Supplemental Examination

Supplemental examination was created by the America Invents Act, effective September 16, 2012, partly in response to the stricter inequitable-conduct standard after Therasense v. Becton Dickinson (Fed. Cir. 2011).

What it is

The patent owner submits information, such as prior art, test data, or corrected statements, that may be relevant to the patent. The Office decides within three months whether the information raises a substantial new question of patentability (§ 257(a)).

• If no SNQ is found, a supplemental examination certificate issues and the process ends.
• If an SNQ is found, the Office orders ex parte reexamination (§ 257(b)), and the patent owner must be ready to defend the claims.

Why owners use it

Under § 257(c)(1), a patent cannot be held unenforceable on the basis of conduct relating to information that had not been considered, was inadequately considered, or was incorrect in an earlier examination, if that information was considered, reconsidered or corrected during supplemental examination. The protection is subject to the exceptions below.

Exceptions

The protection in § 257(c)(1) does not apply to:

• Earlier allegations (§ 257(c)(2)(A)): an allegation pled with particularity in a civil action, or set out with particularity in a Paragraph IV notice received under the Food, Drug, and Cosmetic Act, before the date of the supplemental examination request.
• Enforcement actions filed too soon (§ 257(c)(2)(B)): in an infringement action under 35 U.S.C. § 281 or an ITC action under Section 337, a defense based on the information considered, unless the supplemental examination and any resulting reexamination concluded before the action was brought.
• Fraud: the statute preserves the Office’s ability to refer material fraud to the Attorney General (§ 257(e)).

Practical limits

• The number of items of information per request is capped by the rules; check 37 C.F.R. § 1.605 for the current limit.
• A request that triggers reexamination exposes the claims to rejection without the owner controlling the outcome.
• Requests are published in the file, so consider the strategic effect on litigation.

For third-party options see ex parte reexamination; to correct errors in the claims themselves, see reissue.