whether the district where they're going finding adequate britain description for a claim eleven a claim which was added by amendment years after the application was filed the district's people can ask you question about it maybe i'm confusing this with something else but description and i assume you take issue with that you know it's case law is a little thin on the written description area we just haven't had that many cases but do you isn't that what the district court plaintiff's expert was that that dissolution profile fell within the scope of of the claim right even though there was this open issue about whether or not that was obtained using the proper u s p apparatus to dissolution method as claimed as opposed to the unclaimed u s p apparatus one but leaving that nd issue aside we certainly take issue with the fact that the entire range of dissolution values could be supported by this single  dissolution profile and in fact i don't believe most of all the distinction profile as a result this is a method of creating obesity which consists of steps it's the steps to describe those steps to describe the adventure the dissolution profile is a result that's not a step so why is that relevant to satisfy me written description why and when the steps have adequately and as well i understand the question so the dissolution profile here is an in vitro dissolution profile it's not the inherent result steps in the claim all decided in the patent and therefore the written description weinmann is met the dissolution the particular dissolution profile is absolutely a limitation of this be a property of the tablets that are given those tablets have to be characterized by meeting this certain dissolution profile in other words according cording to this us p standard apparatus to paddle method w happen is the way the tablet is engineered it has to be constructed with sustain released except b n c in a very precise way the testimony was that it took over a year to get just that precise dissolution profile that was claim there was no testimony certainly on this a trial whether or not one percent is in fact less amount or not less than one percent but the the reality is this pattern simply says nothing at all about a range of values at eight hours there is a single data point for the at least ninety nine percent at eight hours that is in table ten of example three and it says ninety nine percent exactly now six years have to the patent was filed maybe it became important for the combinations that can be used for the one into our upper end points and the question was asked by the district court judge to dr tracy plaintiff's expert does it make any sense to mix and match and combine these in that way and dr tracy's explanation i mean submit was less than compelling and he just simply said well there's pharmacokinetics involved and it may not be the case but he certainly didn't say that there was a rhyme or reason for selecting one value over the other for the upper end  or i don't like those were there the court obviously did not concede that there would have been no rhyme or reason to select those values because he so held in the opinion or point being that there was never offered in this court's opinion any reason that a person of ordinary skill in the art looking at this application would have had the appropriate place marks to make this combination together with the multitude of other selections that needed to be made to get this dissolution profile so work disagreed with you there to the court certainly disagreed with us because he found adequate written description for that for the claim but we submit it was a or legal layer on multiple and the court went to the fifteen percent h p and c data plucked two data points from that purpose and use those to support the lower end point even though that was us p one data not us p two and even though the unrebutted testimony was that the us p one in us p two data are not comparable and produce different results and if there were a difference between ten percent and fifteen percent h p mc in that table there is a difference in the testimony was that none of those fell within in the scope of the claim but i think both experts said that the ten percent was too fast for police to qualify as sustained release but there was nothing articulated that would point specifically and say as an integrated whole this profile this dissolution profile where you need at least ninety nine percent at at eight hours even though the there was no range patent at all this was just invented out of whole cloth in the amendment to say i'm going to take this eight hour data from table ten even though there's no range i'm going to combine it with two data points from table five and reject all the other data points and then i'm going to take this aggregation of upper bounds from column thirteen and with no district court credited dr saying dr tree see it committed it also meant the same error that the district court did which was simply look at the claim and work backwards using the claim the amended claim as a roadmap to go hunting for support in the specification there is no way that a person aboard mary schiavo in the art without for knowledge of this amended claim that did not exist in the application would have been directed to select those two data points from the fifteen percent h b m c tablet selectively pluck them out reject the remainder of that profile because he didn't fall within the scope of claim eleven so this claim was amended  prior that was in the prior art so what they were trying to do was quiet down a very narrow niche around their approved drug product contrary to very narrowly trying to capture the dissolution profile for the contrail drug product which did not even exist when this application was filed so that is the the reason this was put in was to try to get it for the very st time a claim to  necessarily predicated on our thinking that it's sufficient to disclose decreasing sugar in carbohydrate with to cope with the way forward cravings is that in your view a qui to trying to achieve weight loss and is that necessary or is your view the prior art also disclose not just the diminishing things but also the weight loss to the company for the woman one i would say all of inhibiting the the weight gain and that was because of appetite control that was because it causes you to eat less have less hunger cravings and the position was that necessarily in the obese population is going to lead to the we score claims were amended to remove the reference to the standard dissolution test and replace it with a specific reference to have them and what does that mean well i think what it means for purposes of infringement you need to use that specific paddle method but if you look in terms of the one hundred and twelve issues it was the patent is clear that you can use one us if you want to u s p two are equivalent to one another the experts are expert testified that they're equivalent and effectively said that they were equated to one another and in addition another important fact is that when in that one time in that amendment when asked for support for the dissolution ranges the inventor's pointed to table is that there were numerous failures in the obesity are at the time of the filing in fact there were only three approved products for obesity as of twenty thousand and thirty one was fanfan which i think everyone knows which was withdrawn by then the other two products one was withdrawn shortly thereafter and the rd one had significant side effects and the reason that this is important is that that's why i did this record said that the defendants were using hindsight because in this art when there's all these failures you need to use hindsight your pick that combination when you look at the references themselves when you look at them closely this is what you'll find you've got the jain reference which talks about the croaker in having a modest that best weight loss effect in fact if you look at the  cessation issues may not have the same thing going on either in their neural system or otherwise and a person who is obese and in fact a person who is smoking cessation could be skinny as a rail not have any obesity issues the same thing for bursting which goes to the carbohydrate craving a judge process you raised that before the testimony on the record that was credited by the district court from dr seeley is that they're not the same the carbohydrate craving doesn't necessarily mean weight loss so i think when you look at the record if you look at  well i would disagree around her st for example if you disagree with what i said the reference t j don't correlate well i think they talk about weight loss but the only testimony on examples two and three was from our expert defendants experts don't rely on for example two and three at all and what our expert said is that those patients were very complicated and if you look at what went on with those patients what it effectively says is that the carbohydrate cry trading came on as a result of the other drugs they were taking so they're taking some other anti depressant you have several references here and why this testimony control one we can simply read the references because as the r x for explaining these patients are very they're the disease states that they have a very different and very specific so i don't think that as a layperson you can look at these references and say well i know exactly what's going on that we had medical doctors both sides had medical doctors take the stand opportunity to provide testimony and directly across the fact the matter is is  the district court credited our experts and did not credit activists experts even including testimony regarding examples two or three of dante what about that  so this record got it right the guy the facts was in that one that this report in fact said was well you don't have anything to back that up right you don't have corroboration in the in the case law it's pretty straightforward on corroboration the clinic in case you need i don't really remember what i did exactly he did not say i remember treating these patients and this would happen and in fact if you look at the table the result is so there are six patients in that table the st four are no truck zone in philosophy in the last two are not trucks on and been programmed and for both they said one had no effect in the other the effects were questionable so even if you were to assume everything came in and that that is not enough to say that the combination would be a success be allowed to to do it but i agree that so if you've got a disclosure particular tasks that absolutely particular task then you can satisfy a great description by saying well this is another test but substantially quickly i don't know what that means maybe functionally result and well i don't think that they're challenging that the u s p to paddle was not described by the patent they're not saying that the claim is invalid because of the u s p they're saying that the data that was obtained was not using right i mean we are driven by the claim even if the specification has other tests and that we're we've got this test here right infringement is going to be determined by the stats yes right right so that test he theorized that they would give different results but he never said that they actually did they never saw any data of course is active is a burden of proof to show in fact that they provide different results and if you will that's not that's i don't know that's my question to you if you to test a firm test one saying they're the same thing neither side submitted any testing data on that point your honor so what the point is is so if you look at this claim the claim is to a dissolution range and as the judge pointed out if you run of the solution task you get one point but of course we all know that this allusion test can vary from test to test so that the inventors have the right to claim the full scope of what they reasonably reasonably believed to be their invention and what they said in that amendment is that we believe that the claimed invention would have particular dissolution profile tham they base that profile based on data and the patent and that's all they were required to do they were required to have data in the patent or something in the did not have to include the entire range as long as they disclosed one whole point on that range and that's all table five a table ten and the bets do right they don't disclose the entire range right they don't enclose entire range for the very reason i just gave which is that they only provide one point so you need to have more than one point for a range so what the district court said it was reasonable for the inventors to take the fifteen percent the solution data from table five which was the st time that there was actually sustained release the testimony from both experts was that the five and the ten were immediate release so that we became the lower range and they went to the specification where it says the higher range could be i think it was seventy percent and because the data only gives you one point in order to come up with a range you have to go somewhere else to develop it whether it be from a discussion in a specification for other dissolution data and that's all that the applicants did and the district court understood that and how and ruled in our favor talk about no less than one data is described the sustained release properties of the drug that's being administered and that was were different than the prior art so this whole bit about ninety nine percent you know needs to be a range or would you know i don't even sure i understand all their argument the bottom line is that ninety nine percent is essentially the same as one hundred so it covers ninety nine percent or above and that's the way they claim limitation rates i would just like to address just a couple quick points that were made there st of all the lockwood case absolutely says does not say that something that is substantially equivalent is the same as the invention itself the holding of lock which is directly contrary to that it says you show possession by showing the invention including all of its claimed limitations not possession of something that renders that obvious so you don't show possession of an invention by showing something similar to the invention and that's really just a kind of saw argument as to why the example to data should somehow support this claim but now as a factual matter the evidence is that they are not similar the testimony of that was not even considered or in that district  it's not mentioned in the opinion whatsoever so there's no indication that the judge did consider this evidence but it's critical because it goes to the fundamental issue for the written description which is disclosure of us p one does not indicate possession whether you use the u s p one technique or the u s b two technique because you get different results for the very drug that we're we're talking about here so that was clear error for the district court judge to either overlook or ignore this testimony and that's range we agree so how can a disclosure d of ninety nine percent exactly so for the range of ninety nine and above it may be a small range but it is still a very very small right it is it is still never the less rang