`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________
`
`FISHER & PAYKEL HEALTHCARE LIMITED,
`Petitioner,
`
`V.
`
`RESMED LIMITED,
`Patent Owner.
`______________
`
`Case IPR2017-00632
`Patent 8,944,061 B2
`______________
`
`Record of Oral Hearing
`Held: JULY 11, 2018
`
`______________
`
`
`
`Before BARRY L. GROSSMAN, BEVERLY M. BUNTING AND
`JAMES J. MAYBERRY, Administrative Patent Judges.
`
`
`
`
`
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`Case IPR2017-00632
`Patent 8,944,061 B2
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`APPEARANCES:
`
`ON BEHALF OF THE PETITIONER:
` JOHN B. SGANGA, JR.
` KNOBBE MARTENS
` 2040 Main Street
` 14th Floor
` Irvine, California, 92614
` 949.760.0404
` john.sganga@knobbe.com
`
`ON BEHALF OF THE PATENT OWNER:
` ROGER A. DENNING
` FISH & RICHARDSON
` 12390 Electric Camino Real
` San Diego, California, 92130
` 858.678.5070
` denning@fr.com
`
`ALSO PRESENT:
` Benjamin J. Everton, Knobbe Martens
` Sheila Swarooop, Knobbe Martens
` Robert Roby, Knobbe Martens
` Curtiss Dosier, Knobbe Martens
`
`ALSO PRESENT:
` Michael Hawkins, Fish & Richardson
` Jason Zucchi, Fish & Richardson
` Michael Rider, ResMed
`
`
`
`The above-entitled matter came on for trial hearing on Wednesday, July
`11, 2018, commencing at 9:04 a.m., at the U.S. Patent and Trademark Office,
`300 River Place South, Suite 2900, Detroit, Michigan.
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`Case IPR2017-00632
`Patent 8,944,061 B2
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` P R O C E E D I N G S
` - - - - - - - -
` JUDGE BUNTING: So we'll go on record, and
` today, this morning we're here for a final hearing in
` IPR 2017-00632 involving Petitioner Fisher & Paykel and
` Patent Owner ResMed, and that concerns Patent Number
` 8,944,061. After the hearing today in IPR2017-00632,
` we'll take a short break and then conduct the hearing in
` IPR2017-00272. So for the record, I'm Judge Bunting and
` I will be presiding today. And appearing remotely is
` Judge Mayberry and Judge Grossman. I don't see Judge
` Grossman, so can you change the -- I guess in
` Alexandria, they'll have to change the camera. There he
` is. Okay. So Judge Grossman will be on your -- I guess
` on your left, and Judge Mayberry on the right. As
` discussed in the hearing Order, each party will have 45
` minutes of total time to present its arguments.
` Petitioner has the burden, and it will go first. Next,
` Patent Owner will argue their opposition to Petitioner's
` case. Petitioner, you may reserve rebuttal time as
` indicated in the Order. May I have the appearances of
` counsel, beginning with Petitioner?
` MR. SGANGA: Good morning, Your Honor. John
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` Sganga for Petitioner Fisher & Paykel Healthcare. With
` me are my colleagues from Knobbe Martens, at counsel's
` table Ben Everton, Sheila Swaroop, Rob Roby, and Curt
` Dosier.
` JUDGE BUNTING: Thank you. And this is
` probably a good opportunity for me to remind the parties
` to step up to the microphone. I'm not sure -- Judge
` Grossman and Judge Mayberry, did you hear that?
` JUDGE GROSSMAN: I did, yes.
` JUDGE BUNTING: Okay. Good.
` JUDGE MAYBERRY: I did as well.
` JUDGE BUNTING: Okay. Good. And so
` Patent Owner, may we have appearances?
` MR. DENNING: Good morning, Your Honor. It's
` Roger Denning from Fish & Richardson on behalf of Patent
` Owner ResMed, and I will be speaking this morning. With
` me are my colleagues from Fish & Richardson, Michael
` Hawkins and Jason Zucchi, as well as Michael Rider, who
` is General Counsel-Americas with ResMed.
` JUDGE BUNTING: All right. Thank you. And,
` again, just a reminder that Judge Mayberry and Grossman
` will not be able to see whatever is presented on the
` screen -- in this case, the wall -- so please explain
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` carefully whatever you're referring to. So if you're
` referring to a demonstrative, state the slide number so
` that the remote judges can follow along, and also for
` clarity of the record. So we have a clock on the wall
` that I'll use, as well as we have a new timer, so
` hopefully that's going to work. I'll probably use both
` to just monitor the time. And I guess this new timer
` will give you -- will give you a 5-minute warning
` when you're reaching the end of your argument time. So
` just a reminder that the hearing is open, and I
` understand there is no confidential information. Does
` either side have any questions? Petitioner?
` MR. SGANGA: No, Your Honor.
` JUDGE BUNTING: And Patent Owner?
` MR. DENNING: No, Your Honor.
` JUDGE BUNTING: All right. Petitioner, you
` may begin when you're ready to present. And will you be
` reserving any time for rebuttal? And how much time?
` MR. SGANGA: Yes, Your Honor. I'd like to
` reserve 20 minutes.
` JUDGE BUNTING: 20 minutes? Okay.
` MR. SGANGA: Good morning, and thank you. I'd
` like to turn to slide number 2 in our presentation to
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` just give a brief overview of the issues that we're
` going to address. There's three grounds. They
` primarily rely on the combination of the two references,
` Berthon-Jones and Barnett, and this relates to the
` primary issues of having two frames on the mask with two
` openings, and ground 2, we also include the Lithgow
` reference. That relates to the forehead support that
` appears in some claims, and ground 3 includes the Burns
` reference, and this deals with the over molding
` limitation that's in fewer claims. And the focus will
` really be in my presentation on the concept of the two
` frames with two openings. Slide 3, we've got the level
` of skill in the art that has not been disputed. The
` point here is that this is a relatively high level of
` skill, a bachelor's degree, two years of experience in
` mask design, where we believe many of the claimed
` features have been used quite frequently. Slide 4, no
` evidence of secondary considerations presented by Patent
` Owner here, and we think this is meaningful,
` particularly in light of the fact that as we look at the
` claim limitations at issue, many of them have not
` only -- have not been subject of a particular commercial
` success or other secondary consideration, but there is
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` very little in the way of expressed disclosure on many
` of these claim limitations, other than a figure or
` perhaps a passing reference to a feature, and we think
` that informs the level of skill in the art and how the
` amount of disclosure that we would expect a person of
` skill to need in order to understand these features.
` whether in the specification or the prior art. Slide 5,
` we have an overview of the issues and arguments we want
` to present. The first bullet point goes to the issue of
` making this direct connection between the elbow and the
` second frame. The second frame is the claim term. I
` want to start off by pointing out that there is a bit of
` an inconsistency in the terminology. Some of the prior
` art references refer to the first frame and the second
` frame in a different sequence than the patent does, but
` I think if we refer to these two frames as the inner
` frame or the cushion frame that's in contact with the
` patient's face, and the outer frame, which is the more
` rigid frame or sometimes referred to as a chassis, that,
` I think, will be more consistent rather than first and
` second. So I'll try to use that nomenclature, but
` certainly please let me know if there's any confusion as
` to which frame we're talking about when we refer to
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` first or second. So the issue is do we have a direct
` connection between the elbow, the air delivery conduit
` to this outer frame, and then the second bullet point
` goes to the issue of would you then also have not only
` that opening to connect the elbow, but a separate
` opening, which is claimed. And the third bullet gets to
` the issue of once we make that combination in Berthon-
` Jones, what has happened to the adjustment wheels that
` are shown in that reference. And Fisher & Paykel's
` position from the outset has been that those adjustment
` wheels are not modified. We never proposed that they
` would be modified or removed. The actual connection
` from the elbow to the inlet conduit on the second or
` outer frame is in a different area than those wheels,
` and we'll get into that in more detail. But I wanted to
` be clear that our view is there is no impact on the
` operation of those wheels that adjust spacing between
` the two frames in the Berthon-Jones reference. And then
` the forehead support and the over molded cushion are the
` issues that we'll spend less time on. So I'd like to
` jump ahead here now to the issue, this first issue about
` how to attach the elbow, and I think slide 8 gets
` directly to the question of how many different ways are
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` there to attach the elbow to the mask. And Patent
` Owner's expert, Mr. Virr, was candid in testifying that
` there were really only three options, a limited number
` of ways to connect the elbow. It's either direct to the
` first or inner cushion that contacts the face; secondly,
` directly to the outer or more rigid cushion, which is
` the way it is claimed in the patent. He also considered
` another option to go directly to the cushion as opposed
` to the cushion frame. But basically we've got the
` option that we see in the prior art in Barnett reference
` on the right here, which is direct to the outer frame,
` we've got the prior art Berthon-Jones reference, which
` is a direct connection to the inner frame, and those are
` two out of the three options. And I think you'll hear
` Patent Owners talking about how we've plucked this
` option out of a sea of prior art, and we don't think the
` record supports that view, but rather this is a more
` typical KSR type of situation with limited options with
` predictable results. And the predictability of those
` results, as we turn to slide 9, was supported in the
` record with the fact that there were masks on the
` market, as Patent Owner's expert admitted, that fit this
` description of having the seal to the -- between the
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` elbow and the second or outer frame, so these were
` well-known. They were known to be useful and reliable.
` And on slide 10, we list a number of reasons that our
` expert, Petitioner's expert, Mr. Eaton, explained as to
` why you'd want to do that. Why is there any reason to
` use that kind of connection that we see in Barnett? Why
` would you want to modify Berthon-Jones to include that?
` Well, there's numerous advantages, and they -- one of
` them relates to the fact that in disassembling the mask,
` which needs to be done regularly in order to clean in
` particular the cushion portion, which is in contact with
` the patient's face, the disassembly is simplified.
` Instead of taking all three parts apart from one another
` to separate them, we can leave the elbow connected to
` that outer frame, and simply remove the cushion frame,
` clean that, and reattach it, and this is a significant
` benefit. Another significant benefit among the others
` here is the fact that the outer frame is more rigid.
` That gives you a more stable connection between the
` elbow and the device with the patient moving. That's a
` benefit as well. And then finally, having a cylindrical
` or annular shaped opening improves manufacturing. And
` there's not really any dispute on that.
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` JUDGE BUNTING: Counsel, Mr. Sganga, I'd like
` to interrupt you a second. And in looking at this
` slide, I'm looking at the citation, which is to really a
` broad span of your expert's declaration. Can you point
` us to the Petition and specifically where this was
` discussed, your reasons to combine?
` MR. SGANGA: The reasons to combine were
` addressed in the -- and I'll identify a cite here in the
` Petition momentarily. And perhaps if Your Honor could
` indulge me to rely on my colleagues to point me to a
` particular page?
` JUDGE BUNTING: Certainly, you can even state
` it later at the end. We just wanted to make sure we
` understood where the citation to the record is.
` MR. SGANGA: Thank you, Your Honor. Yes,
` we'll get you the specifics on that.
` JUDGE MAYBERRY: And, Counsel, excuse me.
` Just to follow up on that, I'll help a little. I think
` as far as your first bullet item, you know, I saw it on
` Petition 41–42. A little concerned that the other three
` bullet items are not referenced in the Petition, so if
` you could -- if your colleague could identify where
` those three items were or relied on in the Petition, I
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` think that would be helpful.
` MR. SGANGA: Thank you, Your Honor.
` JUDGE BUNTING: And also, we have a number of
` independent claims here. Do these reasons apply to all
` the independent claims?
` MR. SGANGA: I believe they do, yes.
` JUDGE BUNTING: Okay. Thank you.
` MR. SGANGA: And I want to jump to slide 13
` here on the issue here of the fact that this was the
` connection directly between the elbow and this outer
` frame. This was something that the patent owner's
` expert conceded would have been something that the
` person of skill would have had some experience doing,
` and so not only would there have been this motivation to
` want to make this connection from elbow to outer frame,
` but this is something that was within the level of skill
` in order to implement.
` JUDGE BUNTING: And can you clarify for me
` what your proposed combination is? I'm looking -- I'm
` looking at the patent, but I just want to see if you
` have --
` MR. SGANGA: I think slide 16 has an
` illustration that --
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` JUDGE BUNTING: Okay. That --
` MR. SGANGA: -- that --
` JUDGE BUNTING: Okay.
` MR. SGANGA: -- may be most helpful on that.
` JUDGE BUNTING: Sure.
` MR. SGANGA: So the combination here is that
` the more rigid outer frame from Barnett, which is shown
` in Barnett as directly connecting to the elbow, and
` that's on the far right here in this image, that that
` connection in that outer frame, that would be
` incorporated into this triangular shaped Berthon-Jones
` outer mask. And the way that Mr. Eaton explained it is
` that based on this teaching from Barnett, you would fill
` in material in the lower part of the opening, the lower
` part of this triangular opening 536 in
` Berthon-Jones, and he said there's two ways you could do
` that. One is to either fill in the material there in
` the lower part of that triangular opening, or you could
` add a bracket to the Berthon-Jones frame, again, to the
` lower part of the opening. And what you'd be doing then
` is taking this annular opening in the Barnett frame and
` you'd be incorporating it one of those two ways into the
` outer frame in Berthon-Jones. And it's important to
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` note here that the way that we describe this combination
` is that we would be using the -- this added frame
` material only in the lower part of the opening. And if
` you look at the middle of the three dotted lines that's
` shown in that figure, that lines up the annular openings
` from the inner frame or the cushion frame now with the
` annular opening and the outer frame. That would connect
` to the elbow. And those are already -- in Berthon-
` Jones, those are already offset. Those are at the very
` bottom of the overall device, and at the very bottom of
` that triangular opening in the Berthon-Jones outer
` frame. So the net result is that when we make this
` combination, we still leave a separate upper opening,
` that upper part of the triangular opening that's already
` there in Berthon-Jones. There's no need to fill that
` in. And, in fact, Mr. Eaton, if -- Mr. Eaton goes on to
` give a number of explanations. If you go to slide 18 --
`
` JUDGE BUNTING: Before you go to slide 18, I'd
` like to go back to slide 16. And in the combination on
` the module that I guess you're calling the inner module,
` you do have a connector there, a connector. What
` happens to that connector?
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` MR. SGANGA: If Your Honor's referring to
` those snap fit connectors?
` JUDGE BUNTING: No. No, not on 524. It looks
` like it was a hose connector. There's a lead line 520
` there, but I'm not sure 520 is for that connection or
` this --
` JUDGE MAYBERRY: 520 is the connection for the
` elbow.
` MR. SGANGA: Oh, I see. Yes, 520 is the
` annular opening in the --
` JUDGE BUNTING: Right.
` MR. SGANGA: -- inner frame.
` JUDGE BUNTING: Right. It's the annular
` opening, but you have that structure there that --
` MR. SGANGA: Correct.
` JUDGE BUNTING: -- the elbow connects up to.
` MR. SGANGA: Right.
` JUDGE BUNTING: So when you add Barnett there,
` how is that? Is Barnett fitting over that structure?
` Or have you eliminated that structure? What's
` happening?
` MR. SGANGA: Well, very much like Barnett
` does, that structure 520 then would seal with the -- now
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` the outer frame, and so we see that in Barnett, that
` there is a seal between the more flexible inner cushion
` frame and this more rigid frame. And so we would -- we
` would create -- we would connect 520 with this new
` structure at the bottom of the outer frame. There would
` be a seal there, and then the elbow itself would connect
` to the Barnett structure. And if we --
` JUDGE BUNTING: So and I have -- actually that
` raises another question as I'm looking at this, because
` you said that the Barnett structure would fit into the
` lower section, but it looks like the
` Berthon-Jones is for a full face mask, and Barnett is a
` nasal mask; is that true? So why would it fit in the
` lower portion versus say in the middle or upper portion?
` MR. SGANGA: Well, the approach is to use
` Berthon-Jones and that as the primary reference to leave
` as much of it intact as makes sense, and we've got
` motivations to change the -- this seal arrangement or
` this connection arrangement from the elbow. And in
` doing so, we want to look at what needs to change in
` Berthon-Jones and what doesn't need to change. And this
` particular location of the annular conduit into the
` Berthon-Jones mask is in a good location relative --
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` it's not interfering with the patient's nose. It's in a
` good location. There's no real motivation to change
` that. The point that Barnett is a nasal mask, I think,
` is instructive, because in all of these masks, there's a
` motivation to minimize weight. We've got a concern that
` this is something worn on the patient's face. Weight is
` undesirable. Barnett takes care of that by being a very
` small mask overall. It's lightweight. Berthon-Jones,
` we see does that by this cutout within the frame. So if
` we're going to be adding more frame material to Berthon-
` Jones, the person of skill is going to be mindful about
` how much do we really need to add. There's a benefit to
` adding some material, because we get a better connection
` to the elbow, and that has benefits. We're going to be
` always considering how does that -- how does weight play
` into that. And the person of skill wouldn't simply just
` say, well, I'm going to fill in that entire triangular
` opening in Berthon-Jones without saying do I really need
` that. Is that going to add material cost? Is that
` going to add weight? And that's exactly the analysis
` that Mr. Eaton explained on slide 18 in his declaration
` in paragraph 78. He talked about minimizing weight.
` There's also other advantages to leaving a space open,
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` so that you could visually inspect the inner frame, so
` that you -- maybe you had room now to provide a vent or
` other pressure indicator type device. So in making that
` combination, certainly you would look at now that I'm no
` longer on a nasal mask like Barnett, I'm on a full face
` mask, do I have flexibility to leave openings in the
` frame, save material, save weight. And this is
` something that Patent Owner's expert, Mr. Virr,
` confirmed on slide 19. We quote his testimony at page
` 17 of his -- and 18 of his deposition, where he said
` being a lightweight system is something that you'd want
` to consider, especially as the patient's sleeping.
` Slide 20, his testimony about system level requirements
` from page 43 of his deposition, Exhibit 1020, also talks
` about a weight target as a key concern. So we think
` that the -- this motivation on weight would be top of
` mind to the person of skill, and that as a result, the
` person of skill would incorporate the Barnett feature of
` the direct connection to the elbow, putting it at the
` lower end of that triangular opening in
` Berthon-Jones where the conduit already is, makes sense,
` and then leaving open the top of that triangular open --
` opening makes sense for all the motivations that Mr.
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` Eaton pointed out and that Mr. Virr agreed with. We
` also -- there was setback --
` JUDGE MAYBERRY: Excuse me, Counsel.
` MR. SGANGA: Yes, Your Honor?
` JUDGE MAYBERRY: If I heard you right, you
` just said something that this minimizing weight, that
` was a key consideration and a key motivation for keeping
` the upper half of opening 536 open. And in my review of
` the Petition, it seems like a key point that is made in
` the Petition is this anti-rotation aspect. And indeed -
` - and you can correct me if I'm wrong, or your colleague
` can correct me -- I didn't see any mention of Mr.
` Eaton's other reasoning as far as venting exhaled gases
` or minimizing weight and material cost actually in the
` Petition, but only in his declaration. And instead, it
` was this anti-rotation aspect. And that gives me some
` pause, because doesn't Berthon-Jones already have
` structures that provide this anti-rotation? That's the
` pair of structures 524, 526. Once you snap the two
` frames together, because you've got two structures 524,
` two structures 526, you're not going to rotate. And so
` I'm a little hard-pressed to see how -- why you would
` leave it open for
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` anti-rotation.
` MR. SGANGA: Well, Your Honor, the
` anti-rotation issue, I think, is interesting, because in
` Berthon-Jones to begin with, it has these redundant
` anti-rotation systems. It has the snap fit connectors,
` which could have an anti-rotation feature, but it also
` has this -- these interlocking triangular shapes, the
` opening in the outer frame as well as this protrusion,
` 518, on the inner frame. So Berthon-Jones is already
` teaching that having these interlocking shapes is
` something that you would want to use, and, you know,
` there could be benefits to redundancy. There could be
` issues as to tolerances as to which of the openings has
` a tighter fit, the triangular -- does the triangular
` opening have a tighter fit with the protrusion that
` mates with it, or do those snap fits have a tighter
` opening? And you certainly do need some clearance for
` the snap fit in order to allow the part to deflect and
` snap open again. So our view is that the anti-rotation
` feature certainly is one that we pointed to and that Mr.
` Eaton relied on among a number of motivations, but
` that -- those aren't necessarily mutually exclusive,
` that if you've had -- if you've got one anti-rotation
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`Case IPR2017-00632
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` feature, that that means you never want another one,
` especially given that Berthon-Jones starts with those --
` both of those features that would have that benefit to
` begin with.
` JUDGE BUNTING: Mr. Sganga, you're getting
` close to the 5-minute warning here.
` MR. SGANGA: Thank you, Your Honor. So why
` don't I talk a bit about the issue of the connection and
` the -- how that would impact the wheels here? And if we
` jump ahead to slide 28, what -- well, before I get to
` slide 28, I want to -- here. Let me go to slide 29.
` And this is the Berthon-Jones reference, and the reason
` I'm pointing to this is we've put a red dotted line
` across the place where these adjustment wheels are
` located, and that is at a higher elevation, if you will,
` in -- within this triangular opening in the frame than
` the conduit, the annular conduit 520. We see the
` annular conduit 520 again. It's at the bottom. It's
` very close to the snap fit connector 524 at the bottom.
` And the modification that we proposed by adding the
` structure to connect to 520, that is in a different
` place than these wheels, and there was no argument by
` this in the Petition, no testimony by Mr. Eaton that
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` those wheels would be removed. There's really no need
` to remove them, and we feel that Patent Owner has, in a
` sense, set up a straw man to suggest that we've tried to
` deviate from the teaching of Berthon-Jones. It's never
` been our position that those wheels need to be modified.
` And what Patent Owner has done is it has proposed that
` if we make the modification to have the elbow connect
` directly to the inner frame, that somewhat we're going
` to change the operation of those wheels. We think
` that's speculation from their expert, Mr. Virr, and if
` we look at the way that this system is described working
` in Berthon-Jones on slide 28, and we submitted a
` corrected version of slide 28, and I hope the panel has
` that now, these red circles we added to the images that
` the Patent Owner presented to show where the pivoting is
` basically. When you rotate these wheels, if we look at
` the figures on the left which are from Berthon-Jones, if
` you rotate the wheels and you focus on what's happening
` in the red circled area, that's the place where these
` two frames essentially form the apex of a triangle and
` there's pivoting about that point. Berthon-Jones
` explains in paragraphs 177 and 188 several times that
` it's that inner or cushion module. That's the one that
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` deflects, that moves relative to the outer module. And
` we're not proposing any changes to the flexibility to
` that inner cushion module, and there's no reason to
` believe that it wouldn't work in the same way after we
` make the elbow connection. On the right-hand side,
` we've got ResMed's proposed modifications, and instead
` of having that pivoting action where the two frames meet
` in the corner, they're showing now a complete axial
` separation, completely different direction of movement
` of that inner cushion module, and there's no basis for
` that. The testimony on cross-exam by Mr. Virr
` essentially admitted that he was speculating and we've
` cited to that before. It's on slide 33, where he says
` that he's speculating on the direction that the forces
` would end up moving things. And if we look at slide 32,
` which is a little closer view, if anything, we've got
` now yet another connection between the two frames,
` what's referred to as the seal here, and that would tend
` to keep these parts together. And instead, what Mr.
` Virr is proposing, which just doesn't make sense, is
` that these annular -- the annular seal, the annular
` cylinder, and this outer more rigid frame is going from
` an annular shape to being spread apart into a conical
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` shape. So we're really causing a -- he is proposing a
` tremendous amount of deflection to change the shape from
` a cylinder to a cone, hasn't done any analysis to back
` that up, hasn't done any analysis to support the idea
` that the deflection would be in different directions
` than in Berthon-Jones expressly disclose
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