this is not a typical obviousness case in the typical obviousness case all of the claim limitations can be found somewhere in the prior art and the courts task is to determine whether there is a motivation to combine those to your honor there are some very specific differences between the patents that i think are important the first is that if you view the patents as a whole they are solving a different problem in the three twenty three patent the question was how to solve  particular instability that the earth have had a molecule has and that's the instability at the parole of being nitrogen atom you can see this because the three twenty three patent and the reference both define manufacturing process to get to a final formulation product and a final formulation product requires solving not just dimer ization but also opening degradation which is a significant problem opening degradation decision when it found that the three to three patent wasn't obvious over the prior eight twenty patent one of the reasons it found that lack of obviousness was because for beta lactamase the prior art taught to use a ph of three defined stabilize form of art a penname as only dealing with with dimer ization this one five zero patent took on a bigger problem it was not about short term stability it was not about just solving the problem of court that there are differences the one psychopath and as you noted start by charging a solution of carbon dioxide source nothing in the three to three patents spoke to us starting with a carbon dioxide source and solution the second thing that step two in the one and speaks to adding a base and an active ingredient simultaneously as the district court recognized that appendix page thirty nine there is nothing in the three to three patent that talks about the simultaneous addition the only thing that the district court relied on in looking at the one five zero patent and looking at these steps was dr murray troitsky hindsight testimony and we know that that's hindsight testimony for a couple of reasons it is not rooted in any prior art use common sense or common knowledge in the art to impose our or find claim limitations missing claim limitations in an obviousness analysis and i would direct the court specifically to the r n d versus apple case from last year which the court said there are three kaviak to the first is that supplying a missing claim limitation exceeding the motivation to combine is generally about taking limitations that exist and combining them it is not about supplying missing plane limitations the second is that is an exception rather than a rule to be able to say common knowledge provides a missing claim limitation and the third is that a missing plane limitation should not be supplied to common knowledge where it plays a major role in the subject matter claimed to our knowledge there's only one case in which this court has ever allowed common sense or common knowledge to supply a that was the perfect web case in which the patent involved very simple technology and the missing limitation did not play a major role in that technology the here where case which was cited in a rand in the prior art or the facts are quote capable of instant and unquestionable demonstration of being well known now that's before the patent examiner here we have a patent in which spirit was invoking two prior  patents both of which were before the examiner at the time the one five zero patent was issued so not only do we have the presumption that the one five zero patent is valid but that's an enhanced burden that haas the i face given that these two prior art rather than starting with a three two three patent and saying what would this make obvious to a practitioner a skilled practitioner at the time of two thousand and one the district started with the three process steps broke them up into  subparts and said well here's what subpart one says can i find anything that might have suggested you start you would go to sub part one then we moved as part two can i find anything that suggests you might have gone next to step two but that's not the formulation product and the district court's markman definition of final formulation product was that a final formulation product was one that had low by products and low by products include diners and open patent took what was in the three to three patent and took it significantly further and it did that by finding what was really an unexpected result which is that there was a way to resolve open ring degradation in a different ph range than the prior art had taught was the range that should be targeted for beta lactamase the district court out of kendrick's twelve you can see the district court speaks specifically to the fact that sorry no were known in the prior art to have maximum stability in the range of three point five to five and the district court in fact used that is part of its reasoning in why the three to three patent was not obvious by pointing out that people taught two things and it didn't teach one things that are very critical to analyze in the one five zero padding it taught that you could form an adequate in the ph range of six to nine the prior art taught that to have maximum stability of you wanted to be in a range of three point five to five of course those two ranges cannot be simultaneously reached and what it didn't teach was that within the range of six to nine there was this divergence a fact of ph on and open ring degradation so the one five zero patent not only solved the open ring degradation problem but it also provided a solution to this previously undisclosed and unknown problem of how to deal with the divergent and to be clear again the patent as a whole is not just a manufacturing process for forming the addict that is what huskier argues it's what led hosp era to encourage the district court to view the three twenty three patent as a recipe but of course you can't have a recipe for something that doesn't tell you what you're making and the one final patent made something different it made an earth a pen in product a final formulation product that had two plus years of stability it took something that previously stability data from the one of the three to three in the commerce and it was in terms of hours and days the one five zero process through that very specific manufacturing process again with steps that are not set forth there's nothing that speaks to starting with a sea of carbon dioxide source and simultaneously adding the base and the and the active ingredient at the same time it was able to come up with merck was able to come up with a manufacturing process that solve degradation sufficient to have long term stability and therefore be able to have what really could then become a commercially available product on a hospital shelf if i could just mention one other thing the unexpected results are a critical aspect here of showing nine obviousness and the district court failed to mention or addressed merck's argument on unexpected results which was made that again is a legal error this court has required district courts to address the objective in disha of non obviousness before reaching an obviousness conclusion and here in the district court did not do so i think one of the quotes that really highlight pattern the district court addressed copying which it found hostler i had copied the manufacturing process there was no question about that it addressed commercial success and it did not address unexpected results that was something that merck had briefed in its post trial brief were these unexpected results particularly on the opening degradation problem and the divergent ph effect which were not something that were previously discussed or described or that there was any suggestion in the prior art that if ph range of six thank you your honor may please the court the district court appropriately ruled that the one fifty and twit have been obvious because the three to three patent arms the person of ordinary skill in the art with the structure for that molecule it provides the stabilisation averted penname critically by reacting at that parole with the nitrogen with a carbon dioxide source to between success or failure it's the reaction of that carbon dioxide source in the ph range of six to nine and then lie awfully sation that's what gets you success all of that is in the three to three and a three to three pat dioxide source with your pen him and you lie off allies one aboard every skill in the art would understand that you want to be operating in that ph range of six to nine that's what's in the three two three  patent that's what's in the one fifty patent that gives you information if you're one of ordinary skill in the art about how you bring these ingredients together so dr murray detroit testified that one skilled in the art would know that you would first dissolve your carbon dioxide source because you have essentially a finite number of choices here you could put all of your ingredients in together at once or you can put one into solution and then the a low sex you would want to have that present with the base sodium hydroxide to counteract the ph of the earth dependent so you would be within that maintains range of six to nine the range that three to three teaches dr mirka try to explain that and judge answers found that judge andrews also understood from the testimony that you would not combine all three components together even dr staley mercs expert said that as a matter of chemistry if you added all three components together one skilled in the art would understand you'd have uncontrolled reactions one skilled result that is not accounted for totally by the three to three patent the result of stability is taught in the three to three patent as the result of operating to form that adequate in the ph range of six to testified with respect to the three two three patent that the three to three patent taught what he called the sweet spot a sweet spot between preventing timers ation and also minimizing this ring opening following the three to three that and bringing together the carbon dioxide source with the earth in the sweet spot ph range of six to nine there is nothing else claimed in the claims of one fifty leading to an unexpected result there is nothing else alleged to provide some unexpected property dr stella testified that the three to three patent doesn't just teach an addict it teaches a pharmaceutical composition sufficiently stable that it can be suitable for intravenous administration to humans the three to three pack gives you a pharmaceutical that can be put on the shelf the one fifty patent ad nothing in that regard one fifty five and has no claim to two years of stability but even if there were some level of stability achieve that level of stability is achieved following the three to three forming  in the p h range of six to nine these were mercs own experts who provided this supporting testimony dr stella is an eminent researcher at trial he tests hard to having invented several pharmaceutical products that have been approved by the f d a and are out in the field and he said that three to three patents when you follow it gives you a pharmaceutical composition suitable for administration intravenous administration to humans ordinary skill in the art would understand that one of ordinary skill in the art would understand the ph range of six to nine so the experts were not providing expert testimony only known to experts they were simply explaining  brief and just well patentability is not negative by the invent the manner in which the invention is made i think it was the merit of the buyer craft case that said neither does the fact that it takes the inventors a little bit of time to do their work makes it patentable and of itself one must look at what is known in the prior art and whether the differences would have been obvious to one of ordinary skill here at the three two three patent which took some that's correct your honor there was a patent called the eight twenty patent which claimed hertz append of itself the molecule that patent was not challenge to the three to three patent claimed the earth find him abduct and had pharmaceutical compositions suitable for intravenous administration that patent was challenge that trial based on the eight twenty patent and knowledge of one of skill in the art judge  held the validity of the three two three patent it was only the one in fifty patent which is the simple lab it was a sion process that judge andrews found would have been obvious based on three to three  exposing the carbon dioxide source to the pen and solution and that happens in the three to three pattern that happens in one fifty one fifty has the steps of first adding the carbon dioxide to solution then adding the earth to pen and with the base one of ordinary skill in the art would have been motivated to take those steps based on the chemistry that was undisputed amongst the experts dr margaret tried testified why one of skill in the art would have done it in that fashion dr staley confirmed and judge andrews found that one skilled in the art would have known there were problems if you tried to do things a different way like adding all three of the components at same time three two three arms one honor frankly because three to three patent doesn't arm someone with what they need it speaks about blending a powder of carbon dioxide source and order penname and then it speaks about using a base at some later point upon dilution to give it to a forty eight and seven forty nine of the appendix that those manufacturing steps were not set out what he offered instead was his own say so that that's what he would have done but that say so was not rooted in any prior art it wasn't rooted in anything that would give the factual underpinning that this court has said is required to find that an expert's testimony has the sufficient protections against hindsight bias  counsel for the other side suggested that there's nothing in the one five zero patent that relates to two years of stability with all due respect i disagree if you look at column nine of the one five zero patent lines one to nine there is a definition for solid state stability this is the specific shortcoming that the one five zero patent sets out as missing from the three twenty three patent and and oh marson there is no way to take what's in the three twenty three and almost an end up with solid state stability and reconstitution stability that is what the one tries oh patent added to the knowledge at the time that the patent examiner who had the three twenty three and elmer sent in front of him when he issued the one five zero patent certainly could have looked at those and did not think that they armed someone with what they would need the main difference here is yes the three twenty three gets to a pharmaceutical composition but it's a and so there are a number of answers to that one is that they don't point to any prior art that suggests that to be true they are relying simply on common sense and that reliance on common sense conflicts with what this court has said about the appropriate use of common sense to fill in missing claim limitations in both the a randy and the here where case the other problem with it is that it conflicts with the prior art and what it taught about beta lactamase which were that to treat beta l a way that would give the maximum stability you had to be at a different ph range from what dr murray tried was saying somehow it would be obvious to have been using to solve hydrolysis in the patent process set out in the one  zero and again there's no basis for doing that your honor pointed out that it had taken five years to get from the three twenty three patent to the one five zero patent the process manual that's in the joint appendix spells out all of the significant work that was done during that year including importantly moving from what's in the three twenty three patent this blending of powder form of earth a pandemic a carbon dioxide source and instead moving to a situation where they started with carbon dioxide source by not starting with the three twenty three patent and saying what would be obvious from they are forward looking district court really engaged in the type of hindsight analysis that this court has consistently said is improper you can't start with