Burden Of Section 101 Following Myriad

The Supreme Court's decision in Association for Molecular Pathology v. Myriad Genetics Inc., 2013 DJDAR 7484 (2013), held that Myriad's claims directed to "a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated." In addition, the court held that "cDNA is patent eligible because it is not naturally occurring."

Left largely unaddressed by this decision was who bears the initial burden during the patent examination process of showing that a claimed invention is in fact naturally occurring as well as what evidence is needed to meet that burden.

Shortly after Myriad, the U.S. Patent and Trademark Office (USPTO) issued a memorandum on June 13 instructing patent examiners to reject composition claims drawn solely to naturally occurring nucleic acids or fragments thereof. Unfortunately, the memorandum failed to address which party (patent applicant or patent examiner) bears the initial burden of demonstrating that the claimed invention is naturally occurring (or not) and what sort of evidence would need to be presented, if any, to make that showing. No additional Myriad-related guidance has been issued by the USPTO to-date.

The examination guidelines of the Manuel for Patent Examining Procedure (MPEP) for Section 101 provide some additional insight in Section 2106: "USPTO personnel should review the totality of the evidence (e.g., the specification, claims, relevant prior art) before reaching a conclusion with regard to whether the claimed invention sets forth patent eligible subject matter. USPTO personnel must weigh the determinations made above to reach a conclusion as to whether it is more likely than not that the claimed invention as a whole either falls outside of one of the enumerated statutory classes or within one of the exceptions to statutory subject matter. 'The examiner bears the initial burden... of presenting a prima facie case of unpatentability.' In re Oetiker, 977 F.2d 1443, 1445, 24 USPQ2d 1443, 1444 (Fed. Cir. 1992). If the record as a whole suggests that it is more likely than not that the claimed invention would be considered a practical application of an abstract idea, physical phenomenon, or law of nature, then USPTO personnel should not reject the claim."

This section of the MPEP states that the initial burden of presenting a prima facie case of unpatentability under Section 101 falls on the patent examiner based on Federal Circuit precedent from 1992. However...