[00:00:00] Speaker 02: The final case this morning is number 25, 1005, Biofer, S.P.A. v. Whitefield International. Okay, Mr. Ball. [00:00:10] Speaker 01: Good morning. If it may please the Court, Jonathan Ball for Appellant Biofer. There are two constructions. [00:00:18] Speaker 02: Too far into this. I am confused as to why this structuromonic question is before us because that wasn't included in the stipulation. of non-infringement. How does that issue get before us? [00:00:35] Speaker 02: The stipulation did not reference the second issue that's discussed in the brief, the stipulation of non-infringement, right? [00:00:46] Speaker 01: The stipulation of non-infringement was based on the district court's construction of the term between as it appeared in the phrase. [00:00:54] Speaker 02: How is this other issue before us? [00:00:57] Speaker 01: Are you asking about the second term, the stoichiometric? I think in the stipulation we reserved the right to appeal other terms that were at issue. [00:01:09] Speaker 02: You can't appeal terms just in the abstract. [00:01:12] Speaker 01: The The term we want to focus on regardless, the term that this case turns on is... Okay, so the sociometric issue is not properly before us, right? [00:01:24] Speaker 01: We think it is. We think we are appealing the district court's order. [00:01:28] Speaker 02: You can't appeal claim constructions of the abstract. Some years ago there was a Senator Leahy proposed that that be permitted. It wasn't. That's not. You can't do that. [00:01:40] Speaker 01: Your Honor, I mean... [00:01:42] Speaker 01: We think that the stipulation reserved the rights to appeal the both- Reserving the rights to appeal something doesn't give us jurisdiction over it. [00:01:53] Speaker 01: Understood, Your Honor. The case, the dispositive term below was the construction of the term between. That's the term that I do want to focus on today. Okay. [00:02:03] Speaker 01: So as I said, there's two constructions, but we're going to focus on between as that phrase appears or that term appears in the phrase pH between 7.0 and 9.0. [00:02:21] Speaker 01: I submit that if ever there was a case that embodied this court's observation from Phillips, that sometimes claim construction involves little more than the application of widely accepted meaning of commonly understood words. It is this case. Between is not a term of art. Between is not an ambiguous term. It is a simple preposition that in this context simply defines a range of pH values from 7.0 to 9.0. [00:02:56] Speaker 01: It serves the role essentially of a hyphen. The same claim could have been written, pH 7-9, and it would have meant The exact same thing. [00:03:08] Speaker 01: That is the plain and ordinary meaning of the term between, and the clean construction exercise should have stopped there. I would submit that the only way that we could get to the court's reading of this, which smuggled in from the specification, functional requirements that the PHs maintained throughout the duration of the oxidation reaction is through perhaps disclaimer, but disclaimer was not at issue. [00:03:40] Speaker 01: So the court didn't apply Thorner, the court didn't apply Hill-Rum to say that absent lexicography or disclaimer, We're going to go with the plain and ordinary meaning. Instead, what the court did below was rely on this, what I'll call the holistic line of cases, such as GP&E and more of the Wisconsin alumni research. [00:04:03] Speaker 01: Federation line of cases that says, well, we can determine the plain and ordinary meaning by looking at the specification to see if it repeatedly and consistently defined a claim term in a particular way. [00:04:18] Speaker 03: Well, here the claim talks about a solution at a pH between 7.0 and 9.0. [00:04:29] Speaker 03: Doesn't that suggest that that Range be maintained through the course of the reaction? [00:04:36] Speaker 01: I would submit there's nothing in the claim language itself that suggests that. It suggests that that is an important range. [00:04:44] Speaker 03: Well, take a hypothetical. I'm going to bake a cake at a temperature between 325 and 350 Fahrenheit. [00:04:54] Speaker 03: That certainly doesn't mean I can bake the cake at 200 degrees Fahrenheit. [00:04:59] Speaker 01: I think this is exactly the facts of the in vitrogen case, which we cite in our briefs and which we rely on, where in that case, the claim was a step of growing E. coli cells at a particular temperature range. I think it was 28 to 32 degrees. That claim had been amended. Originally, it said below 37. It was amended to say... [00:05:25] Speaker 01: Between the 28 or 32 or whatever the particular range was, the patentee had argued to get that claim allowed through an inventor declaration that there was unexpected results with that range. The examiner required them to put that range in, calling it essential. But this court still said it didn't preclude growth of those cells outside of that range because the word comprising allows activity outside of this specifically claimed step. [00:05:57] Speaker 02: But this reaction wouldn't work unless it were maintained at this pH during the course of the reaction, right? [00:06:05] Speaker 01: No, the reaction certainly will work if the pH is not maintained. [00:06:09] Speaker 02: And in fact, the expectation from... It won't work in terms of the parameters set forth in this particular claim. [00:06:17] Speaker 01: I don't think that's correct, Your Honor. The patent recognizes that when sodium hypochlorite is added to the reaction... [00:06:27] Speaker 01: The whole purpose of this reaction is to generate slowly small amounts of bromine in situ as the oxidant. Sodium hypochlorite is added slowly during the reaction, generating very small amounts of bromine, which selectively oxidize aldehyde residues on the maltodextrin. What the patent teaches, and this is column seven. [00:06:51] Speaker 02: The invention here is to have the reaction occur within this range for a millisecond, right? [00:06:57] Speaker 01: That is not the issue, a millisecond. The evidence is going to show. [00:07:01] Speaker 02: How much does it have to, how much of the reaction has to be within the range? [00:07:06] Speaker 01: Enough to get selective oxidation of the terminal aldehydes and avoid the deleterious effects of prior art, which is off-target oxidation, depolymerization of the maltodextrin molecule. [00:07:22] Speaker 03: So you're saying as long as the solution is maintained long enough to comport with the rest of the limitations in the claim, there would be infringement? [00:07:31] Speaker 01: Correct. As long as it is beneficially used to achieve the outcomes. [00:07:36] Speaker 03: Even though it may, maybe the pH is 6.0 for 20 minutes, but then again, it goes up to 7.5 for another 20 minutes, and during that second 20-minute interval, the rest of the claim terms are met. [00:07:55] Speaker 01: That's correct. The patent specifically addresses exactly the situation you described. [00:08:02] Speaker 02: Did you present that theory to the district court, that construction? [00:08:05] Speaker 01: We did. We did. That column 7 says that when... Where did you present that theory to the district court? In the briefing and the argument before the district court, this argument was squarely put forth that there are... Where? [00:08:22] Speaker 01: Yeah, Your Honor. [00:08:27] Speaker 01: I mean, I will... We can find the briefing, but this was the essence of our argument was that The embodiments in the panel. [00:08:43] Speaker 02: Tell us where the argument was made. [00:08:53] Speaker 02: You can try to find it on the floor. [00:09:01] Speaker 01: Your Honor, I don't want to use up all my time going through the district court briefs. [00:09:07] Speaker 01: So the patent says at the top of column 7 that when the sodium hypochlorite is added, there is a remarkable lowering of the pH. And it says that is okay provided the pH never goes below 7 on the low side or above 10 on the high side. So the patent is recognizing that there are going to be excursions from that claimed range based on the fundamental chemistry [00:09:37] Speaker 03: But that still leaves us in a predicament of trying to interpret what this particular claim means, because this particular claim claims this range, 7.0 to 9.0. That has to mean something. [00:09:54] Speaker 01: And we would agree with that, 7.0 to 9.0. That is the language of the claim. I don't think that deciding hypothetical infringement issues as to whether or not there is a certain time that that has to be used is necessary to understand that the claim has that limitation. That is a factual inquiry, whether or not someone has infringement. practiced this claim by using this range for long enough. [00:10:26] Speaker 01: But maintaining throughout the duration of that is a preferred embodiment. It is clearly stated as a preferred embodiment in the specification. There are disclosures of the broader embodiments of carrying it out between 7 and 9 that make no reference to any requirement to maintain the pH between So if we're going to read that into the claim, we're just taking a preferred embodiment, grafting it onto the claim. [00:10:59] Speaker 03: I also didn't see any other temporal limitations in this claim. It doesn't talk about how long this process takes or how much time you must expose these things to this solution. Is that? Relevant in any way? [00:11:21] Speaker 01: I think it is relevant because I think the patentee, had they wanted to impose temporal limitations, had they wanted to impose functional limitations on the timing of the pH, they could have done so. [00:11:36] Speaker 03: In other words, if a party meets the terms of this claim for 30 seconds, that's enough? [00:11:46] Speaker 01: I mean, I think you're probably getting into an issue if there is de minimis infringement. Is that enough? And our law says de minimis infringement is infringement. It may be a damages issue to take into consideration. [00:12:01] Speaker 02: I will articulate a different claim construction than you told me your claim construction was a couple of minutes ago. You're now saying that even a brief maintenance during this pH range is sufficient. [00:12:15] Speaker 01: If you're getting selective oxidation, the claim requires selective oxidation of terminal aldehydes. So if one is getting the beneficial result claimed in this claim by getting selective oxidation, that's a requirement. So if that is not happening... then the claim is not being practiced. But I think by design, deliberately, the patentee chose not to put restrictions on how long the PH had to be maintained or how the PH had to be maintained. [00:12:49] Speaker 02: So your view is that the claim construction is, even for a brief instant, is sufficient? [00:12:54] Speaker 01: If the goals of the invention, if the limitations of Claim 1 are being met... [00:13:02] Speaker 01: then that's just not even the issue here because the issue in this case is brief excursions out of the range, whether or not those take it out of infringement. And it's just inconsistent with the teachings of the patent itself. [00:13:23] Speaker 01: Your Honor, so we'll reserve the rebuttal time. [00:13:39] Speaker 00: Good afternoon, Your Honors. Sonia Suktuang on behalf of Apple EV4. [00:13:46] Speaker 00: When you read Claim 1 and the language of Claim 1, the phrase pH between 7.0 and 9.0, in light of the specification, requires that the pH be maintained in the interval separating 7.0 and 9.0. [00:13:59] Speaker 03: But it doesn't say how long it has to be there. [00:14:03] Speaker 00: It does, Your Honor. And this is where, if you look at Claim 1, Claim 1 says the step of activating the sugar. That is, the time duration is that oxidation step. It doesn't have to say 5 minutes, 10 minutes, 15 minutes, or 2 hours. The fact of the matter is the claim, the invention includes four different and distinct steps. The first step is the oxidation step. And so when the Claim 1 reads... the step of reacting the sugar, that is the oxidation step, and that is the temporal limitation that applies to this plant. [00:14:39] Speaker 03: Otherwise... What if that oxidation takes place in 30 seconds? That's enough? [00:14:46] Speaker 00: Then if the activation takes place in 30 seconds, then the oxidation starts and ends in 30 seconds, and in that time frame, that 30-second time frame, the pH is maintained in that interval 7 and 9. We know that. [00:15:00] Speaker 03: Well, let's just say in that time interval it exists in that range. [00:15:04] Speaker 00: That's not what the claim says. [00:15:06] Speaker 03: Well, it just says the solution between 7 and 9. [00:15:11] Speaker 00: Sure, and we know. that the claim cannot be construed to say it exists for some short period of time in this 7-9 range because Biafra actually claimed that in prosecution. And if you take a look at the way they amended their claims, this is at Appendix Page... This is at Appendix Page... [00:15:43] Speaker 00: getting to it, 1355. The original claim claimed a range of 5 to 12, a pH of 5 to 12. That is the construction Biafra is advocating now. They canceled that claim, and then at Appendix Pages 806 to 809, they amended that claim to say, bringing the pH of the resulting solution to a value of 7 to 9. [00:16:08] Speaker 00: So under your interpretation, Judge Lynn, and under BioFirst construction, they would allow these instances where you start below 7, ramp up into 7 and 9, and then go past 9 or start above 9 and move into that range. That is the construction they're advocating for. They had claimed that. That's language in the specification. And they canceled that claim to get where we are today. And when they canceled that claim that says bring in the pH – They did two things. [00:16:38] Speaker 00: They amended the claim to say the step of activating the sugar, that's the temporal limitation, and they said pH between 7.0 and 9.0. [00:16:46] Speaker 03: Did the district court rely on prosecution history disclaimer? [00:16:52] Speaker 00: No, and we didn't argue disclaimer, and the Canopy growth case is a good example of that, and we cite that in our brief. The Canopy growth case dealt with the phrase supercritical, excuse me, subcritical pressure and temperature. That was the actual claim being construed. During prosecution and in the specification of that patent, the patentee had three options, supercritical temperature and pressure, supercritical temperature and subcritical pressure, and then the final option, which was claimed, subcritical pressure and temperature. [00:17:27] Speaker 00: What this court said is that when you have those three options and you claim those three options and then you cancel those first two options and lead to the third option, you don't need disclaimer or disavowal to reach the claim construction that we have here because that is the claim. That is the embodiment they specifically claim. You don't need disavowal or disclaimer. Here, you can't ignore the fact that they had originally claimed exactly what they want to do today. bringing the pH up to a certain range for any period of time, they canceled that claim. [00:18:00] Speaker 00: And when they did that, they did something very important. They submitted a declaration from Dr. Marchi. He's an inventor. And this is Appendix Page 882. [00:18:10] Speaker 00: In 882, when Biaffer submitted the Marche Declaration, they specifically said, namely, to corroborate the criticality of the claim conditions, in particular of the pH interval, applicants submit the Marche Declaration. Dr. Marche said, repeated example 5. Example 5 falls within the scope of claim 1. In example 5, he said when you use the claim condition, he used the word maintained, maintained the pH at 8 and got good results within the scope of the claim. [00:18:46] Speaker 00: When he maintained, and again, he used this word, maintained the pH at 10, he got significant depolymerization. What biofuel construction allows you to do is to conduct the oxidation at a pH of 10. [00:19:03] Speaker 00: Dr. Marchi said you cannot do that because you get depolymerization that is opposite of what the claimed invention is. And importantly, when they submitted that declaration, they pointed to Dr. Marchi's declaration, and they confirmed in their statements, and this is at Appendix Page 883, this is Biafra speaking, this means that outside the claimed range, even application of somewhat under-sorchiometric reaction additions, it is not effective in preventing the destructive attack of bromine. [00:19:35] Speaker 00: They point to this. [00:19:37] Speaker 00: They go on to say that in the particular settings laid down by the claim, that's pH 7 to 9, it's critical to achieving a novel and highly selective method. [00:19:51] Speaker 03: But it doesn't say how long it has to be in that range. [00:19:54] Speaker 00: I respectfully disagree because the claim one is directed to a single step, and it's throughout that step. Claim nine, excuse me. [00:20:04] Speaker 03: It's throughout that step, but again, where does it say how long? [00:20:09] Speaker 00: When you read that oxidation step and you look at column nine of the specification, column nine of the specification, starting at line 24, It says throughout activation of the sugar. Throughout activation of the sugar. That is the step. [00:20:26] Speaker 03: So let's suppose the process normally takes 30 minutes. Yes. And for 25 of the 30 minutes, it's within the 7 to 9 range. Yes. [00:20:36] Speaker 03: But for 5 minutes at some point, either the beginning, the middle, or the end, it sort of deviates outside that range. Yes. And at the end, the accomplishment... set forth in the terms and conditions of the rest of the claim are met. [00:20:52] Speaker 00: No, they're not. They're not. Because claim one requires the oxidation to occur at this defined pH range. The oxidation. [00:21:03] Speaker 03: It may occur under those conditions for 25 of the 30 minutes, and maybe for five minutes it's outside the bounds. But nonetheless, it's within the bounds of the claim for 25 of the 30 minutes. [00:21:18] Speaker 03: Why isn't that enough? [00:21:20] Speaker 00: Because that is not enough. For claim construction purposes, you have to look at the claim. You have to look at that phrase in light of the claim. The claim says the step of oxidation, the step of activation. [00:21:31] Speaker 03: And you have to look at... I'm saying in my hypothetical that occurs for the 25 of the 30 minutes. [00:21:36] Speaker 00: It occurs from a temporal standpoint in your hypothetical, but not from a claim standpoint. Because the claim requires... [00:21:44] Speaker 00: when you look at claim one, in light of what the specification says in the prosecution history, the specification is abundantly clear. Column nine, throughout the activation reaction of the sugar, the pH value is controlled and maintained in the fixed range, preferably between 7.0 and 9.0, throughout the activation. And they go and explain why it has to be that in the very next sentence. [00:22:06] Speaker 02: Did the patentee during the proceedings before the district court argue that For a claim construction that permitted minor deviations? [00:22:14] Speaker 00: No. Their argue was, and as Mr. Ball indicated, it's a hyphen. [00:22:21] Speaker 00: Between means between. Plain and ordinary meaning. They did not offer this construction of... Their theory was that even if it was within that range for any... [00:22:30] Speaker 02: In a short period of time, that was sufficient. [00:22:32] Speaker 00: There was a specific question asked by the district court, Judge Bulsara, to my opponent that said, are you saying to me that if the oxidation reaction occurred in a pH range between 7 and 9, even for a millisecond, that satisfies the claim? The answer was yes. That is the absurdity of the claim because you cannot ignore what the specification says and what the prosecution history says. The invention... [00:23:00] Speaker 02: So it sounds to me as though they're arguing for a claim construction on appeal that they never offered. [00:23:04] Speaker 00: That's exactly right, Your Honor. And it's not even in response to your question, it's not even the construction that they applied in their brief. [00:23:13] Speaker 00: Mr. Ball said you apply the plain and orderly meaning of between. The plain and orderly meaning between was adopted by the district court. It's included in our construction, the interval separating. He's just saying between means a hyphen. They're not even adopting the plain and orderly meaning. [00:23:27] Speaker 00: Byfer argues just look at the word between. [00:23:30] Speaker 00: This court's decisions, including Phillips, says you cannot look at a word, a term, and a claim in isolation. You have to look at it in terms of the abstract, excuse me, in terms of the specification and the claim. And Judge Lynn, when you do that, and when you look at it in light of the prosecution history, there is a single conclusion reached. All the examples say this as well, repeatedly, that during this oxidation step, and I understand your temporal question, but examples 5, 6, and 7, and the prosecution history answers your temporal question, it is during the entirety of the oxidation step that this oxidation takes place between 7 and 9. [00:24:12] Speaker 00: There is no deviation. Counsel brought up in vitrogen, the comprising language. In vitrogen is not the case that we have here. In in vitrogen, the court didn't just look at the term comprising. The specification contemplated two distinct growing steps. The specification explained in in vitrogen that the master E. coli cells are usually frozen, and you have to prepare them before the claim step of growing between 18 and 32 degrees C. [00:24:41] Speaker 00: And in order to prepare them, you have a completely distinct growing step at 37 degrees C. And under that scenario, when the specification supports two distinct growing steps, that's how comprising allowed an additional step before the claim step. [00:24:58] Speaker 03: Here, there's not a... I think the hypothetical that I talked about a minute ago, 25 minutes out of 30, is... [00:25:10] Speaker 03: is an important hypothetical. It is. It would have some significant bearing on the outcome of this case. But I, and I'd be anxious to hear from Mr. Ball whether this was actually presented to the district court. Because if it was not, I think that's also significant. [00:25:26] Speaker 00: It was presented. So during the claim construction argument. [00:25:30] Speaker 02: No, it wasn't presented. Their argument about the minor deviations there, it was not presented. [00:25:37] Speaker 00: That was not presented. I thought you were asking me, Judge Lynn, was time temporal discussed during the claim construction position? Yes. It was. So you're correct, Judge Dyke, that Biafra's construction today, which seems to be shifting, was not presented. But temporal limitations were. So during the Markman hearing, temporal limitation was discussed, and the step of was the temporal limitation. [00:26:00] Speaker 00: Judge Bulsara, at the end of the claim construction hearing, said if the parties believe that additional briefing is needed to address this, let him know. The parties agreed and submitted supplemental briefing. The docket entries supporting that are Appendix Pages 59 and 60. So the temporal limitation is there. And when you look at, Your Honor... the temporal limitation. Examples 5, 6, and 7 tell you that. Examples 5, 6, and 7 talk about this oxidation process taking, in their case, two hours. [00:26:34] Speaker 00: And throughout that entire two-hour period, The PH, in the words of the example, is maintained. There is never a situation in the specification at all, as counsel suggests, that you can start at one PH, move to seven to nine, move out of seven to nine, and back into seven to nine. It is not there. The prosecution history confirms that it's not there. So going to your temporal limitation, Your Honor, I believe it is in claim one. It was discussed during Markman. [00:27:05] Speaker 00: It was discussed in supplemental briefing. And the step of activating the sugar is the duration in which the pH must be maintained. Otherwise, according to Dr. Marchi, according to the claimed specification, you do not get the object of the claimed invention, which is a clean reaction with minimal depolymerization. [00:27:28] Speaker 00: Council also pointed to a preferred embodiment. Well, this case, they claimed the preferred embodiment. They had claimed the broader range, 5 to 12. You cannot look to that language in the specification to support their construction here because they canceled that claim. They had claimed bringing the pH to a value of 7 to 9. They canceled that claim. You cannot look to that language in support of their construction here. What is left is between 7 and 9, and the specification is repeatedly stating that when you look at that range in the context of the oxidation step, there is one thing done, the pH is maintained between 7 and 9. [00:28:10] Speaker 00: Your Honors, if you have no other questions. [00:28:13] Speaker 02: Okay, thank you. Thank you. [00:28:20] Speaker 03: What can you tell us about what was actually argued to the district court? [00:28:26] Speaker 01: Sure. All of this was argued to the district court. [00:28:28] Speaker 02: But where? Where did you argue the minor deviations theory to the district court? [00:28:35] Speaker 01: Unfortunately, the briefs, our briefs, by a first briefs, are not part of the appendix here. So we were going through the appendix, and the substance of those are not in the appendix. [00:28:44] Speaker 02: And where did you argue it here? [00:28:48] Speaker 01: That... Where's it in the blue brief? It is in our briefs here on appeal. [00:28:53] Speaker 02: Where do we argue... Where's the minor deviations theory in your brief on appeal? [00:28:57] Speaker 01: Our theory, Your Honor, is not that minor. Our theory is that... The claim says what it says, that you carry the reaction out at a pH of 7 to 9. So you didn't argue a minor deviation? No. Minor deviation is all throughout our brief. Are you asking about our briefs on a pH here? Where in your brief did you argue minor deviations? [00:29:19] Speaker 01: Sure. We argue throughout that we call it an excursion in the range. [00:29:24] Speaker 03: It's throughout, but pick a page. [00:30:21] Speaker 02: can't find it, never mind. [00:30:22] Speaker 01: Well, it's, I mean, that was, we argued throughout this brief that the judge restricted this claim to that range, and in doing so, prohibited brief excursions, and that was fundamentally what this issue of this case was about, whether or not brief excursions are permissible or not. [00:30:47] Speaker 02: We documented... Unfortunately, you can't show us where you made the argument. [00:30:51] Speaker 01: I think we're out of time. Page 9, page 10, for example, of our opening brief. [00:31:00] Speaker 01: Okay, I think we're out of time. [00:31:02] Speaker 02: Thank you.