On Friday, November 9th, the Court of Appeals for the Federal Circuit issued a nonprecedential decision in NuVasive, Inc. v. Iancu, which vacated certain findings of the Patent Trial and Appeal Board (PTAB) in an inter partes reexamination proceeding involving a NuVasive patent covering a system and methods for minimally invasive surgical procedures. The Federal Circuit panel of Circuit Judges Pauline Newman, Raymond Chen and Todd Hughes determined that on the issue of secondary considerations the PTAB erred in finding no nexus between NuVasive’s claimed method and the surgical procedure actually commercialized by NuVasive. The panel also held that further fact-finding was required in order to determine whether an asserted prior art publication teaches a certain nerve-monitoring technique necessary to support the Board’s determination of obviousness. Therefore, the decision of the PTAB was vacated and the case remanded for further proceedings consistent with the Court’s opinion.
The patent-at-issue in this appeal is U.S. Patent No. 7691057, titled Surgical Access System and Related Methods and issued to NuVasive in April 2010. It covers a surgical access system for accessing a target site within a spine, the system having tissue distraction and tissue retraction assemblies which may be equipped with electrodes to detect the existence and direction of neural structures before, during and after the establishment of an operative corridor to a surgical target site.
NuVasive asserted the ‘057 patent in an infringement suit filed against Globus Medical in October 2010. The following February, Globus filed the request for the reexamination on claims of the ‘057 patent to determine obviousness based on combinations of four pieces of asserted prior art. In the first office action, the examiner rejected all claims as obvious because all of the references pertained to minimally invasive surgical techniques and a skilled artisan would have found it obvious to combine them to achieve the claimed system and methods.
After both sides submitted evidence in response to the first office action, the examiner reversed the obviousness finding upon finding that one piece of prior art, which taught the establishment of a narrow operative corridor from the side of a patient’s body to repair spinal injuries taught blunt dissection using a finger or sponge rather than the dilators or retractors found in the ‘057. Globus appealed to the PTAB, which reversed the examiner’s findings. NuVasive then amended one of the challenged claims which again led the examiner to find that the challenged claims were nonobvious but the PTAB reversed this decision again on review.
On appeal, NuVasive argued that the PTAB erred in construing the term “lateral, trans-psoas path to the targeted lumbar spinal disc” by failing to consider how the word “lateral” was used in the context of the ‘057 patent. On appeal, counsel representing the U.S. Patent and Trademark Office conceded that the PTAB’s construction might be too broad in light of similar claim construction stemming from the Federal Circuit’s 2016 decision in In re: NuVasive, Inc., and the Federal Circuit decided to adopt the construction from that case.
Second, NuVasive argued that the PTAB’s overly broad construction of the aforementioned claim term caused the PTAB to err in disregarding evidence of secondary considerations leading to its conclusion that the claims were not reasonably commensurate with the objective evidence; NuVasive also argued that the PTAB misunderstood the scope of the eXtreme Lateral Interbody Fusion (XLIF) technique covered by the ‘057 patent. After reviewing a XLIF surgical technique guide submitted into evidence by NuVasive, the Federal Circuit determined that there was a nexus between the claimed invention and the surgical technique. Although the Federal Circuit agreed with the USPTO’s characterization that the ‘057 patent covered method claims whereas NuVasive’s XLIF-related products cover methods, devices and systems, the Court found that the commercial success evidence presented by NuVasive, which included sales of devices and systems for use in other surgical procedures, didn’t mean that there was no nexus.
Finally, the Federal Circuit looked at the PTAB’s analysis on the motivation to combine the asserted prior art. Although the appellate court didn’t find the majority of NuVasive’s arguments to be persuasive, the panel decided that the PTAB’s decision that a skilled artisan would be motivated to use a nerve-monitoring technique covered in prior art to detect the presence of iliohypogastric and ilioinguinal nerves. NuVasive argued that the particular nerve-monitoring technique at issue would be ineffective for monitoring those nerves, which are part of the lumbar plexus, because those nerves don’t supply motor neurons to the legs and the nerve-monitoring technique relies on the detection of motor neurons. Because the question of whether the technique was applicable for monitoring those nerves was a new finding to which NuVasive hasn’t had an adequate opportunity to respond, the Federal Circuit decided to remand this “very narrow issue” back to the PTAB for more fact-finding, although the Federal Circuit also noted that there was nothing in its decision that wouldn’t allow the PTAB to return to its original position once more fact-finding was complete.