A biological composition is patent‑eligible when the claimed construct, viewed as a whole, does not occur in nature and exhibits characteristics or utility that differ meaningfully from its natural components.
A patent owner fails to meet its burden of proving structural equivalence when it does not address a significant part of the structure identified in the specification as the corresponding means‑plus‑function element.
When a damages expert employs a facially reliable apportionment methodology grounded in evidence and tied to the claimed invention’s incremental value, challenges to data selection, assumptions, or modeling choices ordinarily go to weight, not admissibility.
The Director’s instructions to the PTAB regarding institution of IPRs are not subject to formal notice-and-comment rulemaking since these instructions constitute general statements of policy rather than substantive rules.
A modifying phrase is presumed to attach to the nearest semantically plausible term, but that presumption can be overcome if the claim language, specification, or prosecution history indicates a contrary interpretation.