The U.S. Patent and Trademark Office (USPTO) today released its latest iteration of guidance—referred to as the "Interim Eligibility Guidance"—to its examiners. This guidance is aimed at assessing whether an invention claimed in a patent contains subject matter that is eligible for patenting.
Background
In the United States, subject matter eligible for patenting is described in 35 U.S.C. § 101 and includes "any new and useful process, machine, manufacture, or composition of matter." Courts have created judicial exceptions to these categories, including laws of nature, physical phenomena, abstract ideas, and natural products. The scope of these exceptions is defined in part by the U.S. Supreme Court case Diamond v. Chakrabarty, which held that a bacterium comprising four plasmids added by scientists was patent eligible because it had "markedly different characteristics from any found in nature." In Myriad, the Supreme Court relied on Chakrabarty in holding that merely isolating naturally occurring DNA (i.e., breaking covalent bonds) does not render such DNA patent eligible.
More recently, the scope of the judicial exceptions to patentability—i.e., those inventions that do not qualify for a patent under U.S. patent law—has been the subject of four Supreme Court cases in just the past four calendar years, each of which was previously analyzed in a WSGR Alert: Bilski in 2010 regarding the abstract idea of hedging risk; Mayo in 2012 regarding a correlation in a medical diagnostic method as a law of nature; Myriad in 2013 regarding genomic DNA as a product of nature; and, most recently, Alice Corp. this past June regarding computer-implemented abstract ideas.
The Eligibility Guidance
The stated purpose of the Interim Eligibility Guidance is to "offer[] a comprehensive view of subject matter eligibility in view of Alice Corp., Myriad, Mayo, and the related body of case law." It addresses the public comments received regarding the March 4, 2014, guidance that was issued in view of the Mayo and Myriad Supreme Court cases. The recent Interim Eligibility Guidance remains subject to comment and review from interested stakeholders following its publication in the Federal Register on December 16, 2014. The guidance is expected to supplement the USPTO's June 25, 2014, Preliminary Examination Instructions in view of the Alice Supreme Court case, and supersede the USPTO's previous guidelines from March 2014.
The USPTO continues to extend Myriad's "marked difference" standard to all potential natural products, even though Myriad specifically limited its holding to excluding from patent eligibility isolated, naturally occurring DNA. This standard applies to claims that recite not only nucleic acids (such as DNA in Myriad), but also other subject matter that could be considered a natural product, such as peptides, proteins, extracts, modified organisms, antibodies, chemicals, and minerals. However, the Interim Eligibility Guidance requires changes that, if implemented and applied, may significantly impact the examination of patent applications that claim or relate to "products of nature," including what the USPTO has characterized as "nature-based products." The Interim Eligibility Guidance provides an analytical framework that departs from the March 2014 procedure in several respects. The key changes are summarized below.
First, the March 2014 guidance relegated the Supreme Court inquiry into whether the claim at issue has markedly different characteristics when compared to the judicial exception (e.g., anything found in nature) to a single factor in the analysis. The prior guidance required consideration of an exemplary list of six factors that weigh toward eligibility and six factors that weigh against eligibility. Under the new Interim Eligibility Guidance, if a claim recites subject matter that is markedly different based on structure, function, and/or properties when compared to its naturally occurring counterpart, the claim is patent eligible and no further analysis is required. There is no required factor-based analysis under the Interim Eligibility Guidance to determine the patent eligibility of an invention. However, the USPTO's view of precedential case law is described and hypothetical examples are provided.
Second, the analytical framework that carves out inventions that are not patentable is the same for all statutory classes of invention, including products and processes alike. With respect to all claim types, the judicial carve-outs to patentability are only applicable to claims that specifically recite a judicial exception in the patent claim. The soon-to-be superseded March 2014 procedure applied the framework to claims that merely raise "any doubt" as to whether the claim may "involve a judicial exception" or even something "similar" to a judicial exception (i.e., a law of nature, a physical phenomenon, an abstract idea, or a natural product). Unlike the previous framework, the new guidance does not require the rejection of a process invention merely because a step in the invention uses a nature-based product.
Further case law developments in this area should continue to be monitored. Whether precedential court decisions extend the Myriad holding to subject matter beyond isolated, naturally occurring DNA remains to be determined. It also remains to be seen the extent to which examiners at the USPTO heed the most recent guidance and consider the often markedly different structure, function, and properties of a product compared to its closest naturally occurring counterpart when determining which inventions should qualify as patent eligible.
