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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`Orthopediatrics Corp.,
`Petitioner
`
`v.
`
`K2M, Inc.,
`Patent Owner
`
`
`Case IPR2018-00429
`U.S. Patent No. 9,532,816
`
`
`
`
`
`
`
`EXHIBIT 2032
`
`
`
`
`
`
`
`1
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`K2M, INC.,
`
`
`IN THE UNITED STATES DISTRICT COURT
` FOR THE DISTRICT OF DELAWARE
`- - -
`) Civil Action
`)
`
`Plaintiff,
`
`) No. 17-61-GMS
`- - -
`Wilmington, Delaware
` Tuesday, April 3, 2018
`9:30 a.m.
` Markman Hearing
`- - -
`BEFORE: HONORABLE GREGORY M. SLEET, Senior Judge, U.S.
`District Court,
`District of Delaware
`
`APPEARANCES:
` RODGER D. SMITH, II, ESQ.
` Morris Nichols Arsht & Tunnell LLP
`-and-
` MICHAEL S. CONNOR, ESQ., and
` BRIAN D. HILL, ESQ.
` Alston & Bird LLP
` (Washington, DC)
`
`Counsel for Plaintiff
` SELENA E. MOLINA, ESQ.
` Saul Ewing Arnstein & Lehr, LLP
`-and-
` JOHN F. BENNETT, ESQ.,
` PAUL M. ULRICH, ESQ., and
` LUCAS HAUGE, ESQ.
` Ulmer & Berne LLP
` (Cincinnati, OH)
`
`Counsel for Defendants
`
`))
`
`))
`
`))
`
`v.
`ORTHOPEDIATRICS CORP., et al.,
`Defendants.
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`K2M, Ex. 2032-1
`IPR2018-00429
`
`
`
`2
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`
`THE COURT: Good morning. Please, take your
`seats. Let's start with introductions, if we could.
`MR. SMITH: Good morning, Your Honor. Rodger
`Smith from Morris Nichols on behalf of the plaintiff K2M. I
`am joined at counsel table by Brian Hill and Mike Connor,
`both from Alston & Bird. With the Court's permission, Mr.
`Hill will handle the argument today.
`THE COURT: Okay.
`Good morning, counsel.
`MS. MOLINA: Good morning, Your Honor. Selena
`Molina from Saul Ewing Arnstein & Lehr here on behalf of the
`defendants. I have with me at counsel table John Bennett,
`Paul Ulrich, and Lucas Hauge from Ulmer & Berne. With the
`Court's permission, Mr. Bennett and Mr. Ulrich will be
`presenting argument today.
`THE COURT: Counsel, have you discussed how you
`would like to proceed today?
`MR. HILL: Your Honor, we were going to present
`in the same way the briefs were structured, which is term by
`term. We will go first, and opposing counsel will follow.
`THE COURT: You will get the last word. I
`usually give plaintiffs the last word. There may be some
`back-and-forth. This isn't an appellate argument. So let's
`go.
`
`MR. HILL: Thank you, Your Honor.
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`09:35:07
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`K2M, Ex. 2032-2
`IPR2018-00429
`
`
`
`3
`
`
`Since this is the first time we are meeting, I
`was hoping to introduce K2M and exactly what they do.
`K2M started in 2004. It was started by Dr.
`Kostuik, who is a doctor. He is a former Chief of Spine
`Surgery at Johns Hopkins Medical University. He started K2M
`with our current CEO, who is Eric Major.
`K2M makes products that are focused on helping
`surgeons do the most complex spinal surgeries.
`One of those very difficult spinal surgeries is
`scoliosis, and that is something you will hear about today.
`Scoliosis can be complicated for a number of reasons, one of
`which is it frequently involves children. These become
`particularly delicate.
`One of K2M's early innovations was its Cricket
`rod reducer. This was a real industry-changing device. And
`this is a product that K2M sells as part of its Mesa
`Performing Spinal System. This is a system that is very
`popular with doctors. I would like to tell you why.
`One of the biggest challenges with these
`scoliosis procedures is getting a spinal rod, which is large
`and rigid, getting that seated into bone anchors which are
`drilled into patients vertebra.
`So getting that large --
`THE COURT: Do you have a slide which shows
`where the bone anchors are located?
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`K2M, Ex. 2032-3
`IPR2018-00429
`
`
`
`
`MR. HILL: We do. In the very next slide, we
`have a short video that will demonstrate how the procedure
`operates.
`
`4
`
`This is the Cricket rod reducer right here. And
`next we will show how these Crickets are attached to the
`individual bone anchors into the vertebra.
`THE COURT: Stop that, please.
`Back up.
`Can you point out the device, please.
`MR. HILL: If I may approach the screen here.
`THE COURT: Yes.
`MR. HILL: Bone anchors, here, here, here
`(indicating), these are screws that are screwed directly
`into the patient's vertebra.
`THE COURT: It almost looks like a jewel a
`
`little bit.
`
`MR. HILL: Yes. And you will see a spinal rod
`is going to come and be threaded through these spots in
`between the bone anchors, which is the screw screwed in
`here.
`
`THE COURT: So there is a space right close to
`legs or arms straddling the bone anchor.
`MR. HILL: That is correct, Your Honor. This
`was one of the innovations that is so attractive to doctors.
`I will press play on this.
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`K2M, Ex. 2032-4
`IPR2018-00429
`
`
`
`5
`
`
`So threading this rigid spinal rod through the
`gap here, then what you see here is we are gradually
`reducing the large spinal rod into these bone anchors.
`And that is what the Cricket rod reducer --
`THE COURT: Why don't you pause that for a
`
`second.
`
`Would it be descriptive or accurate, when you
`say reduced, I sort of thought I saw the -- what is the
`device that's standing upright?
`MR. HILL: That is the screwdriver. Those have
`a variety of shapes and sizes that they come in.
`THE COURT: That pushes the rigid rod down on
`top of the anchor.
`MR. HILL: That's correct.
`THE COURT: And that is through a screwing
`action of some sort.
`MR. HILL: That's correct.
`THE COURT: That's what "reduced" means.
`MR. HILL: The reduced is to take the rigid rod
`from not seated into the bone anchor and seat it into the
`bone anchor. And the reason this is difficult is these
`patients have deformities of the spine. And then these
`rigid rods are what is going to correct that deformity. So
`getting it into it is a difficult part of that procedure, in
`fact, the most difficult.
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`K2M, Ex. 2032-5
`IPR2018-00429
`
`
`
`6
`
`
`THE COURT: Go ahead. I am sorry.
`MR. HILL: So the final part of this is seating
`that correction. So by reducing the spinal rod into the
`bone anchor, you see that there is a correction of the
`spine, which is correcting the deformity that the scoliosis
`patients have been experiencing.
`THE COURT: Are those vertebra that I see
`
`moving?
`
`MR. HILL: That's correct, Your Honor.
`What is a characterizing innovation of the
`Cricket rod reducer is the ability to reduce the rod
`gradually, so a crude example may be screwing in lug nuts
`into a car, changing a tire, you don't screw one completely
`in and move to the next. It's something that is gradual.
`The reason for that is it avoids point loading
`on individual vertebra. So you are able to spread that
`force along.
`You can imagine that if you were to build up a
`lot of force on one particular screw, that could be
`damaging, particularly with these scoliosis patients, who
`are frequently small children or have for some reason of
`other problems with the bone requiring spreading that force
`out while you are reducing the rod into the bone.
`The patents at issue in this case, there is a
`parent application that was filed and granted. The original
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`K2M, Ex. 2032-6
`IPR2018-00429
`
`
`
`
`parent application was filed in 2007. That patent issued in
`2015.
`
`7
`
`The two asserted patents in this case are both
`children of that parent application. One thing I would like
`to note about these patents is that the heart of these
`patents is not what OrthoPediatrics claims. You will hear
`the argument that these patents are limited to a specific
`mechanism that is disclosed and that specific mechanism is
`by screwing in the central screw that you get a
`corresponding motion in the arms that stick out.
`OrthoPediatrics would like to say that is the heart of the
`invention, that the invention is in fact limited to that.
`In fact, the specification says the opposite,
`Your Honor, that these are not limiting descriptions. These
`are features. And, in fact, these features do show up in
`the claims and subsequent dependent claims.
`What this really is is attorney argument
`designed for a noninfringement position, Your Honor.
`I would be happy to proceed with the first claim
`term, or I can --
`THE COURT: Is there a, in terms of tutorial, is
`there something you want to add to this?
`MR. BENNETT: Your Honor, if it pleases the
`Court, we will have a short overview of the written
`description before we address these claim terms after Mr.
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`K2M, Ex. 2032-7
`IPR2018-00429
`
`
`
`
`
`8
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`Hill goes, if that is okay.
`THE COURT: In terms of tutoring me, is there
`something additional that you think I need to hear from you
`to help me understand the parties' positions?
`MR. BENNETT: Not by way of a tutorial, Your
`Honor. Simply the written description.
`THE COURT: That's fine.
`We can go through "grasping members."
`MR. HILL: Yes, Your Honor.
`The first claim term is "grasping members."
`This is actually a group of two claim terms that we have
`condensed and addressed together. Those two claim terms
`appear separately on the parties' joint claim construction
`chart. And they are the "grasping members configured to
`grasp a portion of a bone anchor therebetween" and also
`"first and second elongated grasping members."
`So two different claim terms, and I can address
`them together.
`Just as some context.
`The grasping members are identified in the
`patents as the legs that come down -- I know it is hard to
`see -- it is 64 and 66.
`THE COURT: I have the hard copy.
`MR. HILL: Fantastic.
`So the specification discloses these grasping
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`K2M, Ex. 2032-8
`IPR2018-00429
`
`
`
`9
`
`
`members as the 64 and 66 elements. And the claims provide
`some structural description of these. First, the claims
`describe the grasping members structurally as being
`configured to grasp the bone anchor that we were discussing
`earlier between them. That is one way the claims describe
`at least structurally.
`The second is that the grasping members are such
`that the first and second grasping members define a plane.
`Just in terms of context, those are two ways that the claims
`describe these features structurally.
`K2M's position, Your Honor, is that both of
`these terms, the grasping members, can be understood by
`their plain and ordinary meaning. We have, if Your Honor
`determines that it would be helpful to have some sort of
`construction, we have proposed an alternate construction
`with just modest clarifications that don't change the plain
`and ordinary meaning of the term.
`The alternate construction we have proposed
`clarifies just two things. One, that the first and second
`grasping members are opposing. We think that is a
`clarification of the structural recitation, that they are
`configured to grasp something between them. So we have
`proposed in the alternate instruction that they can be
`understood as being opposing.
`And also, the claims say "therebetween," and we
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`K2M, Ex. 2032-9
`IPR2018-00429
`
`
`
`10
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`have clarified that therebetween is between the first and
`second grasping members.
`So configured to grasp that bone anchor between
`the first and second opposing grasping members. That is a
`modest clarification we have proposed as an alternate
`construction. We don't think it is necessary. But if Your
`Honor thinks it would be useful, we have proposed that.
`THE COURT: What is the source of the plain and
`ordinary meaning, how do I understand, what would a POSA
`would understand plain and ordinary meaning to be?
`MR. HILL: Thank you, Your Honor.
`The plain and ordinary meaning, as we described,
`is we think how someone would understand it who has seen
`these devices and worked with these devices. And in our
`alternate construction, this is how we have brought it even
`one more level down, to be understandable by someone who may
`not deal with these devices on a daily basis. We think this
`is --
`
`THE COURT: The claims are directed to a person
`of ordinary skill. Right?
`MR. HILL: Yes, Your Honor.
`THE COURT: That is who I am interested in
`understanding your understanding, and the other side doesn't
`agree that this is subject to plain and ordinary meaning.
`It is strictly the dilemma presented to judges trying to do
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`K2M, Ex. 2032-10
`IPR2018-00429
`
`
`
`11
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`claim construction that the parties suggest plain and
`ordinary meaning. We have no idea what the jury will
`understand the plain and ordinary meaning to be. I don't
`want to open it up to the battle of the experts. We would
`violate Markman and 02 Micro.
`What is the plain and ordinary meaning?
`MR. HILL: In this case, Your Honor, we would
`submit that the plain and ordinary is as we have put right
`here in K2M's alternate proposed construction. We think
`that this presents a clarification of that plain and
`ordinary meaning.
`THE COURT: I tend to agree with that, not
`necessarily -- I am not saying I agree that this is not
`means-plus-function yet. But I think, and I am asking you,
`don't you agree that the jury would be better served by an
`alternate construction than me simply advising them that I
`have defined the term to mean plain and ordinary meaning?
`MR. HILL: We do agree with that, Your Honor. I
`think we are trying to make clear that we think that the
`alternate construction is consistent with that plain and
`ordinary meaning.
`THE COURT: That is fine, however you get to it.
`I am thinking about the glossary and definitions that are
`going to be in the jury instructions. That's all I am
`asking.
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`K2M, Ex. 2032-11
`IPR2018-00429
`
`
`
`12
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`
`MR. HILL: Understood.
`Your Honor brought me to the very next point
`here. That is the application of 112, Paragraph 6 and a
`discussion of whether means plus function should be applied
`in the claim terms. We think that the application of 112,
`Paragraph 6 would be improper. And I would like to tell you
`why.
`
`The first reason is because these claims do, in
`fact, provide structural limitations for these terms. The
`claims recite that the "grasping members are configured to
`grasp therebetween," which is a structural limitation, and
`the claims also recite that the "first and second grasping
`members define a plane."
`So this is not a case, Your Honor, where we have
`a word that is defined by a function and any possible
`structure can perform that function. This is a case where
`the claims do, in fact, provide structural limitations that
`take these claim terms out of the application of 112,
`Paragraph 6.
`We know that it has been discussed about whether
`or not the terms use the word means. We know that they do
`not. But our argument is not that because the word means is
`not utilized that this is necessarily not going to be a 112
`Paragraph 6 case.
`We understand that there is the Williamson case.
`
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`09:48:59
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`K2M, Ex. 2032-12
`IPR2018-00429
`
`
`
`13
`
`
`And we know that there is no more relying on the heavy
`presumption. But the reason is because the claims do, in
`fact, recite structure.
`I would like to also point to the MPEP, which
`was cited by OrthoPediatrics in their briefs. The MPEP 2181
`section has a description in it. And they describe some
`possible, I think they call them nonce words or a black box
`term that can signal application of 112, Paragraph 6. And
`one of those is Member 4. OrthoPediatrics cites to that and
`relies on that portion of the MPEP. What I would like to
`draw your attention to is the section that immediately
`follows that, when they give some examples of words that
`have been found not to trigger the 112, Paragraph 6
`application. And two of those words, one is "reciprocating
`member," and the other is "eyeglass hanging member."
`I will submit to you, Your Honor, that these are
`more analogous scenarios. We have here grasping member.
`And the distinction that the MPEP I think is identifying
`here is one of Member 4 versus a member where there is some
`sort of structural significance given to the member. In
`other words, is the member being used as a placeholder for
`the function that follows it, or is there some sort of
`structural significance being applied to that?
`That was what was found in the Al-Site versus
`VSI case. That is the genesis of the eyeglass hanger
`
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`K2M, Ex. 2032-13
`IPR2018-00429
`
`
`
`14
`
`
`member. In that case they found that there was some
`significant structural limitations being placed on the
`member. And it wasn't being used in the same way as the
`MPEP describes in this Member 4 line of cases.
`And that's how we would submit that 112,
`Paragraph 6 would be improper.
`THE COURT: Okay.
`MR. HILL: In addressing OrthoPediatrics's
`proposed construction, we would like to point out just the
`general unworkability of the proposed construction. They
`have included a rod contact member 20 as part of the
`disclosed structure as performing the function of grasping a
`portion of a bone anchor. Simply, Your Honor, the rod
`contact member is the part that pushes down that rigid rod,
`to be seated into the bone anchor. It does not play a role
`in terms of grasping the bone anchor. Those are separate
`parts of the device.
`THE COURT: 20, the rod contact member -- I am
`trying to reflect back on your illustration. Can you point
`it out to me?
`MR. HILL: So in this case 20 is this central
`piece right here, which kind of comes down, and would push
`the rigid rod --
`THE COURT: That is what the screw is driving
`down on top of the anchor.
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`09:52:48
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`K2M, Ex. 2032-14
`IPR2018-00429
`
`
`
`15
`
`
`MR. HILL: That is correct. In the
`corresponding structure of the grasping member, which is
`identified in fact, at 64 and 66, these legs, they have also
`included the rod contact member as part of that
`corresponding structure.
`We would submit, Your Honor, that that is
`incorrect, that that corresponding element does not play a
`role in that function.
`THE COURT: In the grasping function.
`MR. HILL: That's correct, Your Honor. You will
`hear that it all works as one. So it plays a necessary role
`in it. We would respond that this whole device necessarily
`works together. It all kind of works together, and in which
`case everything would be included. So there no clear reason
`to include the rod contact member 20 in this. We would say
`that supports this being just a generally unworkable --
`THE COURT: Could you go back to the
`illustration. As 20, the rod contact member, is screwed
`down on top of the rigid rod, is it forcing the grasping
`members, what's that, 66 and 64, together?
`MR. HILL: In this illustration, Your Honor,
`
`yes.
`
`function?
`
`THE COURT: So isn't it part of the grasping
`
`MR. HILL: It is disclosed in this embodiment
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`K2M, Ex. 2032-15
`IPR2018-00429
`
`
`
`16
`
`
`that by driving down the rod contact member 20, it pushes
`the 64 and 66 grasping members together by use of this kind
`of scalloped feature that is disclosed in the figure. This
`is not something that is described as a necessary feature.
`THE COURT: Not wishing to confine the invention
`to a preferred embodiment, I understand, but just looking at
`this figure, which figure is this we are looking at, by the
`way, Figure 5 and Figure 4?
`MR. HILL: Yes, Your Honor.
`THE COURT: So it appears that in Figure 5 that
`the grasping members, 64 and 66, are sort of angled off, and
`I guess that's to leave space to go over the anchor?
`MR. HILL: I am sorry, Your Honor?
`THE COURT: 64 and 66. There seems to be some
`space, they seem to be at an angle, not 90 degrees.
`MR. HILL: Here?
`THE COURT: Look at 5. They don't appear to me,
`to my naked eye, drawn to be at 90 degrees. That's why I
`asked the question is 20 forcing them together.
`MR. HILL: Yes, Your Honor. That is correct. I
`think typically there is some play with these grasping arms
`in these styles of devices to receive the bone anchor in
`between these rigidly and tightly.
`THE COURT: In terms of structure, why would it
`be incorrect for me to conclude, as the defendants urge,
`
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`K2M, Ex. 2032-16
`IPR2018-00429
`
`
`
`17
`
`
`that 20 is a part of the structure, if I were to conclude
`that this is -- whether or not I were to conclude this is
`means plus function?
`MR. HILL: Because the grasping occurs,
`potentially aided by the movement of the rod kind of on
`contact but not necessarily by.
`THE COURT: How does the invention grasp? How
`does this device that we are looking at, Figure 5, grasp the
`anchor if not but for 20 being screwed down on top?
`MR. HILL: In this embodiment, it's the rod
`contact member, Your Honor, that when it comes down it will
`bring these grasping arms together. That is just an added
`feature that is disclosed and claimed in some of the
`dependent claims. But certainly, because of the interaction
`here, these are on an axis.
`THE COURT: Let me let you continue so we are
`not here all morning on the answer to my question.
`MR. HILL: One thing just to point out, Your
`Honor, the screw also pushes the rod contact member. One
`thing we would object to is as separating, we don't see it
`as being separable, the rod contact member, because it is
`pushed by the screw.
`THE COURT: Could the device perhaps be
`spring-activated to grasp, there be some spring activation
`to cause the grasping of the anchor, 64 and 66 in another
`
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`K2M, Ex. 2032-17
`IPR2018-00429
`
`
`
`
`
`18
`
`embodiment?
`MR. HILL: That is certainly possible, Your
`
`Honor.
`
`kind?
`
`THE COURT: Would that be equivalent of some
`
`MR. HILL: That is certainly possible. I
`believe that is, some of these devices do in fact do that.
`THE COURT: Your colleague has a word for you.
`MR. HILL: One thing to notice, that the rod
`contact member does not touch the bone anchor.
`THE COURT: Right. I see that.
`MR. HILL: I wanted to address --
`THE COURT: Hold on just a second.
`Does the contact member go over 80 and 82, is
`the question.
`MR. HILL: It does not go past 80 and 82.
`THE COURT: Does not go past.
`MR. HILL: Because the bone anchor will be
`received into 80 and 82.
`THE COURT: She asked the question, but you can
`look at me -- I am giving you a hard time.
`MR. HILL: Your Honor, I would like to address
`for you on the same issue, of the 112, Paragraph 6 the cases
`that have been relied on and discuss them very briefly.
`THE COURT: Your colleagues on the other side
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`K2M, Ex. 2032-18
`IPR2018-00429
`
`
`
`19
`
`
`frequently, or always refer to post-AIA 112(f). Is there a
`difference?
`MR. HILL: No, Your Honor.
`THE COURT: I didn't think so. I thought maybe
`there was something going on that I missed in patent land.
`Okay. Go ahead.
`MR. HILL: So the three cases that are being
`relied upon for the argument that 112, Paragraph 6 or 112(f)
`does apply. The first I would like to briefly mention is
`the SoftSpikes case, which of course Your Honor wrote the
`opinion for. This is a case where the discussion was about
`a gripping member for engaging the ground. Of course, in
`that case Your Honor found that that was a
`means-plus-function limitation.
`This is a very different situation. The most
`clear reason, this is exactly the distinction that's
`described in the MPEP at 2181, where the MPEP describes the
`member floor as being a claim term that was a 112, Paragraph
`6 and then the eye glass hanging member as being not one.
`The distinction is that Member 4, where it is claimed
`entirely functionally and there is no structure given for
`how that function is to be achieved.
`In this case, Your Honor, we would say that the
`claims do in fact recite some structural features of that.
`And that's the plain orientation of the first and second
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`K2M, Ex. 2032-19
`IPR2018-00429
`
`
`
`20
`
`
`grasping members and also that they are configured to grasp
`that bone anchor between them. That does illustrate some
`structural features.
`A similar situation is the Mas-Hamilton case,
`which has also been cited to Your Honor. There we have a
`movable link Member 4 holding the lever out of engagement,
`another instance where we have purely functional claiming.
`The same thing as being recognized in the MPEP at 2181. No
`structural significance or description of how to perform
`that function, which we would submit is different than the
`present scenario.
`In the Toshiba case, which has also been cited
`in the briefs, we have an optical penetration member, which
`has been found to be means plus function. This case is one
`where they found that there was no structural significance
`given to that member word. This case is also interesting
`because in that case optical penetration member did not
`appear at all in the written description. So there was this
`sort of extra question in that case. Unlike in that Toshiba
`case, here grasping member does appear in the written
`description and there is structural significance being
`imparted on to that member term.
`My final point to make regarding the grasping
`members claim term -- excuse me. This is a discussion of
`the alternate construction. OrthoPediatrics has proposed an
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`K2M, Ex. 2032-20
`IPR2018-00429
`
`
`
`21
`
`
`alternate construction that I would like to address briefly.
`In the proposed alternate construction, they
`have added the limitation where downward movement of the rod
`contact member forces the first and second opposing members
`inward towards one another.
`Initially, we would submit that this is an
`improper importation from the specification into the claims
`of a preferred embodiment. There is a lot of discussion in
`the briefs, Your Honor, about disavowal. We would submit
`that there has been no disavowal.
`The standard for disavowal is significant. One
`case we would point to, this is a case that OrthoPediatrics
`has relied on, this is the Hill-Rom case, this is a Federal
`Circuit 2014 case. One thing we are certainly in agreement
`with OrthoPediatrics is that this case is very relevant. In
`fact, potentially the most relevant for offering the
`decision in this case, very insightful. And that case
`describes that standard for disavowal and describes it is
`very exacting, and requiring clear expression of intent to
`redefine those claim terms.
`We would submit that that is not the case here.
`And the descriptions in the embodiments do not in fact
`rising to the level of a clear disavowal.
`One last point is on the topic of claim
`differentiation, Your Honor. I have put that on to the
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`K2M, Ex. 2032-21
`IPR2018-00429
`
`
`
`22
`
`
`slide for you. That is Claim 19 in the patent, which is
`dependent on the independe
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