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Since the Alice decision, there has been a lot of confusion about what is patentable – especially for life science and software related patents. At the beginning of 2019, the USPTO has issued new guidelines for determining patetability. These new guidelines set forth that non-patentable subject matter, or “judicial exceptions”, include abstract ideas such as “mathematical concepts, certain methods of organizing human activity, and mental processes.” Additionally, it also includes “laws of nature and natural phenomena.” It further goes on to say that a judicial exception may be patentable if it is “integrated into a practical application.” We look now into what this would mean in a practical matter:

“Integrated” occurs when the claims of a patent application “imposes a meaningful limit on the judicial exception, such that the claim is more than a drafting effort designed to monopolize the judicial exception.”

“Integrated” may also happen when (a) there are “additional elements recited in the claim beyond the judicial exception” and (b) “evaluating those additional elements individually and in combination to determine whether they integrate the exception in a practical application.”

It further provides that “additional elements” may be present when the claim (i) provides “improvement in the functioning of a computer, or an improvement to other technology or technical field”, (ii) “effects a particular treatment or prophylaxis for a disease or medical condition”, (iii) “uses a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim”, and (iv) effects a transformation or reduction of a particular article to a different state or thing”.

In what most view as favorable to patentability, the guidelines state that even if there is no integration, the patent claim is patentable if there is an inventive concept. This includes claim limitations that are “not well-understood, routine, or conventional activity”.

That is, one may argue that a “judicial exception” can be “integrated” into a practical application even if additional claim elements do not include “not well-understood, routine, or conventional activity.” Accordingly, this limits the number of options an Examiner at the USPTO has to reject a claim and perhaps make it more predictable.