Page 1
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` IN THE UNITED STATES DISTRICT COURT
` FOR THE DISTRICT OF DELAWARE
` ---oOo---
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`ABBOTT DIABETES CARE INC.,)
`and ABBOTT DIABETES CARE, )
`LIMITED, )
` )
` Plaintiffs, )
` )
`vs. ) Case No. 1:21-cv-00977-KAJ
` )
`DEXCOM, INC., )
` )
` Defendant. )
`__________________________)
`
` VIDEOTAPED DEPOSITION OF JOHN MASTROTOTARO, Ph.D
`
` SAN FRANCISCO, CALIFORNIA
`
` TUESDAY, APRIL 26, 2023
`
`STENOGRAPHICALLY REPORTED BY:
`
`ANDREA M. IGNACIO, CSR, RPR, CRR, CCRR, CLR ~
`
`CSR LICENSE NO. 9830
`
`JOB NO. 5885863
`
`www.veritext.com
`
`888-391-3376
`
`Veritext Legal Solutions
`
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`Abbott Diabetes Care, Inc., Ex. 1092, p. 1
`Abbott Diabetes Care Inc. v. DexCom, Inc., IPR2022-00913
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`

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`Page 4
`
`1 I N D E X
`
`WITNESS: John Mastrototaro, Ph.D.
`
`2 3
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`4 5
`
`EXAMINATION PAGE
`6 By Mr. Hansen 9
`
`7 8
`
` E X H I B I T S
`9 EXHIBIT PAGE
`10 Exhibit 1 Curriculum Vitae 13
`11 Exhibit 2 Opening Expert Report of 50
`12 John Mostrototaro, Ph.D. Regarding
`13 CGM Development and Invalidity of
`14 U.S. Patent No. 10,827,954
`15 Exhibit 3 Supplemental Opening Expert Report 51
`16 of John Mostrototaro, Ph.D. Regarding
`17 CGM Development and Invalidity of
`18 U.S. Patent No. 10,827,954
`19 Exhibit 4 Rebuttal Expert Report of 51
`20 John Mostrototaro, Ph.D. Regarding
`21 CGM System Technology and Use
`22 Exhibit 5 Preliminary Clinical Results from 55
`23 an Electroenzymatic Glucose Sensor
`24 Implanted in Subcutaneous Tissue
`25
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`Page 2
`1 IN THE UNITED STATES DISTRICT COURT
`2 FOR THE DISTRICT OF DELAWARE
`3 ---oOo---
`
`45
`
`ABBOTT DIABETES CARE INC.,)
`and ABBOTT DIABETES CARE, )
`6 LIMITED, )
` )
`7 Plaintiffs, )
` )
`8 vs. ) Case No. 1:21-cv-00977-KAJ
` )
`9 DEXCOM, INC., )
` )
`10 Defendant. )
`__________________________)
`
`11
`12
`13 Videotaped Deposition of John Mastrototaro,
`14 Ph.D., taken on behalf of the Plaintiff, Pursuant
`15 to Notice, at Keker Van Nest & Peters, LLP,
`16 633 Battery Street, San Francisco, California, on
`17 April 25, 2023, beginning at 9:00 a.m., and ending
`18 at 6:27 p.m., before me, ANDREA M. IGNACIO, CSR,
`19 RPR, CCRR, CRR, CLR ~ License No. 9830.
`20
`21
`22
`23
`24
`25
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`Page 3
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`Page 5
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`1 E X H I B I T S
`2 EXHIBIT PAGE
`3 Exhibit 6 U.S. Patent 6,424,847, Bates 77
`4 DXCMDEL00058838 - '860
`5 Exhibit 7 U.S. Patent 11,000,213 96
`6 Exhibit 8 U.S. Patent 10,827,954, Bates 102
`7 ABTDEL_00103705 - '46
`8 Exhibit 9 Pages 167 - 174 171
`9 Exhibit 10 Provisional Application for 177
`10 Patent Cover Sheet, Bates
`11 DXCMDEL10055809 - '63
`12 Exhibit 11 U.S. Patent Application 197
`13 Publication, US 2006/00944944,
`14 Bates DXCMDEL00060012 - '56
`15 Exhibit 12 U.S. Patent Application 213
`16 Publication US 2009/0178459
`17 Bates DXCMDEL00059290 - '480
`18 Exhibit 13 U.S. Patent Application 223
`19 Publication US 2006/0258959,
`20 Bates DXCMDEL00059879 - '93
`21 Exhibit 14 U.S. Patent US 10,001,450 227
`22 Exhibit 15 U.S. Patent US 9,623,179 232
`23 Exhibit 16 Accuracy of the Enlite 6-Day 247
`24 Glucose Sensor with Guardian and
`25 Veo Calibration Algorithms
`
`1 A P P E A R A N C E S:
`
`2 3 4
`
` FOR THE PLAINTIFF:
`5 MCANDREWS HELD & MALLORY LTD
`6 By: LELAND G. HANSEN, Esq.
`7 ALAND MONTERA, Esq.
`8 THOMAS WIMBISCUS, Esq.
`9 500 W. Madison Street, Suite 34
`10 Chicago, Illinois 60661
`11 Phone: 312.775.8000
`12 lhansen@mcandrews-ip.com
`13
`14 FOR THE DEFENDANT:
`15 KEKER VAN NEST & PETERS
`16 By: MATTHEW WERDEGAR, Esq.
`17 OLIVER FONG, Esq.
`18 350 South Grand Avenue, Suite 3100
`19 Los Angeles, California 90071
`20 kgregory@swlaw.com
`21
`22 ALSO PRESENT: Peter Yaroschuk, Videographer
`23 Scott Davis, Klarquist
`24 ---oOo---
`25
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`www.veritext.com
`
`Veritext Legal Solutions
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`
`Abbott Diabetes Care, Inc., Ex. 1092, p. 2
`Abbott Diabetes Care Inc. v. DexCom, Inc., IPR2022-00913
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`Page 8
`1 MR. WERDEGAR: Matthew Werdegar of Keker --
`2 oh, excuse me. Sorry. Why don't you finish with the
`3 defendant's counsel.
`4 MR. HANSEN: Plaintiff's counsel.
`5 MR. WERDEGAR: Correct. Plaintiff's counsel.
`6 MR. WIMBISCUS: Thomas Wimbiscus on behalf of
`7 Abbott Diabetes Care, attending remotely.
`8 MR. WERDEGAR: Matthew Werdegar of Keker,
`9 Van Nest & Peters, on behalf of DexCom, Inc., and the
`10 witness.
`11 MR. FONG: Oliver Fong. I'm of Keker,
`12 Van Nest & Peters, on behalf of DexCom and the
`13 witness.
`14 MR. WERDEGAR: Also present is Scott Davis of
`15 Klarquist.
`16 THE VIDEOGRAPHER: Thank you.
`17 Will the court reporter please swear in the
`18 witness.
`19
`20 JOHN MASTROTOTARO, Ph.D.,
`21 having been sworn as a witness
`22 by the Certified Shorthand Reporter,
`23 testified as follows:
`24
`25 ///
`
`Page 9
`
`1 EXAMINATION
`2 BY MR. HANSEN:
`3 Q Good morning. You have provided three expert
`4 reports in this matter; is that correct?
`5 A Yes, I have three documents that I've
`6 prepared for this.
`7 Q And do those expert reports that you provided
`8 describe all of the opinions that you intend to offer
`9 in this matter?
`10 A Yes. The three reports that I've written,
`11 edited, put together, represent my thoughts on the
`12 matter at hand.
`13 Q Do you have any opinions that you have formed
`14 relating to this matter that are not set forth in your
`15 expert reports?
`16 A No, I do not have any further opinions beyond
`17 what's written in these reports.
`18 Q In connection with this matter, did DexCom
`19 provide you any information about the calibration of
`20 their products?
`21 MR. WERDEGAR: Objection; vague.
`22 THE WITNESS: I have not spoken to anyone
`23 from DexCom about how their product works in terms of
`24 the calibration process.
`25 MR. HANSEN: Q. Did their counsel provide
`
`Page 6
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`1 P R O C E E D I N G S
`2 TUESDAY, APRIL, 25, 2023
`3 9:00 A.M.
`4 ---oOo---
`
`5 6 7
`
` THE VIDEOGRAPHER: Good morning. We are
`8 going on the record at 9:08 a.m. on April 25th, 2023.
`9 Please note that the microphones are
`10 sensitive and may pick up whispering, private
`11 conversations, and cellular interference.
`12 Please turn off all cell phones or place them
`13 away from the microphones as they can interfere with
`14 the deposition audio.
`15 Audio and video recording will continue to
`16 take place unless all parties agree to go off the
`17 record.
`18 This is Media No. 1 of the video-recorded
`19 deposition of John Mastrototaro, taken by counsel for
`20 defendant.
`21 In the matter of Abbott Diabetes Care,
`22 Incorporated, versus DexCom, Incorporated. Filed in
`23 the United States District Court for the District of
`24 Delaware. Case No. 21-CV-00977 KAJ.
`25 This deposition is being held at 633 Battery
`
`Page 7
`1 Street, San Francisco, California 94111, and on Zoom.
`2 My name is Peter Yaroschuk from the firm
`3 Veritext. I an the videographer.
`4 The court reporter is Andrea Ignacio from the
`5 firm Veritext.
`6 I am not related to any party in this action,
`7 nor am I financially interested in the outcome.
`8 Counsel and all present in the room, everyone
`9 attending remotely, please now state your appearances
`10 and affiliations for the record. If there are any
`11 objections to proceeding, please state them at the
`12 time of your appearance, beginning with the noticing
`13 attorney.
`14 MR. HANSEN: Leland Hansen from McAndrews
`15 Held & Malloy, on behalf of Abbott Diabetes Care.
`16 And just one correction. Counsel for the
`17 Plaintiff.
`18 THE VIDEOGRAPHER: Oh, I'm so sorry.
`19 MR. HANSEN: We're not the defendant. We'll
`20 be taking the deposition today.
`21 THE VIDEOGRAPHER: Thank you for that
`22 correction. Appreciate it.
`23 MR. MONTERA: Alan Montera, also from
`24 McAndrews Held & Malloy, representing Abbott Diabetes
`25 Care.
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`Veritext Legal Solutions
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`Abbott Diabetes Care, Inc., Ex. 1092, p. 3
`Abbott Diabetes Care Inc. v. DexCom, Inc., IPR2022-00913
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`Page 10
`1 you any information orally or via documents about how
`2 DexCom's products are calibrated?
`3 MR. WERDEGAR: I'm just going to caution you.
`4 If you were provided some information that you relied
`5 on in preparing one of your opinions, you can disclose
`6 that information.
`7 Otherwise, I object that it calls for
`8 privileged information and ask you not to disclose it.
`9 THE WITNESS: I was not provided any
`10 information, in forming these opinions, from --
`11 about -- from the attorneys about how DexCom's
`12 calibration algorithms work.
`13 MR. HANSEN: Q. Do you have any information
`14 from any source about how DexCom's calibration
`15 algorithms work?
`16 A No, I don't have any knowledge about exactly
`17 how their calibration algorithms work at DexCom.
`18 Q Do you have any information about how their
`19 calibration algorithms work generally?
`20 MR. WERDEGAR: And same cautions as before
`21 about disclosing anything you learned.
`22 THE WITNESS: From my prior work at Medtronic
`23 and MiniMed prior to that, we developed calibration
`24 algorithms for continuous glucose monitors that I was
`25 very much involved with.
`
`Page 12
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`1 reveal any communications with counsel.
`2 THE WITNESS: Yeah. As it relates to this
`3 matter and what's in these reports, I have been
`4 provided no information about the DexCom product
`5 and -- and how it works.
`6 MR. HANSEN: Q. So separate and apart from
`7 what you relied on in forming your opinions and
`8 preparing your reports, did DexCom or its counsel
`9 provide you any information about the manufacture,
`10 operation, construction of DexCom's products?
`11 MR. WERDEGAR: And I'm going to object that
`12 that calls for information that's protected by the
`13 attorney work product privilege.
`14 I'll instruct you not to answer that
`15 question.
`16 MR. HANSEN: Q. Have you formed any opinions
`17 about whether DexCom's products infringe any of the
`18 patents that are asserted in this lawsuit?
`19 A I -- I don't know specifically how the
`20 DexCom's product works.
`21 So what I comment on in this report is the
`22 validity of the -- of the claims of the patent that I
`23 was asked to opine on, which are Claims 1, 15, 16, and
`24 17 of the '954 patent. So that's all I really focused
`25 my energy on in this, and it's what's included in
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`Page 11
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`Page 13
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`1 MR. HANSEN: Right.
`2 Q I'm asking you specifically about calibration
`3 of DexCom's products.
`4 A No, I have no information about DexCom's
`5 calibration method that they use.
`6 Q Do you have information about the
`7 construction, the mechanicals of their products?
`8 A When I was at Medtronic and MiniMed, we
`9 looked at the DexCom product. We would see, you know,
`10 what the sensors looked like, the transmitter,
`11 et cetera. We even had some employees use the system
`12 at some point in time. So we had that exposure to the
`13 product.
`14 And obviously, at those times, there are the
`15 documentation that comes along with the product, the
`16 user guide and whatnot.
`17 Q Has DexCom or its counsel provided you any
`18 information about the manufacture, construction, or
`19 operation of their products?
`20 MR. WERDEGAR: Again, with respect to
`21 information provided by counsel, same caution.
`22 If you were told something that you've relied
`23 on in forming an opinion, you can reveal that.
`24 THE WITNESS: Okay.
`25 MR. WERDEGAR: Otherwise, I'd ask you not to
`
`1 these documents.
`2 Q And by "this," you're referring to the
`3 three --
`4 A The three.
`5 Q -- expert reports?
`6 A That's correct.
`7 Q So you didn't form any opinions on
`8 infringement then, only validity; is that correct?
`9 A I do not know the specifics of how the DexCom
`10 product works, so I would have no way of assessing
`11 whether or not it may infringe if these claims were
`12 deemed valid.
`13 MR. HANSEN: I'll ask the court reporter to
`14 please mark Exhibit 1.
`15 (Document marked Exhibit 1
`16 for identification.)
`17 THE WITNESS: Thank you.
`18 MR. HANSEN: Q. Do you recognize this as a
`19 copy of your CV that was attached to one of your
`20 expert reports?
`21 A Yes, I do recognize it. This is my CV that I
`22 provided to counsel.
`23 Q And on page 3 of your CV, there is a
`24 description of your education?
`25 A Yes.
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`www.veritext.com
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`Veritext Legal Solutions
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`4 (Pages 10 - 13)
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`888-391-3376
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`Abbott Diabetes Care, Inc., Ex. 1092, p. 4
`Abbott Diabetes Care Inc. v. DexCom, Inc., IPR2022-00913
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`Page 14
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`Page 16
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`1 Q Is that a complete description of your
`2 education after high school?
`3 A Yes, it is. I have a B.A. in math and
`4 physics from Holy Cross College, and a master's and
`5 Ph.D. in biomedical engineering from Duke University.
`6 Q And beginning on page 1 and continuing over
`7 to page 3, there's a description of your professional
`8 experience?
`9 A Yes. My professional background and
`10 experience with the various companies I was with and
`11 the positions I held are provided on pages 1 through
`12 3.
`13 Q And is that a complete and accurate
`14 description of your professional experience?
`15 A I -- I believe it is fully complete. There
`16 may be a position or two or a title change left out
`17 from very early in my career. But all -- all of the
`18 entries listed are accurate.
`19 Q The -- under "Professional Experience," the
`20 first entry in order -- in order of time, I presume,
`21 is a position with Eli Lilly?
`22 A I -- I joined Eli Lilly after I graduated
`23 from Duke with my Ph.D. in biomedical engineering,
`24 and -- and that was my first job after the completion
`25 of my Ph.D.
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`Page 15
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`1 Q When did you complete your B.A. degree in
`2 math and physics?
`3 A I completed my B.A. degree from Holy Cross in
`4 1982.
`5 Q And when did you complete your M.S. degree at
`6 Duke?
`7 A At Duke University, I received my M.S. degree
`8 in 1984.
`9 Q And when did you receive your Ph.D. from
`10 Duke?
`11 A Got my Ph.D. from Duke University in 1989.
`12 Q And when did you begin working at Eli Lilly?
`13 A I began working at Eli Lilly in 1989.
`14 Q And how long did you work at Eli Lilly?
`15 A I worked at Eli Lilly for four years, from
`16 1989 to 1993.
`17 Q While you were at Eli Lilly, did you do any
`18 work relating to glucose monitoring?
`19 A I did work on development of glucose
`20 monitoring in two capacities when I was at Eli Lilly.
`21 One related to subcutaneous indwelling sensors for
`22 glucose. And the second was, I also looked at some
`23 noninvasive glucose monitoring technologies.
`24 Q What were the noninvasive glucose monitoring
`25 technologies that you looked into?
`
`1 A While I was there, we were looking at some
`2 near infrared and infrared optical-based monitoring to
`3 try to ascertain if using different frequencies of
`4 light shined into the body could discriminate and
`5 detect varying ox -- glucose concentrations.
`6 Q And what was the result of that work?
`7 A That was very challenging to try to make an
`8 optical sensor work for glucose monitoring. There's a
`9 lot of interference due to water and other
`10 constituents in the body.
`11 So in some cases you could see a little bit
`12 of a trend with those approaches, but we weren't able
`13 to develop something that could -- we thought could be
`14 commercialized in that regard.
`15 Q Now, the other project you worked on you
`16 described as a subcutaneous indwelling sensor?
`17 A That's correct.
`18 Q Can you describe that in a little more
`19 detail.
`20 A It was a sensor that was built up planer
`21 fashion. My Ph.D. work involved developing sensors
`22 with a planer construct using innovative circuit
`23 fabrication technology.
`24 And we did some basic work building up a -- a
`25 sensor that could be used subcutaneously with a --
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`Page 17
`1 with a fairly traditional glucose oxidase-based system
`2 with three -- three electrodes working counter
`3 reference and membrane and membranes on top of it.
`4 Q And what happened to that project?
`5 A I -- two things. One, Eli Lilly started to
`6 look more into the noninvasive approaches. Also, they
`7 started to back off a little bit more from medical
`8 devices in general.
`9 Around that time, I was also basically
`10 interviewed for a job at a company called MiniMed
`11 who -- who had an insulin pump and was looking to
`12 establish a continuous glucose monitoring program.
`13 Q So Eli Lilly was moving away from invasive
`14 glucose monitoring technology, and they were moving
`15 away from medical devices generally.
`16 And I take it you were interviewed for a
`17 position at MiniMed. And I assume then that you were
`18 suggesting that you then left for MiniMed in this time
`19 frame?
`20 MR. WERDEGAR: Objection; compound.
`21 THE WITNESS: I would say that a few things
`22 were going on at the same time.
`23 Eli Lilly was starting to look at
`24 transitioning out of medical devices. In fact, they
`25 ultimately did. They sold off of a lot of the medical
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`Abbott Diabetes Care, Inc., Ex. 1092, p. 5
`Abbott Diabetes Care Inc. v. DexCom, Inc., IPR2022-00913
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`Page 18
`1 device divisions that they had. And so -- so that was
`2 going on.
`3 But I actually, interestingly, didn't
`4 interview for a job at MiniMed to start. I had a
`5 couple of visitors, the then founder and CEO, who came
`6 to visit me and talk to me. And I didn't know they
`7 were interviewing me at the time, but they were.
`8 MR. HANSEN: Q. So what ultimately happened
`9 to the project that you worked on relating to a
`10 subcutaneous indwelling glucose sensor?
`11 A After I left the company and took a role with
`12 MiniMed, which I was interested in because they had an
`13 insulin pump, and there was the -- the promise of an
`14 artificial pancreas, I -- I did not -- I have no
`15 knowledge of what they may have done after that fact.
`16 Q Was there ever a commercial product, based on
`17 the work you did at Eli Lilly, relating to a
`18 subcutaneous indwelling glucose sensor?
`19 A I'm unaware of any commercial product that
`20 Lilly ever -- ever distributed that was a glucose
`21 sensor like the one that I was describing.
`22 Q Did this subcutaneous indwelling glucose
`23 sensor require calibration?
`24 A In -- in the -- the form factor that we had
`25 at the time, it did require calibration of the sensor,
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`Page 20
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`1 sensor is measuring and the glucose concentration.
`2 Q And so could that be described with the
`3 often-used equation for a linear relationship,
`4 y = mx + b?
`5 A Yes. For the linear relationship we had, it
`6 was basically a y = mx + b equation. There could be a
`7 "b," which means an offset associated with the -- with
`8 the system that's incorporated, as well as the ratio
`9 of the calibration factor.
`10 Q And what you're referring to as the
`11 calibration factor would be "m" in the equation
`12 y = mx + b?
`13 A Yes. The calibration factor or sensitivity
`14 factor. People use different terms for it. But that
`15 would be the "m" in the equation.
`16 Q And in that equation, "x" would be the
`17 glucose concentration?
`18 A No. "x" is the signal occurring -- coming
`19 out of the sensor. And then the -- the -- the answer
`20 is the glucose concentration, which would be
`21 y = mx + b. So the glucose equals a factor times the
`22 current that you're measuring plus the offset, and --
`23 and that provides the glucose.
`24 Q And so in the equation y = mx + b, "b" would
`25 be the offset?
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`Page 19
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`Page 21
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`1 yes.
`2 Q And how was it calibrated?
`3 A The way we would calibrate a glucose sensor
`4 is we would -- in in vivo uses, we would ask the user
`5 to perform a finger stick glucose measurement, and
`6 they would get that value of the finger stick. They
`7 would enter that value into a device so that we could
`8 pair it with what the sensor was reading at that time,
`9 and use that to develop our calibration factor for
`10 ongoing prospective data from that point forward.
`11 Q Was it a -- a single finger stick data point
`12 that was used to calibrate?
`13 A As it relates to the work that I did at
`14 Eli Lilly, and maybe early in MiniMed, we sometimes
`15 asked users to perform more than one finger stick at a
`16 particular time to assure that there was no problem
`17 with an individual finger stick reading when we were
`18 doing some of the clinical work that was part of the
`19 development of the -- of the platform.
`20 Q Did the calibration of this sensor at
`21 Eli Lilly involve any type of a mathematical equation
`22 used to model the relationship between the sensor
`23 signal and the glucose concentration?
`24 A Yes. There is a relationship that in general
`25 terms is somewhat linear between the current that the
`
`1 A "b" is the offset in the equation y = mx + b,
`2 yes.
`3 Q And are there other names that have been used
`4 to describe the offset, such as baseline?
`5 A The -- the "b" or the offset could be --
`6 like, a baseline current with a sensor in zero
`7 glucose, as an example, would often be referred to
`8 as -- as "b" or the offset, yes.
`9 Q So "b" could be an off- -- described as an
`10 offset. It could also be described as a baseline;
`11 correct?
`12 A If -- if it's -- if -- if "b" is described as
`13 a baseline with respect to the zero glucose
`14 concentration, you know, a certain value of current
`15 that may be associated with that, then -- then that
`16 would be correct.
`17 Q And if you're using the linear equation
`18 y = mx + b to model your sensor, "b" would represent
`19 the current generated by the sensor when there is zero
`20 glucose concentration; correct?
`21 MR. WERDEGAR: Objection; asked and answered.
`22 THE WITNESS: Yes. "b" would represent that
`23 baseline -- that baseline value in -- in the presence
`24 of zero glucose.
`25 MR. HANSEN: Q. A mathematician would call
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`Abbott Diabetes Care, Inc., Ex. 1092, p. 6
`Abbott Diabetes Care Inc. v. DexCom, Inc., IPR2022-00913
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`Page 22
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`1 that the Y intercept; correct?
`2 A A mathematician, if you draw that equation,
`3 would refer to the -- the "b" as the Y intercept,
`4 yeah, where it crosses the 0 line.
`5 Q So I need clarification on one thing you
`6 said. We're discussing using a linear equation as a
`7 mathematical model to describe the relationship
`8 between the sensor signal and the glucose
`9 concentration.
`10 And a mathematician often writes the equation
`11 for a line as y = mx + b; correct?
`12 A The mathematician would often use the
`13 equation y = mx + b to represent a line.
`14 Q And in that -- in that equation as used to
`15 model a glucose sensor, isn't it true that "x"
`16 represents the glucose concentration, and "y"
`17 represents the sensor signal?
`18 A It depends. You can actually write the
`19 equation whichever way you want. I can take the
`20 equation for -- and put it in terms of "y", and I can
`21 take the equation and put it in terms of "x".
`22 Q Right.
`23 A So I can -- I can put y - b, and then I can
`24 divide by m. And I can say y - b ÷ m = x. So in a
`25 linear equation, I can put the equation in terms of
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`Page 23
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`1 the Y axis or the X axis. It's a matter of which way
`2 you want to -- to write the equation --
`3 Q Right.
`4 A -- and what you're measuring. You can do it
`5 either way.
`6 Q Right. I understand that the equation can be
`7 written in various forms.
`8 A Right.
`9 Q What I'm trying to understand is: In that
`10 equation, regardless of the form in which it's written
`11 in, isn't "x" typically associate -- isn't the
`12 variable "x" typically assigned to the glucose value,
`13 the glucose concentration, and "y" assigned to the
`14 sensor signal that is associated with that glucose
`15 concentration, the glucose concentration typically in
`16 milligrams per deciliter, and the sensor signal, for
`17 example, in nanoamps or however you're measuring the
`18 signal?
`19 A The way that we did the equation was, we had
`20 to calculate the glucose from a sensor current, so we
`21 measured the sensor current.
`22 If the sensor current is 10 nanoamps, and the
`23 glucose is 100 milli- -- let's assume "b" is 0, for
`24 the sake of argument, to make the math easier. I'm
`25 going to come up with a calibration factor for -- for
`
`Page 24
`1 my sensor to convert from nanoamps to glucose.
`2 So "m" in the example I gave would be 10.
`3 And so if I determined that I take nanoamps and
`4 multiply by 10 to get glucose of 100, then later on,
`5 if I'm measuring 20 nanoamps per current and I
`6 multiply by 10, I would calculate what the glucose is,
`7 which is 200.
`8 So in the way I've described the equation,
`9 the glucose is equal to this calibration factor of 10
`10 times the ISIG, which is the current, plus "b".
`11 And that's the model that we used when we
`12 were calculating glucose.
`13 Q And this is at Eli Lilly?
`14 A This is at Eli Lilly.
`15 We also used a similar algorithm at MiniMed,
`16 and then later, Medtronic.
`17 Q Now, if we look at the equation y = mx + b,
`18 and if "b" represents the sensor signal when the
`19 glucose concentration is 0, then if -- if that's how
`20 we're using the equation, "y" is the sensor signal;
`21 correct?
`22 A If -- if -- if "b" represents a current, then
`23 it has to be multi -- it has to be converted to a
`24 glucose in that regard.
`25 If "b" represents the offset of what the
`
`Page 25
`1 glucose reads, what the -- what the glucose represents
`2 from the offset, then it's not.
`3 So yes. If you -- if you do it that way,
`4 then the -- then the offset is subtracted from the
`5 ISIG and then multiplied by the -- by "m".
`6 Q So you said that you left Eli Lilly and went
`7 to MiniMed.
`8 And how long did you work at MiniMed?
`9 A I worked at MiniMed from 1993 to -- I believe
`10 it was 2001 when -- when we were acquired by
`11 Medtronic. And then I stayed on and -- and stayed on
`12 with the company -- with Medtronic after that. So
`13 MiniMed became part of Medtronic, and I continued on
`14 there. And I was then at Medtronic all the way
`15 through 2017.
`16 Q What type of company is Medtronic?
`17 MR. WERDEGAR: Objection; vague.
`18 THE WITNESS: Medtronic is a medical device
`19 company.
`20 MR. HANSEN: Q. Do they sell medical devices
`21 other than products associated with diabetes?
`22 A Yes. Medtronic has many subdivisions that
`23 are developing many different products that are
`24 medical devices for people with different chronic
`25 conditions and whatnot.
`
`www.veritext.com
`
`Veritext Legal Solutions
`
`7 (Pages 22 - 25)
`
`888-391-3376
`
`Abbott Diabetes Care, Inc., Ex. 1092, p. 7
`Abbott Diabetes Care Inc. v. DexCom, Inc., IPR2022-00913
`
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`Page 26
`1 Q Can you give me some examples of Medtronic
`2 products that are not related to diabetes?
`3 A Medtronic makes pacemakers. They make
`4 implantable defibrillators. They make stents. They
`5 make hospital-based products and -- and platforms.
`6 They make some neuro platforms, some stimulating --
`7 stimulators for different chronic condition platforms;
`8 a number of different medical devices.
`9 Q At Medtronic while you were there, were the
`10 diabetes-related devices considered as important as
`11 these other technologies?
`12 MR. WERDEGAR: Objection; vague.
`13 THE WITNESS: If you base importance on the
`14 percentage of the company's revenue, they were -- I
`15 believe that when we first joined, we were, you know,
`16 generating several hundred million dollars in revenue,
`17 and that revenue was growing faster than the other --
`18 most of the other divisions.
`19 So from a growth perspective, it was deemed
`20 as very important, and overall, just important to
`21 their mission of helping people who are living with
`22 chronic conditions.
`23 MR. HANSEN: Q. Do you feel that Medtronic
`24 devoted adequate resources in terms of sales force and
`25 management and marketing to their diabetes-related
`
`Page 28
`
`1 A Yes. There were several products that we
`2 released during my tenure at MiniMed and then
`3 Medtronic Diabetes.
`4 Q And starting with the earliest such product,
`5 what were these products?
`6 A The earliest product was the Medtronic CGMS
`7 platform. It was launched in 1999.
`8 Q And what was next?
`9 A The next after that would have been the CGMS
`10 System Gold, maybe, I believe. I -- I would have to
`11 check back at all the different iterations, because we
`12 had a number of different products that we launched
`13 over time. But it was another version of the CGMS,
`14 which was a retrospective monitoring system.
`15 Q Which was a retrospective monitoring system?
`16 A The initial CGMS product launched in 1999 was
`17 a retrospective monitor. It worked in an analogous
`18 way to a cardiac holder monitor, that it was worn for
`19 several days, collect all the data in the memory. And
`20 then after wear -- the wear period, the data would be
`21 downloaded. And the endocrinologist would get a
`22 report of all of the CGM data over the course of the
`23 time frame that the user was wearing the system.
`24 Q And what was the wear period?
`25 A Excuse me?
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`Page 27
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`Page 29
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`1 products?
`2 MR. WERDEGAR: Objection; vague; vague as to
`3 time.
`4 THE WITNESS: When I was there, we had a very
`5 significant product development team in terms of size,
`6 marketing, sales. Customer service was very important
`7 to us as an organization, and those departments
`8 continued to be supported, similar to the way they
`9 were prior to the acquisition.
`10 MR. HANSEN: Q. So in your answer that you
`11 just gave, were you speaking to the diabetes-related
`12 products, or their -- Medtronic's entire product
`13 portfolio?
`14 A I was referring to the diabetes-related
`15 business unit which I was in at the time. I didn't
`16 have as much clarity to how the other business units
`17 may be staffing and whatnot.
`18 Q What was the name of the diabetes-related
`19 business unit at Medtronic?
`20 A Originally, I think we kept the MiniMed name
`21 as part of it. But then later on, it just became
`22 Medtronic Diabetes.
`23 Q During the time that you were at MiniMed and
`24 Medtronic, did the company release products for
`25 continuous glucose monitoring?
`
`1 Q What was the wear period for the --
`2 A The wear --
`3 Q -- CGMS?
`4 A The wear period for the CGMS was 72 hours.
`5 Q And how was the CGMS Gold different from the
`6 original CGMS?
`7 A The CGMS System Gold had some im