DC indefiniteness findings vacated and remanded (Nautilus standard controls, only general-purpose computer or processor requires a specific algorithm)

Nevro Corp. v. Boston Scientific Corp. et al.

Docket No. 2018-2220, -2349
April 9, 2020

Brief Summary: DC grant of SJ based on its indefiniteness finding vacated and remanded (e.g., the correct standard is the Nautilus “reasonable certainty” standard).

Summary: Nevro appealed DC summary judgment (SJ) that certain of its claims of seven patents including method of treatment, system and device claims related to using high-frequency spinal cord stimulation therapy to inhibit pain are invalid for indefiniteness. Boston Scientific (BSC) cross-appealed the DC decision finding certain other claims not indefinite and infringed. In making its decisions, the DC construed the terms “paresthesia-free” (e.g., tingling of the skin), “configured to”, “means for generating”, and “therapy signal”, which the FC panel reviewed in this opinion. The system claimed in illustrative claim 18 of the ‘125 patent comprises a “means for generating a paresthesia-free therapy signal” and illustrative claim 1 of the ‘472 patent describes “[a] method for alleviating pain or discomfort, without relying on paresthesia or tingling to mask the patient’s sensation of pain”. The DC construed paresthesia-free to have the “clear meaning” of “therapy or therapy signal ‘does not produce a sensation usually described as tingling, pins and needles, or numbness” (“based on extrinsic evidence”, “a skilled artisan would be able to quickly determine whether a signal creates paresthesia for any given patient”), but that the term was indefinite in the system and device claims (not indefinite in the method claims). The FC panel reviewed these holdings de novo, explaining to comply with 35 USC 112, the “[c]laims, when viewed in light of the specification and prosecution history, must ‘inform those skilled in the art about the scope of the invention with reasonable certainty’”, “recognizing that absolute precision is unattainable” (Nautilus, US 2014; Interval Lic., FC 2014).

The FC panel found “paresthesia-free” satisfy the definiteness standard for all of the method, system and device claims (“a functional term, defined by what it does rather than what it is”, “[b]ut that does not inherently render it indefinite” (Halliburton, FC 2008); Enzo, FC 2010 (“the ambiguity inherent in functional terms may be resolved where the patent ‘provides a general guideline and examples sufficient to enable a person of ordinary skill in the art to determine the scope of the claims’”); “Definiteness does not require that a potential infringer be able to determine ex ante if a particular act infringes the claims.” Star Sci., FC 2008; Invitrogen, FC 2005; Geneva, FC 2003; Halliburton).

The DC held “configured to” indefinite because it “is susceptible to different constructions” but the FC panel disagreed as the standard is the Nautilus “reasonable certainty” standard, explaining that the DC’s position “would render nearly every claim indefinite so long as a party could manufacture a plausible construction” (“the Supreme Court declined to adopt such a rule” (Nautilus)). Based upon its review of the specification and prosecution history, the FC panel concluded the DC erred in finding “configured to” indefinite and that it means “programmed to”.

The DC “determined that there was ‘not an adequate disclosure of a corresponding structure” for the means-plus-function limitation (112, section 6) “means for generating” limitation. The FC panel disagreed, finding “the specification clearly recites a signal or pulse generator…as the structure”, “not a general-purpose computer or processor”, and therefore “does not require a specific algorithm” (Aristocrat, FC 2008). The FC panel therefore found the DC erred in finding the “means for generating” limitation indefinite.

The DC found “therapy signal” was not indefinite, but the FC panel found it erred in its construction (reviewed de novo as the underlying fact findings relate to extrinsic evidence (Teva, US 2015; Thorner, FC 2012)). The FC panel wrote that “[t]he plain language of the claims makes clear that the claimed ‘therapy signal’ is for pain-relief spinal cord stimulation therapy” and the specification the DC relied upon for its definition “does not meet the exacting standard for redefining” the term (Hill-Rom Servs., FC 2014; Interval Lic., FC 2014).

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