A new USPTO guidance memorandum describes how the USPTO will review patent-eligibility of process claims for biotechnology inventions in the wake of the Supreme Court’s decision in Mayo v. Prometheus.
The memo, titled 2012 Interim Procedure for Subject Matter Eligibility of Process Claims Involving Laws of Nature, applies to patent applications that include process claims having a natural principle as a limiting step. The memo explains that the USPTO will ask three questions when determining whether a process claim covers patent-eligible subject matter:
- Is the claim directed to a process?
- Does claim focus on a natural principle (i.e., a law of nature, a natural phenomenon, or naturally occurring relation or correlation)?
- Does the claim include additional elements or combinations of elements that integrate the natural principle into the claimed invention such that the natural principle is naturally applied, and sufficient to ensure that the claim amounts to significantly more than the natural principle itself?
If the answer to either question #1 or #2 is “no”, then no further analysis is needed. However, if the answer is “yes” to both questions #1 and #2, then the USPTO will apply question #3 to the claim.
The memo provides several examples to illustrate when a claim “amounts to significantly more than the natural principle itself.” These include:
- A claim covering a method of diagnosing an infection by (i) correlating the presence of a certain bacterium in a person’s blood with a particular type of bacterial infection, and (ii) recording the diagnosis on a chart is not patent-eligible. This is because part (i) of the claim is a natural principle, and part (ii) of the claim is extra-solution activity that is unrelated to the correlation and does not integrate the correlation into the invention.
- A claim directed to administering a man-made drug is patent-eligible if it does not recite other steps directed to use of a natural principle.
- A claim that involves a novel drug or a new use of an existing drug is patent-eligible because the claim amounts to significantly more than the natural principle itself.
Note that in the last two examples above, the USPTO would still assess whether the invention meets the requirements of being new and non-obvious. The new guidance memo simply addresses the threshold question of whether an invention covers subject matter that can be patented under U.S. patent law.
The USPTO expects this procedure to apply primarily to patent applications in the field of biotechnology (USPTO Technology Center 1600), and directs examiners to continue using a 2010 guidance memorandum for processes that may involve abstract ideas – such as those involving business methods. The memo is intended to serve as an interim measure until the Federal Circuit renders decisions in certain cases involving process claims — specifically, Assn. for Molecular Pathology v. Myriad Genetics, and WildTangent v. Ultramercial.