accepted marquez's constructions of the claims and for example it well was there something that in the record where marcus proposed the construction that the beat every object in absolutely are ok where's that in the record wave wave and that a lot more than claims thirty three and thirty four are here but you would bet that in with less we reached that applicable conclusion that you will allow you to overcome your waves are as to all of the other if we agree with the board that they got the enablement rejection right on thirty three and thirty four and that it's a free rule in your favor on enablement then we would have to look at the want to one rejection as it relates wasn't properly before the board because it relies on thirty seven c f r forty one point six seven it that is an error on the p t o s part but it's important because if that is still the p t o position and that alone is enough construction issues one error was the p t o has always taken the position that these are product by process limitations and that's fundamentally wrong only apply this court's precedent and in a recent case  re north development that came out in february of this year goes through and provides a two step process of how we look at a claim and whether it's a product by process claim and in that case that invention was directed to an injection mo has always looked at that term assembled as to be a process limitation meaning that there's no patent will we get into it but during prosecution from the very first office action the examiner took the position that well this is a product by process limitation therefore of as no patent in weight but if you look at the specification which you have to do when you're looking at claim plain terms and trying to determine whether they a product a process limitation it's clear that the term assembled refers to the characteristics of this not unnatural construct there is no there is no dispute that these are not unnatural constructs in terms of what's described in the application of their individual cells that are first taken separately and then they are assembled into a particular construct that uses electrostatic forces or hydrophobic forces  to create these novel constructs and that's what the term assemble means and so it's been always our position that regardless of whether you look at the one and one wanted to one of three one quite of rejections the examiners always printer relied aren't there correct your honor but that brings up another error that the p t o committed in terms of its name analysis and this again pervades the admit to the court that there is some question about whether the specification as drafted and all the articles and evidence are submitted as part of the prosecution history adequately enable in vivo uses so for example one of the is the constructs is to help in terms of organ reconstruction there's no working example of that there is no article that describes that incessantly done so that's questionable but it's also black letter law that in terms of claiming a composition of matter it's sufficient to enable one use to enable the claims that composition of matter and that's in the argument from day one during prosecution to the work and the west for you use is for a and effective control release of some substance it's similar to control of the drug delivery device whether it's in vitro in a lab dish or some sort of construct like that whether it is in a body where it's controlled release of a substance and that doesn't necessarily require that you have particular efficacy or particular safety and there's one point in the final office action by the examiner in twenty fourteen where the i think there's a difference between saying there has to be a use to which it can be put and something that's truly useful within the bounds of correct judge a mallet but i think that brings us to another error in the board's reasoning and it's my visit was my understanding that the p t o is now given up on this position with respect to the utility requirement because it was clear from my reading of the board's decision that the p t o the board was taking the position that these claims are unable because they don't provide a specific utility under one twelve as cited in ray fischer which is a classic one twelve utility requirement before this court as i read the read free speech doesn't stand by that position but also undermines the entire you are not no i disagree with that in terms that there's no mechanism for the release but i disagree with that but that's what the p t o well i think tell me where in the spec you think there's a mechanism for the and there it is there is there is absolutely description of a mechanism for a lease and in addition if you look at the specification in connection with the numerous articles that were submitted and and part of the file history this is the the idea of using these constructs to release a substance that's contained within the construct is not necessarily novel and there's no dispute about how the process works and what's novel and non obvious about this invention is instead of using chemicals such as polymers to create these colloidal zones the inventors here for the first time use living cells that create the same structure and the same construct they're held together by the same fundamental physical and chemical properties and there's an expectation and reasonable expectation that they would operate under the same manner now the examiner and this has been our position also during prosecution and before this court is that the examiner and the board never identified any scientific explanation or cited to any article that dis explanation and the rationale that's provided in the specification that explains how these constructs work and there are numerous examples let me turn to one the one at least one working example is the example that uses red blood cells  and in addition to this that to the description in the application itself also part of that file history of publications that were published by the inventors confirming both the method of making this it's a reasonable inference but i think that brings us to an important point about an error that the examiner made and video made about the whole process they took the term artificial gland to require that these constructs had to function like a grand plan there is no limitation there's no requirement in the claim that they actually provide controlled release in the same fashion as an artificial gland and looking back on it is maybe an instance where instead of using artificial when another term terminology should have been used so i think in terms of your question judge o'malley it gets to the examiners error in understanding the invention as requiring an actual  characteristic or function that is similar to an artificial when that's not what these are these are similar to colloidal zones they're made of chemicals and there is no doubt based on the literature that cited that those construct with the fact that the examiner had construed thirty three and thirty four at one point two to mean that the subcomponents could really disagree that they agreed with the elements but that had to do with the prior art rejections and the eligibility rejections and what the examiner have said initially aside and for the purposes of those rejections i construed this claim to not be limited to sell components i slipped by themselves isolated separated from sellers and therefore they rejections but that doesn't change the enablement issue and if i can turn to the name one issue i think would be helpful to walk through what was going on here effectively all of the clients were were upheld on for i'm sorry and they want crowns and mark has failed to make any arguments with respect and he claims that thirty and three and thirty four and therefore those were probably was crying as if they weren't understanding that that the land that was claimed the artificial and it was claimed would have a use separate and apart from and in vitro use now that i thought not at all  prophetic examples and non prophetic and from principle a they point to example seven which is what we were just looking at figure seven i'm sorry if that's what you wanted to as i have a non prophetic example and all that shown they are if i could just walk you through that it's a one sixty eight of the record all that's shown here in the top figure is they take and this is explained at pages ninety seven to one hundred of the record what they do here is they have a micro channel which is pictured at seven ten they have an eight with solution which they explain includes cells includes a pre and gel precursor and some other components like a buffer it's cetera then introduce an oil which is at seven twelve and then  effectively you get these droplets appearing at seven thirteen which is a drop let me put a solution containing cells that's also shown in seventy two the droplets then at seventy three they add an ass and they lower the ph the gel then solidifies in the center think clearly these have to be man made right these are man made but they don't look anything different than it looked at they examiner's rejection which is at pages nine they don't look anything different i mean are you saying that quickly get an artificial pancreas an artificial anything else that somehow because if it works the same it's not patentable even though it is not a product of nature it's a product of me and this effective and work in the same way that a gel can exam or also said that there is no guidance in terms of drug delivery so you have absolutely no is none of these most of this is prophetic and if you look in fact examples seven to twenty one a wish list of how this could be used and they know are you saying that the word artificial doesn't modify the word gland at all now the issue is the oh it has so you you agree that what what you let basically the examiner said is you can't be one issue is that doesn't it doesn't work like a claim and the other issues is that you haven't shown how to do this with something like aghast the other issues that you haven't shown any private any guidance on drug delivery which is some of the things one of the things the principle things that you say you seems like think them or said well ok you come up with this whole invention but i think you should have come up with a cooler invention you know that covers a lot more stuff and so is that the examiner asking that more enabled then actually is being claimed now what they examine her is saying is that yes we grant you that you have this very limited example and you've you've developed this sort of structure but you haven't shown anyway how do you use it in particular in claims thirty three and thirty four using cell components which is very different and you haven't shown how to use any of these things and so like we sat in and with respect to all these arguments the examiner made in response and the appeal brief before the board mark has a ph a seven thirty to seven thirty three of the record only argued claims thirty three and thirty four they waived all the other issues but that then it would be more enabled now i'm really having a hard time finding this other two of parts of it the two is the two parts one is how to make and one is how to use and let's focus on claims thirty three and thirty four because those are the principal ones that were not waive claims thirty three and thirty four and i just wanted to raise that as a backdrop that there were a lot of issues going on and much of which was not was not argued was not disputed before the board by marquez so those arguments were waived with respect to claims thirty three and thirty four what the what the examiner said is that the only guidance with respect to sell components and that is at paragraph fifty nine in the record in the examiners decision at eight twelve eighteen the basically said there is nothing other than this paragraph fifty nine there is no teaching about cellular components there is nothing no citation to prior art that would provide guidance in terms of how you would assemble shall you like components and given that there is really not enough in the specification to guide a person skill in the art to construct some kind of going on and using cellular component and furthermore they said doesn't that there's no teaching about how to make it also similarly like with the ones with cells there's no teaching about how to use and if i may like the exam and the order recognized for example that that the introduction of the specification describes potential use as being a stem cell engineering organ and tissue repair and replacement a lot of big ideas and again not the least example isn't that seem to be unable they teach you how to make again all that is taught and it's very much like what we just looked at a figure seven is a gel with yeast around it but in terms of how to use that in terms of examples of drug delivery certainly no examples of getting tissue regeneration doing tissue or repair or replacement in b and example seven twenty one have a whole host of things they on those on the ground question about whether cell components operate in the same way as cells i think what the lord did incorrectly here is ignore all the evidence where we have an established field that uses small components to make lawyers arms and we have evidence in the specification that uses cells we describe that they operate on the same basic scientific principles and the board never respond to that other than a single sentence which is that i believe if there are three and they don't provide the board doesn't provide an explanation of why it disagrees with the statement and the specification about how these operate and under this course case law that evil in vivo testing correctly and there's been no in vivo testing and our position is that based on that in vitro uses of the similar chemical base constructs and the working examples that we've shown here and the absence of any scientifically based explanation by the board that's sufficient to show that our claimed constructs are and it was there any further questions now thank you