediate of the cladins. You have a separation problem in practice. It's difficult to get grand quantities. We claim use of a unique starter material, that's what the amendments in the prosecution history was talking about

. Come 4 is referring to the prior heart car process. And it does use the term regiolicinous in its chemical correct sense that all of these compounds along the synthetic half regiolicinous. That's the prior art. When we turn to the rest of the specification, the inventor was meticulous. He was only using the word regiolicinous, substantial pure regiolicinous to refer to the intermediate and meticulous, in referring to end products as piper-D derivatives. Very clear and tensed by the applicant. The one he's referring in claims of, substantial pure regiolicinous, it's the enemy. And of course, it is, that's what's referred to. Secondly, much of the arguments by Appleese hinges on this idea that the regiolicinous are inseparable and what column 4 actually is referring to, a quote is that in the prior art, they have been unable to obtain a practical separation of random quantities. And that's column 4 in the paragraph 1st and 1st paragraph 1st. So that doesn't that mean the purity level at the regiolicinous, isomer level is going to be the same as the end product? No, no. What this is referring to is that in the prior art process, because you start in the prior art process with a different intermediate, a different intermediate, not the cycle intermediate of the cladins. You have a separation problem in practice. It's difficult to get grand quantities. We claim use of a unique starter material, that's what the amendments in the prosecution history was talking about. And it's that unique starter material that allows us to more easily get a preferred body part, which would be... So you can alter the purity level in your particular starting. Where do you say that in specification? I don't believe we do have a statement of that, but it's implied from the fact that you don't get practical separation in the prior art, what we do in our process. And that was the argument made in the amendment relied on by the district board, where it took the 95% number and different student groups. Thank you, Mr. Frigel. All right.

Thank you Mr. Stobl. Our next key, the same heading. At this time we're talking to Mr. Berga, Mr. Lee and Mr. Wright. Mr. Berga, may I please the court? The district court's denial of the event as his motion for preliminary injunction in this case was based on an erroneous construction of the only claim that was an issue with preliminary injunction motion. Plain 7, and according to this court's law, that should be enough, even though we are in the context of a tentative point construction to send the case back to the district court, because the claim construction is at odds with the intrinsic record. And we have cited the jackup in case we're in a proposition. As recognized by the district court, the term to be construed was substantially pure regionalizer, all three words together. And in claim 7, the substantial pure regionalizer, the starter material, that you used to make the end product referred to as a PIPRA Dean derivative compound, and the fact that ten of you is a particular PIPRA Dean derivative compound that issue here. And the intermediate is described, the PCK intermediate is described in claim as being a substantially pure regionalizer. Why should we begin our assumptions with our claim construction, with the assumption that substantially pure means different things with respect to the intermediate and the end product? Well, I don't think you even need to address the issue because it is not used in different ways in the claims in this patent ad-issue. There's only one use of the word substantially pure in claim 7, or indeed in any of the claims in the patent ad-su. And that is to describe the standard substantially pure regionalizer, the intermediate starting material, the PCK. It is pointedly never used to describe the purity of the end product in the claim line. In the claim line, in the claim line, in the specification, the term substantially pure regionalizer is only used in describing the invention of the applicant as attaining attaching to the intermediate. When the patent specification talks about the end products as related to the invention, it pointedly refers to them as PIPRA Dean derivative compounds, and sometimes refers to them as being substantially pure, sometimes not. But the important thing that I think distinguishes this case from thin control and some of the other cases of this court that have been cited, that you have to construe words in the claims of the given patent that the same does not apply here, because the words were worried about it. Stanchially pure regionalizer only occur with respect to the intermediate. But in the spec, it does refer to the specification to substantially pure end product, whatever. Yes, that's a good one. And would you construe substantially pure end product in the spec of this patent as referring to something other than greater than 95%. With all of the respect, I'm not sure we construe words in the specification, but does it have the same meaning? What does it mean? The meaning when they use the end product is substantially pure, and it may have the same meaning or not. That's going to depend on how many of these things are there. I'm not talking about the same as the intermediate. I'm just saying when it refers to substantially pure end product in the specification, is there any dispute that they're talking about over 95%. Yes, I believe there is dispute on that. So you've got to be skilled in the art would construe that as being could the construe substantially pure end product in the spec of this patent as being less than 95% online. That is in dispute here. There is an argument in a different patent that actually claims the substantially pure end product, the 610 patent, that the particular prosecution history in that patent may have limited the scope of those claims under this courts law. Because it was an explicit disavowal or this claim or a claim. So let's assume hypothetically that we accept that. And so we would construe substantially pure in the spec, not a claim construction, just what the spec is talking about, substantially pure end product based on that prosecution history to being greater than 95%. We accept that hypothetically. How would we, wouldn't there be an assumption at least when construing substantially pure end claim that that two means over 95% and if not why not? It may be a starting point here, but that's all because the term to be construed is substantially pure regialisomer, the chemical intermediate. And one of ordinary stealing art would understand that the purity that needs to attach to an intermediate something that's going to be made into something else need not be as pure as a pharmaceutical grade product that's going to be administered to a patient. The important distinction in our case, you're on is the claim seven never requires the end product to be substantially pure or any particular level of purity. All you need to do to practice that claim is to make some effects of funding of whatever purity. And that claim could have been limited to use the same words substantially pure to define that product. And it wasn't the applicant could have done that, the examiner could have done that, but it is very clear that the only use of the term substantially pure in the claim is to define the purity level of the regialisomer intermediate. When we were talking about purity, that word itself talks in terms of something being 100%. Substantially is going to back off that at most a little bit, right? Well, back and off 100% a little bit. And that's the question. Well, I understand that's the question, but now I'm just sticking right with the claim language and we're not even going to tinker around with the specification. And I'm saying pure is 100%. Now, you're going to back me off to 67% with the use of a weasel word? No, no, our belief is that one of the word there's still the argument read substantially pure regialisomer and understand it. And it's normal, ordinary and customary meaning. Substantially is a word that this coordinate is a number of its cases. Clearly we have, but when you put it in the context of purity, is one of you're telling me that one of skill in the art, what in the record would suggest to me that one of skill in the art would back that off by a third? We don't, it's not our position that would be back off by a third. There is evidence that people of ordinary skill in the art, can't let's just understand substantially pure regialisomer to me largely but not whole and pure. It still doesn't answer the question of a hard numerical limit. One of ordinary skill in the art would not put a hard numerical limit on those words. How far do you have to back it off in order to be able to alleged that the accused product is free? Well, in this case, you're on early evidence is that red back sees intermediate is either 88% or 92% pure. And they use that intermediate to make far and suitable grade effects of finity. So it's our position that it's clear that what they're doing is largely but not whole, substantially pure because they get to the preferred embodiment described in the past. They use that intermediate to make the very preferred embodiment the pure end product of the past, even though that's not required by the claim of issue in this case. So we believe our definition of largely but not fully pure is exactly what one of ordinary skill in the art would come to the conclusion that this is what it means and it would not put a hard numerical limit on the other. Would be anything over 51%. Well, it clearly has to. You're out of refer to 67. Pure purity is pure that's 100%. I'm still troubled a little bit by with you back in the off. More than even isn't 10% already getting impure. It may in a given context. It may not. Okay, what is your best best record evidence that one of skill in the art would say even 90% is still pure. Our best record evidence would be from Professor Jack Baldwin, have you ever had a chemistry department at Oxford, a world renowned campus for the attitudes. And his view is that this term would mean largely but not fully. Not putting a hard numerical limit on it had the examiner or the applicant wish to put a hard numerical limit on the purity of the reach of ice. Well, not only almost me and definite. I mean, if assume that I'm presented with a patent that says the intermediate is largely but not fully pure. So I how do I know when I'm in trouble? If I want to design around your question. If that were that we of course don't believe the claim is indefinite or it's an issue. But if that were the case, then the use of the terms of stanchology which by its nature means you don't have a hard precise limit on whatever the topic is. The judge there is not any kind of a suggestion that you do. If you say substantially pure, that means pure means pure and the driven is not dirty snow. You didn't claim largely, you claim pure. No, we claim substantially pure. And that makes it abundantly clear. Absolutely, but the main thing after the only percentage is clevengers points you could have claimed largely but not wholly. And then we would still get to the well, yes we would because they'd be saying they'd be prying because it's purity. It has to be it has to be. It might be saying your claim was indefinite and then you would be claiming why it's not. Yes. At this point of the case you are. We believe that the claim construction of the district court which imported a hard numerical limit into the claims from only one spot of the prosecution history. But you can't you can't quibble with the process right. I mean the manner in which the trial judge went about construing the claim. And there's clear sensitivity to you're not supposed to import a limitation and there's clear sensitivity saying like I can't just sort of do this while in woolly. I'm marching through the sort of Phillips failings and I finally get to the point where I find this file history on with the 610 patent and I see a disclaimer. Saying at least within in product substantially cure me in north of 95% or get around a prior reference right. So assume for purposes of argument where the judge first started that we that we agreed that the trial judge made no error at least the data point of establishing that or an in product in this field substantially curious north of 95%. Once that happens then. Aren't you going to have a problem? No because the term to be construed here with with all respect. No because the term is substantially pure regional isomer defined in this claim in this patent as an intermediate right. And that's a different invention claim to a different patent with a different prosecution history in which claims code was disavowed specifically. It was not disavowed in this case and the district court aired in taking the 95% number from an amendments in the prosecution of the patent ensued and inserting it into the claim. And that was legal error. Well, it shouldn't be said that but at least we're talking about in that other prosecution the word purity and at least getting some idea of what they meant by purity. But pure and they were talking about 95%. Yes, actually in the 610 patent or under they were talking about 98% pharmaceutical grade purity for effects of fendivine the end product because that's what's required under FDA law for end product. There is no such requirement for a chemical intermediate that is only used inside of a chemical plant that that concept of it has to be pure enough to put into humans is completely absent and want to steal the art of building. So that's the only thing that I would like to say. Thank you Mr. Progop. You know the dangers of trying to split time we're not going to tell you when to stop and him to win the start. You're going to have to sit down when you want your partner to start. And that would be a pro-favorite. Only the issue that I'm going to be addressed has been addressed for me for a larger. No, okay. In that case you're... I just like you're going to have all the time go ahead. I would be more than happy to see it sometime. Go ahead and record what? We may have to see. May please the court. I only have a few comments and then we'll be available to answer questions from the court. As an initial matter Mr. Progop pointed out that the government case and its line of case is included in Bell and Hall. Explain that this area, this type of area is one with the court of real reverse on a preliminary juncture. And with respect, the air and the government and in Bell and Hall were a district court ignoring and express definition of specification. Still legal air as alleged, but it's qualitatively a different type of air. From the initial point you've gone from there. On the claim construction issue per se at the none of the issue, what event is asking is for this court to forgive its choice of using the same descriptive terms substantially purer to describe the purity of end products and the purity of intermediates. But there's no necessity that the two purity levels be the same. Absolutely. They could have clarified in the specific. Absolutely meaning what? Absolutely. You agree that there's no need to be a correct or not. They could have specified that the intermediates has a certain purity limit, certain purity standard and the end product. Why didn't they specify? Because one of skill in the art is certainly going to know the difference. They're going to know that an intermediate is not a final product. In this case, axiomatic. No, no, no. In this case, the purity of one is not going to be the purity of the other reason. In the abstract, the purity of intermediates does not have to match the purity of the product. But I believe that was the question. In this case, the point that's repeatedly made in specification that's confirmed by the testimony of the inventor is that there was no mechanism, no, no method to increase purity or separate after the intermediate stage. So logically, from the description in the specification and particularly that appendix 334, column 4 in the background of the invention, it was made clear that there's no practical separation once you have the intermediate. So the level of impurities between the two regional isomers must remain constant in subsequent steps. So the logic of using the same descriptive phrase as purity is compelling. It fits with their decision, which is a clear decision. Another point that has to be addressed is that Mr. Berghof continually repeats here as he did the district court that the phrase substantially pure regional isomer is only used in the claim and only used to describe the intermediate. I must point the court to column 4, line 19, line 18 and 19, a practical separation to obtain grand quantities of substantially pure regional isomers has not been achieved. The reference there to the second and third mixtures, artifacts of anadone and effects of anadine. Those are the final products and there the precise phrase granted to the plural is substantially pure regional isomers. They're properly described as regional isomers. In the claim, the regional isomer describes an intermediate but here it's a final product. Where does that get us? I mean, the claim language is talking about intermediate. Then why I mean, and you can see that you're not arguing that the claim language also covers end products because the why is the throughout what the argument is that the court was correct on the facts and based on the what he calls an assumption single single term will have a single meaning is that substantial purity substantially pure regional isomers is used to describe the end product in the specification. But you're not suggesting that the use of that term in the claim language is used to describe the substantial purity as as modifying regional isomers and as modifying piperding derivatives. And then you look and you say there's a single definition of substantially pure substantially pure piperding derivatives. That's the level of purity for final product substantially pure regional isomers. That's the level of as to the claims level of purity for the intermediate. Now when I was speaking with Mr. Burgoff, I said, give me your best record evidence that substantially pure has the meaning attributed to it. He spoke sir Baldwin and his expert testimony. Did your expert rebut that? Yes indeed. That's Dr. the expert testimony said a 54 and I mean three pointing out not only that every example in the patent has a substantially pure intermediate but that in the context of this patent, one would understand substantial purity has a single meaning. That expert testimony on claim structure or testimony on science. As I mentioned, he's a certified expert. Mr. Baldwin from Oxford University who said substantially pure means largely been not holy. He's a certified expert. He's a certified expert. He's a certified expert. He's a certified expert. He's a certified expert. He's a certified expert. He's a certified expert. He's a certified expert. He's a certified expert. He's a certified expert. He's a certified expert. He's a certified expert. 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What there is, and I would point the court to not only the 703 prosecution history at 845, 68, but also in the 610 prosecution history, one of the cores of a Ventus' claim construction position is that it's not permissible to separate substantially pure from the term it modifies, but throughout the 610 prosecution history, particularly at 842, 60, 42, 69, 42, 76, 42, 81, in every instance in their submissions in the 610 Sivling application, they define quote substantially pure. And it's some of the claims that were issued in that case, intermediates were issued with respect to some of the prior art, which was at stake in, which was an issue in that appeal, or in that prosecution, a metabolite or intermediate based on synthesis, intermediates were an issue, and they repeatedly used substantially pure set aside from what it was modified. Why did they do that? Because in the 610, substantially pure is used to modify both regio-ICIers and end products. The logic is unassailable, even the assumption, but buttressed with the statements in the 7103 patent that separation is not possible after the intermediate stage. One would have to assume that the purity level at the intermediate stage would be retained at the final product. So there's a logical decision, and of course the same phrases are used as to the point of the same phrase as being used, in reference to the course to the black city or in the taxi case, in which the applicant laid out different levels of different degrees of purity in that case in an independent and dependent claim, and made it perfectly clear that while non-emorable limits were spelled out, that there were different degrees and different grades of purity. As patent drafters, we used words to build our claims. And that's an important decision. And if you're going to continually use the phrase substantially pure, and not use the myriad of other words that you might use to describe purity, you should be held to that decision. Well, except when you realize you're speaking to one of skill in the art, and you can assume that they're going to note the distinctions, and they didn't define substantially pure regio-ICI-Somer at any point in the specification we have before us. They defined it in a prostitution, history, and bigger corrector. They didn't define it, but they did link the purity of the intermeasant. They defined it, defined the term substantially pure regio-ICI-Somer. They expressly defined substantially pure in the context of the 6-10, they did not regio-ICI-Somer. No one is debating what regio-ICI-Somer is in this case. Obviously, the context of an end product. Yeah, so in other words, you're only definition is the end product, and we've already discussed one of skill in the art. Would know there's a distinction? No, based on Professor Schuster's testimony, and of course, a lot of it. Well, that gets us back to Sir Baldwin's testimony, which is a little bit different. So there is a relevance there, isn't it? You're ultimately building on that distinction. The distinction between what one of skill in the art would understand the difference between a regio-ICI-Somer and end product to be. Sir Baldwin says one thing, Schuster says something else. Frankly, what Mr. Baldwin says is they might be different. And seeing the same words, one skill in the art is not a blue. It's a little bit obvious to the use of the English language. But your trump card, oh, this minds all in the intrinsic evidence really kind of breaks down here. Clearly, it's in the intrinsic evidence. Well, and clearly what is in the intrinsic evidence is the end product. What we have is the intermediate. Now, we just went through the logic here. We've got to get back to the point what would one of skill in the art to understand that distinction to be? One skill in the art would place reliance on the use of the same phrase. Why wouldn't they? First, because of the logic of the 703 patent that in turn between the intermediate stage and the final stage, no practical separation is possible. Now, is that, in that particular context, is significant to you if there had been no disclosure in column 4 that you couldn't purify? After the intermediate goes in, your case would be substantially weaker with a child. The case would rest as the district court's analysis would rest on the so-called assumption that the same words in the specification mean the same thing. Aventus makes much of that. Well, you'd have that on one side of the scale, and you'd have one of our nearest skill in the art, justifying the Oxford set on the other side. So what is intrinsic evidence? The same to me that the heart of your case, you hang on this disclosure in column 4 of this very embedder saying, once I throw the intermediate in, games over purification. That would be part of it. Obviously, the 610 prosecution history, which links the phrase substantial purity with the purity of the regialisomer. In that order, substantiality of regialisomer, is used in the claim that is at issue in the 610. And there, definitely. But definitely, one one, scale in the art probably would understand, or narrowly, you can have a 50% pure intermediate. That's correct. A series of 50% ingredients. That's correct. And you can do double, double, twilight trouble in the earth and throw some stuff in, and you can bring out a 99.9% pure improv. Yes, and again, I would turn it to the beginning of the art, which would be what they're asking for as forgiveness, that they use the term that they need not have used or should have used. Substantial purity is substantial purity. It's been clearly defined and explained in the specification. Now, did they have to use it? Obviously, the logic of column 4 is there. The logic compels the purity level of the intermediate to be akin to the purity level of the final product. And that's why the error, if there was an error made by the district court here, is certainly not akin to the error. But at some level, you're not dealing with an expert step. If the court has any questions. Thank you, Mr. Lee. Mr. Burgo, you have a couple of minutes remaining? I'd just like to come back to column 4 and address some missing questions that may. Let's begin the error here. Come 4 is referring to the prior heart car process. And it does use the term regiolicinous in its chemical correct sense that all of these compounds along the synthetic half regiolicinous. That's the prior art. When we turn to the rest of the specification, the inventor was meticulous. He was only using the word regiolicinous, substantial pure regiolicinous to refer to the intermediate and meticulous, in referring to end products as piper-D derivatives. Very clear and tensed by the applicant. The one he's referring in claims of, substantial pure regiolicinous, it's the enemy. And of course, it is, that's what's referred to. Secondly, much of the arguments by Appleese hinges on this idea that the regiolicinous are inseparable and what column 4 actually is referring to, a quote is that in the prior art, they have been unable to obtain a practical separation of random quantities. And that's column 4 in the paragraph 1st and 1st paragraph 1st. So that doesn't that mean the purity level at the regiolicinous, isomer level is going to be the same as the end product? No, no. What this is referring to is that in the prior art process, because you start in the prior art process with a different intermediate, a different intermediate, not the cycle intermediate of the cladins. You have a separation problem in practice. It's difficult to get grand quantities. We claim use of a unique starter material, that's what the amendments in the prosecution history was talking about. And it's that unique starter material that allows us to more easily get a preferred body part, which would be... So you can alter the purity level in your particular starting. Where do you say that in specification? I don't believe we do have a statement of that, but it's implied from the fact that you don't get practical separation in the prior art, what we do in our process. And that was the argument made in the amendment relied on by the district board, where it took the 95% number and different student groups. Thank you, Mr. Frigel. All right