[00:00:07] Speaker 00: The United States Court of Appeals for the Federal Circuit is now open and in session. [00:00:12] Speaker 00: God save the United States and this honorable court. [00:00:26] Speaker 05: All right, if we're ready, I'll call the first argued case, number 2012-01, Valley and Pharmaceuticals Against Activist Laboratories, FL, Mr. Steindler. [00:00:38] Speaker 02: Good morning, Your Honor, and may it please the Court. [00:00:41] Speaker 02: There are two terms at issue here, mixture and compressed blend. [00:00:46] Speaker 02: I'll start with mixture. [00:00:48] Speaker 02: It is common ground that sometimes mixtures are homogeneous and sometimes they're not. [00:00:53] Speaker 03: Mr. Steinler, so that we know what our starting point is here, do you agree that the term matrix is used in the specifications of the three patents means homogeneous composition [00:01:08] Speaker 02: So I'm not contesting that it does. [00:01:11] Speaker 02: We're not appealing that issue. [00:01:13] Speaker 02: I don't agree with it, but for purposes of this appeal, it is understood that matrix is a homogeneous composition. [00:01:20] Speaker 02: Yes. [00:01:21] Speaker 03: Okay. [00:01:23] Speaker 02: All right. [00:01:24] Speaker 02: With respect to mixtures, as I say, they're not inherently homogeneous. [00:01:28] Speaker 02: You have to make them homogeneous. [00:01:31] Speaker 02: You've got to mix them, blend them, heat them. [00:01:34] Speaker 02: You've got to process them in some way, depending on the kind of ingredients that you're working with, to create a homogeneous mixture. [00:01:42] Speaker 02: It takes work. [00:01:43] Speaker 02: And if you don't do that, the mixture is not going to be homogeneous. [00:01:48] Speaker 02: That's true in ordinary life. [00:01:49] Speaker 02: That's true in the pharmaceutical arts. [00:01:51] Speaker 02: And we use chocolate chip ice cream as example. [00:01:55] Speaker 02: But take your pick. [00:01:56] Speaker 02: There are lots of others. [00:01:57] Speaker 02: They're all mixtures, but they're not necessarily homogeneous. [00:02:02] Speaker 03: But if mixture means the same thing as matrix in the specifications of these patents, then it's homogeneous, right? [00:02:12] Speaker 02: Yes, but it does not. [00:02:14] Speaker 02: And I'll get to that in just a second. [00:02:18] Speaker 02: But that's their basic argument. [00:02:20] Speaker 02: Their central argument is that mixture means the same thing as matrix, that two terms are interchangeable. [00:02:27] Speaker 04: But I'll come to that in a moment, if I could, because they- Look, Council, let me ask you this question before we get a little bit further into your argument. [00:02:38] Speaker 04: When I started studying this case, [00:02:41] Speaker 04: it seemed awfully familiar to me. [00:02:43] Speaker 04: And it turns out that I was on the panel that heard use for us one, the prior decision in this case. [00:02:53] Speaker 04: And indeed, we're dealing with almost identical specification. [00:02:57] Speaker 04: And everything seems to be pretty much the same, except that you've taken a couple of words and now come to us with a different definition for just the words. [00:03:10] Speaker 04: There's nothing that has changed that I can see that relevant change in the specification. [00:03:15] Speaker 04: Are we looking at the same horse but of a different color? [00:03:19] Speaker 02: We are looking at different claim terms. [00:03:24] Speaker 02: And that's why they're importantly different. [00:03:27] Speaker 02: In this patent, it is teaching that you can either have homogeneous cores or not homogeneous cores. [00:03:36] Speaker 02: In the first case, [00:03:37] Speaker 02: The claim term that was at issue was to a homogeneous core. [00:03:41] Speaker 02: You will recall, Judge Raina, that it was to a macroscopically homogeneous composition. [00:03:46] Speaker 02: That was what was litigated in the first claim. [00:03:49] Speaker 02: The claims terms that were litigating now, that issue here, mixture and compressed blend, were not at issue in that first case. [00:03:58] Speaker 02: And as was previously said, the argument is, well, they're interchangeable, but they are not. [00:04:05] Speaker 04: The claims appear to be the same, it's just that you've changed a couple of words in the claim. [00:04:14] Speaker 02: Well, with respect, changing words in a claim is important. [00:04:20] Speaker 02: These claims are not to homogeneous compositions, they're to mixtures. [00:04:25] Speaker 02: And mixtures, the plain and ordinary meaning of the word mixture, [00:04:29] Speaker 02: includes both homogeneous compositions and non-homogeneous compositions. [00:04:34] Speaker 02: And you can see the pattern is teaching that. [00:04:36] Speaker 02: You can see that most clearly from the examples. [00:04:40] Speaker 02: Some of these examples specify mixing the homogeneity at intermediate steps, but not at the final step. [00:04:48] Speaker 02: Example two is a good illustration. [00:04:50] Speaker 02: It calls for mixing to complete homogenization at an intermediate step, but then at the end you dump in double the amount of ingredients and you just mix it for five minutes. [00:05:00] Speaker 02: It doesn't specify mixing to homogeneity at that final step, and this example is teaching that homogeneity is not important in that final mixture. [00:05:12] Speaker 02: Where it's important, where homogeneity is important, it's specified. [00:05:16] Speaker 02: And where it's not, it's not. [00:05:18] Speaker 02: One step, mix the homogeneity. [00:05:21] Speaker 02: Next step, not. [00:05:23] Speaker 02: That's not just silence. [00:05:25] Speaker 02: That is clear teaching that the final mixture does not have to be homogeneous. [00:05:30] Speaker 02: And if there was any doubt about that, just look at example C. Example C does specify that you mixed the homogeneity at that last step. [00:05:41] Speaker 02: The juxtaposition of these examples makes it clear as a bell. [00:05:45] Speaker 02: When homogeneity is required, it's specified. [00:05:49] Speaker 02: And when it's not, it's not required. [00:05:52] Speaker 02: But let's take a step back for just a second. [00:05:56] Speaker 02: What's the question here? [00:05:57] Speaker 02: The question is not whether the patent is affirmatively teaching that mixtures don't have to be homogeneous. [00:06:04] Speaker 02: That's the plain and ordinary meaning of the term. [00:06:07] Speaker 02: They could either be homogeneous or not homogeneous. [00:06:10] Speaker 02: The patent certainly teaches that the mixtures don't have to be homogeneous, but that's not the question. [00:06:15] Speaker 02: The question under Thorner is whether there's lexicography or disclaimer. [00:06:21] Speaker 02: that limits the plain and ordinary meaning to homogeneous mixtures? [00:06:25] Speaker 02: The answer is no, we don't have that here. [00:06:28] Speaker 02: And frankly, to the extent there is lexicography, it confirms plain and ordinary meaning. [00:06:34] Speaker 02: There's an express definition of mixture in the prosecution history. [00:06:39] Speaker 02: It's that Wikipedia definition where the patentee wrote, [00:06:44] Speaker 02: In chemistry, quote, a mixture is a material made up of two or more different substances which are mixed, full stop. [00:06:53] Speaker 02: That's plain and ordinary meaning, defined there in the intrinsic record. [00:06:58] Speaker 02: The Thorner case says a patentee is free to choose a broad term and will get the full scope of its plain and ordinary meaning unless the patentee explicitly redefines the term [00:07:10] Speaker 02: or disavows its full scope. [00:07:12] Speaker 02: That didn't happen here. [00:07:14] Speaker 02: Now, the argument was, well, mixture means the same thing as matrix. [00:07:18] Speaker 02: Matrix is homogeneous. [00:07:20] Speaker 02: Therefore, mixture is homogeneous. [00:07:22] Speaker 02: But that syllogism breaks down. [00:07:25] Speaker 02: These two terms are not interchangeable. [00:07:28] Speaker 02: Let me make two quick. [00:07:29] Speaker 03: Take, for instance, the page 47, which is the 878 specification. [00:07:35] Speaker 03: They're all the same pretty much. [00:07:38] Speaker 03: It says that the invention can be prepared by the method comprising the following step. [00:07:46] Speaker 03: And then in the first step, you set A, talk about incorporating the active ingredient with the other ingredients. [00:07:57] Speaker 03: And then B refers to the result as a matrix, the matrix obtained in A. So doesn't that [00:08:08] Speaker 03: pretty clearly suggests that the mixture is the same as the matrix and that what we have here is homogeneous composition? [00:08:19] Speaker 02: Not at all. [00:08:21] Speaker 02: First of all, the patent teaches, if you look at the abstract, it talks about matrix granules. [00:08:27] Speaker 02: You've got matrices, matrix granules that have, as you just described, the active ingredient in globulated in that little matrix. [00:08:37] Speaker 02: But those are particles. [00:08:38] Speaker 02: There's nothing in this patent that says the whole tablet core has to be a matrix. [00:08:44] Speaker 02: And also, the patent teaches that you can include functional excipients. [00:08:49] Speaker 02: You see that in example A. You can add binders. [00:08:52] Speaker 02: You can add lubricants. [00:08:54] Speaker 02: Homogeneity is not important or essential to the functioning of this invention. [00:09:00] Speaker 02: What's essential is having these matrix-forming excipients in there. [00:09:05] Speaker 02: And the cores will include them, but the whole core does not have to consist of a matrix. [00:09:14] Speaker 02: And these claim terms are fundamentally different. [00:09:17] Speaker 02: And bear this in mind, matrix and mixture are not interchangeable. [00:09:21] Speaker 02: Two quick points. [00:09:22] Speaker 02: One, by definition, a mixture has to have two or more ingredients. [00:09:27] Speaker 02: That's the definition of a mixture. [00:09:29] Speaker 02: But in the patent, the patent teaches that a matrix can be just a single ingredient. [00:09:36] Speaker 02: In example 11, for example, the inner matrix is just cetyl alcohol, one ingredient. [00:09:42] Speaker 02: So right off the bat, matrix is different from mixture. [00:09:46] Speaker 02: Those are not interchangeable. [00:09:48] Speaker 02: And more fundamentally, though, the patents teach that you can start from a mixture to create a matrix. [00:09:56] Speaker 02: It teaches various ways of doing it, kneading, mixing, heating, stirring. [00:10:00] Speaker 02: But by definition, if you have to manipulate a mixture to make a matrix, [00:10:07] Speaker 02: mixture and matrix can't mean the same thing. [00:10:10] Speaker 02: That starting mixture is not a matrix until you make it into a matrix. [00:10:15] Speaker 02: Those terms are not interchangeable. [00:10:18] Speaker 02: And as I say, remember the patent teaches that you can add functional excipients here and when you mix in those functional excipients, you're not creating a matrix at all. [00:10:29] Speaker 02: You're creating a mixture which is not necessarily homogeneous. [00:10:34] Speaker 02: Plain and ordinary meaning includes both homogeneous and non-homogeneous. [00:10:39] Speaker 02: There's no reason, there's no basis for limiting it just to homogeneous matrix. [00:10:44] Speaker 02: I see I've effectively run out of my time here. [00:10:48] Speaker 02: So, if there are any other questions, I'd like to reserve the rest of my time for rebuttal. [00:10:54] Speaker 05: Any more questions at this point for Mr. Steindler? [00:10:59] Speaker 04: No, I'm fine. [00:11:00] Speaker 04: Just a moment. [00:11:02] Speaker 05: All right. [00:11:03] Speaker 05: Good. [00:11:03] Speaker 05: Thank you. [00:11:03] Speaker 05: Well, then we'll hear from Mr. J and we'll save you a full rebuttal, Mr. Steindler. [00:11:08] Speaker 05: Okay, Mr. J? [00:11:10] Speaker 01: Good morning, Your Honor. [00:11:11] Speaker 01: May it please the Court, William Jay, on behalf of activists. [00:11:15] Speaker 01: As Mr. Steinler said at the outset, there are two terms here, and although Mr. Steinler didn't spend much, if any, time in the argument or in the brief on compressed blend, I do want to make clear later in the presentation that there are separate and independent arguments for why compressed blend connotes homogeneity. [00:11:35] Speaker 01: But as Mr. Steinler did, I will start with mixture. [00:11:37] Speaker 01: And I think that the [00:11:39] Speaker 01: Detailed disclosure of the invention, which is where the colloquy with Judge Dyke began, includes the most important contextual indications of what mixture means in the context of these claims in this patent with this prosecution history. [00:12:00] Speaker 01: In addition to the point that Judge Dyke brought out in the colloquy with my friend, I would point the court to the interchangeable use of matrix and mixture in column four in the paragraph that begins at line 53. [00:12:15] Speaker 01: This is talking about the matrix that is reduced into granules. [00:12:21] Speaker 01: And up above, at the top of the column, where it's talking about that matrix, it just describes it as an inert matrix. [00:12:29] Speaker 01: and then down here after some further explanation, it refers back to it and says that the granulation can be done by any process [00:12:41] Speaker 01: which retain the homogenous dispersion and matrix structure of the starting mixture. [00:12:47] Speaker 01: And there are two important points about that. [00:12:49] Speaker 01: One is that this is both a matrix and a mixture, but second, and really more importantly, and this is the key point that I hope the court will take from this and another example that I'll give, that it's just not the case that where this specification means homogeneity, it says homogeneity. [00:13:08] Speaker 01: Quite to the contrary, here's a good example of where the specification says up above just matrix. [00:13:16] Speaker 01: And it refers back to it as having a homogeneous dispersion much later because it's understood that that term connotes homogeneity. [00:13:29] Speaker 01: And it also uses it interchangeably. [00:13:31] Speaker 01: It says the starting mixture [00:13:33] Speaker 01: is homogeneously dispersed and has a matrix structure. [00:13:37] Speaker 01: And I think that's confirmed in the next column, column five, where here you're talking about the final step that produces the final product. [00:13:50] Speaker 01: So the lipophilic, this is in column five, the second full paragraph beginning at line six, the lipophilic matrix granules containing the active ingredient are mixed, okay? [00:14:00] Speaker 01: What happens, you see in the next paragraph, [00:14:03] Speaker 01: The compression of the mixture yields a macroscopically homogeneous structure in all its volume, namely a matrix. [00:14:10] Speaker 01: So here again, the same two points. [00:14:12] Speaker 01: You see the mixture and the matrix being used interchangeably. [00:14:17] Speaker 01: And you also see that this mixture, even though in the first quote that I read, it doesn't say how long it's mixed for and does not specifically say it is mixed to homogeneity, [00:14:29] Speaker 01: Once that mixture is finished and compressed, you have a macroscopically homogeneous structure in all its volume, namely a matrix. [00:14:38] Speaker 01: So in other words, even though in that first paragraph it didn't say mixing to homogeneity, that is exactly what the patent means and that is made clear by the fact that this statement in the second paragraph says that the compression yields a macroscopically homogeneous structure in all its volume. [00:14:58] Speaker 01: That is consistent with how the examiner understood the claims. [00:15:03] Speaker 01: We've pointed the court to the statement at 3717 of the appendix in which the examiner clearly understood that the core, the tablet core, and not just the excipients would be a homogeneous structure. [00:15:21] Speaker 05: What's your view of the use of the word macroscopically? [00:15:28] Speaker 05: Doesn't that support their position that if it were not macroscopic but microscopic, you might have a different view of the substance? [00:15:39] Speaker 01: I understand the question, Judge Newman, but I think that the use of macroscopic here is simply to clarify what frame of reference homogeneity is being assessed at. [00:15:56] Speaker 01: And that was the contested issue in the first Euceras case in which at that time the plaintiffs were asking the court [00:16:08] Speaker 01: to infer that a matrix was a macroscopically homogeneous structure. [00:16:14] Speaker 01: And they wanted the term macroscopically in the claim construction because it was important to understand at what frame of reference it was homogeneous. [00:16:24] Speaker 01: Because heterogeneity at the very, very, you know, [00:16:31] Speaker 01: down to the atomic or molecular level didn't change the fact that the substance could be homogeneous for purposes of the patent. [00:16:42] Speaker 01: So I think that this specification was, of course, originally written to support those claims, and although it's been changed to claim a mixture, [00:16:55] Speaker 01: excipient structure that's claimed in the 878 patent still refers to macroscopic homogeneity and that's the frame of reference that we're looking at. [00:17:07] Speaker 01: But to turn for a moment to the prosecution history statement, this passage [00:17:13] Speaker 01: I'm sorry, this statement by the examiner makes pretty clear that the examiner understood the applicant to be advocating for a tablet core that was homogeneous. [00:17:26] Speaker 01: And that, of course, is consistent with the position that the plaintiff took in the prior case. [00:17:32] Speaker 01: And this is summarized at footnote 10 of the district court's opinion. [00:17:39] Speaker 01: referring back to the claim construction hearing that the court had held in the prior case, the plaintiff's position, as reflected in the slides that it put up in that case, was that the core was macroscopically homogeneous, not just the structure. [00:17:52] Speaker 01: I understand that my friend on the other side says that that's not what the submission [00:18:00] Speaker 01: by the applicants in the prosecution history means that it's just referring to the excipient structure as macroscopically homogeneous. [00:18:13] Speaker 01: I understand the point but respectfully disagree with it and I think that the most natural reading of that part of the prosecution history is the one that the examiner had. [00:18:25] Speaker 01: even if it didn't matter that the examiner had demonstrably read it that way and said so in the prosecution history, which would be available for anyone trying to discern the scope of these claims to read. [00:18:39] Speaker 01: I think even if you look at the submission at page 2389 of the appendix, you'll see that the emphasis in this paragraph is on the mixture. [00:18:52] Speaker 01: It corresponds to the [00:18:55] Speaker 01: Well, it tells you in the first sentence that the tablet core contains a mixture, and then in the second sentence it tells you what the [00:19:09] Speaker 01: excipients are in the excipient structure. [00:19:12] Speaker 01: In the third sentence, it goes back to just saying other recited components for the excipient structure, because that's not the focus of this sentence, the key sentence. [00:19:20] Speaker 01: Instead, it says it comprises a mixture of budesonide and other recited components in the form of a macroscopically homogeneous structure, which controls the release of the budesonide from the tablet in the gastrointestinal tract. [00:19:33] Speaker 01: Now, my friend says, well, that's just talking about the claim language. [00:19:36] Speaker 01: And I agree with that up to a point. [00:19:38] Speaker 01: And here's what I mean by that. [00:19:40] Speaker 01: The claim language, and this is the part of claim one of the 878 patent that's at the end of the claim. [00:19:49] Speaker 01: The budesonide is dispersed in the macroscopically homogeneous structure. [00:19:55] Speaker 01: And the macroscopically homogeneous structure controls the release kinetics of the budesonide. [00:20:00] Speaker 01: So I think the sentence is naturally read to refer to both parts of that. [00:20:03] Speaker 01: And so the Budesonide is dispersed in this macroscopically homogeneous structure. [00:20:10] Speaker 01: What is the dispersion of the Budesonide in that structure produce? [00:20:13] Speaker 01: It produces itself a homogeneous structure. [00:20:16] Speaker 01: And that's what the tablet core consists of. [00:20:20] Speaker 01: And that is what the statement of the prosecution history is talking about. [00:20:24] Speaker 01: And I want, if I may, to switch to compressed blend for a moment. [00:20:30] Speaker 01: Now I understand that my friends on the other side have said at page 36 of their brief that the meaning of mixture and the meaning of blend are the same. [00:20:40] Speaker 01: And I think that the definitions that we've given [00:20:46] Speaker 01: for blend at pages 54 to 55 of our brief are really quite powerful evidence that if that's right then we win as a matter of plain and ordinary meaning because the plain and ordinary meaning of compressed blend is a uniform combination of two or more materials. [00:21:04] Speaker 01: Another example is [00:21:06] Speaker 01: a mixture so combined as to render the parts indistinguishable from one another. [00:21:11] Speaker 01: And the plaintiffs really have no response to that ordinary meaning of blend. [00:21:16] Speaker 01: Really all they've come back with is example one. [00:21:21] Speaker 01: But I want to point the court first to the two things in the specification that [00:21:28] Speaker 01: I'm sorry, to the place in the specification that supports both parts of compressed blend. [00:21:32] Speaker 01: So during the application process, when they amended these claims to add the term compressed blend, they pointed to written description support for compressed, and they pointed to written description support for blend. [00:21:47] Speaker 01: The only place it overlaps between the two of them is example three, and so I'd like to take the court to that, to example three of the 799 patent. [00:21:56] Speaker 01: And that is at page 96. [00:22:02] Speaker 01: And as my friend Mr. Steinler said, no I'm sorry, that's a different example, I apologize. [00:22:10] Speaker 01: In example three, the mixture is blended until a homogeneous powder dispersion is obtained and then the powder mixture is subject to compression. [00:22:18] Speaker 01: So it's quite clear that the blend results in a homogeneous composition and that mixture is subjected to compression. [00:22:29] Speaker 01: So the only place where you have compressed blend in this, you have compression of a blend in this specification, we know that it is a homogeneous blend being compressed. [00:22:40] Speaker 01: Now, I understand that there are some other places in the specification that support individual terms. [00:22:45] Speaker 01: We think, for example, that the part in column five that I spent some time on before, which is expressly cited as support for compression, there too, it's the compression of the mixture yields a macroscopically homogeneous structure in all its volume. [00:23:00] Speaker 01: So we think these are really quite powerful. [00:23:03] Speaker 01: points on our side for compressed blend. [00:23:06] Speaker 01: And my friends on the other side just point to example one as really the only thing they do with compressed blend in their briefing. [00:23:13] Speaker 01: And they say, well, it doesn't stay homogeneous in the final step. [00:23:18] Speaker 01: But what it does say is after a final blending, tablets of around 300 milligrams of unitary weight are generated. [00:23:24] Speaker 01: This is column 14. [00:23:27] Speaker 01: outlines eight and nine. [00:23:29] Speaker 01: And as I said, the ordinary meaning of blend is to mix thoroughly or to produce a homogeneous combination, a uniform combination. [00:23:41] Speaker 01: So we think that it's not necessary to say homogeneous here. [00:23:46] Speaker 01: It's a final blending that produces a homogeneous composition. [00:23:50] Speaker 01: And as I say, we think that [00:23:55] Speaker 01: If the other side wants to link the two, then that's fine because the meaning of blend clearly supports our interpretation, which is also consistent with the now accepted construction of the term matrix. [00:24:10] Speaker 01: But even if they were delinked, it's important for the court to understand that the compressed blend patent is the only patent that's still in force and it is [00:24:19] Speaker 01: It adds an extra 11 years of patent term, so it is important to address that term on its own merits, and we think that the ordinary meaning and the intrinsic record strongly support us on that term. [00:24:33] Speaker 01: With that, unless the court has further questions, we're prepared to submit our case. [00:24:39] Speaker 05: Any more questions for Mr. Jay? [00:24:44] Speaker 05: Okay, all right, Mr. Stanley, we have your rebuttal time. [00:24:48] Speaker 02: Thank you, Your Honor. [00:24:49] Speaker 02: Let me just make a few points. [00:24:51] Speaker 02: First, what I did not hear is any contesting of the plain and ordinary meaning of mixture. [00:25:00] Speaker 02: The plain and ordinary meaning of mixture clearly and obviously includes both homogeneous and non-homogeneous mixtures. [00:25:08] Speaker 02: And in order to limit the plain and ordinary meaning, you have to have disclaimer, which is not here. [00:25:15] Speaker 02: My friend went to the detailed disclosure of the invention. [00:25:19] Speaker 02: What he forgot to mention was the detailed disclosure of the invention is an example. [00:25:24] Speaker 02: It's an embodiment. [00:25:26] Speaker 02: That method for making the tablets here is just an exemplary method. [00:25:37] Speaker 02: Many of the examples don't follow that method. [00:25:40] Speaker 02: It says on line 55 in column 3, [00:25:44] Speaker 02: Compositions can be prepared by a method. [00:25:46] Speaker 02: It is common ground that this is an example. [00:25:49] Speaker 02: Everything that follows it are examples and embodiments. [00:25:53] Speaker 02: And what, including the statements in column four, all of those pertain to particular embodiments. [00:26:02] Speaker 02: These particular embodiments do indeed reflect homogeneous compositions. [00:26:10] Speaker 02: But as we all know, I mean, the Thorner case [00:26:14] Speaker 02: For example, just because every single embodiment happens to pertain to one portion or one part of a common and ordinary meaning, that does not limit the plain and ordinary meaning of the term. [00:26:27] Speaker 02: Same true with respect to the statements in column five about compressing to get a matrix. [00:26:36] Speaker 02: My friend acknowledges in his papers that that's an embodiment. [00:26:42] Speaker 02: So we can't go from an embodiment to a disclaimer. [00:26:46] Speaker 02: Point the first. [00:26:47] Speaker 02: Point the second. [00:26:48] Speaker 02: With respect to the statements of the examiner, we all know that statements of the examiner are not controlling. [00:26:57] Speaker 02: Examiner's statements do not define claims. [00:27:03] Speaker 02: This court's in the 3M case. [00:27:05] Speaker 02: Said that we rest on statements made by the patentee [00:27:10] Speaker 02: over conflicting statements by an examiner because it's the patentee's words that define the claim. [00:27:16] Speaker 02: In Innova pure case that we cite in our papers, the examiner can't disclaim subject matter. [00:27:23] Speaker 02: And if you look after the examiner made its statements, the applicants corrected that. [00:27:34] Speaker 02: There was a rule 312 amendment that was filed [00:27:38] Speaker 02: it's at appendix page 2378. [00:27:42] Speaker 02: And they said quite clearly that the examiner had that wrong, and that's on page 2378 and 2379. [00:27:50] Speaker 02: It says the amendment amended the claims to make clear that the tablet cores consisting of a mixture does not have layers. [00:28:01] Speaker 02: That's why they were distinguishing the prior art, not because it was or wasn't homogeneous. [00:28:07] Speaker 02: Then, with respect to, again, with respect to compressed blend, my friend is citing a bunch of dictionary definitions, which he now says are plain and ordinary meaning. [00:28:26] Speaker 02: Those dictionary definitions are not controlling. [00:28:29] Speaker 02: There are many other dictionary definitions, some of which we include in our papers. [00:28:34] Speaker 02: But all you have to do is look at the example that he cited, my friend cited himself, example three. [00:28:41] Speaker 02: Example three describes blending to homogeneity. [00:28:47] Speaker 02: If you have to blend something to get it to be homogeneous, it is not inherently homogeneous, just like mixture. [00:28:56] Speaker 02: blends aren't necessarily homogeneous. [00:28:59] Speaker 02: You have to make them homogeneous. [00:29:01] Speaker 02: That's exactly what's taught in the example that is described here. [00:29:07] Speaker 02: In that particular example, you blended it to become homogeneous, but that's just an example. [00:29:14] Speaker 02: If we're talking about what the plain and ordinary meaning of blends means, the patent is quite clearly teaching that [00:29:22] Speaker 02: a blend is not necessarily homogeneous, you have to make it homogeneous. [00:29:27] Speaker 02: And there's nothing here in this patent that limits either compressed blend or a mixture to just homogeneous blends, just homogeneous mixtures, because their plain and ordinary meaning encompass both. [00:29:44] Speaker 02: Unless there are other questions, that's my submission. [00:29:47] Speaker 05: Any more questions for Mrs. Steinberg? [00:29:51] Speaker 05: All right. [00:29:52] Speaker 05: Thank you. [00:29:52] Speaker 05: Thanks to both counsels. [00:29:55] Speaker 05: The case is taken under submission.