Patent attorneys are well-versed in the function of the Information Disclosure Statement (IDS) during prosecution. We understand that listing prior art in an IDS satisfies the duty of candor, helps insulate patents from future invalidity attacks by establishing that the art was “considered” by the USPTO, and protects against charges of inequitable conduct when material references are disclosed in good faith. However, a recent decision by the USPTO Director in iRhythm v. Welch Allyn IPR2025-00363, Paper 10 revealed that IDSs can also be a powerful tool even after the patent is issued, influencing whether the Patent Trial and Appeal Board (PTAB) will even institute an inter partes review (IPR) years later.
In iRhythm, the Petitioner, iRhythm Technologies, filed IPRs against five Welch Allyn patents related to cardiac monitoring technology and Welch Allyn filed discretionary denial briefing under the new guidelines In the Board’s institution decision, several Fintiv factors initially appeared to favor institution – the Board’s final written decisions were projected to be issued well before the District Court trial, and the parties made minimal investments in the District Court proceedings, with a high likelihood of a stay if IPR was instituted. Nonetheless, the Director denied institution, not because the merits were weak or litigation was duplicative, but because iRhythm had cited Welch Allyn’s parent application and later-issued patent in IDSs more than a decade earlier. Specifically, iRhythm filed an IDS in August 2013 citing the publication that would later issue as U.S. Patent No. 8,214,007 and filed another IDS in May 2015 citing the ’007 patent itself. These documents, introduced as Exhibits 2001 and 2002, gave the Director a clear record of iRhythm’s longstanding awareness of the Welch Allyn patent family. That awareness, in the Director’s view, created settled expectations in Welch Allyn’s favor and tipped the discretionary balance under 35 U.S.C. § 314(a) against institution.
This decision marks a meaningful shift in how the PTAB and Director may evaluate equitable considerations. Under the USPTO’s March 2025 Interim Guidance on workload management, the Director is authorized to deny institution where the parties’ “settled expectations” warrant it. A prior IDS citation is arguably the most persuasive form of documentary evidence showing that the Petitioner had actual notice of the patents at issue well before they filed for IPR. In iRhythm, the Director explicitly credited iRhythm’s IDS filings as dispositive evidence of awareness, noting that despite knowing about the patents for more than ten years, the Petitioner delayed challenging them until litigation began. That delay supported an inference of strategic gamesmanship, especially given the long-standing nature of the patents and the fact that iRhythm had submitted them in its own prosecution records, showing not only passive awareness but also active engagement.
This use of the IDS as a weapon against the Petitioner underscores an important shift. Traditionally, an IDS fortifies a patent against invalidity by invoking the presumption of validity under 35 U.S.C. § 282. However, in the post-Fintiv landscape, the same IDS may be wielded to defeat institution of an IPR on discretionary grounds. Once a party has cited a patent or application in its own filings, it becomes exceedingly difficult to argue that it only recently discovered the patent or became aware of its significance. Any effort to challenge the patent years later—especially in response to litigation—will appear reactive, belated, and contrary to the equitable goals of the AIA.
For Petitioners
The iRhythm decision underscores a critical but often overlooked step in preparing an IPR petition: carefully analyzing the citation history of the challenged patent. Specifically, Petitioners should examine both the backward citations (i.e., the prior art cited on the face of the patent or in related prosecution histories) and the forward citations (i.e., subsequent references—including the Petitioner’s own applications—that cite the challenged patent). These citations can dramatically affect whether the PTAB institutes review—not because of the merits of invalidity, but because of how they reflect on the Petitioner’s past awareness and conduct.
Forward citations are particularly dangerous. If the Petitioner cited the challenged patent in an IDS during the prosecution of its own patent applications, or even a related application, the Petitioner could use that record to demonstrate that the Petitioner had actual knowledge of the patent as far back as the filing date of those applications. That’s exactly what occurred in iRhythm: the Director denied institution in large part because iRhythm had cited the parent application, as well as a later-issued patent, in IDSs it filed more than a decade earlier. Those references were treated as evidence of long-standing awareness, and ultimately supported the conclusion that iRhythm’s delay in filing for IPR was inconsistent with the equitable goals of the AIA framework.
On the backward citation side, Petitioners must be equally vigilant. If references being asserted in an IPR were already cited or considered during prosecution, the Petition is subject to additional scrutiny under the frameworks articulated in Advanced Bionics, LLC v. Med-El Elektromedizinische Gerate GMBH, IPR2019-01469, Paper #6, 7-8 (P.T.A.B. 2020) (Precedential): and Becton, Dickinson & Co. v. B. Braun Melsungen AG, IPR2017-01586, Paper 8 at 17–18 (PTAB Dec. 15, 2017) (precedential). Under Advanced Bionics, the Board must determine whether the Petitioner previously brought the same (or substantially the same) art to the Office’s attention, and whether the Petitioner’s arguments or evidence are materially different from what the Office already considered. If not, the Board may deny institution under 35 U.S.C. § 325(d). The Becton, Dickinson factors further guide that analysis, requiring the Board to consider whether the prior art was merely listed or actually relied upon, whether it was cumulative, and whether the petition presents new arguments or evidence not previously before the Examiner.
Petitioners who fail to address these questions run the risk of having their petitions denied for being redundant or cumulative. Worse, failing to acknowledge that a reference was cited on the face of the patent may undermine credibility and suggest a lack of diligence.
For Patent Owners
The Director’s denial of institution in iRhythm offers important lessons not only for Petitioners but also for Patent Owners preparing to defend their patents in inter partes review. One of the most powerful tools available to Patent Owners—often hiding in plain sight—is the administrative record itself. The iRhythm decision allows Petitioners to use their IDSs in their filings as affirmative evidence of long-standing awareness, supporting a discretionary denial under 35 U.S.C. § 314(a).
For Patent Owners, this creates a significant opportunity. First and foremost, during the prosecution of a patent application that has a high likelihood of being litigated, Patent Owners should be sure to make their prosecution counsel aware of their competitors’ IP and insist on filing IDSs on any close or related competitor patents. Then, once litigation begins and IPRs begin to be filed, counsel should conduct a thorough forward citation analysis of the patent family to determine whether the Petitioner has previously cited the challenged patent (or any member of its family) in an IDS, publication, or other filing. As in iRhythm, this can show that the Petitioner was aware of the patent for many years prior to filing the IPR, which weighed heavily in favor of discretionary denial.
Patent Owners should also incorporate settled expectations arguments into their discretionary denial briefing. Under the March 2025 USPTO guidance on PTAB workload management, “settled expectations” of the Patent Owner are a recognized factor in institution analyses. Petitioners cannot stand by for years, with knowledge of a patent and only initiate review when litigation becomes likely or inevitable – the Patent Owner can frame that delay as unfair and strategically opportunistic. The Board and the Director have both shown a willingness to deny institution on that basis.
Finally, when a Patent Owner prepares a POPR, or discretionary denial brief, they can strengthen their position by pointing to additional facts that corroborate the theme of delay or acquiescence. For example, evidence of licensing discussions, co-participation in standard-setting bodies, or continued product development in the face of known patent claims can all support the inference that the Petitioner made a strategic decision not to challenge the patent, until it became financially or procedurally convenient to do so. That kind of narrative was compelling in iRhythm, and can and should be used to Patent Owners’ advantage.
