Agilent Technologies, Inc. v. Synthego Corp. (Fed. Cir., June 11, 2025) illustrates how a word in the law can mean different things in different contexts. In Agilent Techs., the Janus-like word was “enablement.”
Synthego successfully challenged via Inter Partes Reviews (IPRs) two Agilent patents, U.S. Patent Nos. 10,337,001 and 10,900,034, directed to CRISPR technology for gene editing. The Court of Appeals for the Federal Circuit affirmed the Patent Trial and Appeal Board (PTAB) IPR decisions finding every claim invalid in view of prior art (i.e., prior technology).
35 U.S.C. § 102 indirectly defines what constitutes prior art, which is (roughly) any disclosure of technology that came before a patent application’s priority date. Common forms of prior art include issued patents, published patent applications, and printed publications (e.g., scientific journal articles). Under § 102, a patent’s claim can be invalidated (“anticipated” in patent vernacular) if the prior art reference (1) teaches all the limitations of the patent claim and (2) is “enabled.”
Enablement commonly arises under 35 U.S.C. § 112, which requires a patent’s specification to support its claims. But enablement for § 112 purposes does not mean the same thing as enablement for § 102 prior art purposes.
Enablement Under § 112
Under § 112, a patent’s specification, which includes the explanatory text and drawings, must enable each patent claim as a prerequisite to obtaining the claim. To meet this enablement requirement, the specification must teach one skilled in the art how to make and use the claimed invention without undue experimentation. Importantly, for a given claim, the “full scope” of the claim must be enabled.
“Full scope” matters where a single claim encompasses many variants as, for example, a claim to an antibody that targets a specific protein, which was the case in Amgen v. Sanofi, 598 U.S. 594 (2023). Antibodies are complex, three-dimensional molecules, and hundreds, thousands, or even millions of variations in their chemical structures are possible while still performing the function contemplated in the patent. Enabling the “full scope” of claims does not mean literally disclosing every embodiment; but it does mean providing enough examples and/or explaining the structural commonality behind the operable family of structures. Uncovering this information can be tedious, time consuming, and expensive. Pressure to file patent applications quickly can cause applicants to file before they have completed all the work.
Enablement Under § 102
Whereas enablement under § 112 focuses on a patent applicant seeking to obtain issuance of a patent claim, enablement under § 102 arises when a challenger seeks to defeat (invalidate) a patent claim with prior art. Again, to anticipate a patent claim, prior art references must be enabling. That means, as with § 112, that the prior art must teach one skilled in the art how to make and use the invention without undue experimentation.
In contrast to § 112, however, the prior art “need not enable the [challenged] claim in its entirety, but instead the reference need only enable a single embodiment of the claim.” Agilent Technologies (slip opinion at 13) (quoting In re Morsa, 803 F.3d 1374, 1377 (Fed. Cir. 2015)). In other words, instead of providing examples or disclosing the general structural commonality behind all the claimed embodiments (as required under § 112), under § 102, the prior art reference anticipates a challenged claim by enabling merely one example that falls within the claim’s scope. It does not matter that the challenged claim encompasses one million or one billion embodiments; if the prior art teaches a skilled artisan how to make one of them (without undue experimentation), the challenged claim is invalid.
Deferring to PTAB Factual Findings
Enablement is a question of law based on underlying factual findings. On appeal, the Federal Circuit must give deference to the PTAB’s findings of fact because the PTAB is an administrative agency. Pursuant to the Administrative Procedure Act, a reviewing court can only set aside agency findings of fact found to be arbitrary, capricious, an abuse of discretion, or unsupported by substantial evidence. Dickinson v. Zurko, 527 U.S. 150 (1999).
Though the technical details are beyond the scope of this alert, the PTAB in Agilent Techs made factual findings regarding what the prior art disclosed, the level of predictability in the art, what a person of ordinary skill in the art would understand about the technology, and, ultimately, whether one skilled in the art could make the compound without undue experimentation. The Federal Circuit upheld all the challenged factual findings as supported by substantial evidence.
Key Takeaways
- When applied to prior art, the enablement requirement does not require enabling the full scope of the challenged claim; it only requires enabling a single example that falls within the scope of the challenged claim. Prior art disclosing many examples can therefore be a powerful tool with which to challenge patent claims.
- Take the time and effort to make clear factual showings to Patent Office because, if adopted by the Patent Office, the Federal Circuit gives those factual findings “substantial deference.”