and here we have two institution decisions in a very truncated short amount of time genzyme hand to respond to those two institution decisions it did everything the regulations required of it it responded fully to the grounds of on time ability i set forth in those institutions actions at the end of the day when the final written decisions the board actually agreed with the board recognized that the grounds of unchain ability set forth in those institutions actions with insufficient i thought that the board said that it was in fact making its decision on the exact that was instituted so it's clear that they didn't make the decision on the same grounds as were instituted you think just because they referenced another time and time again is you can use another reference to see if the first reference does in fact disclose everything why isn't that what they did here you raised the question of reasonable expectation of success  reasonable expectation of success it's clear that the institution decision references themselves actually could not supply the reasonable expectation of success that's very clear because at that last they  vitro data and what we have is a recognition at the end of the day that in vitro day that is not predictive of what happens in vivo it's not predictive of what happens when the patient finally i didn't see a fact finding to that extent and it's my understanding that it's your obligation to prove that fact if true well the argument that was made in the past no response was it the institution decision only references reference references that have in vitro data the argument was twofold one you have in the institution decisions set forth a reasonable expectation of success analysis at all full stop jones i went further to say and in any event if you look at it in detail at the references they only had in vitro data i don't understand in vitro data in many instances can be predictive of success even in humans jump over the step of  in some instances absolutely it cannot be so the patent office presenting in the institution decision a conclusion that by a preponderance of looked is no more likely than not going to be invalidated based on these four which basically your concerns why i don't understand why that changes the nature of the grounds of institution the pan ops at the end of the day jeanette robots are concerned they want to round written sessions they call it out one two three four they define what is the scope of the conscience of the prior art they include in vitro they don't and then they include in vivo data they don't say that in vitro data is predict what happens in vivo they redefine the scope of the conscience of the prior are using it in vivo data and then conclude that based on that information there is a reasonable expectation of success number did they say that in vitro is predictive of what happens in vivo and quite the opposite if they if they believe that there would have been no reason at all to add or rely on new references and let's not forget one of the new references exclude the evidence because the case had been set forth by the patent office as it's required to do this court's kelvin decision makes it very clear it is the p t up in the institution decisions that has to set forth the facts and the walk that the relied on in vivo data from new references not at all mentioned in the institution decision including as i mentioned before the kuchi reference now of course time genzyme given been given notice decision sat the patent office can't just change the aris midstream without giving notice that's why this court in peter and other court cases have said you have to stick with the thrust of the rejection there's been unclear change in the theory there's been a clear change in the thrust of the rejection here there's no question about that you have an institution decision that doesn't really need at all the reason why expectation of success that  to in the institution decisions to find a consensus what if any use would you say and your theory case that the board could and not just in this case but in general  we can apply and that is has the thrust of the rejection change so to the extent you rely on a new reference or new information or new arguments as long as you haven't changed the thrust of that rejection as long as you haven't changed your theory of the case it's ok but when you have a situation where you don't discuss reasonable expectation of success at all let alone the importance of in vivo data and then in the final written session the find the scope and the content of the prior art in the bullet it out and you include in vivo data including a one of the two a reference that could have been sworn behind that's clearly changing the thrust of the rejection it's clearly prime official case the patent owner should in that case prevail now to the extent the board recognizes there's an error there's an opportunity to say yes i'll give you notice and you have a full opportunity to respond if that's what the board did we wouldn't be here but you have to give the patent owner that full in fair opportunity to respond to whatever it is the board wants to explore at the end of the day now the i'd like to talk about what this case is really all about and in this case the board instituted it or parties were proceeding against two patents on certain grounds and what i guess one of the issues is what is a grant and the institution decision identified the grounds for the former no patent for example as grounds one was claim one is decisions for this patent of the of a parallel rulings in the other patent broke out those same two browns in their final written opinion joint appendix eleven through eighteen for around one joint appendix  notice of the grounds comes from the court before didn't vary from the grounds the grounds remain the same from of the institution decisions to the final written decision and addition to the grounds of the formal grounds of the elements was actually missing from the reference in this in which case you know that once the openings that the board realize that one of the elements of the claim was actually not in any of the permitted in this final decision to add another reference to the ground to supply the missing element i think that there's case all the suggest they would not be able to do that in certain circumstances when i was there  board is free to add additional references even if those references were somewhere in your petition but not the basis upon which your protection ground not the basis upon which grounds for granted that just the fact that those references may be here in other grounds that you allege which the board did not i that still wouldn't make it sufficient for the board to pull one of those in for a missing element of the supply or in this case this is sufficiently different from that because in this case the board is only trying to explain what these four references actually teach one of skill in the art at that time in the field is that exact their position yes facts so the ministry of procedure act allows bayamon to respond to any issues raised during the proceeding and to submit rebuttal of evidence essential question is whether genzyme had a full and fair opportunity to respond to the issue of reasonable expectation of success genzyme interjected or raise that issue and its patent on a response and they came  it from all different angles in addition to genzyme raising it in their patent on a response with page we've cited in our brief to pages where they dealt with reasonable expectation of success our witness dr pastore us covered that in great detail in his brief and that's the citation for i mean in his declaration and we covered reasonable expectation of success in great detail in our petition so this was not a surprising issue he can't make an think what genzyme is trying to do is we have a case we raise reasonable expectation of success noctis and we talked about in vivo data we talked about in vitro data witness testified witness testified from the state of the art a year before the filing date and then he confirmed his opinion that it would be the same right before the filing date when he discussed those intervening references genzyme chose to go with the it's it's hard to understand how you can say that this is the critical date and that the prior art has to be viewed from our position in this case law that are directed towards accessories that it is presumed that an inventor has knowledge of all relevant art so the grounds have all the elements the grounds are motivation and we took a position that it was a reasonable expectation of there's no expectation of success that was fully litigated they raised that we raised that everybody argued it and the board found that the rounds that were instituted there was a reasonable expectation of success they found that once in the institution decision and they found it again in the final written decision and in the final written decision they relied primarily on the references on the ground and then they by the way you know there's other prior results or anything like that was there a determination either way on this there was no expressed finding that i'm not aware either where the board said in the vote just predictive myself but you they're looking at the state of the art from december one nine hundred ninety eight according to both parties you look at the in vitro data and then you also look what's the state of the art of that time and say the art there was all kinds of prior art talking about our briefs that people were excited people thought this was going to work now nobody could predict for sure that it was going to work so the board properly found all you need is a reasonable expectation of success you don't need a guarantee you don't need to run clinical trials all you references do in fact discuss if the p t o was seeking to add a reference in order to provide a missing element that would constitute a new ground then it wouldn't be appropriate for the board to do that without that i would disagree that it would be a new ground in the sense that i disagree that the new grounds of rejection doctrine would have to the i p r cont t so you mean all of the cases from the four even in the m p e p which discusses when something constitutes a new ground of rejection if made by the board for the first time in a normal prosecution outside of i p r context that constitutes a new grounds of rejection which it clearly would under the board's own p t o s on procedure or adding a new reference for the purpose of supplying a missing element has always been recognized as constituting a new ground of rejection by the board excel as well as by this card and it requires notice i said no this in comments i meant notice an opportunity to be heard you're saying that be required probably to issue something that would probably some sort of order coming from the board that actually notify the parties as to what this new reference  reference part of the combination that's now in play basically really to clarify what the board's institution decision was  i think way say the new ground cases from the examination context would not directly apply if because we don't have an examiner involved we don't have the rejection response format in so the way there are very different many different permutations throughout in i p r trial as to how a new issue that might require notice might come up and how the board might satisfy it and so for instance if if there was something rule out the possibility that the board even at a later stage could still provide adequate notice and still provide the patent owner a fair opportunity to respond it could it could have been by issuing an order it could and i wouldn't rule out that it could they can they wouldn't rule out that it couldn't happen at an oral hearing it would depend on sort of what happens through the course of discovery and through the briefing so my answer is a yes that notice an opportunity to respond would be required but there are different ways that that that could be satisfied is it if i can just versus references relied on as providing evidence of the state of the my instinct is that there are some significant risk of struggle over between two but i wonder if the p t o has  some three of the a p a says for every decision rendered by an agency everyone that would include this institution you have to set forth your reasons your reasons why that threshold requirement is met and all not vitro data that's material that's clearly material and so clearly mandated by the a p a that it be set forth in that institution cision and that just makes sense the papua should be left to guess what is material in terms of interpret in whatever it is that is in the grounds the a p a demands demands notice of all the facts and all the law you can get is that point and in the in the litigation you sheena's the reference morphin from one that information field in the art two to one that's going to command really be the primary reference why why don't you object at that time why don't you move to exclude that evidence and say more and you're more free in this reference now from one that informs and fill your team something else or you're out of that's because you don't know that they're actually going to take that path and we were told that they were going to take that path until the final written decisions here were given notice of the case as they were supposed to give us notice no other notice was provided by the board they didn't say you have to deal with any other case they said deal with our facts from the same references fit which peter many consider to be new grounds and then the board went beyond just extracting new facts from the same references they've added references not discussed in the institution decisions at all including a one on to a reference providing genzyme with absolutely no notice and absolutely no no no opportunity to respond including including swearing behind that reference and that's