UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`SMITH & NEPHEW, INC.,
`Petitioner,
`
`v.
`
`COMFORMIS, INC.,
`Patent Owner.
`____________
`
`Case IPR2016-01874
`Patent 9,055,953 B2
`____________
`
`Record of Oral Hearing
`Held: December 18, 2017
`____________
`
`
`
`
`Before PATRICK R. SCANLON, JAMES A. WORTH, and AMANDA F.
`WIEKER, Administrative Patent Judges.
`
`
`
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`SMITH & NEPHEW, INC.,
`Petitioner,
`
`v.
`
`COMFORMIS, INC.,
`Patent Owner.
`____________
`
`Case IPR2016-01874
`Patent 9,055,953 B2
`____________
`
`Record of Oral Hearing
`Held: December 18, 2017
`____________
`
`
`
`
`Before PATRICK R. SCANLON, JAMES A. WORTH, and AMANDA F.
`WIEKER, Administrative Patent Judges.
`
`
`
`
`Case IPR2016 01874
`Patent 9,055,953 B2
`
`
`
`APPEARANCES:
`
`ON BEHALF OF THE PETITIONER:
`
`
`CHRISTY G. LEA, PARTNER
`Knobbe, Martens
`2040 Main Street
`14th Floor
`Irvine, California 92614
`(949) 760-0404
`
`
`
`ON BEHALF OF THE PATENT OWNER:
`
`
`SANYA SUKDUANG, PARTNER
`Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
`901 New York Avenue, Northwest
`Washington, D.C. 20001
`(202) 408-4377
`
`
`
`
`The above-entitled matter came on for hearing on Monday, December
`
`18, 2017, commencing at 10:00 a.m., at the U.S. Patent and Trademark
`Office, 600 Dulany Street, Alexandria, Virginia.
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`
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`Case IPR2016 01874
`Patent 9,055,953 B2
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`P R O C E E D I N G S
`- - - - -
`JUDGE WORTH: Before we begin, let's test the video setup with the
`Midwest office. Judge Scanlon, can you hear us?
`JUDGE SCANLON: Yes, I can.
`JUDGE WORTH: Okay. This is an oral hearing in PTO case
`IPR2016-01874, between Petitioner, Smith & Nephew, Inc. and owner of
`U.S. Patent 9,055,953 B2, Conformis. My name is Judge Worth, on my left
`is Judge Wieker, and participating from teleconference in the Midwest office
`is Judge Scanlon.
`As you know, per our order, each party has 30 minutes to present their
`arguments. Because Petitioner has the burden to show unpatentability of the
`claims, Petitioner will proceed first followed by Patent Owner. Petitioner
`may reserve rebuttal time but may only use it to rebuttal with respect to
`what's been raised. At this time we'd like to ask counsel to introduce
`yourselves beginning with Petitioner.
`MS. LEA: Sure. Good morning, my name is Christy Lea and I
`represent Petitioner, Smith & Nephew. With me from my firm, Knobbe
`Martens, is Collin Hydemen. I also have Joe Ray from my firm, and Nathan
`Reeves, as well as Bill Climens from Smith & Nephew.
`JUDGE WORTH: And are there other people that you brought with
`you today?
`MS. LEA: Well, we do have another attorney for Smith & Nephew in
`the room, Brad Lenny, observing.
`JUDGE WORTH: Okay, thank you. For Patent Owner?
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`MR. SUKDUANG: Good morning, Your Honor. Sanya Sukduang
`from Finnegan and Henderson. I have with me my colleague Tim McAlalty.
`Also from Finnegan and Henderson, Cassandra Officer, Sydney Kesley, Dan
`Glenoaski. And then from Conformis, Dave Sarity and Nicholas Shouder.
`JUDGE WORTH: Is there anyone else in the room we haven't
`identified?
`MR. SUKDUANG: Not from Patent Owner, Your Honor.
`JUDGE WORTH: Thank you. Before we begin, with respect to
`demonstratives, each party may state objections to demonstratives during its
`allotted time, and we will take any objections under advisement for the final
`written decision. With that being said, counsel are asked to refrain from
`using demonstratives that introduce material that's not already in the briefing
`or exhibits that are part of the record. When rendering our final decision, we
`will disregard any new evidence or argument. In the hopes of keeping this
`hearing focused on the merits, we ask the counsel not to interrupt the other
`side to make objections. Petitioner, would you like to reserve time?
`MS. LEA: I would, I would like to reserve ten minutes.
`JUDGE WORTH: Are there any issues before we begin? Petitioner,
`you may begin when ready.
`MS. LEA: Thank you, may I hand up my slides?
`JUDGE WORTH: Please.
`MS. LEA: They are Exhibit 1208.
`JUDGE WORTH: Also, please keep in mind that we have a Judge
`who's participating remotely. Thank you.
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`MS. LEA: So, I will turn to slide 2. Slide 2 is an outline and gives an
`overview of what I'm going to discuss today, but I'll mainly be focusing on
`the references Radermacher, Alexander, and Fell.
`Turning to slide 3, slide 3 shows the patient-specific instrument that is
`claimed in the '953 patent. On the right-hand side we have the figure from
`the '953 patent. The green shows the patient-specific instrument. The
`yellow highlighting shows the patient-specific surface, and the blue is the
`femur. And we also have an indication for the slit. The claims in this case
`only claim the patient-specific surface and the slit. There's no dispute about
`the slit element. This case will focus on the patient-specific surface and
`what it matches.
`On the left-hand side we have Radermacher, the prior art, showing the
`same instrument with the same slit with the same patient-specific surface
`being applied to a femur. So, the '953 patent disclosure says that the
`patient-specific surface may match the cartilage or the bone or both. There's
`only two surfaces on the femur that can match, the cartilage or bone, and
`they talk about matching both. But they never give any significance to
`either surface and they certainly never give any significance to matching
`cartilage. The '953 patent claim operates the same way. They claim
`matching both surfaces, the bone or the cartilage or both. They use the word
`"articular joint surface" sometimes that this Board construed to mean
`cartilage or bone or both, and no party challenges that construction.
`Now, after institution in this case Conformis, the Patent Owner,
`disclaimed all claims to the articular joint surface and to the subchondral
`bone. And that's because they admit that Radermacher discloses a
`patient-specific surface that matches bone. So, there's no dispute about that
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`in this case. The only dispute is over whether Radermacher teaches
`matching cartilage.
`JUDGE WORTH: Before we move on, what do you want us to do
`with the disclaimed claims?
`MS. LEA: Well, I'm glad you asked. So, we have on slide 7 I list all
`the disclaimed claims for you, there's 27, and we ask that adverse judgement
`be entered with those claims under the statute.
`JUDGE WORTH: And what is the reasoning for that adverse
`judgement?
`MS. LEA: Well, first of all, the statute provides that, if instituted,
`final written decision would be on any claim challenged, and the regulation
`actually gives estoppel against the Patent Owner from prosecuting any claim
`that might claim the same subject matter as the claims under adverse
`judgement.
`JUDGE WORTH: So, it's the subject matter under the rule?
`MS. LEA: I'm sorry?
`JUDGE WORTH: Under the rule, under 42.73, it would be the
`subject matter?
`MS. LEA: That is right, any claim inconsistent -- they can not take
`any action inconsistent with the adverse judgement.
`JUDGE WORTH: With respect to the statute, if we look at another
`part of the Patent Act that disclaimed claims are as if they -- as if the original
`patent reflects the disclaimer, would it be the case then that those claims
`simply don't exist for purposes of 318?
`MS. LEA: I don't know that I would say they simply don't exist. I
`just know that under the regulation when they file the disclaimer that it can
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`be acquainted to a request for adverse judgement, and there's a reason to
`enter adverse judgement to preclude them from trying to seek the same
`claims later.
`JUDGE WORTH: Please, proceed with your presentation. Thank
`
`you.
`
`MS. LEA: So, I want to come back quickly to slide 6 and show that
`Conformis has drawn this arbitrary line between the bone claims and the
`cartilage claims, even though their patent has no disclosure as to the
`significance of cartilage.
`I'm going to skip ahead to slide 8. This is an overview of the grounds
`that were instituted, and we have the red line over all of the claims that were
`disclaimed. So, there's no need to address ground 1, but we still need to
`address grounds 2, 3, 4 and 5, all which depend up on Radermacher.
`So, I will start with the Radermacher reference from 1993. Again, it
`shows a patient-specific instrument for the knee. I've already talked about
`the figure shows the claim limitations of the inner surface, the
`patient-specific surface, and the slit. Now, Radermacher discloses matching
`the natural surface of the osseous structure, and in the case of the femur or
`the tibia the natural surface is the articular surface that includes cartilage.
`The not pre-treated surface of the femur or the tibia is the articular surface
`that includes cartilage.
`JUDGE WORTH: So, Patent Owner says that
`Dr. Mabrey had no supporting basis for his conclusion about that
`interpretation, can you respond to that?
`MS. LEA: Sure. First of all, Dr. Mabrey was the chief of orthopedic
`surgery at Baylor Medical, so he has certainly his own knowledge and
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`experience of what the natural surface of the femur and the tibia would be.
`He also has references to Alexander and Fell, both of which describe the
`natural surface as being the -- as having cartilage and bone. And then we
`also have Conformis's own admissions. In their briefs they say one would
`not necessarily conclude that Radermacher reference cartilage when
`describing the natural and not pre-treated osseous structure. That is an
`admission that that could be read either way as corresponding to bone or
`cartilage, and all we're looking for here is -- the Federal Circuit reminded the
`Board this week in CRFD Research, we're looking for suggestion to match
`bone -- I mean to match cartilage.
`JUDGE WORTH: I think it's also possible that Patent Owner's
`referring to the test for inherency in saying that it's not necessarily present
`and I think what you just said is that there's a suggestion of cartilage even if
`it's not disclosed; is that what your argument is?
`MS. LEA: Absolutely. So, we believe it is disclosed by certainly at a
`minimum there is a suggestion or a teaching and that's the standard.
`Whether a person of ordinary skill likely would’ve found Radermacher
`teaches or suggests matching cartilage, that's all that's required. By the way,
`in the CRFD case this week the Federal Circuit took this exact statement to
`mean an admission of two finite choices that would’ve been obvious.
`JUDGE WORTH: So, just to explore that, and I understand that you
`argued this in the alternative. So, let's put aside the alternative that
`Radermacher discloses cartilage, and I think what you're saying is there's an
`alternate that Radermacher does not disclose cartilage but that it suggests
`cartilage. So, could you explain what that means?
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`MS. LEA: Certainly. If you accept their argument that it does not
`explicitly use the word "cartilage," does not disclose matching cartilage then
`it at least suggests it. There's two choices, right, there's only two surfaces
`that can be matched when you're talking about the femur, the cartilage or
`bone. So, by showing a continuous surface when you look at the picture for
`Radermacher, on slide 10, he shows the continuous surface of the instrument
`on top of the femur. Well, most patients have cartilage there, at least some
`cartilage. So, he's not avoiding the cartilage but he's been told -- Dr. Clark's
`admitted he's not removing the cartilage so it's still there, there's no
`pre-treatment, we're putting a continuous cohesive region on top of that and
`so it would just be the reasonable inference is that he's suggesting you can
`match the cartilage.
`JUDGE WORTH: What is the cite for the admission for Dr. Clark?
`MS. LEA: Sure. So, on slide 14, there are two of the cites, he
`actually says this about five different times. So, two of the cites are on slide
`14 where Dr. Clark admitted on cross examination that removing cartilage is
`pre-treatment. Radermacher says you don't need to do this and so
`Radermacher says no pre-treatment. So the non-pre-treated surface on the
`femur has cartilage on it and this is true for most patients.
`JUDGE WORTH: To be clear, Radermacher, in the portion that we're
`discussing, doesn't say of the femur, it says of the osseous structure.
`MS. LEA: That's correct. So, he writes a general disclosure that can
`be used with different osseous structures, but he actually discloses a knee
`embodiment, draws a knee embodiment, and the bones in the knee are the
`femur and the tibia.
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`Okay, so there's only two design choices for Radermacher, because
`cartilage is present and an image, Radermacher discloses MRI for imaging
`the cartilage. The only two choices are to match the cartilage and any
`exposed subchondral bone or remove the cartilage and match the underlying
`subchondral bone and both experts agree Radermacher does not do number
`2, he says no pre-treatment. So, that leaves choice number 1, match the
`cartilage. Conformis argues there's a third choice, they argue that
`Radermacher discloses matching only exposed subchondral bone and using
`recesses to avoid the cartilage. So, you can see on slide 17 Conformis is
`pointing to another embodiment in Radermacher, this fine template
`embodiment, where Radermacher used recesses to avoid the vertebrae -- the
`boney protrusions, protrusions in the vertebrae of the spine and they're
`applying that embodiment to the knee embodiment even though the knee
`embodiment shows the continuing surface. They're saying it would be more
`reasonable-- or actually the only reading in Radermacher they say is that he
`is using recesses to avoid cartilage the two millimeters of cartilage on the
`end of the femur instead of using the continuous surface to simply match the
`cartilage and any exposed subchondral bone.
`JUDGE WORTH: They're also relying on other joints, such as the hip
`joint, in Dr. Clark's declaration.
`MS. LEA: They do point to other joints but none of those are actually
`showing recesses on the bone. This is the only one showing the recess on
`the vertebrae. And what Conformis is doing is taking that and applying it to
`the knee and not just applying it, not just saying it's another option, it's a
`third choice, they're saying it's the only choice. The only reasonable reading
`of Radermacher is that he's using recesses to avoid the two millimeters of
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`cartilage on the knee and we would just contend that under KSR that's
`simply not reasonable.
`JUDGE WORTH: Why doesn't the Radermacher reference discuss
`the cartilage?
`MS. LEA: Why doesn't Radermacher discuss the cartilage? Well, he
`says "natural surface," so he writes a disclosure that can be applied to any
`different osseous structure in the body. Some of those have cartilage and
`some don't. In the case of the femur and tibia there's cartilage. So, his
`disclosure is written to be able -- to be applicable to all of the different
`osseous structures, including the ones that don't have cartilage and the ones
`that do have cartilage.
`JUDGE WORTH: Also just going with your alternative argument
`that Radermacher subjects cartilage, but doesn't disclose it. Is that consistent
`with combining (inaudible) to remove the cartilage? Is there -- between
`suggesting adding cartilage or keeping cartilage and then removing the
`cartilage?
`MS. LEA: I don't believe so. Even under the CRFD Research case
`this week the Federal Circuit dealt with that very issue, and they said that
`one disclosure or teaching does not negate another. So, we have
`Radermacher disclosing to match the cartilage and expose subchondral bone
`without pre-treatment and then we have Carignan saying, hey, you can also
`scrape off the cartilage and match the underlining subchondral bone. They
`don't cancel each other out, they're just both out there.
`JUDGE WORTH: Did you put anything in the record on this new
`case? Did you put in an additional briefing?
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`MS. LEA: The case came out three days ago, but we'd be happy to
`submit to you and give additional briefing if you would like. It's CRFD
`Research versus Matel.
`JUDGE WORTH: I think the counsel's going to take that under
`advisement about whether --
`MS. LEA: Sure. Now, at the end of the day Dr. Clark's opinion about
`recesses in Radermacher and what he's doing with the cartilage is pure
`speculation. Dr. Clark, Conformis's expert, admitted on cross examination
`he's not sure what Radermacher does with the cartilage. First of all, he
`admits it, it's there. He's not sure what Clark does with it, he knows he's not
`removing it but he's postulating and assuming that the cartilage may be in
`recess. Dr. Clark's assumption, the problem with it is it ignores two
`categories of patients. It ignores the category of patients that have no
`exposed subchondral bone whatsoever and have cartilage covering the entire
`end of their femur and ignores the patients that have substantial articular
`cartilage remaining and there wouldn't be enough exposed subchondral bone
`to only match the bone with recesses. And Conformis has never addressed
`these patients, they've never explained how a person of ordinary skill would
`have dealt with the Radermacher template for such patients. But Dr. Mabrey
`did, a Smith & Nephew expert, that a person of ordinary skill would have
`designed the template to match the cartilage surface.
`JUDGE WORTH: The problem that I have with talking about
`patients is that it seems that our task is to read the Radermacher reference
`itself instead of in the first instance, instead of asking how an expert would
`apply it to other patients. That could play into an obviousness analysis but I
`think the first task is to read the Radermacher reference. I'm not sure that
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`testimony, for example, about orthopedic surgical patients helps us read the
`Radermacher reference itself and it certainly wouldn't be prior art under 311.
`MS. LEA: Well, certainly the obviousness question is viewed from
`one of ordinary skill in the art and the experts are testifying how a person of
`ordinary skill in the art would have viewed Radermacher in light of the
`patient population, and when you're trying to propose a reading of
`Radermacher that would eliminate 90 percent of the patients that it's
`intended for, that suggests that that reading is illogical and not the correct
`one, and not the one that would’ve been suggested to a person of ordinary
`skill in the art. So, if there's no further questions about Radermacher, I'll
`move on to Alexander.
`So, it's undisputed that Alexander discloses matching the cartilage
`surface. Alexander is absolutely within the scope and context of the prior
`art. Conformis makes many arguments that are attempting to suggest that
`Alexander is outside the field or does not address the problem. None of
`those arguments are supported by case law whatsoever. And Conformis
`admitted Alexander and IDS during prosecution of the '953 patent, and even
`more telling, Conformis relies upon the Alexander disclosure in the '953
`patent for cartilage matching to show it was well-known to match cartilage.
`You see the Conformis figure on the left, '953 patent figure on the right with
`the black circles are the exposed subchondral bone and the white is the
`cartilage. Finally, Alexander itself references joint replacement surgery and
`it shows a full thickness cartilage defect that would be a candidate for joint
`replacement surgery, the photo I just showed you in the last picture. So we'd
`just like in our brief, we'd ask the Board to reject all of their
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`non-analogous-type arguments and we have many reasons to combine
`Radermacher and Alexander.
`JUDGE WORTH: Going back to Alexander, does Alexander suggest
`surgery for that patient?
`MS. LEA: I'm sorry?
`JUDGE WORTH: Were you saying that Alexander suggests surgery
`for a patient?
`MS. LEA: Absolutely that is suggested, yes. One of ordinary skill
`would look at this film and know that this patient in figure 22B is a
`candidate for knee replacement surgery.
`JUDGE WORTH: Let me be clear, does Alexander explicitly
`disclose that a patient is a candidate for surgery?
`MS. LEA: Alexander does not state that the patient in figure 22b is a
`candidate for joint replacement surgery but it says that its data can be used to
`access a cartilage defect and to guide the choice of surgery, for example,
`joint replacement surgery. So, motivation to combine, we are down to two
`surfaces, I mean this is the ultimate KSR case. We can either match
`cartilage or bone. They're the only two surfaces, it's a mere design choice,
`one would’ve had a reasonable expectation of success, that alone is a
`motivation to combine including under the Federal Circuit this week CRFD
`Research, surgery is simplified on slide 27, surgery simplified when
`cartilage is left alone and number 3, increasing the surface template area
`using a continuous surface as opposed to recesses increases the accuracy of
`the template positioning. So, I'm told that I'm down to my rebuttal time so I
`will save it for rebuttal.
`JUDGE WORTH: Okay.
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`MR. SUKDUANG: May we pass up our slides?
`JUDGE WORTH: Please, thank you.
`MR. SUKDUANG: May I begin, Your Honor?
`JUDGE WORTH: Please, thank you.
`MR. SUKDUANG: Good morning, Sanya Sukduang, again, from
`Finningen and Henderson representing the Patent Owner, Conformis.
`Moving to slide 2, as Petitioner indicated there were five grounds that
`were instituted. Ground 1, is now moot in light of the disclaimer of the
`claims and specifically with the questions you asked, Judge Worth, there
`does not need to be an adverse judgement with respect to these claims. If we
`look at IPR Number 2016-00524, in that instance claims were declaimed
`after institution, after the institution the final written decision only addressed
`those claims that remained. There was no adverse judgement brought with
`respect to those claims and specifically, again, to your point a declaimed
`claim is a claim that never existed, therefore no adverse judgement is
`necessary with respect to those claims. The claims that do remain, Your
`Honor, are all directed to surgical instruments that match diseased or
`damaged cartilage and the grounds that remain all require an obviousness of
`Radermacher with Alexander or Fell, and with respect to Radermacher,
`Radermacher was argued in the alternate. Those alternates were not
`accepted. The grounds that are at issue here, and if we go to slide 4, the
`grounds that were instituted here the Petitioner argued that Radermacher
`would be relied upon for an individual template and Alexander and Fell
`would be relied on for matching disease or damaged cartilage.
`If you go to slide 5, that was the decision that was made in the
`institution decision. So, again while Radermacher was argued by itself as
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`teaching all of the elements that was not the ground that was instituted. I'd
`like to move back to slide 2 in these grounds, the Petitioner bears the burden
`of establishing that there would be a motivation to combine with a
`reasonable expectation of success. Their petition, however, just like the
`presentation on the slides, provide a very high-level discussion of a
`motivation to combine and absolutely zero disclosure with respect to a
`reasonable expectation of success.
`JUDGE WORTH: Before we go to the issue of combinations or
`applying the references, I'd like to start with what Radermacher itself
`expressly discloses, inherently discloses, or as Petitioner just argued,
`suggests. And on that last point, does Patent Owner have a response to this
`new case that was cited? Does Patent Owner wish to submit briefing with
`respect to that new case?
`MR. SUKDUANG: We don't have a response because it was not in
`any paper that was filed. Petitioner did not notify Patent Owner that they
`intended to rely on that case and thus we have no response at this particular
`time. If the panel would like briefing on that, we'd be more than happy to
`submit that but, again, we're talking about instances well past post-institution
`and past the briefing stage. So, we would suggest that that briefing is not
`necessary. But, again, if it's something that the panel would like to hear
`from we'd be more than happy to submit a short paper addressing that case.
`JUDGE WORTH: Thank you. So, on the issue of what Radermacher
`expressly or inherently discloses, we just heard Petitioner argue that because
`-- I believe it's the figure itself of Radermacher shows a template placed onto
`the femur that that would inherently disclose or perhaps suggest cartilage
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`being in contact and that because Radermacher does not disclose removing
`cartilage that means that cartilage is there. So could you respond to those?
`MR. SUKDUANG: Sure, and I think what's important with respect to
`Radermacher is to actually consider the reference as a whole, which the
`Petitioner has not done in its petition. They focus in on the figure, figure 13
`that Your Honor mentions, but I think before we get to that figure, and I will
`touch on it in a moment, it's important to understand how Radermacher gets
`to that figure.
`I'm on slide 6, Your Honor, Judge Scanlon, and on slide 6,
`Radermacher states on page 11 of his reference that the invention is realized
`by simply setting the individual template onto the exposed surface of the
`bone. That's an expressed statement of what his invention is supposed to
`match. The Petitioner never once addressed that in their petition, the
`Petitioner's expert, Dr. Mabrey, never addressed that.
`So, you have to look at the rest of Radermacher in light of what page
`11 says, and again, that disclosure is common to all of the entire disclosure,
`it's not specific to one embodiment. But then if you go to the embodiments,
`the vertebrae embodiments, again, Dr. Radermacher says that the individual
`template is set onto the exposed bone surface as provided by the invention.
`If we move to slide 7, slide 7 discusses figure 13 in Radermacher
`which Petitioner points to, but you have to look at what the description
`actually says about that figure. Radermacher says, and I'm on slide 7, that
`the individual template of figure 13 is set onto the bone, 17. It doesn't say
`it's set onto the femur even though that's a picture of the femur, but his
`description is it could go to the femur, it could go to the tibia, he didn't say
`femur, he didn't say tibia, he said the bone, 17. And when you look at the
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`reference as a whole number 17, whether you're talking about the vertebrae,
`the hip, the foot, any other structure in that reference, it's always to the bone.
`So, that gets up to the figure, and I'm on slide 9, figure 13C, and if
`you'll actually take a look at Petitioner's slide 3, in addition to figure 13C,
`that template of Radermacher touches and matches the bone only. Dr.
`Radermacher never drew in cartilage and the reason why we know that and
`if Petitioner wants to use our own reference to interpret what another
`reference looks like or is to interpret as Radermacher as they've done on
`their slide 3, slide 3 depicts figure 15 of the '953 patent. When you look at
`figure 15 and its description on column 8, it describes that the template is on
`the bone, but if you were to go look at the '953 patent figures 10, 11, 12, and
`13, the '953 patent draws a femur but draws in cartilage and when you look
`at the description of those figures again in column 8 of the '953 patent,
`there's a distinction between cartilage and bone. Petitioner argued in one of
`the very first statements there is no distinction between cartilage and bone in
`the '953 patent, that is absolutely incorrect. There is a distinction and the
`skilled artisan would understand looking at figure 13C of Radermacher that
`that is only a picture of bone because a skilled artesian would know how to
`draw in cartilage. So there's no -- in Patent Owner view, there's no
`expressed teaching of cartilage and in fact, Radermacher never once uses the
`word "cartilage." There's no inherent teaching of cartilage. Inherency
`requires necessary and inevitable. Petitioner has not argued inherency with
`respect to cartilage and there's no suggestion. And the reason why there's no
`suggestion to have that template match cartilage is because Radermacher
`expressly states a statement that was never considered by the Petitioner or
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`their expert, Dr. Mabrey, that the individual template sits on the exposed
`surface of the bone.
`Now, going again to Radermacher, another point with respect to why
`it's only bone and there's teaching, disclosure, suggestion or inherency with
`respect to cartilage is you look how does Radermacher actually make his
`template, and I'm on slide 8, Your Honor, Judge Scanlon.
`There are 13 paragraphs within Radermacher that describes how to
`utilize his invention. Paragraphs 1 and 2, which start on page 12, are the
`most relevant here. The Petitioner has focused only on paragraph 1.
`Paragraph 1 is to make a negative mold, which is a digital image, it's not a
`physical template. Paragraph 2 goes to the physical template, the individual
`template which is the subject matter of the claims, the surgical instrument.
`Our claims are not directed to some digital embodiment. Paragraph 1 tells
`you that you make a negative mold of parts of the individual natural, i.e. not
`pre-treated surface of the osseous structure. It's not just a generic surface,
`it's a surface of an osseous structure.
`That term, "osseous" means bone, there is objective evidence
`supporting that, that's our Exhibit 2008. Both experts agree that the term
`"osseous" means bone.
`What the Petitioner is asking the panel to do is to infer that a bone
`surface is not really a bone surface but instead is a cartilage surface and a
`skilled artisan understands the distinction between a cartilage surface which
`might be touching bone and a bone surface. And if you were to look at
`Alexander, Fell, Carignan, even the '953 patent as I discussed earlier, skilled
`artisans understand how to draw cartilage when they want to depict
`cartilage. They understand how to use the word "cartilage" when they
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