John Koreth, M.D., Ph.D. - March 13, 2020
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` UNITED STATES PATENT AND TRADEMARK OFFICE
`
` _________________________
`
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
` _________________________
`
` Sandoz Inc.,
`
` Petitioner
`
` v.
`
` Pharmacyclics LLC,
`
` Patent Owner
`
` _________________________
`
` Case IPR2019-00865
`
` Patent No. 9,795,604
`
` _________________________
`
` Deposition of John Koreth, M.D., Ph.D.
`
` Friday, March 13, 2020
`
` Finnegan Henderson Farabow Garrett & Dunner LLP
`
` World Trade Center East
`
` Two Seaport Lane - 6th Floor
`
` Boston, Massachusetts 02210
`
`J. Edward Varallo, RMR, CRR
`
`Registered Professional Reporter
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`GregoryEdwards, LLC | Worldwide Court Reporting
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`SAN EX 1030, Page 01
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` UNITED STATES PATENT AND TRADEMARK OFFICE
`
` _________________________
`
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
` _________________________
`
` Sandoz Inc.,
`
` Petitioner
`
` v.
`
` Pharmacyclics LLC,
`
` Patent Owner
`
` _________________________
`
` Case IPR2019-00865
`
` Patent No. 9,795,604
`
` _________________________
`
` Deposition of John Koreth, M.D., Ph.D.
`
` Friday, March 13, 2020
`
` Finnegan Henderson Farabow Garrett & Dunner LLP
`
` World Trade Center East
`
` Two Seaport Lane - 6th Floor
`
` Boston, Massachusetts 02210
`
`J. Edward Varallo, RMR, CRR
`
`Registered Professional Reporter
`
`GregoryEdwards, LLC | Worldwide Court Reporting
`GregoryEdwards.com | 866-4Team GE
`
`SAN EX 1030, Page 01
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`John Koreth, M.D., Ph.D. - March 13, 2020
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`Attorneys for Petitioner Sandoz Inc.:
`
` Kirk T. Bradley, Esq.
`
` Alston & Bird LLP
`
` Bank of America Plaza - Suite 4000
`
` 101 South Tryon Street
`
` Charlotte, North Carolina 28280
`
` 704.444.1000 ~ Fax 704.444.1111
`
` kirk.bradley@alston.com
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` Christopher L. McArdle, Esq.
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` Alston & Bird LLP
`
` 90 Park Avenue - Suite 1200
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` New York, New York 10016
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` 212.210.9400 ~ Fax 212.210.9444
`
` chris.mcardle@alston.com
`
`Attorneys for Patent Owner Pharmacyclics LLC:
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` William B. Raich, Ph.D., J.D.
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` Angela X. Gao, Esq.
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` Yoonjin Lee, Esq.
`
` Finnegan Henderson Farabow Garrett & Dunner LLP
`
` 901 New York Avenue, N.W.
`
` Washington, D.C. 20001-4413
`
` 202.408.4000 ~ Fax 202.408.4400
`
` william.raich@finnegan.com
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`John Koreth, M.D., Ph.D. - March 13, 2020
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`Page 3
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` I N D E X
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`----------------------------------------------------
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`DEPONENT PAGE
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`----------------------------------------------------
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`John Koreth, M.D., Ph.D.
`
` by Mr. Bradley.............................. 5
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`----------------------------------------------------
`
`DEPOSITION EXHIBITS FOR IDENTIFICATION PAGE
`
`----------------------------------------------------
`
`Exhibit 1024 13
`
`Article titled Current and Future Approaches
`
`for Control of Graft Versus Host Disease,
`
`lead author John Koreth, published in 2008
`
`in Expert Reviews, Ltd.
`
`Exhibit 1025 14
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`Article titled Altered B-cell Homeostasis
`
`and Excess BAFF in Human Chronic Graft
`
`Versus Host Disease, lead author Stefanie
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`Sarantopoulos, published 16 April 2009 in
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`Blood
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`John Koreth, M.D., Ph.D. - March 13, 2020
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`----------------------------------------------------
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`DEPOSITION EXHIBITS FOR IDENTIFICATION PAGE
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`----------------------------------------------------
`
`Exhibit 1026 16
`
`Article titled Rituximab Prophylaxis Prevents
`
`Corticosteroid-Requiring Chronic GVHD after
`
`Allogeneic Peripheral Blood Stem Cell
`
`Transplantation - Results of a Phase 2 Trial,
`
`lead author Corey Cutler, published 22 August
`
`2013 in Blood
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`Exhibit 1027 22
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`Document titled NCCN Clinical Practice
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`Guidelines in Oncology, Hematopoietic Cell
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`Transplantation (HCT): Pre-Transplant
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`Recipient Evaluation and Management of Graft
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`Versus Host Disease, Version 1.2020 - October
`
`30, 2019
`
` *********
`
`
`
`
`
`
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`John Koreth, M.D., Ph.D. - March 13, 2020
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`----------------------------------------------------
`
` MORNING SESSION
`
` 9:05 a.m.
`
`----------------------------------------------------
`
` JOHN KORETH, M.D., PH.D.,
`
` having been first duly sworn on oath,
`
` was examined and testified as follows:
`
` EXAMINATION
`
`BY MR. BRADLEY:
`
` Q. Good morning, sir.
`
` A. Good morning.
`
` Q. I'm Kirk Bradley. I'm an attorney in
`
`Charlotte, North Carolina.
`
` A. Okay.
`
` Q. And thank you for being here today.
`
` A. Thank you.
`
` Q. Have you ever been deposed before?
`
` A. I have not.
`
` Q. Okay. So let me tell you a little bit
`
`about how I think it'll go today. So I will be
`
`asking you questions --
`
` A. Mm-hmm.
`
` Q. -- and of course we would like you to
`
`respond, and it would be best if you respond
`
`verbally, because the court reporter is writing
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`John Koreth, M.D., Ph.D. - March 13, 2020
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`everything down and it's hard to record nods and
`
`head shakes and mm-hmms and things like that. Does
`
`that sound good?
`
` A. Understood.
`
` Q. And if I ask a question that you don't
`
`understand or if I didn't use the correct
`
`terminology, I'd like you to let me know so that
`
`I can correct it. Okay?
`
` A. Okay.
`
` Q. If you need a break at any time, just
`
`let me know and we'll sort that out. Okay?
`
` A. Okay.
`
` Q. What did you do to prepare for the
`
`deposition today?
`
` A. I met with counsel; I reviewed the
`
`various documents; I read my declaration; and I'm
`
`here.
`
` Q. When did you meet with counsel to
`
`prepare?
`
` A. Well, ever since I was engaged last
`
`year, but more recently on Monday, on Wednesday,
`
`involving this meeting this week.
`
` Q. What about yesterday?
`
` A. I did not meet with him.
`
` Q. You are a practicing physician at the
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`John Koreth, M.D., Ph.D. - March 13, 2020
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`Dana-Farber Institute. Right?
`
` A. Correct, at the Dana-Farber Cancer
`
`Institute.
`
` Q. And does your work include investigating
`
`approaches for treating patients with chronic GVHD?
`
` A. That is correct. Part of my work is
`
`treating patients whom we transplant for various
`
`hematomalogic malignancies and when transplanted
`
`patients can end up with complications such as
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`chronic GVHD, and I treat them both with regards to
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`standard therapies and with regards to
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`investigational therapies; in other words, clinical
`
`trials.
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` Q. And there are ongoing clinical trials
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`for chronic GVHD?
`
` A. Yes, there are ongoing clinical trials
`
`for chronic GVHD.
`
` Q. Are you involved in some of those
`
`trials?
`
` A. Yes.
`
` Q. Do you know about how many clinical
`
`trials are ongoing related to chronic GVHD and
`
`methods of treatment?
`
` A. You mean at the Dana-Farber? In the
`
`world?
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`John Koreth, M.D., Ph.D. - March 13, 2020
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` Q. In the world, as far as you know.
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` A. I have no idea. I would say probably in
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`excess of several dozen.
`
` Q. And you work with patients but do you
`
`also do research on the side?
`
` A. I primarily do research on patients. I
`
`collaborate with people who do bench research or
`
`basic research, but I personally do not do bench
`
`research.
`
` Q. And you personally have ongoing work
`
`related to treatment options for chronic GVHD?
`
` A. I'm not sure I'm understanding your
`
`question.
`
` Q. You personally have ongoing work related
`
`to investigating new treatment options for treating
`
`patients with chronic GVHD?
`
` A. I am involved in clinical trials that
`
`I'm investigating novel therapies for chronic graft
`
`versus host disease, yes.
`
` Q. And I assume your colleagues are
`
`involved in those as well?
`
` A. Yes, several of my colleagues are
`
`involved in similar studies.
`
` Q. Has your work at the Dana-Farber
`
`Institute included studying how inhibiting or
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`John Koreth, M.D., Ph.D. - March 13, 2020
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`removing B-cells might be useful in treating chronic
`
`GVHD?
`
` A. I have been involved in trials not in a
`
`direct fashion. In other words, I don't have any
`
`specific intellectual property on any study that is
`
`evaluating the role of any therapy that is targeting
`
`B-cells, to the best of my knowledge. My primary
`
`work has been actually focused on T-cells and more
`
`specifically in chronic GVHD on regulatory T-cells,
`
`the deficiency or dysfunction of which is thought to
`
`be a major mechanism for the development of chronic
`
`graft versus host disease.
`
` Q. Others at the Dana-Farber Institute have
`
`been involved in studying how inhibiting or removing
`
`B-cells might be useful in treating chronic GVHD.
`
`Right?
`
` A. Yes.
`
` Q. Which of your colleagues that you can
`
`think of have been involved in that sort of work?
`
` A. I would say probably the first name that
`
`comes to mind is Corey Cutler, my colleague at the
`
`Dana-Farber. He has been involved with some of the
`
`early work showing that rituximab, for instance, a
`
`monoclonal antibody that is targeting CD20, which is
`
`an antigen that is present on the surface of some,
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`though not all, B-cells, and results in their
`
`physical depletion, may have efficacy in chronic
`
`graft versus host disease. So he was I believe the
`
`lead author on one of the early papers to that
`
`effect. There have also been other groups that have
`
`found similar results; some groups have also found
`
`dissimilar results.
`
` Q. When you've treated patients that have
`
`chronic GVHD, what drugs have you prescribed?
`
` A. Over the years we have used a plethora
`
`of agents, to be honest. We have used T-cell
`
`targeting agents such as ATG, anti-thymocyte
`
`globulin. We have used T and B-cell agents such as
`
`alemtuzumab, or Campath. We have routinely used
`
`steroids as our first go-to. I think that is almost
`
`universal in the field, I would say.
`
` We have used agents that can enhance
`
`regulatory T-cells such as low-dose interleukin-2.
`
`We have used rituximab, which can deplete CD20-
`
`positive B-cells, as I mentioned. We have since the
`
`FDA approval of ibrutinib, we have certainly used
`
`that. Before that, we used ibrutinib or Imbruvica
`
`in a clinical trial. And we have used ruxolitinib,
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`or Jakafi, as a therapeutic -- I mean, I can list
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`more, but these are the ones that readily come to
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`mind.
`
` Q. Okay. What about etanercept?
`
` A. I personally have not. We have not
`
`really used it that much. Previously it used to be
`
`used. Probably the major role right now would be in
`
`acute graft versus host disease, an unusual variant
`
`of graft versus host disease called idiopathic
`
`pneumonitis: lung inflammation thought to be
`
`mediated by inflammatory T-cells as part of the
`
`acute GVHD process, which is distinct from chronic
`
`graft versus host disease both clinically and in
`
`terms of its idiopathology.
`
` MR. BRADLEY: Objection, nonresponsive.
`
`BY MR. BRADLEY:
`
` Q. Have you used etanercept to treat graft
`
`versus host disease?
`
` A. I have not.
`
` Q. Have your colleagues?
`
` A. In the past they may have. We certainly
`
`don't use much of it at this point, but I can't
`
`speculate beyond that as to what they may have used.
`
` Q. Have you used to treat chronic graft
`
`versus host disease mycophenolate mofetil, or MMF?
`
` A. Yes, we have used mycophenolate.
`
` Q. Have you used pentostatin to treat --
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` A. I have not. In the past people have,
`
`have tried it both in acute and chronic, yes.
`
` Q. From looking over your materials, sir,
`
`I saw that you have clinical interests in multiple
`
`myeloma. Is that right?
`
` A. Hmm. I treat multiple myeloma patients
`
`who need allogeneic transplantation, so in that
`
`regard I have a clinical interest in multiple
`
`myeloma. I don't treat multiple myeloma patients
`
`per se, so I am not a multiple myeloma treating
`
`clinician in the way that I would consider the
`
`typical definition.
`
` Q. Multiple myeloma is a B-cell
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`proliferative disease. Right?
`
` A. Multiple myeloma is a malignant
`
`proliferation of plasma cells which are part of the
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`B-cell lineage but do have certain distinct and
`
`unique properties, yes.
`
` Q. Chronic graft versus host disease is not
`
`categorized as a B-cell proliferative disease.
`
`Right?
`
` A. Chronic graft versus host disease is not
`
`a neoplastic disease involving B-cells, that is
`
`correct.
`
` Q. And as part of your work over the years,
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`John Koreth, M.D., Ph.D. - March 13, 2020
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`you've published papers. Right?
`
` A. Yes.
`
` MR. BRADLEY: Let's go through a couple
`
`of those. The next number is 1024.
`
` MR. RAICH: I will object to the exhibit
`
`on relevance and hearsay grounds.
`
` (Deposition Exhibit 1024 marked for
`
`identification.)
`
`BY MR. BRADLEY:
`
` Q. Dr. Koreth, I've handed you an exhibit
`
`that's been marked as Number 1024. Have you seen
`
`this before?
`
` A. Yes.
`
` Q. And the authors are yourself and Joseph
`
`Antin. Is that right?
`
` A. That is correct.
`
` Q. And just generally what does this paper
`
`discuss?
`
` A. This paper is discussing treatments both
`
`currently available and looking ahead for the
`
`control of graft versus host disease. I would like
`
`to read this if you want to ask more specific
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`questions because it's been many years since I have
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`written this and read it.
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` Q. This paper is from 2008. Right?
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` A. The paper is from 2008, correct.
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` Q. And it was published in Expert Reviews,
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`is that right, or in -- yeah. Well, you can --
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` A. Expert Reviews of Hematology, yes.
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` Q. Thank you. And you co-wrote this paper
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`with Dr. Antin. Right?
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` A. Yes, I co-wrote it with Joseph Antin.
`
` (Deposition Exhibit 1025 marked for
`
`identification.)
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` MR. RAICH: Well, ask your question.
`
`I'm going to object to the exhibit on relevance and
`
`hearsay grounds, Exhibit 1025.
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`BY MR. BRADLEY:
`
` Q. Sir, you've been handed a document
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`that's been marked as Exhibit 1025.
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` A. Yes.
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` Q. This is a paper you co-authored with a
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`series of other folks. Right?
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` A. This is a paper, Altered B-cell
`
`Homeostasis and Excess BAFF in Human Graft Versus
`
`Host Disease. The first author is Stefanie
`
`Sarantopoulos, the last author is Jerome Ritz, and
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`I am one of many middle authors, correct.
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` Q. You co-authored this paper along with
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`the other people listed here under the title.
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`Correct?
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` A. I am one of the many middle authors on
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`this paper, yes.
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` Q. And this paper was published in Blood
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`around 2009. Is that right?
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` A. This paper was published in Blood,
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`prepublished online on January 23, 2009.
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` Q. And then as shown here in the footer, it
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`was published in Blood on April 16, 2009, in Volume
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`113, Number 16. Right?
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` A. Where is that listed? Hmm. I'm sorry.
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`Can you point that out to me?
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` MR. RAICH: Right here.
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` THE WITNESS: Oh, yes, thank you.
`
` A. Yes, 16th April 2009, Volume 113, Number
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`16, correct.
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` Q. And, sir, what does this paper generally
`
`discuss?
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` A. I'd have to read this paper. I've
`
`written many papers, so do you want me to read it
`
`and answer your questions?
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` Q. Are you able to just answer generally
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`aside from reading the title or the abstract?
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` A. I believe it talks about abnormalities
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`in B-cell reconstitution of allogeneic
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`transplantation, and I believe the reference to BAFF
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`is a B-cell growth factor whose levels are elevated
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`in such patients.
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` Q. And the "such patients" being humans
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`with chronic graft versus host disease. Right?
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` A. Humans who undergo a transplantation and
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`end up having chronic graft versus host disease,
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`correct.
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` (Deposition Exhibit 1026 marked for
`
`identification.)
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` MR. RAICH: Objection to Exhibit 1026 on
`
`relevance and hearsay grounds.
`
`BY MR. BRADLEY:
`
` Q. Sir, you've been handed a document that
`
`has been marked as Exhibit 1026. Do you recognize
`
`this as another article that was published in Blood
`
`by yourself and others?
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` A. This article, Rituximab Prophylaxis
`
`Prevents Corticosteroid-Requiring Chronic Graft
`
`Versus Host Disease After Allogeneic Peripheral
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`Blood Stem Cell Transplantation - Results of a Phase
`
`2 Trial, with first author of Corey Cutler, a last
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`author of Joseph Antin and myself as one of one,
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`two, three, four, five, six, seven, eight, nine,
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`ten, eleven, twelve, thirteen, fourteen, fifteen
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`middle authors, yes.
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` Q. So you co-authored Exhibit 1026.
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`Correct?
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` A. Again, as I've said, I am one of fifteen
`
`middle authors in a paper that was first authored by
`
`Corey Cutler.
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` Q. And this article, if you look at the
`
`footer on the first page, was submitted April 10,
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`2013, and accepted June 27, 2013, by Blood. Right?
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` A. I read it was prepublished online,
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`that's when it became part of the medical record, as
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`a Blood first-edition paper July 16, 2013, and it
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`was published in the journal on the 22nd of August
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`2013.
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` Q. So it was first available to the public
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`online as of July 16, 2013. Right?
`
` A. Correct.
`
` Q. And, sir, what does this paper generally
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`discuss?
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` A. Again, I've written and co-authored and
`
`been middle author on very many papers. Would you
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`like me to read through the paper or do you need a
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`general impression which is subject to revision, if
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`you have more detailed questions?
`
` Q. I would like your general recollection
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`of what this paper discusses.
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` A. Sure. This paper is focused on using
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`Rituxan or rituximab to prevent the development of
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`chronic graft versus host disease. In doing so, it
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`sketches out in quote/unquote shorthand a rationale
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`for considering a role for B-cells in the
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`development of chronic graft versus host disease and
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`thereby postulates that depleting them could help
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`prevent the development of chronic graft versus host
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`disease, and then presents data from a Phase 2 trial
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`that was performed with that objective. That is my
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`summary impression or recollection.
`
` Q. And the first sentence of the abstract
`
`says, quote, "B-cells are implicated in the
`
`pathophysiology of chronic graft versus host disease
`
`and Phase 2 trials suggest that B-cell depletion can
`
`treat established chronic GVHD," close quote. Did
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`I read that correctly?
`
` A. You did read that correctly.
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` Q. And you agree with that sentence.
`
`Right?
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` A. I agree with the thesis, which is that
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`B-cells are implicated in some fashion, still
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`remains to be determined entirely how, but yes,
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`implicated in some fashion in the pathophysiology of
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`chronic graft versus host disease. And there are
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`indeed Phase 2 trials that suggest but are not
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`definitive in that B-cell depletion can treat, i.e.,
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`improve the clinical manifestations of patients who
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`have established chronic GVHD.
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` Q. You can set that aside.
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` A. Are we done with these?
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` Q. You can just set them in a stack to the
`
`side, yes, sir.
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` A. Okay.
`
` Q. Are you aware of the organization called
`
`NCCN or the National Comprehensive Cancer Network?
`
` A. Yes, I am aware of the NCCN.
`
` Q. And the Dana-Farber Institute is a
`
`member of that organization. Right?
`
` A. I believe that it is a comprehensive
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`cancer center and therefore it is a member of the
`
`National Comprehensive Cancer Network, yes.
`
` Q. And other NCCN members include the Mayo
`
`Clinic, St. Jude, Memorial Sloan-Kettering, M.D.
`
`Anderson, and others. Right?
`
` A. I don't -- I would have to check
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`personally, but that sounds plausible. That sounds
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`right. They are major cancer centers; they should
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`be included.
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` Q. Are you familiar with the NCCN
`
`guidelines for hematopoietic cell transplantation?
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` A. I have certainly as a fellow in
`
`training, I have certainly experienced the NCCN
`
`guidelines for the treatment of a variety of
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`different malignancies. As I understand it, the
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`role of the NCCN is to kind of lay out in very
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`general terms what the consensus is as to what
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`treatment options or specific treatments should be
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`offered in a variety of different conditions. With
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`regards -- If I may continue?
`
` Q. Yes.
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` A. With regards to stem cell
`
`transplantation and more specifically complications
`
`of stem cell transplantation, the usual guidelines
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`that I will be looking to would not be NCCN
`
`guidelines, though I'm sure that they're worthy
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`individuals. It would be more specialized, since
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`the field is more specialized than general cancer.
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`And I would typically be looking towards guidelines
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`such as the NIH consensus criteria for chronic graft
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`versus host disease, of which more recent revisions
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`I have been a part, where I feel that we have tried
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`to assemble every one of the chronic GVHD
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`specialists that we can put together.
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` So without knowing more about the NCCN
`
`guidelines, that's my a priori impression.
`
` Q. The NCCN describes its guidelines as
`
`being, quote, "widely recognized and used as the
`
`standard for clinical policy," close quote. Do you
`
`agree with that view?
`
` A. I think --
`
` MR. RAICH: Objection, foundation.
`
` A. I think they certainly have had success
`
`with payers. So insurance companies like having
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`sort of black-and-white answers even if there are
`
`shades of gray; complexity is not something
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`obviously that a busy payer wants to deal with
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`necessarily. But certainly as a provider in a
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`subspecialty where there is a lot of complexity, I
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`worry a little bit that overly simplistic reductions
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`of a sometimes conflicting set of data points can
`
`lead to conclusions that are not fully supported by
`
`the data. And so those kind of documents, I think
`
`one really has to look towards, you know, what was
`
`discussed and why were certain things said and why
`
`were certain things not said.
`
` Q. Do you know a gentleman named Vincent
`
`Ho?
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` A. I do. Vincent Ho is my colleague at the
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`Dana-Farber Cancer Institute.
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` Q. And are you aware whether he is a
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`participant in the group that develops the NCCN
`
`guidelines for hematopoietic stem cell transplants?
`
` A. I believe he is indeed on some of the
`
`NCCN committees or consensus groups. I'd have to
`
`confirm which ones he's on. With regards to his
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`practice in treating transplant patients, I know his
`
`research interests are certainly with regards to
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`transplant complications of thrombotic
`
`microangiography and hepatic veno-occlusive disease,
`
`VOD, and he has published in both of those areas.
`
`But certainly in terms of taking care of patients,
`
`he takes care of chronic graft versus host disease
`
`patients and I'm sure would have insights into
`
`treating them.
`
` (Deposition Exhibit 1027 marked for
`
`identification.)
`
` MR. RAICH: I'll object to Exhibit 1027
`
`on hearsay, relevance, and authentication grounds.
`
`BY MR. BRADLEY:
`
` Q. Sir, you've been handed a document
`
`that's been marked as Exhibit 1027. Do you
`
`recognize this to be the NCCN guidelines for
`
`hematopoietic cell transplantation?
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` A. This document reads Hematopoietic Cell
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`Transplantation, Pre-Transplant Recipient Evaluation
`
`and Management of Graft Versus Host Disease. The
`
`date is October 30, 2019, yes.
`
` Q. And do you recognize this as the NCCN
`
`guidelines --
`
` A. Yes.
`
` Q. -- for hematopoietic cell
`
`transplantation?
`
` A. Yes. It says National Comprehensive
`
`Cancer Network, NCCN.
`
` Q. And if you would, sir, turn to the
`
`second page and the middle column near the top.
`
` A. Middle column near the top? Okay.
`
` Q. Do you see a Dr. Vincent Ho?
`
` A. Yes, I see Vincent Ho, M.D.
`
` Q. And with the Dana-Farber Institute?
`
` A. Dana-Farber/Brigham and Women's Cancer
`
`Center, correct.
`
` Q. We may look more at this in a little
`
`bit, but you can set it aside for now.
`
` A. Okay.
`
` Q. It does remind me, and I think you just
`
`recognized, but one other sort of ground rule for
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`the deposition is we need to try to not talk over
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`each other. So when I'm asking a question, you try
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`not to answer; and then of course as you're
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`answering, I'll try not to ask another question.
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`That way, the kind gentleman can try to record all
`
`of what we're saying, including quite a few medical
`
`terms.
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` A. Understood.
`
` Q. Dr. Koreth, you've been handed a
`
`document that's been previously marked as Exhibit
`
`1001. Do you recognize this?
`
` A. This is United States Patent Number
`
`9,795,604 and I believe I have referenced this in my
`
`opinion here as the '604 patent. Yes, I recognize
`
`this.
`
` Q. Okay. And have you read this patent?
`
` A. Yes, I have read this patent.
`
` Q. You've read all of it?
`
` A. Did I read every last word? Probably
`
`not. But I believe I read the sections that I felt
`
`were important, and I'm happy to read every word
`
`with you if there's a point that you wish to raise.
`
` Q. If you could, turn to page 26. And I'm
`
`referring to the exhibit page number 26.
`
` A. Okay.
`
` Q. And do you see on the left-hand column,
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`column 1, there's a heading called Summary of The
`
`Invention? Do you see that?
`
` A. Yes, on the left-hand there's a
`
`paragraph header which says Summary of The
`
`Invention.
`
` Q. And if you look, the Summary of The
`
`Invention actually goes on for a couple pages ending
`
`in column 10. Do you see that?
`
` A. Yes, it continues till column 10 and
`
`then the next part says Incorporation By Reference,
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`so I presume you're referring to from Summary of The
`
`Invention up to but not including Incorporation By
`
`Reference?
`
` Q. Yes, sir.
`
` A. Okay.
`
` Q. And do you understand that section you
`
`just described to be the summary of the invention of
`
`the '604 patent?
`
` A. That is --
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` MR. RAICH: Objection to form. You can
`
`answer.
`
` A. That is how it's stated. The header
`
`says Summary of The Invention, so that summary of
`
`the invention is what it is.
`
` Q. And the first sentence in the Summary of
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`The Invention of the '604 patent states that, quote,
`
`"Disclosed herein in some embodiments are methods of
`
`preventing the occurrence of graft versus host
`
`disease (GVHD) or reducing the severity of GVHD
`
`occurrence in a patient requiring cell
`
`transplantation comprising administration of a
`
`therapeutically effective amount of an ACK
`
`inhibitor, e.g., an ITK or BTK inhibitor." Do you
`
`see that?
`
` A. My understanding is that the history of
`
`the litigation that goes into the patent, the
`
`granting of the patent, has to be considered, as
`
`does the lexicography of the patent. That is my
`
`understanding. I'm not a legal expert, but that is
`
`
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