Last December, the US Patent and Trademark Office issued the “2014 Interim Guidance on Patent Subject Matter Eligibility” as further guidance to its examining corps for assessing patent eligible subject matter of claims reciting or involving laws of nature, natural phenomena, and natural products under 35 USC §101. The guidelines were issued in light of the high-profile Supreme Court decisions in Alice Corp., Myriad, and Mayo. Dr. Anthony Sabatelli, partner and chair of Dilworth IP’s pharmaceutical and biotech patent practice group provided his comments in person at the USPTOin January of this year.
On July 30, the USPTO published an update to the Interim Guidance titled “July 2015 Update: Subject Matter Eligibility.” This update was produced in response to the public comment on the 2014 Interim Patent Eligibility Guidance. The update contains additional examples for claims directed to the judicial exceptions, as well as further explanation of the “markedly different” analysis for natural products and information about the implementation of the 2014 Interim Guidance. The update does not, however, consider recent Federal Circuit decisions, such as Ariosa Diagnostics v. Sequenom.
The latest update can be accessed from the USPTO website: http://www.uspto.gov/patent/laws-and-regulations/examination-policy/2014-interim-guidance-subject-matter-eligibility-0