i like to make two points to outline for the court where i intend to proceed to address the merits first claim one we submit is not indefinite because the district court misconstrued claim one and under the proper an extended release formulation providing concentration profile you're talking about how to measure it this is an empty claim it doesn't tell you what there that gives you that at that profile aside from how you measure it and your honor with respect first of all with respect to the extended release it's our position that any well your honor we would say it's definite because it it also tells you what you compare it to what you want you conduct the human trials with a single dose of the extended release it gives you certainty biked indicating to you because five to fifty milligrams memantine where in the administration of the dose provides a plasma membrane concentration profile as measured in the single dose human p k study and we say once that's done it's measured figure that shows two computer things teaches that when as you as you agree the claim requires one of them has to be human the other one stays computer of figures one and two d to hold otherwise we submit respectfully would read one a and to be out of the claims they would have no meaning at all that's what they teach the skilled artist is to is to compare the human trial to the comparative which is one a in one b and i would add your honor that the information that is contained in one a and two d comes from the gastro plus program which as a record will  show stimuli that simulates the actual behavior of the drugs in individuals and it's been used by the f d a office of generic drugs to predict what will take place so that's the compar to the individual profile that's in one a in two d which is end up being formal a standard is what the inventor disclose so aside from any qualitative judgment that's what the inventors chose therefore we contend it's not indefinite one may not have found the same solution that the inventor found but as we know the test for indefiniteness is whether or not to reasonable certainty and it also has is supplemented by the public declaration the gastro plus computer simulation is well known in the r and posa would have known out was generated the know or she or she would know that how castro plus works this is a well recognized tool and you get the figure one day which is the i r curve and what it actually gives the poster something very concrete and firm not subject to many of the variables that i i expect my opposing counsel talk about they could give you figure one gives you that and it's you get a judge that's what i'm looking at to that the human plus to generate in this case the immediate release curve is has been derived from human data and there has been found by the f d a to be an excellent predictor and so what i'm attempting to make in terms of the point is it actually gives the poster some comfort in terms of definiteness they know exactly where to go with the results of the extended release formulation you look at one eight you know what the t max is half of that yes you looking at human study versus human study that is wrong in suggesting as an alternative that the i r in the e r have to be assessed in the same human study i've had a difference of opinion below your honor that's correct the gentle way of making the point that you have your hands difference of opinion however the court the district court had that construction for them but how can you rely on that know whether a given thing was inside or out of reasonable certainty and what we're saying is both constructions were before the court we've briefed get i would suggest that the waiver doctrine as i understand that often the court of appeals applies is resistance to a claim construction that's offered for the first time on appeal and was not there to be considered by the district court so we can attend the air was committed in two ways one we believe the district court should have adopted our claim construction and using one a as replicated in two d for purposes of the comparison and its not as  variable it's indefinite and that as i understand it is what judge starr concluded that a that's the right construction and b that under that construction is unfair but then he said in the alternative  match studies so why is that your alternative construction not the right construction ok so when we notice that issue wave it is certainly waved where in your red brief did you say they waved they can't believe where it is your honor because that's the waiver footnotes don't ask pardon me i think the footnote of company tax i'd have to find it  appellate side though you do have a waiver if you are making that argument and you're changing positions on appeal but let me ask you sir answered of such in a week of this i think it's more important to understand what happened when we know what our claim i both e r and i are to be done to be evaluated in the same human study simply has not been decided i believe it halves your honor and here's why because when we narrow definition down well let's take must take a step back read the district court as having final and that if you take that approach it would be indefinite i i think i take it this to be i guess i understood this issue really has not been litigated because the claim construction that it depends on is one that forest said was wrong and judge starr seems to have agreed with that i think george stark findings were broad enough to cover three alternatives for an appendix creech thirty six that testimony referred to was a variation in the relative numbers that is between the e r n r but at the more or less full stop there may have been testimony about whether you'll get a different result with that ratio between tests so one skilled in the art could pick test eighty and run it and eliminate or minimize our expert said some of the variables there but then you could run  well and minimize the variables there but you still have variation between these two tests or between test your age or x y z and that was the point of the district court's finding on the first claim of trepidation and it doesn't that's adults that are fed or of his designs that he see that are pediatrics and unfed and i can mix and match the variables and that's what the grab i'm in of the opinion wise is that you can design all of these studies specific concrete example of that in his declaration so the district court's findings extend beyond the initial claim interpretation that he made if you choose that there's not a waiver and choose th alternative interpretation the district courts finding still are not clearly erroneous and render the claim indefinite you would have to affirm in my opinion regardless but i do believe there's a way to your honor i do believe you cannot it's not in all fairness to district court judge make an argument and then win on it which is what happened here and then they want to appeal they say they didn't live you know standing to be a certain i mean you reach kind of arguing now against exactly what you argue for law except that as an apple levy as your honour's are aware i am allowed to support the judge and with any arguments whether they contradict him or not because that is the judicial process for trying to give certainty to what's happening at the record and to respect the process so apple isn't a balance or i think situated differently in this issue of stop jesus show tha it can i ask you yes highly technical of question there's this old seven zero nine patent that was originally in the one to one action and yet i don't see a judgment about that patent judgment now is on the phone for the worker does contain a short single dose human p k study and that's in the prosecution history why isn't that enough to support the the figures one a into opinion when he got to this claim limitation he basically focus this says human trial everything has to be a human trial and that was that was the end of the analysis and so he never there's no evidence that we can find in the record that he actually considered the alternate construction but nevertheless it was before him and his read read the waiver cases that was not in any sense waived argument then as it is in what is today's we believe our primary position is correct but if not this court we believe is obligation is to decide whether or not this calling is indefinite and if you adopt the alternate construction which is th profile and the e r profile are produced in the same study then all the variability is gone and judge drunkery your questions i want to i think we need to point to memantine composition is less than fifty percent of the i r is to use the same study he tells us it's the same study and an appendix six forty he says by putting him in the same study  minimizes the impact of any differences and therefore you get accurate test of the formulation finally an appendix six sixty seven tempests gave their alternate can claim construction and thought they propose that in the district court as an alternative construction i don't read this you know crucial i guess was a paragraph one nineteen on page six seventy one as going beyond saying to get a reliable number for it to killer study comparison you have to put them in the same study i don't read that as conceding that if you did studies one through fifteen fifteen each one with the r and i are in each one that you would get in fact a reliable we lie at least stable ratio across across all of those studies at what i'm not sure about is whether this issue has actually liberated and that's why we suggest and ask for if not an outright reversal than re man to give the chief judge a chance to consider a very important question which is if you adopted the construction urged by tabla would it be indefinite i'm confident that he would reach the conclusion that it's not indefinite but he hasn't had while he had the construction perform he didn't rule on it is just opinion