[00:00:00] Speaker 01: Our third case this morning is number 24, 14LH, progenic bio versus serotonin therapeutic. [00:00:08] Speaker 01: Ms. [00:00:08] Speaker 01: Morrison? [00:00:09] Speaker 01: Good morning, Your Honor. [00:00:12] Speaker 00: This is Maya Pace, the court. [00:00:15] Speaker 00: The district court's decision here must be reversed on straightforward application of chocobarty, of myriad, and of AMP. [00:00:26] Speaker 00: Claims of the six-month set of patents at issue in this case are composition of matter claims, and they require an artificial genetically engineered cultured host cell that includes an artificial genetically engineered recombinant nucleic acid molecule which has nucleic acid material from two organisms chemically joined together into a single new nucleic acid molecule. [00:00:53] Speaker 00: It is undisputed between the parties [00:00:56] Speaker 00: that neither the cultured host cell nor recombinant nucleic acid molecule previously existed in nature for the work of the inventors. [00:01:06] Speaker 00: And disruptive experts admitted that, and we have the sites in our brief, but in particular, disruptive experts were asked at their deposition whether the cultured host cells [00:01:17] Speaker 00: features required by the authority claims it existed in nature. [00:01:21] Speaker 00: And the answer given was no. [00:01:24] Speaker 01: OK, let me tell you what I see the problem is here. [00:01:27] Speaker 01: I mean, I think you make a good point that Funk Brothers is different in this case. [00:01:32] Speaker 01: Let's put Funk Brothers aside. [00:01:33] Speaker 01: And it seems to me that you make a good case that the use of this RH10 vector for the use in gene therapy was an invention which would be one-on-one eligible. [00:01:48] Speaker 01: The problem that I see is that the claim is so much broader than that. [00:01:52] Speaker 01: Indeed, it seems to cover, and I think the library talks about this, all sorts of possible uses of the RH10 vector together with some other gene sequence. [00:02:11] Speaker 01: for purposes that are unknown at this point. [00:02:16] Speaker 01: So why under certain, I mean one of the main purposes of 101 is to prevent preemption and to confine the inventor to what was invented. [00:02:27] Speaker 01: Why shouldn't this be a situation in which the invention is limited to the use of the RH10 vector in gene therapy rather than [00:02:37] Speaker 01: the broad claim of any RH10 vector attached to some other undefined thing which might be useful in some undefined situation. [00:02:51] Speaker 01: So what's the answer to that? [00:02:54] Speaker 01: Why should the breadth of this claim be accepted? [00:02:57] Speaker 00: So, Your Honor, the different functions that we listed in our briefing and that we talked about [00:03:06] Speaker 00: using a bacterial cell to create multiple copies of plasmids, using mammalian cells to create gene therapies, which is the function your honor just talked about, using mammalian cells to create capsid proteins, which can be used for diagnostics, and using mammalian cells to create empty capsids. [00:03:23] Speaker 00: All of those relate in some way to gene therapy. [00:03:27] Speaker 00: The bacterial cells create these capsid, or excuse me, create these [00:03:32] Speaker 00: additional placements which can then be put into mammalian cells and those mammalian cells can be used then either to create a complete gene therapy or... So why not require a method claim that describes those uses rather than just saying that [00:03:52] Speaker 01: any RH10 attached to anything which isn't an ABT is patentable. [00:03:59] Speaker 01: An incredibly broad claim that, you know, that reach things that are unknown at this point. [00:04:05] Speaker 00: Well, Your Honor, I don't think it's an incredibly broad claim. [00:04:08] Speaker 00: I understand what you're saying, but I don't think it's incredibly broad because it is, and it's a new composition of matter that's different than what was in nature, and that's really the question. [00:04:19] Speaker 00: because this case requires that RH10-capsid protein sequence, which did exist in nature before, to be chemically joined with something else. [00:04:30] Speaker 01: But it can be anything that's not an AVV. [00:04:33] Speaker 00: That's correct. [00:04:34] Speaker 00: It can be any sequence that is not an AVV sequence. [00:04:37] Speaker 01: Sounds almost as though it's a way to overcome myriad, is to say, well, the isolated RH10 wouldn't be cannibal, but if we say it's attached to something else, covering the whole world, then it suddenly becomes pathway. [00:04:54] Speaker 00: Well, it's not covering the whole world, because it then has to be put into this cultured host cell. [00:04:59] Speaker 00: And as we describe in our brief, that cultured host cell does have those four functions that I was just talking about. [00:05:05] Speaker 00: But respectfully, Your Honor, Myriad is much less patentable than this invention. [00:05:12] Speaker 00: Because in Myriad, the gene at issue, the cDNA claims in Myriad, the gene at issue, the claims at issue, require taking pieces [00:05:22] Speaker 00: from two different pieces from the same gene and joining them together. [00:05:26] Speaker 00: And the Supreme Court said, that is patentable. [00:05:29] Speaker 00: We take two pieces from the same gene in Korea and join them together. [00:05:33] Speaker 00: That's patentable. [00:05:34] Speaker 00: Here, the inventors took a piece of DNA from the AAV-RH10 virus, and they joined it to a non-AAV set of melanocytes. [00:05:47] Speaker 00: That's correct, Your Honor. [00:05:49] Speaker 00: Any non-AAV. [00:05:50] Speaker 00: But it's a non-AAV set of nucleic acids. [00:05:52] Speaker 00: It can't be AAV. [00:05:54] Speaker 00: And there is evidence where AAV-RH10 is joined to AAV2, for example. [00:06:02] Speaker 03: The client does say it has to be heterologist. [00:06:05] Speaker 00: Yes. [00:06:06] Speaker 00: What does that mean? [00:06:07] Speaker 00: Heterologist means it's from a different organism. [00:06:10] Speaker 03: It's not AAV, it's AAV. [00:06:12] Speaker 00: Correct. [00:06:12] Speaker 00: It cannot be from any AAV. [00:06:14] Speaker 00: Not just AAV-RH10, but any AAV. [00:06:16] Speaker 03: I have a question also about the first phrase, the AAV VP vector, I guess, vector protein 1 capsid protein. [00:06:23] Speaker 03: Is that the shell? [00:06:25] Speaker 03: Do I understand that correctly? [00:06:26] Speaker 00: It is. [00:06:26] Speaker 00: So the capsid, the AAV virus, I don't know if you've seen pictures of coronavirus, it sort of looks like a ball. [00:06:34] Speaker 00: The outside of the virus is this cap ball of proteins called a capsid. [00:06:40] Speaker 00: The claim requires the one of the proteins, the BP1, and one requires BP1, which is one of the capsid proteins that forms this protein ball. [00:06:50] Speaker 00: It requires the sequence of that capsid protein, which is why the claim is broader than just gene therapy, because those capsid proteins, those cells, have uses. [00:07:01] Speaker 00: And then the empty capsid, without anything in it, without a gene in it for gene therapy, those have uses. [00:07:08] Speaker 00: And then, of course, the gene therapy itself has uses. [00:07:11] Speaker 00: And the bacterial cells that can be used in the process of making all of these things, those have uses. [00:07:17] Speaker 00: That's why the claim is broader than just the gene therapy, because there are a variety of cells that have a variety of uses. [00:07:25] Speaker 03: One of the things that the district court judge said below was that the claim did not expressly [00:07:33] Speaker 03: recite those functions that you talked about that are clear from the specification. [00:07:38] Speaker 03: Do you know if our case law requires the claimant to recite those functions? [00:07:42] Speaker 00: It does not. [00:07:43] Speaker 00: Does the Supreme Court use law in court? [00:07:44] Speaker 00: It does not. [00:07:45] Speaker 00: And indeed, myriad, there is no function recited from those CDNA claims that the Supreme Court held those to be patentable. [00:07:54] Speaker 00: And I believe it's undisputed between parties [00:07:57] Speaker 00: that material only requires markedly different structure. [00:08:01] Speaker 00: It does not also require markedly different function. [00:08:04] Speaker 01: OK, so to the extent that you're relying on unclaimed functions, that doesn't really help you here. [00:08:13] Speaker 01: I mean, you have to put your eggs in the markedly different structure basket, right? [00:08:20] Speaker 00: I have two answers to that. [00:08:22] Speaker 00: One, the case law does not require the market the different function to be in the claim. [00:08:27] Speaker 01: Yeah, but generally under 101, there's a large body of case law saying that you can't say something is 101 eligible because of things that you didn't put in the claim. [00:08:38] Speaker 00: I think that those are largely method claims, Your Honor. [00:08:42] Speaker 01: So there are- It's a general principle. [00:08:44] Speaker 01: I mean, it strikes me as that it would be pretty unusual to say that you can say that something is one-on-one eligible because it has a function that wasn't claimed. [00:08:53] Speaker 03: Does Marriott have the function of it? [00:08:56] Speaker 01: It does not. [00:08:57] Speaker 03: Does, um, Dr. Brady have the function of it? [00:09:00] Speaker 00: It does, it does not. [00:09:01] Speaker 00: But, um, I'm sorry. [00:09:04] Speaker 03: I remember that it also talked about remarkably different structure and remarkably different function. [00:09:10] Speaker 00: It does talk about both. [00:09:11] Speaker 00: But in Chakrabarti, there were a number of plasmids that were transferred. [00:09:16] Speaker 01: But in Chakrabarti, there was a function aspect to the plan. [00:09:21] Speaker 00: I don't agree, Your Honor. [00:09:24] Speaker 00: What the plasmids had to encode was described in the same way [00:09:30] Speaker 00: as the claims here describe that the plasmid must have, or the DNA molecule must encode the AA, the RH10 capsid protein sequence. [00:09:39] Speaker 00: But in Chakrabarti, it didn't require that the bacteria had to be able to do the thing in the end. [00:09:46] Speaker 00: It simply said that the plasmids must encode these different elements of breaking down Google. [00:09:54] Speaker 00: And so the myriad, I think, just stepping back from it, [00:09:58] Speaker 00: Myriad says, and Serepti concedes at page 32 of their brief, Myriad's very clear that markedly different structure is all that's required. [00:10:07] Speaker 01: Well, that may well be true, but that doesn't mean that you can say that if the structure is the same, that some unclaimed function makes it panible. [00:10:16] Speaker 01: That's the only point I'm making to you. [00:10:19] Speaker 00: And understood, Your Honor. [00:10:21] Speaker 00: And I'm not saying that some unclaimed function makes this patentable. [00:10:24] Speaker 00: I'm saying that these claims do allow for a market different function than the AAV RH10 capsid protein sequence. [00:10:32] Speaker 00: We have not claimed the AAV RH10 BP1 capsid protein sequence. [00:10:38] Speaker 00: We did not claim an isolated capsid protein sequence. [00:10:42] Speaker 00: Instead, we planned to take that, putting it into something else, and then putting it into a host cell. [00:10:48] Speaker 00: In the same way, the Chakravarti took four different plasmids, and he used a natural process called bacterial conjugation to put those four plasmids into a single pseudomonas. [00:11:01] Speaker 00: The pseudomonas was natural, and all those plasmids were natural, and the process he used was natural, and he created something that was structurally new by using all those natural pieces. [00:11:12] Speaker 00: in the same way, and actually in a more patent-eligible way, the inventors here genetically engineered the capsid protein sequence to something else. [00:11:22] Speaker 00: They joined them together chemically to create a new molecule, and then they put it into a host cell that was something that was a new composition of matter that did not exist before the inventors created it. [00:11:39] Speaker 00: And I think [00:11:40] Speaker 00: Additionally, this court's decision in AMP versus USPTO, which was a decision that was not appealed to the Supreme Court, a portion of that decision that was not appealed to the Supreme Court in the area, is very similar. [00:11:54] Speaker 00: There, there were host cell claims. [00:11:57] Speaker 00: And the court found that those host cell claims that decided a screening method, that they were premised on the use of transformed host cells. [00:12:07] Speaker 00: And those cells, I'm quoting from CORE, like the patent-eligible cells in Chakrabarti, are not naturally occurring. [00:12:15] Speaker 00: Rather, they are derived by altering a gene of cells to include a foreign gene, which is exactly what the inventors did here. [00:12:22] Speaker 00: These cells could be not even included if A, A, B, R, H, 10 capsic protein gene until the inventors transformed them. [00:12:29] Speaker 00: I see I'm in my rebuttal time, so unless the floor has questions, I have to restart the re-interview. [00:12:33] Speaker 00: OK. [00:12:34] Speaker 01: Thank you. [00:12:35] Speaker 01: Mr. Wilson? [00:12:41] Speaker 02: Please record. [00:12:43] Speaker 02: To understand the claims in this case, all we have to do is look at the title of the patent. [00:12:48] Speaker 02: The application is two methods for detecting AAD sequences and isolating those sequences. [00:12:55] Speaker 03: Are we supposed to be looking at the claim to figure out what the claim is directed to, not the title? [00:13:00] Speaker 02: Yes, Your Honor. [00:13:01] Speaker 02: And these are claims to an isolated, naturally occurring RH10 sequence. [00:13:06] Speaker 02: which has nothing else patentable added onto it. [00:13:10] Speaker 03: Actually, doesn't the claim also recite having another part in the claim, another element in the claim? [00:13:15] Speaker 02: Yes, there are many other elements. [00:13:17] Speaker 02: All of those elements are admittedly conventional and well-known. [00:13:22] Speaker 02: What we have here is an attempt to sidestep variant by taking a patent application of the named inventors, isolating the naturally occurring LRH tests. [00:13:30] Speaker 01: I don't understand that. [00:13:33] Speaker 01: In so far as the use of the house cell, that's true. [00:13:37] Speaker 01: But in terms of combining the RH10 with some other genetic sequence, that's not conventional. [00:13:47] Speaker 00: Yes. [00:13:48] Speaker 01: I do think that under the Brackett case and the Roche case, you make the case about the [00:13:56] Speaker 01: injecting it into the cell is being conventional and not making it one on one eligible. [00:14:02] Speaker 01: But let's put that aside because it also says that the RH10 vector is going to be combined with something else which is not an ABV. [00:14:11] Speaker 01: Right, a non-AAV sequence. [00:14:14] Speaker 02: It is conventional to combine a non-AAV sequence, any other sequence in the world, with a naturally occurring sequence. [00:14:21] Speaker 02: Those were admissions from the named inventors, as well as Regenexx BIOS technical experts. [00:14:27] Speaker 02: Why isn't that an obviousness? [00:14:31] Speaker 02: Because conventionality goes to the point of, when you take a look at the claims [00:14:36] Speaker 02: And we've got this naturally occurring sequence. [00:14:38] Speaker 02: What's going on here? [00:14:41] Speaker 02: The claims aren't reciting a practical application. [00:14:44] Speaker 02: They're reciting generic, conventional elements. [00:14:48] Speaker 03: Under the Supreme Court's decision in Myriad, why aren't they reciting a composition of math? [00:14:53] Speaker 02: Well, they are reciting a composition. [00:14:56] Speaker 03: So why is that not an eligibility? [00:14:58] Speaker 03: Whereas when we start looking at how this is so broad, it's conventional, or it's known to provide this to do exactly what's in this claim, why isn't that something that you would consider under obviousness or anticipation doctrines in patent law? [00:15:15] Speaker 02: No, but it also applies to patentability. [00:15:17] Speaker 02: Because when we're looking for marketing different characteristics, we're looking for something that's not just non-natural. [00:15:23] Speaker 03: I thought you were looking at remarkably different characteristics than what is natural, not markedly different characteristics from the prior earth. [00:15:32] Speaker 02: Right. [00:15:32] Speaker 02: And the question is whether these additional elements add anything that's markedly different structurally or functionally from the naturally occurring sequence itself. [00:15:41] Speaker 02: So that's correct. [00:15:42] Speaker 02: So we're starting with the RH10 naturally occurring sequence. [00:15:45] Speaker 02: Then the question is, are these additional elements [00:15:49] Speaker 02: adding something markedly different. [00:15:52] Speaker 02: As you were talking about earlier, here there are no markedly different functional characteristics because all of the asserted functional characteristics are not defining features of the claims. [00:16:03] Speaker 02: And so they're irrelevant. [00:16:05] Speaker 01: Suppose they had drafted a method plan which said the use of Rh10 in gene therapy as a vector to introduce genetic material in the cells. [00:16:19] Speaker 01: Would that be patent eligible? [00:16:22] Speaker 02: I think that's a very different claim from what we have here. [00:16:25] Speaker 01: Yeah, but that wasn't my question. [00:16:28] Speaker 01: Would that be patent eligible? [00:16:30] Speaker 02: By reciting a practical application of the RH10 sequences, then I think we're working in a practical application, or a patentable range, that yes, that is something that would be patentable. [00:16:42] Speaker 02: But here, we don't have that. [00:16:44] Speaker 02: We don't have a markedly different function. [00:16:48] Speaker 01: So it's an overclaiming situation. [00:16:50] Speaker 02: It is an overclaiming situation. [00:16:52] Speaker 02: There may be situations, and I think that the district court recognized this in its opinion. [00:16:57] Speaker 02: There may be situations, and there are claims that recite naturally occurring things all the time that are patent eligible. [00:17:05] Speaker 02: But here, we have such broad, high-level elements that are just added onto the naturally occurring sequence. [00:17:11] Speaker 02: It's essentially an attempt to monopolize the sequence as myriad. [00:17:16] Speaker 03: How do you distinguish myriad? [00:17:18] Speaker 02: Well, I don't distinguish myriad. [00:17:19] Speaker 03: The claims that were found eligible in myriad. [00:17:22] Speaker 02: I don't distinguish myriad. [00:17:24] Speaker 02: I think myriad helps us understand the claims in this case. [00:17:27] Speaker 02: So the claim in myriad was to an isolated DNA. [00:17:30] Speaker 02: I think that if you look at the additional elements in these claims, they are so broad that all they really say is that the RH10 sequence has been isolated. [00:17:41] Speaker 02: the cultured host cell and attaching it to a non-AAB sequence means that the naturally occurring sequence has been taken out of its natural environment. [00:17:51] Speaker 03: You agree that the cultured host cell and the recombinant nucleic acid molecule did not exist in nature, right? [00:17:59] Speaker 03: I think that they are not natural. [00:18:01] Speaker 03: I mean, you're experts. [00:18:02] Speaker 03: Three of your experts agreed. [00:18:04] Speaker 02: Exactly. [00:18:04] Speaker 03: But it's very hard for you to not say yes to my question. [00:18:07] Speaker 02: So yes, a cultured host cell. [00:18:10] Speaker 02: and a non-AAV sequence attached to a naturally-occurring sequence, the RH10 sequence here, those are non-naturally-occurring things. [00:18:18] Speaker 02: But I don't think that's the end. [00:18:20] Speaker 02: Why did that end the ink? [00:18:20] Speaker 03: Why did the Supreme Court's decision in Myriad? [00:18:22] Speaker 02: Exactly, because I don't think that that's the standard. [00:18:25] Speaker 02: It's markedly different characteristics. [00:18:27] Speaker 02: And the court in Myriad said, [00:18:29] Speaker 02: isolated DNA is a non-naturally occurring thing. [00:18:33] Speaker 03: But why is it important to be different structure sufficient? [00:18:36] Speaker 02: They identify this as an issue in Myriad. [00:18:39] Speaker 02: They say that the isolated DNA sequences are a non-naturally occurring molecule. [00:18:44] Speaker 02: And they recognize that in the Supreme Court's decision. [00:18:47] Speaker 02: But they say that the breaking of chemical bonds and removing something from its natural environment is not enough. [00:18:55] Speaker 02: And so Myriad helps us, because essentially, [00:18:58] Speaker 02: They claim cultured host cells are basically reciting a naturally occurring sequence. [00:19:04] Speaker 02: It's got some unspecified other sequence that doesn't necessarily have any functional relationship to that added on. [00:19:12] Speaker 02: And then that DNA is put in, essentially, a cultured host cell, which is containing it. [00:19:17] Speaker 02: It's basically just saying the naturally occurring sequence has been taken out of the environment and is being stored in a cultured host cell. [00:19:25] Speaker 02: And so myriad. [00:19:27] Speaker 02: The reasoning in myriad exactly tracks these claims, because myriad is saying just the use of it. [00:19:34] Speaker 03: In myriad, it was naturally occurring. [00:19:37] Speaker 03: There was near isolation, right? [00:19:39] Speaker 03: Near isolation. [00:19:41] Speaker 03: And in this case, there's no dispute that the cultured host cell did not exist in nature, right? [00:19:50] Speaker 02: Again, there's no dispute the cultured host cell did not exist in nature. [00:19:53] Speaker 03: I understand your point that it's broad. [00:19:56] Speaker 03: which might go more to enablement or obviousness or anticipation, right? [00:20:00] Speaker 03: I mean, are those defenses being presented in this case? [00:20:04] Speaker 02: No, because they're not presented in this case. [00:20:06] Speaker 02: But in their Mayo, under 101, you do look at the breadth of additional claim elements in order to understand whether there's something markedly different, whether the characteristics are markedly different. [00:20:18] Speaker 03: We also have to look at whether the structure is marketable. [00:20:22] Speaker 02: Correct. [00:20:23] Speaker 02: We can look at the structure. [00:20:24] Speaker 02: We can look at the function. [00:20:25] Speaker 03: Does it matter to you at all that they're really focusing on that capsid protein, like that shell? [00:20:33] Speaker 02: Well, the DNA, there's no shell that's actually claimed. [00:20:37] Speaker 02: So it's the DNA encoding the capsid shell. [00:20:42] Speaker 02: No, I mean, it's a naturally occurring DNA, which falls squarely under myriad, that is the RH10 sequence. [00:20:50] Speaker 02: So that sequence encodes a capsid protein, but there's no protein that's recited in that. [00:21:00] Speaker 02: Your Honor, you asked earlier if there were any cases that talked about whether or not functional characteristics had to be a defining feature of the claims. [00:21:08] Speaker 02: And there absolutely are cases. [00:21:10] Speaker 02: This court's case in Chromadex [00:21:12] Speaker 02: we just cited in our brief, talks about functional characteristics having to be elements of the claims. [00:21:20] Speaker 02: And in fact, in that case, the functional characteristic was enhanced by bioavailability. [00:21:27] Speaker 02: And the court here said that the claims do not necessarily require enhanced bioavailability, so that that functional characteristic is not relevant to the patentability. [00:21:38] Speaker 02: Because the claims rely on milk. [00:21:39] Speaker 02: because the claims were too broad. [00:21:42] Speaker 02: They didn't include that language functional. [00:21:46] Speaker 03: Do you have anything like a natural product that these read on? [00:21:51] Speaker 02: The naturally occurring sequence is the RHS sequence. [00:21:53] Speaker 03: So your view is that because the language [00:21:58] Speaker 03: non-ADP sequence is so broad, we should just act as if that language is not even in the claim. [00:22:04] Speaker 02: I don't think we should act that the language is not in the claim, but I do think that we ought to take a look at that language and, under Mayo, identify whether or not that recites or identifies any markedly different characteristics beyond just being an isolated DNA. [00:22:20] Speaker 02: attaching heterologous non-AADD DNA is not markedly different from isolating the DNA, taking it out of its natural environment. [00:22:28] Speaker 02: Same thing with the clang-cultured host cell. [00:22:31] Speaker 02: Clang-cultured host cell is a container for this naturally occurring DNA sequence. [00:22:37] Speaker 02: And so there's no markedly different structural or functional characteristic there under the Mayo test, which is talking about appending conventional elements [00:22:47] Speaker 02: at a high level of generality to a natural product, a natural law, or an abstract idea. [00:22:55] Speaker 02: And those things are not patentable in your mail. [00:23:01] Speaker 02: Unless the court has any further questions. [00:23:05] Speaker 01: OK. [00:23:05] Speaker 01: Thank you. [00:23:07] Speaker 01: Ms. [00:23:07] Speaker 00: Morrison. [00:23:15] Speaker 00: Thank you, Your Honor. [00:23:17] Speaker 00: beginning where closing counsel passed off, the markedly different test is not about whether each piece of the claim is markedly different from what's in nature. [00:23:28] Speaker 00: It's about whether the composition as a whole is markedly different than what is natural. [00:23:33] Speaker 00: And in the Chromadex case, the reason the court moved to function, as Your Honor noted, is because the structure of the claim in Chromadex was broad enough to read on natural milk. [00:23:45] Speaker 00: Here, that is not the case. [00:23:47] Speaker 00: The structure here is not broad enough, as Serebta has admitted, to read on anything that is natural. [00:23:53] Speaker 00: And so that's why Prometex went to the function question. [00:23:57] Speaker 01: But the claim here seems to cover almost any use of RH10 together with another genetic sequence, right? [00:24:08] Speaker 00: It covers the use of the RH10 sequence [00:24:11] Speaker 00: if it has been chemically joined in a single molecule to anything else. [00:24:16] Speaker 00: But that does not cover any use of RH10. [00:24:20] Speaker 00: You could chemically join the RH10 molecule to another sequence from AAV, which is done, a different AAV. [00:24:28] Speaker 00: And it also requires putting that new molecule into a cultured host cell. [00:24:34] Speaker 00: So, for example, the prosecution history reflects this. [00:24:37] Speaker 01: But it covers uses of RH10 that go beyond gene sequencing, right? [00:24:43] Speaker 00: Beyond gene therapy, Your Honor. [00:24:46] Speaker 00: It covers functions of RH10 that are all within the gene therapy umbrella. [00:24:50] Speaker 01: It covers... Well, yes, yes. [00:24:53] Speaker 01: It covers any use of RH10 together with anything which is an AAV, right? [00:25:02] Speaker 00: It covers if they have been chemically joined together. [00:25:06] Speaker 01: So it covers inventions that haven't been made yet. [00:25:11] Speaker 00: I don't think that's quite right, Your Honor. [00:25:15] Speaker 00: Certainly the inventors have not chemically joined RH10 to every other sequence in the world. [00:25:21] Speaker 00: But it doesn't cover all uses of RH10. [00:25:23] Speaker 00: And the question of preemption is not whether [00:25:26] Speaker 00: there is some removal of the use of what's invented. [00:25:31] Speaker 00: The question is whether there's improper preemption. [00:25:34] Speaker 00: And here, the inventors do not. [00:25:35] Speaker 01: Well, improper preemption is directed to covering things that haven't been invented yet. [00:25:41] Speaker 01: And the breadth of this claim seems to extend that far. [00:25:44] Speaker 00: Well, I think, Your Honor, that improper preemption is intended to cover whether they have improperly removed the natural thing, the work of nature, the RH10 sequence from use. [00:25:55] Speaker 00: And here, that's simply not the case, because there are other uses of RH10 that structure could engage in, for example, using the actual virus, putting the virus into an animal for replication as opposed to a cultured host cell, attaching the RH10 sequence to another sequence from AAV. [00:26:13] Speaker 00: All of that is outside the claims and would not be covered. [00:26:15] Speaker 00: And so there is no solution. [00:26:18] Speaker 01: OK, I'll just add further questions. [00:26:20] Speaker 01: Thank you. [00:26:20] Speaker 01: Thank both councils.