By: Claire E. Reynolds-Peterson, Ph.D. & Teige P. Sheehan, Esq., Ph.D.
A recent decision from the Federal Circuit Court of Appeals is another reminder for patent applicants of the ease by which description of a technology in a prior publication can prevent the grant of a patent on a subsequent application. Importantly, this is true even if the prior description might not have been sufficient for obtaining a patent had it been the basis of a patent application itself. The ease of preventing a patent from being granted on a future application because of a public disclosure that may not in and of itself constitute sufficient support for a patent, weighed against the importance of filing a patent application early enough to get ahead of would-be “prior art” publication dates, is a nuanced calculation innovators should consider very carefully when strategizing development of their patent portfolios. This is especially so in so-called “unpredictable” technology spaces like biotechnology.
In Agilent Technologies v. Synthego (June 11th, 2025), the Court of Appeals for the Federal Circuit upheld the PTAB’s invalidation of Agilent’s CRISPR-Cas patent claims as anticipated by a patent prior art in conjunction with two scholarly articles. This decision is merely the most recent casualty of a longstanding hazard facing patent applicants: the double standard for enablement as applied to prior arts for anticipation analysis, versus its meaning when analyzing sufficiency of the written description of a patent specification.
To be eligible for patent protection, an invention must be novel and non-obvious as compared to the current state of the art, as well as useful and usable by a person of ordinary skill in the art (POSA) based on the information provided in the patent specification. “Enablement” is a legal standard applied to disclosures when analyzing each of these requirements, which weighs the level of functional detail provided by a disclosure. However, the type and amount of technical description required to meet the standard and “enable” the information provided by a disclosure is very different depending on which section of the Patent Act applies to the legal analysis being performed.
Enablement with respect to the written description under § 112 of the Patent Act requires a much higher level of functional detail, a complete showing of the invention’s purpose and how a POSA can use it. To be sufficient, the specification must encompass the full breadth of the patent’s claimed matter. Prior art must also enable the information it discloses to anticipate a patent claim. However, the enablement standard for anticipation falls under § 102 of the patent act, which does not require a showing of utility nor a full teaching of usability– thereby applying a much lower functional threshold for enablement of prior arts as compared to the patent specification. Furthermore, a prior art only needs to enable any portion of a claim’s scope in order to anticipate the entire claim.
This double-standard, arising directly from the statutory framework of the Patent Act itself, has been a stumbling block for inventors since at least 1969 when the predecessor of the Federal Circuit clarified both meanings in Application of Hafner. As noted in that decision,
“a disclosure lacking a teaching of how to use a fully disclosed compound for a specific, substantial utility . . . is, under the present state of the law, entirely adequate to anticipate a claim to . . . the product . . . and, at the same time, entirely inadequate to support the allowance of such a claim.”
The discrepancy in enablement standards for the purpose of attacking novelty and non-obviousness versus securing a patent claim lays a particularly dangerous trap for inventors in the fields of biotechnology and biomedical science. It is difficult sufficiently enable claims (especially broad claims), but almost trivially easy to create publications which poison the well of future patentability– both in the form of premature patent applications and scholarly publications.
For anticipation purposes, enablement only requires subject matter to have been publicly disclosed in some way. As the Federal Circuit reiterated in this decision, an anticipating disclosure does not need to reduce the claimed invention to practice or enable the full scope of a claim. It merely needs to provide information a POSA could combine using their familiar tools and skills to develop or practice any single embodiment within the scope of the claim, without undue experimentation. To compound this issue, published prior art references (both patent and non-patent publications) enjoy a rebuttable presumption of enablement. Once a potentially anticipating prior art is identified, the patentee or applicant is burdened with proving the reference was not enabling.
Whether a prior art enables and anticipates a claim is highly specific to the particular claim language at issue, creating the greatest danger for the broadest claims. In the recent Agilent decision, the patentee made a very broad claim to “gRNA”– any RNA structure bearing specified structural modifications, which can associate with Cas protein and recruit it to a target DNA sequence. The court held this claim anticipated by an abandoned patent application, Pioneer Hi-Bred, which disclosed RNA constructs meeting both criteria. Although some experimentation would have been required to produce the gRNA specifically described in Agilent’s patent, scientific publications at the time showed that the structural modifications claimed would have been known to a POSA at the time, and the experiments needed to create them would have been routine. Agilent argued that Pioneer didn’t meet the enablement standard because it didn’t directly show its gRNAs had complete functionality but, critically, a showing of utility is only required for patentability of a patent claim, not for a prior art reference to render the claim unpatentable.
If Agilent had introduced an additional functional limitation to their claim, for instance by including detectable target DNA cleavage in the “gRNA” definition, this case could have come out in their favor. Language of that nature would require the prior art to show functionality in order to fall within scope of the claim, circumventing the absence of functional utility from the prior art enablement standard. Based on their broad claim language, Agilent could not overcome the presumption of enablement afforded to Pioneer’s potentially non-functional gRNAs. Pioneer High-Bred was never issued a patent from the application cited in this case, quite possibly because its application lacked this exact showing.
Pioneer’s failure to obtain a patent claiming these modified guide RNAs, and the subsequent anticipation of Agilent’s claims by their fruitless application, serves as a cautionary reminder against both over-broad claims and premature patent applications. The enablement standard for patent claims is not only higher than that required for anticipation, but also a crucial requirement of a complete patent application. Insufficient enablement is a fatal defect, which cannot be cured through amendment if doing so requires the addition of new matter not included in the application as originally filed. This is of significant consequence, because the ability to claim priority to a previously filed application requires sufficient enablement to support the claims of the subsequent application. If a previous application’s specification is insufficient, the subsequent application cannot claim priority to it, and the previous application can become anticipating prior art which significantly curtails or even forecloses entirely the inventor’s ability to secure a patent going forward, as discussed by the Federal Circuit’s 2005 decision in Rasmussen v. SmithKline Beecham.
Claire E. Reynolds-Peterson, Ph.D., is a law clerk and Teige P. Sheehan, Esq., Ph.D. is a partner with Heslin Rothenberg Farley & Mesiti P.C.