The USPTO has issued updated guidance regarding eligibility of subject matter related to natural products, in particular, diagnostic methods, in the light of the 2013 Myriad decision and the Prometheus decision.
The updated “Subject Matter Eligibility Examples: Life Sciences” can be found here.
This includes additional examples 28 to 33 which give guidance on eligibility of claims relating to vaccines, diagnostic methods, dietary sweeteners, screening for gene alterations, a paper making machine and hydrolysis of fat.
Example 29 is a hypothetical example setting out seven specimen claims to methods of diagnosis and methods of treatment of a fictional autoimmune disease, “julitis”, based on the “discovery” that the presence of a protein “JUL-1” in a person’s body is indicative that the person has the disease.
Of the seven specimen claims, only claim 2 is deemed ineligible.
It seems that “a method of detecting JUL-1” [the newly identified protein marker] would be acceptable at a high level of generality (see Example 29, claim 1). Methods of “diagnosing and treating julitis” (claims 5 and 6) also appear to be acceptable at a high level of generality. A claim to a method of treatment of julitis is also acceptable (claim 7).
Claim 2 to “a method of diagnosing julitis”- which adds a step of diagnosing julitis when JUL-1 is detected – is not acceptable at this level of generality, because the correlation between JUL-1 and the disease is a “law of nature” and/or because the step of diagnosis is an abstract idea. Adding specificity, however, for example by limiting claim 2 to specific antibodies, would appear to render the claim acceptable – see claims 3 and 4 – assuming use of the specific antibody is not a “well understood, routine or conventional” technique.
The reasoning is explained in some detail, and will be useful to those interested in claiming inventions in the biomarker, diagnostic method, and method of treatment fields. The claims themselves are not particularly ground-breaking, but the associated reasoning gives a good idea of how one might develop supporting arguments that should encourage USPTO examiners to allow claims to this kind of subject matter.
This article is for general information only. Its content is not a statement of the law on any subject and does not constitute advice. Please contact Reddie & Grose LLP for advice before taking any action in reliance on it.