By Frank Amini, Ph.D. and Lekha Gopalakrishnan, Ph.D.

Under the U.S. Patent Act, one can patent “any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof.”[1]  Common exceptions to what can be patented include laws of nature, natural phenomena, and abstract ideas[2].

In recent years, the U.S. Supreme Court has expanded the scope of the common exceptions to what can be patented.  For instance, in Mayo v. Prometheus (Mayo), the U.S. Supreme Court held that methods of administering a drug to a patient, measuring metabolites of that drug, and deciding whether to increase or decrease the dosage of the drug are not eligible for patenting because the methods pertain to natural phenomena[3].  Likewise, the U.S. Supreme Court later held in Alice Corp. v. CLS Bank International (Alice) that a computer-implemented electronic escrow service for facilitating financial transactions was not eligible for patenting because it pertained to an abstract idea[4].

The lower courts have been relying on Alice and Mayo to invalidate many patents related to diagnostic methods and computer-implemented processes.  As result, the United States Patent and Trademark Office (USPTO) has issued numerous patent examination guidelines and supporting examples for evaluating the patent eligibility of inventions in view of the aforementioned rulings[5].

However, the previously issued USPTO guidelines were found to lack clarity, consistency and predictability in determining patent eligibility.  In fact, the USPTO has admitted that “it has become difficult in some cases for inventors, businesses, and other patent stakeholders to reliably and predictably determine what subject matter is patent eligible.”[6]  The USPTO has also admitted that “concerns have been raised that different examiners within and between technology centers may reach inconsistent results” in their patent eligibility analyses[7].

In an effort to address the aforementioned concerns, the USPTO published its “2019 Revised Patent Subject Matter Eligibility Guidance” on January 7, 2019 (“New Guidelines”)[8].  The New Guidelines modify the prior guidelines by directing the Examiners to perform a more detailed and systematic patent eligibility analysis.

The steps involved in determining the patent eligibility of inventions when one combines the prior guidelines with the New Guidelines are illustrated in Figure 1.  The steps are also described herein as Steps 1-4.
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