Trials@uspto.gov
`Tel: 571-272-7822
`
`Paper 8
`Entered: September 12, 2017
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`SMITH & NEPHEW,INC.,
`Petitioner,
`
`V.
`
`CONFORMIS,INC.,
`Patent Owner.
`
`Case IPR2017-00983
`Case IPR2017-00984!
`Patent 8,657,827 B2
`
`Before PATRICK R. SCANLON, JAMES A. WORTH,and
`AMANDAF. WIEKER,Administrative Patent Judges.
`
`WORTH,Administrative Patent Judge.
`
`DECISION
`DenyingInstitution of Inter Partes Review
`37 CFR. § 42.108
`
`| A copy ofthis Decision is to be entered in each of the referenced
`proceedings. Although weare using a consolidated caption for this
`Decision, we note that the proceedings have not been consolidated and the
`parties have not been authorized to use a consolidated caption orto
`otherwise treat the proceedings as consolidated.
`
`
`Tel: 571-272-7822
`
`Paper 8
`Entered: September 12, 2017
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`SMITH & NEPHEW,INC.,
`Petitioner,
`
`V.
`
`CONFORMIS,INC.,
`Patent Owner.
`
`Case IPR2017-00983
`Case IPR2017-00984!
`Patent 8,657,827 B2
`
`Before PATRICK R. SCANLON, JAMES A. WORTH,and
`AMANDAF. WIEKER,Administrative Patent Judges.
`
`WORTH,Administrative Patent Judge.
`
`DECISION
`DenyingInstitution of Inter Partes Review
`37 CFR. § 42.108
`
`| A copy ofthis Decision is to be entered in each of the referenced
`proceedings. Although weare using a consolidated caption for this
`Decision, we note that the proceedings have not been consolidated and the
`parties have not been authorized to use a consolidated caption orto
`otherwise treat the proceedings as consolidated.
`
`
`
`IPR2017-00983
`IPR2017-00984
`Patent 8,657,827 B2
`
`I.
`
`INTRODUCTION
`
`Petitioner Smith & Nephew,Inc. filed two petitions requesting inter
`
`partes review of claims 1-25, 28, 29, 32-46, and 50-64of U.S. Patent No.
`8,657,827 B2 (Ex. 1001, “the ’827 patent”)* pursuant to 35 U.S.C. § 311(a),
`
`as indicated in the chart below. Patent Owner ConforMIS, Inc.filed a
`
`Preliminary Response in each proceeding,as indicated in the chart below.
`
`
`
`Claims
`
`Case Number__|Challenged|Petition Preliminary Response
`
`
`
`
`IPR2017-00983|1-25, 28,|Paper 2 Paper 6
`
`
`29, 32-46|(““Pet.”) (“Prelim. Resp.’’)
`
`
`IPR2017-00984|50-64 Paper1 Paper 7
`
`(“-984 Pet.”)|(“‘-984 Prelim. Resp.”)
`
`Institution of an inter partes review is authorized by statute when “the
`
`information presentedin the petition filed under [35 U.S.C. §] 311 and any
`responsefiled under [35 U.S.C. §] 313 showsthat there is a reasonable
`likelihood that the petitioner would prevail with respect to at least 1 of the
`
`claims challengedin the petition.” 35 U.S.C. § 314(a); see also 37 C.F.R.
`§ 42.108. For the reasons set forth below, we determinethat Petitioner has
`not demonstrated a reasonable likelihood that claims 1-25, 28, 29, 32-46,
`
`and 50-64 are unpatentable. Accordingly, we do notinstitute an inter partes
`
`review of claims 1—25, 28, 29, 32-46, and 50-64 ofthe ’827 patent based on
`
`the groundsasserted in thepetitions.
`
`2 Unless otherwise specified with the “-984”prefix, references to papers and
`exhibits cited herein are to those filed in Case IPR2017-00983.
`
`
`
`IPR2017-00983
`IPR2017-00984
`Patent 8,657,827 B2
`
`A. Related Matters
`
`Theparties identify the following district court proceeding as a related
`
`matter: ConforMIS, Inc. v. Smith & Nephew, Inc., No. 1:16-cv-10420-IT
`
`(D. Mass. Feb. 29, 2016). Pet. 1; Paper 4, 2. Petitioner identifies the
`
`following Board proceedingsas related: IPR2016-01874; IPR2017-00115;
`
`IPR2017-00307; IPR2017-00372; IPR2017-00373; IPR2017-00487;
`
`IPR2017-00488; IPR2017-00510; IPR2017-00511; IPR2017-00544;
`
`IPR2017-00545; IPR2017-00778; IPR2017-00779; and IPR2017-00780.
`Pet. 1-2; see also Paper 4, 2 (Patent Owner Mandatory Notice).
`
`B. The ’827 Patent (Ex. 1001)
`The ’827 patentis titled “Surgical Tools for Arthroplasty” and relates
`to methods, systems, and prosthetic devices for articular resurfacing.
`
`Ex. 1001, 1:65-67. The ’827 patentalso relates to surgical molds designed
`
`to achieve optimalcut planesin a joint in preparation forinstallation of a
`
`joint implant. Jd. at 1:67-2:4.
`The °827 patent describes a problem in the prior art with available
`devices that do not always provide ideal alignment with the articular
`
`surfaces and joint congruity. Jd. at 5:37-39. The 827 patentstates that poor
`alignment and poorjoint congruity can, for example, lead to instability of
`the joint, e.g., lateral instability of the knee joint. Id. at 5:39-42.
`The ’827 patent discloses forming a template with at least one contact
`surface to engage a surface associated with a joint. Jd. at 9:56-10:5. The
`template may avoid a deformity, such as an osteophyte, and engage a portion
`of a surface not affected by the deformity, or the deformity may be removed
`
`prior to placing a mold. Jd. at 73:25—50.
`
`
`
`IPR2017-00983
`IPR2017-00984
`Patent 8,657,827 B2
`
`Placementof a template is depicted in Figures 32 and 33:
`
`3310 3210
`
`’11''11'
`
`3320
`
`3230
`
`1{
`
`'I1
`
`3210
`
`3310
`
`230
`
`3250
`
`3230
`
`3220
`
`FIG. 32
`
`FIG. 33
`
`Figures 32 and 33 illustrate 3D guidance templates designed to guide
`a posterior and an anterior cut, respectively, using posterior and anterior
`reference planes, in accordance with embodiments ofthe invention. Id. at
`28:31-42. In Figure 33, the facing surface ofthe template is, at least in part,
`a mirror imageofportionsof the joint that are altered by thearthritic
`process, including osteophyte 3240. Id. at 28:37-42; 84:2—-7. However,in
`Figure 32, the template contains recess 3250 to avoid the osteophyte. Jd. at
`
`83:61-622
`
`3 The 827 patent is subject to a certificate of correction, which issued on
`Sept. 30, 2014. Ex. 1001, 140.
`
`
`
`IPR2017-00983
`IPR2017-00984
`Patent 8,657,827 B2
`
`C.
`
`Illustrative Claim
`
`Claims 1, 50, 53, 56, and 59 are independent. Independentclaim 1,
`
`reproduced below,is illustrative of the subject matter:
`
`instrument for use in
`A patient-specific surgical
`1.
`surgically repairing a diseased or damaged joint of a
`patient, the instrument comprising:
`a
`engaging
`for
`a
`patient-specific
`surface
`corresponding portion of the diseased or damaged joint,
`the
`patient-specific
`surface
`including
`cartilage
`information derived from image data of the diseased or
`damagedjoint, wherein the corresponding portion of the
`diseased or damagedjoint includes an osteophyte, wherein
`the patient-specific surface references the osteophyte
`whenthe patient-specific surface is engaged and aligned
`with the correspondingportionofthe diseased or damaged
`joint; and
`a guide sized and shaped to accommodateasurgical
`tool, wherein the guide has a position and orientation
`relative to the patient-specific surface to provide a
`predeterminedpath for the surgicaltool.
`
`Ex. 1001, 119:11-28.
`
`D. The Prior Art
`
`Petitioner relies on the following priorart:
`
`US 4,759,350,iss. July 26, 1988 (Ex. 1036, “Dunn’’);
`US 4,841,975, iss. June 27, 1989 (Ex. 1031, “Woolson”);
`WO 93/25157, pub. Dec. 23, 1993 (Ex. 1003, “Radermacher”);
`WO 95/28688, pub. Oct. 26, 1995 (Ex. 1007, “Swaelens”);
`WO 00/35346, pub. June 22, 2000 (Ex. 1004, “Alexander’’);
`WO 00/59411, pub. Oct. 12, 2000 (Ex. 1005, “Fell’’);
`
`
`
`IPR2017-00983
`IPR2017-00984
`Patent 8,657,827 B2
`
`1047,
`
`7, 2001
`
`(-984 Ex.
`
`EP 1,074,229 A2, pub. Feb.
`“Schuster I”);
`US 6,510,334 B1, iss. Jan. 21, 2003 (Ex. 1008, “Schuster IT’’);
`Aaron A. Hofmannetal., Effect ofthe Tibial Cut on Subsidence
`Following Total Knee Arthroplasty, 269 CLINICAL ORTHOPAEDICS AND
`RELATED RESEARCH 63 (1991) (Ex. 1090, ““Hofmann”).
`E. The Alleged Grounds of Unpatentability
`Petitioner challenges claims 1-25, 28, 29, 32-46, and 50-64 ofthe
`
`’827 patent as unpatentable under 35 U.S.C. § 103(a) on the following
`
`grounds:
`
`References
`
`Claims Challenged
`
`
`IPR2017-00983|Radermacher and Alexander 1-13, 32, 33, 38,
`
`
`and 44-46
`
`
`IPR2017-00983|Radermacher, Alexander, and:|14-19, 22-25, 28,
`Woolson
`29, 34-37, and 39-—
`
`43
`
`IPR2017-00983|Radermacher, Alexander, 20 and 21
`
`
`Woolson, and Hofmann
`
`
`
`
`
`
`
`
`
`
`
`
`
`IPR2017-00983|RadermacherandFell 1-13, 32, 33, 38,
`
`and 44-46
`
`
`IPR2017-00983|Radermacher, Fell, and 14-19, 22-25, 28,
`
`Woolson
`29, 34-37, and 39-
`
`
`43
`
`IPR2017-00983|Radermacher, Fell, Woolson, 20 and 21
`
`
`and Hofmann
`
`IPR2017-00984|Schuster I, Schuster II, and 50-58
`
`
`Alexander
`
`4 Wewill refer herein to the pages of the English Translation ofrecord, -984
`Ex. 1046.
`
`
`
`IPR2017-00983
`IPR2017-00984
`Patent 8,657,827 B2
`
`IPR2017-00984|Schuster I, Schuster I, 59-64
`
`
`Alexander, and Dunn
`
`
`
`
`
`
`
`
`
`
`
`
`Alexander, and Woolson
`
`IPR2017-00984|Radermacher, Swaelens, and 50-58
`
`
`Alexander
`>
`
`IPR2017-00984|Radermacher, Swaelens, 59-64
`
`Il. ANALYSIS
`
`A. Claim Construction
`
`In an inter partes review, the Board interprets claim terms in an
`unexpired patent according to the broadest reasonable construction in light
`
`of the specification of the patent in which they appear. 37 C.F.R.
`
`§ 42.100(b); see Cuozzo Speed Techs. v. Lee, LLC, 136 S. Ct. 2131, 2142-46
`(2016). Under that standard, and absent any special definitions, we give
`claim terms their ordinary and customary meaning, as would be understood
`by one of ordinary skill in the art at the time of the invention. See Jn re
`Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). Any special
`definitions for claim terms must be set forth with reasonable clarity,
`
`deliberateness, and precision. See In re Paulsen, 30 F.3d 1475, 1480 (Fed.
`
`Cir. 1994).
`Weconstrue claim terms only as relevantto the parties’ contentions
`and only to the extent necessary to resolve the issues in dispute. See Vivid
`Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999).
`Petitioner requests a construction of the term “references the osteophyte.”
`Pet. 17-18. Patent Owner does not propose construction of any terms.
`
`
`
`IPR2017-00983
`IPR2017-00984
`Patent 8,657,827 B2
`
`Asto “references the osteophyte,” Petitioner states that the °827
`
`patent does not define the term “reference,” but argues the broadest
`reasonable construction ofthe limitation includes “at least a patient-specific
`
`surface that engages or avoids an osteophyte.” Jd. Patent Owner does not
`
`|
`
`addressthis issue directly in this proceeding.
`For purposesof this Decision, we determine that the broadest
`reasonable construction of the “references the osteophyte”limitation
`
`includes a patient specific surface that “engages or avoids the osteophyte,”
`
`consistent with the embodiments of Figures 32 and 33 of the ’827 patent.
`
`Wenote that dependent claims 2 and 3 use the phrase “not engage” with
`
`respect to a “second osteophyte.” Ex. 1001, 119:30, 119:36-37 (claims 2,
`3). Nevertheless, dependent claims 4 and 5 require that the patient-specific
`
`surface “substantially engage[s]” an osteophyte (id. at 119:41—-46), and
`
`therefore the principle of claim differentiation indicates that independent
`
`claim 1 has a broader scope than dependent claims4 and 5.
`
`B.
`
`Obviousness of Claims 1-13, 32, 33, 38, and 44-46 over
`Radermacher (Ex. 1003) and Alexander (Ex. 1004)
`Petitioner contendsthat claims 1-13, 32, 33, 38, and 44-46 are
`
`unpatentable as obvious over Radermacher and Alexander. Pet. 20-48.
`Patent Ownerdisagrees. Prelim. Resp. 11-24, 28-30.
`
`1. Radermacher
`Radermacheris titled “Template for Treatment Tools and Method for
`the Treatment of Osseous Structures” and relates to certain improvementsin
`
`the planning and performanceof orthopedic surgery. See Ex. 1003, 1, 9.
`Radermacherdescribes a method in which parts of the surface of an arbitrary
`
`
`
`IPR2017-00983
`IPR2017-00984
`Patent 8,657,827 B2
`
`osseousstructure, which are to be operated upon, are copied as a negative
`
`image using computer or nuclear-spin imaging so that an individual template
`can be set intra-operatively onto the osseousstructure with mating
`
`attachment. Jd. at 10:5-13. Radermacherdiscloses that the template can
`
`provide a guide correspondingto the limiting edge of a cut through the
`osseous structure (e.g., a vertebra) and can guarantee sufficient accuracy by
`
`exact positioning and guidanceofthe cutting tool. Jd. at 16:5-19. Figures
`
`13a and 13c of Radermacherare depicted below:
`
`
`
`Figures 13a and 13c schematically show an individual template 4 for the
`preparationofthe seat for a knee-joint head prosthesis.
`/d. at 30:5—8.
`
`2. Overview ofAlexander
`Alexanderis titled “Assessing the Condition of a Joint and Preventing
`Damage”andrelates to using joint assessmentin aiding in prevention of
`damageto the joint or treatment of diseasedcartilage in the joint. Ex. 1004,
`1:15-17. Alexanderdiscloses a methodof obtaining an image ofcartilage,
`
`
`
`IPR2017-00983
`IPR2017-00984
`Patent 8,657,827 B2
`
`(preferably a magnetic resonance image), converting the imageto a three-
`
`dimensional degeneration pattern, and evaluating the degree of degeneration
`
`in a volumeof interest of the cartilage. Jd. at 2:25—-27. Alexander further
`
`discloses calculating the thickness or regional volumeofthe region thought
`
`to contain degenerated cartilage, both at an initial time and a later time, to
`
`determinea loss in thickness. Jd. at 3:2-8. Alexander also describes
`
`creating a 3D thickness map. Jd. at 3:8—9.
`
`3. Analysis
`In its Petition, Petitioner sets forth its contentions as to how the
`
`limitations of claims 1-13, 32, 33, 38, and 44-46 are disclosedin, or
`
`obvious over, the combination of Radermacherand Alexander. Pet. 20-48.
`Claim | recites, in relevant part, the limitation:
`a patient-specific surface for engaging a corresponding portion
`of the diseased or damaged joint, the patient-specific surface
`including cartilage information derived from image data of the
`diseased or damaged joint, wherein the corresponding portion of
`the diseased or damaged joint includes an osteophyte, wherein
`the patient-specific surface references the osteophyte when the
`patient-specific surface is engaged and aligned with the
`correspondingportion of the diseased or damagedjoint.
`
`Ex. 1001, 119:14—23. Petitioner argues thatthis limitation is satisfied by
`
`Radermacher, in combination with the knowledge of a person of ordinary
`
`skill in the art and Alexander. Pet. 20-31, 40. Patent Owner opposes. See
`
`Prelim. Resp. 11-24, 28-30.
`Petitioner argues that when Radermacherdiscloses that the template is
`
`“set onto the bone” (Ex. 1003, 30), a person of ordinary skill would have
`
`understood that the template is set onto the un-treated bonesurface, i.e., on
`
`10
`
`
`
`IPR2017-00983
`IPR2017-00984
`Patent 8,657,827 B2
`
`top of any remaining cartilage, any exposed subchondral bone, and any
`osteophytes, or that this would have been obviousto a person of ordinary
`skill in the art in view of Radermacher. Pet. 24, 29-30 (citing Ex. 1002
`
`{7 93-95, 115-117). Petitioner asserts that Radermacherdiscloses using CT
`or MRI to generate a three-dimensional negative mold ofparts ofthe
`individual “natural” (i.e., not pre-treated) surface of the osseousstructure.
`
`|
`
`Pet. 23, 29-30, 37, 40 (citing, e.g., Ex. 1003, 10-12, 21-22, 30, Fig. 18; Ex.
`1002 ¥] 93-94 111-117). Petitioner relies, inter alia, on the ’827 patent for
`the contention that osteophytes may be part of the “natural” surface of a
`
`joint. Id. at 29 (citing Ex. 1001, 83:56—-84:7, 13:2—24, 73:25-27; 93:53-
`94:2, Figs. 32, 33; Ex. 1002 JJ 118). Petitioner asserts that osteophytes are
`present in the vast majority of patients requiring knee replacement surgery
`(over 90% of patients who undergo knee replacement), and “Radermacher’s
`template would inherently have a portion that engages an osteophyte,if
`present.” Jd. at 29 (citing, e.g., Ex. 1002 {J 111-113).
`Thecited portions of Radermacher, however, disclose creating an
`individual template to match a bone surface based on imagingofa joint (Ex.
`1003, 10-12, 21-22, 30) and surgical planning (id. at Figs. 18, 19). As
`argued, Radermacherdiscloses creating a negative mold to fit onto the
`natural surface of an osseousstructure. Jd. at 12. Radermacheralsostates
`
`that an individual template can “reproduce geometries of osseousstructures
`or reflect them in some other manner.” Jd. at 30. Wefindthat this
`|
`disclosure, with respect to the presence or absence of osteophytes,is
`ambiguousat best. Radermacherdoesnot contain a disclosure of
`osteophytes, nor matching the surfaces of osteophytes, as argued, nor
`
`11
`
`
`
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`Patent 8,657,827 B2
`
`“referencing” osteophytes as recited by independent claim 1. Weregard this
`
`as a gap in thepriorart reference.
`In support of Petitioner’s assertion that a person of ordinary skill in
`
`the art would have understood Radermacherto disclose referencing
`
`osteophytesor that it would have been obviousto do so in view of
`Radermacher, Petitioner relies on the declaratory evidence of Dr. Mabrey.
`
`Dr. Mabrey avers that Radermacher’s template surface would also match
`osteophytes (Ex. 1002 9] 113, 117), that over 90% of Dr. Mabrey’s patients
`who undergo knee replacement surgery have osteophytes (id. { 111), and
`that osteophytes were well-known and well-documented inthe literature
`(id.). Dr. Mabreyrelies onarticles from thescientific literature that report
`radiographicfindings of osteophytesin patients, e.g., patients with
`osteoarthritis. Exs. 1066-1069(cited in Ex. 1002
`111).
`In response, Patent Ownerargues that Petitioner cannot establish that
`the “osteophyte”limitation is inherent in any of the asserted references, and
`cites case law for the proposition that inherency “maynotbe established by
`probabilities or possibilities. The mere fact that a certain thing mayresult
`from a given set of circumstancesis not sufficient.” Prelim. Resp. 11-13
`(citing, e.g., In re Oelrich, 666 F.2d 578, 581 (CCPA 1981)) (emphasis
`omitted). Patent Owner maintains that Petitioner fails to show that
`osteophytes are necessarily present in the diseased or damagedjoints
`assessed bytheprior art.
`/d. at 14. Patent Ownerinsists that Petitioner’s
`own characterizations, using language such as “mostpatients,” constitute an
`acknowledgementthat the joints disclosed and assessed in the prior art do
`not necessarily have osteophytes, and that the referencesare silent onthis
`
`12
`
`
`
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`Patent 8,657,827 B2
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`issue. Jd. at 16 (citing Pet. 29). Patent Owner addsthat the simple fact that
`
`MRI imaging “could be used”to obtain information about osteophytes does
`
`not cure the primary problem that osteophytes are not necessarily presentin
`
`the prior-art references. Jd. at 17.
`
`The Federal Circuit has explained that “the use of inherency, a
`
`doctrine originally rooted in anticipation, must be carefully circumscribed in
`
`the context of obviousness.” PAR Pharm., Inc. v. TWI Pharms., Inc., 773
`F.3d 1186, 1195 (Fed. Cir. 2014). The Court further states:
`|
`Inherency, however, may not be established by probabilities or
`possibilities. The mere fact that a certain thing may result from
`a given set of circumstances is not sufficient.
`If, however, the
`disclosure is sufficient to show that the natural result flowing
`from the operation as taught would result in the performance of
`the questioned function, it seems well settled that the disclosure
`should be regardedas sufficient.
`
`Id. (quoting In re Oelrich, 666 F.2d at 581).
`
`Wefind that Petitioner has not established sufficiently that
`
`Radermacherexpressly or inherently discloses osteophytes or referencing
`
`osteophytes. As above, Radermacher does not mention osteophytes.
`
`Admittedly, Petitioner does not assert that Radermacherinherently
`anticipates independentclaim 1, as this is a ground based on obviousness.
`
`Nevertheless, to the extent that Petitioner contends that a person reading
`
`Radermacher would have understood Radermacherto disclose referencing
`
`osteophytes, we disagree. The declaratory evidence does notestablish that
`Radermacher’s disclosure necessarily concerns patients with osteophytes, or
`
`that Radermachernecessarily contemplates osteophytes as being subject to
`its method. The Petition’s logic appears to be that Radermacher teaches a
`
`13
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`Patent 8,657,827 B2
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`method of matchingthe “natural,” not pre-treated, surface of a joint (citing
`
`Ex. 1003, 12), but the Petition and the Declaration do not offer more than
`
`conclusory assertions that an osteophyte is necessarily part of the “natural”
`
`or “not pre-treated” surface of the bone described in Radermacher, beyond
`
`mere possibilities or probabilities.
`
`The next question is whether referencing osteophytesis the “natural
`
`result flowing from” Radermacher’s technique, under the aforementioned
`
`Oelrich test, or whether it otherwise would have been obviousto apply
`
`Radermacher’s technique to a bone surface with osteophytes. Petitioner
`
`argues that it would have been obvious to apply Radermacher’s technique to
`
`a bone surface with osteophytes because (1) such a template would be a.
`
`negative of the “natural(i.e. not pre-treated) surface”; (2) referencing any
`osteophyte would, in somecases,aid in alignment because the unique |
`structure of the osteophyte would help ensure that the template was placed in
`
`the proper position; and (3) it would eliminate the need to pre-treat the joint
`
`to remove the osteophyte in a preliminary surgical step, thus reducing
`
`surgical time and improving patient safety. Pet. 30 (citing, e.g., Ex. 1003,
`
`10, 12; Ex. 1002 4 116-117).
`
`Patent Owner respondsthat Petitioner provides no evidence to support
`
`this position and that one of ordinary skill would not have been motivated to
`modify a reference to account for osteophytes whenthe reference does not
`
`expressly or inherently disclose this feature. See Prelim. Resp. 18-19.
`Patent Ownerarguesthat Petitioner cannot rely on general knowledge and
`the ’827 patent because theyare not printed publications or patents under35
`U.S.C. § 311, and also argues that Petitioner improperly refers to other
`
`14
`
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`
`exhibits not formally relied upon in a stated ground. Jd. at 28-30 (citing,
`
`e.g., Deere & Co. v. Graham, Case IPR2015-00898, slip op. at 20-21 (PTAB
`
`Sept. 23, 2015) (Paper 7)).
`
`Wedeterminethat Petitioner has not established adequately that
`
`referencing an osteophyte would have been “the natural result flowing from”
`Radermacher’s technique,or that it would have been obviousin light of
`
`Radermacher’s disclosure. In particular, Petitioner admits with respect to
`
`dependent claims 2 and 3 that a personofordinary skill in the art might “not
`engage an osteophyteif the shape of the osteophyte was too complex to
`mimic or would cause other alignment problems.” Pet. 35 (citing Ex. 1002
`
`{ 124). As such, Petitioner admits that there is not necessarily a reasonable
`likelihood of success when engaging an osteophyte using a template. Or, in
`the language of Oelrich, Petitioner admits that engaging an osteophyteis not
`necessarily the natural result flowing from Radermacher’s technique because
`the osteophyte may present too complex a shape or cause alignment
`
`problems. Seeid.
`Indeed, the ’827 patent explains that alternate surgical methodsexist,
`i.e., to cut off an osteophyte before placing a template or to place a template
`
`on areas of the bonefree of the osteophyte. See Ex. 1001, 56:7—8; 73:36—39.
`
`Wedeterminethat the declaratory evidence does not establish adequately
`
`that a person reading Radermacher would have understood Radermacherto
`have engaged an osteophyte(or otherwise referenced an osteophyte) as
`opposed to performing an alternative surgical method on a bone with an
`
`osteophyte, such as removing the osteophyte.
`
`15
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`Petitioner additionally contends with respect to dependent claims 2
`
`and 3, that Radermacherdiscloses a second embodiment whereby a surgeon
`
`can form a template that extends overa plurality of geometrically non-
`
`abutting partial segments of bone, instead of engaging the bone segments.
`
`See Pet. 33-35 (citing, e.g., Ex. 1003, 12, 22, Fig. 3b, 4). In this
`embodiment, Radermacher discloses a template for operating on a vertebra
`where the template extends over the spinous processes. Although Petitioner
`
`does not explicitly rely on this embodimentfor the unpatentability of
`independentclaim 1 in the body ofthe Petition, Petitioner does include, in
`its claim chart for independentclaim 1, citations to pages 21 and 22 of
`
`Radermacherand to portions of the Declaration of Dr. Mabreythat refer to
`
`this second embodiment of Radermacher. See Pet. 40 (citing, e.g., Ex. 1003,
`
`22; Ex. 1002 ff 114). Petitioner asserts that avoiding osteophytes,if not
`engaging osteophytes, would have been obvious because a person of
`ordinary skill would have made a choice from a finite numberofoptions,
`i.e., removing the osteophyte, engaging the osteophyte, or avoiding the
`
`osteophyte. Pet. 25 (citing Ex. 1002 498). However, wefind that the
`Petition and cited portions of the Declaration do not provide anything more
`than conclusoryassertions that a surgeon would havetreated an osteophyte
`
`in a similar mannerto the spinous processesof a vertebra, as argued by
`
`Petitioner. In other words, Petitioner has not established a sufficient basis
`
`that it would have been obviousorfeasible to treat an osteophyte in the same
`
`manneras a spinous process.
`
`Wefurther note that the asserted ground of unpatentability is not
`
`based on anyprior art reference,i.e., a patent or printed publication,
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`cognizable under 35 U.S.C. § 311 for the “osteophyte” element of
`independent claim 1. Petitioner and Dr. Mabreyrefer to certain articles on
`imaging of osteophytes. Exs. 1066-1068 (cited in Pet. 30; Ex. 1002 {J 111,
`115). However, we agree with Patent Ownerthat the Petition hasnotrelied
`on thesearticles for its stated grounds of unpatentability. We decline the
`
`invitation to rewrite the asserted grounds of unpatentability set forth in the
`
`Petition to include additional references, or combinationsthereof.
`
`Petitioner also asserts that Alexander discloses imaging bones and
`
`cartilage, that this would provide information regarding osteophytes, and
`that it would have been obviousto a person of ordinary skill in the art to.
`
`combine the teachings of Radermacher and Alexander becausethe patient-
`specific surface described in Radermacher“could engage (andtherefore
`reference) an osteophyte.” Pet. 31, 40 (citing, e.g., Ex. 1004, Abstract,
`23:31-32, 26:20-27:26, 39:22—24, 61:19-25, Figs. 1OA-C, 12A—B, 18C-—I;
`
`Ex. 1002 § 118). However, the cited passages of Alexanderdisclose only
`imaging of cartilage and the use of biomechanical data. The cited passages
`of Alexander do not disclose osteophytes. Further, the portions of the
`Mabrey Declaration discussing Alexander do not show that Alexander
`necessarily disclosed osteophytes. See, e.g., Ex. 1002 118. For these
`reasons, we concludethat Petitioner does not adequately show that
`
`Alexander renders obvious a surgical technique of engaging an osteophyte
`or otherwise referencing an osteophyte when applying the template of
`
`Radermacher.
`
`Thus,the priorart relied upon in the asserted ground doesnotdisclose
`referencing an osteophyte, expressly or inherently. Additionally, Petitioner
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`does not provide adequate evidence that it would have been obviousto apply
`
`the technique of Radermacherin patients with osteophytes to engage (or
`
`avoid or reference) the osteophyte, as opposed to performing an alternate
`
`technique, such as first removing the osteophytes. In particular, Petitioner
`has not provided adequate evidence of a reasonable likelihood of success of
`
`applying Radermacher’s technique to a bone surface with osteophytes
`
`beyond unsupported and conclusoryassertions thereof.
`
`For these reasons, we determine that Petitioner has not demonstrated a
`
`reasonable likelihood that the combination of Radermacher and Alexander
`
`renders obvious independentclaim 1. Accordingly, we determine that
`
`Petitioner has failed to establish a reasonable likelihood that it would prevail
`
`in its assertion that independent claim 1, or dependent claims 2—13, 32, 38,
`and 44-46, are unpatentable as obvious over Radermacherand Alexander.’
`
`C. Obviousness ofClaims 14-19, 22-25, 28, 29, 34-37, and
`39-43 over Radermacher, Alexander, and Woolson (Ex.
`1031)
`
`Petitioner contends that claims 14-19, 22-25, 28, 29, 34-37, and 39-
`
`43 are unpatentable as obvious over Radermacher, Alexander, and Woolson.
`Pet. 49-77. Patent Ownerdisagrees. Prelim. Resp. 11-24, 28-30.
`
`1. Overview of Woolson (Ex. 1031)
`Woolsonis titled “Preoperative Planning of Bone Cuts and Joint
`Replacement Using Radiant Energy Scan Imaging” andrelates to a method
`of preoperative planning to determine the position of a bone-cut-defining
`
`5 We consider Patent Owner’s additional arguments,i.e., that Petitioner’s
`asserted grounds are redundant, to be moot.
`
`18
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`
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`guiderelative to the bone to be cut. Ex. 1031, 1:12—14. Woolson discloses
`steps of (1) preoperative determination of the angle between the anatomical
`and mechanical axes of the femur from radiographs; (2) localization of the
`
`center of the femoral head by external markers after operative radiographs
`
`are taken and correct estimation of the centerof the distal femurfor the
`
`external alignment system of femoral alignment; and(3) visual estimation of
`the centers of the proximaltibia and of the ankle joint in both the coronal
`and sagittal planes for correcttibial componentalignment. Jd. at 1:65-2:10.
`Woolson further discloses surgical guides, as shown in Figures 7A
`
`and 7B, which are reproduced below:
`
`Figures 7A and 7Bpresenta lateral view and a perspective view of a
`cutting guide for making final femoral cuts. Jd. at 3:39-40.
`
`2. Analysis
`Petitioner does not argue, and wedonotfind, that Woolson remedies
`the deficiency in the asserted ground of obviousness of independentclaim 1
`based on Radermacher and Alexander. Accordingly, we determinethat
`Petitioner has not established a reasonable likelihood that Radermacher,
`
`Alexander, and Woolson render obvious claims 14-19, 22-25, 28, 29, 34—
`
`19
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`
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`37, and 39-43 (whichall depend,directly or indirectly, from claim 1), for
`
`similar reasons as for the ground based on Radermacher and Alexander. See
`
`supra Section II.B.3.
`
`D. Obviousness ofClaims 20 and 21 over Radermacher,
`Alexander, Woolson, and Hofmann (Ex. 1090)
`Petitioner contendsthat claims 20 and 21 are unpatentable as obvious
`
`over Radermacher, Alexander, Woolson, and Hofmann. Pet. 78-80. Patent
`
`Ownerdisagrees. Prelim. Resp. 21-24, 34-36.
`
`1. Overview ofHofmann (Ex. 1090)
`Hofmannis anarticle,titled “Effect of the Tibial Cut on Subsidence
`
`Following Total Knee Arthroplasty,” which reviews the follow-up
`evaluation of 33 knee arthroplasties conducted on 31 patients between 1982
`and 1984. See Ex. 1090, 64. Tibial tray subsidence wasassessedas follows:
`
`subsidence was defined roentgenographically as at least 2 mm sinking of the
`prosthesis into cancellous bone associated with any secondary sclerosis of
`the cancellous bone when combined with lift-off of the prosthesis on the
`
`opposite side. Jd. The authors found that subsidence ofthe tibial component
`occurred in ten of 33 knees. Jd. Patients with subsidence had a mean
`
`preoperativetibial slope of “9° + 2° (range, 4° to 12°).” Jd. The authors
`also conducted a laboratory study of force to failure. Jd. at 65-67. The
`authors concludedthat cutting the tibial parallel to the articular surface of
`the tibia during total knee arthroplasties provides increased load carrying
`capacity andstiffness to the bone supporting the tibial prosthesis. Jd. at 68.
`
`20
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`2. Analysis
`Claims 20 and 21 depend from claim 19, which ultimately depends
`
`from claim 1. Ex. 1001, 120:27-36. Petitioner does not argue, and we do
`
`not find, that Hofmann remedies the deficiency in the asserted ground of
`
`obviousness of dependent claim 19 based on Radermacher, Alexander, and
`
`Woolson. Accordingly, we determine that Petitioner has not established a
`
`reasonable likelihood that Radermacher, Alexander, Woolson, and Hofmann
`
`render obvious claims 20 and 21, for similar reasons as for the ground based
`
`on Radermacher, Alexander, and Woolson. See supra SectionII.C.2.; see
`
`also Section II.B.3 (discussing ground of obviousness based on
`
`Radermacher and Alexander).
`
`E. Obviousness of Claims 1-13, 32, 33, 38, and 44-46 over
`Radermacher and Fell (Ex. 1005)
`
`Petitioner contends that claims 1-13, 32, 33, 38, and 4446 are
`
`unpatentable as obvious over Radermacherand Fell. Pet. 81-84. Patent
`
`Ownerdisagrees. Prelim. Resp. 12-20, 25-30.
`
`1. Overview ofFell
`Fell is titled “Surgically Implantable Knee Prosthesis” and relates to
`prosthetic devices and, more particularly, to self-centering knee joint
`prostheses which maybesurgically implanted between the femoral condyle
`andtibial plateau of the knee. Ex. 1005, 1:4—5. Fell discloses a hard,self-
`centering meniscal device suitable for implantation into the knee
`compartmentdefined by the space between the femoral condyle and the
`respectivetibial plateau. Jd. at 4:6—9. Fell discloses that the natural
`meniscus may be maintainedin position or may be wholly orpartially
`
`removed. Jd. at 5:13—15. Fell further discloses that the meniscal device
`
`21
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`allows for the provision of non-contacting or recessed areas to encourage
`articular cartilage regeneration. Jd. at 8:28-30. Fell describes that the
`shapes ofthe affected femoral condyle andtibial plateau are ascertained
`using X-ray or MRI ima
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