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Misapplied, “All Elements Rule” Leads To Summary Judgment Reversal

Client Alert | 1 min read | 11.27.06

In Depuy Spine, Inc. v. Medtronic Sofamor Danek, Inc. . (November 20, 2006), the Federal Circuit reverses summary judgment of non-infringement of Depuy's medical device patent by certain Medtronic spinal implant screw devices, finding error in the district court's application of the doctrine of equivalents. Resort to the doctrine of equivalents may be foreclosed under the “all elements rule” if the facts and theories in the case are such that “a limitation would be read completely out of the claim.” Thus, summary judgment of non-infringement may be appropriate when a party's theory or evidence of equivalence is legally incapable of establishing that the differences between the claim limitation and the accused device are insubstantial ( i.e. , either the infringement theory fails to address a claim limitation, or there are substantial differences between the asserted equivalent and the claimed structure).

The Federal Circuit finds that the district court erred in applying the ”all elements rule”. The district court had adopted Medtronic's argument that a conically-shaped portion of Medtronic's spinal implant screws could not infringe a “spherically-shaped” limitation without reading the limitation out of the claims. The Federal Circuit panel finds that there was no basis for the district court's conclusion, noting that contrary to Medtronic's arguments, Depuy had not argued that “any shape” could be an equivalent to the claimed spherical surface. Rather, the panel determines that Depuy's argument had retained the “spherically-shaped” limitation, noting Depuy's provision of specific, substantial expert testimony establishing the equivalence of certain shapes, and the lack of equivalence of other shapes. Accordingly, summary judgment of non-infringement is reversed with instructions for further proceedings on the question of whether the Medtronic conically-shaped device was an infringing equivalent. The Court also rejects Medtronic's request to set aside a jury verdict of infringement by other Medtronic spinal screw devices, where Medtronic's argument was based on the now-repudiated theory that Depuy failed to satisfy the “all elements rule.”

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Client Alert | 5 min read | 12.12.25

Eleventh Circuit Hears Argument on False Claims Act Qui Tam Constitutionality

On the morning of December 12, 2025, the Eleventh Circuit heard argument in United States ex rel. Zafirov v. Florida Medical Associates, LLC, et al., No. 24-13581 (11th Cir. 2025). This case concerns the constitutionality of the False Claims Act (FCA) qui tam provisions and a groundbreaking September 2024 opinion in which the United States District Court for the Middle District of Florida held that the FCA’s qui tam provisions were unconstitutional under Article II. See United States ex rel. Zafirov v. Fla. Med. Assocs., LLC, 751 F. Supp. 3d 1293 (M.D. Fla. 2024). That decision, penned by District Judge Kathryn Kimball Mizelle, was the first success story for a legal theory that has been gaining steam ever since Justices Thomas, Barrett, and Kavanaugh indicated they would be willing to consider arguments about the constitutionality of the qui tam provisions in U.S. ex rel. Polansky v. Exec. Health Res., 599 U.S. 419 (2023). In her opinion, Judge Mizelle held (1) qui tam relators are officers of the U.S. who must be appointed under the Appointments Clause; and (2) historical practice treating qui tam and similar relators as less than “officers” for constitutional purposes was not enough to save the qui tam provisions from the fundamental Article II infirmity the court identified. That ruling was appealed and, after full briefing, including by the government and a bevy of amici, the litigants stepped up to the plate this morning for oral argument....

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