Today (July 30th), the Patent Office released an 11 page “July 2015 Update” on patent-eligible subject matter (or not). (A copy of the update and appendices can be found at the end of this post.) Most of the “Update” focused on clarifying the December 2014 revised guidance. Also released were new examples 21-26–including ones modeled on Flook and Diehr. None of the new examples related to the life-sciences. Also released were an Appendix 2 that indexed all of the examples released since December 2014, and an Appendix 3, summarizing all of the case law discussed.
So if you are a life sciences person, you need only peruse the “Update.” It spends considerable space discussing how to apply the December 2014 Guidance, but the takeaway is that you need to rebut the natural product exception with a showing of markedly difference characteristics (2A) or else you fall into the dreaded “significantly more” circle of Hell called 2B. There is also some attempt to clarify the role of the “Streamlined Analysis” and preemption, that I don’t think clarified anything and that Examiners ignore anyway.
The most interesting section of the “Update” is IIIC, entitled “An Idea ‘Of Itself.'” This section is a quick review of the case law that found that the claims were an attempt to patent an abstract idea. The PTO is basically adhering to Judges Lourie and Moore’s reasoning in the two Myriad decisions that invalidated claims to comparing a BRACA DNA sequence from a subject with a reference BRACA sequence. The biggest problem for the biotech industry in these decisions was the accidental (I hope) invalidation of one claim that recited that alterations from the reference sequence were indicative of a predisposition to cancer.
As described generally in Section IIIC, “Processes of comparing data that can be performed mentally [are] abstract, such as comparing information regarding a sample or test subject to a control or [to] target data (Ambry, Myriad CAFC).” Intema is characterized as “comparing data to determine a risk level.” In the case law appendix Intema is summarized as “antenatal screening for Down’s syndrome.” Ariosa is summarized as involving “non-invasive prenatal diagnosis.” In re Grams , that as I recall, had extremely broad claims was summarized as “method of diagnosing abnormal condition in an individual.” Section IIIC summarizes it as “diagnosing an abnormal condition by performing clinical tests and thinking about the results.” At least Mayo cannot be wedged into this crew – the Supreme Court decided that the claims were an attempt to monopolize a natural correlation, but also said that the fate of diagnostic claims was not a question before them.
This suggests that the PTO has no intention of backing off its extreme position that diagnostic test claims are not patent-eligible, including the most specific “If A, then B” assays that are the foundation of the diagnostic test industry and of advances in personalized medicine and companion diagnostics yet to come. I still hope that diagnostic test claims that are more focused–both on the correlation being assayed and the diagnostic conclusion itself – will not simply be lost in the growing cult of the “abstract idea.”