are standard reasonable expectation of success don't i come out with the office no your honor and for two reasons first in the your feral standard if you which separates protest good you're talking process to me and frankly the only difference between developed belly and the process in the coogan process is the difference between a liquid amino absorption technique and have an assault immuno to nail and the method easily for producing the sequence why hasn't the prior art shown a reasonable expectation they get everything you claimed very quickly well i didn't give it she quotes but again that's where you can use the commonly used methods that any one of skill in the art knows to get the sequence and the only difference between the way they got the sequence and you got the sequence is the difference between the liquid in the solid immuno absorption technique when no but did we get the library under samberg that's why they cite that as part matthew is kind of a reinforcing reference that shows that they did do everything you said they haven't done in the mirror  suggests to me the sort of teaching away and i think that's relevant to this question but what i do think that the example twelve the prophetic example in  to take a look at but i don't think it's i don't think it dictates the result i mean there's no started to it doesn't matter that it's it doesn't matter that it's prophetic but i will say that one of these to look at everything  had not done that for purposes of cloning all that had done was taken so what relevance is the fact that they had not done it for that particular purpose well you need to be able to get looking for the d n a not just looking for the protein you're looking for the d that you need to start excel i have a sufficient amount of that particular gene that will produce that but that's the sort of thing you assign to your lab assistant us signed in a lab assistant to to do it and yes it's trial and error and yes you make lots of mistakes but remember we've dealt with that in our case a lot lampy after lost power for instance you can have lots of mistakes and still produce it and is just a general clothing no it tells the one of skill in the art how to produce those libraries and when you've got the pro that's not so hard to do it does not tell me on a scale of the our how to produce an excel library and if you look at the meth and that's not disclosed anywhere and nor is it any of the seen forty eight binding aspects of this claim disclosed anywhere and this is really getting down to the problem that we see with the board's analysis is looking at the methodology and that's not the proper way it's easy to say sure you know the endpoint could someone have used a hammer and nails it get there when someone can't use conventional tools to get there that's a different question from is this claim subject matter as a whole obvious from what came in and looking at go looking at this invention as it should be looked at the genetic basis for the binding region for a very important interaction between l and c forty eight when that interaction was not known and has significant biological within that five you also have to have you describe all of the structures which bit within the eighty percent limitation we've described we've described them as in terms of the eighty percent structural limitation and the ability to exceed forty and there should in this instance you're not dealing with some of the other cases that have been cited by other cases or do you see if you want to stick with your structure structure structure argument per obviousness you've got to stick with it for your lily written description too and you haven't described all those structures for  well you can have different code that recycler the same amino acid the variance is just at that level not to mention the substitutable amino acids gives you a vast amount of variation that you have to account for but the specification cast of the way it was oh well that's what we were just doing with the obviousness and you didn't you didn't want to give us much skill in the art there is is there anything at all in the written description that discloses or suggests which parts of the i mean oh yes its sequence could be changed and still ma binding regions you can still have substitution of mito acids that look like one another and still retain the function so our position is that we have specific variants described here not by a lot of volumin significant that it's enabled and i think that the written description requirement should be as this court has repeatedly applied flexibly and when you have a situation here where you have a finite structural class unlike other cases this is not a plane that is trying to capture unknown biological materials that might exist out there but this is a defined class within which you can have a limited amount of variation up to twenty percent forty eight so the fact that the antibodies is binding tells you nothing about c e forty eight that's a completely unknown interaction and it is important that there are no name starting with periods because you cannot additional minutes to ms she needs to use it reno just one second while our clock catches up with my mind structures good we give you ten extra minutes so we'll give no that's fine ms rudolph will have a little extra time beyond her seemed independently because it lacks written descriptions yeah but i started ms rudolph with o'farrell i'm going to start she would do well if we look at biotechnology is requiring structure structure structure as chemical inventions do don't you lo distinct from the fact you need to go into the court explained that the identification of the structurally similar molecule in the prior art is normally where you would start to make a chemical obvious normally that word is key because that means it's just descriptive of one way you can establish chemical obviousness it's not pretty scripted and they always have to do it that way in this case our fact pattern is different and all yes but here guess you're trying to distinguish if i follow the rule of do all it says general methodologies are irrelevant you lose sam broken if you don't have sam book you prior art disclosure of the process residing in a particular compound is another matter raising issues of anticipation and obviousness we are that other matter what the board specific kind of m k cell library that a person of skill in the art would have known to use this kind of goes to the question of reasonable expectation of success mathews provides that reasonable expectation of board made specific findings in this regard it page eighty nine of its decision it explained that  and provides the reasonable expectation of success common itself before the board and the board made this finding at finding of fact thirteen at mit's that conventional cloning methodologies were known in the are people who knew how to so the board did consider it the invention is a hole that's not a problem for the obvious are with regard to obviously cry within the context of a very simple mechanical invention and it's easy to see that no finite number of he lucian in that context  does not have any real relevance to my own technology which i think very few people would characterize almost anything biotechnology  that following the principles and nouns in that case in case might not be as easy in other cases all inventions and these are the supreme court's words don't involve a simple substitution of one element for another or the application of the technique to a piece of prior to ride improvement so this is a print or it was contemplating applying j s are beyond a mechanical combination of two parts to the biotechnology selected that content it represented the limited number of methodology this court said no it didn't because the prior art there taught hundreds of compounds nothing singled out to compound b and on top of that  that can i ask you something i'm going to read a sentence from the lilly amicus brief the board's radical deviation from this court's well settled precedent on chemical structural obvious if not reverse unbalance the careful calculus of risk and investment in the pharmaceutical industry and the detriment of patients the point i'm going to focus yon is chemical structural obvious is there a distinction between the standards we are to use for chemical structure or obviousness and the code based on a biotechnology which is probably has more in common with  obviousness into the written description area this court found that written description was not satisfied and are the only two tests that can ever raise before the board the representative number of species  acid residues should be changed to maintain function so that discussion of conservative substitution may teach how to make the variance but it doesn't teach what those variants are it doesn't five amino acids candide very we have no idea which of that twenty one to two twenty twenty two to twenty one portion of male to change and maintain binding which amino acids have to remain and which can be substituted but more than that even if this court would accept the destructive dispassion that the conservative substitution could somehow provide written description support for variance it would still do scale for the that discussion would only apply to variants made by substitution applicant cuban has just defined a variant to be made by substitution and insertion or a deletion concerted substitution variations are is also linked to the protein having activity why there is satisfies the function structure alternative test for written description  it seems to me that there's at least an argument and it's certainly going to make the argument that matthews points away from any connection with dahlia right suggesting that one of the everything human counterpart analysis what are your comments today of two hundred first the board did considers he is and did consider this conflicting language the board said that that only shows that there is conflicting evidence regarding the success and at the same time that the reference questions whether the human how the law is expressed the reference also teaches at a nine thirty three where explains that meaning the human have a lot it's not expressed a couple of pages later at nine the art to establish does or does not human homologs exist but it certainly isn't a discouragement those are the words of written just a teaching a way lot for someone to look at math used only for the teaching of a reasonable expectation before but one point i wanted to make sure i brought out was the legal aspect of it here and see for obviousness it's our position that that if there is an inherent if there is a claim limitation and that is going to be looked at under a theory of inherent see there has to be recognition of that in here and specter in the prior art for that to be something that can be counted against the claim of the obviousness determination  something that is argued to be and obviously we don't say it is but is are going to be obvious from what came before and the per hour and those unexpected results are unpredictable aspects or here properties that one could not have predicted need to be taken into account in the obviousness calculus and those should weigh on the side of navi isness if if inherent property were not to be looked at it all then unexpected results could never be an issue in the obviousness determination and the supreme court has said that that's important evidence to look at for not what it binding with forty eight necessarily occur in every again with an obviousness case not an anticipation case then it does make a difference but i also want to point out that we are disputing whether what was disclosed in valley n t how can there be an unexpected result if it is the only result and one of skill in the art while knowing that it is the only result is the thing that binds but there is no basis in this record for what it would bind to encase thought technology cell biology is extremely complex and we've cited two specific portions of the record that make it clear this is very complicated business and there are a whole host of proteins and substances that can interact with in case  and some of them have been identified cd forty eight was not and there are statements in the record to say boy this biology is complicated it's we don't know the basis yet for this activation and it's possible that encase cell activation could occur on multiple pathways there is no mention of c t forty eight in that interaction whatsoever in the record that's a completely unexpected result unpredictable result and it's a claim limitation so the board was not entitled to simply ignore that claim limitation when assessing obviousness the other point i want to make is that counsel for the p t o mentioned that valiant did not or  identify c d n a for pete thirty eight they did not what value to it was no more than what dual did except for they combined the references into one reference in other words in dual you ha acid sequence and they combined it with the mini i just reference which is some general cloning techniques now and it just basically put those two pieces together into one reference but it's no more perfect example twelve is just sort of a cookbook so the facts that are at play in this case are very different from tool and counsel in favor of not vs inus not isness so even if we had a dual situation dual should still control but we have beyond that counterpart for peak thirty eight it's the mass counterpart that was not recognized for an hour so to the extent that the board is relying on well you can have a reasonable expectation because this was a similar protein but doesn't  you shown that the method works the it does isolate the gene in the mouse and it also provides a motivation to do the same thing to obtain the human homologs what matthew shows is that you can get using the materials the specific methods starting with mass else you can get that mouse protein there's nothing that would connect it so you can probably do the same thing in humans right it says you can't i mean it says that if you look at what matthew showed they tr find a counterpart in humans what they found was a region of the genome that was a homologs region of the genome that was an all off a lot of the human genome is not expressed so the second finding yes there's a whole  lot but it doesn't look like it's expressed so what is that telling you that's telling you if there's anything with matthew that you would not expect to find that same thing in humans it's a teaching away have any further questions no the court is has not made your job easy today but you have magnificently represented your client help the court thank you very much