The PTO has released a new set of life sciences’ examples to teach Examiners how and when to reject claims and, hopefully, teach the patent bar how to write allowable claims. (A copy if found at the end of this post.)
The Guidelines have examples on vaccines, diagnostics, methods of medical treatment and BRCA-type Myriad claims. There are some surprises. Although Ariosa was decided about a year ago, the Guidelines approve of a claim to detecting a marker indicative of a certain disease by detecting whether the marker is present when a plasma sample is contacted with an anti-JUL-1 antibody and detecting any binding (e.g., an ELISA-type assay). The Guidelines justify this position by noting that the steps do not recite any recognized exceptions to s. 101, citing Mayo. This hypothetical claim could have come from Ariosa, which the Office must have made a hard decision to ignore.