USPTO Issues Examination Guidelines For Claims Involving Natural Phenomena

On March 4, 2014, the United States Patent and Trademark Office (USPTO) published a guidance memorandum for their patent examining corps entitled Guidance for Determining Subject Matter Eligibility for Claims Reciting or Involving Laws of Nature, Natural Phenomena, & Natural Products (Guidelines). The purpose of the Guidelines is to guide patent examiners when making determinations on subject matter eligibility after the considerable new statements of law in the recent US Supreme Court (USSC) decisions Mayo Collaborative Services v Prometheus Laboratories, Inc (2012) (Prometheus) and Association for Molecular Pathology al v Myriad Genetics, Inc (2013) (Myriad). The Guidelines are effective immediately. Though the Guidelines are not law and do not bind US courts, they do represent the USPTO’s interpretation of Prometheus and Myriad and how it will implement those decisions in their examination procedure going forward. Due to their scope, the Guidelines are critical reading for patent practitioners and innovators in most scientific and technical fields. US courts have long accepted the judicial doctrine that certain types of subject matter are ineligible for patenting under 35 USC §101 (so-called “judicial exceptions” to patent-eligible subject matter). One judicial exception that has evolved is the rule against patenting naturally occurring things (variously called “laws of nature”, “natural phenomena”, “natural products” and concepts of similar meaning). Prometheus and Myriad were significant decisions for their interpretation of this judicial exception (for background, see prior reporting by ETIPS® on the Prometheus and Myriad cases). According to the Guidelines, examiners will assess any machine, composition, manufacture or process claim that might “recite or involve” a naturally occurring thing according to a factor-based analysis. The examiner will determine the subject matter to be patent-eligible only if, after that analysis, the claim is “significantly different” from that naturally occurring thing. The breadth of this language suggests that most claims would meet the threshold to proceed to the factor-based analysis – that is, most claims “might involve” a naturally occurring thing (examples in the Guidelines include gravity, barometric pressure, sunlight, chemicals derived from natural sources, foods, metallic compounds existing in nature, minerals, nucleic acids, proteins/peptides, organisms, and other substances found in or derived from nature). Generally speaking, the analysis stage is geared to assess whether and to what degree a claim includes (i) steps or elements added to a natural law or product that result in its application in a significant way, or (ii) features or steps that create a demonstrable difference from what exists in nature. Examiners are to weigh the factors (12 in all) and determine on balance if the subject matter is significantly different. Notably, the weight accorded to each factor can vary, depending on the facts of each application. The Guidelines represent a significantly new process for patent applicants to navigate. Claims involving natural materials or functions are assured closer scrutiny. However, the concepts of balancing and examiner discretion allow for some finesse in making your case. Summary by: John Lucas