Consider a familiar device-company scenario. A regulatory team prepares a 510(k) and tells FDA that a design feature tracks a predicate device, is supported by familiar engineering literature, and does not raise new questions of safety or effectiveness. Around the same time, the patent team argues to the USPTO that the same feature, or a particular implementation of it, is central to novelty or nonobviousness. Each position may be defensible. The risk begins when no one has p

Restriction requirements are often treated as administrative noise—something to get past on the way to allowance. The Federal 2025 decision in Focus Products Group International, LLC v. Kartri Sales Co. shows how dangerous that mindset can be. In that case, a species restriction and the patentee’s handling of it became the backbone of a prosecution history disclaimer argument that narrowed claim scope enough to wipe out two patent infringement wins. I. From hookless curtains