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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`PAIN POINT MEDICAL SYSTEMS, INC., d/b/a MIBO
`MEDICAL GROUP,
`Petitioner,
`
`v.
`
`BLEPHEX, LLC,
`Patent Owner.
`____________
`
`Case IPR2016-01670
`Patent 9,039,718 B2
`____________
`
`Record of Oral Hearing
`Held: November 15, 2017
`____________
`
`
`
`
`Before MEREDITH C. PETRAVICK, SCOTT A. DANIELS,
`and SCOTT C. MOORE, Administrative Patent Judges.
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`Case IPR2016-01670
`Patent 9,039,718 B2
`
`APPEARANCES:
`
`ON BEHALF OF THE PETITIONER:
`STEVEN E. ROSS, ESQUIRE
`Ross IP Group, PLLC
`6860 North Dallas Parkway
`Suite 200
`Plano, Texas 75024
`
`ON BEHALF OF PATENT OWNER:
`MICHAEL ROSATO, ESQUIRE
`TASHA THOMAS, ESQUIRE
`Wilson, Sonsini, Goodrich & Rosati
`701 Fifth Avenue
`Suite 5100
`Seattle, Washington 98104-7036
`
`
`
`
`The above-entitled matter came on for hearing on
`Wednesday, November 15, 2017, commencing at 10:10 a.m., at
`the U.S. Patent and Trademark Office, 600 Dulany Street,
`Alexandria, Virginia.
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`Case IPR2016-01670
`Patent 9,039,718 B2
`
`
`P R O C E E D I N G S
`- - - - -
`JUDGE PETRAVICK: We are here today for a hearing
`in IPR2016-01670, Pain Point Medical Systems versus BlephEx.
`I am Judge Petravick. Joining us from Denver is Judge Moore
`and joining us from New Hampshire is Judge Daniels. Can we
`know who is here from the petitioner?
`MR. ROSS: Good morning, Your Honor. My name is
`Steven Ross. I'm here on behalf of the petitioner.
`JUDGE PETRAVICK: And from the patent owner?
`MR. ROSATO: Yes, thank you, Your Honor. Michael
`Rosato on behalf of the patent owner. I have Tasha Thomas at
`counsel table with me.
`JUDGE PETRAVICK: Thank you. And before you
`leave, if you could get a business card to the court reporter so that
`she has the correct spelling of your name.
`Okay. So since we have remote judges participating,
`it's very important that when you speak, you speak at the podium
`and into the microphone. Otherwise they will not be able to hear
`you. Also, they have copies of your demonstratives on their
`computers, but they will not be able to see the screen in the room.
`You will need to refer to the slide number on the screen.
`We see that some objections were filed to the
`demonstratives, and we want to address that issue right now. The
`first thing I would like to address is petitioner's objection -- I'm
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`Case IPR2016-01670
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`sorry, patent owner's objection to petitioner's demonstratives
`being untimely served. That's correct, right?
`MR. ROSATO: Yes, Your Honor, that's correct. They
`were two days late.
`JUDGE PETRAVICK: Petitioner, could you tell us if
`you agree whether they were untimely served and why.
`MR. ROSS: Your Honor, I believe that both sides were
`somewhat caught by surprise by the Veteran's Day holiday. The
`patent owner -- well, the order for the oral argument came out on
`November 2nd, and counting back seven business days, it would
`make the demonstratives be due on Friday, November 3rd. We
`did not receive patent owner's demonstratives until 9:00 --
`JUDGE PETRAVICK: I'm not asking you about patent
`owner's demonstratives. I'm just asking you right now about your
`demonstratives.
`MR. ROSS: Our demonstratives were not served until
`Sunday afternoon.
`JUDGE PETRAVICK: Because of a miscalculation
`because of the holiday?
`MR. ROSS: That's right.
`JUDGE PETRAVICK: Thank you. Petitioner, can you
`tell me whether you have suffered any harm because of the late
`filing of these demonstratives?
`MR. ROSATO: Patent owner? Yeah, let me just cut to
`the chase. While I would say there are probably more
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`Case IPR2016-01670
`Patent 9,039,718 B2
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`cooperative ways to deal with the issue, overly concerned about
`the timing issue is not really a concern. So we are willing to
`overlook the timing issue.
`JUDGE PETRAVICK: So are you withdrawing your
`objection?
`MR. ROSATO: We'll withdraw the timing objection.
`There is another objection that is of particular note. And that is
`this continuing issue of new types of materials being relied --
`JUDGE PETRAVICK: Right now we are only talking
`about the timing issue. So your objection is withdrawn?
`MR. ROSATO: We are willing to overlook it, because
`quite frankly, it's the content --
`JUDGE PETRAVICK: I'm going to take that as your
`objection is withdrawn.
`Patent owner [sic], as to your objection to timeliness of
`petitioner's demonstratives, are you willing to withdraw that
`objection?
`MR. ROSS: Yes, Your Honor. Our objection was
`purely contingent upon their objection.
`JUDGE PETRAVICK: So we have no more objections
`as to timeliness. Those are handled. There are objections as to
`alleged material never previously presented in the petition being
`in petitioner's slides. Petitioner, what we are going to do is we
`are going to reserve ruling on those objections. During your
`presentation or at the end of your presentation, if you want to tell
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`Case IPR2016-01670
`Patent 9,039,718 B2
`
`us exactly where that material is found in your substantive papers,
`whether in the petition or in the petitioner file, that would be very
`helpful to us. When we go back and consider it, we will then sift
`through the material.
`I think that takes care of all of the objections. So each
`side has 45 minutes. We will start with the petitioner. Petitioner,
`you can reserve some time for rebuttal. Would you like to
`reserve any time?
`MR. ROSS: Yes, Your Honor, we would like to reserve
`15 minutes for rebuttal.
`JUDGE PETRAVICK: So I'm going to set these lights
`for 30 minutes.
`MR. ROSS: Thank you.
`JUDGE PETRAVICK: You may begin when you are
`
`ready.
`
`MR. ROSS: Thank you. May it please the Board, the
`facts of this case are simple and straightforward. The patent is
`directed to a motorized swab used to remove debris from eyelid
`margins to treat ocular conditions. And the facts of this case fall
`squarely within the two -- the following two rules from the KSR
`case: Quote, when a patent simply arranges old elements with
`each performing the same function it had been known to perform
`and yields no more than one would expect from such an
`arrangement, the combination is obvious.
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`Case IPR2016-01670
`Patent 9,039,718 B2
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`
`The second rule is, quote, if a technique has been used
`to improve one device and a person of ordinary skill in the art
`would recognize that it would improve similar devices in the
`same way, using the technique is obvious unless its application is
`beyond his or her skill. That's the situation we have here, Your
`Honor.
`
`MR. ROSATO: Your Honor, I'm just going to note an
`objection to any new argument. This is another new one. I'll
`reserve this until the end. I don't want to disrupt flow here, but
`I'll note a standing objection to any new content that's being
`raised here.
`JUDGE PETRAVICK: I'm going to reiterate that our
`rule did not allow for new arguments or evidence to be raised at
`the oral argument merely to emphasize arguments that you have
`already made in the substantive papers. And therefore, new
`arguments will not be considered. Please hold any objections
`either party has about new arguments or evidence until the end of
`your presentation.
`MR. ROSS: Your Honor, the Board has instituted IPR
`on three grounds. And the involved claims are claims 1
`through 11 and claims 14 through 17 of the '718 patent. Ground
`1, of course, is based on the AlgerBrush II reference combined
`with Seminara and Stevens. Ground 2 is the AlgerBrush II
`reference combined with Hamburg. And ground 3 is the
`Yamaura reference combined with Stevens.
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`Case IPR2016-01670
`Patent 9,039,718 B2
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`
`I have one comment with respect to ground 3, Your
`Honor. The institution was for claims 1 through 11 and 14
`through 17 under ground 3. But our petition did not argue
`unpatentability of claim 11 with respect to ground 3. So I wanted
`to clear up that bit of confusion in the record.
`JUDGE PETRAVICK: Thank you. And we'll note
`
`that.
`
`MR. ROSS: We do, however, maintain our position of
`unpatentability of claim 11 under grounds 1 and 2.
`Moving on, Your Honor, I would like to begin with the
`anatomy. I think it helps us to understand the structures that we
`are dealing with here. I'm looking at slide 4 of our
`demonstratives. And this is an image taken from patent owner's
`Exhibit 2025 at page 10. This is a diagram that shows the
`anatomy of the eyelid. And you can see that the eyelid margin is
`positioned there at the top of the screen. You see the eyelashes
`extending from the eyelid margin. And you see the gray line
`which is an anatomical structure which is positioned posterior to
`the eyelashes. And then behind that you see the meibomian gland
`orifices. Those are even farther to the posterior side of the eyelid
`margin. They are -- you can view that as being posterior or to put
`it in the language of the case that we are dealing with here, they
`are on the interior portion of the eyelid margin.
`The claim itself, claim 1 uses language that defines
`everything behind the eyelashes as being the interior portion or
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`Case IPR2016-01670
`Patent 9,039,718 B2
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`near the interior portion. So I just wanted to point out that
`significant anatomical fact that the meibomian gland orifices are
`on the inner portion or interior portion of the eyelid margin.
`JUDGE DANIELS: Counsel, I just want to make sure
`that we are with both parties, and I'll ask patent owner the same
`question, the left side top line here, looking at claim 1 we have an
`inner edge portion, the language an "inner edge portion." Which
`part of the anatomy is that inner edge portion?
`MR. ROSS: Your Honor, claim 1 recites contacting a
`portion of the eye between the eyelashes and the inner edge of the
`eyelid margin. So with respect to that claim, it basically doesn't
`require any construction, in our mind. And anything behind the
`eyelashes or in slide 4, anything to the left of the eyelashes would
`be a portion of the eye between the eyelashes and the inner edge
`of the eyelid margin.
`JUDGE DANIELS: Okay. So you said the claim is
`pretty clear,
`
` is what you are saying, that as long as it touches
`anywhere between there and is contacting, then we are within the
`claim scope?
`MR. ROSS: Yes, Your Honor. I think the language of
`the claim is quite clear. Claim 17 uses slightly different
`language, but the parties have treated it as meaning essentially the
`same thing. Claim 17, of course, says, quote, contacting at least
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`Case IPR2016-01670
`Patent 9,039,718 B2
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`an inner edge portion of the eyelid margin. And petitioner
`contends that once again, anything behind the eyelashes or in
`slide 4, anything to the left of the eyelash line would be an inner
`edge portion of the eyelid margin. And that would certainly be
`consistent with the broadest reasonable interpretation rules that
`are applied in IPRs.
`JUDGE DANIELS: Do we need to construe or
`consider construing the word "contacting"? I know that there is
`an argument that there is a difference between, I believe -- I don't
`want to speak for them, but patent owner has an answer that
`discriminates between gently and aggressively contacting or
`treating this. Do we need to -- in that vein, do we need to
`construe the word "contacting"?
`MR. ROSS: Your Honor, it's petitioner's position that
`either a gentle touching or an aggressive touching would
`constitute contacting within the meaning of this patent.
`JUDGE DANIELS: Thank you.
`MR. ROSS: Thank you, Your Honor. So moving on to
`ground 1, of course this was the AlgerBrush II reference
`combined with Seminara and combined with Stevens. On slide 5,
`we have Figures 6, 8 and 10 from the Stevens reference. And that
`is Exhibit 1017. And Figure 6 on the top of the slide, you can
`see, that is an example from the -- that's given in the reference of
`cleaning the eyelashes using a swab. In Figure 8 from
`Exhibit 1017, that is an example or depicting the operation of
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`Case IPR2016-01670
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`cleaning the eyelid margin with a swab. The lower eyelid
`margin, I should be clear about. And then to the right on the
`lower right-hand side of slide 5, which is Figure 10 of
`Exhibit 1017, that depicts using a swab to clean the upper eyelid
`margin of the patient.
`Now, there was some discussion and question in the
`briefing about whether -- well, specifically it's patent owner's
`position that Stevens does not depict the cleaning or removal of
`debris from the eyelid margin. And I just wanted to point out on
`slide 6 the language of the Stevens reference itself. With respect
`to cleaning eyelashes, it says eyelashes. With respect to cleaning
`the eyelids, it says cleaning the lower eyelid margin and also
`cleaning the upper eyelid margin. And it's our position that use of
`eyelashes with respect to cleaning of the eyelashes means just
`that, to clean the eyelashes, and that the Stevens reference
`communicates something different when they say cleaning the
`eyelid margin. And of course, as we've argued in our papers, we
`believe that that communicates that the entire eyelid margin is
`cleaned with a cotton swab.
`JUDGE DANIELS: Counsel, is there anything in the
`record from your declarant that he understands this as -- let's just
`assume for a second he's one of ordinary skill in the art, that a
`person such as him, one of ordinary skill, would understand this
`phrase, the lower eyelid margin, to be the same as the eyelid
`margin that's in the claim?
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`Case IPR2016-01670
`Patent 9,039,718 B2
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`
`MR. ROSS: Your Honor, at the time we filed our
`petition, this was not an issue. And we simply took it when it
`says clean the eyelid margin, we took it to mean the entire eyelid
`margin. So the declaration that was filed with our petition did not
`address this issue.
`JUDGE DANIELS: Thank you.
`MR. ROSS: But again, we think that there's nothing in
`the record that would indicate that cleaning the lower eyelid
`margin means anything less than the entire eyelid margin. The
`AlgerBrush --
`JUDGE DANIELS: Sorry, just to be clear, so this
`disclosure is what you are indicating, that the claim language falls
`within this description. In other words, the contacting between --
`hang on. Let me look at the claim and make sure I'm saying this
`correctly. I'm looking at claim 1 and it recites contacting a
`portion of the eye between the eyelashes and the inner edge of the
`eyelid margin, that what you have in slide 6, the lower eyelid
`margin and the upper eyelid margin, pertains to that claim
`language.
`MR. ROSS: Yes, Your Honor. I believe our expert
`also testified on cross-examination that he was taught when he
`was going to school to clean wherever the crusting was on the
`eyelid margin. The crusting, of course, develops over the orifices
`of the meibomian glands, which are located on the inner edge of
`the eyelid margin.
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`Case IPR2016-01670
`Patent 9,039,718 B2
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`
`And while we are on this point, claim 1, of course, says
`contacting a portion of the eye between the eyelashes and the
`inner edge of the eyelid margin. Going back to slide 4, if you
`look at the top right side, you see the lash line. We contend that
`any contacting that takes place behind the lash line satisfies that
`claim limitation that I just read because it is contacting a portion
`of the eye between the eyelashes and the inner edge of the eyelid
`margin.
`
`JUDGE DANIELS: So it's reasonable for us to infer a
`little bit from these figures that that is what is occurring? Even
`though we can't quite tell exactly where the contacting is
`happening, that that is what would be happening in Figures 8 and
`10?
`
`MR. ROSS: Your Honor, on slide 5 and specifically on
`the lower left-hand corner of slide 5, which is a depiction of
`Exhibit 1017, Figure 8, we see a swab being applied to the lower
`eyelid margin. And although you can't exactly see the eyelashes
`there, a fair inference is that that swab is being applied behind the
`lash line. It's depicted there in Figure 8. Also, and perhaps more
`clearly in Figure 10 of Exhibit 1017, we see the swab -- we see a
`better view of the eyelashes and we see the swab being positioned
`behind those eyelashes in Figure 10.
`JUDGE DANIELS: Okay. Thank you. Before you get
`off the Stevens reference, I was wondering if you were going to
`address one of the points that patent owner brings up that is
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`Case IPR2016-01670
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`certainly at issue here is, I believe your declarant, and I can't
`point to the paragraph number, and also in the petition you all
`argued that Stevens provides motivation, some motivation for the
`combination. Is there somewhere in Stevens that points to the use
`of a mechanical device apart from a Q-tip or cotton swab, as we
`see here?
`MR. ROSS: No, Your Honor. Stevens doesn't discuss
`or address the use of an electromechanical device. But Stevens
`does discuss and address the use of a swab to clean the eyelid
`margins. And if one proceeds from having the AlgerBrush and
`the swab of the Seminara reference which we will discuss,
`Stevens suggests and motivates using those to clean the eyelid
`margin because it's well known that processes may be made more
`efficient and more effective through automation or the use of an
`electromechanical motor.
`JUDGE DANIELS: Okay. Thank you.
`MR. ROSS: Moving on to the AlgerBrush reference, I
`have on slide 7 images from Exhibit 1013 and Exhibit 1014.
`Now here we see that the AlgerBrush shows it has an
`electromechanical device which includes a motor. It has a chuck
`position near the top of the device. And mounted within the
`chuck is a burr. And that burr is used to remove rust rings from
`the eyes of patients. As I'm sure the Board knows from the
`papers that were filed, a rust ring forms when a piece of metal is
`lodged on the eyeball and it begins to rust and discolors the
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`Case IPR2016-01670
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`eyeball. So what has to be done is that debris has to be removed.
`You have to remove the foreign matter. You also have to remove
`the discolored tissue. So the AlgerBrush is used with the burr to
`remove the debris. And I'll point out right here that patent
`owner's expert admitted that when the AlgerBrush is used to
`remove rust rings, it necessarily is removing debris from the eye
`because the foreign body and the dead tissue would constitute
`debris.
`
`On the right side of slide 7, we have Exhibit 1014,
`which is some text from advertising materials from the
`AlgerBrush. And here we see that the applicator tips are known
`to be interchangeable depending upon the particular purpose or
`use at hand. On the left you see -- on the left side of Exhibit 1014
`you see corneal rust ring products. And there we see burrs of
`different sizes along with the combination of chucks and burrs.
`On the right side of Exhibit 1014, we see pterygium products. In
`our briefing we included a photograph of what a pterygium looks
`like. It's a growth on the eyeball. And those are removed with
`this AlgerBrush instrument as well, but it's known to use different
`applicator tips.
`JUDGE DANIELS: Counsel, is there anywhere in here
`that talks about using the AlgerBrush II on anything except the
`corneal tissue?
`MR. ROSS: It is in our expert's declaration. I can
`provide you a reference to that.
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`Case IPR2016-01670
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`
`JUDGE DANIELS: Yeah, that would be great. And
`does he say there that this is known to be used on other tissues
`besides corneal tissue?
`MR. ROSS: Yes, Your Honor, he does. And patent
`owner's expert agrees.
`JUDGE DANIELS: You don't have to give it to me
`right now either. If you want to look for it later afterwards, that's
`fine too, but that would be particularly helpful.
`Let me ask one other thing. This is not -- we are not
`having any issue with understanding the technology. And both
`parties have done a very good job of explaining how the anatomy
`and how things work. What I'm a little more concerned about
`from your perspective is the combination of these references.
`And let me go back to a little bit with the combination that you
`have of Stevens with this AlgerBrush II. Can you point me to
`somewhere in your petition where you said that it was just a plain
`matter of replacing a manual process with an automated process?
`MR. ROSS: Yes. Petitioner's expert, Dr. Benjamin, in
`Exhibit 1002, in paragraph 37 testified that the use of
`electromechanical devices and swabs for debriding tissue and
`removing debris or buildup from the eye was well known to eye
`care professionals. And later in paragraph 59 of Exhibit 1002,
`Dr. Benjamin testified that any eye care specialist would
`recognize that the burr used with the AlgerBrush device could be
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`Case IPR2016-01670
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`replaced with a softer material such as a swab to clean the eyelid
`margin.
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`JUDGE DANIELS: Did you all reiterate this argument
`in any way in the petition itself?
`MR. ROSS: Yes, Your Honor. Just one moment,
`please. Essentially the same arguments are made on pages 12, 13
`and 14 of the petition.
`JUDGE DANIELS: Okay. Thank you.
`JUDGE MOORE: Counselor, just to make sure I
`understand, your argument is that the person of ordinary skill in
`the art would have had reason to take the AlgerBrush and to
`replace this burr on the end with the swab of Seminara, correct?
`MR. ROSS: Correct.
`JUDGE MOORE: Is there -- now, the AlgerBrush, it
`operates by rotating the burr, correct?
`MR. ROSS: Correct.
`JUDGE MOORE: So in your proposed combination,
`the swab would be rotating?
`MR. ROSS: Correct.
`JUDGE MOORE: Is there any teaching you can point
`to of using the swab in a rotating motion to clean the margin of an
`eyelid?
`
`MR. ROSS: Your Honor, I'm not aware of any at the
`moment other than simply the manual operation. But the claims,
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`Case IPR2016-01670
`Patent 9,039,718 B2
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`I'll point out the claims themselves don't require a rotating
`motion. They simply require contacting.
`JUDGE MOORE: Right, but they also require that the
`swab being moved by the electromechanical device. So in your
`proposed combination in which this swab was on the end of this
`rotating device, in your proposed combination, the movement
`would be rotational.
`MR. ROSS: That's correct.
`JUDGE MOORE: So what I'm trying to understand is
`why a person of ordinary skill in the art would have combined a
`swab with a rotating electromechanical device such as
`AlgerBrush, why that would have been obvious.
`MR. ROSS: Well, Your Honor, I'm jumping ahead a
`little bit here, but under ground 3, the Yamaura reference shows
`an electromechanical device with a rotating swab. And that was
`known in the art. But once again, as we are looking at ground 1,
`the claim itself doesn't require rotating. In fact, it's intentionally
`intended to be broad enough to include any kind of a motion,
`including a lateral type of a motion or longitudinal.
`JUDGE MOORE: I understand that, counselor. I'm not
`looking at the claim right now. I'm setting aside -- no hindsight
`here. I'm setting aside the challenged patent. Your argument, as I
`understand it, is a person of ordinary skill in the art just not
`looking at that patent at all would have had reason to combine
`this swab with the rotating electromechanical device of
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`Case IPR2016-01670
`Patent 9,039,718 B2
`
`AlgerBrush to clean an eyelid margin. And I'm trying to
`understand why such a person would have combined this swab
`with this particular electromechanical device which does rotate.
`Is there any teaching that's spinning the swab, whether manually
`or electromechanically, as a way to clean the margin? Because
`I'll tell you it looks like from Stevens, the swab is just being
`swept -- you know, swept along the eyelid margin. It doesn't look
`to me like that swab was being spun rapidly. So I'm trying to
`understand just with respect to ground 1 why a person of ordinary
`skill in the art would have put a swab on the end of an
`electromechanical device which would have spun the swab
`rapidly for this purpose.
`MR. ROSS: Your Honor, our expert testified that it's
`essentially a simple substitution of known elements. It's a -- you
`have an electromechanical device with a chuck which is intended
`to, by a clear reading of the reference, indicates that it's intended
`to accept different applicator tips. Yes, Your Honor, it certainly
`does rotate. That's the operation of the AlgerBrush. But the swab
`of Seminara is also rotationally symmetrical and would easily fit
`within the chuck of the AlgerBrush.
`JUDGE MOORE: I understand you could have done
`that. You know, it would have been relatively trivial to remove
`this burr and put on the swab. But these claims aren't just for a
`simple combination of elements. They require using this device
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`Case IPR2016-01670
`Patent 9,039,718 B2
`
`for a particular purpose. So I am not sure that just saying, well,
`you could have done this gets you there.
`I'm just trying to understand, you know, why -- I
`understand you could have done that. I'm trying to understand
`why a person of ordinary skill in the art, given that AlgerBrush is
`a device that rotates whatever you attach it to rapidly, why would
`you have thought to add a swab to this rotating device and then
`use that on the eyelid margin? Is there some teaching that an
`eyelid margin could be cleaned with a rotating swab, for
`example?
`MR. ROSS: There is teaching that similar methods can
`be made more efficient and effective through motorization or
`automation. And that clearly is in the record. I believe patent
`owner's expert has admitted to that.
`So even though Stevens doesn't show rotation, and we
`clearly admit that, a person of ordinary skill in the art would
`know that using the electromechanical device would make the
`cleaning more efficient. And Dr. Pau admitted -- and I'm citing
`to Exhibit 1026 at lines -- sorry, page 143, line 13 through
`page 145, line 4. Dr. Pau admitted that a person of ordinary skill
`in the art would have known as early as 1975 that automation of
`the manual process of removing rust rings from the cornea by
`using an electromechanical motor to operate the burr, as in the
`AlgerBrush, was actually a more effective way to remove rust
`rings.
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`Case IPR2016-01670
`Patent 9,039,718 B2
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`
`JUDGE PETRAVICK: Mr. Ross, you are out of time.
`You can continue into your rebuttal time if you would like.
`JUDGE MOORE: If you have anything else to say,
`counselor, please go ahead, but otherwise feel free to continue.
`MR. ROSS: Very briefly, let me just move to ground 3,
`which is the Yamaura reference. Ground 3 is Yamaura combined
`with Stevens. I have on slide 10 Exhibit 1019, Figure 1, and a
`description of the Yamaura reference. It's essentially an
`electromechanical device. It has a motor. It has a chuck or a
`collet. And swab is received into that chuck. And the patent
`describes it as being used to clean ear canals. Our expert -- it
`essentially meets all of the structural limitations of the device in
`claims 1 and 17. The only difference is that this device happens
`to be used for cleaning ears.
`Now, Stevens, as we've talked about, describes using a
`cotton swab to clean the eyelid margins. Now, this cotton swab
`11 that's shown in Exhibit 1019, Figure 1, is simply a
`conventional cotton swab. So as I mentioned, Yamaura meets all
`of the structural limitations. The only difference is to use it to
`clean the eyelid margins. And Stevens suggests that by using the
`cotton swab to clean the eyelid margins. So it's not much of a
`change or modification or advancement at all to simply use this
`existing device to clean eyelid margins. And for decades swabs
`have been used to clean the eyelid margin in the treatment of
`ocular conditions such as blepharitis.
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`Case IPR2016-01670
`Patent 9,039,718 B2
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`
`I'll yield the rest of my time for rebuttal.
`JUDGE DANIELS: I have one quick follow-up
`question. I do recall that somewhere Dr. Benjamin may have,
`either under cross-examination or his declaration, discussed being
`taught or learning to scrub the eyelid with a swab. Is my
`recollection -- am I right?
`MR. ROSS: That's correct, Your Honor. That was in
`his deposition testimony.
`JUDGE DANIELS: Okay. Thank you.
`MR. ROSS: Thank you, Your Honor.
`JUDGE PETRAVICK: Thank you. We asked you a lot
`of questions. So we are going to give you your full 15 minutes on
`rebuttal.
`MR. ROSS: Thank you, Your Honor.
`MR. ROSATO: If you could give us a moment to
`connect up to the projector here, we would appreciate it. Thank
`you. May it please the Board, Mike Rosato appearing on behalf
`of patent owner, BlephEx. I would like to start by pointing out a
`few things that we all know but sometimes bear repeating. And
`that starts with the fact that in an IPR it is the petitioner that bears
`the unshifting burden of proof to prove their unpatentability
`challenges. In other words, the burden never is on the patent
`owner to prove patentability. And we all know that based on
`relevant statutes, Board rules and the Federal Circuit decisions.
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`Case IPR2016-01670
`Patent 9,039,718 B2
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`As part of that burden, the petitioner must be clear in
`their petition of what their case is. That must be substantiated
`with evidence and that must be sufficiently developed in the
`petition. IPRs are not notice-pleading cases like contemplated in
`the District Court where these theories can be developed later on
`in a proceeding. Nor are they the same type of proceeding as a
`re-examination proceeding where prior art --
`JUDGE PETRAVICK: Mr. Rosato, could we just start
`right in to talk about motivations in this case.
`MR. ROSATO: Absolutely.
`JUDGE PETRAVICK: Specifically as to ground 1, the
`combination of the swab and the AlgerBrush reference. So
`petitioner says --
`JUDGE MOORE: I can't hear whatever is being said
`from Denver right now.
`JUDGE PETRAVICK: I'm sorry, my microphone got
`turned off. Can you hear me now, Judge Moore?
`JUDGE MOORE: Yes.
`JUDGE PETRAVICK: So if the AlgerBrush reference
`is a device that

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