applying the doctrine of routine optimization to overcome the legal requirements of motivation to combine and reasonable expectation of success for audiences and odp specifically there is no only one reference patent specification and by finding that there is in essence a presumption that where there's a broader gene as claimed a species claim cannot be patentable rd the district court erred by finding and creating a rule of law that commercial success and long felt need can never be shown for a product until it is approved by the f d a creating a bright line test that would undermine the force ability of patents by life science companies in this in the united states and then finally the district court with respect to bookbinder errors by saying there is no beginning and point in the i don't want to spend really need time on this one make one point on that briefly for the court the court says there's no beginning an end point but if you look at the decision at page eleven appendix twelve right district court's decision let's turn st though to i think is the main issue here which is the routine optimization that was used to overcome the legal requirements of the proper conclusion obviousness for motivation to combine and reasonable expectation of success there is no ratio here there is no range that is provided here p t o in the court in the decision do not point to any language braxton or the thompson references that provide a specific range why is that a court that's important because it's the range in the court case l peterson case which had zero to seven percent that provide the framework for motivation to provide the framework for reasonable expectation of success in the peterson clan that had one to three percent we don't have that here we have no guidance in braxton as to a specific range that this court has used in the past can for example in the peterson case also other ranges are not broadly applicable here as w one protein to another without the range it's improper to in essence then use the doctrine of routine optimization because there's nothing in the art and effectively what the court did was to use hindsight bias by looking at the range in the claim of three dollars to six dollars and then saying well that one would get to with thirteen optimizations but how does one know that there's no guidance in the art  range in the art there's nothing that guides one to a person of ordinary skill to that three to six solution your arguments about range so what you're looking is the range what a larger range cut a large they would it would have needed to be a larger range in the prior art and this would be a species of that is that what you're exactly that has a range that provides the teaching that then one of skill can use routine optimization order to apply the optimization well i think it becomes it becomes to the point then it's necessary when you go to your other cases such as in the step on case where there wasn't a precise range that was provided in fact there  claim was at seventy degrees centigrade and there is a suggestion in the step on case of this up to sixty five dollars degree centigrade and the court found in that case that there was no guidance as to the why to go to the sevent degrees centigrade so that's an example right there and step by case i think also you could look to the genetics institute case where there are multiple different species within the scope of the genus claim just as there are here range here is first of all there is no range so we're not limiting down the number of potential bottom it's by the prior our range secondly left with the fact that you just have the general guidance in are a multitude of potential different structures and portly rahner it's not just that you can attach a pag it's that you will have in this claim for this pharmaceutical composition must have that property and among all of the multitude of the myriad different possibilities that exist there's nothing in the guide one of ordinary skill in the art through a range where the routine optimization could apply think then secondly but we're looking at the range then i think then the nd that brings us to the nd fundamental are so to find the motivation and to find the reasonable expectation of success the court that's cited in our briefs and what it has and what that the district court to it relied on one sentence in the background of the invention and ignored the entire thrust way more importantly even in the background section that the court relies upon there are two key points in there is well st it says that if you use sort of a random a limitation of the class nd it's unsuitable for certain lysine residues are essential for biological activity and those were clear and knowns in the art as to what specific i provide that specific teaching necessary for the systemic use where you have all the clearance mechanisms of the body in play and secondly know point you in any way that is suitable for a and otherwise the doctrine of teaching away is undermined if you can find the motivation or the reason the expectation success in a single sentence in the background to an invention which in fact despaired is the very technique now the doctrine of teaching the way of the reference which must be considered as a whole is undermined because the references undisputedly as a whole there's no doubt about it teach a technique that if  would destroy the activity it would not be suitable to the other f d a approved drugs that the f d a that the p t o points to do not help them because there is no range pointing to three to six a approved drugs it actually talks about letting the histed in which is different so there are more people different ways that these products can be pegylated it is specific to each and every one and it's not transferable from one to the other just simply stating that there is a reference claimed to modify nine higher on a days by doesn't get you through braxton thompson to the clear invention here which is and develop a new drug abuse for systemic use never before application that have been identified and that there is no clear guiding  may please the court for helen side to prevail and must establish that all four of the courts rejections were in error the correct starting point for the board's rejections is not an unpaid related heiler on a dates it higher on the days which is claimed by each of the reference patents and disclosed by bookbinder using these starting points the board did using these correct starting points the district court did find motivation to optimize in a reasonable is that the case that bookbinder is only missing the three to six nothing else everything is there so i don't know how to say all those words lysine elation it's all disclosed in there right everything is in there right ok case where you can apply to you know to the station well actually there is a range disclosed in the prior art because a person of ordinary skill knew that there were only thirty one license so the the largest number that could be pixellated was thirty one and all of the experts explained that a person of ordinary skill in the art knew how to pick a lake they knew how to attach pigs they knew how to figure out how many pics were there and so it would just be narrowing the thirty one dollars possible sites down to assigns own experts said a person would make a pickle a bit higher on the days tested for activity i'm going to have it and if the result didn't meet your desired criteria you could vary the degrees a person of ordinary skill knew what the variables were knew how to pick the lay it and would simply put pegs on tested for activity and longevity and if the result didn't meet your desired criteria you would vary the degre weighted average of about three to six pits of some of the proteins could actually have a pick some of the proteins could have won so it's actually quite a long range and our expert dr joe said that that would be easy for a person of ordinary skill to achieve and there was no rebuttal testimony to that it would be easy why you and it would be easy because you what you only have thirty one dollars possible choices and a person would know like i said what the variables are one of the variables is ph one of the variables is the concentration of craig picks per protein so you would just put that on you would test it if you did and as dr fleming said if you didn't see an increase in half life you would have more picks and you could do that by changing the ph or changing the concentration until you got to the range where it was the optimal balance or person of ordinary skill knew that peculation increased have place decreased activity and they would be motivated to find that so st of all they're teaching a way argument is actually asking and it's actually ignoring the primary reference which is bookbinder which already teaches to use lysine peculation what they're asking the court to do what they ask the kid district court to do was ignore bookbinder pretend bookbinder doesn't exist and pretend you have an unpaid allayed at hyaluronic days and only braxton and thompson in hand and then would you choose li they don't tell us i was the one that's cherry picking the once and tense which says such mixtures of diversity modified proteins are not suitable as pharmaceutical compensations diverse they modified proteins means related but the very next sentence braxton tells you how to solve that he tells you to use purification and characterisation and dr joe testified that both of those techs need techniques had improved tremendously since bra both of those grounds or to pick one or another where are there any consequences to what how do you decide to resolve this case if we are interested for me so if you are this since all the claims were rejected four read all four rejections if you are from any one of them that will end this dispute in other words how the same has to show there are and there's no consequence to no other pending cases or things or reason to resolve a double patenting issue on these claims or specification of the reference patents but that was an alternative so if this court were to affirm the district court its analysis without looking at the specifications of the forty three dollars want to know it one patents it would not even have to look at that legal issue going back to the one application after district court so it was their burden to show written description this is actually a new argument that their expert didn't make their expert at trial only relied on paragraph thirty nine dollars of the one hundred and seventy one application the district court did not let them did not let the expert rely on another paragraph paragraph seventy four dollars because it had not been disclosed during discovery hellas i'm now trying to rely on seven o four again even though the district court didn't let their expert rely on it and they're expert had every opportunity to rely on them at trial in their expert reports and did not limited to just thirty six to forty three they have their starting points and nd of all their expert never relied on six id number for he he generally pointed and said there are thirty pages of sequences there are fifty three sequences and there somewhere but he did not point to see i did number four to support as yes very briefly your honor st with respect to the routine optimization d it also includes the requirement formulated for systemic activity to have activity it's not just half life it also has to have in bookbinders part of the obvious is that the p t o does is improper because book under itself does not qualify under the prior art because it relates back to the one hundred and seventy one application relates back to the seven hundred and sixteen application and therefore provider is not prior art so the contents of book liner should not be properly siddur as part of the obviousness finally with respect to what binder itself again  o points out that we didn't raise a specific point about seek idea number four that the court's opinion relies upon at page eleven but of course we can have the court's opinion the trial this is what came out afterwards this shows  the contradictory nature of the clear evidence that was before the court the beginning and the end points were all disclosed in the application that was in evidence and the court said there's no beginning m point