and six years after its january two thousand invention date for whatever reason braintree didn't proceed with one of the three hundred thirty millimeter solutions that met the fleet calling cleaning benchmarked but instead commercialise a product with a volume of nine hundred forty millimeters so now braintree is trying to take this later developed a square peg that is super app and fit it into an earlier in fear of offending you've described it saying that is that what that one single bottle one single bottle is a composition that falls within the claim to the pat the other just the other half dose is another composition that falls within their claim interpretation so each bottle is its own to this aspect of the case one of them is the creation means cleansing and let's assume that we reject that and we say the purgation can see either means of causing copious amounts of stool or cl sing but is there still an argument at that point that even of purgation can mean either cleansing or partial cleansing that still the volume that is required by the here is nine hundred forty milliliters in that it makes no difference that it's split into two parts now yes your honor knows the volume is nine hundred forty million but that doesn't depend does it on the label talks about and that is the volume of nobbles product and that's also consistent with the representations that braintree made to the patent office in their patent term extension request where they had a claim chart claim fifteen and they said that the volume of provision has meaning either cleansing or copious amounts doesn't make any difference because the indian in the end both require nine hundred forty million dollars doesn't make any difference what the purpose of it is it's still nine hundred forty million liters it seems to me that that the argument is there's infringement because it's two separate doses now that there are that that is there are going around but you're right when when you say that volume is nine hundred forty millimeters and that volume falls outside the one hundred to five hundred milliliter claim range so why shouldn't we treat it as two separate doses that's the issue where your honor two separate doses of four hundred seventy demonstrates that they're outside of the significant thing then there's no infringement they're saying if one demonstrates that they were in there is infringement on a not comprehend is that correct is that the position being taken with respect to even if we accept your claim construction what and yes you're honest when you look at the claim limitation claim languages of the compositions cannot produce any clinically significant electoral chips that is the limitation in the claim if this patents construed to be a known to produce purgative effect and braintree is essentially saying that the composition can produce clinically significant electrolyte shifts but you want that question in the district court right i mean that you argued obvious they're characterizing those an unexpected results in the context of colon cleaning and they're also forgetting that under their construction the patent compositions only need to be effective in one patient well that's what i'm getting back to so just stick with me on the client instruction let's assume we agree with your point construct in that regard to the end or piece of this where does that leave you in terms of what that means for infringement is it your view that if a thousand people take this and one of them has this clinically significant shift then there's no infringement yes your honor and that's a very few is the exact opposite right if one person and that was the gist of court if one person takes it and there's no shift then is that there's infringement for ever patient either way makes that infringing or not infringing that strikes me as ridiculous sorry the question is what what does this claim language me and has to mean something in context that is least it seems to me it has to mean that a substantial number of patients are experiencing what are white ships outside of the normal range not just one right what were your honored again if you look at the specific lexicography in the patent they talked about blood experience shifts outside the normal range no we aren't good at that that's not our in our argument no that's not your argument but it isn't that it is a matter of common sense isn't that what somebody looking  referring to are we looking we say we use the term clinically significant shifts are we looking at generally in the population and then ascertaining what percent would be clinically significant with respect to the patient population and your honor there was there was testimony about physicians evaluating patients for the effects on their health but the district court also noted that that subjective analysis was too open ended in fact if you look at the  the things to in the phase three trials and the phase two trials of computation is correct for my course competition is correct shows fifty percent outside the normal elect a wide range and for the chemistry alterations outside the normal range those patients and the and those that data is described in table two of the label at one twenty four and one twenty five and talks about the patients that experienced these baseline alterations in their blood chemistry so on yes you are big because there are many patients who have suffered these alterations in blood chemistry that's correct but just going back for a second i realise that there are many patients who have and all of that i included in the patent let me ask you how could you have something statistically significant for a total sample of three people i know that the preferred embodiment in this case and every table in it to start describes clinical significance in terms of only recommending a split dosage said take the whole nine hundred forty million liters wants would that be an infringement i think that would be problematic as an infringer but the and it does not  and the n d a don't speak in those terms ok so your entire argument with respect to the volume limitation then turns on treating this as two separate those which is correct correct each each dose would be divided up into two separate doses sophist optimally the effect of those may be divided and administered to the patient in two or more in ministration over an appropriate period of time doesn't talking about i'm talking about the patent specification itself in terms of understanding what is meant by one hundred five hundred milliliters does not this language suggest that even if you divide it  two parts is in optimal according to the pattern that you still have to meet the one hundred to five hundred dollars a year limitation you have to meet the one hundred to five hundred millimeter limitation for  claims that deal with purgation in the administration of a single dose claim twenty three which talks about this split does regimen is directed to this type of language in which two doses are being administered over the treatment period one in the evening and one in the morning iran or so effectively what was going on in the structure of the patent is that two composition claims fifteen and eighteen which are incorporated through a series and complain twenty three triggering that so you're saying that even if you follow the patents recommendation and give a split those of five hundred nine hundred forty millimeters that each dose still infringes yes you're on that does not seem to be consistent with what the specifications i think it is your honor because if you look at the specifications and you track it down to the lower portion of our column five for instance starting at line forty nine and following and then over on to column six beginning at line fifty three i'm following that talks about two administrations one in the evening one in the morning and the collection of stool at the inventor's dead after each administer it's each of those  how the specification was set out purged uncleaned are are set up as two concepts and now line eighteen of column one and then over in column two when it's talking about the phosphate it talks about a tremendous osmotic effect being produced the triggering event from the ingestion of the solution and that's to be contrast it with what's in column one it line twenty five which talks about the intestines being thoroughly high and standard then you're probably right about that that taking taking the two doses looked at collectively in order to thoroughly clean the colon after would be outside of the range obviously because of the by the limitation by but the courts focus given the structure of the claim should be on each does not on the two doses collectively it's the focus on each dose which is what was coined if it because to ask a question is it because the nine hundred forty millimeters in your claim twenty three really speaks to the cleansing concept because it's talking as judged i prefer to be true doses over the treatment period and not about what is the and the worry about dosage  didn't because in that hypothetical would truly be a hypothetical you would have a pro geishas a copious watery diarrhea after the first dose in five minutes in your hypothetical you'd take the second  have another copious watery diarrhea that would be the second purgation your honor that would be the second infringement so each administration is an infringement that's the way the claim was made they could have claimed this differently they could have claimed cleansing the collective dose of the nine hundred and and forty millimeters that was not done except with respect to claim twenty twenty three your honor but you distinguishing hector you say you've got to consider what the instructions and there was no instruction to stop the administration at the when that first leader so here too there's no instruction to stop the administration the instruction in for act is to give the whole nine hundred forty mi the telling to get the whole nine hundred forty right at the end that and the label do say that with respect to hector the one leader in hector was never administered to any well that's just so that that  that no one was told to stop and have to the first leader i don't think it matters whether you keep your honor respectfully if you're told to stop or not to stop and the f d a indication as we've discussed is for two doses over the period of time they have to be looked at separately with respect to each dose because of the structure of the claims and each dose constitutes a pro geishas which is the infringing about the inducing of the provision the fact that there is no instruction to stop is is frankly besides the point it doesn't matter if i can turn quickly to  but where does that leave us in this case if there still because i'm confused there's that issue and then there's the paper one patient only issue and you'll take opposite sides of the assuming we jack the clint conception of the district court with it that way there would still be be infringement because even hundred novels interpretation of the clinton structure which as you know is any value or point zero zero one outside of the upper or lower range as was pointed out by judge judge died there is a significant portion in the record of the clinical trial subjects who had  infringement because fifty one percent did not have shifted that's your view i mean in the analysis here peach if you were taking the one patient theory well it's struck me as a little story well actually your honor i think injunction but with that go to a measure of damages meaning if we had the view that this claim construction seemed absurd to us but nonetheless was consistent with the step back with the answer be damages if it really is the case that ninety nine percent of their people are going to have problems only one is not or whatever you know maybe would that be a measure of damages it would bear on damages but i think it's critical that the record you are reviewing his not this hypothetical are asking that the claim construction be one or more which is consistent with what the court's decisions are and we asked the district judge to apply when we want to say one or more that was one form or so you're extreme as a position of one but on the record that was presented below and the expert testimony that was creditable law clearly by the district judge he was looking at a situation in which a substantial number of people first of all had no ships and secondly under the construction that were originally just fully supported by this fact which we haven't talked about that that that's that that was supported because all of those out of the range that judged i prefer to work classified by the clinical investigators as not clinically significant using that term as it used in the arts and as it was expressed in this  think is how many people have to be outside the normal range before there is non infringement the only data here are the ten summary judgment record of the phase two  arguing this i'm not sure if i want to be sure are you saying that there is a limitation in this claim somewhere i think you're not arguing this but i'm not sure you said yes to judge dykes i want to be clear about what you are arguing think there's a limitation somewhere in this claim that requires you to establish a certain number of people who do not have the abnormal shifts in order to successfully infringement a percentage fifty one percent whatever judge take was referencing the studies and you were saying yes to him in terms of yes the evidence shows this but i didn't think that you were saying to him yes the claim requires that sort of thing i thought you were still arguing your one person right i am i am clearly not saying that there's any requirement for braintree to prove as a matter of its return for burden of specified percentage of people are you in your position i demographics so your argument is your evidence i e the number of people that have no shift support the injunction you got because like if we really were talking about that hypothetical of only one person the injunction would seem extreme remedy right if only one person out of the five hundred thousand people that take this product actually experience don't experience a shift it would seem that offering an injunction in that case would be overkill correct but that is not this record that my time is expired children the conclusion we would ask that the courts four nine to five based on that data there is no infringement if the court were to revise the claim construction and find that clinically significant were to mean something beyond just one patient braintree admi copious amount of diarrhoea then that broad construction must be applied with respect to obviousness and your hon to create an imbalance and are not associated with the side effects like fleet so if braintree is saying that this patent is about sulfate salts for inducing only purgation a copious amount of stool without