Question 1: Is the claimed invention directed to one of the four statutory patent-eligible subject matter categories: process, machine, manufacture, or composition of matter? If no, the claim is not eligible for patent protection and should be rejected under 35 U.S.C. 101, for at least this reason. See MPEP § 706.03 for a description of the appropriate form paragraphs to use in rejecting the claim. If yes, proceed to Question 2.
Question 2: Does the claim recite or involve one or more judicial exceptions? If no, the claim is patent-eligible, and the analysis is complete. If yes, or if it is unclear whether the claim recites or involves a judicial exception, proceed to Question 3.
Question 3: Does the claim as a whole recite something significantly different than the judicial exception(s)? If the claim recites or involves a judicial exception, such as a law of nature/natural principle or natural phenomenon (e.g., the law of gravity, F=ma, sunlight, barometric pressure, etc.), and/or something that appears to be a natural product (e.g., a citrus fruit, uranium metal, nucleic acid, protein, etc.), then the claim only qualifies as eligible subject matter if the claim as a whole recites something significantly different than the judicial exception itself.The Guidelines provide more elaboration of factors that can be applied to the “significantly different” analysis. What’s noteworthy is that neither Supreme Court case, from which the Guidelines follow, used an explicit “significantly different” framework to sort the eligible from the ineligible. Actual touchstones for analysis from the Court include whether a law of nature is “preempted” by a patent claim or whether a natural product is more than merely “isolated” from the surrounding environment. However, the lineage of the new formulation can be traced back to Diamond v. Chakrabarty (1980):
[T]he patentee has produced a new bacterium with markedly different characteristics from any found in nature.The new Guidelines call for an examiner to consider whether the claim includes features or steps that demonstrate that the claimed subject matter exhibits a marked difference from what exists in nature (and the focus is on structure, not function). The Guidelines do reveal that the PTO interprets the force of the AMP decision to apply to all manner of natural products and substances, not just nucleic acids (DNA):
In particular, claimed subject matter that must be analyzed under Question 3 to determine whether it is a natural product includes, but is not limited to: 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 animals); proteins and peptides; and other substances found in or derived from nature.There was little doubt that the rationale for the Court’s rejection of the Myriad gene patent claims could easily be extended to all manner of natural products, and the Guidelines confirm that. Yet this expansive view could be litigated down the line, as proponents of patent claims on isolated products could try again to revive the Parke-Davis v. Mulford (1911) reasoning to argue commercial and therapeutic transformations of a natural product as a basis for patent eligibility (actually a more function-oriented argument). I don’t think this strategy will prevail, ultimately, but the life science-wide implications of the very recent AMP decision are not likely to go unchallenged.