Navigating Patent Eligibility for Process Claims
What This Means to You
- Although recent Federal Circuit cases suggest the court may apply a "coarse filter" to find patent-eligibility, patentees should still be careful to distinguish their method claims from purely mental steps.
- Consider describing your invention in the context of complex technology, or by defining terms to exclude mental steps.
- Draft some process claims to include an active step or to explicitly implicate a technical procedure that cannot be performed by a mental thought.
- When possible, include at least one claim that satisfies the traditional “Machine or Transformation” standard, since this test can still be relied upon as a basis for patent eligibility.
- The Supreme Court’s decision in Prometheus (expected in 2012) will address diagnostic and therapeutic methods in more detail and also may provide some guidance on patent-eligibility for computer-implemented methods.
In 2011, the US Court of Appeals for the Federal Circuit (Federal Circuit) addressed the patent-eligibility of process claims in a series of decisions related to diverse technologies, including biomedical techniques, financial services, and internet-based methods. Significant questions remain unanswered, but these decisions provide a current framework for prosecuting and evaluating patent claims related to processes for managing and using information.
Although processes are one of the four statutory classes of patentable invention, the courts have long recognized exceptions for ideas, laws of nature, and natural phenomena. As a result, the patentability of process claims related to many biomedical, business, and software methods has been challenged in different court cases.
In the 2010 Bilski decision, the US Supreme Court affirmed that a mental process itself was not patent-eligible, but also clarified that the “Machine or Transformation” standard applied by the Federal Circuit was not the sole test for determining the patent-eligibility of process claims.
This decision was generally welcomed, because the “Machine or Transformation” test was developed for traditional device and manufacturing methods and was not readily applicable to diagnostic and therapeutic applications or computer-implemented methods that involved manipulating information. However, the Bilski decision provided only general guidelines and left the Federal Circuit to wrestle with the details.
Where Did 2011 Leave Us?
Two Federal Circuit decisions in 2011 addressed the patent-eligibility of process claims in the biomedical field.
In Association for Molecular Pathology, v. United States Patent and Trademark Office (better known as the Myriad decision—see our IP Alert on case here), the Federal Circuit invalidated several diagnostic method claims as not patent-eligible, because they recited only mental steps. The invalidated claims related to correlations between genetic variations and disease, and only recited steps that involved “comparing" or "analyzing" information, both of which were found by the court to be mental steps. In contrast, the court held that the recitation of "inherently transformative" experimental steps such as growing cells and determining cell growth rates was sufficient to confer patent eligibility on method claims relating to drug screening.
Even though the diagnostic claims were invalidated, the court’s analysis in Myriad suggests that diagnostic claims may be patent-eligible if they recite one or more transformative steps that are central to the purpose of the diagnostic process. Examples of steps to consider include isolating, sequencing, or amplifying nucleic acids. However, whether the inclusion of a preparative step would be sufficient to confer patent eligibility remains uncertain, and the analysis is likely to be fact-dependent.
In another biomedical case, the Federal Circuit held that process claims can be patent-eligible if they recite physical implementation steps. In Classen Immunotherapies, Inc. v. Biogen Idec (see our case analysis here), the court held that process claims reciting data gathering steps can be patent-eligible if they also recite a physical implementation based on the gathered information. Claims in two of the three patents at issue included the active step of immunizing subjects. These were found to be patent-eligible, because they were directed to specific and tangible applications that were central to the claimed process. However, the court found a third patent to be invalid, because the claims only included steps of collecting and comparing data, and did not include any physical steps that involved using or applying the information derived from the data.
Related issues also were addressed by the Federal Circuit in 2011 in the context of data analysis and computer-implemented methods.
In CyberSource Corporation v. Retail Decisions, Inc. (see our case analysis here), the Federal Circuit also invalidated process claims that were found to read on human mental activity. The invalidated claims related to credit card transactions and only recited “obtaining” information, “building” a map of credit card numbers, and “utilizing” the map to determine validity of a transaction, all of which the court found could be performed mentally. The analysis in CyberSource set a high bar by holding that process claims are not patent-eligible if they are so broadly written that they do not contain any limitations that would prevent them from reading on human mental activity and mere equivalents of human mental activity.
The CyberSource decision was subsequently distinguished in Ultramercial, LLC v. Hulu, LLC (see our case analysis here). The Ultramercial decision clarified that the limits on the patent-eligibility of software methods are narrowly drawn to claims reciting purely mental steps, in contrast to claims that require hardware. The CyberSource claims related to an Internet-based method of monetizing media products by providing access to consumers who view advertising material. The independent claim recited multiple steps including one with a specific reference to an Internet website. The court found that the claim limitations implicated a “cyber-market environment” and involved “intricate and complex computer programming” and were therefore patent-eligible.
What Next for 2012?
Even though the analysis was different in each case, the Federal Circuit is looking for limitations that exclude purely mental steps in order for a process claim to be patent-eligible. The Federal Circuit did not articulate a specific and generally applicable test. Rather, the Federal Circuit relied on different analyses to exclude mental steps.
In the biomedical field, a step that transforms biological material or that requires a physical act can be sufficient to confer patent eligibility. However, it seems that the mere recitation of a physical act may not be sufficient, because the Federal Circuit emphasized that the act should be central to the purpose of the claimed process.
This analysis may be clarified by the Supreme Court when it rules on the Prometheus case, a decision expected in 2012. In Prometheus, the recitation of the term “determining” was found by the Federal Circuit to be sufficiently transformative in the context of claims that involved analyzing biological material to determine the levels of certain substances.
The anticipated Prometheus decision may provide some guidance for computer-implemented methods. However, many specific questions are likely to remain unanswered. For example, can the courts exclude mental activities and find claims to be patent-eligible when the recited method steps are sufficiently complex to require computer-implementation in practice, even if they theoretically could be implemented by mental activity?
In addition to looking beyond the narrow “Machine or Transformation” test for evaluating patent-eligibility of process claims in recent decisions, the Federal Circuit has stressed that subject matter eligibility analysis should be a coarse filter, and not a substitute for other requirements (e.g., novelty and non-obviousness). This may suggest that the Federal Circuit can apply a relatively low bar to find patent-eligibility, in some cases.
Nonetheless, in the absence of further guidance from the courts, patentees should be careful to unambiguously distinguish their method claims from purely mental steps. In some instances, this may be accomplished by describing the invention in the context of complex technology, or by defining terms to exclude mental steps.
At least some process claims also should be drafted to include an active step or to explicitly implicate a technical procedure that cannot be performed by a mental thought. However, when possible, it only makes sense to include at least one claim that satisfies the traditional “Machine or Transformation” standard, since this test can still be relied upon as a basis for patent eligibility.
[The authors wish to acknowledge the contributions of Melissa Beede, A.J. Tibbetts, and Janice Vatland to this article.]