Prosecution Strategies For Avoiding Patent Eligibility Rejections For Diagnostics

Under the Mayo/Alice test for patent eligibility, answering the questions of whether any particular claim is "directed to" a "judicial exception" without "significantly more" remains in many ways a substantial and unpredictable challenge for U.S. patent applicants in the diagnostic space. In cases where the detection processes are typically deemed "routine and conventional" (e.g., PCR) and the targets are known (e.g., expression of a known gene), claims must be crafted in ways that avoid rejections for both patent eligibility and anticipation and/or obviousness over the prior art. The recent PTAB decision in In re Srivastava et al. expressly addresses obviousness in this context, while highlighting a possible strategy for dealing with patent eligibility challenges as well (Appeal 2017-1981, Application 13/974,007, decided October 22, 2018; hereafter "In re Srivastava").