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` BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`Page 1
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` - - - - - - - - - - - - - -x
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` AMGEN INC., :
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` Petitioner, :
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` v. :
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` ALEXION PHARMACEUTICALS, :
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` INC., :
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` Patent Owner.
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` - - - - - - - - - - - - - -x
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` Videotaped Deposition of BERNHARDT LEVY TROUT
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` Boston, Massachusetts
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` Tuesday, January 28, 2020 - 9:06 a.m.
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`
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`
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`Reported by:
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`Alan H. Brock, RDR, CRR
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`Job No.: 26641
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`TransPerfect Legal Solutions
`212-400-8845 - Depo@TransPerfect.com
`
`AMG1078
`Amgen Inc. v. Alexion Pharmaceuticals, Inc.
`IPR2019-00739 and -00740
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`1
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`
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` Videotaped deposition of Bernhardt Levy
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` Trout, held at the offices of:
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`Page 2
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` Nelson Mullins Riley & Scarborough LLP
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` One Post Office Square
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` Boston, Massachusetts 02109
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` Pursuant to agreement, before Alan H. Brock,
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` RDR, CRR, Notary Public in and for the Commonwealth
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` of Massachusetts.
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` A P P E A R A N C E S
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` ON BEHALF OF PETITIONER:
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` DAVID H. HOLMAN, PH.D., ESQ.
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` DEBORAH STERLING, PH.D., ESQ.
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` STERNE, KESSLER, GOLDSTEIN & FOX, P.L.L.C.
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` 1100 New York Avenue, N.W.
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` Washington, D.C. 20005
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` dholman@sternekessler.com
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` dsterling@sternekessler.com
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` ON BEHALF OF PATENT OWNER:
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` EVAN DIAMOND, ESQ.
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` NICHOLAS CHOI, ESQ.
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` GERALD J. FLATTMANN, ESQ.
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` KING & SPALDING LLP
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` 1185 Avenue of the Americas
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` New York, New York 10036-2601
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` ediamond@kslaw.com
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` nchoi@kslaw.com
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` gflattmann@kslaw.com
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` ALSO PRESENT:
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` Paula S. Fritsch, Amgen Senior Counsel
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` Tara Rahemba, Alexion Senior Director,
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` Patent Counsel
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`3
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` C O N T E N T S
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`Page 4
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` EXAMINATION OF BERNHARDT LEVY TROUT PAGE
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` By Mr. Holman 5
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` E X H I B I T S
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` January 28, 2020 9:06 a.m.
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` P R O C E E D I N G S
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` BERNHARDT LEVY TROUT,
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` being first duly sworn or affirmed to testify to the
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` truth, the whole truth, and nothing but the truth,
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` was examined and testified as follows:
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` EXAMINATION
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` BY MR. HOLMAN:
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` Q. Good morning, Dr. Trout.
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` A. Good morning.
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` Q. My name is David Holman. I'm an attorney
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` with the law firm Sterne Kessler Goldstein & Fox. I
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` represent Amgen in this case, and I'm going to be
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` taking your deposition today.
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` Can you please state your full name for
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` the record, please.
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` A. Yes. Bernhardt Levy Trout.
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` Q. So, Dr. Trout, have you ever been deposed
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` before?
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` A. Yes, I have.
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` Q. And can you give us an idea, what was the
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` context of your previous depositions?
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` MR. DIAMOND: And in answering these
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` questions, just I caution you not to reveal any, you
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` know, third-party confidential information that
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` might be involved in any of those matters.
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` THE WITNESS: Okay.
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` A. I've been deposed in a variety of cases,
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` all having to do with technical issues, mostly
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` pharmaceuticals.
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` Q. Again, without disclosing any confidences
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` from those cases, were they related to patents?
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` Were they patent cases?
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` A. I would say that all the times I've been
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` deposed the cases had to do with patents. There
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` were probably other issues, but I was focusing on
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` patents.
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` Q. And again without disclosing any
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` confidences from those cases, did any of those, your
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` previous depositions, involve formulations of
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` antibodies?
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` A. By "involve" -- it's kind of vague.
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` Q. Sure. So you mentioned that the previous
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` cases involved, I think you said, technical issues,
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` mostly pharmaceuticals. So did those cases relate
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` to pharmaceutical formulations comprising
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` antibodies?
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` A. And again, by "relate" -- it sounds very
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` broad, so....
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` Q. The technology at issue, was it a
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` therapeutic antibody?
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` A. I can't remember all the details. Sitting
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` here, I don't remember exactly if it -- if there was
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` directly an antibody involved.
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` Q. Okay.
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` A. It may not have been.
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` Q. You can't recall?
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` A. I can't recall exactly.
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` Q. Do you recall when, time frame, this was,
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` what year this might have been?
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` A. Well, I mean, I've been deposed several
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` times before, so I was trying to recall the various
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` cases in which I, you know, was a witness in for
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` which I've been deposed. And I don't think that,
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` using your termination, there was antibodies
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` directly -- formulation of antibodies directly in
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` those cases, but there may have been.
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` Q. Okay, and you said you've been deposed
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` several times. Are there several cases? Do you
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` recall how many cases that you were involved in as a
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` witness?
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` A. And again, "as a witness," you mean having
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` been deposed?
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` Q. Yeah, let's stick with the depositions for
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` now. So as an expert witness, depositions, how many
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` cases do you recall being involved in before this
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` one?
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` A. I don't have the exact number. Maybe
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` somewhere eight-ish, maybe close to ten, something
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` like that.
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` Q. Okay. So eight to ten. And as far as you
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` can recall today, the best of your recollection is
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` these cases did not involve therapeutic antibodies
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` as a technology?
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` A. Well, again, I'd have to go through them
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` and kind of think about them. But just as I recall,
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` I don't remember in particular one that directly
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` involved antibodies. But that's the best I can do
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` right now.
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` Q. Okay. That's fine. So in some of those
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` cases -- let's see, you have a lot of cases you've
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` previously done. So have you ever testified at
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` trial?
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` A. Yes.
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` Q. And how many cases have you testified at
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` trial before?
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` A. Again, exact number, probably three or
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` four, something like that, plus or minus, but about
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` that number.
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` Q. And can you recall if any of these cases
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` where you testified at trial involved therapeutic
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` antibody technology?
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` A. I think those cases, as best as I can
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` recall, did not involve therapeutic antibody
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` technology.
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` Q. And is it safe to say that in these cases
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` that you also prepared and submitted expert reports?
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` A. I'm sorry, I didn't understand.
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` Q. So in these cases where you were deposed or
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` where you testified at trial, did you also submit an
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` expert report in those cases?
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` A. Yes, I think I submitted an expert report
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` in all of those cases.
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` Q. Okay.
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` A. It may have been more than one. Sometimes
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` you have to submit other reports, followup reports.
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` Q. And do you recall any of these -- going
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` back to your deposition experience: Were any of
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` your depositions related to a Patent Office
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` proceeding, such as today's proceeding, inter partes
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` review?
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` A. As best as I can answer sitting here, I
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` don't think so. I know this is a -- inter partes
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` review -- I think that the other cases I was deposed
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` in were not, as best as I can remember sitting here.
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` Q. Okay. So today this deposition may be a
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` little similar to what you've experienced, but there
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` are going to be some differences.
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` A. Sorry, I just remembered. Again, I was
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` trying to recall as best I can. I think I was
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` deposed in the inter partes review before, now that
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` I -- now that I recall.
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` Q. All right. And do you recall what the --
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` if that inter partes review involved therapeutic
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` antibody as the patented technology?
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` A. Again, if you mean therapeutic antibody is
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` the main subject, it was not.
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` Q. Do you recall if that deposition as part of
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` an inter partes review involved formulations of
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` therapeutic antibodies?
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` A. Again, I know you used that word
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` "involved." It seems pretty broad. I mean, the
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` main subject was not antibodies.
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` Q. Okay. And do you recall in your deposition
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` experience in the IPR case that we're discussing,
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` did you provide expert testimony on behalf of the
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` patent owner or the patent challenger, petitioner,
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` in that case? Do you remember?
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` A. Yes, in the case I'm recalling it was on
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` behalf of the patent owner.
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` Q. All right. Thank you. So you understand
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` that today you're here to provide testimony related
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` to declarations that you've submitted in two
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` different IPR proceedings? Right? Do you
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` understand that?
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` A. Yes.
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` Q. And more specifically, you have two written
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` declarations that you've submitted. And so today
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` is, you know, my opportunity -- I'm entitled to
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` cross-examine you to better understand the opinions
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` and information and statements in your declarations.
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` Do you understand that?
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` MR. DIAMOND: Objection to form.
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` A. As a nonlegal person, layperson in the law,
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` I think I understand that.
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` Q. So as you can see, we have a court reporter
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` here today, and he's going to be transcribing our
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` conversation for the record. And so because he's
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` generating a written transcript, you understand
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` that, assuming we don't discuss any confidential
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` information, that the written transcript will become
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` a public record? Do you understand that?
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` A. Again, it sounds like a legal issue. But
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` that's my understanding.
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` Q. Okay. So you've been sworn in, and you
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` understand that you are testifying under oath and
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` under penalty of perjury today?
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` A. Yes.
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` Q. And you understand that you're here today
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` to testify truthfully and accurately regarding the
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` opinions and information and statements set forth in
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` your declarations?
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` A. Yes.
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` Q. Now, Dr. Trout, is there any reason you
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` can't -- any reason you will be unable to testify
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` truthfully and accurately today?
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` A. No.
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` Q. Great. So today I'm going to use plain
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` English. I'm going to do my best to speak clearly
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` so you can understand each of my questions.
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` However, if you at any point don't understand a
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` question I'm asking, just ask me, just please let me
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` know, and I'll do my best to try and clarify it for
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` you. Does that sound fair?
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` A. Okay.
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` Q. All right. And on the flip side, if you
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` answer my question, I'm going to assume that you
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` understood the question that I've asked you. Okay?
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` A. Okay.
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` Q. So I mentioned we have our court reporter
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` here who's transcribing our conversation. So this,
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` of course, means it's very important that we not
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` speak over each other or interrupt each other, you
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` know, during our conversation today. So I'll do my
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` best to let you make sure you're finished with your
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` answer before I move on to my next question, and I
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` ask that you do the same for me: let me finish my
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` question before you begin your answer. Does that
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` sound fair?
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` A. Yes.
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` Q. So that helps create a clean transcript,
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` but it also makes it easier on our court reporter
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` for transcribing.
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` Okay. So as you've probably experienced
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` in your previous depositions, your counsel may
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` object to some of the questions that I ask today.
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` That's his right during these depositions. But if
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` your counsel objects to a question, do you
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` understand that you still need to answer my question
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` unless he specifically instructs you not to answer?
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` A. Yes.
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` Q. So I may ask a question, counsel may
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` object, and then you still need to answer unless he
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` says specifically -- a specific instruction not to
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` answer. Right?
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` A. That's my understanding.
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` Q. Okay, great. So your counsel's objections,
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` should he decide to raise any, they're supposed to
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` be limited to single-word objections: "Objection,
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` form." "Objection, hearsay." "Objection,
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` foundation" -- things like that. Does that make
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` sense?
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` MR. DIAMOND: I object to your legal
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` statement there. But go on.
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` Q. Does that make sense?
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` A. It's a legal -- it sounds like it's legal
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` terms. But I understood the words you said.
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` Q. Sure. I mean, I just want to sort of lay
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` out the rules of engagement, because this deposition
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` is a conversation, but it's not an everyday
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` conversation. It's a little bit awkward, because
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` I'm asking questions and then there's objections and
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` then you're answering. So I'm just trying to lay
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` the groundwork, the framework, of how we're going to
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` proceed today.
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` MR. DIAMOND: Object to that, too, but
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` go on.
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` Q. Regarding the objections, your counsel is
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` not allowed to make statements or suggestions that
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` suggest an answer to you. Do you understand that?
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` A. Yes.
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` Q. And those types of speaking objections and
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` general coaching of the witnesses are prohibited in
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` proceedings before the Patent Trial and Appeal
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` Board.
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` MR. DIAMOND: Counsel, first of all, I
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` object to this line of questioning. I'm not going
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` to coach the witness. And if you have a problem,
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` you can talk with me about it. Okay?
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` MR. HOLMAN: I'm just setting the
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` groundwork so the witness understands how today is
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` going to go.
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` MR. DIAMOND: It's silly. Go on.
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` Q. So as I mentioned, the cross-exam today,
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` this deposition, is conversation between the
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` examining attorney -- that's me -- and the
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` witness -- that's you.
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` MR. DIAMOND: Objection to form.
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` Q. The defending lawyer, counsel, can't act as
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` an intermediary, can't interpret questions for you,
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` can't decide which questions you should answer, help
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` you formulate your answers or help you correct your
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` answers while you're testifying. Do you understand
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` that, Dr. Trout?
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` MR. DIAMOND: Objection, calls for legal
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` conclusion. But again, counsel, I'm not going to do
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` that, and if you have a problem, you can talk to me
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` about it.
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` A. I understood, you know -- at least to the
`
` extent that I'm not a legal expert, I understood the
`
` words you were saying.
`
` Q. So today I'm going to do my best to take a
`
` break about every hour. If you need a break, if we
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` haven't taken a break and you need one, just let me
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` know, speak up. I'm happy to take one. All I ask
`
` is that if there's a question pending, that you
`
` please answer the question, and then we can break
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` after that. Does that sound reasonable?
`
` A. Okay.
`
` Q. All right. So Dr. Trout, it looks like you
`
` have a couple of documents that you have brought
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` with you there. Are those two documents there in
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` front of you?
`
` A. They're two documents. Counsel brought
`
` them. I didn't bring them. But there are two
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` documents here, yes.
`
` Q. And what are those two documents?
`
` A. The two documents are the two declarations
`
` that I submitted in this case.
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` Q. And have you inspected those? Do you know
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` if they have any markings or highlighting or notes
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` in them that were not in the originals?
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` A. I have not inspected them.
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` Q. Do you mind if I inspect them, please?
`
` A. No.
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` MR. HOLMAN: So just for the record, Dr.
`
` Trout has a copy of the declaration of Bernhardt
`
` Trout, marked as ALXN2024 in Case No. IPR
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` 2019/00739. This is the '504 patent declaration.
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` And Dr. Trout has a copy of the
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` declaration of Bernhardt L. Trout, marked as
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` ALXN2024 in Case No. IPR 2019/00740. This is the
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` '880 patent declaration.
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` Q. Dr. Trout, it appears that those documents
`
` are copies of the as-filed declarations. To the
`
` best of your knowledge is that the case, that those
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` are copies of the original declarations as filed?
`
` A. That's my understanding. I haven't
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` reviewed them as of now, but that's my
`
` understanding.
`
` Q. So we brought copies as well. But since
`
` you already have two copies in front of you, we're
`
` happy to burden you with two more duplicates, or
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` you're free to work from those copies.
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` MR. DIAMOND: Counsel, we don't have any
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` issue with him using the copies that are in front of
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` him now.
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` Q. Would you like to just work from those
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` copies that your counsel has provided you?
`
` A. Yes.
`
` (Discussion off the record.)
`
` Q. So Dr. Trout, let's look at your -- today
`
` we'll probably refer to these as the '504
`
` declaration and the '880 declaration. Does that
`
` sound okay?
`
` A. Okay.
`
` Q. If I use that terminology, will you
`
` understand when I say the '504 declaration, I'm
`
` referring to your declaration directed to the '504
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` patent, and when I say the '880 declaration, I'm
`
` referring to your declaration referring to the '880
`
` patent? Okay?
`
` A. Okay.
`
` Q. So let's look at your '504 patent
`
` declaration. We've already established that this is
`
` the declaration of Bernhardt Trout, Ph.D., directed
`
` to Patent No. 9,725,504. Do you see that on the
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` front page there?
`
` A. Yes.
`
` Q. And so if you could turn to the last page
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` of the declaration, just before Appendix A. It's
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` Page 52, but it doesn't have a page number.
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` A. Okay.
`
` Q. And here you have a statement that says, "I
`
` hereby declare that all statements made herein of my
`
` own knowledge are true and that all statements made
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` on information and belief are believed to be true.
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` I further declare that I made these statements with
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` the knowledge that willful false statements and the
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` like so made are punishable by fine or imprisonment
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` or both under Section 1001 of Title 18 of the United
`
` States Code." And then there's a signature
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` underneath that. Do you see that?
`
` A. Yes.
`
` Q. Can you please confirm for me that that
`
` signature here is your signature?
`
` A. Yes, it is.
`
` Q. Thank you. So, Dr. Trout, did you prepare
`
` this declaration yourself?
`
` A. I prepared the declaration together with
`
` counsel.
`
` Q. And are you aware of any errors in this
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` declaration?
`
` A. Upon review, I found some typos, but there
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` are no substantive errors that I'm aware of.
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` Q. Anything you wish to correct on the record
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` today?
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` A. I think the typos will be evident. If you
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` ask me about them, I can correct them at that time,
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` if need be.
`
` Q. Okay. To the best of your recollection,
`
` how much time would you say you spent preparing this
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` declaration?
`
` A. I don't remember the exact number of hours.
`
` Q. I mean, can you give me an estimate?
`
` A. I mean, probably, I don't know, 50-ish,
`
` plus or minus -- maybe a little more, maybe a little
`
` less, something like that. Maybe more than that.
`
` I'm not sure the exact number.
`
` Q. So approximately 50 hours, maybe a little
`
` more?
`
` A. Maybe more. It could be substantially
`
` more. But just sitting here, that's kind of about
`
` the number, very roughly. Probably more than 50,
`
` maybe a little less.
`
` Q. But as you said, it could be substantially
`
` more. Could it be a hundred hours?
`
` A. Could be. I think probably less than a
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` hundred, though.
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` Q. So probably more than 50, less than a
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` hundred.
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` A. In rough terms. I didn't add up the
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` numbers.
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` Q. If we split the difference, would 75 hours
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` be a good guess?
`
` MR. DIAMOND: Objection to form.
`
` A. I would just stick with my answer.
`
` Q. Somewhere between 50 and a hundred?
`
` A. Well, I think I said maybe 50, plus or
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` minus, maybe substantially more, up to around a
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` hundred, something like that.
`
` Q. Okay.
`
` A. I think less than a hundred, though.
`
` Q. All right. So I'm going to sort of ask the
`
` same types of questions on your '880 declaration.
`
` So if you could just switch documents and turn to
`
` the '880 declaration. Again, on the first page of
`
` this one it says the declaration of Bernhardt L.
`
` Trout, Ph.D., and this is directed to the Patent
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` 9,718,880. Right?
`
` A. Yes.
`
` Q. And if you could just turn again to the
`
` last page, just before Appendix A, which, again, is
`
` on Page 52. Are you there?
`
` A. Yes.
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` Q. Great. And you have the same statement
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` here. You say, "I hereby declare that all
`
` statements made herein of my own knowledge are true
`
` and that all statements made on information and
`
` belief are believed to be true. I further declare
`
` that I made these statements with the knowledge that
`
` willful false statements and the like so made are
`
` punishable by fine or imprisonment or both under
`
` Section 1001 of Title 18 of the United States Code."
`
` And again I see a signature underneath there. Can
`
` you confirm for me that that is your signature?
`
` A. Yes, it is.
`
` Q. All right. And so you mentioned for the
`
` '504 declaration that you prepared it with the
`
` assistance of counsel. I'm going to ask you the
`
` same question: Did you prepare the '880 declaration
`
` yourself?
`
` A. I prepared the '880 declaration together
`
` with counsel.
`
` Q. And since there's a lot of overlap between
`
` these two declarations, are there any errors in the
`
` '880 declaration that you're aware of?
`
` A. I think that there are some typos that I
`
` found upon review. There's nothing substantive.
`
` Q. Okay. And so is there anything you wish to
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` correct on the record for the '880 patent
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` declaration?
`
` A. Similarly to the other: I think typos are
`
` pretty evident. So we can just correct them or note
`
` them if they come up.
`
` Q. Okay. And so when we were discussing the
`
` amount of time you spent preparing for your
`
` declaration for the '504 patent declaration, did
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` that include the time spent preparing the '880
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` patent declaration as well? Were you lumping those
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` together, or were you just focusing on the '504?
`
` A. I was lumping them together.
`
` Q. So if I asked you how much time you spent
`
` preparing the '880 patent declaration, your answer
`
` would be the same? Collectively, preparing the '504
`
` and '880 declarations is somewhere between 50 and a
`
` hundred hours? Is that reasonable?
`
` A. Well, I would stick to my original answer
`
` on that.
`
` Q. All right. So when you were preparing your
`
` declarations, did you perform any literature
`
` searches?
`
` A. It's kind of vague. Could you rephrase or
`
` be more specific?
`
` Q. Let's see. So did you, let's say, search
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` for scientific literature in a database such as
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` Google Scholar, PubMed, to help inform or develop
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` your opinions for your declarations?
`
` A. As far as I recall, I didn't use those
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` databases.
`
` Q. Did you use any other databases?
`
` A. I don't -- I don't recall.
`
` Q. Can't recall?
`
` A. I don't recall using a database.
`
` Q. Do you recall doing any other types of
`
` searches for literature to inform your opinions for
`
` preparing your declaration?
`
` A. Again, it's kind of vague. Could you maybe
`
` clarify?
`
` Q. I'm just trying -- so you have a list of
`
` documents in your declaration. Like, for example,
`
` in Appendix B there's a list of documents. Did you
`
` identify any -- did you yourself identify any of
`
` those documents, or were they provided to you by
`
` counsel?
`
` A. I worked together with counsel in preparing
`
` these and finding the -- I'd say incorporating the
`
` references. So it was together.
`
` Q. So do you know -- you don't recall doing
`
` any online literature searches to identify
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` references that are in your table of exhibits in
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` Appendix B? Is that right?
`
` MR. DIAMOND: Objection to form.
`
` A. I would just stick to the words that I used
`
` in my original answer.
`
` Q. Your original answer being -- I asked you
`
` if you did any literature searches. You said you
`
` didn't understand, it was vague. And so then I
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` said -- I gave you some examples, like Google
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` Scholar and PubMed. You said, "I don't recall using
`
` those databases." And then I asked you did you use
`
` any other databases, and you said you didn't recall.
`
` So is that your testimony, that you
`
` don't recall searching any databases for references
`
` as part of your declaration?
`
` MR. DIAMOND: Object to the summary of
`
` the testimony.
`
` A. Yeah, I would just stick to my answer for
`
` the questions as I originally answered them.
`
` Q. So one more question about that: So your
`
` answer -- one of your answers was, you said, "I
`
` worked together with counsel in preparing these and
`
` finding the -- I'd say incorporating the references.
`
` So it was together." So when you said you worked
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` with counsel in preparing these and finding the or
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` incorporating the references, do you know who did
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` the finding of the references?
`
` MR. DIAMOND: And in answering this or
`
` any other question, just don't reveal the substance
`
` of any communications with counsel. I think counsel
`
` is asking you who. So that's the question.
`
` A. I worked together with counsel on that.
`
` Specifically who, it's Mr. Diamond. Oh, and --
`
` Mr. Diamond in particular.
`
` Q. Anyone else?
`
` A. I think it was -- I think it was just
`
` Mr. Diamond.
`
` Q. So to the best of your recollection, you
`
` and Mr. Diamond worked together to find the
`
` references that are included in your declaration.
`
` MR. DIAMOND: Objection to form.
`
` A. That's correct. I worked directly with
`
` Mr. Diamond.
`
` Q. All right. Okay, so Dr. Trout, now I'm
`
` going to switch gears and ask you some questions
`
` about today's deposition -- not the declaration, but
`
` the deposition. A lot of time we get some confusion
`
` on those two because they sound somewhat similar.
`
` So if you could give me an estimate of
`
` how much time did you spend preparing for today's
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` deposition?
`
` A. I'd say several days, a couple of days,
`
` several days.
`
` Q. And so I'm going to ask you some questions
`
` about people you may have met with. Please
`
` understand, I'm not intending to ask about the
`
` substance of any of your conversations that you had
`
` with -- may have had with counsel.
`
` So in these preparations, you said a
`
` couple of days, several days. Did you meet with
`
` anyone to prepare for today's deposition?
`
` A. Yes.
`
` Q. And with whom did you meet?
`
` A. So I met with the four folks to my left, in
`
` front of you.
`
` Q. If possible, could you state their names
`
` for the record.
`
` A. I don't know their full names necessarily.
`
` So I know Evan Diamond. Primarily with him.
`
` Q. So you met with the four counsel, four
`
` counsel that are sitting in this room today to
`
` prepare for this deposition. Anyone else?
`
` A. No.
`
` Q. And were these meetings in person or by
`
` phone, a mixture of the two?
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` MR. DIAMOND: And again, counsel is not
`
` asking you for the substance of any communications,
`
` just that question.
`
` A. I think we may have had -- I think both.
`
` Q. So some in-person meetings and some phone
`
` meetings.
`
` A. That's right. There may have been just one
`
` phone meeting, but there was a combination of phone
`
` meeting and in person.
`
` Q. And I believe previously you said it was
`
` several days. So could you give me an estimate of
`
` how long these meetings were, number of hours you
`
` spent in these meetings?
`
` A. I mean, roughly something like, you know, a
`
` little over 16 -- phone calls, I think it was just
`
` one phone call and then two in-person meetings,
`
` approximately eight hours, maybe a little less,
`
` maybe a little more.
`
` Q. Did you review any documents when you were
`
` preparing for this deposition?
`
` A. Yes.
`
` Q. Which documents did you review to prepare
`
` for today's deposition?
`
` A. I reviewed my declarations, and I reviewed
`
` the materials considered, and I reviewed the -- I
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` guess it was the petition and preliminary response,
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` and then the PTAB decision. I don't know if I got
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` the terms right.
`
`

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