adjudication of those claims should not should be done so not only under the proper burden but also on the proper claim construction and that is with the korean wills limiting let me ask about this preamble to you is it your position that the preamble is just further defining the patient population or is it your position that the preamble also describes the purpose for practicing the method the purpose you are under janssen that it is that when when the preamble sets forth the purpose of of the method in the body of the claim directs it that method to be directed to a patient in need it is a statement of intentional purpose for which the claim should needs to be for but in janssen at least and i think that going on the other side is that in janssen you need was was was the thought was that a need was helping to define the patient population which was described in the preamble here we've got the preamble we have the in need of language and then we've got a separate description of the detailed description of the patient i disagree with the notion that that the language  population any further though the preamble that claim is treating or preventing pernicious and so so it doesn't define patients with anemia i think the suggestion from from milan was during prosecution history there was a preamble directed to treating anemia in general and the examiner said that that is not commensurate with the scope of your unexpected results of the claims were issued when that when that this dismisses specific type of anemia was chosen but i don't understand i mean i the reason before the district court you argued that all people all humans are in need of preventing and need and then this language was supposed to connect this particular and media to the patient population treating right it is that was milans argument that all patients are in need of increase in survival that is that is that is not our problem the position before or here and in fact that i mean we the idea that we're all in need of a method of increasing survival is true just by our mortality but just as in janssen we're all in need of a method of preventing you need we all need vitamin b twelve sometimes you know we get it we get it through the food we eat but but just because we don't thought the limitation whisper purposes of women right that limitation was construed to limit the population i enjoy ansun yes not not the population of patients that can that can receive the claim composition the mixture of fol acid in miami it defines patients who have been meaning in the media that are treated that way and also patients who are taking it that that vitamin combination for prevention of any so what  had a vitamin d of vitamin b twelve and full of gas a combination and what the court held was for purposes of infringement if that if that combination was taken by a patient without a recognized need of treating preventing anemia that is not correct infringement of that claim so unless you have the patient in that case here we're talking about the physicians and that the patient in that case if they are not taking  that up in other words someone who needs to increase their survival well isn't that the entire world i have i think that's that's the point when we come to what is the after after there's a a decision on whether the preamble is limiting is the question of what is what is the construction of that preamble i think just just because of the fact that we're talking about increasing survival and we're humans we think well this is this is yes this is what we all need but keep in mind your honor well that the science behind that i'm not sure anybody knows but but that the issue here is in what's what's borne out all over the prior art is you can give a drug to a patient with met a static prostate cancer and you can reduce their tumors you can drop their a level that doesn't mean you're going to they're going to live in all those are those are not surrogates for one another as both part both both experts in this case agree what's what's the what's the difference here is now having having now for the first time a method of treating these patients where you can actually prolonging the life so i ask you and that when you're talking about increasing survival how is that measured like is it a couple of days and so it has to be statistically relevant because you speak to d you know whether you're actually prolong the life of the patient i'm not sure that is defined as as a certain number of days or a certain number of months we do have we do have established circumstances from from milan we do we know for sure for certain whether it was the drug that lived them all no but we physicians can reasonably determine that because of that drug that patient is still alive  comfortable while you know while they were dying while they were in hospice but before or after the results of the study that's it's always so we're talking are there are there other all right it wasn't as if it was treated if the idea was we would use this for some other purpose and now we're coming up with a new use we have come up with data that supports its use at all beforehand you have you didn't chemotherapy to these patients you're putting them at risk of serious harm or death so if you're if you are and are not if you do not have sufficient clinical data from which to determine that the benefit you get from the dr outweighs that risk of harm you don't give it to that and i did literally reading the in the i mean it seems to me the board is right that virtually all terminally ill patients define the cl because the claims were drafted with jackson in mind with the specific idea that it would incorporate this specific intent out that that these claims are limited to sit mental and and i guess what jeff process is getting at is once you have the drug and once you know that this is the result that the drugs yes why that is you're saying it's used the intent for the purposes detrimentally say is for increasing survival and not for politic that was that was the proposed limitation and and and in the expressed we relied on that added limitation to distinguish the claims from the priorities since increasing survival in this context we're not talking here right increasing survival is that's right managing no there's no evidence of anything before the claimed method of use for these particular patients after they have failed docetaxel treatment that any of the known drug therapies or any of the the also provide pelleted because it could you could you could have you could have those two purposes at the same time but for both of those purposes you need you need actual clinical data that supports that use right eat you a physician does not administering a drug for a specific purpose without clinical data supporting just supporting that  because of all the risks that are involved they would neither have done it for that purpose nor would they have done it for the purpose of increasing survival yes your  while as opposed to palliative care why isn't that a natural limitation i mean there hasn't been an obvious determinate obvious determination whatever but why isn't that different than the other ordinary use which was that is different because in the bristol myers case the b m s cases specifically on point here there is no difference in the steps you perform as a result of having increased survival in the preamble or not would been treated with this drug about as attacks all without having the clinically significant data showed an increase in survival is is incorrect in fact there were three drugs that are all tax into the related saying so i don't think he said something inconsistent with what you just set to him i'm missing something he was drawing a very fine line between when are we talking about in the doctor's mind does the doctor yet have the clinical results and he supposed one day minus one when the doctor doesn't have the clinical results but the doctor cannot practice this method because the doctor doesn't possess those results in his or her memory and day plus one after the results now suddenly something's changed and that doctor's mind makes a difference that cannot be the kind of limitation that this preamble language was meant to include in this quite i don't know distinguish language doesn't add anything it doesn't give life meaning vital ality ten including b m s the that question i thought one of the major problems there was that they were proffering one construction for infringement in a different construction for  construction if this party wants to limit themselves so dramatically for purposes of infringement but as you know unless this is the purpose for which you're practicing the method you can't be infringing then doesn't the patentee have the right to limit their claim they could have done some of they didn't the language that they chose simply using the phrase increasing survival and then putting the the thereof in the there of claim right after it is part of the body of the claim really doesn't import the kind of limitation that my colleague on the other side of suggesting it does have a kind of used words like clinically significant statistically tell me what you're doing to the claim a method of increasing survival are you talking about putting that new preamble language in the plan amendment in fluids in the preamble a method of increasing survival they could have and added into that preamble language like this clinically significant statistically significant some kind of language like that and then that would have to differentiate it for you absolutely and the problem with that is that that cannot be a limitation because the statistically significant data come from a population study and what we're talking about in the claim is an individual patient so we would run into all kinds of one twelve problems if they tried to insert that into this language or there would be an indefinite problem there would be a written description probably going to be enablement there might be a a problem with written description or enablement from their use of the term survival and how that should be contemplated but that's not the same as whether or not it's limit right viber would be great but they're also in need of palliative care right absolutely yes these patients are suffering from terminal cancer but there's not been a cure found for this cancer so these patients are inevitably going to continue to suffer with the disease and ultimately die from the disease or complication of the disease what i understand your friend to be saying was that before this amendment the prescribing this was for the purpose a palate of care of a terminally ill patient and that this is a different purpose increase prolonging life is a different purpose than existed previous i don't think that's right i clinic that's right is it not that is not arguing that or that it's factually i think it's factually incorrect i think that the the those who are conducting the phase one study for instance had as one of the purposes of their study this is the what would a person of skill in the art reasonably expect with attacks aimed that is showing this type of anti cancer activity a person a reasonable person school now would have a reasonable expectation that you would the board in its decision explicitly says that seventy two that to the extent the preamble may be considered limiting at all it refers to a patient in need of increase accept everything you say there's still a problem with british shifting that doesn't comport with that so there is a question of whether or not even accepting what you say we would at least have to return to the limited purpose of applying the correct  not only for the apple issue but also for the obvious i respectfully disagree with my colleagues suggestion that the absolutely has to be remanded in light of aqua products this case is uniquely position obligation to see reconsideration before you repeal there's no such obligation this no you're suggesting there's some sort of waiver thing that they didn't if we consider race and it's not waiver but it is a factor it's a factor then when you take into consideration the fact that they had an obligation to go back to the board under what they believed to be a wrong claim construction so they would have gone back to the board to reconsider where they place the burden but they were still would have been stuck with the same claim construction so it would have been an exercise  futility in their mind i understand that that's what was perhaps going through their mind with respect to the claim construction issue but in fact when it comes to imposing the burden what the board did below is it found the federal circuit had granted rehearing on voc to address burdens of persuasion and production regarding motions to amend so they were keenly aware even before the issue of this final decision that that was pending and that was a potential decision and page seventy five for instance the first full paragraph begins petitioner persuasively establishes that's that's mylan bearing the burden in meeting that burden of of the claims here so the claims really can be thought of in terms of having this treatment with combats attacks all in the one hand and then also another new addition from the amendment having the  pretreatment regiment so there are those two parts those two pieces and the focus so far i think has been on the first part i'm using as a tack so that the board said on page seventy four right in the middle of the page we because just because the elements of the claim were not well were or well known does not establish that there was a specific motivation for a person of orders in the art to combine those elements with the reasonable expectation of success that's just one point on a on a the  and i do want to point out that in section two point b point four the board actually did find that the results of tropic were the increasing survival were unexpected so on on the issues of the idea that the even under the the different burden that there should be no rematch i think those points disagree with that going back to the preamble issue  the prior art here that's not true there is there is no dispute that there is no single reference setting forth all of the steps of the claim so this is not an anticipation play case again like  is an issue of obviousness on the point about did did the patent owner do enough to limit the claims to to seek this limitation include this limitation and rely on that limitation to overcome the prior art it's not just the language of the claim i want to remind you writers they also expressly relied on that for distinguishing the invention patent owner specifically limiting the claims in a way adding limitations and those and we submit that the board has no degree no discretion to ignore that clear