AMERICA INVENTS ACT - Supplemental Examination

This is the sixth article in a series of 10 relating to the Leahy-Smith America Invents Act of 2011 (AIA). The AIA went into effect on Sept. 16, 2011, and is the first major change to United States Patent Law in over five decades.

This article discusses the new procedure under 35 U.S.C. 257 "Supplemental examinations to consider, reconsider, or correct information". 35 U.S.C. 257 is effective Sept. 16, 2012, and will be 

Previously, a patent owner or a third party could request reconsideration of the patentability of a patent under the reexamination procedure. In a reexamination, the requestor could only submit patents and/or printed publications that created a substantial new question of patentability (SNQ). Patentability issues arising under other aspects of the patent laws could not be presented.

Under 35 U.S.C. 257, a patent owner (not a third party) is permitted to request supplemental examination to consider, reconsider, or correct information believed to be relevant to the patent. A request for supplemental examination can be filed at any time during the period of enforceability of the patent. Importantly, the information is not limited to consideration of patents and printed publications, and may include issues of patentability under 35 U.S.C. 101 and 112. The Patent Office must conclude supplemental examination within three months of a properly filed request by issuing a supplemental examination certificate, which indicates whether a SNQ was raised.

The standard for determining whether an item raises a SNQ in supplemental examination is the same standard as is used in reexamination: whether there is a substantial likelihood that a reasonable examiner would consider the item of information important in determining patentability.

The information submitted in a supplemental examination request may include any information that the owner believes to be relevant to the patent. For example, a journal article, a patent, an affidavit or declaration, or a written transcript of an audio or video recording may be provided (non-English documents must be accompanied by a written English translation of all relevant portions). This may be important if the request relates to evidence of public use or sale, or the lack thereof. The discussion in the body of the request will be considered to be an item of information if there is no supporting document submitted as part of the request (for example, an issue supporting the request under 35 U.S.C. 101). Each supplemental examination request is limited to the presentation of 12 items of information (more than one request may be filed at any time if more than 12 items need to be presented).

The request has numerous requirements. Importantly, the request must provide an explanation of the relevance and manner of applying each item to each claim for which supplemental examination is requested, and must include a summary of the relevant portions of any submitted item.

If the Patent Office determines that the information raises a SNQ, the Patent Office will order ex parte reexamination, and any information raising a SNQ resulting from the supplemental examination will be considered in the ex parte reexamination. In this ex parte reexamination, the patent owner does not have the right to file a statement pursuant to 37 C.F.R. 1.530. The ex parte reexamination concludes with an ex parte reexamination certificate.

Supplemental examination can potentially cure inequitable conduct which occurred during the initial prosecution of the patent. If the information forming the basis of a potential inequitable conduct charge is considered during supplemental examination, the patent cannot be held unenforceable on this basis in a subsequently filed lawsuit thus providing a shield for the patent owner from a charge of inequitable conduct. There are two exceptions. First, the finding does not apply to an allegation pled with particularity in a civil action, or set forth with particularity in a notice received by the patent owner under section 505(j)(2)(B)(iv)(l1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(2)(B)(iv)(II)), before the date of the supplemental examination request. Second, in an action brought under section 337(a) of the Tariff Act of 1930 or in a patent infringement lawsuit under 35 U.S.C. 281, the finding shall only be applied if the supplemental examination and its resulting ex parte reexamination are concluded before the date on which the action is brought.

If during supplemental examination or during the resulting ex parte reexamination the Patent Office becomes aware of a material fraud on the Patent Office, the matter will be referred to the U.S. Attorney General for appropriate action. The Patent Office regards the term "material fraud" to be narrower in scope than inequitable conduct as defined in Therasense, Inc. v. Becton, Dickinson & Co. , 649 F.3d 1276 (Fed. Cir. 2011).

The Patent Office has set the fees at: $5,140 for processing and treating a request for supplemental examination and $16,120 for conducting the ex parte reexamination ordered as a result of the supplemental examination (additional fees will apply for processing lengthy non-patent documents which are identified as an item of information). All fees must be paid at the time of requesting supplemental examination. The fee for the ex parte reexamination will be returned to the patent owner if ex parte reexamination is not ordered by the Patent Office.