March 6, 2014
On March 4, 2014, the U.S. Patent and Trademark Office (USPTO) distributed an internal memorandum titled “Guidance for Determining Subject Matter Eligibility of Claims Reciting or Involving Laws of Nature, Natural Phenomena & Natural Products.” This memorandum supersedes an earlier memorandum that was issued by the USPTO in 2013 in the aftermath of the U.S. Supreme Court decision in Assoc. for Molecular Pathology v. Myriad Genetics, Inc. (See IP Alert: U.S. Supreme Court Holds That Isolated DNA Cannot Be Patented.)
Under the protocols set out in the new guidance memorandum, examiners are instructed to reject any claims that define anything that is not “significantly different” from an abstract idea, natural product, natural material, natural law, or phenomenon (judicial exceptions). Such subject matter 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.”
The memorandum instructs examiners how to analyze the “significantly different” screening criterion, and provides factors for and against patent eligibility. The memorandum states that a “significant difference” can be shown in “multiple ways.” For example, a claim is “significantly different” from an abstract idea if “(1) the claim includes elements or steps in addition to the judicial exceptions that practically apply the judicial exception in a significant way… and/or (2) the claim includes features or steps that demonstrate that the claimed subject matter is markedly different from what exists in nature. . . .” The guidance provides an exemplary list of factors that weigh toward patent-eligible subject matter and a contrary list of factors that weigh against patent eligibility.
The criteria and examples in the guidance may be helpful when drafting patent applications. The memorandum is complicated, and we invite you to contact Fitch Even partner Kendrew H. Colton with any questions.
In addition, as earlier noted here, the U.S. Supreme Court is evaluating a case that may alter the law in the area of subject matter eligibility. We will report on the Court’s decision and on future significant developments in the area of subject matter eligibility in future alerts.
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