cannot simply make a conclusory analysis cannot merely summarize the party's arguments and reject them without explaining why but that's exactly what the piece happened here with respect to this issue and so so  guess and tell me why the following is wrong as a characterization of what it or that the board looked at the evidence including some passages in the specification and not by any means only that and said that evidence would have reasonably been read by relevant artisans to say as a general matter there is an aggregation risk with ins she came back and said as evidence that tries to persuade us that gardening is really an exception to that general recognition of her risk we're more persuaded by the opposite evidence that we don't think that our gene would have been understood by relevant artisans to be outside the category of aggregation risk insulin from all the other insulins that it at that it looked at and if you look at those pages you don't see that answer there because they didn't address that question they didn't ever answer the question why an artist a knowing that one of the key differentiations between glargine and other insulins is the fact that it does precipitate upon injection and that needs the aggregation in order to work why that would dissuade or would have told an arson that it's a fact and should not be added they simply didn't make that finding or draw the conclusion the the of different types and energy to different degrees than we've got finding they also made a finding that the the container matters right that agard the insulins aggregate more readily in pumps than in other devices but they never made the finding and this is again the kit critical point that the amounts are degree of aggregation in our genes would have been sufficient to motivate an artisan to modify the gardening formulation particularly given all of the other evidence that we know an arson would have understood about margin at the time number one that i like i mentioned that it depends on aggregation upon injection to work but at the same time the lantus label that tells you that it's clear in color of us and it's whoosh and secondly they would have known that of all the other vial formulations of that when you store them and glass vials that those hydrophobic surfaces have a tendency to induce execution same with the airspace that's in the vials that when you your insulin is acidic there's a higher tendency to have accusation and when your insulin is more model merrick then you're also going the having a higher tendency for aggregation and that's precisely how clare jing is stored and marketed it's in a glass file with some ready running around in it so therefore when you put all that together when knowing that even other insulins at the neutral ph have had problems with aggregation and then of lantus label says definitely don't take this if it looks cloudy to you there's enough of a collective concern through all those factors or to find out one would be motivated to try to address potential concerns that claritin just like all these other insulins and we don't know of any other insulins that i don't have any susceptibility those were that's correct but that was about our insulins naturally occurring instance not margin which was designed fundamentally different really and was designed to be both clear in its mission and not aggregate in solution and to aggregate upon injection and that's what an artisan would have understood about the invention of carving at the time but the people have never really found that regardless of whether there was any propensity or tendency to aggregate based on all the fact that you know that you mentioned the beat understood it was a matter of degree but never found but what do you what do you make of the sentence right at the top of column three that says especially and this is right after this is a paragraph talking about larger right this is  there's this other problem and one of the ways you know there's this other problem is a nine hundred and ninety seven article that says mix insulin and acids and that's a good church and so my understanding of this is the inventors are describing the problem that they've identified doing there is they're the inventors invoking their own knowledge in their own contributions to connect with the art said might happen with certain other insulins to guardian when you know that was an unexpected result based on all under seems to be evidence of the record that there were other insulins that trouble with education and there were certain factors that were known to cause those aggregation problems is there evidence in the record that there were still other insulin you never had any problem with aggregation and so therefore what we've got on our hands is kind of a mixed record so are ok we've got some insulins that aggregation problem and that was known and so there perhaps reason to believe that claritin as an insulin would also share that her vision problem but you know there is actually a lot of other insulins out there that have never reported a provision so so my response to that is that the market of aggregation to work and so i don't know the answer to that whether there was anything to definitely said there was no aggregation problem but than ours in looking at the available market said none of these other vial insulins have done anything about an aggregation problem to add anything that's necessary and so arson would be especially reluctant to modify an already approved on a already stability tested formulation to add something additional when i thought that that something additional could be you know a counter indication for the actual operation of example of an insulin that has no aggregation certainly if there were such evidence in the record my friend would have been able to point to a chapter and verse readily and was unable to what snuffy's position here is is they don't think that the board below paid enough attention to the fact that they think the clergy new special the clergyman is different but that's a factual determination and there was ample record evidence presented below that led to three i think fundamental and critical factual finding people of that are supported by more than a mere scintilla of evidence and i think judge shannon church trying to both of you identify those some of those those factual findings in the context of your questions you're not relying on the proposition that anything that is more than a mere scintilla suffices no i think i think there's certainly all of these i think that's the legal standard through which  have more than ample evidence which absolutely supports each of these critical factual findings the st is a final written decision of page thirty two dollars where the panel the board below says the record supports that were merely skilled artists and would as it pertains to one of the two they are essentially identical but for these two patents so this notion that the board didn't even consider this idea or this factual presentation especial is just incorrect they just disagreed with what the board did secondly the board at the final written decision on page thirty six dollars went further and said we find that a person of ordinary skill in the art would have had an additional reason to be concerned about aggregation in the not different and then furthermore if you look at page thirty five dollars of the final written decision apx thirty five dollars the board considered that to the extent that largely was different that that difference actually led to than other insulin preparation and you're on our church and you're absolutely right to point out that that's one of the risk factors identified by a branch or bronc a reference that we talk about there's two brown gay references insulins insulins not this is something magic and specific to insulin glargine they themselves were lumping glargine in together and if you don't want to look at the specification to render that conclusion said i think in response to one of judge chen's questions that the lantus label warned of warned patients or not to use trials at which the liquid was cloudy which makes clear that there's some recognition of a potential for cloudiness which i assume everybody agrees in this context stu aggregation i believe that's correct and the more not that i think nineteen in which they're describing the import of the various prior art materials that were cited and this is bridging pages eighteen dollars to one thousand dollars about the lantus label itself lantus was originally on the else being marketed in a vial so that it doesn't actually imply a recognition of a problem i don't know the answer to that question directly i've not scoured the art to see if each and every file pharmaceutical product contains that i know that certainly for protein products and for insulins which are injectables it is common to have an instruction not to inject anything into your body that contains particulate matter for obvious reasons you don't want to inject anything particulate into your body into your bloodstream and several can cause deleterious effects having said that that the presence here recognizes that there is a potential for aggregation that there is a potential to have particulate matter develop in a vial of this particular formulated that's why i guess i asked the question it seems to me that if if this is standard maybe not universal but coast universal or standard and maybe it doesn't actually reflect a recognition of the potential it's just that you always say that in coding labels of files where there is no possibility because who knows well i think there are there's no record evidence that no insulins no insolence of void aggregation altogether and so i would submit it's a different issue it's not that this particular vial doesn't have a risk of aggregation because it's just like all the others i put it differently and that is this file does have a risk of aggregation and so you need to check it just like all the others i mean i think that's an obvious said somewhere here that it's one in ten thousand and one in i don't know where exactly the record evidence of this but you know short maybe it's a minor problem this is the but did something about when it started getting reports from from patients and st was quite surprised about this that's what they claim they were quite surprised about this of course yeah the board's findings below the factual findings which are entitled to deference suggest and tell a very different story and moreover to the extent that we saw in reply etc that we didn't identify or the board didn't identify a motivation you know you don't need to have the same motivation to solve the problem that the inventors the inventors were were motivated by having a particular vial or a particular report past their desk whereas here we have a generalized understanding by people of skill in the art that this is a temperature and time and so on with this particular search fact and and isn't that really the problem to be resolved in this case i don't believe so i don't believe that there is this enhanced ability  looking at the particularized data to see if the claimed invention solved the problem certainly i think that there's record evidence we had press or wire provide twenty examples of insulins being agree i think the question is one of this is at what stage other than with hindsight do we say well just put in some polysorbate it's oh oh i think there was absolutely no hindsight here at all of the factual findings  board below look specifically at primary references those two bronco articles for example but lantus label itself and they all identify as well as another sanofi product  required the inclusion of acer fact and and the board a bit of specific factual finding about that crediting my lens experts over so no peace experts here saying that it was the exposure to the hydrophobic surface that was the cause of concern for aggregation it was not the particular delivery system or some of this problem doesn't solve any special problem or any other answer of fact it would do what is your client's interest well this pression to the able to effect the patent structure for this product well so there are two there's a product on the market and under f d a guidelines an analysis we are required to duplicate centrally duplicate the formulation that is the brand product here and so we've we are required to include a circus act into our formulation and i'm not clipping in saying that the surf act and does nothing to stabilize the formulation of fact i think the reasonable expectation of success to an artist and is that it would enhance the the stability of the formulation but it's an it's a business decision ultimately whether a now needs to include a certain fact and so the f d a never as far as i can tell based on the record before us the f d a never said you have to my understanding is and perhaps by my learned friend representation if you can provide further color to the extent it's not in the reformulated product was approved in two thousand and four or five and it entered the market in two thousand and five or six it was about a year i remember the year delta between the approval and the introduction to sell material so your honor i have just you and i do agree that i think that the addition of the surfactant was beneficial and i think that the evidence of record the twenty odd references that professor langer identified suggests and  make a reasonable expectation that you're going to succeed here a final point in that there's there's this tension or notion and i've heard snuppy sort of say well there's desired aggregation and non desired aggregation those are very different things and those are explained pretty clearly and understood by a person of ordinary skill in the viola versus under the skin exactly and that's understood in the formation of hex simmers the proper the desirable sort of  instrument of enhancing absorption and so therefore the argument goes that well this this therefore is some kind of proof that the introduction of a surf act and will actually undo the desired native of glom aeration once you inject modern american solution into the human tissue so what's your answer to that so the the panel didn't consider that argument they recognized it at page thirty one they say among other things and then they identify a string of things that they use air quotes around the would could in characterizing some of snow peas arguments about why a person of ordinary skill in that seemed to me the board just summed it up by saying well you don't need absolute predictability expectations well i think that's true and i think also the board did go ahead and analyze so this was essentially snuffy's snuffy it presented these arguments and and the board was taking them seriously and considered them all and for several of those arguments concluded a significant analysis including one about potential interference of a surf act and with another additive medicare all and found as a matter and found in there arguments that an ordinary skilled artisan would not have recently expected success so we did absolutely consider those those arguments in addition to that your honor i think there is record evidence that suggests and supports the notion that  expert has testimony that surfactant would have been expected to interfere with the native formation of the hex mers that are vital to our genes mechanism of action once it's injected to form precipitates necessary to give it its long acting effect and again i think if you look at my understanding of the way the glare gene precipitates when once it's injected it's because of the glare gene while it's sitting in a vial in a at a neutral ph it ends up becoming unstable and then  formations i guess what i'm i'm just trying to figure out whether the statement that you got out of the other side's expert whether that's in the right context of what's going on in terms of simply doesn't contend with the question that was presented here about whether the mechanism of action would be disrupted based on based on the fact and be at it if i may just address a couple of more points that came up in my counsel's and my colleagues fourteen to eighty six and then if you look at pending seven hundred and twenty six that is of the board's institution decision where they pretty much agree with us that what major is that sorry it's seven hundred and twenty six and that's the board institution decision where they essentially agree that patent that argument regarding that just labels ph morning has merit and they want to talk about other evidence but i think it's a good indication of why they didn't rely on it and the nd time around and that  declaration and the additional references that that she cited and we have a center brief but just to make the point you know those were references that mylan introduced for the st time in connection with this required reef that we weren't allowed to respond to with evidence and in fact the board use that declaration and those references to discredit our expert without giving our expert or or santa fe an opportunity to response with that was a part that was improper and that was a matter of fairness we should have had the opportunity to do  particular evidence and we should have been had we should have had the opportunity to do that this was evidence that mining could have and should have introduced with this petition introduce it for the st time on reply and it is prejudicial because we know from the board's own