absolutely absolutely both parties in this case your honor provide genetic tests for and you ploy also known as down syndrome now that's not the invention that was well established in that too is not the alleged invention here that also is taught in dolphin patent claims that you can take this these samples from a variety of sources and combine them together now that was taught in part in shoe maker shoe maker teachers that you can index and tag cme pulls from various different sources in shoemaker all of those sources are from the same person so the alleged point of novelty in this testing so called multiplexing now what we offered before the board was both evidence of a specific third reference the bin laden reference which taught multiplexing but we also offered a description of the state of the art which demonstrated that multiplexing was well known and at there were indeed products already commercially available for sale such as the alumina gene sequencing system that did multiplexing so we think the first error the board made here was ignoring that evidence of state of the art and the question is mr lemley in your blue break that thirty you say the board recognized that the prior references in combination satisfied all and the motivation to combine all of those references in addition petition or provides a claim chart detailing were various elements of the challenge claims can be found in shoemaker dahlan and bin laden and for each element of cause of the claims claims are purportedly identifies where some aspect of that element or cause is disclosed now purportedly is of course the magic word there but there is no finding in the board at any time that any that there's any part of the claim that is not taught in one of these three references so that you're saying single reference and so i think this is a classic but let me let me say i mean i i i take it that the gist of the board's decision is that what is absent is a understandable explanation of why the hypothetical relevant skilled artisan would have been motivated to take these pieces from different prior art shed some of what those pieces of prior art taught we're not going to do distinguishing the fetal from the maternal samples any more all with a reasonable expectation of success and enough proceeding in a form form in a forum in which speed is an imperative you have got to put that explanation that connective tissue into the petition and can't rely on the kind  claim charts in the in the petition itself as it did at the time or whether it now wants them attached we did in fact in the record at two o nine specifically give the motivation to combine references in the  petition and we then referred to the expressed discussions of those motivations in the nussbaum declaration and the morton declaration the board was well aware of this this was not an area case in which they simply failed to artisan that they could carry it out right is the very thing the board ultimately decides is missing here the board never says there's no motivation to combine words as we don't know how you would combine in fact the board itself quote but suppose i read i read that to mean i mean that the board used language that had a certain element of frustration that is you're making us do far too much work and when it said you're not showing us you agree changes would have to the made in particular pieces you point to and to combine you haven't explained how all of this is would be understood by ace relevant skilled artisan and maybe i'm not maybe i'm now adding something that i took implicitly or was saying or therefore why somebody would want to do that well i think we did very clearly explain in the last bomb declaration why someone would want to do it and the board understood that and they quoted it at length in their decision at eleven as to the motivation to combine dr news bob said i believe one of skill in the art would have been motivated to combine these techniques as the combination would clearly result in an enhanced productivity and increased throughput of sample analysis the sequencing and multiplexing technology of bin laden would have made the procedures of shoemaker and dahlan less expensive faster and more efficient because one could sequence index samples from many different patients in a single sequencing run that is precisely the sort of motivation intrinsic improve operation of the science that k s are recognised now that can i ask you if this is shifting gears a little bit and that's one form of the question is why didn't you argue so there chew references two thousand mid two thousand and eight right and and or the end of two thousand and eight december two thousand and eight and then june of two thousand and nine they could not be clear i think in describing conceptually the counting process that is claimed in this or described and claimed in this four thirty patent and they and this at least the second one probably even the first one is and they refer to the illumina genome analyzer second one at least is even after the genome indexing kit brochure and yet there is no obviousness case presented based on the counsel before the board wanted to focus on prior art references that were not cited on the face of the patent because they believe the board was more likely to pay attention to those references that said that's a kind of a strategic i think sac ok that's right but and so and so we are not of the lunar brochure and your experts declaration that argument is seems to me to be raised for the first time in your reply brief to the board absolutely not you're our first show me where first it is raised in  the petition itself one seventy eight and one seventy nine we have a whole section of the background on the art and that section on one seventy nine explains that multiple mass multiplexed massively parallel sequencing of a pool sample which is precisely what we're talking about from alumina e g efficiently sequencing a mixed or pool sample containing the d n a fragments from several different individuals after indexing the d n a fragments from each individual were also well known and in widespread use as of two thousand and ten then refers to both the nussbaum and the morton declarations which specifically call out the alumina system they are attached and submitted to the board with the petition in fact the illumina system is mentioned not once but twice in the four thirty patent itself as background as background art and in the institution decision the board itself specifically acknowledges that the illumina gene analyzer is present and that it is taught in shoemaker as a reference so there is i think no reasonable way to conclude that this was raised for the first time what did happen i think is that quite frankly this was in our view background everybody knew that you could in fact multiplex and people had been doing it that there were commercial products designed precisely to do it and it was only when vera not out to our view somewhat oddly decided to make that their stand in opposing the obviousness case that we then discussed it in more detail but the  evidence is precisely it's presented it as the state of the art as background art and the board chose to give it quote no weight because it wasn't identified as a special as a separate prior art reference but instead only in the suppose you were to try to tell me right now what's missing with respect to the four thirty in at least the combination of the two chew references i don't know that there is anything missing your hon but i mean i think that the thing what's what's odd here and i kind of infer that this is what the board thought was odd was that you were making an argument based on prior art references that were s different methods the one with the cells the one with the illegal based method in each of which there was an effort required effort to distinguish stuff from the feet fetus and stuff from the mother and and eat and everybody kind of knew that i guess back in the old days of doll and prehistoric times nobody was quite sure what the ratio of the fetal d n a was compared to the the counting to give you a meaningful difference by two by two thousand and eight or two thousand at least by early two thousand and by january two thousand and ten there were ways of getting those large samples and choose seems to suggest that and i think the board was thinking why are you starting from this bizarre place of radically different techniques well and picking pieces you're out i mean as i said earlier i think the decision to use these references was a decision based on the fact that they were not cited on the face of the patent but i would suggest that the fact that there are as i believe there are other references that also render the very not a patent obvious can't be used as a basis to defend the board's decision unless unless the fact that the the references that quite specifically discuss the actual counting technique going on being used here by not being sighted and communicate there was actually something missing in a skilled artisans understanding of whether that technique the actual technique not the dahlan technique or the shoemaker technique which are meaningfully different could be used with the reliability implicit in prenatal testing so you're out of late let me suggest that there is absolutely nothing in the board's opinion that suggests that that is  their conclusion there was no discussion of the references that you're talking about there is no discussion of the counting issue at all there is no discussion in vera not his briefing or or frankly at all in the board below on that issue and i think this leads me to the  fact it is the case that the board could have come to a conclusion like that but didn't put it on the record that itself is independent grounds for remain and this court and the supreme court in general have made it very clear that the board's obligation under the administrative procedure act is to set out in detail the factual findings they are making right and it's and it's possible at least and i know you're not going to you're not prepared to concede this but that if the matter went back to the board that the board could say week our procedures are such that it is important that we insist on certain levels of explanation in the petition and we're not going to give you an opportunity to make new arguments we're just going to make new findings i think that is entirely possible your honor and if that happens on remain and we will deal with that on remand but i think that is not an argument for a firm it's one of the things that this court has made clear most recently in the power integrations case decided after the briefing was completed is that there is this is not something for the court to decide this is something that the board has to articulate in the first instance it can't be supported on independent grounds as vera nada repeatedly tries to do that is simply not the law the law in fact says quite the opposite what this court said in power integrations is as a general proposition our view of a patentability determination is confined to the grounds on which the board actually relied we have no warrant to accept appellate counsels post hoc rationalisations for agency action now it may be on re mans that the board says there's just not enough here and we pick up part of the motivation we pick apart the ability to combine although honestly there is nothing in the board's decision now that suggests there isn't a motivation to combine except the absence of plug and play compatibility between dahlan and bin laden and this court made quite clear in the movie ted case that that's not the legal standard you don't ask can i actually plug these references together and make them work you ask it once people understand the knowledge in each of these references do they have the motivation to put these things together and if they have that motivation would they reasonably have an expectation of success i've had over my time here i guess thank you lou we start three minutes of marriage and say we just generally when i appeared in front of the judiciary committee for some reason they asked me specifically if i would promise to wear my hearing aid i do so you don't have to talk quite so i've  we speak and the choice is apart or not good because it's going in dissonant directions but chu i mean i realize they didn't make anything of chu but i'm very puzzled and i would love to have some of the puzzle  or even that counting is the invention a couple of the innovations this is a as a synergistic set of of innovations the characterization of the innovation as being really multiplexing is a cartoon i mean it's not even  can't be serious one of the things they do is they reduce the sequencing instead of doing a whole genome sequencing like choose where you would sequence the sequence everything you get all your data for all twenty one chromosomes and then you go in you match it to the g e with the standard sequence alignment and you figure out how much twenty one you have in there how much of a control you have that's kind of a longish two lines ok they do something here which is called selective enrichment where all they sequence is twenty it's not perfect there's piracies an application and otherwise when you sequence everything you're doing that much more sequencing twenty times the sequencing but you don't have those errors so to make the decision to do selective enrichm very clever idea ok now the references show that combining that idea with using cell free and doing the counting where you have to be so exact because there's only ten percent fetal d i'm sorry that i did yeah i mean you're i thought i was remembering that selective enrichment appears in some of the prior art may be discussed as a as a way of selectively the idea of look in the cell for a region that's the want to one issue that's big on that case so he came up with let's look at the cell free that's a huge two body divide there then within that looking at the cell free region they spent ten years just trying to get looking at the fetal and separating the fetal out with no success at all and they continue people continue to try to stage because if you can just get the fetal d n a look how efficient it would be so the selective enrichment that you're recalling is the kind of the illegal in the cell based in shoemaker where you're just trying to get just the field d n a it's completely different than saying i'm not going to i'm going to do this consider the maternal and the fetal and i think the beginning the end of their prior art theory is in morton's deposition it's not even a deposition or report it was one of the thing i'm not sure it was the wisest thing for have to put in from a tactical perspective but she said grouping the maternal and fetal d n a together and trying to figure out from there is a completely different problem f all the art that she just described including their own art and the board relied on that this combination of priorities terrible i mean they've got one person doing cell they've got dollin which are trying to minimize i's d n a sequencing but don't want to do is  when you look to see you what concrete problem of combination the board identified as not sufficiently a stablished the only one it talked about was this the use of of some of the amplification techniques and that's a problem if if as the board did it gave you no paging nineteen gave short shrift a highly informal term to exhibit ten ten the aluminum brochure why is why do we not take the board's decision on its own terms that it didn't identify with much concreteness or at all any other reasons to be uncertain about the picking and choosing of elements from these pieces of prayer i think the frustration they had which your are described earlier of how would you even begin to pick and choose even in this motivation this four lines its conclusion really it says you take techniques from one and techniques from the other what techniques from them it doesn't describe anything about the techniques with respect to ten ten things i want to add about ten times i think this is important is we respect the ten ten they didn't mention they mention ten ten once in their discussion of the art to state but if you go to one seventy four where they say they don't remember that provision of the a p s number just i mean common sense but if you go to one seventy four which is there the beginning of their description in their petition that they control they are high powered legal team and all that good at what would you say to them they want seventy four one seventy four they cite the regulation of the board at the last sentence and they say the exhibit numbers of the supporting evidence relied upon to support the challenges and the  evidence that the challenges raised including identifying specific portions of the evidence that support the challenges are provided in section seven below which is not the discussion of in section five and even in section five ten ten isn't even cited by exhibit number it's just they say oh during prosecution history it was granted over a two thousand eight alumina publication which happens to be it and the thing and this picks up on w time they really raise ten ten was in the reply wrong that's what everyone thought i read the i p r reply it's not in there they double down on this three ring circus of d bin ladin and schumacher in the i p o reply they don't say oh wait we've got ten ten you're forgetting ten ten how can you expect the board to take that kind of thing seriously now on top of all that the statement that they didn't  professor lemley didn't get that quite right what they said is they were not going to tolerate replied declaration after we put in all our submissions that attempted to substitute ten ten for dollars or for whatever event or bin laden or whatever they were trying to substitute for and all they said is there's only two paragraphs of the morton reply declaration that they were going to consider that's all they said they did not say they weren't considering is completely different from the randall case about which you know everything because you wrote it because in that case one of the conclusions was it wasn't going to be inconsistent with the combination keep in mind let's not give the board you know it's a long opinion and it's well reasoned that the the the simple multiplexing that's referred to as bin ladin they say bin laden is the state of the art now they want to say ten ten but they said way they labeled the five prime and that wouldn't work it's another clash between their references i mean i guess i take it that the gist of the criticism of the board's treatment of ten ten and the general issue is something like this the only specific thing that the board focused on the only specific thing of the board focused on as missing from the explanation as opposed to the general characterization you just haven't really given us explanation about how to combine these things is about the  amplification techniques including the whole set of amplification techniques including the indexing and from using multiple sources and what not and that really is a matter of background knowledge by the time january two thousand and ten comes there's really no dispute about that characterizing my understanding of their argument and there's really no dispute about that a variety of these sources including the petition mention of variety of amplification techniques there is at least in direct reference to the alumina system using multiple multiple sources doing it with the multi multiplexing and that just wasn't taken seriously by the board when the only specific omission that the board focused on was all about that i mean i'd have so many problems with that because the what the board focused on w their own admission that the difference that the technical challenge presented by this is different than the references morton made that admission there's no reason you do all these combinations or how does the board have the board saying what are we supposed not down what are you taking reference on the line you floyd and analysis is citing right on the cover of the patent and there's a version of schumacher that's on there too for for for for even more so that's that doesn't work so can you just get back to something i think i interrupted your answer chromosome of i'm not sure what that means i'm sorry is that this goes back to the explanation i had before which is you go through the sequencing process you get all the information and the and then you pair a picket out after against a whole genome  line and this you do twenty last so you're feeling bad that you might be letting a invalid patent slip through i don't think should be any concern this path is incredibly different it pulls together dispar for the priorities so different because it's there's not there's not good priority out there i mean that's what this shows and to blame the board for saying we don't even know what they're saying and in fact i mean their whole statement of motivation is one sentence in their petition that superficial and doesn't tell you says well you can combine these techniques from these three references what techniques and expect the board to like parse that down and with respect  to your state and your honor bin laden was selected surely surely for saying that you do how you do the tagging i think we can all agree with that there's no room to wiggle around that how can you were placed that with some kind of background knowledge about a general secret you know a general concept and say ok we're going to push out that whole current state of the art they're selected reference by something that's background knowledge with no real analysis is the why people would pick that dahlan is trying to minimize sequenc he's not moving to a massively parallel sequencing and when you add more to the point when you add tags that's more dahlan wants to sequence one nucleotide right a snap a polymorphism so we can figure out is it mother is it father do we have an extra you know a second one he wants to minimize that he's going to all these troubles why would he added a twelve a twelve ba the board acknowledge that and with pegging it's like in your kegging arguments terrible because it wouldn't work with the invention because in order to do the d n a seek that the test that you're suggesting for dolphin you'd have to chop off the ta and the fact that they were referenced in that they're still trying to do cell based analysis tells you how far afield they had to go ambiguous claim one is a little ambiguous on whether it is limited to a particular chromosome it makes reference to a single chromosome and a reference chromosome but it also uses the word comprising so even if you covers the entire genome genome rather than one chromosome it's not obvious that the claim is limited in a way that would distinguish it from you but let me let me focus though on the oil in the language from power integrations that i cited earlier today we have no warrant to this court said to accept appellate councils post hoc rationalization for agency action you heard a lot of discussion of the science and mr ryan this is theory that was a bad combination of references and the science is different in various respects you will find that none of that in the board's opinion not his new theory on this argument that selective enrichment wasn't taught anywhere that's wrong the board in its initiation decision found that schumacher taught selective enrichment that's a seventy one bin laden taught selective enrichment that's a thirteen fifty nine but more importantly it's irrelevant the board did not make any of the inclusions that mr wryness is now offering the argument that he makes is replete with references to things that the word simply didn't find and that's not appropriate under general and i think the appropriate thing for this court to do is to remain and then to say if you are in fact persuaded that this is a bad combination of references and it can't teach us what we need give us a set of findings that shows us that but what they have done now is not to pay any attention to the evidence of skill in the art  m declaration was quite clear up front at the initiation of the petition that it quote multiplexing was so widespread as a technique that the company alumina offered a commercially available kit for production an analysis of index libraries this ki enabled the sequencing of ninety six different samples on a single flow cell and was designed to be used with their meet multiplex sequencing platform the alumina genome analyzer this is in the record eight seventy six so as a molecular geneticist in two thousand and eight i would have had the ability to order a commercially available kit for the production of these libraries which i could have analyzed on a commercially available massively parallel sequencing platform sold by the same vendor now it is simply not the case that this wasn't before the board it was before the board in the petition it was before the board because it was cited in their own patent it was before the board because in their initiation decision they make affirmative reference to it to suggest that they can somehow ignore alumina after the fact by saying it