[00:00:00] Speaker 01: Happy everyone made it here on time. [00:00:02] Speaker 01: The first case this morning is 17-1-7-1-4 in Ray Burgos. [00:00:08] Speaker 01: Ready? [00:00:09] Speaker 01: Please proceed. [00:00:14] Speaker 02: May it please the court, my name is Mark Pohl here representing the Patent Applicants Burgos. [00:00:21] Speaker 02: I'm here not so much to argue the case as to answer questions from you. [00:00:24] Speaker 02: My client found that a blue pigment in berries, if you extract it and give it to a person that has diabetes, they can eat this pigment before they have a meal and their blood sugar will be stabilized so they don't need to have insulin. [00:00:40] Speaker 01: So this case feels a lot like fung feathers, as I'm sure you realize. [00:00:45] Speaker 01: Yes, yes. [00:00:46] Speaker 01: So maybe you could direct us our attention to what you think is the strongest argument as to why fung feathers does not control [00:00:53] Speaker 02: In Funk Brothers, the Supreme Court invalidated about half of the claims at issue and left valid the remaining half. [00:01:02] Speaker 03: But were all the claims actually in front of the Supreme Court? [00:01:05] Speaker 03: My understanding was the only claims that were in front of the Supreme Court were the claims that the Supreme Court affirmed the invalidation of. [00:01:14] Speaker 02: Correct. [00:01:15] Speaker 02: And Funk Brothers found that in Funk Brothers there were [00:01:20] Speaker 02: bacteria, naturally occurring bacteria, and what the patentee had done is they had accumulated different species of bacteria, co-packaged them together, but the co-packaging together, the resulting product, didn't have any different function [00:01:38] Speaker 02: than the naturally occurring bacteria themselves. [00:01:41] Speaker 02: You get a bacteria A, B, and C, and you put them all together in a bag, bacteria A functions no differently in the bag than bacteria A functioned in the ground. [00:01:51] Speaker 02: And so the Supreme Court said, if all you're doing is getting bacteria A, B, and C and packaging them together in a bag, it really seems to be more of an innovation in packaging rather than providing a new functional utility. [00:02:04] Speaker 02: Here, we actually have something different. [00:02:06] Speaker 02: Here we have [00:02:07] Speaker 02: these dyes that naturally occurring do not stabilize blood sugar because naturally occurring they are with five times their weight or more of sugar and so a person taking the naturally occurring pigment in the naturally occurring state, which would be eating fresh fruit, that would actually precipitate hyperglycemia rather than prevent it. [00:02:31] Speaker 02: By extracting the dyes and providing them in a purified form, our inventors have [00:02:37] Speaker 04: found a new utility for these dyes, a utility that can't... But the problem is, you know, for the breast cancer gene in the human body, in the Myriad case, it was much the same. [00:02:50] Speaker 04: And the breast cancer gene is in the human body itself. [00:02:52] Speaker 04: You can't use it as a marker. [00:02:54] Speaker 04: It's only when you extract it and purify it and then test it can you find out it's in fact a marker for breast cancer. [00:02:59] Speaker 04: Exactly. [00:03:00] Speaker 04: But we say exactly, but that's not good for you, right? [00:03:03] Speaker 04: Because your Supreme Court held those claims were not eligible. [00:03:07] Speaker 03: Um, the Supreme court held the Supreme court affirmed with this court, this court found that the claims to purified CDNA, where you take the, I wish you wouldn't call it purified CDNA because I mean, I understand your conception of usage of purified there, but it wasn't, I mean, the, it was the G DNA, the genomic DNA that was isolated from the rest of the DNA and then extracted the CDNA was something that was [00:03:35] Speaker 03: engineered in a laboratory somewhere, removing the introns of course, but that is a series of nucleotides that doesn't exist in nature like the isolated genomic DNA. [00:03:48] Speaker 03: So just for my purposes, if you wouldn't refer to the seed DNA as something that's purified from the natural source, I'd appreciate that. [00:03:59] Speaker 02: Okay. [00:03:59] Speaker 02: Would we want to call it a DNA from which the introns have been [00:04:05] Speaker 04: Well, cDNA is not found in nature. [00:04:08] Speaker 04: Your extract is found in nature. [00:04:10] Speaker 04: The rest of the DNA in myriad was found in nature and that was found to be ineligible. [00:04:14] Speaker 04: So I don't see how you're like cDNA as opposed to like the rest of the DNA that was in myriad found to be ineligible. [00:04:21] Speaker 02: Because we're not claiming the compounds in the abstract. [00:04:25] Speaker 02: We're not claiming a specific pigment in the abstract, which actually, which claim could read on [00:04:32] Speaker 02: the wild naturally occurring pigment, we're claiming an extract that has at least 35% by weight of these pigments. [00:04:42] Speaker 02: And that kind of composition, 35% by weight or more, doesn't exist anywhere in nature. [00:04:49] Speaker 03: Right. [00:04:50] Speaker 03: But I guess for the myriad case, going back to the isolated genomic DNA nucleotide sequence, it doesn't exist in nature. [00:05:02] Speaker 03: in an isolated form. [00:05:03] Speaker 03: So if you had, once you isolate it and then mix it with, I don't know, 20,000 other DNA sequences just like that one that you isolated, you haven't really achieved anything in the Supreme Court's eyes. [00:05:21] Speaker 03: So I guess that's the concern. [00:05:24] Speaker 02: My own feeling with Myriad is that the Supreme Court made [00:05:27] Speaker 02: a very insightful distinction, but they weren't necessarily clear in articulating it. [00:05:35] Speaker 02: We'd known for years and years that there was a gene correlated with breast cancer risk. [00:05:40] Speaker 02: We'd known for years and years that that gene was somewhere on chromosome 17. [00:05:44] Speaker 02: Myriad found it. [00:05:45] Speaker 02: They found the location of it on chromosome 17. [00:05:48] Speaker 02: And the Supreme Court, in invalidating their claims to the gene, the Supreme Court was, I think, thinking [00:05:57] Speaker 02: You're not really patenting the gene, you're patenting the knowledge of where it is, kind of like patenting the location of a town on a map. [00:06:04] Speaker 02: That's knowledge in the abstract and we can't let you guys at Myriad co-opt the abstract knowledge of where on chromosome 17 this gene happens to begin and end because it'll stop all the scientific research in that area. [00:06:22] Speaker 02: That said, the Supreme Court said any sort of, the commercial embodiment of that [00:06:27] Speaker 02: the test kits and whatnot, the cDNA, that was all found patentable. [00:06:34] Speaker 03: If I were to take an orange, cut it open, and then squeeze all the juice out of it into a glass so that I had four ounces of orange juice, and I've isolated the juice from the orange, so I don't have to go through all the trouble of eating the entire orange, including the [00:06:57] Speaker 03: peel around it, have I created a patent-eligible composition of matter in that glass with juice? [00:07:07] Speaker 02: Does the juice have a function different than the... It increases my vitamin C levels. [00:07:12] Speaker 02: Does the orange fruit itself, when you peel the orange and just eat the fruit, does that have the same function? [00:07:23] Speaker 03: It increases your vitamin C levels. [00:07:25] Speaker 02: Okay, so that's a convenient rule of thumb. [00:07:31] Speaker 02: If the orange fruit, peeling the orange and eating the orange fruit, or alternatively squeezing the orange juice, if the orange fruit and the orange juice, if you eat them and you have the same function provided by both, then no, that's not patentable. [00:07:46] Speaker 03: All right, so you're saying squeezing the juice into a glass isn't good enough. [00:07:55] Speaker 03: Correct. [00:07:56] Speaker 03: What about if I squeeze in a bunch of grapefruit juice into that same glass? [00:08:02] Speaker 03: And so now I have a mix of orange juice and grapefruit juice. [00:08:06] Speaker 03: And I can say, well, I've increased my vitamin C level that much more because I've added grapefruit juice to the orange juice. [00:08:16] Speaker 02: To the mix. [00:08:17] Speaker 03: Is that patent-eligible? [00:08:19] Speaker 02: If eating a grapefruit and an orange fruit [00:08:24] Speaker 02: provides the same benefit as eating a grapefruit orange mix, I'm not convinced that the juice would be non-obvious, that it would provide a surprising [00:08:37] Speaker 02: counterintuitive, unexpected benefit. [00:08:39] Speaker 03: So it's not patent eligible under Section 101? [00:08:45] Speaker 02: I tend to rely more on 102 and 103. [00:08:47] Speaker 03: Right, but for purposes of this appeal, I need to think about Section 101. [00:08:53] Speaker 03: So I'm looking for your [00:08:55] Speaker 03: thinking on that for section 101 purposes? [00:08:59] Speaker 02: For section 101? [00:09:00] Speaker 03: I've created a mixture. [00:09:01] Speaker 03: It doesn't exist in nature, the mixture of grapefruit juice and orange juice. [00:09:06] Speaker 02: Then yes, I would say that that is patent eligible under section 101. [00:09:09] Speaker 03: OK, but why is it if we know in Funk Brothers that the uniting, bringing together naturally existing bacteria strains into a mix is not patent eligible, why would the [00:09:24] Speaker 03: orange juice and grapefruit juice mix be eligible? [00:09:34] Speaker 02: Because the bacteria in Funk Brothers are not, they are, they're physically in the same bag, but they're not actually, they're not combined with each other. [00:09:45] Speaker 02: It's as if you took whole oranges and whole grapefruits and put them in a bag. [00:09:50] Speaker 02: You can still, you can get Funk Brothers as [00:09:53] Speaker 02: sac of bacteria and pull out bacteria A or pull out bacteria B. They're not ad-mixed in a way that combines them, that mixing grapefruit and orange juice, you really can't separate the two. [00:10:11] Speaker 04: I guess here's my problem with your argument. [00:10:14] Speaker 04: I mean, it has enormous amount of superficial appeal for me. [00:10:18] Speaker 04: It has enormous amount of appeal for me, not just superficial, but [00:10:23] Speaker 04: superficial in light of Marriott and Funk Brothers. [00:10:26] Speaker 04: And here's why. [00:10:27] Speaker 04: You seem to disagree with Judge Chen's examples and I think give a legitimate reason because your idea is, well, but if these extracts were in the fruit and you ate the fruit, it wouldn't reduce your blood sugar. [00:10:39] Speaker 04: Whereas if you eat just the extract, i.e. [00:10:41] Speaker 04: the purified or isolated component, it does reduce your blood sugar, right? [00:10:45] Speaker 04: That's your argument. [00:10:47] Speaker 04: The problem is actually the extract inside the fruit [00:10:51] Speaker 04: would still act to reduce your blood sugar. [00:10:53] Speaker 04: It still functions the same way. [00:10:55] Speaker 04: Nothing changes about its function inside the fruit or outside of the fruit. [00:11:00] Speaker 04: It's just that when it's in the fruit, the fruit itself has a lot of natural sugar as well, so it kind of cancels each other out. [00:11:07] Speaker 04: So it isn't that your extract performs differently [00:11:10] Speaker 04: when purified, then it performs in the fruit. [00:11:13] Speaker 04: It's just the fruit has some natural sugar, which adds to your insulin sugar or whatever you want to call it. [00:11:19] Speaker 04: And so you don't have something that performs differently inside the fruit than it does outside of the fruit. [00:11:25] Speaker 04: And the Supreme Court was really clear in Myriad. [00:11:27] Speaker 04: Let me read you a couple of quotes from Myriad. [00:11:30] Speaker 04: For the reasons that follow, we hold that a naturally occurring DNA segment is a product of nature and not patent-eligible merely because it has been isolated. [00:11:38] Speaker 04: but that cDNA is patent eligible because it's not naturally occurring. [00:11:42] Speaker 04: But then another part, which is even more important, is that Myriad noticed and identified that in isolation, it's necessary. [00:11:51] Speaker 04: Isolation is necessary to conduct genetic testing, i.e. [00:11:54] Speaker 04: there's a different function when you can isolate the DNA and connect to genetic testing on it that you couldn't do when it was inside the human body. [00:12:02] Speaker 04: That wasn't enough to make it eligible, just like here. [00:12:06] Speaker 04: There's a different function that can be achieved when you can separate out and get rid of the sugar in the fruit. [00:12:11] Speaker 04: And I just don't see how Myriad hasn't closed the door to your claims. [00:12:17] Speaker 04: Not that I want it to, but I don't know what to do about these sentences out of Myriad that I'm reading you. [00:12:24] Speaker 02: The cDNA is in fact naturally occurring. [00:12:29] Speaker 04: No, it's not. [00:12:31] Speaker 04: It's not found in nature. [00:12:32] Speaker 04: The cDNA is not found in nature. [00:12:35] Speaker 02: This is how genes are expressed. [00:12:37] Speaker 02: We don't express the introns. [00:12:41] Speaker 02: We express the exons of a gene. [00:12:43] Speaker 04: The gene is trans... Well, I assume I disagree with you on the science because the Supreme Court did, because it expressly said it's patent-eligible because it's not... cDNA is patent-eligible because it is not naturally occurring. [00:12:55] Speaker 04: So whether you think they got that right or wrong on the technology is irrelevant. [00:12:59] Speaker 04: They've set the standard for the law. [00:13:03] Speaker 04: I don't know what to do. [00:13:04] Speaker 04: Can you spend one minute on your examples? [00:13:07] Speaker 04: Because you have a separate argument that you seem to have not addressed at all about the fact that even if these extracts are found in nature, there's an inventive concept because when combined, they offer unexpected results. [00:13:22] Speaker 02: Yes. [00:13:23] Speaker 02: The blue pigments that are naturally found in Chilean wineberry, for example, [00:13:32] Speaker 02: They have one effect on their own. [00:13:35] Speaker 02: And the inventors also found that if you take those pigments and you combine them with either a crystalline compound from another kind of plant, that they have a different effect. [00:13:48] Speaker 02: And if you take these pigments and combine them with yet a third, alternatively, class of compounds, they have yet another effect. [00:13:58] Speaker 02: And those combinations of [00:14:00] Speaker 02: chemicals are not found, to my knowledge, anywhere in nature. [00:14:04] Speaker 02: You have to actually take several different plants and put them together. [00:14:07] Speaker 03: I guess this is something that I was curious about in terms of looking at the examples in your specification. [00:14:13] Speaker 03: Let's just call them natural ingredient number one, natural ingredient number two, and natural ingredient number three. [00:14:19] Speaker 03: And you're saying that you get a better health benefit when you're combining natural ingredient one with two, or one with two and with three, and I'm just [00:14:30] Speaker 03: curious, it wasn't clear to me that the specification made clear that when you combine all three ingredients, you get a better health benefit than if you were to take the three ingredients individually in series. [00:14:45] Speaker 03: So instead of taking the three ingredients, mixing them together, and gulping it down in one shot, you first take the first ingredient, then immediately you take the second ingredient, and then you take the third cup, and you take the third ingredient, do you get a [00:14:58] Speaker 03: Your specification didn't make clear that you get some kind of, I'll just call it synergistic extra plus benefit when you take all three ingredients when mixed together as opposed to taking them individually. [00:15:12] Speaker 03: Do you understand my question? [00:15:13] Speaker 02: I understand your question. [00:15:14] Speaker 03: What is the answer to my question? [00:15:16] Speaker 02: I don't think temporarily it matters if you take them in one pill or if you take them in three different pills one right after the other. [00:15:23] Speaker 02: What matters is that these compounds are in your bloodstream at the same time. [00:15:28] Speaker 02: And to my knowledge, no one has ever tried doing that before. [00:15:32] Speaker 03: OK, so let me make sure I understand. [00:15:34] Speaker 03: You're saying that there's no difference, as you understand it, in whether the three ingredients are mixed together in a single composition versus them being three individual compositions that are then taken in series. [00:15:52] Speaker 03: Correct. [00:15:53] Speaker 03: Because all the action is going on inside the body. [00:15:56] Speaker 03: Exactly. [00:15:56] Speaker 04: No, but just to be clear, because I think that somebody just got left out, and not to your advantage. [00:16:02] Speaker 04: It matters that they're all three in your body at the same time. [00:16:05] Speaker 02: Right, in your bloodstream. [00:16:06] Speaker 04: They interact with each other, whether three separate pills or one pill, the presence of all three of them in your body simultaneously has some sort of markedly different characteristics. [00:16:16] Speaker 02: Exactly, yes. [00:16:17] Speaker 04: Right, so take one pill, wait two days later, take one pill, wait two days later, take one pill. [00:16:22] Speaker 04: It might have some benefit for you. [00:16:25] Speaker 04: But what you're saying is if all three of these chemicals are in your body at the exact same time, they have a greater reaction that they would have had each individual. [00:16:33] Speaker 03: Exactly. [00:16:34] Speaker 03: The concern I have is that there's nothing necessarily beneficial about having all three of them united together in a single composition. [00:16:45] Speaker 03: It sounds more like maybe there would be an opportunity for a method claim. [00:16:51] Speaker 03: these three natural ingredients, maybe doesn't even matter in what order or in the specific timing, because they'll all react together inside the system, your human system. [00:17:02] Speaker 03: But I don't understand how you get a markedly different characteristic by uniting the three together in a single composition. [00:17:14] Speaker 02: You get a markedly different characteristic when you have all three in your body at the same time. [00:17:20] Speaker 02: And so it could be [00:17:21] Speaker 02: as claimed in the same pill, or it could be alternatively three different pills. [00:17:27] Speaker 02: You take one now, wait two minutes, take another one, wait two minutes, take another one. [00:17:30] Speaker 02: As long as they're all in your bloodstream at the same time, they seem to produce an effect that no one of them alone produces. [00:17:43] Speaker 01: Okay. [00:17:43] Speaker 01: We're well in beyond your rebuttal. [00:17:44] Speaker 01: I'm sorry. [00:17:45] Speaker 01: I'm sorry. [00:17:47] Speaker 01: Thank you. [00:17:48] Speaker 01: Not your problem. [00:17:48] Speaker 01: We'll ask a lot of questions. [00:17:53] Speaker 00: May I please the court? [00:17:54] Speaker 00: We think here that the problem with Burgess's claims is that they bump up directly to Myriad and Funk Brothers and therefore are not patent eligible. [00:18:05] Speaker 00: I'd be happy to talk about each claim individually because I think there are sort of different issues for the three different claims. [00:18:11] Speaker 01: Why don't you start where we left off, talking about the examples and this sort of synergy when they're all taken at one time or all in the bloodstream at one time. [00:18:21] Speaker 03: Is it the agency's position that examples 18 and 27 represent patent-eligible subject matter? [00:18:29] Speaker 03: We do not believe that they do. [00:18:31] Speaker 03: Okay, the examiner believed that they did. [00:18:35] Speaker 03: Okay, let me say this. [00:18:36] Speaker 03: And then the board seemed to suggest that the examiner had it right. [00:18:44] Speaker 00: came out, the first office action issued early on, shortly after Marriott, where there was preliminary guidance, the agency had issued. [00:18:52] Speaker 00: The examiner sort of hints at it, says it appears that. [00:18:55] Speaker 00: I don't think the examiner has never had to really reach it because it thought that whatever, given the breadth of the claim, that there wasn't adequate evidence of showing markedly different characteristics. [00:19:06] Speaker 00: It did sort of seem to hint at. [00:19:08] Speaker 00: But let me say this, that since that time there's been additional examples and guidance from the office and I think certainly with that guidance material we think that it wouldn't and we believe that the guidance material is consistent with what we have in Funk Brothers and in Myriad. [00:19:22] Speaker 00: And if I could look at the examples and this is why. [00:19:25] Speaker 04: Well wait, you think, but I don't see the board, whether you think it does now [00:19:33] Speaker 04: isn't really relevant, right? [00:19:34] Speaker 04: What's relevant is, what did the board conclude and the examiner conclude? [00:19:39] Speaker 04: And is there substantial evidence to support those findings? [00:19:44] Speaker 04: The board didn't rely on any office guidance and say, oh, in later guidance, the examiner was wrong. [00:19:49] Speaker 04: If anything, the board seems to have endorsed the examiner. [00:19:51] Speaker 00: Right. [00:19:52] Speaker 00: And I was answering his question about, I think, whether or not there was anything at all in the example that was sufficient enough to show market differences [00:20:03] Speaker 00: The decision of the board and the examiner was based on the fact that the claims are broad. [00:20:09] Speaker 00: And if we look, if I can, maybe I think it would be helpful to go through the claims individually. [00:20:13] Speaker 00: But if I could, for example, point you to what the examiner actually found. [00:20:21] Speaker 04: But Judge Chen's question to you wasn't whether these claims are broad, and it wasn't whether these claims are eligible. [00:20:27] Speaker 04: He said, is example 18, and is example 27, [00:20:32] Speaker 04: patent eligible. [00:20:33] Speaker 04: That was his precise question to you. [00:20:35] Speaker 04: Given the examiner's finding that they're markedly different characteristics, I understand you've got a great argument for example 18 and example 27 are not even close to the breadth of these claims, right? [00:20:46] Speaker 04: I get that argument. [00:20:48] Speaker 04: Try to put that aside and just focus on the hypothetical. [00:20:51] Speaker 04: If there are two very specific examples in a specification, like say 1% this, 3% this, 5% this, [00:20:58] Speaker 04: And it is articulated that that particular combination has unexpected results. [00:21:03] Speaker 04: The examiner says, looks to me like has unexpected results. [00:21:06] Speaker 04: The board kind of acknowledged it didn't take issue with that. [00:21:10] Speaker 04: If this claim were limited to that example under those circumstances, would that be eligible? [00:21:17] Speaker 00: Well, at this point, we don't have that. [00:21:19] Speaker 00: And so we don't actually have a definitive determination from the examiner to the board on that. [00:21:23] Speaker 00: What we have, I think, fairly in the board and examiners [00:21:27] Speaker 00: fact-finding is that, given the breadth of the claim, that there is not sufficient evidence to establish eligibility for the claim. [00:21:40] Speaker 01: And if I may, I mean, I would like to... I'm just interested at this point, because I think we started with not withstanding what the board and the examiner held, just out there, whether or not it's at least the offices [00:21:55] Speaker 01: current physician, whether or not that's reflected in another case that affects our decision here is another matter. [00:22:00] Speaker 01: But just what is your view on the examples? [00:22:02] Speaker 00: I think the view on the examples, and it gets to exactly what the questioning that Judge Chen was giving, is that what is shown in the examples is a comparison between, for example, an example 18, is the anthocyanins with andrographylides [00:22:20] Speaker 00: compared to just the anthocyanins, and they never do a comparison to the endograftylides alone. [00:22:25] Speaker 00: So to the extent you were questioning, do we have to show more than, that they do something more than they do independently, I think we don't have evidence to show that. [00:22:35] Speaker 00: Because we don't have anything, we're comparing A and B together, and we compare the A and B to A, we never compare A and B to B. So we don't know if it's more than additive, [00:22:46] Speaker 00: and what they do individually just put together as opposed to something synergistic. [00:22:51] Speaker 03: To simplify or analogize the, as I understand example 18, it says if you take, if you drink four ounces of orange juice with four ounces of grapefruit juice, you're going to get more vitamin C than if you drink just four ounces of orange juice alone. [00:23:10] Speaker 03: And so the question is, okay, but it doesn't explain to me if the mixture of [00:23:15] Speaker 03: your orange juice and grapefruit juice creates a better vitamin C effect, say, than drinking four ounces of orange juice, waiting a few minutes, and then drinking a second glass with the second glass as four ounces of grapefruit juice. [00:23:32] Speaker 03: Correct. [00:23:32] Speaker 03: And so that was my question to you, which is, does the agency really believe that that example 18 is patent eligible when there's no evidence that I can see that says that [00:23:45] Speaker 03: drinking the mixture of orange juice and grapefruit juice yields a better healthful benefit than drinking them separately. [00:23:55] Speaker 00: And the agency position, I think, under our current guidance and examples, which I have in page eight of the director's brief, I cite to where those are. [00:24:04] Speaker 03: You cite the link. [00:24:05] Speaker 00: The link. [00:24:06] Speaker 00: And in that link, there are two different sets of examples. [00:24:11] Speaker 00: There are nature-based product examples. [00:24:14] Speaker 00: And there are subject matter eligibility examples for life sciences. [00:24:19] Speaker 00: And there are examples within them that discuss the whole issue of whether you have to, that you should have more than an additive effect. [00:24:27] Speaker 04: So that is the agency's priority. [00:24:29] Speaker 04: So just to be clear, because I want to make sure I understand that. [00:24:31] Speaker 04: So just Shin's example, suppose you get a 5% boost in your vitamin C level with the OJ, and you get a 5% boost, you would otherwise get a 5% boost with the four ounces of grapefruit juice. [00:24:43] Speaker 04: So each one individually would give you 8%. [00:24:45] Speaker 04: But if you drink them both, suppose the finding is your vitamin C jumps up 20%. [00:24:48] Speaker 04: Right. [00:24:49] Speaker 04: I realize this is a simple and stupid example. [00:24:51] Speaker 04: But suppose that were the case. [00:24:53] Speaker 04: That would be markedly different and unexpected, right? [00:24:55] Speaker 04: That is right. [00:24:56] Speaker 04: Oh, that's all I wanted to know. [00:24:58] Speaker 04: Perfect. [00:25:00] Speaker 04: OK. [00:25:00] Speaker 04: There's no evidence that's this case. [00:25:01] Speaker 00: There is no evidence that that's this case. [00:25:03] Speaker 04: Even example 18 or 27, there's no evidence. [00:25:06] Speaker 04: And even if example 18 and 27 contain such evidence, the claims are so broadly written. [00:25:11] Speaker 04: It covers many, many extracts beyond what are in examples 18 and 27. [00:25:15] Speaker 04: It has an unlimited almost number of percentages that these extracts would come in. [00:25:21] Speaker 04: And there isn't an expert that said, oh, well, we would expect to see the same synergistic benefit across the entire ring. [00:25:26] Speaker 00: Right. [00:25:27] Speaker 00: That's exactly it. [00:25:28] Speaker 00: And the examiner was struggling with, I think, if you look, the examiner trying to figure out what the amounts even were in the specific examples. [00:25:35] Speaker 04: So one of them definitely doesn't have amounts. [00:25:38] Speaker 04: I think it was at 27. [00:25:40] Speaker 00: Yeah, example, well, at page 93 of the supplemental appendix, the examiner was trying to figure out with the anthocyanin and andrographalide how much it was and figured out maybe the weight-to-weight ratio was something like 1 to 29, meaning 29 times more andrographalide, which is actually possibly outside of even the claim. [00:26:05] Speaker 00: But nevertheless, it said you have this, but you don't have anything to sort of cover the entire range. [00:26:09] Speaker 00: And that's the examiner's findings, which the board condoned. [00:26:15] Speaker 00: And? [00:26:16] Speaker 03: Your brief seemed to stress that there's no real structural difference at all when you mix these chemical compounds together. [00:26:26] Speaker 03: like the chemical compound number one, chemical compound number two, you mix them together. [00:26:31] Speaker 03: There's no structural difference. [00:26:33] Speaker 03: There's no chemical reaction that occurs between the compounds. [00:26:36] Speaker 03: They're just mixed together. [00:26:38] Speaker 03: Do you think that's necessary to establish a markedly different characteristic? [00:26:43] Speaker 00: I think if you have, if the two compounds don't change, I mean, the reason we stress that is that in the case of like cDNA or the case of chocobarties, [00:26:54] Speaker 00: modified, genetically modified bacteria, there is a structural difference or something different structurally from what's in nature. [00:27:00] Speaker 00: But we also think that if you combine two things, and even if they are structurally the same in the combination, if they either create a new function or give more than an additive effect, that that may put you into the realm of something that's markedly different. [00:27:15] Speaker 03: So I guess getting back to, as Judge Moore said, [00:27:22] Speaker 03: my silly and stupid example, if you mix together orange juice and grapefruit juice, and instead of getting the expected extra benefit of 4% plus 4%, 8%, but you get something like 20% benefit, then even if there isn't any kind of chemical reaction going on between the mixed orange juice and grapefruit juice, whatever is going on there, [00:27:49] Speaker 03: somehow by simultaneously consuming both juices together, you get the extra plus benefit. [00:27:55] Speaker 03: That's good enough to be considered a markedly different characteristic? [00:27:59] Speaker 00: That would be the agency's view. [00:28:00] Speaker 00: I mean, we're trying to be as careful as possible to apply these without stretching them beyond what we think they reasonably say. [00:28:08] Speaker 00: And that is sort of the agency's position that in those circumstances, you wouldn't necessarily have to have a change in structure of the underlying compounds as long as [00:28:18] Speaker 00: they actually together act synergistically. [00:28:25] Speaker 03: I never understood what exactly is the invention in Chakrabarti in the sense that it feels like factually that it's similar to the facts of Funk Brothers in a way. [00:28:40] Speaker 03: Funk Brothers, you're mixing together all these bacteria strains, and then Chakrabarti, it's mixing together some [00:28:48] Speaker 03: plasmids, housing them in a bacteria? [00:28:51] Speaker 00: Well, they've transformed, which is something that humans had to do. [00:28:55] Speaker 00: They've taken plasmids DNA, they've taken DNA, multiple different pieces of DNA, and they've transformed the bacterium. [00:29:03] Speaker 00: Merely just transforming is something that doesn't, the transformed bacterium doesn't occur in nature, so it's different from anything that occurs in nature. [00:29:10] Speaker 03: What's the transformation? [00:29:12] Speaker 03: Just the housing them in the bacteria? [00:29:14] Speaker 00: It's actually being able to take the DNA from an [00:29:18] Speaker 00: another source and actually be able to get it incorporated into the bacterium and get the bacterium to actually utilize that DNA and express it, et cetera. [00:29:28] Speaker 03: The Myriad opinion from the Supreme Court, it didn't actually use the two-step framework from Mayo. [00:29:37] Speaker 03: But it seems like the agency wants to use the two-step framework from Mayo when considering these [00:29:44] Speaker 03: isolated natural products in doing the patent eligibility inquiry. [00:29:50] Speaker 03: Do you think that's the right, is that the agency's position that we should funnel these types of cases through the two-step Mayo-Alice inquiry? [00:30:01] Speaker 03: I'm trying to understand what is the interplay between Chakrabarti and Myriad's markedly different characteristics inquiry versus the [00:30:14] Speaker 03: two-step framework set out in Mayo and Alice? [00:30:19] Speaker 00: Well, it is interesting that none of the nature, the natural products cases have actually discussed the two-step process. [00:30:29] Speaker 00: So Myriad Chakrabarti, they've never really gone through the two-step process. [00:30:34] Speaker 00: This court in Roslyn has never gone through the two-step process. [00:30:38] Speaker 00: The agency's guidance sort of has these in a separate box. [00:30:42] Speaker 00: And so it's basically taking the natural products cases and applying Myriad and Roslyn and not really going through the two-step process and sort of handling them independently. [00:30:52] Speaker 00: The board did kind of do the two-step process, but it seems fairly redundant because you're kind of doing the same thing in step one and step two. [00:31:03] Speaker 00: So I think you could fairly do it either way, but the agent has taken the position that [00:31:09] Speaker 00: These are kind of a separate category of things, and there's case law that applies to them, and this is how the analysis is done. [00:31:18] Speaker 00: But at the end of the day, I think the inquiry is very similar, because it's basically looking at whether or not there's something either significantly more or markedly different from the natural, whether it be an abstract idea or whatever the exception is, it's looking at and comparing to what exists in nature and whether or not there is something different from that. [00:31:40] Speaker 03: Do you think claim 86 is patent eligible? [00:31:46] Speaker 00: The examiner did drop that. [00:31:48] Speaker 00: And again, this was a preliminary period where the agency was trying to figure out where to draw the line on that. [00:31:57] Speaker 00: The agency's position right now is probably that it might not be because they haven't actually done more than add something that is routine and conventional. [00:32:10] Speaker 00: At this point, that's not in this case. [00:32:13] Speaker 00: If you have additional questions. [00:32:32] Speaker 01: We're restoring two minutes of rebuttal, if you'd like to take that. [00:32:39] Speaker 02: Thank you very much. [00:32:46] Speaker 02: We just talked about the idea of a synergy across the entire range of ostensibly very broad claim and whether the examples support that. [00:32:57] Speaker 02: That could be an issue, but that would, I think, be an issue better raised under Section 103 rather than Section 101, because if we, for example, have orange juice and grapefruit juice, combine them together, if that combination is not seen anywhere in nature, that dispenses with Section 101 and product of nature [00:33:20] Speaker 02: right at the threshold. [00:33:21] Speaker 02: And then we can move on to the next question, which is, does the combination of orange juice and grapefruit juice, if one gives 4% vitamin C and the other gives three, does the combination give an unexpected synergistic result? [00:33:35] Speaker 02: That is the kind of question that we would routinely raise under section 103, not under section 101, the combination of orange and grapefruit juice, because it's never seen in nature. [00:33:48] Speaker 02: cannot really be a product of nature. [00:33:58] Speaker 02: Questions? [00:33:59] Speaker 01: Thank you.