Clarifying the Two-Part Advanced Bionics Framework

In Ecto World, LLC and SV3, LLC v. RAI Strategic Holdings, Inc. (Ecto), the petitioner sought Director Review of the Patent Trial and Appeal Board (PTAB) denial of an inter partes review (IPR) request challenging U.S. Patent No. 11,925,202 B2. The challenge relied exclusively on prior art references listed in the information disclosure statement (IDS) submitted during the prosecution of the ’202 patent. The examiner had initialed the IDS, indicating that all references, except those lined through, were considered.

In Advanced Bionics, LLC v. MED-EL Elektromedizinische Geräte GmbH, IPR2019-01469 (PTAB 2020) (Advanced Bionics), the PTAB articulated a well-known two-part framework for applying discretionary denial under 35 U.S.C. § 314(a) when the prior art asserted in an IPR was previously considered by the U.S. Patent and Trademark Office (USPTO).

In Ecto, the PTAB denied institution, citing that:

• The prior art was already presented via the IDS, satisfying prong one of the Advanced Bionics frameworks, and

• Petitioners failed to show a material error by the Office in considering the prior art under prong two of the Advanced Bionics framework.

Petitioners sought Director Review, arguing that the Board misapplied both prongs of the Advanced Bionics test and failed to fairly evaluate the strength of their petition.

For prong one, the PTAB clarified that references listed on an IDS during prosecution are considered to have been "presented to the Office" for purposes of prong one of the Advanced Bionics framework, even if those references were never relied upon in a rejection or substantively discussed by the examiner. This means that petitioners can no longer argue that an IDS-listed reference was not “presented” to the Office merely because the examiner did not cite it in a rejection; formal submission alone satisfies the requirement. As a result, many IPR petitions invoking art from prosecution histories must now confront part two of the framework directly.

For prong two, once it is established that the Office previously considered, or at least received, the reference, the burden shifts squarely to the petitioner to show that the Office materially erred in its prior consideration of the art. Importantly, this burden applies even if the examiner did not substantively analyze the reference apart from acknowledging its inclusion on the IDS.

To satisfy prong two, petitioners must do more than repackage known art or point to the examiner's silence. They must identify how the examiner’s failure to meaningfully engage with the reference constituted a material error that would likely have altered the outcome had it been appropriately addressed. Boilerplate assertions or general critiques of the examination process will not suffice. The Director clarified that petitioners must explain how the Examiner erred using Becton, Dickinson factors, especially (c), (e), and (f), which concern the extent of evaluation, failure to consider specific teachings, and whether additional evidence warrants reevaluation.

However, the PTAB has indicated that petitioners may potentially avoid discretionary denial in cases where the applicant submitted an unusually large IDS and failed to identify particularly relevant references when prompted by the examiner. In these scenarios, if the examiner was overwhelmed by an excessive volume of materials and received no guidance from the applicant, it may be reasonable to conclude that the art was not meaningfully considered, thus undermining the rationale for discretionary denial.

This nuanced exception acknowledges the practical limitations of examination and avoids unduly penalizing petitioners when the nature of the IDS submission itself effectively bypasses the USPTO's review process.

Conclusion

The PTAB’s ongoing interpretation of Advanced Bionics reflects a maturing jurisprudence surrounding discretionary denial. Practitioners must recognize that merely appearing on an IDS is sufficient to trigger part one, and part two imposes an affirmative burden to demonstrate examiner error, even without substantive engagement with the reference. That said, petitioners may still have room to maneuver in situations involving overwhelming IDS submissions, especially when applicants fail to assist the examiner in identifying key references. As always, the specific prosecution context and the record before the Office will drive the outcome. Understanding and adapting to these clarified standards is essential for any party navigating the IPR landscape.