and nd the district court made a finding that our it was unpredictable which is the touchstone of non obviousness those findings alone should have resulted in a conclusion that the claims were not obvious and as the written description there's no dispute that the district court said that the prior are was unpredictable he didn't make any carve out for any prior art that made it predictable he said all the prior art was unpredictable in the one hundred and twelve dollars analysis and in fact based on those understated findings this court should reverse the obviousness and with regard to written description not only was there an example in the pattern that shows that the inventors possessed it but there was other information will allow for latest other examples and what happened here contrary to our country bar the district court added additional requirements that are legally irrelevant before i go into the such as i just want to make sure we're all clear as to what the claims are here they are they address the appropriate  all the drug they could get either respiratory side effect or overdosing and potentially even die from the drug and prior to the invention every commercial extended release opioid product that had been tested in inventor's their invention did not require that dose adjustment for a particular parents which is important because it allowed the doctors to give the proper dose to alleviate the pain and not have to worry about potential overdose here the district court's conclusions guidance as to the proper dose of the pain formulation and i pad if your parent patient however in another section of the decision the district court directly contradicted that he said nothing and are providing guidance as to which should have ignored the teaching to change what i'm saying is that he said specifically the jane provided no guidance as to what the proper dose would have been and in fact he is in the on that point he also if you look at the motivation finding the ultimate finding it only says that the art would have quote provided guidance he doesn't say what guidance and if you look at other parts of the of the decision the district court says through it right he says the vein of pain just goes up when relation that's identical to the one above what would be expected and the court said presumably that that would be the same for hydrocodone without having any data whatsoever and a presumption is not clear and convincing evidence and efficient to go back to your point  acetaminophen that was over than what they expected would have been subject to a potential dose adjustment so you would be able to know whether there was a dose adjustment based on those values or not and in fact their expert said you couldn't predict what the weather you need a dose adjustment  not for the hydrocodone formulation alone and to the extent that the district court assume that it would be the same for a child versus nonny patients because of this data in defending that's basically speculation because every place you turn you see and i think what happened here is that i think that the decision falls into a hindsight trap because as i mentioned earlier there was no information into vein as to whether or not you needed to adjust the dose there expert agree to that there's no  information at all and there's no statement intervening it doesn't say you don't need to just with those none of the references none of the prior art references say there's no need to adjust the dose for our particular formulation and so fundamentally neither the district court nor artisan unpredictable is inconsistent with a finding that the claims are obvious i mean we could go the next layer and say yes i also disagree with the particular findings but i think at a threshold matter our argument is that it is of course the so and i wasn't intending to say that i was it that was understood that way but i also remember remember earlier in the opinion he stood district court says that there was nothing in the art that would give anyone confidence h patient so it's not just what he said in the written description section it's also in the beginning when he was looking at the prior art as a whole when he said well there's nothing in the art that would give any confidence as what the prior are for had patent we find we believe that those statements are entirely inconsistent with one another i like to just touch on written descriptions very briefly the test for written description is whether the specification allows a person of on a scale whether the test for the task is whether the specification excuse me allows a post of the recognize whether the inventors had the claimed invention there's no dispute here that example represents a claim invention there's also no dispute that the provides additional formulations it provides the dissolution data it provides p k data and with regard to those additional formulations and p k data a one person already skilled could use that p k data and dissolution data as target data became well there's a limiting us an important limiting factor the number that would fit within it and that is that the ratio of the extended release portion to the immediate release portion has to be to eighty to twenty and so you have to have that limitation by itself will narrow the universe of potential formulations that could be used the fact that it's hydrocodone only narrows the universe the fact that it's an extended release narrows the universe so if you have any rodgers no one provided a specific number i mean that in fact th testimony from allergies expert who's conclusory just had a myriad input a number he's not a formulator so he wasn't really capable of giving that information our experts said that well based on all the information here one skill you are could easily make additional formulations that really explains why you would come to write them those that was the expressed district court issue but the problem is that the district court didn't consider structural limitations that were provided in the specification and testified by the experts that would limit the breath of the claims so the district court said that unclaimed unclaimed structural features like the eighty to twenty ratio doesn't count and in fact in the  court ruled that fun claim characteristics can be used and likewise in the abbey case this course this court rejected an argument that unclaimed characteristics can't be used the district court also made a few other legal errors by adding certain types of requirements that are legally permissible there's all of them are just in our brief but i want to judge just two more that aside from the unclean character it's one way and here a bottle of keeping you know i'm going to take the next twenty seconds and do these  engine case and he was setting forth why this case is distinguishable from the amgen case and he was also doing it in the context of the specification here the specification here talks about the fact that it's a person's position it's consistently been their position the case of farce where the state of the state of the hour is unpredictable that cuts dramatically against an obvious determination doesn't correct it could go against an obviousness determination but if you read the i mean was he talking about apples and oranges there because or was he just talking about well the state of this field is unpredictable period and therefore there's a conflict with the motivation to buy an analysis so specifically what it what i believe in it's always difficult get into somebody else's mind when they're writing it i believe he was focused on distinguishing the emphasis in the engine case it was it was very different because it talked about whether there was a correlation and there still important i mean is there something to do with written description that makes the state of the art different than for purposes of obviousness so a couple points written description obviousness obviously are  different standards and with obviousness it was incumbent to demonstrate on our mission which we read in the district court found that a single formulation would have been expected and predictable to produce the claim pharmacokinetics or the non adjustment would which flows from the plain pharmaco we're talking about the specific prior art formulation described in the vat correct and for written description the standards broader it's not the case that if you have a reasonable expectation of success that you will not the serially demonstrate that you have possessed the invention and in fact the area case exactly direct excuse me directly address that and said that a description that merely i want to address a couple other points that were raised certainly it was clear in persons presentation that the heart of this case are a number of factual determinations made by the court and in fact counsel started by saying that those factual that this case should be reversed because of those factual determination so the problem with that is there is a very high bar when there are factual determinations underlying in this record case and this court can only overturn them if they're clearly erroneous certainly vary and we will look at it very carefully to make sure that that is fair and to apply it in those circumstances as opposed to anticipation where it's it's more appropriate yes absolutely your honor and you think th below there is no dispute here that the divine formulation inherently has these claims properties so you know this fits squarely within the court's discussion of when you should use and hear and see an obvious in this case believe in what a person would like you to believe that the prior are total away from that the district court made multiple findings based on the art in based on expert testimony that simply wasn't the case and gene which is the primary reference a court relied on  so it's it's very interesting your honor so what person doesn't say is that it was legally improper for the district court to take judicial notice of the f d a guidance and there's a very good reason for is that was one of four separate reasons why the district court found motivation and it wasn't even the most important so the court made four separate findings of why a person born or skill in the art significant finding the court said most significantly a person a skill in the art would have appreciated that acetaminophen minutes and hydrocodone are metabolized differently so the court made four separate findings in the most significant was not based on are just quickly i'd like to address some of the risk groups in point some of the written description points that were brought up st on the test itself counsel mention a very broad test with a very specific test when you have functional claims that are a gene and directed to a genius and two things one of two things have to be met either representative number of species need to be disclosed or structural features that are common to the members of the genus need  honor about how many different formulations could potentially fall under the claims here and i think that's a key finding a dentist is a key factual finding that could only be reversed declare the court there's testimony that a myriad number of formulation in the district court heard all this testimony and came to the conclusion that there was a limitless number of formulation that potentially fall within the functional genius that's in the claims council mention some twenty requirement that functional limitation is not in the clean the claims don't just don't have that in the claim so that's really irrelevant for the written description and maybe most importantly t specification nowhere and persians expert invented this at trial the specification no were disclosed as a special sauce so nowhere says if there are these special things you need to put in your formulation and if you do you don't have to adjust if you don't you're going to have to adjust let me just to just the last issue st about special sauce that just goes back to the fact that event is did not understand how the invention actually works and so the special sauce essentially irrelevant turning back to obvious sarkozy sure others didn't understand how conventional the invention the inventors that know why i should you should use the word why the invention work they didn't know why there was not a need for dos it just means they just knew that these formulations that you didn't need a dose adjustment the unknown right now i don't think anyone needs to know why the invention works what causes the invention to work one skill the art will look at the other information in the patent including the solution data which could be used as a target to make other formulations that would fit within the claim and ultimately have to make the the formulation you would just run a p k study which all the experts agree was a standard study in this area just to address inherent see judge mallya raise that issue the issue here is that the divan doesn't naturally flow to having a just and that goes for how to prepare patients because it's silent on the issue and whether you could do that or not is but is not the point is under inherent see the fact that you could do something doesn't make york could have adjusted the dose just like dr smith said it's i have hospice is whether you could adjust the dose or not you needed to run testing to figure that out i see i've gone over my time ok right cases will be submitted