going principally to how many where in clauses they have contained within them but i think generally speaking it's fair to treat the forty five to me as being representative and with that on their face the claims at issue here look virtually indistinguishable from those at issue in bristol myers or compact soon or other cases where this court has held that the recitation of results where in closets or preambles was not limited much like those cases the asserted methods here where in cl learned they can be just like language in a preamble can be limiting and the question really here is when when is that the case like like those cases the asserted methods here involve a single manipulative step that is administering a fix law twice daily and this is not a case where allergan used its results to delineate between compositions that were claimed and compositions that were not claimed on whether they achieve those results there is no evidence of any such distinction anywhere in the intrinsic record and the intrinsic record does not reflect is that i mean if the test is that we all agree that the test is whether or not it makes the manipulative difference and if on the face of the claim we're reading the claim and that limiting phrase that that phrase that we you know we're deciding whether is limiting or not differentiate between which formulations would be covered by the claims and which were not well adjusted net well i don't understand what more you have to prove that's what the claims that claims that are not do not meet the e and safety limitations would not be covered by the claims well she just respectfully i think that is really the question here is whether or not the compositions that would not meet the efficacy and  the adverse results terms would be excluded by these claims and you won't find anywhere in the intrinsic record where they suggested that the use of such terms was instance wasn't there was that the one where there is it was the the court relied on the fact that it was redundant for other language so it didn't serve the purpose of being a manipulative deference because it was already included in another portions of the clay so isn't that a basis for differentiating that case from this one well respectfully chief judge prose i don't think that that's true with respect to all of the terms that were at issue in comparison for example there were terms that required th advocacy as twenty milligrams being administered daily or the same reduction in adverse events as twenty milligrams being administered daily this court found that those were were not limiting and i think that there's really no difference here the question on whether something is a manipulative step goes to whether or not it changes the method so whether or not a patient experiences a reduction in adverse events in this case the steps are going to be performed the same way that's exactly what bristol myers says is not a limiting term and the only reason that it would be limiting is if it would be quote material dependability that is this court said it's either got to be manipulative it's got to be structural it's or it's got to be manipulated to meet material dependability and so the question is what what has this court meant when it has said material to pad the building it can't just be oh well it's not obvious were it wasn't in the prior art because this is claim construction we're talking about it's got to be that it's being used to draw a line to exclude material in the words of georgetown rill that it would that reflects the quote intent to exclude in this case formulation that does not meet providing consult terms is not covered by the claims and they reiterate this pages for thirty seven dollars forty cents of their brief the problem for them though is that before this litigation they claim construction i mean that it before that in order to reach the conclusion that he or she did reached they conclude that this was a distinction in other words under the claimed construction no matter what they said before after under this claim construct from certain claims who don't need this ep to see and safety limitation would not be covered by the claims and what this plane construction correct that that is the conclusion i think of that would come from their construction the question is whether their construction is right which of course i spent revising to know that that's what i was it's not a question of what they said before what they are or the question is whether or not this claim construction is right and i don't see how using statements they made or appropriate well the reason i think they're not only probative but honestly dispositive chief judge gross's because we're trying to answer the question of whether or not something that is recognized as being exceptional that is a for seventy years the jurisprudence has been results are not claimable they don't add anything that's limiting and the only exception to that is have the used their results to basically engage in functional claim drafting then instead of claiming that we have a lot of these kinds of claims and if their challenge didn't go down typically it's on the validity side right rights protection and enablement that's where we see with some frequency challenges to these types of of this is really a question i don't know is the differentiation to be made between whether they were intended results or whether they were unexpected results well i just can't to claim unexpected results isn't that she just froze and i think the question i think the question is whether or not they are resigned it as intended results and part of how you know that that's all they are here is that when you look at what they say that they have to prove for purposes of infringement they don't have to prove that these results occur in any particular given individual person and that is exactly what this court has recognized is the kind of kind of in this indicia that it's not that it's not limiting and that gets back to when you look at georgetown record and looked and asked was it being used to draw a line was it being used to define it wasn't in the words of a bias a group is not a list wasn't about ascertaining the boundaries and it just simply say the only reference in the intrinsic records of these unexpected so so called unexpected result was in supporting arguments about non obviousness or why there would have been a motivation also prosecution history you're right it may have been in the prior obvious the contact that the patent examiner where they say that treatment with the composition claimed here in is what unexpectedly resulted in reducing side effects that's at nine hundred and forty six and the that it is that the twice daily administration  know wearing clause is limiting because it's not doing any work to distinguish what's in what's out and if you say well they can just written write it in the claim and then argue after the fact what it was many claim construction and says whether or not we think that we would have they shouldn't be allowed to have the choice they shouldn't be allowed to write these types of things into their claims just simply go out and test do their testing and write the absolves they observe that's literally what they did here you can see at appendix three  or i think we have a situation where i have a tougher in french me case but i feel ok about invalidity so i'm going to say they're not limiting they don't get to make the choice after the fact the question is did they argue either in the examiner well respectfully just well i think what they were doing was was telling the examiner that yes these are attributes that different prior art compositions didn't have these are results that  new compositions not found in the prior art so they were distinguishing their new composition from prior art compositions and yes they were if you know extolling the virtues of their new composition and why and in and in fact they were extolling the composition as presently claimed and they can't say well that includes the efficacy because the whole point that they're saying is that the composition is what it used the efficacy and also point you to the earlier prosecution of the composition patent which shares for all practical composition was not inferior to that of concurrent treatment i see that i had a call i think it's my rebuttal time but i'm happy to take further questions from the court thank you thank you very much the same place telling the examiner that the prior art does not teach that you would yield this combination that would have these results and that's the dividing line that you're looking for work between those combinations that achieve the results and obvious subject matter and fundamentally their position as this courtroom will that allegan with all the record that we've made in this case over a decade went back to the patent office to cure some claiming defects about the salts and secured canada obvious subject matter it doesn't make sense of course allare and in the intrinsic record in the file history described these as effects that are required if it is even in the specification describing the need for these compositions that it cheve these results question is whether or not and that is issue and it's versus others that does that mean that laid out and that is laid out actually we actually t on but but it the debate was under the bristol myers case and it's very interesting we have the st american case referred examiner by all the parties and even in the st and as to whether or not this was an inherent result in the court concluded on the record in the st case we couldn't conclude one way or the other whether was inherent and therefore the claims that we then went had a trial that was the trial of the nd case where sandoz attempted to marshal evidence to prove it was inherent and the court ruled the claim both said that it had to be the regiment being sufficient to reduce the frequency of relapses that was the where in clause but are also required the claim be therapeutically effective and it was that redundancy between therapeutic effect and the regiment being sufficient to reduce so that was a redundancy bristol myers it was a redundancy between and tinea plastic and the actual claimed amounts and and so those cases about redundancy in this case is the opposite it's about n redundancy it's about drawing the dividing line between those formulations that do have the effort to see and safety of com began which was proven to do this and by the way com again is specifically claimed in the later cla s and those that do not and we tried the issue their expert admitted on the stand that things like the preservatives you need not preserved like it was admitted the preservative be a k would affect the end results that you would get from a clinical trial so i don't think it's particularly in this case whether or not inherent c is a good standard or a bad standard or too difficult then it doesn't matter they did not meet it in their expert and needed it that it that it wasn't and so we have in this you know kind of a rare circumstance where the record that went before that we can bring into the claim construction addresses the issue of apparency which i agree with you is an exacting standard so i   there i do not think so just but that's the distinction between the claims you know really i mean i'm more interested in an answer your questions and i am and making arguments we've laid out our position and as i said we have travel long long road i will simply add this case is not the st time that we've advocated that i heard that from council i'm surprised this is not the st time we've advocated this we advocated back in the very st case and in the nd case it was the determine the litigation and i think the parties agree that the issue here really should be whether or not these terms were being used to delineate what's in and what's out and the question this really before the court is how do you decide whether particular terms were being used that way and i think the answer that you find consistently from the case law is that you look to the intrinsic record because again it's if you if you allow it to come from the litigating positions after the fact it's subject to manipulation i saying some compositions work and some compositions don't and giving any indication is what the special sauce is for knowing which it's going to be no what they were doing was they were claiming all compositions and they were including these statements of intended result you would expect to see examples of what's in and what's out and would expect to see examples of the don't work and the fact that they're there that they're not there is what shows you that these were not being used to draw lines instead what they rely on now are thought maybe if you added so much of something else then the thing wouldn't work there were no admissions from our expert what there was was a hypothetical question in which the experts said well maybe and that's what they rely on think the court makes a couple points that are relevant here one as it says there's no meaningful difference between the claims and bristol myers here and shows how there isn't being used to make a manipulative difference you know the claims look a lot like the ones here and nd if you look at claim twelve which is in the which is referenced on page twenty three i don't think there's any basis for saying redundancy was was an issue there because it was a method for improving the tolerability of glitter it's good to remember acetate treatment of a human patient suffering f relapses which is as effective as the administration of twenty milligram ga daily that's exactly like the kind of limitations we have here is no redundancy the court said it wasn't limiting the same results that apply here the court has further questions thank you thank you very much thank you we thank both sides of the case