Supplemental Examination: A Detailed Look at the Procedure

Supplemental examination was created by the America Invents Act and became available on September 16, 2012. It gives patent owners a way to have the USPTO consider information that was not considered, was inadequately considered or was incorrect during original examination. When the process is completed, that information generally cannot later be used to hold the patent unenforceable for inequitable conduct, subject to statutory exceptions.

The USPTO proposed implementing rules in 2012 and adopted final rules the same year. This article describes the procedure as it now stands. For an overview, see the supplemental examination guide.

Who can file and what can be submitted

Only the patent owner may request supplemental examination; the rules require the request to be filed by the owner of the entire right, title and interest in the patent. The request asks the Office to “consider, reconsider, or correct information believed to be relevant to the patent” (35 U.S.C. § 257(a)).

Unlike ex parte reexamination, the information is not limited to patents and printed publications. It can include, for example, test data, declarations, transcripts or other documents bearing on any ground of patentability, including issues under §§ 101 and 112.

Contents of a request

Under 37 C.F.R. §§ 1.605 and 1.610, a request must include, among other things:

• A list of items of information. Each request may include no more than twelve items (§ 1.605). Owners with more information can file multiple requests.
• Identification of each claim for which supplemental examination is requested.
• Identification of each issue raised by each item, for example anticipation, obviousness or written description.
• A separate, detailed explanation of the relevance and manner of applying each item to each claim.
• A copy of each item, with translations of non-English documents.
• A summary of the relevant portions of any lengthy document, as the rules require.
• The required fees.

The Office checks the request for compliance and accords a filing date only when the requirements are met. A defective request may be returned for correction.

Fees

Supplemental examination has two principal fee components: a fee for processing and treating the request, and a fee for the ex parte reexamination that will be conducted if one is ordered. Both are paid when the request is filed. If no reexamination is ordered, the reexamination fee is refunded.

The fees are substantial, and they have changed over time. Check the current USPTO fee schedule before relying on any figure.

The determination and the certificate

Under § 257(a), the Office must conduct the supplemental examination and conclude it within three months of the filing date of the request. It does so by issuing a supplemental examination certificate that states whether the information presented raises a substantial new question of patentability.

The certificate becomes part of the public record of the patent, along with the request and the items of information.

If reexamination is ordered

If the certificate identifies a substantial new question, the Office orders ex parte reexamination under § 257(b). That reexamination largely follows the ordinary ex parte reexamination procedure, with some differences:

Feature	Ordinary ex parte reexamination	Reexamination ordered after supplemental examination
Who starts it	Any person	Patent owner, via supplemental examination
Grounds	Patents and printed publications	Each substantial new question identified, not limited to patents and printed publications
Patent owner statement under § 304	Available	Not available
Third-party participation	Requester may reply to owner statement	None

The patent owner may amend claims and respond to rejections in the usual way. The reexamination ends with a reexamination certificate confirming, amending or cancelling claims.

Effect on enforceability and the exceptions

Under § 257(c)(1), a patent may 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 was considered, reconsidered or corrected during supplemental examination.

Section 257(c)(2) carves out important exceptions, including allegations pleaded with particularity, or set out in a specified Hatch-Waxman notice, before the request was filed, and defenses in an action brought before the supplemental examination and any resulting reexamination conclude. Under § 257(e), if the Director becomes aware during the process that a material fraud on the Office may have been committed, the Director must refer the matter to the Attorney General.

Why many owners hesitate to use the procedure is discussed in why supplemental examination is less attractive after Therasense, and usage patterns in how often supplemental examination is used.

Key takeaways

• Only the patent owner may file, and information is not limited to patents and printed publications.
• Each request may include up to twelve items of information, with a detailed explanation of each.
• The Office decides within three months whether a substantial new question exists and issues a certificate.
• If reexamination is ordered, the owner cannot file a § 304 statement and no third party participates.
• Fees are substantial and change over time; check the current fee schedule.