The specification must enable the full scope without undue experimentation, assessed through the Wands factors. Amgen v. Sanofi confirmed that broad functional claims require commensurate disclosure.
The requirement scales with claim breadth.
Alternative Names:
Enablement Requirement|Section 112 Enablement
Why it Matters?
Amgen strengthened the defense against broad functional claiming substantially, holding that a specification disclosing examples cannot support a claim covering an entire genus defined by function, which reaches antibody, software, and chemical claims drafted functionally. Identifying the gap between what the specification teaches and what the claims cover is the analysis. The defense is available in district court and post-grant review but not inter partes review.
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What did Amgen establish?
Where is the defense unavailable?
