Life Spine, Inc. v. Globus Med.

• Decision Date: 19 April 2023
• Docket Number: IPR2022-01435,Patent 10,137,001 B2
• Parties: LIFE SPINE, INC., Petitioner, v. GLOBUS MEDICAL, INC., Patent Owner.
• Court: Patent Trial and Appeal Board

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

IPR2022-01435

Patent 10,137,001 B2

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

April 19, 2023

For PETITIONER: Michael R. Houston Scott D. Anderson Jeffrey N Costakos Foley & Lardner LLP

For PATENT OWNER: Stephen D. Zinda James H. Hall J. David Cabello CABELLO HALL ZINDA, PLLC

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

DECISION GRANTING INSTITUTION OF INTER PARTES REVIEW 35 U.S.C. § 314 GRANTING PETITIONER'S MOTION TO FILE UNDER SEAL 37 C.F.R. §§ 42.14, 42.54

SAWERT, ADMINISTRATIVE PATENT JUDGE

I. INTRODUCTION

Petitioner Life Spine, Inc. requests inter partes review of claims 1-11 of U.S. Patent No. 10,137,001 B2 ("the '001 patent," Ex. 1001). Paper 2 ("Pet."). Patent Owner Globus Medical, Inc. filed a Preliminary Response. Paper 9 ("Prelim. Resp."). With our authorization, Petitioner filed a Preliminary Reply and Patent Owner filed a Preliminary Sur-reply. Paper 10 ("Prelim. Reply"); Paper 11 ("Prelim. Sur-reply").^[1]

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

The following preliminary findings of fact and conclusions of law are made solely for determining whether to institute review. Any final decision will be based on the full trial record.

A. Real Parties in Interest

Petitioner and Patent Owner each identify themselves as the real party in interest. Pet. 1; Paper 7 (Patent Owner's First Updated Mandatory Notices), 1. B. Related Matters

The parties identify Globus Medical, Inc. v. Life Spine, Inc., l:21-cv-01445 (D. Del), as involving the '001 patent. Pet. 1; Paper 7, 1. The parties also identify a number of patent applications related to the '001 patent, i.e., 17/192,231, 17/409,079, 17/410,335, 17/589,029, and 17/931,913. Pet. 1-2; Paper 7, 1. Patent Owner also identifies a number of related inter partes review proceedings, i.e., IPR2022-01434, IPR2022-01599, IPR2022-01600, andIPR2023-00041. Paper 7,1.

C. The '001 Patent (Ex. 1001)

The '001 patent, titled "Expandable Fusion Device and Method of Installation Thereof," relates to an expandable device for insertion between adjacent vertebrae to facilitate fusion and a method for promoting intervertebral fusion using the expandable device. Ex. 1001, code (54), 1:19-22. 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 . . . can maintain a normal distance between adjacent vertebral bodies when implanted." Id. at 1:57-61. The '001 patent purports to meet this need with a fusion device including first and second endplates and a central ramp capable of moving in a first direction to push the endplates outwardly into an unexpanded configuration. Id. at 2:2-6. The fusion device can be placed into a disc space via an endoscopic tube and then expanded into an expanded configuration. Id. at 2:6-9.

The Specification describes exemplary expandable fusion devices for installing in an intervertebral disc space to facilitate intervertebral fusion. Id. at 1:65-2:2. One exemplary device is depicted in Figure 50, reproduced below.

(Image Omitted)

Figure 50 of the '001 patent, reproduced above, is a perspective view of expandable fusion device 10 in an expanded position. Id. at 4:46-59, 17:20-21. Expandable fusion device 10 includes first endplate 14, second endplate 16, central ramp 18, actuator assembly 200, and driving ramp 300. Id. at 17:21-24. Actuator assembly 200 functions to pull central ramp 18 and driving ramp 300 together, which forces apart endplates 14 and 16. Id. at 17:24-28.

Figure 52 of the '001 patent is reproduced below.

(Image Omitted)

Figure 52, reproduced above, is an exploded view of expandable fusion device 10. Id. at 4:53-55. Central ramp 18, which has first end 408 and second end 410, includes first expansion portion 412, second expansion portion 414, rod-receiving extension 416, and longitudinally-extending through bore 418. Id. at 19:5-10. Rod-receiving extension 416 is threaded to receive threading of extension 404 of actuator assembly 200. Id. at 19:51-54. Driving ramp 300 includes bore 366 sized to receive extension 404. Id. at 19:61-63. Actuator assembly 200 includes head portion 324 with rim 332, which engages contact surface 368 of driving ramp 300. Id. at 19:67-20:3.

In operation, expandable fusion device 10 is seated into an intervertebral disc space. Id. at 20:44-45. An instrument is used to engage head portion 324 of actuator assembly 200. Id. at 20:47-48. 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 20:49-57. 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. Mat 20:58-60, 21:12-18.

The Specification also describes an exemplary technique for endoscopically inserting the expandable fusion devices into the intervertebral disc space between adjacent vertebrae. Id. at 5:26-51, 21:60-22:61. An access path to the intervertebral disc space is created, for example, by using a posterolateral approach. Id. at 21:62-65. The expandable fusion device 10 is placed into the intervertebral disc space and expanded to the desired height. Id. at 22:28-30. A bone graft or similar bone-growth inducing material is then introduced around or within the expandable fusion device 10. Id. at 5:53-55, 22:30-32.

D. Challenged Claims

Petitioner challenges all 11 claims of the '001 patent. Claims 1 and 10 are independent. Claim 1, reproduced below with bracketed and bolded lettering added,^[2] is illustrative:

1. [pre] A surgical method comprising:

[a] creating an access path to an intervertebral disc space; inserting an expandable implant into the disc space,

[b] wherein the expandable implant comprises: a first endplate having a pair of first tongues; [c]a second endplate opposed to the first endplate, the second endplate having a pair of second tongues;

[d]a central ramp positioned between the first endplate and the second endplate, [e] wherein the central ramp comprises a first end and a second end, [f| wherein the second end includes a first ramped portion configured to engage a portion of the first endplate and a second ramped portion configured to engage a portion of the second endplate, and [g] a third ramped portion configured to engage a portion of the first endplate and a fourth ramped portion configured to engage a portion of the second endplate positioned between the first and second ends, [h] wherein the central ramp has a longitudinal bore, and [i] wherein the first ramped portion has a pair of first grooves, each of the first grooves sized to receive one of the first tongues, and [j] wherein the second ramped portion has a pair of second grooves, each of the second grooves sized to receive one of the second tongues;

[k] a driving ramp positioned between the first endplate and the second endplate, [1] wherein the driving ramp comprises a first end and a second end, [m] wherein the second end includes a first angled portion configured to engage a portion of the first endplate and a second angled portion configured to engage a portion of the second endplate, [n] wherein the driving ramp has a non-threaded longitudinal through bore extending from the first end to the second end of the driving ramp, [o] the longitudinal bore of the of the [sic] central ramp and the nonthreaded longitudinal through bore of the driving ramp are coaxially aligned;

[p] an actuator insertable through the driving ramp, [q] wherein a portion of the actuator extends through the non-threaded longitudinal through bore of the driving ramp and the longitudinal bore of the central ramp, [r] the actuator is disposed and remains within the non-threaded longitudinal bore, and the actuator is movable with respect to the central ramp and the driving ramp, and [s] wherein the actuator is configured to translate the driving ramp such that the second end of the driving ramp is moved closer to the second end of the central ramp to thereby cause expansion of the first endplate and the second endplate;

[t] wherein the first tongues and the second tongues are configured to move within corresponding first grooves and second grooves to expand and compress the expandable implant;

[u] wherein the third ramped portion and the fourth ramped portions extend outwardly from a rod receiving extension of the central ramp; and

[v] introducing bone graft material adjacent the expandable implant.

Ex. 1001,23:4-60.

Challenged independent claim 10 is similar to claim 1, but broader in scope. Specifically, claim 10 does not recite a "non-threaded longitudinal through bore" for the driving ramp found in limitations [n] through [r] of claim 1. Compare id. at 23:34-45 (claim 1), with id. at 24:45-50 (claim 10). Additionally, claim 10 does not recite the step of "introducing bone graft material" found in limitation [v] of claim 1. Compare id. at 23:59-60 (claim 1), with id. at 24:63 (claim 10).

Challenged claims 2-9 and 11 depend directly or indirectly from independent claim 1 and recite additional features, including with respect to the access path (claim 2), the actuator ...