Originally uploaded at SSRN.


The Patent Office has the power to issue rules that “shall govern the conduct of proceedings in the Office,” 35 U.S.C. § 2(b)(2), but not the power to issue substantive rules. It has been this way since 1870, when Congress first granted the Office this regulatory power, in nearly these same words. Just how broad is this grant? How should a reviewing court determine whether a challenged Patent Office rule is procedural (and thus valid) or substantive (and thus invalid)? It is remarkable that in 2010, 140 years after Congress gave the Patent Office this power, the proper sorting standard is as unclear as it has ever been. This paper provides the best answer. The key is realizing that the proper route to the answer is to model it after the Rules Enabling Act analysis for testing the validity of Federal Rules of Procedure, not the Administrative Procedure Act analysis for requiring notice-and-comment rulemaking or the Rules of Decision Act analysis for hewing to state substantive law in diversity cases. In brief, a Patent Office rule that incidentally affects applicants’ substantive rights does not violate § 2(b)(2) of the Patent Act if the rule is reasonably necessary to establish or preserve the fair and effective patent examination process that the Office’s rules must organize.