Nuvasive, Inc. v. Hirshfeld

CourtCourt of Appeals for the Federal Circuit
DecidedAugust 18, 2021
Docket20-1708
StatusUnpublished

This text of Nuvasive, Inc. v. Hirshfeld (Nuvasive, Inc. v. Hirshfeld) is published on Counsel Stack Legal Research, covering Court of Appeals for the Federal Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Nuvasive, Inc. v. Hirshfeld, (Fed. Cir. 2021).

Opinion

Case: 20-1708 Document: 46 Page: 1 Filed: 08/18/2021

NOTE: This disposition is nonprecedential.

United States Court of Appeals for the Federal Circuit ______________________

NUVASIVE, INC., Appellant

v.

ANDREW HIRSHFELD, PERFORMING THE FUNCTIONS AND DUTIES OF THE UNDER SECRETARY OF COMMERCE FOR INTELLECTUAL PROPERTY AND DIRECTOR OF THE UNITED STATES PATENT AND TRADEMARK OFFICE, Intervenor ______________________

2020-1708 ______________________

Appeal from the United States Patent and Trademark Office, Patent Trial and Appeal Board in No. 95/001,888. ______________________

Decided: August 18, 2021 ______________________

MICHAEL T. ROSATO, Wilson, Sonsini, Goodrich & Rosati, Seattle, WA, argued for appellant. Also repre- sented by SONJA ROCHELLE GERRARD, JAD ALLEN MILLS; RICHARD TORCZON, Washington, DC.

MONICA BARNES LATEEF, Office of the Solicitor, United Case: 20-1708 Document: 46 Page: 2 Filed: 08/18/2021

States Patent and Trademark Office, Alexandria, VA, ar- gued for intervenor. Also represented by BENJAMIN T. HICKMAN, THOMAS W. KRAUSE, FARHEENA YASMEEN RASHEED. ______________________

Before CHEN, CLEVENGER, and HUGHES, Circuit Judges. CHEN, Circuit Judge. This inter partes reexamination of NuVasive, Inc.’s (NuVasive’s) U.S. Patent No. 7,691,057 (’057 patent) ap- pears before us a second time. The patentability of claims 17–22 and 24–27 under 35 U.S.C. § 103(a)1 remains at is- sue. In the first appeal to our court, NuVasive, Inc v. Iancu, 752 F. App’x 985 (Fed. Cir. 2018) (NuVasive I), we vacated the Patent Trial and Appeal Board’s (Board’s) obviousness determination, overturning the Board’s finding that NuVa- sive’s “eXtreme Lateral Interbody Fusion” (XLIF) surgical technique lacked a nexus to the claimed method. We re- manded for the Board to (1) conduct a new analysis of the objective indicia of nonobviousness consistent with our nexus finding, and (2) make sufficient factual findings to support its conclusion about the existence of a motivation to combine two prior art references. After reconsidering the prior art references and NuVa- sive’s objective evidence of nonobviousness, the Board again found that claims 17–22 and 24–27 would have been

1 Congress amended § 103 when it enacted the Leahy-Smith America Invents Act (AIA). Pub. L. No. 112- 29, § 3(c), 125 Stat. 284, 287 (2011). As the challenged claims of the ’057 patent have an effective filing date before March 16, 2013, the pre-AIA version of § 103 applies. See id. § 3(n)(1), 125 Stat. at 293. Case: 20-1708 Document: 46 Page: 3 Filed: 08/18/2021

NUVASIVE, INC. v. HIRSHFELD 3

obvious. 2 NuVasive challenges this holding. Because the Board’s fact findings are supported by substantial evidence and its conclusion of obviousness is correct, we affirm. BACKGROUND A Our prior opinion, NuVasive I, provides a thorough overview of the ’057 patent and technical background. In relevant part, the ’057 patent covers a surgical-access sys- tem and related methods for creating a minimally invasive operative corridor to the lumbar spine through the psoas muscle, a tissue comprising significant neural structures (e.g., the lumbar plexus, a network of nerves originating in the spinal column and exiting through the opening of the lumbar vertebra). ’057 patent col. 2 1. 61–col. 3 l. 7. The access system and methods include detecting the presence of neural structures before and during establishment of the operative corridor. Id. at col. 3 ll. 14–19. Specialized nerve- monitoring (i.e., electromyography (EMG)) using elec- trodes attached to the surgical instruments employed for creating the operative corridor detects any nerves present. See id. at col. 12 ll. 17–52. The electrodes emit a charge as they go through the body, and if the charge reaches a nerve, the nerve stimulates the muscle group it controls, resulting in a muscle twitch. See id. When a surgeon observes a muscle twitch, the surgeon knows that the instrument may be too close to a nerve. See id. The data about muscle movement can also be fed to a graphical user interface that

2 The Board issued three decisions during this inter partes reexamination. The third decision, J.A. 1–37, is the subject of the present appeal. The second decision, J.A. 2895–2927, was the subject of the first appeal decided in NuVasive I. Following the Board’s first decision, J.A. 957–79, NuVasive chose to reopen prosecution, J.A. 1058–90. Case: 20-1708 Document: 46 Page: 4 Filed: 08/18/2021

displays information to the surgeon about the instrument’s direction and location relative to a nerve. See id. Claim 17, from which all of the challenged claims de- pend, covers NuVasive’s surgical method. NuVasive amended claim 17 during the reexamination proceeding to incorporate neuromonitoring. J.A. 1059–60. The amended claim, in relevant part, recites: 17. A method of accessing a surgical target site within a spine, comprising the steps of: (a) creating a distraction corridor along a lateral, trans-psoas path to a targeted lumbar spinal disc in a lumbar spine using a distraction assembly comprising at least two dilators that are sequen- tially inserted along the lateral, trans-psoas path to the targeted lumbar spinal disc, and performing neuromonitoring during at least a portion of the time the distraction assembly is used in creating the distraction corridor along the lateral, trans- psoas path, wherein the neuromonitoring com- prises causing the emission of a plurality of electri- cal stimulation signals from a stimulation electrode provided on a distal portion of at least one component of the distraction assembly and moni- toring for resulting electromyographic (EMG) ac- tivity after the emission of each stimulation signal, and wherein the component of the distraction as- sembly is coupled to a control unit of a neuromoni- toring system that is capable of displaying to a user an indication of at least one of proximity and direc- tion of a nerve to the stimulation electrode pro- vided on the component of the distraction assembly based on the monitored resulting electromyo- graphic (EMG) activity . . . . Id. Case: 20-1708 Document: 46 Page: 5 Filed: 08/18/2021

NUVASIVE, INC. v. HIRSHFELD 5

In NuVasive I, we ordered that the Board on remand “conduct a new [obviousness] analysis consistent with [our] opinion.” 752 F. App’x at 986. Regarding the Board’s posi- tion that a skilled artisan would be motivated to combine Kossmann 3 and Kelleher, 4 we observed that the Board’s finding that Kelleher’s nerve-monitoring technique is ap- plicable to the iliohypogastric and ilioinguinal nerves— nerves Kossmann’s lateral, trans-psoas spinal surgery technique sought to avoid—was a new finding that NuVa- sive never had an opportunity to address. Id. at 998–99. Therefore, in reconsidering obviousness, we instructed the Board to do further fact finding to address NuVasive’s ar- gument that Kelleher’s nerve-monitoring technique could not detect the iliohypogastric and ilioinguinal nerves. 5 Id. at 986. In considering NuVasive’s objective indicia of nonobvi- ousness, we found nexus between the claimed invention and NuVasive’s XLIF procedure, noting that “the scope of the claimed invention is reasonably commensurate with the XLIF surgical technique.” Id. at 995. Accordingly, we directed the Board to “reevaluate NuVasive’s objective evi- dence of nonobviousness such as long-felt need, skepticism followed by praise and recognition, and commercial

3 Thomas Kossmann et al., Minimally Invasive Ver- tebral Replacement with Cages in Thoracic and Lumbar Spine, 6 Euro J. of Trauma 292–300 (2001). 4 WIPO Publication No. WO 01/37728. 5 In NuVasive I, we affirmed the Board’s obviousness analysis as to the combination of Kossmann, Branch (U.S. Patent No.

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