Life Spine, Inc. v. Globus Med.

• Docket Number: IPR2022-01600,Patent 10,973,649 B2
• Decision Date: 15 June 2023
• Parties: LIFE SPINE, INC., Petitioner, v. GLOBUS MEDICAL, INC., Patent Owner.
• Court: Patent Trial and Appeal Board

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LIFE SPINE, INC., Petitioner,
v.
GLOBUS MEDICAL, INC., Patent Owner.

No. IPR2022-01600

Patent 10,973,649 B2

United States Patent and Trademark Office, Patent Trial and Appeal Board

June 15, 2023

FOR PETITIONER: GEORGE BECK SCOTT ANDERSON JEFFREY COSTAKOS MICHAEL HOUSTON ROBERTO FERNANDEZ

FOLEY &LARDNER LLP

FOR PATENT OWNER: HEATH BRIGGS ELANA ARAJ ANDREW SOMMER VIVIAN KUO JOSHUA RUDAWITZ

GREENBERG TRAURIG, LLP

Before KRISTI L. R. SAWERT, CYNTHIA M. HARDMAN, and MICHAEL A. VALEK, Administrative Patent Judges.

DECISION GRANTING INSTITUTION OF INTER PARTES REVIEW 35 U.S.C. § 314

SAWERT, Administrative Patent Judge.

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I. INTRODUCTION

Petitioner Life Spine, Inc. requests inter partes review of claims 1-20 of U.S. Patent No. 10,973,649 B2 ("the '649 patent," Ex. 1001). Paper 1 ("Pet."). Patent Owner Globus Medical, Inc. filed a Preliminary Response. Paper 7 ("Prelim. Resp."). With our authorization, Petitioner filed a Preliminary Reply and Patent Owner filed a Preliminary Sur-reply. Paper 8 ("Prelim. Reply"); Paper 9 ("Prelim. Sur-reply").^[1]

We have authority under 35 U.S.C. § 314 to determine whether to institute an inter partes review. The standard for instituting an inter partes review is set forth in 35 U.S.C. § 314(a), which provides that an inter partes review may not be instituted unless "there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition." The Supreme Court has held that the Board, in a decision to institute under 35 U.S.C. § 314(b), may not institute review on fewer than all claims challenged in the petition. SAS Inst. Inc. v. Iancu, 138 S.Ct. 1348, 1355-56 (2018). Moreover, if the Board institutes trial, it "will authorize the review to proceed on all of the challenged claims and on all grounds of unpatentability asserted for each claim." 37 C.F.R. § 42.108(a).

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After considering the Petition, Preliminary Response, Preliminary Reply, Preliminary Sur-reply, and associated evidence, we institute an inter partes review.

A. Real Parties in Interest

Petitioner and Patent Owner each identify themselves as the real party in interest. Pet. 1; Paper 5 (Patent Owner's Updated Mandatory Notices), 2.

B. Related Matters

The parties identify Globus Medical, Inc. v. Life Spine, Inc., 1:21-cv-01445 (D. Del.), as involving the '649 patent. Pet. 1; Paper 5, 2. The parties also identify a number of patent applications related to the '649 patent, including 12/875,637, 13/530,691, 13/531,844, 13/531,700, 13/531,943, 13/793,481, 13/793,668, 13/961,603, 14/466,468, 15/142,142, 15/391,133, 15/900,833, 15/996,792, 16/870,260, 16/910,279, 17/192,231, 17/409,079, 17/410,335, 17/589,029, and 17/931,913. Pet. 1-2; Paper 5, 2-3. There are a number of related inter partes review proceedings, including IPR2022-01434, IPR2022-01435, IPR2022-01599, IPR2022-01601, IPR2022-01602, IPR2022-01603, and IPR2023-00041. Pet. 1; Paper 5, 2.

C. The '649 patent (Ex. 1001)

The '649 patent, titled "Expandable Fusion Device and Method of Installation Thereof," relates to an expandable device for insertion between adjacent vertebrae to facilitate fusion. Ex. 1001, code (54), 1:26-30. According to the Specification, a need exists for a fusion device that is "capable of being installed inside an intervertebral disc space at a minimum to no distraction height and . . . that can maintain a normal distance between adjacent vertebral bodies when implanted." Id. at 1:65-2:2. The '649 patent purports to meet this need with a fusion device including first and second

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endplates and a central ramp capable of moving in a first direction to push the endplates outwardly into an unexpanded configuration. Id. at 2:10-14.

The Specification describes exemplary expandable fusion devices for installing in an intervertebral disc space to facilitate intervertebral fusion. Id. at 2:6-10. One exemplary device is depicted in Figure 60, reproduced below.

(Image Omitted)

Figure 60 of the '649 patent, reproduced above, is a perspective view of expandable fusion device 10 in an expanded position. Id. at 5:17-19, 22:4546. Expandable fusion device 10 includes first endplate 14, second endplate 16, central ramp 18, actuator assembly 200, and driving ramp 300. Id. at 22:46-49. Actuator assembly 200 functions to pull central ramp 18 and driving ramp 300 together, which forces apart endplates 14 and 16. Id. at 22:49-52.

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Figure 58 of the '649 patent, reproduced below, is an exploded view of the expandable fusion device shown in Figure 60. Id. at 5:10-12.

(Image Omitted)

Figure 58, reproduced above, depicts central ramp 18 with a first end 408 and second end 410, expansion portion 412, and a rod-receiving extension 416 extending longitudinally from the expansion portion 412. Id. at 23:5762. Driving ramp 300 includes side portions 360 and 362, each having ramped portion 438. Id. at 24:40-48.

Figure 61 of the '649 patent, reproduced below, is a side cross-section view of the expandable fusion device of Figure 58 in an expanded position. Id. at 5:20-22.

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(Image Omitted)

Figure 61 of the '649 patent, reproduced above, depicts the expandable fusion device having actuator assembly 200, which includes head portion 324 and an extension 404. Id. at 23:43-45. Rod-receiving extension 416 of central ramp 18 is threaded to receive threading of extension 404 of actuator assembly 200. Id. at 24:8-11.

In operation, expandable fusion device 10 is inserted into an intervertebral disc space and seated into position. Id. at 24:57-59. An instrument is used to engage head portion 324 of actuator assembly 200. Id. at 25:7-8. Rotating actuator assembly 200 in a first direction pulls central ramp 18 linearly towards driving ramp 300 and pushes driving ramp 300 linearly towards central ramp 18. Id. at 25:9-17. Ramped portions of central ramp 18 and driving ramp 300 push against corresponding ramped portions of endplates 14 and 16, which forces the endplates outward into an expanded position. Id. at 25:18-33, 39-42.

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D. Challenged Claims

Petitioner challenges all 20 claims of the '649 patent. Claims 1 and 10 are independent. Claim 1, reproduced below with bracketed lettering added,^[2] is illustrative:

1. [pre] An expandable intervertebral implant, the expandable implant capable of moving from a collapsed position to an expanded position, the implant comprising:

[a] a first endplate extending from a proximal end to a distal end, wherein the first endplate has a first surface, a second surface, a first side surface and a second side surface,

[b] a second endplate extending from a proximal end to a distal end, wherein the second endplate has a first surface, a second surface, a first side surface and a second side surface;

[c] a central ramp positioned between the first endplate and the second endplate, the central ramp positioned proximate the distal end of the first endplate and the distal end of the second endplate;

[d] a driving ramp positioned proximate the proximal end of the first endplate and the proximal end of the second endplate, wherein the driving ramp is operably connected with the central ramp,

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[e] an actuator assembly configured to move at least one of the central ramp and the driving ramp;

[f] wherein the expandable implant defines a horizontal plane that extends through the central ramp, driving ramp and the actuator assembly;

[g] wherein the first side surface of the first endplate includes at least one ramped portion, [h] wherein the first side surface of the second endplate includes at least one ramped portion,

[i] wherein in the collapsed position, the at least one ramped portion of the first side of the first endplate extends through the horizontal plane such that the at least one ramped portion of the first endplate is positioned on both sides of the horizontal plane.

Ex. 1001, 32:55-21.

Challenged independent claim 10 is similar to claim 1, but differs with respect to limitations relating to the expandable implant's configuration in an "collapsed position." In particular, claim 1 recites that "the expandable implant defines a horizontal plane that extends through the central ramp, driving ramp and the actuator assembly" (limitation 1[f]), and that, when "in the collapsed position, the at least one ramped portion of the first side of the first endplate extends through the horizontal plane such that the at least one ramped portion of the first endplate is positioned on both sides of the horizontal plane" (limitation 1[i]). Id. (emphases added). The parties refer to these limitations in claim 1 as the "Horizontal-Plane Limitation." Pet. 89; Prelim. Resp. 5-6.

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Claim 10, on the other hand, recites several limitations relating to "overlap": "wherein the first side surface of the first endplate includes at least one ramped portion having an inwardly facing surface and an outwardly facing surface" (limitation 10[f]); "wherein the first side surface of the second endplate includes an inwardly facing surface and an outwardly facing surface" (limitation 10[g]); and, when "in the collapsed position, at least a portion of the inwardly facing surface of the ramped portion of the first endplate overlaps at least a portion of the outwardly facing surface of the first side surface of the second endplate" (limitation 10[h]). Ex. 1001, 34:3-34 (emphasis added). The parties refer to these limitations in claim 10 as the "Overlap Limitation." Pet. 8-9; Prelim. Resp. 5-6.

Challenged claims 2-9 depend directly or indirectly from claim 1 and recite additional features, including with respect to the endplates (claims 2 and 3), the central ramp (claim 4), the actuator assembly (claims 5-7), and the driving ramp (claims 8 and 9). Ex. 1001, 33:22-34:2. Similarly, challenged claims 11-20 depend directly or indirectly from claim 10 and recite additional...