IPR2015-00765, Paper No. 34
`May 27, 2016
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`trials@uspto.gov
`571-272-7822
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`BLUE BELT TECHNOLOGIES, INC.,
`Petitioner,
`
`v.
`
`ALL-OF-INNOVATION GMBH,
`Patent Owner.
`____________
`
`Case IPR2015-00765
`Patent 7,346,417
`____________
`
`Held: April 7, 2016
`____________
`
`
`
`
`
`BEFORE: SALLY C. MEDLEY, KEVIN F. TURNER, and
`WILLIAM M. FINK, Administrative Patent Judges.
`
`The above-entitled matter came on for hearing on Wednesday,
`April 7, 2016, commencing at 1:00 p.m., at the U.S. Patent and
`Trademark Office, 600 Dulany Street, Alexandria, Virginia.
`
`
`
`
`May 27, 2016
`
`trials@uspto.gov
`571-272-7822
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`BLUE BELT TECHNOLOGIES, INC.,
`Petitioner,
`
`v.
`
`ALL-OF-INNOVATION GMBH,
`Patent Owner.
`____________
`
`Case IPR2015-00765
`Patent 7,346,417
`____________
`
`Held: April 7, 2016
`____________
`
`
`
`
`
`BEFORE: SALLY C. MEDLEY, KEVIN F. TURNER, and
`WILLIAM M. FINK, Administrative Patent Judges.
`
`The above-entitled matter came on for hearing on Wednesday,
`April 7, 2016, commencing at 1:00 p.m., at the U.S. Patent and
`Trademark Office, 600 Dulany Street, Alexandria, Virginia.
`
`
`
`
`
`Case IPR2015-00765
`Patent 7,346,417
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`APPEARANCES:
`
`ON BEHALF OF THE PETITIONER:
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`ON BEHALF OF PATENT OWNER:
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`STUART M. ROSENBERG, ESQUIRE
`BRIAN M. BUROKER, ESQUIRE
`Gibson, Dunn & Crutcher LLP
`1881 Page Mill Road
`Palo Alto, California 94304-1211
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`MATTHEW I. KREEGER, ESQUIRE
`WALTER WU, M.D.
`Morrison & Foerster LLP
`425 Market Street
`San Francisco, California 94105-2482
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`Case IPR2015-00765
`Patent 7,346,417
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`P R O C E E D I N G S
`- - - - -
`JUDGE MEDLEY: Good afternoon. This is the
`hearing for IPR2015-00765 between Petitioner Blue Belt
`Technologies and Patent Owner All-Of-Innovation.
`Per our March 17th order, each party will have 30
`minutes of total time to present arguments. Petitioner, you may
`proceed first, present your case with respect to the challenged
`claims and grounds for which the Board instituted trial and
`thereafter, Patent Owner, you may respond to Petitioner's
`presentation and also present arguments for your motion to
`amend.
`
`Each party may reserve rebuttal time. Petitioner, during
`your rebuttal time, you may respond to all matters. However,
`Patent Owner, during your rebuttal time, you may only respond to
`Petitioner's arguments in connection with your motion to amend.
`At this time we'd like the parties to please introduce
`counsel beginning with the Petitioner.
`MR. BUROKER: Good afternoon, Your Honor. Brian
`Buroker and with me is Stuart Rosenberg and for this proceeding
`Mr. Rosenberg will be presenting argument.
`JUDGE MEDLEY: Okay. Thank you.
`And for Patent Owner?
`MR. KREEGER: Good afternoon, Your Honor.
`Matthew Kreeger from Morrison & Foerster for the Patent
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`Owner. With me today is Walter Wu. Also present is Gregory
`Plaskon, Vice President of Intellectual Property for Stryker,
`licensee to the patent, and Dr. Tim Lueth, one of the named
`inventors on the patent.
`JUDGE MEDLEY: And you'll be presenting?
`MR. KREEGER: I'll be presenting, yes, Your Honor.
`JUDGE MEDLEY: Okay. Thank you.
`Okay. Petitioner, you may begin.
`MR. ROSENBERG: Thank you, Your Honor. Stuart
`Rosenberg from Gibson, Dunn & Crutcher on behalf of Blue Belt
`Technologies. With the Board's permission, I'd like to reserve 10
`minutes for rebuttal and I'd like to start on slide number 2 of our
`demonstratives, which is just an outline of the topics I'd like to
`discuss today.
`I'll start with a few brief introductory remarks about the
`claims at issue here and the prior art references, Mushabac and
`Klimek, and then turn quickly to what we think are the key
`points, first, the claim term manually guiding, which is the only
`term that's in dispute between the parties as a matter of claim
`construction and as a matter of whether that element is present in
`the references. Everything else is not disputed.
`Then turn to from our construction of manually guiding,
`which is moving by hand, to the construction that the Board
`adopted preliminarily, at least in the Institution Decision, which is
`somewhat narrower, and I want to explain why even under that
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`narrower construction the moving by hand or rather the manually
`guiding limitations are clearly met in the art in this proceeding
`and then turn to motivations to combine Mushabac and Klimek,
`explain where those motivations were present in the art and
`respond to some of the Patent Owner's arguments about those,
`and then I'll address point 4 here on slide 2, the motion to amend,
`only in rebuttal time.
`So turning to slide 5, this just shows the two
`independent claims at issue in this proceeding. There are
`dependent claims at issue as well, but the Patent Owner hasn't
`made any arguments specific to any of the dependent claims, so
`they rise and fall on the independent claims.
`These are to a method or in the case of Claim 40 a
`system that involves removing material from an object. The
`object can be a bone. It doesn't need to be a bone. It can be soft
`tissue. It can be something like the patent specification discloses,
`the hull of a sailboat, and so it's a broad range of potential objects
`that are the subject of these claims.
`All the claims require that you remove the material
`from the object using an effector, a drill, a bur, and then the key
`limitation here is that you are manually guiding the effector in
`relation to the object and we'll talk about what that means.
`You're storing information about where the effector is by using a
`navigation system to track the effector and then you control the
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`power of the effector based on one of these volumes that's
`disclosed in the last limitation of both claims here.
`And the simplest example and the one we've pointed to
`in the prior art is as you hit the boundary of the predetermined
`work volume, that is the amount of material you wanted to
`remove, you turn the power off automatically.
`So if we can now skip ahead to Claim 6 as an
`introductory -- or, sorry, slide 6 as an introductory point. I just
`wanted to call out a disconnect between what the claims say that
`we just looked at and how Patent Owner has characterized the
`"inventive contribution" in this patent.
`The Patent Owner has described it as a freehand
`invention, but, of course, freehand does not appear in the claims.
`We'll talk about that word when we get to the contingent motion
`to amend. But the term in the claims is manually guiding and
`there's no dispute, even the Patent Owner's expert agrees that
`manually guiding is broader than freehand.
`If we'll turn one more slide to slide 7, this is the Patent
`Owner's expert agreeing that there are devices that are manually
`guiding but are not freehand. Likewise, if we turn one more slide
`to slide 8, the Patent Owners describe this invention as providing
`the best of both worlds, the accuracy of a robotic system but with
`the ease of use of a freehand system, but there are no accuracy
`limitations in the claim.
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`The claims do not require that any particular level of
`accuracy be obtained, achieved, which makes sense, given the
`wide range of objects that are potentially subject to these claims,
`the difference between let's say a tooth on the small end and a
`boat hull on the larger end.
`And if we turn one more slide to slide 9, this is the
`Patent Owner's expert agreeing that claims don't specify the
`accuracy level. Instead, accuracy is really going to be a function
`of how accurate your tracking system is. And so a tracking
`system, like the one in Klimek that we've relied on, will provide
`enough accuracy to cover many embodiments within the scope of
`the claims and, therefore, the alleged teaching away about
`accuracy really isn't a teaching away because it doesn't get you
`outside the scope of the claims.
`So if we can now turn to slide 16, this is the Mushabac
`reference. It's a method. It's disclosed in this example as being
`for dental surgery, but Mushabac says explicitly it's not limited to
`dental surgery. It can be other bones. And you have the surgeon
`manually guiding an instrument, which is highlighted in green
`there. It may be a little hard to see towards the top left of the
`figure in the patient's mouth.
`The instruments being tracked, in this case a pantograph
`system where the camera is tracking the pantograph or circled in
`red and the computer in -- circled in orange 24 is controlling the
`power of the instrument, so that as you reach the boundary of the
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`area you wanted to remove, the power can be turned off so you
`don't accidentally remove more than you wanted to.
`If we now turn to slide 17, this is the Klimek reference
`which discloses navigation systems that use either active or
`passive markers where you have light being either emitted or
`reflected. And on the right-hand side there you can see the
`markers that are attached to a surgical tool and it's a freehand tool
`there.
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`And that's the navigation system that is recited in Claim
`40, Independent Claim 40 of the '417 patent, which talks about a
`navigation system in which you have markers and a marker
`support on the patient or on the object rather and then also on the
`tool that you're using.
`So turning now to the manually guiding issue. If we
`can go to slide 41. These are the proposed constructions for the
`key limitation here manually guiding. As the Petitioner, we
`propose what we think is the broadest reasonable construction.
`Also, it would be the same construction we propose under the
`District Court standard, which is moving by hand.
`Manually means moving by hand. I don't think there's a
`dispute that manually means by hand. Guiding refers to the
`process of moving the effector, determining where it's going to
`go.
`
`The Patent Owner's construction is narrower, included
`this limitation that it be without moving restrictions and the gloss
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`that the Patent Owner put on that in its response is that would
`exclude in their view any kind of mechanical assembly that is
`either helping you move or impeding your movement or
`connected to the instrument in such a way that there's any force
`whatsoever in any direction and we think that's unduly narrow.
`If we turn one more slide, we'll see the Board in its
`Institution Decision adopted something of a middle ground. And
`as we understand the Board's preliminary construction as
`explained at page 15 of the Institution Decision, manually
`guiding in the Board's view is -- means it's not a robot. It's not
`something where a force other than a person is determining that
`the effector will move, but it does not preclude any -- you know,
`all mechanical assembly, so an arm attached to the instrument.
`And we think -- and we'll explain why we think that's
`actually too narrow of a construction. But even under that
`construction, as the Board recognized in the Institution Decision,
`that's taught clearly in Mushabac.
`So if we turn now to slide 43, this is really the key piece
`of the patent that we believe shows why our construction moving
`by hand is correct, which is that Claim 26 is a dependent claim.
`It depends from Claim 1, so Claim 1 has to be broad enough to
`cover to include all of the things recited in Claim 26.
`And one of the things recited in Claim 26 is the
`kinematically guiding the effector. Another thing is having a
`placement and guidance mechanism for the effector. And so you
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`can't read the term manually guiding in Claim 1 as excluding
`kinematically guiding the effector having a placement and
`guidance mechanism, because otherwise then Claim 26 no longer
`falls within the scope of Claim 1 and it's a bedrock principle of
`claim construction that the dependent claims have to fall within
`the scope of the independent claims.
`If we turn to the next slide here, which is slide 44, this
`is something that the Board discussed in the Institution Decision
`explaining that there's a distinction in the specification between
`being guided manually on the one hand and kinematically
`supported on the other.
`We agree that that's a distinction, but it's not a
`distinction of mutual exclusivity, because the specification makes
`that clear in saying that the drill is guided manually but can also
`be kinematically supported. It doesn't say, but can instead be
`kinematically supported. It doesn't say but in the alternative
`without manual guidance can be kinematically supported. These
`are just options the same way, for example, you could have a
`sandwich that has lettuce parentheses, but can also have tomato
`and onion. It doesn't mean --
`JUDGE FINK: So you're reading that as it can also be
`kinematically supported in addition to guided manually.
`MR. ROSENBERG: Correct.
`JUDGE FINK: That's how you would read that instead
`of as an alternative to manually guiding.
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`MR. ROSENBERG: That's correct, and we think that
`that's clear from the context of the specification and especially
`Claim 26. Because if you read that as stating mutually exclusive
`options, then you couldn't account for Claim 26.
`Even under the Board's construction, though, if we
`move to slide 46, as excluding robotic and kinematic support,
`Mushabac still discloses that. So if we turn to slide 47, this is
`Figure 14 of the Mushabac reference and some discussion of it by
`Dr. Davies, Petitioner's expert.
`As the Board recognized in the preliminary -- I'm sorry,
`in the Institution Decision, Figure 14 is a mechanical assembly,
`but it's not providing kinematic assistance as you move the
`effector. It's your hand that is determining when and where the
`effector is going to move.
`If you let go, the friction in the joints of Figure 14
`prevent the tool from falling to the ground, but that's not assisting
`in the guidance, in the motion. And since the parties all agree
`that, you know, the phrase manually guiding refers to the moving
`process, we think that the Board was correct to note in the
`Institution Decision that even on the narrower construction
`Mushabac still discloses this reference or this element.
`Patent Owner's response to this is to say that there's
`friction in the joints and that, therefore, there is kinematic support
`being provided when you stop moving, because it doesn't fall to
`the ground. We don't think that that's a limitation in the claims
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`for the reasons we've explained. But even if it were, Mushabac
`still discloses that you can have an arm that need not have friction
`and an example of that is in Figure 11.
`So if we now turn to slide 49. Figure 11 in the
`Mushabac reference shows a different arm that the specification
`describes as being an alternative to what's shown in Figure 14.
`As the specification goes through and discusses the figures, it
`talks about Figure 11, Figure 12 and then when it turns to Figure
`14 says as an alternative you can do what's shown in 14, and in
`that discussion of Figure 14 says you can have friction in the
`joints.
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`There's no such teaching about friction in Figure 11,
`instead, the specification says that those linkages in Figure 11 are
`merely pivotably connected and so what Dr. Davies, the
`Petitioner's expert has explained, as a person of skill reading the
`Mushabac reference would understand this arm to be comparable
`to something called a FaroArm, which is what's shown at the
`right here, which is an arm that does not provide support even
`when you stop moving and you move your hand away.
`And if we go back one slide to slide 48, this is the
`Patent Owner's expert discussing what a FaroArm is and
`explaining that there's no kinematic support. And so we believe
`even under the narrowest loss of the Board's construction, which
`we think is unduly narrow, that Mushabac still discloses this
`limitation.
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`In addition, as our experts explained, if we go to slide
`56, a person of skill would have understood that the arm
`disclosed in Figure 14 where the specification of Mushabac says
`there can be friction in the joints could have been adjusted so that
`the friction is adjusted to taste based on any individual surgeon's
`preferences and, therefore, would have disclosed to a person of
`skill in the art that you don't need to have any kind of support.
`And this is an obviousness situation, so we're not just
`looking at what's in the four corners of Mushabac or in Klimek,
`we're asking what a person of skill in the art reading these
`references would have understood and been motivated to try. So
`we think any way you slice it, Mushabac discloses manually
`guiding and, therefore, there's no dispute that all of the claim
`elements of all the claims are present in these two references.
`Turning to motivation to combine, if we can turn to
`slide 58. So the petition in our view and Dr. Davies'
`declaration --
`JUDGE FINK: I'm sorry, I don't mean to interrupt your
`flow there.
`MR. ROSENBERG: Please.
`JUDGE FINK: But could you go back a second to the
`Faro -- is it the Faro?
`MR. ROSENBERG: FaroArm, yeah.
`JUDGE FINK: FaroArm?
`MR. ROSENBERG: It's 48 I think.
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`JUDGE FINK: Where does that come from, is that --
`MR. ROSENBERG: So the FaroArm was --
`JUDGE FINK: -- Patent Owner's product or --
`MR. ROSENBERG: Is it the Patent Owner's product?
`No, I don't believe so. I believe it's -- this is something that was
`known in the prior art. I'm not sure that it has any relationship to
`any of the parties in the proceedings. It was raised by the Patent
`Owner's expert in talking about the ways of tracking an effector
`that were known in the art.
`JUDGE FINK: I see. Okay. Thank you.
`MR. ROSENBERG: And so if we now turn to
`motivation to combine, there were several motivations to
`combine and we'll start with the one on the right here, which is
`paragraph 137 of the Davies' declaration, Exhibit 1002. The
`Klimek reference itself -- so this is the reference with the
`marker-based system for tracking the location of the tool -- touts
`the advantages of this system, including that you can use these
`markers on any common instrument in the operating room and,
`therefore, the motivation is to try it with a wide range of
`instruments and there certainly isn't any teaching away in Klimek
`or Mushabac to say don't use a marker-based system.
`Instead, Mushabac talks about the systems that it
`discloses, which include the pantograph and which include
`having cameras on the tool itself so that you're getting more direct
`information about where the tool is, but there is no teaching that
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`those are the only ways you can do this. And, instead, Mushabac
`says there are alternative and additional ways to track the tool.
`Looking at the left side here, Dr. Davies also explained
`that even though the arms that are disclosed in Mushabac
`wouldn't stop you from positioning the tool wherever you want to
`position it in the operating space, for example, near the patient's
`mouth, the arm itself might interfere with the surgeon's freedom
`of motion, meaning if a surgeon, let's say he wants to raise his
`elbow, but the arm is in the way.
`So if you have a tracking system like in Klimek that
`allows you to use a freehand instrument that doesn't require an
`art, then there is a motivation to, by virtue of increasing your own
`freedom of motion, give yourself more options.
`The Patent Owner has responded to this with a few
`arguments about why in the Patent Owner's view there's a
`teaching away or a person would not have been motivated to
`combine Klimek and Mushabac and I want to respond briefly to
`those. If we turn to slide 59.
`So all of the arguments that the Patent Owner has made
`are about the dental applications in Mushabac and the fact that
`Klimek is not specific to dental surgery. In fact, Klimek is
`specific to ear, nose and throat and the Patent Owners argued that
`the error ranges that are appropriate for dental surgery are
`narrower and, therefore, someone wouldn't have been motivated
`to try Klimek with Mushabac, but Mushabac makes explicit that
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`the methods it teaches are not limited to dental surgery and,
`likewise, neither are the claims in this case.
`We're talking about objects that can be as small as a
`tooth or as big as the hull of a boat and the notion that an error
`tolerance in the single number of millimeters, I think the largest
`number in terms of error in Klimek with something on the order
`of four millimeters, would discourage someone of skill in the art
`from even trying this combination I don't think holds water.
`So if we turn now to slide -- the next slide. These are
`the two tracking mechanisms that are taught in Klimek for
`tracking where the -- for establishing where the patient is before
`the surgery.
`And if we turn to the next slide, which is slide 61, there
`is a dispute about whether using the fiducial markers, the things
`that are on the left-hand side of the last slide, would have required
`shaving a patient's head. And what our expert has explained is
`that that would be required at most only in dental applications
`and, of course, Mushabac is broader than that.
`We think that's undisputed that Patent Owner's expert
`agreed in deposition that if you're doing non-dental surgery, you
`don't need to shave a head, and that even for dental surgery there
`are other options, like putting the markers on the patient's
`temples. That's something that Dr. Davies explains here.
`And if we turn to the next slide, a dental cast, which is a
`way of figuring out where the patient is by making a cast that
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`they hold in their mouth, the Patent Owner said someone wouldn't
`have been motivated to try that in conjunction with Mushabac.
`Because if you're performing surgery on teeth, you need access to
`the teeth, but, of course, again that's only specifically if you're
`working on teeth.
`And Dr. Davies explained that even if you are working
`on teeth, you can make a partial cast so that you would not need
`to occlude or block access to the bone you're working on.
`And, lastly, if we turn to slide 68. No, I'm sorry, that's
`too far. 60, slide 60. Moving forward one more, 61. One more,
`one more. There we go. Sorry, slide 63.
`The Patent Owner says that the accuracy level that the
`error range in Klimek is just too broad. Dr. Davies has explained
`that by 2001, which is the relevant date here, the accuracy of
`these kind of passive marker systems, like the one disclosed in
`Klimek, had improved substantially to the point where they were
`within the tolerance that even Patent Owner's expert says was
`required.
`So unless there are questions, I'll reserve my time for
`rebuttal.
`JUDGE FINK: Is there any other evidence of that in
`the record?
`MR. ROSENBERG: So apart from the Traxtal
`technologies, so Dr. Davies in his second declaration in our reply
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`refers to Traxtal technologies and refers to his own system that
`used certain passive-based markers.
`In response to a question at deposition from the Patent
`Owner, Dr. Davies, our expert, responded that at the time of the
`mid-'90s tracking could have been more accurate using an
`arm-based system than using the optical-based system with the
`markers, but that over time that changed and the markers got
`better as time went on. So we think that the record amply shows
`that by the relevant date here, early 2001, it would have been
`within the scope of what a person of skill would have attempted,
`even with the error ranges that are disclosed explicitly in Klimek.
`Because, of course, for different shaped and sized objects, those
`error ranges wouldn't be even remotely problematic.
`JUDGE FINK: What are the -- there was an argument
`that Mushabac uses this pantograph system where I think the way
`it looks is this, essentially it's mirroring the motion of the tool and
`there's a sensor array that's tracking that?
`MR. ROSENBERG: Right.
`JUDGE FINK: Okay. And I guess there was an
`argument that that's far more accurate and so a person of ordinary
`skill in the art wouldn't depart from that to go to a less accurate --
`MR. ROSENBERG: Well, so I think there are two
`responses. The first is you wouldn't need to depart from it
`necessarily. There's no reason you couldn't use both and,
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`therefore, improve your error rates by having two sources of
`information about where the tool is.
`And, second, that improving the surgeon's freedom of
`motion and not having to jockey with an arm would encourage a
`person of skill to try an alternative technique, which had been
`shown to have error ranges that were good enough for ear, nose
`and throat surgeries, so certainly not large errors, errors that were
`acceptable for certain procedures.
`JUDGE FINK: Does Klimek say anything about
`whether this is an acceptable range for this kind of surgery?
`MR. ROSENBERG: You know, I don't recall whether
`Klimek says, you know, this is good enough for commercial
`applications or not good enough for commercial applications.
`Klimek says, you know, the errors were as low as under a
`millimeter, which is certainly under anyone's contention is good
`enough and that improvements are being made.
`JUDGE FINK: I guess the argument was that the
`outliers are problematic. It looked like something like up to four
`millimeters or something.
`MR. ROSENBERG: Right, and I think the response to
`that is it depends on the surgery you're performing. And so even
`if that wouldn't be good enough for dentistry, it would be good
`enough for other procedures and then, of course, the outlier need
`not be a patient. It can be the hull of a boat under these claims.
`In the '417 patent the object need not be a bone to begin with and
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`so the notion that a four-millimeter error rate was just so high that
`no one would have tried this system when it had such advantages
`we think doesn't hold water.
`JUDGE MEDLEY: Okay. Thank you.
`JUDGE FINK: Thank you.
`MR. KREEGER: Good afternoon, Your Honors.
`Matthew Kreeger of Morrison & Foerster for the Patent Owner,
`and I'm going to reserve five minutes of time to respond on the
`motion to amend.
`I'm going to begin with a little background on what the
`invention is about and the problem that it was designed to solve
`and then I want to move into this claim construction issue about
`manually guided and, third, I want to address the question about
`why in our view under the proper construction Mushabac and
`Klimek clearly do not disclose the claimed invention and, lastly, I
`want to address the motivation to combine and our motion to
`amend.
`
`Okay. So first the background. This patent in its own
`text explains that it's improving on the prior art by permitting a
`surgeon to use a manually guided instrument to remove tissue
`with the precision previously only available in robotic systems.
`So if we look at the patent itself and I -- oh, let me --
`excuse me, may I approach, Your Honor?
`JUDGE MEDLEY: Yes, please.
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`MR. KREEGER: I have some binders. They're not
`demonstratives. These are simply for your ease of reference,
`exhibits that I intend to speak about today.
`So if we could turn to Exhibit 1001.
`JUDGE MEDLEY: Excuse, me, I'm sure you've served
`the other side.
`MR. KREEGER: I did.
`So in looking at Exhibit 1001 on column 2, beginning at
`line 1 it reads, a physician has been unable until now to use a
`manually guided instrument for removing tissue so that the
`position and/or geometry of the removed tissue corresponds
`precisely to predefined or dynamically specified medical criteria.
`And the patent acknowledges that there were prior art
`navigation systems available to people and that's in column 1
`where it describes various aspects of the prior art. Beginning at
`line 38 it says, medical navigation systems are known from
`computer-assisted surgery which enable to display the position
`(position and orientation) of the instrument relative to a patient's
`tissue after registration of the tissue.
`So the patent acknowledged that there were prior art
`systems similar to the Klimek system we're seeing here today that
`would track the position of an instrument and let the surgeon
`know where they were based on that instrument. But it goes on
`to say in column 2, beginning at line 14, even when using that
`navigation system, a physician has until now been unable to
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`Case IPR2015-00765
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`remove tissue with a manually guided instrument so that it has the
`precision required.
`And how does the patent accomplish this? Well, there
`was a key insight that the inventors had, which was if you have a
`tool that is tracked and you have a patient that is tracked using a
`navigation system, you can construct a system that controls the
`effector, for example, a drill, so that if the surgeon accidentally
`strays beyond the desired volume, power to the tool or speed of
`the tool or some other kind of control to the tool can be invoked,
`so that the surgeon can then perform the surgery confident that
`they won't move beyond the area desired.
`And that was a fundamental insight and none of the
`prior art that is at issue in this case or that was before the
`Examiner, frankly, disclosed a manually guided instrument with
`that feature.
`So let's turn to the claim construction issue about
`manually guided because I do agree with my opposing counsel
`that that is the key claim construction issue.
`Now, in the Institution Decision the Board construed
`the term manually guided to mean moved by hand without
`robotic or kinematic support and that is different from the
`construction we originally proposed, but we accept it and we
`think that that's a fine construction.
`And the Board based its decision largely on column 12
`of the patent. This is the same excerpt that opposing counsel just
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`mentioned. And that column says, beginning at line 22, the
`effector 2 can be, for example, a cutter, a drill or a laser which is
`guided manually via a corresponding hand piece 1 (but can also
`be kinematically supported, braked, damped or d
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