Legal Case Summary

The other court is in session. Thank you. To continue from where we left off, the next case is number 051490, Fire and Stem Therapeutics against by us, Mr. Andre. Please report Paul Andre, representing the Palantin Patentee Pharmacintherapeutics. I apologize for the impropriary poetry for today, but I am prepared to talk about a lot of substantial evidence that was presented to the jury, in which the jury base is decision on in this case. And as this whole basis for pharmacism is a pill, what is substantial evidence to support the jury? The jury is verdict. In this case, pharmacists present evidence in the form of scientific publications, peer-reviewed scientific publications, newly-endural medicine and the FDA. They prepared to produce internal documents of the company, stating that the goals of these companies were to store stem cells in sufficient amount to reconstitute adults. Are we talking about the 681 patent? I'm sorry, you know what I'm saying? The 681 person, the 553 after that's a thing. The internal documents of the defendant actually states, very specifically, that the goal is to store stem cells in sufficient amount to therapeutic use and that therapeutic use is tar-reviewed adult. We have public statements by these companies in form of advertising and various other contracts, in which they tell the public who buy the core blood, the priorivature, core blood from them. That they can be used for adults, parents, grandparents, et cetera. That marketing material was stick to as being truthful. So there's no debate as to what they were actually selling. We also have fact testimony from at least a dozen witnesses talking about the business plan of these companies that they collect the core blood to be used with the future therapeutic use and that use can be for adult users. Finally, we have expert testimony. The marketing didn't guarantee that it would be useful for reconstitution for adult correct. That's correct. Just in the fact it was a possibility. There are some of the marketing that actually said it can be used. It can be used. There are no guarantees. The guarantee in transplant medicine is not existed. The fact of the matter is you can have more than sufficient number of stem cells and not be successful

. It's just because of the various nature of transplant surgery or transplant procedures. You never know. There are no guarantees and no one would be foolish enough to make a guarantee. But they did say on several of their marketing material they can be used for the adults, they can be used for the mother, they can be used for the parents, grandparents, et cetera. So how do we know if there's infringement up until the point at which if it's got a cover adult and you don't know until you actually try the transplantation? How can you determine infringement other than waiting enough time so that there's actually successful transplantation for adult? The claims of the 681 patent require a sufficient number of cells. It's not a successful transplantation. Well what is that number stem cells of progenitor cell? The claims are called sufficient number of stem cells. And how that is determined? There is no. You cannot count stem cells. You can look at the surrogate acids that were used for the first time in stem cells to show transplantation that the emitteres came up with. The surrogate acids can be in a form of colony forming the unit acids. They can be towed nucleate cells. They can be CD34. They can be void. So different parties use different surrogate acids. But those acids are discussed in the patent. And the couple of the defendants in this case actually set their standard operating procedures to actually screen those type of acids to ensure that they had a sufficient number of cells. So the question here is- Is that correct? It was the screaming to determine the sufficient number of cells for transplantation to adult. It was for therapeutic utility. Isn't there a difference between therapeutic utility and successful transplantation into adult? And if checker instance there's not. Why not? I thought the reason you got a patent and the reason we're here is because you limited your patent to use it by adult. The adults obviously cover children's well. Does the patent cover just a duck? It covers adult and children. It has to be sufficient amount for adults but also that would be sufficient amount of children as well obviously

. But it has to be a sufficient amount for adult. That's correct. That's all your patent covers. If it's insufficient for adults it's not covered by the patent. That's correct. Okay. So how do we know based on you said the tests they can adopt? That that test tells you definitively that there's a sufficient amount of sun cells for adult. Especially amount of adult. The evidence that was presented to the jury in the sentencing of the jury line up on was based on the scientific publications where they did large clinical studies using adults. Then the medical biology boards of these companies set up a number to be therapeutic to use for. And they sell their product to be used for adults. So there is a logical inference that if they're selling their product to the public saying that you can use this for adults and we will tell you that we will make sure to make sure that you do have enough sufficient numbers to them cells. Then there's a logical inference can be drawn that their screening procedure is screened exactly for that. Well that might be true if they guarantee that whatever they sold would be therapeutic, futically useful for adults. But as you acknowledged earlier there's no guarantee. So I'm having a hard time. You can see that you're drawing some sort of line here between we're going from therapeutically useful to necessarily working successfully for adults. The scientific publications get made the same standard once you reach a threshold amount. They're futically successful, a therapeutic useful amount. Then that should be used for adults. And that's what the FDA, the blue paper said is what? It's the once you have a- But we don't know what that amount is. Well you can't count stem cells, that's correct. So we don't know what the amount is. So when you're saying that the other side is a threshold matter whether they were useful, had determined they were therapeutically useful

. But you're conceding that their determination of their therapeutically useful didn't involve knowing how many stem cells were within. That's the basis for the surrogate assays. The surrogate assays are used by doctors every day. There have been thousands and thousands of transplants into adults of these types of stem cells. And stem cells have never been able to be counted. But those surrogate assays they use allow doctors to make life and death decisions as to the matter of fact that they do believe they're a sufficient number of stem cells. And based on these surrogate assays. So what these companies did was set up these type of surrogate assays that would actually allow them to make a determination where they would be therapeutically useful or not. And if you tie that together with what evidence of jury heard, then there's a logical inference that a reasonable juror could not only conclude that those samples of past the screening that their medical biogen was set up had sufficient stem cells. It's almost impossible in France to escape from. So in this particular instance, the evidence that was put forward and was all cited in our briefs, there was just more than substantial. There was overwhelming evidence that was showed that would allow a reasonable jury to make that conclusion. With respect to the 553 pattern, it's understood that this is the method pattern. And there are several steps. And it's understood that all these steps are performed when a court blood sample is transplanted into anybody, a adult child or whatever. That was, there's no dispute as to that whatsoever. The jury was presented with three very specific factual questions that were proposed by the defendants. They had to answer and they formed it to find contributed or infringement. That was the, the, the, the non infringing use, the, the fact that it is a, it is sold in, as a crop reserved, a unit is sold to a third part for direct infringement. And the questions are three through five on the jury voted for. The jury answered all those affirmatively finding that there was contributed or infringement. The sole basis for setting aside that from the district court's perspective was a definition of sale that required ownership or title. Now, is this court? Well, what will it look at sale to whom? Wasn't that also a question about who, were we looking at sale to the family or sale to the transplant? The, the district court set aside the, the jury's verdict based upon the sale of to any third party based on the jury verdict. He denied the, the, the district court didn't mention the, the jury instruction

. So the sole basis was the definition of sale, which is the, the whole ownership. And the sole basis saying aside was that since the defendants do not have ownership of this, these court blood samples, they cannot sell it. Well, it's questionable where they have ownership or not. The fact of matter is that that restricted definition of sale has already been rejected by this court. And, I believe it was last year, year four, last case of the NTP versus the RM case, on which sale was defined pursuant to the Black small dictionary, which is a transfer of title or possession. You used, you used, you used transport for a price. So the district court setting aside based on that is clearly error. You never, you didn't argue, did you, the, the sale, it was a sale of constitute to sale of the service. Correct. You weren't arguing that it was the sale of this, it came under 271, the sale of the service. It was an alternative to the bancer trial, that's correct. So it was something, we believe that a sale of the service is also a cover in which you said you want to see it. And that was argued in the alternative to trial when we got the jury instructions in the verdict form. We also believe that the jury did have a reasonable and more than substantial evidence to show that there is a sale of the, the court blood unit, two a third party. I like to reserve a list. Yes, we'll save your re-battle time, Mr. Andre. Mr. Rogers. I actually, Mr. Inglender, like there are. We do. May please the court, I represent the defendant lies, so I'm speaking on behalf of all the defendants here today. If they're very specific factual questions, they may need to address them otherwise

. I'm going to take the entire time. How would you get into the thrust of your, I remember me asking about the cross appeal, with the invalidity issues presented at the counter plane in the original case by anyone or where they simply defend. Your Honor, when I heard that question earlier today, I tried to check the record. We do have counter claims, but we had an interest conference, so looking at the record quickly, I'm not sure. I believe we have declared to a judgment conference on the validity. There's nothing in the judgment that would so indicate. The district to a court's judgment, simply on infringement. Your Honor, I'm sorry, I should know the answer to the question, but I don't as I stand here. But the understanding of the law, however, is that whether this issue was raised by counter claim or not, this court still needs to address that issue, even if it were to affirm on. Or do you get that? The series of cases which I read recently would say that, I believe. Even if there's no counter, no defense. That's my understanding of this. Phil Rom, do you know that case? Was that one of the cases you read? Because that case, which I wrote, says, I think, pretty much the contract, the proposition you just articulate, and it's about four years old. And the notion is that if all you've done is to raise a defense, and if you prevail on. And how the part of a that leads to upholding the judgment of infringement, there's no need or justification to go on and decide something else that would give you relief that you never saw, then your complaint or in your counter claim. I understand the point exactly on. I can say that I did do research on this issue because I was concerned about it before I came. Obviously, it wasn't addressed in any of the briefs. And I saw a series of cases which I read to hold pretty clearly that this court needed to address validity. And they did not, to me, turn on the question of whether we had a counter claim or not. I would like the court's indulgence to spend a page on that after this. But when there is an issue of infringement, and even if we were to decide that there is no infringement, nonetheless, we have held that Supreme Court told us in Cardinal Chemical that we needed to review a district court's decision on validity. But here, there was no district court's decision on validity. Oh, yes, sure there was

. There was. The jury verdict. But it was in the field. We crossed the field. Not a separate counter claim, though, of validity. Is that in the form of a defense? It's so far as we understand. I'm certain that I have a memory because I was proud of someone. I wasn't involved in this. That when we saw the judgment, we asked the question whether or not there was some kind of the territory judgment issue that needed to be addressed. And you're on, I'm just not repunked in that context. If I could, I had three points that I wanted to focus on today. The first is, as the 681, that J. Mall was appropriate in this case. And the fundamental and root reason for that is that there was no expert testimony given on the critical claim element, the amount sufficient stem cells in an amount sufficient to affect modification of the human adult. If faced with that, science-based claim language, you would have expected someone to provide a standard. What is the amount sufficient for an adult? To look at the individual units stored by the defendants, compare them to the standard and say, these have it, these don't, or they all have it. There was no such testimony in this case. The only expert testimony focused on marketing materials. And actually, that expert testimony was excluded after trial by the district court underdog. The second point I want to focus on is that, and these are related, I understand, the claim language is indefinite. And there are really two pieces to the indefinite assignment. The first piece is, for the extended claim stem cells, it's admitted and undisputed that you cannot identify or quantify a stem cell. So the only way that there could be content given to this claim language would be to go to some kind of surrogate, something that suggests stem cells. Mr

. Andre, for the first time today, in this entire litigation has said, we're relying on surrogates, which is fascinating to me, because we have had this issue front and center since we've tried to file letter briefs on summary judgment years ago. The reason that there's a real problem with going to surrogates is, surrogates are expressly disclaimed over and over and over again in the prosecution history. In the prosecution history, faced with prior art that addressed progenitor cells. Now, there's lots of prior art where court blood was taken and examined and shown to have progenitor cells. And over and over again in order to distinguish that prior art, the patent he said, those acids for those kinds of cells do not demonstrate stem cells. There is no way on this record, on this intrinsic record, that the court can construe the amount of sufficient language to be as encompassing a surrogate, i.e. progenitor cells or volume of court blood that show stem cells, because that was repeatedly disclaimed in the prosecution history. It can give an example of the kinds of language that was used. So, wouldn't that relate to when or what stage when might determine whether there is in fact an infringing composition? Well, but I'm on the indefinite point. Okay. The indefinite point is determined as of the time of five. And so, the prosecution history, on this point, says over and over again progenitor cells are not indicative of stem cells. So, we can't construe the claim. The exon I think you're on. But you're construing for the purpose of determining infringement. Well, I'm, but I'm, for the purpose of determining infringement, if a standard were put forward that construdes the amount of sufficient language as being represented by a surrogate. Okay. If that was the claim destruction, I was not the claim destruction of district court adopted here, district court didn't adopt any standard as much as is needed. But if the court were to construe that language, as providing a standard, I say that that language, that standard is disclaimed because in the prosecution history they said over and over again progenitor cells are not indicative of stem cells. They can't then turn around and say this claim language means that if you have a certain number of progenitor cells, then you have the amount of sufficient because they've told the patent office in order to get their patent progenitor cells are not indicative of stem cells. They can't switch like that. So, you're saying never made this argument. So, you're saying under the infringement issue, not the indefiniteness issue, the only way they could prove up infringement was once the court blood had been transplanted successfully into an adult that had been stored

. Actually, then they could come in and say, yeah, that infringed it. We've never taken that position, although that is a position that I suppose could have been taken. Nor have they taken that position because, in the reason for that, that's how else it is clear. Well, I know why they haven't taken that position. Well, they haven't taken it because we've never transplanted an adult so they would have zero infringement under that standard. But these two are related, obviously, and this sort of the way the case has preceded. Either it's indefinite because there is no standard. Or if someone comes up with a standard, which is assertive, which I say, you can't do it because it's disclang. Then you need to take that standard and you need to apply science to it. You need an expert. This is very similar, I mean, infringement side of this case, to the centric case, to the judge's deproton. Because you would need to look at individual units. And you would need to ask the question, what is the cell content and how does that compare to the standard? And they didn't do that. They had no expert testing at all. They astute it. Can I just ask you about the contributory infringement of 553 patent? Is it your view or do you know? It's my understanding that our case, we've never decided the issue of whether or not to sale of a service is covered or is not. Can you confirm that or do you think we've decided that we've... I don't think this court needs to reach the issue. The 553 argument is very straightforward and simple. It's based on the jury instruction, which was not objective to. The piece of the jury instruction was not objective to said they must show a sale or offer to sell to a transplanter. They objected to the sale or offer to sell part of that

. There was a lot of argument about that. We think that's clearly right under the contributory infringement statute. They actually proposed a language to a transplanter. And there is no evidence at all of any sale or offer to sell to a transplanter. Therefore, under the jury instruction as given, there was no evidence that would support the jury. That's straightforward. That means you don't have to address the issue of a service. We did brief the issue. You don't need to reach it because they just can't cite any evidence of a sale. So, either banks to the transplanter. We have the blood, its crop reserve, its stored, and the family then says family owning the blood, releases it to the transplanter at a particular time. But you don't think there's a sale for the family either. You don't think it's sufficient for a sale. I don't think it's stronger for the transplanter than for the family. I think you just don't need to reach it. We don't believe there's a sale to the family either. It's a matter of quantum, misinterpreted, and of the amount, the evidence of damages. It doesn't really go to the issue of whether, in fact, when there is a transplant, whether the conditions of the claim are being met. I disagree, Your Honor. We're talking about the 553 method patent. And what I'm saying is that the instruction to the jury, whether the method patent was in French, required, because it was a contributory infringement theory on the 553, required a sale or offered a sale to the transplanter. The transplanter being the last entity that performed the final step of the method. On the principle that once we have it in our freezing units, there it stays forever, and will never be sold. The point is there's no sale

. See, the contributory infringement statute only talks about a sale or offer a sale, not make you sell or offer a sale. Very specifically, Congress limited the contributory infringement statute. Only the sales are offered a sale. We don't sell. That's undisputed. Not to the transplanter. We don't sell. Because we're banking for the family, and when the time comes to use it, we're simply asked to release it. There's nothing that could... You'd support the notion that it's a sale. There's no money exchanging hands. This is an even more minor area. Charitable activity? No, we're not selling to the transplanter. Somebody argues that we... Obviously, we provide something to pay for. It's to the family. We provide a service to the family. But the jury was instructed, and there was no objection to it, that they needed to prove a sale or offer to sell to a transplanter. No objection. You're going to ask. No, I think it's probably not worth taking every time. Let me ask you, if you would, to speak to the question of validity of the 553, in particular attention to Kauiki and Zedall. I would... If I could just make one more point very quickly, which is, regardless of how this court comes out, MJMOL, the verdict cannot be reinstated. There are two reasons for that. One is the exclusion of Henry's after trial. And the second is the judges finding that the 100% infringement was against a great way to be able to... I just wanted to make sure that there are no circumstances that the verdicts come back and be reinstated. You mean there would be a reinstatement of the judges of regional new trial order? That's the way of looking at it, you're on it, yes. I mean, wouldn't that be practical impact of what would happen? I think if you were to refuse the JMOL, you would have to go back for a new trial. For those two reasons, both of those are discretionary decisions within the district court's discretion. But that would be something we would have to say to the district judge. You now have the case back where you decide what to do with it. District Judge might have a different view of it depending on anything we might say, as was independent. Understood. Okay. Can I address a Kawiki? Sure, I would please. The Kawiki argument is, again, it's also very straightforward. And it's as simple as this. Kawiki, he took a build the court, and he froze the entire court

. No, I think it's probably not worth taking every time. Let me ask you, if you would, to speak to the question of validity of the 553, in particular attention to Kauiki and Zedall. I would... If I could just make one more point very quickly, which is, regardless of how this court comes out, MJMOL, the verdict cannot be reinstated. There are two reasons for that. One is the exclusion of Henry's after trial. And the second is the judges finding that the 100% infringement was against a great way to be able to... I just wanted to make sure that there are no circumstances that the verdicts come back and be reinstated. You mean there would be a reinstatement of the judges of regional new trial order? That's the way of looking at it, you're on it, yes. I mean, wouldn't that be practical impact of what would happen? I think if you were to refuse the JMOL, you would have to go back for a new trial. For those two reasons, both of those are discretionary decisions within the district court's discretion. But that would be something we would have to say to the district judge. You now have the case back where you decide what to do with it. District Judge might have a different view of it depending on anything we might say, as was independent. Understood. Okay. Can I address a Kawiki? Sure, I would please. The Kawiki argument is, again, it's also very straightforward. And it's as simple as this. Kawiki, he took a build the court, and he froze the entire court. And that's what he taught that he did. That is, that inherently must be, each and every element of the court. Because the patent describes exactly the same thing. The patent says, take the blood from the built the court, trial preserved. And then the patent adds some claim elements to that. It says, and have stem cells and amounts of fish and fern adult. But the point is, Kawiki did exactly what the patent taught. And he taught exactly what the patent taught. Very similar to Christopher Sprouts in this way. The built the court blood has been around forever. The built the court blood has stem cells. It was admitted at trial by their expert. Yes, we know now that there were stem cells in those built the court units. That's it. I mean, that, and there is really no difference. And there has been no suggested difference in Kawiki's methodology. And what Kawiki taught. Okay. What about the enablement issue? And connection with the various prior references? I mean, Kawiki does say the use, maybe useful as one of the sources of hematopoietic progenitor cells for marrow transplantation. Of course, progenitor cells, presumably, was the expression that was used in the after-use. And then, as to the flow of potent progenitor cells at another point. Testimony was those are stem cells, but that was the same thing. Okay. But in any event, so there's a reference to the transplantation, but there's no, the argument, as I understand it in part, on the other side is that there was no enablement of the pet dispensation

. And that's what he taught that he did. That is, that inherently must be, each and every element of the court. Because the patent describes exactly the same thing. The patent says, take the blood from the built the court, trial preserved. And then the patent adds some claim elements to that. It says, and have stem cells and amounts of fish and fern adult. But the point is, Kawiki did exactly what the patent taught. And he taught exactly what the patent taught. Very similar to Christopher Sprouts in this way. The built the court blood has been around forever. The built the court blood has stem cells. It was admitted at trial by their expert. Yes, we know now that there were stem cells in those built the court units. That's it. I mean, that, and there is really no difference. And there has been no suggested difference in Kawiki's methodology. And what Kawiki taught. Okay. What about the enablement issue? And connection with the various prior references? I mean, Kawiki does say the use, maybe useful as one of the sources of hematopoietic progenitor cells for marrow transplantation. Of course, progenitor cells, presumably, was the expression that was used in the after-use. And then, as to the flow of potent progenitor cells at another point. Testimony was those are stem cells, but that was the same thing. Okay. But in any event, so there's a reference to the transplantation, but there's no, the argument, as I understand it in part, on the other side is that there was no enablement of the pet dispensation. Agreed. I guess there are two points here. First of all, that enablement argument only goes to the 553. The 681 is a composition. And enabling the composition is right there. And Kawiki saying, I created these compositions. Right, but we're talking about the bi- So we're talking about the 553. As to the 553, the enablement argument that they made, if you look at Dr. Bernstein's testimony, was that it wasn't enabled because people wouldn't believe there were stem cells in it until somebody actually did an injection and a transplant. Now, that argument I submitted is really end-or-round, inherently. We know that there were stem cells in it. Okay. And so the enablement argument is just an attempt to end-or-round inherently. We know that enablement under 102 is different than enablement under 112. The suggestion is enough. It's clear in this court's opinion. And so what we have here is clearly the suggestion. So the question is, what's not enabled? Because the only element that isn't inherent is injection into a human. That's it. That's the fourth element of the method. And the evidence on that is what you do is you hook up an IV, which is what they- And they knew how to do that because they transplant bone marrow all the time. And if you read Kawiki, that's clearly what he's doing. He's comparing this to bone marrow. He's saying, is this good enough for bone marrow? So what's not enabled would be my question

. Agreed. I guess there are two points here. First of all, that enablement argument only goes to the 553. The 681 is a composition. And enabling the composition is right there. And Kawiki saying, I created these compositions. Right, but we're talking about the bi- So we're talking about the 553. As to the 553, the enablement argument that they made, if you look at Dr. Bernstein's testimony, was that it wasn't enabled because people wouldn't believe there were stem cells in it until somebody actually did an injection and a transplant. Now, that argument I submitted is really end-or-round, inherently. We know that there were stem cells in it. Okay. And so the enablement argument is just an attempt to end-or-round inherently. We know that enablement under 102 is different than enablement under 112. The suggestion is enough. It's clear in this court's opinion. And so what we have here is clearly the suggestion. So the question is, what's not enabled? Because the only element that isn't inherent is injection into a human. That's it. That's the fourth element of the method. And the evidence on that is what you do is you hook up an IV, which is what they- And they knew how to do that because they transplant bone marrow all the time. And if you read Kawiki, that's clearly what he's doing. He's comparing this to bone marrow. He's saying, is this good enough for bone marrow? So what's not enabled would be my question. And the question I think you're on to would ask is, was there evidence on that? And I would say no. Now there's an issue. Who has the bird? But there's no evidence from their side explaining what's not enabled about that particular claim element. Now, one more further question. It's a very lengthy patent, 64 columns, I think, in both cases or roughly. And I labored through all 128 columns. Actually, I did. I cheated. We had only one of the specifications. And I was looking for what was in the patent that wasn't either an explicit reference to prior R-Cord. It wasn't effectively covered by some of the prior references that are in the record. What I did find was the mouse examples, which appeared to be new, is that your view that there's anything else of significance. I wasn't sure about the essays. But is there anything other than the mouse examples? And please tell me about the essays, whether this is new in the patent. It wasn't the prior. The essays are identical to the clue you can literally put them side by side. The mouse studies, this was an argument that wasn't made. And what I will say on the score, I'll try to be as clean as I can. Mouse studies weren't new. Someone named Barnes did its identical mouse studies 20 years earlier. That was an evidence at trial. There was no rebuttal to Barnes. In other words, Barnes was presented by Dr. Wagner and I were at the expert

. And the question I think you're on to would ask is, was there evidence on that? And I would say no. Now there's an issue. Who has the bird? But there's no evidence from their side explaining what's not enabled about that particular claim element. Now, one more further question. It's a very lengthy patent, 64 columns, I think, in both cases or roughly. And I labored through all 128 columns. Actually, I did. I cheated. We had only one of the specifications. And I was looking for what was in the patent that wasn't either an explicit reference to prior R-Cord. It wasn't effectively covered by some of the prior references that are in the record. What I did find was the mouse examples, which appeared to be new, is that your view that there's anything else of significance. I wasn't sure about the essays. But is there anything other than the mouse examples? And please tell me about the essays, whether this is new in the patent. It wasn't the prior. The essays are identical to the clue you can literally put them side by side. The mouse studies, this was an argument that wasn't made. And what I will say on the score, I'll try to be as clean as I can. Mouse studies weren't new. Someone named Barnes did its identical mouse studies 20 years earlier. That was an evidence at trial. There was no rebuttal to Barnes. In other words, Barnes was presented by Dr. Wagner and I were at the expert. There was no rebuttal to Barnes. However, we're now in obviously, I suppose, because now we're trying to combine references. And I'm not trying to combine references for the anticipation argument, at least. So what I would say to you is, I don't think the mouse studies get around the anticipation of Kuigi. Because if anything, what they proved is that an animal, that there was reconstitution using the only blood in an animal. But to the extent that that's what was relied on, it's not. It was done 20 years earlier. Okay. Thanks. Thank you. Yes, I'll do that for a little bit. Mr. Andre. Thank you. One of the things that the Court probably noticed about the defendant's argument here today and also in the brief is they talk about what was not presented at trial. What shouldn't have presented at trial? They do not focus on what was actually presented at trial and what the jury relied upon and coming down with this jury. It's a bird. And very detailed special bird form that was prepared by the defendant's. Making infringement very difficult and invalidated very easily. The jury went through that special bird form based on the substantial evidence and found that the patent was valid in the French. Judge protests about the sale and the 553. Counsel said all about the jury session, sale to the transplant. But if you look at the actual version, special bird form, it's a sale to a third party. There is a contradiction

. There was no rebuttal to Barnes. However, we're now in obviously, I suppose, because now we're trying to combine references. And I'm not trying to combine references for the anticipation argument, at least. So what I would say to you is, I don't think the mouse studies get around the anticipation of Kuigi. Because if anything, what they proved is that an animal, that there was reconstitution using the only blood in an animal. But to the extent that that's what was relied on, it's not. It was done 20 years earlier. Okay. Thanks. Thank you. Yes, I'll do that for a little bit. Mr. Andre. Thank you. One of the things that the Court probably noticed about the defendant's argument here today and also in the brief is they talk about what was not presented at trial. What shouldn't have presented at trial? They do not focus on what was actually presented at trial and what the jury relied upon and coming down with this jury. It's a bird. And very detailed special bird form that was prepared by the defendant's. Making infringement very difficult and invalidated very easily. The jury went through that special bird form based on the substantial evidence and found that the patent was valid in the French. Judge protests about the sale and the 553. Counsel said all about the jury session, sale to the transplant. But if you look at the actual version, special bird form, it's a sale to a third party. There is a contradiction. And under the doctors invited error, if the jury's verdict can be reconciled, then it should be so. There is clearly a sale to a third party. And we would have even argued that there is a sale to a transplanter. If the transplanter is an agent of family, which obviously they are, they're doing a service for the family. Can I ask you just a question about that since you're talking about the jury verdict. So on that number, question 15, when they talk about the 553. The question is, what is the number of units that infring? Can you enlighten me as to other than out of thin air, where they got these number of units? I mean, was this with these numbers that one side was the other presented? They were the ones that were presented by the defendant's expert witness. And what did they represent? They represent the actual number of court blood units that were transplanted. The number of that were transplanted? Yes. So these are ones that were actually went through the entire four-step process of being collected, pro-preserved, followed, and transplanted for chemotherapy, for reconstitution. And all the numbers of the damages came from the damages expert with the exception of the world jury. With respect to the quickie reference, the minute we went step back from the survey that asked this. These are pioneering patents. No one had ever shown that stem cells were in court blood. They suspected that there was never shown. It was the mice studies that were quintessential to show that they were actually there. They had a very specific genetic strand mice that were needed to show this. One of the inventors had an event, a strand mice, that you could show, that the stem cells that they were recovering from were actually transplanted stem cells, or certain genetic markers. That was key to this whole process. There's no way that a physician is going to inject court blood into a patient once their bone marrow has been ablated. In fact, if you look at the prior art of this day, it's back in 1974, 1979, 1981, 1983. There were no transplants. In the thousands of people who were dying every single year because they could not get stem cell transplants. No one was willing to try this

. And under the doctors invited error, if the jury's verdict can be reconciled, then it should be so. There is clearly a sale to a third party. And we would have even argued that there is a sale to a transplanter. If the transplanter is an agent of family, which obviously they are, they're doing a service for the family. Can I ask you just a question about that since you're talking about the jury verdict. So on that number, question 15, when they talk about the 553. The question is, what is the number of units that infring? Can you enlighten me as to other than out of thin air, where they got these number of units? I mean, was this with these numbers that one side was the other presented? They were the ones that were presented by the defendant's expert witness. And what did they represent? They represent the actual number of court blood units that were transplanted. The number of that were transplanted? Yes. So these are ones that were actually went through the entire four-step process of being collected, pro-preserved, followed, and transplanted for chemotherapy, for reconstitution. And all the numbers of the damages came from the damages expert with the exception of the world jury. With respect to the quickie reference, the minute we went step back from the survey that asked this. These are pioneering patents. No one had ever shown that stem cells were in court blood. They suspected that there was never shown. It was the mice studies that were quintessential to show that they were actually there. They had a very specific genetic strand mice that were needed to show this. One of the inventors had an event, a strand mice, that you could show, that the stem cells that they were recovering from were actually transplanted stem cells, or certain genetic markers. That was key to this whole process. There's no way that a physician is going to inject court blood into a patient once their bone marrow has been ablated. In fact, if you look at the prior art of this day, it's back in 1974, 1979, 1981, 1983. There were no transplants. In the thousands of people who were dying every single year because they could not get stem cell transplants. No one was willing to try this. That's the reason the prior art does not demonstrate stem cells. It doesn't demonstrate stem cells. It's true that coikie doesn't mention stem cells, although Vidala does. That's prior art. I don't understand what significance there is in the fact that as a matter of scientific proof, there was a failure to demonstrate that there was something in there that was therapeutically effective. That was called stem cells, as opposed to simply knowing that it was therapeutically useful. No one had ever taken those cells in court blood and transplanted them into an animal or a human and changed long-term hematocotic reconstitution. Does it come down to the mice? The mice were a one-day-one. What was that what your contribution was? Is to go from coikie. When you went from coikie to this patent, is the mice examples? Was that really the major step that gives you an advance over coikie and Vidala? Well, there were several. With coikie, for example, coikie only throws down one milliliter of cells. Even defense on a tetanide expert stated that would not be anything therapeutic useful. So there's no inherently argument. Coikie actually taught away from using stem cells because if you look at coikies recovery rates, when they crowd-preserved the cells over 50%. We're not going to be revived. So what coikie actually did, what all the other cryoactually did, was actually teach away from transplanting. Because you get a small volume anyway of this core blood. And all that prior art taught that when you crowd-preserved these cells, the recovery rates were very low. And sometimes it seemed down to like 20%. What art and venerate was able to do was to actually show that when you actually crowd-preserved these cells, you can use a smaller amount. And they demonstrated this by clicking over 104 blood samples, clicking the volumes of the volume, other cells and all the assays. They did animal studies. And with the 553, they actually did the very first core blood transplant. That's not disputed

. That's the reason the prior art does not demonstrate stem cells. It doesn't demonstrate stem cells. It's true that coikie doesn't mention stem cells, although Vidala does. That's prior art. I don't understand what significance there is in the fact that as a matter of scientific proof, there was a failure to demonstrate that there was something in there that was therapeutically effective. That was called stem cells, as opposed to simply knowing that it was therapeutically useful. No one had ever taken those cells in court blood and transplanted them into an animal or a human and changed long-term hematocotic reconstitution. Does it come down to the mice? The mice were a one-day-one. What was that what your contribution was? Is to go from coikie. When you went from coikie to this patent, is the mice examples? Was that really the major step that gives you an advance over coikie and Vidala? Well, there were several. With coikie, for example, coikie only throws down one milliliter of cells. Even defense on a tetanide expert stated that would not be anything therapeutic useful. So there's no inherently argument. Coikie actually taught away from using stem cells because if you look at coikies recovery rates, when they crowd-preserved the cells over 50%. We're not going to be revived. So what coikie actually did, what all the other cryoactually did, was actually teach away from transplanting. Because you get a small volume anyway of this core blood. And all that prior art taught that when you crowd-preserved these cells, the recovery rates were very low. And sometimes it seemed down to like 20%. What art and venerate was able to do was to actually show that when you actually crowd-preserved these cells, you can use a smaller amount. And they demonstrated this by clicking over 104 blood samples, clicking the volumes of the volume, other cells and all the assays. They did animal studies. And with the 553, they actually did the very first core blood transplant. That's not disputed. In a human. In a human. In eight years after the application. It was part of the CIP application. It was not at the time of this application, nothing had been done other than mice. On 553, it was a CIP in which there was actually a human transplant. It's in the actual application itself. It's the last column that was added in. The 553 patent has the human transplantation evidence. So that is a big distinction between all of our prior art. Okay, we are out of time. Let's report the flow of your journey. I do have a question. I don't know which of you might answer it. But when you find for us and point us to where in the record, the issues of validity were raised by the by counter claim. Or affirmative defense. Is this something that we should ask you to do? We are happy to have a head reserve two minutes for a certain model. What is the cross appeal for the company? Yes, all right. But you will make a note also to provide us for this information. Absolutely, our allowable piece of vision. That would be fine. And please check with Mr. Andre so that if he wants to argue with you about something, you can put it all together. Okay

. In a human. In a human. In eight years after the application. It was part of the CIP application. It was not at the time of this application, nothing had been done other than mice. On 553, it was a CIP in which there was actually a human transplant. It's in the actual application itself. It's the last column that was added in. The 553 patent has the human transplantation evidence. So that is a big distinction between all of our prior art. Okay, we are out of time. Let's report the flow of your journey. I do have a question. I don't know which of you might answer it. But when you find for us and point us to where in the record, the issues of validity were raised by the by counter claim. Or affirmative defense. Is this something that we should ask you to do? We are happy to have a head reserve two minutes for a certain model. What is the cross appeal for the company? Yes, all right. But you will make a note also to provide us for this information. Absolutely, our allowable piece of vision. That would be fine. And please check with Mr. Andre so that if he wants to argue with you about something, you can put it all together. Okay. I'm doing cross appeal. Okay, just on the cross appeal. Just on the cross appeal, then I will address one issue, which is Mr. Andre said that we can only throw one milliliter. And in fact, the evidence on that is that the contrary evidence is that he throws an entire court. There are two pieces of evidence. At the first is Dr. Wagner's testimony. That's the appendix 38 or 3 where on redirect, he says. What is the observation made in that article? As you understand it, as a personal order in skill, you have a portion of each of the samples was cultured. And as we are all the tables around, however it says the rest was processed for cryo preservation. So he stored the rest of it. So Quique he stored the whole. And in fact, if you look at appendix 13346, which is the Quique article, you will see that that's what he says he did. So to the extent there's anything here that turns on whether he only throws one milliliter, whether he throws the entire court, he clearly throws the entire court and taught that you would freeze the entire court. There was one issue back on infringement. Am I not allowed to address that? We assume that it's well covered in your brief. I believe it is your honor, but it is important going to the issue of what those tests that we did show. And we've pretty clear in every what we say the evidence was on our tests. Thank you. Thank you both. The case is second under submission.

The other court is in session. Thank you. To continue from where we left off, the next case is number 051490, Fire and Stem Therapeutics against by us, Mr. Andre. Please report Paul Andre, representing the Palantin Patentee Pharmacintherapeutics. I apologize for the impropriary poetry for today, but I am prepared to talk about a lot of substantial evidence that was presented to the jury, in which the jury base is decision on in this case. And as this whole basis for pharmacism is a pill, what is substantial evidence to support the jury? The jury is verdict. In this case, pharmacists present evidence in the form of scientific publications, peer-reviewed scientific publications, newly-endural medicine and the FDA. They prepared to produce internal documents of the company, stating that the goals of these companies were to store stem cells in sufficient amount to reconstitute adults. Are we talking about the 681 patent? I'm sorry, you know what I'm saying? The 681 person, the 553 after that's a thing. The internal documents of the defendant actually states, very specifically, that the goal is to store stem cells in sufficient amount to therapeutic use and that therapeutic use is tar-reviewed adult. We have public statements by these companies in form of advertising and various other contracts, in which they tell the public who buy the core blood, the priorivature, core blood from them. That they can be used for adults, parents, grandparents, et cetera. That marketing material was stick to as being truthful. So there's no debate as to what they were actually selling. We also have fact testimony from at least a dozen witnesses talking about the business plan of these companies that they collect the core blood to be used with the future therapeutic use and that use can be for adult users. Finally, we have expert testimony. The marketing didn't guarantee that it would be useful for reconstitution for adult correct. That's correct. Just in the fact it was a possibility. There are some of the marketing that actually said it can be used. It can be used. There are no guarantees. The guarantee in transplant medicine is not existed. The fact of the matter is you can have more than sufficient number of stem cells and not be successful. It's just because of the various nature of transplant surgery or transplant procedures. You never know. There are no guarantees and no one would be foolish enough to make a guarantee. But they did say on several of their marketing material they can be used for the adults, they can be used for the mother, they can be used for the parents, grandparents, et cetera. So how do we know if there's infringement up until the point at which if it's got a cover adult and you don't know until you actually try the transplantation? How can you determine infringement other than waiting enough time so that there's actually successful transplantation for adult? The claims of the 681 patent require a sufficient number of cells. It's not a successful transplantation. Well what is that number stem cells of progenitor cell? The claims are called sufficient number of stem cells. And how that is determined? There is no. You cannot count stem cells. You can look at the surrogate acids that were used for the first time in stem cells to show transplantation that the emitteres came up with. The surrogate acids can be in a form of colony forming the unit acids. They can be towed nucleate cells. They can be CD34. They can be void. So different parties use different surrogate acids. But those acids are discussed in the patent. And the couple of the defendants in this case actually set their standard operating procedures to actually screen those type of acids to ensure that they had a sufficient number of cells. So the question here is- Is that correct? It was the screaming to determine the sufficient number of cells for transplantation to adult. It was for therapeutic utility. Isn't there a difference between therapeutic utility and successful transplantation into adult? And if checker instance there's not. Why not? I thought the reason you got a patent and the reason we're here is because you limited your patent to use it by adult. The adults obviously cover children's well. Does the patent cover just a duck? It covers adult and children. It has to be sufficient amount for adults but also that would be sufficient amount of children as well obviously. But it has to be a sufficient amount for adult. That's correct. That's all your patent covers. If it's insufficient for adults it's not covered by the patent. That's correct. Okay. So how do we know based on you said the tests they can adopt? That that test tells you definitively that there's a sufficient amount of sun cells for adult. Especially amount of adult. The evidence that was presented to the jury in the sentencing of the jury line up on was based on the scientific publications where they did large clinical studies using adults. Then the medical biology boards of these companies set up a number to be therapeutic to use for. And they sell their product to be used for adults. So there is a logical inference that if they're selling their product to the public saying that you can use this for adults and we will tell you that we will make sure to make sure that you do have enough sufficient numbers to them cells. Then there's a logical inference can be drawn that their screening procedure is screened exactly for that. Well that might be true if they guarantee that whatever they sold would be therapeutic, futically useful for adults. But as you acknowledged earlier there's no guarantee. So I'm having a hard time. You can see that you're drawing some sort of line here between we're going from therapeutically useful to necessarily working successfully for adults. The scientific publications get made the same standard once you reach a threshold amount. They're futically successful, a therapeutic useful amount. Then that should be used for adults. And that's what the FDA, the blue paper said is what? It's the once you have a- But we don't know what that amount is. Well you can't count stem cells, that's correct. So we don't know what the amount is. So when you're saying that the other side is a threshold matter whether they were useful, had determined they were therapeutically useful. But you're conceding that their determination of their therapeutically useful didn't involve knowing how many stem cells were within. That's the basis for the surrogate assays. The surrogate assays are used by doctors every day. There have been thousands and thousands of transplants into adults of these types of stem cells. And stem cells have never been able to be counted. But those surrogate assays they use allow doctors to make life and death decisions as to the matter of fact that they do believe they're a sufficient number of stem cells. And based on these surrogate assays. So what these companies did was set up these type of surrogate assays that would actually allow them to make a determination where they would be therapeutically useful or not. And if you tie that together with what evidence of jury heard, then there's a logical inference that a reasonable juror could not only conclude that those samples of past the screening that their medical biogen was set up had sufficient stem cells. It's almost impossible in France to escape from. So in this particular instance, the evidence that was put forward and was all cited in our briefs, there was just more than substantial. There was overwhelming evidence that was showed that would allow a reasonable jury to make that conclusion. With respect to the 553 pattern, it's understood that this is the method pattern. And there are several steps. And it's understood that all these steps are performed when a court blood sample is transplanted into anybody, a adult child or whatever. That was, there's no dispute as to that whatsoever. The jury was presented with three very specific factual questions that were proposed by the defendants. They had to answer and they formed it to find contributed or infringement. That was the, the, the, the non infringing use, the, the fact that it is a, it is sold in, as a crop reserved, a unit is sold to a third part for direct infringement. And the questions are three through five on the jury voted for. The jury answered all those affirmatively finding that there was contributed or infringement. The sole basis for setting aside that from the district court's perspective was a definition of sale that required ownership or title. Now, is this court? Well, what will it look at sale to whom? Wasn't that also a question about who, were we looking at sale to the family or sale to the transplant? The, the district court set aside the, the jury's verdict based upon the sale of to any third party based on the jury verdict. He denied the, the, the district court didn't mention the, the jury instruction. So the sole basis was the definition of sale, which is the, the whole ownership. And the sole basis saying aside was that since the defendants do not have ownership of this, these court blood samples, they cannot sell it. Well, it's questionable where they have ownership or not. The fact of matter is that that restricted definition of sale has already been rejected by this court. And, I believe it was last year, year four, last case of the NTP versus the RM case, on which sale was defined pursuant to the Black small dictionary, which is a transfer of title or possession. You used, you used, you used transport for a price. So the district court setting aside based on that is clearly error. You never, you didn't argue, did you, the, the sale, it was a sale of constitute to sale of the service. Correct. You weren't arguing that it was the sale of this, it came under 271, the sale of the service. It was an alternative to the bancer trial, that's correct. So it was something, we believe that a sale of the service is also a cover in which you said you want to see it. And that was argued in the alternative to trial when we got the jury instructions in the verdict form. We also believe that the jury did have a reasonable and more than substantial evidence to show that there is a sale of the, the court blood unit, two a third party. I like to reserve a list. Yes, we'll save your re-battle time, Mr. Andre. Mr. Rogers. I actually, Mr. Inglender, like there are. We do. May please the court, I represent the defendant lies, so I'm speaking on behalf of all the defendants here today. If they're very specific factual questions, they may need to address them otherwise. I'm going to take the entire time. How would you get into the thrust of your, I remember me asking about the cross appeal, with the invalidity issues presented at the counter plane in the original case by anyone or where they simply defend. Your Honor, when I heard that question earlier today, I tried to check the record. We do have counter claims, but we had an interest conference, so looking at the record quickly, I'm not sure. I believe we have declared to a judgment conference on the validity. There's nothing in the judgment that would so indicate. The district to a court's judgment, simply on infringement. Your Honor, I'm sorry, I should know the answer to the question, but I don't as I stand here. But the understanding of the law, however, is that whether this issue was raised by counter claim or not, this court still needs to address that issue, even if it were to affirm on. Or do you get that? The series of cases which I read recently would say that, I believe. Even if there's no counter, no defense. That's my understanding of this. Phil Rom, do you know that case? Was that one of the cases you read? Because that case, which I wrote, says, I think, pretty much the contract, the proposition you just articulate, and it's about four years old. And the notion is that if all you've done is to raise a defense, and if you prevail on. And how the part of a that leads to upholding the judgment of infringement, there's no need or justification to go on and decide something else that would give you relief that you never saw, then your complaint or in your counter claim. I understand the point exactly on. I can say that I did do research on this issue because I was concerned about it before I came. Obviously, it wasn't addressed in any of the briefs. And I saw a series of cases which I read to hold pretty clearly that this court needed to address validity. And they did not, to me, turn on the question of whether we had a counter claim or not. I would like the court's indulgence to spend a page on that after this. But when there is an issue of infringement, and even if we were to decide that there is no infringement, nonetheless, we have held that Supreme Court told us in Cardinal Chemical that we needed to review a district court's decision on validity. But here, there was no district court's decision on validity. Oh, yes, sure there was. There was. The jury verdict. But it was in the field. We crossed the field. Not a separate counter claim, though, of validity. Is that in the form of a defense? It's so far as we understand. I'm certain that I have a memory because I was proud of someone. I wasn't involved in this. That when we saw the judgment, we asked the question whether or not there was some kind of the territory judgment issue that needed to be addressed. And you're on, I'm just not repunked in that context. If I could, I had three points that I wanted to focus on today. The first is, as the 681, that J. Mall was appropriate in this case. And the fundamental and root reason for that is that there was no expert testimony given on the critical claim element, the amount sufficient stem cells in an amount sufficient to affect modification of the human adult. If faced with that, science-based claim language, you would have expected someone to provide a standard. What is the amount sufficient for an adult? To look at the individual units stored by the defendants, compare them to the standard and say, these have it, these don't, or they all have it. There was no such testimony in this case. The only expert testimony focused on marketing materials. And actually, that expert testimony was excluded after trial by the district court underdog. The second point I want to focus on is that, and these are related, I understand, the claim language is indefinite. And there are really two pieces to the indefinite assignment. The first piece is, for the extended claim stem cells, it's admitted and undisputed that you cannot identify or quantify a stem cell. So the only way that there could be content given to this claim language would be to go to some kind of surrogate, something that suggests stem cells. Mr. Andre, for the first time today, in this entire litigation has said, we're relying on surrogates, which is fascinating to me, because we have had this issue front and center since we've tried to file letter briefs on summary judgment years ago. The reason that there's a real problem with going to surrogates is, surrogates are expressly disclaimed over and over and over again in the prosecution history. In the prosecution history, faced with prior art that addressed progenitor cells. Now, there's lots of prior art where court blood was taken and examined and shown to have progenitor cells. And over and over again in order to distinguish that prior art, the patent he said, those acids for those kinds of cells do not demonstrate stem cells. There is no way on this record, on this intrinsic record, that the court can construe the amount of sufficient language to be as encompassing a surrogate, i.e. progenitor cells or volume of court blood that show stem cells, because that was repeatedly disclaimed in the prosecution history. It can give an example of the kinds of language that was used. So, wouldn't that relate to when or what stage when might determine whether there is in fact an infringing composition? Well, but I'm on the indefinite point. Okay. The indefinite point is determined as of the time of five. And so, the prosecution history, on this point, says over and over again progenitor cells are not indicative of stem cells. So, we can't construe the claim. The exon I think you're on. But you're construing for the purpose of determining infringement. Well, I'm, but I'm, for the purpose of determining infringement, if a standard were put forward that construdes the amount of sufficient language as being represented by a surrogate. Okay. If that was the claim destruction, I was not the claim destruction of district court adopted here, district court didn't adopt any standard as much as is needed. But if the court were to construe that language, as providing a standard, I say that that language, that standard is disclaimed because in the prosecution history they said over and over again progenitor cells are not indicative of stem cells. They can't then turn around and say this claim language means that if you have a certain number of progenitor cells, then you have the amount of sufficient because they've told the patent office in order to get their patent progenitor cells are not indicative of stem cells. They can't switch like that. So, you're saying never made this argument. So, you're saying under the infringement issue, not the indefiniteness issue, the only way they could prove up infringement was once the court blood had been transplanted successfully into an adult that had been stored. Actually, then they could come in and say, yeah, that infringed it. We've never taken that position, although that is a position that I suppose could have been taken. Nor have they taken that position because, in the reason for that, that's how else it is clear. Well, I know why they haven't taken that position. Well, they haven't taken it because we've never transplanted an adult so they would have zero infringement under that standard. But these two are related, obviously, and this sort of the way the case has preceded. Either it's indefinite because there is no standard. Or if someone comes up with a standard, which is assertive, which I say, you can't do it because it's disclang. Then you need to take that standard and you need to apply science to it. You need an expert. This is very similar, I mean, infringement side of this case, to the centric case, to the judge's deproton. Because you would need to look at individual units. And you would need to ask the question, what is the cell content and how does that compare to the standard? And they didn't do that. They had no expert testing at all. They astute it. Can I just ask you about the contributory infringement of 553 patent? Is it your view or do you know? It's my understanding that our case, we've never decided the issue of whether or not to sale of a service is covered or is not. Can you confirm that or do you think we've decided that we've... I don't think this court needs to reach the issue. The 553 argument is very straightforward and simple. It's based on the jury instruction, which was not objective to. The piece of the jury instruction was not objective to said they must show a sale or offer to sell to a transplanter. They objected to the sale or offer to sell part of that. There was a lot of argument about that. We think that's clearly right under the contributory infringement statute. They actually proposed a language to a transplanter. And there is no evidence at all of any sale or offer to sell to a transplanter. Therefore, under the jury instruction as given, there was no evidence that would support the jury. That's straightforward. That means you don't have to address the issue of a service. We did brief the issue. You don't need to reach it because they just can't cite any evidence of a sale. So, either banks to the transplanter. We have the blood, its crop reserve, its stored, and the family then says family owning the blood, releases it to the transplanter at a particular time. But you don't think there's a sale for the family either. You don't think it's sufficient for a sale. I don't think it's stronger for the transplanter than for the family. I think you just don't need to reach it. We don't believe there's a sale to the family either. It's a matter of quantum, misinterpreted, and of the amount, the evidence of damages. It doesn't really go to the issue of whether, in fact, when there is a transplant, whether the conditions of the claim are being met. I disagree, Your Honor. We're talking about the 553 method patent. And what I'm saying is that the instruction to the jury, whether the method patent was in French, required, because it was a contributory infringement theory on the 553, required a sale or offered a sale to the transplanter. The transplanter being the last entity that performed the final step of the method. On the principle that once we have it in our freezing units, there it stays forever, and will never be sold. The point is there's no sale. See, the contributory infringement statute only talks about a sale or offer a sale, not make you sell or offer a sale. Very specifically, Congress limited the contributory infringement statute. Only the sales are offered a sale. We don't sell. That's undisputed. Not to the transplanter. We don't sell. Because we're banking for the family, and when the time comes to use it, we're simply asked to release it. There's nothing that could... You'd support the notion that it's a sale. There's no money exchanging hands. This is an even more minor area. Charitable activity? No, we're not selling to the transplanter. Somebody argues that we... Obviously, we provide something to pay for. It's to the family. We provide a service to the family. But the jury was instructed, and there was no objection to it, that they needed to prove a sale or offer to sell to a transplanter. No objection. You're going to ask. No, I think it's probably not worth taking every time. Let me ask you, if you would, to speak to the question of validity of the 553, in particular attention to Kauiki and Zedall. I would... If I could just make one more point very quickly, which is, regardless of how this court comes out, MJMOL, the verdict cannot be reinstated. There are two reasons for that. One is the exclusion of Henry's after trial. And the second is the judges finding that the 100% infringement was against a great way to be able to... I just wanted to make sure that there are no circumstances that the verdicts come back and be reinstated. You mean there would be a reinstatement of the judges of regional new trial order? That's the way of looking at it, you're on it, yes. I mean, wouldn't that be practical impact of what would happen? I think if you were to refuse the JMOL, you would have to go back for a new trial. For those two reasons, both of those are discretionary decisions within the district court's discretion. But that would be something we would have to say to the district judge. You now have the case back where you decide what to do with it. District Judge might have a different view of it depending on anything we might say, as was independent. Understood. Okay. Can I address a Kawiki? Sure, I would please. The Kawiki argument is, again, it's also very straightforward. And it's as simple as this. Kawiki, he took a build the court, and he froze the entire court. And that's what he taught that he did. That is, that inherently must be, each and every element of the court. Because the patent describes exactly the same thing. The patent says, take the blood from the built the court, trial preserved. And then the patent adds some claim elements to that. It says, and have stem cells and amounts of fish and fern adult. But the point is, Kawiki did exactly what the patent taught. And he taught exactly what the patent taught. Very similar to Christopher Sprouts in this way. The built the court blood has been around forever. The built the court blood has stem cells. It was admitted at trial by their expert. Yes, we know now that there were stem cells in those built the court units. That's it. I mean, that, and there is really no difference. And there has been no suggested difference in Kawiki's methodology. And what Kawiki taught. Okay. What about the enablement issue? And connection with the various prior references? I mean, Kawiki does say the use, maybe useful as one of the sources of hematopoietic progenitor cells for marrow transplantation. Of course, progenitor cells, presumably, was the expression that was used in the after-use. And then, as to the flow of potent progenitor cells at another point. Testimony was those are stem cells, but that was the same thing. Okay. But in any event, so there's a reference to the transplantation, but there's no, the argument, as I understand it in part, on the other side is that there was no enablement of the pet dispensation. Agreed. I guess there are two points here. First of all, that enablement argument only goes to the 553. The 681 is a composition. And enabling the composition is right there. And Kawiki saying, I created these compositions. Right, but we're talking about the bi- So we're talking about the 553. As to the 553, the enablement argument that they made, if you look at Dr. Bernstein's testimony, was that it wasn't enabled because people wouldn't believe there were stem cells in it until somebody actually did an injection and a transplant. Now, that argument I submitted is really end-or-round, inherently. We know that there were stem cells in it. Okay. And so the enablement argument is just an attempt to end-or-round inherently. We know that enablement under 102 is different than enablement under 112. The suggestion is enough. It's clear in this court's opinion. And so what we have here is clearly the suggestion. So the question is, what's not enabled? Because the only element that isn't inherent is injection into a human. That's it. That's the fourth element of the method. And the evidence on that is what you do is you hook up an IV, which is what they- And they knew how to do that because they transplant bone marrow all the time. And if you read Kawiki, that's clearly what he's doing. He's comparing this to bone marrow. He's saying, is this good enough for bone marrow? So what's not enabled would be my question. And the question I think you're on to would ask is, was there evidence on that? And I would say no. Now there's an issue. Who has the bird? But there's no evidence from their side explaining what's not enabled about that particular claim element. Now, one more further question. It's a very lengthy patent, 64 columns, I think, in both cases or roughly. And I labored through all 128 columns. Actually, I did. I cheated. We had only one of the specifications. And I was looking for what was in the patent that wasn't either an explicit reference to prior R-Cord. It wasn't effectively covered by some of the prior references that are in the record. What I did find was the mouse examples, which appeared to be new, is that your view that there's anything else of significance. I wasn't sure about the essays. But is there anything other than the mouse examples? And please tell me about the essays, whether this is new in the patent. It wasn't the prior. The essays are identical to the clue you can literally put them side by side. The mouse studies, this was an argument that wasn't made. And what I will say on the score, I'll try to be as clean as I can. Mouse studies weren't new. Someone named Barnes did its identical mouse studies 20 years earlier. That was an evidence at trial. There was no rebuttal to Barnes. In other words, Barnes was presented by Dr. Wagner and I were at the expert. There was no rebuttal to Barnes. However, we're now in obviously, I suppose, because now we're trying to combine references. And I'm not trying to combine references for the anticipation argument, at least. So what I would say to you is, I don't think the mouse studies get around the anticipation of Kuigi. Because if anything, what they proved is that an animal, that there was reconstitution using the only blood in an animal. But to the extent that that's what was relied on, it's not. It was done 20 years earlier. Okay. Thanks. Thank you. Yes, I'll do that for a little bit. Mr. Andre. Thank you. One of the things that the Court probably noticed about the defendant's argument here today and also in the brief is they talk about what was not presented at trial. What shouldn't have presented at trial? They do not focus on what was actually presented at trial and what the jury relied upon and coming down with this jury. It's a bird. And very detailed special bird form that was prepared by the defendant's. Making infringement very difficult and invalidated very easily. The jury went through that special bird form based on the substantial evidence and found that the patent was valid in the French. Judge protests about the sale and the 553. Counsel said all about the jury session, sale to the transplant. But if you look at the actual version, special bird form, it's a sale to a third party. There is a contradiction. And under the doctors invited error, if the jury's verdict can be reconciled, then it should be so. There is clearly a sale to a third party. And we would have even argued that there is a sale to a transplanter. If the transplanter is an agent of family, which obviously they are, they're doing a service for the family. Can I ask you just a question about that since you're talking about the jury verdict. So on that number, question 15, when they talk about the 553. The question is, what is the number of units that infring? Can you enlighten me as to other than out of thin air, where they got these number of units? I mean, was this with these numbers that one side was the other presented? They were the ones that were presented by the defendant's expert witness. And what did they represent? They represent the actual number of court blood units that were transplanted. The number of that were transplanted? Yes. So these are ones that were actually went through the entire four-step process of being collected, pro-preserved, followed, and transplanted for chemotherapy, for reconstitution. And all the numbers of the damages came from the damages expert with the exception of the world jury. With respect to the quickie reference, the minute we went step back from the survey that asked this. These are pioneering patents. No one had ever shown that stem cells were in court blood. They suspected that there was never shown. It was the mice studies that were quintessential to show that they were actually there. They had a very specific genetic strand mice that were needed to show this. One of the inventors had an event, a strand mice, that you could show, that the stem cells that they were recovering from were actually transplanted stem cells, or certain genetic markers. That was key to this whole process. There's no way that a physician is going to inject court blood into a patient once their bone marrow has been ablated. In fact, if you look at the prior art of this day, it's back in 1974, 1979, 1981, 1983. There were no transplants. In the thousands of people who were dying every single year because they could not get stem cell transplants. No one was willing to try this. That's the reason the prior art does not demonstrate stem cells. It doesn't demonstrate stem cells. It's true that coikie doesn't mention stem cells, although Vidala does. That's prior art. I don't understand what significance there is in the fact that as a matter of scientific proof, there was a failure to demonstrate that there was something in there that was therapeutically effective. That was called stem cells, as opposed to simply knowing that it was therapeutically useful. No one had ever taken those cells in court blood and transplanted them into an animal or a human and changed long-term hematocotic reconstitution. Does it come down to the mice? The mice were a one-day-one. What was that what your contribution was? Is to go from coikie. When you went from coikie to this patent, is the mice examples? Was that really the major step that gives you an advance over coikie and Vidala? Well, there were several. With coikie, for example, coikie only throws down one milliliter of cells. Even defense on a tetanide expert stated that would not be anything therapeutic useful. So there's no inherently argument. Coikie actually taught away from using stem cells because if you look at coikies recovery rates, when they crowd-preserved the cells over 50%. We're not going to be revived. So what coikie actually did, what all the other cryoactually did, was actually teach away from transplanting. Because you get a small volume anyway of this core blood. And all that prior art taught that when you crowd-preserved these cells, the recovery rates were very low. And sometimes it seemed down to like 20%. What art and venerate was able to do was to actually show that when you actually crowd-preserved these cells, you can use a smaller amount. And they demonstrated this by clicking over 104 blood samples, clicking the volumes of the volume, other cells and all the assays. They did animal studies. And with the 553, they actually did the very first core blood transplant. That's not disputed. In a human. In a human. In eight years after the application. It was part of the CIP application. It was not at the time of this application, nothing had been done other than mice. On 553, it was a CIP in which there was actually a human transplant. It's in the actual application itself. It's the last column that was added in. The 553 patent has the human transplantation evidence. So that is a big distinction between all of our prior art. Okay, we are out of time. Let's report the flow of your journey. I do have a question. I don't know which of you might answer it. But when you find for us and point us to where in the record, the issues of validity were raised by the by counter claim. Or affirmative defense. Is this something that we should ask you to do? We are happy to have a head reserve two minutes for a certain model. What is the cross appeal for the company? Yes, all right. But you will make a note also to provide us for this information. Absolutely, our allowable piece of vision. That would be fine. And please check with Mr. Andre so that if he wants to argue with you about something, you can put it all together. Okay. I'm doing cross appeal. Okay, just on the cross appeal. Just on the cross appeal, then I will address one issue, which is Mr. Andre said that we can only throw one milliliter. And in fact, the evidence on that is that the contrary evidence is that he throws an entire court. There are two pieces of evidence. At the first is Dr. Wagner's testimony. That's the appendix 38 or 3 where on redirect, he says. What is the observation made in that article? As you understand it, as a personal order in skill, you have a portion of each of the samples was cultured. And as we are all the tables around, however it says the rest was processed for cryo preservation. So he stored the rest of it. So Quique he stored the whole. And in fact, if you look at appendix 13346, which is the Quique article, you will see that that's what he says he did. So to the extent there's anything here that turns on whether he only throws one milliliter, whether he throws the entire court, he clearly throws the entire court and taught that you would freeze the entire court. There was one issue back on infringement. Am I not allowed to address that? We assume that it's well covered in your brief. I believe it is your honor, but it is important going to the issue of what those tests that we did show. And we've pretty clear in every what we say the evidence was on our tests. Thank you. Thank you both. The case is second under submission