Lead Prior Art Methodology: Applying Lead Compound Case Law to Other Disciplines for Enhanced Objectivity

This article aims to complement the traditional Graham-KSR obviousness framework by extrapolating the well-established “lead compound” approach used in the obviousness analysis of new chemical compounds across all fields of innovative endeavor. This extrapolation is designed to provide proponents and opponents of prima facie obviousness for a particular claimed invention, judges, and patent examiners with tools to analyze obviousness to an improved degree of objectivity. To that end, the authors present a methodology for identifying those pieces of prior art (“Lead Prior Art”) that the mythical person of ordinary skill in the art (“POSITA”), without employing hindsight, would have selected for subsequent modification at the time that the invention was made. That method is based on identification of starting point(s) for further innovation that one of ordinary skill in the art would have selected based on the relevant available information at the time the invention was made, as statutorily required. “Relevant available information” includes teachings or suggestions in the prior art as well as inferences that would have been apparent to a POSITA based on ordinary creativity and common sense. In general, any information properly available to a POSITA that is capable of elevating the desirability of one or more potential starting points over others is relevant to the identification of the Lead Prior Art. In some situations, the Lead Prior Art’s potential for modification to achieve the claimed invention may have been very apparent or even certain to a POSITA, given the relevant information that would have been available to the POSITA. In other situations, however, a POSITA’s ability to have achieved the claimed invention given the Lead Prior Art may implicate questions of lack of straightforwardness and “reasonable expectations of success.” Once Lead Prior Art is selected, modifications to that Lead Prior Art may be identified and evaluated to determine whether a POSITA could have achieved the claimed invention from the Lead Prior Art. That evaluation is then used in a determination of nonobviousness or of prima facie obviousness. Thus, rather than making a single, and quite possibly relatively difficult, determination of whether the differences between the prior art and the claimed invention as a whole would have been prima facie obvious, our methodology allows that difficult determination, given appropriate facts, to be partitioned into several simpler, objective determinations that lead to a deduction that the claimed invention is either nonobvious or prima facie obvious. A major goal, of course, is to reduce problems caused by hindsight bias, “pigeonholing,” and/or lack of harmonized analytical methodology. Accordingly, we present our proposal, essentially a synthesis and extension of existing principles, as a step forward in obviousness analysis that can be utilized by patent prosecutors, patent litigators, and decision makers at both the United States Patent and Trademark Office (“USPTO”) and in the relevant U.S. courts.

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