[00:00:08] Speaker ?: Okay. [00:00:43] Speaker 02: The next case is Roxanne Laboratories versus Canberra Pharmaceuticals et al. [00:00:49] Speaker 02: 2016-1028. [00:00:50] Speaker 02: Mr. Shule. [00:00:54] Speaker 03: May it please the court. [00:00:55] Speaker 03: We are here because the district court fundamentally erred in its construction of the claim term said capsule that is size 00 or less. [00:01:04] Speaker 03: The intrinsic evidence shows [00:01:06] Speaker 03: that the phrase size 00 has an ordinary meaning that includes any capsule with that designation, including an elongated version. [00:01:15] Speaker 03: The patentees during prosecution explicitly stated that size 0 capsules are one size smaller than in the claimed invention. [00:01:25] Speaker 03: Now, under the district court's construction, that size means precisely that size. [00:01:33] Speaker 03: That statement can't be squared. [00:01:35] Speaker 02: But the claim says zero zero or less. [00:01:38] Speaker 02: Correct. [00:01:40] Speaker 02: And so you want to bring something that is elongated, which is obviously more, into a claim that says or less. [00:01:48] Speaker 02: And the claim is leaning beyond, if it had said zero zero, it might be a different story. [00:01:55] Speaker 02: But this is zero zero or less. [00:01:58] Speaker 03: It's interesting you say that, Your Honor, because I think the example I would use is if I went to a store this afternoon and they said we're having a sale for all people that are suit size 44 or less, and I was a 44 long, I would expect to get that discount because I'm a size 44 or less. [00:02:15] Speaker 03: And so I think that the claim act language, especially when it says said capsule that is size 00, if it really meant only one capsule, the 00, it would say the size 00 capsule. [00:02:28] Speaker 03: The patentees actually chose to claim using different language. [00:02:32] Speaker 03: The said capsule, that is size 00. [00:02:34] Speaker 03: They did not specify a length. [00:02:36] Speaker 03: They did not specify a volume. [00:02:39] Speaker 03: And if you take the district court's construction. [00:02:41] Speaker 01: I mean, using your own analogy, I get what you're saying that size 44 and size 44 long, you would view them as the same. [00:02:50] Speaker 01: But if you were talking about not just the length of the code, but the volume of what goes inside of it, [00:02:57] Speaker 01: Couldn't there be a distinction? [00:03:00] Speaker 03: Yeah, but think about a 42 extra wide. [00:03:03] Speaker 03: I mean, the volume of that might be larger than a 44 long. [00:03:07] Speaker 03: But we in common parlance would still agree, I think, that the person that comes in as a 44 long would be entitled to the discount if the discount is triggered by size 44 or less. [00:03:17] Speaker 01: Would you agree that there is a volume measurement that's different between the two? [00:03:23] Speaker 03: Between 00 and 00 elongating? [00:03:25] Speaker 03: Yes, and in fact, we know that the examiner, I think, shared our view that the elongated size 00 capsules are included within the size 00 capsules instantly claimed. [00:03:36] Speaker 03: And that's his phraseology from, I think it's A228. [00:03:41] Speaker 03: We know that because when you do the math, and we set this forth in our briefs, you can only do the math if you take the 1.02 milliliter volume of the [00:03:50] Speaker 03: elongated 00 capsule minus 0.68 for the non elongated 0 capsule, you get 0.34. [00:03:57] Speaker 03: That is precisely 50% of 0.68, which is the volume of the non elongated size 0 capsule. [00:04:05] Speaker 01: If there was contemplation of the elongated capsules, how hard would it have been to simply mention that in the written description? [00:04:13] Speaker 03: Well, I think that that would make patents inordinately long. [00:04:16] Speaker 03: I mean, we are entitled to use and rely upon what is known to people of ordinary skill in the art. [00:04:22] Speaker 03: As you recall, we asked their experts, the people that they propose have the requisite skill and expertise in this field. [00:04:29] Speaker 03: We said, what does it mean when you say zero, zero? [00:04:32] Speaker 03: And their expert, Dr. Banker, said, that tells you the diameter. [00:04:35] Speaker 03: That is the ordinary meaning. [00:04:37] Speaker 03: We asked their other expert, Dr. Goldberg, and he said, [00:04:41] Speaker 03: If you just said size zero to a capsule supplier, they would come back to you and say, well, which one do you mean? [00:04:47] Speaker 03: That is because in this field, in this industry, the size designator includes both elongated and non-elongated capsules. [00:04:56] Speaker 03: That's just the way that the industry has grown up. [00:04:58] Speaker 03: We explain the history and how these came to be. [00:05:01] Speaker 01: But doesn't the which one do you mean sort of cut both ways here? [00:05:05] Speaker 01: I mean, wouldn't that also mean that they are two different things? [00:05:09] Speaker 03: No, it means that they are both within the size designator, but that you have to specify when you have a particularized need to specify the other dimensions. [00:05:17] Speaker 03: In other words, if you have a fill amount, a particular drug that you need to get into a capsule, you know the amount of the active ingredient, et cetera. [00:05:25] Speaker 03: When you have a particularized need to say, I need this particular volume, then you might specify what you mean elongated or not elongated. [00:05:34] Speaker 03: Otherwise, it means both. [00:05:36] Speaker 03: It can be both. [00:05:37] Speaker 03: And you've got an example of that in the Health Caps USA reference. [00:05:40] Speaker 03: You've got an example. [00:05:41] Speaker 03: I think the best one is the GPHA, the Generic Pharmaceutical Association. [00:05:47] Speaker 01: Are we even allowed to consider that extrinsic evidence? [00:05:53] Speaker 01: I mean, if we conclude that there's not enough in the intrinsic record, wouldn't we have to send it back? [00:06:00] Speaker 03: Perhaps. [00:06:00] Speaker 03: I simply use it to say, are we offering an ordinary meeting construction? [00:06:05] Speaker 03: And when the GPHA says, [00:06:07] Speaker 03: in this field typically going from zero to size zero. [00:06:10] Speaker 01: Well, I understand that's what you're offering it for. [00:06:12] Speaker 01: You're offering it for a different claim construction. [00:06:14] Speaker 01: The way this court addressed it was to simply say, I don't even go there. [00:06:20] Speaker 01: So as a result, we're stuck with looking at only the intrinsic record. [00:06:24] Speaker 01: And if we can't decide, if we think it's not clear, then it has to go back, doesn't it? [00:06:30] Speaker 03: I think that if you think that it's not clear, then I would agree with you. [00:06:34] Speaker 03: I would urge you that I think that it is clear. [00:06:36] Speaker 03: The reason I mention the GPHA is just to, I think, acknowledge that when they say typically, then I think it's hard for anyone to accuse us of anything other than the ordinary meaning. [00:06:46] Speaker 03: I mean, that's what's typical in this field. [00:06:48] Speaker 03: And it may seem a bit arcane, but that's exactly why, when you're construing technical terms of art, that you need to be careful that you're coming at it from the perspective of the person of ordinary skill. [00:06:57] Speaker 01: But what in the intrinsic record do you think indicates what the ordinary meaning to one of skill and the art would have been as of that relevant point in time, other than your [00:07:06] Speaker 01: argument that you think that's what the examiner thought? [00:07:09] Speaker 03: Two things. [00:07:10] Speaker 03: The first, and I think the most important, is when we said to the board that the zero capsules of the prior art were one size smaller than in the claimed invention. [00:07:20] Speaker 03: That's at A2883. [00:07:23] Speaker 03: That can only be true using our construction. [00:07:25] Speaker 03: The reason why is that it was known in the field that there were zero elongated capsules. [00:07:30] Speaker 03: So if you take the district court's construction that it's precisely that capsule, [00:07:35] Speaker 03: Then you've got a two size increase. [00:07:37] Speaker 03: It would be zero, non elongated from the Dennett reference, to the zero elongated that was known in the field, to double zero, non elongated of the preferred embodiment of the 032 patent specification. [00:07:50] Speaker 03: So that would be two sizes. [00:07:52] Speaker 03: But we said that the prior art was only one size smaller than in the claimed invention. [00:07:58] Speaker 03: That indicates to a person of ordinary skill in the art, [00:08:01] Speaker 03: that we are using size to indicate any capsule of that designation, including elongated. [00:08:06] Speaker 01: And then we have the math of the... At what point in time did the elongated capsules become something that was regularly used? [00:08:15] Speaker 03: I do not. [00:08:15] Speaker 03: That's not in the record that I'm aware of, Your Honor. [00:08:18] Speaker 03: I do know that there are references from 2002, for instance, the Bank of Reference, explains that there are zero elongated and zero zero elongated. [00:08:27] Speaker 03: capsules that are in the field, and that is at A1704. [00:08:47] Speaker 03: You also have the Ridgeway reference, which is in the 2000 timeframe. [00:08:51] Speaker 03: That's A2672 that says, [00:08:54] Speaker 03: For each capsule size, and it lists them number 0, 1, 2, 3, et cetera, there is both a standard length and an elongated length. [00:09:02] Speaker 03: And so that is the evidence from the record as to the use of the elongated capsules. [00:09:09] Speaker 01: And what was the application date here? [00:09:11] Speaker 03: 2005 is the provisional. [00:09:16] Speaker 03: Now, moving on through the intrinsic record, I think we have the math from the examiner and the prosecution history. [00:09:21] Speaker 03: We have the claim language. [00:09:23] Speaker 03: As I indicated that I think with the analogy to size 44 long, the specification, the district court fundamentally erred in its analysis there because it said that the specification, the strong piece of evidence that the district court relied on was the fact that in one of the embodiments, it was a non-elongated 0-0 capsule. [00:09:43] Speaker 03: But as this court has repeatedly held, we don't read the embodiments into the claims absent extraordinary circumstances. [00:09:52] Speaker 03: The embodiment itself explicitly says that it is limited to being according to one embodiment of the invention. [00:10:00] Speaker 03: That's A6 at column 3, lines 29 to 31. [00:10:05] Speaker 03: So in those circumstances under this court's precedent, you can't read that embodiment or limit the claim scope to that single embodiment. [00:10:12] Speaker 01: Do you agree that the extrinsic evidence sort of has something for everyone, that there is some support for your construction and some support for the opposing construction? [00:10:23] Speaker 03: I think that it's near uniform, but I think that there is at least one piece of evidence from the extrinsic that arguably would be in their favor. [00:10:33] Speaker 03: But I think when you've got the unanimity of experts, when you have our two experts, Dr. Park and Mr. Silverman, and you've got both of their experts acknowledging that when I say to you, size zero zero, what comes to your mind? [00:10:45] Speaker 03: Well, I know that I am there. [00:10:46] Speaker 03: And when you ask the other expert, what would happen if you would call a supplier? [00:10:50] Speaker 03: Because that's how this works in the field. [00:10:52] Speaker 03: You call a supplier, and you say, I want a size zero capsule. [00:10:55] Speaker 03: He said, they would ask you, which one do you mean? [00:10:58] Speaker 03: Because the meaning encompasses both elongated and non-elongated. [00:11:01] Speaker 01: I think that's- So you would put the same volume of granules in the elongated capsules as you would in the non-elongated capsules, even though the former can hold more? [00:11:17] Speaker 03: Certainly you could. [00:11:18] Speaker 03: Imagine that many people would do that. [00:11:21] Speaker 01: But doesn't the claim call for a precise volume? [00:11:24] Speaker 03: No. [00:11:24] Speaker 03: In fact, I would suggest the opposite of what the claim says. [00:11:27] Speaker 03: We deliberately chose not to claim a volume. [00:11:30] Speaker 03: We claimed a size of capsule. [00:11:33] Speaker 03: We could have specified a length. [00:11:34] Speaker 03: We could have specified a volume. [00:11:36] Speaker 03: We did not. [00:11:37] Speaker 03: And I think that that's one of the problems with the district court's construction is that it improperly and erroneously [00:11:43] Speaker 03: implies that we chose language that we did not under this court's authority. [00:11:48] Speaker 03: We're entitled to the broadest ordinary meaning of the terms from the perspective of a person of ordinary skill in the art. [00:11:54] Speaker 01: Well, the Urazi Declaration does claim a specific volume, does it not? [00:12:00] Speaker 03: It doesn't claim it. [00:12:00] Speaker 03: I'm sorry. [00:12:02] Speaker 03: It does explain an experiment that she did, a comparative experiment, that did use a non-elongated size 0, 0 capsule. [00:12:10] Speaker 03: What she did was she tested [00:12:11] Speaker 03: The preferred embodiment, which if you look at her declaration, the example it says, this is an example. [00:12:19] Speaker 03: And then using good scientific practice, she used the same as her preferred embodiment to test the Nikai prior art process. [00:12:29] Speaker 02: Just to fill your empty rebuttal time, would you like to save? [00:12:32] Speaker 03: I would like to save unless there's any further questions at this time. [00:12:34] Speaker 02: Mr. Silver? [00:12:38] Speaker 04: May I please report good morning? [00:12:39] Speaker 04: I'm Robert Silver on behalf of APOLI. [00:12:41] Speaker 04: As to housekeeping matters, I believe council may have misspoken when he said Bridgeway reference at 1550 is from 2002, I believe it's from 1987. [00:12:50] Speaker 04: That reference specifically says that elongated versions at that time period were only available on special order. [00:12:59] Speaker 04: Also as a housekeeping matter, we submit that there are four references that Roxanne submitted in its opening brief. [00:13:05] Speaker 04: in the section entitled other authorities that were not in the record below, namely the final FDA draft guidance and the three references they use to equate needle gauge and suture size to capsule size. [00:13:22] Speaker 04: And therefore, we don't believe those are properly before this court for failing to be in the record below. [00:13:30] Speaker 04: We submit that the district court was proper [00:13:33] Speaker 04: using only intrinsic evidence incited several times Your Honor's opinion in Phillips and also Judge O'Malley's key pharma, which said that the specification is a single most important guide and that uncorroborated expert testimony is rarely reliable to the court. [00:13:54] Speaker 04: And the danger in relying on extrinsic evidence in this case is illuminated by [00:14:00] Speaker 04: Going back to the preliminary injunction stage, Roxanne's first definition of capsule size said that capsules came in families. [00:14:09] Speaker 04: And their expert, Dr. Park, stuck out his neck and said there are families of capsules. [00:14:15] Speaker 04: And I criticized that at the preliminary injunction stage because I told Judge Chesler that after hours of searching, there was no document I could find that said that capsules came [00:14:27] Speaker 04: in families. [00:14:28] Speaker 04: And in fact, Judge Chesler put forth in his opinion, he queried whether there was such a metaphor as capsules of families. [00:14:36] Speaker 04: And so they dropped that argument. [00:14:37] Speaker 04: And as Your Honor said to Roxanne at the last hearing, well, don't you get a second shot at claim construction. [00:14:43] Speaker 02: Chancellor, we speak for the court when we write opinions. [00:14:46] Speaker 04: And so they dropped that argument because there is not a single reference in the extrinsic or intrinsic evidence [00:14:55] Speaker 04: that equates capsules to families. [00:14:58] Speaker 04: They now rely upon diameter. [00:15:00] Speaker 04: And they say, well, let's diameter alone determines capsule size. [00:15:05] Speaker 04: And on page 33 of their opening brief, they say length is immaterial to capsule size designation. [00:15:13] Speaker 04: And I posited this example the last time. [00:15:16] Speaker 04: Since they say length is irrelevant, let's take a 12-inch long capsule that's the same size as 00. [00:15:24] Speaker 04: There's no way in the world most people are going to be able to swallow a 12-inch long capsule. [00:15:30] Speaker 04: But they say length is irrelevant to determining capsule size. [00:15:34] Speaker 04: But then when you go into their proposed definition, which was completely different from the preliminary adjunction states, they say, well, size 00 is the same diameter, regardless of length, because that relates to swallowability. [00:15:48] Speaker 04: So they link diameter to swallowability. [00:15:51] Speaker 04: Judge Chesler found, in his opinion, [00:15:52] Speaker 04: swallowability was, quote, yet another unpersuasive tangent. [00:15:56] Speaker 04: They then link swallowability to pharmaceutically acceptable. [00:16:01] Speaker 04: So now you have to have, it has to be pharmaceutically acceptable, it has to be for oral consumption, it has to be swallowable, and it has to have the same diameter regardless of length. [00:16:13] Speaker 04: And the extrinsic evidence not only contradicts [00:16:19] Speaker 04: the intrinsic evidence, but it contradicts their own construction. [00:16:24] Speaker 01: Let's stick with the intrinsic evidence, because if we get to extrinsic, I think that we can't... Well, Your Honor, if you look at the intrinsic evidence... Excuse me, I have to speak until I'm done, and then you get to talk. [00:16:34] Speaker 01: But if we get to the extrinsic evidence, I don't think we're allowed to make findings based on that extrinsic evidence. [00:16:40] Speaker 01: So we've got to find if there is enough in the intrinsic record, and it's pretty thin here. [00:16:46] Speaker 01: So let's just focus on what's in the intrinsic record. [00:16:48] Speaker 04: Certainly, Your Honor. [00:16:49] Speaker 04: If you look at the intrinsic evidence they relied upon in the Eresi Declaration and attached to their appeal brief is the Lightfoot reference. [00:16:59] Speaker 04: And when you look at the Lightfoot reference, which is at 303 to 307, the first page, table one, has a table of capsule sizes. [00:17:11] Speaker 04: And the only thing that it mentions there is [00:17:15] Speaker 04: powder tap density and volume. [00:17:18] Speaker 04: And they distinguish between 00, 000, 00EL, 00. [00:17:21] Speaker 04: Which table are you on? [00:17:25] Speaker 04: Table one, just below the photograph of the capsule. [00:17:34] Speaker 04: I'm sorry, maybe on A386. [00:17:45] Speaker 00: So that's a different reference. [00:17:48] Speaker 04: Well, I have this one here, Your Honor. [00:17:50] Speaker 00: I've got one at 303 with the table one underneath the picture. [00:17:54] Speaker 04: Yes, that's the one I'm referring to. [00:17:55] Speaker 04: And if you see there, that reference only differentiates based on volume. [00:18:03] Speaker 04: And as our expert, Dr. Osberger, said, that's what a pharmaceutical formulator would rely upon. [00:18:09] Speaker 04: And what is happening is that, according to Dr. Osberger, [00:18:13] Speaker 04: they're conflating pharmaceutically acceptable with patient acceptable. [00:18:19] Speaker 04: Not every patient can swallow even a 0-0 capsule. [00:18:24] Speaker 04: And so therefore, formulators, based on the intrinsic evidence, look to volume. [00:18:31] Speaker 04: If you're going on an overnight trip and you have three pieces of clothing, as I believe Your Honor raised this question to my opponent, even though you could fit it in a larger [00:18:43] Speaker 04: volume, you're not going to use it. [00:18:46] Speaker 04: I mean, if you have three pieces of clothing, you can put it in a satchel that you can carry on an airplane. [00:18:50] Speaker 04: You're not going to put it in a steamer trunk because the larger the size capsule, the more expensive. [00:18:57] Speaker 04: And Dr. Urazi came out and said in her declaration, although I believe her statement was false, that 00 is the largest acceptable capsule that can be swallowed [00:19:12] Speaker 04: despite the fact that she attached Lightfoot that shows that triple zero can be swallowed. [00:19:20] Speaker 04: And we submit that their definition, which is like a chameleon, it just doesn't make sense. [00:19:30] Speaker 04: Because also, because their definition requires swallowability or oral consumption, if you look, for example, at their own experts' treatise at 2150, [00:19:41] Speaker 04: or Durgan's at 1762, they describe how triple zero capsules cannot oftentimes be swallowed by either the elderly or the children. [00:19:52] Speaker 04: So you can merely twist the capsule apart, put the contents in it into a juice or applesauce, and immediately consume it. [00:20:01] Speaker 04: Well, in that case, there's no oral consumption of the capsule. [00:20:04] Speaker 04: Does that mean it's not pharmaceutically acceptable? [00:20:07] Speaker 04: Of course not. [00:20:08] Speaker 04: It just means that some people can't swallow it. [00:20:11] Speaker 04: And the claim should be given their ordinary construction, as Judge Chesliff stated when he cited Phillips. [00:20:23] Speaker 04: And I think Roxanne's argument that merely focuses on diameter ignores the fact that other factors, such as length, surface area, shape, and volume, relate to swallowability. [00:20:53] Speaker 02: Anything further counsel? [00:20:56] Speaker 04: No, not at this time, Your Honor. [00:20:57] Speaker 04: Thank you. [00:20:58] Speaker 02: That's the only time you have. [00:21:00] Speaker 04: I understand that. [00:21:01] Speaker 02: Thank you. [00:21:02] Speaker 02: Mr. Schuler, you have a little rebuttal time. [00:21:05] Speaker 03: Thank you, Your Honor. [00:21:08] Speaker 03: I think the salient consideration here is that [00:21:11] Speaker 03: Invigin hasn't addressed the intrinsic evidence. [00:21:13] Speaker 03: I mean, the prosecution history statement alone shows that we were using the phrase psi zero zero according to its ordinary meaning to encompass more than simply a non-elongated capsule. [00:21:22] Speaker 03: You cannot square that statement with the district court's construction. [00:21:25] Speaker 01: But you agree that Lightfoot is part of the intrinsic record. [00:21:28] Speaker 03: Yes. [00:21:29] Speaker 03: But Lightfoot actually shows the examiner's math. [00:21:31] Speaker 03: That's exactly the spring point from us showing that the volume that's there, 1.02, is the only volume that can get you to 50% [00:21:40] Speaker 03: larger volume for a double zero EL capsule. [00:21:43] Speaker 03: So the intrinsic evidence shows that Dr. Eurasi and the examiner were speaking the same language. [00:21:48] Speaker 03: They understood that it was simply a matter of math and that one could figure out the fill amount from the volume and the bulk density. [00:21:55] Speaker 03: And so if you recall from the prosecution history, the examiner's response to her declaration was telling, by the way, it's in our brief and the calculations in the record at A2473, we showed below that [00:22:07] Speaker 03: You can do simple math, and the 00EL capsule will not fill the requisite fill amount of the Nikai material. [00:22:14] Speaker 03: And that's in our opening brief and footnote 8 at page 40 of our opening brief. [00:22:19] Speaker 03: So the intrinsic record, which is what this court says it needs to look at, you have the prosecution history statement by us. [00:22:25] Speaker 03: You have math in several places by the examiner that reflects the volume in lightfoot of a 00EL capsule. [00:22:32] Speaker 03: You have statements in the prosecution history [00:22:34] Speaker 03: that we were explaining that it's any capsule having size 00, which again is consistent with our construction. [00:22:41] Speaker 03: And you've got really the district court's decision being predicated on basically restricting us to one embodiment in the specification, which under this court's precedent is error. [00:22:54] Speaker 03: The claim language itself, as we discussed earlier, is amenable to our proposed construction. [00:22:58] Speaker 03: We're entitled to the broadest reasonable construction, and I think that that's [00:23:03] Speaker 03: Probably all I need to say. [00:23:05] Speaker 03: I mean, I think the intrinsic record is fairly cogent here. [00:23:08] Speaker 01: The broadest reasonable construction? [00:23:10] Speaker 03: I'm sorry. [00:23:10] Speaker 03: We're entitled to the ordinary meaning. [00:23:12] Speaker 03: I mean, that's what we're searching for under Phillips. [00:23:14] Speaker 03: We're searching for what would a person of ordinary skill in the art understand this claim to mean. [00:23:18] Speaker 03: And I want to reemphasize that at A228, the examiner said, a size zero capsule is 50% smaller than the size zero zero capsules instantly claimed. [00:23:29] Speaker 03: When we made our statement, we tied it to the claim dimension. [00:23:33] Speaker 03: So we know we were talking about the phrase at issue. [00:23:35] Speaker 03: And when the examiner says that, and he says 50%, and the only math that makes that work is the light foot reference with the volume of 1.02 milliliters, I think you understand that those two people of skill in the art, the examiner and Dr. Eresi, were speaking the same language. [00:23:50] Speaker 03: And it dovetails with our construction. [00:23:52] Speaker 01: Do you have a DOE claim? [00:23:55] Speaker 03: For which claim? [00:23:55] Speaker 03: For which element? [00:23:57] Speaker 01: For this issue? [00:23:58] Speaker 03: No, because it was added by amendment. [00:24:01] Speaker 01: OK. [00:24:03] Speaker 02: Thank you. [00:24:03] Speaker 02: Mr. Shula will take the case and revise it.