The PTO has issued a guidance memo titled “2012 Interim Procedure for Subject Matter Eligibility Analysis of Process Claims Involving Laws of Nature” which can be found at the uspto.gov website under that name. The memo is for use of patent personnel in determining subject matter eligibility of process claims involving laws of nature under 35 USC 101 in view of Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. -, 132 S.Ct. 1289, 101 USPQ2d 1961 (2012) (Mayo).

Some highlights from the memo are that for process claims which focus on use of a law of nature, a natural phenomenon, or naturally occurring relation or correlation, the claim must amount to significantly more than the natural principle itself by including one or more elements or steps that limit the scope of the claim and do more than generally describe the natural principle with generalized instructions to “apply it.” The additional elements or steps must narrow the scope of the claim such that others are not foreclosed form using the natural principel (a basic tol of scientific and technological work) for future innovation. Elements or steps that are well-understood, purely conventional, and routinely taken by others in order to apply the natural principle, or that only limit the use to a particular technological environment (filed-of-use) will not be sufficiently specific.

Example: Claim 1 in Joe’s application reads “a method of determining the increased likelihood of having or developing rheumatoid arthritis in a patient, comprising the steps of: obtaining a serum sample form a patient; contacting the serum sample with an anti-IgM antibody; and determining that the patient has rheumatoid arthritis or an increased likelihood of developing rheumatoid arthritis based upon the increased binding of the anti-IgM antibody to IgM rheumatoid factor in the serum sample.

Claim 2 read, the method of claim 1, wherein the anti-IgM antibody is antibody XYZ.

Claim 1 would be rejected under the PTO analysis because there is a naturally occurring correlation (natural principle/law of nature) between a patient having rheumatoid arthritis and their level of rheumatoid factor IgM, and increased levels of rheumatoid factor IgM shown by increased binding of an anti-IgM antibody indicate a higher likelihood of a patient being diagnosed with rheumatoid arthritis. The additional steps of obtaining and contacting are well understood steps that are routinely conducted to analyze a serum sample.

However, if the antibody XYZ does not occur in nature and is novel and non-obvious, claim 2 would be patent-eligible because it is a practical application as it does not cover substantially all practical application of the correlation because it is limited to those application that use the antibody XYZ.

Some questions here which arise is what if the correlation above between rheumatoid arthritis and antibody XYZ is not known in the art. Does this make a difference?