Court Of Appeals For The Federal Circuit Rules That Conception Doesn’t Require Success
On the 12th of May 2025, the Court of Appeals of the Federal Circuit vacated and remanded a decision of the Patent Trial and Appeal Board (PTAB) in an interference proceeding, concluding that Broad Institute, Inc. (Broad Institute) has priority over Regents of University of California (Regents) with respect to CRISPR-Cas9-related patent claims at issue. Regents of University of California v. Broad Institute, Inc., no. 22-1653 (C.A.F.C. 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 in question use a CRISPR/Cas9 system containing a single-guide RNA to edit the DNA of eukaryotic cell. The CRISPR-Cas9 technology had been used before in prokaryotic cell types. Both parties began their research and development of this use in early 2012. The PTAB declared a 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 the 35 U.S.C. Priority is given to the first person to invent the subject matter that is claimed by both parties. There is a rebuttable assumption that inventors made their inventions chronologically, according to their effective filing dates. However, the later-filing parties can prove that they reduced the invention into practice before the filing date of the earlier-filing parties, or that they were the first to conceive the invention, and that they exercised reasonable diligence to later reduce that invention into practice. Broad Institute claimed that it was the first organization to demonstrate successful results in editing a eukaryotic cellular with the CRISPR Cas9 system. Regents provided proof that they understood how to use this system to edit eukaryotic cellular at an earlier date. The PTAB determined that Broad Institute was the first to demonstrate successful editing of eukaryotic cell using CRISPR-Cas9 system. Broad Institute submitted a manuscript in October 2012 to Science demonstrating reduction to practice. Regents, on the other hand, were unsure about the documentation they had gathered to support their research into the applicability and effectiveness of the CRISPR/Cas9 system for editing in eukaryotic cell. According to the Board, they hadn’t reduced their invention to use before October 2012. Broad Institute filed a cross-appeal, challenging a claim construction issue. Broad Institute filed a cross-appeal, challenging a claim interpretation issue.
The Court found that the PTAB had “legally erred” by confusing the legal standards for conception with those for reduction to practice. The Court clarified conception does not require proof of success or demonstration that the invention actually works. Failures in experiments and internal doubts are not grounds for dismissing conception, unless they lead to substantial changes in the design of the invention. The correct question is whether the inventors were able to have a “definite, permanent idea” of the operative design such that a person with ordinary skill in their art could put it into practice without extensive experimentation or research. The Court remanded the case 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 to practice the invention or (2) it had “prior conception of the claimed subject matter and communication to the adverse claimant.” 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.
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