A guest post from Edward Sandor, attorney at Schwegman.
The Post-Prosecution Pilot Program (P3) launched at the USPTO Monday, combining features of the AFCP 2.0 and Pre-Appeal Brief Conference Pilot programs, with the notable addition of Applicant participation in the process.
Once a P3 request is received, the SPE will coordinate a panel experienced in the relevant field of technology to conduct a conference with the Applicant in person, by phone, or via WebEx video conference, where the final rejection will either be upheld, the application allowed, or prosecution reopened.
The FDA is charged with regulating “Next Generation Sequencing (NGS) Tests,” and has just released draft guidance on what needs to be regulated. (A copy of the first draft and second draft can be found at the end of this post.) The strategies involve the generation of reliable diagnostic conclusions for patients based on one or, oftentimes, many many mutations that are compared to those of other patients and to reference databases. Under “Scope,” the FDA has stated:
On July 5, 2016, a three – judge Fed. Circuit panel of Moore, Prost and Stoll (Appeal no. 2015-1570) reversed the district court’s holding that claims to a method of isolating “hardy” twice -frozen hepatocytes (as I called them in my post of April 26 summarizing the oral argument) were patent-ineligible as no more than a law of nature accompanied by routine cryopreservation steps. (Please go 
