[00:00:00] Speaker 01: Regents of the University of California. [00:00:03] Speaker 01: Are you ready? [00:00:05] Speaker 01: I assume so. [00:00:07] Speaker 01: Let me score away some of the housekeeping here. [00:00:12] Speaker 01: Mr. Blanton, you reserved four minutes of your time for rebuttal. [00:00:17] Speaker 01: That's correct. [00:00:18] Speaker 01: And Mr. Nimrod, you have 14 minutes. [00:00:21] Speaker 01: And you have 15 minutes. [00:00:23] Speaker 01: But one of those, you reserved a minute for your cross appeal. [00:00:26] Speaker 03: Yes, sir. [00:00:27] Speaker 01: And then you'll respond with your four minutes, both to the cross appeal and also to rebut. [00:00:34] Speaker 01: Correct. [00:00:34] Speaker 01: Is that correct? [00:00:35] Speaker 01: Yes. [00:00:35] Speaker 01: OK. [00:00:36] Speaker 01: We're all set. [00:00:37] Speaker 01: You may start. [00:00:40] Speaker 06: Thank you, and may it please the court. [00:00:42] Speaker 06: The PTAP's decision in this case deems Broad the inventor, without ever ending in finding any inventive contribution Broad made. [00:00:49] Speaker 06: Because Broad, after receiving CVC's conception through Marifuni, reduced to practice earlier, but the PTAP never found [00:00:57] Speaker 06: that more than inventive skill was required to reduce to practice for Broad or any of the other five labs that promptly reduced to practice after CVC's invention was announced. [00:01:06] Speaker 06: The PTAC reached that surprising result, finding someone to be the inventor without identifying anything in a inventive contribution, without finding any exercise of more than ordinary skill, because it applied the wrong legal standard in at least two respects. [00:01:21] Speaker 06: The first, on the standard of conception, [00:01:24] Speaker 06: Whether conception's complete depends on whether skilled artisans can reduce the invention of practice. [00:01:29] Speaker 01: Counselor, it seems to me that one of the primary issues dealing with conception in this case is the idea of reduction to practice. [00:01:44] Speaker 01: Does just the concept, the element of reduction to concept, what role does it play in conception? [00:01:52] Speaker 06: So it doesn't, your honor, because reduction for practice is different from conception. [00:01:56] Speaker 06: Conception is having the idea of the invention. [00:01:59] Speaker 06: Reduction to practice is what the skilled artisan does once the idea occurs. [00:02:03] Speaker 06: So long as the conception is sufficiently complete, that a skilled artisan can reduce it to practice with ordinary skill without further invention, the conception is complete. [00:02:12] Speaker 01: But how do we know, for example, in this case, if it's complete, if there seems to be significant experimentation going on [00:02:21] Speaker 06: And the standard is, you can tell if it's complete, and I'm going to ask the court to turn to page 180 and 181 of the appendix to explain the error that occurred. [00:02:30] Speaker 06: But you can tell if it's complete if you see that only ordinary skill is required to reduce it to practice. [00:02:36] Speaker 06: If inventive skill is required, then obviously your invention was complete because further invention was contemplated. [00:02:41] Speaker 06: You need to do further invention. [00:02:44] Speaker 06: But if you can do it with ordinary skill, like Morgan and Thaler says, it's ready for handoff to a skilled artisan without any further exercise inventive skill, or Tanzel, ready for handoff to a skilled mechanic, or Dolbert, where Alexander Graham Bell couldn't reduce the telephone to practice, couldn't make audible sounds. [00:03:00] Speaker 06: But the fact that a skilled mechanic could meant that it was ready for patenting. [00:03:05] Speaker 06: So if you turn to page 180 of the appendix, I think this shows exactly what went wrong with the board's reasoning. [00:03:11] Speaker 06: The board says, and I didn't turn to 180 myself, but the board says, and this is where they're responding to our argument, they said, you could tell the ordinary skill, only ordinary skill is required. [00:03:21] Speaker 06: You could tell that our invention was complete because so many so quickly reduced to practice. [00:03:26] Speaker 06: And the argument they're responding to is on the line four to five, because reducing to practice and body might count one quickly and easily. [00:03:33] Speaker 06: The CD8C inventors had a complete invention. [00:03:36] Speaker 06: But rather than say anything about what it took anybody else to reduce to practice, [00:03:40] Speaker 06: The board's response, or the PTAS response, is the broad inventors' activities do not inure to the CVC, at least because CVC never submitted anything to broad inventors for testing. [00:03:51] Speaker 06: If you understand the standard, which is what's left for others to do, is it just the skill of a skilled mechanic, or is further invention required? [00:03:59] Speaker 06: That doesn't make any sense. [00:04:01] Speaker 06: We're not saying that somebody else's reduction of practice inures to our benefit. [00:04:04] Speaker 01: To what extent do you rely on subjective thought of the inventor? [00:04:10] Speaker 06: The subjective thoughts of the inventor, as Burroughs makes clear, doesn't matter. [00:04:14] Speaker 06: The inventor doesn't have to know it will work. [00:04:17] Speaker 06: And I think that was one of the fundamental mistakes. [00:04:19] Speaker 06: Having not looked at, on page 180, what was the skill required to reduce the distance to practice? [00:04:26] Speaker 06: Instead, the PTAB went to, did you know it would work? [00:04:29] Speaker 06: Did the skilled inventor have... [00:04:33] Speaker 01: Did they really say that? [00:04:35] Speaker 01: Did you know that it worked? [00:04:37] Speaker 06: So page 155, or excuse me, 161, 162, it said the inventors needed a definite permanent idea of a system they knew would cleave DNA in eukaryotes. [00:04:47] Speaker 06: Or when they talked about the embodiment of microinjecting zebrafish, they rejected that our [00:04:53] Speaker 06: our desire to reduce to practice that way because they were not persuaded that the inventors, quote, understood that reducing the invention to practice in zebrafish required ordinary scale. [00:05:02] Speaker 06: Page 179, Stanley's real uncertainty. [00:05:04] Speaker 03: I want to make sure that I know exactly what you're contending are the two errors. [00:05:07] Speaker 03: It sounds like the first error is that you contend that maybe there was some interlinking of the concept of conception reduction to practice. [00:05:18] Speaker 03: And for that, you were pointing to the 1A to 181 pages. [00:05:21] Speaker 03: Is that accurate? [00:05:22] Speaker 06: So I think that it's roughly correct. [00:05:26] Speaker 03: Correct me in the way you think it's inaccurate. [00:05:28] Speaker 06: The only modification I would make to that is that the PTAP simply didn't understand that when you're trying to figure out, is invention complete, the standard's an objective one. [00:05:37] Speaker 06: What does it take? [00:05:39] Speaker 06: Is it just what an ordinary skilled artist would do in the ordinary course through this to practice, or does it require further invention? [00:05:44] Speaker 06: It just didn't apply that standard. [00:05:45] Speaker 06: And you can tell it wasn't, because it refused to look beyond the inventor's own efforts. [00:05:50] Speaker 06: I think 181 makes it also clear. [00:05:52] Speaker 06: Because if you're looking at 181, this is the explanation as to why our response to our argument that Broad used ordinary skill because they didn't do anything inventive. [00:06:02] Speaker 06: And the PTAB's response, this is line 8, is Broad raises technical reasons why the Broad inventors had success when other eukaryotic CRISPR-Cas9 systems failed. [00:06:11] Speaker 03: So is that the subjective intent argument that you're making? [00:06:14] Speaker 03: I'm trying to understand how many errors you contend there are, and where they link up in the decision. [00:06:19] Speaker 06: Right. [00:06:20] Speaker 06: I think there's multiple errors. [00:06:21] Speaker 06: But I think the basic one is not knowing that it was not understand it's an objective test of whether skilled artisan can reduce it to practice. [00:06:28] Speaker 06: Because if you don't understand that, then Dolbert comes out the other way. [00:06:31] Speaker 06: Alexander Graham Bell loses. [00:06:33] Speaker 06: The other one is, instead of looking to that, the board, the PTAB, then went to, all right, we'll look at just what the inventors did, and we'll focus on their subjective intent. [00:06:42] Speaker 06: Did they know this would work? [00:06:44] Speaker 06: And that's a mistake as well. [00:06:45] Speaker 06: Everybody agrees that when it comes to conception, the inventor's idea of whether it's going to work is simply irrelevant. [00:06:52] Speaker 04: We agree the PTAB... Can I just ask you on that point? [00:06:55] Speaker 04: Because I struggle with some of our case law on this, and it looks like [00:06:58] Speaker 04: And I'm talking in particular about Heisman. [00:07:00] Speaker 04: And the board relied, I think, kind of heavily on that case. [00:07:03] Speaker 04: And at least I read that case. [00:07:06] Speaker 04: It looks at the count or the claim and says, the claim itself suggests that it's going to produce something. [00:07:13] Speaker 04: I don't remember the exact facts, but I'm sure you do. [00:07:16] Speaker 04: And then the board looks at this one and says, the count requires that it's capable of doing something. [00:07:22] Speaker 04: And then it says that there's nothing in that, by putting that language in the count, [00:07:28] Speaker 04: That shows the inventor had to know it was capable of doing something, which is, I don't know if that's the same as actually working, but it seems to me that's one way you can read the board's decision. [00:07:40] Speaker 06: Right, and I think Heisman is all about whether or not that was a 20 nanometer particle. [00:07:46] Speaker 06: And when you claim the 20 nanometer particle, [00:07:48] Speaker 06: You have to know you can actually produce the 20-nanometer particle, so you don't know that you can actually produce what you're claiming. [00:07:54] Speaker 06: You're positing a solution, positing a problem, but you don't have in your hand the structure to solve the problem. [00:08:00] Speaker 06: This is the exact opposite, where we say, here is your structure. [00:08:04] Speaker 06: We have a CRISPR-Cas9 single guide, and it is your solution, because it will leave. [00:08:09] Speaker 06: And we don't have to know it'll work, because Burroughs tells us that. [00:08:12] Speaker 04: And your view is, you don't have to explain how it's going to work, because all of that was done through [00:08:17] Speaker 04: routine experimentation and prior art techniques. [00:08:21] Speaker 06: I think that's exactly right. [00:08:23] Speaker 06: Whatever skilled artists would have thought in advance, we understood, and the board makes this point at 148, that only the typical zinc fingers, talons, techniques would be required, and in fact we were right. [00:08:33] Speaker 04: The board seems to rely heavily on the fact that there was a lot of experimentation here. [00:08:38] Speaker 04: throws around the words undo experimentation which I think is unfortunately in some of our case all on this point too which I find confusing if you don't have to show it to have conception but is there a line there can it seems to me that there might be a line between [00:08:58] Speaker 04: routine experimentation performed by skilled artisans which doesn't interfere with conception and the type of experimentation that really is taking the idea and changing it and adding something new to it and did the board find [00:09:14] Speaker 04: that the experimentation here by anybody added something new to your original CRISPR and eukaryotic cells? [00:09:22] Speaker 06: And the answer is no, and that's the mistake on page 181, because this is where we're responding. [00:09:26] Speaker 06: It's the paragraph beginning on line five, where they reject the argument that Broad did not add anything inventive. [00:09:33] Speaker 06: And they say, well, there's technical reasons why Broad succeeded. [00:09:36] Speaker 06: by October 5 when others failed. [00:09:38] Speaker 06: And mind you, our claim to date was October 29, so like 25, 26 days later. [00:09:43] Speaker 06: And then they don't identify what those technical differences is. [00:09:47] Speaker 06: The board never says, hey, this was invented. [00:09:50] Speaker 06: This is what made the difference. [00:09:51] Speaker 06: This is beyond routine or ordinary skill. [00:09:54] Speaker 04: And so hypothetically, if [00:09:57] Speaker 04: What Broda did was say none of these prior art techniques worked of getting your CRISPR thing into the DNA of the eukaryotic cell. [00:10:05] Speaker 04: And they came up with some kind of new method of inserting that CRISPR, whatever you call it, structure into the cell. [00:10:15] Speaker 04: And that's what they ended up claiming. [00:10:17] Speaker 04: Then you might not have conception. [00:10:19] Speaker 04: If there was, yes, if there was a further invention required, [00:10:22] Speaker 06: using routine skill that all the other five labs did that we eventually succeeded with as well within five months, if that was not sufficient, you needed further invention. [00:10:31] Speaker 06: That would be proof that we didn't have a complete thought. [00:10:36] Speaker 01: We needed further invention. [00:10:37] Speaker 01: Did Broad's experimentation go outside the lines of claim 15? [00:10:44] Speaker 01: Is this what Broad also invented? [00:10:47] Speaker 06: Yeah, so the elements of the count, what we [00:10:52] Speaker 06: claimed in the first instance, and proposed reducing, and what they reduce are all the same. [00:10:57] Speaker 06: And the question is, is ordinary skill used required to reduce it? [00:11:01] Speaker 06: If so, the invention was complete when we conceived it. [00:11:03] Speaker 06: If more than ordinary skill is required, if you need invention, then it's not complete. [00:11:08] Speaker 04: And there's no dispute that you invented the CRISPR-9 [00:11:13] Speaker 04: in the generic environment right that's correct and so the only thing additional in this case is whether you invented it or had the conception of it for the eukaryotic cells or did bro do that that's exactly right evidence that you had conception for eukaryotic [00:11:31] Speaker 04: before Brode. [00:11:33] Speaker 06: So the conception before Brode, we start with page 8 of our brief, which is actually from the lab notebook, which is back in March. [00:11:40] Speaker 06: You have the actual drawing of the single-guide CRISPR-Cas9 system, and it says up in the corner, using mammalian cells. [00:11:48] Speaker 06: And then as the board explained, this is on page 148, 149, [00:11:55] Speaker 06: We, in our invention disclosure statement, said, use techniques, ordinary talents, to reduce the practice. [00:12:03] Speaker 06: And if you look at the invention disclosure statement, it walks through and talks about specific types of things that we're going to do, such as knockouts in model organisms, rats, that's 65647, therapeutic correction of disease-linked point mutation in human cells, 65648. [00:12:20] Speaker 06: It goes on and on about eukaryotic cells. [00:12:23] Speaker 06: And then if you look at page 13 of our brief, that shows by June we've had this idea to reduce the practice in fish cells and human cells. [00:12:31] Speaker 06: We're talking about the NLS that we were going to use, we're talking about the vectors that you use, talking about all those types of routine optimizations you use in order to reduce the practice. [00:12:41] Speaker 06: If I could turn very quickly to written description in the minutes I have left. [00:12:47] Speaker 01: Of course Go ahead, and I'm going to give you sufficient time to get into given the amount of questions that we do have we may go a little bit of time I'll adjust everybody's time accordingly [00:12:59] Speaker 04: Let's assume we agree with you that the board, even though this case I find very difficult, because throughout their decision, they cite the correct legal statements, it seems like. [00:13:11] Speaker 04: But then when they actually describe your arguments and why they fail, they seem to be applying a different standard. [00:13:18] Speaker 04: If we agree with you on the law, don't we still have to remand this? [00:13:22] Speaker 04: Because there's not enough factual determinations for us to reverse outright. [00:13:27] Speaker 06: Yeah, I think the standard is, unless this court can say with confidence there's only one possible outcome on remand. [00:13:33] Speaker 06: And frankly, I think we're there. [00:13:35] Speaker 06: But if you don't think we're there, then the answer would be the typical Idaho Power and Light remand for further proceedings not considered. [00:13:41] Speaker 04: Let me just ask you one further question about this, because this is the one. [00:13:44] Speaker 04: I mean, on page 48 of their decision, which is page 161 of the appendix, [00:13:51] Speaker 04: At the top, they say, we acknowledge CBC's argument that in the end, only routine materials and techniques were required so that it would work in eukaryotic cells. [00:14:03] Speaker 04: That seems pretty close to if you're applying the right legal standard to suggest that you're right. [00:14:09] Speaker 06: I think it is, if you apply the right standard, it is a concession or a right. [00:14:13] Speaker 06: And the only question is, is that correct? [00:14:15] Speaker 06: And then boards? [00:14:17] Speaker 04: Sorry, the other part of that sentence, and this is what's troubling, and I think they're relying on Heitzman for this, but I'm not sure that's correct, is we look to what the CB considered, and then is understood as evidence of their conception that others might have understood later. [00:14:31] Speaker 04: Yeah, and that where is that supported in the case law? [00:14:34] Speaker 06: I don't think it is because remember it burrows is very clear that you don't have to understand it'll work It was actually a path marking invention used in the 80s used AZT to treat AIDS and the claim there was apply a Therapeutically effective amount they didn't know AZT would actually treat AIDS but because they had that concept and [00:14:54] Speaker 06: and it required only ordinary skill to reduce its practice, to prove it works, they were the inventors. [00:14:59] Speaker 06: And I think that's the fundamental rule that they lost track of here, is that under Applegate and McMillan, you aren't the inventor simply because you proved that it works. [00:15:07] Speaker 06: You don't give the invention to the guy who tested it and proves it worked, you give the invention to the person who had the thought. [00:15:14] Speaker 06: If I could turn very briefly to a written description. [00:15:16] Speaker 03: I know you want to get there. [00:15:19] Speaker 03: We're going to let you get there. [00:15:20] Speaker 03: I wanted to just do a few follow-up questions on what Judge Hughes asked you. [00:15:25] Speaker 03: So if we agree that there is some errors in terms of the conception analysis, legal errors, and I think we've been talking through them, do we need to reach your arguments on APA errors in the conception analysis? [00:15:39] Speaker 06: The court doesn't necessarily have to reach them. [00:15:42] Speaker 06: Once the court identifies an error, it can vacate the decision and remand. [00:15:46] Speaker 06: But I think it would be helpful if the court identified the additional errors so the board would have the ability to fix them on remand and we wouldn't have to come back here. [00:15:54] Speaker 06: and argue those same errors again if the board repeats on its reasoning. [00:15:57] Speaker 06: But that would be simply in the court's discretion, whether they think it would be useful in favor of judicial economy to address additional issues. [00:16:04] Speaker 06: But the court wouldn't be required to do so. [00:16:06] Speaker 06: They would just burgle them back up if they became problematic errors again in the next decision. [00:16:11] Speaker 03: And now I'm going to give you a question that's going to let you segue to written description, which I think will make you happy. [00:16:15] Speaker 03: So if we agree with you on conception but disagree with you on a written description, what do you contend the overall disposition should be? [00:16:22] Speaker 06: So if you disagree with us on written description but agree with us on conception, the court would vacate and remand for further proceedings in connection with conception. [00:16:32] Speaker 06: You can end up with different outcomes in this because they apply to standard and written description that isn't the ordinary description, excuse me, the standard [00:16:40] Speaker 06: conception that isn't the ordinary standard, but I think this is the segue to try and convince you that you shouldn't affirm a written description, which you could also not reach. [00:16:48] Speaker 06: You could just reach conception. [00:16:49] Speaker 04: Is there any dispute that you ultimately reduce this to practice so that if you win on conception, you have priority? [00:16:57] Speaker 06: Well, I don't think it is disputable that we actually reduced to practice no later by October 29, or October 31, when that non-POSA first-year graduate student, Ms. [00:17:08] Speaker 06: East Celeste, succeeded. [00:17:10] Speaker 06: Is that another thing that the board might have to decide on? [00:17:13] Speaker 06: I think that the board declined to address that issue, and that would be something for the board to address. [00:17:18] Speaker 01: Exactly, Your Honor. [00:17:18] Speaker 01: What do you think is the conception day, the priority day, [00:17:22] Speaker 06: So we would give our conception data as no later than June of 2012. [00:17:27] Speaker 06: And that's because we rely on the invention disclosure form, the lab notebook, and also, just to make sure to be absolutely certain, the fact that Jinek had mapped out exactly how we wanted to reduce it to practice through microinjection in zebrafish, through the vector expression in human genes using the particular promoters and vectors that he had described. [00:17:50] Speaker 01: I'm turning to written description before we go there. [00:17:54] Speaker 01: So let's go back to conception. [00:17:57] Speaker 01: This is a legal question. [00:17:59] Speaker 01: And we review that de novo. [00:18:01] Speaker 01: But when we look at some of the underlying facts and some of the factual findings that PTAB made, we review that for substantial evidence, correct? [00:18:12] Speaker 06: That's exactly right. [00:18:14] Speaker 06: Conception is a question. [00:18:15] Speaker 01: I think that's where you start getting bogged down a little bit. [00:18:18] Speaker 01: You know, for example, the emails. [00:18:20] Speaker 01: that went back and forth that showed that gives at least the basis for a legitimate argument to be made that conception had not taken place. [00:18:33] Speaker 06: If the board had looked at those emails and said that these emails show, in light of what everybody else did and all the other evidence, that this required more than ordinary skill, that ordinary skilled artisans had to further invent, that would be a different story for us. [00:18:48] Speaker 06: But what the board said instead is, oh, it shows that you weren't sure it was going to work. [00:18:52] Speaker 06: That subjective that you didn't expect it to work means that you don't have conception. [00:18:56] Speaker 06: And that's simply not the standard. [00:18:57] Speaker 06: The standard is, looking at the evidence, could a skilled artisan reduce this to practice? [00:19:02] Speaker 06: And the answer is skilled artisans without further skill, as page 161, could reduce it to practice without further invention. [00:19:09] Speaker 06: It was ready for the handoff to the skill mechanic. [00:19:13] Speaker 01: What about the other organizations? [00:19:15] Speaker 01: There's five other groups of organizations that also were experimenting. [00:19:19] Speaker 01: Did they add anything to the invention? [00:19:22] Speaker 06: I don't think they did. [00:19:23] Speaker 06: And if you look at page 18 of our brief, there's a chart there showing what everybody did that was different. [00:19:28] Speaker 06: Everybody took what was the ordinary techniques that they were using at that point in time for talons and zinc fingers, the sort of very similar use of proteins to cuttings, but they didn't have the DNA component there. [00:19:41] Speaker 06: Though they just apply the same techniques that they've been previously relying and simply use those same techniques on CRISPR-Cas9 and achieve success in relatively short periods of time, which is precisely what we had thought would happen, as the board said on page 148, that you would simply apply the standard techniques and you would achieve success, and that is in fact what happened. [00:20:02] Speaker 01: I have one remaining question, but my colleagues may have more on this point. [00:20:07] Speaker 01: This notion about whether the inventor knows or knew or should have known, it seems to me that the PTAB lists that up out of the Burroughs case. [00:20:19] Speaker 01: And Burroughs is argued by both sides to attack the other side and to support their position. [00:20:27] Speaker 01: How does Burroughs help you? [00:20:29] Speaker 06: So Burroughs, I think, is absolutely clear. [00:20:32] Speaker 06: And I think it says this on page [00:20:37] Speaker 06: 1228, I'm just going to quote, an inventor's belief that his invention will work or his reasons for choosing a particular approach are irrelevant to conception. [00:20:46] Speaker 06: I don't think you can get around that quote that says the inventor's beliefs are irrelevant. [00:20:51] Speaker 06: What you're looking at is what did the inventor propose as their invention and was further invention required, in which case it's incomplete? [00:20:59] Speaker 06: Or could a skilled artisan take it? [00:21:01] Speaker 06: Or in the words of Morgan Thaler, was it ready for handoff to a skilled mechanic? [00:21:05] Speaker 06: Was it ready for ordinary skill to reduce to practice? [00:21:08] Speaker 06: And that's why, for example, in acromed, the surgeon came up with a plate, but he didn't know how to keep it from sliding. [00:21:15] Speaker 06: So the machinist said, oh, use countersinks. [00:21:17] Speaker 06: What about arcuate recesses? [00:21:19] Speaker 06: The surgeon had no idea how to do that. [00:21:21] Speaker 06: But he was still the inventor because it was only ordinary skill, ordinary mechanical skill, to come up with a further idea of arcuate recesses. [00:21:29] Speaker 06: The same thing with Barba. [00:21:31] Speaker 06: Put the air conditioning unit up in the head, in the head area of the train car. [00:21:35] Speaker 06: That was the invention. [00:21:36] Speaker 06: They didn't have any idea of how to do it. [00:21:38] Speaker 06: But because it could be worked out by a skilled mechanic, it was a complete invention and ready for animal. [00:21:44] Speaker 01: Okay, you're out of time and we're going to restore you for a minute. [00:21:49] Speaker 01: Did you have a question? [00:21:50] Speaker 03: Well, I promised him I'd let him get a word in on written description, so I don't know if he still wanted that word. [00:21:55] Speaker 06: I would beg for the word, but if it's too far, I don't want to strain the course of patience. [00:22:00] Speaker 01: Thank you, Judge. [00:22:01] Speaker 01: Yes, let's hear about written description. [00:22:03] Speaker 06: All right, I'll endeavor to keep it really quick, which is that I think here, too, that PTAP just simply applied the wrong standard, because the [00:22:11] Speaker 06: The provisional application doesn't have to convince skilled artisans that it's going to work. [00:22:16] Speaker 06: It doesn't have to walk through every conceivable barrier. [00:22:19] Speaker 06: What it has to do is it has to disclose the invention so people can understand what it is, what it is that your claim is your invention, and describe it so they can see it. [00:22:28] Speaker 06: And critically, this is a compound claim. [00:22:31] Speaker 06: P1 explicitly describes the structure of your single-guy CRISPR-Cas9 system. [00:22:35] Speaker 06: There's a picture on page 653. [00:22:37] Speaker 06: That's the page one of the application. [00:22:40] Speaker 06: And on paragraph 73 to 154, it walks and explains in detail, excruciating detail, I might add, exactly what this is. [00:22:47] Speaker 06: And it's clearly on Cavill that it's claiming it and describing it in a eukaryotic cell as well, and not just because it describes it. [00:22:53] Speaker 06: as defining a host cell to include eukaryotic cells. [00:22:56] Speaker 06: If you look at paragraphs 124 and 127, 124 says that it's discussing appropriate vectors for eukaryotic health cells. [00:23:04] Speaker 06: The following vectors are provided for eukaryotic host cells, PTX1 strategy, paragraph 127. [00:23:11] Speaker 06: Suitable eukaryotic promoters, promoters function in eukaryotic cell. [00:23:14] Speaker 06: Eukaryotic mentions outnumber, prokaryotic two one, it's eight to one if you just say it mentions a cell that turns out to be eukaryotic, [00:23:22] Speaker 06: And it's an original application. [00:23:24] Speaker 06: This is the old granddaddy original application, 21 claims specific to Eukatic cells. [00:23:29] Speaker 06: You'd have to be willfully blind to not understand that they were describing and claiming CRISPR-Cas9 in the Eukatic cell. [00:23:36] Speaker 06: And with that, I'll reserve whatever I have left for a bottle. [00:23:38] Speaker 06: Thank you very much. [00:23:40] Speaker 01: Thank you. [00:23:47] Speaker 00: May I please start? [00:23:49] Speaker 01: Mr. Neumann, yes, sir. [00:23:50] Speaker 00: Thank you, Your Honor. [00:23:52] Speaker 00: So this is an initial matter. [00:23:55] Speaker 00: There was no finding made by the PTAB that in the end only routine materials and techniques were needed to make this work. [00:24:02] Speaker 04: Was there a finding the other way that Zheng or any of the other people that worked on this contributed non-routine efforts to make this work? [00:24:15] Speaker 00: what they found was that you can't look at these techniques in isolation because it's not one technique like they focus on microinjection microinjection by itself didn't work what you're looking at are adaptations okay but you're not answering my question did the board make because i think the problem here for me is [00:24:32] Speaker 04: They're looking at the word experimentation, which certainly appears in some of our precedent on this in a way that sounds to me not necessarily legally correct. [00:24:41] Speaker 04: If it's experimentation that shows you went beyond or made some kind of patentable modification to the conception, then that's undue experimentation. [00:24:51] Speaker 04: But just using routine prior art techniques is not, right? [00:24:56] Speaker 00: You're right, I wouldn't, I don't think I'd agree with that for this reason because the situation that... Okay, I don't want to quibble on that. [00:25:02] Speaker 04: Let's just assume that's right as a statement of law. [00:25:04] Speaker 04: That if the inventor conceives of something and that there are routine techniques to make it work, that that still doesn't disprove conception. [00:25:14] Speaker 04: So you, so in this case, [00:25:16] Speaker 04: the board would have to find that it was something other than routine prior art techniques. [00:25:21] Speaker 04: Did they make that finding anywhere? [00:25:23] Speaker 00: No, they did not make that finding anywhere, Your Honor, because there were... Is there any evidence of... Yes, there is much evidence that there are 12 adaptations that are invented or made to the systems to make it work in eukaryotic cells. [00:25:34] Speaker 00: There were no... Sorry, Your Honor. [00:25:37] Speaker 05: Did they use non-routine prior art techniques? [00:25:39] Speaker 00: Yes. [00:25:40] Speaker 00: Techniques? [00:25:41] Speaker 05: Or were they all prior art techniques? [00:25:42] Speaker 00: No, there were no prior art techniques because there were no techniques known for making CRISPR work in the eukaryotic cell. [00:25:47] Speaker 00: He points to talons and zinc fingers, which are protein systems. [00:25:51] Speaker 00: This is a protein RNA complex, which is why, two things you have to put together, there were no known techniques for how to make that work in the eukaryotic cell. [00:26:00] Speaker 00: In their brief, they say we admit that only routine techniques were used, and we said that we admit it below, [00:26:06] Speaker 00: The quote they go to is when we said he did not use routine techniques. [00:26:09] Speaker 00: They themselves point to 12 different adaptations that our inventor did to make this work. [00:26:14] Speaker 04: So your inventor invented the specific techniques to bring this into the DNA? [00:26:19] Speaker 00: Yes, he did, Your Honor. [00:26:20] Speaker 00: He did that. [00:26:21] Speaker 00: And the reason is because... Where's the evidence for that? [00:26:23] Speaker 04: Not that it's just adapting a technique used in some other area. [00:26:27] Speaker 04: to eukaryotic. [00:26:29] Speaker 04: It seems to me too narrow. [00:26:30] Speaker 04: Did he invent specifically new techniques of importing something into a eukaryotic DNA? [00:26:38] Speaker 00: He did that by using the techniques that he knew of from prior work he did in his own lab. [00:26:43] Speaker 00: He was not a posa, your honor. [00:26:46] Speaker 00: He'd been working on eukaryotic CRISPR for a year using dual molecule systems. [00:26:50] Speaker 00: And he developed techniques in his lab. [00:26:52] Speaker 04: I think we're talking past each other. [00:26:54] Speaker 04: I'm not talking about specifically adapting CRISPR to a eukaryotic cell. [00:27:00] Speaker 04: I'm talking about the techniques underlying that adaptation. [00:27:05] Speaker 04: Are any of those new techniques that were invented for the first time by your inventor? [00:27:11] Speaker 00: Yes, I would say that is the case, Your Honor, because you don't consider... Which ones are they? [00:27:15] Speaker 00: I can go through a list of them, Your Honor. [00:27:18] Speaker 00: It's the modifications to the vector, modifications to the promoter, modifications to a vector map. [00:27:24] Speaker 00: All those things are individual things that he put together that had never been done before. [00:27:29] Speaker 04: As I said, there's 12 adaptations... So the vector map had never been done before? [00:27:33] Speaker 00: Not for the CRISPR, Your Honor. [00:27:35] Speaker 04: OK, but that's where we're talking past each other. [00:27:38] Speaker 04: I don't think that that's the correct statement from the law. [00:27:41] Speaker 04: If you do, that's fine. [00:27:42] Speaker 04: You can push that. [00:27:44] Speaker 04: But if you have an idea, and they have an idea of, let's just assume that what they've pointed to is sufficient to show this CRISPR structure [00:27:54] Speaker 04: and the idea of using it in a eukaryotic cell to cleave or whatever it is. [00:28:01] Speaker 04: That's their idea. [00:28:03] Speaker 04: And it seems like there's no dispute that they invented CRISPR as for the generic cell. [00:28:09] Speaker 04: For the single cell, whatever. [00:28:11] Speaker 04: The original CRISPR structure. [00:28:14] Speaker 04: The dispute is over whether they invented it for eukaryotic, right? [00:28:17] Speaker 00: I think the point is that there's no dispute that they conceived of SG RNA. [00:28:22] Speaker 00: The use of CRISPR in a eukaryotic cell was not their idea first. [00:28:26] Speaker 00: In fact, the evidence is in the record that in 2011 our inventor was using it for dual molecule RNA. [00:28:32] Speaker 00: And so what they invented in 2012 was something called sgRNA, which is one of two types of RNA that you can use in a cell. [00:28:41] Speaker 00: And, in fact, in the first appeal, right now, this whole appeal is going forward in the way where the other side is saying, well, sgRNA was it. [00:28:49] Speaker 00: That was the invention. [00:28:50] Speaker 00: Once you had that in the word eukaryotic, you were done. [00:28:53] Speaker 00: But that was the point of the first appeal. [00:28:55] Speaker 00: The first appeal in this case, this court affirmed the PTAS finding that sgRNA, which they came up with, it's a nifty RNA to use with CRISPR. [00:29:05] Speaker 00: There's also a dual molecule, which we've been using before. [00:29:08] Speaker 00: that that did not render the claim to have eukaryotic functionality obvious. [00:29:13] Speaker 00: They were patently distinct. [00:29:15] Speaker 00: And now we're just throwing that out, saying, well, no, if you use the word eukaryotic, that's enough. [00:29:20] Speaker 03: Why is it not error that the PTAB refused to take into account evidence of other labs' alleged success? [00:29:27] Speaker 00: We're honored that he they did not refuse to take into account. [00:29:30] Speaker 00: So if I guess preface this a little bit We've been hearing and I'll get to this one is the background here. [00:29:36] Speaker 00: We've been hearing all about how the p-tab Failed to make a finding that there was some inventive skill required the standard that they proposed to the p-tab was the borough standard that said [00:29:48] Speaker 00: They said, quote, in their brief, their Motion 2, conception is complete when only ordinary skill would be necessary to reduce the invention to practice without extensive experimentation or research. [00:29:59] Speaker 00: That's in Appendix 66858. [00:30:02] Speaker 00: And then they went on in their Motion 2 to say this. [00:30:04] Speaker 00: I think this is very important. [00:30:06] Speaker 00: Quote, there were no prolonged periods of extensive research, experiment, and modification or perplexing intricate difficulties that plagued the inventors, the CDC inventors, [00:30:16] Speaker 00: from their conception to their reduction to practice. [00:30:19] Speaker 00: So they were relying on their own work to say, look at our work. [00:30:23] Speaker 00: That confirms that we had a conception. [00:30:25] Speaker 00: So the PTAP took them up on that and did two things. [00:30:28] Speaker 00: They analyzed CDC's own work. [00:30:30] Speaker 00: And they made the findings we're talking about, which is, quote, at appendix 158, contrary to CDC's argument, the argument CDC said, look to our inventors. [00:30:40] Speaker 00: It was easy for them. [00:30:41] Speaker 00: We find that the CDC inventors engage in a prolonged period of extensive research [00:30:46] Speaker 00: experiment, and modification. [00:30:48] Speaker 00: I think a real key word there is modification. [00:30:51] Speaker 02: I'm not sure if you've answered my question yet. [00:30:52] Speaker 00: I was going to get to that, Your Honor. [00:30:54] Speaker 02: Can we get there sooner? [00:30:55] Speaker 00: Sure, I'll get to that. [00:30:56] Speaker 00: I'm sorry. [00:30:57] Speaker 03: then they want to make these findings saying that their own research shows that they didn't have any plan and they went on and said now, can we just take the answer to my question, some of your time is running, I'd just love to get the answer just on these labs before we go back into your other argument. [00:31:12] Speaker 00: Right, so at appendix page 179 the PTEP made a finding, it didn't ignore the other labs at all. [00:31:18] Speaker 00: It says, quote, regardless of any success by the road inventors, the proponents of the evidence presented by the parties [00:31:25] Speaker 00: demonstrates that the CDC inventors' experimental failures reveal uncertainty undermining a definite and permanent idea of an sgRNA CRISPR-Cas9 system that edits or cleaves DNA in a eukaryotic cell. [00:31:38] Speaker 00: So they waited. [00:31:39] Speaker 00: They said, okay, [00:31:40] Speaker 00: You told us to look at your own experiments and look at the broad experiments. [00:31:45] Speaker 00: We've looked at both of them. [00:31:46] Speaker 00: Your own experiments show that you had no definite and permanent idea, that you engaged. [00:31:50] Speaker 00: This is a fact finding. [00:31:52] Speaker 00: A fact finding on a standard. [00:31:53] Speaker 04: Well, it's a fact finding if they're using the correct standard of law. [00:31:56] Speaker 04: But if this is not the correct standard of law, then these fact findings are not useful. [00:32:01] Speaker 00: But Your Honor, this is the standard of law they told you to have to use. [00:32:05] Speaker 04: You know, he's going to get up and say that that's not what they said. [00:32:08] Speaker 04: And we can read Burroughs for ourselves and determine what Burroughs says is the standard of law. [00:32:13] Speaker 04: I don't think that Burroughs says you can only rely on the inventor's experiments. [00:32:18] Speaker 04: I wasn't saying that, Your Honor. [00:32:19] Speaker 04: Well, this is what the board says. [00:32:21] Speaker 04: We're not persuaded that these other inventors evident in nurse to CDC. [00:32:28] Speaker 00: But there's a couple of reasons for that. [00:32:30] Speaker 00: They looked at both. [00:32:31] Speaker 00: This is a wane of evidence. [00:32:33] Speaker 00: We looked at which research were armed with CDC's plan. [00:32:36] Speaker 00: He says, well, we had a plan to do these things. [00:32:39] Speaker 00: That plan was not given to anybody but CDC and its collaborators. [00:32:42] Speaker 00: And they failed every time they tried to do it. [00:32:44] Speaker 00: And the important thing is when they experienced failures, they didn't know what to do. [00:32:48] Speaker 00: They had no plan. [00:32:49] Speaker 00: The case now is almost like, well, we said the word eukaryotic, and that's all we needed to say. [00:32:54] Speaker 04: Well, I don't think that that's a very accurate representation of what they said. [00:32:58] Speaker 04: They have those lab notebooks. [00:33:00] Speaker 04: They have all the other techniques they described you might be able to use. [00:33:04] Speaker 04: sure their experiments took a long time and the board relied on those experimental failures. [00:33:10] Speaker 04: But if the legal standard the board uses is wrong, the fact that they couldn't initially make it work doesn't mean that they didn't have the conception and that others used prior art techniques or were just skilled artisans making it work. [00:33:25] Speaker 04: My problem is, I understand you think that there's evidence in the record that shows there were [00:33:31] Speaker 04: Techniques that went beyond the skilled artisan or aren't pirate techniques that bro did the board didn't make any of those findings [00:33:41] Speaker 00: The board didn't make findings that weren't asked to be made, I would say that, number one. [00:33:45] Speaker 00: But I will say this, you mentioned, Your Honor, just by the skilled artisan. [00:33:48] Speaker 00: So I want to get to the third-party labs again. [00:33:50] Speaker 00: The board, excuse me, CDC put in no evidence that any of the other labs were of ordinary skill. [00:33:57] Speaker 00: The board made an explicit finding, that's a fact finding, that the scientists performing the evidence, the experiments for CDC were at least of ordinary skill. [00:34:04] Speaker 00: And then they relied on those experiments to make a finding, a fact. [00:34:08] Speaker 00: And the board then went on and looked at the third party labs. [00:34:13] Speaker 00: And CBC did not put in any evidence whatsoever that those groups were of ordinary skill or that any of them were armed with CBC's plan. [00:34:20] Speaker 00: And to say that our inventor, who'd been working in eukaryotic cells for a year with CRISPR, no one else, he's not at POSA, he's got a year's worth of lab experience. [00:34:31] Speaker 00: So the board was free to say, they say, [00:34:35] Speaker 00: excuse me, appendix page 179. [00:34:36] Speaker 00: CBC attempts to shift our focus to the activities of other competing labs rather than the activities of its own inventors. [00:34:43] Speaker 00: We are not persuaded these other activities are evidence of CBC's inventors' ideas or their conception. [00:34:50] Speaker 00: So the CBC didn't put in any evidence that they gave their plan to any of these other third parties. [00:34:54] Speaker 00: They put no evidence in that the broad inventors were only ordinary skilled because... Did they have to give them their plan? [00:35:00] Speaker 04: I mean, there's the disclosures at the conference, or whatever we're talking about, about the idea of using CRISPR in eukaryotic cells. [00:35:09] Speaker 04: If people can take that and run with it with prior art techniques, that doesn't undermine conception, does it? [00:35:17] Speaker 00: There's no evidence that people were able to. [00:35:19] Speaker 00: Yes, I would say, yes, it does. [00:35:21] Speaker 00: It does. [00:35:21] Speaker 00: The reason it does, Your Honor, is because you have to have a conception of a complete and operative invention. [00:35:28] Speaker 00: And that's what you're looking to. [00:35:29] Speaker 00: They said, OK, try it. [00:35:31] Speaker 04: Let me ask you this. [00:35:32] Speaker 04: And maybe you dispute that this is what they disclosed in those lab notebooks and stuff. [00:35:36] Speaker 04: But let's just assume what they disclosed was their CRISPR, the SGNRA, or whatever it is you're talking about. [00:35:43] Speaker 04: I want to get a debate about what that is. [00:35:47] Speaker 04: They disclosed that, and they disclosed [00:35:50] Speaker 04: that it can be used in eukaryotic cells and that it can be done with prior art techniques. [00:35:58] Speaker 04: You can dispute that as a factual matter, but for hypothetical, let's just assume all that's true, that they had the conception of using the CRISPR in eukaryotic cells and that it could be accomplished with prior art techniques. [00:36:15] Speaker 04: If only party art techniques were used to accomplish that, then didn't they conceive of the idea? [00:36:20] Speaker 00: No, I would say they did not, Your Honor. [00:36:24] Speaker 00: They did not do that. [00:36:25] Speaker 00: Why? [00:36:25] Speaker 00: Because to say simply that go try it, that was the whole point of the CBC, the first lawsuit here. [00:36:32] Speaker 04: I don't want to talk about the first lawsuit. [00:36:33] Speaker 04: I don't think it's an issue here. [00:36:35] Speaker 00: OK. [00:36:35] Speaker 00: But all that is a disclosure of is a wish or a hope, which is what the PTAP found. [00:36:39] Speaker 00: They said all they had was a wish or hope. [00:36:42] Speaker 00: One of the evidences they have is their invention disclosure form. [00:36:44] Speaker 00: And they say, well, it was all there. [00:36:46] Speaker 00: Well, the PTAP made a fact finding about that. [00:36:48] Speaker 00: They said at appendix page 148, line 13, [00:36:52] Speaker 00: Quote, the IDF demonstrates that the CDC inventors plan to use their sgRNA CRISPR-Cas9 system in eukaryotic cells, but does not provide many of the details of how the inventors envisioned such a system would be operable. [00:37:07] Speaker 00: And that's what you need. [00:37:08] Speaker 00: You have to have a definite and permanent idea of an operable system. [00:37:12] Speaker 00: You can't just say, go out and try routine techniques. [00:37:15] Speaker 01: That's not how it works. [00:37:17] Speaker 01: So the inventor needs to show or establish that it works. [00:37:21] Speaker 00: They have to have a definite permanent idea of a system that they believe will work. [00:37:25] Speaker 01: We agree that that's not our law. [00:37:26] Speaker 01: We don't require that in order to have conception that the inventor must prove [00:37:31] Speaker 00: uh... that invention works okay your honor uh... is that correct i would not agree with that in this particular situation i would not agree with that in this particular situation why not would you agree with it in another situation well this this is this is this gets out of the issue in the boroughs case uh... council just quoted you a page from boroughs at page twelve twenty eight which has to do with the first five patents in that case and if you read the hitsman case your honor of course it talks about the fact that boroughs had six patents at issue [00:37:59] Speaker 00: And it does have the quote that he read regarding the first five patents. [00:38:04] Speaker 00: But the sixth patent in Burroughs required a function that was recited as a claim element, increased T cell production. [00:38:11] Speaker 00: Like here, we have a claim element, both halves of the count, that requires functionality in a eukaryotic cell. [00:38:19] Speaker 03: And what the Hitzman court said was... Are you contending that this case [00:38:23] Speaker 03: is closer to the set of claims relating to a patient's T cell levels or closer to the set of claims that opposing counsel is talking about with using AZT to treat HIV? [00:38:35] Speaker 00: It's the effect in the T cell production, right. [00:38:39] Speaker 00: Biological result. [00:38:41] Speaker 03: Why do you think that that's the closer more analogy? [00:38:43] Speaker 00: Because in this case it says, the CDC portion of the account says, quote, a eukaryotic cell comprising a target DNA molecule. [00:38:52] Speaker 00: And then it goes on and says, whereby said system is capable of cleaning or editing the target DNA molecule or modulating transcription of at least one gene product encoded by the target DNA molecule, which is in the cell. [00:39:04] Speaker 00: And there was no dispute down below that before the PTAB, excuse me, [00:39:08] Speaker 00: that functionality was a claim element. [00:39:10] Speaker 00: That's one of the major problems with their appeal, is they're trying to ignore that that is in fact a claim element. [00:39:16] Speaker 00: And I could read a couple quotes from Hitzman. [00:39:19] Speaker 00: Hitzman is a case where there was a biological result that was required. [00:39:23] Speaker 00: And so Hitzman then goes on and explains, well, Burroughs had the first five patents, but then there was a sixth one that required a biological result. [00:39:31] Speaker 00: And Hitzman says, at 243 F-13, [00:39:34] Speaker 00: 54 quote in establishing conception a party must show possession of every feature recited in the count and That every limitation of the count must have been known to the inventor at the time of the alleged conception and in that case there is this there's a couple limitations that [00:39:52] Speaker 00: have to do with yeast and how they're functioning, but they're recited as claim elements. [00:39:56] Speaker 00: That's a key thing. [00:39:57] Speaker 00: It's not like the first five. [00:39:58] Speaker 00: It's recited as a claim element. [00:39:59] Speaker 00: There's no dispute here. [00:40:01] Speaker 00: It says only by... Oh, I'm sorry. [00:40:02] Speaker 01: That's okay. [00:40:04] Speaker 01: Get back. [00:40:04] Speaker 01: I asked you a pretty simple question. [00:40:08] Speaker 01: Yeah. [00:40:08] Speaker 01: And that is, do you agree that you don't have to show that invention will work in order to have conception? [00:40:17] Speaker 01: You said yes and no. [00:40:19] Speaker 01: You gave me two. [00:40:21] Speaker 00: I think you have to know. [00:40:22] Speaker 00: You do have to know. [00:40:22] Speaker 00: Yes. [00:40:23] Speaker 01: Let me follow up with this question. [00:40:26] Speaker 01: Didn't the PTAB say that for this invention that the inventor should have known that the invention was going to work and that they did not? [00:40:35] Speaker 00: OK, can I answer that on the law and then on what the PTAB did? [00:40:39] Speaker 01: Well, you're really out of time, but I'd like to have the answer to the question and not go over it. [00:40:44] Speaker 00: The PTAB did not find that that was necessary for its decision on conception. [00:40:47] Speaker 00: What it did is it applied the borough standard. [00:40:49] Speaker 00: And it said that the borough standard allows us to look at [00:40:53] Speaker 00: the evidence of what happened after they led to conception. [00:40:55] Speaker 00: It found that the IDF did not have enough in there to show an operative invention. [00:40:59] Speaker 00: It then made fact findings based on the evidence of what went back and forth in the emails saying, not that it's just that they failed, and not the length of time, it's that the emails reflected the fact that they did have a plan. [00:41:11] Speaker 00: No, no. [00:41:12] Speaker 00: Actually, what it went to was the fact that they didn't have an idea. [00:41:15] Speaker 00: The documents they were lying for conception are completely devoid of any real plan. [00:41:20] Speaker 00: So what they were doing, it's them that told the PTAD to look at what happened later. [00:41:24] Speaker 04: Can I ask, let me ask you another question. [00:41:28] Speaker 04: This relates back to what we were talking about, but I'd like to see if I can get a little bit more of an answer. [00:41:33] Speaker 04: Let's just assume that I think [00:41:35] Speaker 04: that they conceived of this basic idea of doing CRISPR in a eukaryotic cell. [00:41:42] Speaker 04: And I think you answered that Zhang, your inventors, whoever, added something that wasn't prior art techniques or something that was beyond the skill of artisan to the invention. [00:41:57] Speaker 04: But the board didn't make any fact findings on this. [00:41:59] Speaker 04: Do you have specific [00:42:02] Speaker 04: Evidence in the record that points to what you think Jing added to this invention Well, yes, your honor. [00:42:09] Speaker 00: We have in our brief The different techniques that he applied that were not known to CDC and others because no, no, no, wait I don't want to know not known to CDC or others. [00:42:17] Speaker 04: I want to know not known That they're not in the prior art and are not known to skilled artists. [00:42:23] Speaker 04: Well, your honor our position is that none of them know I know what your position is we've heard it for like [00:42:28] Speaker 04: 20 minutes and you very well represented your position. [00:42:32] Speaker 04: I'm just trying to figure out if I have a different view of the law what factual evidence is in the record to support the idea that even if CBC had CRISPR and eukaryotic cells that there was something beyond ordinary experimentation that was required to accomplish this and that in fact meant that Zheng is the inventor not CBC. [00:42:55] Speaker 00: Well, Your Honor, I would point, Your Honor, to the adaptations that were made at appendix 81091 and 81092 as examples. [00:43:03] Speaker 00: And I believe in our brief, we point out some of the other adaptations, for example, at... No, I point you to those. [00:43:10] Speaker 00: And there's more in our brief as well, Your Honor. [00:43:12] Speaker 00: Okay. [00:43:12] Speaker 00: But, Your Honor, the... [00:43:16] Speaker 01: That's all. [00:43:17] Speaker 01: So I'll give you two minutes if you want to address your cross-appeal now. [00:43:21] Speaker 00: Your Honor, if I could just adjust a couple more points on this. [00:43:24] Speaker 00: I can stand on the brief and the cross-appeal. [00:43:26] Speaker 01: Make it very brief. [00:43:27] Speaker 00: I just want to read the one quote from Hitzman I didn't get to, which is, the Hitzman court says, quote, only by demonstrating that he had a definite and permanent understanding as to whether and how the yeast would produce the 20 nanoparticles, [00:43:40] Speaker 00: could Hitzman establish conception of the particle size and sedimentation rate limitations prior to reducing the invention of practice. [00:43:47] Speaker 00: That's at 243, F3, 1356. [00:43:50] Speaker 00: So the Hitzman court is explaining that if you have a functional claim element, you have to know how to make it work. [00:43:57] Speaker 00: But as I said, that statement by the PTAB actually was one where they were simply rejecting CBC's argument that it could ignore [00:44:08] Speaker 00: the functional claim element entirely. [00:44:10] Speaker 00: They'd already found that there was no conception because of the prolonged period of extensive research and modifications. [00:44:17] Speaker 00: While they say now that everything was known, if you look in the appendix, the PTAPs position at pages 152 to 156, you'll see they say codon optimization was always in the plan. [00:44:29] Speaker 00: The PTAP cites an email from the inventor saying, we're not sure, even in October, whether to use codon optimization. [00:44:36] Speaker 00: They say our SGRN never changed. [00:44:38] Speaker 00: The PTAP cites emails saying, no, you tried all these different SGRNs. [00:44:42] Speaker 00: SGRN is not just one thing. [00:44:44] Speaker 00: It's a category of different ones you can try. [00:44:45] Speaker 00: And it's all... Councilor, I think we have that. [00:44:49] Speaker 03: I just have one question on the cross appeal. [00:44:50] Speaker 00: Yes, Your Honor. [00:44:52] Speaker 03: If we agree that resolving the claim construction issue that leaves the PTAP's decisions on motions two and three intact, would you contend it's the right disposition here? [00:45:02] Speaker 00: I'm sorry. [00:45:03] Speaker 03: If we agree, [00:45:04] Speaker 03: that resolving the claim construction issue would leave the PTAP's decision on motions two and three intact. [00:45:10] Speaker 03: What is the correct disposition here in your opinion? [00:45:14] Speaker 00: Is that just on the cross appeal, Your Honor? [00:45:15] Speaker 03: Yeah. [00:45:15] Speaker 03: I'm asking your question strictly on the cross appeal. [00:45:17] Speaker 00: On the cross appeal, I think we also have established that there were claims that were too generic RNA. [00:45:23] Speaker 00: It was a dual molecule, single guide, and generic, whether or not you interpret guide RNA that way. [00:45:28] Speaker 00: So we think it still should be sent back with instructions to consider whether to broaden the account to include both dual and single guide RNA. [00:45:34] Speaker 01: Were your claims mooted? [00:45:36] Speaker 01: Did you say? [00:45:37] Speaker 01: Was the cross appeal mooted by the P tab? [00:45:41] Speaker 01: in reaching different motions and different motions? [00:45:44] Speaker 00: It was mooted in the sense that since there was no conception, it didn't matter. [00:45:47] Speaker 00: Since CBC, we were first reduced to practice. [00:45:50] Speaker 00: It was mooted for that reason. [00:45:51] Speaker 01: Yes. [00:45:55] Speaker 01: OK. [00:45:55] Speaker 01: All right. [00:46:01] Speaker 01: Thank you, Ken. [00:46:08] Speaker 01: We stored you back to four minutes. [00:46:10] Speaker 04: Thank you. [00:46:10] Speaker 04: Very much appreciated. [00:46:12] Speaker 04: Can I just jump in? [00:46:14] Speaker 04: And before he got to the cross appeal, he was talking, and we talked a little bit about this, but I want to go back to this because I find this the most troubling aspect of the case is our Hitzman decision, which suggests that when you have some kind of language in the claim or the count that suggests it's capable of working or it's operative or it will produce a result. [00:46:36] Speaker 04: that you have to have conception of that at the beginning. [00:46:39] Speaker 04: And the board made a finding here that you didn't. [00:46:43] Speaker 04: And whether Hitzman is right or not is irrelevant. [00:46:46] Speaker 04: We have to follow it. [00:46:49] Speaker 04: What's your response to the notion that [00:46:52] Speaker 04: even though you had, let's just assume, I know you'll agree with this, but let's just assume you had the idea of using CRISPR and eukaryotic cells with prior art techniques of getting it into the DNA, that we agree that you had that, but that Hitzman requires something more, that you knew it was capable of cleaving. [00:47:14] Speaker 04: What evidence is there in the record that shows you knew it was capable of cleaving, which is the language in your claim? [00:47:21] Speaker 04: or how would you deal with Hitzman? [00:47:24] Speaker 06: So I think Hitzman is very different, because Hitzman was acclaimed to a 20 nanometer particle. [00:47:29] Speaker 06: And part of conception is, one, do you have the conception, do you have the idea? [00:47:33] Speaker 06: And the other part is, do you have means for reducing it to practice? [00:47:37] Speaker 06: can you build it? [00:47:39] Speaker 06: And in Hitzman, the problem was they didn't know how to build that 29-millimeter particle. [00:47:43] Speaker 06: They didn't have that idea. [00:47:45] Speaker 06: I think Burroughs makes very clear, and Hitzman builds on Burroughs, you don't have to know it's going to work. [00:47:51] Speaker 04: I'm sorry to interrupt you, but your time is short. [00:47:54] Speaker 04: So, in your view, Hitzman, what they didn't have was [00:47:59] Speaker 06: routine prior our techniques to get from their idea to the 29 exactly exactly it was going to be that further invention was required and I know opposing counsel says oh there's five claims and there's a sixth claim in boroughs but the problem in boroughs with the sixth claim the five claims all talk about treating AIDS therapeutically effective amount and they just didn't know that AZT in the 1880s was going to be therapeutically effective there was a sixth claim that talked about raising T cells and the problem there was there was no evidence that they conceived that T cells [00:48:29] Speaker 06: were linked, the T cell increases, would be linked to treating AIDS. [00:48:33] Speaker 06: And so there's a remand saying, well, did you think about the T cells in particular? [00:48:37] Speaker 06: Or is that something you came up with later and added to your account? [00:48:40] Speaker 06: Here we don't have any questions about what was being thought. [00:48:44] Speaker 06: We know that they were looking at eukaryotic cells. [00:48:46] Speaker 06: We know they specifically thought. [00:48:48] Speaker 04: So the other question I discussed with your friend centered on the board, I think we agree that there's no finding from the board [00:48:59] Speaker 04: that one way or another of whether the other experimenters used other than prior art or just skilled artists and techniques. [00:49:09] Speaker 04: Did you argue to the board either that they were just skilled artisan techniques or respond on why they, that basically? [00:49:20] Speaker 04: Because if we send it back, I'm a little worried that there's nothing in the record one way or the other to the board. [00:49:27] Speaker 06: Certainly we did, and we invoked not only that Zain did not [00:49:31] Speaker 06: And for that, I would point to 81090. [00:49:35] Speaker 06: Zang did not innovate. [00:49:37] Speaker 06: He used ordinary skill routine techniques to reduce CVC's invention to practice, further confirming CVC's prior conception was complete. [00:49:44] Speaker 06: That's the argument. [00:49:45] Speaker 06: He didn't innovate. [00:49:46] Speaker 06: Only ordinary skills required. [00:49:47] Speaker 06: Therefore, our conception's complete. [00:49:49] Speaker 06: In terms of the other labs, I would go to page 66888. [00:49:53] Speaker 06: It says, third-party implementations in the inventors' sgRNA CRISPR-Cas9 system further corroborates the inventors' conception [00:50:01] Speaker 06: such that ordinary skill was needed to reduce the invention of practice. [00:50:04] Speaker 06: 85657, multiple lab groups use CVC systems with only ordinary skill and routine techniques, further confirming CVC's conception. [00:50:13] Speaker 06: We repeatedly went and pointed right to the other labs, really pointed to the fact that Zhang did not actually innovate and said, that confirms that our techniques, our conception was complete. [00:50:24] Speaker 06: I know that there's been extensive argument that Zhang did innovate in some way, and we've responded in our brief on pages 21 to 23 in the reply to explain why that's not true. [00:50:34] Speaker 06: But the key thing is if you look at page 181, and this is the board's reasoning, 181 of the appendix, what does the board say? [00:50:41] Speaker 06: The board says, well, there are technical reasons potentially why Zhang succeeded before others did. [00:50:48] Speaker 06: By October 5, they said, when our claimed reduction was the 29th or 31st of October. [00:50:52] Speaker 06: But it doesn't tell you when they are, it just simply says, because there was failure on one hand, while there were successes on another, there must have been differences. [00:51:01] Speaker 06: Well, are those differences ordinary skill, or are those differences inventive capability, inventive effort? [00:51:07] Speaker 06: And that's a question for the board. [00:51:09] Speaker 06: That is, in the end, a question for the board. [00:51:11] Speaker 06: We think there's only one answer. [00:51:13] Speaker 06: We've argued below that everything that Zhang did was ordinary skill. [00:51:17] Speaker 06: These are just ordinary vectors, precisely types of promoters that ordinary skilled artists would do. [00:51:21] Speaker 06: But that would be something for the board on remit. [00:51:24] Speaker 06: If there are no further questions, I would like to... [00:51:26] Speaker 06: So I could talk about the Cross Appeal very quickly. [00:51:30] Speaker 06: I think the fundamental problem with the Cross Appeal is they're appealing Motion 2 and Motion 3, but for each of them there was an alternative ground that isn't addressed in the opening brief. [00:51:40] Speaker 06: Do we have to address any of this if we remand to the board on this legal standard issue? [00:51:45] Speaker 06: I don't think the court necessarily has to. [00:51:47] Speaker 06: I think they would have the possibility of renewing it. [00:51:49] Speaker 06: But in the end, I think that it's all waived, because the opening brief simply doesn't address the alternative ground for denying Motion 2, that they tried to make other changes to the count and didn't justify it, which was described as an independent ground for denial. [00:52:02] Speaker 06: And on Motion 3, the board said, you haven't explained why the disclosure of Christopher Kastanian's single guide [00:52:11] Speaker 06: Wouldn't make obvious the generic invention and therefore you haven't explained you haven't given methods justification for deconcentration Consolidation, thank you. [00:52:20] Speaker 06: There are no further questions. [00:52:21] Speaker 00: Thank you We'll rest on the briefs on our crossfield once you have questions We thank you council for that. [00:52:31] Speaker 01: We thank the party for the arguments this morning. [00:52:33] Speaker 01: We'll take this this case under advice