Supplemental Examination is only filed by the patent owner, and covers any “information” (e.g., not limited to submitting prior art).1 Congress intended Supplemental Examination to remedy the “plague” that the “inequitable conduct” defense spawned.2 According to § 257(c), supplemental examination would prevent the patent from being held unenforceable (in a court proceeding) on the basis of conduct relating to information that had not been considered, was inadequately considered, or was incorrect, if submitted or corrected during Supplemental Examination. As explained below, there are several differences between filing a reissue application versus pursuing Supplemental Examination.
I. The Goal of Supplemental Examination
Under this new proceeding, information that was not considered, was inadequately considered, or was incorrect can be reviewed by the USPTO upon request by the patent owner. If any of the submitted information in the request raises a “substantial new question of patentability” (“SNQ”) the USPTO will issue a Supplemental Examination certificate ordering supplemental ex parte reexamination.
At the same time, a patent subjected to a Supplemental Examination cannot 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 of the patent if the information was considered, reconsidered or corrected during a Supplemental Examination of the patent.3 What this means for the patent owner is that future accused infringers cannot assert an inequitable conduct defense concerning the information previously examined in a Supplemental Examination proceeding. However, this protection against an allegation of inequitable conduct is not without limitation; the protection does not apply where the item of information contained in the supplemental examination request is (1) already contained in an allegation pled with particularity in a civil action or is set forth in a notice received by the patent owner under § 505(j)(2)(B)(iv)(II) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 335(j)(2)(B)(iv)(II));4 or (2) the basis of a defense in an action brought under § 337(a) of the Tariff Act of 1930 (19 U.S.C. § 1337(a)) unless the supplemental examination and any reexamination ordered are concluded prior to the date on which the action is brought.5
The AIA statute does not specifically define or specify what “information” must be included. Types of possible “info” may include: Office Action from co-pending or foreign application not yet considered; previously submitted incorrect arguments of a declaration; previously submitted incorrect interpretation of prior art; public sale before critical date not earlier disclosed; litigation papers; small entity status wrongly claimed; not submitting all experimental results; etc.
III. Requesting Supplemental Examination
A request for Supplemental Examination of a patent must be ﬁled by the patent owner. Each request for Supplemental Examination is limited to the presentation of ten items of information. Supplemental Examination addresses allegations of inequitable conduct during patent litigation, which allegations typically concern far fewer than ten items of information. In addition, if a limit of ten items of information is not sufﬁcient for a particular situation, more than one request for Supplemental Examination of the same patent may be ﬁled at any time. The request for Supplemental Examination must be accompanied by the fees for processing and ex parte reexamination ordered under 35 U.S.C. 257,6 as well as any applicable document size fees.
Obtaining a filing date is crucial to receiving the protection afforded by 35 U.S.C. § 257(c)(2)(A); however, the USPTO will not record a filing date to the request until all required materials are submitted. A request for supplemental examination must meet certain content requirements. Speciﬁcally, the request for supplemental examination must include:
- A cover sheet itemizing each component;
- A table of contents;
- An identification of the number, the date of issue, and the first named inventor of the patent for which supplemental examination is requested;
- A list of each item of information that is requested to be considered, reconsidered, or corrected, and the publication date for each item of information; additionally, a statement must accompany each item of information explaining why the consideration, reconsideration or correction is being requested;
- A list identifying any other prior or concurrent post grant proceeding (e.g., inter partes review) involving the patent for which Supplemental Examination is requested, the identifying number, and filing date;
- An identification of each “aspect of the patent” (including the abstract, any drawing, specification, patent claims, or benefit claims) (if a claim identified for examination includes a mean-plus-function or step-plus-function element, the request must identify the structure, material, or acts in the specification that correspond to each means-plus-function or step-plus-function element);
- An identification of each issue of patentability raised by the item of information. An item of information can raise multiple issues of patentability;
- A detailed explanation for each identified issue of patentability; the explanation must include a discussion regarding how each item of information is relevant to each aspect of the patent and how each item of information raises each issue identified for examination;
- A copy of the patent, any disclaimer, certificate of correction, certificate of extension, Supplemental Examination certificate, post-grant review certificate, inter partes review certificate, or ex parte review certificate issued for the patent;
- A copy of each item of information and a written English translation of all of the necessary and pertinent parts of any non-English language documents (copies of U.S. patents and U.S. patent application publication are not required);
- A summary of the relevant portions of any submitted document (including patent documents) that is over 50 pages in length (the summary should include citations to the particular pages of the relevant portions); and
- A submission by the patent owner in compliance with 37 C.F.R. § 3.73(b) establishing the entirety of the ownership in the patent requested to be examined.
If the Supplemental Examination request is defective, the USPTO will notify the patent owner and afford him an opportunity to remedy the defect within a specified time.
Within three months of the filing date, the USPTO will determine whether a SNQ exists. An SNQ exists when there is a substantial likelihood that a reasonable examiner would consider the item of information important in determining patentability. This is a relatively lower standard, and even lower than the prima facie case of unpatentability standard. In other words, it is possible that a SNQ is found, but the claims are confirmed as patentable/allowable since the prima facie standard was not met.
V. Supplemental Ex Parte Reexamination and Conclusion
The ex parte reexamination is ordered if an SNQ is found, and reexamination is identical to normal ex parte reexamination with several exceptions: (1) the patent owner will not have a right to file a statement pursuant to § 1.530; (2) reexamination of any aspect of the patent may be conducted on the basis of any item of information, not just patents and printed publications; (3) issues other than those raised by patents and printed publication s and subject matter deleted during an ex parte reexamination may be raised and resolved; and (4) information material to patentability will be defined by § 1.56(b) for the purposes of a Supplemental Examination proceeding, and any resulting ex parte reexamination.
If the request does not raise an SNQ, ex parte reexamination will not be ordered and the ex parte reexamination fee paid with the filing of the request will be refunded.
A Supplemental Examination proceeding will conclude when the Supplemental Examination certificate is electronically issued. The certificate will indicate whether any of the items of information presented in the request raise an SNQ.
- See Leahy-Smith America Invents Act, Pub. L. No. 112-29, § 12, 125 Stat. 284, 325 (2011).
- See H.R. Rep. No. 112-98, pt. 1, at 50 (2011) (“The Act addresses the inequitable conduct doctrine by authorizing supplemental examination of a patent to correct errors or omissions in proceedings before the Office”).
- 35 U.S.C. § 257(c)(1).
- For example, if the information is contained in a generic drug company’s abbreviated new drug application paragraph IV certification supporting the generic’s claim that the brand manufacturer’s patent is invalid or unenforceable.
- 35 U.S.C. § 257(c)(2)(A) and (B).
- Currently at $16,500 if ex parte reexamination is granted. See 37 C.F.R. 1.20(k) (through May 9. 2013).