As precursors to the more wide-ranging Alice decision and the USPTO guidance that came after it, the impacts of the Mayo and Myriad decisions have gotten somewhat lost in the scuffle of all of the attention paid to § 101 rejections in the software and business methods technology sectors. While Mayo and Myriad were limited to patent applications touching on laws of nature, these two cases established the framework that the Supreme Court and the USPTO examiner corps would eventually apply to all applications touching on any type of judicial exception. Just like Alice in the software and business methods tech sector, Mayo/Myriad rejections have also made patent prosecution for biotech, pharma, and life science applications much more difficult.
In this study, we will briefly review the Mayo and Myriad cases, take a look on the lasting effects they have had on the USPTO, and discuss a few ways that big data can help applicants get around Mayo/Myriad rejections.
In Mayo Collaborative Services v. Prometheus Laboratories, 566 U.S. ___ (2012), the claims at issue were directed to a method of giving a drug to a patient, measuring the metabolites in that drug, and deciding whether to increase or decrease the dosage of the drug. The Supreme Court held that the methods were patent-ineligible and invalid. The court found that the correlation between the naturally-produced metabolites and therapeutic efficacy and toxicity were unpatentable natural laws. Further, it found that the steps in the claims at issue were well-known in the art and directed doctors to engage in well-understood, routine, and conventional activity. Thus, they were not sufficient to transform an unpatentable law of nature into a patent-eligible application of such a law. The court stated that the only way to do this is to recite additional features that provide practical assurance that the process is more than a drafting effort to monopolize the law of nature itself.
The patent claims at issue in Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. ___ (2013) covered isolated DNA sequences, methods to diagnose propensity for cancer by looking for mutated DNA sequences, and methods to identify drugs using isolated DNA sequences. The court held that the claims were patent-ineligible because a naturally-occurring DNA sequence is a product of nature and is not patent-eligible merely because it has been isolated. The court distinguished naturally-occurring DNA from complementary DNA (cDNA), holding that the latter is patentable because it is not naturally-occurring, but has been synthetically modified. Thus, claims directed to laws and products of nature must have an inventive concept that distinguishes them from their naturally-occurring counterparts in order to be patentable under Myriad.
The USPTO subsequently issued guidance in the wake of the later Alice decision that set out a two-part process for evaluating patent eligibility for applications with claims directed to any of the judicial exceptions:
The USPTO also clarified that, if a claim includes a nature-based product that has markedly different characteristics, the claim does not recite a “product of nature” exception and is patent eligible unless the claim recites another exception. If the claim includes a product that has no markedly different characteristics from the product’s naturally-occurring counterpart, the claim is directed to an exception and the patentability inquiry must proceed to the second step of the Mayo/Alice test.
Examples of elements that qualify as “significantly more” under the Mayo/Alice framework include:
Examples of elements that do not qualify as "significantly more" include:
Before we examine the rates of Mayo/Myriad rejections by year, it would first be helpful to give a brief overview of when each case was decided.
With this in mind, we will now turn our attention to the percentage of Mayo/Myriad rejections that were issued across the USPTO over the same time period in Figure 1 below.
As shown above in Figure 2, there was a predictable surge in the percentage of § 101 rejections citing Mayo/Myriad from 2012 to 2014, during the period when each case was decided, reaching a peak of 10.9% in 2014. There was then a small dip in this percentage from 2014 to 2015, but this dip had largely corrected itself by 2016, although the 2016 percentage was slightly lower than the 2014 high. One possible explanation for this apparent leveling-off of Mayo/Myriad rejections between 2014 and 2016 was that many examiners began citing to Alice in their § 101 rejections from 2014 onward, which may have lessened the need to cite to the earlier Mayo and Myriad cases.
Another way to conceive of the timeline in Figure 1 would be to define it by jurisprudential era rather than year, since the Supreme Court handing down landmark § 101 decisions has a much greater impact on § 101 rejections issued at the USPTO than simple calendar year. Looking at things this way, we can split this timeline into five distinct eras, beginning before Bilski and ending in the current post-Alice era. See Figures 2 and 3 below for the percentage of overall § 101 rejections and the percentage of § 101 rejections citing to Mayo/Myriad during these eras.
As shown above in Figure 3, the rate at which examiners across the USPTO issued § 101 rejections actually declined through the Bilski and Mayo eras, but increased dramatically after Myriad, and has continued to increase in the post-Alice era. However, as shown in Figure 4, the percentage of § 101 rejections citing to Mayo/Myriad increased throughout all of the eras during which either type of rejection could have been issued, notwithstanding the decline in overall § 101 rejections between the Bilski and Myriad decisions.
As we have seen with other recent § 101 cases like Alice, the effects of Mayo and Myriad are highly concentrated into a handful of art unit groups, with particularly strong implications for several technological fields. While Alice had the strongest impact on the software and business methods tech sectors, Mayo and Myriad have had a similar, although less extreme, effect on the biotech, pharma, and life sciences industries. The ten art unit groups at the USPTO with the highest percentage of § 101 rejections that city Mayo/Myriad are as follows:
Applicants have a few different choices when deciding how to respond to Mayo/Myriad rejections. Just like we have seen with almost every other type of rejection, RCEs are by far the most popular rejection response for Mayo/Myriad rejections. The second most popular response is outright abandonment, which accounts for almost a third of all Mayo/Myriad rejections responses. That so many applicants choose to abandon their applications after receiving a Mayo/Myriad rejection indicates that these cases have a reputation among applicants as application-killers. For exact figures on the frequency of each type of response to Mayo/Myriad rejections, see Figure 4.
(Note: Because almost all successful responses to final rejections also include a subsequent amendment, we did not consider an amendment to be a distinct response to a final rejection, and thus we calculated how applicants responded whether or not that response included an amendment. For applications in which there were multiple responses (i.e., an RCE and an interview), we did not determine the chronological order of those responses, but merely that each response was made to the rejection at some point prior to a subsequent rejection or an allowance.)
Not all rejection responses are similarly successful. Although RCEs are usually the most popular final rejection response, they are also usually the least successful way of getting around most types of rejections. This is not the case for Mayo/Myriad rejections, as RCEs are actually the second-most successful way to respond to one. The only way to increase an applicant’s chances of overcoming a Mayo/Myriad rejection is to add an interview to their RCE, but this strategy only works if the applicant undertakes an interview in addition to an RCE; interviews alone are far less successful than RCEs alone. See Figure 5 for the success rates for all types of responses.
(Note: A rejection is “successful” if the next office action is either a Notice of Allowance or another rejection that does not cite the same rejection basis as the previous office action. For example, assume that an applicant receives a final rejection that cites §§ 101 and 103, she responds with an RCE, and the next rejection only cites § 103. We assume that the RCE was successful at overcoming the §101 rejection, since it was not raised again in the subsequent rejection. We also narrowed the data to instances where the response highlighted was the only response to the rejection in order to measure the effectiveness of each of the responses on their own, unaffected by other responses that could be influencing the outcome.)
Luckily for applicants working in the biotech, pharma, and life sciences sectors, there are tools available to help you increase your chances of success when dealing with a Mayo/Myriad rejection. Juristat’s Examiner Reports are a comprehensive tool that provides you with everything you need to get inside your examiner’s head and get around Mayo/Myriad rejections. They have several features that give their users the advantage over other applicants, including:
Mayo, Myriad, and even Alice have made patent prosecution in the biotech, pharma, and life sciences tech sectors much more difficult than it used to be, meaning that applicants now need to change their strategies to cope with this new reality. The most effective way of doing so is to use big data in every patent prosecution to maximize your chances of success should you receive a Mayo/Myriad rejection. Sign up today and see what Juristat can show you.