2816 Determination on the Request [R-07.2022]

I. GENERAL GUIDANCE

35 U.S.C. 257(a) and 37 CFR 1.620(b) require that, within three months following the filing date of a request for supplemental examination, the Office will determine whether a SNQ affecting any claim of the patent is raised by any of the items of information properly presented in the request. The standard for determining whether an item of information properly submitted as part of the request raises a SNQ will be the same as the standard set forth in the MPEP § 2242 for ex parte reexaminations filed under 35 U.S.C. 302: i.e., whether there is a substantial likelihood that a reasonable examiner would consider the item of information important in determining patentability. See MPEP §§ 2816.02 and 2242.

The determination of whether such an item of information raises a SNQ will generally be limited to a review of the item(s) of information identified in the request with respect to the identified claim(s) of the patent. For example, a determination on a request that includes three items of information, where each item is requested to be considered with regard to claim 1, will generally be limited to whether any of the three items of information raise a SNQ with respect to claim 1. If the patent owner wishes to request consideration of an item of information with respect to multiple claims of the patent, the request for supplemental examination must include an identification of each claim in view of which the item of information is to be considered, and the required detailed explanation with respect to each claim. For example, if the patent owner fails to request that the Office consider certain claims in view of an item of information, then the patent owner is not entitled to a determination for that item of information with respect to those claims. The determination will be based on the claims in effect at the time of the determination. See MPEP § 2816.01. The supplemental examination certificate, which contains the results of the determination of whether a SNQ was raised by one or more of the items of information submitted as part of the request, will become a part of the official record of the patent.

II. TREATMENT OF REQUEST WHEN LITIGATION IS COPENDING

The patent owner may wish to consider the provisions of 35 U.S.C. 257(c)(1) and 35 U.S.C. 257(c)(2) on the effectiveness of any supplemental examination on already pending litigation when determining whether and when to file a request for supplemental examination. The Office takes no position on this issue.

The patent owner must promptly notify the Office of any federal court decision involving the patent.

A.Litigation Search

Before making a determination on the request for supplemental examination, a litigation search from the Technical Support Staff (TSS) of the Central Reexamination Unit (CRU) or the Scientific and Technical Information Center (STIC) may be done to check to see if the patent has been, or is, involved in litigation. A copy of the litigation search is scanned into the IFW file history. In the rare instance where the record of the supplemental examination proceeding or the litigation search indicates that additional information is desirable, guidance for making an additional litigation search may be obtained from the library of the Office of the Solicitor.

If litigation has concluded or is taking place in the patent on which a request for supplemental examination has been filed, or if the examiner discovers, at any time during the supplemental examination proceeding, that there is litigation or that there has been a federal court decision on the patent, the request must be promptly brought to the attention of the Central Reexamination Unit (CRU) Supervisory Patent Reexamination Specialist (SPRS) or Technology Center (TC) Quality Assurance Specialist (QAS), who should review the decision on the request and any examiner’s action to ensure that it conforms to current Office policy and guidelines set forth below.

B.Supplemental Examination With Concurrent Litigation Prior to Federal Court Decision

In view of the statutory mandate to make the determination on the request within three months, the determination on the request based on the record before the examiner will be made without awaiting a decision by the federal court. It is not realistic to attempt to determine what issues will be treated, or what issues will be finally decided, by the federal court prior to the court decision. Accordingly, the determination on the request will be made without considering the issues allegedly before the court. If an ex parte reexamination is ordered under 35 U.S.C. 257, the reexamination will continue until the Office becomes aware that a court decision has issued. At such time, the reexamination proceeding ordered under 35 U.S.C. 257 will be reviewed in accordance with the guidelines set forth in MPEP § 2286.

C.Federal Court Decision Issues After Request Filed But Before Supplemental Examination Certificate Issues

A non-final federal court decision concerning a patent under supplemental examination will have no binding effect on the Office’s determination whether a substantial new question of patentability has been raised in a supplemental examination proceeding. A non-final holding of claim invalidity or unenforceability (or, for that matter, a non-final holding of claim validity or enforceability) will not be controlling on the question of whether a substantial new question of patentability is present. A final federal court decision, i.e., after all appeals, which upholds the validity of one or more of the patent claims also has no binding effect on the supplemental examination proceeding. See, e.g., Ethicon v. Quigg, 849 F.2d 1422, 7 USPQ2d 1152 (Fed. Cir. 1988), in which the court states the Office is not bound by a court’s holding of patent validity. While the Office may accord deference to factual findings made by the court, the determination of whether a substantial new question of patentability exists will be made independently of the court’s decision on validity as it is not controlling on the Office. See, e.g., In re Swanson et al., 540 F.3d 1368, 1378 (Fed. Cir. 2008), where the Federal Circuit approved of the Office’s interpretation in MPEP § 2242. See MPEP § 2286 for further guidance.

A final holding of claim invalidity or unenforceability (after all appeals) is controlling on the Office. In such cases, a substantial new question of patentability would not be present as to the claims held invalid or unenforceable. This policy tracks the Office’s policy for ex parte reexamination. See, e.g., MPEP § 2286, citing Ethicon v. Quigg. The Office will not intentionally conduct supplemental examination of patent claims which have been finally held to be invalid or unenforceable by a federal court.

If it is brought to the Office’s attention that a federal court has issued a final holding of invalidity or unenforceability, any claims which are finally held invalid or unenforceable, and for which supplemental examination has been requested, will not be examined. If only some of the claims requested to be examined have been finally held invalid or unenforceable, the examiner will indicate, in the Reasons for Substantial New Question of Patentability Determination which accompanies the supplemental examination certificate (see MPEP § 2816.03, subsection II), which requested claims were not under supplemental examination due to the final holding of invalidity or unenforceability. If all of the claims requested to be examined have been finally held invalid or unenforceable, the Office will not conduct the supplemental examination. If a filing date has been granted, it will be vacated by the Office. If it is brought to the Office’s attention that, prior to the issuance of the supplemental examination certificate, a federal court has rendered a final decision, i.e., after all appeals, holding that all of the patent claims under supplemental examination are invalid or unenforceable, and if a supplemental examination certificate has inadvertently issued, the supplemental examination certificate will be vacated.

If a final federal court holding of invalidity or unenforceability is rendered after the date of electronic issuance of the supplemental examination certificate in the Office’s electronic Image File Wrapper system (IFW) and in Patent Center (see MPEP § 2817.01), the supplemental examination certificate will not be vacated. If reexamination has been ordered as a result of the supplemental examination proceeding, and if a final holding of invalidity or unenforceability is brought to the Office’s attention, claims which are held invalid or unenforceable will be withdrawn from consideration in the reexamination. If all of the claims being examined in the reexamination proceeding are finally held invalid or unenforceable, the reexamination will be terminated by the CRU or TC Director as no longer containing a substantial new question of patentability. See MPEP § 2286, subsection IV for further guidance.