The USPTO has recently issued an update to their training materials and guidance on subject matter eligibility. The new materials, which may be found here, contain a memo to US patent Examiners and some more examples in the life sciences area. There is an open ended comment period for the general public to make comments about patent subject matter eligibility topics (comments may be sent to 2014_interim_guidance@uspto.gov and will be uploaded for viewing onto the USPTO website).

The Federal notice that forms part of the May 2016 update notes that following the July 2015 update a total of 37 submissions were received from the public which have been carefully considered.  The USPTO has, in response, issued a memo to the Examiners titled “Formulating a Subject Matter Eligibility Rejection and Evaluation the Applicant’s Response to a Subject Matter Eligibility Rejection”.

The memo to the Examiners aims to improve the communications that Applicants receive from an Examiner when they’re raising a section 101 objection. According to the memo, when an Examiner regards a claim as being directed to an abstract idea, the rejection should identify the abstract idea as it is set out in the claim and should explain, with reference to court decisions, why the concept relates to an abstract idea. In a similar manner, life sciences rejections should identify a law of nature or natural phenomena as it is recited in the claim and provide a reasoned argument why the Examiner considers it to be caught by the ineligibility test.

Rejections should also identify any additional claim elements and explain why those taken in isolation or combination do not amount to significantly more than the exception identified in the first part of the eligibility test.

The memo notes that the examples that have been issued by the USPTO are not to be used as the basis of an eligibility rejection and reference should instead be made to court decisions. Guidance is also provided to the Examiners as to how to handle Applicant rebuttals to section 101 objections. Some examples are provided of appropriate Examiner responses in cases where the Examiner deems it appropriate to maintain the objection.

The new life sciences eligibility examples may be found here and contain examples relating to vaccines (to illustrate the application of markedly different characteristics and significantly more analysis on nature based products); diagnosing and treating Julitis (illustrating the significantly more analysis to diagnostic and treatment claims); dietary sweeteners (illustrating the application of markedly different characteristics and significantly more analysis on nature based products containing mixtures); screening for gene alterations (this example considers the actual claims of US5753441 plus some hypothetical claims); and a paper making machine (demonstrates the use of the streamlined analysis).

A table of all the examples released by the USPTO (now 33 examples in the set) has also been published along with some tables providing further information on selected eligibility cases from the Supreme Court and CAFC.

Mark Richardson 10 May 2016