IP Law Daily, PATENT NEWS—Agilent asks High Court to rein in ‘presumed enablement’ of printed publications in CRISPR IPRs, (Nov 14, 2025)

By Saurabh Kashyap, B.A., M.A., LL.B., LL.M.

Petitioner requests the Supreme Court to hold that IPR challengers, not patentees, must prove printed publications are enabling for anticipation.

Agilent Technologies has petitioned the U.S. Supreme Court to review a Federal Circuit judgment that, in Agilent’s view, allows the Patent Trial and Appeal Board (PTAB) and challengers in inter partes review (IPR) to presume that “printed publications” cited for anticipation are enabled—effectively shifting the burden to patentees to prove non-enablement. The petition faults the Federal Circuit’s reliance on Rasmusson v. SmithKline Beecham 413 F.3d 1318, 1326 (Fed. Cir. 2005), and similar lines of authority, and asks the Court to clarify that challengers bear the burden to prove that any anticipatory printed publication actually enables the claimed invention (Agilent Technologies, Inc. v. Synthego Corp., Dkt. No. 25-570 (U.S. filed Nov. 13, 2025)).

Background. Agilent Technologies, Inc. is a global life-sciences and diagnostics company whose offerings include instruments and solutions for genomics, proteomics, and chemical analysis. Synthego Corp., the respondent, is a biotechnology company that supplies CRISPR genome-engineering tools and reagents to research and therapeutic developers.

The dispute originates from two IPRs that Synthego filed in 2022 against Agilent’s U.S. Patent Nos. 10,337,001 (the ’001 patent) and 10,900,034 (the ’034 patent), which concern chemically modified CRISPR guide RNAs. On May 17, 2023, the PTAB issued final written decisions, finding all challenged claims of both patents unpatentable and granting sealing motions on certain filings. The Board's orders entered judgment under 35 U.S.C. § 318(a). Agilent appealed, and on June 11, 2025, the Federal Circuit consolidated the cases and affirmed the decision. Meanwhile, overlapping district-court litigation in the Northern District of California—comprising Synthego’s declaratory-judgment action and Agilent’s transferred infringement suit—has been stayed pending the IPRs and appeals.

De facto presumption. Agilent’s central allegation is doctrinal. It argues that the PTAB and Federal Circuit treated printed publications offered as anticipatory prior art as if they were presumptively enabled, thereby requiring Agilent—not Synthego—to disprove enablement. That approach, Agilent contends, conflicts with the statutory allocation of proof in both district-court invalidity (§ 282) and IPRs (§ 316(e)), which places the burden squarely on the challenger to establish every element of anticipation, including enablement, by a preponderance of the evidence. The petition frames this as a recurring and important question of patent adjudication that warrants review: whether tribunals may presume enablement for printed publications cited as anticipatory prior art, with the patentee bearing the burden to show otherwise.

Rasmusson’s “no proof of efficacy” dictum. A second prong of the petition targets the Federal Circuit’s statement in Rasmusson that "proof of efficacy is not required" for enablement in the context of anticipation. According to Agilent, that phrase has been read too broadly and has become a "permission slip" to accept prophetic, unworked disclosures as enabled anticipatory references, even where the claims require specific functional performance (here, a modified guide RNA that associates with Cas proteins and guides targeting). Agilent asks the Court to vacate or significantly narrow the Rasmusson language so that challengers must show enablement commensurate with the claims, and cannot defeat patent rights on the strength of speculative disclosures untethered to operative teachings.

Non-enabled printed publication. Agilent asserts that Synthego’s petitions leaned heavily on an international patent application commonly referenced in the record as “Pioneer Hi-Bred.” In Agilent’s telling, the document never matured into a patent and reads as prophetic rather than enabling. The PTAB’s decision charts list “Pioneer Hi-Bred” among the references marshaled against multiple claim sets, culminating in orders finding all claims unpatentable. Agilent argues that accepting such a reference as anticipatory without an affirmative showing of enablement epitomizes the burden-shifting error it asks the Court to correct.

Functional claiming. The petition emphasizes that Agilent's claims require guide RNAs with defined chemical modifications that nonetheless retain gRNA functionality in CRISPR systems. In Agilent's view, a challenger invoking anticipation must therefore show that the cited publication actually teaches the skilled person to make and use such modified gRNAs without undue experimentation. The petition criticizes what it characterizes as a formalistic approach—one that ticks boxes for disclosure while eliding the enablement tied to the functional heart of the claims—again, in tension with §§ 282 and 316(e).

Policy stakes. Beyond doctrine, Agilent paints a policy backdrop: if later-discovered, prophetic, or otherwise non-enabled printed publications can anticipate without an enablement showing by the challenger, patentees lose the predictability needed to invest in research, while accused infringers may deploy hindsight-laden references untethered to operable teachings at the relevant time. The petition suggests that this dynamic is particularly destabilizing in fields like CRISPR, where incremental chemical modifications can make the difference between in-cell functionality and failure.

Need for Supreme Court review. Agilent situates the issue in a live controversy with a complete administrative and appellate record. The consolidated Federal Circuit judgment of June 11, 2025, affirmed the PTAB’s May 17, 2023, final written decisions in IPR2022-00402 ('001 patent) and IPR2022-00403 ('034 patent). Related district-court actions—Synthego’s declaratory-judgment suit and Agilent’s infringement case, now consolidated in the Northern District of California—are stayed pending the IPR path. The petition’s Related Proceedings section inventories these matters to show that Supreme Court intervention would not be advisory; rather, it would direct the proper burden-and-enablement framework to concrete disputes already adjudicated below.

The final written decisions granted judgment of unpatentability on all challenged claims across both patents, with the Board's orders entered under § 318(a). The petition points to those outcomes to argue that burden misallocation has real bite: when challengers may point to printed publications without proving enablement, patentees face claim cancellation even where the claimed functionality (here, the operation of modified gRNAs) allegedly was not actually taught.

The appeal flows straightforwardly from the PTAB’s final written decisions: Agilent maintains that the Board allowed Synthego to rely on printed-publication prior art without proving enablement, and that the Federal Circuit affirmed by endorsing a framework inconsistent with §§ 282 and 316(e) and overbroadly reading Rasmusson. Those asserted legal errors—not merely disputes about fact-finding—are the petition’s reason for Supreme Court review. The petition packages the issue as an opportunity for the Court to restore the proper anticipation-enablement standard and to harmonize IPR practice with the Patent Act’s allocation of proof.

Reliefs requested. Agilent asks the Supreme Court to grant certiorari to resolve whether printed publications used as anticipatory prior art may be presumed enabled, and to hold that challengers bear the burden to prove enablement commensurate with the claims when asserting anticipation based on printed publications. It further requests that the Court vacate or significantly narrow Rasmusson’s "no proof of efficacy" language to the extent it has been applied to dispense with enablement. As to case disposition, Agilent seeks reversal of the judgment below or, at a minimum, vacatur and remand with instructions that the PTAB and Federal Circuit apply the correct burden and enablement standards to the printed-publication art relied upon against the '001 and '034 patents.

The Case is Dkt. No. 25-570.

Attorneys: Denise Marie De Mory (Bunsow De Mory LLP) for Agilent Technologies, Inc.

Companies: Agilent Technologies, Inc.; Synthego Corp.

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