me break it into two parts to answer your honor's question first if this claim were simply a species claim to a single compound area and says you need this precise definition there is no definition at tell us i think the answer to your honor's question so the first is for the species itself if there was only one precise definition structure for me off chemical name physical properties there is none but there is a genius here and claim to claim three thirteen claim fourteen and four the genus ariad says you have to have a representative number and there is it is zero can't be a representative number or you have to the common struck if we go immediately to let it go to every description issue which your honor has direct us to those legal principles are clear the undisputed facts in this case are there are no examples is no example demonstrating that the particular antibody was in fact made i mean there are certainly material in the specification that indicates how one would go about the description that gives you gives the public and one of or grayscale me our notice that they had session of the invention that's what ariad require it's both for the genus and species but actually to go to the second part i would bracha but that's not to say that there isn't in the specification indications of directions to global methods technologies to use that would point you in that direction the only question enablement their argument was it's all out there it's all prior art we disclosed a couple of things nineteen words in column eighteen and affinity to that issue the key area is the complimentary terming region it's referred to in the question first is in the record at eighty five seventy nine to five eight and two thousand twenty thousand one hundred twenty thousand and twenty you will find the amino acid sequence of the variable regions honor has just described we didn't have the x ray to make a fully human body the third thing your honor is the undisputed record is not that someone just had six months and it popped out you had the best scientists in the world working over for a period of years making innovations in inventions innovations inventions and phased display guidance election affinity modulation all the way the end fact there was a jury verdict there in fact was competing expert that's what i was going to get you to backing away from the science and getting back to the law because as you well know it's a question of we've got a jury verdict here we can assume the jury  specification and looked at the record and what in both cases this court looked at were the fundamentally undisputed facts the fact of matter is they didn't call an expert but if you took dr marks and we pretended or we soon  had never testified never testified at all let's just assume that for a second and we look at this tent in the specifications and we're looking at what they claimed to have done as of thousand nine hundred ninety four there is no disclosure that satisfies an area that even if this were a species claim where is the written description of the precise definition of physical properties the chemical structure formula there is for the genius there certainly is enablement to go to judge price and second question on enablement i don't think anybody disputes that the argument that it's all well fair is not good enough before this court you have to enable the novel workings of your invention and again if you go to bat issues there is no dispute you don't need dr marks and your own appears the best indication that they have been enabled the novel portions of their invention what do they say my understanding of the context of that statement is that with the same technology is available and we describe the technology in the in the specification and it is out there and in that sense of  so if you step back and astronomer and you think about the progression that's been presented to the court and judge post to your question what you can decide is a legal matter here's the progression or the first stopping point is the fully characterized energy if alpha was out there and we don't find the binding site that's not enough that's enough but if that's not enough then those two things plus identifying dr mar article plus referring to fit fit if you modulation is enough but if that's not enough of these five other articles out there now at the end of the day it's critical to distinguish the two concepts these other articles that were out there were are pointing in the right direction if that's what they did isn't sufficient for written description but and when you're didn't believe what actually roger that's no different than experimentation i think it's hard to get over that the jury just believe marks under cross examination dr marks under possible nomination i think on the question of undue experimentation i see it as slightly different than the area that was limited to fair question various seemed out there and you seem to feel that you're on somewhat firmer ground with the written description with respect to this issue of the problem that the jury verdict percents you said a fair characterization your honor if i were i think it's a fair question and a question we've thought about i think if i were to rank them for your honor on the basis of what's supposed in the specification as a matter of law now yet you like the gentex case in the enablement case it area because it is in some respects pretty close it gently cases actually very close right and so if i were to say which is the most easily dealt with as a matter of law an undisputed fact great description is it enablement on the specific fact entirely a question of fact we're here you just we're just you know what the specification what specification adequately describes it so i don't see that there are undisputed facts i think there's to the extent that description is a question that there's an entire actual i q i don't think any dispute in the following there is no example of a human and body disclosed there is no there is not to go to judge price was question there is no teaching as to how to make a fully human anybody with the claimed characteristics there is no amino acid sequence or d n a sequence in coding the hyper variable or complimentary determining re if we believe if we apply area precise definition chemical structure or formula physical properties what is there and the answer is there is nothing and honour's what they point to they say to you the following they say that disclosing the fully characterized antigen and the binding site is enough that's wrong for five reasons the first is they don't claim just one binding site to go to cut interest question they claim multiple binding sites and epitope or epitopes so they're claiming eighteen is the second is the disclosure of column the lock somewhere on there and find the lock maybe you can find the key the third thing your honor is the case the if they were correct if they were correct it was in the language saying that it's dipped maybe true but it isn't a terribly warm indorsement of a path for us to follow in design ok so sillett any other help that you can give us with the kno empire and it is not sufficient to disclose the human and body that's the holding now p t o guidelines for training materials in the well collapse let me address both of them together because no well is commenting upon routine conventional the presumption of the example is that there is a well established correlation between function and struck there is  here so the time that's different they claim with different the technology was different and the presumption that there is a well established correlation is different well is that it is what you are saying  suggesting that in some instances or perhaps many instances there is such a correlation that there just doesn't i mean i'm talking about an intense in any way but there just doesn't have to be here are you saying what you've just been saying and saying well you know this and maybe this is an effort to respond to my question about what beyond dictum you can say about the well but it seems to me in your brief you were saying that that's just wrong as a matter of abided abundance in the end it doesn't have any of the additional ornaments we have here right but that presumably would be broader plans right right right but remember with the written description requirement there if you dependent claim it says i have and jet airplane and i sort the jet airplane i get the subsequent inventor of the jet airplane that i need a written description of that and claim that subsidy is good airplanes in my specifications and it's it in some ways it's almost counterintuitive but it's correct if you're going to have additional requirements of high end affinity neutralizing it and competitive inhibition you need to describe that because the fact the matter automobile in the nineteenth century in rochester they then pointed to the jury and you and said oh but see all of this over here about high affinity neutralizing competitive innovation that was all the day the holding is one that we actually embrace i think should extend and this is said the best indication it is picked i think in some ways if you take what they're doing in taking the training materials and building it into a suggestion that there is rebuttal one of the thing i want to go back to this question of whether disclosure of the fully characterized energy in the binding site is enough and you go back to the examples you if that's a big there's something wrong no against letterman when you read if you try to read it literally they're saying that if you invent you know if you have the energy and you invent the engine and you know the vining side then you're going to get all the antibodies advancement in science and the jury verdict which rejected abbott's position that the specification does not provide a written description or enablement is correct and supported by substantial evidence and this is not a we're is that the right place on the on the t n f is identified in the patent as in two ways by the competition with a two if an antibiotic competes with a two for binding t n f that means they bind in the same or similar region and that is one way of defining the structure and that the patent even talks about the particular are amino acid residues on the t n f antigen which are implicated in as the pat limitation right to say that it competes with too doesn't tell me anything about what it's sequences it doesn't tell me about what structure is it doesn't tell me anything about where if you've got the energy and then you've got the antibody notion you know your brief certainly in the sense that mentions that concept but then seems this may not be a fair characterization but seems not certainly not to fully embrace it and perhaps one you have a category and then we're into the problem of deciding how how well you've defined the category and so right in the particular category here are the antibodies that are specific that compete with a well to the effect of if you've got the energy and you have the anybody it's just wrong i do not and i have and there's no basis on this record to change that we're in one of over a decade the expectations of the industry have been based on the patent office written description guidelines and this court's guidance in cases like noel and ends that way that's the expectation of the industry and that's those these are the experts at the patent office talking about the recognized correlation between structure and science is that scientifically correct i have no basis have to disagree with that based on the record and based on what the path of the experts at the patent office to have to do with me you have no basis to disagree i have no basis to believe that it's true then why doesn't holding was i believe he said that the holding of the disclosure of the murine engine was not a description of the human and a body to it and that that's not the issue the issue in no wealth was that they were trying to claim all and of antibodies to both human and you're human cd forty so it wasn't an issue about who owned it or who discovered cd forty it was the issue was he disclosed the sequence of the energy because based on what the patent office has done in its guidelines which this court has accepted in a number of cases the issue is whether you have a forward characterized and to change or not who owns it but did you fully characterize it and if you did that according to the guidelines and you can claim antibodies based on their  from the one that i suggested is exactly what i want to make sure i had sure exactly what your view and it's not that no well didn't own were discover the human cd for no sequence it's that they didn't disclose the sequence number on what happened in a well this is i think everybody agrees this is is it is a piece of dictum which isn't tied directly to the holding in that case but what the court is saying there as i understand it is again if you've got the  things in the claims but part of the written description of our invention according to the guidelines and again with this court has said is if you have a fully characterize which we do here t n f you can claim antibodies to it based on their binding affinity was once an agent based on their binding affinity but i was reading that language to mean is if you have something that binds then you've got the antibody that you can fully claim all you have to  under the p t o guidelines that's all that would be required but we do go farther than that we go farther because we describe the antibodies as being a too specific and that is a structural depth definition of the antibodies and the patent defines where that is on the t n f molecule it says these particular amino acid residues are implicated in this binding and because of the known correlation between structure and function of an bodies and other t n f antibodies that might be out there that aren't effective in neutralizing t n f like dr mark says and a body the ones that are specific to a to turn off if the are neutralized t n f and that is a at the time that the ninety four application was filed it was entirely possible that no one would ever find a fully humanized antibody that competitively  that there's no way you can tell me that there are i take it that there was definitely one out there or more but this was the best we could do scratch right now the patent it's and it's been estab button and you make one go right right might be able to make you might be saying you wouldn't know it when you found it but the question is would you find it and if you didn't find it is it because it's not out there i mean what is  we don't need to have an actual example well i'm not leaping to that i just want to know before we get to that question whether there's anything that would that you can point to that would satisfy me that yes the  four application tells us that there is such an animal we just can't give it we can't describe it with any more specificity in other words if i make some something in the putty or something lighter whatever you know if somebody makes by accident i know how i made it but i have absolutely no idea what the structures but i've got it and so i know it exists and i characterize it by function and smell and a few other things a pretty cumbersome characterization but i put it in a patent application because i don't want to wait to get the thing sorted out chemically i'm fine now the question is is this that case do you did you know that there was such and then a body or were you saying if anybody comes up with this antibody we get the invention here was the specific class of antibodies that bind to teaneck like a chip and did you demonstrate that there was at least one member not that you'd made it but that there was at least one member of that class out there in the kind there can the bodies you know see in the human and bonnie's there is not a specific example no there is not a specific feeling that we're not claiming this antibodies to t n f we're claiming a very narrow class of antibodies that have at least a human constant region human variable regions that are a too specific that bind to neutralizing epitope and that have a particular affinity so we're not claiming trying to preempt the whole field of anti t n f antibodies we're claiming this very narrow k class and this is not like area where they just said hey go out and find a compound that'll inhibit and a ca told you these are the antibodies that are going to neutralize t n f the ones that bind the same way as a two and arc that compete with a two so this was a contribution to science and the claims are commensurate in scope with the contribution of these inventors to me it seems to me that competing with a two is just million another way of saying well you know we don't know what up there is going to work but we do know that a tube works and therefore if this competes with a two then it has the same leader from old sounds like a from everything we know we're pretty good affinity but those are just ways of saying it seems to need correct me if this is wrong just ways of saying we're not going to ask for all of the energy and we're just going to ask for the ones that we know will work but then describing them in a functional well i would agree that the affinity might be functional but the age the specificity is not functional because you have to it's a description of the structure because we know that there is a correlation between the structure of the antibody and the engine it's a lock and key analogy we now know where i am t n f is in a body has to bind to be affected to be neutralizing and we're only claiming the antibodies that bind to that same or similar region and there's nothing in this record to suggest that there are two specific antibodies that don't work to the contrary the evidence of the record is that the two and the two specific antibodies that have been manufactured are wildly successful you know why not copy the months and your claim says it has to compete with a two which is to say that that's we know that that is going to work it may be others that work but you're taking your chances out there in the wilderness of all the other potential acid structure but the tertiary structure of the three d structure which is effective for this lock to fit the key it's going to have to be somewhat similar to fit into that same walk and antibodies have a relevant three d structure that's describ the pattern of columns thirty three and thirty four so it's a description of the three dimensional structure when you talk about the lock in the key analogy in the fact that these antibodies that are claimed in this narrow play us have to bind to the same or similar place as  two and if i may i'd like to go back to bring this back down to the record because we've had a lot of talk here about scientific theory but we are here for a jury verdict and i invite you to look in the record to see exactly what was presented by of this court or the patent office guidelines that requires a particular amino acid sequence and it's either point was and you didn't enable it if you look through his discussion of his written description requirement he goes on and on about well you couldn't make human antibodies and that was rebuffed that was his enablement opinion it was ribeye to the jury rightfully disregarded his testimony because he was just discredited time and again the one part that they  if you look at that in context of what he was saying he was commenting on the affinity maturation section in our patents were talks about you know about the three dimensional structure you can you can make modifications of mutations  you said but i thought you said that dr marx testified that no one made in the form of of fully human and the body i thought it was at the ten to description of opinion in his enablement opinion he starts out in the very first page of that transcript he's asking three different ways why isn't this enabling he says because it doesn't disclose how to make human and bodies period later on when he's asked about what your opinion do experimentation then he does say because there's nothing to this there disclose how to make a high affinity neutralizing antibody and of course that was soundly discredited as well now i might add and i corrected and i i don't know if the da begin there's nothing in this record we hear a lot about we need the amino acid sequence of the antibody there's nothing in this record to suggest that the patent office guidelines and a long time  terry from this court on those guidelines should be overturned if that's going to be done this is not the record to do it on because there's no scientific basis to do so based on this record i'd like to turn quickly to enablement if i may you counsel talked about the  there is enabling disclosure in the seven seven five patent that the jury rightfully accepted dr graham who is one of the inventors painfully took the jury through the specification of a patent he pointed them to the discussion in column eighteen about how the variable region of a human antibody could be obtained referred to page display and explain how that could be used to get the human variable region of the in the body then he talked about the affinity maturation section in columns of the argument that we just said hey it's all out there it's frankly you know  discredited one of his bases for saying that i'm do experimentation was required he said well we had to make a lot of innovation we had to learn how to increase the size of these spacious play libraries they were too small well dr southall their inventor had said in his one thousand nine hundred two memo that the faces played libraries the cat had were of unprecedented size ten to the twenty three hundred even know how you say that number but that was how big their libraries will work that's undisputed dr marcus testimony and do experimentation just sound discredited and the jury rightfully disregard i'd like to close by just commenting on on one last thing this verdict got a lot of attention because of the size of the damages the board and that damages the word was as large as it was because the infringing product fall as it is there are over eight point seven billion dollars worth of infringing sales and the jury's verdict was understandably large in view of those infringing sales but all the issues we've discussed here today and that we discuss brief were hotly contested but the jury was properly instructed you haven't heard one word one argument with the way the jury was instructed they did their job they did the right thing and that should not be body describe it seventy one is one that is not neutralized so it doesn't satisfy the claims judge clevenger asked whether the claim language can perform the written description function and the answer is there's been court about that but doesn't matter here because this claim language wasn't in the ninety four specification or application it was an ad it till two thousand to that same language there were lying upon to cover a fully human and a body wasn't there so let me go to the written description issue and the question of what structure was disclosed because each of you ask yourself what structure was disclosed and their w it's describing competitive in addition it couldn't be more functional as describing a result but here's the second most important thing the primary date we're talking about is one nine hundred ninety four as a result of that being the late one nine hundred ninety two application was in the prior art as of ninety two the competitive binding site of eighty two was in a prior art so there are two answers to their argument the first is the engine was characterized by someone else and competitive inhibition of a two is purely functional the second is whether it is or it is it that was in a prior work to the purposes of this case because ninety four is a priority so if you take their argument based upon the p t o guidelines and you take their argument based upon no well to its logical conclusion this claim is invalid now the truth of the matter is four for a fully human and a body with these claimed characteristics you should be able to provide an example because you should be able to have it this is a lot like kyra and that the state of discord it three sixty three fed second it twelve fifty five and then basically the court said what doesn't make any sense that you're claiming a kind marriage in a body american a body is didn't exist at the time and this goes to judge price was question in us is there any reason to believe or to believe with confidence that there would be such an antibody discovered or that it even existed and i take it you answer would be and there is which they began working on it in one thousand nine hundred seventy with the technology that didn't even exist in one thousand nine hundred four at the end of the day we step back from all the detail we're almost there yes we are we're at the end of this day for sure at the end of the day the written description requirement you know has it's groundings in the supreme court's eight hundred fifty four decision in morse and the supreme court said if you happen to recover that amount or any amount when they filed an application at a time when they did not have quit n