"Preliminary guidance" has been replaced by "interim guidance." The United States Patent and Trademark Office has released its 2012 Interim Procedure for Subject Matter Patentability Analysis of Process Claims Involving Laws of Nature. The interim guidelines, based on the recent Supreme Court decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc., are to be followed "for examination of process claims in which a law of nature, natural phenomenon, or naturally occurring relation or correlation (collectively referred to as a natural principle in the guidance) is a limiting element or step." The interim guidelines replace the preliminary guidelines issued by the PTO back in March, the day after the U.S. Supreme Court handed down its decision in the Prometheus case.
The PTO expects these new guidelines to have the most applicability in Tech Center 1600, which covers the biotechnology arts. However, inventions that implement or evaluate natural principles are very often implemented in software. Thus, in a great many cases, software patent attorneys will need to pay attention to both the interim Mayo v. Prometheus guidance as well as the “Interim Bilski Guidance” that was issued July 27, 2010, and which the PTO says examiners should continue to follow.
A link to the PTO's memorandum is provided above. To summarize, claims involving natural principles are analyzed using a simple flowchart. If the claims do not encompass a process, then the PTO's August, 2009, Interim Examination Instructions for Evaluating Subject Matter Eligibility Under 35 U.S.C. § 101 should be followed. If the claims do not include a law of nature, then the 2010 Bilski Guidance (linked to above) should be followed. For process claims directed to laws of nature, the inquiry is whether the "the claim include[s] additional elements/steps or a combination of elements/steps that integrate the natural principle into the claimed invention such that the natural principle is practically applied, and are sufficient to ensure that the claim amounts to significantly more than the natural principle itself?" Explanations of how to identify natural principles, and factors to consider in whether the natural principle is practically applied, are then provided in some detail. Without repeating the memorandum, suffice it to say that, unsurprisingly, once the simple flowchart leads to the substantive Section 101 analysis, things get a little murky.
And why are these guidelines interim? Because the PTO is waiting at least for the Federal Circuit to decide Assn. for Molecular Pathology v. Myriad Genetics and WildTangent v. Ultramercial, both recently remanded from the U.S. Supreme Court for further consideration in view of Mayo v. Prometheus. As the PTO explains:
While Mayo has provided additional details for the eligibility analysis that the Office developed after Bilski, the technology areas currently being addressed by the Federal Circuit, most notably in Myriad and Ultramercial, will provide insight regarding the full reach of Bilski and Mayo. The Office believes that the prudent course of action is to wait for resolution of these cases before issuing comprehensive updated guidance.
So as seems to be the takeaway from so many developments relating to 35 U.S.C. § 101, stay tuned.