remember ok both the seven to seven patent which is directed to a product and the three four three patent which is directed to a product like the the let me ask about the seven twenty seven record as what the district court of course fair i think that's a fair characterization i think i think it's consistent i'm not quite sure what your enemy might mean by consistent but the claim says that the maximum asked nine level which is the impurity is not above a yes but when you're when you're saying prior there was no prior art other then what the medicines company was doing in the earlier versions of well sure anybody matches which is as if that's prior art so i mean that you were making batches under point six so you can't say the point when they were making some batches below point six however you have to go to the claim in the seventy seven patent the claim says pharmaceutical batches which is a specifically defined term you're under the hospital i mean that that's clear enough i'm not talking about the one six limitation i'm talking about the consistency station the consistency limitation as you interpret it is not  and they have well i would disagree that they have only one exhibit that only made one batch and they said what how they made the batch they have a compound in process that they use and it it resulted in an asinine level they are telling us what their manufacturing process will be and you have to assume i think the f d a assumes that they will use the manufacturing process they represent they did use to make the exhibit back then it will continue sorry  made one batch and it is representative of all batch is therefore they satisfy the claim limitation for a pharmaceutical batch the ast nine level is below zero point six they satisfy that it was adjusted by a basis the ph was adjusted by a  basically satisfy that limitation and they also measure the asinine level by h p l c so a new magic they meet all the limitations of claim one tell me where our house spiritus are mixing doesn't share the characteristics of for example for as was found by the court they did not have rapid mixing in other words an example for they they had rapid they rapidly next day added the ph adjusting solution rapidly that spirit did not do that and in fact the court made fact finding saying that how he distinguished have a court distinguish what they were doing from one of the next the well actually it went very rephrase that i spirit didn't follow example for exactly but it did follow example for so far as the court found it to be inefficient next thing right inefficient exist because they they they did if certain of the steps too quickly basically what the court found and therefore made those facts findings and because there was a limitation in the claimed requiring fission lexing the court found no infringement and our position here is there should not have been that requirement in claim one of the seven to seven requiring a fission mixing that's example five it's in the muddy mitt but in addition the court went further and said what official mixing had to be and and took out part of example five took out the high share mixing f  ample and slow and controlled dition which is an example sockets in body movements of what efficient mixing as it's not according to this invention the only way you can officially next in any event the court below found that what has spirit did was close enough to example for that it was inefficient and therefore not infringing and and the appeal here in that one we think it was legal era to put that limitation into the claim one of the seven to seven it was also legal era to as i just went through want to apply the new jersey courts well the new jersey court did not add that they did not incorporate that limitation neither did the chicago court judge same eve which you're going to hear about a little while that judge didn't put in that limitation and i just found that problematic and i want you to discuss the old certainly i think where we are maybe there's some confusion here is as i understand the hospital argument they're saying because we can't really determine if we're infringing or not it's indefinite and that's not that that's not the legal tell it comes out until it comes out and it until it comes out right and so you will know then and i don't think a person or skill anyone has any problem with definiteness in terms in the terminating the scope of this claim you know what all those claim limitations are more than sixteen batches or any number of that it's either one batch that's representative or all that is that are made by the same compound in process well some sold under my hypothetical thirty one batches are made by the compound in  process and when you make perhaps sixteen you can't tell with those infringement oh you know what happens with batches seventeen to thirty one if you if you if you make sixteen batches and then you look at all the hypothetical is you're making thirty one batches and you can't tell about that sixteen until you've made the rest of the batches and know that all the batches were wins that i think a person on a scale you're reading this would understand that if you're using the same compound in process to make batch after batch after batch and you're using a fish and fish and mixing the way the pattern teaches the person or skill or as you say you infringe and if they somehow make those batteries and they get to batch thirty one and it's outside the claim well maybe it doesn't infringe at that point but i think that's a fact question you'd have to look at what they did how did they do it it's more a question whether they botched that it could be approached secretly it would be a fact  what was recognized by the inventors is that once a holes that was the whole problem that they had to suffer what was going on here what's wrong with what we're doing here with these eighty nine batches and they figured out what was wrong with it it was the process and the overall  it isn't example for for for example crip that's right it's not example for example for is quite clearly an example of the prior right as you're referring to your honor which was the prior batches they were making and though that's the actual data the actual data that they had so they put it in the pattern as they should and then they they they conceived then they came up with their invention with the new compound in process if you will officially mixing and that is what's exemplified in example five but that doesn't mean the claim has to be limited to what they didn't claim five if someone today follows example for they don't infringe clearly not when i'm friends with plan i don't for seven points i don't think they would infringe either one because a three foot three as a limitation in it for efficiently mixing while i don't think it has all those other subservient narrower limitations it does say fission mixing so if they're not officially mixing meaning they're following example fo the efficient mixing is described from i think it's column eight line fifty or so for about the next three or four columns is a lot of disclosure about examples of what a sufficiently mixing is but those don't provide any s all the testing they did the analysis they did and they change different parameters they change slow conditions you know whether you mix quickly slowly whatever it is there are a lot of different parameters and and using up my time but  far i come back to the limitation for efficiently next thing should not be in claim one he has to make us to make the complete set of batches it has to be a closed set and then he examines the outcomes and in this entire set and if he finds or she finds that the maximum has been met by the entire set of batches made using the process then you can make a determination that but that's that that is an indefinite limitation and it's very essence because the essence of definiteness is to be able to results always come out below six know until you've completed the sat well i think that i think the outcome is that some twenty seven claims and it will in fact this will apply to both because the maximum limitation is in both both patents and i think the outcome is that the in that's the argument we've we have consistently and we made that in the district court judge enters the not agree with us we meet up when we are due to this panel originally and i think that's the necessary outcome because of the very unusual nature of the claimants question which you well i don't think a what i don't think of what i think kind of confuses the analysis because because it shifts the focus to a fish and mix and of course judgment is found that oscar does not officially mix and if you look at what cost or it does it's it's but let me return to the point about how did efficiently mixing get into claim one of the seven twenty seven that wasn't judge and reset that happened during prosecution playing one of the seven twenty seven pa so the language that was agreed upon was the where in clause and that's why judge interest was right to read that clause as distinguishing is being that's that's the language at least in the mind of the when you look at the specification what you find in unavoidably find is that the where in clause must mean that whatever the process is it can't be it can't be the old process of can't be inefficient mixing and so i think judge interest was absolutely right given the prosecution history was absolutely right to read the claim the way he did and to include efficient mixing in his understand in his construction of the claim but there are other clues to it's not just this disclaimer i mean that's what that alone is enough but if you take out the we are in clause if you remove that from playing one of the seven twenty seven pat when you wind up with this  yourself we've shown you one way or claim the ways that you can avoid exceeding the maximum a functional functional type claim which which i think i think there's a consensus now those are not good cl that the wearer in language be added to the clinic that would be that would be our argument that's why i think the judge the trial judge was right but there's more and there's there's the the pharmaceutical bachus limitation that requires an efficient mixing minute you don't infringe does that resolve the case you have the counterclaims of invalidity does the court have to reach those if it finds non infringement what's your position well my position is if the court found there's no infringement my client would be threats but i think the court does have an obligation to address the rest of the arguments and so i'm prepared to talk about our answer any other questions the court might happen but my thought was that the time that i have i would speak next three years to be resold in that state how do we know that that's the new product as opposed to the well because that's all that there was at that point your honor after october twenty fifth they never use a new thing in the agreement that specifies what the product limited in any way to the old that would have been completely counterintuitive whatever whatever was the current commercial product that's what was being offered and as of february in this agreement does that because the  that would be the natural reading of income i guess that's yeah that but there's a contract construction issue here which wasn't resolved by judge and or well i think that's right and i will say i am one hundred percent clear on whether contract construction constitutes a fact finding or a legal finding that's an interpretation of legal documents i think it's something that this court is capable of doing to novell i wouldn't think you have to send it back for him just on that particular point and and i would urge this court that the normal natural reading of the contract is what whatever the commercial current commercial product is that's what's being offered for sale and as of february of two thousand and seven when it became affective the current commercial product in the pipeline were the new batches and in fact the old batches the old way of making batches was never used again by stipulation the parties in the trial after october twenty fifth two thousand and six they knew it worked in they changed their november and december of two thousand and six the contract i don't know what was signed i know that recites the hymn effective in february of two thousand and eight so those batches were made before the contract was signed the next eight batches i'm unclear when they were made the record doesn't reflect this but i should say the record doesn't reflect exactly when they were made but they were made thoroughly before the critical day so they were made during the spring and they were part of what was offered for sale in the fact that they didn't didn't actually deliver the batches using the new process until after the critical date is of no moment that's exactly what happened in philips the offer was made and in the what was the chip connectors the whatever they were and with this they say it's not a complete sets that doesn't qualify as a commercial offer because it's not like the group one where a simple acceptance would form and enforceable contract but that's just not right i mean what happens under this i c s agreement which has all of the all of the elaborate terminology that one would expect that the uniform commercial code article to contract for sale everything is in the supreme and one of the things is that when a purchase order is submitted it automatically becomes effective if it's not rejected and in forty eight hours recall there's this little term in the i c s about being able to have to not honor but clearly the sense of this agreement is that purchase orders are going to be on it would be nonsensical for for the medicines company not to on these purchase orders because this is the only way they can sell angi this three year period in the united states this is an exclusive arrangement they can't sell to anybody else for resale in the united states so they've been out of the purchase orders ninety percent of their revenue back in that time period  and there's never any idea that they would dishonor purchase orders except when the needed to and the contract limits their ability to dishonor a purchase order to when it's commercially reason or maybe the language is commercially necessary but it's the concept is if i can't limitation he was reading to the clinic and he found that they followed example for more closely and they added it to fast ok and therefore it wasn't efficiently mixing as judged in drew's was construing the term and that's what we think the legal was ok but he had no problem with definiteness indefiniteness i should say a spirit never challenged what a pharmaceutical batch is that was not a claim construction term that was being challenged that any time in this case i heard something today from a story earlier about it should be like in the end so case that was found by this court however in this case the distribution agreement was found by judge andrews not to be requirements contract and as a matter of law i think why isn't there an arms because there was no obligation on the part of the medicines company to supply the requirements of i see yes period there's nothing in the scheme it says they have to do that what it says in the agreement is i c s is a distributor exclusive distributor for sure and they were being paid for that less than twenty five batches and they didn't appreciate it and realize they had an invention too after they made twenty five batches that didn't happen until the middle of two thousand and seven well after the critical date and well after this contract was entered into other words an hour until the medicines company till the inventors made twenty five that is and looked at the compound in process and the fact that it had it maintained or or resulted in the s nine level consistently below invention was ready for patents in which is another element that has to be satisfied to find a non self bar here and we challenge that also because he couldn't possibly be ready for patenting that in even though they had made an invention and so and what judge interest was looking at for patenting if the claim construction falls clearly that can't be the case and even as i said the conception here by the inventors was not until much later after they made twenty five batches so they can't be ready for patenting if i thought you couldn't  write a pen application how would you satisfy one twelve at that time you don't know what the boundaries are of your invention before you know what it is and so in february of two thousand and seven when this distribution agreement was entered into we would know that  it using the scientific method not really i mean i think there was a master batch record and they distribution and reader and section work you have to says that on medicines will use its commercially reasonable efforts to fill your words why isn't that  much we want and a third of the our african party has to use reasonable efforts to fill the orders wasn't that just the standard requirements i think in an equal in a standard requirements contract is it some kind of provision that says you're going to supply us with up to seventy percent of our work that's a contractual obligation that the other party has to satisfy that the men when it's made if they don't they have a they have a contractual problem here i say yes they could say you know we're intending to sell tons of stuff but there's no legal obligation on the part of the medicine or even legal obligation to use reasonable efforts as month to satisfy orders which are made and except the order has to be accepted by the medicines company it's in three point one the product and we're talking a lot of money to make a product and they say the market is down because a generic competition or because of some other reason whatever it may be they say we're out of this business it doesn't make sense for us to make this post some reasonable efforts is meaningless because and that there is no obligation to philly or lunch they stuffed it in no obligation to use reasonable efforts unless they accept the order and that they can reject the order for any reason they want to i think they don't have an obligation to use reasonable levels commensurate with historical levels they knew a good thing had been doing business together for a long time before this distribution agreement i c s was merely a distributor after the distribution agreement i or so so of course it was clear they were going to be orders and of course they were going to be satisfied this because it was a requirement for a specific quantity to be purchased by i c s in fact the way it's phrase i think in the agreement was that i see a showing inventory commensurate but that implies orders to is up to a certain level over over the period the three year period of the agreement and it requires it requires obviously the submission of purchase orders in order to maintain that level the agreement also imposes on the medicines company a commercially reasonable obligation to fill those orders and the exception where a purchase order is for some reason not except it isn't isn't dealt with with any long discussion in the agreement because it's not something that's contemplate is going to happen very often why in the world would they reject purchase orders unless they absolutely had to when rejecting a purchase order meant that they weren't making any sales in their biggest and best territory namely united states of america and some other other like i think perhaps puerto rico was also included in the in the definition of territory why would they would reject those purchasers because also for bade the medicines company from selling angiomax to anybody else who might resell it into that area so so it was an exclusive dealing arrangement was a it was a a sales agreement to supply it reseller for exclusive resale in the most important character for three years so these were serious obligations it's a it's a it's a very sophisticated document that no doubt was negotiated by some sophisticated people they knew what they were doing and the idea that they were just willy nilly not well to them the only person they could contractually sell to the only entity they could contractually sell to seems to me to be sort of fantastic and so i think you know i just i don't think that's a serious counterargument must appreciate all of the inherent qualities of his or her invention in order for it to be ready for packing for purposes and so and we can see why because there would be no end to new patents on all things if that were the case because we are forever figuring out new things about something we've been doing for a long time and so so what they did know was this they knew in october of of of two thousand and six they knew that they had a better method for batches that are the result of that we don't know what the maximum will be at that point in time but we still can write a claim and therefore it's on say the badges were on sale from that moment forward as they went into the product pipeline and this reduces variability we know what we do says variability it's better than the old way of doing it but we don't know for sure everything there is to know about we might figure out some things years from now but in the meantime it's been on sale and those sales count as prior art and the and the batches of example four in the vessels of example five the discussion is really but the reduction of variability then they say now our way of reducing variability is to use a fission mixing that's what they tell one of ordinary skills our way of reducing variability is official somebody else might find another way another new way of reducing variability but our invention at the end of the day is efficient mixing and that's the message that comes through and that's the that's what the patent examiner found out what he was worried about or she was worried about when i think it's a she required that the language referring to the process we put back in the back in clean one of the seven twenty seven