and in particular obviousness over the nine forty patent it's an interesting five history that is provided in this case perhaps more on point and you find in many if you look at the receipt or background in this case you find that the examiner below rejected many many times the claims that were pending over a very similar patent before ninety patent for ninety patents in fact was filed by two of the same inventors as background clearly shows that the nine eight four patent claims were directed to substantially twenty four for a regimen twenty four days a combination pill  of analyzing the references and discussing the witnesses certainly the judge wrote an extensive opinion the error i do believe that this is an error that's substantial and that presents an interesting issue to this panel it hinges on wind the nine forty patent wasn't really convincing prior to the court and it's a very very telling i believe if you forty patent the this report in particular found for example when referring to the point of the defendant's expert dr barnard that he did not point to any commercially successful product or any product for that matter that resulted from the nine forty patent but that's only a very small point in the very existence of the pin your honor i would respectfully disagree with that because it goes much deeper he goes of the absence of data in the nine forty patents regarding the efficacy or psycho control of a fifteen microgram regimen a pulse that would not necessarily have been led to make an oral contraceptive combining fifteen micrograms of the with nine forty patents by the district court was clearly in error the district court discounted if it considered at all the teachings of the nine forty patent because it couldn't find a commercial product and it couldn't find data in the pa t so then it moved on to disregard the explicit teachings in the nine forty pattern of the same regiment and that is a twenty four day interval at the beginning of combine for justin of the ninety four patent is it came at the end of those four days the nine forty chose to put it in between the combination polls and the two unopposed estrogen pills that truly is the only difference but the trials and that we before the district court dealt with what i would say are issues that really should have never been dealt with because the judge explicitly set to sign the explicit teachings of the nine forty pat and then the while really devolved into an issue of i'd say a relevant cities for example the question of whether to choose a twenty four four regiment in the first  the nine forty pat and teaches the twenty four for ransom and i think also telling on this point is the four ninety patent which similar to the nine for the patent also had twenty four days of combination followed by simply glossed over nine forty and didn't consider it in any specificity because i thought they had my foot back and there is considerable discussion then thing i apologize if it came across  night for the last two days of that twenty eight day cycle and what is that the ninety four and this is not disputed either and dr darren you agree with it that the nine forty patents and the reason why it's in that location is it reduces a mineral bria a mineral ria is an instance where a wall and simply does not experience a normal middle period and the issue as to whether that pattern then you would be increasing that arena so the only fact dispute that came out of this was was at the time of the patent for the ninety four patent but the desired effect to you look at the cross examination which follow which so stanch really went after the publication by dr darden which is an appendix eleven forty four in two thousand and five which is the relevant timeframe for the in two thousand and five dr darcy reports in the clinical guide to contraceptive contraception more and more women are embracing the idea that fewer menstrual periods provide welcome relief from bleeding and still symptoms many do not require the periodic experience of the actual bleeding to assure themselves that they are not pregnant modern society is long past the notion that menstrual bleeding is a cleansing event for ordered the type of  foregoing pleading as an individual woman's choice and he agreed that he wrote that and as of two thousand and five what is that establishes establishes clearly that there had been a change from back to ninety four hundred five to two thousand and five in the mindset of woman and that he testified that many women in fact as of two thousand and five would desire as an after view to picking the oral contraception pills the a minaret had that motivation the changes and which was found not to exist by the district court is refuted by the point of own expert witness i see that i'm in the rebuttal time so you have any further questions at this time turning to that i think the biggest complaint we have or disagreement with lupin's argument is that it focuses on one piece of prior art but it does not do what the court has repeatedly reminded counsel they must do and that isn't considering the obvious which question problems unintended pregnancies bad cycle control and in fairly easy years after that no oral contraceptive approved in the united states of america was made with one milligram of north and grown as a city and twenty micrograms indeed to the extent that in the twenty years after nine hundred seventy three all of the or contraceptives used thirty micrograms why because it was beyond cavil among skilled artist that if you go to twenty with one milligram of north internet acetate you will have an unacceptable pill i mean by acceptable unintended pregnancies and spat cycle control which will lead the women to not take the pill they get pregnant and then we have all the moral and religious issues that go along with that and even after twenty years there were additional oral contraceptives and reduced in this country most of more third a couple was to twenty five and a couple went to twenty but you know what they used just to be leavin or just roll your justman second and third generations for stronger put justin's ark for now because they have longer halflife which makes it more forgiving in case the woman forgets to take the pill on time and it's more potent which means that prime protesting receptors to improve cycle control and again to lessen the chance of pregnancy now that's the second teaching which is if you even want to consider going below twenty micrograms  estrogen you must use a more powerful protested case in point evidence man that's the only pill in the world that had fifteen micrograms in your not united states below twenty indeed all the way down to ten and its logo western so that's what the telling the priority is now let me turn to the pill flip again the before the combination so they said insurers with for all bleeding which contrary to what mr green said is preferred by most women why did they want to withdraw bleed it similar to men see you take the pill because you don't want to get pregnant having that withdrawal bleed is comfort and assurance to the woman that she's not pregnant can some women put up with the men arena yes but it's not preferred and the court made a factual finding that it's correct not only is it not of interest cyclic menstrual bleeding compared with conventional locos so nine four teaches the post put the placebo first put the unopposed estrogen right before the combination pills and you'll get nothing no prior art simply put that people's no motivation to do it and no expectation of success and moreover why would you do it nine four  when there's two of the united states patents and a successful product that doesn't just like that and there is no suggestion not any articles or patents that says flip the pills so some of your questions the judge did a very careful wrote articles express talking about the differences there was no suggestion you could use one milligram of north is from the paper there was also no suggestion or teaching in the ninety four out and remember these are regimens gentleman not a little not competition these arrests are made with six variables there's no suggestion the nine for all that you can use one milligram of one of the weakest for justin's known to science with a ten milligram or microgram that it works indeed as the only ten milligram microgram estrogen pill in the world the results could not have been more unexpected second the pearl index which measures for unwanted pregnancies was a found that the cycle control in low low aspirin was comparable to other products with more estrogen all of those are unexpected results but what could be more unexpected or surprising which is what your case is captured then the leading expert let alone the persons of ordinary skill not the leading experts say we didn't think it would work when it came out we're still surprised shocked that it does these are eminent physicians which leads me now to long felt need and why this is so important and commercial success only in the sense that three million prescriptions were written in the first twenty four months i learned in the reader's doctors don't prescribe those that don't work or aren't good for the gave on rebutted and the judge accepted her testimony it met the need for thousands we know three millions of women who pill this pill does something that no one or a contraceptive does it satisfies the need for in the first twenty three months three million women who whose bodies simply cannot tolerate substantial did not need that first and the judge made in each and every case this court has said here the questions of fact motivation to do it reasonable expectation of success what a reference teaches whether reference teaches a way p five microgram e e embodiment otherwise somewhere to the commercial product low oscar and would work he said he did not it's clear that to have an expected result or any type of secondary consideration is considered bases all of the low aspirin sales were transferred over to localized street sure it was successful because it would cannibalize below as from product which they withdrew essentially from the market at that time with respect to the benefits astron and the records replete with the testimony that there was there was a switch in the marketing that took place at that time but with respect to unexpected results there is no comparison with a nine forty pat texas issue the lowest pearl index ever was achieved which is bad not good for the low low aspirin product that was noted in the reviewers approval papers the testimony by the expert the third was no statistically significant difference indeed it was in the record that the fact that there is no statistically significant difference only means just that there was no different in the statistics but it didn't show was whether the product in fact was the same no conclusion can be reached as to the similarity between the low tester and the low low aspirin product in the absence of some amount of statistical significance i think it's basic statistics  long with respect to project and potency the testimony by dr darby and i think it is quite clear and if you look at appendix page ten ninety one he specifically said that the potency of a drug does not determine the epica city or state the only the amount of drug required to achieve and the fact there is no clinical evidence that a particular project is better or worse in terms of of the particular side effect or clinical response the oral contraceptive should be judged by the clinical characteristics advocacy side effects consult for essentially saying if it's less potent you use more with respect to the amount of in  used every approved product as of the critical day in the us it used more than or acetate used one milligram we have that in the brief the prior art suggested