Supplemental Examination (SE) is a mechanism of the AIA that is designed to effectively cure inequitable conduct via a new post grant proceeding of the USPTO. This mechanism, effective September 16, 2012 will be available to all issued patents.
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 or correct such information; that is to say the Office will perform a “supplemental examination.” Once such issues are considered, any patent issuing as a result of the SE would be free of inequitable conduct charges based on the same issues considered in the SE.
In the proposed rules to implement SE, the USPTO has limited the number of “items of information” for presenting a SNQ to 10. Public comments directed to this implementation detail have been largely negative.
A few days back, the Director more or less made clear that this limitation will remain in the Final rules.
In justifying the 10 item limitation, the Director explained:
The supplemental examination procedure was designed to provide patentees with a quick and decisive examination of items that were overlooked during the patent’s original prosecution. So quick in fact, that the AIA set a three-month period for us to conduct and conclude a supplemental examination after a request is filed. That’s just three months to determine if any of the items of information raise a substantial new question of patentability.
In order to meet this timeframe, we have proposed a limit of 10 items of information that a patent owner can submit to the USPTO for consideration in each request. The purpose of this limit is to strike a balance between the needs of the patent owner and the ability of the Office to timely conclude the proceeding. That said, we did not limit the number of issues that these 10 items of information can raise, nor did we limit the number of separate supplemental reexamination requests that a patentee can file.
Following publication of the proposed rules, the Office received a number of suggestions requesting us to accept more than 10 items of information in a single supplemental examination request. While we’re still considering this and all of the other input we have received, I wanted to share with you the factors the Office took into consideration in proposing a limit of 10 submissions.
First, far fewer than 10 prior art documents form the basis for most inequitable conduct allegations. In fact, we are unaware of any publicly reported inequitable conduct dispute involving more than 10 items of information – if you know of one, please let us know. Second, in over 85 percent of the requests for ex parte reexamination, the requester cites 10 or fewer items for consideration by the Office. Third, the Office was very mindful of the time necessary for examiners to analyze the items of information submitted, particularly since the items are not limited to patents and printed publications, and each item may raise multiple issues.
Accordingly, limiting the number of items of information to 10 will help the USPTO establish a procedure that is not only practical, but also one enabling an examiner to fully, comprehensively, and timely analyze all submitted items of information and issues to accurately determine whether there is a substantial new question of patentability.
The Office would seem to be on solid ground here.
A more interesting question is, post-Therasense, whether or not SE is a risk worth taking at all.