The USPTO issued new patent eligibility guidelines (“Guidelines”) on March 4, 2013 which supersedes the previous guidance of the June 13, 2013 memo “Supreme Court Decision in Association for Molecular Pathology v. Myriad Genetics Inc.”. The Guidelines and a Quick Reference Sheet are available here:
Quick Reference Sheet
Under the Guidelines, examiners are instructed to review “all claims…reciting or involving laws of nature/natural principles, natural phenomena, and/or natural products”. The Guidelines note that there is “no change to examination of claims reciting an abstract idea, which should continue to be analyzed for subject matter eligibility under the existing guidance of MPEP section 2106(II).” A flow chart for analyzing eligibility is provided on page 2 and in the Quick Reference Sheet. Subject matter specifically listed as potentially falling within the judicial exceptions (“abstract ideas, laws of nature/natural principles, natural phenomena, and natural products”) that must be analyzed under these Guidelines include: “chemicals derived from natural sources (e.g., antibiotics, fats, oils, petroleum derivatives, resins, toxins, etc.); foods (e.g., fruits, grains, meats and vegetables); metals and metallic compounds that exist in nature; minerals; natural materials (e.g., rocks, sands, soils); nucleic acids; organisms (e.g., bacteria, plants and multicellular antimals); proteins and peptides; and other substances found in or derived from nature”. Any such products must be “significantly different than the judicial exception(s)” and how to conduct this analysis is explained in section II beginning on p. 3. Six factors that “weigh toward eligibility (significantly different)” and six that “weigh against patentability (not significantly different)” are provided on pp. 4-5. For instance, one factor on each list (factors a and g) relate to whether a product is “markedly different” (“a significant difference, i.e., more than an incidental or trivial difference”) from a “natural product” (e.g., “merely isolating a nucleic acid…does not create a marked difference in structure [from] its naturally occurring counterpart.”) The Guidelines explain that under Myriad, “the mere recitation of particular words (e.g., “isolated”) does not automatically confer eligibility…claims reciting or involving natural products should be examined for a marked difference under Chakrabarty” (recombinant and synthetic are also referenced on p. 2). The Guidelines also explain that a “marked difference” resulting from “routine activity or via human manipulation of natural processes does not prevent the marked difference from weighing in favor of patentability.” Multiple examples are provided in section III beginning on p. 5. Example B, discussing the patentability of “purified amazonic acid” (purified from the “Amazonian cherry tree”, not eligible), “[p]urified 5-methyl amazonic acid” (eligible due to “addition of the 5-methyl group”), and method of treatment using a particular dose of “amazonic acid” (eligible)) may be of particular interest to the pharmaceutical industry but is certainly not alone. Each example considers how the claimed subject matter satisfies or does not satisfy the twelve factors weighing for or against patent eligibility. Finally, the form of a rejection under these Guidelines is reviewed on p. 18.