throbber
Filed August 10, 2018
`
`
`On behalf of Smith & Nephew, Inc.
`By: Christy G. Lea
`Joseph R. Re
`Colin B. Heideman
`KNOBBE, MARTENS, OLSON & BEAR, LLP
`2040 Main Street, 14th Floor
`Irvine, CA 92614
`Fax: (949) 760-9502
`Tel.: (949) 760-0404
`Email: BoxSMNPHL.168LP3@knobbe.com
`
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________________________
`
`SMITH & NEPHEW, INC.,
`Petitioner,
`
`v.
`
`CONFORMIS, INC.,
`Patent Owner.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`IPR2017-00778
`IPR2017-00779
`IPR2017-007801
`Patent 8,062,302 B2
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`SMITH & NEPHEW’S SUPPLEMENTAL REPLY TO
`CONFORMIS’S SUPPLEMENTAL PATENT OWNER RESPONSE
`
`
`1 Pursuant to the Decision instituting trial, a word-for-word identical paper is filed
`in each proceeding identified in the caption. Each petition is identified herein as
`Pet1, Pet2, and Pet3, respectively.
`
`
`
`

`

`TABLE OF CONTENTS
`
`Page No.
`
`I. 
`
`b. 
`
`B. 
`
`CLAIMS 13, 18, AND 38 ARE UNPATENTABLE ...................................... 1 
`A. 
`Claim 13 Is Unpatentable ...................................................................... 2 
`1. 
`The Board Made No Threshold Findings Regarding
`the Patentability of Claim 13 in View of
`Radermacher, Alexander, and Woolson ..................................... 2 
`a. 
`It Is Undisputed That Matching a Tibial
`Surface Would Have Been Obvious ................................. 4 
`It Is Undisputed That Having Drilling Paths
`“Through the Tibial Plateau” Would Have
`Been Obvious .................................................................... 5 
`Claim 13 Would Have Been Obvious in Further View
`of Kenna ................................................................................................ 7 
`1. 
`The Board’s Findings Were Preliminary .................................... 7 
`2. 
`The Board’s Preliminary Findings Were Incorrect. ................... 8 
`3. 
`The Board Made No Findings Regarding
`Petitioner’s Alternative Theory ................................................. 11 
`Claim 18 Is Unpatentable .................................................................... 12 
`C. 
`Claim 38 Is Unpatentable .................................................................... 12 
`D. 
`CLAIMS 14-17 AND 19 ARE UNPATENTABLE ..................................... 12 
`II. 
`III.  CLAIMS 9, 10, AND 12 ARE UNPATENTABLE ...................................... 13 
`IV.  ALL CHALLENGED CLAIMS ARE UNPATENTABLE
`OVER RADERMACHER, FELL, AND WOOLSON. ................................ 14 
`A. 
`Claims 95-125 (IPR2017-00780) ........................................................ 14 
`
`i
`
`

`

`TABLE OF CONTENTS
`(Cont’d)
`
`Page No.
`
`B. 
`
`C. 
`
`Claims 1–3, 5–8, 11, 13, 18, 20, 21, 24, 25, 28, 29, 34–38,
`and 47 (IPR2017-00778) ..................................................................... 15 
`Claims 9, 10, 12, 14–17, 19, 30–33, and 39–43
`(IPR2017-00779) ................................................................................. 15 
`CONCLUSION .............................................................................................. 15 
`
`V. 
`
`
`
`ii
`
`

`

`TABLE OF AUTHORITIES
`
`Page No(s).
`
`Campbell Soup Co. v. Gamon Plus, Inc.,
`IPR2017-00087, 2018 WL 2084933 (P.T.A.B. May 2, 2018) ............................. 8
`CRFD Research, Inc. v. Matal,
`876 F.3d 1330 (Fed. Cir. 2017) ............................................................................ 3
`Medtronic, Inc. v. NuVasive, Inc.,
`IPR2014-00081, Paper 44 (P.T.A.B. Apr. 3, 2015) ............................................. 3
`Mobotix Corp. v. E-Watch, Inc.,
`IPR2013-00255, Paper 15 (P.T.A.B. Dec. 3, 2013) ............................................. 3
`Novartis AG v. Torrent Pharms., Ltd.,
`853 F.3d 1316 (Fed. Cir. 2017) .......................................................................... 13
`Trivascular, Inc. v. Samuels,
`812 F.3d 1056 (Fed. Cir. 2016) ............................................................................ 7
`
`
`
`
`iii
`
`

`

`Smith & Nephew v. ConforMIS
`IPR2017-00778, -779, -780 – Patent 8,062,302
`
`I.
`CLAIMS 13, 18, AND 38 ARE UNPATENTABLE
`Claims 13 and 18 are crucial because they are the only newly instituted
`
`claims that ConforMIS asserts in the co-pending litigation. Despite the importance
`
`of those claims, ConforMIS elected not to file any evidence to attempt to show that
`
`these claims are patentable. Instead, ConforMIS relies entirely on attorney argu-
`
`ment and the Board’s preliminary findings in its Institution Decision and its Deci-
`
`sion Denying Smith & Nephew’s Request for Rehearing (collectively, the “Prelim-
`
`inary Decisions”).
`
`ConforMIS’s reliance on the Preliminary Decisions is misplaced for several
`
`reasons. First, those decisions did not address the threshold issue of whether the
`
`additional limitations would have been obvious in view of Radermacher. That ar-
`
`gument was fully explained in the petition and supported by the testimony of Dr.
`
`Mabrey. Moreover, ConforMIS’s expert, Dr. Clark, admitted that these limita-
`
`tions would have been obvious in view of Radermacher alone. Thus, both experts
`
`agree, and the only evidence of record conclusively establishes, that these claims
`
`are unpatentable.
`
`Second, ConforMIS’s Supplemental POR hinges on the Board’s preliminary
`
`findings regarding a purported lack of motivation to combine Radermacher and
`
`Kenna. But the Board now has the benefit of a full record and a better understand-
`
`ing of ConforMIS’s patent, the prior art, and the proposed combination. As the
`
`1
`
`

`

`Smith & Nephew v. ConforMIS
`IPR2017-00778, -779, -780 – Patent 8,062,302
`
`Federal Circuit has explained, the Board can, and should, change its preliminary
`
`findings when the full record demonstrates that the preliminary findings were in-
`
`correct. Based on the full evidentiary record, the Board can only conclude that
`
`these claims are unpatentable.
`
`A. Claim 13 Is Unpatentable
`Claim 13 depends directly from claim 1, which recites a tool having a pa-
`
`tient-specific surface that is substantially a negative of an articular surface of a
`
`joint, and two drilling holes. Claim 1 recites verbatim the surgical tool in claim 15
`
`of ConforMIS’s ’025 patent, which the Board unanimously held unpatentable.
`
`IPR2017-00115, Paper 33 at 64 (April 19, 2018) (hereinafter the “’025 FWD”).
`
`Claim 13 simply adds that: (a) the patient-specific surface matches a surface
`
`of the tibia; and (b) the holes define a drilling path “through a tibial plateau.”
`
`These limitations cannot make the claim patentable.
`
`1.
`
`The Board Made No Threshold Findings
`Regarding the Patentability of Claim 13 in View
`of Radermacher, Alexander, and Woolson
`In its Radermacher-Alexander-Woolson-Kenna ground, Petitioner squarely
`
`argued, as a threshold matter, that the additional limitations of claim 13 would
`
`have been obvious in view of Radermacher alone. Pet1., 68 (matching the tibial
`
`surface would have been obvious in view of Radermacher), 69 (having drilling
`
`holes define a path through the tibial plateau would have been obvious in view of
`
`2
`
`

`

`Smith & Nephew v. ConforMIS
`IPR2017-00778, -779, -780 – Patent 8,062,302
`
`Radermacher and the knowledge of a POSITA). Second, and alternatively, Peti-
`
`tioner argued obviousness in further view of Kenna. Pet1., 69, 70. The Board
`
`recognized these as alternative arguments. D.I., 17 (summarizing arguments based
`
`on Radermacher and stating that “Petitioner alternatively argues” that it would
`
`have been obvious in further view of Kenna).
`
`As the Board noted in its ’025 FWD, the mere inclusion of an additional ref-
`
`erence (here, Kenna) does “not serve to eliminate Petitioner’s contentions based
`
`upon, e.g., Radermacher alone.” ’025 FWD, 8. As a matter of law, if Raderma-
`
`cher, Alexander, and Woolson render the claims obvious, then the claims must also
`
`be obvious in view of those references and a fourth reference. Finding the claims
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`unpatentable based on fewer than all references in the ground is entirely consistent
`
`with Petitioner’s arguments, due process, and PTAB practice. Id.; see CRFD Re-
`
`search, Inc. v. Matal, 876 F.3d 1330, 1345-48 (Fed. Cir. 2017) (primary reference
`
`alone may suggest or provide motivation for proposed modification); Medtronic,
`
`Inc. v. NuVasive, Inc., IPR2014-00081, Paper 44 at 41 n.3 (P.T.A.B. Apr. 3, 2015)
`
`(“we conclude that claim 6 would have been obvious over [a subset of the refer-
`
`ences in the ground], without resort to the additional teachings of [the remaining
`
`reference]”); Mobotix Corp. v. E-Watch, Inc., IPR2013-00255, Paper 15 at 3
`
`(P.T.A.B. Dec. 3, 2013) (“If Petitioner proves that all elements of the claim are
`
`found in [the first reference] alone, then [it] alone would be sufficient to render the
`
`3
`
`

`

`Smith & Nephew v. ConforMIS
`IPR2017-00778, -779, -780 – Patent 8,062,302
`
`claims … obvious, and the status of [the second reference] would be of no conse-
`
`quence.”).
`
`The Preliminary Decisions never addressed the threshold issue of whether
`
`Radermacher rendered the additional limitations obvious. The Preliminary Deci-
`
`sions addressed only whether a POSITA would have been motivated to combine
`
`Radermacher and Kenna. D.I., 17-21. Now that the Board must determine the pa-
`
`tentability of claim 13, the Board should first determine the threshold issue of
`
`whether the additional limitations would have been obviousness in view of Rader-
`
`macher. The evidence overwhelmingly shows that claim 13 would have been ob-
`
`vious.
`
`a.
`
`It Is Undisputed That Matching a Tibial
`Surface Would Have Been Obvious
`As the Board recognized (D.I., 17), Petitioner provided four reasons as to
`
`why it would have been obvious to use Radermacher’s patient-specific template for
`
`the tibia (Pet1., 68), all of which were supported by Dr. Mabrey. First, Raderma-
`
`cher teaches that the template could be used with any osseous structure, which
`
`would include the tibia. Pet1., 68; Ex. 1002 ¶156. Second, Radermacher ex-
`
`plained that the standard tool guides upon which he sought to improve included in-
`
`struments for the tibia. Id. Third, conventional knee arthroplasty typically in-
`
`volved resecting the tibia, and Radermacher was not limited to the femur. Id.
`
`4
`
`

`

`Smith & Nephew v. ConforMIS
`IPR2017-00778, -779, -780 – Patent 8,062,302
`
`Fourth, numerous references disclosed patient-specific templates for the tibia.
`
`Pet1., 68 (citing Ex. 1033, 1008, 1007); Ex. 1002 ¶156.
`
`ConforMIS never disputed these arguments or Mabrey’s testimony. Prelim.
`
`Resp. at 13-14; Suppl. POR, 2-5. To the contrary, ConforMIS’s expert, Dr. Clark
`
`admitted that it would have been obvious to use Radermacher’s patient-specific
`
`template for the tibia:
`
`Q. [A] person of ordinary skill in the art would have
`known that that type of patient-specific template [as de-
`scribed in Radermacher] could be used in other parts of
`the body, including on the tibia, right?
`[Objection]
`A. Yes.
`Ex. 1219 (Clark Tr.), 228:20-229:1 (emphasis added); Ex. 1203, 146:7-147:12 (“Q:
`
`A [POSITA] in 2001, reading Radermacher, would have understood that a patient-
`
`specific instrument could be made for resecting the tibia, correct? [Objection] A. I
`
`would assume so.”). Thus, both experts agree that it would have been obvious to
`
`use Radermacher’s template for the tibia.
`
`b.
`
`It Is Undisputed That Having Drilling
`Paths “Through the Tibial Plateau”
`Would Have Been Obvious
`The petition established that, when applying Radermacher’s template to the
`
`tibia, it would have been obvious to have the two drilling holes define a path
`
`“through the tibial plateau.” Pet1., 69-73. Mabrey explained that this would have
`
`5
`
`

`

`Smith & Nephew v. ConforMIS
`IPR2017-00778, -779, -780 – Patent 8,062,302
`
`been obvious in view of Radermacher alone because tibial implants commonly had
`
`two pegs, and therefore the tool had to provide two drilling holes defining a path
`
`through the tibial plateau. Ex. 1002 ¶156. Mabrey’s testimony was supported by a
`
`prior art reference. Id. (citing Ex. 1041).
`
`ConforMIS does not dispute this, and Clark again admitted that this limita-
`
`tion would have been obvious in view of Radermacher. Ex. 1219 (Clark), 231:8-
`
`14 (admitting that a POSITA “making Radermacher’s template for the tibia would
`
`have understood that the template could include two drilling holes for making
`
`holes through the tibial plateau”). Clark also confirmed that this limitation reflects
`
`no more than the conventional practice. Id., 229:2-231:7 (admitting that it was
`
`common in the 1990s for tibial implants to have two pegs, that the drill holes for
`
`receiving those pegs would be aligned relative to the mechanical axis, and that the
`
`drilling path would extend “through the tibial plateau”); Ex. 1203 (Clark), 99:24-
`
`100:11 (drilling holes vertically through the tibial plateau were conventional); Ex.
`
`1206 (Clark), 17:12-18 (it was standard in the 1990s for some tibial cutting blocks
`
`to have two drilling holes).
`
`Faced with these unequivocal admissions, ConforMIS could not submit any
`
`declaration from Clark with its Supplemental POR. In view of the record, the only
`
`conclusion that the Board can reach is that the additional limitations in claim 13
`
`would have been obvious. It would be the epitome of injustice to allow these
`
`6
`
`

`

`Smith & Nephew v. ConforMIS
`IPR2017-00778, -779, -780 – Patent 8,062,302
`
`claims to survive—in the face of undisputed evidence from both parties’ experts—
`
`simply because the instituted “ground” includes even more evidence (Kenna).
`
`B. Claim 13 Would Have Been
`Obvious in Further View of Kenna
`Kenna was provided as additional evidence that the limitations in claim 13
`
`would have been obvious. Pet1., 69-70; Ex. 1002 ¶157. Kenna is simply one ex-
`
`ample of a reference disclosing a tibial cutting block comprising two drilling holes
`
`that define a path through the tibial plateau, which Mabrey (and later Clark) testi-
`
`fied was entirely conventional. The Board’s preliminary findings regarding a lack
`
`of motivation to combine Radermacher and Kenna should be corrected in view of
`
`this evidence.
`
`1.
`The Board’s Findings Were Preliminary
`The Federal Circuit has emphasized the preliminary nature of findings made
`
`at the institution stage and encouraged the Board to correct those findings when
`
`necessary:
`
`[T]he Board is not bound by any findings made in its In-
`stitution Decision. At that point, the Board is considering
`the matter preliminarily without the benefit of a full rec-
`ord. The Board is free to change its view of the merits
`after further development of the record, and should do so
`if convinced its initial inclinations were wrong.
`Trivascular, Inc. v. Samuels, 812 F.3d 1056, 1068 (Fed. Cir. 2016).
`
`7
`
`

`

`Smith & Nephew v. ConforMIS
`IPR2017-00778, -779, -780 – Patent 8,062,302
`
`Consistent with the Federal Circuit’s instruction, the Board has corrected
`
`preliminary findings in its Final Written Decision. For example, in Campbell Soup
`
`Co. v. Gamon Plus, Inc., IPR2017-00087, 2018 WL 2084933, *16 (P.T.A.B.
`
`May 2, 2018), the Board corrected a “preliminary finding” from the institution de-
`
`cision “[i]n light of the arguments developed during the trial,” which showed that
`
`the “initial determination, made without the benefit of a full trial record, was based
`
`on a misunderstanding of [the prior art reference].” There, the Board acknowl-
`
`edged that they “failed to appreciate the nuances” at the institution stage.
`
`The same is true here. The Board is now more familiar with ConforMIS’s
`
`patents and the prior art. The Board now has the benefit of a full record, including
`
`Clark’s admissions. To the extent that the Board did not appreciate some of the
`
`nuances of Radermacher and Kenna (or the proposed combination), the Board is
`
`free to change its preliminary findings. It should do so for the reasons below.
`
`2.
`
`The Board’s Preliminary Findings Were
`Incorrect.
`Petitioner explained that a POSITA would have been motivated to modify
`
`Radermacher’s template to include two drilling holes for the tibia in view of Ken-
`
`na’s disclosure. Pet1., 69-70. Although the Board acknowledged this argument
`
`(D.I., 18), the majority of the Board’s analysis in the Institution Decision focused
`
`on an alternative argument, namely that it would have been obvious to modify
`
`Kenna’s tibial template to include a patient-specific surface (id. 18-20).
`
`8
`
`

`

`Smith & Nephew v. ConforMIS
`IPR2017-00778, -779, -780 – Patent 8,062,302
`
`The Board’s analysis of Petitioner’s proposed modification of Radermacher
`
`to include a second drilling hole was limited to two sentences. First, the Board
`
`found that Petitioner did not explain how a POSITA “would have incorporated the
`
`teachings of Kenna into the device of Radermacher.” D.I., 20-21. That prelimi-
`
`nary finding was incorrect, as the only feature Petitioner proposed incorporating
`
`from Kenna was a second drilling hole, and the petition thoroughly explained why
`
`that would have been obvious. Pet1., 70-71 (Radermacher contemplates multiple
`
`drill holes, the ’302 patent admits this is within the knowledge of a POSITA, two
`
`drilling holes were commonplace in the industry, it would involve nothing more
`
`than combining Radermacher with Kenna to yield predictable results). The Institu-
`
`tion Decision ignored this argument, and the supporting evidence, entirely. Peti-
`
`tioner hardly needed to do more to explain the very basic proposition that Rader-
`
`macher’s device would be modified to include a second drill hole.
`
`The next sentence of the Board’s decision states that, “In particular, Peti-
`
`tioner does not explain how a person of ordinary skill would have adapted the
`
`teachings of Kenna, which discloses alignment during an operation, to provide
`
`alignment pre-operatively, as in Radermacher.” D.I., 21. But that is irrelevant be-
`
`cause nothing from Kenna—aside from the concept of adding a second hole—is
`
`being used in the proposed modification of Radermacher. The combination in no
`
`way depends on alignment of the respective cutting blocks during surgery.
`
`9
`
`

`

`Smith & Nephew v. ConforMIS
`IPR2017-00778, -779, -780 – Patent 8,062,302
`
`When Petitioner raised this issue in its Rehearing Request, the Board simply
`
`referred back to the incorrect and incomplete analysis in its Institution Decision.
`
`Dec. Denying Reh’g, 5. The Board then stated that the two references describe dif-
`
`ferent alignment methods and that “Petitioner did not identify a sufficient rationale
`
`to combine the different disclosed approaches.” Id., 6. But Petitioner never pro-
`
`posed a combination of the surgical approaches. Petitioner’s proposal was simply
`
`that, if Radermacher’s template were to be used for the tibia, a POSITA would
`
`have understood that it would include two drilling holes, because conventional tib-
`
`ial templates included two drilling holes, as Kenna discloses. Pet1., 70-71.
`
`To be sure, Kenna discloses a conventional, intra-operatively aligned tibial
`
`template. The purpose of Radermacher was to improve on such devices by shifting
`
`the alignment work to the preoperative planning stages. But a POSITA would
`
`have understood that Radermacher’s template would still include the conventional
`
`drilling holes, which were necessary to implant the implants. Ex. 1002 ¶¶156-159.
`
`Thus, Petitioner did not discuss combining Radermacher’s and Kenna’s sur-
`
`gical or alignment approaches because they are irrelevant to the proposed combina-
`
`tion. The issue is whether it would have been obvious that Radermacher’s tem-
`
`plate could be used for the tibia and, if so, whether it also would have been obvious
`
`for such a template to include two drilling holes. The petition established—and the
`
`10
`
`

`

`Smith & Nephew v. ConforMIS
`IPR2017-00778, -779, -780 – Patent 8,062,302
`
`additional evidence presented during the trial confirms—that these limitations
`
`would have been obvious in view of Kenna. Thus, claim 13 should be canceled.
`
`3.
`
`The Board Made No Findings Regarding
`Petitioner’s Alternative Theory
`Petitioner also explained that claim 13 would have been obvious because
`
`ConforMIS’s construction of “drilling holes” includes holes for fixation pins.
`
`Pet1., 71. Radermacher discloses using such fixation pin holes (id., 72) and Kenna
`
`discloses that such holes may define a path horizontally “through the tibial plat-
`
`eau” (id.). ConforMIS has never disputed these arguments. Prelim. Resp., 13-14;
`
`Suppl. POR, 2-5.
`
`The institution decision did not address this argument. D.I., 17-21. The De-
`
`cision Denying Rehearing summarily rejected the argument, purportedly because
`
`“the above-identified problem remains with the combination of Radermacher and
`
`Kenna.” Reh’g Dec., 7. But that makes no sense. Radermacher discloses the use
`
`of fixation pins, and Kenna is relied on solely for its disclosure of placing those
`
`pins on the anterior of the tibia. Petitioner fully explained how and why a POSITA
`
`would have implemented this feature. Pet1., 72-73 (Radermacher contemplates
`
`fixation pins, this was common practice, and Kenna expressly teaches it). This
`
`provides an alternative, undisputed, basis for canceling claim 13.
`
`11
`
`

`

`Smith & Nephew v. ConforMIS
`IPR2017-00778, -779, -780 – Patent 8,062,302
`
`C. Claim 18 Is Unpatentable
`Claim 18 requires that the drilling holes define a path “at a predetermined
`
`orientation relative to a mechanical axis of the joint.” Petitioner explained why
`
`this would have been obvious. Pet1., 73-75. ConforMIS did not dispute this.
`
`Again, Clark admitted that it would have been obvious. Ex. 1206, 17:12-18:17
`
`(tibial drilling paths were aligned parallel to mechanical axis), 76:1-20 (Woolson
`
`discloses tibial drilling holes aligned relative to the mechanical axis). Accordingly,
`
`the only evidence of record establishes that this claim is unpatentable.
`
`D. Claim 38 Is Unpatentable
`ConforMIS did not separately dispute the patentability of claim 38, and is
`
`unpatentable for the reasons set forth above and in the petition. Pet1., 75-79.
`
`II. CLAIMS 14-17 AND 19 ARE UNPATENTABLE
`The Board’s preliminary findings for these claims mirrored its findings for
`
`claim 13 (D.I., 30), which were incorrect. The only portion of Kenna upon which
`
`Petitioner relied was the concept of having anteriorly-positioned pin fixation holes.
`
`There is nothing “inconsistent” about placing Radermacher’s pin holes on the ante-
`
`rior of the tibia (as taught by Kenna), regardless of how the jigs are adjusted. Be-
`
`cause the only evidence establishes that these claims are unpatentable, they should
`
`be canceled.
`
`12
`
`

`

`Smith & Nephew v. ConforMIS
`IPR2017-00778, -779, -780 – Patent 8,062,302
`
`III. CLAIMS 9, 10, AND 12 ARE UNPATENTABLE
`The Board’s preliminary findings that Petitioner’s arguments were “conclu-
`
`sory” and lacked explanation (D.I., 24) were incorrect. Petitioner offered several
`
`rationales as to why this limitation would have been obvious. First, Radermacher
`
`itself discloses using two pin holes for securing a template to bone. Pet2., 39.
`
`Second, using pin holes to secure cutting blocks was conventional. Id., 39-40.
`
`Third, it was disclosed in several prior art references. Id., 40 (citing Exs. 1041,
`
`1037, 1034, 1033, 1012). These references can provide a motivation to combine.
`
`Novartis AG v. Torrent Pharms., Ltd., 853 F.3d 1316, 1327-1328 (Fed. Cir. 2017).
`
`Moreover, Petitioner provided a specific reference—Woolson—disclosing anteri-
`
`orly positioned pin fixation holes. ConforMIS did not dispute any of these argu-
`
`ments or offer any evidence to the contrary.
`
`The Board never addressed these undisputed arguments or offered any ex-
`
`planation to why, in view of Radermacher’s teaching of using pin fixation holes
`
`and overwhelming—and undisputed—evidence that anteriorly positioned pin fixa-
`
`tion holes were the industry standard, the claim would not have been obvious to a
`
`POSITA. These claims should also be canceled.
`
`13
`
`

`

`Smith & Nephew v. ConforMIS
`IPR2017-00778, -779, -780 – Patent 8,062,302
`
`IV. ALL CHALLENGED CLAIMS ARE UNPATENTABLE OVER
`RADERMACHER, FELL, AND WOOLSON.
`Petitioner explained that the challenged claims are unpatentable based on
`
`combinations that substitute Fell—which discloses matching cartilage—for Alex-
`
`ander. Each petition is addressed below.
`
`A. Claims 95-125 (IPR2017-00780)
`The petition explained that these claims are unpatentable in view of Rader-
`
`macher, Fell, and Woolson. Pet3., 88-91. The Board has already resolved this is-
`
`sue with respect to a virtually identical independent claim in the proceeding for the
`
`’025 patent. See ’025 FWD at 60-64 (holding claims unpatentable).
`
`The evidentiary record here weighs even more heavily in favor of obvious-
`
`ness because, while ConforMIS’s arguments mirror the arguments it made in the
`
`’025 proceeding, it has not submitted any expert declaration regarding this com-
`
`bination in this proceeding. ConforMIS’s entire Supplemental POR is based on
`
`attorney argument and mischaracterizations of Mabrey’s testimony. ConforMIS
`
`ignores Clark’s key admissions, including that Fell discloses a “patient matched”
`
`device in which “parts of” the patient-specific surface “substantially matches” car-
`
`tilage. Ex. 1206, 109:11-110:4; Ex. 1203, 245:22-246:3; see also Ex. 1203, 246:4-
`
`7 (if Fell’s device precisely matched the articular surface, it would lock onto the
`
`surface in a single position). The evidence is conclusive and one-sided: these
`
`claims would have been obvious in view of Radermacher, Fell, and Woolson.
`
`14
`
`

`

`Smith & Nephew v. ConforMIS
`IPR2017-00778, -779, -780 – Patent 8,062,302
`
`B. Claims 1–3, 5–8, 11, 13, 18, 20, 21, 24, 25, 28, 29, 34–
`38, and 47 (IPR2017-00778)
`Petitioner argued that these claims would have been obvious in view of Ra-
`
`dermacher, Fell, Woolson, and Kenna. Pet1., 79, 82. For most of the claims, the
`
`Board made no findings and the claims should be canceled for the same reasons as
`
`claims 95-125. D.I. 22-23. The Board denied institution on claims 13, 18, and 38
`
`for the same reasons it denied institution on those claims for the Radermacher-
`
`Alexander-Woolson-Kenna ground. Id., 23. As discussed above, those prelimi-
`
`nary findings were incorrect, and these claims should be canceled.
`
`C. Claims 9, 10, 12, 14–17, 19, 30–33, and 39–43
`(IPR2017-00779)
`The Board denied institution on these claims for similar reasons to the sets
`
`of claims discussed above. D.I., 31-32. Accordingly, these claims should also be
`
`canceled.
`
`V. CONCLUSION
`Accordingly, all of the challenged claims should be canceled.
`
`
`
`
`
`Dated: August 10, 2018
`
`
`
`Respectfully submitted,
`
`KNOBBE, MARTENS, OLSON & BEAR, LLP
`
`
`
`By: /Colin Heideman/
`Christy G. Lea (Reg. No. 51,754)
`Joseph R. Re (Reg. No. 31,291)
`Colin B. Heideman (Reg. No. 61,513)
`Attorneys for Petitioner
`SMITH & NEPHEW, INC.
`(949) 760-0404
`
`15
`
`

`

`Smith & Nephew v. ConforMIS
`IPR2017-00778, -779, -780 – Patent 8,062,302
`
`CERTIFICATE OF COMPLIANCE
`
`Pursuant to 37 C.F.R. § 42.24(d), the undersigned certifies that the foregoing
`
`SMITH & NEPHEW’S SUPPLEMENTAL REPLY TO CONFORMIS’S
`
`SUPPLEMENTAL PATENT OWNER RESPONSE, exclusive of the parts
`
`exempted as provided in 37 C.F.R. § 42.24(a), contains 3,191 words and therefore
`
`complies with the type-volume limitations of the Board’s June 8, 2018 Order.
`
`This paper also complies with the typeface requirements of 37 C.F.R.
`
`§ 42.6(a)(2)(ii) and the type style requirements of 37 C.F.R. § 42.6(a)(2)(iii) &
`
`(iv).
`
`
`Dated: August 10, 2018
`
`
`
`
`
`By: /Colin Heideman/
`Colin B. Heideman (Reg. No. 61,513)
`Attorney for Petitioner
`SMITH & NEPHEW, INC.
`
`
`
`
`
`

`

`Smith & Nephew v. ConforMIS
`IPR2017-00778, -779, -780 – Patent 8,062,302
`
`CERTIFICATE OF SERVICE
`
`I hereby certify that a true and correct copy of the foregoing SMITH &
`
`NEPHEW’S
`
`SUPPLEMENTAL
`
`REPLY
`
`TO
`
`CONFORMIS’S
`
`SUPPLEMENTAL PATENT OWNER RESPONSE is being served on
`
`August 10, 2018 via e-mail to counsel of record for patent owner CONFORMIS,
`
`INC., at the addresses below:
`
`Sanya Sukduang
`Sanya.sukduang@finnegan.com
`Timothy P. McAnulty
`Timothy.mcanulty@finnegan.com
`Daniel F. Klodowski
`daniel.klodowski@finnegan.com
`Kassandra M. Officer
`kassandra.officer@finnegan.com.
`
`FINNEGAN, HENDERSON, FARABOW, GARRETT & DUNNER, LLP
`901 New York Ave. N.W.
`Washington, DC 20001
`
`
`Dated: August 10, 2018
`
`
`
`By: /Colin Heideman/
`Colin B. Heideman (Reg. No. 61,513)
`Attorney for Petitioner
`SMITH & NEPHEW, INC.
`
`
`
`
`26987022
`
`
`
`

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