On May 6, 2016, the United States Patent & Trademark Office offered more guidance to the life science industry and the public overall, as well as to its patent examiners, regarding how patent claims are to be analyzed for subject matter eligibility. Companies that own patents or have applications for patents pending will find the new information both interesting and helpful.

Of particular interest to the life sciences industry, the new guidelines include additional subject matter eligibility examples demonstrating how certain patent claims should be analyzed. The examples deal with the subjects of vaccines, diagnosing and treating disease, dietary sweeteners, gene alteration screening, a machine using gravity, and hydrolysis of fat. The USPTO was quick to point out that the examples are intended to be illustrative only, and that they should be interpreted based on the fact patterns set forth because other fact patterns may lead to different outcomes. Nonetheless, the examples provide a path to better understanding what an examiner may be looking for when reviewing pending claims covering life sciences concepts, and moreover, how the patentee may formulate a response. The examples also assist a company in its consideration of the strength of patents both it and others own. The life sciences examples may be found here.

By way of background, pursuant to 35 U.S.C. § 101 of the Patent Act, "[w]hoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title." In 2014, the U.S. Supreme Court in Alice Corp. v. CLS Bank Int'l, provided a two-step framework to determine subject matter eligibility under § 101. The first step includes deciding whether a patent claim is directed to a patent-ineligible concept, e.g. a law of nature, a natural phenomenon, or an abstract idea. If such is the case, the second step asks if additional elements and claim limitations beyond the patent-ineligible concepts, if any, make the claim as a whole patent-eligible, i.e. significantly more than the ineligible concept. Since Alice, companies, the courts, and the USPTO have worked conscientiously to apply the Supreme Court's test.

Toward this goal, the USPTO issued its 2014 Interim Guidance on Patent Subject Matter Eligibility, which provided assistance to examiners reviewing applications. On July 30, 2015, the agency followed up with an update to the interim guide in view of public comments received. Then, Friday, the May 6th guidance was provided in the form of a memorandum to examiners, among other things. The import of the most recent instruction is so that examiners articulate clearly the reasons for rejecting claims within the context of Alice's test. All guidance to date, including life sciences examples, may be found here.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.