is very important to note that the only question is whether the claims of the second patent are obvious in light of the claims of the first that has been held over and over again in the odp case we know that the four four two pat novel we know that it's not obvious of the prior art we know that it claims a different invention we know that there was no misconduct and prosecution my friend mr moore and his colleagues did not raise any statutory challenges o didn't make in the lower court as first on this court second the americas routinely doesn't have a definition in that if you look at the website what it has a series of criteria for diagnosing rheumatoid arthritis which have changed over time it does not have any definition of active disease which was the question in this case any ambiguity there was completely resolved during that prosecution history the salmon are initially rejected the four core two application for indefiniteness on this term that the term active disease was not on a page or five a five nine nine seven the patents he specifically pointed the examiner to the definition of the patent the activities the six hole in joints and so forth and said that gives the term meaning and the examiner then said ok an adult in an interview ok then i'm in the claims to include the active disease as a limitation that appears a day five nine hundred sixty six or two the claims were amended specifically to include activities as defined in the prosecution history if you wanna look at a disclaimer if you will your honor if this were infringement case the patent the disk defined activities in that very specific way the examiner accepted that and then recited it in the reasons for allowance a six or seven and also as grounds for overcoming the rejection of a six one one two examiner specifically relied on that definition of active disease to allow the four four to claim so that the that was the series of events in the prosecution history none of which my friends of challenge none of which had been referred to or the north of the district court instead what  trial was put on its expert to say well that's a perfectly good definition for clinical trials but it's not a definition that a treating physician would use in the examination room if a patient were sitting in the chair which may or may not be true doesn't matter in fact that  are referenced in the footnote shows that there are many diagnostic criteria for for rheumatoid arthritis not for active disease what was the question in this case the question of claim construction is what does active disease meet in that respect it's this it's in the specification it's in the prosecution's history and it's recited as a limitation in the claims and there the district court made an absolute error of law in flying a different construction supported only by expert testimony so when you set up a definition with a phrase like as used here in that to me is much stronger disha of some attempt at the congress than what we have here which seems to be at least the way it's used in the spectrum more in the context of how that term was used for purposes of doing a clinical trial your honor in the specification it sets forth the definition of active disease that was used for the patient population that was studied for example one to fourteen trucks which of course is the data set in which the later claims before for two claims are premised so that it is the definition used to generate the data on which before two things are premised your question echoes the examiner's initial objection your what the examiner said is yes you recites a clinical trial definition but is that really the definition for the claims and that's where as i said a page a five nine nine seven  depending came back and said yes that is the definition that we are using for this new application for two applications specifically two to defer to this new treatment of four for two treatment methods and that's in the examiner responded ok then you need to recite it in the claims and the claims were makes clear that the famine or believes that it is he is or she is granting your four for two patent because active disease leans all of these very particular  said it is definite because of the active disease limitation and how it is  a five nine five seven if we could start there in response to the examiner's assertion that the firm's activities is indefinite applicants direct the examiners attention to the specification which states that and then it has a block submission in which the nine nine seven and five nine nine eight which show that all of the claims now at issue including claim to were amended to include active disease as a claim limitation applicant on a promise to parrot what difference let's suppose that you're correct as to both of your point construction but let's assume also that we can look at the specification of the seven six six patent to determine the scope of the claims there why isn't it clear that the four forty two is directed to the very heart of the invention which is claimed in the seven sixty to answer your honor the term active disease is not used in the seven six six claims the seventy six claims are a generic method that applies to every person with rheumatoid arthritis in need of treatment which is every person  is in that respect as others it is a species of the genus that is the difference between the two patterns the reason that the claim construction error matters to directly answer your original question just ike is that the district court by rejecting the proper construct there's a different treatment history there's a different mode of ministration there's a different mechanism of action there's a different dosages and there are different clinical results and if i can focus on that last one because it's absolutely critical the seven six six patent claims generally following which are saying in the in the seven six six patent they were dealing with patient populations who had been receiving meth and trixie and they were going to have the any body and it had desirable results will have a reduction a substantial reduction in the signs and symptoms of rheumatoid arthritis signs and symptoms means the observable not laboratory test will be observable manifestation of this disease from the patients in the doctor's perspective the incurable disease the best that can be hoped for is remission and this new invention novel and non obvious invention conceitedly has the amazing results of these patients go into remission that was totally unexpected their expert agreed that that was a totally unexpected result so it's a it's a it is a species your honor that is not obvious claims are not limited to people who go into remission as it is they are limited in the claims of cells to persons for a substantial reduction in the s includes remission your honor includes seven six six this doesn't require any reduction sciences only a therapeutic effect amount it's a dramatically different patient population with a dramatically different result that and you add up all the difference with the district court said over and over again is that one is in and here's why it doesn't matter to get the first patent the seven six six patent allowed in the first place when it was under rejection kennedy told the patent office that the patient population did not matter that the seven six six method was applicable and got the same result across all patient populations the question of active disease is just a matter of what the patient population is those patients with active disease but they have already answered the question and they got their first patent based on the premise that that patents equally admirable and you get the same result across the entire patient population the only way you even get through the gate the only way you can start looking at their other arguments is if you allow kennedy now after got one patent based on the premise that the patient population is relevant and it's equal across the entire species are genus is to allow them now after they got one hundred million in royalties and after that patent speier have another pat that's based on the exact opposite problem which is all that my friend was talking about during his argument but there's more evidence than that that the definition of active disease does not matter and by the way we've heard talk about whether or not there's been waiver on some aspects of the act disease question there's a reason there's not more evidence in the record blowout is that we didn't think it was really a significant dispute their expert in a four day trial had one question and one answer on the definition of active disease and  thought they were arguing about because of their construction was whether or not you define it qualitatively reducing signs and symptoms are quantitatively here are the signs and symptoms in terms of swollen joints but if i can ask is there is there any evidence of that record that if you use their definition of active disease that there are unexpected benefits no no your honor there's two reasons that there's no evidence in the record the first is is that i think that their statement to get the patent  findings after weighing all the evidence in the expert testimony are reviewed for a clear error and the court specifically found in his findings that that was not unexpected and he based that on the on the on the record evidence what was the record evidence by that point in time it's  it was telling people to do exactly that but if i could direct your honor if i may to the point in which we know that the definition does not matter if we go to the appendix appendix volume one it eight one five nine six pl a fifteen ninety six and if you go to line sixteen through eighteen he's saying what his definition is now keep in mind if we step back for one second that there's no dispute that the ordinary meaning of activities of signs and symptoms that's the ordinary meaning now he's saying i'm going to quantify it for us and it line sixty three eighteen he says it closely closely reflects the kind of activity that would cause a patient to think about changing therapy and what he's saying there is th quantifying the type of disease that people would have the advantage body in the first place it means there's no difference between his definition for the poor or too bad he doesn't want to find out why people would use an antibody and then a body there's no difference between now urging so tell us why that's wrong ok to quote to answer your question judge direct my first answer when i pointed to his definition is just showing that under their definition it's the same result it's pointing to the same patients he's quantifying what's qualitatively defined by the court which is you have signs and symptoms but that's why the district courts definition was right in the first place you'll notice we talk about waiver but they never pointed to the prosecution history in the district court and they never pointed to it in the issue was involved we've had a number of cases i understand it but my point here is that your honor is that there's a reason that it didn't come up before and they didn't rely on it before and it's because they know that other portions of the prosecution history point to the other definition so the end up with two definitions as well as a five seven four eight for example when they introduced the term active disease into the claims of the first time and they give the one twelve support for it they point to the a are definition they say it's not a definition i don't even understand that argument says as determined by those criteria but if you go to a fifty seven forty eight which is in volume three what you will find is that when they introduce claims sixty which as an active disease they point to the specifications at line twenty eight page twenty eight one twenty four twenty sec and you go back to that specification at a fifty six ninety one you'll find that the r definition so they point to bowl definitions the same thing holds true later on during the final of three when they add wayne forty one it fifty eight sixty six for the record fifty eight sixty six they're adding active disease there they point to page twenty eight lines twenty three to twenty six then point to the a t r definition one minor point by the way our friends take us to task a little bit for pointing to the internet for the definition of  active disease i just make the point that it's actually in the record also at eighty four zero five so here's what you have in the end of the day on activities you have in terms of the definitions of stress chang pointed out it was going to be my first point actually when they wanted to define a term point to one of two definitions and the court is clear for example manful in the abbott case that if there are two definitions even if you were to accept that portion of the specification it's not like a conflict so the last thing they hinge on to try to change what everyone agrees is the ordinary meaning and to try to limit this claim to want to clinical trial rather than patient doctors who see signs and symptoms is one shred of prosecution history that has never been mentioned before in the case and as i've shown you even that is inconclusive and ambiguous because other portions of the prosecution is very stand for the exact opposite proposition but the key point of this is that we're arguing about things that don't matter they are out of step as a patent office get their first patent laugh out that there is no difference that applies equally the it might be a slightly different story although i would still say you should hold them to their binding statements is there any evidence here that there was a difference in the population not the there's no evidence that there was a difference in the population as a matter it shouldn't matter as my main key point that what i said in the patent office is absolutely correct because in terms of what actually called ministration properly defined there is no difference but the key point is this is that what we seem to be hearing is that once you get one patent on called ministering to treat people who need it that all of a sudden because they can draw a line and say there's a difference under their assertion that the second patents about treating people who need it who are sick that doesn't make any sense they are to got one patent on treating people who need it getting a second patent treating six people who need it doesn't make any sense especially when their expert dr lecky admitted that only fifteen percent of the population is in remission if you let them get away with this argument they would be getting away with getting one patent on treating people who need it and then getting a second pass by saying it's time to treat the eighty five percent of the people who really need it the record evidence doesn't support it and by the way all the underlying facts are reviewed for claire this was a four day trial with expert testimony by both sides four for two is limited to the really sick patients and the seven six six could go to patients who weren't sick all of the erratic way and they say like people in remission but of course the evidence shows that the people who are being treated before for two were the most likely people to be treated my friends admitted that meth attract it whether it was the gold standard or so these were the patients who were already on meth the track stayed in the first place just because i might say that there's another way for me to get to the fourth floor of the third floor throw rope out the window and go that way just because i can come up with a difference doesn't mean it's not obvious to take the stairs or the elevator that's a situation we have a year on appeal they're trying to go back and they're trying to manufacture difference between the two claim in any way they can to try to get a reman and as i hope i've shown with respect to active disease and what's also true with respect to call it ministration is that even if you can see a radically come up with some difference between claim all of the evidence of trot including from their inventor including from the experts showed that the most obvious way to co administer can't body alone group their argument is that's another type of code ministration and you step back and say why do they need that well they need that because they need another type of code ministration so that they can try to show that the adjunctive is superior that if they don't have that i think everyone agrees on our construction they have no unexpected results because there's nothing to compare it to so they need to fabricate an additional category of code ministration in order to get that done and there was a problem with that the first of which is back prosecution history where they told the patent office to get the first patent allowed not only that the patient population doesn't matter but that the motive of ministration doesn't matter either so again to get that argument off the ground you would have to accept them reneging on exactly and you look at column two it calls that group an antagonist and minister along just doesn't just say and diagnose a long as antagonist administered alone there is no possible way that you can consistently say that that group and how it is better than the antibody alone group if you were allowed or called ministration are going to get off the ground you would have to ignore the six times that they distinguish those things and that is not impermissibly looking at prosecution history like my friend asserts that is exactly what you're supposed to do and claim construction and look at how they define the terms of the seventy six they clearly defined and is not including that group what's your understanding of the law on this type of a pet terms of consulting a specification in only defense is that it's an open west if you didn't have that all sorts of other defenses for pitcher and all sorts of other defenses would exist but but yet and getting to the the the process of of the issue here there are only two issues on appeal and up not mattering at all because they're based on the motive administration and they're based on the patient population and if you allow them to get a new patent on the app on those distinctions and you're unwinding all of history and you're lining  patent on one premise and one on the other in terms of the use of the prosecution history and specification there's one thing everyone can agree on and that's black letter law is that you're at least allowed to rely on the specification and the prosecution history to interpret the claims which is i think what we've done we're of course holding them to their binding statement the patent office but that is not using it as prior art and using the admissions of the other side actually the top of principles of this court among all sorts of other principles such as considering the scope of those cla they said that the results were commensurate with the scope of their claims having said that they can't now unwind it and act as if they haven't said it and i will tell you in that in the three years of this case that's one thing it never had an answer to or response to which is that they directly contradicted what they said to get the first what does the record show in your view as to unexpected results for this very sick population that you say is covered by the four forty two patent yes  what is it with respect to the scope of the claim the full scope of the claims in the four forty two pattern that shows i expected real mt x plus arm of the t fourteen study as described in example one of the specification shows unexpected benefit over the m t x minus arm this is the debate between a junk to versus sequential code ministration this is remission no your honor noticed that is substantial reduction of signs and symptoms which is claimed and that is what the examiner expressly relied on my friends only objection is not to debatable it's different because there are observable symptoms versus laboratory tests that's correct rhonda and the district court and my friends read that out because they say they c examiner had expressed findings that we have a limited patient population and a point that in the claim that was never addressed affect the claims at all i'd like to remind the brief that a page thirty one of our breeders claim chart shows all the different limitations between the claims which haven't been discussed here today inventive methods as if you do this particular dosing of one two step with these measurements and keep them on at the trash truck which itself would have been counterintuitive which is what the experts testified to your honor that was an unexpected result that it had  your best argument and ability is it the patient population is it the meaning of code or ministration which one is it is the claim of the whole your honor which is of course the combination of errors in active disease the claim construction but if we add together the patient population plus the clinical result which is really what the examiner relied on a page a six zero zero seven that shows that the the species of the boat the genus in other words this is an improvement saved or improve the lives of millions of patients this is pop five drugs in the world wrong seconds before four to patent claims an improvement that says for patients whose for whom at the tracks it doesn't work you can have this specialized the tests for asians failing or who did not respond to methe attraction it was not expected that they would have any benefits at all what was actually learned during the clinical trials was not only did they have some benefit but they had observable benefits that is a reduction in signs and symptoms and on that surprising result that unexpected result that thing that nobody expected in the scientific community your honor and again there's no obvious the challenge here there's no prior art that says anything like th