Technology Information Law Blog by Charles Gideon Korrell

Tag: interference

  • Global Health Solutions LLC v. Selner: The Federal Circuit’s First AIA Derivation Appeal Clarifies Conception, Corroboration, and Harmless Error

    The Federal Circuit’s decision in Global Health Solutions LLC v. Selner marks the court’s first precedential review of an America Invents Act (AIA) derivation proceeding. In affirming the Patent Trial and Appeal Board’s judgment, the court provided much-needed guidance on how AIA derivation proceedings differ from pre-AIA interferences, how conception and communication operate under the statute, and how corroboration principles apply when inventorship disputes turn on contemporaneous electronic evidence.

    At a high level, the decision underscores a central theme of the AIA: first-to-file is the rule, and derivation is the narrow exception. The court repeatedly cautioned against allowing derivation proceedings to become a backdoor revival of first-to-invent interference practice. As Charles Gideon Korrell notes, the opinion reflects a broader judicial reluctance to expand statutory exceptions that would undermine the predictability of the AIA’s filing-date-centric framework.

    Background and Competing Applications

    The case arose from competing patent applications directed to an emulsifier-free wound treatment ointment containing nanodroplets of an aqueous biocide suspended in petrolatum. The claimed advance centered on a manufacturing method that separately heats the petrolatum and the biocide to different temperatures before mixing, resulting in a stable suspension without emulsifiers.

    Marc Selner filed his application on August 4, 2017. Four days later, Global Health Solutions LLC (GHS) filed its application naming Bradley Burnam as inventor. It was undisputed that Selner was the first filer and that both applications were governed exclusively by the AIA.

    GHS petitioned for a derivation proceeding under 35 U.S.C. § 135, alleging that Burnam conceived the invention first and communicated it to Selner, who then derived the invention and filed earlier. The Board instituted the proceeding and ultimately ruled in Selner’s favor, finding that although Burnam had conceived and communicated the invention by 4:04 p.m. on February 14, 2014, Selner had independently conceived the same invention earlier that same day, at 12:55 p.m.

    GHS appealed, raising multiple challenges to the Board’s legal framework, evidentiary rulings, and treatment of conception and corroboration.

    AIA Derivation Is Not Interference by Another Name

    A significant portion of the opinion is devoted to clarifying the legal framework governing AIA derivation proceedings and distinguishing them from pre-AIA interferences. Before the AIA, derivation typically arose within interference proceedings, which focused on determining who invented first. Under that regime, proving derivation required establishing prior conception and communication, often under a clear-and-convincing evidentiary standard.

    The AIA eliminated interferences for AIA-governed applications and replaced them with derivation proceedings that serve a narrower function. As the court explained, derivation proceedings do not ask who invented first in an abstract sense. Instead, they ask whether the first filer derived the claimed invention from the second filer before filing.

    To establish a prima facie case of derivation under the AIA, the petitioner must show: (1) conception of the claimed invention, and (2) communication of that conception to the respondent before the respondent’s effective filing date. The respondent may defeat the claim by proving independent conception prior to receiving the communication.

    The Federal Circuit emphasized that while pre-AIA derivation cases can provide helpful guidance, they must be applied cautiously. Judges must avoid inadvertently reintroducing interference concepts that Congress intentionally discarded. Charles Gideon Korrell observes that this portion of the opinion is likely to be cited frequently in future derivation disputes as parties attempt to import familiar interference-era doctrines into AIA proceedings.

    Harmless Error and the Board’s Focus on Earliest Conception

    One of GHS’s principal arguments on appeal was that the Board erred by focusing on which party conceived first, rather than on whether Selner independently conceived the invention before receiving Burnam’s communication. The Federal Circuit agreed that the Board framed its analysis using pre-AIA first-to-invent language, but held that any such error was harmless.

    The reason was straightforward. Selner chose to prove independent conception by showing that he conceived of the invention earlier than Burnam. By doing so, Selner necessarily established that his conception was independent and not derived from Burnam’s later communication. Although the Board’s reasoning tracked interference-style analysis, its factual findings resolved the dispositive AIA question.

    This aspect of the decision is a reminder that not every doctrinal misstep warrants reversal. Under the harmless error rule, the appellant must show not only that an error occurred, but that it affected the outcome. Here, the Board’s findings foreclosed derivation regardless of the analytical path used to reach them.

    Corroboration and the Rule of Reason in the Digital Age

    GHS also argued that Selner failed to adequately corroborate his alleged conception, contending that the Board improperly relied on Selner’s own emails. The Federal Circuit rejected this argument and reaffirmed the applicability of the rule-of-reason standard for corroboration.

    Under that standard, all pertinent evidence is considered to determine whether an inventor’s story is credible. Contemporaneous documentary evidence carries particular weight. In this case, Selner introduced emails sent on February 14, 2014, retrieved from his AOL web-based email account by a law clerk from his attorney’s office. The Board credited not only the content of the emails but also their metadata, including timestamps and sender and recipient information.

    The court emphasized that documentary evidence does not require independent corroboration in the same way as testimonial evidence. Moreover, the metadata associated with the emails was not authored by Selner and therefore constituted independent evidence. Additional circumstantial evidence, including later emails in which Burnam referred to the invention as having been “invented” by Selner, further supported the Board’s findings.

    The opinion draws an important distinction between this case and prior decisions in which alleged conception was supported solely by an inventor’s uncorroborated testimony. As Charles Gideon Korrell notes, the court’s analysis reflects an evolving understanding of how electronic records and metadata can satisfy corroboration requirements that were developed in a paper-lab-notebook era.

    Conception Without Reduction to Practice

    Another key issue on appeal was whether the nature of the invention required simultaneous conception and reduction to practice. GHS argued that because the invention involved unpredictable chemical properties, conception could not be complete without laboratory verification.

    The Federal Circuit rejected this argument. While acknowledging that certain inventions may require reduction to practice before conception is complete, the court reiterated that this is not a categorical rule for unpredictable fields. An inventor may have a complete conception when they have formed a definite and permanent idea of the invention, including a method of making it, even if the invention has not yet been reduced to practice.

    Here, substantial evidence supported the Board’s finding that Selner had fully conceived the invention by the time he described the method in detail in his February 14 email. The court declined to impose a heightened conception standard that would effectively require experimental success in every chemical or materials-based invention.

    Procedural Missteps and Inventorship Correction

    Finally, GHS sought a remand for the Board to consider whether Burnam should be named as a co-inventor on Selner’s application. The Federal Circuit declined, holding that GHS failed to properly preserve the issue.

    Under the Board’s rules, a request to correct inventorship must be made by separate motion, accompanied by specific documentation and a detailed explanation of the legal and factual basis for relief. GHS did none of this, instead including a single conclusory sentence in its petition and never pursuing the issue again.

    The court held that any failure by the Board to address this undeveloped request was harmless and attributable to GHS’s own procedural shortcomings. Charles Gideon Korrell believes this portion of the decision serves as a cautionary tale for parties attempting to hedge derivation claims with alternative inventorship theories without complying with procedural requirements.

    Takeaways

    Global Health Solutions v. Selner reinforces several important principles for AIA-era inventorship disputes:

    First, derivation remains a narrow exception to first-to-file, and courts will resist efforts to revive interference-style priority contests under a different label.

    Second, independent conception by the first filer, even if established through interference-style evidence, is sufficient to defeat derivation.

    Third, contemporaneous electronic communications and metadata can provide powerful corroboration under the rule-of-reason standard.

    Finally, procedural rigor matters. Requests for alternative relief such as inventorship correction must be properly presented and preserved.

    As Charles Gideon Korrell notes, this decision provides a foundational roadmap for future AIA derivation appeals and underscores the Federal Circuit’s commitment to preserving the structural integrity of the post-AIA patent system.

    By Charles Gideon Korrell

  • Regents of the University of California v. Broad Institute: Federal Circuit Faults PTAB for Conflating Conception and Reduction to Practice Standards in CRISPR Interference

    Regents of the University of California v. Broad Institute: Federal Circuit Faults PTAB for Conflating Conception and Reduction to Practice Standards in CRISPR Interference

    In a closely watched battle over the origins of one of the most transformative technologies in modern biology, the Federal Circuit has partially reversed a PTAB ruling in Regents of the University of California v. Broad Institute, Inc., No. 22-1653 (Fed. Cir. May 12, 2025). The dispute centers on who first invented the use of CRISPR-Cas9 systems with single-guide RNA (sgRNA) to edit DNA in eukaryotic cells—a breakthrough that has revolutionized gene editing and spurred enormous commercial and scientific interest.

    The Federal Circuit vacated the PTAB’s finding that the Broad Institute had priority over the University of California, University of Vienna, and Emmanuelle Charpentier (collectively, the “Regents”), holding that the Board applied the wrong legal standard for conception. While affirming the PTAB’s determination that the Regents’ provisional applications lacked adequate written description, the Court remanded for further proceedings on conception.

    Background: A Decade-Long Dispute Over CRISPR Dominance

    This interference proceeding is the latest chapter in a long and contentious legal saga between two groups of academic researchers. The Regents’ team, scientists, directed by Emmanuelle Charpentier, Jennifer Doudna, and Martin Jinek, published a seminal 2012 paper demonstrating that a CRISPR-Cas9 system could be programmed using a chimeric sgRNA to cut DNA in a test tube. The Broad team, led by Feng Zhang at MIT and the Broad Institute, was the first to obtain patents for using CRISPR-Cas9 in eukaryotic cells, including human cells, after submitting expedited applications to the USPTO.

    The potential commercial implications of these patents are immense. CRISPR technologies are foundational in developing gene therapies, agricultural tools, and synthetic biology applications. The 2020 Nobel Prize in Chemistry was awarded to Doudna and Charpentier for their discovery, but the patent rights remained under dispute. This case, involving Interference No. 106,115, marks the second interference declared between the parties and focuses specifically on claims involving the use of a single-guide CRISPR-Cas9 system in eukaryotic cells.

    Federal Circuit: PTAB Misapplied the Legal Standard for Conception

    The Federal Circuit found that the PTAB improperly required the Regents’ scientists to know their invention would work in eukaryotic cells in order to establish conception. This, the Court held, conflated the distinct legal standards for conception and reduction to practice.

    Citing Burroughs Wellcome Co. v. Barr Labs, Inc., 40 F.3d 1223 (Fed. Cir. 1994), the panel emphasized that an inventor need only have a “definite and permanent idea” of the complete invention. Certainty of success or experimental proof is not required at the conception stage.

    The Court also held that:

    • The PTAB placed undue weight on contemporaneous expressions of doubt by the Regents’ scientists, without analyzing whether these doubts led to substantive changes in their design;
    • The Board erred by failing to consider whether others—using the Regents’ published design and routine methods—were able to achieve successful editing in eukaryotic cells, which would support the argument that the invention required only ordinary skill to reduce to practice;
    • The PTAB wrongly disregarded the use of “routine techniques” in the field as a key factor in assessing whether conception had been achieved.

    The Court remanded the case for further findings under the proper legal framework, which will allow the Regents to reargue their priority claim based on their early 2012 planning and public disclosures.

    Written Description: Affirmed Due to Unpredictability in the Field

    The Court affirmed the PTAB’s determination that the Regents’ first (P1) and second (P2) provisional applications lacked adequate written description under 35 U.S.C. § 112. The claims at issue involved an sgRNA-guided CRISPR-Cas9 system functioning in a eukaryotic cell.

    Given the acknowledged unpredictability in adapting prokaryotic systems to eukaryotes, the Court agreed with the PTAB that the P1 application did not sufficiently convey possession of an operative embodiment. The Board reasonably found that the application lacked specific instructions or empirical evidence demonstrating success or feasibility, particularly in light of the complexity of the technology.

    Although the Court reaffirmed that a working example is not required, it found the Regents’ disclosure wanting because it failed to bridge the gap between concept and implementation in eukaryotic systems.

    Broad’s Cross-Appeal: Dismissed as Moot

    Broad’s cross-appeal challenged the PTAB’s construction of “guide RNA” as being limited to a single-molecule configuration. However, the Court dismissed the appeal as moot because the Board had denied Broad’s related motions on independent procedural grounds that Broad did not challenge on appeal. Thus, even if the claim construction were reversed, it would not alter the outcome of those rulings.

    Takeaways

    This decision breathes new life into the Regents’ claims of priority in the eukaryotic CRISPR space and signals the Federal Circuit’s continued insistence on correctly distinguishing between conception and reduction to practice. Some key takeaways:

    • The Court reaffirmed that certainty of success is not required for conception. Inventors need only have a definite and permanent idea of the invention that a person of ordinary skill can reduce to practice.
    • In unpredictable arts like biotechnology, written description demands more. Disclosure must demonstrate possession, not just hypothesis, particularly when transitioning between biological systems.
    • Experimental success by third parties using routine methods is relevant to whether an invention was complete at the time of conception.
    • Procedural missteps can be fatal. Broad’s failure to adequately support its claim construction-based motions before the PTAB rendered its cross-appeal ineffectual.

    As this high-stakes dispute continues to unfold, the next round at the PTAB may prove decisive in determining who truly owns the foundational CRISPR patent rights in eukaryotic systems.

    By Charles Gideon Korrell