Paper 18
`
`Trials@uspto.gov
`Date: January 21, 2020
`
`571-272-7822
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`VETERINARY ORTHOPEDIC IMPLANTS, INC.,
`Petitioner,
`
`v.
`
`DEPUY SYNTHES PRODUCTS, INC.,
`Patent Owner.
`____________
`
`IPR2019-01331
`Patent 8,523,921 B2
`____________
`
`
`
`Before HYUN J. JUNG, CHRISTOPHER G. PAULRAJ, and
`TIMOTHY G. MAJORS, Administrative Patent Judges.
`
`MAJORS, Administrative Patent Judge.
`
`
`
`
`DECISION
`Denying Institution of Inter Partes Review
`35 U.S.C. § 314
`
`
`
`
`
`Trials@uspto.gov
`Date: January 21, 2020
`
`571-272-7822
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`VETERINARY ORTHOPEDIC IMPLANTS, INC.,
`Petitioner,
`
`v.
`
`DEPUY SYNTHES PRODUCTS, INC.,
`Patent Owner.
`____________
`
`IPR2019-01331
`Patent 8,523,921 B2
`____________
`
`
`
`Before HYUN J. JUNG, CHRISTOPHER G. PAULRAJ, and
`TIMOTHY G. MAJORS, Administrative Patent Judges.
`
`MAJORS, Administrative Patent Judge.
`
`
`
`
`DECISION
`Denying Institution of Inter Partes Review
`35 U.S.C. § 314
`
`
`
`
`
`IPR2019-01331
`Patent 8,523,921 B2
`
`INTRODUCTION
`I.
`Veterinary Orthopedic Implants, Inc. (“Petitioner”),1 on July 15, 2019,
`filed a Petition to institute inter partes review of claims 1–11 of U.S. Patent
`No. 8,523,921 (Ex. 1001, “the ’921 patent”). Paper 2 (“Pet.”). DePuy
`Synthes Products, Inc. (“Patent Owner”) filed a Preliminary Response to the
`Petition. Paper 7 (“Prelim. Resp.”). We granted (Paper 11) Petitioner’s
`request to file a pre-institution Reply to Patent Owner’s Preliminary
`Response. Paper 12. We also permitted Patent Owner to file a Sur-Reply to
`Petitioner’s authorized Reply. Paper 14.
`Patent Owner disclaimed claims 10, 11, and 15–18 of the ’921 patent.
`See Ex. 2023, 1; Prelim. Resp. 9 n.2; 37 C.F.R. § 42.107(e) (2019); 35
`U.S.C. § 253; Vectra Fitness, Inc. v. TWNK Corp., 162 F.3d 1379, 1383
`(Fed. Cir. 1998) (“This court has interpreted the term ‘considered as part of
`the original patent’ in section 253 to mean that the patent is treated as though
`the disclaimed claims never existed.”). Among the claims challenged in this
`Petition, claims 10 and 11 are disclaimed and, thus, inter partes review
`cannot be instituted on those claims. See 37 C.F.R. § 42.107(e) (“No inter
`partes review will be instituted on disclaimed claims.”); see, e.g., Paragon
`28, Inc. v. Wright Med. Tech., Inc., IPR2019-00894, Paper 17 at 29 (PTAB
`Sept. 25, 2019) (instituting review on some claims but not those that were
`disclaimed because “we conclude we cannot institute a trial on claims that
`have been disclaimed, and, thus, no longer exist”); Gen. Elec. Co. v. United
`Techs. Corp., IPR2017-00491, Paper 9 at 2–3 (PTAB July 6, 2017)
`
`
`1 Petitioner identifies itself as the real party-in-interest. Pet. 68.
`2
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`(precedential) (determining review cannot be instituted where all claims are
`disclaimed).
`Under 35 U.S.C. § 314(a), inter partes review may not be instituted
`unless the Petition “shows that there is a reasonable likelihood that the
`petitioner would prevail with respect to at least 1 of the claims challenged in
`the petition.” For reasons discussed below, we do not institute review of
`claims 1–9 of the ’921 patent.
`
` Related Proceedings
`The ’921 patent issued September 3, 2013, from U.S. Patent
`Application No. 11/361,245 (“the ’245 Application”), filed February 24,
`2006. Ex. 1001, at [21], [22], [45]. Petitioner identifies the following
`related applications:
`US Patent Application No. 13/538,407, filed June 29, 2012
`(hereafter “the ’407 Application”), which is a child application
`to the ’921 patent; and
`
`US Patent Application No. 16/031,792, filed July 10, 2018
`(hereafter “the ’792 Application”), which is a grand-child
`application to the ’921 patent.
`Pet. 10, 15–20. Both of the above related applications are pending before
`the U.S. Patent and Trademark Office. Id. at 15–20. In addition, Petitioner
`identifies U.S. Design Patent Application No. 29/656,918, which issued July
`2, 2019. Id. at 69; see also Prelim. Resp. 13 (identifying U.S. Patent No.
`D852957).
`Petitioner further states that it is a defendant in a pending litigation
`concerning the ’921 patent: Depuy Synthes Products, Inc. v. Veterinary
`
`3
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`Orthopedic Implants, Inc., 3:18-cv-01342-HES-PDB (M.D. Fla.). Pet. 68.
`Patent Owner, for its part, also identifies a separate lawsuit between
`Petitioner and Patent Owner on the related and above-noted design patent.
`Prelim. Resp. 13; Ex. 2020 (Complaint for Design Patent Infringement, Case
`No. 3:19-cv-00801-MMH-JRK (M.D. Fla., filed July 3, 2019)). According
`to Patent Owner, Petitioner has since agreed to have judgment taken against
`it for infringement of the design patent, including an injunction barring
`further manufacture and sale of Petitioner’s infringing designs. Prelim.
`Resp. 15; Ex. 2021 (notice of the executed offer of judgment).
`Petitioner concurrently filed two additional petitions for inter partes
`review of the ’921 patent (IPR2019-01332 (challenging claims 12–18) and
`IPR2019-01333 (challenging claims 19 and 20)). See Prelim. Resp. 1.
`
`4
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` Asserted Grounds of Unpatentability
`Petitioner asserts two grounds of unpatentability in this Petition
`(Pet. 1–3), which are identified in the table below:
`Claims Challenged
`35 U.S.C. §
`1–112
`103(a)3
`
`References
`Young,4 Forstein,5 O’Driscoll6
`
`1–11
`
`103(a)
`
`Weaver,7 Forstein, O’Driscoll,
`Young
`
`
`Petitioner also relies on the declarations of Dr. Jeffrey N. Peck and
`Troy D. Drewry, among other evidence. Ex. 1005 (“Peck Decl.”); Ex. 1027
`(“Drewry Decl.”). Patent Owner, in its Preliminary Response, cites the
`declarations of Dr. Michael P. Kowaleski and Timothy Horan, among other
`evidence. Ex. 2022 (“Kowaleski Decl.”); Ex. 2112 (“Horan Decl.”).
`
`
`2 Claims 10 and 11 are disclaimed as noted above.
`3 The Leahy-Smith America Invents Act, Pub. L. No. 112-29, 125 Stat. 284
`(2011) (“AIA”), amended 35 U.S.C. §§ 102 and 103. Because the claims of
`the ’921 patent have an effective filing date before the effective date of the
`applicable AIA amendments, we refer to the pre-AIA version of 35 U.S.C.
`§ 103 throughout this Decision.
`4 Young, US 2005/0015089 A1, published Jan. 20, 2005 (Ex. 1008,
`“Young”).
`5 Forstein, US 2006/0173458 A1, published Aug. 3, 2006 (Ex. 1006,
`“Forstein”).
`6 O’Driscoll, WO 2004/024009 A1, published Mar. 25, 2004 (Ex. 1012,
`“O’Driscoll”).
`7 Weaver, WO 01/19267 A1, published Mar. 22, 2001 (Ex. 1010,
`“Weaver”). Petitioner states that a counterpart (U.S. Patent No. 6,623,486)
`to Weaver was cited during prosecution of the ’921 patent. Pet. 11.
`5
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`Patent 8,523,921 B2
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` The ’921 Patent
`The ’921 patent is titled “Tibial Plateau Leveling Osteotomy Plate.”
`Ex. 1001, at [54]. The ’921 patent’s abstract reads as follows:
`An improved tibial plateau leveling osteotomy plate is disclosed.
`The plate is contoured in its proximal head portion to more
`closely resemble the structure of the tibial bone segment that is
`cut and rotated during the procedure. The plate also preferably
`has screw holes in the proximal head portion that are machined
`through the pre-contoured proximal head portion and are
`designed to angle the screw in a targeted screw path with respect
`to the osteotomy.
`
`Id. at [57].
`The ’921 patent describes a tibial plateau leveling osteotomy (or
`“TPLO”) as a surgical procedure “well known in the veterinary art.”
`Ex. 1001, 1:14–15. TPLO procedures “are used to correct ruptured cranial
`cruciate ligaments for various animals, primarily for canines.” Id. at 1:15–
`17; see also id. at 1:22–25 (disclosing that “the cranial cruciate ligament
`stabilizes a canine’s stifle joint (called the knee for humans),” and
`explaining that “[o]ne of the important functions for the ligament is to
`control sliding of the upper femur bone on the lower tibia bone”).
`According to the ’921 patent, TPLO has “become the standard of care for
`medium and large canines.” Id. at 1:19–21; see also id. at 1:27–28 (TPLO
`“provides a way to correct this problem [(rupture of the canine’s cranial
`cruciate ligament)]”).8
`
`
`8 Dr. Kowaleski provides an anatomical overview on canines and other
`
`6
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`The ’921 patent describes an actual TPLO procedure as follows:
`Basically, a curvilinear cut is made to the upper and lower
`portion of the tibia. This cut portion is then rotated on the order
`of about 20–30 degrees thereby creating a more level plane or
`surface on the top of the tibia upon which the femur can rest. The
`cut and repositioned portion of the tibia is then secured to the
`lower portion of the tibia.
`Ex. 1001, 1:29–39; see also Ex. 1005 ¶¶ 16 (describing TPLO procedure to
`control “cranial tibial thrust . . . by leveling the [tibial] plateau to enhance
`the effectiveness of the active forces of the stifle flexors of the thigh”), 17
`(describing TPLO as involving a “medial incision extending from the medial
`aspect of the stifle (knee) joint through the proximal one-third of the tibia,”
`making a “cylindrical cut” to the tibia, rotation of the cut proximal segment,
`and stabilization of the bones in a rotated position with a TPLO plate).9
`The ’921 patent acknowledges that various means have been used to
`fix or secure the cut bone portion to the remaining portion of the tibia as part
`of a TPLO procedure, including the use of metal plates secured with bone
`screws. Ex. 1001, 1:40–45. According to the ’921 patent, however, the
`“problem” with many of the existing plates is “that they require the surgeon
`
`
`quadrupeds. Ex. 2022 ¶¶ 11–16 (showing, for example, relevant bones in
`the hind limb of a dog).
`9 Dr. Kowaleski also provides a step-by-step overview of TPLO, illustrating
`the curvilinear cut made to the tibia’s proximal portion, rotation of that cut
`portion relative to the distal tibia, and finally securing of a plate. See, e.g.,
`Ex. 2022 ¶¶ 17–22; Ex. 2016, 37; see also Ex. 1014 passim (detailing TPLO
`surgical procedure). As Dr. Kowaleski explains, TPLO is performed on the
`medial aspect of the tibia, and cannot be performed on the lateral side due to
`the presence of the fibula. Ex. 2022 ¶ 18.
`7
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`to manipulate the plate to conform to the tibia during the surgical
`procedure,” which is difficult and “can result in the screw holes becoming
`deformed.” Id. at 1:45–51. Further, the ’921 patent discloses, “[a]nother
`drawback with the TPLO plates currently available” is that the screw holes
`are “not designed for optimum fixation.” Id. at 1:52–58 (explaining that
`improved designs that “avoid the screws from being located near a cut
`portion of the tibia or near the articular surface of the tibia and femur” are
`needed).
`The ’921 patent’s drawings are helpful to understanding the invention.
`Figures 1, 2C, and 2D are reproduced below (with annotation10) and show an
`exemplary bone plate of the ’921 patent in several views, including top
`(Figs. 1 and 2D) and side (Fig. 2C) views.
`
`
`
`
`10 Unless otherwise stated, annotations to the drawings provided in this
`Decision were made by the Board.
`
`8
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`Ex. 1001, Figs. 1, 2C, 2D. Figure 1 is a top view of the bone plate (10), and
`shows, among other features, the plate’s distal (12) and proximal (14)
`portions, as well as the superior (30), cranial (31), and caudal (32) screw
`holes. See, e.g., Ex. 1001, 4:42–49.11 Figure 2C is a side view of the bone
`plate and shows a bone-contacting surface (22) of a flat distal portion (12)
`along a base plane (42), and a transverse plane (46) of the plate, which
`transverse plane is orthogonal to the base plane. Id. at 5:31–40. As seen in
`Figure 2C, the proximal portion (14) of the plate is not flat along the base
`plane as is the plate’s distal portion (12); rather it is, as discussed earlier,
`“designed or configured in its dimensions to advantageously contour to the
`tibial bone segment that has been cut and rotated during the TPLO
`procedure.” See id. at 5:31–34.
`The more particular contours of the plate’s proximal portion, the ’921
`patent states, are better explained by defining three orthogonal planes of the
`plate—the base and transverse planes, discussed above, and the mid-plane
`(44), depicted in the side view of the plate in Figure 2D above. Ex. 1001,
`5:34–36.
`The ’921 patent defines the three planes as follows:
`A base plane 42 is defined by the flat distal portion 12 at the
`bone-contacting surface 22. A mid-plane 44 is defined as
`bisecting the base plane in the distal portion of the plate. A
`
`
`11 As Dr. Kowaleski explains, the terms “cranial” and “caudal” are common
`terms in veterinary medicine and, in the context here, indicate the direction
`of the plate holes in relation to the head (cranial, meaning toward the head)
`and the tail (caudal, meaning toward the tail) of the four-legged animal to
`which the plate is attached. Ex. 2022 ¶ 14.
`9
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`transverse plane 46 is defined as being orthogonal to the base
`plane 42 and the mid-plane 44.
`Ex. 1001, 5:38–43. The ’921 patent then states that the contoured shape of
`the proximal portion can be more readily seen by rotating the plate. Id. at
`5:54–56. The patent describes the contour as the “arc of a cylinder” and
`states that a “centerline of the cylinder can be viewed perpendicularly by
`rotating the plate twice” about two “rotation axes” defined by various
`intersections of the planes discussed above (or offsets and rotated versions
`thereof). Id. at 5:58–6:13 (describing a second rotation of the plate
`“downward about a second rotation axis . . . defined by the intersection of
`the off-set, rotated, transverse plane and base plane 42”).
`A result of the multiple rotations of the plate is depicted in the ’921
`patent’s Figure 6, which is reproduced below (with annotation).
`
`
`Ex. 1001, Fig. 6. Figure 6 is a rotated proximal end view of the plate,
`showing an arc of a bone-contacting surface (22) of the proximal portion,
`and showing “cylinder” (29) having a center axis (40) and radius (42). Id. at
`5:58–6:13; see also id. at Fig. 3 (proximal end view of plate, down the
`10
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`Patent 8,523,921 B2
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`plate’s length without rotation), Fig. 4 (proximal end view upon a first
`angular rotation of the plate (as depicted in Fig. 3) about a first rotation
`axis), and Fig. 5 (proximal end view following a second angular rotation of
`the plate (as depicted in Fig. 4) about a second rotation axis).
`As for the proximal portion’s screw holes and screw paths, the ’921
`patent describes its “optimized” TPLO design. See, e.g., Ex. 1001, 5:10–12,
`6:18–39. According to the ’921 patent, the plate is preferably designed to
`have the screws in the proximal portion “angle into the tibia so that the
`screws are directed away from the articular surface between the tibia and the
`femur, away from the osteotomy surface of the tibia, and away from the
`edges of the tibia and into the central mass of the tibia.” Id. at 6:18–31. The
`’921 patent explains that these screw hole paths can be obtained by pre-
`contouring the proximal portion, and then machining the screw holes
`through the pre-contoured portion. Id. at 6:31–35. With screw holes
`designed for use with locking screws, such a design provides for a fixed and
`targeted screw path through the desired section of the cut and rotated tibial
`bone segment. Id. at 6:35–39; see also id. at Figs. 7–9 (showing angled
`screw paths of the superior, cranial, and caudal screw holes and screws); see
`also id. at 9:32–35 (“The plate is also designed such that after the proximal
`portion is pre-contoured, the screw holes for the proximal portion are
`machined through the plate.”).
`The ’921 patent illustrates implantation of the bone plate in a TPLO
`procedure. Figure 13 (with annotation) is reproduced below.
`
`11
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`
`Ex. 1001, Fig. 13. Figure 13 is a top perspective view of the articular
`surface between the tibia and femur (i.e., looking down at the tibial plateau)
`with an exemplary bone plate affixed to the proximal medial portion of the
`animal’s tibia, with screws having a targeted path. Id. at 3:14–16, 9:42–54.
`Figure 13 shows, for example, caudal screw (32a) that is angled slightly
`cranially (in a direction of the animal’s head) toward the center of the cut
`portion of the tibia and away from the outer edge (70) of the tibia; see also
`id. at Fig. 14 (side perspective view of an exemplary bone plate affixed to
`the animal’s distal and cut proximal tibial segments (on inner portion of
`right hind leg) as part of TPLO), 9:42–56.
`
`12
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`
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`IPR2019-01331
`Patent 8,523,921 B2
`
` Challenged Claims
`The ’921 patent includes four independent claims, and several
`dependent claims. Claim 1 is the only independent claim challenged in this
`Petition, and reads as follows:
`1. A bone plate dimensioned for securing two tibial bone
`segments of an animal as part of a tibial leveling osteotomy
`procedure for an animal, the bone plate comprising:
`a distal portion comprising an elongated shaft having disposed
`therein a plurality of distal portion screw holes each designed to
`accept a screw and defining a longitudinal axis and a base plane
`along a bone contacting surface thereof;
`a proximal portion having an upper surface and a bone-
`contacting surface opposite the upper surface, the bone-
`contacting surface of the proximal portion being pre-configured
`and dimensioned to conform to a tibial bone segment and having
`a contour formed as an arc of a cylinder having a contour axis
`extending in a plane including a first rotation axis defined by an
`intersection of a mid-plane and a transverse plane and rotated
`relative to the mid-plane about the first rotation axis by a first
`angle, the mid-plane bisecting the base plane, and the transverse
`plane being orthogonal to the mid-plane and the base plane, and
`wherein the axis is rotated relative to a second rotation axis
`defined by an intersection of the transverse plane and the base
`plane by a second angle;
`a plurality of proximal portion screw holes located in the
`proximal portion that were machined through the pre-contoured
`bone-contacting surface, the proximal portion screw holes being
`designed to accept a locking screw, whereby locking screws
`anchored through the proximal portion screw holes will have a
`targeted screw path through the tibial bone segment.
`Ex. 1001, 9:57–10:19. Claims 2–9 are also challenged here, and those
`claims depend, directly or indirectly, from claim 1. Id. at 10:20–56.
`
`13
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` Prosecution History
`The prosecution history of the ’921 patent (and related applications) is
`somewhat extensive, and we do not summarize all of it here. See Pet. 11–20
`(Petitioner’s summary for the ’921 patent, the ’407 Application, and the ’792
`Application). Of the references asserted in this Petition, Petitioner contends
`that: (i) neither Forstein nor O’Driscoll was cited during prosecution of the
`’921 patent; (ii) Young was identified in an information disclosure
`statement, but not cited in a rejection; and (iii) a U.S. counterpart patent to
`Weaver was cited against then-pending claims of the ’921 patent in a
`rejection, which was appealed to the Board. Pet. 3, 11–15.
`In the lead-up to the appeal to the Board during the ’921 patent’s
`prosecution, the examiner had rejected claims 1–8 as anticipated by a
`reference known as “Wack” (Ex. 1009) and other claims (claims 9–11)
`depending from claim 1 for obviousness over Wack. Ex. 1002, 432–443
`(Board decision dated May 31, 2013). Independent claims 19 and 20, which
`are not challenged in this Petition, but which include many of the same or
`substantially similar elements to claim 1, were rejected over a counterpart to
`Weaver. Id.; see also Pet. 12.
`The Board, in reaching its appeal decision, characterized appellant’s
`argument on claim 1 as “contend[ing] that Wack fails to teach the element of
`‘the mid-plane bisecting the base plane.’” Ex. 1002, 438. The Board then
`determined that Wack “does not contain a proximal portion having a mid-
`plane that bisects the base plane defined by the distal portion of the bone
`plate as required by the claims and shown in Fig. 2D of the Specification.”
`Id. at 439. According to Petitioner, “the Board construed the phrase ‘a mid-
`14
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`plane bisecting the base plane’ to require that ‘the mid-plane of the proximal
`portion must also bisect the base plane of the distal portion.’” Pet. 14–15
`(citing Ex. 1002, 439); see also id. at 24, 38 (Petitioner arguing that the
`Board, thus, determined that “the proximal portion must be symmetrical and
`share the same mid-plane as the distal portion”).
`The Board, upon determining that Wack failed to disclose at least one
`element of the rejected claims, reversed the rejections for anticipation and
`obviousness. Ex. 1002, 438–441 (concluding “the same issues are
`dispositive for both the anticipation rejection and obviousness rejection
`based on Wack”).12 After the Board’s reversal of the rejections, the
`examiner entered a notice of allowance without further comment on any
`particular reasons for allowing the claims. Ex. 1002, 444–449 (Notice of
`Allowance dated June 26, 2013).
`For the related ’407 Application, Petitioner contends the application
`“claims a bone plate similar to that of the ’921 patent, but with some
`additional structural limitations not relevant” to the claims challenged here.
`Pet. 15. Petitioner notes that the claims of the ’407 Application have been
`rejected several times based on different prior art than asserted in this
`Petition, and that the claims have been amended. Id. According to
`Petitioner, in one amendment, the applicant “added limitations reciting a
`
`12 The Board came to a similar conclusion on the Weaver counterpart and
`the rejection of claims 19 and 20. Ex. 1002, 442. The other pending claims
`(i.e., independent claim 12 and its dependent claims) stood rejected for
`anticipation and obviousness based on Wack. The Board, for different
`reasons, reversed those rejections as well. Id. at 440–441.
`
`15
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`‘contour of the bone-facing surface formed as an arc of a cylinder,’” yet the
`examiner maintained that the claims would have been obvious, and
`characterized the applicant’s arguments as relying on “imaginary axes ‘to
`achieve a curved shape’” that do not distinguish the claims from the art. Id.
`(citing, for example, Ex. 1003, 372, 382, 386, 401, 416).13
`Petitioner notes that the examiner’s most-recent rejection of the ’407
`Application was appealed to the Board. Pet. 16; see also Ex. 1003, 424–439
`(Appeal Br.), 453–458 (Examiner’s Ans.), 637–646 (Reply Br.). In fact, the
`Board has now decided that appeal, entering a new ground of rejection under
`35 U.S.C. § 112, second paragraph, and reversing the prior art rejections pro
`forma. See Ex. 3001 (Ex parte Horan, Appeal No. 2019-003128, at 6–7
`(PTAB Nov. 29, 2019) (“We do not reach the merits of the obviousness
`rejections” because “the subject matter encompassed by the claims on appeal
`must be reasonably understood without resorting to speculation.”).
`Turning to the ’792 Application, as Petitioner points out, the Forstein
`reference was cited in a rejection. Pet. 16–20. The prosecution of the ’792
`Application is ongoing, and a rejection citing Forstein has been appealed and
`is awaiting a decision from the Board. Id. at 20; Ex. 1004, 205–221 (Final
`Rejection dated Feb. 1, 2019), 392–413 (Appeal Br.).
`
`
`13 The examiner’s rejection (later appealed) was based on the determination
`that the claims would have been obvious over “Esser” (Ex. 1030) in view of
`“Grady” (Ex. 1031), or Esser in view of Klaue (US 5,002,544 (not an exhibit
`here)). Ex. 1003, 384–401.
`
`16
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`II. ANALYSIS
` Principles of Law
`“In an [inter partes review], the petitioner has the burden from the
`onset to show with particularity why the patent it challenges is
`unpatentable.” Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed.
`Cir. 2016) (citing 35 U.S.C. § 312(a)(3) (requiring inter partes review
`petitions to identify “with particularity . . . the evidence that supports the
`grounds for the challenge to each claim”)).
`“[A] determination of anticipation, as well as obviousness, involves
`two steps. First, is construing the claim . . . followed by, in the case of
`anticipation or obviousness, a comparison of the construed claim to the prior
`art.” Key Pharm. v. Hercon Labs. Corp., 161 F.3d 709, 714 (Fed. Cir.
`1998).
`A claim is unpatentable under 35 U.S.C. § 103(a) if the differences
`between the subject matter sought to be patented and the prior art are such
`that the subject matter as a whole would have been obvious at the time the
`invention was made to a person having ordinary skill in the art to which that
`subject matter pertains. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406
`(2007). The question of obviousness is resolved on the basis of underlying
`factual determinations including: (1) the scope and content of the prior art;
`(2) any differences between the claimed subject matter and the prior art; (3)
`the level of ordinary skill in the art; and (4) objective evidence of
`nonobviousness when presented. Graham v. John Deere Co., 383 U.S. 1,
`17–18 (1966).
`
`17
`
`
`
`IPR2019-01331
`Patent 8,523,921 B2
`
` Person of Ordinary Skill in the Art
`In determining the level of skill in the art, we consider the problems
`encountered in the art, the art’s solutions to those problems, the rapidity with
`which innovations are made, the sophistication of the technology, and the
`educational level of active workers in the field. Custom Accessories, Inc. v.
`Jeffrey-Allan Indus., Inc., 807 F.2d 955, 962 (Fed. Cir. 1986).
`Petitioner contends a person of ordinary skill in the art (or “POSA”)
`as of February 24, 2006, would have had the following qualifications:
`at least a Bachelors of Science in Mechanical, Biomechanical or
`Biomedical engineering, or a related field of science, and at least
`three to seven years of experience in the field of orthopedic
`implants or would be a practicing veterinary surgeon with at least
`three years of experience and at least some experience in the
`design and/or use of orthopedic implants.
`Pet. 3–4; Ex. 1005 ¶ 28; Ex. 1027 ¶ 32. Patent Owner does not oppose this
`definition at this time. Ex. 2022 ¶ 7 (Dr. Kowaleski accepting Petitioner’s
`definition for purposes of his declaration).
`Petitioner’s proposed definition is unopposed and is not inconsistent
`with the cited prior art, and we adopt it for the purposes of this Decision.
`See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining
`that specific findings regarding ordinary skill level are not required “where
`the prior art itself reflects an appropriate level and a need for testimony is
`not shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755
`F.2d 158, 163 (Fed. Cir. 1985)).
`
`18
`
`
`
`IPR2019-01331
`Patent 8,523,921 B2
`
` Claim Construction
`We interpret a claim “using the same claim construction standard that
`would be used to construe the claim in a civil action under 35 U.S.C.
`282(b).” 37 C.F.R. § 42.100(b) (2019).14 Under this standard, we construe
`the claim “in accordance with the ordinary and customary meaning of such
`claim as understood by one of ordinary skill in the art and the prosecution
`history pertaining to the patent.” Id. “[W]e need only construe terms ‘that
`are in controversy, and only to the extent necessary to resolve the
`controversy.’” See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor
`Co. Ltd., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (quoting Vivid Techs., Inc. v.
`Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).
`
`1.
`
`“contour axis extending in a plane including a first
`rotation axis . . . and rotated relative to . . .”
`In its more complete context, claim 1 of the ’921 patent recites, inter
`alia, the following:
`
`a proximal portion having an upper surface and a bone-
`contacting surface opposite the upper surface, the bone-
`contacting surface of the proximal portion being pre-configured
`and dimensioned to conform to a tibial bone segment and having
`
`14 The Office has changed the claim construction standard in AIA
`proceedings to replace the broadest reasonable interpretation standard with
`the same claim construction standard used in a civil action in federal district
`court. Changes to the Claim Construction Standard for Interpreting Claims
`in Trial Proceedings Before the Patent Trial and Appeal Board, 83 Fed. Reg.
`51,340 (Oct. 11, 2018). The change applies to petitions filed on or after
`November 13, 2018. Id. Because the present Petition was filed after that
`date, we construe the claims in accordance with the federal district court
`standard, now codified at 37 C.F.R. § 42.100(b).
`19
`
`
`
`IPR2019-01331
`Patent 8,523,921 B2
`
`a contour formed as an arc of a cylinder having a contour axis
`extending in a plane including a first rotation axis defined by an
`intersection of a mid-plane and a transverse plane and rotated
`relative to the mid-plane about the first rotation axis by a first
`angle, the mid-plane bisecting the base plane, and the transverse
`plane being orthogonal to the mid-plane and the base plane, and
`wherein the axis is rotated relative to a second rotation axis
`defined by an intersection of the transverse plane and the base
`plane by a second angle;
`Ex. 1001, 9:66–10:12 (emphasis added). In general, and based on our
`review of the ’921 patent and other evidence of record, these limitations
`seemingly purport to define, in some manner, a shape and curvature of the
`claimed bone plate’s proximal portion. See generally supra Section I(C).
`Petitioner and its declarants repeatedly state that the above claim
`language is “entirely ambiguous,” “unclear,” and “fails to inform a POSA
`about the scope of the invention with reasonable certainty” (i.e., is
`indefinite),15 and other similar statements. See, e.g., Pet. 22–23; see, e.g.,
`Ex. 1005 ¶ 33 (“Upon review of the claim language it is not clear to me at all
`what is being rotated with respect to the two rotation axes.”); Ex. 1027 ¶ 40
`(“The term ‘contour axis’ does not appear in the specification and it is
`unclear to what this term is intended to refer.”), ¶ 44 (explaining “it is
`unclear which interpretation [for contour axis] would be correct”).
`
`
`15 “[A] patent is invalid for indefiniteness if its claims, read in light of the
`specification delineating the patent, and the prosecution history, fail to
`inform, with reasonable certainty, those skilled in the art about the scope of
`the invention.” Nautilus, Inc. v. Biosig Instruments, Inc., 134 S. Ct. 2120,
`2124 (2014).
`
`20
`
`
`
`IPR2019-01331
`Patent 8,523,921 B2
`
`In the parallel district court proceedings, as Patent Owner notes,
`Petitioner is expressly challenging the above claim language (among other
`claim limitations) as indefinite, rendering claim 1 invalid. Prelim. Resp. 15,
`19–20; Ex. 2011, 49–50 (Petitioner’s invalidity contentions stating, for
`example, that “[i]t is not possible to discern with reasonable certainty which
`axis is the ‘contour axis’ and how the contour axis extends ‘in a plane
`including a first rotation axis’”).
`Notwithstanding the above, Petitioner states that its position, “solely
`for purposes of this petition,” is that “the contour axis is what is rotated.”
`Pet. 22–23. Again, invoking a lack of clarity, Petitioner then states that,
`“[s]olely for purposes of this petition, Petitioner construes [rotated relative to
`the mid-plane] as rotated starting at a point on the mid-plane about the first
`rotation axis for a radial distance defined by a first angle” and that “rotation
`relative to the second rotation axis is similarly construed.” Id. at 23 (“‘the
`axis . . . rotated relative to a second rotation axis’ is the contour axis,
`although it could be any other axis previously set forth in the claim, some
`other axis not defined, hence the ambiguity”). And, for the claim phrase
`“the mid-plane bisecting the base plane,” which is embedded in the lengthier
`limitation block-quoted above, Petitioner contends this phrase means “that
`the proximal portion m
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