New Guidance on Showing Subject Matter Eligibility

A new memo (pdf) from the USPTO director suggests new best practices for using a declaration under rule 1.132. The Director now suggests that practitioners submit these Subject Matter Eligibility Declarations (or SMEDs) to be submitted as separate documents. The intent is that by keeping the evidence and testimony in the declaration limited to eligibility of the subject matter, it should be easier for examiners to determine whether the subject matter itself is eligible. This avoids complicating the work for the examiner by allowing them to think about eligibility without also having to consider all the issues around novelty, obviousness, enablement, or description. The Director highlighted that these concerns are especially relevant for areas of emerging technology. The examples the Office provided include distributed ledger technologies for cryptocurrencies, medical diagnostics, and machine learning models.

Please keep in mind that this is my own analysis. I’m not a lawyer, and nothing that I’m writing here should be taken as legal advice.

There may be an advantage here for practitioners to use these rule 1.132 declarations, given that the Director will be giving them more consideration. While it is more work to prepare, if it increases the chances of approval for a patent application, it could work well for clients. Since anyone with knowledge of the relevant facts is allowed to make the declaration, it could work well to have an inventor do so. An independent expert could also be effective, although that might not be desirable for clients looking to control costs. Based on this new guidance from the USPTO Director, these rule 1.132 declaration could become a common and effective part of patent prosecution.