to please the court during his deposition dr michael weinblatt abbie's expert on the state of the art was asked the following question and gave the following answer and this is a page a one nine answer i think it's unlikely back in one thousand nine hundred five that we would achieve that goal in patients with chronic rheumatoid arthritis nine one nine six five quote one of the surprises in this clinical trial was that many patients achieved a result which was near remission in these quotes from dr weinblatt evidence is alone sufficient to require a reversal of the summary judgment in this case and let me explain why the one two zero patents now before the court was prosecuted after dr wind blew up into separate issues what was going on was abbot was described as a significant reduction in the disclosures polish twenty it did not say paul is fifty but was brought out in the deposition was dr weinblatt would have predicted a polished twenty reduction but would not have predicted what you're arguing today that's correct through the district court before the evidence was even before the pleadings were close no evidence of the second case on from our side or from either side so this is very the starting point of trying to understand the relationship between this case and in fact that is on what i'll call a more general level they shared the same attributes in the sense that last time around the client was trying to get and and that's a little bit what's going on here in the sense that magically those are the two limitations again that we're focused on here where now you have more description of what that patient population and what the district court error here was was simply mapping the decision as to four four two on two and two zero when the relevant to the whole disputed issue was what a person is guilty or could have predicted face of the seven six six we are your honor and last time around the question was was it appropriate to consider the t c fourteen study that was disclosed and described in the specification to try to understand whether there was an unexpected result tween the four for two species climbing the seven six six more can claim and the answer is that background for unexpected result question is why this time around it was appropriate to look at the results of the t t fourteen study to prove up on expected results this particular version in light of what was said  testimony from the challengers expert does a summary judgement case testifying that this species the species claimed in one two zero was unexpected that at that time no person was killed your would have expected near remission and when i stood at this podium a year ago and argued unexpected result judge di pointed out three times and i can give you the citations you like that remission was not claimed in four four two which is absolutely right we went back to the patent office and we claimed near remission one to zero and there was a significant difference because of dr wineglass testimony that if i could see if i understand the point in the last case the question was whether a dosage necessary for even reduction to four for two clients as reduce or eliminate correct was nonobvious unexpected in light of our claims to something therapeutically effect direct the question here is whether a dosage that produces big and long lasting effects correct is non obvious unexpected in light of a claim to therapeutically effective and those are different expert dr windblown and in the first trial judge joan a just rather up in the district court issued this hundred seven page four hundred ten paragraph thirty two footnote opinion in which the word remission nowhere appears so the unexpected result of remission was never examined in the first book and i just keep trying to be precise about one one thing i use the term dosage because if i guess i'm having in mind the background principle that mere new it wouldn't matter what the results were that's correct yes here we are claiming a very specific method much more specific than the seven six six in a particular patient population right i'm putting the side patient population wrong on all of these your honor it says for example that the court already determined that the four four two claims did not yield unexpected results well that's true that was what this court affirmed but the court never determined whether the one to claim achieved unexpected results in our whole point in a collateral estoppel case it's simply too glib and to flip to say it's deja vu all over again as my friend mr moore into what we have to do is look at the actual claims and here we have claims allowed by the office during this litigation we submitted all the briefs all the trial transcripts all the public documents from this litigation to the patent office and got those narrowed claims specifically in light of the arguments that abbott was making against the four for two because remember the first time around what abbott tried to do was broaden the four four two so that it maps straight on to the seven six six and so these are essentially the same thing that was a successful strategy we while they were trying that strategy we went said ok let's get a very narrow  information that the results of the two fourteen study for unexpected results you give your own or we have to rely on the two fourteen study because all the claims have to be supported by specification as is the common specification for this right situation pattern and we are not relying on  construed the seven six six claim of therapeutic benefit was a significant reduction which was what was claimed in four four two they were the same here with claims is near mission a policy if the absolutely not clean defective you look at the undisputed facts in this case  reside in the or court to correct but nevertheless again and supported by the same specification permission from the c fourteen but if that's the answer your honor then you could never have a species claiming a continuation pattern because it always has to be supportive of  to determine what if any differences that there are kennedy here is alleged to differences first they say that the one twenty claims the new claims are directed to a sick or patient population and second they say that they require improved efficacy and this is the remission thing that mr perry has talked about but before we talk about these two large differences and i'll get into those more detail and answer also the remission point i think it's imperative to focus the court on something judge drano asked about which is what the same between the two patterns and that is that it is undisputed that when comparing the two patents that in this new pattern the one that's been invalidated now by the district the exact same method of treating patients with the exact same disease but that i think they're trying to get against that but i guess i that's what i take in fact the claims not that is the amount or completely irrelevant to compatibility because if you're doing the same thing it doesn't matter if you say wow what a great effect we'll always been doing with respect to iran i think that we have said that exactly if you look at our citation for example you're honoring the brick to king pharmaceutical case with the b m s case both of those cases stand for the proposition that if you go and you claim the same method that's already present in the prior art then that is not even if you claim better results even if you claim something better happens out of the that is not the basis for a patent goalie but i would say one step beyond that your honor is that there is no question that they have to hide these results of supposed remission in the previous litigation and litigated all of these issues already if i look at their blueberry from the kennedy one kennedy one case quote kennedy a deuced evidence extensive and under budget evidence that patients receiving the claim therapy that's a therapy of the four four two that you've already invalidated experience relief of signs and sufficient to approach disease remission they have already said that it's the same method that you get disease permission by practicing the claims of the four or too bad that's the same patent that this court has already invalidate administered multiple times and that's an interval of a week or weeks so there's that multiple dosing step moreover the evidence was presented last time this is not a new issue but in terms of the dosing amounts your honor judge toronto if you look at  one for example it's as we've talked about last time it was a dose that would cover any possible doses of point zero one two hundred milligrams per kilogram all of those claims of already been invalidated the only alleged difference in these claims  raised on appeal here is twofold and if you look at their table contents in their blue brief you'll see that the two differences according to them are a patient population and b advocacy they labeled in that way they characterize and there's no difference in the method if you look at i think it's little eye which is their table of contents and how they characterize everything and it's carried through to the rest of the brief as well what you will find is that there's two differences that they say patient population and the efficacy of the treatment not a differen treatment when you turn to patient population the first one your honour's i think that we've been clear on the record that given that the support invalidated the four for two patent claims under the per site's definition of active disease th now a one twenty patent claims that there is no difference in the patient population between the invalidated claims and the claims at issue here that leaves only one difference and that one difference is the alleged difference in africa differently or that there's now a distinction in our view using methods that i would say the answer is no and multiple risk factors first of all there's no difference in what's up for from the claims in terms of the method stop so the method is not claimed to conserve any differently i guess i was just a point that that makes i keep having in my head is when it says give amount that produce terrific the facts those might actually be different than mounts from when the earlier pattern said give amounts that may produce a pretty nice effect yes i understand the action there is a physical possible physical difference in the steps performed in syria i understand what you're saying that different methods could yield different results i would say two things number three things number one is the difference in method isn't claimed if you're comparing two planes and you look at it from an anticipation analysis all the steps of the method are the same but the two other important things are first of all going to the g fourteen study in order to get their first patent was seven six six patent allowed in the first place they relied on the same results and they said those results were commensurate with the first patent that they already achieved the seven six six patent they did not just look for example of the twenty percent false criteria so you cited for the entirety of example one and they did not just look for example at table two which is twenty percent polish criteria they specifically cite table four they were going to these results to the first patent that died a natural death after twenty years having gotten the first patent by saying that those are the results that you get from quote menstruation generally and that's the patent died a natural death  that we paid royalties under they can't then come back and say hey we're getting largely different results here as a matter of fact and this is in the record your honor and we cite to it when they got the first patent allowed in the first place with seven six six patent they said these are  results that you would get from the practice of this method of ministration generally with the entire patient population having done that and having already lied and said that you get this results with the broader patent the one that has expired at this point in time their first patent of this method they can now double back and say you didn't get those results in the first i think the argument you just made in the last two minutes is a great obviousness double patenting argument not a collateral estoppel i disagree your honor for two respects one is all of these aspects of remeasure and fifty percent were heavily in front of both the district court and this court the last time around when the district court misfortune court found that those were not unexpected results that there were no unexpected was unexpected what the four four two said included meal reduction so even if there were other arguments being made those the resolution of those arguments which is actually not not explicit was not whatever else it is necessary to the resolution of the four four two questions because that doesn't claim remission or its equivalent actually i disagree with the respect your honor for two respects one is that both the district court and the supposed court they relied on so called unexpected results that were sub fourth in the specification to try to support the claims of course he's off on or rely on unexpected results that are not specifically set forth in the claims and they say these are unexpected or surprising results they did that did that in the district court with fifty percent and with remission repeatedly they did that in front of this court like i mentioned seven different times this court rejected the notion that there were any unexpected results associated with the practice of the points of the fo i've also read you from the blue brief the last time around how they said that remission was the natural result of the claiming of practicing the four four two patent given that they said all they're trying to do is patent with the same exact method once again just by time you say at least thirty percent and you keep playing the same method again and again and again and each time that you'd ask me the question hey we haven't evaluated thirty percent yet you have to go back you have to do it all over again that is not what a lot of choirs was testimony but he wouldn't expect the results at this time that may be why they got the seven six six pat in the first place which they also based on the same results when he looked at that he says i would respect specter and such great reactions at the time that obviously wasn't in the context of reading the fourteenth study and the imperative point and really the only point that you need to look at the answer this entire question in this case is that this court has already determined this possibility that you are entitled to look at the t v fourteen study when you're looking at the obviousness of the claims and that that can't be a basis of non obviousness and given that that is the case it ends the inquiry here they're relying on the exact same stu question that they're doing the exact same thing that this court said you couldn't do the last time around a kennedy want to tell anyone you said you can't distinguish the obviousness of the second pattern based on the t fourteen study example one of the first found the court said that flat out if there's any question that they're relying on the exact same data again which you cannot use to distinguish obviousness for a different proposition i would say to put there if they're looking at the exact same data though and if it's permissible in is what what you're using it for  i'm not sure that that's the issue they've already used the same data from the cheap fourteen study to get the seven six six patent allowed in the first place once they've relied on that same data for them to go back in and act like these are surprisingly results or are what results were expected at the time of the seven six six application which is the court and two thousand and fourteen case rule out a case of unexpected results that relied on a combination of the teacher fourteen study  your experts admissions assuming that those are properly characterized just assume well first of all the submissions are only not done i don't want to but it's not the same record that this court ruled on in two thousand and fourteen it was certainly the same of vailable record dr wine but testified in that trial after his deposition they had the entire record available in front of them and dr why my testified that case but i think one bought up the money must be seen as a sound bite that my friend is using at the beginning was argument but can't be meaningful when our expert dr was asked whether you would expect that kind of result remission in that timeframe it's obviously in the context of not looking at the t fourteen study once you look at the two fourteen study which permitted them their first pass in the first place with seven six six patents in the first place then of course reading the results of the study you would anticipate the results of the study is tautologically correct once they've set two thousand and fourteen case the predecessor case of this one comes along and says well there's an exception to that for you kyllikki now because of the way the four four two patent was written to cover any  it seems to me like your reaction that this court did not have to parse more finely what the scope of killing the exception was whether it was enough to study with all of its details much of which was not necessary to establish why is and i think you're making the argue the full study looked at why number one is kennedy in order to get its first patent allowed and that's what dr weil was talking about look broadly to the t fourteen study throughout the prosecution history for example it pointed not only to table two  point it's a table for which is the fifty percent policy it's said that these are the results that are gotten generally from the seven six six patent i think when the court talks about whether or not you're going to decide whether there are obviously his differences and then talked about the ability to realign the t fourteen study it is true that it leaves open the question for example of whether an example three or some other example wasn't relied on to establish utility of the first patent in the first place whether or not you could look at those but i think with due respect the court knows what rove you're but i think reading the decision it is pretty clear that it says having relied on the t fourteenth study you're allowed to look at that study to discuss what the anticipated results of practicing the method would be the second aspect of what answer to that is it was true that there was a narrowing in the results from the seven six to the four four two patent so they said you're even allowed to look at it when you're claiming slightly better results in the end of the day and the third thing is to answer a question that judge chimed relevance in that the court did not only say that you could look at the two fourteen study for example in the question of the patient population the court also specifically said you can look at the says the practice of this method is expected to reduce the signs and symptoms that footnote eight there is no difference other than we're changing the patent numbers from four four two to one to zero and other than we're changing the words in which the result is described between the and a one to zero there's no difference between these cases which is where i may be somewhat glibly say it's deja vu all over again we're just changing out the patent numbers and saying the same it's the same result that they're claiming again again if i may your honor in the end of the day if you're going to permit this type of thing we could go on endlessly by claiming the same method again and again and each time giving them another bite of the apple just by slightly narrowing it that's not what the law commit all of these issues have been heard already and decided by the district court  thank you judge well the last point we did not arbitrarily pick the claims of the one to a patent they came from dr wineglass testimony he testified that it was unexpected to have polished defeat a near remission we retained by abbott in this lawsuit to study the specifications of the seven six to patent and testify about the obviousness of four four two the only professional job he had was to testify about the two fourteen study and his testimony was four four two is obvious one two zero is not that's the summary of his testimony all of these explanations that mr morton just offered well the one sentence of explanation you just offered here is brief they could argue that at trial but if there's no doses not all outcomes in the d fourteen resulted in the one two outcomes for example there was a one milligram dosage studied that net did not result in remission it was only multiple dosing at fire outcomes in the four for two thousand for example same single dose unexpected results judge chan as to this prior decision i think it's fair to read page thirteen eighty quoting footnote on the previous page to say the court was looking at the specification to define the babe patient population as allowed and utility in the context of the there's a statement here for example that the results of the p four thousand demonstrate that a sicker patients would be get better results that's correct what the court did not say he would not have said consistently with the odp doctrine is that a person of skill need mark necessarily invision every outcome that might be within the specification what we have here is the only answer a question of what a person skill in the art would have expected as those narrower things that were not  potential claims yes you know all different smalling different but all of them supported by the very same material that appeared and yes you're packing number one so black letter law says the initial granting allowance of a genome plan does not foreclose later species claims that have to be supported by sales of skaters that follow that policy argument has always ready been resolved in the courts less hundred years and this court in the last decision wrote that because the second pattern always has been a continuation of creation always has to be supported by the same specifications as the original then you can change the specification but a staff of showing the expected results are not that that's the point and that is the point of inflection x terminal evidence and that requires external evidence requires expert evidence that with that we had a try forty trial last time and the court wrote in footnote twelve the district court in the last opinion that he credited wineglass rather than lipski our expert so this time around we said ok what does wein t say about this new claim and one less says it's not expected and that's the difference because the chain of genus versus species you always have to be supported by the census became and you always have the ever growing concern in the abstract the