On May 4, 2016, the USPTO issued new guidance memo providing instructions to patent examiners on how to formulate a Section 101 subject matter eligibility rejection and evaluate responses to it. The guidance provides numerous examples including examples of diagnostic methods. The memo requires examiners to follow the 2-step eligibility analysis set forth in the 2014 Interim Guidance but requires them now to explain why "the additional elements [in the claim] taken individually, and also taken as a combination, do not result in the claim as a whole amounting to significantly more than the judicial exception."
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