achieve approved indication in fact they are the only way to achieve the approved implication while following the label and that's why there's clearly infringement under this court's precedents now limiting ourself as we must and why the earlier decision that was made i understand your arguments about the one hundred to five hundred milliliter point and why you believe our earlier decision took that off the table what i don't understand is your argument about judge dykes suicide on tape points about and was an unapproved use if no more party argued to us in any portion of any brief this  party even argued it to the record and then just didn't appeal it to us this was sort of a product of a judge's about education and it appears in the dissent we did not even speak to it in the majority we never mention the words why would the majority be viewed as rejecting an argument never having been made in the case at any stage in the proceedings or an appeal even an oral argument why would the majority viewed as for rejecting such a different argument from anything that had been made before i understand your one hundred five hundred milliliter argument i don't understand if you are claiming that the majority rejected the unapproved use notion which is specific to and the two seventy one he claims how the majority opinion can be viewed as having rejected that if i may just more correct one premise of the question which is that this argument was not made by novel in the district court it was untouched sheridan in the district of new jersey this on a pew proved looses argument seems completely divergent from the arguments related to progression the one bottle theory the number of else's there present those arguments are all very much interest wind and so i understand exactly how you are relying on them in these other cases i believe that the arguments were likewise in zenith for example intertwined in a way that it was reasonable to assume the majority had implicitly subsoil n c o rejected it but i'll be honest with you the unapproved uses idea i was like oh i don't know what to make about that and boy i'm not going to touch it the majority cause was briefed by anybody so there you go there you have an insight into exactly what the heck went through my mind when i saw his does that your honor i'm not going out to convince you of what you mention a prior decision so and we do not need to do that in order to prevail on this issue because even if the novel opinion had never happened the district judge in this case was still wrong to reach the conclusion that the court did and i'm happy to turn way to reverse the district court in this case but even if that opinion had never been issued the district judge was wrong to do can i can i summarize your unapproved uses in a slightly differently than we set it and see if it's not molest something that you think is is an accurate reflection of what you were arguing it's exactly the use this is different from cases where you know it's discovered that we have one pass from birth control pills can help pre menopausal women with hormone imbalances right like that's a totally different use i mean it bears no resemblance to the use for birth control but this is a case where it uses this is from a factual matter i can agree with every statement of law and judged opinion if i want to dissent but nonetheless from a  i thought it was and it's the point is this that the f d a has approved directing a patient to perform the patented method it's just done it in a context where it happens twice once on the first day and once on the second day i but they stipulated to these things they did so this is not a case where i have to conclude and make any fact findings about whether a purgation is the method or whether a purgation occurs after four hundred seventy three because those are all  this case would be to create a special new hatch waxman specific rule which is basically what breckenridge is asking for and what the district judge did which is to say that if you add a second instance of the end of the infringement other unclaimed matter that somehow court has always used the label as a way to figure out what's going to be induced when the generic product is market but there has never been a case that i know of the record certainly doesn't cite the one that says that a patent can only be infringed if it covers every the pride of court's decision didn't address that as to the issue of the volume limitation there are two places in the record where i believe they come very close to admitting that that argument was not made it all the first one is that page  one zero two nine of the record which was a joint letter to the district court judge in connection to a request for permission to file the summary judgment and here's what they said novel did not appeal the district court rejection of that non infringement and what they were referring to was the volume limitation and instead appealed the court's infringement finding on other grounds they also said something very similar although a little more who cares what they said right i mean they can say something wasn't waved or was waved it wasn't decided and was decided doesn't it only matter whether we conclude the court decided that yes yes ok start  issue well i would submit that you can look through that opinion and you can see no discussion except in judge drugs percent of the volume limitation argument that's not true we say at one point four hundred seventy three even milliliters i e the one inducing purgation from about one hundred to five hundred milliliters i'll tell you all of your arguments about what the specification in the example says and how to talk about total volume if there are multiple doses they all add up together i agree with everything you say the difference is a most of those examples go to cleansing and we've already determined and this we are bound by the purgation is not cleansing it something less than cleansing it's the beginning of the process of clean cleansing the colon but you don't have to cleansing and so here what this claim covers which differs from those examples is it focuses on the amount of liquid you must consume to induce purgation not to induce colon cleansing with all due respect which i believe  that inducing purgation is a claim limitation but what has to be administered is from one hundred to five hundred now how do you determine whether one  very simple it's very clean and elegant and it's completely different it's there is an independent limitation a one hundred to five hundred milliliters how do you determine whether that imitation applies to a partial dose or to the full dose the only solution in each and every instance they are referring to the total volume of product that minister which tells you something about it doesn't necessarily dispose of the issue but i believe the prosecution history does it tells you something about what that one hundred to five hundred means now you look at the prosecution history when the braintree folks were trying to distinguish over the new show and the giuliani reference how did they do it they said unlike giuliani which provides for which has four leaders or two leaders i don't know which was which volume we have one hundred to five hundred and they did the same thing for nissho as well so they're saying when you're looking to see what one hundred to five hundred hits you look to the total volume of what's administered twice that i'll get to that issue fifty one hundred one hundred said to five hundred your other under that under that under the proper claim construction but one hundred to five hundred refers only to the total the total total volume necessary to achieve colon cleansing necessary necessarily a disclaimer about what volume is necessary to induce purgation i believe the predicate to your question is incorrect and i would address it or direct you to page  predation versus clones but claim language is kurdish they say this show is different because of the difference in the volume similarly at the age of fourteen twenty six with respect to giuliani they said during the had submitted they said well we understand that there were certain statements made during the prosecution but those statements weren't necessary for us to get all the references they were unnecessary because the prior art solutions disclaimer during the prosecution history even if you were not required to do it even if it wasn't necessary for it was another way to distinguish your invention you were bound by it so our view is number one plain language plain construction using including the prosecution history number two if you don't agree with that there is an expressed disclaimer at the two pages i cited in the other coordinate sites are going to show in giuliani i guess i don't see it as an express disclaimer because what i don't see is them saying that nice so discloses to leaders for purgation what i see is the only use the word purgation in here i mean they talk about a with clarity how their statement relates to purgation vs cleansing which has now in the infinite wisdom of this court been declared to be something different i don't know if that decision is right in hindsight i'll be honest with you i kind of looked at and thought i don't remember that case as well as i now see it but i'm bound by it that much is one hundred percent clear which more i think that you don't have to see those words in their statement to the prosecution is true because the only word in the claim was judge said why if you look at the specification when ever there is a discussion of either the prior art or the experimental solution which was the only example given or what the experimental solution is compared  drinking copious amounts of liquid and here's my favorite part they measure the input and guess what they measure the output so you can cut and put measurements and out put measurements so alone you're consuming various amounts of liquid on route to what i clean clean colon but but the whole point and that's and so it makes sense that they're talking about the total amounts of volume in the course of that experiment but that's different from saying the total amount for  development we increase the volume of the solution relative to the experimental solutions so during the process of getting approval they increased the volume now what they did this patent was directed to their product i assume as it existed at the time they prosecuted the patent they got the original patent two thousand and five they got the re exam certificate issued in two thousand and nine there and they didn't get approved till two thousand and ten and what we learned from cleveland that eight hundred eighty zero is what happened is they increased the volume of the product because it couldn't keep stuff in solution and it was unpalatable it kept products still pending approval we have tentative approval you're our final approval is is  is on hold only only because the f d a has not yet finally determined that there's been a waiver of the first file or exclusivity that lupin which purchased novel hass so that's the only issue holding us from from from final approval so how do we know how can we confirm from the prosecution history that this is in fact what was going on when they felt for a patent term extension when they where we disagree well i think that your honor will not actually disagree on that point because i would suggest that claim language which has a comma and it is saying claim element one claim element to claim element one purgation claim element to is whatever is accused has to be one hundred to five hundred so let me transition very very quickly if i may leave it to the f b i issue and tie it into this the f d a has approved only one product the one product is a nine hundred forty six milliliter product it happens to be administered twice but it is a nine hundred forty six milliliter product we can't sell it for seventy three we can't tell a patient to take only one box there is no evidence on the record and there was no argument that was ever made by braintree that any patient has ever taken just one bought were that we've ever courage the patient to take one bottle or that any patient would take one bottle the instructions are clearly approved use is clear it is only the product that is nine hundred forty six milliliters if you agree with me that there is an independent limitation of one hundred to five hundred there because the only product that that your client also was providing the two separate five hundred milliliter divorce we are required to do that your are we have to sell two bottles and we have to provide the same instructions that are in the absolutely correct and we cannot but a patient we are not allowed to market our product or a top otherwise do anything to induce a patient to take only one of about if  cannot we can only work it that way but again the total volume is nine forty six we sell them one product we can't someone bought the f d a would never approve one bottle because it's got to copy the label of the brand name comic so we're selling one product the product is nine forty six if you decide that that limitation is an independent limitation and you will agree that the independent woman television covers the total volume of that minister that we would succeed i would submit three hours and what would have been even more unpleasant than that is going for the colonoscopy and having the doctor say you know what you must not have had the full gallon because i can't see well enough to do this procedure go back and do it again but that's really what the invention was here instead of the prior art isotonic solutions to prep was specifically designed as a kid with two separate bottles each bottle carefully engineered to have just the right balance of salts just the right volume of liquid so that hear any effort to situate his additional limitation of the entire treatment period in the plain language of the claims he can't do it with district court couldn't do it it's impossible the only way to do it renders the claimant coherent because it means that the back to the antecedent eight composition for some reason that then is going to be referring to the total amount needed to induce cleansing it makes no sense that's why mr lieberman runs directly towards to the way that few reads the specification and the prosecution history but required as long as the label induces performance of the claim method there is infringement the fact that there may be something else besides does not matter after she already when the something else besides is performing the claim method a second time if the court has no