Shifting Arguments on the PTAB

by Dennis Crouch

The Federal Circuit’s new resolution in Rembrandt Diagnostics, LP v. Alere, Inc., 2021-1796 (Fed. Cir. Aug 11, 2023) enhances the court docket’s current resolution in Axonics, Inc. v. Medtronic, Inc., 2022-1532 (Fed. Cir. Aug. 7, 2023). Ordinarily, an IPR petitioner should keep on 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  closing reply transient. The court docket permits these modifications 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 concern that the Supreme Courtroom addressed in SAS Institute.  The PTAB had initially instituted Alere’s IPR petition on some however not all grounds introduced.  In its 2019 resolution, the Federal Circuit affirmed the PTAB’s declare building however remanded for the PTAB to contemplate non-instituted grounds.   On remand, the PTAB instituted on all grounds and ultimately concluded that extra claims have 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 take a look at 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 directly.

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

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

Alere’s reply argument discussing value 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 take a look at strips or an expectation of success. And by discussing time and price 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 another cause to affirm — holding that forfeited its argument.  Earlier than the PTAB, Rembrandt had usually objected to new theories introduced by Alere.  Nonetheless, 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 relating to one other new-theory concern 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 concern, the court docket additionally concluded that the Board’s conclusions have 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 assist the PTAB’s findings on the teachings of the prior artwork and motivation to mix.