Shifting Arguments on the PTAB

by Dennis Crouch

The Federal Circuit’s new choice in Rembrandt Diagnostics, LP v. Alere, Inc., 2021-1796 (Fed. Cir. Aug 11, 2023) enhances the courtroom’s latest choice in Axonics, Inc. v. Medtronic, Inc., 2022-1532 (Fed. Cir. Aug. 7, 2023). Ordinarily, an IPR petitioner should stick with the arguments and reasoning that it units forth within the authentic petition.  These two instances take a opposite place and allow the petitioner to shift as late because the  remaining reply temporary. The courtroom permits these adjustments provided that conscious of new arguments by the patentee and sufficiently linked to beforehand raised arguments.

This submit focuses on Rembrandt.  A previous submit checked out Axonics.

Rembrandt was beforehand earlier than the Federal Circuit on the full-institution difficulty that the Supreme Court docket addressed in SAS Institute.  The PTAB had initially instituted Alere’s IPR petition on some however not all grounds offered.  In its 2019 choice, the Federal Circuit affirmed the PTAB’s declare building however remanded for the PTAB to think about non-instituted grounds.   On remand, the PTAB instituted on all grounds and finally concluded that further claims had been additionally unpatentable as apparent. On enchantment this time, the Federal Circuit has affirmed — discovering that the PTAB had correctly discovered the claims apparent.

Rembrandt owns U.S. Patent No. 6,548,019 associated to assay check strip units for testing organic fluids.  Because the determine exhibits, the setup is sort of easy and permits for a number of strips to be examined without delay.

One of many key points raised on enchantment was the presentation of recent theories mid-stream by the petitioner Alere.  Specifically, Rembrandt pointed to Alere’s reply temporary as providing new theories.

Rembrandt argued Alere raised new theories about price/time financial savings as a motivation to switch the MacKay reference to carry a number of check strips. Nevertheless, the Federal Circuit discovered this was conscious of Rembrandt’s argument that there was no motivation to switch MacKay. Additional, the fee/time financial savings was considered as correctly increasing on Alere’s earlier “effectivity” argument.

Alere’s reply argument discussing price and time financial savings has a nexus to Rembrandt’s prior argument and is responsive. It refutes Rembrandt’s assertions that there isn’t a motivation so as to add a number of check strips or an expectation of success. And by discussing time and value financial savings as a type of effectivity, it additionally correctly expands on and is a good extension of its beforehand raised effectivity argument.

Slip Op.

The Federal Circuit discovered an alternate cause to affirm — holding that forfeited its argument.  Earlier than the PTAB, Rembrandt had usually objected to new theories offered by Alere.  Nevertheless, the Federal Circuit concluded that generic objection was inadequate to well timed assert its proper. The Federal Circuit’s place was bolstered by the truth that Rembrandt had made a really particular objection concerning one other new-theory difficulty that isn’t on enchantment. “We maintain that Rembrandt’s generic objection is inadequate to represent a correct objection—particularly as a result of Rembrandt expressly objected to different allegedly new theories with out doing so right here.”

Along with these procedural difficulty, the courtroom additionally concluded that the Board’s conclusions had been supported by substantial proof. A key right here is that Rembrandt didn’t present skilled testimony to rebut Alere’s skilled. The prior artwork and skilled testimony present substantial proof to help the PTAB’s findings on the teachings of the prior artwork and motivation to mix.