Supplemental Examination Overview

Supplemental examination is a new proceeding created by section 12 of the America Invents Act through the addition of 35 U.S.C. § 257 titled “Supplemental examinations to consider, reconsider, or correct information.” Supplemental examination can only be requested by the owner of the patent after the patent has issued.

Any information not considered, inadequately considered, or incorrectly considered during the examination of a patent which is believed by the patent owner to be relevant may be presented to the Office in a supplemental examination. Information which may be submitted is not limited to patents and printed publication, but may include any “information believed to be relevant to the patent” (AIA § 12(a)). This could be anything from statements regarding inventorship to issues dealing with public use. Among other administrative requirements, a detailed explanation of each issue identified as well as an explanation of each document submitted, along with its relevancy, is required. While each request for supplemental examination is limited to twelve items of information, there is no restriction on the number of requests for supplemental examination that may be filed.

Upon the filing of a request for supplemental examination, the Director will determine within three months whether the information provided by the patent owner creates a substantial new question of patentability. If it does, an ex parte reexamination is ordered with the information submitted by the patent owner admissible in the reexamination proceeding. Aside from the restriction prohibiting the owner from filing a statement under 35 U.S.C. § 304, the reexamination proceeds according to ex parte reexamination procedures. If no substantial new question of patentability is found, the Office will publish a supplemental examination certificate and attach it to the patent.

Generally, a patent will not be held unenforceable on the basis of conduct relating to information that had not been considered, was inadequately considered, or was incorrectly considered in a prior examination of a patent if the information was considered, reconsidered, or corrected during a supplemental examination. There are two exceptions to this: allegations pled with particularity in a civil action or under the Federal Food, Drug, and Cosmetic Act, or allegations brought under the Tariff Act of 1930.

Key Dates

Supplemental examination became effective on September 16, 2012, and applies to any patent issued before, on, or after that date. The USPTO published the final rules on August 14, 2012.

Supplemental Examination: Final Rules

Supplemental Examination: Goals

• Statutory provision aims to provide patentees with a mechanism to immunize a patent from allegations of inequitable conduct

• Final rules designed to:

– create a process that allows for completion of the supplemental examination within the 3-month statutory time frame and for prompt resolution of any ex parte reexamination; and

– avoid a post-patent process involving large submissions of unexplained documents (like IDS practice)

Supplemental Examination: Dates

• Effective Date: September 16, 2012

• Applicability: Patent enforceable on or after September 16, 2012

Request for SE

• Request for supplemental examination may be filed only by the patent owner

• Request may be filed at any time during the period of enforceability of the patent, e.g., generally 6 years after expiration of the patent

• Third party may not request supplemental examination or participate in a supplemental examination

Filing Requirements

• Request ay be filed electronically via the Office’s dedicated Web-based interface or in paper but not by facsimile

• Identify the filing as a supplemental examination request

Contents of Request

• Identification of the patent and of each claim for which supplemental examination is requested;

• List of the items of information requested to be considered, reconsidered, or corrected;

• Separate, detailed explanation of the relevance and manner of applying each item of information to each identified patent claim;

• Summary of the relevant portions of any submitted document, other than the request, that is over fifty pages in length; and

• Fees

Items of Information

• Information must be in writing and is not limited to patents and printed publications

• Request may not include more than twelve items of information

• More than one request for supplemental examination of the same patent may be filed at any time

Standard for Supplemental Examination

• If one or more items of information raises a substantial new question of patentability (SNQ):

– ex parte reexamination will be ordered

• If an SNQ is not raised by any of the items of information:

– ex parte reexamination will be not be ordered; and

– ex parte reexamination fee will be refunded

Conclusion of Proceeding

• Supplemental examination proceeding will conclude with the electronic issuance of the supplemental examination certificate

• Certificate will indicate the result of the Office’s determination whether any item of information raises a substantial new question of patentability

Ex Parte Reexamination Following Supplemental Examination

• Ex parte reexamination regulations govern, except that:

– patent owner will not have the right to file a patent owner statement; and

– reexamination is not limited to patents and printed publications or to subject matter added or deleted during reexamination

Material Fraud

• If the Office becomes aware of a material fraud on the Office in connection with the patent under supplemental examination, then the matter will confidentially be referred to the U.S. Attorney General

• Office may take other action as set forth in 35 U.S.C. 257(e)

• Office regards “material fraud” to be narrower in scope than inequitable conduct