Supplemental Examination (SE) is a new mechanism of the AIA designed to effectively cure inequitable conduct via a new post grant proceeding of the USPTO. The new mechanism went into effect on September 16, 2012 along with the other major post grant provisions.
As reported by Patently-O last week, only a handfulof SE filings have been submitted to date, far fewer than expected by some.
In operation, SE allows a Patentee to submit very detailed explanations of potential issues that may render the patent invalid under an inequitable conduct theory. Upon submission of Substantial New Questions of Patentability (SNQs) detailing such potential defects, the Office will reconsider the information; that is to say the Office will perform a “supplemental examination.” Once such issues are considered and dispatched by an SE certificate, the subject patent would be free of inequitable conduct charges based on the issues considered in the SE. On the other hand, should the materials presented raise an SNQ, a form of patent reexamination is conducted (differing from typical practices in that it is not be limited to patents and printed publications).
Sounds like a great idea….and it was, prior to Therasense.
As SE was fashioned by Congress prior to the Therasense decision, it employs the very liberal (SNQ) standard. Thus, an SE is only concluded favorably if the materials submitted would not be deemed important by a “reasonable examiner.” Yet, Therasense changed the standard from a “reasonable examiner” test for materiality to a ”but for” standard of materiality. The new “but for” standard defines material information as any non-cumulative information which, had it been disclosed prior to patent issuance, would have prevented the patent from issuing.
So, by filing an SE request, the information submitted is actually considered under the old standard of materiality first. Historically, SNQs have been found in roughly 94% of filings for patent reexamination; SE filings are not expected to fare any better. Once an SNQ is found, the examiner will consider the proposed materials relative to the prima facie showing necessary to issue a rejection. Thereafter, a Patentee may rebut the prima facie showing and ultimately demonstrate a lack of “but for materiality,” perhaps years later and at significant cost.
Aside from those cases with seemingly egregious issues of lack of candor, or perhaps instances where infectious enforceability is a concern, SE filings would seem to be of little practical value (not to mention there are other ways to achieve the same end result). Indeed, in light of the fact that courts need to couple “but for” materiality with a showing of specific intent to deceive the USPTO, it is not surprising that many inequitable conduct charges are now falling at the summary judgment stage. As a result, the demand for SE is far less than it was when the statutes were first drafted by Congress.