[00:00:14] Speaker 04: Next case is the University of Maryland Biotechnology Institute versus PreCENSE Precision Sentencing. [00:00:23] Speaker 04: 2016-2745, Mr. Vasquez. [00:00:29] Speaker 02: May I please record? [00:00:30] Speaker 02: Good morning. [00:00:30] Speaker 02: Rene Vasquez for the Upland University of Maryland Biotechnology Institute. [00:00:36] Speaker 02: At the outset, I would like to emphasize a crucial aspect of the legal system that I think [00:00:42] Speaker 02: must be taken into account in an obviousness analysis. [00:00:46] Speaker 02: And that is, the core concept and principle of operation of the legal system is the exact opposite of the core concept and principle of operation of the claim system. [00:00:59] Speaker 02: Specifically, the 532 patent claims a system for the in situ non-invasive monitoring of multiple cell culture parameters without having to take samples [00:01:12] Speaker 02: from the cell culture to a remote sensing system in order to perform measurements. [00:01:19] Speaker 03: Would it make a difference if we started with Banbot as a primary reference and then determined whether there would be a motivation to combine that with Weigel? [00:01:31] Speaker 03: Your Honor, I don't... Recognizing this difference in structure? [00:01:34] Speaker 02: I don't think so, Your Honor. [00:01:35] Speaker 02: And the reason is the Banbot system, in fact, what I like with regards to Banbot, [00:01:42] Speaker 02: The examiner had this to say about BAMBOT in the appendix page 388. [00:01:47] Speaker 02: He said, quote, there is no teaching of simultaneous monitoring in a single spinner flask of at least two parameters using at least one individual detector, light source, and sensor for each parameter. [00:02:00] Speaker 02: Even if it could be implied from BAMBOT that several different parameters could be monitored in a single bioreactor, there is no clear teaching of how a light source sensor [00:02:11] Speaker 02: and detector would be arranged to meet the claimed invention. [00:02:14] Speaker 02: Now, if you're looking at Bambad as a primary and now you look at Weigel, well, what would a person of ordinary skill in the art do when they look at Weigel? [00:02:24] Speaker 02: Well, the first thing they'll notice is that this is a system that is diametrically opposed in terms of their principle of operation. [00:02:34] Speaker 02: Instead of monitoring soil culture parameters, [00:02:37] Speaker 02: using sensors that are actually in the cultivation vessel. [00:02:42] Speaker 02: They are placing those sensors outside of the container that holds the solution that they're measuring. [00:02:48] Speaker 02: What does that mean? [00:02:49] Speaker 02: Well, again, you have to draw samples from the container to the sensors. [00:02:56] Speaker 02: And this is a crucial point. [00:03:00] Speaker 02: The system in Weagle wasn't chosen randomly. [00:03:03] Speaker 02: They didn't just say, OK, we're going [00:03:06] Speaker 02: do this remote sensing configuration just because we could have put the sensors inside. [00:03:11] Speaker 02: But we're going to do this remote sensing configuration. [00:03:15] Speaker 02: A careful read of WIEGL sheds some light into why it is that they first have this remote configuration where you have to draw samples to the flow through cell. [00:03:25] Speaker 02: But also, and critically, each flow through cell has one sensing membrane, one sensing membrane for either pH, CO2, or oxygen. [00:03:36] Speaker 03: The real point that they draw from WIEGL is the concept of multiple sensors, right? [00:03:44] Speaker 02: Yes, Your Honor. [00:03:45] Speaker 03: And WIEGL predates BAMBOT or BAMBO, however you pronounce it, by 10 years. [00:03:51] Speaker 02: Yes, Your Honor. [00:03:52] Speaker 02: But the analysis doesn't end there. [00:03:54] Speaker 02: And you have to look at the reference as a whole. [00:03:57] Speaker 02: And the reference as a whole, WIEGL, teaches that you have isolated sensors for pH, CO2, and oxygen [00:04:06] Speaker 02: Each of these little flow-through cells is one sensor, one detector. [00:04:11] Speaker 01: Now, I'm sorry. [00:04:14] Speaker 03: Just for references, they don't necessarily teach exactly the same thing. [00:04:19] Speaker 03: So the question is, is there a reason that you would put them together? [00:04:24] Speaker 02: There is. [00:04:25] Speaker 02: And actually, Your Honor, there's a reason that you would not. [00:04:28] Speaker 02: And the reason is, and Weigel states it, he says, first of all, the CO2 sensor has to be replaced after every measurement. [00:04:35] Speaker 03: So your teaching away is limited to the CO2 sensor problem? [00:04:41] Speaker 02: Well, it's not just a CO2 sensor. [00:04:43] Speaker 02: What we will also teach is that the oxygen sensor has to be recalibrated once a day. [00:04:49] Speaker 02: When you recalibrate the oxygen sensor, what you have to do is introduce gas with a known amount of oxygen into the sensor and then measure what the output is to see if it's measuring the rate. [00:05:02] Speaker 03: Then you have BAMBOT. [00:05:05] Speaker 03: where they're able to overcome the need to replace the CO2 sensor, right? [00:05:10] Speaker 02: Well, Your Honor, and this is exactly the point that I was trying to make. [00:05:13] Speaker 02: The reason that WIEGL puts their sensors outside and only uses one sensor in each flow-through cell is that when that one sensor fails, they can replace it without contaminating the soil culture and without possibly contaminating or damaging [00:05:32] Speaker 02: other sensors if they had put more than one sensor in a flow-through cell. [00:05:36] Speaker 02: Now, if you take that concept and say, oh, well, just take Weagle, put multiple sensors in the Banbot spinner flask, it goes completely against the problem that Weagle was trying to solve, which is if one of those sensors fail, you're going to have to go into the cell culture to replace it in Banbot, whereas in Weagle, which means you'll have to start over with the cell culture. [00:06:00] Speaker 03: But there are many circumstances in which the prior art is trying to solve a different problem than the current patent or current proposed patent. [00:06:11] Speaker 03: And that doesn't mean that the prior art's not relevant and that there aren't some teachings that can be gleaned from the prior art. [00:06:18] Speaker 03: You don't have to have the same problem that you're trying to solve. [00:06:22] Speaker 02: You're absolutely right, Your Honor. [00:06:25] Speaker 02: My point is that it's not sufficient [00:06:30] Speaker 02: to I don't think it's sufficient to cherry pick elements from references and insert them without looking at the overall teachings of the references. [00:06:43] Speaker 02: And the key again is I'm a person of ordinary skill in the art. [00:06:47] Speaker 02: I've got a system in Banbot with a single sensor for monitoring a single parameter. [00:06:54] Speaker 02: And I look to Weagle. [00:06:56] Speaker 02: And everything about Weagle tells me [00:06:58] Speaker 02: Don't put multiple sensors in a single cultivation vessel. [00:07:03] Speaker 02: And they're clear about why that is. [00:07:05] Speaker 03: And so... When you presented this argument to the board, you focused on the fact that WIEGL is a really totally different system. [00:07:15] Speaker 03: And if you try to squeeze it into BAMBOT or BAMBO, that you would be basically messing up the way it's supposed to work. [00:07:25] Speaker 03: But I never saw you actually argue to the board that the problem is whether one of skill and the art would have had a motivation to combine the two references. [00:07:36] Speaker 03: Did you ever make the argument in that way? [00:07:38] Speaker 03: Because it doesn't seem to be made in that way in the briefs here. [00:07:43] Speaker 01: Your Honor, I think that's on me. [00:07:51] Speaker 04: OK. [00:07:51] Speaker 04: And incidentally, during the break, [00:07:53] Speaker 04: Weigel is from Austria. [00:07:55] Speaker 04: I assume it must be Weigel. [00:07:57] Speaker 04: Weigel? [00:07:57] Speaker 04: It must be. [00:07:58] Speaker 04: It's German. [00:08:01] Speaker 03: OK. [00:08:01] Speaker 03: How about Bamboe? [00:08:02] Speaker 04: No opinion. [00:08:11] Speaker 04: My law clerk said Bamboe. [00:08:14] Speaker 03: OK. [00:08:14] Speaker 03: That's what I thought. [00:08:16] Speaker 03: I mean, this guy probably is affiliated with him. [00:08:27] Speaker 04: You want to continue? [00:08:29] Speaker 02: Yes, Your Honor. [00:08:31] Speaker 02: In terms of the specific motivation to combine, what we did say was that someone looking at Weigel, a person of skill in the art looking at Weigel, would be directed down a path that's completely divergent from the path that the patentee took, which in effect, Your Honor, I would argue goes to exactly that, a motivation to combine. [00:09:01] Speaker 04: Anything further? [00:09:06] Speaker 03: I'm sorry, Your Honor. [00:09:08] Speaker 03: I do have a question. [00:09:09] Speaker 03: You make this distinction between invasive versus non-invasive nature of BAMBOT, and I don't really understand how that relates to the actual claims of the patent. [00:09:25] Speaker 03: Is there anything in the claims of the patent that make that distinction? [00:09:28] Speaker 02: Well, the claims call for the sensors being embedded in the cultivation vessel. [00:09:36] Speaker 02: What that means is that you can now monitor the parameters by shining light on the sensors. [00:09:43] Speaker 02: You don't need to continually insert a probe to measure these parameters. [00:09:48] Speaker 03: So where in the claims is that distinction meaningful? [00:09:54] Speaker 02: the claim element that requires that the sensors be placed inside the cultivation vessel, on the cultivation vessel wall, and that it is in contact with the culture medium. [00:10:08] Speaker 02: Those claim limitations, in effect, result in a system that allows you to monitor these parameters, because these are optical chemical sensors that can be interrogated with light from the outside. [00:10:25] Speaker 03: One last question. [00:10:26] Speaker 03: I don't see any separate reasons for patentability offered with respect to the independent claims. [00:10:33] Speaker 03: Is that correct? [00:10:33] Speaker 03: I mean the dependent claims. [00:10:35] Speaker 01: That's correct. [00:10:37] Speaker 04: I would like to reserve the remainder of my time. [00:10:55] Speaker 00: I want to make two broad points and illustrate those with two examples. [00:11:08] Speaker 00: The two broad points are related. [00:11:10] Speaker 00: The first point is that appellant is ignoring what the board said. [00:11:16] Speaker 00: And the second point is that appellant is ignoring the Bambot reference. [00:11:21] Speaker 00: The first point is that the [00:11:24] Speaker 00: The board's decision is in the appendix of pages A20 through 24. [00:11:29] Speaker 00: When you read through appellant's brief, you see no citation to that portion discussing obviousness. [00:11:36] Speaker 00: And I'm not talking about a technical flaw of failure to cite a page. [00:11:40] Speaker 03: The board's opinion does talk about obviousness, and it talks about the references. [00:11:44] Speaker 03: But their conclusion as to why you would put the references together is one paragraph from which they quote the examiner. [00:11:52] Speaker 03: That's it. [00:11:54] Speaker 00: Correct. [00:11:54] Speaker 03: And they also... They never mentioned the word motivation to combine. [00:11:57] Speaker 03: They never do a motivation to combine analysis. [00:12:00] Speaker 00: Right. [00:12:00] Speaker 03: Didn't that be a problem under... in Renuvasive? [00:12:03] Speaker 00: If it was, the appellant didn't argue it, as you mentioned in your question. [00:12:06] Speaker 00: Appellant failed to argue that there was a motivation problem in the opening brief or in reply. [00:12:12] Speaker 03: Would we be concerned about the board reaching an obvious conclusion without following the law? [00:12:17] Speaker 00: I think they expanded on that at the rehearing. [00:12:20] Speaker 00: But the idea is that both references taught multiple sensors [00:12:25] Speaker 00: measuring different parameters. [00:12:27] Speaker 00: And Bambo teaches put the sensor in the cultivation vessel. [00:12:37] Speaker 00: So the board adopting the examiner's reasoning was that a person of ordinary skill would be highly interested in measuring different analytes, different parameters. [00:12:49] Speaker 00: So it would have made sense to check, as the claim calls for, at least two [00:12:54] Speaker 00: of the analytes are using at least two sensors. [00:12:58] Speaker 00: And that is the nature of obviousness for the board. [00:13:03] Speaker 00: I say that because the appellant prefers to argue anticipation. [00:13:08] Speaker 00: All the sites in the brief are to what the examiner or the board said with respect to anticipation. [00:13:14] Speaker 00: And the appellant is looking for, when combining the two references, the appellant is still looking for it to disclose every single element. [00:13:22] Speaker 00: But that's not the nature of obviousness. [00:13:24] Speaker 03: What's your response to the argument that given the board's own findings with respect to what Weigel teaches and how it operates, that modifying it to obtain the claimed invention would actually be completely inconsistent with how it operates? [00:13:43] Speaker 00: Yeah, I don't think that's what the board said at all. [00:13:45] Speaker 03: If you look at what the board said in those pages on obvious... They didn't say the last, but they certainly said the first about how it operates. [00:13:52] Speaker 03: They made findings about how it operates. [00:13:54] Speaker 00: Yes, but when they made the determination of obviousness, they relied heavily on Bamboe. [00:14:00] Speaker 00: I mean, Bamboe is the star of the show, so to speak. [00:14:03] Speaker 00: Findings of fact 8 through 14, they only had a limited borrowing from Weigel. [00:14:09] Speaker 00: But Appellant tends to characterize this argument as, Weigel is a primary reference. [00:14:15] Speaker 00: How do you modify it in view of Bamboe? [00:14:18] Speaker 00: That's not the way the board worked. [00:14:19] Speaker 00: The board repeatedly said it's both references in combination. [00:14:23] Speaker 00: And if you look at the findings of fact that covered most of what the board did, it all comes from Bamboe. [00:14:30] Speaker 00: This is not a question of how to modify Weigel. [00:14:34] Speaker 00: They took a limited teaching from Weigel. [00:14:37] Speaker 00: That is that you can use multiple sensors. [00:14:39] Speaker 03: Where does the board's decision satisfy the requirement in KSR that the motivation to combine analysis must be made explicit? [00:14:56] Speaker 00: from the examiner's statement would be the best way that the board explained it. [00:15:02] Speaker 00: And what the person of ordinary skill faces is, as I said, all these parameters, these analytes are important. [00:15:11] Speaker 00: It would have been obvious to choose to test more than one analyte at a time within the same vessel. [00:15:22] Speaker 03: And you're relying on what, common sense or was there testimony from one of skill in the arts that it would have been? [00:15:30] Speaker 00: No, there was no testimony. [00:15:31] Speaker 00: Relying on the board's reasoning that... So point to me the words. [00:15:39] Speaker 00: I don't think there's any explicit words other than what the board said in quoting the examiner, what they said was a well-reasoned statement. [00:15:47] Speaker 00: And the conclusion right at the very last portion of the request for rehearing where they cited KSR that this problem, one of ordinary scale, would have looked to solve what was an ordinary problem. [00:16:00] Speaker 00: How do we get more information out of these cultivation vessels? [00:16:05] Speaker 00: I don't think the board took it any further than that. [00:16:07] Speaker 00: I don't think it was necessary to go from one sensor to two sensors when you've already shown that multiple sensors from Weigel can be used. [00:16:16] Speaker 03: What about the problem with respect to the CO2 sensor having to be replaced after each use in Weigel? [00:16:24] Speaker 00: Yes, the board answered that twice in the initial decision and in the rehearing. [00:16:32] Speaker 00: The board specifically said Weigel does not teach away from the patent invention. [00:16:41] Speaker 00: It said look at Bambo and Weigel. [00:16:45] Speaker 00: And from Bambo, you would use the CO2 sensor instead of the problems that Weigel acknowledged. [00:16:53] Speaker 00: Weigel acknowledged that the CO2 sensor was not robust and therefore needed frequent replacement. [00:17:00] Speaker 00: If you look at Bambo, pages 129 to 130, Bambo starts out discussing the problems with CO2 sensors, essentially acknowledging what Weigel said. [00:17:12] Speaker 00: But then Bambo goes on to say, [00:17:15] Speaker 00: these new sensors, these chemical sensors, and he cites a reference, I believe it's Mills et al. [00:17:20] Speaker 00: in the end notes, saying this is a new type of sensor and it works better. [00:17:25] Speaker 00: So in that sense, Bamboo had solved the problem, and that's what the board believed was effective. [00:17:31] Speaker 00: Well, I mean, Appellant spends a great deal of time talking about the problems with the CO2 sensor, and then launches a whole host of arguments, but the board's answer was twice the same. [00:17:43] Speaker 00: Just take the CO2 sensor from the Bamboo reference, it works. [00:17:51] Speaker 00: On this point of invasive and non-invasive, if you look at the patent itself, it calls for the sensors to be in contact with the cultivation vessel and for the sensors to be in contact with the culture cell. [00:18:14] Speaker 00: So the concept of invasive and invasives doesn't really apply. [00:18:18] Speaker 00: This concept comes up with respect to the Bamboo reference of Figure 4, which is a blood oxygen oximeter that showed multiple sensors. [00:18:29] Speaker 00: That is where Appellant argues that it is invasive, but that's comparing apples and oranges. [00:18:37] Speaker 00: The oximeter is a piece of medical technology for your body. [00:18:41] Speaker 00: So obviously there's a medical definition. [00:18:44] Speaker 00: Is it invasive or non-invasive? [00:18:48] Speaker 00: But that doesn't apply to this patent. [00:18:52] Speaker 00: What Appellant does in his brief, he argues that by invasive, Appellant means taking away a sample. [00:19:01] Speaker 00: That's specifically argued in the brief because he uses that with Weigel. [00:19:06] Speaker 00: But if you look at the oximeter disclosed in Figure 4 of Bambo, [00:19:11] Speaker 00: It does not take away a sample. [00:19:13] Speaker 00: I mean, it would be easy to understand taking a blood sample in a vial and testing it. [00:19:17] Speaker 00: Instead, all three sensors are placed directly in the bloodstream, and there's no sample being taken. [00:19:23] Speaker 00: So in that sense, the oximeter is non-invasive, the same way as appellant characterizes the invention as non-invasive. [00:19:33] Speaker 00: Both the same concept. [00:19:35] Speaker 00: And that is why the board, in finding a fact 14, [00:19:40] Speaker 00: took those two consecutive sentences from Bamboe. [00:19:44] Speaker 00: First sentence says, here's what figure four tells us. [00:19:47] Speaker 00: And the second sentence said that similar concepts are applicable to bioreactor monitoring, period. [00:19:56] Speaker 00: So the reference clearly disclosed that that concept was applicable to bioreactors. [00:20:03] Speaker 00: Now, the inventor of this patent, Mr. Rao, R-A-O, is a joint author of the Bamboe reference. [00:20:10] Speaker 00: He, the inventor, more than most people would have appreciated what it meant putting those two sentences in direct conjunction. [00:20:20] Speaker 00: And then to draw the conclusion that this oximeter was applicable to bioreactors. [00:20:27] Speaker 00: So I think when Appellant tries to argue against that now, that's just some post facto rationalization. [00:20:35] Speaker 00: It contradicts what the inventor said in an article published [00:20:40] Speaker 00: five years before the patent application was filed. [00:20:45] Speaker 04: The co-author with Bambo is the inventor, Rao. [00:20:51] Speaker 00: Yes. [00:20:53] Speaker 00: Right, that's what I'm saying. [00:20:54] Speaker 00: So that's why it makes, the board's reasoning makes even more sense. [00:20:59] Speaker 00: Appellant's argument is just a contradiction of what the inventor said. [00:21:03] Speaker 00: That's why it doesn't hang together. [00:21:12] Speaker 00: Appellate characterizes the Bambo reference as rudimentary and generalized. [00:21:21] Speaker 00: It's actually a very good reference because it collects together the state of the art, talking about advances in the past year in that technology. [00:21:31] Speaker 00: So in that sense, it's useful for understanding what the person of ordinary skill in the art would have understood. [00:21:39] Speaker 00: So I think that's why perhaps the board relied so heavily on the Bamboo reference to take the multiple fact findings from it. [00:21:52] Speaker 00: There's almost no discussion of the Bamboo reference in Appellant's brief. [00:21:56] Speaker 00: It's briefly there at pages 17 to 19, which is more of a description of what it is, and this argument, as I just mentioned, about invasive, non-invasive. [00:22:08] Speaker 00: For the rest of the opening brief, for instance, most of the pages are devoted to Weigel, but the board went the other way. [00:22:16] Speaker 00: They relied heavily on Bamboe. [00:22:19] Speaker 00: And that's what Appellant seems to be missing, is grappling with what the board really did in the determination of obviousness. [00:22:40] Speaker 04: Anything further? [00:22:41] Speaker 00: No, I'd be pleased to answer questions. [00:22:46] Speaker 04: No one ever loses a case for not using up all of his time. [00:22:52] Speaker 00: Thank you, Your Honor. [00:22:53] Speaker 04: Mr. Vasquez has some more final time. [00:23:06] Speaker 02: Yes, I'd like to address [00:23:09] Speaker 02: Eileen's comments with regards to the CO2 sensor. [00:23:14] Speaker 02: It's kind of missing the larger point. [00:23:18] Speaker 02: And the larger point is that the configuration of Weigel is tailored to take into account the possibility of a failure in a sensor. [00:23:31] Speaker 02: Now, in this particular case, we're talking about the CO2 sensor possibly failing. [00:23:36] Speaker 02: Well, not possibly. [00:23:36] Speaker 02: You had to replace it every day. [00:23:38] Speaker 02: the oxygen sensor needing recalibration. [00:23:42] Speaker 02: Any sensor can fail at any given time. [00:23:45] Speaker 02: I mean, that's just the nature of mechanical devices, right? [00:23:50] Speaker 02: And so it's informative to know what these bioreactors are used for. [00:23:55] Speaker 02: One of the uses for these bioreactors is for manufacturing of drugs. [00:24:00] Speaker 02: The cells that you cultivate in the bioreactor [00:24:04] Speaker 02: are to create the drugs that you're making. [00:24:10] Speaker 02: And in this sense, the culture conditions are critical. [00:24:15] Speaker 02: You have to monitor them closely. [00:24:17] Speaker 02: You have to control them closely. [00:24:19] Speaker 02: And this is why it is critical as to whether or not you have to go into that cell culture to replace a field sensor. [00:24:26] Speaker 02: But is lack of contamination a claim stuff? [00:24:32] Speaker 02: It's not an explicit claim step, but it naturally flows from the claim limitations of these two sensors on a cultivation vessel wall such that when the culture medium is in there, it's in contact with those sensors. [00:24:52] Speaker 02: That necessarily means now that with those optical chemical sensors, you can interrogate them. [00:25:00] Speaker 02: without physically having to go in with a probe. [00:25:04] Speaker 02: Now, admittedly, the Weagle system is a very robust system for taking care of the problem that they themselves identified, which is we don't want to have to interrupt that cell culture. [00:25:18] Speaker 02: That cell culture has been going for two days out of seven days. [00:25:22] Speaker 02: Oh, gosh, a sensor failed. [00:25:23] Speaker 02: Now I've got to start all over because I've got to replace the sensor. [00:25:26] Speaker 02: In Weagle, you don't have to do that. [00:25:28] Speaker 02: Each individual flow through cell [00:25:30] Speaker 02: is isolated from the cell culture with valves. [00:25:33] Speaker 02: You can replace a sensor and keep going on your way. [00:25:36] Speaker 02: That is a key, key difference, completely the opposite of how Bamboo and the claimed invention operates. [00:25:45] Speaker 02: With regards to the blood gas instrument in Bamboo, that statement that these principles could be applied to bioreactors can mean anything. [00:25:55] Speaker 02: What it means in this case, if you look at the blood gas instrument, [00:25:59] Speaker 02: One excitation source is used for all three sensors. [00:26:04] Speaker 02: One detector and a multiplexer is used for the emission light coming back. [00:26:09] Speaker 02: You could argue, well, OK, the similar concepts from the blood glass instrument applied to bioreactors would still not give you the claimed invention. [00:26:18] Speaker 02: You would have three sensors excited by one excitation source and interrogated by one detector and a multiplexer. [00:26:25] Speaker 02: That's not the claimed invention. [00:26:28] Speaker 02: So even if you go with that statement and say, OK, let's use similar concepts, it's still not what the claimed invention calls for. [00:26:41] Speaker 02: Judge O'Malley, with regards to your question for motivation to combine, on page 21 of our appeal brief, we do get into a discussion with regards to we submitted that the board and the examiner did not [00:26:56] Speaker 02: articulate any reasoning with some rational underpinning to support the legal conclusion of obviousness. [00:27:02] Speaker 02: And I feel that implied in that is that motivation to combine, because Weigel is really leading a person of ordinary skill in the art down a completely divergent path from where the patentee went. [00:27:28] Speaker 02: And that is all I have. [00:27:29] Speaker 04: I understand the questions. [00:27:30] Speaker 04: Thank you, Mr. Vasquez. [00:27:32] Speaker 04: We'll take the case under advisement.