the next very next after paragraph in passage in right to where record said the drug was well tolerated with minimal side effects which promptly subsided after discontinuation of the drug were decreasing dosage that's again on  the record that goes against their case you know we would we would put forth that these passages in right to itself the primary reference being relied upon by the p t o alone here contain that evidence that goes against example which is a twenty four i don't read the whole thing but it says giving professor don't twenty four hundred milligrams per day to a if you pass a pulmonary fibrosis patient which is not a reduced brief that regular itself did not disclose that twenty four hundred milligram per day dose which is required are clean but what they went round and round about with the abc and below and on appeal board and in the decreased dose in fact they seem to keep sight sidestepping the fact that regulate itself said if you want to for example get fatigue an adverse effect a profound atone to decrease you decrease the dosage and then the rest of that sentence is and with the reminder to take the medication with what are likely right now so i think i think your honor the best thing that can be said for ragu is that it's a b and c it said decrease the dose said that twice and in fact emphasize it in particular as the way to get side effect to subside so it's a b and c decrease dose no doubt about that and with liquid in food a b c all three of those things how the teaching away from they then use the food to decrease side effect because it's teaching i think it's consistent just on a for a one in regular with teaching that in order to get side effects to decrease the one thing we can be clear about is you have to his prior reference in the studies that they had done at the university of washington and if your program self believe that food was even part of a way to get side effects such as fatigue or gastric upset to subside surely they would have mentioned that in their subsequent paper talking about giving prevented them to i p s patients and in which they talk about side effects to fall on such analogy question what do you make of the statement this subsided with decreased and with reminded to take medication with food and liquid it seems to me that that saying a and b have this consequence as favorable consequence look at the full scope of what the prior reference teaches and in fact the other prior art as well you're you're left with the conclusion i don't see how you can't be left with the conclusion that reglue is saying a b and c are a good thing decrease the dose twice and then  sane and b and c and with food and liquid now there's some indication they're obviously not seize upon but obviously there's some indication there by ragu that they thought that there was a potential at least a little unclear i think  somewhat vague statement but i think a little unclear but you could say ok they thought that food might play some role but i don't think we can definitively say that from the rugby reference i don't think you have to be a physician and in particular to read those sen food we say get with food but we also say twenty four hundred milligrams of b if you will and we also say easy to decrease business neither of which see any or mentioned anywhere in rockville so we've got at best a prior reference right good which says a b and c and we say not a nothing about b and c b n e that cannot be the basis for obviousness that's not a prime if they should case for obviousness that's not evidence that a reasonable mind would find adequate to support an obvious mistakes simply because the word food is mentioned in combination with the clear teaching in ra do about how to avoid side effects doesn't mean that w obvious that one should simply give food with prevented on at a specific dose to decrease dizziness you know because drug you didn't disclose at twenty four hundred milligrams per day dose that we require in our claim in our claims  the p t o compounded the problem and went ahead and combined the rug new reference with the water reference at a four five now they focused the p t o focused on this water reference despite the fact that the water reference and i think everybody would agree is directed towards getting prevented own to multiple sclerosis multiple sclerosis patients as i said all patients have been classified as secondary progressive multiple sclerosis for at least two years at say fo seven the patent office instead of looking at that and saying well is there any reason why one of ordinary skill of the time around patient was filed would have would have looked to a reference which talks about a dose for multiple sclerosis patients instead they focused on the simple fact that water disclosed giving twenty four hundred milligrams a day to those multiple sclerosis patients which is a paper of seven and some nausea with encounters especially the drug was taken without food that's a four twelve patients who obviously are six but are not certainly sick in the way that if you pass their right i p f patients are i p f is a is a terminal disease and our survival rate for years and you can look in both water itself and in iraq and see that in multiple sclerosis patients they really didn't have anything in the way of side effects or at least the only thing they had to be a little nausea whereas when you give this drug the i p f patients these are really sick patients they've got a we could bad disease most of them did not survive well a large proportion of them didn't even survive the study of iraq how would you take a reference them for multiple sclerosis patients who showed little in the way of side effects and think that that dosage was going to be appropriate both in terms of safety and effectiveness for these really sick i time understanding the arguments about what about the side effects and the connection to the particular disease are you saying that that is a side effect of this medication are different depending on what is treating that certainly seems to be the case and again you don't have to be a physician i think to understand that when you're dealing with multiple sclerosis patients who obviously have oppressive disease that they're sick patients but it's categor different when you're talking about i p s patients these are terminally ill patients and from those prior references walker and regular themselves you can see that there is a different spectrum a different universe and a much more serious universe of side effects in the i p f patients because of the nature of their and perhaps because of the interaction of prevented them with whatever symptoms they already have with the word declaration submitted to the a t o saying that the side effects are no no there wasn't but again i think i think it's a situation where you don't have to be a physician for example to look at them you can look at the evidence the data that's put forth pretty plainly in water and right through where regu talks about i p s patients and in fact the other references azuma moises and the guy talk about that spectrum of side effects which i p s patients suffer when or have when they are mr prevented them and then you look at walker the multiple sclerosis paper and it basically says well they had some nausea and they particularly had some of them had some nazi if they didn't take it with food so i don't think i don't think we needed testimony below in the form of a declaration from one of ordinary skill saying if i read these papers i see this because it's plain on the face step it requires twenty four hundred milligrams per day a profoundly don't be given to an i p s patient all that was known ragu teaches that you should prescribe forty milligrams per  day to the i p f patients and the record shows that there's a segment of the i p s community that weighs sixty kilograms so the board found that for sixty kilograms i p f patient that prescribe doses should be twenty four hundred milligrams and that coincides with the administering step of robinson's administering but there's nothing that says that i p s is limited to women who are very happy i know and that's completely correct your honor but the examiner may to find one with respect to what you just mentioned regarding american women the other with respect to what was provided to it from robinson which was evidence which shows that sixty kilograms was a known weight for a certain segment of the ip of community examiner relied upon that evidence provided to it from robinson and came up with the calculation that twenty four hundred milligrams per day would bioavailability oxymorphone increased with respect to renal failure in comparison to individuals that were healthy and for the administering step they needed to be given an effective therapeutic amount and it determined that there was no functional relationship there because the informing step did not transform the process for taking the dosage it determined that the claims did not require any change in dosage in response to the informing staff and therefore the court concluded that because the administering step was already known and it was a failure to establish a functional relationship between the informing step and the administering step that the claim was properly rejected there were a similar set of facts in king pharmaceuticals where there was again and informing step and in administering step and there the court determined that there was no functional relationship between the informing step and the administering step because simply explaining to the patient the benefits of taking the drug did not transform the process of taking the drug those two cases are now exists to the facts here here robinson's arguing that because they've come up with certain benefits that they should receive a patent however under this court case line coude king's pharmaceuticals they're wrong because they have not they have not established that there is a functional relationship so as in cows and things pharmaceuticals this court should find that there informing cep does not control any patentability at all now they've also argued that because of the benefits that were found with respect to dizziness that they ought to receive a patent for that reason however dizziness and some of the other from a kinetic properties which they uncovered are merely inherent properties of taking the drug with with food but under this court case law simply discovering a new benefit for all property does not render that  process and what robinson has basically done is recognize an inherent property that had always been in existence however it was previously unknown but that does not make but that does not mean that they have actually invented something that was new now they argue that assume a and a guy a stab of some form of teaching away however those two publications other work if at all the prior art continuing plea addresses something like symptoms in ways other than in food then there is a case of this as in the circumstances or simply because we're go and walk or not with the same problem so they would have looked a right to a walker and have found the problem the problem with that solution would have been to combine food with the drug  population we put into the record below that an average weight for a japanese patient is sixty kilograms the examiner on the board relied on that but as course that were being dealt with and medicated in the ragu study who are in washington state that in fact patients who have i p f or are significantly heavier than that so there's no there's actually no evidence in the record that anyone looking at r who was treating i p s patients united states with prevented don't would have had anyone who was sixty kilograms just no evidence at all on the second on the second point on the informing step we never we never get to that i know it's been briefed in the briefs a lot is in particular because in june and cow them attacks long oxymorphone cases they the court found that the administration step was anticipated so the parties there had to rely upon their informed step and did rely on an informant step in order to try to establish a pattern build we don't need to do that here the patent office has been established that they have substantial evidence to support a crime a facia case of obviousness here certainly there's no evidence that  process that was in the order for many years like in some of the other cases we invented because we went and did the research into the studies we invented a new process and found that it was very useful and it had unexpected benefits in that we found our scientists found through scientific research that in fact you could give a full therapeutic dose to an i p s patient and still sidestep or avoid the adverse effects whereas the prior art taught if you look at those prior references that we talk about they taught i think judgment as you pointed out they thought that decreasing the dose now we we can't we can't say that doing the research and finding this finding a new process they're there with a process is just so you don't know until you actually invent the process well that's not in here and see and that doesn't render them obvious and as this court is found in previous cases there's a long line of cases that says you're not going to rely upon that was  fact here they dealt with exactly the same problem they were giving percentage on the i p f patients and they found side effects and what did they say they said were side effects were found we found a decreasing the dos