iRhythm Battles Back: Says Patent Owner’s Delay Shouldn’t Kill IPR Efforts

Now, iRhythm contends that such reasoning undermines the purpose of the IPR system, which was created under the America Invents Act (AIA) to provide a faster, cost-effective alternative to district court litigation for challenging potentially invalid patents. According to iRhythm, the USPTO's decision essentially punishes petitioners for strategic timing—regardless of whether they had actual intent to challenge a patent when it was first cited in an IDS.

Legal experts say this case could reshape how the USPTO applies discretionary denial doctrines, particularly in light of its 2025 updated guidance on discretionary factors. These updates emphasized a “holistic approach” in deciding IPR petitions, including factors like prior art strength, parallel litigation, and now, the so-called “settled expectations” if a petitioner knew about the patent for a long time and waited to act.

iRhythm argues that this factor is being overstated. “A citation in an IDS is not an admission of validity nor an indication of intent to challenge,” one of its legal representatives stated. The company believes that the USPTO’s analysis failed to properly balance all factors and has called on the Director Review process to reconsider the denial.

Critics of the USPTO’s discretionary denial power have long warned that it gives patent owners a procedural shield that circumvents the IPR process, especially when no litigation is pending. In this case, iRhythm says the patent owner remained silent for years and only raised these claims after iRhythm launched a product that became commercially significant.

The outcome of this dispute could influence how companies approach patent risk management and strategic filings in future IPR cases. If upheld, the USPTO’s current stance could encourage petitioners to file IPRs much earlier, potentially triggering a wave of preemptive challenges by companies fearing later discretionary denial.