those good morning may it please the court there are three items i'd like to address this morning although i'm sure the court may have its own opinion on what to discuss as well the first  on the simple facts of this case which were decided by the word below incorrectly there is no correlation between adult testing and basket testing associated with the record here the only evidence was taken from which you didn't claim it in terms of what test and the results of the test you claimed it as a controlled release compound and maloney even recites oxymorphone in its list of the compounds that would respond to its particular way of doing things which whether it's a basket method of measurement or a or a paddle meant method of measurement it's still controlled release which is what you claim with respect or honor the claims do specify that the u s p paddle honor they would not the record evidence is that dr chang put in a declaration saying there is no correlation he attached to his declaration two articles that say there is no correlation they talk about possibly creating a looking at the evidence you get from both methods somewhat of a correlation you know that what the word below did was it took the data submitted by dr trying not data from the prior four data submitted by the clarence during the course and created a mathematical ratio and then set it comes out to a bell one point three five foot if you look at the data that's even in the loonie and compare it to other times the board use one hour time if you look at the data at other time points that's in maloney and the data that's in the cayo application and we've put a chart of that on page twenty five of our brief but the data falls apart and in fact the directors brief it mix that that correlation only works at one hour so now we have a correlation that appears to work in one hour and is only based upon testing one particular type of comp well isn't one hour the only correlation we need to know independently no independent argument any point in the prosecution regard to claim twenty you only references point to the fact that people say claim one in twenty or rejected a claim one in twenty should be allowed but there are no not a single sentence of independent argument that distinguishes from your perspective claim one hundred twenty and the reason for that your honor is that until the board made its finding no one had asserted that there was a mathematical correlation that would bring up that difference it was the board's creation of this one point three not something argued by the example was the board's creation of the one point three that me that the most relevant when you say not something argued by the examiner but the examiner was pointing to maloney only which discloses the basket method and saying it rendered obvious your paddle method claimed so clearly this was an issue at every stage of the prosecution that beat the correlation between basket and paddle was it was the board however that created the one point three factor to do that association and that's when it becomes most clear that you can look at claim twenty and see that the data does not line up using the one point three multiplier but you still got molone reciting oxymorphone we're talking about the same characteristic controlled release are we really getting very far by arguing a difference in shorter list of compounds as well that might be of interest to it but the math of the fact of the matter is and the board discounted this entire the fact of the matter is that dr fiske set forth in his declaration there would be no expectation would not substitute one for the other in a controlled release system because the liver will chew it up the expectation is that it would never make it into the bloodstream to be analgesic lee effective which is required by the client the invention was made the chang comparison of patent basket did not at the time the invention is made the understanding was that the bio they'll bill by your own availability of oxymorphone would mean that you would not use it in a controlled because it would never work for energies and so there is no establishment of this likelihood of success there is no reason why we want to skill in the art would use oxymorphone in controlled release notwithstanding the statements in maloney that it would be a nice result to get that it would be a product the product that would be considered would be just use oxymorphone in control  what's your reaction to the way the board treated the secondary evidence i think that were aired as a matter of law in its handling of the secondary evidence and just like to is it your position that the secondary evidence was considered or was not considered at all it seems that it was not considered a lawyer just let it looks like they took the secondary evidence and simply said no you've only submitted information about one body meant and  mint is not the claimed invention and therefore we're going to ignore it and there are basically two grounds of secondary considerations that were argue then for the unexpected results don't they have a pretty good point you dealt with one formulation and there's some evidence in the record that you might have a variance of depending upon the different formulations and you've claimed much more broadly then you sho unexpected results in their next problem there there in your are the cases allow a factual ingrate into whether or not the nexus is appropriately established for the unexpected results i think the factual submission by dr yeomans shows unexpected results but the cases allow the board below to have some analysis on whether or not it is appropriately shown to be a nexus but on the commercial success company which is the second comp of unexpected results to be of secondary considerations on the commercial success one example is a not this court just last week in the in reg watt case which we submitted a supplemental citation of authority made quite clear that one example one commercialization is quite sufficient and you can't expect someone to commercialize multiple embodiments as competitors against themselves well then one when only one example is provided as there have to be something in the record to suggest or to believe that that example is representative of a large number of factors everything from sales to recognition by those in the industry who set reimbursement two years to the way in which the product was accepted by pain care physicians very narrow class a physician frankly are quite discriminating according to the declaration on what they will prescribe but if the claim covers the composition with oxymorphone and any number of acceptance what is there in the record that would suggest that that the one composition with seymour on and the one except in would be representative of all of those that the product that's developed  this is in the record is example for an example four is described as being typical of the claims that are of the compounds that are covered by the claims the record is that the dr chang that dr suggests that the choice of x subpoenaed wouldn't make any difference here in terms of the unexpected results of the commercial success of the data submitted for the i r the instant release and for the extended release versions indicate that there is a clear clearly demonstrate that this is representative of the scope of the cl appendix page seven eighty seven seven eighty eight he talks about different investigations conducted  alone that is that an argument you're making when the yeoman's declaration which of course goes to the unexpected results point more than the commercial success point one of both under the secondary considerations umbrella and i do know i mean my rebuttal time but i want to dress your question if it does indicate that there are some uniquenesses to the oxymorphone molecule but more particularly it also shows that those uniqueness is only come out in oxymorphone controlled release which is the subject matter of the claim with some some gloss on it in terms of the results of the various dissolution testing because the dissolution testing is what shows one of skill in the art how to make an ethic aisha's compound that will work for twelve hour dose and also required by the claim and so this is a representative example of the scope of the claims l there's definitely been testing on both the paddle and the basket what testing are you talking about dr chang's tests or doctor training and in the prior art if the p t o didn't cite any prior art and there is no statement anywhere that i could find from the examiner otherwise saying one of skill in the art would know if you have something that dissolves between fifteen and fifty percent of the pedal method and then it dissolves at ten percent of the basket method that those two things would be within the same range or something like that there's nothing i couldn't find any citations in the record from the office that would offer its explanation for why those things were known to c so what happened during prosecution i just said the claim is very broad it's fifty to fifty percent at one hour so during prosecution the examiner found the maloney reference and this is on a theory of the board's opinion and he says  that maloney the controlled release delivery system describing only breeds on the claimed as well as the described systems all of maloney's formulations fell within that fifty to fifty percent then it went to cairo to try and report that and it was up to cow to try and say well the basket method is different than the paddle or substituting oxymorphone would change it and count didn't try to rebut it all but substituting oxymorphone for oxy code on him alone he's formulations would change in any way but he did try to rebut that the basket the patent were comparable why i don't understand that the initial premise why is the examiner entitled to say that something that discloses five to twenty five percent according to the basket method is equivalent to something that discloses fifteen to fifty percent of the petaluma but i don't understand his initial premise why the salmon or is allowed why you say there's even a prime official case when you've got t let us know so they try to he doesn't do it doesn't the examiner have an examiner under some obligation to come up with some piece of evidence to support that conclusion you can't just say well black is white  dissolution rate that falls within it but didn't they come up with the fisc next declaration that says oxy cotton and shown in maloney is has a very different  bioavailability rate from oxymorphone suggesting one of skill in the art wouldn't correlate but that's different the bioavailability is different the dissolution rate cow does not argue that the solution which is done in vitro would be different for oxymorphone x code they never say that so when count tried to rebut what he did is he said basket is usually faster he said there's no generally accepted correlation  you like the office has some of legation to say one of skill many are would notice that there's a correlation between the two and or point to a reference which demonstrates a correlation i mean if i say i'm going to take your temperature by putting  similar in your mel forces under your arm i mean maybe a doctor would say well look at those temperatures are going to correlate it may not be exactly the same but they're going to correlate are they going to correlate anough to put the twenty four point three percent within the fifteen to fifty the same measurement you were measuring one using basket and one using pattern you can't say oh well you know you're twenty three kilograms therefore you fall within the fifteen to forty pounds range i mean it's two totally different measurements but but there's nothing to say that they wouldn't have been the same and they turned out to be almost tito's burden you have the burden of proof there's nothing to say they wouldn't be the same they're two different tests they are different tests but they're very very similar it was a broad range fell well within it and count tried to rebut and when he tried to rebut what he showed was that for this particular drug even using his correction factor of one point reasonable assumption that the two were comparable and when they tried to rebut they showed a little bit of a difference but it still fell within the range so i'd like to talk a little bit about the  len mentioned in the case by both greenfield incest say that you need to show that if you're only going to pick one embodiment that it needs to be representative this is the pharmaceutical field you're only going to go through f d a clearance for one product so there's only going to be one product with commercial success you're going to ask them to show commercial success far beyond that no your honor and i want i want to go back to the observations made by this court in class where they said you know you don't have to test every conceivable in body image for commercial success and it's not the p t o s position that you do always have to test every conceivable embody but i don't think the opposite is true i don't think one commercial one embodied that is always enough i think you have to i think it depends on the circumstances you have to look at how broad the claim is and what it is a possible the commensurate scope language that is maybe just not the best set of words to factual finding that there was a difference and in that case they had to show that there wouldn't have been a difference between these and they did not make that showing dr yeomans in his neck religious sect and you say there was a factual showing that there was a difference what with factual showing are you talking about the difference are you talking about the difference between the immediate relief drug and the extended relief drugs so that there were three center is th comparison so why is that relevant when we're talking about whether the except the end of the test in the composition of an extended release drug is representative of all except the ends in a composition of that sort so i've got to compare the right things so so by comparing the controlled release the immediate release we know it's not the oxymorphone itself we know it's something in the formulation and well that's right so it's the formulation right to come composition comprised of the active ingredient the more for and the acceptance and so we know it's something in the formulation it's not the oxymorphone itself but we don't know whether it would be an all controlled release formulation and would you say it's not the oxymorphone itself it maybe there's something it's not necessarily the that any particular characteristic of the except the end but it's the sort of the result of the composition so you're saying it's the combination of the active ingredient with in that formulation that's right so the question i think that has to be addressed is what is there in the record that would cause one to believe that this one particular except you never makes that showing so it was reasonable for the board to say well the immediate release doesn't happen this one one controlled release has it but there's nothing that tells me that all the other controlled release formulations within this claim would hope well maybe if that's what the board said we'd have a different case but that's not what the glass said the board said well if you compare this composition with the immediate release drug well it's obvious that the difference must be due to the except be it and therefore since the evidence of secondary considerations is is just one example it doesn't tell but i think that's consistent and dr yeomans never rebuts that he never says anything different he never says well if you used enough modoc pump instead of this polymer matrix i would expect it to act the same they never make that showing so i think i think the board showing it's a reasonable assumption by the board and should be and they don't put forth anything contrary the court has nothing invented a new test for brock blocking prostate gland ins and so i'm going to claim aspirin now and get coverage for that can i do that i suspect based upon my knowledge of the use of aspirin you'd be you'd be hard pressed if there was prior art that was up against you that showed all of the elements of your claim but if you found a new way to use aspirin for prostate gland in control and it wasn't in the prior art you might very well be able to why isn't this in the prior art though th o points out that both of these tests are just testing they're testing the same thing dissolution in vitro in there's testing it in there and they even show that there seems to be a correlation so i'm having trouble finding out what you have invented other than a new test the chuang declaration says they're not correlative in the prior art and the two articles have submitted and i would specifically refer the poor to the conclusions that a one five five four and a one five six two so just the opposite your are they say that there is no correlation you know just the overall variability of the u s p dissolution test can be reduced and the rate of extent talents dissolution improved by performing the task using the b basket apparatus in place of the paddle and it goes on there is no correlation this is not aspirin for prostate gland and this is a new concept of how to get an oxymorphone controlled release product that's going to perform in a way that will give twelve hours of analgesia also not in maloney there's a failure here of the board to identify these facts there are not fact findings you look at cases like thrift cases like the board is required to make those fact findings they have not and by failing to do so your honor we believe there was a law and this case ought to be reversed if mr lewis were going to have probably a chance to talk about some of th