Section 12 of the Leahy-Smith America Invents Act (AIA) amends the patent laws to provide that a patent owner may request supplemental examination of a patent to consider, reconsider, or correct information believed to be relevant to the patent. ¬†The goal of the new procedure is to provide an opportunity to preempt later inequitable conduct charges.¬†¬†Supplemental examination will determine whether the information presented in a request raises a substantial new question of patentability, and if so, the Office will order ex parte reexamination of the patent. ¬†With certain exceptions, the patent will not be held unenforceable on the basis of conduct relating to information that had not been considered, was inadequately considered, or was incorrect in a prior examination, if the information is considered, reconsidered, or corrected during supplemental examination.
Supplemental Examination under the AIA
35 U.S.C. ¬ß 257(a) provides for a proceeding titled ‚Äúsupplemental examination‚ÄĚ that may be requested by the patent owner to consider, reconsider, or correct information believed to be relevant to the patent.¬† The information that may be presented in a request for supplemental examination is not limited to patents and printed publications and may raise issues of patentability on non-art grounds under 35 U.S.C. 101 and 112.¬† Within three months of receiving a request for supplemental examination, the Office will issue a supplemental examination certificate indicating whether the information presented in the request raises a substantial new question of patentability.¬†
If a substantial new question of patentability is raised by one or more items of information in the request for supplemental examination, the Office will order ex parte reexamination of the patent.¬†The resulting ex parte reexamination proceeding will be conducted according to the usual procedures, except that the patent owner does not have the right to file a statement pursuant to 35 U.S.C. ¬ß 304, and the basis of the reexamination is not limited to patents and printed publications.
35 U.S.C. ¬ß 257(c) specifies the effect of a supplemental examination any resulting ex parte reexamination on the enforceability of the patent. A patent shall not be held unenforceable on the basis of conduct relating to information that had not been considered, was inadequately considered, or was incorrect in a prior examination of the patent, if the information was considered, reconsidered, or corrected during a supplemental examination of the patent.¬†The immunity from unenforceability does not apply to an allegation pleaded with particularity in an action or an ANDA paragraph IV certification before supplemental examination is requested, nor to defenses in an infringement action or an ITC Section 337(a) investigation begun before supplemental examination is completed.¬† Supplemental examination is available for any patent, whether issued before or after the September 16, 2012 effective date.
35 U.S.C. ¬ß 257(e) provides that if the Office becomes aware, during the course of a supplemental examination or a reexamination ordered as a result of it, that a material fraud on the Office may have been committed in connection with the patent that is the subject of the supplemental examination, the Office shall refer the matter to the U.S. Attorney General, in addition to any other actions the Office is authorized to take, including the cancellation of claims.¬† The Office regards the term ‚Äúmaterial fraud‚ÄĚ be narrower in scope than inequitable conduct as defined by CAFC in Therasense. Nothing in 35 U.S.C. 257 precludes the imposition of sanctions based upon criminal or antitrust laws, nor shall it be construed to limit the authority of the Office to investigate issues of possible misconduct and impose sanctions for misconduct involving matters or proceedings before the Office, or to issue regulations relating to sanctions for misconduct by patent practitioners.
The Office issued the final implementing regulations for supplemental examination under the AIA with the goal of permitting ‚Äúefficient processing and treatment of each request for supplemental examination within the statutory three-month time period, and to complete any subsequent ex parte reexamination ordered as a result of the supplemental examination proceeding with special dispatch.‚ÄĚ¬† In view of the comments received after the publication of proposed rules in January, 2012, the Office made the following changes to the rules implementing Section 12 of the AIA.
Responsive to comments requesting higher or no limits on the number of items of information contained in a request for supplemental examination, the final rule now permits a request for supplemental examination to contain up to twelve items of information, up from ten.¬† Essentially, each document is considered a single item of information, regardless of how many issues it raises.¬† In addition, an argument in the request addressing 35 U.S.C. ¬ß 101 or ¬ß 112 may also be an item of information.¬† The Office noted that supplemental examination is designed to preempt allegations of inequitable conduct in litigation, which typically concern far fewer than twelve items of information, so a limit of twelve items of information per request is expected to accommodate the vast majority of patent owners.¬† Further, if twelve items of information are not sufficient for a particular situation, more than one request for supplemental examination of the same patent may be filed at any time.
A number of comments requested fewer and simpler content requirements for a¬† supplemental examination request.¬† In response, the final rule adopts content requirements for a supplemental examination request that are comparable to the requirements for an ex parte reexamination request.¬†(e.g., a list of each item of information to be considered, reconsidered, or corrected; an identification of each claim of the patent for which supplemental examination is requested; and a separate, detailed explanation of the relevance and manner of applying each item of information to each claim of the patent for which supplemental examination is requested). See 37 C.F.R. ¬ß 1.610. ¬†In adopting content requirements that are comparable to a request for ex parte reexamination, the final rule eliminates many of the more burdensome requirements of the proposed rule.
A request for supplemental examination will not be accorded a filing date until a request complying with the applicable regulations in 37 C.F.R. ¬ß¬ß 1.605, 1.610, and 1.615 is received.¬† The AIA requires that the Office conclude supplemental examination within three months of the date on which the request was filed. The Office declined to adopt a rule that accorded a non-compliant request a filing date, with notice and a period to correct, to avoid placing the Office in jeopardy of not meeting the statutory three-month time frame.¬† A request for supplemental examination that is entitled to a filing date will be entered into and be viewable by the public via the Public PAIR system.¬† The request and any other papers or information submitted with it will not be available in Public PAIR until the request meets the conditions to be entitled to a filing date.
The Office declined to adopt a rule allowing an owner of less than the entire right, title, and interest in the patent to request supplemental examination.¬† Consistent with the rules governing ex parte reexamination and other Office proceedings affecting patents, the Office will permit less than all of the joint owners of a patent to request supplemental examination only where a joint owner is deceased or incapacitated, refuses to join, or cannot be found after diligent effort.¬† This does not include exclusive licensees or others having less than an entire right, title, and interest in the patent.
The Office further declined to adopt a rule permitting examiner interviews during the three month period between filing of a supplemental examination request and the issuance of a supplemental examination certificate.¬† The Office noted that prohibiting interviews during this period will assist the Office with its statutory duty to issue the supplemental examination certificate within three months of the request, and that examiner interviews are available in any reexamination ordered following supplemental examination in accordance with the normal rules pertaining to ex parte reexaminations.