Trials@uspto.gov Paper 38
`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 IPR2018-00521
`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
`
`
`
`
`
`
`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 IPR2018-00521
`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
`
`
`
`
`
`
`
`IPR2018-00521
`Patent 9,532,816 B2
`
`
`I.
`
`INTRODUCTION
`
`Orthopediatrics Corp. (“Petitioner”), on January 8, 2018, filed a
`
`Petition requesting inter partes review of claims 16, 18, 19, 21, and 22 of
`
`U.S. Patent No. 9,532,816 B2 (“the ’816 patent”). (Paper 1, “Pet.”). We
`
`issued a Decision to Institute an inter partes review (Paper 8, “DI”) of all
`
`challenged claims (16, 18, 19, 21, and 22) under all grounds, namely
`
`Grounds 1–8 discussed below.
`
`After institution of trial, K2M, Inc. (“Patent Owner”) filed a Patent
`
`Owner Response (Paper 20, “PO Resp.”), to which Petitioner replied (Paper
`
`26, “Pet. Reply”). Patent Owner also filed a Sur-Reply (Paper 31, “PO Sur-
`
`Reply).
`
`Oral argument was concurrently conducted on February 21, 2019, for
`
`this and related proceeding IPR2018-00429, and the transcript of the hearing
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`has been entered as Paper 37.
`
`
`
`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,
`
`we determine that Petitioner has not met its burden of showing, by a
`
`preponderance of the evidence, that any of claims 16, 18, 19, 21, and 22 are
`
`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 another petition requesting inter partes review challenging
`
`2
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`
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`IPR2018-00521
`Patent 9,532,816 B2
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`claims 16, 18, 19, 21, and 22 of the ’816 patent. IPR2018-00429. The final
`
`decision in that proceeding is being issued concurrently with this decision.
`
`Subsequently, Petitioner filed three Petitions challenging claims 1, 3, 5, 6,
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`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
`
`The ’816 patent is directed to “devices for stabilizing and fixing the
`
`bones and joints of the body. Particularly, the present invention relates to a
`
`manually operated 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.” Ex. 1101, 1:14–19. The device described in the ’816 patent
`
`achieves this objective by grasping “the head of a bone screw and reduc[ing]
`
`a rod into the rod receiving recess of the bone screw using a single manual
`
`control that can be activated in a controlled and measured manner.” Id. at
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`2:23–27.
`
`3
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`IPR2018-00521
`Patent 9,532,816 B2
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`
`Figure 4 reproduced below illustrates the device:
`
`Figure 4 is an isometric view of the rod reducing device with the screw jack
`
`mechanism fully retracted and the two elongated grasping members in an
`
`
`
`open configuration. Ex. 1101, 3:27–30.
`
`The ’816 patent explains:
`
`The device . . . is a rod [34] 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
`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
`
`4
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`IPR2018-00521
`Patent 9,532,816 B2
`
`
`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.
`
`C.
`
`Illustrative Claim
`
`Petitioner challenges claims 16, 18, 19, 21, and 22 of the ’816 patent.
`
`Claim 16, reproduced below, is the challenged independent claim.
`
`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. 1101, 10:22–35.
`
`
`D. References Relied Upon
`
`The Petitioner relies in relevant part on the following references
`
`(See Pet. 4):
`
`Name
`
`Reference
`
`Ex. No.
`
`Whipple US 2006/0293692 A1, published Dec. 28, 2006
`
` 1102
`
`Runco
`
`US 2006/0079909 A1, published Apr. 13, 2006
`
` 1103
`
`Varieur
`
`US 2005/0149053 A1, published July 7, 2005
`
` 1104
`
`Jackson US 2005/0192570 A1, published Sept. 1, 2005
`
` 1105
`
`Trudeau US 2006/0089651 A1, Published Apr. 27, 2006
`
` 1106
`
`
`
`5
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`IPR2018-00521
`Patent 9,532,816 B2
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`E. The Asserted Grounds of Unpatentability
`
`Petitioner asserts the challenged claims are unpatentable on the
`
`following grounds:
`
`Reference(s)
`
`Basis
`
`Claim(s) challenged
`
`Whipple (Fig. 11A)1
`
`§ 102(e)
`
`16, 18, 19, 21, and 22
`
`Whipple (Fig. 11A) and Runco
`
`§ 103(a)
`
`22
`
`Whipple (Fig. 11C)
`
`§ 102(e)
`
`16, 18, 19, 21, and 22
`
`Whipple (Fig. 11C) and Runco
`
`§ 103(a)
`
`16, 18, 19, 21, and 22
`
`Varieur
`
`§ 102(b)
`
`16, 18, 19, and 21
`
`Varieur and Runco
`
`§ 103(a)
`
`22
`
`Jackson
`
`§ 102(b)
`
`16, 18, 19, 21, and 22
`
`Jackson and Trudeau
`
`S 103(a)
`
`18
`
`Pet. 4. Petitioner supports its challenge with the Declaration of Ottie
`
`Pendleton, dated January 22, 2018 (Ex. 1107). Patent Owner supports its
`
`opposition to these challenges with the Declaration of Troy Drewry, dated
`
`September 14, 2018 (Ex. 2021).
`
`
`1 “[I]n order to show anticipation, the proponent must show ‘that the four
`corners of a single, prior art document describe every element of the claimed
`invention.’” Net MoneyIn, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1369 (Fed.
`Cir. 2008). In this proceeding, however, Petitioner presents two separate
`challenges based on anticipation by Whipple and distinguishes between
`these challenges by referring to the first as based on anticipation by
`“Whipple (Fig. 11A)” and the second as based on anticipation by “Whipple
`(Fig. 11C).” Pet. 10–26, 29–44. Although these grounds are more properly
`referred to as alternative grounds of anticipation by Whipple, for consistency
`and clarity we adopt Petitioner’s nomenclature while remaining fully
`cognizant that technically these grounds are based on the same prior art
`reference.
`
`6
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`IPR2018-00521
`Patent 9,532,816 B2
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`III. ANALYSIS
`
`A.
`
`Claim Construction
`
`In our Decision to Institute Inter Partes Review, we construed the
`
`terms “housing” and “extending through the housing” and declined to
`
`construe, as unnecessary to that decision, the term “grasping.” Dec. 8–11.
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`In this Final Written Decision, we also decline to construe “grasping” and
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`maintain our construction of “housing” and “extending through the
`
`housing,” as set forth in our Decision to Institute. Id. In accordance with
`
`our definition of “housing,” we understand that claim term to be “the fixed
`
`portion of the rod reducing device that defines the body through passage.”
`
`Id. at 10.
`
`Central to our decision below (Part III.C), regarding Petitioner’s
`
`second challenge based on anticipation by Whipple (FIG. 11C), is whether
`
`claim 16 requires a rotatable member and a rod contact member that are
`
`separate components. Claim 16 sets forth “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.” Patent Owner contends
`
`that the rotatable member and rod contact member are separate components.
`
`See, e.g., PO Resp. 31. Conversely, Petitioner maintains that “under BRI,
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`‘[c]laim 16 does not preclude a rod contact member that is part of the
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`rotatable member.’” Pet. Reply 14 (citing Dec. 19) (emphasis omitted). We
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`address this issue in detail below.
`
`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
`
`7
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`IPR2018-00521
`Patent 9,532,816 B2
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`v. Lee, 136 S. Ct. 2131, 2144–46 (2016) (upholding the use of the broadest
`
`reasonable interpretation approach).2
`
`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
`
`primacy to the language of the claims, followed by the specification.
`
`Additionally, the prosecution history, while not literally within the patent
`
`document, serves as intrinsic evidence for purposes of claim construction.
`
`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
`
`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
`
`1292, 1298 (Fed. Cir. 2015).
`
`2.
`
`Express Claim Language
`
`Claim 16 introduces the rotatable member and rod contact member in
`
`separate phrases which indicates that they are separate components of the
`
`rod reducing device. Ex. 1101, 10:27–30. Further, the claim expressly
`
`locates the rod reducing device at the distal end of the rotatable member,
`
`rather than indicating that it is the distal end of the rotatable device. Id. at
`
`
`2 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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`
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`IPR2018-00521
`Patent 9,532,816 B2
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`10:29–30. Thus, the express language of claim 16 reasonably supports
`
`Patent Owner’s position that the rotatable member and the rod contact
`
`member are separate components.
`
`3.
`
`Specification
`
`The specification does not use the claim term “rotatable member.”
`
`Instead, the specification describes elongated threaded screw shaft 16 of
`
`screw jack mechanism 12, which we understand to correspond to the
`
`claimed rotatable member. Ex. 1101, 4:2–3; see also Ex. 2021 ¶ 51
`
`(describing the movement of elongated screw shaft 16). The specification
`
`describes rod contact member 20 as “connected to the distal end of the
`
`elongated threaded screw shaft 16 . . . by contact member retention pins 28.”
`
`Ex. 1101, 4:29–42. Elongated threaded screw shaft 16, rod contact member
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`20, and contact member retention pins are illustrated in Figure 4, reproduced
`
`again below:
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`9
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`IPR2018-00521
`Patent 9,532,816 B2
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`
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`Figure 4 is an isometric view of the rod reducing device. Id. at 3:27–28.
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`Given that elongated threaded screw shaft 16 and rod contact member 20 are
`
`illustrated as separate components and the description in the specification
`
`that these components are connected via contact member retention pins 28
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`(also shown illustrated above), the specification also supports Patent
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`Owner’s position that the rotatable member and the rod contact member are
`
`separate components.
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`4.
`
`Prosecution History
`
`During prosecution, the Examiner considered the rotatable member
`
`and rod contact members to be separate components. For example, in
`
`10
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`IPR2018-00521
`Patent 9,532,816 B2
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`rejecting claim 17,3 based on anticipation by Jackson ’751 (US 5,720,751,
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`issued Feb. 24, 1998),4 the Examiner identified element 16 of Jackson ’751
`
`as corresponding to the claimed rotatable member and element 15 as
`
`corresponding to the claimed rod contact member. Ex. 2001, 73. Jackson
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`’751 describes element 15 as a pusher bar or rod engaging member and
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`element 16 as a stem. Ex. 3001, 6:27–28. Jackson states that pusher bar 15
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`and stem 16 are components of spinal rod pusher assembly. Id. Thus, the
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`prosecution history supports Patent Owner’s position that the rotatable
`
`member and the rod contact member were understood to be separate
`
`components.
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`5.
`
`Summary
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`Upon reviewing the explicit claim language, the specification, and the
`
`prosecution history, we conclude that the rotatable member and rod contact
`
`member of claim 16 are separate components.
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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
`
`MoneyIN, 545 F.3d at 1369 (Fed. Cir. 2008); Karsten Mfg. Corp. v.
`
`Cleveland Golf Co., 242 F.3d 1376, 1383 (Fed. Cir. 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.” In re Graves, 69
`
`F.3d 1147, 1152 (Fed. Cir. 1995) (internal citation and emphasis omitted).
`
`
`3 Then pending claim 17 was renumbered as claim 16 in the ’816 patent.
`4 We attach a copy of Jackson ’725 as Exhibit 3001 for ease of reference.
`
`11
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`IPR2018-00521
`Patent 9,532,816 B2
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`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, 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;
`
`(3) the level of ordinary skill in the art; and, when presented, (4) objective
`
`evidence of nonobviousness. Graham v. John Deere Co., 383 U.S. 1, 17–18
`
`(1966).
`
`We analyze the asserted grounds of unpatentability in accordance with
`
`the above-stated principles.
`
`C.
`
`Anticipation of Claims 16, 18, 19, 21 and 22
`by Whipple (Fig. 11A)
`
`Petitioner contends that claims 16, 18, 19, 21, and 22 are anticipated
`
`by Whipple (Fig. 11A). Pet. 10–26. 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 are anticipated by Whipple (Fig. 11A). We begin our analysis with a
`
`brief overview of features of Whipple which are common to Figures 11A
`
`and 11C, followed by an overview of the embodiment shown in Figure 11A.
`
`12
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`IPR2018-00521
`Patent 9,532,816 B2
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`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.
`
`1. Whipple
`
`Whipple is directed to “instruments and methods for manipulating a
`
`spinal fixation element, such as a spinal rod, relative to a bone anchor, such
`
`as a polyaxial or monoaxial bone screw.” Ex. 1102 ¶ 5. Figure 2,
`
`reproduced below, illustrates Whipple’s instrument:
`
`
`
`
`
`
`13
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`IPR2018-00521
`Patent 9,532,816 B2
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`Whipple’s Figure 2 is a front view of the instrument. Id. ¶ 11. Instrument
`
`10 shown in Figure 2 is configured to manipulate “a spinal fixation element
`
`12, such as, for example, a spinal rod, a plate, a tether or cable or
`
`combinations thereof, relative to a bone anchor 14.” Id. ¶ 26. Instrument 10
`
`includes “bone anchor grasping mechanism 18 . . . includ[ing] a first arm 24
`
`having a distal end 26” and “first adjustment mechanism 20 . . . includ[ing] a
`
`second arm 50 that is pivotally connected to the first arm 24.” Id. ¶¶ 28, 31.
`
`Instrument 10 also includes “second adjustment mechanism 22 . . . coupled
`
`to the first arm 24 and/or the second arm 50” comprising “elongated tubular
`
`body 60 having a proximal end 62 and a distal end 64 and a lumen 66
`
`extending between the proximal end 62 and the distal end 64.” Id. ¶ 34.
`
`
`
`Figure 9, reproduced below, illustrates an alternative embodiment of
`
`Whipple’s instrument:
`
`
`
`
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`14
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`IPR2018-00521
`Patent 9,532,816 B2
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`
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`Figure 9 is a side view of an alternative embodiment of Whipple’s
`
`instrument. Whipple ¶ 18. In this embodiment, “collar 102 may be
`
`integral to the second arm 50 of the instrument 10. Alternatively,
`
`collar 102 may be integral to first arm 24 or be formed by both first arm 24
`
`and second arm 50.” Id. ¶ 38. “[C]ollar 102 may be configured to allow the
`
`tube 60 to advance distally without rotation.” Id. ¶ 39. “For example, the
`
`collar 102 may include a threaded member 106 that is movable in a direction
`
`perpendicular to the tube 60 to allow the threaded member 106 to selectively
`
`engage the threads 70 on the tube 60.” Id. Whipple explains,
`
`[T]he threaded member 106 is movable between a first position
`in which the threaded member 106 engages the external threads
`70 in the tube 60 . . . and a second position in which the threaded
`member 106 disengages the external threads 70 on the tube 60 to
`permit axial motion of the tube 60 without rotation.
`
`Id. “In this manner, the tube 60 may be quickly advanced, without the need
`
`for rotation, into contact with the spinal fixation element 12.” Id.
`
`15
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`IPR2018-00521
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`Whipple also discloses alternative embodiments of distal end 64 of
`
`tube 60. One such embodiment is illustrated in Figure 11A reproduced
`
`below:
`
`Whipple’s Figure 11A is a side view of an embodiment of distal end of an
`
`adjustment mechanism for interacting with a spinal fixation element. Id.
`
`
`
`¶ 20.
`
`
`
`Distal end 64 of tube 60 is described as “indirectly or directly
`
`contact[ing] the spinal fixation element 12 to adjust the spinal fixation
`
`element 12 in the second direction.” Ex. 1102 ¶ 35. Whipple states, “in the
`
`illustrated embodiment, the tube 60 may be advanced with the closure
`
`mechanism delivery instrument 90 and the closure mechanism 92 may be
`
`positioned distal to the distal end 64 of the tube 60.” Id. Whipple explains
`
`that “closure mechanism 92 may contact the spinal fixation element 12 and,
`
`thus, the tube 60 may adjust the spinal fixation element 12 through the
`
`closure mechanism 92.” Id. Whipple further indicates that “the distal end
`
`64 may be forked or bifurcated to engage the spinal fixation element 12 on
`
`opposing sides . . . the distal end 64 may have an arcuate contact surface 68
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`16
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`having a curvature approximate to the curvature of the spinal fixation
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`element 12.” Id.
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`2.
`
`Petitioner’s Challenge
`
`Petitioner maps elements from Whipple to each limitation of claims
`
`16, 18, 19, 21, and 22. Pet. 10–26. In particular, Petitioner submits that
`
`Whipple’s tube 60 corresponds to the claimed rotatable member. Id. at 15–
`
`16. Specifically, Petitioner asserts that “Whipple discloses the claimed
`
`‘rotatable member extending through the housing along the longitudinal
`
`axis’ as recited in claim 16.” Id. at 15. Petitioner quotes Whipple’s
`
`statement that
`
`“[the] coupling mechanism 100 [the claimed housing] . . . is
`configured to receive the second adjustment mechanism 22, e.g.,
`tube 60 [the claimed rotatable member], and permit motion of
`the second adjustment mechanism 22 relative to the first arm 24
`[the claimed first grasping member] and/or the second arm 50
`[the claimed second grasping member].”
`
`Id. at 15–16 (emphasis omitted) (citing Ex. 1102 ¶ 36). According to
`
`Petitioner, “Whipple further discloses that ‘[r]otation of the tube 60 relative
`
`to the collar 102 causes the tube 60 to advance distally or proximally,
`
`depending on the direction of rotation, relative to the first arm 24 and the
`
`second arm 50.’” Id. at 16 (bracketed information and emphasis omitted)
`
`(citing Ex. 1102 ¶ 36).
`
`3. Patent Owner’s Response
`
`Among other contentions, Patent Owner contends that “Petitioner fails
`
`to demonstrate that the embodiment of Whipple (FIG. 11A) teaches the
`
`claimed ‘rotatable member.’” PO Resp. 33. In support of this contention,
`
`Patent Owner asserts that “tube 60 of FIG. 11A cannot rotate due to tube
`
`60’s configuration and the ‘forked’ or ‘bifurcated’ distal end 64.” Id. (citing
`
`17
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`Ex. 2021 ¶¶ 157–161). Patent Owner explains that (1) “tube 60 cannot
`
`rotate when arcuate contact surface 68 of distal end 64 engages with, or
`
`straddles, the rod 12,” (2) “a POSITA would understand embodiment FIG.
`
`11A only relates to FIG. 9, for which Whipple explicitly states that tube 60
`
`is ‘quickly advanced, without the need for rotation,’” and (3) “tube 60 and
`
`distal end 64 are unable to rotate because the ‘bifurcated’ or ‘forked’ shape
`
`of distal end 64 would hit arm 50 and any rotation would be halted.” Id.
`
`(citations omitted). Thus, according to Patent Owner, “tube 60 in the
`
`embodiment of Whipple FIG. 11A does not and cannot rotate and therefore
`
`fails to disclose the claimed ‘rotatable member.’” Id. (citing Ex. 2021
`
`¶ 161).
`
`Patent Owner also contends that Whipple does not disclose a rotatable
`
`member and a separate rod contact member. PO Resp. 31. This contention
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`is discussed at length below in Part III.E. Although, our analysis below is
`
`equally applicable to this challenge, it is not necessary to our decision for
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`this challenge. Accordingly, we do not discuss Patent Owner’s contention in
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`this section.
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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, we determine Petitioner has not shown the
`
`challenged claims to be unpatentable.
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`As discussed above, this challenge is based on in Whipple (Fig. 11A),
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`wherein distal end 64 of tube 60 is bifurcated or forked. Ex. 1102 ¶ 35.
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`Although we agree with Petitioner that Whipple discloses embodiments
`
`wherein tube 60 is a rotatable member, we also agree with Patent Owner that
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`18
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`IPR2018-00521
`Patent 9,532,816 B2
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`it is not clear the embodiment shown in Figure 11A is one of them. Rather,
`
`we credit the testimony of Patent Owner’s Declarant, Mr. Drewry, that
`
`a person of ordinary skill in the art would understand that the
`“bifurcated” or “forked” shape of distal end 64 would hit and
`interfere with the operation of arm 50. That is, the “bifurcated”
`or “forked” shape of distal end 64 would run into arm 50 and,
`therefore, be unable to rotate.
`
`Ex. 2021 ¶ 160. Further, to the extent that any doubt remains as to whether
`
`tube 60 as illustrated in Figure 11A is rotatable, that doubt must be resolved
`
`in favor of Patent Owner’s position, as Petitioner has the burden to show, by
`
`a preponderance of evidence, that the limitation pertaining to the rotatable
`
`member is met by Whipple (Fig. 11A).
`
`5. Conclusion Regarding Whipple (Fig. 11A)
`
`For the foregoing reason, we conclude that Petitioner fails to establish
`
`by a preponderance of evidence that Whipple (Fig. 11A) anticipates claim
`
`16 in accordance with 35 U.S.C. § 102(e). For the same reason, we
`
`conclude that Petitioner fails to establish that Whipple (Fig. 11A) anticipates
`
`claims 18, 19, 21, and 22, which depend from claim 16 in accordance with
`
`§ 102(e).
`
`D. Obviousness of Claim 22 Based on
`
`Whipple (Fig. 11A) and Runco
`
`Petitioner asserts that claim 22 is unpatentable under 35 U.S.C.
`
`§ 103(a) based on Whipple (Fig. 11A) and Runco. Pet. 26. 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 claim 22 would have been unpatentable over Whipple (Fig.
`
`11A) and Runco. As an overview of Whipple is provided above, we begin
`
`19
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`IPR2018-00521
`Patent 9,532,816 B2
`
`our analysis with a brief overview of Runco. Next, we address the parties’
`
`contentions, and then discuss our reasoning.
`
`1.
`
`Runco
`
`Runco is directed to “[s]pinal fixation systems . . . used in orthopedic
`
`surgery to align and/or fix a desired relationship between adjacent vertebral
`
`bodies.” Ex. 1103 ¶ 2. Figures 27C, reproduced below, illustrates the
`
`elements of Runco’s system pertinent to this challenge:
`
`
`
`
`
`Figure 27C is a side view in cross section of Runco’s instrument. Id. ¶ 53.
`
`This figure illustrates rod adjusting tool 414, which includes “distal
`
`component 419 having a rod engaging surface 421 and a proximal
`
`component 423 connectable to and separable from the distal component
`
`419.” Id. ¶ 104 (emphasis omitted). Runco explains that “[i]n operation,
`
`rotation of the proximal component 423 causes the distal component 419 to
`
`advance axially relative to the bone anchor engaging tool 412.” Id.
`
`1.
`
`Petitioner’s Challenge
`
`For this challenge, Petitioner relies upon the same assertions regarding
`
`Whipple (fig. 11A) discussed above in Part III.C. In particular, Petitioner
`
`asserts that the embodiment of Whipple’s distal end 64 shown in Figure 11A
`
`20
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`IPR2018-00521
`Patent 9,532,816 B2
`
`corresponds to the claimed rod contact member. Pet. 26. Alternatively,
`
`Petitioner asserts that Runco discloses this limitation. Id. at 27. In support
`
`of this assertion, Petitioner contends that “Runco discloses a distal
`
`component 419 (i.e., the rod contact member) attached to a proximal
`
`component 423 (i.e., a rotatable member) by way of cooperating external
`
`and internal threads 425 and 433.” Id. at 28 (emphasis omitted).
`
`Based on these contentions, Petitioner asserts that “[i]t would have
`
`been obvious to a person of ordinary skill in the art to attach the distal end
`
`64 (i.e., the claimed rod contact member) shown in FIG. 11A of Whipple to
`
`the distal end of the tube 60 (i.e., the claimed rotatable member), as taught
`
`by Runco.” Pet. 28 (emphasis omitted). Petitioner explains that “[s]uch an
`
`arrangement would enable the distal end 64 . . . shown in FIG. 11A to
`
`remain proximate to (i.e., does not separate from) the distal-most end [of]
`
`the tube 60 . . . during axial advancement and retraction of the distal end 64
`
`and the tube 60.” Id. at 28–29 (citing Ex. 1107 ¶ 81).
`
`2.
`
`Patent Owner’s Response
`
`Patent Owner contends that “[b]ecause Ground 15 fails to invalidate
`
`independent Claim 16, Ground 26 also fails to invalidate dependent Claim
`
`22.” PO Resp. 37.
`
`3.
`
`Analysis
`
`Claim 22 depends from claim 16. Petitioner’s challenge of claim 16
`
`based on Whipple (Fig. 11A) fails, as discussed above, because Petitioner
`
`has not shown that Whipple (Fig. 11A) discloses a rotatable member as
`
`required by claim 16. Through its dependency from claim 16, claim 22 also
`
`
`5 Challenge based on anticipation by Whipple (Fig. 11A).
`6 The instant challenge.
`
`21
`
`
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`IPR2018-00521
`Patent 9,532,816 B2
`
`requires this rotatable member. Petitioner’s challenge to claim 22 relies
`
`upon the same deficient showing with respect to the rotatable member as the
`
`challenge to claim 16 discussed above in Part III.C. Petitioner’s analysis of
`
`the combined teachings of Whipple (Fig. 11A) and Runco does not cure this
`
`deficiency. In other words, the Petition does not rely on Runco to meet the
`
`limitation directed to a rotatable member. Rather, the Petition only relies on
`
`Runco’s alleged teaching of a distal end attached to the rotatable member,
`
`and thus cannot cure this deficiency. See Pet. 26–29.
`
`4. Conclusion Regarding Combined Teachings of
`
`Whipple (Fig. 11A) and Runco
`
`For the foregoing reasons, we conclude that Petitioner fails to
`
`establish by a preponderance of evidence that claim 22 is unpatentable over
`
`Whipple (Fig. 11A) and Runco in accordance with 35 U.S.C. § 103(a).
`
`E.
`
`Anticipation of Claims 16, 18, 19, 21, and 22 by
`
`Whipple (Fig. 11C)
`
`Above, we addressed Petitioner’s contentions regarding Whipple (Fig.
`
`11A). Petitioner also contends that claims 16, 18, 19, 21, and 22 are
`
`anticipated by Whipple (Fig. 11C). Pet. 29–44. 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 Whipple (Fig.
`
`11C). We begin our analysis with a brief overview of the embodiment
`
`shown in Whipple’s Figure 11C. Next, we address the parties’ contentions,
`
`22
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`IPR2018-00521
`Patent 9,532,816 B2
`
`and then we discuss our reasoning. Our analysis focuses on independent
`
`claim 16, from which all other challenged claims depend.
`
`1.
`
`Fig. 11C of Whipple
`
`Whipple’s Figure 11C illustrates an embodiment of distal end 64 for
`
`use with either of Whipple’s instruments as shown in Figures 2 and 9
`
`discussed above. As shown in Figure 11C, reproduced below, this
`
`embodiment which differs from the embodiment shown in Whipple’s Figure
`
`11A discussed in Part III.C, above.
`
`
`
`Whipple’s Figure 11C is a side view of an embodiment of the distal end of
`
`an adjustment mechanism for interacting with a spinal fixation element. Ex.
`
`1102 ¶ 20. Whipple states that in this embodiment “distal end 64 of the tube
`
`60 may directly contact the spinal fixation element 12 to effect adjustment of
`
`the spinal fixation element 12.” Id. ¶ 35.
`
`2.
`
`Petitioner’s Challenge
`
`For this challenge, Petitioner’s showing is similar to the challenge
`
`discussed above in Part III.C except for the assertions with respect to the rod
`
`contact member. Compare Pet. 11–21, with id. at 30–40. The main
`
`difference between this challenge and the prior challenge is that in this
`
`23
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`IPR2018-00521
`Patent 9,532,816 B2
`
`challenge, Petitioner asserts that distal end 64 illustrated in Whipple’s Figure
`
`11C corresponds to the claimed rod contact member. Id. at 35–36.
`
`3.
`
`Patent Owner’s Response
`
`Patent Owner contends that Whipple (Fig. 11C) does not disclose a
`
`rod contact member disposed at a distal end of the rotatable member as
`
`required by claim 16. PO Resp. 38. Noting that claim 16 requires “a
`
`separate ‘rod contact member positioned at a distal end of the rotatable
`
`member,’” Patent Owner argues that “[t]he rod contact member is a term
`
`that is specifically recited in the claims as a component of the rod reduction
`
`device.” Id. Therefore, according to Patent Owner, “these two elements
`
`[(i.e. the rod contact member and the rotatable member)] ‘logically cannot
`
`be one and the same.’” Id. (citing Engel Indus., Inc. v. Lockformer Co., 96
`
`F.3d 1398, 1404–05 (Fed. Cir. 1996)). Patent Owner explains that
`
`the rotatable member and the rod contact member are movable
`relative to one another in that the rotatable member is configured
`to rotate about the longitudinal axis. Because the two elements
`are claimed separately and configured differently, the claims
`make it clear t
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