Trials@uspto.gov Paper 42
`571-272-7822
` Entered: June 4, 2019
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`ORTHOPEDIATRICS CORP.,
`Petitioner,
`
`v.
`
`K2M, INC.,
`Patent Owner.
`____________
`
`Case IPR2018-00429
`Patent 9,532,816 B2
`____________
`
`
`
`Before LYNNE H. BROWNE, MICHAEL L. WOODS, and
`ROBERT L. KINDER, Administrative Patent Judges.
`
`BROWNE, Administrative Patent Judge.
`
`
`
`
`FINAL WRITTEN DECISION
`35 U.S.C. § 318(a) and 37 C.F.R. § 42.73
`
`
`
`
`
`

`

`IPR2018-00429
`Patent 9,532,816 B2
`
`
`I.
`
`INTRODUCTION
`
`Orthopediatrics Corp. (“Petitioner”), on January 8, 2018, filed a
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`Petition requesting inter partes review of claims 16, 18, 19, 21, and 22 of
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`U.S. Patent No. 9,532,816 B2 (“the ’816 patent”). Paper 1 (“Pet.”). We
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`issued a Decision to Institute an inter partes review (Paper 8, “Dec.”) of all
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`challenged claims (16, 18, 19, 21, and 22) under all grounds, namely
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`Grounds 1–4 discussed below.
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`After institution of trial, K2M, Inc. (“Patent Owner”) filed a Patent
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`Owner Response (Paper 24, “PO Resp.”), to which Petitioner replied (Paper
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`30, “Pet. Reply”), and a Sur-Reply (Paper 35, “PO Sur-Reply).
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`Oral argument was concurrently conducted on February 21, 2019, for
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`this and related proceeding IPR2018-00521, and the transcript of the hearing
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`has been entered as Paper 41.
`
`
`
`We have jurisdiction under 35 U.S.C. § 318(a). After considering the
`
`evidence and arguments of both parties, and for the reasons set forth below,
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`we determine that Petitioner has not met its burden of showing, by a
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`preponderance of the evidence, that any of claims 16, 18, 19, 21, and 22 are
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`unpatentable.
`
`II.
`
`BACKGROUND
`
`A.
`
`Related Proceedings
`
`Petitioner is a defendant in a lawsuit involving the ’816 patent. Pet. 1
`
`(referencing K2M, Inc. v. OrthoPediatrics Corp. & OrthoPediatrics US
`
`Distribution Corp., Case No. 1:17-cv-00061-GMS (D. Del.)).
`
`On the same day that the Petition in the instant proceeding was filed,
`
`Petitioner filed a second petition requesting inter partes review also
`
`challenging claims 16, 18, 19, 21, and 22 of the ’816 patent. IPR2018-
`
`2
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`

`

`IPR2018-00429
`Patent 9,532,816 B2
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`00521. Subsequently, Petitioner filed three petitions challenging claims 1, 3,
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`5, 6, 8–10, 12, and 15–19 of U.S. Patent No. 9,655,664 B2, which is a
`
`divisional of the ’816 patent. IPR2018-01546, 1547, 1548.
`
`B.
`
`The ’816 Patent
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`The ’816 patent is directed “to devices for stabilizing and fixing the
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`bones and joints of the body. Particularly, the present invention relates to a
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`manually operated device capable of reducing a rod into position in a rod
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`receiving notch in the head of a bone screw with a controlled, measured
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`action.” Ex. 1001, 1:14–19. The device described in the ’816 patent
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`achieves this objective by grasping “the head of a bone screw and reduc[ing]
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`a rod into the rod receiving recess of the bone screw using a single manual
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`control that can be activated in a controlled and measured manner.” Id. at
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`2:23–27.
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`3
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`

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`IPR2018-00429
`Patent 9,532,816 B2
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`
`Figure 4 reproduced below illustrates the device:
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`Figure 4 is an isometric view of the rod reducing device with the screw jack
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`mechanism fully retracted and the two elongated grasping members in an
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`
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`open configuration. Ex. 1001, 3:27–30.
`
`The ’816 patent states that
`
`The device . . . is a rod reduction device capable of
`reducing a rod into position in a rod receiving notch in the head
`of a bone screw with a controlled, measured action. The device
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`4
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`

`

`IPR2018-00429
`Patent 9,532,816 B2
`
`
`is an elongated rod reduction device 10 that includes a screw jack
`mechanism 12 moveably engaged with an elongated grasping
`fork assembly 14. The screw jack mechanism 12 includes an
`elongated threaded screw shaft 16 that terminates at its most
`proximal end with a controlling member 18 and terminates at its
`most distal end with a rod contact member 20.
`
`Id. at 3:63–4:5.
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`C.
`
`Illustrative Claim
`
`Petitioner challenges claims 16, 18, 19, 21, and 22 of the ’816 patent.
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`Claim 16, reproduced below, is the only challenged independent claim and
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`illustrative of the claims at issue.
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`16. A rod reducing device comprising:
`a housing defining a longitudinal axis, the housing
`including first and second grasping members configured to
`grasp a portion of a bone anchor therebetween, the first and
`second grasping members defining a plane;
`a rotatable member extending through the housing along
`the longitudinal axis; and
`a rod contact member positioned at a distal end of the
`rotatable member, the rod contact member translatable along
`the longitudinal axis in response to rotation of the rotatable
`member about the longitudinal axis, wherein the rod contact
`member and the rotatable member are translatable within the
`plane defined by the first and second grasping members.
`
`Ex. 1001, 10:22–35.
`
`
`
`
`5
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`

`

`IPR2018-00429
`Patent 9,532,816 B2
`
`
`D. References Relied Upon
`
`The Petitioner relies in relevant part on the following references
`
`(Pet. 3):
`
`Name
`
`Reference
`
`Ex. No.
`
`Iott
`
`US 2006/0247630 A1, published Nov. 2, 2006
`
` 1002
`
`Runco
`
`US 2006/0079909 A1, published Apr. 13, 2006
`
` 1003
`
`Trudeau US 2006/0089651 A1, published Apr. 27, 2006
`
` 1004
`
`Pond
`
`US 2006/0036255 A1, published Feb. 16, 2006
`
` 1005
`
`
`
`E. The Asserted Grounds of Unpatentability
`
`Petitioner asserts the challenged claims—claims 16, 18, 19, 21, and
`
`22—are unpatentable on the following grounds:
`
`Reference(s)
`
`Basis
`
`Claims challenged
`
`Iott
`
`Runco
`
`Trudeau
`
`§ 102(e)
`
`16, 18, 19, 21, and 22
`
`§ 102(b)
`
`16, 18, 19, 21, and 22
`
`§ 102(b)
`
`16, 18, 19, 21, and 22
`
`Trudeau and Pond
`
`§ 103(a)
`
`16, 18, 19, 21, and 22
`
`Pet. 3. Petitioner supports its challenge with the Declaration of Ottie
`
`Pendleton, dated January 8, 2018 (Ex. 1006). Patent Owner supports its
`
`opposition to these challenges with the Declaration of Troy Drewry, dated
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`September 14, 2018 (Ex. 2021).
`
`
`
`III. ANALYSIS
`
`A petition must show how the construed claims are unpatentable
`
`under the statutory ground it identifies. 37 C.F.R. § 42.104(b)(4). Petitioner
`
`bears the burden of proving unpatentability of the challenged claims, and the
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`6
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`IPR2018-00429
`Patent 9,532,816 B2
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`burden of persuasion never shifts to Patent Owner. Dynamic Drinkware,
`
`LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015). To
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`prevail, Petitioner must establish the facts supporting its challenge by a
`
`preponderance of the evidence. 35 U.S.C. § 316(e); 37 C.F.R. § 42.1(d).
`
`A.
`
`Claim Construction
`
`In our Decision to Institute inter partes review in this proceeding, we
`
`construed the terms “extending through the housing” and declined to
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`construe, as unnecessary to our decision, the term “grasping.” Dec. 6–10.
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`As the construction of neither of these terms is necessary to our final
`
`decision, we maintain our construction of “extending through the housing”
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`and again decline to construe “grasping.” In our Decision to Institute inter
`
`partes review, we also adopted the definition of “housing” advanced by the
`
`United States District Court for the District of Delaware. In accordance with
`
`that definition, we understand the claim term “housing” to be “the fixed
`
`portion of the rod reducing device that defines the body through passage.”
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`Dec. 8. For purposes of this final decision, we likewise adopt this definition
`
`of “housing.”
`
`Central to our decision below is our construction of the claim term
`
`“rod contact member.” Accordingly, an issue before us is the proper
`
`construction of this term. Specifically, at issue is whether we construe “rod
`
`contact member” to require direct contact of the rod by the member.
`
`Neither Patent Owner nor Petitioner proposes an explicit claim
`
`construction for this term. See PO Resp. 8–23; Pet. 4, PO Sur-Reply 2–18;
`
`Pet. Reply 1–10. Both Patent Owner and Petitioner, however, allude to their
`
`construction of this term in their arguments. For example, in the Patent
`
`Owner’s Response, Patent Owner states, “[t]he rod contact member, as is
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`7
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`

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`IPR2018-00429
`Patent 9,532,816 B2
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`explicitly recited in the claim, is the element of the claims that is in direct
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`contact with the rod.” PO Resp. 30. Further, in contesting the challenge
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`based on Iott, Patent Owner asserts that “Petitioner overlooks the
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`requirement that the ‘rod contact member’ contact the rod and, instead, opts
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`to identify a component, reducer shaft 304, which never makes contacts with
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`the rod.” Id. at 37. Thus, we understand Patent Owner to construe the claim
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`term “rod contact member” to require actual contact of the rod by that
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`member. Similarly, Petitioner’s construction is apparent from their
`
`arguments. For example, in arguing that “claim 16 . . . does not recite a rod”
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`and that “claim 16 does not recite that anything must directly contact a rod,”
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`Petitioner construes this term to encompass elements that do not directly
`
`contact the rod. Pet. Reply 16–17 (emphasis omitted).
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`1. Principles of Claim Construction
`
`In this proceeding, we determine the meaning of a claim using the
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`“broadest reasonable construction in light of the specification of the patent in
`
`which it appears.” 37 C.F.R. § 42.100(b) (2017); Cuozzo Speed Techs., LLC
`
`v. Lee, 136 S. Ct. 2131, 2144–46 (2016) (upholding the use of the broadest
`
`reasonable interpretation approach).1
`
`In addition to the specification, the prosecution history plays an
`
`important role in claim construction. Tempo Lighting, Inc. v. Tivoli, LLC,
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`742 F.3d 973, 977 (Fed. Cir. 2014) (“In claim construction, this court gives
`
`
`1 On October 11, 2018, the USPTO revised its rules to harmonize the
`Board’s claim construction standard with that used in federal district court.
`See 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). This rule change, however, applies to petitions filed
`after November 13, 2018, and does not apply to this proceeding. Id.
`
`8
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`IPR2018-00429
`Patent 9,532,816 B2
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`primacy to the language of the claims, followed by the specification.
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`Additionally, the prosecution history, while not literally within the patent
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`document, serves as intrinsic evidence for purposes of claim construction.
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`This remains true in construing patent claims before the PTO.” (citing In re
`
`Morris, 127 F.3d 1048, 1056 (Fed. Cir. 1997)). Indeed, the U.S. Court of
`
`Appeals for the Federal Circuit has indicated, in the context of an inter
`
`partes review, that “[t]he PTO should . . . consult the patent’s prosecution
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`history in proceedings in which the patent has been brought back to the
`
`agency for a second review.” Microsoft Corp. v Proxyconn, Inc., 789 F.3d
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`1292 (2015) (citing Tempo Lighting, 742 F.3d at 798).
`
`2. Express Claim Language
`
`In accordance with the broadest reasonable interpretation, the plain
`
`meaning of “rod contact member” is a member that contacts a rod. Any
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`other interpretation reads the word “contact” out of the term. Thus, the
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`express claim language reasonably supports Patent Owner’s construction of
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`“rod contact member” as requiring a member that directly contacts the rod.
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`3.
`
`Specification
`
`The specification describes rod contact member 20 as being “brought
`
`to bear against a rod positioned over [a] screw.” Ex. 1001, 6: 41–42.
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`Further, as shown in Figure 3B of the ’816 Patent, reproduced below, rod
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`9
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`IPR2018-00429
`Patent 9,532,816 B2
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`contact member 20 is designed to come into direct contact with the head of a
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`screw placed in the opening between grasping members 80 and 82.
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`
`
`
`
`
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`Figure 3B is a cross-sectional view of the rod reducing device with the screw
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`jack mechanism fully extended. Thus, the Specification also supports Patent
`
`Owner’s interpretation of “rod contact member.”
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`4.
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`Prosecution History
`
`During prosecution, the Examiner also construed “rod contacting
`
`member” to require a member that directly contacts the rod. For example, in
`
`10
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`IPR2018-00429
`Patent 9,532,816 B2
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`the Final Action mailed August 19, 2016, the Examiner relied upon this
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`interpretation in rejecting claim 17 as anticipated by Jackson (US
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`5,720,751).2 Specifically, the Examiner identified Jackson’s pusher bar or
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`rod engaging member 15 as corresponding to the claimed “rod contact
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`member.” Ex. 2001, 73. Jackson describes its pusher bar or rod engaging
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`member 15 as including abutment member 20 that is “sized and shaped to
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`conform to the shape of a portion of the outer surface of a spinal rod 7.”
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`Jackson, 6:40–41. Describing the operation of its device, Jackson states,
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`“The surgeon (not shown) then rotates the stem 16 to advance the pusher bar
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`15 toward the bone screw 11 positioned within the cradle 67 of the implant
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`engaging portion 52 until the abutment member 20 of the pusher bar 15
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`engages the spinal rod 7.” Id. at 8:11–15. Thus, the Examiner construed
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`“rod contact member” to require a member that directly contacts the rod.
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`Accordingly, the prosecution history supports Patent Owner’s construction
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`of “rod contact member.
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`5.
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`Summary
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`Upon reviewing the explicit claim language, the specification, and the
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`prosecution history, we conclude that “rod contact member” requires a
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`member that directly contacts the rod.
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`B.
`
`Principles of Law
`
`To establish anticipation, each and every element in a claim, arranged
`
`as recited in the claim, must be found in a single prior art reference. Net
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`MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1369 (Fed. Cir. 2008);
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`Karsten Mfg. Corp. v. Cleveland Golf Co., 242 F.3d 1376, 1383 (Fed. Cir.
`
`
`2 Then pending claim 17 is renumbered as claim 16 in the ’816 patent.
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`11
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`IPR2018-00429
`Patent 9,532,816 B2
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`2001). “A reference anticipates a claim if it discloses the claimed invention
`
`such that a skilled artisan could take its teachings in combination with his
`
`own knowledge of the particular art and be in possession of the invention.”
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`In re Graves, 69 F.3d 1147, 1152 (Fed. Cir. 1995) (internal citation and
`
`emphasis omitted). Moreover, “it is proper to take into account not only
`
`specific teachings of the reference but also the inferences which one skilled
`
`in the art would reasonably be expected to draw therefrom.” In re Preda,
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`401 F.2d 825, 826 (CCPA 1968).
`
`A patent claim is unpatentable under 35 U.S.C. § 103(a) if the
`
`differences between the claimed subject matter 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 said
`
`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;
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`(3) the level of ordinary skill in the art; and, when presented, (4) objective
`
`evidence of nonobviousness.3 Graham v. John Deere Co., 383 U.S. 1, 17–
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`18 (1966).
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`We analyze the asserted grounds of unpatentability in accordance with
`
`the above-stated principles.
`
`
`3 In its Response, Patent Owner presents objective evidence of
`nonobviousness. PO Resp. 70–74. As consideration of objective evidence
`of nonobviousness is not necessary to our decision, we do not address this
`evidence in our analysis below.
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`12
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`IPR2018-00429
`Patent 9,532,816 B2
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`
`C.
`
`Anticipation of Claims 16, 18, 19, 21 and 22 by Iott
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`Petitioner contends that claims 16, 18, 19, 21, and 22 are anticipated
`
`by Iott in accordance with 35 U.S.C. § 102(e). Pet. 9–22. Having now
`
`considered the evidence in the complete record established during trial, we
`
`are not persuaded that Petitioner has demonstrated by a preponderance of the
`
`evidence that these claims would have been anticipated by Iott. We begin
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`our analysis with a brief overview of Iott. Next, we address the parties’
`
`contentions and then we discuss our reasoning. Our analysis focuses on
`
`independent claim 16, from which all other challenged claims depend.
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`1.
`
`Iott
`
`Iott is directed “to a vertebral stabilization system, and more
`
`particularly, but not exclusively, to a percutaneous vertebral stabilization
`
`system.” Ex. 1002 ¶ 2. Figures 31 and 32, reproduced below, illustrate one
`
`embodiment of this system:
`
`13
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`IPR2018-00429
`Patent 9,532,816 B2
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`
`
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`Iott’s Figure 31 is a perspective view of an assembly shown in operation in a
`
`first position, and Iott’s Figure 32 is a perspective view of the assembly
`
`shown in operation in a second position. Id. ¶¶ 44, 45.
`
`
`
`The assembly shown in Figures 31 and 32 includes “[r]od reducer
`
`instrument 300 [that] generally comprises a rotation shaft 302, a reducer
`
`shaft 304, and an attachment sleeve 306, configured to engage and attach to
`
`a proximal end of sleeves 22, 24.” Ex. 1002 ¶ 70. Iott explains that
`
`“[r]otation shaft 302 comprises a through-hole 310 adjacent a distal end of
`
`shaft 302 [that] is configured to receive a pin 312 therethrough to axially
`
`14
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`IPR2018-00429
`Patent 9,532,816 B2
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`connect rotation shaft 302 to reducer shaft 304.” Id. Iott further explains
`
`that “[p]in 312 is configured to engage a radial slot 314 of shaft 304 such
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`that shaft 304 may rotate freely while remaining axially fixed to shaft 302”
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`and “[r]otation shaft 302 comprises an externally threaded section 308 along
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`a portion of the shaft configured to threadedly engage or mate with
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`corresponding internal threads along the interior of attachment sleeve 306.”
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`Id.
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`2.
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`Petitioner’s Challenge
`
`Petitioner maps elements from Iott to each limitation of claims 16, 18,
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`19, 21, and 22. Pet. 20–33. For example in challenging independent claim
`
`16, Petitioner submits that
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`a. Iott’s rod reducer instrument 300 corresponds to the claimed rod
`
`reducing device. Pet. 10.
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`b. Iott’s attachment sleeve 306 attached to sleeve 22, which includes
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`inner sleeve member 52 and outer sleeve member 54, corresponds
`
`to the claimed housing. Id. at 11–12.
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`c. Iott’s arms 72, 74 correspond to the claimed first and second
`
`grasping members. Id. at 12.
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`d. Iott’s rotation shaft 302 corresponds to the claimed rotatable
`
`member. Id. at 14.
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`e. Iott’s reducer shaft 304 corresponds to the claimed rod contact
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`member. Id. at 15–16.
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`Specifically, with respect to the claimed rod contact member,
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`Petitioner contends that “Iott discloses ‘a rod contact member positioned at a
`
`distal end of the rotatable member’ as recited in claim 16.” Pet. 15. In
`
`support of this contention, Petitioner explains that “Iott discloses ‘[r]otation
`
`15
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`IPR2018-00429
`Patent 9,532,816 B2
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`shaft 302 [the claimed rotatable member] comprises a through-hole 310
`
`adjacent a distal end of shaft 302 and is configured to receive a pin 312
`
`therethrough to axially connect rotation shaft 302 [the claimed rotatable
`
`member] to reducer shaft 304 [the claimed rod contact member].’” Id. at
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`15–16 (citing Ex. 1001 ¶ 71; Fig. 31) (emphasis omitted). Iott’s Figures 30
`
`and 31, as annotated by Petitioner, are reproduced below:
`
`
`
`
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`Figure 30 (left) is an annotated side view of a rod reducer assembly and
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`Figure 31 (right) is an annotated perspective view of assembly. Ex. 1001
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`¶ 44–45. According to Petitioner, “[a]s shown in FIG. 31, the reducer shaft
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`304 (i.e., the claimed rod contact member) contacts the stabilization member
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`228 (i.e., a rod) and thus is a rod contact member.” Pet. 16.
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`
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`In its Reply, Petitioner provides alternative theories for how Iott meets
`
`the rod contact member limitation. Reply 16–18. Petitioner contends that
`
`claim 16 does not require direct contact between the rod contact member and
`
`the rod. Id. at 16–17. In support of this contention, Petitioner asserts that
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`“K2M’s expert concedes, [that] claim 16 (unlike claim 19) does not recite a
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`16
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`IPR2018-00429
`Patent 9,532,816 B2
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`‘rod.’” Id. (citing Ex. 1006, 59:6–60:12). Petitioner further alleges that
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`“claim 16 does not recite that anything must directly contact a rod.” Id. at
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`17 (emphasis omitted).
`
`Alternatively, Petitioner contends that Iott’s reducer shaft 304 directly
`
`contacts the rod. Id. at 17–18. Noting that “K2M’s expert admits, [that] cap
`
`30—which, according to K2M, prevents direct contact—is not depicted in
`
`FIG. 32,” Petitioner asserts that “a ‘cap’ is not necessarily required in all
`
`embodiments of Iott.” Id. at 17 (citing Ex. 2021, 86). In support of this
`
`assertion, Petitioner notes that “Iott discloses that ‘in one embodiment, the
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`distal end [of reducer shaft 304] comprises cap engaging or holding
`
`protrusions 322 extending inward to engage a cap.’” Id. (citing Ex. 1003
`
`¶ 70). Petitioner further argues that “the Board correctly recognized that
`
`both the cap and the distal end of the reducer shaft 304 together contact the
`
`rod, satisfying the limitation.” Id. at 18 (citing PO Resp. 41; Dec. 19.)
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`3. Patent Owner’s Response
`
`Among other contentions, Patent Owner contends that Iott fails to
`
`disclose “a rod contact member positioned at the distal end of the rotatable
`
`member” as required by claim 16. PO Resp. 40 (emphasis added). Patent
`
`Owner’s contention is premised on the proposition that the rod contact must
`
`directly contact the rod. See id. In support of this contention, Patent Owner
`
`argues that “Iott’s rod reduction device does not contact the rod. Instead Iott
`
`discloses the rod is contacted by an implant—a cap—specifically designed
`
`to contact the rod.” Id.
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`Patent Owner disagrees with Petitioner’s contention that direct contact
`
`by the rod contacting member with the rod is not required by claim 16. See
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`PO Resp. 40–41. According to Patent Owner, “[t]he intrinsic record only
`
`17
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`IPR2018-00429
`Patent 9,532,816 B2
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`supports direct contact of the rod contact member against the rod. As is
`
`clear from the claim, a “rod contact member” is the claim element that
`
`contacts the rod.” Id. at 40. Noting that “[t]he specification states that the
`
`rod contact member is ‘brought to bear against a rod positioned over the
`
`screw’ (Ex. 1001, 6:40–44) so that the ‘rod can be forced downward into a
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`receiving recess of a bone screw head,’” Patent Owner argues that “[t]here is
`
`no support in the specification that the ‘rod contact member’ is anything
`
`other than what makes direct contact with the rod.” Id. at 40–41. Patent
`
`Owner further notes that “Petitioner’s declarant does not cite to anything [in
`
`support of his contention].” Id. at 41 (citing Ex. 1006 ¶ 57).
`
`Responding to Petitioner’s arguments in Petitioner’s Reply that claim
`
`16 does not recite anything that directly contacts a rod (Pet. Reply 16–17),
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`Patent Owner asserts that Petitioner “reads out Claim 16’s limitation of a rod
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`contact member.” Sur-Reply 21.
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`Turning to Petitioner’s alternative theory that Iott discloses direct
`
`contact between its reducer shaft 304 and the rod, Patent Owner asserts that
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`Petitioner disregards the plain language of claim 16. PO Resp. 41 (citing
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`Ex. 2021 ¶¶ 179–180). Patent Owner notes that Iott “explicitly discloses
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`that a cap located at the distal end of the reducer shaft 304 contacts the rod,
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`not the reducer shaft 304.” Id. (citing Ex. 1002 ¶ 71). Based on this
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`description in Iott, Patent Owner asserts that “[t]his cap may not be omitted
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`as it is necessary to secure the rod within the fastener (Ex. 2021[] ¶¶ 180–
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`181). Thus[,] Iott discloses that the cap that contacts the rod, not the reducer
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`shaft 304 alleged by Petitioner.” Id. (citing Ex. 2021 ¶ 182).
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`Responding to Petitioner’s argument in the Reply, Patent Owner
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`asserts that “Petitioner’s reliance on Iott’s figures for arguing reducer shaft
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`304 ‘makes direct contact with rod 228’ not only conflicts with Petitioner’s
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`prior acknowledgement that the figures are imprecise but also with Iott’s
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`clear disclosure that the rod would be affixed into a bone anchor.” Sur-
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`Reply 22 (citing Reply 14, 17). Patent Owner alleges that “Petitioner’s
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`reliance on paragraph 70 of Iott to allege that only one embodiment requires
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`cap 30 fails to acknowledge what was well-known by a POSITA: a rod is
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`affixed, such as by a cap, so the rod would not come free.” Id. (citing Ex.
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`2021 ¶ 181) (footnote omitted). Rather, according to Patent Owner, “Iott
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`disclosed removing the rod reducer only once a cap secured the rod in
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`place.” Id. (citing Ex. 1002 ¶¶ 71, 80). Patent Owner further asserts that
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`“Petitioner’s argument that reducer shaft 304 and cap together contact the
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`rod mixes the roles of instruments and implants.” Id.
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`4. Analysis
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`Having considered Patent Owner’s arguments and the full record
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`developed during trial and if view our construction of the claim term “rod
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`contact member” as requiring direct contact between the member and a rod,
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`we determine Petitioner has not shown the challenged claims to be
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`unpatentable.
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`As noted above, Petitioner’s challenge identifies Iott’s reducer shaft
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`304 as corresponding to the claimed rod contact member. Pet. 15–16.
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`Petitioner does not identify Iott’s cap as corresponding to the claimed rod
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`contact member. See id. Further, Iott does not describe its cap as a part of
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`reducer shaft 304. Rather, as quoted below, Iott states that reducer shaft 304
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`engages the cap in a releasable manner. Ex. 1002 ¶ 71.
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`In paragraph 71, reproduced below, Iott describes its reducer
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`shaft 304 (identified by Petitioner as corresponding to the claims rod
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`contact member) as follows:
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`As best seen in FIG. 33, reducer shaft 304 is a cannulated
`shaft including a central lumen 320 extending therethrough.
`Radial indentation or slot 314 is provided adjacent the proximal
`end to axially connect with rotation shaft 302. The proximal end
`of shaft 304 includes a rotation tool engaging feature to facilitate
`rotation of shaft 304 and the distal end of shaft 304 is configured
`to hold a cap. Referring to FIG. 34, in one embodiment, the
`distal end comprises cap engaging or holding protrusions 322
`extending inward to engage a cap. Furthermore, a pair of slits
`324 may be provided to allow slight movement of the distal end
`of shaft 304 to releaseably engage the fastener cap. A key slot
`326 may be provided to facilitate entry and alignment with
`sleeves 22, 24 and by extension anchors 12, 14 attached at the
`distal end thereof. The cap held in the distal end has a channel
`or trough to engage the rod to push the rod downward toward
`the fastener.
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`Ex. 1002 ¶ 71 (emphases added; numeral emphases omitted).
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`
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`Nothing in this paragraph supports Petitioner’s position that Iott’s
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`reducer shaft 304 contacts the rod as required by claim 16. Rather, this
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`paragraph explicitly states that the cap engages the rod. See id. Moreover,
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`we do not understand Iott’s paragraph 70 to limit the use of a cap to only one
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`embodiment of Iott’s device. We recognize that while it is possible that
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`Iott’s cap could be held in such a way that both the cap and the rod reducer
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`shaft contact the rod, there is no evidence in support of such a determination.
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`This ambiguity weighs against a final determination that Petitioner has
`
`established by a preponderance of the evidence that Iott discloses the
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`claimed limitation. See 35 U.S.C. § 312(a)(3) (requiring inter partes review
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`petitions to identify “with particularity . . . the evidence that supports the
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`grounds for the challenge to each claim”)); 37 C.F.R. § 42.104(b) (requiring
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`a petition for inter partes review to identify how the challenged claim is to
`
`be construed and where each element of the claim is found in the prior art
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`patents or printed publications relied on); see Harmonic Inc. V. Avid Tech,
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`Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016) (“In an [inter partes review], the
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`petitioner has the burden from the onset to show with particularity why the
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`patent it challenges is unpatentable.
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`5.
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`Conclusion Regarding Iott
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`For the foregoing reasons, we conclude that Petitioner fails to
`
`establish by a preponderance of evidence that Iott anticipates claim 16 in
`
`accordance with 35 U.S.C. § 102(e). For the same reasons, we conclude that
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`Petitioner fails to establish that Iott anticipates claims 18, 19, 21, and 22,
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`which depend from claim 16, in accordance with § 102(e).
`
`D.
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`Anticipation of Claims 16, 18, 19, 21, and 22 by Runco
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`Petitioner asserts that Runco anticipates claims 16, 18, 19, 21, and 22
`
`in accordance with 35 U.S.C. § 102(b). Pet. 22–32. Having now considered
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`the evidence in the complete record established during trial, we are not
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`persuaded that Petitioner has demonstrated by a preponderance of the
`
`evidence that these claims would have been anticipated by Runco. We begin
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`our analysis with a brief overview of Runco. Next, we address the parties’
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`contentions and then we discuss our reasoning. Our analysis focuses on
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`independent claim 16, from which all other challenged claims depend.
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`1. Runco
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`Runco is directed to “[s]pinal fixation systems . . . used in orthopedic
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`surgery to align and/or fix a desired relationship between adjacent vertebral
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`bodies.” Ex. 1003 ¶ 2. Figures 27A–27C, reproduced below, illustrate one
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`embodiment of these systems:
`
`
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`Figure 27A is a side view of an instrument for adjusting a spinal rod relative
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`to a bone anchor, illustrating a rod adjusting tool positioned within a bone
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`anchor engaging too. Ex. 1003 ¶ 51. Figure 27B is a side view of the
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`instrument shown in Figure 27A, and Figure 27C is a side view in cross
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`section of this instrument. Id. ¶¶ 52, 53.
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`The instrument 400 shown in Figures 27A–27C “includes an implant
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`(e.g., bone anchor) engaging tool 412 for engaging at least a portion of an
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`implant such as a bone anchor” and “a rod adjustment tool 414 that is
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`connectable to the bone anchor engaging tool 412 [that] may be axially
`
`adjustable relative to the bone anchor engaging tool 412.” Ex. 1003 ¶ 100
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`(emphasis omitted). The bone anchor engaging tool includes “a first jaw
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`member 418A and a second jaw member 418B which can cooperate to
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`engage an implant such as a bone anchor” having “distal ends 422A, 42B to
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`rotate from an approximately closed position in which the jaw members are
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`proximate one another, as illustrated in FIG. 27D, to an open position in
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`which the distal end 422A, 422B are displaced from one another.” Id. ¶ 101
`
`(emphases omitted).
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`Rod adjusting tool 414 also includes “a distal component 419 having a
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`rod engaging surface 421 and a proximal component 423 connectable to and
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`separable from the distal component 419.” Id. ¶ 104 (emphasis omitted).
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`Runco explains that “[i]n operation, rotation of the proximal component 423
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`causes the distal component 419 to advance axially relative to the bone
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`anchor engaging tool 412.” Id.
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`2. Petitioner’s Challenge
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`Petitioner maps elements from Runco to each limitation of claims 16,
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`18, 19, 21, and 22. Pet. 22–32. For example, in challenging independent
`
`claim 16, Petitioner submits that
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`a. Runco’s instrument 400 corresponds to the claimed rod reducing
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`device. Pet. 23.
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`b. Runco’s implant engaging tool 412 corresponds to the claimed
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`housing. Id. at 23–24.
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`c. Runco’s jaw members 418A, 418B correspond to the claimed first
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`and second grasping members. Id. at 24.
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`d. Runco’s proximal component 423 corresponds to the claimed
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`rotatable member. Id. at 26.
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`e. Runco’s distal component 419 corresponds to the claimed rod
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`contact member. Id. at 27–28.
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`As noted above, Petitioner identifies Runco’s engaging tool 412 as
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`corresponding the claimed housing. Petitioner’s position is illustrat