We begin our journey today with the Supplemental Examination Final Rules, which were published in the Federal Register on August 14, 2012. Section 12 of the AIA amended chapter 25 of title 35, United States Code, to add new 35 U.S.C. 257, which permits a patent owner to request supplemental examination of a patent by the United States Patent and Trademark Office. The purpose of supplemental examination is to provide an avenue for the patent owner to ask the USPTO to consider, reconsider, or correct information believed to be relevant to the patent. Although supplemental examination goes into effect on September 16, 2012, it can be used for any patent issued on, before or after September 16, 2012.
Pursuant to 37 CFR 1.610(b), a complete request for supplemental examination must contain: (1) An identification of the number of the patent for which supplemental examination is requested; (2) A list of the items of information that are requested to be considered, reconsidered, or corrected; (3) A list identifying any other prior or concurrent post-patent Office proceedings involving the patent for which supplemental examination is being requested; (4) An identification of each claim of the patent for which supplemental examination is requested; (5) 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; (6) A copy of the patent for which supplemental examination is requested and a copy of any disclaimer or certificate issued for the patent; (7) A copy of each item of information (other than U.S. patents and published U.S. patent applications) accompanied by a written English translation of all of the necessary and pertinent parts of any non-English language item of information; (8) A summary of the relevant portions of any submitted document that is over 50 pages in length; and (9) An identification of the owner(s) of the entire right, title, and interest in the patent requested to be examined, and a submission by the patent owner establishing the entirety of the ownership in the patent requested to be examined.
Upon receipt of a complete request for supplemental examination the USPTO must act quickly. The USPTO interprets 37 U.S.C. 257(a) to require that supplemental examination must conclude within three months of the receipt of a request. The PTO interpretation that supplemental examination must be completed within 3 months is reasonable; perhaps the only interpretation, given the language of the statute. The statute says:
Within 3 months after the date a request for supplemental examination meeting the requirements of this section is received, the Director shall conduct the supplemental examination and shall conclude such examination by issuing a certificate indicating whether the information presented in the request raises a substantial new question of patentability.
However, if a non-compliant request for supplemental examination is filed no filing date will be awarded. The PTO explained that granting a filing date and then seeking correction would make it difficult, if not impossible, to meet the 3 month completion requirement. The USPTO explained:
[I]t would absorb a considerable portion of the three-month period for conducting the supplemental examination for the Office to accord a filing date to a non-compliant request for supplemental examination, issue a notice of the defects in the request for supplemental examination, and await a corrected request for supplemental examination.
Some may argue that 257(a) does not require completion of the supplemental examination within 3 months. Although perhaps stretched, it could be argued that supplemental examination needed to commence within 3 months, although not concluded within 3 months. An open ended time frame would have created delays, no doubt, and would have been inconsistent with the legislative history and the philosophy behind the USPTO rules which are all seeking to minimize prosecution delay.
Because supplemental examination needs to be concluded within 3 months, not only will the USPTO not award a filing date to non-compliant submissions, but the USPTO is also limiting the number of items of information that can be presented to twelve (12), up from ten (10) in the originally proposed rules. In the Final Rules published in the Federal Register the USPTO explains:
The Office must conclude a supplemental examination within three months of the date on which the request for supplemental examination is filed. See 35 U.S.C. 257(b). Thus, the Office must place a limit on the number of items of information that may be submitted with a request for supplemental examination. Ninety-three percent of the requests for ex parte reexamination filed in fiscal year 2011 included twelve or fewer documents. In addition, supplemental examination is designed to preempt allegations of inequitable conduct being raised as a defense during patent litigation, which typically concern far fewer than twelve items of information. 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. Thus, the Office expects a limit of twelve items of information per request to accommodate the vast majority of patent owners.
Note that the citation to 257(b) at the beginning of the above quote seems to be inaccurate. It is 257(a) that sets the 3 months deadline.
Further complicating the USPTO job of completing supplemental examination within 3 months is the fact that the information that may be presented in a request for supplemental examination is not limited to patents and printed publications. According to the USPTO, the patent owner may include ” transcripts of audio or video recordings,” for example. Furthermore, the patent owner may raise issues of patentability under 35 U.S.C. 101 and 112. Thus, the USPTO anticipates that the supplemental examination review will be a “more resource-intensive to process, review, and treat than the information permitted in an ex parte reexamination…” This was further support for the USPTO to limit the number of pieces of information that can be submitted in a request for supplemental examination.
In any event, at the conclusion of the supplemental examination if the certificate issued indicates that a substantial new question of patentability is raised an ex parte reexamination will be ordered by the USPTO. The resulting ex parte reexamination, which will address each and every substantial new question identified, will substantially be conducted according to the rules and procedures associated with ex parte reexamination. Notwithstanding, there is one very notable exception — the ex parte reexamination is not limited to patents and printed publications. Additionally, a less consequential procedural distinction is that the patent owner will not have the right to file a statement pursuant to 35 U.S.C. 304.
So who is going to want to proceed with supplemental examination? This may be a desirable procedural path to follow because it can inoculate a patent owner against potential charges of inequitable conduct. With two exceptions, a patent shall not be held unenforceable based on 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 subsequently considered, reconsidered, or corrected during a supplemental examination of the patent. The first exception is found in 35 U.S.C. 257(c)(2)(A) and says the inoculation “shall 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)(II) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(2)(B)(iv)(II)), before the date of a supplemental examination request…” Thus, one can see why it may be important to know that a non-compliant request for supplemental examination will not be awarded a filing date.
The second exception is found in 35 U.S.C. 257(c)(2)(B) and says the inoculation shall not apply to an action brought under section 337(a) of the Tariff Act of 1930 or to a patent infringement action commenced under 35 U.S.C. 281 “unless the supplemental examination, and any reexamination ordered pursuant to the request, are concluded before the date on which the action is brought.” Therefore, supplemental examination should be viewed as potentially inoculating the proactive patent owner, not the reactive patent owner who is late to learn of a potential problem that is identified during litigation.
Supplemental examination does not come without risks, of course. Most apparent are the potential loss of patent rights upon the Office identifying a substantial new question of patentability and subsequent loss of some or all claims during the ensuing ex parte reexamination. Additionally, 35 U.S.C. 257(e) requires the USPTO to efer the matter to the U.S. Attorney General if the Office becomes aware that a material fraud may have been committed in connection with the patent that is the subject of the supplemental examination. The USPTO explains that they believe “such instances will be rare.” The rarity of becoming aware of a material fraud is explained through the interpretation of what qualifies as a “material fraud.” The USPTO will interpret the term ‘‘material fraud’’ in 35 U.S.C. 257(e) “to be narrower in scope than inequitable conduct as defined by the U.S. Court of Appeals for the Federal Circuit in Therasense, Inc. v. Becton, Dickinson & Co., 649 F.3d 1276 (Fed. Cir. 2011).” Nevertheless, there is a risk of opening a can of worms, and we all know how stable and predictable Federal Circuit case law is relative to issues of materiality and deception.
This final rule also requires the following supplemental examination fees to accompany the initial request: (1) A fee of $5,140.00 for processing and treating a request for supplemental examination; (2) a fee of $16,120.00 for an ex parte reexamination ordered as a result of a supplemental examination proceeding; and (3) a fee for processing and treating a non-patent documents over 20 pages in length (i.e., a fee of $170.00 for a document of between 21 and 50 pages, and a fee of $280.00 for each additional 50 pages or a fraction thereof). The USPTO is simultaneously pursuing efforts to enact new fees pursuant to Section 10 of the AIA. Thee new fees will not likely be in place until February or March of 2013, thus there will be no small entity or micro entity discounts in these fees at least until the first quarter of 2013.