and number two thousand and eleven one three five three this goes to the core of what's troubling me about this case when you say would have worked what you mean by would have worked i mean that there's nothing in the path that i can see that defines a level of e that suggests how we would determine whether it works or not other than simply saying it distributes the drug throughout the body of someone who receives it well it certainly discusses that your honor but it also talks about treating people with diabetes i instead have a guidebook and so the the standard for whether or not it works is whether or not it mitigates the effects of diabetes and puts and controls the blood sugar levels of the patients but we know the the drug delivery platform that has only an individual context with respect to in vitro rather context with respect to glipizide only in the context of a lab bench and their artificial conditions it doesn't to talk about putting it into a patient how it should be put into a patient for what purpose it should be put into a patient it has no reference to diabetes it has no reference to hypoglycemia or any of the other related conditions it seems to be a test situation that they disclose in the context of a laboratory issue of the relationship between pfizer and also a rose i think that that's the reason we put it in that way it was only in the board's decision well that they might examine or specifically reference that and about pfizer  she was rejecting that the opinion of your expert quite she also specifically mentioned pfizer and that relationship there was a mention of pfizer on it but i think in context it wasn't clear what the examiner was relying upon their the weather will have the motivation of pfizer they put exam or latched onto his exam didn't raise the issue pfizer on it on her own it was only in responding to statements why didn't you put in more than just a google search your honor we felt constrained in an evidentiary sense in raising this from rehearing to put in evidence we put in evidence would be publicly available but we didn't relationship between kaiser and also with respect to good control itself is very clear and it wasn't clear from what the examiner had teed up for strongly that the rule that the nature of the relationship between also in pfizer was in question much less that it tolo itself but it in knowledge is with respect to a sustained release dosage form for glipizide we had misgivings about whether it would work and we in fact thought it would they endanger the health of the patient that's a paragraph twenty one so we were addressing the rejection that was being framed at that time which was solely obviousness in view of core cola and that's the reason why we're doing it in the commercial success we felt very confident the arguments that we had with respect to sustain release dosage for administering to patient would work to control the symptoms of diabetes and also because of the prior experience the doctors had with it related to a library that the sustained release  administration of clip as i do patients would actually endanger the patient's health because of the uncontrolled way they did with thought was thought that it would affect the blood glucose levels so what is there in your specifications that suggests that that was incorrect  there's nothing in the scientific underlying nature of the mechanism of how it affects things but what's in our specification your honor is a discussion of actually taking and it's there's of the scutcheon of a once a day glipizide to a patient that's what's in our specification and that is contrary to the thinking at the rope including time as to whether or not that type of method would actually work in a patient and not in fact in danger of the patient's health it was later proven through a number of studies in fact the commercial marketing of that product that that was in fact correct that's the nature of our disclosure but we do but but you had not answered tainted that at the time or at least you didn't say anything in your spec well correct subsequent to the filing a patent was much more scientific investigation and validation of what was disclosed in the patent that is in fact the case one thing here as i mentioned is core towboat discloses simply t on a laboratory bench if fails to disclose how if at all that testing relates actual use and human much has been made of the fact that there's an in vivo vitro test a lab bench test of about twenty three hours or so but there's no indication in the record of how the twenty three hours would have been viewed of supply some of the border still in new york in terms of actual use in a patient there's no disclosure for example of whether that twenty three hour period was believed to be relevant of once a day administration once every twenty four hours were the director has failed to to bridge and moreover there's the length of its declaration standing in the way the only evidence of record in the catering with those of were very skilled would have understood and believe that the relevant point time i see them in the my of treatment but it does if you look at the claims and that's are on it for ninety nine claims fifteen sixteen seventeen and nineteen all claim to method of treatment so he's not adequately describing the state of the art courteau was already telling people to administer clip aside in a controlled release formulation to patients but but the mere fact that it might be in a controlled release form doesn't for that right but the whole point of using glipizide is to control the spikes in blood sugar you can't just lower blood sugar i mean that was the whole point is that when someone eats the spike goes up when their sugar drops it goes down i mean the mere fact that you hand give someone a controlled release doesn't mean that it's something that would be medically sound to do but own because it didn't figure that out either he doesn't have any in vivo results either he just he does the same thing he just has a controlled release book aside and and says to use it so there's no advance over corozal over what his and he was doing and you know obviously pfizer wouldn't have been trying to make a controlled release dosage for if they didn't think it was going to have some efficacy in the market i don't think pharmaceutical companies pursue drugs that they don't think are going to work well this is certainly gets at the key question for me at least uses a much narrower needle it's much less invasive than the standard syringes and then someone comes along and says oh ok i now claim a method of delivering  drugs to a human using that syringe and five years later it turns out that after a lot of research and epidemy illogical studies that the use of that syringe to drink deliver certain drugs actually makes the drugs for some reason that's not entirely clear more efficacious than you would have expected does that fact discovered later not found within the specification render that he wanted to show unexpected results he could have tried to show that there was something about his sustained release that was different think or talk and if he had made a showing of unexpected results the board would have considered that well what would you do with my case i think you would have to look at what those unexpected results were well the unexpected results are let's say that the the the drug when administered in what would amount to a smaller volume in a particular part of the body ends up being absorbed more quickly is more efficacious i think you'd have to look at whether one of ordinary skill in the art would have would have expected that to happen you're saying they i'm saying they wouldn't if it came as a big surprise to everyone including the patent the question is does that later unexpected results in your to the benefit of the patent ability of the patent and let me direct you without here's what's troubling me we have a recent case that you may be familiar with genetics institute against novartis and in which we said well at least with respect to a product in that case a compound that the the surprising results of the compound entitle the compound to  the benefits of patentability even if they weren't known time of the bench do you think that analysis would apply in this setting no your honor because i don't think there are any unexpected results i think but it's wrong you think it was wrong but what other evidence is there in the record to say that he wasn't wrong when you thought there was nothing else in the record that said at the time anyone would have ever expected this to stage release to work to treat diabetes so what the record what the record shows though is pfizer was pursuing it pfizer was pursuing it even if they're correct that pfizer and also collaborated to control in the early one nine hundred ninety s pfizer was pursuing it independently in the of extraordinarily well i mean they were pursuing it i thought they were i mean we would look at this art and say one one of ordinary skill in the art was doing it i mean i don't know why you would think that that was ordinary write more that they were ordinary and you know what could since he's trying to say is that pfizer was only pursuing this because it knew of since his invention but again that's not supported by the record because pfizer was an independent person some of those drugs in these dosage forms to patients it doesn't actually teach doing it for good design now it is true that eight of the eleven laboratory examples are directed to glipizide interesting though there is no claim reciting glipizide counsel mentions that there are claims to methods of treatment yes those claims of methods of treatment are generic now it's interesting that if there were such interesting glipizide that have that many experiments examples on the laboratory bench directed the glipizide there is no attempt made to treat clips of addicted to claim methods of treatment involving glipizide that's consistent with misgivings about whether or not a controlled delivery glipizide would actually work in a patient and disc givings as to whether or not to be danger patients health well it's also consistent i suppose one could argue with wanting to claim generically rather than her specifically it certainly is wrong or it did it's equivocal at best but it doesn't mean it's consistent new way of looking at it if there were such interesting glimpse i there is no claim directed to it in spite of the many examples in the laboratory context and accounts also mentioned pfizer there's evidence of pfizer was pursuing it well that all begs the question of what was it if it is a dosage form that involves lytro for crystals with clippers i guess they were showing that there's evidence of that that's portfolio but w that they pursued it up the core of tolo they said yeah this is a nice laboratory system but we were not put it into a patient that's supported by the record as far as equally well as the idea that they were pursuing it and had an intention and ventured brought that to market his glucotrol so there's no evidence of record of what pfizer was doing or thinking at the relevant point in time what we do have is the declaration of dr levis which states with fact based testimony that people skilled in the or didn't think the methods would work and moreover would endanger the health of the patient now if i may your honor you'd mention this hype a hypothetical situation involving a syringe right if i like make a modification of it a bit to more closely match our practice i believe you talked about a as to whether it endangered patient the patient health the unexpected result as in our instance is the fact that it does work council mentioned we don't have unexpected results well yet we don't have testate of mr portfolios device tested against mr kaczynski as a device we don't have that with and that's not the real difference between the well purpose there seems to be similarity with but we don't know how it actually performs in a patient that things have been known to perform one way in a lab bench and not perform the same way in a patient but what we have here is we have the unexpected result is the fact that the contrary to the thinking of those in the art the controlled release form eclipse i actually does work and this is not diminish in jeopardize the health of haitian but that's the unexpected result that brings us back to the question of whether you get the benefit of an unexpected result that was not discovered at the time but it's more th did you then get the benefit of being able to say well it was later discovered that it actually works better than any of us would have expected and therefore we have a patent that's valid your honor i don't believe in i wouldn't concede that what we did was take or o and put that into patients there seems to be some similarities there but i wouldn't concede that the that the dosage for that was act ok well let's let's pass that issue of potential dispute it get to that the question of whether you get the benefit of a later discovered a special efficacy for the treatment your honor i believe in this particular context we do because it's not merely discovering something which is unexpected that it performs better if there was thinking in the field that it wouldn't work and it would endanger the health of the patient and in those both of those respects that thinking was incorrect that was what kept people the record was consistent with this it kept people from actually administering something of this type to patients and we contrary thinking in the field on both of those points proceeded and found and developed at that dosage form which actually does work and help patients pfizer how do you respond to the fact that even if you put it put aside the question of whether their ultimate embodiment was your was using your invention  before he well i think the activities for your honor there were not as not interest with or either i think or not is consistent with the idea that people were exploring controlled release dosage forms of various platforms or not being a believable difference in court although people had had long lists of drugs with which these could be used people had played with them in a laboratory settings but everything we've seen is consistent with having a misgiving about actually putting that into a patient so i think bernard is consistent in that regard so let me just spin out it perhaps just to make sure i understand what your position is on another hypothetical suppose that i know that the prior art has discovered a particular compound which is extremely effective against a particular form of cancer but it carries brutal side effects that administered to a person would be expected to kill most of the people that are are given it but you're sitting in your lab you saying well you know i know that's what everybody thinks and everything in that that's been studied so far has come to that conclusion but what the heck let's go ahead and put in the patent application for this a method of treatment using this particular compound and if it turns out that it works better then everybody thinks including that we'll have a great patent and you do that and you somehow get it through the patent office and it turns out much to your surprise in the surprise of everybody else that the side effects are not quite as severe as everyone had expected do you get the benefit of that later discovery to make your path that led over the prior art your i think there might be facts situations where you don't then th facts situations where you do there are number of things even in your hypothetical i guess could be nailed down there's no point the point you make about the extent to which the drug was suspected to be used for against cancer it would depend on then that that would depend also on whether or not the inventor had a particular insight he mentioned a good all he had only inventor had was to say you know let's go ahead and toss it in it may turn out that this is better than any of us think and if it does we got a winner your honor i think if the record supports that the inventor is doing nothing more than taking a flyer and saying what the hell i think that that would be the position in which the unexpected result