A new procedure in the Leahy-Smith America Invents Act ("AIA") allows a patent owner to request supplemental examination of a patent by the U.S. Patent and Trademark Office ("USPTO"). Using this procedure, the patent owner can ask the USPTO to consider information and related issues that a challenger might raise against the patent in litigation. Exploring some of the provisions of supplemental examination can help patent owners and patent practitioners identify strategies and potential advantages of using this procedure.
What Is Supplemental Examination?
Effective Sept. 16, 2012, supplemental examination allows a patent owner to have the USPTO consider, reconsider or correct information that the patent owner believes is relevant to the patent. 35 U.S.C. § 257(a). All owners of the patent must file the request for supplemental examination, but third parties cannot participate or file papers in the proceeding. 37 C.F.R. §§ 1.601(a) and 1.601(b). A patent owner may file a request for supplemental examination at any time during the period of enforceability of the patent. 37 C.F.R. § 1.601(c).
A court or agency cannot hold a patent unenforceable based on conduct relating to information considered by the USPTO during a supplemental-examination proceeding. 35 U.S.C. § 257(c)(1). This benefit to the patent owner is not available, however, under some circumstances. First, the benefit is not available if, before the date of a supplemental-examination request, an allegation is pleaded with particularity in a civil action or set forth with particularity in a specified notice received by the patent owner under the Federal Food, Drug, and Cosmetic Act. 35 U.S.C. § 257(c)(2)(A). Second, the benefit is not available if a defense is raised in an action brought in the International Trade Commission (under § 337(a) of the Tariff Act of 1930) or in a civil action brought in a federal district court (under 35 U.S.C. § 281), unless the supplemental examination and any ex parte reexamination ordered pursuant to the request are concluded before the date on which the action is brought. 35 U.S.C. § 257(c)(2)(B).
Within three months of the filing date of a request, the USPTO will determine whether the request raises a substantial new question ("SNQ") of patentability. In its guidance on the rules implementing supplemental examination, the USPTO has indicated that the standard for determining an SNQ of patentability is similar to the standard in the Manual of Patent Examination and Procedure ("MPEP") regarding ex parte reexamination: whether there is a substantial likelihood that a reasonable examiner would consider the item of information important in determining patentability.
If a request raises an SNQ of patentability, the USPTO will order ex parte reexamination of the patent, which is conducted similar to a regular ex parte reexamination proceeding. Unlike a regular ex parte reexamination proceeding, however, the patent owner does not have a right to file a statement about any of the SNQs of patentability raised by the request, and the proceeding is not limited to patents and printed publications. 35 U.S.C. § 257(b).
Up to 12 'Items of Information' in Request
The materials forming the primary basis of a supplemental-examination proceeding are referred to in the USPTO's implementing rules as "items of information." An item of information is a document submitted with a supplemental-examination request that contains information the patent owner believes is relevant to the patent. 37 C.F.R. § 1.605(b). A patent owner must submit only those items of information that are in writing. 37 C.F.R. § 1.605(c). Although an audio or video recording does not qualify as an item of information, a patent owner may instead submit a written transcript of the recording. Id.
A patent owner may submit no more than 12 items of information in a supplemental-examination request. 37 C.F.R. § 1.605(a). But a patent owner may submit more than one request for supplemental examination of the same patent at any time. Id. Therefore, if a patent owner would like to have more than 12 items considered, the patent owner may submit multiple requests, each including up to 12 items.
Because a patent owner can submit only up to 12 items of information in a request, the USPTO has provided guidance for counting items of information. If a copy of a document is included in a supplemental-examination request (e.g., an image of an email or a document), the patent owner must nevertheless submit a separate copy of the document, which constitutes an item of information. The USPTO has indicated in its guidance that items of information are counted, not the number of issues raised by an item of information. For example, a prior art patent may raise an issue under 35 U.S.C. § 102 about claim 1 and an issue under 35 U.S.C. § 103 about claim 2. Although two issues are raised, there is only one item of information—the patent.
A patent owner may submit a declaration or affidavit as an item of information. The USPTO's guidance has indicated that ad declaration or affidavit that relies on a single supporting exhibit will likely count as a sing item of information. But if a declaration or affidavit relies on separate and distinct exhibits, then the USPTO will count each exhibit past the first exhibit separately (e.g., if a declaration has two exhibits, then the declaration and the first exhibit will constitute the first item and the second exhibit will constitute the second item).
In contrast to ex parte reexamination, items of information are not limited to patents and printed publications. 35 U.S.C. § 257(b). Instead, written discussions of issues raised by the patent laws contained in a request can properly constitute items of information. In that instance, a patent owner's request to consider a claim in view of a particular section of the patent laws (e.g., the statutory subject-matter requirement of 35 U.S.C. § 101) and the discussion of any potential application of the law in the request constitutes an item of information.
Explaining and Applying Items of Information to Patent Claims in a Request
In a request for supplemental examination, a patent owner must identify each claim of the patent for which supplemental examination is requested and provide 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. 37 C.F.R. §§ 1.610(b)(4) and 1.610(b)(5). Additional required contents of a request and the required fees are specified in the implementing rules.
The requirement of a separate, detailed explanation in a request is similar to the detailed explanation requirement for an ex parte reexamination request. In its guidance in the implementing rules, the USPTO suggests that patent owners consult MPEP § 2214—which discusses the content of a request for ex parte reexamination—as a guide for preparing the separate detailed explanation.
The rules for supplemental examination also specify optional content a patent owner may include in a request. For example, a patent owner may include an explanation of how claims patentably distinguish over the items of information. 37 C.F.R. § 1.610(c)(3). A patent owner may also include an explanation of why each item of information does or does not raise an SNQ of patentability. 37 C.F.R. § 1.610(c)(4). Although not required, in guidance provided with the implementing rules, the USPTO strongly encourages including this explanation. The ability to explain why an item of information does not raise an SNQ of patentability contrasts with a requests for ex parte reexamination, which does not permit such an explanation.
Potential Advantages of Supplemental Examination
Certain aspects of supplemental examination may lead practitioners to select this new procedure over ex parte reexamination. Because items of information I a supplemental examination request are not limited to patents and printed publications, a patent owner can submit a wider range of documents and related issues for consideration. A patent owner may thus raise issues that a requester may not raise in an ex parte reexamination proceeding. For example, a patent owner may have the USPTO consider issues ranging from the statutory subject-matter requirements of 35 U.S.C. § 101 to the enablement and written-description requirements of 35 U.S.C. § 112.
Another potential advantage is the speed of the supplemental-examination proceeding. The USPTO will determine whether a request raises an SNQ of patentability within three months of the filing date of the request. If an item of information submitted in request do not raise an SNQ of patentability, the USPTO will issue a supplemental-examination certificate indicating that the items of information do not raise any SNQs of patentability and no further proceedings will take place. A patent owner may benefit from receiving such a result in a predetermined, short period of time.
A final potential advantage to the patent owner is the ability to argue that items of information do not raise SNQs of patentability. In some circumstances, a patent owner may not believe that items of information raise SNQs of patentability, but may nevertheless want to have the items considered by the USPTO to resolve any concerns. Such a patent owner may opt to make use of supplemental examination because, in contrast to an ex parte reexamination proceeding, the patent owner may argue that the items of information do not raise SNQs of patentability. This feature may allow a patent owner to quickly resolve concerns of potential charges of inequitable conduct regarding items not submitted during examination.
Considering the provisions of supplemental examination and its contrasts with ex parte reexamination can help practitioners decide whether supplemental examination may benefit a particular patent. Time will tell how widely practitioners adopt supplemental examination and where it will fit among other post-grant tools.
This article first appeared in the March 2013 issue of The IP Strategist.