The new USPTO patent eligibility examples include two examples for “natural products” based inventions which appear to be consistent with the examples provided in the December 2014 set of patent eligibility examples. Although the new examples include additional discussion and guidance that could be helpful in some cases, they largely remain perplexing. Unfortunately, although the new diagnostic methods examples appear to take a stand against unreasonable court decisions, the new natural products examples continue to rely on Funk Brothers for a guiding principle.
The new examples add Examples 28-33 to the USPTO’s body of patent eligibility examples, of which Examples 28 and 30 relate to natural products.
Example 28 relates to vaccines. Out of the seven sample claims, six are said to be “eligible” and one is said to be “ineligible.” Themes that emerge from this example include:
Example 30 relates to nature-based sweetener compositions. Out of the six sample claims, four are said to be “eligible” and two are said to be “ineligible.” Themes that emerge from this example include:
Markedly Different Versus Significantly More
When reviewing these examples, it is important to keep in mind that the USPTO has mapped the two-part Mayo/Alice analysis onto Step 2a and Step 2b of its analytical framework. Thus, the USPTO’s Step 2a asks whether the claim is directed to a judicial exception (e.g., a natural product), while its Step 2b asks “whether any element, or combination of elements, … is sufficient to ensure that the claim amounts to significantly more than the judicial exception.” The USPTO’s “markedly different” test is used in Step 2a, to determine whether a claim that recites a nature-based product really is “directed to” a natural product such that it needs to be subjected to a “significantly more” analysis.
These examples indicate that a “marked” difference can be a structural or functional difference in the nature-based product or composition as a whole. On the other hand, the examples indicate that in order to satisfy the “significantly more” test, the additional component(s) at issue must not be “well-understood, routine or conventional” in the field of the invention. This distinction may work within the USPTO’s Step 2a/Step 2b framework, but a district court applying the Mayo/Alice framework should be able to find that a vaccine composition comprising an immunogenic protein and an adjuvant is directed to something “significantly more” that is eligible for patenting, even if the adjuvant is conventional.
Another question that arises from these examples is whether the “markedly different” test requires a difference that is “relevant to the nature of the invention.” The examples only discuss that concept when the nature-based product is not structurally different from its naturally-occurring corollary. Does that mean that any structural difference will suffice but functional differences only support eligibility if they are “relevant” to the invention?
How can a peptide formulated in a cream be patent-eligible with no further inquiry, while a peptide coated on a microneedle array only is patent-eligible if it was not conventional to do so?