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Applicant Guidance after Myriad and Prometheus

By Phillip M. Pippenger - March 20, 2014

It goes without saying that some ideas are patentable, and some ideas are not. However, the line between the two can be murky.

For example, the boundary line of patentability for software and natural phenomena has been an open question for about as long as it’s been a question at all. Given recent decisions and the reception and interpretation of those decisions, it appears that the question may never be closed to everyone’s satisfaction.

However, unless we are willing to let today’s valuable IP slip away in the confusion, we must proactively take an approach that is most likely to provide protection in light of today’s available decisions and any reasonable forecasts. To that end, the United States Patent and Trademark Office (USPTO) has just issued a set of guidelines1 to assist Examiners in properly examining patent claims in light of recent decisions such as Myriad2 and Prometheus.3 (the Guidelines). The Guidelines prescribe a process to be followed in examining claims related to natural phenomena or laws of nature. Further, with respect to “abstract ideas” (a moniker generally applied to vague claims of various types), the Guidelines confirm that MPEP § 2106(II) still applies to such claims.

Turning to the question of laws of nature and natural phenomena, the Guidelines are intended to “assist examiners in determining whether a claim reflects a significant difference from what exists in nature … or … something that is naturally occurring, like the claims found ineligible by the Supreme Court in Myriad.” The Guidelines are centered on a decision tree that asks three primary questions:

(1) Is the claimed invention directed to one of the four statutory patent-eligible subject matter categories (process, machine, manufacture, or composition of matter)? If not, the subject matter is not eligible. But if so, then question number 2 must be asked.

(2) Does the claim encompass one or more judicial exceptions to patentability? (Judicial exceptions encompass subject matter that technically fits the listing above, but that is deemed to be unpatentable nonetheless; these include, for example, natural phenomena, products of nature, natural products, naturally occurring things, scientific principles, systems that depend on human intelligence alone, disembodied concepts, mental processes and disembodied mathematical algorithms and formulas.) If the claim is clearly not within any judicial exception, then the §101 analysis is over — patentability under §101 is not precluded. However, if the claim seems similar to a known judicial exception, then the Examiner must ask question 3.

(3) Does the claim recite something significantly different than the judicial exception? If the answer is no then the claim is not patent-eligible under §101. But how is one to know whether what is recited in the claim is “significantly different” than the relevant judicial exception? According to the Guidelines, a significant difference is shown when (1) the claim includes additional elements or steps that practically apply the judicial exception in a significant way, or (2) the claim includes features or steps that demonstrate that the claimed subject matter is markedly different from what exists in nature.

However, since these standards themselves are drafted using terms like “markedly” and “significantly,” they beg for further clarification. As such, the Guidelines list a number offactors,someweighinginfavorofpatentability,andsomeweighingagainst. Thefactors that weigh towards patentability include such things as the presence of non-naturally occurring products that are markedly different in structure from naturally occurring products, a limitation on scope such that others are not substantially foreclosed from using the relevant judicial exception, recitations that go beyond general instructions to apply or use the judicial exception, a claimed machine/transformation that implements/integrates the judicial exception into a practical application, and additional steps or limitations that are not well-understood, purely conventional or routine in the relevant field.

Similarly, there are factors weighing against patentability under §101. These include, for example, a determination that a claimed product is not markedly different in structure from naturally occurring products, additional elements or steps that are so general as to preclude substantially all practical applications of the judicial exception, additional elements or steps that when used or taken by others result in application of the judicial exception, additional elements or steps that are well-understood, purely conventional or routine in the relevant field, additional elements or steps that are simply insignificant extra-solution activity, and additional elements or steps that amount to nothing more than a mere field of use restriction.

In short, the USPTO’s analysis and application of current decisions does provide at least a roadmap as to what elements should be emphasized or de-emphasized in claim drafting in this area. For example, knowing that the Examiner will be looking for the presence of the foregoing factors if there is a close call on §101, the drafter may choose to emphasize in their claim the presence of non-naturally occurring products that are different in structure from naturally occurring products, a limitation on scope if possible, and a machine or transformation that evidences a practical application of the rule or product in question. Suffice it to say, while the inclusion of well-understood, conventional or routine steps or elements may be required for clarity, such elements cannot be relied upon to prevent an Examiner challenge under §101.

The professionals at Miller, Matthias & Hull LLP continuously strive to protect our clients’ intellectual property to the fullest extent possible while being cost-effective and budget conscious. For more information on how we can help with your IP needs, please contact us at (312)977-9902.

1 Guidance For Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, & Natural Products, (March 4, 2014).
2 Association for Molecular Pathology v. Myriad Genetics, Inc., 106 USPQ2d 1972 (2013).
3 Mayo Collaborative Services v. Prometheus Laboratories, Inc., 101 USPQ2d 1961 (2012).