The USPTO has issued new Guidelines for US Examiners to use in order to determine whether an invention is patent eligible (i.e. is of a type which is not barred from being patentable). These Guidelines are effective from 16 December 2014 and address concerns raised following the US PTO’s change in practice (subsequent to recent biotech Supreme Court patent decisions) which effectively denied patentability to almost any claim including a natural product.
In the new Guidelines, a 2-step analysis is conducted.
First, the Examiner should ask whether the claim is for a process, machine or composition of matter. If the answer is “no”, then that claim covers subject matter which can’t be patented. If the answer is “yes”, the Examiner moves onto question 2.
Second, the Examiner should determine whether the claim covers, in whole or in part, a “judicial exception under s101″. In other words, does the claim cover a law of nature, a natural phenomena and/or an abstract idea? If none of these exceptions are included, the claim is patent eligible. However, if the claim does cover any one of these exceptions then further analysis is needed, and the Examiner must look to see whether the claimed subject matter amounts to SIGNIFICANTLY MORE than the judicial exception.
Under these new Guidelines, a claim covering a natural product should be compared to its naturally occurring counterpart in order to identify any characteristics which are markedly different in terms of function, structure or any other properties. Such differences could be in terms of biological or pharmaceutical function or activity, or could be in terms of function, structure or any other property. For example a cDNA is considered to be markedly different to the intron-containing natural gene and could therefore be patented. Helpfully, the Guidelines state that an isolated or purified product will be patent eligible where the step of isolation/purification gives a resultant change in characteristics leading to a marked difference from the natural counterpart.
Claims to a combined product (the example given in the Guidelines is a combination of Lactobacillus bacteria and milk) should be analysed as a whole rather than the separate components being individually analysed. This approach should be helpful to patent applicants.
Broader claims considered to “tie-up” a natural phenomena will be analysed more closely, but more focused (narrower) claims will allow a stream-lined eligibility review. Also, claims to a diagnostic process or method are likely to be deemed patent eligible if the claim is sufficiently focused on the practical application.
These new Guidelines look to be a relaxation of the previous draconian approach and we will watch further developments with interest.
The USPTO notes that the Guidelines will be revised as case law develops and there is the opportunity to comment on them until 16 March 2015. You can read more here: USPTO 2014 Interim Guidelines.Share