please the court the district court failed to stand no problem district court failed to understand and apply the proper legal standard for obviousness in the ovation it's order should be reversed for two reasons first regarding obviousness the district court eared and find the wrong standard for reasonable expectation of success instead of considering what would be reasonably expected five percent of skilling on the district court apply a heightened and near absolute predictability  and was known to cause certain adverse effects including fatalities this is admitted in sworn statements under penalty of perjury made by congress on the pad to itself and a citizen petition where it said from the outset that f d a wanted project to succeed namely to get to a sufficiently stable for the suitable product without e t a putting aside the requirement without any  this was in part due to a book called quality by design which is where formulated by the time of two thousand and two but not back in the seventy's when this part of our product was initially developed elsewhere in the world they were looking at all ingredients in active says anything that's in here you've got to make sure it belongs we don't know whether it belongs before we figure before we study it or not well that was the that was the original reason for the justification but then within six days f d a said you have to include beta in your submission and then throughout the next almost two years your fourteen months f d a is consistently saying you need to reformulate to take out e t a you need to study whether e d t a is doing anything in this formulation need to remove the record and they did but you just said three sentences quite different things one is you need to study that it was your second sentence sentence one in three were you need to take it out where's the evidence for that that's if you go to a twenty seven if you order this is the only place where there is a discussion of the expectation of success and it cites to four things it cites to the background section of the patent it talk about other products including and then it cites to three portions of credits three portions of dr kids appellate experts testimony and it's clear by looking at that portion of his testimony that he testifies that there was a reasonable expectation that the f d a would know for sure and so for example if you  well the subtle idea goes to derivation and whether the f d a had a proper conception the reasonable expectation of success goes to where or whether or not the chemistry review and printed or printed publication approval letter render obvious the claimed invention the so then you look at whether the suggestion in the approval letter to study taking out e t a and to remove it from the formulation of the drug product which includes every other element whether or not that would have been obvious to try and why did this express specifically cites in credits testimony that a doctor can't or he says he would have had a reasonable expectation of success but f d a wouldn't know for sure so f d a is not going to approve the drug product so for example that is  removal there's no direct documents but certainly a person of ordinary skill would realize that by removing e d t a there is certainly an ex that expectation that it would be stable then the district court also cites to testimony asking for study right the witness well it's the f d a world a person of ordinary skill season of the information to certainly that would be expected but the f d a wants confirmation because they are obviously not going to approve a change of the drug formulation without doing a full expectation of success the district court just says that you can't predict absolutely success at sites that unit and then it cites to in credits this testimony and the only thing that this testimony shows is that you would have had a reasonable expectation of success but you wouldn't know for sure you wouldn't have a an approved drug product and i think that that's where the standard is completed and i think it's conflated also in the opposing brief where the district court he she didn't she compare  rejects it is there is a large body of prior art that teaches keep the requirement of need just for stability and e d t a into particular and so mr kant may have come from a come along and you know extra experts get paid to say a lot of things and mr kent may have come along and said you know it would be reasonable not to include this but all the prior art went the other way all of it and there's no prior art that went his way so why isn't that this was a bench trial exactly the sort of thing that even if i were to agree with you we leave to the district court because i think i think that to the extent you made a fact finding that no prior are considered taking out e t a or not using it e t a that's clearly erroneous because the approval letter we think she didn't fully consider it she cites it there but she doesn't give any explanation anywhere in her opinion why the approval letter doesn't provide a motivation or suggestion or details are to take out e d t a i've read the approval letter and we just went through parts of it that i'm sorry but that is not adequate for me so i i don't know i mean i i understand dr can't testify very effectively exactly what you would need him to say in this circumstance but it of the four four five pounds of the claimed method of use require a formulation that is a from your existing product we expected to be a success and don't put any key leaving age other collating agent back in place you'd be in a tough spot on that but that yes that would be on expert testimony that she credited that you cannot treat each of the elements separately that it makes a difference because all of the molecules interact they're not like the back of marbles that you can just kind of pick one out and expect the rest to stay the same that was consistent expert testimony that the court credited that these two formulations are entirely different formulations and given the state of the prior art and that there was only the most indirect reference which surprised me in the paper given the answer to and that's how it was approved supplemental to the original yes and both are approved and on market today we would have been possible if a new key lady had been added in place asked that question without having a particular view about why the answer might not i think i actually don't know about the regulatory aspect of it but it may have been like our product a completely different product and may have required a different regulatory process what's important to know about the date that of the approval of our new product is that but two months after that milan internal formulation scientists when considering what product they were going to submit to be approved in and even in  and wrote we've learned about this new product and we are concerned that quote removing e d t a will open up sensitivity to heavy metals at low levels possibly some testing or spiking say should be done to quote define what needs to be in place to compensate for eighty eight removal and this is your part of part of the evidence for why success can be found after they've been reasonably expect  adams type skepticism that even after knowing that the light bulb would keep burning they didn't believe it and they said that again in june of two thousand and eleven that's in that march of two thousand and eleven skepticism is at a fourteen three forty six to forty seven and violent groups are well known to oxidize the district court relied on all of this in finding that it was well known in the art at a four and a twenty six twenty eight a for for a opinion on this issue that stability was known to be a problem and here was not only that a sealed system was highly unstable but that for years every single commercial manufacturer of this treatment for i v use at an e t a so there was a settled expectation go and do it that's a pretty strong motivation here i believe the case law talks about there being a motivation to combine with there are a small number of reasonably successful options not a limitless number of things that you have to be after all told you to do one thing that yes in fact e t a preserve stability you could have very many different parameters mileages expert agreed trial and this was the basis of the court finding no anticipation of one of the parameters you could have modified was adding another question is that it really depends on what it was that there really wasn't one that it i mean that question has to be answered in the context of the state of the art and the options available to the scientist at the time and the specific request here the court also found that there was no directive or instruction to mr pavlov as to what to test what parameters to test out a test the only instruction now was was to conduct a test and the type of test that everyone even mylan scientists agreed that w most likely to be done was a small scale bench scepter testing like well and scientists suggested spiking and getting a result in a few weeks or yes so what the court found on derivation was that the letter which milan argued at trial and i guess argues again on appeal the december tenth letter  t requested justification for e t a s presence in the composition was really just that just a request to provide information and not any instruction or direction to to  generate any test the court found significant in looking at that document that a page later the f d a did ask for a test so that that was really not a request when it said please provide justification and a description of its properties as a finding of fact the court read the documents said that that's not a direction to conduct a test and it couldn't meet the elements all of the elements of the claim methods for several reasons one it was just a request for justification to it didn't provide any definition or instruction on how to conduct a test what tested to conduct it left much open to the imagination it had the f d a said those words you cannot use any killing agents as they said the first thing they just didn't say and replace it with nothing the again in the context of the state of the art knowing that metal could tell us was such a problem for this composition for this molecule a formulation scientist would have looked at other parameters other measures that would have adjusted for claims that needs to be stable for human administration and given the understanding of the state of the art that it would not have been stable and a full and a conception requires a conception and  know yes and the eggs the stables and the and suitable for i v administration is in the claims so it would not have been a concern for conception of all the elements since the expectation is without test without any collating agents it would have been same had they said are are we know in fact it will be stable they don't know that for conception they don't actually have to confirm it either had had the state of the art been different and therefore there could have been an expectation that would have been stable the answer might be different but under these facts and this record and this state of the art that would not have been expected expectation ok thank you very much  commitment that was entered into after a fourteen month negotiation between cumberland f d a in which cumberland it does call out specifically the test that has to be done they have to evaluate the potential benefit of e t a on the stability  to look at the drug product formulation and you have to compare the stability of that versus a concentration of lower e d t a and no e d t a and the fact that that is exactly what the parties understood is borne out by the actual study that mr pavel did and it's also confirmed by the chemistry review where it says you are to look at this the effect of e d t a on the stability in the formulation now it can't be an invention for mr pavlov who admitted that the stability study that he designed that he paid by a nice to implement and then the evaluated the studies he said none of that is inventive and this clearly to the extent that you believe there's not an expressed motivation although we believe there is this clearly falls within k s r where there is a market need and it is a design need in a market pressure that is put forth by f d a saying you need to look at getting rid of and removing e d t a and there's a limited number of options and the most obvious one to try is just to take out adding a b t a and f d a wants it removed then the easiest way to do that the most obvious way to do that is the take out the e t f which is it which includes metal lines so it's not just a suggestion and they did actually tell them exactly what they did they  do what they needed to do now this suggestion that there was an admission by five plaintiffs experts that you could have changed other things and followed within the commitment that spelled out the approval at i think that's incorrect if you look at that i all that mr pavel the alleged inventor did in response to this commitment the f d a put down the approval letter is he told by an age he said go make your par a set it don't product exactly like you make it for us but just don't add e t a and then conduct a stability study just like you conduct all the other stability studies that you've done in the last decade and that we've made subject to approval and then simply the results and then he testify that he didn't have an eventually saw those results bility study the test results three months in and say gee i guess it wasn't needed i have an invention that is not