pleased to welcome and today is yesterday our colleague judge ronald park district judge from the eastern district of texas who obviously is a member of this panel and was a member of panel yesterday he  appears here or doing some extra work out of his generosity and dedication we appreciate his willingness to do that and as many of you may know he follows the line of about forty district will be submitted without argument on the briefs today namely stanisic versus united states postal service appeal thirty one thirty one simonton versus department of veterans affairs appeal seventy sixty one and dumont versus united states appeal five zero six zero on our three case argument list will hear arguments first in promethea celebratory versus mayo collaborative that's appeal fourteen zero three from two thousand and eight mr press good morning to welcome back to the court please proceed i might advise counsel that we've agreed to be a little bit lenient  with the red light and in any event will add five minutes to the normal argument time so you can each be assured of having twenty minutes and if necessary we may even extend that on the spot so please p and i had trouble finding out which claims pacifically were asserted can you help me on that well initially order we asserted claims one of the six twenty three patent and claim seven those are both independent did to how to deal with on eighty some are clearly not your honor and that's one of the difficulties we've got with reading the district judge judge's opinion is that the district judge dealt primarily with one or two independen believe that the district judge intended to invalidate all of the claims in both patents he just didn't identify them by name and he didn't deal with them specifically in his opinion were they all a third no they had not record overreached in addressing claims that it not been a certain bias as in as infringement claims but certainly his ruling i think is probably the best way to cover all of that plame said i think that that's what he was intending to do i don't think y to assure that it's in some kind of efficacious or therapeutic brain and that range of course is determined by the natural processes of the human body and how are you not in effect taking over the entire scope of anything either now or forever under want to want it might have anything to do with sixteen g and now you're thomas one of one of the biggest reefs that it's only a limited to treatment of these intestinal disease has been i just said i think and what it doesn't claim i don't think that i'm digging a hole at least i hope i'm not the one or i do think that this case is quite different from cases where this court has held that it patent was simply too abstract and tried to cover an abstract idea or a law of nature you know if you look at those cases if you look at graham's if you look at meyer those are cases were what was really attempted was to get a patent on an abstract ok but that just tells me that they're open to think family doesn't give me any clue at all whether it's two or twenty or two hundred or a thousand more the ones that are used in the ones that we name for instance and are dependent clincher on or i think number only four or five and you know intestinal to supporters how many diseases are we talking about that are gastrointestinal disorders that have that relationship to the immune system or your honor we we lay out in the in the i don't know precisely i think probably a matter of definition second rate it probably is better definition but these are you know to be clear we are talking about a defined family of drugs creating a particular artificial oh metaboli we're not talking about all drugs that create any metabolite i think that this case would be much more similar to the cases that this court has thrown out if our process were at ministre drug useful for treatment because it creates metabolites measure resulting on i think it's all about particularities i think that in that case what we're really talking about is a construct or protocol for diagnosis generally didn't identify for what particular abnormal condition it didn't identify the particular data that you would it would gather to just settle for any abnormal condition that you're trying to identify this would be a protocol that you would go through that's a very abstract concept in this case is much more like arrhythmia and much more like on a ballet in the sense that you're talking about solving a particular medical problem or a diagnosis or particular medical or just like in arrhythmia the algorithm was used in that case or that stated that a process can be have a subject matter that is tied to a machine as we pointed out in our briefs machines are the special statutory favorite among the statutory subject matter and that it tie to a composition of matter similarly well what technically you want to what happens is even when you administer type one and it turns into type one nucleotides which are are then the active ingredient for purposes of suppressing the immune system this is laid out in the specifications so even in that instance you've got it and certainly if you talk about eighty eight for example which is a pro drug that then turns into one in which then turns into sixty g as well as  well yes your honor and and sure you've got drugs that by their very nature the reason you used them is that they create new substances metabolites in the body that's that's what that treats the disease the sixty g b and if you put that in did not contain a limitation and that order limitation were in the body of the crane and as i understand your brief here you're saying well actually the preamble is important and it does have to be read in conjunction with the step in what i'm calling the body of the claim that it is  metabolite levels were over four hundred or seven thousand depending on the metabolite you had to decrease the dose or in every case where sixty g was a lot to thirty you have to increase the dose and we explained in the district court we are happy to explain here that we don't work choir in you know for practice of of these claims that and actual change and those occur the doctor of course will have ended up con another issue i'm trying to figure out what or the only operative words were a method that's what the talking just so i put myself in the district judge to translate to me they're telling me that nothing in this preamble matters other than to identify it as a method editors and i think that it's only fair to read it in that light in order to better understand what we're talking about and i also don't think you can read the specifications here without understanding what these claims are about these are not methods in the abstract with no point to them these are methods for ensuring therapeutic efficacy or reducing toxicity and to get one design is right and i recall correctly that your position in the district court was that there were no limitation on the a third claim other than the dept set out in the body of the claim we're discussing is that right or not i don't believe that we ever said in the don't like well there's only certain diseases that can accurately be described as immune mediated disease so so i do think that it doesn't cover everything in the entire world it's not like koreans read say diagnosing any condition that exists i it's like saying there are drugs that if there were drug treatment for example that would work for any kind of cancer i think it would be fair to say this works on all cancers but for dave the risk after research may turn out that some kind of immune problem and then you do to clarify our claim has always been against mayo when there was inducing the doctors direct infringement so that's where the dog groton regiment of the clinic you need it you always needed direct infringement yes and so if the defendant wasn't the doctor the defendant was never the a researcher can't come in after the fact or look at a bunch of cold they didn't think about these correlations or otherwise the infringer patent when you've got a doctor like dr ellis sorry who was administering the drugs not for fun and not for purely for research but said that the results are not within the therapeutic range at that point the doctor did practice on one of our dependent claims in that case and that's all the doctor was involved and you're talking about again administration of specific and particular drugs to treat specific diseases measurement of specific metabolites the transformations include not only that broad transformation you're saying and then you just told the chief judge that the preamble was supposed to be read and limitation and you just concrete highly corp oriel process on the one hand and benson was an abstract one struct on the other and it really is in that context that i'm making a distinction your honor and and yes i agree that at the edges that gets difficult but if you want to talk about concrete and highly proportional these tests easily meet that standard these these claims do again we're not talking about all diseases or any malfunction if you're mark meyer or graham to time but anything that might go wrong with any system what about particular auto immune disease is treated with particular drugs in particular ways measured according to only the amount per red blood cell which is a particular form of men meant with very particular wording at four hundred then wouldn't that be true no matter what the disease was no your honor actually from what i know and i don't know the research well people think that the thresholds may well be different for different diseases and it may be that how can that be if it would if the metabolite at a certain concentration can begin to have toxic effect on my bottom and generally for these particular diseases and that threshold you know again could well differ we have depended claims just so it's clear on many of these particular diseases so even if this court were to feel that independent claims were too broad i do think that it would have to address the use of these drugs for particularly named diseases and i do think that those are quite specific even if the planes were never for purposes of the plant construction breach or your honor let me put it this way i think there's two different options right one is for this court to find that those are valid under want to one and the other is for this court to tell the district court that it could not properly have dismissed or or judge those claims to be invalid i don't think the third option of simply affirming that court without dressing it would be appropriate let me ask you because some of the makers friends of court briefs bring this up there are tremendous concern favor i do think that if you get into other biotech patents where you are searching within the body purely for existing compounds for instance genes and that sort of thing and then testing those for diagnostic or treatment purposes you don't either have to rely on the compound itself or you have to rely on the transformation that is occasioned by protest i think the latter would be sufficient by the way as well and i do think that while we don't have to go there in this case blood cells that's that was the only dependent limitation that's what the dish are for discussed so i think i don't think it's fair to attack him with somehow doing something more than the parties proposed all neo proposed is that moved her for the  five infringement contentions so you give notice to the defendants what are you asserting and therefore what will i have to defend against i think this is a bit of salutatory you know i know i know that's all perfectly clear but it seems to me in this case on a host of the claims let me ask your question to the judge graham's summary judgment the infringement on two claim he's leaving open the other thirteen that's correct or later so they're still in the still in play and so you still want to defend against them on they're still in play that i would ask and that is correct and also i did at that time there were other motions pending for infringement of other players and so what the judge was doing was essentially taking on the asserted claims in the case that had been right i think that's correct no it could never well it is significant in the context of the real world that people that minister drugs get better but significant terms of the claims as to what's actually being played this is a i hate to use it it's  the transformation has to be significant within the claims and also didn't the limited the notion of data gathering steps in significant post solution activities no i think you have to make a distinction between they did gathering that nothing in the context of this claim i think it's fair to call it as it gathered is there not the mirror part whether it's merely or not i mean it just just thinking about it in the context of an actual method of treatment and that ministry of drug is fo  in the body there may very well be what i want issues and i would i would hasten to add that the the lack of importance of the administration steps in these claims is is indicated in the patent itself but only like the important nothing happens if you don't administer the drug that starts the chain reaction here fair enough but the method at issue here is to assess the metabolites to assess the body's natural reaction to the drug too to assess the scientific observation quite clear that you may or may not get that assessment that the accuracy of the dosage that it's in the doctor's discretion to come on in step two in this crime a number that's  happened he's patenting a series of steps then you will the number that has that significant but it is in the context of these claims it's packing information or simply no way to get information other than using the two steps and by the way the first step is optional come out looking if something to some other way company can give me the number then it doesn't print because the claim required that you get the number by i ask counsel it seems to claim any time you administer any drug of any kind discovered undiscovered nothing that they had to do it results in sixty and then measure it in any way with any test pattern if they are discovered is there any other way of getting the information that i'm not aware of any other way of getting the information and i don't i don't think it's fair to say that she was preempted from administering the drug and then only then using the information she was trying to do research to identify a new is a very i think straightforward application of the supreme court's principles about preemption but the inability of people to actually make use of this biologically observed correlation telephony way  claim that and that's the distinction when does a claim actually involve a natural process and the law of it as as producing its end result i claim then the fact that the competitors look for another technique that would keep the thing go up if they did they design around to get their own patent everybody get the right boot glue everybody make money and then the next guy tried to get around that and you have generation after generation  progress we can be good at so out of the goal but it's not possible with respect to these patents and in general that's one of the animated for its principles behind the bar in claiming natural phenomena because people can design around it they can design around a scientific fact that a certain level of metabolites is associated with toxicity and a certain level is a sensitive point with this claim doesn't just claim the information the correlation loophole and nothing else it claims is that and those steps are necessary to study the correlation and that's that's the essence of why the plane falls under water one so what you're saying that what under one of one this is stopping anybody from administr low end and toxicity so if someone has done the research in this or any other defying hole look we can look at these metabolites and we can tell whether it's useless not enough or dangerous too advance of knowledge and that's what they claim to have discovered the correlation i think i heard you just say that to then why should that be given protection a lot every advance gets package and that's you know that's a counter intuitive  principle in this day and age where we're used to patenting lots of things but there are basic scientific facts that matter how hard it might have been to discover in a matter how were video of praise that we are not allowed to play but you the claims cover the administration of any drug that yields the metabolites then measure it satellites and then considering the correlation in the context of showing toxicity or advocacy there isn't correlation between body weight and toxicity and so now doctors will not only just throw the patient on the scales they take a look at how much it is and you know don't give many more back it's going to be talking so there's i mean that's a very simplistic obviously way of determining toxicity or advocacy with many drugs you're giving my body weight are you are you really is this claim really preclude precluding all possibilities determining talks with the or lack of it because even the parameters are hypothetical i don't think this claim prohibits that considering body weight is different i'm going to divert right but what about i mean if you're anything or just i think there are there possibly are i mean i sit here i don't know i don't know the answer to that question of but nonetheless when we look back at these claims with respect to what they are relying on right it's the the consideration of the metabolites produced by the bought at an observation made by the scientists of that frankly a statistical sociate that they made from observations that there were certain levels that were in the large associated with toxicity of efficacy and no one can then look at those numbers which anybody can observe and have been observed in the past and make that association themselves and so it's a it's a a it's it's it's an issue  not a new method of treatment but it's a it's a matter of assessing metabolite levels the body that's what's really playing the end of the day in your brief i thought you complained about the fact that the trains don't require a good position to actually be doing thing with the correlation and the readout on what the number or whether it's called between two thirty and four hundred or nine what i much harder question and i think that's the be the right way to look at it i think if a play if this player required the doctor to subsequently treat the patient in a new way in connection with using the metaboli additional step by the dr that is a new method of treatment now we've crossed the url from researching and coming close to something new or learning a scientific fact to using that scientific fact to develop ok under one or one hundred over what not it certainly brings it much closer you would have to still make the assessment that the supreme court made in folk brothers as to whether or not you're still preempting the natural phenomena but this claim is doesn't get there so many factors one of which is this number that's not ok under warning that doesn't seem like a sensible regime well i disagree i think it is a sensible regime because that's the basic scientific fact that you're now saying by having this claim physician cannot consider and basic scientific facts natural phenomena those kinds of things those are the things we build future treatments up we might build that machine that you talked about based on knowing this scientific relationship and that's the improvement the path to saying that that's what we allow happens for for new new things like that not simply for discovering something that's nature seeing as the supreme court has as me that's the difference that i see as your are you patent i think the supreme court has said there's no just there's no invention or discovery as you know patent in the discovery want to nature sequence but in the practical application there are and so the question for claims like this is on which side of that basic information you can correlation but does it make a difference whether it's preventing doctors from using this information without being brought in just this narrow class  gastrointestinal the or in all possible forms of medical treatment that we need there is here difference there particular disease set and then they have other claims to talk about doing it in a different disease say in their fields of use and that's what they are i would submit that below they were considered as having  confusion that we may have caused with respect to what claims are issued and i'd like to offer up i haven't asked my brother here right off for a joint letter from the parties clarifying for this court what claims drugs that are talk sick drugs to people with serious diseases you're doing it to treat them