Trials@uspto.gov
`571-272-7822
`
`
`
`
`Paper No. 56
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`ALPHATEC HOLDINGS, INC. and ALPHATEC SPINE, INC.
`Petitioners,
`
`v.
`
`NUVASIVE, INC.
`Patent Owner.
`____________
`
`Case IPR2019-00361 (Patent 8,187,334 B2)
`Case IPR2019-00362 (Patent 8,361,156 B2)
`Case IPR2019-00546 (Patent 8,187,334 B2)
`____________
`
`Record of Oral Hearing
`Held: April 3, 2020
`____________
`
`
`
`
`Before DENISE M. POTHIER, HYUN J. JUNG, and
`SHEILA F. McSHANE, Administrative Patent Judges.
`
`
`
`
`
`
`
`
`
`571-272-7822
`
`
`
`
`Paper No. 56
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`ALPHATEC HOLDINGS, INC. and ALPHATEC SPINE, INC.
`Petitioners,
`
`v.
`
`NUVASIVE, INC.
`Patent Owner.
`____________
`
`Case IPR2019-00361 (Patent 8,187,334 B2)
`Case IPR2019-00362 (Patent 8,361,156 B2)
`Case IPR2019-00546 (Patent 8,187,334 B2)
`____________
`
`Record of Oral Hearing
`Held: April 3, 2020
`____________
`
`
`
`
`Before DENISE M. POTHIER, HYUN J. JUNG, and
`SHEILA F. McSHANE, Administrative Patent Judges.
`
`
`
`
`
`
`
`
`
`
`IPR2019-00361 (Patent 8,187,334 B2)
`IPR2019-00362 (Patent 8,361,156 B2)
`IPR2019-00546 (Patent 8,187,334 B2)
`
`
`
`APPEARANCES
`
`ON BEHALF OF THE PETITIONER:
`
`
`JOVIAL WONG, ESQ.
`DAVID P. DALKE, ESQ.
`NIMALKA R. WICKRAMASEKERA, ESQ.
`Winston & Strawn LLP
`1700 K Street, NW
`Washington, D.C. 20006
`
`
`
`ON BEHALF OF THE PATENT OWNER:
`
`
`MICHAEL T. ROSATO, ESQ.
`SONJA R. GERRARD, ESQ.
`JAD A. MILLS, ESQ.
`Wilson Sonsini Goodrich & Rosati
`701 5th Avenue, Suite 5100
`Seattle, Washington 98104
`
`
`
`
`The above-entitled matter came on for hearing on Friday, April 3,
`
`2020, commencing at 12:51 p.m., at the U.S. Patent and Trademark Office,
`600 Dulany Street, Alexandria, Virginia.
`
`
`
`
`
`
`
`
`
`
`
`2
`
`
`
`IPR2019-00361 (Patent 8,187,334 B2)
`IPR2019-00362 (Patent 8,361,156 B2)
`IPR2019-00546 (Patent 8,187,334 B2)
`
`
`P R O C E E D I N G S
`- - - - -
`JUDGE JUNG: All right, we’ll proceed on the record. This is the
`
`oral hearing for IPR2019-00361, 362, and 546. Petitioner Alphatec Holding
`and Alphatec Spine challenge certain claims of U.S. Patent Numbers
`8,187,334 and 8,361,156 both of which are owned by NuVasive
`Incorporated. Starting with the Petitioner’s Counsel and followed by Patent
`Owner’s Counsel, please state your names for the record.
`
`MR. WONG: Good morning, Your Honors. Jovial Wong from
`Winston & Strawn for Petitioner. Also with me are co-counsel, and
`hopefully you can see them as well, Nimalka Wickramasekera and David
`Dalke.
`
`JUDGE JUNG: Thank you, welcome.
`
`MR. ROSATO: Good afternoon, Your Honor, Michael Rosato, on
`behalf of Patent Owner, and I have with me co-counsel Sonja Gerrard and
`Jad Mills.
`
`JUDGE JUNG: Thank you. First, thank you all for your flexibility in
`conducting this all-video hearing today. We know that this is a departure
`from our typical practice. Given that, we want to start off by clarifying a
`few items. First, our primary concern is your right to be heard. If at any
`time during the proceeding you encounter technical or other difficulties that
`you feel fundamentally undermines your ability to adequately represent your
`client, please to let us know immediately. For example, by contacting the
`team members who provided you a connection information.
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`
`3
`
`
`
`IPR2019-00361 (Patent 8,187,334 B2)
`IPR2019-00362 (Patent 8,361,156 B2)
`IPR2019-00546 (Patent 8,187,334 B2)
`
`Second, when not speaking, please mute yourself. Third, please
`
`identify yourself each time you speak. This helps the court reporter prepare
`an accurate transcript. Fourth, we have the entire record including
`demonstratives. When referring to demonstratives, papers or exhibits,
`please do so clearly and explicitly by slide or page number. Please also
`pause a moment after identifying it to provide us time to find it. This also
`helps with the accurate preparation of the hearing transcript. And finally,
`please be aware that members of the public may be listening to this oral
`hearing.
`
`Turning to objections, Patent Owner has filed objections to several
`slides in Petitioner’s demonstratives. Petitioner did not file any objections,
`and, Mr. Wong, I would like you to verify that Petitioner has no objections
`to Patent Owner’s demonstratives.
`
`MR. WONG: That’s correct, Your Honor.
`
`JUDGE JUNG: Thank you. As a reminder, any arguments and
`evidence that are not in the record will not be considered by the panel. The
`demonstratives are not evidence and are used only as a visual aid. The
`concern is that demonstratives may be used as a springboard to add new
`arguments not in the record, and as mentioned before, new arguments and
`evidence are not permissible. Rather than spending the time to go through
`all of Patent Owner’s objections now, we are going to decline to strike some
`of the demonstratives at this time. However to be clear to the extent that
`some of the graphics, characterizations, and arguments are not in the record,
`they will be disregarded. The Board can discern the appropriateness of the
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`
`4
`
`
`
`IPR2019-00361 (Patent 8,187,334 B2)
`IPR2019-00362 (Patent 8,361,156 B2)
`IPR2019-00546 (Patent 8,187,334 B2)
`
`arguments and evidence and the counsel can use their allotted time as they
`see fit.
`
`As discussed in the hearing order, each party has one hour of total
`time to present its arguments, and each party may reserve time for rebuttal. I
`will track time and interrupt when you have only a few minutes remaining,
`and as backup, I would like each party to also independently track argument
`time. With all that said, Mr. Wong, you may proceed when you’re ready.
`
`MR. WONG: Yes, thank you, Your Honors, and for Petitioners, the
`argument will be handled by Ms. Wickramasekera and Mr. Dalke, so I will
`be deferring to them.
`
`JUDGE JUNG: Okay, thank you.
`
`MS. WICKRAMASEKERA: Good morning, Your Honors, just
`confirm that you can hear me?
`
`JUDGE JUNG: I can hear you, and how much time would you like to
`reserve for rebuttal?
`
`MS. WICKRAMASEKERA: I’d like to reserve 30 minutes. I’m
`hoping to go less than that in my opening, but at this stage, I think 30
`minutes would be good.
`
`JUDGE JUNG: Okay. I have right now on my computer 12:55, so
`you may start when you’re ready.
`
`MS. WICKRAMASEKERA: Okay, thank you, Your Honor. Thank
`you to everyone for coming into this oral argument during these difficult
`times. We appreciate it. We’ve provided a set of slides that largely covers
`many of the issues that we have briefed in our petition and that have been
`fully briefed in the papers. We do not depart from anything in the papers,
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`5
`
`
`
`IPR2019-00361 (Patent 8,187,334 B2)
`IPR2019-00362 (Patent 8,361,156 B2)
`IPR2019-00546 (Patent 8,187,334 B2)
`
`but we are happy to go into any issues that the Board would like to hear
`more about or that the Board has more questions about. I’m happy to start
`with my slide presentation, and we’ll try to go through it relatively quickly.
`I will of course not be covering every issue that we briefed although many
`slides around those issues appear.
`
`So I’d like to start with -- I will turn to Petitioner’s demonstratives,
`and I will start with the overview of the grounds which starts at about Slide
`3. So as Your Honors know, we are challenging two patents here, the ’334
`patents and the ’156 patents owned by Patent Owner NuVasive. For the
`’334 patents, we have two petitions that cover that, the 361 and the 546, and
`ground 1 for each of the 361 and the 546 relies largely on the same art that
`the Federal Circuit used to invalidate claim 1, the only independent claim in
`the ’334 patent, as well as a number of other claims that have been
`cancelled.
`
`The grounds rely on the same art: Frey and Michelson, and we have
`additionally added Berry. It is our position, and we stated this in the
`petition, that Berry would have been known to people of ordinary skill in the
`art, however out of an abundance of caution, we added Berry as an
`additional ground regarding the known dimensional measurements of the
`vertebrae.
`
`In ground 2, we have raised some new art that wasn’t previously
`considered by the Board in the prior petitions relating to the ’334 or the ’156
`patents, and that involves the primary reference, Brantigan. As we stated in
`our petition, and have briefed this at length in our papers, Patent Owner
`relied on Brantigan, and on many of the same teachings using the same
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`6
`
`
`
`IPR2019-00361 (Patent 8,187,334 B2)
`IPR2019-00362 (Patent 8,361,156 B2)
`IPR2019-00546 (Patent 8,187,334 B2)
`
`rationale of Brantigan in an attempt to invalidate the Michelson patents that
`is prior art here as well as a parent Michelson patent, the ’997 patent. We
`have briefed these in our petition, and we will address a few more of the
`Patent Owner’s statements regarding this reference in the slide presentation,
`and we’ve also discussed in (inaudible) everything.
`
`For the ’156 patent grounds, those are listed on slide 4, and again, for
`the ’156 patent, we largely rely on Brantigan in view of Baccelli and Berry.
`So with that, I will go on to a brief overview of the anatomy here at slide 6.
`I’m not going to go over this in detail, however the known dimensions of the
`human vertebrae were published in Berry. There were detailed
`measurements that were published that were available to people of ordinary
`skill in the art.
`On slide 7, there is an overview of the ’334 and ’156 patents, what the
`claims cover, and many of these features that you can see in slide 7 were
`ubiquitous in the prior art. They were ubiquitous in the references that we
`have cited as prior art. They were ubiquitous in many other references that
`were also known to people of ordinary skill in the art at the time. So with
`that, I’d like to turn to just a brief overview of the state of the art, and I’d
`like to turn first to slide 9 which gives you the different features of the prior
`art implants that were generally known.
`
`Now both sides I think agree on the person of ordinary skill in the art.
`What the parties dispute, it appears, is what would have been known to those
`people of ordinary skill in the art. In particular it is Petitioner’s position that
`Dr. Youssef, Patent Owner’s expert, does not do proper analysis and does
`not provide a qualified analysis because he ignores or was deliberately
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`7
`
`
`
`IPR2019-00361 (Patent 8,187,334 B2)
`IPR2019-00362 (Patent 8,361,156 B2)
`IPR2019-00546 (Patent 8,187,334 B2)
`
`ignorant of the information that was readily available, accessible, and used
`by people of ordinary skill in the art before the critical date.
`
`JUDGE JUNG: Ms. Wickramasekera?
`
`MS. WICKRAMASEKERA: Yes?
`
`JUDGE JUNG: If we decide there is a dispute regarding your level of
`ordinary skill, does it affect your argument at all if we decide to use the
`references as a gauge of what the level of ordinary skill was at the time of
`the invention?
`
`MS. WICKRAMASEKERA: No, and I think that that is exactly the
`proper analysis that references -- in many cases, what Patent Owner is
`disputing is that their position is that the references don’t actually say what
`they say. We think that the references are the best example of what is the
`state of the art at the time.
`
`JUDGE JUNG: Okay, thank you. And also as a follow-up, in your
`reply you cite McAfee and Michelson ’770, but it seems to the Panel that
`those two references are being cited for a proposition that’s already present
`in the references you’ve asserted in your petition. Would that be a correct
`statement?
`
`MS. WICKRAMASEKERA: That’s a correct statement, and the
`reason why we did cite those references is because we could not anticipate
`that Patent Owner would take the position in the Patent Owner response that
`what was actually disclosed in the prior art references that we rely on would
`not have actually been done, and that appears to be Patent Owner’s position.
`And because people of ordinary skill in the art at the time not only knew of
`these prior art references we rely on, Brantigan, Frey, Michelson, Berry, and
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`8
`
`
`
`IPR2019-00361 (Patent 8,187,334 B2)
`IPR2019-00362 (Patent 8,361,156 B2)
`IPR2019-00546 (Patent 8,187,334 B2)
`
`Baccelli, not only did they know of these prior art references, but they
`actually had followed them before the critical date.
`And so it is in light of Patent Owner’s arguments that, for example,
`even though Frey, Michelson, and Brantigan all disclose using multiple
`implants in the same disc space Patent Owner has taken the position that no
`one would ever do that at the time, and so in light of those statements we
`provided real world evidence that Patent Owner was well aware of because
`this is the evidence that Patent Owner had used in prior proceedings for that,
`so does that --
`JUDGE JUNG: So would you agree that we may not need to reach
`your arguments in the reply to actually decide this case, for the final written
`decisions?
`MS. WICKRAMASEKERA: With respect to the two references that
`we added, McAfee and Michelson ’770, I actually agree. I think that those
`two references are consistent with the teachings in Michelson, and they’re
`consistent with our motivation to combine to modify Brantigan and
`Michelson in view of Baccelli to add the four markers, the three markers and
`four markers, and to modify Frey in view of Michelson and Berry for the
`dimensional limitations and the teaching of modularity. So, yes, we
`absolutely agree that is covered in our petition. Those references were
`added simply on reply because Patent Owner took the position that
`essentially the prior art would have been impossible.
`
`JUDGE JUNG: I see. And while we’re on the topic of motivation,
`can you clarify; did you mean to combine these modular implants before
`insertion, or did you mean to have them combined after insertion?
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`9
`
`
`
`IPR2019-00361 (Patent 8,187,334 B2)
`IPR2019-00362 (Patent 8,361,156 B2)
`IPR2019-00546 (Patent 8,187,334 B2)
`
`MS. WICKRAMASEKERA: And that’s the key question here in
`
`terms of the strawman that we believe that Patent Owner has set up to knock
`down. We never took the position in the petition or in any of our papers that
`modularity required assembly. In fact, that is expressly not what each of the
`prior art references states. What the prior art references, each one of them,
`Brantigan, Frey, and Michelson each one of them is drawn to this concept of
`being able to customize the implant that you need for the space that you’re
`trying to achieve the fusion at.
`So each one of them contemplates either one implant in that space or
`multiple implants in the same space. There was never any teaching in
`Michelson that you must assemble when you insert the implants side-by-side
`that you must assemble them. There was never any teaching in Brantigan
`either. We referenced this in the petition, Brantigan’s side-by-side
`disclosure of implants in the same disc space. The point is that you can do
`this using one implant or for various reasons that are actually expressed in
`the prior art references themselves that just Michelson and Frey saying you
`may want to insert this using a tube to do it then and more invasively. If you
`want to follow that teaching in Michelson, Michelson says make it a long-
`and-narrow implant.
`So, no, we never took the position that modularity required assembly.
`I think we were very, very clear that that was not the position, and not only
`that, I think the prior art references, themselves, are very, very clear that that
`is not required for the modular.
`JUDGE JUNG: I see. And so just to verify, when we look at the
`Patent Owner’s arguments, we should understand your petition to be saying
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`10
`
`
`
`IPR2019-00361 (Patent 8,187,334 B2)
`IPR2019-00362 (Patent 8,361,156 B2)
`IPR2019-00546 (Patent 8,187,334 B2)
`
`that these modular implants are already assembled before they’re being
`inserted?
`MS. WICKRAMASEKERA: Sorry?
`JUDGE JUNG: When we look at the Patent Owner’s arguments, we
`should see the petitions as taking the position that the modular implants are
`already assembled prior to insertion?
`MS. WICKRAMASEKERA: That is Patent Owner’s position, and if
`I may, I might be able to flip you to a slide that has -- if you could, turn to
`slide 25 of our demonstrative, the Petitioner’s demonstrative. This is Patent
`Owner’s statement about what our argument is, and I’ve underlined there
`assembling them within the disc space. You don’t have to assemble them
`before you insert them into this space or after. The prior art that we rely on
`is very clear; when you insert these in a modular fashion, all it is saying is
`that you insert them so that they are seated side-by-side. No assembly is
`required before or after the insertion. No assembly is required in the
`references themselves, and we do not state that any assembly is required.
`This is consistent with the Federal Circuit’s opinion invalidating claim
`1, where the Federal Circuit expressly found that the modular disclosure, the
`point of it was to insert more than one implant. There was never any
`requirement from the Federal Circuit or in the references themselves to
`assemble it either before or after you insert it. The assembly isn’t required
`so long as they are seated side-by-side and they achieve the overall fusion
`that you’re trying to achieve. Did I answer your question, Your Honor? I’m
`not sure of that.
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`
`11
`
`
`
`IPR2019-00361 (Patent 8,187,334 B2)
`IPR2019-00362 (Patent 8,361,156 B2)
`IPR2019-00546 (Patent 8,187,334 B2)
`
`
`JUDGE JUNG: Well, I’ll think about it, but please proceed with your
`presentation.
`MS. WICKRAMASEKERA: Okay. So if we could just turn to the
`next, actually. So I had you on slide 25 which has Patent Owner’s
`characterizations of our arguments, and this is what I wanted to point out,
`this characterization of our argument is not accurate. This is the strawman
`that Patent Owner has set up to knock down in terms of trying to defeat the
`motivation to combine. The Federal Circuit never found that assembly was
`required when it combined Michelson’s long-and-narrow teaching with
`Frey.
`And very quickly, I want to turn an additional point regarding the
`state of the art. I’d like to just give an overview of, if you turn to slide 31,
`Frey’s disclosures of 3 radiopaque markers is on 31, and 32 is Baccelli’s
`disclosure of 4 radiopaque markers. And this is another area where there
`appears to be a dispute over what Baccelli discloses, and I want to be very
`clear. In the Petition I think we were very clear; we never relied on Baccelli
`for the dimensions of the implants. Those are disclosed by the combination
`of the primary reference, either Frey or Brantigan, in view of Michelson and
`Berry, but Baccelli has a specific disclosure of the orientation of 4
`radiopaque markers.
`So the claims require a longitudinal length importantly that extends
`between a distal wall and a proximal wall of the implant, so how do you
`identify what the proximal wall is and what the distal wall is; what does that
`mean? All of the experts in this case agree, the proximal wall is the wall that
`would have the threaded insertion hole. It would be the closest to the
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`12
`
`
`
`IPR2019-00361 (Patent 8,187,334 B2)
`IPR2019-00362 (Patent 8,361,156 B2)
`IPR2019-00546 (Patent 8,187,334 B2)
`
`surgeon, an identifiable end of the implant. It’s what you call the trailing
`end as well. The Federal Circuit has used that language.
`The distal wall is the wall of the implant that’s going to be opposite
`the proximal wall. It’s going to be opposite the surgeon. What passes
`between on the sides of the sidewall. Baccelli teaches very clearly you have
`a marker in the distal wall, you have a marker in the proximal wall, and then
`you have a marker dead center in each of the sidewalls between the distal
`and the proximal wall; that this is the middle of the sidewalls. That is the
`teaching, those spikes which are denoted 24, Baccelli teaches you’ll have
`spikes located in this orientation and that you could make those spikes
`radiopaque.
`JUDGE POTHIER: Counselor, this is APJ Pothier. In your petition,
`did you not call that central region the medial plane?
`MS. WICKRAMASEKERA: Yes, Your Honor. So the central region
`is required in the feature in the ’334 patent, and the medial plane is a
`limitation in the ’156 patent. But I’d like to point out -- and thank you, Your
`Honor, for posing the question. This is one of the areas based on the initial
`determination that I thought would be helpful to explain. The medial plane
`has a specific location in the ’156 patent. Give me one second to turn to the
`claim language. Okay, so the ’156 patent requires a longitudinal length
`extending from the proximal end of the proximal wall to a distal end of the
`distal wall.
`It requires a maximum lateral width extending from one sidewall to
`another sidewall along a medial plane that is generally perpendicular to the
`longitudinal length, and the longitudinal length is greater than the maximum
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`13
`
`
`
`IPR2019-00361 (Patent 8,187,334 B2)
`IPR2019-00362 (Patent 8,361,156 B2)
`IPR2019-00546 (Patent 8,187,334 B2)
`
`lateral width. The medial plane bisects the sidewalls between the proximal
`and the distal end. We did refer in the Petition to Baccelli having
`radiopaque markers, their spikes, along the medial plane, but the medial
`plane has both spatial orientation with respect to the implant. In other
`words, it needs to be between the proximal, the distal wall at the midpoint,
`and then the medial plane has other claim requirements that relate to
`dimension.
`We did not rely on Baccelli in the petition for the dimensional
`requirements of the medial plane, but rather to show that where that medial
`plane lies in Baccelli, which is the widest part of the implant on the
`sidewalls between the distal and the proximal end in that middle area, medial
`plane, that is where the markers are located on Baccelli, and Baccelli doesn’t
`have the claimed medial plane because that requires an additional
`dimensional requirement that the longitudinal length be greater than the
`maximum lateral width. But the point teaching --
`JUDGE POTHIER: I hate to just interrupt you again, Counselor.
`MS. WICKRAMASEKERA: Yes.
`JUDGE POTHIER: This is APJ Pothier. If I’m looking at your slide
`32, it seems to me you’ve marked the distal wall where 47 is and not where
`the radiopaque markers 24 are.
`MS. WICKRAMASEKERA: Yes, that’s correct.
`JUDGE POTHIER: And what you were just saying prior, maybe I
`misunderstood or misheard, but it seemed that you were saying that the
`markers had to be in the distal wall; is that --
`MS. WICKRAMASEKERA: Yes, sorry.
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`14
`
`
`
`IPR2019-00361 (Patent 8,187,334 B2)
`IPR2019-00362 (Patent 8,361,156 B2)
`IPR2019-00546 (Patent 8,187,334 B2)
`
`
`JUDGE POTHIER: So this is where I’m confused by your markings.
`MS. WICKRAMASEKERA: Okay. Okay, you know, and I will be
`clearer. Baccelli refers to 24 as spikes. Baccelli refers to 47 as radiopaque
`markers. Baccelli then also teaches that the spikes 24 can be made of
`radiopaque material, which means that they can act as markers. It doesn’t
`call them markers. It means that if you make them radiopaque, they will act
`as markers. So I was using, perhaps, some emphasized language when I
`referred to all four of them as markers. Baccelli refers to them as radiopaque
`spikes 24, and radiopaque markers 47.
`There’s no meaningful difference if the spikes are made of radiopaque
`material. So what Baccelli specifies is that you’re going to have a marker 47
`in the distal wall, a marker 47 in the proximal wall, and then you’re going to
`have spikes 24, that are in the middle of the sidewalls in that central region
`which would also be the medial plane if you’re following the teaching of the
`medial plane bisecting the walls that extend from the proximal to the distal
`end. So in other words, the very middle of the sidewalls. Baccelli teaches
`24. You’re going to have spikes 24 there, and you can make those spikes
`radiopaque. Does that answer your question, Your Honor?
`JUDGE POTHIER: The last part that you’re saying, stand between
`the proximal and the distal walls; are you talking about sidewalls in this
`figure, which looks like figures 1 and 2 of Baccelli?
`MS. WICKRAMASEKERA: Yes, so in slide 32, what I’m referring
`to is the sidewalls are, if you look at the left-hand figure, it identifies a
`sidewall on the right, a sidewall on the left, a distal wall at the top and a
`proximal wall on the bottom. So the proximal wall is identified. If you look
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`15
`
`
`
`IPR2019-00361 (Patent 8,187,334 B2)
`IPR2019-00362 (Patent 8,361,156 B2)
`IPR2019-00546 (Patent 8,187,334 B2)
`
`at the figure on the right, the proximal wall is identified primarily by the
`location at 18, which is the insertion hole. This is all taught in Baccelli, so it
`identifies that as a proximal wall. You then are able to determine what the
`distal wall is.
`Now the claims require that there is a -- try to find that -- go. Slide
`56, claim 1 requires an implant that has a maximum lateral width extending
`from a first sidewall, that you’re looking at slide 32. That would be, for
`example, the left sidewall. View the second sidewall, which would be the
`wall on the right, you have a maximum lateral width extending between
`those two sidewalls along a medial plane, and it further requires that the
`medial plane is generally perpendicular to the longitudinal length. Now --
`JUDGE POTHIER: And in this case, it looks like that is the
`longitudinal length.
`MS. WICKRAMASEKERA: So length is actually defined in the
`claim as -- the longitudinal length is defined in the claim according to its
`spatial orientation. In claim 1 of ’156 patent, it expressly says that it has a
`longitudinal length that extends from a proximal end of the proximal wall to
`a distal end of the distal wall. That’s in the express claim language. It’s the
`same claim language in the ’344 patent that specifies that the longitudinal
`length must extend between the proximal and the distal end. Then it tells
`you that there are also dimensional requirements for the length. For
`example, the length has to be greater than the maximum lateral width.
`But as a first proposition, you have to identify which direction is the
`length, and the length in both of these patents in both independent claims for
`the ’334 and the ’156, it specifies as a starting point, the length must be -- it
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`16
`
`
`
`IPR2019-00361 (Patent 8,187,334 B2)
`IPR2019-00362 (Patent 8,361,156 B2)
`IPR2019-00546 (Patent 8,187,334 B2)
`
`must extend between the distal and the proximal wall. That’s how you
`determine what the length is. Then you have to determine does that length
`meet the dimensional requirements that are also expressly recited in the
`claims.
`So, here, we refer to the length. The length doesn’t vary. This is in
`the Federal Circuit opinion that we cited in our petition. The experts,
`everyone uses this type of nomenclature, and it’s expressly claimed in both
`of these patents that the length extends between the distal wall and the
`proximal wall. We don’t rely on Baccelli for the longitudinal length. What
`we do rely on Baccelli for is to say, okay, if the patent claims are telling you
`that you have a length that extends between the distal and the proximal
`walls, it has dimensional requirements and those must be met as well, but the
`first proposition has a length that extends between the distal and the
`proximal walls.
`That allows you to identify where the length is. It tells you need to
`have markers in the proximal and distal walls, and then it tells you that the
`medial plane bisects that direction between the proximal and the distal walls,
`and that you must have also markers along that medial plane for claim 1 of
`the ’156 patent. So to call the -- from the sidewall to the sidewall, to call
`that the length conflicts with the actual claim language. The claim language
`requires that the length be from the distal to the proximal end. It also has
`dimensional requirements that that’s the spatial orientation required for the
`claims.
`Does that answer your question? So this is the issue that Patent
`Owner has raised. They say that Baccelli has -- that we’ve drawn it wrong,
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`17
`
`
`
`IPR2019-00361 (Patent 8,187,334 B2)
`IPR2019-00362 (Patent 8,361,156 B2)
`IPR2019-00546 (Patent 8,187,334 B2)
`
`and that the longest dimension of Baccelli is actually the width of Baccelli
`that you see here. But the issue is that what Baccelli is teaching you is the
`same thing that the patent claims are teaching you which is that you identify
`your direction of insertion, and you want to make sure you have a marker at
`your leading end, you want to make sure you have a marker at your trailing
`end, and you want to make sure you have a marker in the middle of those
`sidewalls.
`You also have to meet the various dimensional limitations of the
`claims, but as far as the orientation of the markers that is where they want
`the markers. That is exactly what Baccelli teaches. Minus the particular
`dimensions of the implant, Baccelli teaches you exactly the same marker
`location, and that is our point. The medial plane and the central region
`drawn on the diagram, that is where the central region would be when you
`modify the implants Brantigan and Frey in view of Michelson and Berry as
`we’ve suggested in the graphs. We don’t rely in the petitions at all, at all on
`Baccelli to satisfy the dimensional limitations of the medial plane or the
`dimensional limitations of the claim’s central region or the dimensional
`limitations of (inaudible).
`What we rely on Baccelli for is that it’s a quite simple teaching that if
`the direction you’re going to enter an implant, put a marker in the proximal
`wall, put a marker in the distal, and put a marker of some sort or a spike that
`is radiopaque in the middle of the sidewalls, and that orientation of markers
`is the key teaching that we rely on for Baccelli. Did that answer your
`question?
`JUDGE JUNG: Ms. Wickramasekera?
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`18
`
`
`
`IPR2019-00361 (Patent 8,187,334 B2)
`IPR2019-00362 (Patent 8,361,156 B2)
`IPR2019-00546 (Patent 8,187,334 B2)
`
`
`MS. WICKRAMASEKERA: Yes?
`JUDGE JUNG: Ms. Wickramasekera, this is Judge Jung. You have
`two minutes left before you go into rebuttal time.
`MS. WICKRAMASEKERA: Okay. I would like to jump in very
`quickly to claim 18 of the ’334 patent because I think that will also cover the
`18-millimeter width of the ’156 patent. So I want to turn your attention to
`slide 40, if you will. One initial point: claim 1 was invalidated by the
`Federal Circuit based on Michelson’s teaching of a long-and-narrow
`modular implant. It’s very critical to remember two points. For one, claim
`18, the prior petitioner did not cite the same evidence that the Federal Circuit
`used to invalidate claim 1 for claim 18. There was a procedural failure in
`the prior petition. They didn’t cite this information.
`And for two, the prior petitioner withdrew their appeal of claim 18
`before this went up on appeal. This is all stated in the Federal Circuit
`opinion. The Federal Circuit never upended the patentability finding of
`claim 1. It could not have because it didn’t have jurisdiction since the
`aperture (inaudible) was discussed. So just turning very quickly to the
`evidence for claim 18, and I just stated this if you’re looking at slide 40.
`Number one, the Federal Cir
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
