standing and so i think it is appropriate to start there on that issue in view of the parties tenure negotiation history as refusal to license these patents to prove farm and pro farms ongoing methylene blue commercial activity pro forma standing to appeal this position contrary to that is based on two thought the idea is your commercial activity potentially infringing and as i performs meckling blue a p i has to exceed ninety seven percent to be compliant with the f d a standard so certainly perform goes above ninety seven percent in order to ultim better than ninety nine percent so don't we know from mr newman declaration that the very process you use which is detail in two separate patents produces a purity higher than ninety seven  standing that's the hard thing that you're between a rock and a hard place on that one absolutely your honor and i think that's exactly right here there is no requirement to admit to infringement recently i  c general exclusion order and we think the analysis should be the same here for the point exactly that you raise we we certainly know that proof arms process is capable of making a p i that exceeds ninety seven percent  the facts are not in the declaration as to you know in the exact real world commercial environment what that percentage gets up to whether it's exactly consistent with the patents or not but that that's exactly our point is that we we have a process where the overall methylene blue purity is going to be greater than ninety seven percent so very close that minimum to the claimed ninety percent purity explains how your process is actually created by the process described in ninety four to a fifty that and that patent suggests a higher concentration then even his prior declaration that he hasn't stated exactly you know how the patent correlates to the the real world ultimate percentage in blue a p i and so certainly i think the process is capable of exceeding ninety those your commercial product is made by the process articulated in that those two patent those two patents don't cover something that might exceed ninety seven percent they require ninety seven percent what am i missing that's honor that's correct but what evidence did you submit that that the that the differences and it's more than just the the metalink blue purity level that there are other gaps  that between the f d a requirements and and the the claims of the the patent at issue so what evidence did you submit that objective lee those differences are really meaningless limits when you need to get the requirement you're necessarily going to meet the claims requirements for those impurities so that the two impurities that we believe are potentially relevant in terms of potential gaps for standing relate to zero five percent the f d a requirement is less than or equal to point one percent and so the pro forms position that we're looking at standing here and not the ultimate infringement talking about standing those potential gaps shouldn't preclude review particularly women espec you have us adopt that any time someone anytime the f d a requirements are close to the fat limitations we should say there has to be standing i i don't know if it needs to be a some sort of quantitative look at how close you get to the packing claims themselves but looking at what the court a compliant we have a process that absolutely exceeds ninety seven percent and the patents could be beyond that then look at the chart on page thirty the me there's a gap and what's your answer to that and the answer there your honor is that while there may ultimately be a gap in terms of the ultimate infringement proof that we do not believe there needs to be an that you would be sued for infringement and you've discussed the ninety seven percent and in close to the ninety eight percent but i'm asking about these other two items that apparently give testimony that suggests that your patents and the products it produces are not just at the bare minimum level required by the f d a but in fact has a greater purity than what's required by the f and thirteen the that is certainly what the process and do according to that patent and i just don't think the facts exactly are in the record in terms of what the what the ultimate a i that for instance gets incorporated into probate blue the product that's sold and in the us what that purity exactly looks like before it is incorporated into prove a blue what we do with the fact that  obviously list it's been aware of your activities for ten years i mean you say you've been on the market for three years and and there's never been some much as a threat of action against and so here i think you have to look at the totality of and says and that you know while there hasn't been an explicit threat i think it's certainly the circumstances here townson tantamount to an overt threat where the parties in numerous discussions and disputes over the or negotiation excuse me over the past ten years to resolve the underlying patent dispute it got to the point where the parties were discussing licensing in order that if there couldn't be you know certainty so that there would be certainty around the methylene blue business that profar may have to file opposition question and the question is i'm not asking you to admit that the doctrine of equivalence could in fact apply here because again that would be like tantamount to admitting to asking you to admit infringement so i'm not doing that but isn't it possible that within the range for literal infringement not to my knowledge your honor i look a lot of the recent standing cases in preparation for today's discussion and i do not recall that and that's certainly a possibility that  believe so judged you all you argue didn't you think could frenchmen right absolutely and that's the basis of our our standing argument is that in view of this the tally of circumstance and the the right of an infringement suit is absolutely a possibility given the overlap between the f b i requirements and our active process and our a p i manufacturing process unless my colleagues have further questions about standing i think absolutely thank you your honor so the me turning to the merits the st issue regarding the scope and content of the prior art the point that i would like to make there is that the board collapses entire analysis into one perceive a mistake in the petition prior product was irrelevant to the obviousness theory that you asserted in your petition no not that it was irrelevant but that if there was one petition position by proof farm that the board ultimately disagreed with that the analysis cannot stop there and they have to still consider the full petition and the evidence that was put in there and and what the true scope and content of the prior art is and we're certainly not asking the purity range was known in the prior art the scope and content of the prior art was established and then the only question became a reasonable expectation of success and to that to that point a reasonable impurities which is not the same case with the independent claims of we see this pattern and so those statements were directed at using conventional techniques to get rid of both at the same time not that if we're simply looking at the independent claim for example and we want to purify the h p l c preparatory h p l c that is would there be a reasonable expectation of success and so some in some regard that think they were comparing apples to  oranges because the claims and the technology was different enough that it would make a meaningful distinction to a person of ordinary skill ok i think ron time will give you two minutes for a bottle standing so they had a council this is just more under the dupont case if they had a plant and a process that was capable of infringing that might be enough well they express fully allege in their president mr newman's declaration that they produced their product by virtue of the process in the nine for two and a fifty patents and that process when you read the patent produces a product that has greater than ninety seven percent a greater than ninety eight or ninety nine percent purity so why haven't they met the burden that they in fact do have the capability of producing infringing product by virtue of the process they're using that is in fact the preferred embodiment in the patent disclosed that they say they're actually using to produce their product thank you i had full response to their one i believe opposing counsel method that there is no connection necessarily between how provably actually manufactured in the real world and how the in the preferred environment of the pattern but more to the point the patents that are reference require less than one percent of aser be where the f d a permits proveable who to include two and a half times as much of that inherited b and so that gap there between the with the claims and opinion in the jake jake katie corporation decision they don't need to concede current infringement but they do need to establish that it had concrete plans for future activity to create a substantial risk of future infringement or likely cause the patent or circuit claim of infringement and so here had they submitted a declaration that says they have a plant that is currently capable of producing proven blew out within and respectfully we believe that they should be held to the consequence of that strategic decision which would be that they feel they're just best for lack of standing counsel you suggested that one of the problems with their  typical e allege or provide proof that their product is at or less than one percent is that the nature of the argument i'm just making sure i understand it corrected paragraph twenty of the new integration just ninety nine percent greater then ninety nine percent purity of math blue so if the message blue has to be greater than ninety nine percent doesn't that necessarily if we had any evidence in the record that prove that farm was manufacturing true blue using that preferred embodied that we don't know if that was true it would seem to prove a firm could have added a paragraph to dr newman declaration so i have two problems with what you're saying before you just before you said the standard is they have to be capable now you're requiring proof that they do in fact and so i mean i feel like you  raised the level of proof in response to my very specific question so that's kind of point number one point number two that i'd like to raise to you is that paragraph twenty expressly says that they're preparing prove ment is the ninety nine percent or greater purity so if they're using a process that they have described in detail in a patent just capable of producing best blue at greater than ninety nine percent purity why isn't that enough you said the standard was capable of they said this is the process we're using here's a patent and the patent describes the preferred embodiment as producing greater than ninety nine percent  they're capable of doing it they are right that they're capable in the sense of having provided it in their patent specifications or whether or not they're actually commercially capable of doing it that's the missing link it we don't know if they're actually  there but let's go back to something else why do you think they would spend ten years negotiating with you over this if they weren't planning to or didn't have the capacity to infringe why would you bother spending if you're really really close because they are really really close at a minimum to them but the bottom threshold because they're using a process which requires the production to be over ninety seven percent and then their preferred body requires it over ninety nine percent so just out of curiosity what do you think would motivate a company to spend ten years negotiating for a patent license if they are capable of infringing and prove a crime in which they never reached that agreement and then they had no further communications for four years from two thousand and eleven to two thousand and fifteen when at that point through a firm again approached with them the parties had some initial discussion during which available by the time they mentioned at ninety seven to ninety nine percent purity meaning the purification would have been even easier than at the time of the so they clearly premise their entire petition the scope and content petition they had complete control of the argument that they were going to disclosed an analytical h p l c process and didn't explain how you would go from observing meddling gluing fractions from an analytical process to actually obtaining an isolated pure methylene blue and on page forty one techniques inevitably produce impurities and the position that they took repeatedly in from the european office in which they said that that existing conventional techniques such as h p l c made it difficult or impossible to actually points on the merits with the remaining time that i have the st regarding the scope and content of the prior art and starting methylene blue purity if you look at attendance thirty one which is the board's final decision which quotes directly ninety five percent methylene blue is dean that's disclosed in the prior art and this goes to the board finding what they believe to be one mistake as a higher percentage ninety nine percent being disclosed and then they stopped their analysis fair they recognize that we said there were lower purities that could be further purified such as ninety five percent and that's dean and that gets us to the reasonable expectation of success analysis and this is where the board i just didn't understand and appreciate pro pharms argument and the distinction between analytical h p l c and preparatory h b o see and you can see this clearly at appendix forty where the board states that it credited and agreed with dr settler's testimony l c processes that are disclosed in dean would have to be bodily incorporated into the obviousness combination into the hypothetical h p l c protocol to get to successful isolation what and with that goal in mind a person of ordinary skill would have selected an appropriate mobile phase that would have allowed for successful isolation after separation and purification  chug bottle incorporation which it doesn't all you would have to do is look at dean's figure one deems figure on it's a completely volatile mobile phase so that when the solvent when the thing that comes out of the h