`
`Transcript of Dr. Lakshmi Prasad
`Dasi
`
`Date: August 25, 2021
`Case: Edwards Lifesciences Corp., et al. -v- Colibri Heart Valve LLC (PTAB)
`
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`WORLDWIDE COURT REPORTING & LITIGATION TECHNOLOGY
`
`Edwards Lifesciences Corporation, et al. Exhibit 1039, p. 1 of 166
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`
` IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`-----------------------------------x
`EDWARDS LIFESCIENCES :
`CORPORATION AND EDWARDS
`LIFESCIENCES, LLC, : Case No.
` Petitioners, : IPR2020-01649
`v. :
`COLIBRI HEART VALVE, LLC, : US Patent No.:
` Patent Owner. : 9,125,739
`-----------------------------------x
`
` D E P O S I T I O N
` o f
` DR. LAKSHMI PRASAD DASI,
` taken on behalf of Petitioners
`
` DATE: August 25, 2021
` TIME: 9:01 a.m. to 1:37 p.m.
` PLACE: *** REMOTE ***
` BEFORE: Dawn A. Hillier, RMR, CRR
` Stenographic Reporter
` Notary Public - State of
` Maryland, at Large
` JOB NO: 393691
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`Transcript of Dr. Lakshmi Prasad Dasi
`Conducted on August 25, 2021
`APPEARANCES: ALL PARTIES ATTENDING REMOTELY
`
`2
`
`On Behalf of the Patent Owner:
` SKIERMONT DERBY LLP
` BY: SARAH E. SPIRES, ESQ.
` 1601 Elm Street, Suite 4400
` Dallas, Texas 75201
` (214) 978-6600
`
`On Behalf of the Petitioners:
` MORRIS, NICHOLS, ARSHT & TUNNELL LLP
` BY: BRIAN P. EGAN, ESQ.
` 1201 North Market Street, 16th Floor
` Post Office Box 1347
` Wilmington, Delaware 19899
` (877) 772-6628
`
`ALSO PRESENT:
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`Transcript of Dr. Lakshmi Prasad Dasi
`Conducted on August 25, 2021
`
`3
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` INDEX PAGE
`WITNESS - DR. LAKSHMI PRASAD DASI 4
`DIRECT EXAMINATION BY MR. EGAN 5
`REPORTER'S CERTIFICATE 131
` EXHIBITS
`Exhibit 1001 Patent No.: US 9,125,739 8
`Exhibit 2019 Declaration of Dr. Lakshmi 28
` Prasad Dasi for IPR2020-01649
`Exhibit 1006 US Patent No.: 5,855,601 36
`Exhibit 1012 US Patent No.: 5,957,949 99
`Exhibit 1007 US Patent No.: 5,332,402 106
`Exhibit 1019 US Patent No.: 2001/044633 109
`
` REPORTER'S KEY TO PUNCTUATION:
` -- At end of question or answer references
` interruption.
` ... References a trail-off by the speaker.
` No testimony omitted.
` "Uh-huh" "Um-hum" References affirmative sound.
` "Huh-uh" "Um-um" References negative sound.
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`Transcript of Dr. Lakshmi Prasad Dasi
`Conducted on August 25, 2021
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`4
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` TECHNICIAN: Thank you to everyone for
` attending this proceeding remotely, which we
` anticipate will run smoothly.
` Please remember to speak slowly and do
` your best not to talk over one another. Please
` be aware that we are recording this proceeding
` for backup purposes. Any off-the-record
` discussions should be had away from the
` computer. Please remember to mute your mic for
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` If you are unable to connect with video
` and are connecting via phone, please identify
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` We will provide a complimentary, unedited
` recording of this deposition with the purchase
` of a transcript.
` I apologize in advance for any
` technical-related interruptions. Thank you.
` DR. LAKSHMI PRASAD DASI,
`was called as a witness and, having first been duly
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`Transcript of Dr. Lakshmi Prasad Dasi
`Conducted on August 25, 2021
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`5
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`sworn, was examined and testified as follows:
` THE WITNESS: Yes.
` STENOGRAPHIC REPORTER: Thank you.
` DIRECT EXAMINATION
`BY MR. EGAN:
` Q Good morning, Dr. Dasi. It's nice to meet
`you.
` A Morning.
` Q You're appearing here today as an expert
`on behalf of Colibri Heart Valve, LLC; is that
`correct?
` A Okay.
` Q Okay. And this proceeding involves the
`validity of Colibri's United States Patent
`Number 9,125,739; is that correct?
` A Yes, that is correct.
` Q Okay. And if I refer to that today as the
`'739 patent, will you understand that that's the
`patent that we're referring to?
` A Yes.
` Q Okay. And this is not the first time
`you've been deposed with regards to the subject
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`Transcript of Dr. Lakshmi Prasad Dasi
`Conducted on August 25, 2021
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`6
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`matter of the '739 patent; is that correct?
` A That is correct.
` Q Okay. Now, I know you've been deposed
`before but let me just cover a few of the ground
`rules at the outset, just so that we don't speak
`over one another throughout the day.
` But you understand that you'll be
`answering questions under oath today; correct?
` A Yes.
` Q And if at any time you don't understand
`one of my questions, just let me know, and I'll do
`my best to rephrase the question until you do
`understand it. Okay?
` A Sounds good.
` Q And, you know, we're on a Zoom platform
`today, which makes it even more difficult for the
`court reporter. So if you could be mindful of
`making verbal responses rather than non-verbal
`responses, that would be helpful.
` And finally, if you need to take a break
`at any point, just let me know. And I'll find a
`reasonable stopping point, and we can take a break.
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`Transcript of Dr. Lakshmi Prasad Dasi
`Conducted on August 25, 2021
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`7
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` A Sure. Thank you.
` Q Is there anything that would preclude you
`from answering truthfully today?
` A No.
` Q And as you know in this field, there's a
`lot of acronyms in the field of transcatheter heart
`valves. If I referenced "THV" today, do you
`understand today that means transcatheter heart
`valve?
` A I do.
` Q And if I say "TAVI," does TAVI stand for
`transcatheter aortic valve implantations?
` A Yes, that it does.
` Q Okay. And are you familiar with the
`acronym "TAVR," T-A-V-R?
` A Yes, I'm familiar with that.
` Q And is that -- that's transcatheter aortic
`valve replacement?
` A That is correct.
` Q And finally, "TMVR," is that transcatheter
`mitral valve replacement?
` A That is also correct.
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`Transcript of Dr. Lakshmi Prasad Dasi
`Conducted on August 25, 2021
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`8
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` Q Okay. I've provided you a binder of
`exhibits, Dr. Dasi. If you could turn to what's
`Exhibit 1001 in that binder.
` (Exhibit 1001 was marked.)
` THE WITNESS: Okay. I'm at Exhibit 1001.
`BY MR. EGAN:
` Q Okay. Could you identify for the record
`what Exhibit 1001 is?
` A Exhibit 1001 is the '739 patent.
` Q Okay. Now, could you turn to the final
`page of the '739 patent, where you'll see Claims 1
`through 5?
` A Okay. I'm there.
` Q Okay. I would just like to start today
`making sure we're on the same page regarding the
`scope of Claims 1 through 5 of the '739 patent.
` So starting with Claim 1 of the '739
`patent, Claim 1 claims an assembly to treat a native
`heart valve in a patient.
` Do you see that?
` A Yes.
` Q Okay. Do you agree that the claims of the
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`Transcript of Dr. Lakshmi Prasad Dasi
`Conducted on August 25, 2021
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`9
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`'739 patent are not limited to treating a specific
`heart valve?
` MS. SPIRES: Object to form.
` THE WITNESS: So you're -- so could you
` elaborate what you exactly mean by that?
`BY MR. EGAN:
` Q Yes.
` You understand a patient's anatomy. A
`patient has four heart valves; correct?
` A Correct.
` Q A patient has an aortic valve; correct?
` A Yes.
` Q A mitral valve?
` A Absolutely.
` Q A pulmonary valve?
` A Yes.
` Q And a patient also has a tricuspid valve?
` A Yes.
` Q Okay. Do you agree that the assembly that
`is being claimed in Claim 1 of the '739 patent can
`be used to treat any one of those four heart valves
`in a patient?
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`Transcript of Dr. Lakshmi Prasad Dasi
`Conducted on August 25, 2021
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`10
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` A Yes. A native heart valve in a patient.
`That's what the claim says.
` Q And the native heart valve in a patient
`would include any one of those four valves; correct?
` A Yes.
` Q Okay. Would you also agree that the
`claims of the '739 patent are not limited to
`treating a particular valve disease?
` A Correct.
` Q Okay. So you understand that the valve
`prosthesis that is claimed in Claims 1 through 5 of
`the '739 patent could be used to treat aortic
`stenosis?
` A Yes.
` Q Okay. And could the valve prosthesis
`claimed in Claims 1 through 5 of the '739 patent be
`used to treat a patient with mitral stenosis?
` A Yes.
` Q Okay. Could the valve prosthesis that's
`claimed in the claims of the '739 patent be used to
`treat a patient with aortic regurgitation?
` A Yes.
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`Transcript of Dr. Lakshmi Prasad Dasi
`Conducted on August 25, 2021
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`11
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` Q Could the valve prosthesis that is claimed
`in the claims of the '739 patent be used to treat a
`patient with mitral valve regurgitation?
` A Yes.
` Q Are you familiar with the term "pure
`aortic regurgitation"?
` A Pure aortic regurgitation? I'm familiar
`with aortic regurgitation. Maybe you could
`elaborate a little bit more what the "pure aortic
`regurgitation" means.
` I'm assuming that that just means that the
`patient has nothing other than just aortic
`regurgitation.
` Q That's correct. So my understanding -- I
`don't -- you know, I want to make sure you agree or
`disagree, but -- strike that.
` You understand that a patient can have
`regurgitation without any calcification on their
`leaflets?
` A I understand that.
` Q Okay. And if we refer to that condition
`as "pure aortic regurgitation," is that fair?
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`Conducted on August 25, 2021
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`12
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` A That's fair.
` Q Okay. And can the valve prosthesis that's
`claimed in the claims of the '739 patent be used to
`treat a patient with pure aortic regurgitation?
` A Yes. In theory, yes.
` Q Okay. Are you aware of any teachings in
`the '739 patent that explain what, if any, changes
`need to be made to the prosthesis depending on
`whether it's used in the aortic or the mitral
`position in a patient?
` A So your question's basically asking me to
`think about changes; what changes need to be made to
`the prothesis that's been disclosed to be able to
`make it treat these different diseases.
` Is that what you're asking?
` Q That's correct.
` A Are you asking whether those changes are
`disclosed within the patent, or just what changes I
`would make to use the teachings of the patent to
`treat?
` Q I'm asking if a person of ordinary skill
`in the art, as of January 2002, when reviewing the
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`13
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`specification of the '739 patent, is there anything
`in the '739 patent that discloses what needs to be
`done in order to use the claimed valve prosthesis in
`the aortic valve versus the mitral valve?
` MS. SPIRES: Object to form.
` THE WITNESS: Let me take a few moments to
` browse through the patent here.
`BY MR. EGAN:
` Q Sure. Yeah, no, take your time.
` And if there's any questions I ask today
`that you need to reference any materials, just feel
`free to do so.
` A So the teachings of the '739 patent are
`very broad and foundational, in the sense of what is
`described in those claims.
` And a person of ordinary skill in the art
`would understand how to apply these teachings when
`they are -- when they are, you know, specifically
`coming up with a device that would go after
`individual, you know, diseases that you just
`mentioned; mitral regurgitation or aortic
`regurgitation versus mitral stenosis or aortic
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`14
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`stenosis.
` The person of ordinary skill in the art
`would know the general characteristics or features
`that the device needs to have to be able to address
`each of these different diseases, and at the same
`time, be able to adopt the teachings of the '739
`patent, which brings with it its own, you know,
`advantages that are already described here in the
`patent itself and the claims.
` Q Okay. So there's no specific disclosure
`that you can point me to in the '739 patent that
`teaches a person of ordinary skill in the art how it
`would be able to adapt a mitral valve prosthesis,
`for example, to an aortic valve prosthesis, as
`claimed in the patent?
` A Just a moment here.
` So there are teachings here, for example,
`paragraph -- or Column 12, paragraph 60. It talks
`about when the device is used to treat severe
`leakage of the aortic valve, the native valve is
`left in place and the prosthetic stented valve is
`deployed below -- I lost my place here -- below the
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`Transcript of Dr. Lakshmi Prasad Dasi
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`15
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`subclavian artery.
` When the device is used to treat aortic
`stenosis, first the stenotic valve needs to be
`opened using the aortic valvuloplasty, or cutting.
`And if this procedure induces insufficiency, the
`stented valve is placed to prevent the
`regurgitation.
` And so it does -- it does about different
`valves and different diseases about stenosis of the
`aortic valve regurgitation.
` Q You would agree that the portion of the
`'739 patent that you just read at Column 12,
`lines 57 to 63, that that disclosure's limited to
`the aortic valve; correct?
` A Yes. That is -- that is correct. It's
`giving an example here of how the device could be
`used in the aortic position.
` Q Okay. Would a person of ordinary skill in
`the art, in January 2002, without the benefit of the
`'739 patent, know how to adapt a teaching of a
`mitral valve prosthesis for uses in aortic valve
`prosthesis?
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` MS. SPIRES: Object to form.
` THE WITNESS: It obviously depends on what
` that mitral valve prosthesis is.
` A person of skill in the art would know
` what would be a reasonable -- would understand
` what would be reasonable and what would not be
` reasonable, in terms of which mitral valve
` prosthesis might be used in the aortic
` position, with reasonable expectation of
` success, and which ones would not be used.
` Because the mitral valve, each of these
` valves are anatomically different. And most
` prostheses are designed specifically for these
` different diseases.
`BY MR. EGAN:
` Q Would you agree that a person of ordinary
`skill in the art, in January 2002, through routine
`experimentation, could adapt a mitral valve
`prosthesis to a prosthesis that could be implanted
`in the aortic position?
` MS. SPIRES: Object to form.
` THE WITNESS: I think what you asked is a
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`17
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` very general question. And I'm not sure I
` would agree with that because -- yeah.
` I don't know what you mean by "routine
` experimentation" here.
`BY MR. EGAN:
` Q What would a person in the ordinary skill
`in the art, as of January 2002, have to do to use a
`transcatheter mitral valve prosthesis in the aortic
`position?
` MS. SPIRES: Object to form.
` THE WITNESS: Well, as of January 2002,
` there were no approved transcatheter mitral
` valves. Transcatheter aortic valves were just
` a beginning to, you know, be known through some
` of the conferences and studies that were
` published.
` So I guess your question assumes that
` there were already transcatheter mitral valves
` out there, but there were none.
` So I'm not sure if your question, you
` know, can be asked in the way you've just
` posed.
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`18
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`BY MR. EGAN:
` Q You agree in January of 2002, there was no
`FDA-approved aortic transcatheter heart valve
`either; correct?
` A Correct. The FDA approvals came much
`later.
` But by 2002, transcatheter aortic valves,
`at least, were known to exist in the research stage.
`And they were at various stages of preclinical
`research.
` Q And you would agree that in January 2002,
`there was also a discussion in the literature about
`mitral valve prosthesis that could be implanted by a
`catheter; correct?
` A There were certainly discussions, but
`there was no -- nothing as far along as what was
`known about transcatheter aortic valves at that
`time.
` And so the original question goes back to
`whether a person of skill would know what changes to
`make on a transcatheter mitral valve to make it work
`in the aortic valve, is still not -- not a thing.
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`19
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` I would -- I just -- I would just say that
`there were no mitral -- transcatheter mitral valves
`successful in order to even start thinking about
`using a transcatheter mitral valve, and you put it
`into the aortic position.
` Q Let me ask you from the other direction,
`then.
` In January 2002, how would a person of
`skill in the art adapt a transcatheter aortic valve
`to be used in the mitral valve position?
` MS. SPIRES: Object to form.
` THE WITNESS: I guess -- that would not be
` an easy task. It also depends on what mitral
` disease we're talking about.
`BY MR. EGAN:
` Q Are you done?
` A Yeah. Yeah. I think I'll just leave it
`there.
` You know, like, your question, I guess, is
`just so open about how a person of skill in the art
`would take an aortic valve and use it in the mitral.
`It really depends on so much specifics of what --
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`what are we really talking about here in terms of
`what aortic valve and what mitral disease.
` And until the person of skill in the art
`has those tasks in front, the next step is not
`really -- I cannot really talk about what the next
`step would be without knowing those specifics.
` Q Okay. Other than knowing what disease
`you're using the transcatheter valve to treat, what
`other considerations would a person of skill in the
`art, in January 2002, take into account in adapting
`an aortic valve transcatheter prosthesis for use in
`the mitral valve?
` A So the general -- the general things that
`wouldn't be necessary to think about adapting would
`be -- the delivery system of the aortic valve would
`be generally bringing a valve to the aortic
`position. So the person of skill would be thinking
`about how do you now bring the valve to the mitral
`position. That would be one adaptation.
` And then the second adaptation would be
`how do you anchor this valve in the mitral position,
`because the anchoring mechanisms for the aortic
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`Transcript of Dr. Lakshmi Prasad Dasi
`Conducted on August 25, 2021
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`21
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`position don't necessarily work in the mitral
`position. And that definitely depends on the
`disease as well.
` And then, thirdly, there are other
`considerations in the mitral valve that are
`important to be addressed, including the obstruction
`to flow into the, you know, left ventricular outflow
`tract. That's potentially possible. And the
`prevention of leaks. Yeah.
` So it would not be a straightforward thing
`to just take one design, and just expect it to work.
`There would be a lot more going on.
` Q And would you agree that those same
`considerations would be taken into account by a
`person of skill in the art, in January 2002, in
`designing a transcatheter aortic valve?
` A From a mitral valve, you mean, or...
` Q Just in general.
` Just in designing a transcatheter aortic
`valve, would those same considerations be taken into
`account?
` A Yes. Similar considerations.
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`Transcript of Dr. Lakshmi Prasad Dasi
`Conducted on August 25, 2021
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` The aortic valve, again, it depends on the
`disease. Any valve, in order to work, needs -- you
`need to think about anchoring the valve, and then
`avoiding some of the expected issues which are
`unique to that portion of the anatomy.
` And for the aortic valve, it's about
`anchoring, preventing leaks, avoiding coronaries
`from getting obstructed, delivering valve to the
`aortic position.
` These are just -- yeah. These are just a
`few of the things of consideration for anybody to be
`thinking about doubling up on the aortic valve.
` Q And these are all things that a person of
`ordinary skill in the art would take into account,
`in January of 2002, in designing a mitral or aortic
`transcatheter valve?
` A Yes.
` Q How would a person of ordinary skill in
`the art, in January of 2002, reading the '739 patent
`know how to adapt the claimed prosthesis for use in
`the mitral valve?
` A So we can go claim by claim.
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`Transcript of Dr. Lakshmi Prasad Dasi
`Conducted on August 25, 2021
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`23
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` So the Claim 1 basically talks about "An
`assembly to treat a native heart valve in a patient,
`the assembly for use in culmination with the guide
`wire, the assembly comprising:
` "A heart valve -- prosthesis heart valve
`including:
` "A stent member having an inner channel.
`The stent member collapsible, expandable, configured
`for transluminal percutaneous delivery."
` So here, the person of ordinary skill in
`the art knows that this is a stent member. A stent
`which is "tubular structure" that "flares at both
`ends in a trumpet-like configuration."
` So that's pretty clear.
` And then it talks about the valve means
`including two to four leaflets. And that's also
`very well understood by a person of skill in the
`art.
` And then it goes to talk about the
`"delivery stem including a pusher member and the
`movable sheathe." And the "pusher member including
`a guidewire lumen," et cetera.
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`Conducted on August 25, 2021
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` So a person of skill in the art would
`essentially understand some of the key, you know,
`features that are getting enabled here with this
`idea that is in '739 patent about having this pusher
`member that pushes. And you can release the stent.
` And this could be used in the mitral
`position as long as the delivery system has the --
`these features, and the stent has these features
`that are described here.
` Furthermore, it talks about
`"self-expanding nitinol." So that also teaches a
`person in the ordinary skill of the art to pursue a
`nitinol-based stent that had that sheathe membrane
`properties.
` Q So even though there's no discussion in
`the '739 patent specification about how to design a
`transcatheter mitral valve, a person of ordinary
`skill in the art would know how to do so based on
`the claims of the '739 patent?
` MS. SPIRES: Object to form.
` STENOGRAPHIC REPORTER: Counsel, did you
` say "would" or "wouldn't"?
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`Conducted on August 25, 2021
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` MR. EGAN: Would.
` STENOGRAPHIC REPORTER: Thank you.
` THE WITNESS: Well, the claims are really
` disclosing features that are, you know, a more
` higher level, and very important elements of
` the heart valve prosthesis. And that includes
` the flaring aspect and then the
` controlled-release mechanism. And it talks
` about how that is achieved in the context of a
` heart valve itself.
` So a person of ordinary skill in the art
` would recognize that these are extremely
` desirable features that he or she would want it
` up to the mitral valve or an aortic valve. So
` it could be any valve.
` But the ideas here and the teachings are
` very clear. And a person of skill would know
` how exactly to bring these on and apply them.
`BY MR. EGAN:
` Q So you agree that a person of ordinary
`skill in the art, in January of 2002, had the
`ability and knowledge to adapt teachings of
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`Transcript of Dr. Lakshmi Prasad Dasi
`Conducted on August 25, 2021
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`transcatheter heart valves for use in either the
`mitral or aortic valve position; is that correct?
` MS. SPIRES: Object to form.
` THE WITNESS: Specifically to the claims
` disclosed here in '739?
`BY MR. EGAN:
` Q No. Let me -- let me ask the question
`again. And I'm asking it just as a general point of
`knowledge of a person of ordinary skill in the art
`in January of 2002, without the '739 patent in hand.
` Would you agree that a person of ordinary
`skill in the art, in January of 2002, would have the
`knowledge and skill to be able to adapt teachings of
`a transcatheter heart valve, generally, for use in
`both the aortic and mitral valve positions?
` MS. SPIRES: Object to form.
` THE WITNESS: I think that question, it
` really depends on the teachings. When you say
` "adapt the teachings"...
` I can give you an example. So if the
` teaching is about a balloon, yes, then they
` can -- they can adapt that teaching about the
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`Transcript of Dr. Lakshmi Prasad Dasi
`Conducted on August 25, 2021
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` balloon. Whether the balloon is going to the
` aortic or mitral position, those teachings
` could be adapted there.
` But there's -- I wouldn't necessarily
` agree that all teachings are adaptable. And it
` really depends on what we're talking about.
` With specifics to the '739 patent, I can
` say that the claims here are teaching elements
` that are applicable to transcatheter heart
` valves in general.
`BY MR. EGAN:
` Q You referenced the element in Claim 1 "a
`stent member" -- Claim 1 claims "a stent member";
`correct?
` A Yes, that is correct.
` Q Okay. And in your declaration -- and I
`don't think we have to go to it quite yet -- but you
`refer to a stent member of the '739 patent as having
`a "network pattern."
` Do you recall that?
` A I think I would like to take a look. If
`you can just point me where.
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` Q Sure. Your declaration is Exhibit 2019.
` (Exhibit 2019 was marked.)
` THE WITNESS: Just give me a moment as
` well.
`BY MR. EGAN:
` Q I'll get it as well.
` A Yes. In paragraph 106, I write, "A person
`of skill in the art would have recognized that
`Bessler's stent design was not a desirable design at
`that time. In January 2002, the most common stent
`design was a network pattern that was more than just
`one wire bent around in a wavy pattern."
` Q So what's your understanding of a "network
`pattern," as you've used it in your declaration?
` A So a network pattern is basically -- for
`example, the Bessler just has a sinusoidal wire
`that's going around. And a network would actually
`have cells that you can basically identify.
` Like, just as an example, the figure
`that's following that paragraph is an example of a
`network pattern where you have, instead of one wire
`that's just going in a wavy pattern, you can
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`identify these cells or nodes
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