regarding a lot and non small cell lung cancer not even in a pre clinical trial based on secret can i just double check something the briefs seem to agree with each other that the only indicate condition that needs to be discussed is the non small cell lung cancer even though there are a couple of others in the claim is that because nobody has suggested there is prior art on those other conditions correct the challenge blows smoke so live on non small soap and cancer i that that was progress and so you have no data about how you pre clinical models the board then tried to back fill with speculation based on the mere initiation of clinical trials and there must have been because you could occur is there any evidence at all what those studies for see what they would have sought to treat for example would they be for other conditions other than non small cell lung cancer or i mean do we know is there do you know what the criteria is for those kind of clinical testing as that would allow the phase one testing to occur right doesn't have to be test be advancing there and in fact there is no evidence anywhere in the record that such studies were done when we were and on this point that the preclear i gather there was some testimony or declaration or something that says when you have a phase one study we think there should have been some kind of preclinical testing right there is that kind of declaration right right and in that deposition of one of our deposition that there would have been a what we would expect there to have been in the preclinical testing leading to the phase one testing of non small  absolutely not ok no evidence on that whatsoever so it's a huge speculative week that the board is making here that isn't grounded in any evidence and that's the basis on which principally maybe even solely you attack the reliance on the ten k right now but that was the basis on which the board actually relied on the temporary and so focusing on its reasoning under generally we say that reasoning can stand and also the basis for which the board relied on th fourteen of sex the actual reference to non small cell lung cancer in that statement was in an exemplary clause yet it begins with the word particularly singling out a particular attribute here and not necessarily even on its face applying to both compounds and more importantly any statements like that in this course be very clear need to be read in context and gives in that paragraph cites two references the woodburning reference which is about to fit in have entirely different compounds discloses anti tumor activity in non small cell lung cancer the more your reference which is actually about  is entirely about had an acting coach rectum and undisputed that there is nothing no disclosure of activity in non small cell lung cancer in more records and the reason that you think context for the relevant sentence however a sentence would look to lawyer and the other one is what those are twelve and thirteen in the two said about it right mean then they are the the two references that are cited in that section and ones about another compound and talks about non small cell lung cancer the one about her wagner doesn't talk about nonsmokers on cancer that's pretty strong contacts saying this statement is not giving you an expectation of success in non space are you asking us too clarifying the legal meaning of reasonable expectation of success to say that a person of skill in the art would not have as a matter of law a reasonable expectation of success based on a sentence put that points to two references without going and looking what those references say to make sure that the sentence is read one way rather than another and i think that is an available out here and could be phrased in those terms and could also just be presented in substantial evidence terms getting to the same result in terms of that bare sentence where these references are are pointing to saying well this isn't a disclosure about our law neven non small cell lung cancer that is substantial evidence to support this and at the very least didn't look to the underlying references to understand the key sentence and that any brief you have a suggestion that they are legally and how they interpreted the reference but not also said that the reference has to be reading context references read for everything that it teaches and so when you when the board looks at that want isolated portion it isn't considering not contacts then you've it's put itself in a position where it doesn't have a fact finding to be deferred to there and by the way this is all reinforced by the fact that it gives at the beginning of the ar heard about those proceedings and he said this is appendix four thousand five hundred and seventy one question so you look to these proceedings and not find anything they relied on to support your opinion is that right answer correct so we're going to be enforcing not only is there this clear contrast between woodburn and mourner but when you look to the background of that of the only other proceedings there cited there there's also not showing any evidence and non small cell lung cancer and in fact there are x for you have it you have a straight up concession in this case that he's not aware of any pre clinical or clinical data before the priority date regarding non small cell lung cancer well guarded the data you lead with that issue in your brief but you're not suggesting it was my question are you suggesting that the only way that they could have shown reasonable expectation of success was data because of the nature of treatment of cancer and no i'm not sure it's the only way but you certainly it's undisputed thi fifteen so do i understand that maybe your argument is that all these references have holes in one way they could have filled it up as with data and they haven't done that here or is it more that they had to have data  a we're not arguing a person but in the context of a highly unpredictable part here and when we talk about data i mean whether it's the underlying data itself or whether it's the disclosure of the results that's what a that's what a medical oncologist you're making these decisions you're going to need some sort of scientific evidence before being able to reasonably conclude but not necessarily to see the evidence there could be a highly reliable representation that such evidence exists so that if i thought that the board said something like that's kind of what that sentence from gibbs is standing alone hardly reliable indication that of what's being asserted until you go and look at the two  that clarifies that actually that couldn't really be what he was saying right and so that doesn't you know you have to look at all of those together as a package and you know when you look at the actual we have that might well be a sufficient basis for finding a reasonable expectation of success even if they the skilled artisan had no access to that data right someone's reporting on their own experiments for example  after members gives here was a review article gibbs was canvassing what other people had reported and was insane i have undisclosed knowledge here about a lot of and so that has to be red light of those references give cites more woodburn is abstract and you don't see any of the results here regarding non small cell lung cancer and so you know their expert when pressed about this  it made it you know said well i think you should be saying something important here but then admitted that he would look to the underlying references being cited and then his final learned line of argument was used well i would call i would call a doctor gives and so on to check that box we did call doctor gives a new team and testified as a fact witness in this case and confirmed you know i didn't i didn't do the test and you know i didn't have any knowledge of this was going to have and the fact of non small cell lung cancer and the board's only response to that was the circular argument they said well you didn't correct your are but not not assumes that we have an unambiguous disclosure here baseball players with the opening pitcher in the closing yes exactly and i haven't i mean there was no response in the response of relief to that basic point that you can't just say on the face of that sentence necessarily  when you're not talking about we know friends now talk about employers game here we're talking about what isn't medical oncologist when you rely on to say i expect this is going to treat non small cell lung cancer and in how you divided your time if you divided your of the issues yes your honor i will take ten minutes in the government which takes us may please the court i was size argument that a person of ordinary skill in the art would need clear that it's scientific evidence and that the board misapprehended the reason work spectating of success requirement is predicated on too high of a standard a reasonable expectation no evidence of any clinical testing and humans or animals of this company for this condition there was there is evidence name and you would immediately see that's not actually what it meant so what evidence is there that when checked in the most minimally responsible way would show that there was preclinical taste testing of this compound for this condition in humans or animals looking at gibson the way that that particular paragraph is laid out the specific the specific references that are addressed there address a completely different it's and those specific those specific references actually modify a sentence that demonstrates that these two compounds were in clinical trials it's not until two sentences later we see that look at o s i as ten k and we look at the gibbs reference what we see is that they finished the phase one trials and begun phase two trials now when asked about that asked about and investigational do drug applications and investigator brochures dr bunce said yes there would have been preclinical data that would have been submitted and there would have been targeted position isn't that proof clinical data would have been about using this compound for this condition the kid is his overall statement was that you have the preclinical episode data and i think the answer is no he did not say but i also think that he said that the that the therapeutic conditions would have been listed in there as well where it was i have to look at the record  was previously done i think that it was it a dentist be the preclinical data but also identifies to therapeutic but it didn't applies to therapeutic targets that they intend to study in those particular trials but i think that looking at killer that particular conditions that you are targeted indications that you've identified in your investigators brochure as part of the record i can't identify anything that says that specifically but i would say that when we look at requiring data i would i would say that that would be an absolute predictability of success what we have here is that when we look at board looking action or the board found that sure had jack i said i mean that that that seems to me to be a leap that is it's one thing to say i have some data or reliable representation that some da exists and what that data reliably tells me is this looks and i'm now going to use some non legal word promising something like that it doesn't mean absolute you know i  at this data and the data maybe the data says this is spectacular there's no doubt at all but there's a large wahoo i'm on the spectrum between that and there is some data that begins to give me some expectation you know using my reasonable scientific methodology in my head i think that the board and its factual findings were made a reasonable perhaps based off the testimony of dr bond and dr g economy about preclinical trade data being done but also nd that if we look at the gibbs reference the board made factual findings on the gibbs reference and what a person orders go in the or how they would read that specific reference and looking at that specific reference when it says these compounds had been through preclinical studies had good in our history activity and had a good successfully and that's enough for reasonable expectation of success and i ask you about sure you meant we were mentioning earlier grades or is disclosing at least one hundred and five different compounds many most of be used for lung cancer now or do i see it linking that and just forgetting about the non small cell lung cancer issue but am i correct in my understanding of that and there's no place in that reference where it claim that when names it treats lung cancer i think that how you're collecting that i think if we look at the claims themselves we see that there are beautifully effective amount of memories and we also see that some of the conditions listed one of those being lung cancer particular if you look at if we do a gram factor analysis and we look at the nd grand factor and we look at the scope of the prior art compared to the challenge claims if we look at what the challenge claims require it only requires ther the inventors the only conclusion they can make is that are a lot of the active in a c l c and when dr bond was asked about such plenary data he said that's not enough information to a person who has gone the art to determine whether it was effective in treating humans you know it in a c l c in humans and so when we look at that nd grand factor and we look at what's required for disclosure of the prior art we see that sure has everything you need except for the and you have contemporaneous references you know from a medical point of view using the compound for the right conditions seems like not a small thing you i'm sorry used in the compound for the for the right to condition as opposed to a different condition seems like not a small detail but compound i think the compound among is a preferred compound that is listed as there are people effective amount to treat lung cancer and what the case law tells us is that sure is unable for everything is closed it's overside and never was i never argued before the board that sure was not enabled so it's an able for at the in view of those looking at sure in view of those two references it's right there right there for a person for your skill in the art given what the challenges lay it's there if you put them together knowing what happened if up to lung cancers there are only two s e l c n n a c l c not a big genus only two and a person born is killing the art knowing at that particular time that eighty percent of lung cancers are in a c and the only one that over expresses distinction in terms of the combination of the public benefit and the cost of proceeding to serve the public i think that the from gibbs or somewhere is going the art we look that it is enabled for everything it discloses in the efficacy data is not required for looking at the united states on the constitutional issues in which we've intervened on obviously this court has heard many of these issues i number of times already and so if there are no questions i would just briefly like to address a waiver the government has granted a property right we can debate whether it's personal property were french eyes or whatever it is a federal grant the same agency the granted us now comes forward and says government's responsibility for that mistake we've crossed the bridge that there is an opportunity in the last for this engine to correct it because in the opening brief in this case they've raised constitutional challenges this court issued a roll forty four dollars certification asking the government whether they would intervene to address the constitutional challenge in this case  theory is that because there would be some sort of due process or taking issue at the government's i p r action could it proceed at all that the government couldn't even go through interparty its review not that there should be some back even be in the prior art and some of the backfilling it's being done is testimony from our expert dr bond as i think has been clearly revealed here is not in any way sane  clinical evidence regarding non small cell lung cancer and there is there i think two questions i'd like a little bit of clarify cation are probably unrelated to each other  so by the time of this but the present by the time of the priority date here there might have been that there would have been pre clinical testing but there was also the phase one testing i understand i think that there's an argument that was made that the pre clinical testing would have had some relevant data it was an argument made that the phase one process would have had when you combine it with the ten k that is your investigating non small cell isn't that enough all by itself not only to put the are the generic disclosures about compound one you're talking about a genus of more than a one thousand compounds and a list of at least eighteen conditions and so this court has recognize compound and claims as a compound no disclosure specifically about her lot in treating anything in only this broad genus disclosure that's a prophetic disclosure and you know with their own expert talking about the disclosure it or said here that you well you know people quote and that's why there's appendix forty five dollars or one people quote cast a broad net so they would indicate like in these cases several the tank a total potentially targeting a lot of commission conditions even in the ten k when it talks about entering phase two it doesn't even that doesn't say we're going into phase two for non small cell  a long line of precedent in this court and particularly again when we're talking about sure not being accompanied by any data and we're not saying you have to finish your phase two clinical trials we're not we're talking about not even the talked about this issue and said that if the phrase reasonable expectation of success or the expectation to be reasonable and said what we've tied to reasonable expectation of success standard to the supreme court's use of predictable in k s r no here i am likely to treat cancer with this compound and in such an unpredictable art with with that dearth of scientific evidence we talked him out you would not have that expectation here and so the board  bottom line results and then as we've discussed also eric procedurally in reaching that result in terms of its approach to the prior art references and what it