The central theme in this interference decision involving U.S. Pat. No. 8,697,359 is the amount and type of evidence required to support the conception of an invention. Joe Friday wanted the witness to focus on the facts of the matter, a focus that the Fed. Cir. found that the Board lacked.
In The Regents of the University of California v. Broad Institute, Appeal no. 2022-1594 (Fed. Cir., May 12, 2025), the PTAB had awarded a priority date to Broad that made them the senior partly, even though the Regents had given a presentation and published a paper in Science magazine describing the invention that spurred Broad (“Zhang”) to begin researching the same gene-editing CRISPER-Cas system. The two groups addressed the question of whether or not the system would work in eukaryotic cells, particularly in a form comprising two linked RNA linked into a “single guide” RNA.
Regents also published its initial work on the single guide system in June 2022. Regents filed three provisional patent applications, P1 on May 25, 2022, P2 on Oct. 12, 2022, and P3 in Jan. 2023. The PTAB rejected Regents asserted date of reduction to practice of August 9, 2022 and only granted Regents’ priority claim to the Jan. provisional. The PTAB also found that P1 and P2 failed to meet the written description requirement of s. 112. The Board also awarded a priority date of October 5, 2022 to Broad, on the basis of a paper that Zhang submitted to Science on that date.
The Fed. Cir. held that the Board legally erred “by conflating the distinct legal standards for conception and reduction to practice” and held that the Board erred by requiring Regents’ scientists to know their system would work at the conception stage.
The Fed. Cir. also agreed with Regents that the court erred in solely focusing on the back and forth statements by the Regents scientists about their progress and failures in getting the system to reproducibly transform eukaryotic cells, without considering whether Regents “actually and substantively modified the system” to the extent that Regents did not initially have a “definite and permanent idea” of the “complete invention as it will be used in practice.”
“The appropriate analysis should turn on whether Regents scientists ‘had formed the idea of their use [for transforming eukaryotic cells] in sufficiently final form that only the exercise if ordinary skill remained to reduce it to practice’—more than a general hope”. [distinguishing Hitzeman v. Rutter].
The court also found that it was legal error for the Board to “categorically disregard evidence of purported experimental success by others” and to disregard Regents’ arguments that, despite difficulties, only routine methods as used by the POSA were required to reduce the invention of count I — a functional CRISPER system — to practice. The court vacated the Boards decision on conception and remanded for the Board to decide on conception under the “proper application of the legal framework.”
Regents are not in the legal clear, because the court, relying on Ariad, held that P1 and, by implication, P2 failed the written description requirement (WDR) of s. 112.
“[/t] test for sufficiency is whether the disclosure ‘reasonably conveys to those skilled in the art that the inventor had possession of the claimed invention as of the filing date…This test and its concept of possession required us to determine how a [POSA] would understand the four corners of the specification” [citing Ariad]
The court held that the Board did not err in finding that the system was complex and unpredictable and that the P1 applicants had failed to disclose “specific instructions or conditions necessary for CRISPER-Cas9 activity in a eukaryotic cell, or an indication that no specific instructions or conditions were necessary.” The court agreed with the Boards ruling that a [POSA] would not understand P1 to show or establish possession.
The Board had noted that there were no working examples in P1 but did not treat this as dispositive, and the court agreed with the Board’s application of the possession test. The court noted Broad’s argument that “the unpredictable nature, well-known obstacles, and prior failures and difficulties in adapting prior art prokaryotic cells to eukaryotic cells’ support that P1 lacks written description.
Since the parties claim construction arguments are specific to this case, they are of less interest. The question remains, however, if Regents can establish conception, perhaps based at least in part on their publications.
