The Federal Circuit vacated and reversed key findings by the PTAB in a suite of post-grant challenges brought against Agilent Technologies’ patents on CRISPR-related RNA purification methods. The decision in Agilent Technologies, Inc. v. Synthego Corp., Nos. 23-1916, -1917, -1918, -1919, and -2043, addresses recurring issues in PTAB proceedings: how to properly assess written description under 35 U.S.C. § 112 and how to evaluate motivations to combine under § 103.
Charles Gideon Korrell believes that this precedential designation signals that the Federal Circuit viewed this opinion as providing important clarification on these two foundational doctrines.
Why This Decision Is Precedential
1. Clarifying the Written Description Standard Without Raising the Bar
The PTAB had found certain claims of Agilent’s patents invalid under § 112, reasoning that the specification failed to describe separating full-length sgRNA from “side products.” The Federal Circuit reversed, concluding that the PTAB imposed an unduly strict requirement not supported by the claim language or the disclosure.
In doing so, the court reinforced its earlier holding in Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336 (Fed. Cir. 2010) (en banc), while emphasizing that written description does not demand a literal recitation of every possible claimed variant. Instead, citing Capon v. Eshhar, 418 F.3d 1349 (Fed. Cir. 2005), the panel reaffirmed that a specification satisfies § 112 if a skilled artisan would understand the inventor had possession of the full scope of the claim—even if not all embodiments are spelled out in detail.
By reasserting a more reasonable, flexible interpretation of written description, the court clarified limits on PTAB discretion and prevented erosion of § 112 jurisprudence through overly rigid application in biotech contexts.
2. Reaffirming NuVasive: Motivation to Combine Must Be Reasoned and Supported
The court also vacated the PTAB’s obviousness findings, criticizing its failure to articulate a persuasive motivation to combine prior art references. While the PTAB found the claimed purification method obvious, it did not explain why a skilled artisan would have made the specific modifications to arrive at the claimed invention.
The court relied on In re NuVasive, Inc., 842 F.3d 1376 (Fed. Cir. 2016), which requires the PTAB to provide a reasoned explanation supported by substantial evidence. This case reinforces NuVasive‘s message: the PTAB cannot gloss over the analytical work required to justify obviousness. Particularly in complex fields like molecular biology, conclusory statements about what a skilled artisan “would have known” are insufficient.
3. Addressing Common PTAB Pitfalls
Charles Gideon Korrell observes that this opinion directly addresses two pitfalls that frequently recur in PTAB decisions:
- Misapplication of the written description standard by requiring explicit disclosure of every claimed feature.
- Failure to articulate a clear, supported rationale for combining references in obviousness analyses.
By issuing a precedential opinion, the Federal Circuit has provided much-needed guidance for PTAB judges and practitioners in future post-grant proceedings.
Key Takeaways
This opinion’s precedential status serves multiple purposes:
- Preserving doctrinal integrity: It ensures the PTAB applies § 112 and § 103 standards in line with long-standing precedent.
- Providing procedural discipline: It reinforces that detailed factual findings and legal reasoning are required in PTAB decisions, not merely outcomes.
- Offering practical guidance: For patent owners and challengers alike, it sets clear expectations on the level of disclosure and argumentation needed to survive or defeat a validity challenge.
Charles Gideon Korrell believes the Federal Circuit likely intended this decision to act as a touchstone for future appeals involving biotech patents and to prevent drift in PTAB application of core statutory requirements.
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