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Court Of Appeals For The Federal Circuit Holds That Conception Does Not Require Certainty of Success
05/28/2025On May 12, 2025, the Court of Appeals for the Federal Circuit vacated-in-part and remanded a Patent Trial and Appeal Board (“PTAB”) decision in an interference proceeding concluding that the Broad Institute, Inc. (“Broad Institute”) has priority over the Regents of the University of California (“Regents”) with respect to the CRISPR-Cas9 system-related patent claims in dispute. Regents of the University of California v. Broad Institute, Inc., No. 22-1653 (C.A.F.C. May 12, 2025). The Court held that the PTAB applied the wrong test for conception by requiring Regents to show that they knew their invention would work.
The patent applications at issue use a CRISPR-Cas9 system containing a “single-guide” RNA to edit DNA in eukaryotic cells. (The CRISPR-Cas9 system had already been used in prokaryotic cells.) Research and development on this use by both parties began around early 2012. Both parties filed provisional patent applications on the invention, and the PTAB declared an interference proceeding (No. 106,115) in June 2019 to determine which party first invented the use of single-guide RNA in the CRISPR-Cas9 system to genetically edit eukaryotic cells.
In an interference proceeding under 35 U.S.C. 135 (pre-AIA), priority goes to the first to invent the commonly claimed subject matter. A rebuttable presumption exists that the inventors made their inventions in the chronological order of their effective filing dates, but the later-filing party can alternatively prove, for example, that it reduced the invention to practice before the filing date (priority date) of the earlier-filing party or that it was first to conceive of the invention and that it exercised reasonable diligence in later reducing that invention to practice. Broad Institute argued that it was the first to show successful results of editing a eukaryotic cell with the CRISPR-Cas9 system; Regents provided evidence that they had the plans and understanding of how to use the system to edit eukaryotic cells at an earlier date. The PTAB found that Broad Institute had invented editing in eukaryotic cells, as evidenced by Broad Institute’s submission of a manuscript to Science showing reduction to practice in October 2012. Regents, in contrast, lacked certainty in the documentation surrounding their research on the applicability of the CRISPR-Cas9 system to editing in eukaryotic cells and, according to the Board, had not reduced their invention to practice prior to October 2012. Regents appealed the decision, arguing that the PTAB improperly conflated the requirements for conception and reduction to practice. Broad Institute cross-appealed, challenging a claim construction issue.
The Court held that the PTAB “legally erred by conflating the distinct legal standards for conception and reduction to practice.” The Court held that the PTAB applied the wrong legal standard by requiring Regents to prove that they knew their invention would work in order to establish conception. The Court clarified that conception does not require certainty of success or actual demonstration that the invention works. Experimental failures and internal doubts do not negate conception unless those doubts lead to substantive changes in the invention’s design. The correct inquiry is whether the inventors had a “definite and permanent idea of the operative invention” such that a person of ordinary skill in the art could reduce it to practice without extensive research or experimentation. The Court additionally faulted the PTAB for failing to consider whether ordinary techniques known in the field could have been used to implement Regents’ design, emphasizing that the ability of skilled technicians to achieve the invention using routine techniques is highly relevant to the conception analysis. The case was remanded with instructions that the later party to reduce to practice be given the opportunity to show, under a conception date established by the correct standard, either (1) it was the first to conceive of the invention and that it exercised reasonable diligence in later reducing that invention to practice, or (2) it had “prior conception of the claimed subject matter and communication of the conception to the adverse claimant.”
The Court also affirmed the Board’s findings that the Regents’ earliest provisional patent applications lacked adequate written description and dismissed Broad Institute’s cross-appeal related to claim construction as moot.
