Latest Director Discretionary Denial Decision in iRhythm Provides Valuable Insights

Sterne, Kessler, Goldstein & Fox P.L.L.C.

On June 6, 2025, Acting USPTO Director Stewart issued a decision in iRhythm Tech. v. Welch Allyn, Inc., IPR2025-00363, Paper 10 (and four related IPRs), which granted Patent Owner’s request for discretionary denial. This is the fifth decision issued by the Acting Director under the “Interim Process for PTAB Workload Management” and provides important insights on how the Acting Director is evaluating discretionary factors under the new bifurcated briefing process.

The Interim Process memorandum identified additional discretionary considerations that may be considered in determining whether to discretionarily deny a petition. Two of these factors were addressed in this decision: i) the extent of the petition’s reliance on expert testimony; and ii) the settled expectations of the parties.

In the decision, the Acting Director disagreed with Patent Owner’s arguments that Petitioner was over-reliant on expert testimony. The testimony did not suggest that Petitioner was using its expert to fill gaps in the prior art, but instead Petitioner was relying on its expert to explain background knowledge and the testimony was supported by cited evidence.

However, the Acting Director found persuasive Patent Owner’s argument that settled expectations favored denial because one of the patents has been in force since 2012 and Petitioner was aware of it as early as 2013. Petitioner’s awareness and failure to seek early review outweighed considerations against discretionary denial, including the expert testimony consideration and the Fintiv analysis. Notably, the projected final written decision was due approximately seven months before the district court trial date, there was little investment in the district court proceeding, and a high likelihood of a stay if review was instituted.

As with the previous discretionary decisions issued under the new process, this decision notes the determination was based on a holistic assessment of all of the evidence and arguments. Thus, other factors may also have weighed in favor of denying institution in this proceeding.

More information about the new PTAB discretionary institution practice can be found in our previous alert on the Interim Process memorandum and our alert on additional information provided by the USPTO in response to frequently asked questions (FAQs).

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations. Attorney Advertising.

© Sterne, Kessler, Goldstein & Fox P.L.L.C.

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