· · · · · · · ·UNITED STATES PATENT AND TRADEMARK OFFICE
`
`· · · · · · · ·BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`· · · · · · · - - - - - - - - - - - - - - - - - - - - -
`
`· · · · · · · · · · THERMO FISHER SCIENTIFIC INC.
`
`· · · · · · · · · · · · · · ·Petitioner,
`
`· · · · · · · · · · · · · · · · ·v.
`
`· · · · · · · · · · ·BIO-RAD LABORATORIES, INC.
`
`· · · · · · · · · · · · · · Patent Owner.
`
`· · · · · · · - - - - - - - - - - - - - - - - - - - - -
`
`· · · · · · · ·Case IPR2017-00054 (Patent 8,236,504)
`· · · · · · · ·Case IPR2017-00055 (Patent 8,236,504)
`·
`
`· · · · · · · ·Videotaped deposition of DEAN P. NEIKIRK,
`
`· · ·PH.D., taken pursuant to Notice, was held at the Law
`
`· · ·Offices of JONES DAY, 250 Vesey Street, New York, New
`
`· · ·York, commencing August 22, 2017, 9:06 a.m., on the
`
`· · ·above date, before Amanda McCredo, a Court Reporter and
`
`· · ·Notary Public in the State of New York.
`
`·
`· · · · · · · · · · · · · ·- - -
`·
`
`·
`
`·
`
`·
`
`·
`
`·
`
`·
`
`THERMO FISHER EX. 1050
`
`Agilent Exhibit 1245
`Page 1 of 145
`
`
`
`· · · · · · · ·BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`· · · · · · · - - - - - - - - - - - - - - - - - - - - -
`
`· · · · · · · · · · THERMO FISHER SCIENTIFIC INC.
`
`· · · · · · · · · · · · · · ·Petitioner,
`
`· · · · · · · · · · · · · · · · ·v.
`
`· · · · · · · · · · ·BIO-RAD LABORATORIES, INC.
`
`· · · · · · · · · · · · · · Patent Owner.
`
`· · · · · · · - - - - - - - - - - - - - - - - - - - - -
`
`· · · · · · · ·Case IPR2017-00054 (Patent 8,236,504)
`· · · · · · · ·Case IPR2017-00055 (Patent 8,236,504)
`·
`
`· · · · · · · ·Videotaped deposition of DEAN P. NEIKIRK,
`
`· · ·PH.D., taken pursuant to Notice, was held at the Law
`
`· · ·Offices of JONES DAY, 250 Vesey Street, New York, New
`
`· · ·York, commencing August 22, 2017, 9:06 a.m., on the
`
`· · ·above date, before Amanda McCredo, a Court Reporter and
`
`· · ·Notary Public in the State of New York.
`
`·
`· · · · · · · · · · · · · ·- - -
`·
`
`·
`
`·
`
`·
`
`·
`
`·
`
`·
`
`THERMO FISHER EX. 1050
`
`Agilent Exhibit 1245
`Page 1 of 145
`
`
`
`·1· ·A P P E A R A N C E S:
`
`·2· ·MORRIS, NICHOLS, ARSHT & TUNNELL, LLP
`· · · · · · · · · 1201 North Market Street
`·3· · · · · · · · Suite 1800
`· · · · · · · · · Wilmington, Delaware 19801
`·4· ·BY: BRIAN EGAN, ESQ.
`· · ·began@mnat.com
`·5· ·(212)227-5000
`· · ·Attorneys for Petitioner
`·6
`
`·7
`
`·8
`
`·9· ·JONES DAY
`· · · · · · · · · 250 Vesey Street
`10· · · · · · · · New York, New York 10281
`· · ·BY: KELSEY I. NIX, ESQ.
`11· ·knix@jonesday.com
`· · ·(212)326-3939
`12· ·Attorneys for Patent Owner
`
`13
`
`14
`
`15· ·ALSO PRESENT:
`
`16· ·Sean Boyle - In-house counsel at Thermo Fisher
`
`17· ·Adam Nicolais, Esq. - Jones Day
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`THERMO FISHER EX. 1050
`
`Agilent Exhibit 1245
`Page 2 of 145
`
`
`
`·1· · · · · · · · · · · · I N D E X
`
`·2· ·WITNESS· · · · · · ·EXAMINATION BY· · · · · · · PAGE
`
`·3· ·Dean P. Neikirk· · ·Mr. Egan· · · · · · · · · · · 5
`
`·4
`
`·5· · · · · · · · · · · · ·EXHIBITS
`
`·6· ·EXHIBIT· · · · · · · · · · · · · · · · · · · · ·PAGE
`
`·7· ·Exhibit 1· · ·Declaration Under 37 C.F.R.· · · ·120
`· · · · · · · · · ·Section 1.132 by Paul J. Patt
`·8
`
`·9
`
`10· · · · · · · · · PREVIOUSLY MARKED EXHIBITS
`
`11· ·EXHIBIT· · · · · · · · · · · · · · · · · · · · ·PAGE
`
`12· ·Bio-Rad 2001· · · · · · · · · · · · · · · · · · ·22
`
`13· ·Bio-Rad 2003· · · · · · · · · · · · · · · · · · ·22
`
`14· ·Thermo Fisher 1001· · · · · · · · · · · · · · · ·24
`
`15· ·Thermo Fisher 1005· · · · · · · · · · · · · · · ·69
`
`16· ·Thermo Fisher 1006· · · · · · · · · · · · · · · ·83
`
`17· ·Thermo Fisher 1009· · · · · · · · · · · · · · · ·89
`
`18· ·Thermo Fisher 1004· · · · · · · · · · · · · · · 107
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`THERMO FISHER EX. 1050
`
`Agilent Exhibit 1245
`Page 3 of 145
`
`
`
`·1· · · · · · THE VIDEOGRAPHER:· This is the videotaped
`
`·2· · · · deposition of Dr. Dean Neikirk in the matter of
`
`·3· · · · Thermo Fisher Scientific Inc. v Bio-Rad
`
`·4· · · · Laboratories, Inc.
`
`·5· · · · · · This deposition is being held at Jones Day
`
`·6· · · · on August 22, 2017.
`
`·7· · · · · · My name is Charlie Bowen from U.S. Legal
`
`·8· · · · Support, and I am the video specialist.· The
`
`·9· · · · court reporter today is Amanda McCredo, also
`
`10· · · · from U.S. Legal Support.
`
`11· · · · · · We are going on the record at 9:06 a.m.
`
`12· · · · · · Counsel, please state your appearances for
`
`13· · · · the record.
`
`14· · · · · · MR. NIX:· Kelsey Nix for the patent owner,
`
`15· · · · Bio-Rad, and for the witness, from Jones Day.
`
`16· · · · · · And with me today is associate Adam
`
`17· · · · Nicolais.
`
`18· · · · · · MR. EGAN:· Brian Egan on behalf of
`
`19· · · · petitioner, Thermo Fisher, from the Morris,
`
`20· · · · Nichols, Arsht & Tunnell law firm.
`
`21· · · · · · With me today is Sean Boyle, who is
`
`22· · · · in-house counsel with Thermo Fisher.
`
`23· · · · · · THE VIDEOGRAPHER:· Will the court reporter
`
`24· · · · please swear in the witness.
`
`25· ·D E A N· ·N E I K I R K, the witness herein, after
`
`THERMO FISHER EX. 1050
`
`Agilent Exhibit 1245
`Page 4 of 145
`
`
`
`·1· · · · · · ·having been first duly sworn by a Notary
`
`·2· · · · · · ·Public of the State of New York, was
`
`·3· · · · · · ·examined and testified as follows:
`
`·4· ·EXAMINATION BY
`
`·5· ·MR. EGAN:
`
`·6· · · ·Q· · Good morning, Dr. Neikirk.
`
`·7· · · ·A· · Good morning.
`
`·8· · · ·Q· · Can you please state your full name and
`
`·9· ·address for the record?
`
`10· · · ·A· · Dean Paul Neikirk of 6604 Auburn Hill,
`
`11· ·Austin, Texas.
`
`12· · · ·Q· · Okay.· And you're appearing here today as
`
`13· ·an expert on behalf of Bio-Rad Laboratories,
`
`14· ·Incorporated in two separate IPR proceedings
`
`15· ·involving U.S. Patent 8,236,504, correct?
`
`16· · · ·A· · That is correct.
`
`17· · · ·Q· · Okay.· And you've referred to that patent
`
`18· ·in your analysis as the '504 patent or the 504
`
`19· ·patent?
`
`20· · · ·A· · Yes, that's correct.
`
`21· · · ·Q· · Okay.· Have you ever been deposed before?
`
`22· · · ·A· · I have.
`
`23· · · ·Q· · How many times have you been deposed
`
`24· ·before?
`
`25· · · ·A· · Probably well in excess of 20 times.
`
`THERMO FISHER EX. 1050
`
`Agilent Exhibit 1245
`Page 5 of 145
`
`
`
`·1· · · ·Q· · Okay.· And did any of those matters involve
`
`·2· ·patent disputes?
`
`·3· · · ·A· · They all did, yes.
`
`·4· · · ·Q· · They all did?· Okay.
`
`·5· · · ·A· · Well, I'm trying to think.· Two trade
`
`·6· ·secret cases, I don't even know whether those
`
`·7· ·involved depositions.· But all the rest are patent
`
`·8· ·cases.
`
`·9· · · ·Q· · Okay.· In those 20 or so patent cases, you
`
`10· ·were acting as an expert in each of those cases?
`
`11· · · ·A· · That's correct.
`
`12· · · ·Q· · Okay.· So, you've been through this process
`
`13· ·before, but I'll just go over the basic ground rules
`
`14· ·of depositions.
`
`15· · · · · · First, do you understand that you'll be
`
`16· ·answering questions today under oath?· Correct?
`
`17· · · ·A· · I do understand that, yes.
`
`18· · · ·Q· · Okay.· And if at any time you don't
`
`19· ·understand one of my questions, let me know, and
`
`20· ·I'll do my best to rephrase it until you do
`
`21· ·understand it.
`
`22· · · ·A· · Yes, I'll certainly do that.
`
`23· · · ·Q· · Okay.· You understand that all of your
`
`24· ·answers should be verbal so that we can get it on
`
`25· ·the record, because the court reporter can't take
`
`THERMO FISHER EX. 1050
`
`Agilent Exhibit 1245
`Page 6 of 145
`
`
`
`·1· ·down nonverbal responses, right?
`
`·2· · · ·A· · Yes, I understand that.
`
`·3· · · ·Q· · Okay.· And if you need to take a break at
`
`·4· ·any point, just let me know, and I'll try to find a
`
`·5· ·reasonable stopping point.
`
`·6· · · ·A· · And I'll certainly do that.
`
`·7· · · ·Q· · Okay.· Is there anything that would
`
`·8· ·preclude you from answering truthfully today?
`
`·9· · · ·A· · No, there is not.
`
`10· · · ·Q· · Okay.· In the cases where you have
`
`11· ·previously served as an expert witness, have you
`
`12· ·ever served as an expert witness in cases involving
`
`13· ·real-time PCR technology?
`
`14· · · ·A· · No, I don't think I've done anything on
`
`15· ·real-time PCR specifically.
`
`16· · · ·Q· · Okay.· And when we use the term "real-time
`
`17· ·PCR," what do you understand that to mean?
`
`18· · · ·A· · Well, PCR is a DNA amplification process
`
`19· ·involving temperature cycling; real-time in the
`
`20· ·sense that you're trying to monitor the samples in
`
`21· ·place, as opposed to doing separations with
`
`22· ·something like gel electrophoresis.
`
`23· · · ·Q· · Okay.· And you mentioned gel
`
`24· ·electrophoresis.
`
`25· · · · · · What is the difference between gel
`
`THERMO FISHER EX. 1050
`
`Agilent Exhibit 1245
`Page 7 of 145
`
`
`
`·1· ·electrophoresis and PCR?
`
`·2· · · ·A· · Well, PCR is a method that amplifies DNA,
`
`·3· ·and then you also want to couple that with a method
`
`·4· ·of detecting what DNA is present.
`
`·5· · · · · · Gel electrophoresis is a method of
`
`·6· ·separating the DNA, based on its mass, into bands.
`
`·7· ·It's kind of the old way to do it, as opposed to
`
`·8· ·techniques which, for instance, use a fluorescent
`
`·9· ·labeling technique, which would be more amenable to
`
`10· ·so-called real-time analysis.
`
`11· · · ·Q· · Okay.· So, is it fair to say that in an
`
`12· ·electrophoresis process, the sample is already
`
`13· ·complete, there is no further reaction being
`
`14· ·performed?
`
`15· · · ·A· · Yes.· In that case, the PCR, which is the
`
`16· ·technique to amplify the DNA, comes first.· And then
`
`17· ·you do a separations technique to separate the
`
`18· ·different strings by mass.
`
`19· · · ·Q· · Okay.· Fair enough.
`
`20· · · · · · When were you first contacted to serve as
`
`21· ·an expert in this case?
`
`22· · · ·A· · In this case, I think it was about a year
`
`23· ·ago.· I think it's a little bit less than a year.
`
`24· ·But in rough terms, about a year.
`
`25· · · ·Q· · And you were retained through an agency
`
`THERMO FISHER EX. 1050
`
`Agilent Exhibit 1245
`Page 8 of 145
`
`
`
`·1· ·through Teklicon, Incorporated; is that correct?
`
`·2· · · ·A· · That is correct.
`
`·3· · · ·Q· · Okay.· And do you have a relationship with
`
`·4· ·Teklicon?
`
`·5· · · ·A· · I have known the people at Teklicon for
`
`·6· ·many years and have -- they typically contact me if
`
`·7· ·they have a case that they think I might be a good
`
`·8· ·fit for.· I've probably done a couple of other cases
`
`·9· ·through Teklicon over the years.
`
`10· · · ·Q· · Okay.· Are you aware that, in this case,
`
`11· ·Bio-Rad filed what's called a preliminary patent
`
`12· ·office -- or a patent owner's response?
`
`13· · · ·A· · Yes.
`
`14· · · ·Q· · Okay.· Do you know if you were retained
`
`15· ·before or after that response was filed?
`
`16· · · ·A· · I believe it was before.
`
`17· · · ·Q· · Okay.· Do you know if you provided any
`
`18· ·assistance to Bio-Rad in, in writing that
`
`19· ·preliminary response?
`
`20· · · ·A· · If I recall the timeline correctly, I'd
`
`21· ·certainly -- I believe I had reviewed the patents
`
`22· ·that had been asserted against the '504 and had had
`
`23· ·general discussions with counsel about those.
`
`24· · · ·Q· · Okay.· Are you billing hourly for your time
`
`25· ·spent on this matter?
`
`THERMO FISHER EX. 1050
`
`Agilent Exhibit 1245
`Page 9 of 145
`
`
`
`·1· · · ·A· · Yes, I am.
`
`·2· · · ·Q· · And what is your hourly rate?
`
`·3· · · ·A· · My hourly rate is $500 an hour.
`
`·4· · · ·Q· · Can you estimate how much time to date
`
`·5· ·you've spent?
`
`·6· · · ·A· · Probably somewhere around, I guess, maybe
`
`·7· ·80 hours, since we started.· Might be, might be a
`
`·8· ·little bit more than that, a little bit less, but I
`
`·9· ·think that's about the right order of magnitude.
`
`10· · · ·Q· · Okay.· And you've submitted two
`
`11· ·declarations so far, correct?
`
`12· · · ·A· · That's correct.
`
`13· · · ·Q· · Okay.· And did you, yourself, draft those
`
`14· ·two declarations?
`
`15· · · ·A· · So, in both cases, portions of those I
`
`16· ·typed myself, portions I didn't type myself.· But
`
`17· ·they were only done after extensive discussion with
`
`18· ·counsel who was assisting me, where I made it very
`
`19· ·clear what my opinions were, and those are what went
`
`20· ·into the first draft and any subsequent revisions.
`
`21· · · ·Q· · Okay.· Now, without disclosing the content
`
`22· ·of any of your conversations with counsel, what did
`
`23· ·you do to prepare for today's deposition?
`
`24· · · ·A· · I reviewed the petitioner's petitions, I
`
`25· ·reviewed the board's initial response -- I may have
`
`THERMO FISHER EX. 1050
`
`Agilent Exhibit 1245
`Page 10 of 145
`
`
`
`·1· ·the name of that not quite right -- Bio-Rad's
`
`·2· ·replies, my own declarations, Dr. Matthew's
`
`·3· ·declarations, his -- the transcript of his
`
`·4· ·deposition, and all of the prior art that's been at
`
`·5· ·issue.
`
`·6· · · ·Q· · Dr. Neikirk, you hold a degree in
`
`·7· ·mathematics and physics from Oklahoma State; is that
`
`·8· ·correct?
`
`·9· · · ·A· · That's my undergraduate degree, a B.S.,
`
`10· ·yes.
`
`11· · · ·Q· · Okay.· And you also have a master's and a
`
`12· ·Ph.D. degree?
`
`13· · · ·A· · Yes, I do, from the California Institute of
`
`14· ·Technology and Applied Physics.
`
`15· · · ·Q· · And in your declarations, you identify
`
`16· ·yourself as an independent consultant in
`
`17· ·technologies related to sensor systems, including
`
`18· ·those used for biochemical sensing; is that correct?
`
`19· · · ·A· · That's correct.
`
`20· · · ·Q· · Now, what do you mean by, quote, unquote,
`
`21· ·sensor systems?
`
`22· · · ·A· · For the last -- what is it now? -- 38
`
`23· ·years, I have worked on the development of sensors
`
`24· ·of all sorts, ranging from optical sensors to
`
`25· ·infrared sensors to radio wavelength sensors to
`
`THERMO FISHER EX. 1050
`
`Agilent Exhibit 1245
`Page 11 of 145
`
`
`
`·1· ·chemical sensors.· So, a lot of different types of
`
`·2· ·sensor systems.· And that ranges all the way from
`
`·3· ·the fundamental transducer to its integration into a
`
`·4· ·complete system to provide information out the other
`
`·5· ·end.
`
`·6· · · ·Q· · So, when we're talking about real-time PCR
`
`·7· ·technology and sensor systems, is it -- you know,
`
`·8· ·when you say you're an expert in sensor systems, do
`
`·9· ·you mean that you consider yourself an expert on the
`
`10· ·optical components of the real-time PCR technology?
`
`11· · · ·A· · I would say not just the optical
`
`12· ·components; the mechanical systems, the assembly
`
`13· ·into a system.· I have done a lot of work on
`
`14· ·chemical sensors.
`
`15· · · · · · I would not characterize myself as an
`
`16· ·expert -- having enormous expertise on the
`
`17· ·chemistry, specifically.· When I've worked on that,
`
`18· ·I've worked with other biochemists.· But integrating
`
`19· ·their chemistry into a complete system, that's
`
`20· ·typically the part that I coordinated.
`
`21· · · ·Q· · Now, when you reference your limited
`
`22· ·expertise on the chemistry of a real-time PCR
`
`23· ·reaction, does that also include the thermodynamics
`
`24· ·that would be necessary to make that reaction
`
`25· ·happen?
`
`THERMO FISHER EX. 1050
`
`Agilent Exhibit 1245
`Page 12 of 145
`
`
`
`·1· · · ·A· · No, I wouldn't say that.· I've done a lot
`
`·2· ·of work on thermal systems, so I'm very familiar
`
`·3· ·with heat transfer.· I have three years of
`
`·4· ·undergraduate and graduate education in
`
`·5· ·thermodynamics, being a physics and applied physics
`
`·6· ·major.
`
`·7· · · · · · What I would -- what I would say, then, is
`
`·8· ·that I typically don't create new molecules.· That's
`
`·9· ·what my chemistry colleagues do.· I might use the
`
`10· ·molecules they developed, but I don't create the new
`
`11· ·molecules.
`
`12· · · ·Q· · Have you personally ever used a real-time
`
`13· ·PCR machine?
`
`14· · · ·A· · I don't -- I have not personally operated
`
`15· ·one.· There are PCR equipment in the laboratories of
`
`16· ·the chemistry, and biochemistry faculty with whom
`
`17· ·I've collaborated, but I haven't run the machines.
`
`18· · · ·Q· · Okay.· Have you personally ever designed a
`
`19· ·real-time PCR machine?
`
`20· · · ·A· · Again, the systems that I worked on were,
`
`21· ·in many cases, to be alternatives to classical PCR.
`
`22· ·So, no, I haven't built that specific type of
`
`23· ·systems.· I worked on systems we hoped might replace
`
`24· ·them.
`
`25· · · ·Q· · Were there certain shortcomings that you
`
`THERMO FISHER EX. 1050
`
`Agilent Exhibit 1245
`Page 13 of 145
`
`
`
`·1· ·saw in PCR technology as, you know, driving your
`
`·2· ·motivation to design a different type of machine?
`
`·3· · · ·A· · The work that we did, we were hoping to
`
`·4· ·develop handheld, in-home diagnostic systems, which
`
`·5· ·need to be very small and very inexpensive.
`
`·6· · · · · · Now, if, by cost and size, those are
`
`·7· ·disadvantages to PCR, well, not as they're
`
`·8· ·conventionally used they're not.· In the markets
`
`·9· ·that we were interested in, that would have been.
`
`10· ·They're balanced by the fact that they work
`
`11· ·exceedingly well.
`
`12· · · ·Q· · And those handheld devices that you were
`
`13· ·working with, did those involve LED light sources?
`
`14· · · ·A· · They involved LED light sources and other
`
`15· ·light sources, a variety of different sources of
`
`16· ·light.
`
`17· · · ·Q· · Did they include laser light sources?
`
`18· · · ·A· · We had -- we looked at lasers, we looked at
`
`19· ·LEDs, we looked at arc lamps.· Many of the systems
`
`20· ·that we put together as benchtop models used arc
`
`21· ·lamps.
`
`22· · · ·Q· · And the work that you're referring to on
`
`23· ·these handheld devices, did that occur prior to May
`
`24· ·of 2003?
`
`25· · · ·A· · Prior to May 2003 -- I think we started on
`
`THERMO FISHER EX. 1050
`
`Agilent Exhibit 1245
`Page 14 of 145
`
`
`
`·1· ·that, I believe, in the mid '90s and continued
`
`·2· ·working on that until the 2005 to 2010 frame --
`
`·3· ·timeframe, roughly.
`
`·4· · · ·Q· · Are there any PCR machines that you're
`
`·5· ·personally aware of that were commercially available
`
`·6· ·prior to May of 2003?
`
`·7· · · ·A· · That I personally used, no.
`
`·8· · · · · · But in that timeframe, I do a lot of work
`
`·9· ·with micromechanical systems, and certainly was
`
`10· ·aware of efforts to reduce thermal mass in the
`
`11· ·thermal cycling modules.· That was a big push in the
`
`12· ·'90s into the 2000s.
`
`13· · · · · · So, certainly was aware that the machines
`
`14· ·existed.· I wasn't using them personally at that
`
`15· ·time.
`
`16· · · ·Q· · Okay.· And what do you mean by "efforts to
`
`17· ·reduce thermal mass"?
`
`18· · · ·A· · Well, PCR requires temperature cycling up
`
`19· ·and down.· And the speed at which you can heat and
`
`20· ·cool depends on the thermal mass of the entire
`
`21· ·system that you heat and cool.· And there was a lot
`
`22· ·of interest in trying to reduce that thermal mass to
`
`23· ·increase the speed, the cycling time.
`
`24· · · ·Q· · Okay.· And that interest existed prior to
`
`25· ·May of 2003?
`
`THERMO FISHER EX. 1050
`
`Agilent Exhibit 1245
`Page 15 of 145
`
`
`
`·1· · · ·A· · I believe it's -- yes, it certainly did.
`
`·2· · · ·Q· · Now, one component of a real-time PCR
`
`·3· ·machine is a thermal cycler, correct?
`
`·4· · · ·A· · Yeah.· That's one of the generic terms
`
`·5· ·that's used, yes.
`
`·6· · · ·Q· · Okay.· What is your understanding of what a
`
`·7· ·thermal cycler is?
`
`·8· · · ·A· · Well, I think, both generally and in the
`
`·9· ·context of the '504 patent, the thermal cycler
`
`10· ·usually refers to the part of the system which you
`
`11· ·heat -- that contains heaters and coolers, if
`
`12· ·necessary, and the other elements, the samples
`
`13· ·themselves, that you're trying to heat and cool.
`
`14· · · · · · And broadly speaking, I think a lot of
`
`15· ·people tend to refer to that as the thermal control
`
`16· ·module for the PCR.
`
`17· · · ·Q· · Are you aware of any thermal cyclers in
`
`18· ·which the heating component for the thermal cycler
`
`19· ·is positioned below the sample wells?
`
`20· · · ·A· · I think it's very common to use a -- in a
`
`21· ·thermal cycler, for instance, a thermoelectric
`
`22· ·cooler that would be, the samples would be clamped,
`
`23· ·attached to that module.· It could be below it, it
`
`24· ·could be in some other configuration, depending on
`
`25· ·how you arrange the rest of the system.
`
`THERMO FISHER EX. 1050
`
`Agilent Exhibit 1245
`Page 16 of 145
`
`
`
`·1· · · ·Q· · Now, is it fair to say that a thermal
`
`·2· ·cycler is not a thermal cycler until it's connected
`
`·3· ·electrically to a component that can provide power
`
`·4· ·to heat and cool the thermal cycler?
`
`·5· · · ·A· · I don't -- no, I don't think I would view
`
`·6· ·it that way.· I think the object would be called the
`
`·7· ·thermal cycler.· Whether it's performing thermal
`
`·8· ·cycling at any instant in time, obviously it has to
`
`·9· ·be provided energy to heat and cool.· But I think
`
`10· ·people would refer to the thing that has -- where
`
`11· ·its intent, that's what it's going to be used for,
`
`12· ·is a thermal cycling module.
`
`13· · · ·Q· · Have you personally ever used just a
`
`14· ·thermal cycler as opposed to a real-time PCR
`
`15· ·machine?
`
`16· · · ·A· · Absolutely.· We do a lot of testing of
`
`17· ·devices that require measuring data as a function of
`
`18· ·temperature, and those are thermal cyclers.
`
`19· · · ·Q· · And have you personally ever designed a
`
`20· ·thermal cycler?
`
`21· · · ·A· · Yes, I have.· Much of my research,
`
`22· ·especially in the '80s, but it's continued since,
`
`23· ·involves devices that are fundamentally thermal
`
`24· ·devices.· And so, we look at all the heat transport
`
`25· ·issues, self-heating, external heating, all the
`
`THERMO FISHER EX. 1050
`
`Agilent Exhibit 1245
`Page 17 of 145
`
`
`
`·1· ·conduction and convention and transport -- thermal
`
`·2· ·mechanisms.
`
`·3· · · · · · So, yeah, both myself and my graduate
`
`·4· ·students built our own temperature controllers and
`
`·5· ·temperature control modules.
`
`·6· · · ·Q· · Okay.· So, for that work, you weren't, you
`
`·7· ·know, pulling off the shelf a thermal cycler and
`
`·8· ·then incorporating it into the designs that you were
`
`·9· ·working with?
`
`10· · · ·A· · In some of our test equipment, we were
`
`11· ·using an off-the-shelf temperature control module
`
`12· ·thermal cycler.· In other cases, we built them
`
`13· ·ourselves.
`
`14· · · ·Q· · What thermal cyclers are you aware of that
`
`15· ·were commercially available prior to May of 2003?
`
`16· · · ·A· · Gee, I don't recall specific brand names
`
`17· ·right now, as I sit here.
`
`18· · · ·Q· · Now, in the thermal cyclers that you would
`
`19· ·have used prior to May of 2003, have you ever taken
`
`20· ·one of those thermal cyclers and turned it upside
`
`21· ·down and tried to operate it?
`
`22· · · ·A· · So, for some of our work, we probably
`
`23· ·oriented it in all sorts of different positions
`
`24· ·because of the way we were using it.
`
`25· · · · · · I can remember one system where we, where
`
`THERMO FISHER EX. 1050
`
`Agilent Exhibit 1245
`Page 18 of 145
`
`
`
`·1· ·we were doing our work sort of -- I don't know how
`
`·2· ·to describe it.· You said upside down.· Then let's
`
`·3· ·call it vertical -- vertically (indicating) -- it's
`
`·4· ·a hand motion, which she can't get -- up and down.
`
`·5· · · · · · So, I've used heating blocks that were
`
`·6· ·above the sample, below the sample, to either side
`
`·7· ·of the sample, depending on what the rest of the
`
`·8· ·system needed to do.
`
`·9· · · ·Q· · And you said you've used heating blocks
`
`10· ·that were above the sample, below the sample, to
`
`11· ·either side of the sample, depending on what the
`
`12· ·rest of the system needed to do.
`
`13· · · · · · In the positioning of those heating blocks,
`
`14· ·in what orientation were the samples themselves?
`
`15· · · ·A· · So, I don't know exactly how to describe
`
`16· ·it.
`
`17· · · · · · In most cases, the samples were something
`
`18· ·that you might view as approximately -- let's call
`
`19· ·it like a flat sheet, like a business card.· And
`
`20· ·typically, the area of contact, thermal contact
`
`21· ·between the sample and the temperature control
`
`22· ·module or thermal control module is important, so
`
`23· ·they would be face to face, if you will.
`
`24· · · · · · That's the best I think I can describe it.
`
`25· · · ·Q· · Were any of the samples that you were
`
`THERMO FISHER EX. 1050
`
`Agilent Exhibit 1245
`Page 19 of 145
`
`
`
`·1· ·testing liquid samples?
`
`·2· · · ·A· · So, for some of that work, there were
`
`·3· ·liquids.· In other cases, they were PEG polystyrene
`
`·4· ·beads, which are hydrated.· In other cases, they
`
`·5· ·were solids.· And in some cases, they were gases.
`
`·6· ·So, pretty much all of the -- all phases of matter.
`
`·7· · · ·Q· · In those instances where you were using a
`
`·8· ·liquid sample, prior to May of 2003, can you recall
`
`·9· ·any instances where you would have turned that
`
`10· ·liquid sample upside down?
`
`11· · · ·A· · So, in most of those cases, they were --
`
`12· ·so, if -- I don't know what you mean by "upside
`
`13· ·down."· So, if you mean are the liquids below the
`
`14· ·heater?
`
`15· · · · · · So, let me try to get a clarification of
`
`16· ·what "upside down" means.
`
`17· · · ·Q· · Sure.
`
`18· · · · · · Now, in thermal cyclers, for example, there
`
`19· ·are oftentimes sample tubes that are used with
`
`20· ·those, correct?
`
`21· · · ·A· · Yes.
`
`22· · · ·Q· · Okay.· And is it fair to say that a sample
`
`23· ·tube has an opening at the top and, you know, some
`
`24· ·kind of curvature at the bottom to, to hold a liquid
`
`25· ·sample?
`
`THERMO FISHER EX. 1050
`
`Agilent Exhibit 1245
`Page 20 of 145
`
`
`
`·1· · · ·A· · I think that would be pretty common for a
`
`·2· ·sample or -- a sample vessel, yes.
`
`·3· · · ·Q· · Okay.· So, in terms of my questions, if you
`
`·4· ·assume that where the opening is at the top is the
`
`·5· ·top of the sample tube --
`
`·6· · · ·A· · Okay.
`
`·7· · · ·Q· · -- and where the sample is positioned at
`
`·8· ·the bottom of the sample tube would be the bottom of
`
`·9· ·that tube, are there any instances in which you were
`
`10· ·running thermal cycling operations where you turned
`
`11· ·that sample tube upside down?
`
`12· · · ·A· · So, certainly, in most cases, we did not.
`
`13· ·In some cases, we were doing work where capillary
`
`14· ·forces were the dominant force on the liquid.· And
`
`15· ·in those cases, we turned them in all directions.
`
`16· · · · · · In some cases, where there was mixing, we
`
`17· ·might well have a capped tube, and that tube might
`
`18· ·have been rotated.· And so, at some points, it might
`
`19· ·have been upside down.· But when coupled to the
`
`20· ·thermal system, I'd say the most common would put
`
`21· ·the open end up.
`
`22· · · · · · But again, as I said, there were some
`
`23· ·systems that we worked on where we turned them
`
`24· ·sideways or upside down.
`
`25· · · ·Q· · Are you aware of any real-time PCR machines
`
`THERMO FISHER EX. 1050
`
`Agilent Exhibit 1245
`Page 21 of 145
`
`
`
`·1· ·available prior to May of 2003 that could be
`
`·2· ·operated both right-side up and upside down?
`
`·3· · · ·A· · I don't know whether there were or were
`
`·4· ·not.
`
`·5· · · ·Q· · I'm going to hand you a couple of exhibits,
`
`·6· ·so we can use them as reference points.· And all of
`
`·7· ·these exhibits have been previously marked in the
`
`·8· ·IPR proceedings.
`
`·9· · · · · · I'll hand you, first, what's previously
`
`10· ·been marked Bio-Rad Exhibit 2001 in the
`
`11· ·IPR 2017-00054.
`
`12· · · · · · I'm also going to hand you what's
`
`13· ·previously been marked as Thermo Fisher 1001 in what
`
`14· ·I'll call the '054 petition, and this is United
`
`15· ·States Patent 8,236,504 to Kordunsky, et al.
`
`16· · · · · · And I'm also going to hand you what's been
`
`17· ·marked Bio-Rad Exhibit 2003 in IPR2017-00055.
`
`18· · · · · · And again, we'll just shorten that as the
`
`19· ·'055 petition, if that's okay.
`
`20· · · ·A· · Okay.
`
`21· · · ·Q· · So, I'd like to start by looking at Bio-Rad
`
`22· ·Exhibit 2003 from the '055 petition, which is titled
`
`23· ·"Declaration of Dean P. Neikirk, Ph.D., In Support
`
`24· ·of Patent Owner's Response to Petition for Inter
`
`25· ·Partes Review."
`
`THERMO FISHER EX. 1050
`
`Agilent Exhibit 1245
`Page 22 of 145
`
`
`
`·1· · · · · · Do you have that?
`
`·2· · · ·A· · I do.
`
`·3· · · ·Q· · Okay.· And is this the declaration,
`
`·4· ·Dr. Neikirk, that you submitted in support of the
`
`·5· ·patent owner's response in the '055 IPR?
`
`·6· · · ·A· · Flipping to make sure all the pages are
`
`·7· ·here.· Yes, it certainly appears to be.
`
`·8· · · ·Q· · Okay.· And if you could turn to the very
`
`·9· ·last page, page 32.
`
`10· · · ·A· · I'm there.
`
`11· · · ·Q· · Is that your signature at the bottom?
`
`12· · · ·A· · It is.
`
`13· · · ·Q· · Okay.· Could you turn to pages 9 -- let's
`
`14· ·start at page 9 of the Exhibit 2003.
`
`15· · · ·A· · Okay, I'm on page 9.
`
`16· · · ·Q· · Okay.· And do you see the section titled,
`
`17· ·"H, Basis of My Opinions and Materials Considered"?
`
`18· · · ·A· · I do.
`
`19· · · ·Q· · Okay.· And in paragraph 25 -- that extends
`
`20· ·across page 10, as well -- you have a list of bullet
`
`21· ·points of documents that you reviewed and considered
`
`22· ·for purposes of forming your opinion, correct?
`
`23· · · ·A· · That's correct.
`
`24· · · ·Q· · Okay.· Does this list constitute the
`
`25· ·universe of what you considered in forming your
`
`THERMO FISHER EX. 1050
`
`Agilent Exhibit 1245
`Page 23 of 145
`
`
`
`·1· ·opinions for this case?
`
`·2· · · ·A· · For the --
`
`·3· · · ·Q· · And let me clarify that.
`
`·4· · · ·A· · Okay.
`
`·5· · · ·Q· · In forming your opinions for the '055 IPR?
`
`·6· · · ·A· · Yes, it is -- that's the list of materials
`
`·7· ·I've considered in forming my opinions for the '55.
`
`·8· · · ·Q· · Okay.· So, for example, you considered the
`
`·9· ·'504 patent, correct?
`
`10· · · ·A· · That's correct.
`
`11· · · ·Q· · And you considered the prosecution history
`
`12· ·of the '504 patent, correct?
`
`13· · · ·A· · Yes, that is correct.
`
`14· · · ·Q· · Okay.· Now, with regards to the prosecution
`
`15· ·history of the '504 patent, did you review the
`
`16· ·entire prosecution history or only excerpts?
`
`17· · · ·A· · I've been through the entire thing.· I've
`
`18· ·concentrated on certain sections, certainly.
`
`19· · · ·Q· · Okay.
`
`20· · · ·A· · It's a large document, as they frequently
`
`21· ·are.
`
`22· · · ·Q· · Okay.· And you also have in front of you
`
`23· ·Thermo Fisher Exhibit 1001, which is the '504
`
`24· ·patent.
`
`25· · · ·A· · Oh, the patent itself, yes, I do.
`
`THERMO FISHER EX. 1050
`
`Agilent Exhibit 1245
`Page 24 of 145
`
`
`
`·1· · · ·Q· · Okay.· And on the cover of the patent, do
`
`·2· ·you see, on the left-hand column, a reference to
`
`·3· ·related U.S. application data?
`
`·4· · · ·A· · Yes, I do.
`
`·5· · · ·Q· · Okay.· And listed there, it says,
`
`·6· ·"Continuation of application No. 11/555,642 filed on
`
`·7· ·November 1st, 2006, now Patent 7,749,736."
`
`·8· · · · · · Do you see that?
`
`·9· · · ·A· · I do.
`
`10· · · ·Q· · Okay.· In forming your opinions that are
`
`11· ·set forth in Bio-Rad Exhibit 2003, did you consider
`
`12· ·application number 11/555,642 and its prosecution
`
`13· ·history?
`
`14· · · ·A· · So, the prosecution -- that's not the
`
`15· ·prosecution history that I was looking at, as I
`
`16· ·stated in my '55 report.
`
`17· · · ·Q· · Okay.
`
`18· · · ·A· · So, it wasn't the 11/555.
`
`19· · · ·Q· · Okay.· So, for purposes of your report, you
`
`20· ·only considered the file history of the '504 patent,
`
`21· ·correct?
`
`22· · · ·A· · Yes.· The one that's labeled there as
`
`23· ·12/827,525.
`
`24· · · ·Q· · Sorry for all the long numbers.
`
`25· · · · · · Now, there's a second application that's
`
`THERMO FISHER EX. 1050
`
`Agilent Exhibit 1245
`Page 25 of 145
`
`
`
`·1· ·listed on the cover of the '50 patent [sic], as
`
`·2· ·well, which is -- it says, "Continuation of
`
`·3· ·application number 10/431,708, filed on May 8, 2003,
`
`·4· ·now patent No. 7,148,043."
`
`·5· · · · · · Do you see that?
`
`·6· · · ·A· · I do.
`
`·7· · · ·Q· · Okay.· And that is not a prosecution
`
`·8· ·history that you reviewed in forming your opinions
`
`·9· ·as set forth in Exhibit 2003 either, correct?
`
`10· · · ·A· · That's correct.· I've looked at the
`
`11· ·'12 patent application.
`
`12· · · ·Q· · Okay.· And I'm sorry, we'll bounce around
`
`13· ·between some of these declarations throughout the
`
`14· ·day, but if we could turn, then, to Bio-Rad
`
`15· ·Exhibit 2001 from the '054 petition.
`
`16· · · ·A· · I have it.
`
`17· · · ·Q· · And I have the same series of questions for
`
`18· ·this as we just stepped through for the '055
`
`19· ·petition.
`
`20· · · · · · Exhibit 2001 is entitled "Declaration of
`
`21· ·Dean P. Neikirk, Ph.D., In Support of Patent Owner's
`
`22· ·Response to Petition for Inter Partes Review."
`
`23· · · · · · Is this the declaration that you submitted
`
`24· ·in support of the patent owner's response in the
`
`25· ·'054 IPR?
`
`THERMO FISHER EX. 1050
`
`Agilent Exhibit 1245
`Page 26 of 145
`
`
`
`·1· · · ·A· · And again, yes, it certainly appears to be.
`
`·2· · · ·Q· · Okay.· And again, turning to the final
`
`·3· ·page, which is page 47 in this declaration, is that
`
`·4· ·your signature that appears on page 47?
`
`·5· · · ·A· · Yes, it is.
`
`·6· · · ·Q· · Okay.· Now, if we could turn to pages 9
`
`·7· ·through 11 of Exhibit 2001.
`
`·8· · · ·A· · Okay, I'm on page 9.
`
`·9· · · ·Q· · And again, in paragraph 25, you list a
`
`10· ·series of bullet points of documents that you
`
`11· ·reviewed and considered for purposes of forming your
`
`12· ·opinions set forth in the declaration, correct?
`
`13· · · ·A· · That's correct.
`
`14· · · ·Q· · And is the same answer true with regards to
`
`15· ·this declaration that, in terms of file histories
`
`16· ·that you reviewed in forming your opinions, you only
`
`17· ·reviewed the file history for the '504 patent?
`
`18· · · ·A· · Yes.· As I've shown in the second bullet,
`
`19· ·it was the 12/827,521 that I reviewed.
`
`20· · · ·Q· · Okay.· And do the bullet points in
`
`21· ·paragraph 25 constitute the entirety of what you
`
`22· ·considered for purposes of forming your opinions in
`
`23· ·support of patent owner's response in the
`
`24· ·'054 patent [sic] owner's -- in the '054 IPR?
`
`25· ·Excuse me.
`
`THERMO FISHER EX. 1050
`
`Agilent Exhibit 1245
`Page 27 of 145
`
`
`
`·1· · · ·A· ·
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
