USPTO AIA Final Rules Provide for New Supplemental Examination Procedure and Third-Party Preissuance Submissions

The AIA created 35 USC § 257 to provide a new procedure called “supplemental examination” in an effort to provide patentees an opportunity to inoculate their patents against unenforceability arising out of certain charges of inequitable conduct (but not actual fraud). In essence, in a supplemental examination proceeding, the patentee requests that the USPTO consider, reconsider, or correct information believed to be relevant to the patent. The USPTO either agrees that there is a substantial question of patentability and orders an ex parte reexamination, or the USPTO finds that there is no substantial question of patentability and the matter is closed. As of September 16, 2012, supplemental examination may be requested on any patent, including those patents granted before September 16, 2012.

For a review of the final rules governing the new patent trial proceedings (including inter partes review and post-grant review) and/or for a review of other key provisions relating to an assignee’s ability to file and prosecute patent applications as well as other key AIA changes, please see the August 14, 2012 Legal News Alerts available here and here, respectively.

Supplemental Examination

Rules specific to supplemental examination are codified at 37 CFR § 1.601, et seq., Subpart E. The rules take effect on September 16, 2012. Notable rules include:

• Who may file: The request for supplemental examination of a patent must be filed by the owner(s) of the entire right, title, and interest in the patent. (§ 1.601(a)) Third parties are prohibited from participating in the proceedings. (§ 1.601(b)) 
• Time for filing: A request may be filed at any time during the period of enforceability of the patent. (§ 1.601(c)) This period may include up to six years after the expiration date of the patent. 
• Fee: The fee for filing the request is initially set at $5,140. (§§ 1.20(k)(1), 1.610(a)) The requestor also must pay the fee for the ex parte reexamination that may be ordered as a result of the supplemental examination. This fee is initially set at $16,120. (§§ 1.20(k)(2) and § 1.610(a)) Additional fees apply if the request is more than 20 pages and more than 50 pages in length. (§ 1.20(k)(3)) The ex parte reexamination fee is returned if reexamination is not ordered. (§ 1.26(c)) 
• Items of information: Each request may include up to 12 items of information that are requested to be considered, reconsidered, or corrected. The items of information include any document believed to be relevant to the patent. Unlike traditional reexamination proceedings, items of information are not limited to patents and printed publications and may address issues of patentability under 35 USC §§ 101 and 112.

Items must be submitted in writing. Therefore, to have any audio or video recordings considered, a written transcript must be provided. (§ 1.605) Further, if any items of information are longer than 50 pages, the requester must include a summary of the relevant portions (§ 1.610(b)(8)).

The USPTO notes that if the patentee wants to obtain consideration of more than 12 items, more than one request for supplemental examination may be filed for the same patent.

• Content of request: The request must include the fees as set forth above. The request also must list the items of information; list any other post-patent USPTO proceedings; identify each claim for which supplemental examination is requested; provide a detailed explanation of relevance and manner of applying each item of information to each claim for which supplemental examination is being requested; include a copy of the patent; include a copy of each item of information; provide a summary of relevant portions of any submitted document more than 50 pages in length; and identify the owner(s) of the entire right, title, and interest in the patent. (§ 1.610) 
• Incomplete request: The filing date of the request will not be granted if the request does not comply with the rules. If the request is deemed incomplete, the patent owner will have a specified timeframe to remedy the deficiencies. If the patent owner does not comply timely with the notice, a refund of the ex parte reexamination fee will be awarded. (§ 1.610(d)) The filing date of the request may be critical, because supplemental examination only is effective to shield a patent from unenforceability if the request for supplemental examination is made before an allegation of unenforceability is raised with particularity in a civil action or in an Abbreviated New Drug Application Paragraph IV certification notice letter, or if the supplemental examination and any reexamination are concluded before inequitable conduct is raised as a defense in a patent infringement or Section 337 action. 
• Proceeding: Within three months after the filing date of the request for supplemental examination, the USPTO will determine whether a substantial new question of patentability affecting any claim has been raised. The patent owner must keep the USPTO apprised of any prior or concurrent post-patent USPTO proceedings. (§ 1.620(d)) Interviews are prohibited during the supplemental examination, as are amendments. The USPTO retains the right to hold in abeyance any petition or other paper filed in a supplemental examination proceeding until after the proceeding is concluded. If it is found during a reexamination issued in conjunction with a supplemental examination that a material fraud has been committed on the USPTO, the USPTO will refer the matter to the U.S. Attorney General. (§ 1.620) 
• Conclusion of supplemental examination: The supplemental examination proceeding will conclude with the electronic issuance of a supplemental examination certificate. The certificate will indicate the result of whether a substantial new question of patentability was raised. If raised, an ex parte reexamination of the patent will be ordered under 35 USC § 257. If not, the supplemental examination certificate will say so and the reexamination fee will be refunded. Any ex parte reexamination will be conducted largely as set forth in §§ 1.530 – 1.570, except the patent owner will not have a right to file a statement and the reexamination may be conducted on the basis of any item of information (not just patents and printed publications).

Third-Party Submissions

The AIA added new 35 USC § 122(e) to facilitate the ability of third parties to bring relevant information to the attention of the USPTO. The final rules package relating to third-party submissions was published on July 17, 2012. The rules take effect on September 16, 2012 and apply to any pending application in which the timing requirements can be satisfied. The final rules add 37 CFR § 1.290 and modify the current protest procedures in § 1.291. Notable provisions include: 

• Who may file and what may be filed: A third party may submit any patents, published patent applications, or other printed publications of potential relevance to the examination of an application. (§ 1.290(a)) There is no requirement that the cited patents or printed publications be prior art, or be new to the record. Further, there is no requirement to identify the third party making the submission and no requirement to provide notice to the applicant. Third-party submissions are not available for reissue applications. 
• Timing for submission: The submission must be filed earlier than (i) the date of the notice of allowance or (ii) the later of six months after the date of publication or the date of the first rejection on the merits. (§ 1.290(b)) Thus, a third-party submission can be made in any pending application for which a first rejection on the merits or notice of allowance has not yet been issued. 
• Submission: The submission must be in writing and must include the following: a list identifying the documents being submitted; a concise description of the relevance of each item in the list; a legible copy of each item in the list; an English translation of any non-English language item on the list; a statement that the party submitting does not have a duty of disclosure with respect to the application and that the request is proper; and the fee. (§ 1.290(d)) Other nominal requirements must be satisfied, but are not further elaborated upon here. 
• Fee: The fee is set forth in § 1.17(p) and is currently set at $180 for every 10 items. There is no fee for submitting less than three items so long as the submission is accompanied by a statement that the party making the submission, after reasonable inquiry, believes that the current submission is the first and only submission made by the party or a party in privity with the party.

For additional information, see:

USPTO Issues Final Rules Establishing Post-Grant Trial Procedures Under the AIA

USPTO’s AIA Final Rules Permit Assignee Filing, Late Inventor Declarations, and Simplify Other Requirements

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Legal News Alert is part of our ongoing commitment to providing up-to-the-minute information about pressing concerns or industry issues affecting our clients and colleagues. If you have any questions about this Alert or would like to discuss the topic further, please contact your Foley attorney or the following:

Lorna L. Tanner
Partner, Chemical, Biotechnology & Pharmaceutical Practice
Palo Alto, California
650.251.1104
[email protected]