HEARING BEFORE THE BOARD
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` 1 UNITED STATES PATENT AND TRADEMARK OFFICE
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` 2 BEFORE THE PATENT TRIAL AND APPEAL BOARD
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` 3
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` 4 PRAXAIR DISTRIBUTION, INC.
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` 5 Petitioner
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` 6 v.
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` 7 INO THERAPEUTICS, LLC,
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` 8 Patent Owner
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` 9 Case IPR2015-00529
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`10 U.S. Patent No. 8,846,112 B2
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`11
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`12
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`13 HEARING BEFORE THE BOARD
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`14
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`15 The Telephonic hearing was held on Tuesday,
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`16 January 5, 2016, commencing at 2:36 p.m., at the Law
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`17 Offices of Latham and Watkins, LLP, 555 Eleventh Street,
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`18 N.W., Suite 1000, Washington, D.C. 20004, before Steven
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`19 Poulakos, RPR, Notary Public.
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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 REPORTED BY: Steven Poulakos, RPR
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`1
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`Ex. 2020-0001
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`

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`HEARING BEFORE THE BOARD
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` 1 APPEARANCES:
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` 2
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` 3 ON BEHALF OF PRAXAIR DISTRIBUTION, INC.
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` 4 SARA N. KERRANE, ESQUIRE
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` 5 K&L Gates
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` 6 One Park Plaza
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` 7 Twelfth Floor
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` 8 Irvine, California 92614
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` 9 Telephone: 949.253.0900
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`10 Email: Sara.kerrane@klgates.com
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`11
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`12 ON BEHALF OF INO PHARMACEUTICALS, LLC:
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`13 KENNETH G. SCHULER, ESQUIRE
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`14 MARC ZUBICK, ESQUIRE
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`15 Latham & Watkins, LLP
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`16 330 North Wabash Avenue
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`17 Suite 2800
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`18 Chicago, Illinois 60611
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`19 Telephone: 312.876.7700
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`20 Email: Kenneth.schuler@lw.com
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`21 Marc.zubick@lw.com
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`22
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`23
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`24 ALSO PRESENT: Kenneth D. Goetz, Esquire. In-house
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`25 counsel for Mallinckrodt Pharmaceuticals
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`2
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`Ex. 2020-0002
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`

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`HEARING BEFORE THE BOARD
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` 1 PROCEEDINGS
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` 2 - - -
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` 3 MR. SCHULER: Hello. These are the
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` 4 participants at the deposition, counsel for both
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` 5 parties and the court reporter.
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` 6 MR. MURTHY: Hi, Your Honor, Sanjay Murthy
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` 7 also on the call for Petitioner.
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` 8 MS. KERRANE: Can you hear me as well?
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` 9 MR. MURTHY: I can.
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`10 THE COURT: Good afternoon. This is Judge
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`11 Green, and I have Judge Hulse on the line with me. My
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`12 understanding, this is a conference call on
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`13 IPR2015-00529 regarding a deposition that's ongoing.
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`14 Who do I have for petitioner.
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`15 MR. MURTHY: Your Honor, Sanjay Murthy on
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`16 behalf of petitioner.
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`17 MS. KERRANE: And Sara Kerrane also on
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`18 behalf of petitioner.
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`19 THE COURT: And then who do I have for
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`20 patent owner?
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`21 MR. SCHULER: Ken Schuler on behalf of the
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`22 patent owner, Your Honor.
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`23 THE COURT: Okay. Thank you.
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`24 MR. SCHULER: I just wanted to let the
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`25 Court know, we also have additional counsel for the
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`3
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`Ex. 2020-0003
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`

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`HEARING BEFORE THE BOARD
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` 1 patent owner, including in-house counsel, and there's
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` 2 no objection from Petitioner as to their participation.
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` 3 We also have the court reporter still here
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` 4 for the deposition, but the deponent is not in the
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` 5 room.
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` 6 THE COURT: Okay, and is the court reporter
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` 7 doing a transcript of this call.
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` 8 THE COURT REPORTER: Yes, Your Honor.
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` 9 THE COURT: So if one of the parties could
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`10 arrange to have the transcript filed in this case as an
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`11 exhibit, when it's possible, I would appreciate it.
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`12 MR. SCHULER: We will arrange for it, Your
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`13 Honor. This is counsel for the Respondent.
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`14 THE COURT: Okay. I only have very limited
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`15 information about this call. So I'm not sure who
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`16 requested it. So whoever requested the call can go
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`17 ahead and start.
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`18 MR. SCHULER: Yes, Your Honor, it's Ken
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`19 Schuler. We did request the call.
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`20 The issue is the scope of the deposition.
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`21 We have a question about a nonprior art reference,
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`22 which is the current labeling for the product.
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`23 The question proceeded to say about a
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`24 contraindication that's in the label and what's not a
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`25 contraindication in the label. There is parallel
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`4
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`Ex. 2020-0004
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`

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`HEARING BEFORE THE BOARD
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` 1 District Court litigation that involves questions of
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` 2 infringement.
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` 3 I asked counsel for the Petitioner to
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` 4 explain how that would be would relevant to issues of
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` 5 102, 103 that are at issue with the declaration, and at
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` 6 issue with regard to the institution decision. Counsel
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` 7 declined to provide any explanation, and so we would
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` 8 ask that any such questioning, because it appears to be
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` 9 calculated to go to issues other than the issues at
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`10 hand, not be permitted.
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`11 THE COURT: Now, was there anything about
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`12 the product label or anything else in the declaration
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`13 that the declarant is being cross-examined on?
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`14 MR. SCHULER: The only thing that counsel
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`15 have pointed me to is a paragraph that recites the file
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`16 history that says that a labeling supplement was
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`17 submitted.
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`18 I don't know if counsel has anything else
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`19 in mind, but she declined to identify anything else.
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`20 MS. KERRANE: Actually, Your Honor, I
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`21 referred counsel here to paragraph 65 in the deponent's
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`22 declaration in which he distinctly discusses this and,
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`23 in fact, the new label is an exhibit to his
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`24 declaration, and he discusses the fact that the
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`25 prescribing information of the INOmax now includes
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`5
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`Ex. 2020-0005
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`HEARING BEFORE THE BOARD
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` 1 certain features.
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` 2 So I indicated to counsel that I was asking
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` 3 about the prescribing information and that label that
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` 4 is cited by the deponent, and he indicated that he
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` 5 thought I was only allowed to ask about the very
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` 6 specific points that were referenced in paragraph 65
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` 7 and that I could not go beyond that and talk about
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` 8 anything else in the label.
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` 9 THE COURT: Okay. Can you tell me what the
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`10 exhibit number is that we're talking about?
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`11 MS. KERRANE: Yes. It's Exhibit Number
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`12 2023.
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`13 THE COURT: Okay. Give me one second.
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`14 MS. KERRANE: And the declaration of the
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`15 Deponent is Exhibit 2020.
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`16 THE COURT: 2020?
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`17 MS. KERRANE: Yes.
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`18 THE COURT: Paragraph 65?
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`19 MS. KERRANE: Correct. And it actually
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`20 starts on paragraph 64 where the deponent -- the
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`21 declarant says that prior to the study there was a
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`22 different understanding, and then in paragraph 65 it's
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`23 discusses how the label was then changed based on the
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`24 study.
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`25 THE COURT: Right.
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`6
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`Ex. 2020-0006
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`HEARING BEFORE THE BOARD
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` 1 MR. SCHULER: And that's not what was
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` 2 asked. The question at hand had nothing to do with how
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` 3 the labeling changed.
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` 4 THE COURT: But 2023, what is the label,
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` 5 correct?
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` 6 MR. SCHULER: That is correct.
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` 7 THE COURT: And it was submitted with the
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` 8 declaration?
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` 9 MR. SCHULER: Correct.
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`10 THE COURT: Okay. At this point it looks
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`11 like it's reasonably related to the declaration, so I'm
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`12 going to allow it; but I do caution Petitioner that you
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`13 have to keep it reasonably related to the declaration.
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`14 If it goes beyond the scope of what's in the
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`15 declaration and we find that you've gone too far
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`16 outside the scope, we can institute sanctions,
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`17 including the cost of the cross-examination, and I also
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`18 remind patent owner, that you can still object to this
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`19 and file a motion to exclude later; but at this point,
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`20 because the declarant did mention the label and talked
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`21 about the label in the declaration and also submitted
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`22 the label as an exhibit to the declaration, I'm not
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`23 seeing how that's completely outside the scope of what
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`24 was submitted by the declarant.
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`25 MR. SCHULER: Okay. Thank you, Your Honor.
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`7
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`Ex. 2020-0007
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`

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`HEARING BEFORE THE BOARD
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` 1 If I may seek some prospective guidance and maybe
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` 2 counsel can just assure me. She's just asked a series
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` 3 of questions about hypothetical prior art that is not
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` 4 before the witness, and I assume that they're not going
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` 5 to be permitted to try and introduce new prior that was
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` 6 not part of the institution decision or anything else
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` 7 that's not in the record.
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` 8 THE COURT: Is the prior art of record at
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` 9 all?
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`10 MR. SCHULER: I don't know. I'm asking
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`11 counsel hopefully to represent that she's not going to
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`12 try and introduce new prior art references in the
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`13 deposition.
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`14 MS. KERRANE: Your Honor, it was just a
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`15 hypothetical question. There was no prior art being
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`16 introduced at all.
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`17 THE COURT: So it's just saying
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`18 hypothetically the prior art taught this?
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`19 MS. KERRANE: Exactly.
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`20 MR. SCHULER: Yes. And we've allowed that.
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`21 I'm assuming that they don't then get to just start
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`22 bringing in new prior art references that they believe.
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`23 THE COURT: Anything that they would want
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`24 the declarant to testify on, especially as to the
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`25 statements of prior art, they should have provided the
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`8
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`Ex. 2020-0008
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`HEARING BEFORE THE BOARD
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` 1 declarant time to look at it because it's very hard for
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` 2 a declarant to look at a piece of prior art during the
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` 3 declaration, unless they're giving it to impeach the
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` 4 declarant, but they still have to give the declarant
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` 5 time to look at the reference because somebody can't
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` 6 just opine on something off the top of their heads in
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` 7 the middle of a deposition if it hasn't previously been
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` 8 done.
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` 9 MR. SCHULER: Thank you.
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`10 MR. MURTHY: Just one point of
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`11 clarification on this last point, Your Honor. In my
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`12 experience, it has been permitted to use additional
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`13 prior references, especially to impeach an expert
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`14 witness at a deposition such as this where an expert
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`15 has opined on a particular issue or that something is
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`16 not taught or disclosed, it's reasonable and fair to
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`17 bring forth a reference to show that that's not
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`18 correct, and I've done that in other matters before.
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`19 THE COURT: And I guess I thought that's
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`20 what I said. If it's being used to impeach the
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`21 witness, but usually it's being used to impeach the
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`22 witness, it's usually something the witness was aware
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`23 of or was an author of, and if it's not, you have to
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`24 give the witness time to look at it because if it's not
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`25 something based on what they received before to ask
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`9
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`Ex. 2020-0009
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`HEARING BEFORE THE BOARD
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` 1 them questions on the fly and say, what do you think of
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` 2 this, and they haven't had a chance to form an opinion
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` 3 yet, you have to give them that time.
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` 4 I think when you're doing impeachment it
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` 5 tends to be more the declarant's own work.
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` 6 MR. MURTHY: Understood, Your Honor.
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` 7 THE COURT: Okay. If you're bringing a
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` 8 reference that I feel you did not present before the
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` 9 deposition and allow the declarant time to form an
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`10 opinion, I think it's unfair to tell the declarant,
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`11 well, you know, what do you think of this and expect
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`12 the declarant to say something when they've never had a
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`13 chance to read it or form an opinion on it. Okay.
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`14 MR. MURTHY: Thanks, Your Honor, for the
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`15 clarification.
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`16 THE COURT: Patent owner, anything else?
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`17 MR. SCHULER: No, Your Honor. Thank you
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`18 very much.
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`19 THE COURT: Petitioner, anything else?
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`20 MS. KERRANE: No, Your Honor. Thank you.
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`21 THE COURT: Okay. Thank you. This call is
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`22 adjourned.
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`23 (Hearing before the Board recessed at 2:50 p.m.)
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`24
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`25
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`10
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`Ex. 2020-0010
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`HEARING BEFORE THE BOARD
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` 1 CERTIFICATE OF SHORTHAND REPORTER - NOTARY PUBLIC
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` 2 I, Steven Poulakos, registered
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` 3 Professional Reporter, the officer before whom the
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` 4 foregoing proceedings were taken, do hereby certify
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` 5 that the foregoing transcript is a true and correct
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` 6 record of the proceedings; that said proceedings were
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` 7 taken by me stenographically and thereafter reduced to
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` 8 typewriting under my supervision; and that I am neither
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` 9 counsel for, related to, nor employed by any of the
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`10 parties to this case and have no interest, financial or
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`11 otherwise, in its outcome.
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`12 IN WITNESS WHEREOF, I have hereunto set my
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`13 hand this 13th day of January, 2016.
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`14
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`15
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`16 _________________________
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`17 Steven Poulakos, RPR
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`18 NOTARY PUBLIC IN AND FOR
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`19 THE DISTRICT OF COLUMBIA
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`20
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`21
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`22
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`23 My Commission Expires:
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`24 May 31, 2016
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`25
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`11
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`Ex. 2020-0011
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`

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`PRAXAIR DISTRIBUTION, INC. v.
`INO THERAPEUTICS, LLC
`
`HEARING BEFORE THE BOARD
`January 5, 2016
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`A
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`Actually (2)
` 5:20;6:19
`additional (2)
` 3:25;9:12
`adjourned (1)
` 10:22
`afternoon (1)
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`ahead (1)
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`allow (2)
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`allowed (2)
` 6:5;8:20
`appears (1)
` 5:8
`appreciate (1)
` 4:11
`arrange (2)
` 4:10,12
`art (9)
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` 18,22,25;9:2
`assume (1)
` 8:4
`assuming (1)
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`assure (1)
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`author (1)
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`aware (1)
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`B
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`based (2)
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`behalf (3)
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`beyond (2)
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`Board (1)
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`both (1)
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`bring (1)
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`bringing (2)
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`C
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`calculated (1)
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`call (7)
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`Can (7)
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`Min-U-Script®
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`case (2)
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`caution (1)
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`certain (1)
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`CERTIFICATE (1)
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`certify (1)
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`chance (2)
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`changed (2)
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`cited (1)
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`clarification (2)
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`COLUMBIA (1)
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`Commission (1)
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`completely (1)
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`conference (1)
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`contraindication (2)
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`cost (1)
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`counsel (13)
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` 6,14,18,21;6:2;8:2,
` 11;11:9
`court (29)
` 3:5,10,19,23,25;
` 4:3,6,6,8,9,14;5:1,
` 11;6:9,13,16,18,25;
` 7:4,7,10;8:8,17,23;
` 9:19;10:7,16,19,21
`cross-examination (1)
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`cross-examined (1)
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`current (1)
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`D
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`day (1)
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`decision (2)
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`declarant (12)
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` 8:24;9:1,2,4,4;10:9,
` 10,12
`declarant's (1)
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`declaration (12)
` 5:5,12,22,24;6:14;
` 7:8,11,13,15,21,22;
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` 9:3
`declined (2)
` 5:7,19
`deponent (4)
` 4:4;6:4,15,20
`deponent's (1)
` 5:21
`deposition (8)
` 3:4,13;4:4,20;
` 8:13;9:7,14;10:9
`different (1)
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`disclosed (1)
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`discusses (3)
` 5:22,24;6:23
`distinctly (1)
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`District (2)
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`done (2)
` 9:8,18
`during (1)
` 9:2
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`E
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`else (7)
` 5:12,18,19;6:8;
` 8:6;10:16,19
`employed (1)
` 11:9
`especially (2)
` 8:24;9:13
`Exactly (1)
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`exclude (1)
` 7:19
`exhibit (6)
` 4:11;5:23;6:10,11,
` 15;7:22
`expect (1)
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`experience (1)
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`expert (2)
` 9:13,14
`Expires (1)
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`explain (1)
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`explanation (1)
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`F
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`fact (2)
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`fair (1)
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`far (1)
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`features (1)
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`feel (1)
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`file (2)
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`filed (1)
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`financial (1)
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`find (1)
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`fly (1)
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`foregoing (2)
` 11:4,5
`form (3)
` 10:2,9,13
`forth (1)
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`G
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`giving (1)
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`goes (1)
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`Good (1)
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`Green (1)
` 3:11
`guess (1)
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`guidance (1)
` 8:1
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`H
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`hand (3)
` 5:10;7:2;11:13
`hard (1)
` 9:1
`heads (1)
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`hear (1)
` 3:8
`Hearing (1)
` 10:23
`Hello (1)
` 3:3
`hereby (1)
` 11:4
`hereunto (1)
` 11:12
`Hi (1)
` 3:6
`history (1)
` 5:16
`Honor (14)
` 3:6,15,22;4:8,13,
` 18;5:20;7:25;8:14;
` 9:11;10:6,14,17,20
`hopefully (1)
` 8:11
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`Hulse (1)
` 3:11
`hypothetical (2)
` 8:3,15
`hypothetically (1)
` 8:18
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`I
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`identify (1)
` 5:19
`impeach (4)
` 9:3,13,20,21
`impeachment (1)
` 10:4
`includes (1)
` 5:25
`including (2)
` 4:1;7:17
`indicated (2)
` 6:2,4
`information (3)
` 4:15;5:25;6:3
`infringement (1)
` 5:2
`in-house (1)
` 4:1
`INOmax (1)
` 5:25
`institute (1)
` 7:16
`institution (2)
` 5:6;8:6
`interest (1)
` 11:10
`introduce (2)
` 8:5,12
`introduced (1)
` 8:16
`involves (1)
` 5:1
`IPR2015-00529 (1)
` 3:13
`issue (4)
` 4:20;5:5,6;9:15
`issues (3)
` 5:4,9,9
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`J
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`January (1)
` 11:13
`Judge (2)
` 3:10,11
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`K
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`keep (1)
` 7:13
`Ken (2)
` 3:21;4:18
`KERRANE (11)
` 3:8,17,17;5:20;
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`Barkley Court Reporters
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`(1) Actually - KERRANE
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`Ex. 2020-0012
`
`

`
`PRAXAIR DISTRIBUTION, INC. v.
`INO THERAPEUTICS, LLC
`
`HEARING BEFORE THE BOARD
`January 5, 2016
`
` 6:11,14,17,19;8:14,
` 19;10:20
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` 6:10,11
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`O
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`L
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`label (11)
` 4:24,25;5:12,23;
` 6:3,8,23;7:4,20,21,
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`labeling (3)
` 4:22;5:16;7:3
`last (1)
` 9:11
`later (1)
` 7:19
`limited (1)
` 4:14
`line (1)
` 3:11
`litigation (1)
` 5:1
`look (4)
` 9:1,2,5,24
`looks (1)
` 7:10
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`M
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`matters (1)
` 9:18
`may (2)
` 8:1;11:24
`maybe (1)
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`mention (1)
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`middle (1)
` 9:7
`mind (1)
` 5:19
`more (1)
` 10:5
`motion (1)
` 7:19
`much (1)
` 10:18
`MURTHY (8)
` 3:6,6,9,15,15;9:10;
` 10:6,14
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`N
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`neither (1)
` 11:8
`new (4)
` 5:23;8:5,12,22
`nonprior (1)
` 4:21
`nor (1)
` 11:9
`NOTARY (2)
` 11:1,18
`number (2)
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`Min-U-Script®
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`object (1)
` 7:18
`objection (1)
` 4:2
`off (1)
` 9:6
`officer (1)
` 11:3
`one (3)
` 4:9;6:13;9:10
`ongoing (1)
` 3:13
`only (3)
` 4:14;5:14;6:5
`opine (1)
` 9:6
`opined (1)
` 9:15
`opinion (3)
` 10:2,10,13
`otherwise (1)
` 11:11
`outcome (1)
` 11:11
`outside (2)
` 7:16,23
`own (1)
` 10:5
`owner (5)
` 3:20,22;4:1;7:18;
` 10:16
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`P
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`paragraph (6)
` 5:15,21;6:6,18,20,
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`parallel (1)
` 4:25
`part (1)
` 8:6
`participants (1)
` 3:4
`participation (1)
` 4:2
`particular (1)
` 9:15
`parties (3)
` 3:5;4:9;11:10
`patent (5)
` 3:20,22;4:1;7:18;
` 10:16
`permitted (3)
` 5:10;8:5;9:12
`Petitioner (8)
` 3:7,14,16,18;4:2;
` 5:3;7:12;10:19
`piece (1)
` 9:2
`
`pm (1)
` 10:23
`point (4)
` 7:10,19;9:10,11
`pointed (1)
` 5:15
`points (1)
` 6:6
`possible (1)
` 4:11
`Poulakos (2)
` 11:2,17
`prescribing (2)
` 5:25;6:3
`present (1)
` 10:8
`previously (1)
` 9:7
`prior (11)
` 6:21;8:3,5,8,12,15,
` 18,22,25;9:2,13
`proceeded (1)
` 4:23
`PROCEEDINGS (4)
` 3:1;11:4,6,6
`product (2)
` 4:22;5:12
`Professional (1)
` 11:3
`prospective (1)
` 8:1
`provide (1)
` 5:7
`provided (1)
` 8:25
`PUBLIC (2)
` 11:1,18
`
`R
`
`read (1)
` 10:13
`reasonable (1)
` 9:16
`reasonably (2)
` 7:11,13
`received (1)
` 9:25
`recessed (1)
` 10:23
`recites (1)
` 5:15
`record (3)
` 8:7,8;11:6
`reduced (1)
` 11:7
`reference (4)
` 4:21;9:5,17;10:8
`referenced (1)
` 6:6
`references (3)
` 8:12,22;9:13
`referred (1)
`
` 5:21
`regard (1)
` 5:6
`regarding (1)
` 3:13
`registered (1)
` 11:2
`related (3)
` 7:11,13;11:9
`relevant (1)
` 5:4
`remind (1)
` 7:18
`reporter (6)
` 3:5;4:3,6,8;11:1,3
`represent (1)
` 8:11
`request (1)
` 4:19
`requested (2)
` 4:16,16
`Respondent (1)
` 4:13
`Right (1)
` 6:25
`room (1)
` 4:5
`RPR (1)
` 11:17
`
`S
`
`sanctions (1)
` 7:16
`Sanjay (2)
` 3:6,15
`Sara (1)
` 3:17
`saying (1)
` 8:17
`SCHULER (16)
` 3:3,21,21,24;4:12,
` 18,19;5:14;7:1,6,9,
` 25;8:10,20;9:9;
` 10:17
`scope (4)
` 4:20;7:14,16,23
`second (1)
` 6:13
`seeing (1)
` 7:23
`seek (1)
` 8:1
`series (1)
` 8:2
`set (1)
` 11:12
`SHORTHAND (1)
` 11:1
`show (1)
` 9:17
`somebody (1)
` 9:5
`
`specific (1)
` 6:6
`start (2)
` 4:17;8:21
`starts (1)
` 6:20
`statements (1)
` 8:25
`stenographically (1)
` 11:7
`Steven (2)
` 11:2,17
`still (3)
` 4:3;7:18;9:4
`study (2)
` 6:21,24
`submitted (4)
` 5:17;7:7,21,24
`supervision (1)
` 11:8
`supplement (1)
` 5:16
`sure (1)
` 4:15
`
`T
`
`talk (1)
` 6:7
`talked (1)
` 7:20
`talking (1)
` 6:10
`taught (2)
` 8:18;9:16
`tends (1)
` 10:5
`testify (1)
` 8:24
`Thanks (1)
` 10:14
`thereafter (1)
` 11:7
`thought (2)
` 6:5;9:19
`top (1)
` 9:6
`transcript (3)
` 4:7,10;11:5
`true (1)
` 11:5
`try (2)
` 8:5,12
`typewriting (1)
` 11:8
`
`U
`
`under (1)
` 11:8
`Understood (1)
` 10:6
`unfair (1)
`
`Barkley Court Reporters
`
`(2) label - unfair
`
`Ex. 2020-0013
`
`

`
`PRAXAIR DISTRIBUTION, INC. v.
`INO THERAPEUTICS, LLC
`
`HEARING BEFORE THE BOARD
`January 5, 2016
`
` 10:10
`unless (1)
` 9:3
`use (1)
` 9:12
`used (2)
` 9:20,21
`usually (2)
` 9:21,22
`
`W
`
`what's (2)
` 4:24;7:14
`WHEREOF (1)
` 11:12
`witness (7)
` 8:4;9:14,21,22,22,
` 24;11:12
`work (1)
` 10:5
`
`102 (1)
` 5:5
`103 (1)
` 5:5
`13th (1)
` 11:13
`
`1
`
`2
`
`2:50 (1)
` 10:23
`2016 (2)
` 11:13,24
`2020 (2)
` 6:15,16
`2023 (2)
` 6:12;7:4
`
`31 (1)
` 11:24
`
`3
`
`6
`
`64 (1)
` 6:20
`65 (4)
` 5:21;6:6,18,22
`
`Min-U-Script®
`
`Barkley Court Reporters
`
`(3) unless - 65
`
`Ex. 2020-0014