- within Compliance topic(s)
In Regents of the University of California v. Broad Institute, Inc., the Federal Circuit addressed the issue of conception and reduction to practice as related to the written description of multiple patent applications.
Background
Regents of the University of California ("Regents") and Broad Institute were engaged in a patent interference proceeding involving the adaptation of CRISPR systems to edit eukaryotic DNA. Both parties were engaged in extensive testing related to editing eukaryotic DNA during the time of the invention, and both filed multiple patent applications that became the subjects of the patent interference proceedings. Before deciding preliminary motions, the PTAB determined that the claim term "guide RNA" in both parties' applications encompassed a single-molecule RNA configuration under the broadest reasonable interpretation. The PTAB also determined that Regents was only entitled to a January 2013 priority date because its earliest applications did not satisfy the written description requirement. Because of this priority date, the PTAB designated Regents as the junior party and designated Broad Institute as the senior party for the priority phase of the interference proceeding. In its final written decision, the PTAB determined that Broad Institute reduced the invention to practice in October 2012, and denied Regents' claims to an earlier reduction to practice based on emails, notebook entries, and reports related to microinjection and expression vector tests. Regents appealed the PTAB's decisions related to conception and written description. Broad Institute appealed the claim construction decision.
Issues
The Court analyzed whether the PTAB correctly analyzed the conception and reduction to practice for both parties and whether the PTAB correctly determined the priority date based on the written description requirement. The Court also analyzed whether the claim construction determinations impacted the legal interests of both parties.
Holding
The PTAB overly relied on statements from Regents' scientists in determining conception and reduction to practice. The PTAB correctly analyzed the Regents applications under the written description requirement. Broad Institute's claim construction appeal was moot because it did not impact the legal interests of the parties.
Reasoning
The Federal Circuit agreed with Regents that the PTAB legally erred by focusing on statements made by Regents' scientists expressing uncertainty about whether the experiments had succeeded. The Court distinguished that what matters for conception is whether the inventors had a definite and permanent idea of the operative inventions, and determined the PTAB should have considered whether the scientists' statements led to modifications in their experiments that substantively changed their original ideas. The Court also found the PTAB failed to consider routine methods or skill, and instead focused entirely on the scientists' statements. The PTAB should have considered whether a person of ordinary skill could have achieved the function of editing eukaryotic DNA without requiring certainty that the invention would work. Furthermore, the Court found the PTAB failed to consider evidence of purported experimental success by others as presented on the record. Finally, the Court reasoned that the PTAB failed to consider whether Regents' scientists described routine methods or skill in their disclosures at the asserted conception dates, and whether they used routine methods or skill in subsequent, purportedly successful experiments. Based on the above, the Federal Circuit vacated the Board's decision on conception.
The Federal Circuit also determined the PTAB did not err in its analysis addressing the written description requirement. In particular, the Court found the PTAB correctly analyzed whether a person of ordinary skill in the art would understand that Regents had possession of the claimed subject matter, given the uncontested determination that the subject matter was highly unpredictable and complex. The Court held the PTAB correctly determined the earlier applications did not show or establish possession of the claimed subject matter. The Court also held the PTAB's analysis satisfied the Administrative Procedures Act.
Finally, the Federal Circuit determined that the claim construction issue was moot because the preliminary motions were decided on issues independent of the claim construction determinations. In particular, the PTAB explicitly stated that its decisions were made independent of the claim construction issues. The Court held that the appeal would not have an impact on the legal interests of the parties and dismissed the issue as moot.
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