On 16 December 2014 the USPTO published its 2014 Interim Guidance on Patent Subject Matter Eligibility. The new Guidance can be found in this extract from the Federal Register.

This came into force with immediate effect and replaces the highly controversial guidance issued by the USPTO in March 2014 that was issued after the Myriad and Mayo decisions concerning natural phenomena/laws of nature and supplements the guidance issued following the Alice Corp decision concerning abstract ideas. The new guidance, unlike the previous guidance issued in March 2014, requires the examiner to evaluate the claim as a whole. Examples are given of how the new approach should be applied, using the facts from previously decided cases including Myriad, Mayoand Alice.

The new guidance includes a flow chart setting out what the USPTO argues is a two-part test but the second part is itself divided into two steps. In step 1, the examiner must first decide if the claim is related broadly to patentable subject matter: is the claimed invention a process, machine or a composition of matter? If not, then the claim is not eligible subject matter under 35 U.S.C. Section 101. If it is, then the claim is analysed to determine if it relates in whole or in part to a judicial exception to patent-eligibility (step 2A). If not, then the claim satisfies Section 101. If the claim is determined to relate in part to a judicial exception, then the claim is analysed to determine if the claim recites additional elements that amount to significantly more than the judicial exception (step 2B). The analysis will only proceed to step 2B when the claim is directed to an exception, i.e. when no markedly different characteristics are shown.

Step 2A appears to be an important improvement for pharmaceutical and biotech companies in the approach to be adopted by examiners when considering eligibility of natural products. The approach that is now required is markedly different to that under the March 2014 Guidance. Thus, for example, under the Interim Guidance published in December 2014 combination products comprising two known products must now be evaluated as a whole rather than separately evaluating the individual elements as was the case under the March 2014 Guidance.

Another important example that is given to examiners in considering natural products under Section 2A in the Interim Guidance is how they should approach claims directed to or comprising isolated or purified natural products. Under the Interim Guidance, such a product may be eligible if there is a resultant change in characteristics sufficient to show a marked difference from the natural counterpart. Differences that are exemplified include a change in the biological or pharmacological functions or activities, chemical or physical properties, changes in phenotype, or changes in structure and form, whether chemical, genetic or physical.

For a claim that does not recite something “markedly different” from the natural counterpart (Step 2B), the Interim Guidance looks to Mayo for a framework to determine if the claim is patent-eligible. The Interim Guidance in this respect does not depart significantly from the March 2014 Guidance, namely that the claim must be analysed to determine if elements other than those related to a judicial exception amount to something more than the exception itself. The Interim Guidance provides examples of what is and is not “significantly more” as recently interpreted by the US Courts.

A similar approach is adopted for abstract ideas following the Alice decision. Step 1 is to determine whether the claims are directed to an abstract idea. If the answer is yes, then under Step 2 the examiner must determine whether the claim as a whole recites additional elements that amount to significantly more than an abstract idea.

Examples given that are deemed to represent “significantly more” than an abstract idea include improvements to another technology or technical field, improvements to the functioning of the computer itself, effecting a transformation or reduction of a particular article to a different state or thing and adding a specific limitation other than what is well-understood, routine and conventional in the field, or adding unconventional steps that confine the claim to a particular useful application. Limitations that do not qualify as “significantly more” include adding the words “apply it” (or an equivalent) with the abstract idea, or mere instructions to implement an abstract idea on a computer, adding insignificant extra-solution activity to the abstract idea (e.g. mere data gathering in conjunction with the abstract idea), and generally linking the use of the abstract idea to a particular technological environment or field of use.

The public has been invited by the USPTO to submit written comments up to 90 days from publication of the Interim Guidance in the Federal Register (a deadline of around 16 March 2015).

The issuance of the earlier March 2014 Guidance caused considerable and understandable concern in the biotechnology and pharmaceutical industries as to exactly what might now be patent eligible as a result of this change to approach over patent eligibility. It had never been imagined afterMyriad and Mayo that the USPTO would seek to take the reasoning of those decisions and extrapolate it beyond where most observers believed the Courts had ever intended. 35 U.S.C. Section 101 eligibility was always intended to be a coarse sieve, not a fine filter. The first months immediately after the issuance of the March 2014 Guidance saw a sharp rise in eligibility objections. After all the ensuing clamour and the resultant partial retreat by the USPTO in the revised Interim Guidance, it is to be hoped that the promised ‘balanced’ approach will be seen in practice. Time, of course, will tell and in the meantime we will be watching closely to determine how things are developing and then devising the best strategies to adopt in this changing scenario.