Case 8:13-cv-01436-AG-JPR Document 81 Filed 08/28/14 Page 1 of 41 Page ID #:1034
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` UNITED STATES DISTRICT COURT
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` CENTRAL DISTRICT OF CALIFORNIA
`
` SOUTHERN DIVISION
`
` THE HONORABLE ANDREW J. GUILFORD, JUDGE PRESIDING
`
` CERTIFIED TRANSCRIPT
`
` ALLERGAN USA, INC., et al., }
` Plaintiff, }
` vs. }
` } SACV-13-1436-AG
` MEDICIS AESTHETICS, INC., )
` et al., )
` Defendants. }
` ----------------------------}
`
`
` REPORTER'S TRANSCRIPT OF PROCEEDINGS
`
` Santa Ana, California
`
` August 12, 2014
`
`
` SHARON A. SEFFENS, RPR
` United States Courthouse
` 411 West 4th Street, Suite 1-1053
` Santa Ana, CA 92701
` (714) 543-0870
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`Exhibit Page 1 of 41
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`Exhibit 1065
`Prollenium v. Allergan
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` UNITED STATES DISTRICT COURT
`
` CENTRAL DISTRICT OF CALIFORNIA
`
` SOUTHERN DIVISION
`
` THE HONORABLE ANDREW J. GUILFORD, JUDGE PRESIDING
`
` CERTIFIED TRANSCRIPT
`
` ALLERGAN USA, INC., et al., }
` Plaintiff, }
` vs. }
` } SACV-13-1436-AG
` MEDICIS AESTHETICS, INC., )
` et al., )
` Defendants. }
` ----------------------------}
`
`
` REPORTER'S TRANSCRIPT OF PROCEEDINGS
`
` Santa Ana, California
`
` August 12, 2014
`
`
` SHARON A. SEFFENS, RPR
` United States Courthouse
` 411 West 4th Street, Suite 1-1053
` Santa Ana, CA 92701
` (714) 543-0870
`
`
`
`
`
`
`
`
`
`Exhibit Page 1 of 41
`
`Exhibit 1065
`Prollenium v. Allergan
`
`
`
`Case 8:13-cv-01436-AG-JPR Document 81 Filed 08/28/14 Page 2 of 41 Page ID #:1035
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`APPEARANCES OF COUNSEL:
`
`For the Plaintiffs:
`
`MICHAEL J. KANE
`FISH & RICHARDSON P.C.
`3200 RBC Plaza
`60 South Sixth Street
`Minneapolis, MN 55402
`(612) 337-2502
`
`LARA S. GARNER
`FISH & RICHARDSON P.C.
`12390 El Camino Real
`San Diego, CA 92130
`(858) 678-4332
`
`ELIZABETH M. FLANAGAN
`FISH & RICHARDSON P.C.
`222 Delaware Avenue, 17th Floor
`Wilmington, DE 19899
`(302) 778-8472
`
`
`For the Defendants:
`
`DONALD G. NORRIS
`NORRIS & GALANTER, LLP
`523 W. Sixth Street, Suite 716
`Los Angeles, CA 90014
`(213) 232-0855
`
`WILLIAM F. CAVANAUGH
`SCOTT B. HOWARD
`PATTERSON BELKNAP WEBB & TYLER, LLP
`1133 Avenue of the Americas
`New York, NY 10036-6710
`(212) 336-2793
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`Exhibit Page 2 of 41
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`Case 8:13-cv-01436-AG-JPR Document 81 Filed 08/28/14 Page 3 of 41 Page ID #:1036
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`SANTA ANA, CALIFORNIA; TUESDAY, AUGUST 12, 2014; 9:04 A.M.
`
`THE CLERK: SACV-13-1436-AG, Allergan USA, Inc.,
`
`et al., versus Medicis Aesthetics, Inc., et al.
`
`THE COURT: Good morning.
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`Let's have appearances, please.
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`MS. GARNER: Good morning, Your Honor. Laura
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`Garner, and I have with me Michael Kane and Elizabeth
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`Flanagan.
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`MR. NORRIS: Good morning, Your Honor. Donald
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`Norris for the defendants.
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`MR. CAVANAUGH: Good morning, Your Honor. Bill
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`Cavanaugh on behalf of the defendants.
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`MR. HOWARD: Good morning, Your Honor. Scott
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`Howard on behalf of the defendants.
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`THE COURT: All right, welcome all. I hope you
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`all received the tentative that was sent out.
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`I am prepared to describe how we should proceed,
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`but I am also open to suggestions. Do the parties before me
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`have any suggestions on how we should proceed?
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`MR. CAVANAUGH: Your Honor, we conferred briefly.
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`Based on the Court's tentative ruling, it certainly appears
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`that the Court understands the technology at issue in this
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`case, and we don't think -- I don't think either side
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`believes that a tutorial is really necessary.
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`THE COURT: I agree.
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`Exhibit Page 3 of 41
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`Case 8:13-cv-01436-AG-JPR Document 81 Filed 08/28/14 Page 4 of 41 Page ID #:1037
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`MR. CAVANAUGH: From our perspective at oral
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`argument, there is only really one claim construction issue
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`we would like to take up with the Court, and that's on the 2
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`to 20 percent degree of cross-linking issue.
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`THE COURT: I found that one of the most
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`interesting. So you want to talk about 2 to 20 percent.
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`MR. CAVANAUGH: Right.
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`MR. KANE: Your Honor, as counsel said, we did
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`discuss it the hallway, and we don't believe that a
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`tentative is necessary.
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`THE COURT: You mean a tutorial.
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`MR. KANE: We don't believe that a tutorial is
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`necessary. We have reviewed the tentative as well. We
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`stand by our constructions and proposals that were submitted
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`in the briefing, but in the sense of what we do today to
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`accomplish and move things forward, Allergan is prepared to
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`submit on the tentative and has no issues that it would like
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`to raise with the Court. Obviously we would like a chance
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`to respond to the defendants on the 2 to 20.
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`THE COURT: All right, let's hear 2 to 20. We
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`will go back and forth on that. That really helps focus,
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`and that's one of the reasons we issue tentatives.
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`MR. CAVANAUGH: Thank you, Your Honor.
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`THE COURT: By the way, it's always helpful to
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`focus on any specific passages or lines or sections in the
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`Exhibit Page 4 of 41
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`Case 8:13-cv-01436-AG-JPR Document 81 Filed 08/28/14 Page 5 of 41 Page ID #:1038
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`tentative, but proceed as you wish.
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`MR. CAVANAUGH: Your Honor, I think it would be
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`helpful if the Court has the '475 patent because I will
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`refer to sections there. No graphics are really necessary.
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`THE COURT: Very well. I agree. I'll get the
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`'475 patent. Go ahead.
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`MR. CAVANAUGH: Your Honor, in the tentative, you
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`concluded that this was not a clear statement of the scope
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`of the invention in column 9 at 30 to 34. The Court gave a
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`number of reasons for that conclusion while noting I believe
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`that it is a close question.
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`Let me start with column 9, Your Honor, and the
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`language -- and the two sentences that follow that
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`statement.
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`THE COURT: Just a moment. I have to gather the
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`patent.
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`MR. CAVANAUGH: I know it's Exhibit A to Ms.
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`Flanagan's deposition.
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`THE COURT: All right. I have it.
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`MR. CAVANAUGH: Column 9, Your Honor, line 30,
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`this is what we are contending is the clear statement of the
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`scope of the invention: "The degree of cross-linking in the
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`HA component of the present compositions is at least about
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`2 percent and is up to about 20 percent." The two sentences
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`that follow when read in context with that are simply
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`Exhibit Page 5 of 41
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`Case 8:13-cv-01436-AG-JPR Document 81 Filed 08/28/14 Page 6 of 41 Page ID #:1039
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`pointing out ranges that fall within 2 to 20.
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`Now, in its decision -- and, for example, it says:
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`"In some embodiments, the degree of cross-linking is less
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`than about 6 percent, for example, is less than about
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`5 percent. In other embodiments, the degree of
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`cross-linking is greater than 5 percent, for example, is
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`about 6 to 8 percent," and they talk about 4 to 12 percent.
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`Now, in its tentative, the Court noted, well,
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`there's not necessarily a lower bound being provided, and
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`the Court noted certain claims that refer to less than 6
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`percent and less than 5 percent. I have two points as to
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`that, Your Honor.
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`The first is those are dependent claims. You have
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`an independent claim that talks about the composition, which
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`we would say is defined by 2 to 20 percent degree of
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`cross-linking, so those are dependent claims.
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`The second point, and perhaps more importantly, is
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`if you look at column 16 and you look at those dependent
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`claims, claim 5 talks about less than about 6 percent.
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`Claim 6 talks about less than about 5 percent, but then
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`significantly, Your Honor, what the inventor does in
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`dependent claim 7 -- it talks about the soft tissue filler
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`of claim 4 wherein the HA composition has a degree of
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`cross-linking of about 2 percent. He departs from using the
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`phrase "less than" and specifically uses the phrase "of
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`Exhibit Page 6 of 41
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`Case 8:13-cv-01436-AG-JPR Document 81 Filed 08/28/14 Page 7 of 41 Page ID #:1040
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`about 2 percent" thereby following the language in the
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`specification, which we say defines the scope of the
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`invention, up to 20 and at least 2 percent.
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`THE COURT: If I were to say that range is not
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`consistently applied throughout the specifications and
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`claims, what would your response be?
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`MR. CAVANAUGH: I think it is applied
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`consistently, Your Honor, because the only references to
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`degree of cross-linking are always within 2 to 20 in all the
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`examples that are provided. When they use the term "present
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`composition," the inventor when talking about specific
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`embodiments is very clear. He says, for example, in some
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`embodiments -- in column 7 at lines 11, 20, 29, he uses the
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`phrase "in other embodiments," column 7, line 18.
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`The Court notes that in one instance the inventor
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`uses the phrase "present description," which is different
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`from "present composition," but in that context, it's
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`clearly a specific example -- and they're talking about
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`column 14 -- that illustrates the release pattern of
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`Lidocaine. So I think that there is a consistency
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`throughout the specification. They're talking about this
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`range, 2 to 20. That's what the inventor studied, and they
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`define the clear scope of that invention.
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`Now, in its opinion, the Court notes, well, that's
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`only used once. Two thoughts on that, Your Honor. The
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`Exhibit Page 7 of 41
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`Case 8:13-cv-01436-AG-JPR Document 81 Filed 08/28/14 Page 8 of 41 Page ID #:1041
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`first is if you look at the Astrazeneca case where they
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`found that Astrazeneca based on a statement in the invention
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`that the scope of the invention was simply the six
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`identified salts, there is one reference to that in the
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`specification. There is a vaguer description in the
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`abstract, but if you focus on the body of the specification,
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`in Astrazeneca, they just said it once.
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`If you think about it, this isn't the type of
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`statement that you would necessarily repeat throughout the
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`specification. You're saying here is my range. This is
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`what I have invented, 2 to 20 percent, and then they go on
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`to discuss the specific examples that follow.
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`The Court also notes an issue of claim
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`differentiation, that claim 27 --
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`THE COURT: Well, isn't it superflous for claim 27
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`to be stating that if I were to adopt your definition, and
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`isn't that a pretty powerful rule of construction?
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`MR. CAVANAUGH: I would say no, Your Honor,
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`because if you look at the Astrazeneca case and the Edwards
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`case, in both of those Federal Circuit decisions, the
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`patentee raised claim differentiation. In Astrazeneca,
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`there was a statement in the specification: The present
`
`invention is based on the following six salts. There is
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`then a claim that recites those six salts.
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`Astrazeneca argued claim differentiation. Our
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`Exhibit Page 8 of 41
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`Case 8:13-cv-01436-AG-JPR Document 81 Filed 08/28/14 Page 9 of 41 Page ID #:1042
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`invention isn't limited to those six salts because there is
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`a specific claim on it. The Federal Circuit disagreed and
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`said, no, claim differentiation can't be used to override a
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`clear statement of the scope of the invention.
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`THE COURT: Well, is this a clear statement of the
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`scope of the invention?
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`MR. CAVANAUGH: It says the present composition
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`and a range of 2 to 20 percent. I will give you a second
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`example of where claim differentiation while a rule of thumb
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`is not a rigid rule. In addition to the Astrazeneca case,
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`the Edwards case, involving grafts that are intraluminally
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`introduced into the body. The specification speaks of
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`the term -- the claim spoke of the term "graft." The
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`District Court claim construction said "graft" is defined as
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`"intraluminal grafts." Even though the claim only says
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`"graft," they added the term "intraluminal" based on the
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`language of the specification.
`
`Edwards argued we have a claim that says "inside
`
`of a vessel," and that's the definition of "intraluminal."
`
`Claim differentiation. Our claim should not be limited to
`
`intraluminal grafts because we have a claim that essentially
`
`says "intraluminal." Again, as in the Astrazeneca case, the
`
`Court disagreed and found claim differentiation could not be
`
`used in that instance to override a clear statement of the
`
`scope of the invention in the patent because the patentee
`
`Exhibit Page 9 of 41
`
`
`
`Case 8:13-cv-01436-AG-JPR Document 81 Filed 08/28/14 Page 10 of 41 Page ID #:1043
`
` 10
`
`0 9 : 1 7
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`0 9 : 1 7
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`0 9 : 1 7
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`0 9 : 1 8
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`0 9 : 1 8
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`0 9 : 1 8
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`0 9 : 1 8
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`0 9 : 1 8
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`0 9 : 1 8
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`0 9 : 1 8
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`0 9 : 1 8
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`0 9 : 1 8
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`0 9 : 1 8
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`0 9 : 1 8
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`0 9 : 1 8
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`0 9 : 1 8
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`0 9 : 1 8
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`0 9 : 1 8
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`0 9 : 1 8
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`0 9 : 1 9
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`0 9 : 1 9
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`0 9 : 1 9
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`0 9 : 1 9
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`0 9 : 1 9
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`0 9 : 1 9
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` 1
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` 2
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`25
`
`had referred throughout the specification to grafts as
`
`intraluminal.
`
`So I don't think claim differentiation ends up
`
`being a powerful argument for the patentee in this instance,
`
`Your Honor, based on Astrazeneca and based on the Edwards
`
`decision. Here there is a clear unequivocal statement.
`
`Here is the range of the present compositions of my
`
`invention.
`
`Finally, Your Honor, the Court noted that, well,
`
`this wasn't used to distinguish prior art, but that's not
`
`the sole test for whether there has been a clear statement
`
`of the scope of the invention.
`
`THE COURT: Surely you don't think I am saying
`
`that's the sole test.
`
`MR. CAVANAUGH: No, I didn't, Your Honor.
`
`THE COURT: You mean it's a factor.
`
`MR. CAVANAUGH: But the Federal Circuit -- for
`
`example, in the Edwards case, during the prosecution they
`
`deleted the term "intraluminal." Edwards said how could
`
`this be construed as limited to "intraluminal" when we
`
`deleted that term at one point during the prosecution
`
`history? The Federal Circuit said it wasn't material. Your
`
`deletion of it during prosecution wasn't particularly
`
`material, so you can't cite it.
`
`Here, Your Honor, the fact that -- what didn't
`
`Exhibit Page 10 of 41
`
`
`
`Case 8:13-cv-01436-AG-JPR Document 81 Filed 08/28/14 Page 11 of 41 Page ID #:1044
`
` 11
`
`0 9 : 1 9
`
`0 9 : 1 9
`
`0 9 : 1 9
`
`0 9 : 1 9
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`0 9 : 1 9
`
`0 9 : 1 9
`
`0 9 : 1 9
`
`0 9 : 1 9
`
`0 9 : 1 9
`
`0 9 : 1 9
`
`0 9 : 2 0
`
`0 9 : 2 0
`
`0 9 : 2 0
`
`0 9 : 2 0
`
`0 9 : 2 0
`
`0 9 : 2 0
`
`0 9 : 2 0
`
`0 9 : 2 0
`
`0 9 : 2 0
`
`0 9 : 2 0
`
`0 9 : 2 0
`
`0 9 : 2 0
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`0 9 : 2 0
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`0 9 : 2 0
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`0 9 : 2 1
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` 1
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` 2
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`25
`
`come up during the prosecution history doesn't answer the
`
`question whether the inventor limited it for purposes of --
`
`because if you look at all the prior art they cite, whether
`
`it was done for those purposes or whether because as the
`
`specification makes clear that's what they were testing.
`
`That was the range that they were testing.
`
`So for all those reasons, Your Honor, we think
`
`this does come down to a clear statement. I think the
`
`language of those dependent claims strengthens that
`
`argument because if the inventor's view was I'm not bound
`
`by this 2 percent, why would that dependent claim be
`
`written differently than the two others? In that
`
`dependent claim, he confirmed not that 2 percent -- that's
`
`his lower boundary -- but that confirms what's in the
`
`specification.
`
`THE COURT: Is it your position that the range 2
`
`to 20 is consistently applied throughout the specifications
`
`and claims?
`
`MR. CAVANAUGH: I believe it is, Your Honor.
`
`THE COURT: Okay. Let's hear from the plaintiff,
`
`and that might be a good lead-off question to the plaintiff.
`
`MR. KANE: Your Honor, we do not believe that it's
`
`used consistently throughout the specification or the
`
`claims. I think what is important is how often it is used,
`
`when it is used, and where it is used. I think you have to
`
`Exhibit Page 11 of 41
`
`
`
`Case 8:13-cv-01436-AG-JPR Document 81 Filed 08/28/14 Page 12 of 41 Page ID #:1045
`
` 12
`
`0 9 : 2 1
`
`0 9 : 2 1
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`0 9 : 2 1
`
`0 9 : 2 1
`
`0 9 : 2 1
`
`0 9 : 2 1
`
`0 9 : 2 1
`
`0 9 : 2 1
`
`0 9 : 2 1
`
`0 9 : 2 1
`
`0 9 : 2 2
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`0 9 : 2 2
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`0 9 : 2 2
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`0 9 : 2 2
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`0 9 : 2 2
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`0 9 : 2 2
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`0 9 : 2 2
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`0 9 : 2 2
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`0 9 : 2 2
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`0 9 : 2 2
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`0 9 : 2 3
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`0 9 : 2 3
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`0 9 : 2 3
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`0 9 : 2 3
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`0 9 : 2 3
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` 1
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`24
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`25
`
`look at the entire invention here.
`
`I will refer the Court to the '475 Patent as well.
`
`I would start with the title of the patent, "Hyaluronic
`
`Acid-Based Gels Including Lidocaine." So that's the title.
`
`That's telling what the invention is about, adding
`
`lidocaine.
`
`If you look at the abstract --
`
`THE COURT: You know what I am going to ask you to
`
`do? Put it on the elmo.
`
`MR. KANE: Your Honor, if you look at the
`
`abstract, the very first sentence says: "Disclosed herein
`
`are soft tissue fillers, for example, dermal and subdermal
`
`fillers based on hyaluronic acids and pharmaceutically
`
`acceptable salts thereof. In one aspect, the hyaluronic
`
`acid-based compositions include a therapeutically effective
`
`amount of at least one anesthetic agent, for example,
`
`lidocaine." There's nothing here about the degree of
`
`cross-linking. There is nothing here about that. It's all
`
`about the gel with the anesthetic agent.
`
`We then continue through the patent. I'm
`
`referring to the Background Section, Your Honor. This is at
`
`column 2 starting at about line 29. They identify the
`
`problem that the patent is attempting to solve. "It has
`
`been proposed to incorporate certain therapeutic agents, for
`
`example, anesthetic agents such as Lidocaine." Then it
`
`Exhibit Page 12 of 41
`
`
`
`Case 8:13-cv-01436-AG-JPR Document 81 Filed 08/28/14 Page 13 of 41 Page ID #:1046
`
` 13
`
`0 9 : 2 3
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`0 9 : 2 3
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`0 9 : 2 3
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`0 9 : 2 3
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`0 9 : 2 3
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`0 9 : 2 3
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`0 9 : 2 4
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`0 9 : 2 4
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`0 9 : 2 4
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`0 9 : 2 4
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`0 9 : 2 4
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`0 9 : 2 4
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`0 9 : 2 4
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`0 9 : 2 4
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`0 9 : 2 4
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`0 9 : 2 4
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`0 9 : 2 4
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`0 9 : 2 4
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`0 9 : 2 4
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`0 9 : 2 5
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`0 9 : 2 5
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`0 9 : 2 5
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`0 9 : 2 5
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` 1
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`22
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`23
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`24
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`25
`
`continues in the last paragraph of the background: "It is
`
`an objective of the HA-based soft filler compositions and
`
`methods of making them" --
`
`THE COURT: "Making and using them."
`
`MR. KANE: Yes. "Making and using them as
`
`described herein to provide soft tissue fillers that do not
`
`cause allergic reactions in patients, are biocompatible and
`
`stable and usable in vivo and include one or more local
`
`anesthetic agents." Again, there is no description about
`
`the degree of cross-linking or any kind of range of degree
`
`of cross-linking.
`
`Then you move to the summary of the invention, the
`
`very first description of what the invention is. Again,
`
`Your Honor, the present description relates to soft tissue
`
`fillers, for example, dermal and subdermal fillers based on
`
`hyaluronic acid, and pharmaceutically acceptable salts of
`
`HA" -- and they give some examples -- "including a
`
`therapeutically effective amount of at least one anesthetic
`
`agent."
`
`Then it continues. Again, Your Honor, in terms of
`
`is it consistent, this sentence is very important starting
`
`at line 42: "The present HA compositions describing the
`
`invention, including at least one anesthetic agent, have
`
`enhanced stability relative to conventional HA-based
`
`compositions, for example, Lidocaine," and it continues.
`
`Exhibit Page 13 of 41
`
`
`
`Case 8:13-cv-01436-AG-JPR Document 81 Filed 08/28/14 Page 14 of 41 Page ID #:1047
`
` 14
`
`0 9 : 2 5
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`0 9 : 2 5
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`0 9 : 2 5
`
`0 9 : 2 5
`
`0 9 : 2 5
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`0 9 : 2 5
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`0 9 : 2 5
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`0 9 : 2 5
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`0 9 : 2 5
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`0 9 : 2 6
`
`0 9 : 2 6
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`0 9 : 2 6
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`0 9 : 2 6
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`0 9 : 2 6
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`0 9 : 2 6
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`0 9 : 2 6
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`0 9 : 2 6
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`0 9 : 2 6
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`0 9 : 2 6
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`0 9 : 2 6
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`0 9 : 2 6
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`0 9 : 2 6
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`0 9 : 2 6
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`0 9 : 2 7
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`0 9 : 2 7
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` 1
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`23
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`24
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`25
`
`There is a description of the invention, the present HA
`
`compositions. There is no discussion about the degree of
`
`cross-linking.
`
`The entire invention here, the disclosure, the
`
`problem that is being solved is this is going to tell the
`
`world how to make -- and it's the first of its kind of HA
`
`fillers -- that it can have Lidocaine that is stable and
`
`usable. That's the problem. It has nothing to do with the
`
`degree of cross-linking.
`
`THE COURT: Hold on. I'm not getting that
`
`statement. Cross-linking does affect stability doesn't it?
`
`MR. KANE: But the degree of cross-linking is not
`
`the novel invention. That's not the novel aspect of this.
`
`There were HA fillers that had a degree of cross-linking
`
`between 2 and 20 before this invention. There's nothing
`
`here where the applicant is saying other people have a
`
`degree of cross-linking at 50. Other people have a degree
`
`of cross-linking at 1. I have found out that the important
`
`range is 2 to 20. That's my invention.
`
`It's not what this is about at all. It's all
`
`about being able to take an HA filler that has the desirable
`
`characteristics for the treatment and being able to add
`
`Lidocaine and maintain a useable stable product.
`
`If you continue on in the summary --
`
`THE COURT: Hold on just one moment.
`
`Exhibit Page 14 of 41
`
`
`
`Case 8:13-cv-01436-AG-JPR Document 81 Filed 08/28/14 Page 15 of 41 Page ID #:1048
`
` 15
`
`0 9 : 2 7
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`0 9 : 2 7
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`0 9 : 2 7
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`0 9 : 2 7
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`0 9 : 2 7
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`0 9 : 2 7
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`0 9 : 2 7
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`0 9 : 2 7
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`0 9 : 2 7
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`0 9 : 2 7
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`0 9 : 2 7
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`0 9 : 2 7
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`0 9 : 2 8
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`0 9 : 2 8
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`0 9 : 2 8
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`0 9 : 2 8
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`0 9 : 2 8
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`0 9 : 2 8
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`0 9 : 2 8
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`0 9 : 2 8
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`0 9 : 2 8
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` 1
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`20
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`21
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`22
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`23
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`24
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`25
`
`MR. KANE: Certainly.
`
`THE COURT: Why is there a mention of 2 to 20?
`
`MR. KANE: Well, that is a range that was looked
`
`at, but that's not limiting, Your Honor.
`
`THE COURT: When I asked a specific question about
`
`whether that range is consistently applied, you said no,
`
`correct?
`
`MR. KANE: Correct.
`
`THE COURT: But are all your inconsistent
`
`applications within that range?
`
`MR. KANE: We don't think so, no. As I will show
`
`you, in the summary of the invention, there are
`
`inconsistencies. Again, at the very beginning of the
`
`patent --
`
`THE COURT: Inconsistencies outside that range?
`
`MR. CAVANAUGH: Yes. There are statements here,
`
`for instance, less than 5 percent at the very beginning of
`
`the patent.
`
`THE COURT: Five percent is within the range of 2
`
`to 20.
`
`MR. KANE: One percent is less than five percent
`
`and is not within the range.
`
`THE COURT: I understand your point.
`
`MR. KANE: If you look at the summary of the
`
`invention -- we are at column 3, line 25. It says, "the
`
`Exhibit Page 15 of 41
`
`
`
`Case 8:13-cv-01436-AG-JPR Document 81 Filed 08/28/14 Page 16 of 41 Page ID #:1049
`
` 16
`
`0 9 : 2 8
`
`0 9 : 2 8
`
`0 9 : 2 8
`
`0 9 : 2 8
`
`0 9 : 2 8
`
`0 9 : 2 8
`
`0 9 : 2 8
`
`0 9 : 2 8
`
`0 9 : 2 9
`
`0 9 : 2 9
`
`0 9 : 2 9
`
`0 9 : 2 9
`
`0 9 : 2 9
`
`0 9 : 2 9
`
`0 9 : 2 9
`
`0 9 : 2 9
`
`0 9 : 2 9
`
`0 9 : 2 9
`
`0 9 : 2 9
`
`0 9 : 2 9
`
`0 9 : 2 9
`
`0 9 : 2 9
`
`0 9 : 2 9
`
`0 9 : 3 0
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`0 9 : 3 0
`
` 1
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` 2
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` 3
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` 4
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` 5
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` 6
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`20
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`21
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`22
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`23
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`24
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`25
`
`degree of cross-linking less than about 5 percent. Then it
`
`it continues, "for example, about 2 percent." It doesn't
`
`say greater than 2 percent. It doesn't say less than 5 and
`
`greater than 2. It says less than 5, for example, about 2.
`
`THE COURT: Well, "about" is the phrase the
`
`defendants are proposing.
`
`MR. KANE: I understand. I will come to that in a
`
`minute, but certainly it doesn't say greater than 2 or
`
`greater than about 2.
`
`If we continue down to column -- again, we are
`
`still in column 3, lines 63 to 64. "The HA component has a
`
`degree of cross-linking of less than about 6 percent or less
`
`than about 5 percent." No mention of 2. It covers 1. It
`
`covers one-half. It covers three-quarters. Unequivocal.
`
`Column 4 --
`
`THE COURT: Unequivocal? You can't say that less
`
`than 5 percent unequivocally references 1 percent.
`
`MR. KANE: I think it covers 1 percent.
`
`Unequivocally -- there is no limiting language about that.
`
`THE COURT: Okay.
`
`MR. KANE: Same thing in column 4. Again, still
`
`in the summary of the invention. "HA component having a
`
`degree of cross-linking of less than 5 percent."
`
`THE COURT: When you're reading from it, I just
`
`want the record to be clear that it says, "less than about 5
`
`Exhibit Page 16 of 41
`
`
`
`Case 8:13-cv-01436-AG-JPR Document 81 Filed 08/28/14 Page 17 of 41 Page ID #:1050
`
` 17
`
`0 9 : 3 0
`
`0 9 : 3 0
`
`0 9 : 3 0
`
`0 9 : 3 0
`
`0 9 : 3 0
`
`0 9 : 3 0
`
`0 9 : 3 0
`
`0 9 : 3 0
`
`0 9 : 3 0
`
`0 9 : 3 0
`
`0 9 : 3 0
`
`0 9 : 3 0
`
`0 9 : 3 0
`
`0 9 : 3 0
`
`0 9 : 3 0
`
`0 9 : 3 1
`
`0 9 : 3 1
`
`0 9 : 3 1
`
`0 9 : 3 1
`
`0 9 : 3 1
`
`0 9 : 3 1
`
`0 9 : 3 1
`
`0 9 : 3 1
`
`0 9 : 3 1
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`0 9 : 3 1
`
` 1
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` 2
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`18
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`19
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`20
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`21
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`22
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`23
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`24
`
`25
`
`percent."
`
`MR. KANE: I apologize.
`
`Then at line 17, it says: "HA composition with a
`
`degree of cross-linking less than about 5 percent." So in
`
`the Background Section, there is no discussion about the
`
`degree of cross-linking at all. It's all about adding
`
`Lidocaine. In the beginning of the summary of the
`
`invention, the discussion is about HA fillers with
`
`Lidocaine. There is no limitation at all on the amount of
`
`degree of cross-linking. Then here throughout the summary
`
`of the invention, there are four references to a degree of
`
`cross-linking, none of which have the 2 to 20 range, one of
`
`which says about 2, but three of which has no mention of 2
`
`at all.
`
`This is absolutely inconsistent with -- that the
`
`invention is limited and consistently limited to 2 to
`
`20 percent. As the Court knows, the case law is very clear.
`
`The Phillips case is very clear. The Thorner case, which is
`
`a relatively recent Federal Circuit case, is again very
`
`clear. There are only two exceptions to this general rule
`
`that you get the plain meaning, lexicography -- they are not
`
`arguing lexicography here -- or a clear disavow of scope,
`
`meaning words of "manifest exclusion."
`
`THE COURT: What are you reading from?
`
`MR. KANE: I am reading from Thorner, "words of
`
`Exhibit Page 17 of 41
`
`
`
`Case 8:13-cv-01436-AG-JPR Document 81 Filed 08/28/14 Page 18 of 41 Page ID #:1051
`
` 18
`
`0 9 : 3 1
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`0 9 : 3 2
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`0 9 : 3 2
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`0 9 : 3 2
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`0 9 : 3 2
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`0 9 : 3 2
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`0 9 : 3 2
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`0 9 : 3 2
`
`0 9 : 3 2
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`0 9 : 3 2
`
`0 9 : 3 2
`
`0 9 : 3 2
`
`0 9 : 3 2
`
`0 9 : 3 2
`
`0 9 : 3 3
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`0 9 : 3 3
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`0 9 : 3 3
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`0 9 : 3 3
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`0 9 : 3 3
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`0 9 : 3 3
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`0 9 : 3 3
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`0 9 : 3 3
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`0 9 : 3 3
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`0 9 : 3 3
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`0 9 : 3 3
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` 1
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`20
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`21
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`23
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`24
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`25
`
`manifest exclusion consistently and uniformly being used
`
`throughout the specification. They just aren't here, and
`
`the Court has noted that they're not here.
`
`The other portions of the intrinsic evidence
`
`conflict with that interpretation. As the Court noted in
`
`its tentative order, this 2 to 20 percent doesn't ever
`
`appear except in claim 27, but it's never anywhere else in
`
`the specification. If that was important, if the invention
`
`was so limited, you would have expected to see this
`
`described elsewhere. You don't.
`
`The Court also noted that -- again, claims 5, 6,
`
`and 7 that we just went through are also inconsistent. In
`
`fact, those claims come right out of the summary of the
`
`invention that I just went through. There is no discussion
`
`of 2 and 20 in the summary of the invention, so counsel's
`
`argument that claims 5, 6 and 7 confirm that we are in the
`
`range is actually completely inconsistent with the summary
`
`of the invention.
`
`Actually I would argue claim 7 doesn't confirm any
`
`kind of a lower limit. If it was going to confirm some
`
`lower limit, there would be language such that it would say
`
`greater than about 2 percent, 2 percent or greater,
`
`something like that. This is actually calling out it's
`
`about 2 percent, which of course has to have some value
`
`below 2 percent. It's not saying 3 percent. That claim
`
`Exhibit Page 18 of 41
`
`
`
`Case 8:13-cv-01436-AG-JPR Document 81 Filed 08/28/14 Page 19 of 41 Page ID #:1052
`
` 19
`
`0 9 : 3 3
`
`0 9 : 3 3
`
`0 9 : 3 3
`
`0 9 : 3 3
`
`0 9 : 3 4
`
`0 9 : 3 4
`
`0 9 : 3 4
`
`0 9 : 3 4
`
`0 9 : 3 4
`
`0 9 : 3 4
`
`0 9 : 3 4
`
`0 9 : 3 4
`
`0 9 : 3 4
`
`0 9 : 3 4
`
`0 9 : 3 4
`
`0 9 : 3 4
`
`0 9 : 3 4
`
`0 9 : 3 4
`
`0 9 : 3 4
`
`0 9 : 3 4
`
`0 9 : 3 4
`
`0 9 : 3 4
`
`0 9 : 3 5
`
`0 9 : 3 5
`
`0 9 : 3 5
`
` 1
`
` 2
`
` 3
`
` 4
`
` 5
`
` 6
`
` 7
`
` 8
`
` 9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
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`18
`
`19
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`20
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`21
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`22
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`23
`
`24
`
`25
`
`wouldn't cover 6 percent. It only covers about 2 percent.
`
`So it's not calling out a range. It's calling out --
`
`THE COURT: Patentable would be discovery of a 2
`
`to 20 percent range -- the problem has been solved, and it's
`
`2 to 20 percent. Do you think that would be patentable?
`
`MR. KANE: I don't think so. I think the people
`
`who were doing this -- I think Allergan's previous products
`
`fell within that range. There's lots of products that fell
`
`within that range that are all prior art, so that can't be
`
`the novel aspect. That's not the invention here, finding a
`
`new range.
`
`THE COURT: My question does not preclude it from
`
`being part of the novel aspect, but go ahead. I understand.
`
`MR. KANE: That alone I don't think could be a
`
`distinguishing feature because there was present plenty of
`
`art out there that had cross-linking in that range.
`
`As the Court noted, there is nothing in the
`
`prosecution history. These are the things that the cases
`
`have talked about being important.
`
`If you look at the two cases that were cited in
`
`the briefs primarily -- one was the Honeywell case. In that
`
`case, the Court found that there was a limitation, but in
`
`that case, there were four separate statements that the
`
`Court relied upon, so it was uniform. It was consistent.
`
`In the Astrazeneca case that counsel mentioned,
`
`Exhibit Page 19 of 41
`
`
`
`Case 8:13-cv-01436-AG-JPR Document 81 Filed 08/28/14 Page 20 of 41 Page ID #:1053
`
` 20
`
`0 9 : 3 5
`
`0 9 : 3 5
`
`0 9 : 3 5
`
`0 9 : 3 5
`
`0 9 : 3 5
`
`0 9 : 3 5
`
`0 9 : 3 5
`
`0 9 : 3 5
`
`0 9 : 3 5
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`0 9 : 3 6
`
`0 9 : 3 6
`
`0 9 : 3 6
`
`0 9 : 3 6
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`0 9 : 3 6
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`0 9 : 3 6
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`0 9 : 3 6
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`0 9 : 3 6
`
`0 9 : 3 6
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`0 9 : 3 6
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`0 9 : 3 6
`
`0 9 : 3 6
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`0 9 : 3 6
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`0 9 : 3 6
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`0 9 : 3 6
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`0 9 : 3 6
`
` 1
`
` 2
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` 3
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` 4
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` 5
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` 6
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` 7
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` 8
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` 9
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`10
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`11
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`12
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`13
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`14
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`15
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`16
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`18
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`19
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`20
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`21
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`22
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`23
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`24
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`25
`
`interestingly what the Court noted was that the very first
`
`senten
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