The current trajectory of innovation is resulting in the convergence of biological and electronic discoveries into hybrid technologies that incorporate aspects of both scientific disciplines. Wearables replete with biological sensors and analysis as well as the use of complex electronics, software, and algorithms in biological sciences are just some examples of these hybrid inventions. As these types of technologies become more and more prevalent, consideration of how patent protection applies to them becomes increasingly important, particularly with developing application-drafting strategies to best protect them.
United States patent law allows inventors to patent “any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof.”1 Inventions must overcome this preliminary threshold, referred to as statutory subject matter eligibility, to even be considered for potential patent protection. Throughout the years, the courts have added and refined additional criteria for meeting this statutory threshold. These judicial exceptions include a bar against obtaining patents on (1) laws of nature or (2) abstract ideas, among others. But the courts have struggled to define and apply specific definitions and tests for these concepts. In 2012, the Supreme Court elaborated a two-part test for evaluating what are commonly known as diagnostic patents for determining whether those patents cover a law of nature and, therefore, would not qualify for patent protection.2 The court extended this analysis to computer- and software-related patents that could be considered to cover an abstract idea.3 Under this two-part test, courts first determine whether a patent is directed to a law of nature, an abstract idea, or some other category not eligible for patent protection. If it is, the court must then determine whether the patent includes an inventive concept or significantly more than the abstract idea or law of nature that would warrant patent protection.
Since those decisions, courts have typically applied the “law of nature” analysis to patents in the biology and medical spheres, while applying the “abstract ideas” analysis for patents directed to software or computer-based technologies. Despite the convergence of electrical and biomedical innovations, courts have not typically dealt with how to analyze the potential eligibility of patents covering technologies with a foot in both worlds. But recently, a district court in San Francisco considered such a technology in a dispute between 23andMe and Ancestry.com, and its analysis could inform the way courts evaluate the validity of similar patents under current law.
23andMe’s patent4 describes analyzing recombinable DNA to identify related individuals in a database. As described in the patent, the technology is premised on the recognition that because recombinable DNA includes mutations that occur from generation to generation such that only relatives will share long stretches of recombinable DNA that is identical or nearly identical, the existence of those stretches of DNA can identify related individuals. The patent refers to these stretches as “Identical By Descent” or “IBD” regions. The patented technology includes sequencing the entire genome of an individual to determine IBD regions or, in some cases, identifying certain markers that tend to vary in different individuals as the basis of the IBD regions. 23andMe’s patented process determines a predicted degree of relationship between individuals based on the IBD regions.
23andMe filed a complaint against Ancestry.com, claiming that Ancestry.com infringed the claims of its patent by using the same process to identify potentially related individuals. In response to 23andMe’s allegations, Ancestry.com asked the court to dismiss the case based on the argument that the patent is invalid. As noted by the court, Ancestry.com specifically argued that the patent “claims an abstract idea (determining a relative relationship by comparing similarities between DNA), and a law of nature (people who share similar DNA are related).”5 Accordingly, Ancestry.com challenged both the software component, the determination of a relative relationship, and the biological component, the nature of shared recombinable DNA sequences, of the technology.
The court, in turn, analyzed previous rulings in each of these areas in an attempt to apply the previously independent threads of subject matter eligibility jurisprudence to a combined technology. First, the court examined cases analyzing patents related to laws of nature finding that these cases generally hold that inventions that cover naturally occurring phenomena or simple observations of naturally occurring phenomena are not eligible for patent protection. Second, the court considered cases involving patents alleged to be directed to abstract ideas. In particular, the court focused on cases holding that patents were not covering an abstract idea itself, but rather new and novel ways of using the abstract idea to achieve some other result. The court admitted that the 23andMe patent claims could stand or fall based on which line of cases were most applicable (i.e., whether the claims were more directed to a law of nature used for biological-type components or to an abstract idea used for computer-software components).6
Ultimately, the court held that the claims were more directed to the biological component. That is, it concluded that the claimed method was directed to comparing IBD regions in DNA for determining the probability of matches between people. Due to the claims’ reliance on the IBD regions, the court determined that the statutory subject matter question should be whether the claims are directed to a law of nature.
The court declined to address the question under the abstract-idea approach because it felt, in part, that the claims did not elaborate enough on how the improved process for determining the similarities was performed. In particular, the court noted that the 23andMe patent claims did not quantify any degree of similarity for determining a relationship and did not identify any other specifics of the analysis of the IBD regions. According to the court, the lack of specificity of the claims prevented their survival.
Although the court ultimately determined that 23andMe’s patent claims were invalid (which 23andMe has since appealed), the court’s analysis can provide instructive clues for claiming hybrid inventions. While mere observation or comparison of naturally occurring phenomena would not be eligible for a patent under the court’s analysis, explicitly claiming the specific functionality of the software or other components using the naturally occurring phenomena may provide the ability to overcome the statutory-subject-matter hurdle. Under such an approach, the claims may have a better chance of surviving when faced with whether they are directed to an abstract idea.
Moreover, courts have held that the patent specification can be a useful tool in determining whether the claims are directed to statutory subject matter. Accordingly, it is important to provide enough specificity when drafting the application to help with overcoming these types of challenges down the road.
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