And yet diagnostic methods are still wandering in the wilderness…
The PTO has issued yet another revision of its Subject Matter Eligibility Guidance for Examiners. The ﬁrst of these Guidance documents arrived in March 2014 following the Supreme Court’s landmark Myriad decision. The subsequent torrent of feedback and new case law developments (especially the Federal Circuit’s decision in Roslin Inst. and the Supreme Court’s Alice decision) made it necessary to revise the Guidance in December 2014. Now the PTO has again revised the Guidance in the wake for further decisions from the Federal Circuit too numerous to list. One expects that this regular and periodical reassessment of §101 examination standards is going to be the new normal for a while as the Federal Circuit works out the “brass tacks” applications of the Supreme Court’s Bilski, Mayo, Myriad, and Alice decisions.
The most notable aspect of the July 2015 Guidance is how little it changes from the December 2014 Guidance. Time and again we are told (July 2015 Guidance at pg. 8) “the current analysis… will be retained… .” Perhaps the only real change (or at least the most notable) from the December 2014 Guidance is the greatly expanded explanation of how to identify an “abstract idea.” This is very helpful to the community of inventors, because it gives prospective guidance to a would-be patent applicant about how to determine whether a given invention is or is not going to be rejected as an “abstract idea.”
The PTO had a difﬁcult task in crafting this part of the Guidance because, as noted (July 2015 Guidance pg. 3) “the courts have declined to deﬁne abstract ideas, other than by example… .” However, the July 2015 Guidance distills these various examples into four categories: (1) “fundamental economic practices”; (2) “an idea ‘of itself’”; (3) “certain methods of organizing human activity”; and (4) “mathematical relationships/formulas.” A “quick reference sheet” is helpfully provided that lists the salient features and constituent members of each category, so that one can recognize in advance whether one’s claim is likely to fall into any of these four categories.
Inventors in the computer-implemented arts have reason to be cheered by the additional examples in the new Guidance. The PTO has taken the commendable step of articulating examples that are not copied literally from any particular case, but rather which represent extensions by analogy from existing precedent to cover common situations that have not yet been addressed by the Federal Circuit or the Supreme Court.
These include many helpful examples of claims that are subject matter eligible. For example, Example 27 discusses a claim directed to a method for loading Basic Input/Output System software, and explains in admirable detail what sort of claim elements make the claim §101 eligible.
Similarly, Example 21 presents two different claims directed to the same invention, one of which is ineligible and the other of which is eligible, so that one can see what sorts of limitations are necessary to get one across the §101 threshold. This is useful information.
The most notable omission from the July 2015 Guidance (at least from the perspective of someone working in the Biotech/Pharmaceutical art ﬁelds) is the absence of additional examples of eligible or ineligible diagnostic method claims. The July 2015 Guidance (pg. 1) says that such examples are still in development, so there is nothing to do but wait for them.