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`Frank Fronczak, Ph.D. - June 6, 2019
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`Page 1
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` UNITED STATES PATENT AND TRADEMARK OFFICE
`
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
` Petitioner,
`
`INTUITIVE SURGICAL, INC.,
`
`____________________________________
` )
` )
` )
` ) IPR No.
` )
` vs. ) 2018-00936
` )
`ETHICON, LLC., )
` )
` Patent Owner. )
` )
`____________________________________)
`
` DEPOSITION OF FRANK FRONCZAK, Ph.D.
`
` Washington, D.C.
`
` June 6, 2019
`
`REPORTED BY: Tina Alfaro, RPR, CRR, RMR
`
`GregoryEdwards, LLC | Worldwide Court Reporting
`GregoryEdwards.com | 866-4Team GE
`
` 1
`
`Exhibit 1023
`Intuitive v. Ethicon
`IPR2018-01254
`
`
`
`Frank Fronczak, Ph.D. - June 6, 2019
`
`Page 2
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` Deposition of FRANK FRONCZAK, Ph.D., held
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`at the offices of:
`
` Weil Gotshal & Manges, LLP
`
` 2001 M Street, NW, Suite 600
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` Washington, D.C. 20036
`
` Taken pursuant to notice before Tina M.
`
`Alfaro, a Notary Public within and for the District
`
`of Columbia.
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`Page 3
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`APPEARANCES:
`
` ON BEHALF OF THE PETITIONER:
`
` FISH & RICHARDSON
`
` BY: STEVEN KATZ, ESQ.
`
` One Marina Park Drive
`
` Boston, Massachusetts 02210
`
` (617) 542-5070
`
` ON BEHALF OF THE PATENT OWNER:
`
` WEIL GOTSHAL & MANGES
`
` BY: CHRISTOPHER PEPE, ESQ.
`
` 2001 M Street, NW, Suite 600
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` Washington, D.C. 20036
`
` (202) 682-7000
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`Frank Fronczak, Ph.D. - June 6, 2019
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`Page 4
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` I N D E X
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` EXAMINATION
`
`WITNESS PAGE
`
`FRANK FRONCZAK, Ph.D.
`
` By Mr. Katz 5
`
` ******
`
` PREVIOUSLY MARKED EXHIBITS
`
`PETITIONER EXHIBITS DESCRIPTION PAGE
`
`Exhibit 1001 '658 Patent 41
`
`Exhibit 1003 Knodel declaration 88
`
`Exhibit 1004 Wales reference 180
`
`Exhibit 1006 Tierney patent 72
` application
` publication
`
`PATENT OWNER EXHIBITS DESCRIPTION PAGE
`
`Exhibit 2005 Fronczak declaration 6
`
`Exhibit 2008 Article 127
`
`Exhibit 2013 '320 Patent 121
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` ******
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`Frank Fronczak, Ph.D. - June 6, 2019
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` (Witness sworn.)
`
`WHEREUPON:
`
` FRANK FRONCZAK, Ph.D.,
`
`called as a witness herein, having been first duly
`
`sworn, was examined and testified as follows:
`
` EXAMINATION
`
`BY MR. KATZ:
`
` Q. Welcome, Dr. Fronczak. Could you spell
`
`your name for the record.
`
` A. Sure. F-R-O-N-C-Z-A-K.
`
` Q. And do you understand that you're here to
`
`testify regarding IPR 2018-00936?
`
` A. I -- the numbers don't ring a bell, but I
`
`presume that you've got it correct.
`
` Q. Okay. Well, do you understand that you're
`
`here to testify about an IPR concerning the
`
`'658 Patent?
`
` A. Yes, I do.
`
` Q. Okay. Great. And you believe you're an
`
`expert in the relevant field of the'658 Patent?
`
` A. I believe I am, yes.
`
` Q. And what do you generally view that field
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`Frank Fronczak, Ph.D. - June 6, 2019
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`Page 6
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`to be?
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` A. Surgical devices, in general surgical
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`devices. I think I have some of this in my report.
`
`Would you mind giving me a copy of my report
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`because it will help refresh my memory as we go
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`along. I'm sorry, declaration, not a report.
`
` Q. Yeah. I had that out here a moment ago.
`
`I think it's 2005. So I'm going to hand you what
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`has been previously marked as Exhibit 2005 which
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`is, I believe, your declaration; is that correct?
`
` A. Looks like it, yes.
`
` Q. Okay. So feel free to reference that. So
`
`my question is, again, what do you view the field
`
`to be at issue in this proceeding?
`
` MR. PEPE: Object to form.
`
`BY THE WITNESS:
`
` A. The broad field is surgical -- surgical
`
`devices, and then in particular this particular
`
`device -- let's just leave it as surgical devices
`
`as the broad field.
`
` Q. Can you just tell me what is the basis for
`
`your expertise in surgical devices?
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`Frank Fronczak, Ph.D. - June 6, 2019
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`Page 7
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` A. Well, a variety of things. I'm a retired
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`professor, title is emeritus professor. I was a
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`professor of mechanical and biomedical engineering
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`at the University of Wisconsin, Madison for about
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`30 years or so. During that time I taught courses
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`in mechanical design. I also instituted and taught
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`a sequence of courses in biomedical engineering
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`design of devices. Some of those devices that we
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`designed, the students with my supervision designed
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`was -- were surgical devices.
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` I also am -- have been and am currently
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`the principal mechanical design advisor for Marvel
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`Medtech, LLC, which is a small, relatively early
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`startup firm. In time we've been doing this for --
`
`working on this for several years, but I still
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`consider us a startup firm working on a surgical
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`device, minimally invasive robotic surgical device.
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`So that work certainly is particularly relevant.
`
` I've also worked on projects both in
`
`conjunction with my teaching as well as my research
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`in advising grad students in the area of robotics,
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`some haptics surgical devices, for example. Marvel
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`Frank Fronczak, Ph.D. - June 6, 2019
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`Page 8
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`Medtech is an outgrowth of a product that we
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`designed, a minimally invasive MRI image-guided
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`breast cancer biopsy needle-positioning device.
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`We've extended beyond that instead of just doing it
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`for taking biopsies, but also extending on into
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`doing treatment of the tumors.
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` We also -- I've also worked on a liver
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`biopsy tool, surgical device, an intracranial
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`router for infant surgery -- an intracranial -- I'm
`
`sorry -- a router for intracranial surgery on
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`infants. I've also worked on a goniometer which
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`was used for control -- providing input for control
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`of a robotic hand. I've worked on meso scale,
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`that's M-E-S-O scale, hydraulic systems for robotic
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`applications, particularly a high torque, low speed
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`harmonic drive hydraulic motor. I've worked on a
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`continuum hydraulic pneumatic actuator.
`
` I don't think I've captured everything,
`
`but I think I've given you pretty much most of what
`
`is relevant. Oh, there's another one comes to
`
`mind. I worked on an intramedullar bone
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`lengthening device.
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`Frank Fronczak, Ph.D. - June 6, 2019
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`Page 9
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` Q. All right. And so you mentioned a lot of
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`robotics in there. Do you view the '658 Patent as
`
`being limited to robotics?
`
` A. No. No. I didn't mean to -- there were a
`
`lot of things in there that I talked about that
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`were not robotics as well.
`
` Q. And so in the Marvel Medtech company, do
`
`you view that as a company that is or is going to
`
`be in competition with Intuitive Surgical?
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` MR. PEPE: I'm going to object and, Frank,
`
`caution you this is a public record. So be careful
`
`in terms of your response and any confidential
`
`information of that company.
`
`BY THE WITNESS:
`
` A. I don't know what all Intuitive's plans
`
`are. So I don't know if we would be in competition
`
`with them.
`
` Q. Okay. Setting aside Intuitive's plan,
`
`based on what Intuitive Surgical does today, does
`
`Marvel Medtech intend to develop robots that would
`
`be sold in competition to what Intuitive Surgical
`
`is offering today?
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`Frank Fronczak, Ph.D. - June 6, 2019
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` A. You know, I couldn't say, and I couldn't
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`say -- on the basis of two reasons I couldn't say.
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`Partly because our plans are continuously evolving
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`with Marvel Medtech, we're still in relatively
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`early stages, we're still deciding what we're going
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`to do and how we are going to proceed with our
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`device, and furthermore, I don't know the details
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`of all that Intuitive is doing in this particular
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`area.
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` Q. Are you familiar with the Intuitive
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`da Vinci robot?
`
` A. Let me back up and add to that just a
`
`little bit, elaborate on this. I don't see us in
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`direct competition, although that does not mean
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`that it couldn't happen or that there might be
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`something that Intuitive is doing that I'm not
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`aware of. But I'm not aware of any direct
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`competition that we have with our device with what
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`Intuitive is doing.
`
` Q. Are you familiar with the Intuitive
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`robots?
`
` A. I'm generally familiar with the Intuitive
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`da Vinci system robot.
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` Q. Which one are you referring to?
`
` A. Well, which model number you're saying?
`
` Q. What time period?
`
` A. Oh, I'm generally aware of it from
`
`probably over the last ten years or so, give or
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`take.
`
` Q. Okay. Have you ever actually used one?
`
` A. No, I have not.
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` Q. Have you ever physically seen one?
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` A. I may have. I don't recall specifically
`
`if I have or not.
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` Q. All right. And so where -- where does the
`
`general familiarity come from?
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` MR. PEPE: Object to form.
`
`BY MR. KATZ:
`
` Q. I'll ask it again. You say you're
`
`generally familiar with the da Vinci robot. Where
`
`does your information come from?
`
` A. Published information, conversations with
`
`surgeons. I guess that would be it.
`
` Q. Okay. And is some of the published
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`Page 12
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`information including the exhibits that you cite in
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`your declaration that refer to the da Vinci robot?
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` A. Well, that would be included, but I don't
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`know if there's anything particularly new that I've
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`seen. Perhaps there is, but, once again, you know,
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`I'm generally -- have been generally familiar with
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`it. I've been working in the area of medical
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`devices for several years, and so part of that is
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`to become familiar with what's going on. Not
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`necessarily intimately familiar, but at least
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`generally familiar.
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` Q. Do you consider yourself to be an expert
`
`in robotics?
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` A. Well, I consider myself to be an expert in
`
`the robotics sufficiently to be able to assess the
`
`'658 Patent and the technology associated with the
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`'658 Patent.
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` Q. And the '658 Patent in addition to robotic
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`embodiments has kind of handheld surgical
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`instrument embodiments as well?
`
` A. I would have phrased it differently. I
`
`would say it has handheld surgical instruments and
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`Frank Fronczak, Ph.D. - June 6, 2019
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`Page 13
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`in addition it has robotics, yes.
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` Q. Do you believe that your expertise extends
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`to handheld surgical instruments as well as robotic
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`surgical instruments?
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` A. Yes, I believe that would be correct. As
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`I said, Marvel Medtech is a robotic medically-
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`invasive surgical device, and so certainly
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`they're -- I'm intimately familiar with our system.
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` Q. Actually, I was referring to the handheld
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`piece. Do you consider yourself to be an expert in
`
`just nonrobotic handheld surgical instruments?
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` A. I believe that my expertise includes
`
`handheld surgical devices as well.
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` Q. Have you ever designed a handheld surgical
`
`device?
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` A. Certainly the liver biopsy tool is a
`
`handheld device. The intracranial router for
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`infant surgery is a handheld device as well.
`
` Q. And what year was, if you know, the liver
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`biopsy tool developed or over what period of years?
`
` A. I don't recall. It's been several years
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`ago.
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`Page 14
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` Q. A lot -- in this deposition we're going to
`
`be talking a lot about what people would have known
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`in 2006, which was before the earliest priority
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`date of the '658 Patent.
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` A. I thought it was 2007.
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` Q. I'm saying -- I'm picking the year before
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`that.
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` A. Oh, okay. Okay.
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` Q. So I'll be using 2006 because we know
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`that's before --
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` A. Okay.
`
` Q. -- the 2007 date of the '658 Patent. Do
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`you know if the liver biopsy tool you designed was
`
`before or after 2006?
`
` A. I don't recall.
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` Q. What about the cranial router tool?
`
` A. I don't recall.
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` Q. Can you tell me a little bit about what
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`the liver biopsy tool was physically?
`
` A. Well, it's a tool for taking biopsies of
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`suspect tissue in livers, and in particular there's
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`an issue with cauterization and a large -- part of
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`Page 15
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`the work that I was focusing on at that time was
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`including -- was looking at the cauterization
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`issues associated with that tool.
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` Q. Did the tool have like some kind of a
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`gripper at the end, like a handle on one side, a
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`long shaft, and a gripper on the other?
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` A. I don't recall. It's been a long time
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`since I've worked on that. I really don't recall
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`and I haven't reviewed it in several years. So I'm
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`really drawing a blank on that.
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` Q. Have you ever worked on like the
`
`mechanical linkages of a surgical tool, you know,
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`going from a handle through gears to some end
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`effector?
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` A. Certainly without going into too much
`
`detail in our work in our Marvel Medtech, yes.
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` Q. What year did that start?
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` A. I don't know. If you give me my CV -- I'm
`
`sorry. My CV is here. I might be able to nail it
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`down, but I'm not sure that I can or not.
`
` Q. Why don't you take a look and see if you
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`can at least give it a range.
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` (Witness reviewing document.)
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`BY THE WITNESS:
`
` A. I don't have the specific dates down here
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`for when I was doing some of this work, but the
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`best I can -- hang on a second. Maybe I can find
`
`one more thing here.
`
` Looks like the work on the liver biopsy
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`tool was started somewhere around 2000 and extended
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`for several years after that because I see that we
`
`have a paper in 2001. There was another paper in
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`2003 on that, and then the work continued on after
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`that.
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` So that's -- and the breast cancer biopsy
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`positioning device, that would have started about
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`the same time. So I'd say late 1900s through --
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`and then the work on the biopsy was extended from
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`the late 1900s until now, continuously. I've been
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`working on that somewhat in fits and spurts, but
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`pretty much continuously over that period of time.
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` Q. And your focus has been on the
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`cauterization aspect of the tool?
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` A. No, no, no. That was for the -- just for
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`the liver biopsy tool, the Marvel Medtech tool.
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`The MRI image-guided breast cancer positioning tool
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`focuses on everything, pretty much everything.
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` Q. And you're saying that the breast cancer
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`positioning tool work started prior to 2006?
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` A. Oh, yeah. Yes. I'm sorry. Oh, yes.
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` Q. Just as a reminder, the court reporter is
`
`motioning it's important that we don't talk over
`
`each other. That time I was talking over you. I'm
`
`going to refrain from doing that. Again, I'll wait
`
`until you finish, and if you wait until I finish,
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`the court reporter will be much happier.
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` A. I agree. I understand. I don't want to
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`make her job any more difficult than it is. We've
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`already thrown some words at her that I think
`
`probably challenge even the best court reporter.
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` Q. Were there -- so in the tool you were just
`
`referring to, the breast cancer positioning tool,
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`can you describe what is that tool? What does that
`
`mean?
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` MR. PEPE: Object to form.
`
`BY THE WITNESS:
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` A. Well, it's more than just the tool, it's a
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`system. So what we have without -- there are
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`certain things I can't tell you about it because
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`some of this material is being protected by trade
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`secret -- or the plan is to protect it by trade
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`secret, our intellectual property. So I can't tell
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`you everything about it, but I can tell you in
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`general terms.
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` Q. Let me just interrupt you there to make
`
`sure we're talking about the same thing. I want to
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`talk about only work that was prior to 2006. So
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`that's over ten years ago now. Is there -- are
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`there still trade secrets tied to the work you did
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`before 2006?
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` A. Yes.
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` Q. Okay. So, again, talking about what this
`
`tool you were working on did in 2006, if you could
`
`tell me just generally without revealing
`
`confidential information what the tool consisted
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`of.
`
` A. Okay. So what it -- it is a system which
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`includes devices and control of those devices for
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`Page 19
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`detecting and inserting a biopsy tool for -- which
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`is MRI-image guided while in the bore of an MRI
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`machine and actively guiding the positioning and
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`insertion of the tool -- actually guiding the
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`positioning of the tool while the tool is being
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`inserted by hand.
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` Q. To the extent you can tell me, how does a
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`machine guide a tool if it's being inserted by
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`hand?
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` A. The insertion of the tool -- I have to be
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`careful here on what's been revealed or not.
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` MR. PEPE: Frank, before you answer, I'll
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`just caution you to be conservative obviously --
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` THE WITNESS: That's what I'm thinking.
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` MR. KATZ: I'm going to actually withdraw
`
`the question.
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` THE WITNESS: Okay.
`
`BY MR. KATZ:
`
` Q. Let's talk about the biopsy tool. A
`
`biopsy tool is a tool that removes tissue?
`
` A. We're getting into some of the technology
`
`that -- let me ask -- I can only give you a partial
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`answer to that. It can be.
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` Q. Okay. And you're saying that's a partial
`
`answer due to confidentiality, not due to lack of
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`knowledge?
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` A. Not due to lack --
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` Q. Are you telling me you can only give me a
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`partial answer because to go any further would be
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`confidential or that's the extent that you know?
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` A. Confidentiality issues.
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` Q. Okay. I'm just trying to figure out what
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`this tool is. So this is a tool that was never
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`released publicly you're talking about?
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` A. Was not what?
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` Q. Released publicly.
`
` A. Not to the general public, no.
`
` Q. Okay.
`
` A. Not the version that we've been working
`
`on. An earlier version was, but not the one that
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`we're working on and have been working on
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`continuously since around 2000.
`
` Q. Okay. So earlier version, you mean
`
`pre-2000?
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` A. I think it was pre-2000, yes.
`
` Q. Okay. I just want to understand what a
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`biopsy tool is. I'm not a surgeon. So the one
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`that was publicly known around or before 2000, what
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`did that tool do?
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` A. Okay. I can talk about that.
`
` I know we filed a patent application for
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`that and I thought we got a patent on that early
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`tool. We've gone well beyond that. Yeah. I think
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`the early one -- I don't remember the year, but in
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`my CV we have positional for medical devices such
`
`as biopsy needles, U.S. Patent No. 6,558,337.
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` Q. Okay.
`
` A. So that work has been published -- public
`
`information. I don't remember the year of that
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`patent, though. So that I can talk freely about to
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`the best of my recollection. Our current work has
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`changed -- progressed from that initial patent
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`significantly.
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` So what you have -- I can talk in general
`
`terms about this particular device and what is
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`particularly important for us. MRI is generally
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`Page 22
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`considered by a large number of -- I shouldn't say
`
`generally -- is considered by a large number of
`
`surgeons, oncology surgeons and radiologists as the
`
`premium way of detecting early cancer in breasts
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`particularly. So roughly -- a tumor roughly the
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`size of a BB can be identified pretty readily using
`
`an MRI machine.
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` Now, currently when this is done or the
`
`standard practice has been to then insert a biopsy
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`tool which is basically a cannula, a trocar, the
`
`needle goes in, severs the tissue, and then the
`
`cutting device is withdrawn. A biopsy tool is
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`inserted, a small tissue is taken and pulled out,
`
`and then a biopsy is done on that.
`
` Q. Let me interrupt you right there just to
`
`make sure we're talking about the date. You used
`
`the word currently in your answer. I'm referring
`
`to technology around 2000.
`
` A. Certainly 2000. I'm not aware of any
`
`major changes since then.
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` Q. So, again, you used the word then a biopsy
`
`tool is inserted. What I'm asking you is what is a
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`biopsy tool circa 2000?
`
` A. Well, to do the biopsy you've got to get
`
`access to the tumor. So the tool consists of the
`
`cannula, the trocar, and then the tool that you
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`insert inside the cannula that then cuts a small
`
`piece of tissue away.
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` So you can call the tool all of those
`
`components or you could specifically if you want
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`to, if you're -- you could refer to it just as the
`
`device that cuts and removes the tissue inside the
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`cannula, but you can't do it unless you've got the
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`cannula there. So you've got to have all these
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`things, you know.
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` In a way it would be like -- a comparable
`
`thing would be, say, well, what's a socket? Well,
`
`a socket by itself is only the socket, the thing
`
`that goes on the nut, but that by itself doesn't do
`
`anything. You need the wrench as well. So you
`
`need to have these other things take place.
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` So when I'm talking about a biopsy tool,
`
`I'm thinking about the tool that consists at least
`
`of these three parts and within the one part you
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`may have multiple components within the one part.
`
` Q. Well, the biopsy tool that cuts and
`
`removes tissue, does it -- is it a fixed tool or
`
`does it have movable parts in it?
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` A. There's different ways of doing it. I
`
`can't recall specifically which one or ones we
`
`looked at at this point in time.
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` Q. Well, do you know if biopsy tools in the
`
`2000 area used either cables or gears or anything
`
`like that?
`
` A. Typically I would think no. I'm not
`
`familiar with ones that used cables and gears and
`
`such.
`
` Q. Okay.
`
` A. I never finished what the MRI -- what our
`
`MRI tool did. I think the question was a broader
`
`question and I was answering that, and then I think
`
`you got away from that and started asking a
`
`specific question.
`
` Q. So you were working on an MRI tool that
`
`was used in conjunction with other people's biopsy
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`tools?
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`Frank Fronczak, Ph.D. - June 6, 2019
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` A. We would be -- no. We would have to
`
`have -- either modify existing biopsy tools or have
`
`someone else manufacture them, or we would have
`
`to -- it has to have certain characteristics.
`
`Typical biopsy tools did not have -- exhibit those
`
`characteristics because it was working inside the
`
`bore of an MRI machine.
`
` Q. So what are those characteristics you're
`
`referring to?
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` A. Generally it has to be generally
`
`nonconductive. It certainly has to be nonmagnetic
`
`and it generally has to be a nonconductor of
`
`electricity.
`
` Q. So it didn't use metal?
`
` A. We're getting into proprietary --
`
` Q. Okay.
`
` Well, have you ever designed a surgical
`
`instrument prior to 2006 that used either gears or
`
`cables to transmit forces?
`
` A. The guide for the -- the guide for the
`
`biopsy tool itself, yes, used gears, mechanical
`
`components to transmit motion and to exert torques
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`and/or forces.
`
` Q. Okay. And is that -- can you say any more
`
`about that? You're saying anything further would
`
`go into confidential information?
`
` A. Certainly the details of much of the work
`
`is very confidential.
`
` Q. Okay. Let me try to get your expertise
`
`another way. I did notice in your CV that you said
`
`you designed -- or developed and taught various
`
`courses. One of them seems to be the basic
`
`mechanical engineering course that's called ME342,
`
`Elements of Machine Design?
`
` A. That is correct. I didn't develop that
`
`course. I taught that course.
`
` Q. You taught that course. Okay. I looked
`
`at the description on-line and one thing that that
`
`course involves is basic things like gears and
`
`other mechanical components to transfer forces?
`
` A. That's true. That's correct. That's one
`
`of many things that the course covers.
`
` Q. When you say that certainly prior -- what
`
`year are we talking about? When did you teach that
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`course? Was it prior to 2006?
`
` A. I'm pretty sure it was, yeah. I would say
`
`with confidence that it was prior to 2006. Then
`
`also I taught senior design 349 -- ME349. I also
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`taught 491, 492, 351, and 352, which are all
`
`mechanical design courses, as well as ME549, which
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`is also pretty much a mechanical design course.
`
` Q. And would you say that certainly prior to
`
`2006 standard introductory mechanical design
`
`courses would teach things like different types of
`
`gears that are used to transmit forces in
`
`mechanical devices?
`
` A. I'm sorry. Could you repeat the question?
`
` Q. Yeah. I'm saying prior to 2006 would you
`
`say that it was very typical that an introductory
`
`mechanical engineering design course would cover
`
`things like gears and different types of gears that
`
`are used to transmit forces?
`
` A. I would not characterize these as
`
`introductory courses. I would consider these as
`
`intermediate to senior-level courses. These are
`
`junior- and senior-level courses.
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` Q. Are they? So introduction of mechanical
`
`engineering wouldn't cover gears?
`
` A. It might, it might not, but not in much
`
`depth. An introduction to mechanical engineering
`
`course would not cover gears in much depth. You
`
`wouldn't have the background to be able to do much
`
`to analyze gears in an introductory course because
`
`you'd have to have a strength of materials or
`
`mechanics of materials course, and that in turn is
`
`usually taught sophomore year.
`
` Q. Okay. Fair. So let me ask a different
`
`question. By the time that a mechanical
`
`engineering student graduates with a degree in
`
`mechanical engineering they have taken a higher
`
`level mechanical engineering design course that
`
`certainly would have covered using various types of
`
`gears to transmit forces?
`
` A. You skipped over -- you jumped straight
`
`from introductory to higher level.
`
` Q. Yes.
`
` A. The word I used was intermediate, and I
`
`would call it intermediate. I would not consider
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`those higher level courses.
`
` Q. I'm sorry.
`
` A. That's fine. It's not a hard-and-fast
`
`thing, but at the University of Wisconsin the
`
`introductory courses are the 100 and maybe some 200
`
`level courses. Generally speaking, the
`
`intermediate courses are 3-, 4-, and 500 level
`
`courses. Advanced courses are 4-, 5-, 6-, and 700
`
`level courses with some exceptions.
`
` Q. Okay. That's helpful. So let me just ask
`
`it again. In your experience, certainly prior to
`
`2006, a mechanical engineering student taking
`
`intermediate level courses in mechanical design
`
`would learn about different types of gears to
`
`transmit forces?
`
` A. Characteristically, certainly in our
`
`curriculum and at the time, that would be
`
`characteristi