CONFIDENTIAL - ATTORNEYS' EYES ONLY
`
` UNITED STATES PATENT AND TRADEMARK OFFICE
`
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`Page 1
`
`HOLOGIC, INC., )
` )
` Petitioner, )
` )
` vs. ) Case IPR2016-00820
` ) Case IPR2016-00822
`ENZO LIFE SCIENCES, INC., )
` )
` Patent Owner. )
`_______________________________ )
`
` CONFIDENTIAL - ATTORNEYS' EYES ONLY
`
` VIDEO DEPOSITION OF NORMAN NELSON, PH.D.
`
` WEDNESDAY, DECEMBER 21, 2016
`
` SAN DIEGO, CALIFORNIA
`
` REPORTED BY:
`
` LISA MOSKOWITZ
`
` CA-CSR 10816, RPR, CRR, CLR
`
` Job No. 17750
`
`TransPerfect Legal Solutions
`212-400-8845 - Depo@TransPerfect.com
`
`Exhibit 2017 Page 1
`
`Enzo Exhibit 2017
`Hologic, Inc. v. Enzo Life Sciences, Inc.
`Case IPR2016-00820
`
`

`
`CONFIDENTIAL - ATTORNEYS' EYES ONLY
`
`Page 2
`
`Page 4
`
` INDEX
`Examination By: Page
` BY MR. STADNICK 8
`
` EXHIBITS
`Petitioner's Page
` 1001 U.S. Patent Number 7,064,197 14
` 1002 Declaration of Dr. Norman Nelson in 181
` the 820 IPR
`
` 1002 Declaration of Dr. Norman Nelson in 200
` the 822 IPR
` 1006 Article Titled "A Sensitive Solid 50
` Phase Microradioimmunoassay for
` Anti-Double Stranded DNA Antibodies
` 1007 Article Titled "Nucleic Acid 215
` Hybridization Using DNA Covalently
` Coupled to Cellulose"
` 1008 Article Titled "In Situ 160
` Hybridization of DNA Sequences in
` Human Metaphase Chromosomes
` Visualized by an Indirect
` Fluorescent Immunocytochemical
` Procedure
`
` 1009 U.S. Patent Number 3,572,892 205
`
` 1019 Article Entitled "Immobilized 187
` Polynucleotides and Nucleic Acids"
` 1021 Article Entitled "Manufacturing DNA 139
` Microarrays of High Spot Homogeneity
` and Reduced Background Signal
`
`Page 5
`
` EXHIBITS (Cont'd)
`Petitioner's Page
` 1028 Article Titled "Effects of 215
` Mobilization on the Kinetics of
` Enzyme-Catalyzed Reactions. I.
` Glucose Oxidase in a Recirculation
` Reactor System
` 2019 U.S. Patent Application Number 238
` 2016/0017392
`
` 2119 U.S. Patent Application Number 238
` 2016/0017392
`
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` Video deposition of NORMAN NELSON, PH.D.,
` taken before Lisa Moskowitz, a Certified Shorthand
` Reporter for the State of California, Registered
` Professional Reporter, Certified Realtime Reporter,
` Certified LiveNote Reporter, NCRA Realtime Systems
` Administrator, commencing at 9:09 a.m. on Wednesday,
` December 21, 2016, in the offices of Hologic, Inc.,
` at 10210 Genetic Center Drive, San Diego, California.
`
`Page 3
`
` APPEARANCES
`
` For the Petitioner:
` FINNEGAN, HENDERSON, FARABOW, GARRETT &
` DUNNER, LLP
` Attorneys at Law
` BY: M. PAUL BARKER, ESQ.
` Stanford Research Park
` 3300 Hillview Avenue
` Palo Alto, California 94304-1203
` (650) 849-6620
` paul.barker@finnegan.com
` FINNEGAN, HENDERSON, FARABOW, GARRETT &
` DUNNER, LLP
` Attorneys at Law
` BY: ARPITA BHATTACHARYYA, ESQ.
` Two Seaport Lane, Sixth Floor
` Boston, Massachusetts 02210-2001
` (617) 646-1675
` arpita.bhattacharyya@finnegan.com
`
` For the Patent Owner:
` DESMARAIS, LLP
` Attorneys at Law
` BY: MICHAEL P. STADNICK, ESQ.
` BY: KERRI-ANN LIMBEEK, ESQ.
` 230 Park Avenue
` New York, New York 10169
` (212) 351-3422
` mstadnick@desmaraisllp.com
` klimbeek@desmaraisllp.com
`
` Also Present:
`
` MARINA HERNANDEZ, Videographer
` CHUCK CAPPELLARI, ESQ.
`
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`TransPerfect Legal Solutions
`212-400-8845 - Depo@TransPerfect.com
`
`2 (Pages 2 to 5)
`
`Exhibit 2017 Page 2
`
`

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`CONFIDENTIAL - ATTORNEYS' EYES ONLY
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` SAN DIEGO, CALIFORNIA, WEDNESDAY, DECEMBER 21, 2016
` 9:09 A.M.
`
` THE VIDEOGRAPHER: Good morning.
` This is tape number 1 of the videotaped
` deposition of Dr. Norman Nelson in the
` matter of Hologic, Incorporated versus Enzo
` Life Sciences, Incorporated, in the United
` States Patent and Trademark Office, Case
` Number IPR2016-00820. This deposition is
` being held at 10210 Genetic Center Drive,
` San Diego, California on December 21, 2016,
` at 9:09 a.m.
` My name is Marina Hernandez from the
` firm of TransPerfect Legal Solutions, and I
` am the legal video specialist. The court
` reporter is Lisa Moskowitz in association
` with TransPerfect Legal Solutions.
` Will counsel please introduce
` themselves.
` MR. STADNICK: Michael Stadnick from
` the Desmarais law firm, representing Enzo,
` and with me here today is Kerri-Ann
` Limbeek.
` MR. BARKER: Paul Barker from
`
`Page 7
`
` Finnegan, representing Hologic. I'm here
` with Arpita Bhattacharyya, who's also from
` Finnegan, and Chuck Cappellari, in-house at
` Hologic.
` THE VIDEOGRAPHER: Thank you. Will
` the court reporter please swear in the
` witness.
`
` NORMAN NELSON, PH.D.,
` called as a witness,
` was examined and testified as follows:
`
` THE REPORTER: And Counsel, just to
` let you know, I can already tell I need
` everybody way louder than when you
` introduced yourselves. Thank you.
` MR. STADNICK: Before we begin, I
` just want to note for the record I believe
` the IPR caption you read in was just for
` the 820-case, but we're here today jointly
` in both IPR2016-00820 and IPR2016-00822.
` Agreed?
` MR. BARKER: That's correct.
` ///
` ///
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` EXAMINATION
` BY MR. STADNICK:
` Q Okay. Good morning, Dr. Nelson.
` A Good morning.
` Q Can we begin by having you state
` your full name for us?
` A Norman C. Nelson.
` Q Where do you live?
` A San Diego, California.
` Q What do you do for a living?
` A I'm a consultant in biotechnology.
` Q You understand that you're here
` today to provide sworn testimony in some patent
` office proceedings involving a patent owned by
` my client Enzo; correct?
` A Yes.
` Q You understand there are two
` separate patent office proceedings currently?
` A Yes.
` Q One is, we just mentioned a few
` moments ago, is IPR2016-820, which we'll call
` the 820 IPR, if that's okay with you?
` A Yes.
` Q And the other one is IPR2016-822,
` which we'll call the 822 IPR. Is that fair?
`Page 9
`
` A Yes.
` Q I'm going to mark a number of the
` exhibits here today, and in most cases, the
` exhibits will bear the same number in both of
` those IPR proceedings. If there's any reason to
` deviate from that process, I'll let you know,
` but otherwise, you can assume that the exhibit
` I'm giving you is an exhibit in both
` proceedings. Fair?
` A Yes.
` Q You understand that the two IPR
` proceedings we're here in connection with today,
` the 820 and the 822, involve one of Enzo's
` United States patents which is number 7,064,197
` or the '197 patent; correct?
` A Yes.
` Q You've been hired by Hologic to
` offer certain opinions concerning the validity
` of the '197 patent. True?
` A I'm not sure I'm offering validity
` of the patent in regards to if that's a legal
` determination. I'm here as an expert witness in
` the field.
` Q You've been hired by Hologic to
` offer opinions as to whether certain pieces of
`
`3 (Pages 6 to 9)
`
`TransPerfect Legal Solutions
`212-400-8845 - Depo@TransPerfect.com
`
`Exhibit 2017 Page 3
`
`

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`CONFIDENTIAL - ATTORNEYS' EYES ONLY
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`Page 10
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`Page 12
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` prior art anticipate or are obvious in Enzo's
` '197 patent; correct?
` A Correct.
` Q In connection with your work for
` Hologic on these IPR matters, you submitted two
` declarations in support of petitions for
` institutions of IPR proceedings; correct?
` A Correct.
` Q I think you submitted both of those
` petitions back in March of 2016.
` Does that sound right?
` A That is correct. Whether it was
` March or they were submitted early April, I'm
` not sure, but that is the correct time frame.
` Q Let's just say first half of 2016.
` You submitted your declarations in connection
` with these IPR proceedings in the first half of
` this year; right?
` A Correct.
` Q Since that time, has anything come
` to your attention that's contained in either of
` those declarations that you want to change or
` you've come to realize is incorrect.
` A No.
` Q Have you ever had your deposition
`Page 11
`
` taken before?
` A Yes.
` Q How many times?
` A Twice before.
` Q Without getting into the details of
` the matters, could you give me some indication
` of what your role was in each of those prior
` depositions?
` A I believe it's called just a fact
` witness where I was giving testimony to the
` facts in regards to the scientific nature of
` those two cases.
` Q How long ago were those two
` depositions?
` A I don't recall exactly, but
` somewhere between 10 and 15 years ago. Although
` I do not recall exactly.
` Q Is it fair to say that your prior
` deposition testimony as a fact witness related
` to your employment at Gen-Probe?
` A To the best of my recollection, that
` is correct.
` Q Do you recall if the prior
` depositions that you provided 10 to 15 years ago
` in connection with your work at Gen-Probe
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` related to patent infringement litigation?
` A I believe they were in regards to
` patents. I don't recall if it was an
` infringement case.
` Q Did any of your testimony in either
` of your two prior depositions while you were
` employed at Gen-Probe relate in any way to the
` technology that's at issue in your analysis for
` the purposes of these IPR proceedings?
` A I don't recall precisely, but I
` don't believe so.
` Q So you do understand that you're
` testifying under oath here today; correct?
` A Yes.
` Q You understand that your testimony
` here today is under oath in the same way it
` would be if you were testifying in a court
` proceeding. Fair?
` A Yes.
` Q There's a court reporter here who's
` going to be making a written transcript of our
` questions and answers.
` Do you understand that?
` A Yes.
` Q There's a videographer here who's
`Page 13
`
` taking a video of the proceedings.
` You're aware of that; correct?
` A Yes.
` Q Is there any reason you can think of
` why you're unable today to provide full and
` accurate testimony in response to my questions?
` A No.
` Q I have a bit of a cold; so if I'm
` too quiet and you can't hear one of my questions
` or for any other reason you think that one of my
` questions doesn't make sense or you're not sure
` you understand what I'm asking you, I'd
` appreciate it if you'd let me know; so we can
` have a clear record.
` Does that sound fair?
` A Yes.
` Q And finally, to have a clear record,
` it's important that you and I make a concerted
` effort to try to not talk over each other. I
` know I've violated that rule already at least
` once here today, but if we can try to do that,
` it will be easier for the court reporter to make
` sure she gets an accurate record of our
` discussion here today. Fair?
` A Yes.
`
`4 (Pages 10 to 13)
`
`TransPerfect Legal Solutions
`212-400-8845 - Depo@TransPerfect.com
`
`Exhibit 2017 Page 4
`
`

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`CONFIDENTIAL - ATTORNEYS' EYES ONLY
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`Page 14
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` Q Okay.
` (Exhibit Number 1001 was marked
` for identification.)
` BY MR. STADNICK:
` Q I handed you the first exhibit to
` your deposition today. It's been pre-marked as
` Exhibits 1001 in both the 820 and the 822 IPRs.
` Exhibit 1001 is a copy of U.S. Patent 7,064,197;
` correct?
` A Correct.
` Q And that's the Enzo patent that you
` analyzed in connection with your work for
` Hologic on the IPR matters; correct?
` A That is correct.
` Q When did you first -- when is the
` first time you ever saw the '197 patent?
` A I don't recall exactly. It's
` possible it was 2014. That's possible but
` certainly early this year in 2016. I don't
` recall the 2014 for sure.
` Q Let me try it a different way.
` Prior to getting involved in working with
` Hologic on these IPR matters, had you seen the
` '197 patent at all?
` A I honestly don't recall for sure.
`Page 15
`
` Q In what context do you suspect that
` you might have seen the '197 patent before
` getting involved with the IPR proceedings for
` Hologic?
` A I've worked in this industry for
` three decades; so it's possible that just in my
` normal course of researching literature that I
` have read it in the past. That's the part I
` just don't recall for sure.
` Q Is there something particular about
` the 2014 time frame that makes you think you may
` have come across it then?
` A I do recall that I did a brief
` amount of work, not as a -- hired as an expert,
` although I don't recall the exact title, but a
` small amount of work on another Enzo matter
` which may have been this same patent. It was
` brief, and that's why I don't recall for sure.
` It may have been this particular patent, but I
` just don't recall.
` Q The prior work you did on another
` Enzo matter, was that in your capacity as an
` independent consultant?
` A Correct.
` Q Who were you doing that work for?
`
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` A You mean -- other than Hologic, you
` mean the specific individual that I worked with?
` Q No. Hologic is the answer I was
` looking for.
` A Oh.
` Q That work was also for Hologic?
` A Correct.
` Q Backing up to your role as an
` independent consultant, other than operating
` your own independent consultant business, are
` you employed by anybody currently?
` A I do contract work, work as a
` consultant, but it's all through my business.
` So I'm not employed by anyone else outside of my
` business.
` Q Do you hold any positions, executive
` positions, board positions, anything like that
` with any companies currently?
` A I do not.
` Q Okay. Going back to the '197
` patent, Exhibit 1001, could you please describe
` for me, in general terms, the subject matter of
` the '197 patent?
` A Can we pause for just a moment? I'm
` reconsidering my answer. I also work for a
`Page 17
`
` company here in San Diego termed -- named Aegea,
` and I do that as a consultant, but I also have
` an arrangement with them which I don't know if
` it's technically construed as an employee. I
` don't think so, but that is possible as I'm
` reconsidering my answer.
` Again, when I -- it's a small amount
` of work, and when I'm paid, it's always paid --
` I bill them as NCN Enterprises which is my
` business. I may have some sort of an employment
` agreement with them, but I don't recall the
` exact nature of that. Aegea is A-e-g-e-a.
` Q A-e-g-e-a?
` A Yes.
` Q What business is Aegea in?
` A It's also biotechnology. It's
` molecular.
` Q Does Aegea have any products?
` A No.
` Q Is Aegea currently developing any
` products with the intent to market them?
` A No. It's in just a research phase,
` not developing any products, feasibility
` research of technology.
` Q Is any of the work going on at
`
`5 (Pages 14 to 17)
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`TransPerfect Legal Solutions
`212-400-8845 - Depo@TransPerfect.com
`
`Exhibit 2017 Page 5
`
`

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`CONFIDENTIAL - ATTORNEYS' EYES ONLY
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`Page 18
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` Aegea, as far as product development or research
` or feasibility or whatever the molecular biology
` area, related in any way to the type of nucleic
` acid support technology that's addressed in the
` '197 patent?
` A No.
` Q None of the work at Aegea is --
` rephrase that.
` Is Aegea working at all in the area
` of solid phase nucleic acid detection?
` A Not to my knowledge.
` Q Next generation sequencing?
` A Not working in it. Considering a
` possible application in next generation
` sequential but not actively working in it, to
` the best of my knowledge.
` Q Any capture technology using nucleic
` acids fixed to a solid support under development
` at Aegea?
` A Not to my knowledge.
` Q Okay. Back to the '197 patent then.
` A Yes.
` Q Could you go ahead and provide for
` me a general high level description of the basic
` subject matter of the '197 patent as you
`Page 19
`
` understand it?
` A The '197 relates to binding of
` nucleic acids on non-porous supports in
` hybridizable form, and other claims also relate
` to the detection of those nucleic acids.
` Q I'd like to go back to the time
` frame when the work that led to the '197 patent
` was being done and just call it generally the
` early 1980s.
` Could you describe for me how
` nucleic acid hybridization and detection was
` typically performed in the early 1980s?
` A The nucleic acid detection was
` performed using solid supports that are
` non-porous supports. There was radioactive
` detection. There was non-radioactive detection.
` There were in-solution methods, as I recall at
` that time. I don't recall the exact detection
` modalities.
` So that is a portrayal of how they
` were detected in that time frame.
` Q You personally were in grad school
` in the early 1980s; is that correct?
` A I finished my degree in the very
` early 1980s. December of 1981.
`
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` Q Is when you got your Ph.D.?
` A Yeah.
` Q So you said that in the early 1980s,
` nucleic acid hybridization and detection was, in
` your belief, performed using non-porous solid
` supports; correct?
` A Yeah. I was just listening to my
` answer. Non-porous and porous as well such as
` blots.
` Q Would you agree that, by far, the
` most common way of performing nucleic acid
` hybridization and detection in the early 1980s
` was through the use of porous supports?
` A As far as on solid matrices like
` that, the majority at that time, early '80s,
` very early '80s, was porous. I almost said it
` again. I almost said non-porous. It's porous
` and non-porous, but yes, the majority was
` porous, to my knowledge.
` Q Just to make sure my question was
` clear then, would you agree that, by far, the
` most common way of performing nucleic acid
` hybridization and detection on solid supports in
` the early 1980s time frame was using porous
` solid supports rather than non-porous solid
`Page 21
`
` supports?
` A I don't know if it was the vast
` majority, but I know that there were -- they
` were methods on porous supports. That is
` correct. I don't really know if it was the vast
` majority.
` Q It was more common for folks working
` in this area in the early 1980s to perform
` nucleic acid hybridization and detection on
` solid supports that were porous than on solid
` supports that were non-porous. Fair?
` A I believe that's correct.
` Q In the early 1980s, did you
` personally perform nucleic acid hybridization
` and detection analyses using solid supports?
` A I joined Gen-Probe in 1985; so
` that's mid '80s. Before that time, I did not
` personally perform nucleic acid hybridization
` assays on solid supports.
` Q After you joined Gen-Probe in 1985,
` did you personally perform nucleic acid
` hybridization and detection analyses on solid
` supports?
` A Yes.
` Q What types of solid supports? By
`
`6 (Pages 18 to 21)
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`Exhibit 2017 Page 6
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`CONFIDENTIAL - ATTORNEYS' EYES ONLY
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` that, I mean porous or non-porous? Let's start
` there.
` A Correct. I'm trying to decide if
` supports are porous or non-porous. Probably
` some of each but definitely both porous and
` non-porous. I'm thinking to recall exactly.
` Yes, both. Both supports.
` Q So why don't we step back from the
` distinction between porous and non-porous for a
` moment, and we can circle back to it. Why don't
` we start by having you identify for me the
` different types of solid supports that you
` recall using after joining Gen-Probe in 1985 to
` do nucleic acid hybridization and detection
` analysis.
` A I would categorize it in two major
` areas. One is through porous material such as
` column supports, Sephadex hydroxyl appetite are
` two examples. The other is on beads which are
` non-porous. To the best of my knowledge, as far
` as the definition of porous and non-porous.
` Q So you referred to Sephadex in the
` context of column supports. You're not
` referring to beads?
` A I'm not sure how one would describe
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` Sephadex as beads or not beads. Yes, they are.
` They are beads. It's just a matter of the
` definition of beads.
` Q I'm not trying to pick an
` unnecessary argument.
` A I understand.
` Q I'm just trying to make sure I
` understand the difference between what you refer
` to as non-porous beads and porous Sephadex
` column supports.
` A Right.
` Q Maybe you can just tell me a little
` bit more about the way you believed to be
` non-porous beads that you worked with?
` A Sure. They are beads that are
` typically smaller than Sephadex beads, if we
` agree to call them that, and they do not have
` pores in them.
` Q What were those beads made of?
` A They were made of -- I don't recall
` exactly, but magnetite cores. They were
` magnetic microparticles. I don't recall the
` exact composition of those, but they were
` magnetic microparticles.
` Q Were those beads used for capture
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` applications?
` A Capture and detection.
` If I'm recalling the exact format,
` again, it would have to decide what detection
` is, but they were both capture and detection as
` I recall.
` Q Were the beads that you believed to
` be non-porous that you worked with after
` starting at Gen-Probe in 1985, were they sold
` commercially by Gen-Probe, or were they
` something you were using?
` A Som