circa virus type two to be limited to only the representative embodiments in the specification you know you could have saved everybody a lot of time if you could claim to percent mallaby right and you didn't do that is there any reason you c naturally occurring viruses and getting into perhaps genetically engineered variants that are not naturally occurring and you could get potentially get into problems with the claim constructions such as were at issue the broader claim constructions in the genentech the welcome case where this court decided that claims that were broader than the naturally occurring viruses were not  naturally occurring virus under i don't i'm having trouble with that there's no discussion in the briefs about patentable subject matter but claim thirty two at least seems to implicate patentable subject at least under your construction because you're saying we can claim not only the isolates that we created but anything that occurs in nature naturally occurring as you put it that is similar to that it was first of all as you correctly pointed out judge di section one hundred one is not been raised in this case so i don't think it's an issue for this court to decide here but with repetitive respect to the particular claims that issue we are not claiming  porcelain circle viruses themselves the claims are directed to isolated d n a molecules that have been placed into vectors for use in creating novel vacuum but you're you're also claiming as i understand your interpretation of these claims that it would extend i slips created by other people not just the i but the claims are not directed simply to the virus the issue is in this what is meant by the term portside sort of r s type two but the claims that issue are not directed solely to the virus but there are only about thirty two was directed to who would naturally in coding epitopes so it does your honor it's not claiming the virus itself it's claiming the isolated d n a molecules ok but if somebody creates another isolate which you're saying is that it's covered by that you're allowed to patent that even though it was naturally occurring in nature i mean it sounds like a problem i think there's some confusion about creating an isolated we're not maybe the confusion is i mean you are for to an isolated d n a molecule versus an isolated night my understanding is that those mean two rather different things so maybe maybe to to make sure all three for us on the same to five i guess including  that i think the question is if somebody else isolates the d n a molecule from some completely different source but that satisfies the requirement of comprising the nucleotide sequence including an epidemic which is specific to p c v two and not one of the infringing in the answer you answer has to be yes it's the plain terms but how can i think is that appropriate matter your distinction is correct there is a difference between an isolated porcelains work a virus and an isolated d n a molecule and i do agree with the proposition that you put forth is what we are saying is that if an a curious product is an isolated d n a molecule that meets the elements of the claims then it doesn't matter what the source of that isolated d n a molecule is for purposes of infringement isn't it correct that there is little subject matter problem under your claim construction with all due respect your honor i don't believe there is a patent will subject matter with respect to these claims that are directed to isolated d n a molecules and i would suggest what if there there is a problem with respect to this claims then there's a problem with regard to the entire united states biotechnology industry which is based on claims to isolate sure whether that and again i'm troubled by the word created because what we're talking about here are what isn't the scope of the term force i'm circovirus type two and the question is whether or not that term is pro limited to the representative embodiments in the specification or whether that term in light of the intrinsic evidence covers all naturally occurring porcelain circa virus isolates that are of the same type as the representative in position here the other side will point out it's been evolving and i don't want to discuss the waiver part of it but it seems like at least what you would do you posing to us now is the collective construction i understand it includes a seventy six percent to my right that's correct i'm just wondering looking at the relevant paragraph in column one that we've all been looking at what is the justification for war using the seventy six percent disclosed there but not also the ninety the distinction between the two tides is the previous type of force on circa virus is the patent makes clear is nonpathogenic that the type that is claimed by the inventors here is the pathogenic type  similarity among the representative embodiments is not necessary to distinguish between the two types the seventy six percent limitation provides sufficient the definitive for this for a person of skill in the art to with regard to written description but that's not at issue in this case here and whether or not the the embodiments in the specification provide sufficient disclosure of the breadth of all i say that supports on circovirus type two but here for purposes of this case the ninety six percent is also not relevant because the accused islip which is ninety nine point seven percent identical to one of the representative embodiments is clearly within the scope of that ninety six percent limitation so if this court were in the swine for purposes of this case to believe that the ninety six percent limitation needed to be included as part of the claim construction it wouldn't have any bearing on the particular  infringement issues in this case and pursuant to the pickle opinion that we cite in our brief it's not messages necessary for this core to construe the outer limits of a of a claim that are not an issue for was all thing the embodiments whether or not that would constitute prior art or not an issue such as that is not raised in this case with respect to these particular or science or viruses there are very tightly knit groups as we discuss in our brief you have  include viruses that have this little is fifty two percent homology with each other do you agree with that statement i don't agree with that statement your honor as a matter of biology i think it would be impossible for you to have a naturally another if they are to have the same ports i'm circovirus properties and be pathogenic and and come from b m w s pigs which are the other limitations that we propose what is it just to make sure you understand your one strain was added if it was a limitation that we discussed in our original briefing as as being a characteristic of the new type but it was specifically added to try and address what the district court believed  you want that to be the case but what i'm positing for you to try to test the limits of your definition of a genetic structure that is substantially different from both p c v one and what you now are looking at is your five sequenced strains of four sequence traits what you're calling pct well i think as guidance there's there's two recent cases from this court that were issued after the briefing this case and that's the the apple where it was decided march twenty sixth of this year and the hearing component to be sure case there was decided able first in those cases stand for the proposition that a claim term is not necessarily indefinite merely because it doesn't define the scope of the claim with mathematical precision if there are representative embodiments or examples in the specification the provide sufficient guidance to a person of skill in the are such that they could determine the scope of the claim terms than the claimed term is not indefinite here we provided several representative embodiments in the specification that give a person of skill in the art guidance as to the proper scope of the claims as we you know point out and we've always claimed included within the scope of our claims would be highly homologous naturally occurring variants of the same virus type the representative  the the claims at issue they are not and you know that this is a dependent claim referring to several independent claims but for example referring back to claim  claim one would not be at issue in this case but no but twenty five is as i understand is a vaccine comprising a vector of of not so why why is it that we're dealing with i don't believe so your honor but i can't recall at this point why that particular claim was not assert unable to articulate any construction of p c b to beyond the five strains that is supported by the patent specification well if they went beyond the five strains would there be a patent will subject matter  but i believe there would be if they went beyond the five strains i think that there is one twelve problem so i think that there is an validity problem with respect to whether there's a panel subject matter problem these are naturally occurring viruses that's all they did was isolate naturally occurring viruses so i think there may be an issue with respect to the patent ability of the staff to administer their have been raised but it has never been not there are no kind of claims in this case it in any event i think and still to be fair i think until recently people believed that these types of claims to isolated d n a molecules were subject matter and the united states patent law and that therefore there wasn't a serious argument made that these weren't patentable because they were simply isolated products of nature but assuming that the law the it's true that they're not in others other than the ones that they've pointed out but they've pointed out five they've pointed out five but there is no direction in the patent that would allow you to interpret the term p c b two more broadly than those five appears to have this is just a mutation of one of them and these are viruses my understanding is a very sloppy copier so it's not going to take long before you can end up with a mutation even if you don't try to engineer one so why why wouldn't that be a perfectly good example of something that falls within the class of which these five are representative the reason is that though that definition of p b to embracing say let's say natural variance is not set forth in the patent specification and a claim to piece these p c b to viruses and natural variants was  presumably just about anything you engineered by way of a deviation a very small deviation from one of these strains would still have the same agenda quality and therefore the same quality for creating an engine i actually think that the  that if you change to nucleotides it probably isn't going to be a vast change in the properties it might but i think in biotechnology it very well might and we know that in biotechnology that minor changes in nucle sequence can lead to major changes in amino acid sequence and because they didn't identify the active portion of these viruses we have no idea which portions of the virus you're going to change ok but yours works mean that one it  be the case that in some hypothetical instance it would lose its pathogenic quality but of course the reason that yours works is because it didn't lose its pathogenic well i think that there's an open question as to whether our virus is pathogenic our virus well the virus in which an antigen which to which the immune system of the pig responds in a way that gives the the pig immunity so it has at least that quality that is correct where  in the prior art what was in the prior art was an identification that this disease pm ws was likely caused or associated with new variants new genetic variants of porcelain circle virus so they and i'd like to talk if we could just for a moment about that the issue of of waiver before you get to that i guess i'm struggling a little so maybe i just want to be sure you have nothing to add i mean the language we've been looking at with the ninety six percent says they  our exhibit the strains exhibit a very strong commodity with each other that's good nucleotide level exceeding ninety six percent level and they should be considered as represented and i'm not sure i understand  why that translates into only the five strains as opposed to these five strains and anything that meets this limitation of ninety six percent with each other and as well right that line forty eight it says the applicant has succeeded in isolating five new p c b strains it tells you where they isolated them from and then there's a definitional statement here an after called circle viruses according to the invention and then in the paragraph you're looking at they give you some ology observations with respect to four of those viruses they're not even characterizing all five of the viruses that they isolated they provide you with these two observations ninety six percent among the group seventy six percent with p c v one and there are good scientific reasons why no person of skill in the art would read that as a definition of p c b to first of all the of ninety six percent from ology to one of those viruses tells you nothing about the function of the virus whether it will actually be pathogenic whether it will be a causative agent of p c a p o w s excuse me and then with respect to seventy six percent just to say to define a virus by its similarity to the prior our virus tells you nothing again about the twenty four percent that presumably makes that unique that makes it special that makes it work that makes  so as we set forth in our brief it leads to absurd results if you just define it by seventy six percent where you could have two viruses that are as different as they are life both being determined to be p c too and also you it would be ok if you crafted a construction that included ninety six percent at the markham hearing counsel for marielle said point blank that ninety six percent does not define p c b two and is in the record at one time only they want more but it the quest to the fact that they want more it doesn't mean that they're not entitled to some subset of everything that they want me i don't know that the fact that they s their definition section they would say certainly is p c to us so why not but i'm sorry i don't know why is that not the case what you or you or i think i think what i was trying the point i was trying to make was that that they've already said mary alice that this portion of the specification that judge approached was pointing me to does not define p c b to those whom ology limitations do not define p c b to that's what they told the district court that's what their expert said and so then the question is i think is being rather raised by judge bryson is ok well if they don't get that then is there something broader than the five strains that they're entitled to right that's and the patent specification provides no direction as to where you go once you get beyond the five strain that was offered in in a patent claim to the patent office it's simply not there but if i did i'd like to address the waiver issue just briefly and counsel said that there their latest claim construction is essentially the same as their first two claim constructions and that's simply not accurate in their latest claim destruction they say that it the virus needs to be isolated from a pig with p o w s but the term isolated in another context in this case has been a their expert to have a very narrow meaning and interval disagrees with that meaning and so if you import the idea of isolation into this tech into this definition of p c b to it will have ramifications in the invalidity portion of this case it is a significant claim it's difference in the claim scope you're saying that isolated in this context means something very different from derived it does yes it  mean lots of different things it could mean derived by a specific technique that's what their experts said it meant it could be isolated in a sense has been removed from its natural environment and there's there's going to be a dispute about what the term isolated means and the point is that that is a significant claim changing claims go it's not like the harris case where there was an infant testable tweak in there in the claim scope that was affected just simply by changing arguments these are not new arguments in support of an old claim construction this is a totally new claim construction with a totally different scope and they've waived it and we think that the issue that issue has not been preserved for and what this claim is directed is claiming is the d n a sequence but i want to make a diagnosis the term specific is used in the claim and the only use of the term specific in the patent specific ation is in the context of diagnosis so what this claim is really directed to are d n a sequences that allow you to detect p c two and not p c one and not get a false positive so that if you have a sample and you want to know if it has allows the scope of the claim thirty two to embrace mostly p c the one and only a little p c v two and it's crystal clear that that type of d n a would would not allow for a specific diagnosis it would allow for a false positive if you were to use that kind of d n a you wouldn't get a specific diagnosis and therefore we think that the claimed instruction we proposed is the correct claim construction flows from the prosecution history of flows from the language of claim thirty two and should be adopted if the court is going to entertain a new claim construction claim thirty two your constructions has to be derived from one of the five streams are construction w district court said it had to be found only on or unique to one of the five strains and we believe that that is the correct interpretation of the district court's claim construction that wasn't the claim destruction we proposed that was the claim construction that mary l propose that the district court adopted verbatim and now wishes to change because of the climate change and the scope of p c b to and we think that they should not be allowed to change that that claim construction based on principles o a factual question which you can help me with we've been talking about the five strange now fight correct me if this is wrong but i understood that four of the five strange the five strange were all identified as we strains again we get into problems with the use of that term but let it i think we can all agree that if i say i say we know what we're talking about right yes i suppose set aside ok strike strange five isolates  now four of them were sequenced right yes the fifth was not sequenced correct right now how do we know given your construction of the claims whether something determine with certainty you would have to get it from the u c a c c ok so it's because it's deposited corrupt and then you'd have to sequence it and decide whether you so so as far as the patent goes right now you would say it's indeterminate as to whether something until and unless you sequence the deposit i would say that based on what is in the patent specification you can determine whether you have any of those you know it just seems it isn't a little odd to say well we have we have a definition which ought to be limited to these specific isolates and we've sequenced some of them that's how we're going to tell if you are if out the the inadequacy of the patent specification in defining a broader genus as as required under you lie lily in order to  of skill me or could it could recognize as a genus you have to identify some common structural feature of the members of the genus and then use that to define the genus here there's no there's none of that and much sequencing in order to determine infringement of that claim construction wise than because it's incredibly broad because it means that if your virus is anything but if it's a circle virus and now they say it's isolated from a sick pig whatever that means then if it's greater than seventy six percent homologous to p c if you want i'm sorry less than seventy six percent of all against p c one then it's theirs but if we come up with the that i'm not familiar with because i don't believe it was identified in the briefing that that intervent believe that there was a difference between those two terms or explain why they presented in issues in this case obviously the patent specifications biggs in terms of the five representative strains being isolated from p m w s pigs and then in column two it lines twenty says the invention aims to consider the porcelain circovirus isolated from a disease pig so that's the context in which we're claim a genus of biological species that you have to somehow define the structure associated with pickler functionally claim that genus that is in conflict with this court recent decision an area had in which the court said that there are two ways in which you can claim a genus one being the one that council was referring to and the other was to provide a sufficient number of representative examples of the genus and that was sufficiently worked with the evidence in this case which we cite in our brief is that when you're dealing with viruses a single prototypical viruses a first this is sufficient guidance to a person of skill in the ark to understand  the scope of that tick or virus type and here the inventors provided several representative examples of their newly discovered virus type so if we're talking about a written description issue here which is the direction i think council going but it's really not an issue before this or i think the evidence is clear that there is a written description there certainly not clear and convincing evidence that there is not a sufficient written description in this case do you mean i want to make sure i understand the point you just made about representative of the genus if you mean to say that as a single specie would be enough to establish the bounds of the  you give a using that you give an expert a sequence of the wires and that expert knows with the bounds of the genus or the evidence in this case is that when you're dealing with viruses that person of skill in the ark are able to determine whether or not they're viruses of the same type of that virus based on a single representative prototype virus and indeed not knowing anything with their properties just looking at the knowing the properties of other of other virus types that are that are know and and i think with reference to the council's assertion that we did not represent to the district court that the seventy six percent homology limitation was imported i think if you'll look at the record from the market hearing that in fact we're saying that we said the same thing to the district court that we're saying today that it is the seventy it's not necessary to identify structure associate with to function if you provide sufficient representative examples of the scope of your claims and here we provided several representative examples that provide guidance or personal ones are i think i person of skill in the art would understand based on the disclosure in the specification and that is representative examples that they would be able to recognize that if you isolated a poor sign ology doesn't define what's pathogenic in that area and says that the representative sample you can't i can't import a function limitation here you have to from the representative specifications teach isolating from the lesions of pm ws pigs to determine pathogenicity and and and in fact the definition of that's why it's important that the definition that we propose