USPTO Director Stewart Denies Institution of Five IPRs Due to Petitioner’s “Failure to Seek Early Review”

6.18.25

On June 6, 2025, USPTO Acting Director Stewart exercised authority under the USPTO’s new bifurcated discretionary review process to deny institution of five inter partes review (IPR) petitions filed by iRhythm Technologies (“Petitioner”) against patents owned by Welch Allyn (“Patent Owner”). The Acting Director’s decision indicates that knowledge of a patent family for more than a decade may create “settled expectations” among the parties that the claims of the patent family are patentable over the prior art and that such knowledge can weigh in favor of exercising discretion to deny instituting the IPR(s).

For background, the March 26, 2025 Memorandum on the Interim Process for PTAB Workload Management enumerates various “relevant considerations” parties may address in their discretionary denial briefing, including the following:
1. Whether the PTAB or another forum has already adjudicated the validity or patentability of the challenged patent claims;
2. Whether there have been changes in the law or new judicial precedent issued since issuance of the claims that may affect patentability;
3. The strength of the unpatentability challenge;
4. The extent of the petition’s reliance on expert testimony;
5. Settled expectations of the parties, such as the length of time the claims have been in force;
6. Compelling economic, public health, or national security interests; and
7. Any other considerations bearing on the Director’s discretion.

Although the Acting Director’s decision emphasizes that these factors are weighed holistically, the Acting Director’s decision and analysis show “settled expectations” can outweigh other competing factors.

Here, the petitions targeted several Welch Allyn patents, the earlier of which (U.S. Patent No. 8,214,007) issued on July 3, 2012. Welch Allyn responded with requests for discretionary denial, arguing several theories. One of Welch Allyn’s arguments invoked Fintiv to deny institution based on the parties’ parallel district court litigation, emphasizing the parties’ alleged substantial investment, lack of a stay, and lack of any Sotera-type stipulation. Acting Director Stewart determined the Fintiv analysis alone weighed against exercising discretion to deny institution, since the PTAB’s final written decision was projected to issue before the district court trial scheduled for March 22, 2027, the parties had invested little in the district court proceeding, and a stay was likely if the IPRs were instituted.

Welch Allyn also argued the petition heavily relied on expert testimony presented as “general knowledge of a person of ordinary skill in the art,” which “cannot take the place of a disclosure in a prior art reference.” Again, Acting Director Stewart determined this discretionary consideration weighed against exercising discretion to deny institution , because the petitions properly relied on expert testimony for background knowledge of a POSITA, supported with sufficient citation to evidence.

Finally, Welch Allyn highlighted the parties’ settled expectations, emphasizing that iRhythm was aware of the challenged patents since at least 2013 but delayed challenges for over a decade, “creating an implicit expectation . . . and acquiescence as to the patentability of the claims.” The Director agreed and found that iRhythm’s twelve-year delay in challenging the patents weighed heavily against institution. The Director described Welch Allyn’s argument on settled expectations as “persuasive” and concluded this factor “favors denial and outweighs” other considerations supporting institution.

Approximately one week after the iRhythm decision, Acting Director Stewart issued a number of additional decisions clarifying how “settled expectations” and timing of patent issuance may factor into discretionary denial. In Tesla, Inc. v. Charge Fusion Technologies, LLC and ResMed Corp. v. Cleveland Medical Devices, Inc., the Director declined to deny institution, highlighting that the “recent” issuance of the challenged patents (in 2023 and 2024, respectively) favored robust, predictable patent rights and weighed against discretionary denial.

Similarly, in Globus Medical, Inc. v. Spinelogik, Inc., decided June 12, 2025, the Acting Director declined to exercise discretion to deny institution, even though the challenged patent had been in force for nearly eight years. The Director credited the petitioner’s argument that Spinelogik had allowed the patents to lapse for non-payment of maintenance fees just four years after issuance—creating, in the petitioner’s view, an expectation of non-enforcement. This expectation, the Director reasoned, undermined the weight of “settled expectations” and tipped the scale against discretionary denial.

These recent decisions underscore that while longstanding knowledge of a patent may weigh in favor of discretionary denial, it is not dispositive. In some cases, as in iRhythm, a petitioner’s prolonged inaction can establish “settled expectations” that tilt against institution. But other decisions—such as Tesla, ResMed, and Globus—illustrate that factors like recent patent issuance or lapses in patent maintenance may rebut such expectations. Accordingly, prospective petitioners should not assume early knowledge alone is outcome-determinative. Instead, they should carefully assess the full context, including patent prosecution history, enforcement behavior, and timing of challenges. The USPTO continues to emphasize that any exercise of discretion rests on a holistic assessment of all evidence and arguments presented.

Samuel Raque | Associate Attorney