How To Do The Two-Step In The United States: The Current State of Patent-Eligible Subject Matter

By: Rebecca Lindhorst (2018 Summer Associate)

In the wake of the Supreme Court’s Mayo and Alice decisions, uncertainty has surrounded what inventions are patent eligible in the United States. In Mayo and Alice, the Supreme Court developed a two-step test to determine patent eligibility. Step one determines if the invention is directed to a law of nature, natural phenomenon, or abstract idea. If so, the second step determines if there is an inventive concept sufficient to ensure the patent amounts to significantly more than the ineligible concept itself.[i] While this test has led to uncertainty in what inventions remain patent eligible, post-Mayo/Alice case law has begun to shed light on what is patent eligible in the United States. The current state of patent eligibility in the technology areas most impacted by the Mayo/Alice two-step are outlined below.

Plant and Animal Claims

Claims directed to plants and animals are generally patent ineligible in the United States. The Federal Circuit has held that even cloned animals are ineligible because the “claimed clones are exact genetic copies of patent ineligible subject matter.”[ii] Exceptions exist, however, for certain plant patents. The Plant Patent Act provides protection for plants that are asexually reproducing, distinct, and new.[iii] While the Supreme Court has held that newly developed plant breeds are eligible for utility patents under 35 U.S.C. § 101[iv], it is important to note that this decision was pre-Mayo/Alice.

Compositions Comprising Products Found in Nature

There have been a limited number of decisions addressing composition of matter claims under § 101 since the Mayo and Alice decisions. The underlying rationale in the decisions thus far have held that compositions of matter are ineligible unless they have “markedly different” characteristics from any composition found in nature.[v] While the genomic form of a gene is ineligible under § 101, certain complementary DNA (cDNA) forms encoding the gene are eligible if they do not exist in nature.[vi] Following this decision, the Federal Circuit has held that single-stranded DNA primers are also patent ineligible.[vii]

Diagnostic Method and Method of Treatment Claims

Diagnostic method claims have faced frequent and difficult eligibility challenges post-Mayo/Alice. Courts have consistently held diagnostic method claims ineligible when they recite the general steps of: (1) take a sample; (2) measure/analyze/detect/determine the presence of a biomarker; and (3) reach a conclusion/diagnosis.[viii] A recent Federal Circuit decision, Vanda Pharmaceuticals v. West-Ward Pharmaceuticals, held that a diagnostic claim which also recited an administration step is patent eligible.[ix] This decision is consistent with statements by both the Supreme Court and the Federal Circuit that method of treatment claims are generally patent eligible.[x] In light of the Vanda decision, the USPTO issued a memo to the examining corps in line with the court’s holding explaining that method of treatment claims that apply natural relationships should be considered patent eligible and that it is not necessary for method of treatment claims to include non-routine or unconventional steps to be patent eligible.[xi] While the Federal Circuit denied West-Ward’s petition for rehearing en banc, West-Ward may still file a petition for writ of certiorari to the Supreme Court. Consequently, it is too early to fully determine the impact these recent developments will have on the eligibility of diagnostic methods.

Software and Business Method Claims

Software and business method patents have faced significant challenges since the Mayo/Alice decisions. Software claims, are not per se ineligible, however software claims that merely gather, analyze, and output data are patent ineligible.[xii] Software claims can be patent eligible when they are directed to an improvement in the way computers operate.[xiii] Additionally, claims which recite specific limitations to overcome deficits or problems in the prior art have been found patent eligible.[xiv] Based on these holdings, to be patent eligible software claims must recite specific steps to obtain a desired result rather than recite merely the result itself.[xv]