made please the court allows us three seventy three points treatment methods the treatment methods it claims solve the problem that stumped researchers for decades namely how to provide effective all day treatment  drug in an ascending rate of release over extended period of time the product also introduced concert to practice these points with a big commercial success it's one of the primary treatment options today of the district court not surprisingly and correctly found the claims not obvious but the court also found the claims not infringed by his generic equivalent and found them invalid for lack of enablement and we submit that both of those rulings are wrong as a matter of law not the infringement ruling turns entirely on plain construction the district court held after trial that the ascending release rate limitation requires drug release in the first time interval after administration of the drug or we believe the specification makes clear that  construction is in correct another specification defines virtually all of the relevant terms and that's in columns the bottom of column a through column ten the specification explains that in ascending release rate is a periodic release rate that's higher than the immediately preceding periodic release rate not periodic release rate in turn is defined as the total amount of drug released from the dosage form in a particular time interval as measured at the column four thirty six to thirty nine your honor is the first reference and it indicates there to provide for an initial rapid onset of drug action and the dosage form would comprise an immediate release rare layer the other thing i would point to your honor is in column ten of the specifications which is where the district court found the support for requiring immediate release in the very sentence that the district court cited which is  and then when you go on into the next paragraph in column ten in a sequel to zero but that us referring to the time period at least in the first period yes your honor release coating and it talks about the release and i'm up on a bit about line twenty three twenty four the drug release measured at people's one hour will generally reflect both the drug release from the immediate release drug coating and any drug release not the drug release any drug released from the sustained release part of the drug and indicating clearly that there could be no release in that first dollar and this ties into your honour's of the purpose of the invention the purpose of this invention was not to provide immediate therapeutic effect that had been done for decades with conventional dosing the purpose here was to provide release later therapeutic invented later in the day and i mean it's both right no i don't think it's both you are not in the claimed invention because the immediate release trying to do with the obviousness they use this in the judgment of invalidity and there are plenty of cases there probably six peter ten of which say the under those circumstances you don't have to cross appeal up respectfully around or three on makes very clear that where the judgment is not a judgment of invalidity but a judgment of invalidity for a specific reason and invalidity for another reason is not an alternative grounds for affirming that judgment because it requires modifying the judgment that requires across a or anything else i think that's probably right yes and the difficulty i'm having with your position on enablement is that everything that judge fighting did here seems highly fact specific and there are factual findings arguably there's really not a factual dispute i think it boils down to the ultimate conclusion of lack of enablement it's undisputed that sustained release dosage forms were very well known they've been used for decades for scribed impact by our patents and texts including some referenced in the pa honest so what you're having to rely on is that someone skilled in the art would know how to do it yes absolutely and you also have a situation in which also never did it right there wasn't else's business as it yes and everybody says that it would take months of experimentation to to do you having this the knowledge of someone skilled in the oral and here's the key your honor it would also take months of experimentation to make any sustained release doltish or if this is not a problem specific to a sending release dosage forms that both sides experts were very clear on this it's a trial and error interactive process you designed it does it for me make that goes from a test that you see whether you hit your target rate if you didn't then you were just a dosage form tested again it's a matter of varying the thickness of coatings varying the size of a drug drug containing beads changing the shape of the matrix that sort of thing these are these are all conventional techniques and the techniques don't change and the amount of testing doesn't change depending on which release pattern you're trying to trying to achieve now but what the record shows here and this is from all sides experts is that those of ordinary skilled were very familiar with sustained release dosage forms and with the techniques for adjusting and manipulating them to produce specific desired products producing any sustained release dosage form as i just mentioned is an iterative process where you make the form   and in particular i direct the court's attention to the five nine three parent application the parent of this patent apparently it wasn't so easy to do since als i was unable to do your out of the evidence here is all we have is the testimon mr lamb about efforts by somebody else for a couple of months to try to produce them a particular kind of not us motto to form a matrix dosage form we know nothing about what they tried how intensive the effort was even who it was and  just having a hard time comporting your any your theory which is it was known that they are let's assume that but it would still require experimentation but that's how i'm do at putting that with the language of the statute which says statute in the absence of judge dyke suggested of anything in the specification but your honor i think this court's cases are pretty clear that you don't have to reproduce in the patent techniques that are known in the art now technology was a new technology so that's described in detail but these other dosage forms of matrix dosage forms and the other wrote a bill systems and that kind of thing those were known for decades and along with how you would just the release rate it but that might be true if it were are for those of skill in the art it wouldn't be easy for me certainly but this is what these people do need them as experts said it would take an experience formulator a month or more to make any dosage for it it's not a problem of ascending release it a problem any dosage for any sustained those dosage form and in fact here ascending released dosage forms you used may have been made using that these techniques he c'mon therm or unless you were told how to do it in the specification that he said it would take a month or more with the know where and i p if you look at i believe it's page seven of the transfer page seven zero seven and he's and you see the question there about line six and one of ordinary skill in the art with the disclosure of the three seven three  and that's perfectly consistent with the testimony about his expert that that was standard in the event but well at the district court does sort of refer to that but then when he cites dr needham's testimony he goes on to then say particular do direct the court to for example appendix pages twelve seven twenty one twenty two where he goes through the disclosure he's taken through the disclosure in the five nine three parent application which talks about the knots modoc dosage forms and how you could use them to provide a standing release and he goes through example by example and he confirms that yes these techniques were well were familiar to one school in the army could be used by want to kill in the are so i think even if you ignore dr davies testimony altogether and you look just at necessity to go into this trial and error and because that's when you specifically had to do and you gave examples right but was it still not clear that you don't i don't think the record is clear that you still didn't need some trial and error in fact i think that's what needham's testimony indicates that even with that guidance you're we talked about that a little bit earlier it's general testimony describing some some efforts by somebody to make up a matrix dosage form it at als and there was no evidence of a clue what their skill level was what they did you know how intensive the efforts were whether this was a power kind of thing or whether it was occupied all their time for some period of time so it was in the judge and to assume that they had competent people billing i don't think the judge was entitled to assume that they had people of ordinary skill in the arguing and not in the absence to make these other those forms why are you going such a complication understanding that als is by and large an os model company but they do do other things transformers and some other things but having said that the point is this if it's so easy if you've got such a broad invention nobody ever thought of this in the release wait for nobody ever thought of assuming past profiles they got broad public for that certainly it's the case that not every company stays with a particular dosage or if it's simple to do these things why one that's horrible wants factors so i think that's all eight of the eight factual findings that the district court went through specifically addressing the point was made about dr needham the point with all due respect was not made is as judged like without i don't think about i was there about the specific examples and replicating those it was ok if you went from those two different osmotic those that form what would happen might take you about a month to get it if you went to any other dosage form and i would if we have specific examples as to the one that's right and you're not obviously if you develop those for some or are unable to hear like osmotic others or not he says well into probably six months or so or more for one dosage and i think it's important here that we were told we're talking about a scope a name we're not we're talking about a multiplicity of approaches which the court recognizes which the pattern itself recognizes and it's also in a way i don't know that it requires obviously you claim a thousand knows it forms and we is full scope all you have and you were making a scope but argument if you're talking about specifically as a matter of wall the claims are just too broad yes the district court did reject that i would agree with that so a lot of the district court's interpretation what's your contention of whether even one of them is unable i'm going to put that to one side let's assume that we're addressing the question of how many dosage forms need to be enabled what's your position as to how under the the claim construction we have here what do they have to do how many other besides the one would they have to enable our position is if you're talking about the full scope of the claim it goes back to our argument as a matter of law the claims are this broader and valid he said not even one with a name yes i agree with that but but i would say that's still the full scope and all but not the same argument certainly that the stope of the claim includes more and they did and they both these other items so  but certainly that's what he said and with regard to the factual findings we've been through some of those lamb hamel we would also say you look at the provisionals which he relied on which specifically said there were along need for these things if for these types of dosage forms  and also that the the art here was unexpected in a breakaway and as far as something to do so all those facts in addition to needham's testimony in addition to discounting dr davies testimony which it was untitled to do with the finder of fact all support his finding here so i think this court can affirm certainly just because it's a factual finding although enablement reviewed the novo has factual findings on the want certainly support the argument here in question so i did want to address one question on obviousness and perhaps it  not be addressed but sense council raised it and judge doc responded there's certainly cases that we would submit that talk about non waiver here and specifically it's a nonpresidential opinion but a case that we and that case specifically mirrors this case there was a finding of summary judgment not enablement summary judgment of non obviousness the other way the final word judgement orders and in that way and specifically was held not only w specifically included the requirement that you have a standing release starting to equal zero given that they won their claim destruction we believe they're stopped from arguing differently here based on the judge's findings however that particular twist i mean it's believe there are stocks certainly we think if you go to the specification and self specification supports the judge here i with all due respect to my colleague i don't understand why we start piecing together what an ascending release rate is and what an extended time periods when the entire phrase ascending lease period over an extended period of time is defined a column ten lines forty one through fifty two s cation and that portion specifically says that you have the time point of peak was zero when you look up the column ten and it's like reading a story here well what how do you determine whether or not there is an ascending lease rate during the first time period you determine that by saying is there any any release if it's that it's basically says that you look at the immediately preceding time period which is by definition zero so you look at that as long as you have some or at least the next course in the specification says we don't count i are released with regard to the extended release component with regard to the ascending at least calculation so that piece together is a storybook is that why you leave us in a lease or why the definitions requires a new release in the first time period and they don't require it from they don't include the any certainly we're not saying that it was not contemplated here but you might have a situation where you have no release from the our what we're saying is by these definitions they specifically did not claim that they specifically require that you don't count the i r and they have released it on the first time period so given that those bets the specification in column ten we think that just that's the way it reads i don't think there's any real argument in the court certainly found those paragraphs on ambiguous so with regard to claim structure we believe that's where that lies i'm happy to address any other questions the court may have otherwise i'll use my time thank you your honor trying to enablement first this is not a case like the automotive technologies case where you had specific expert testimony not just asserting this would be difficult to do but identifying specific problems with the new technology that would risk his own obstacles for somebody of ordinary skill in the are you have here if you have an expert saying at this this would be hard this would take a lot of time obvious would be very difficult with no explanation of why no backup for that at all no explanation of what's different about ascending released dosage forms from all these other dosage forms that have been made for decades and in fact that the testimony is that there's not anything different it's the same techniques used the same we have an expert's assertion that essentially an assertion on the ultimate question that this would take undue experimentation with no factual back and that's the fundamental problem with the district court's conclusion here we thank  ascending released dosage forms in fact had been made i was up as we pointed out in our brief it was a problem set in a in an undergraduate textbook from before the time of this the record contains patents like the two one for patent for nine seventy one i think describing a particular form of ascending release not as monica sending released dosage form so the notion that this was somehow surprising new technology that would take an experience formulator untold effort to  produce is just not supported by the actual facts it's a conclusion but it's not supported by the evidence now on this question of the full scope of the claims the enablement decision turns on specifically and only testing but there was absolutely no evidence presented as to any not not oral dosage form other than transdermal patches and both sides experts agreed that in fact those could be made with an ascending release r  different kinds of not automatic dosage forms i think to the extent that there's a showing that the techniques for one are very different from the techniques for another you might have to separately enable them by which i mean either in the patent or in the knowledge  of one of ordinary skill in the art but i don't think you necessarily for example one of these textbooks that that cited in the record identifies ten different non osmotic dosage forms i don't think you necessarily would have to show that each and every one of th always could be made with an ascending release rate without undue experimentation why not because many of them utilize the same basic techniques it's the thickness of it you vary the release rate by varying the thickness of a coating by bearing the fitness of a drug containing layer that sort of thing so to the extent that you're really talking about the same techniques and people of military skill and they are what i understand that the techniques are transferable from this capsule to this tablet i don't think you would have to separately share that but perhaps by saying that i've said that it in fact is enabled because a person of ordinary skill in the art would know how to do it which is of course is our view of what enablement in this kind of a case requires where you have both novel ways of performing the method and ways of performing the method that are quite conventional now on the turning to the claim construction point the the specification as as consul noted acknowledges the possibility that there may be no no release in that first period and i think it's significant that in column ten where it does that and i mean the paragraph that begins it about line eighteen in column and it's talking about dosage form embodiments i mean it's  talking about don't you know just random dosage from just talking about those reforms that i'm this from embodiments that are used and in this invention and it's talking about any sustained release not the sustained release a clearly contemplate that there might be no release and significantly it goes on to say then in determining whether there is an ascending release rate you compare the release rated peoples to for the release rated peak was one while disregarding any immediate release