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`P R O C E E D I N G S
`THE VIDEOGRAPHER: We're on video.
`THE REPORTER: We are on the record.
`Before I swear -- Before I swear the witness I would
`like to state for the record it is my understanding
`there is no objection to swearing the witness
`remotely. Please speak up only if you have an
`objection.
`
`Hearing none; Dr. Graham, would you raise
`your right hand to be sworn?
` (Witness sworn.)
`DR. JOHN J. GRAHAM, MB ChB, MRCP (UK),
`Called as a witness, being first
`duly sworn, was examined and
`testified as follows:
`EXAMINATION
`
`BY MR. MORTON:
`Q.
`Good morning, Dr. Graham.
`A.
`Good morning.
`Q.
`Obviously you've had your deposition taken a
`couple times before, so I'm not going to go over
`everything that we've discussed in the past, but I do
`have a few things to discuss with you this morning.
`Do you have the documents that we shipped
`
`over?
`
`STIREWALT & ASSOCIATES
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`Yes. They just arrived last night, yes.
`Okay. Good. Do you have your declaration
`
`A.
`Q.
`handy?
`A.
`I've not opened the documents, so if I can
`-- Can I open it just now?
`Q.
`Yes, please.
`A.
`(Witness complying.) There was a Secure
`DocuShare sent yesterday evening, and I've just
`accessed that, and my declaration I saw was included
`in that.
`Q.
`Yeah, whichever is easier for you to look
`at. I'm looking at hard copies, so.
`A.
`Okay. Exhibit 2145. I have my declaration.
`Q.
`Okay. The first topic I want to cover is
`the -- your definition of an "interventional
`cardiology device," so that starts at paragraph 92 of
`your declaration, and you give your definition in
`paragraph 98.
`Are you with me?
`Intervention --
`Yes, I am there, 98.
`Q.
`Okay. So your definition of an
`interventional cardiology device is, "a device that is
`delivered beyond the end of the guide extension
`catheter to a location in the cardiac vasculature
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`________________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________
`MEDTRONIC, INC., AND, MEDTRONIC VASCULAR, INC.,
`Petitioner,
`v.
`TELEFLEX LIFE SCIENCES LIMITED,
`Patent Owner.
`________________
`Case No. IPR2020-01341
`Case No. IPR2020-01342
`Case No. IPR2020-01343
`Case No. IPR2020-01344
`U.S. Patent No. 8,142,413
`________________
`DEPOSITION OF DR. JOHN J. GRAHAM, MB ChB, MRCP (UK)
`VOLUME I, PAGES 1 - 118
`JUNE 30, 2021
`
` (The following is the deposition of DR.
`JOHN J. GRAHAM, MB ChB, MRCP (UK), taken pursuant to
`Notice of Taking Deposition, conducted remotely and
`via videotape, commencing at approximately 7:55
`o'clock a.m., June 30, 2021.)
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`STIREWALT & ASSOCIATES
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`APPEARANCES:
` On Behalf of the Petitioner:
` Cyrus A. Morton
` ROBINS KAPLAN, LLP
` 2800 LaSalle Plaza
` 800 LaSalle Avenue
` Minneapolis, Minnesota 55402
`
` On Behalf of the Patent Owner:
`
` Shelleaha L. Jonas
` Peter M. Kohlhepp
` CARLSON CASPERS VANDENBURGH
` & LINDQUIST, P.A.
` 4200 Capella Tower
` 225 South Sixth Street
` Minneapolis, Minnesota 55402
`
`ALSO PRESENT:
`
` Ronald M. Huber, Videographer
`
`EXAMINATION INDEX
`WITNESS EXAMINED BY PAGE
`Dr. Graham
`Mr. Morton
` 3
`Ms. Jonas
` 112
`
`EXHIBIT INDEX
`EXHIBIT DESCRIPTION PAGE
`Medtronic
`1127
`
`Article, Mani, "Novel Use of a
`Guide Extension Mother-and-Child
`Catheter for Adjunctive
`Thrombectomy During Percutaneous
`Coronary Intervention for Acute
`Coronary Syndromes," 6 pgs.
`
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`requiring treatment, to provide treatment to that
`location"; right?
`A.
`Correct.
`Q.
`And so the first topic I want to discuss
`there is your inclusion twice of the word "treatment,"
`okay?
`A.
`Yes.
`Q.
`So in your paragraph 95 you note that the
`specification of the patents, you said, uses the terms
`"cardiac treatment device," "interventional cardiology
`treatment device," and "interventional cardiology
`device" interchangeably. Do you see that?
`A.
`I do, yes.
`Q.
`Now two of those terms use the word
`"treatment"; right?
`A.
`Correct.
`Q.
`And one does not, "interventional cardiology
`device" does not say "treatment."
`A.
`Correct.
`Q.
`And that's the term that we are defining is
`"interventional cardiology device," the one that does
`not say "treatment"; right?
`A.
`Could you be more specific? What do you
`mean, that is the one we are defining?
`Q.
`Well this whole section of your report is
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`about defining what an interventional cardiology
`device is; right?
`MS. JONAS: Object to the form.
`A.
`Yes, the heading of Section VII on page 46
`does say, under headline A, "Interventional Cardiology
`Device."
`Q.
`Right. So we're defining that term; right?
`A.
`I am, yes.
`Q.
`Okay. And you say there's three terms, I
`just read them, that are used interchangeably. Two of
`them say "treatment," and the one you're defining does
`not say "treatment"; right?
`MS. JONAS: Object to form.
`So although heading A on page 46 under --
`Subheading A, under heading VII,
`"Interventional Cardiology Device," in paragraph 95
`they are interchangeable. So a cardiac treatment
`device, interventional cardiology treatment device and
`an interventional cardiology device I think of
`interchangeable, but heading "A" states
`"Interventional Cardiology Device."
`Q.
`Okay. And so you think they all require
`treatment, even though two of them say "treatment,"
`and one of them does not say "treatment"; right?
`A.
`Well they not -- they probably don't require
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`treatment, they are providing treatment.
`Q.
`So let's explore that a little.
`So they don't require that the device
`provides treatment?
`A.
`That's not what you said. Sorry, you said
`"they require treatment." You are implying that the
`device would require treatment is what I was
`understanding you to say, but the device is providing
`treatment.
`Q.
`Okay. So for two of these they explicitly
`say the device provides treatment, "cardiac treatment
`device" and "interventional cardiology treatment
`device." Do you see that?
`A.
`I do see that, yes.
`Q.
`But the term you're defining,
`"interventional cardiology device," does not use the
`word "treatment," doesn't say the device has to
`provide treatment; correct?
`A.
`That is --
`MS. JONAS: Object to the form.
`A.
`That is correct.
`Q.
`Okay. But nevertheless, when you define it,
`you say it does require treatment, or providing
`treatment.
`A.
`So as you mentioned, in paragraph 95 there
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`are two explicit uses of the word "treatment," and the
`final one, the "interventional cardiology device," I
`-- I would think that a POSITA would accept that that
`is an implicit requirement of using treatment.
`Q.
`Okay. But given that it does not say
`"treatment," while the other ones do say "treatment,"
`wouldn't a POSITA reasonably infer that it may or may
`not provide treatment if it's an interventional
`cardiology device?
`MS. JONAS: Object to form.
`A.
`I don't agree with that.
`Q.
`What's your basis for saying it's used
`interchangeably, when two of them actually say
`"treatment," and one of them explicitly does not?
`A.
`So in the field of cardiology there are
`phrases that are used that are --
`So interventional car -- cardiology in
`general, and interventional cardiology especially is a
`global specialty, subspecialty, and at meetings there
`are phrases that are used frequently that are
`interchangeable. And I think that a POSITA would
`accept that the three phrases are interchangeable.
`Do I have an -- a dictionary definition that
`says they're interchangeable? No. But a POSITA, I
`would argue, would use these interchangeably globally.
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`Q.
`Okay. It's certainly true that there are
`devices that are used in interventional cardiology
`that do not provide treatment; right?
`MS. JONAS: Object to form.
`A.
`In any interventional cardiology procedure
`there are things that are used in the procedure that
`would not provide treatment. In my previous
`deposition I mentioned the scrubs that I wear, they
`are essential for the procedure for sterility, but
`they do not provide treatment. So there are facets
`and as -- and pieces of equipment that are essential,
`but do not provide "treatment" as I'm defining in this
`part of my declaration.
`Q.
`Okay. Well let's set aside scrubs and talk
`about devices inside the body.
`There are certainly devices that are used
`inside the body in interventional cardiology that do
`not provide treatment; right?
`MS. JONAS: Object to the form.
`A.
`There are devices that are essential to the
`procedure that do not provide treatment in the
`coronary artery.
`Q.
`Okay. Can you give some examples?
`A.
`So when you start the procedure the first
`thing that you do is place a sheath in an artery;
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`radial artery or femoral artery or whatever other
`artery you're using, brachial or whatever. And that
`is a te -- usually, typically, a 10 centimeter sheath.
`And that goes nowhere near the heart, but it's in the
`body, and it's essential for the procedure.
`Q.
`Okay. Can you give me some more examples?
`A.
`Okay. The guide catheter that we use is
`advanced through the arterial system to the ascending
`aorta and is engaged in the ostium of the coronary
`artery, and that is essential for the procedure but is
`not an interventional cardiology device. That guide
`catheter is advanced over a large bore wire, usually
`35 or 30 thousandths of an inch, and that is essential
`for the procedure but it does not provide treatment to
`the lesion in question.
`Q.
`Okay. Are there other devices used in
`interventional cardiology that you would say are not
`interventional cardiology devices?
`MS. JONAS: Object to form.
`A.
`There may well be. I -- I can go through my
`declaration. I talk about devices that are
`interventional devices, there may well be others, but.
`I can go away and think about it and come back and
`give you a list, which may not be exhaustive, but I
`could do that.
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`Q.
`Yeah. I'm just looking to see if you have
`any other examples based on your experience and the
`many procedures that you've done.
`A.
`Okay. So if you're doing a high-risk case,
`a patient who has impaired ventricular function or is
`very unwell or they have very complex anatomy such
`that you think there is a risk of hemodynamic
`cardiovascular collapse during the procedure, then you
`can place a form of mechanical circulatory support
`that would usually typically be an intraaortic balloon
`pump which is placed in the aorta, by its name, or a
`left ventricular assist device, which is commonly
`called an impeller, which is placed through the
`femoral artery into the heart itself. And in extreme
`cases you would place someone in extracorporeal
`membranous oxygenation, abbreviated to ECMO, and they
`are very invasive interventional procedures using big
`devices, but I would not classify them as an
`interventional treatment device. Those devices are
`used to stabilize the heart to allow treatment to take
`place in the coronary artery that you're interested
`in.
`
`Q.
`All right. Do you have any other examples
`that are used in, I guess I would say, more standard
`interventional cardiology procedures that are devices
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`definition?
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`MS. JONAS: Object to form.
`A.
`I've given a few examples. I really would
`have to go away and think about this. That wa -- They
`were just three, four or five off the top of my head.
`Q.
`Okay. Let's focus then on the word that you
`used in your definition, of "treatment."
`What does that mean, "provide treatment"?
`A.
`Within my field of interventional
`cardiology, "treatment" would be -- So I talk about
`this in the background. The field of interventional
`cardiology, as directed towards coronary artery
`disease, is aimed at relieving a blockage in an
`artery, so treatment would involve relieving that
`blockage.
`Q.
`
`Okay. Is another word --
`I know a word you use a lot in here is
`"therapy" or "therapeutic." Is it providing direct
`therapy to a lesion or a blockage in an artery, is
`that what "treatment" means?
`MS. JONAS: Object to form.
`Most people would say treatment --
`I'm -- I'm thinking of a derivation of
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`treatment and therapy. I can't remember if they're
`both related in their derivation.
`I think in our field most people would say
`"treatment," but "therapy" potentially could be used.
`It would be quite unusual to use it.
`Q.
`Okay. So just want to make sure I got it
`right. Your -- Your definition of --
`Your understanding of what it means to
`"provide treatment" was provide relief for a -- a
`lesion or a blockage in an artery; is that right?
`MS. JONAS: Object to the form.
`A.
`That may have been the wording that I said,
`but to expand on that, it would be maybe not "relief,"
`I said maybe "alleviate the blockage," but you would
`want to -- to effectively open up a blocked artery,
`whether it be 80, 90 or a hundred percent blocked.
`Q.
`Okay. So I'll try to go with that.
`"Treatment" is -- is alleviating a blockage or opening
`up a blockage in an artery.
`And so --
`A.
`Usually -- When I say "artery," it could be
`a vascular structure in the heart. We usually say
`"artery," but it could be a bypass graft, which would
`be venous usually, unless it was a mammary arterial
`graft. So we conventionally say "artery," but it
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`could be a venous bypass graft.
`Q.
`Okay. So if a device is used in
`interventional cardiology, but that device itself is
`not what's used to alleviate a blockage, then it's not
`an interventional cardiology device; is that right?
`A.
`So in this -- where did we say, paragraph
`98. So I would say that it's "a device that is
`delivered beyond the end of the guide extension
`catheter to a location in the cardiac vascular
`requiring treatment, to provide treatment to that
`location." And we've already agreed, when you asked
`me earlier, that guide catheters and the introducer
`sheath, and the long exchange-length wire are not
`interventional cardiology devices, but from what you
`just said there, the -- you made it sound as if any
`piece of equipment we use in the procedure is an
`interventional cardiology device, but I've already
`said that that's not the case.
`Q.
`Okay. So I think you mentioned three
`things. You're saying the sheath is not an
`interventional cardiology device?
`A.
`Correct.
`Q.
`And the guide catheter is not an
`interventional cardiology device?
`A.
`Agreed.
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`Q.
`And the full-length guidewire is not an
`interventional cardiology device?
`MS. JONAS: Object to the form.
`A.
`The 035 or large-bore guidewire that you use
`to put the guide catheter in is not an interventional
`cardiology device for the reasons I state in 98.
`Q.
`Okay. Are there other guidewires that you
`think are interventional cardiology devices?
`A.
`So within this, the devices that we say are
`an interventional cardiology devices includes
`guidewires, balloons, stents and stent catheters. So
`coronary guidewires would be classified as an
`interventional cardiology device.
`Q.
`Okay. Well I'm just trying to figure out
`where the line is.
`So now it sounds like some guidewires that
`are used in interventional cardiology are
`interventional cardiology devices, but other
`guidewires used in interventional cardiology are not
`interventional cardiology devices. Is that right?
`MS. JONAS: Object to the form.
`A.
`That would be one way of describing it.
`Again, as I said, there are pieces of equipment that
`you must use in the procedure but it's not an
`interventional cardiology device, and you -- you made
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`16
`the distinction of a device that's placed into the
`body, but there are numerous devices essential to the
`procedure that don't go in the body. And again, there
`are pieces of equipment that go into the body that are
`not interventional cardiology devices.
`Q.
`Okay.
`A.
`And I actually just thought of a couple
`more. So at the end of the procedure if you're going
`the femoral arterial route, occasionally you may seal
`the hole in the artery, in the femoral artery, with a
`closure device; essential for the procedure, but goes
`nowhere near the lesion needing treatment in the
`coronary artery, does not go past it, so it is not an
`interventional cardiology device, treat -- treatment
`device, interventional cardiology device.
`Q.
`Okay. So I'm understanding your definition
`a little bit better. Devices that are used in cardiol
`-- interventional cardiology that are essential for
`the procedure but don't go beyond the guide catheter
`are not interventional cardiology devices?
`MS. JONAS: Object to form.
`A.
`I don't think that's what I said. You may
`have misheard me, or maybe I misspoke. But I think in
`98, paragraph 98 is delivered beyond the end of the
`guide catheter to a location in the cardiac
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`vasculature requiring treatment, and to allow -- or to
`provide treatment to that location.
`Q.
`I understood that.
`And my understanding of what you're telling
`me is that there are all these devices that are
`essential for an interventional cardiology procedure,
`but they are not interventional cardiology devices,
`under your definition, because they don't extend past
`the guide catheter in the area of the lesion or the
`blockage that requires treatment.
`MS. JONAS: Object to form.
`Q.
`Is that right?
`A.
`So that is what I wrote in 98, yes.
`Q.
`Okay.
`A.
`So an interventional device is one that goes
`beyond the end of the catheter to the lesion, to
`provide treatment to the lesion.
`Q.
`Okay. So if a -- if a device that's
`essential for an interventional cardiology procedure
`goes beyond the end of the guide catheter, then it
`becomes an interventional cardiology device?
`MS. JONAS: Object to form.
`A.
`I'm sorry, that's not what 98 says.
`Q.
`I know, but we've been talking about this
`for awhile and I thought that's what you said, that's
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`18
`
`the distinction you've been making. And I'm just
`trying to find where that line is, where these devices
`that are used in interventional cardiology get to a
`point where they become interventional cardiology
`devices.
`
`MS. JONAS: Object to the form. Counsel,
`is there a question pending?
`MR. MORTON: Yes.
`MS. JONAS: Okay.
`Q.
`Do you understand the question, Dr. Graham?
`A.
`I'm sorry, I did not get it. I didn't
`realize it was a question. I do apologize, I'm sorry.
`Q.
`Okay. You've given me a number of examples
`of devices that are used in interventional cardiology
`that you've said are not interventional cardiology
`devices because they don't extend past the guide
`catheter and -- and get out, you know, near a lesion
`or a blockage for providing treatment; right?
`MS. JONAS: Object to form.
`A.
`In 98 that's what we say, beyond the guide
`catheter to the lesion -- or to the location requiring
`treatment, to provide treatment, yes.
`Q.
`Right. And so this is how you've kind of
`split the difference between a guidewire used to
`insert the guide catheter you've said is not an
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`19
`interventional cardiology device because it doesn't go
`beyond the end of the guide catheter, but then other
`guidewires that do go beyond the end of the guide
`catheter, those become interventional cardiology
`devices; right?
`MS. JONAS: Object to form.
`A.
`That's what I say in my dec -- in my
`declaration, yes.
`Q.
`Okay. And so that's what I'm trying to get
`to understand.
`So if you have a device that's important or
`essential for an interventional cardiology procedure
`and that device protrudes past the end of the guide
`catheter, that's when it becomes an interventional
`cardiology device under your definition.
`MS. JONAS: Object to form.
`A.
`Well every time I say my definition, you
`then put it back to me by saying extends out the end
`of the guide catheter, but then you omit anything
`about the lesion needing treatment.
`So my definition of an interventional
`cardiology device is something that goes beyond the
`end of the guide catheter down to the lesion, to
`provide treatment to the lesion. It is not just
`coming out the end of the guide catheter, because the
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`20
`038 wires come out the end of the guide catheter,
`that's how they're safe, it avoids trauma to the
`aorta, but they don't go into the coronary artery, and
`they don't provide treatment to the coronary artery.
`Everything else that I mention there provides
`treatment to the coronary artery.
`Q.
`Okay. So your definition of an
`interventional cardiology device is a device that
`extends past the end of the guide catheter and
`provides treatment to a lesion.
`MS. JONAS: Object to form.
`A.
`Comes out the end of the guide catheter to a
`location in the cardiac vasculature requiring
`treatment, to provide treatment to that location, yes,
`that is what I say.
`Q.
`Okay. Let's talk then specifically about
`the guidewires that are advanced past the end of the
`guide catheter out near the lesion, okay?
`A.
`Umm-hmm.
`Q.
`You've testified previously that you've
`never used a guidewire to provide treatment; right?
`A.
`I --
`MS. JONAS: Object to the form.
`I think I said that I did, or I have done.
`All right. Well we can certainly check the
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`Q.
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`
`transcript on that.
`Have you been able to point to any document,
`any evidence anywhere in the record that shows a
`guidewire being used to -- to be a treatment device,
`provide treatment?
`MS. JONAS: Object to form.
`A.
`Within my declaration?
`Q.
`Yeah, I'm just asking if you have any -- any
`evidence, any document you can cite to that would say
`a guidewire provides treatment to a lesion.
`MS. JONAS: Object to form.
`A.
`So in my previous deposition we talk about
`this, where the guidewire in the -- in the context of
`a ST-elevation myocardial infarction, the guidewire
`itself will poke a hole in the thrombotic occlusion
`and allow blood to flow down the artery and will end
`the infarct and will cause resumption of coronary
`flow. Simply penetrating the occlusion with this
`14-thousandths-of-an-inch guidewire is enough to
`provide treatment to end the infarction. Also, if you
`have something -- a relatively rare condition called
`spontaneous coronary dissection where your artery has
`torn and has a spiral tear along it, putting a
`guidewire down the true lumen can be enough to
`buttress the dissection flap back to allow flow down
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`22
`that, so opening up the blockage and essentially
`providing treatment. There is another in the field
`that I work in in complex intervention, when you're
`working through a 100 percent chronic occlusion, so a
`chronic total occlusion or a CTO, you've often got a
`long segment of gnarly thrombotic occlusion, and
`within that, rather than poke the guidewire the way
`it's conventionally meant to be, you can fold it over
`on itself, we call this "knuckling," as in the knuckle
`in your hand, and you force that knuckle through the
`blockage. So the knuckle itself, the wire itself is
`providing treatment, it's almost the way a surgeon
`dissects through tissue under direct vision, you push
`this wire through and it knuckles through, providing
`treatment to it. So I -- I can get references that
`will define that last treatment. I didn't mention
`that in my declaration, I just thought of it there.
`So yes, I have provided treatment with guidewires.
`Q.
`Okay. And so just to be clear, you haven't
`cited a single document outside of the patent that
`says a guidewire is a treatment device; is that right?
`A.
`I'm --
`MS. JONAS: Object to form.
`A.
`I'm relatively new to this, as you know, so
`I don't know if the previous deposition that I had, if
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`that was cited. If that is -- If that's evidence, or
`citable, I'm not sure, and I would be educated on
`that.
`
`Q.
`Okay. And I don't mean whether the
`attorneys have cited it, I mean whether you have
`found/provided any other documentary evidence,
`anything showing that a guidewire is a treatment
`device.
`
`A.
`
`MS. JONAS: Object to form.
`I'd have to -- I --
`From memory from the top of my head in my
`declaration, I don't think there's typical evidence I
`cite.
`
`The last thing I mentioned there about
`knuckling, I -- I -- I just thought of that, so I
`could get evidence afterwards, but no, I have not,
`before now, cited that.
`Q.
`Okay. Have you ever, in your career, done a
`procedure where all you used was a guidewire to
`provide treatment, and once you inserted the guidewire
`you were done, the patient was treated?
`MS. JONAS: Object to form.
`A.
`The clearest thing I can say is "yes," but I
`will have to give you context. So the -- the
`spontaneous dissection case that I mentioned it was a
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`young female came in in extremis with a large
`dissection of her main coronary artery, and by putting
`the guidewire down we buttressed back, we -- the --
`the tension in the guidewire pushed the dissection
`flap back, she then had perfusion down her coronary
`artery, her ECG normalized, her