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`bluebird bio, Inc. v. Sloan Kettering Institute for Cancer Research
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`Chad May, Ph.D.
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`Page 1
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` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`___________________________
`BLUEBIRD BIO, INC. ) Case No. IPR2023-00070
` Petitioner, ) Patent No. 7,541,179
`v. )
`SLOAN KETTERING INSTITUTE ) Case No. IPR2023-00074
`FOR CANCER RESEARCH, ) Patent No. 8,058,061
` Patent Owner. )
`___________________________)
`
`
` DEPOSITION OF CHAD MAY, PH.D.
` Friday, October 6, 2023
` Fox Rothschild LLP
` 101 Park Avenue, 17th Floor
` New York, New York 10178
` 9:03 a.m. EDT
`
`
` REPORTED BY: AMANDA GORRONO, CLR
` CLR NO. 052005-01
`__________________________________________________
` DIGITAL EVIDENCE GROUP
` 1730 M Street, NW, Suite 812
` Washington, D.C. 20036
` (202) 232-0646
`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2023
`
`202-232-0646
`
`BLUEBIRD EXHIBIT 1053
`bluebird v. SKI
`IPR2023-00070
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`bluebird bio, Inc. v. Sloan Kettering Institute for Cancer Research
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`Chad May, Ph.D.
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` A P P E A R A N C E S
`
` Attorneys for Petitioner
` Paul Hastings LLP
` BY: MAX H. YUSEM, ESQ.
` 200 Park Avenue
` New York, NY 10166
`(212) 318-6375
` maxyusem@paulhastings.com
` -and-
` Paul Hastings LLP
` BY: MARIA I. CAZACU, ESQ.
` 200 Park Avenue
` New York, NY 10166
` (212) 318-6613
` mariaisabellacazacu@paulhastings.com
`
` Attorneys for Sloan Kettering
` WilmerHale
` BY: TIMOTHY A. COOK, ESQ.
` 60 State Street
` Boston, Massachusetts 02109
` (617) 526-6005
` tim.cook@wilmerhale.com
`
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`www.DigitalEvidenceGroup.com
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`Digital Evidence Group C'rt 2023
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`202-232-0646
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`bluebird bio, Inc. v. Sloan Kettering Institute for Cancer Research
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`Chad May, Ph.D.
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`Page 3
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` A P P E A R A N C E S CON'T
`
` Attorneys for San Rocco Therapeutics
` Fox Rothschild LLP
` BY: JOE CHEN, PH.D., ESQ.
` Princeton Pike Corporate Center
` 997 Lenox Drive
` Lawrenceville, NJ 08648-2311
` (609) 844-3024
` joechen@foxrothschild.com
` -and-
` Fox Rothschild LLP
` BY: MICHAEL W. GLYNN PH.D., ESQ.
` 101 Park Avenue, 17th Floor
` New York, NY 10178
` (646) 601-7634
` mglynn@foxrothschild.com
`
`
` ALSO PRESENT:
` Jonathan Juarez, Legal Videographer - Digital
` Evidence Group
`
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`Chad May, Ph.D.
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`Page 4
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` I N D E X
`WITNESS EXAMINATION BY PAGE
`CHAD MAY, Ph.D. MR. YUSEM 5
`
` E X H I B I T S
`EXHIBIT DESCRIPTION PAGE
`Exhibit 2007 Declaration of Dr. Chad May............ 11
`Exhibit 1005 May Nature article..................... 38
`Exhibit 1006 May Abstract........................... 43
`Exhibit 1001 US Patent No. 7,541,179................ 57
`Exhibit 1032 Prosecution History of US Patent ...... 61
` 7,541,179
`Exhibit 2033 Document............................... 73
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` THE VIDEOGRAPHER: We are now on the
` record. My name is Jonathan Juarez. I am a
` legal videographer for Digital Evidence
` Group.
` Today's date is October 6, 2023.
` And the time is 9:03 a.m.
` This deposition is taking place at
` 101 Park Avenue New York, New York in the
` matter of bluebird bio, Inc. versus Sloan
` Kettering INS.
` The deponent is Dr. Chad May.
` All counsel will be noted on the
` stenographic record.
` The court reporter is Amanda
` Gorrono. And will now swear in the witness.
` CHAD MAY Ph.D., called as a witness, having been
` first duly sworn by a Notary Public of the State
` of New York, was examined and testified as
` follows:
` THE WITNESS: I do.
` THE COURT REPORTER: Thank you.
` EXAMINATION
` BY MR. YUSEM:
` Q. Good morning, Dr. May. Have you
` been deposed before?
`
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`www.DigitalEvidenceGroup.com
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`202-232-0646
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` A. Yes, I have.
` Q. How many times?
` A. Once.
` Q. Once. And was that deposition at
` all related to the TNS9 vector?
` A. No.
` Q. All right. And can you just
` generally tell us what that deposition was
` related to?
` A. Previous company I was at we, along
` with our partner, Takeda Pharmaceuticals sued
` Harpoon Therapeutics for breach of contract. And
` I acted as a subject -- excuse me -- subject
` matter expert for the team that I was employed
` by.
` Q. Did your testimony at all relate to
` patents in any way?
` A. No.
` Q. Okay. So you might remember from
` your last deposition, but just some sort of
` general ground rules today to make sure we're on
` the same page.
` If you don't understand any of my
` questions today, please just let me know.
` For the stake of the reporter it's
`
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`www.DigitalEvidenceGroup.com
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`202-232-0646
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`bluebird bio, Inc. v. Sloan Kettering Institute for Cancer Research
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`Chad May, Ph.D.
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` usually good we don't talk over each other. I'll
` ask my question, you can give your answer.
` If you need to take a break at any
` time just let me know. I do ask though that if
` there is a pending question, that you answer the
` question before we take a break.
` Is that okay?
` A. Yes, sir. That's okay.
` Q. Okay. Is there any reason you
` wouldn't be able to provide truthful testimony
` today?
` A. No.
` Q. Can you generally describe how you
` prepared for today's deposition?
` A. I met over the Wednesday and
` Thursday with members of Fox Rothschild and I
` briefly spoke with Tim Cook on last Friday.
` Q. And anyone else apart from members
` of Fox Rothschild or attorneys -- or Tim Cook,
` did you speak with anyone else in preparation for
` your deposition?
` A. No.
` Q. Okay. Did you review documents in
` preparation of today's deposition?
` A. Yes.
`
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` Q. And what documents are those?
` A. My declaration; briefly the
` provisional patents; briefly the Nature article;
` and briefly the Abstract.
` Q. Anything else?
` A. That's all I recall.
` Q. And you understand that you're here
` today in connection to an -- two different IPR
` proceedings?
` A. Yes.
` Q. Okay. And they relate -- each of
` those proceedings relates to one of your patents,
` the '179 patent and the '061 patent?
` A. Yes.
` Q. Okay. And you've prepared a
` declaration for those proceedings; is that
` correct?
` A. That's correct.
` Q. All right. Can you describe
` generally how you prepared that declaration?
` A. Mainly going back on memory of the
` time and the occurrence of the steps involved in
` developing the work.
` Q. In preparation for that declaration,
` did you speak with anyone apart from counsel?
`
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` A. No.
` Q. Okay. As you prepared that
` declaration, you mentioned going off memory. Did
` you review any documents in preparation of the
` declaration?
` A. It was mainly just looking back at
` like the manuscript and trying to piece together
` when certain experiments were likely done.
` Q. And when you say "manuscript" is
` that the thesis --
` A. The Nature -- well, not my thesis.
` I didn't review my thesis.
` Q. Okay.
` A. Just the Nature article.
` Q. Okay.
` A. And thinking back to when I joined
` the lab and when these different experiments were
` occurring.
` Q. Okay. Did you review any documents
` in preparation for your declaration that are not
` cited in the declaration?
` A. I don't believe so.
` Q. Okay. Do you know a company called
` San Rocco Therapeutics?
` A. I'm familiar with the name.
`
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` Q. Okay. And are you aware they were
` previously called Errant Gene Therapeutics?
` A. Yes.
` Q. Have you ever consulted for SRT or
` EGT?
` A. No, I have not.
` Q. Do you understand that your patents,
` the '079 and '061 patents were recently licensed
` from SKI to SRT?
` A. I'm aware.
` Q. Are you aware that SRT is currently
` asserting infringement of your patents in the
` District Court of Delaware?
` A. I don't know the specifics. I know
` that there is legal action ongoing.
` Q. Okay. Are you in any way working
` with Fox Rothschild or any counsel in
` consultation regarding that district court
` action?
` A. No.
` Q. How did you first learn about the
` IPR proceedings that we're here today to discuss?
` A. Well, specific to this, I was
` contacted by Fox Rothschild. I think I believe
` Wanda -- I forget her last name -- through an
`
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` e-mail initially. I knew from press releases
` that there was some legal action ongoing, but at
` that time I didn't know what it was exactly. But
` it wasn't really until the contact from Fox
` Rothschild that I knew what was --
` Q. And in that contact were you asked
` to provide a declaration for the IPR proceedings?
` A. Yes, maybe not initial but later on.
` Q. All right -- okay. So I'd like to
` hand you the declaration that you submitted.
` Give me a second.
` (Whereupon, Exhibit 2007,
` Declaration of Dr. Chad May, was identified.)
` BY MR. YUSEM:
` Q. And I'm handing you Exhibit 2007
` Declaration of Chad May.
` MR. CHEN: Thank you.
` MR. YUSEM: Sorry. I only got one
` extra copy.
` MR. GLYNN: I'm good.
` MR. CHEN: This is for '179,
` correct?
` MR. YUSEM: Yeah. For the record,
` too, there was only -- the same declaration
` was submitted in both proceedings. In fact,
`
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` you actually -- the one submitted in the '061
` also said '179 on it.
` BY MR. YUSEM:
` Q. So, Dr. May, do you see the document
` I've just handed you Exhibit 2007?
` A. Yes, I do.
` Q. Okay. And is this the declaration
` that you prepared in this action?
` A. Yes.
` Q. Okay. Did you prepare any other
` declarations apart from Exhibit 2007 that I just
` handed you?
` A. I believe there was the -- '170 and
` then another one, which was identical for the
` other. I forget the number of it.
` Q. '061?
` A. '061.
` Q. So you prepared two declarations?
` A. They were the same. They were the
` same -- I prepared one, but they were the same.
` And I signed two.
` MR. YUSEM: Okay. Counsel, just for
` the record, if you could take a look at that
` and if there is an '061 declaration, could
` you please provide that to us?
`
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`Chad May, Ph.D.
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` What's on the PTAB docket right now
` is the same declaration in both proceedings.
` If there is another declaration.
` MR. GLYNN: There isn't a separate
` declaration.
` MR. CHEN: There -- I definitely
` remember I saw.
` MR. YUSEM: For the record, there's
` only a single Chad May declaration in both
` proceedings for the '179 and the '061?
` MR. GLYNN: Yes.
` BY MR. YUSEM:
` Q. I just want to make sure. I don't
` want to be missing anything.
` A. Yeah. Sure.
` Q. Let's take a look at your CV, which
` is appended to the end of Exhibit 2007. It's on
` Page 12 of 18.
` Are you there?
` A. Yes.
` Q. And actually I want to turn to --
` let's turn to Page 14 of 18. Top of the page.
` You started as a graduate student in
` the laboratory of Dr. Sadelain in September of
` 1995; is that correct?
`
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`Chad May, Ph.D.
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` A. Yes.
` Q. And that was at Memorial Sloan
` Kettering Cancer Center?
` A. Yes, so -- well, the -- sorry -- the
` September 1995 was when I joined the graduate
` program. I didn't join Dr. Sadelain's lab until
` the summer of 1996.
` Q. Okay. So you started at Memorial
` Sloan Kettering in September 1995 but didn't join
` Dr. Sadelain's lab until the summer of 1996?
` A. Yeah. I joined as a graduate
` student. So I wasn't assigned to a thesis lab at
` that time. I had to -- we did rotations and then
` I selected Dr. Sadelain's lab that following
` summer.
` Q. Got it.
` So when you started in
` Dr. Sadelain's lab in the summer of 1996, what
` was the focus of that lab at that time?
` A. It was gene therapy, generally
` speaking. Some of the work was within the
` hemoglobinopathies and some of it was within the
` immunology space.
` Q. And when you joined Dr. Sadelain's
` lab in summer of 1996, what was your area of
`
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`bluebird bio, Inc. v. Sloan Kettering Institute for Cancer Research
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`Chad May, Ph.D.
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` focus?
` A. Initially it was broad around gene
` transfer into hematopoietic stem cells. And
` there were a number of programs or projects that
` I had initiated around that space.
` Q. And you initiated that as part of
` Dr. Sadelain's lab or prior to joining
` Dr. Sadelain's lab?
` A. As part of Dr. Sadelain's lab.
` Q. And then -- so you were a graduate
` student in Dr. Sadelain's lab until January of
` 2001 when you received your Ph.D.?
` A. I defended my Ph.D. in January of
` 2001.
` Q. When -- so if you take a look at
` Page 12 of 18. It says here, Ph.D. Immunology
` January 2001.
` Is that when you received your
` Ph.D.?
` A. That's when I defended and my
` defense was accepted. I didn't actually walk
` until May of 20- --
` Q. May of 2001?
` A. May of -- yeah, May of 2001.
` Q. And then after you received your
`
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`Chad May, Ph.D.
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` Ph.D. you did stay on in Dr. Sadelain's lab for
` sometime?
` A. I did for until September of 2001 as
` a post-doctoral fellow to finish up work.
` Q. So just to make sure I got the
` timeline correct. You started in Dr. Sadelain's
` laboratory in the summer of 1996 and you worked
` in his laboratory until September of 2001?
` A. Correct.
` Q. Okay. And then, and then you left
` his lab and left MSK as of September 2001?
` A. Correct.
` Q. After that time, did you ever work
` with Dr. Sadelain again?
` A. No.
` Q. Okay. After you left in
` September 2001, did you ever work with the TNS9
` vector again?
` A. No.
` Q. Okay. Any reason for leaving
` Dr. Sadelain's lab in September 2001?
` A. I had finished my work as a graduate
` student and I wanted to move outside of academics
` into industry. And so I pursued opportunities in
` industry.
`
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`bluebird bio, Inc. v. Sloan Kettering Institute for Cancer Research
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`Chad May, Ph.D.
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` Q. Could we turn to Paragraph 8 of your
` declaration. Let me know when you're there. Are
` you at Paragraph 8?
` A. Yes. 8. Sorry.
` Q. Here it says your "Ph.D. program was
` part of a joint program with Sloan Kettering
` Institute (SKI)."
` Do you see that?
` A. Yes.
` Q. In your CV though, it talks about
` Memorial Sloan Kettering. Just for terminology,
` what's the difference between those two?
` A. I don't have a specific knowledge.
` I know they are -- they are connected.
` Q. Yeah.
` A. I -- my understanding is Sloan
` Kettering Institute is the research institute of
` the hospital. And so if you draw a Venn diagram,
` there is an overlay there. It's not all -- and
` Sloan Kettering Institute at the time was the
` area of Sloan -- of Sloan Kettering that was
` connected with the Cornell Graduate School.
` Q. Just to make it -- I want to make
` sure things are a little easy today. If I talk
` about MSK, is that going to refer in your mind to
`
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`bluebird bio, Inc. v. Sloan Kettering Institute for Cancer Research
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`Chad May, Ph.D.
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` both? I want --
` A. Yeah, if I you MSK, SKI, MSKCC. In
` my mind they are all the same thing.
` Q. Okay. So if there is a question
` that I ask that for some reason applies to one
` entity and not another, let me know.
` A. I will, yeah.
` Q. Okay. Thank you.
` And so then from 1996 to 1997 you
` worked with Dr. Rivella to design viral vectors
` with LCRs for use in gene therapy?
` A. It was around that time we started
` working together in that space. Yes.
` Q. And your work with Dr. Rivella was
` to design viral vectors with LCRs for use in gene
` therapy?
` A. We collaborated in that area.
` Q. And Dr. Rivella started at MSK in
` November of 1997. So were you designing vectors
` for over a year before he started then?
` A. There was some work that was
` initiated prior to him joining, but that was
` really some early designs that I don't recall if
` they even led to the TNS9 work.
` Q. Yeah. Any -- so could you just sort
`
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`bluebird bio, Inc. v. Sloan Kettering Institute for Cancer Research
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`Chad May, Ph.D.
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` of generally describe what vectors you might have
` designed before Dr. Rivella joined in November of
` 1997?
` A. I really don't recall what I was
` working on to that degree.
` Q. But you don't believe that it
` resulted in the sort of TNS9 family of vectors?
` A. No, it definitely did not.
` Q. So while you were working with
` Dr. Rivella in this time period, was the 3.2
` kilobase LCR fragment designed?
` MR. CHEN: Objection to form.
` A. So during the time I worked with
` Dr. Rivella, between, yeah, between when he
` joined and when TNS9 was eventually completed, in
` the form that I used, we collaborated.
` I'm not sure if I'm answering your
` question. Can you repeat?
` BY MR. YUSEM:
` Q. Yeah. Maybe I'll try to rephrase
` it.
` Why don't you take a look at
` Paragraph 12 of your declaration.
` Are you there?
` A. Yes.
`
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`bluebird bio, Inc. v. Sloan Kettering Institute for Cancer Research
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`Chad May, Ph.D.
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` Q. Okay. So here in Paragraph 12 you
` say "From 1996-1997, I worked with Dr. Stefano
` Rivella to design and create viral vectors that
` included larger nucleotide sequences from the
` locus control region (LCR) than those that were
` previously reported, for use in gene therapy
` approaches to treat hemoglobinopathies."
` Do you see that?
` A. Yes.
` Q. This time period from 1996 to 1997,
` had you designed the longer 3.2 kilobase LCR
` fragment?
` A. I don't recall when that was
` ultimately designed. I believe it was later than
` this. But I don't recall.
` Q. And who designed that longer 3.2
` kilobase LCR fragment?
` A. I don't recall a specific person
` designing it. It was a team effort. It was
` between myself and the other inventors.
` Q. Yourself and all the other
` inventors?
` A. I don't recall who specifically
` designed each fragment and who put them together.
` But as a team, we came to the final design.
`
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`bluebird bio, Inc. v. Sloan Kettering Institute for Cancer Research
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`Chad May, Ph.D.
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` Q. So the LCR fragment itself is made
` up of different hypersensitive fragments, HS2,
` HS3, HS4, right?
` A. The LCR in context of our design or
` the LCR in the context --
` Q. Sorry. Let me rephrase.
` The LCR fragment that's part of the
` TNS9 vector is made up of HS fragments, HS2, HS3,
` HS4; is that correct?
` A. In the design -- in some of the
` designs we looked at, yes.
` Q. Did individual people pick
` individual HS fragments or was someone
` responsible for designing the entire LCR
` fragment?
` A. I don't recall. Again, it was a
` team effort. I don't recall one person doing
` anything specific to either a HS2 domain or in
` the context of the full length.
` Q. Were any of the inventors on the
` patent not involved in the design of the LCR
` fragment used in TNS9?
` A. I only recall the work that I did
` during that time, I don't recall who specifically
` contributed what elements to the design.
`
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`Chad May, Ph.D.
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` Q. Okay. What did you contribute to
` the design of the LCR used for the TNS9 vector?
` A. I contributed to -- I can't name a
` specific, again a specific element, because it
` was really done -- it evolved over time it was a
` step-wise process which involved a number of
` people and a number of experimental results to
` get to that final outcome. So people were
` inputting thoughts during that whole process.
` Q. Who actually made -- physically made
` the LCR fragment that was used in TNS9?
` A. Again, I don't recall specifically
` who did the hands-on work at that time to piece
` these together or to decide which -- what the
` boundaries of these elements were.
` It was -- again, it was a group
` effort which there was no one -- one decision.
` It was an evolution that brought us to that.
` Q. Did you -- were you actually hands
` on in making some of the LCR fragments that were
` used in the vectors that you were testing at that
` time?
` A. I don't recall specifically what
` elements I worked on directly. But I know as a
` whole that I was involved, as were others.
`
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`bluebird bio, Inc. v. Sloan Kettering Institute for Cancer Research
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`Chad May, Ph.D.
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` Q. Right. I guess -- let me rephrase.
` Did you ever physically make an LCR
` fragment, when you were working in Dr. Sadelain's
` lab?
` A. Just a generic LCR fragment?
` Q. Yeah.
` A. I worked on LCR fragments, yes.
` Q. Okay. So I've asked about the
` design of the LCR fragment used in TNS9. In --
` in all the TNS9 vector, was that designed in a
` similar way or a different way than how you've
` described the LCR fragment?
` MR. CHEN: Objection to form.
` BY MR. YUSEM:
` Q. Yeah. Let me see if I can ask it a
` different way.
` Who designed the TNS9 vector?
` A. I don't recall specifically who.
` Again, it was an evolution, so it wasn't one --
` one person saying okay I'm putting these
` together. It was an evolution did this work this
` didn't work. What's possible, what's impossible.
` And then taking that -- taking that forward.
` Q. Okay. The LCR fragment that was
` used for TNS9, was that designed separately from
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`bluebird bio, Inc. v. Sloan Kettering Institute for Cancer Research
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`Chad May, Ph.D.
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` TNS9?
` A. I believe it was. I don't know if
` you can separate those two. It was, again, an
` evolution, there was a step-wise process to get
` to TNS9.
` So I don't -- I'm not clear that you
` can separate in that way, if I understand that
` question.
` Q. To make sure I understand in your
` mind, the 3.2 kilobase LCR fragment is sort of
` part of the definition of TNS9?
` MR. CHEN: Objection to form.
` A. Can you clarify what "definition of"
` in this context?
` BY MR. YUSEM:
` Q. Yeah. What I'm trying to get an
` understanding of is if LCR fragments were
` designed separately from the vector in total.
` The vector itself is made up of components beyond
` the LCR?
` A. The component within the LCR may
` have been used individually in other designs with
` different variations. But eventually they all
` came together as it evolved into that