Insights

Acting USPTO Director Coke Morgan Stewart issued a Director Discretionary decision on June 6, 2025, in iRhythm Technologies Inc. v. Welch Allyn Inc., IPR2025-00363, -00374, -00376, -00377, and -00378 Paper 10 (PTAB June 6, 2025). This decision granted Patent Owner’s request for discretionary denials of institution in five related IPR challenges.  It follows several recent Director decisions that have all discretionarily denied petitions for reasons other than the substantive merits of the challenges. However, this decision is the first one that relies upon “[s]ettled expectations of the parties, such as the length of time the claims have been in force,” a new consideration that was first articulated in the USPTO’s “Interim Process for PTAB Workload Management” memorandum (“Interim Memo”) dated March 26, 2025.

Acting USPTO Director Coke Morgan Stewart recently issued a Director Review decision on May 19, 2025, in Ecto World, LLC v. RAI Strategic Holdings, Inc, IPR2024-01280, Paper 13 (PTAB May 19, 2025), that was subsequently designated as precedential by the Patent Trial and Appeal Board (PTAB). The decision seeks to eliminate inconsistencies amongst PTAB panels in using its discretion to deny institution under 35 U.S.C. § 325(d). 

As part of the 2012 America Invents Act, statutory estoppel was included to balance the interests of patent owners and patent challengers following an inter partes review (“IPR”).  Estoppel prevents an IPR petitioner from later asserting in court that a claim “is invalid on any ground that the petitioner raised or reasonably could have raised” during the IPR.  35 U.S.C. § 315(e)(2).  As applied, estoppel prevents petitioners from later relying in district court or in ITC proceedings on most patents or printed publications – the limited bases upon which petitioner can rely in an IPR.  But a question remained, and contradictory district court decisions arose, as to whether petitioners would be estopped from relying on a prior art commercial product (known as “device art,” which could not itself have been raised in the IPR) even if a printed publication describing the product (i.e. a patent or technical manual) was available and presumably could have been raised. 

In a bipartisan show of support for American inventors and technological leadership, Senators Chris Coons (D-DE), Thom Tillis (R-NC), and Mazie Hirono (D-HI) and Representatives Kevin Kiley (R-CA) and Scott Peters (D-CA) held a press conference on Wednesday, May 1, 2025, to highlight growing momentum behind the Promoting and Respecting Economically Vital American Innovation Leadership Act (known as the PREVAIL Act) and the Patent Eligibility Restoration Act (known as the PERA Act).  

On Wednesday, March 5, 2025, the United States Patent Trial and Appeal Board (“PTAB”) handed down the latest decision in the COVID vaccine proceedings between Pfizer Inc. (“Pfizer”) and BioNTech SE (“BioNTech”) and ModernaTX, Inc. (“Moderna”). The PTAB found all challenged claims unpatentable in two patents held by Moderna related to Moderna’s COVID-19 vaccine technology: U.S. Patent Nos. 10,702,600 (the “’600 patent”) and 10,933,127 (the “’127 patent”), both entitled “Betacoronavirus mRNA Vaccine.”

On February 28, 2025, the USPTO announced that it was rescinding a 2022 memorandum issued by former USPTO Director Kathi Vidal, entitled “Interim Procedure for Discretionary Denials in AIA Post-Grant Proceedings with Parallel District Court Litigation,” which had curtailed discretionary denials of PTAB post-grant proceedings. The February 2025 announcement directs parties to refer to PTAB precedent for guidance, including the decisions in Apple Inc. v. Fintiv, Inc., IPR2020-00019, Paper 11 (PTAB Mar. 20, 2020) and Sotera Wireless, Inc. v. Masimo Corp., IPR2020-01019, Paper 12 (PTAB Dec. 1, 2020). The announcement further indicates that, to the extent any PTAB or Director Review decisions relied on the 2022 memorandum, the portions of those decisions shall not be binding or persuasive on the PTAB.

The Federal Circuit recently issued a decision in Kroy IP Holdings, LLC v. Groupon, Inc., No. 23-1359 (Fed. Cir. Feb. 10, 2025), holding that collateral estoppel does not preclude a patentee from asserting any unadjudicated claims of a patent where other claims of the same patent were held unpatentable in an inter partes review (“IPR”) by the Patent Trial and Appeals board (“PTAB”).

The Federal Circuit in Sanho Corp. v. Kaijet Technology International Limited, Inc., No. 2023-1336 (Fed. Cir. July 31, 2024) recently addressed the prior art exception of a “public disclosure” under 35 USC § 102(b)(2)(B).  Affirming a decision of the U.S. Patent Trial and Appeals Board (“PTAB”), the court held that “publicly disclosed” is only satisfied if the invention was made available to the public, and a non-confidential but otherwise private sale of an invention is not a sufficient “public disclosure”.  This case provides a cautionary tale that disclosing or selling an invention before filing a patent application is fraught with risk.

Starting in June 2021, the U.S. Patent and Trademark Office (USPTO) instituted a policy to allow for the Director of the USPTO to review certain decisions by the Patent Trial and Appeal Board (PTAB) issued in inter partes reviews (IPRs) and post grant reviews (PGRs).  That process, known as Director Review, was created in response to the decision in United States v. Arthrex, Inc., whereby the Supreme Court held that final written decisions of administrative patent judges in IPR proceedings must be subject to the review of the Director of the USPTO before they become the decisions of the agency.  141 S. Ct. 1970 (2021).

A petition for Inter Partes Review (IPR) kicks off an IPR proceeding, and is required to set forth the grounds of invalidity and how the claim terms should be construed. In the precedential opinion Axonics, Inc. v. Medtronic, Inc., the Federal Circuit held that if the patent owner proposes, or the Patent Trial and Appeal Board (PTAB) adopts, a claim construction that is different from the construction proposed by the petitioner, the petitioner should be given an opportunity to present invalidity arguments and evidence under the new construction. In responding to the new claim construction, however, the petitioner is limited to the prior art of record, and it may not rely upon new prior art references. The Federal Circuit left open whether the petitioner may rely upon different embodiments in a previously cited reference.

The PTAB ruled last week that the common law doctrine of claim preclusion only applies at the PTAB in one direction, holding that Congress did not intend for an adverse district court judgment to block a party from pursuing a subsequent inter partes review challenge. 

On February 24, 2023, the Director of the United States Patent and Trademark Office (“USPTO”) issued a precedential Director Review Decision in the Inter Partes Review (“IPR”) of Nested Bean, Inc. v. Big Beings Pty Ltd.[1] The decision modified the Patent Trial and Appeal Board’s (PTAB) final written decision that had found all challenged multiple dependent claims fully invalid, notwithstanding the fact that one of the independent claims from which the multiple dependent claims depended was not found to be invalid.[2]

Although the Patent Trial & Appeal Board’s (PTAB) reliance on Fintiv to deny petitions for Inter Partes Review (IPR) has waned since Kathi Vidal was named Director of the USPTO and the advent of Sotera stipulations, these so-called Fintiv denials remain the subject of intense scrutiny by the patent bar. On March 13, 2023, the Federal Circuit Court of Appeals revived a challenge to the PTAB’s practice of discretionary denials under Fintiv, allowing it to proceed before the district court.[1] This revival will no doubt be welcomed by patent challengers who dislike the PTAB’s current practice under Fintiv.

When you are embroiled in a contentious battle with your competitor in an inter partes review (IPR) proceeding, what is your ultimate goal? To win, of course. But what are your odds of success? This alert delves into the win rates for both patent owners and patent challengers over the last four years at the PTAB and provides predictions for what to expect in 2023.

Just over a week after the Supreme Court’s decision in Arthrex, the USPTO has issued preliminary guidance on how the Office plans to implement the Director-review process required by the Court’s decision. The Office intends to treat the Director reviews much like the current request for rehearing process. Namely, a request for the Director’s review must satisfy the timing requirements of a request for rehearing (37 C.F.R. 42.71(d)), and a timely request for Director review will reset the time for appeal or civil action pursuant to 37 C.F.R. 90.3(b). But unlike requests for rehearing by the panel of administrative patent judges, which must point out an argument or issue that the Board “misapprehended or overlooked,” the Director can review any issue, whether one of fact or law. The Director also has de novo review authority, so need not give deference to the panel’s decisions under review. Further, the Director can initiate a review sua sponte. When sua sponte review is initiated, the parties to the proceeding will be given notice and may be given an opportunity for briefing.

Trademark applicants and registrants may experience increased scrutiny of their trademark use claims in light of the results of a recent Pilot Program, conducted by the United States Patent and Trademark Office (USPTO), showing that fifty percent (50%) of approximately 500 randomly selected registrants could not support the claims made in previously filed Declarations of Use. See USPTO Report. Each selected registrant had been asked to submit specimens showing use for two additional goods or services per class in addition to the specimen already submitted with the Declaration.

On June 20, 2014, the U.S. Patent and Trademark Office's Trial and Appeal Board, for the first time, rendered final written decisions in inter partes review proceedings of pharmaceutical related patents, specifically claims covering compositions for and methods of making and using folate-containing dietary supplements said to address elevated levels of homocysteine in the blood that can lead to cardiovascular, ocular, neurological and skeletal diseases. Since the inter partes review procedure went into effect in September 2012, more than 1350 patent challenges have been initiated, more than 700 trials instituted, and more than 65 final written decisions issued, but these are the first final written decisions in cases involving pharmaceutical related patents. Of particular significance, the Board found all of the challenged patent claims it reviewed to be unpatentable.