Supplemental Examination: A More Detailed Review of Procedure Including the USPTO Proposed Rules
By Eugene T. Perez and Kelly E. Rose
On January 25, 2012 the United States Patent and Trademark Office (“USPTO”) published a Notice of Proposed Rulemaking entitled “Changes to Implement Supplemental Examination Provisions of the Leahy-Smith America Invents Act” in the Federal Register.1 The proposed rules dictate a complex procedure that commands meticulous attention to the requirements as the failure to submit a complete request2 will result in a denial of a filing date.3 The procedural complexity conceived by the USPTO’s rule makers suggests that Supplemental Examination may not be as useful or worthwhile as originally predicted.4 This article seeks to explain the procedure for filing, examining, and granting requests for Supplemental Examination as provided by Section 12 of Title 35 of the Leahy-Smith America Invents Act (“AIA”)5and the USPTO’s proposed rules.
II. Procedure for Supplemental Examination Provided by Statute
The Leahy-Smith America Invents Act provides patent owners with a new post grant proceeding dubbed Supplemental Examination.6 Section 12 of the AIA amends chapter 25 of Title 35, United States Code, to add a new Section 257, allowing a patent owner to request Supplemental Examination of a patent to consider, reconsider, or correct “information” believed to be relevant to the patent in accordance with the procedures set forth by the USPTO.77 The proceeding may be an attractive option to patent owners as the information is not limited to patents and printed publication, and may include, for example, issues of patentability under 35 U.S.C. §§ 101 and 112.
Congress intended Supplemental Examination to remedy the “plague”8 that the “inequitable conduct” defense9 spawned.10 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.9 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 ex parte reexamination12 With two exceptions explicitly provided for in the statute,13 the ensuing reexamination will be identical to an ex parte reexamination.
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.14 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))15or (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.16
III. Procedure for Supplemental Examination as Proposed by the USPTO
35 U.S.C. § 257 provides that the request for Supplemental Examination must be made “in accordance with such requirements as the Director may establish.”17 Accordingly, the USPTO published proposed rules detailing the requirements of a supplemental examination request and the procedure the USPTO will follow during the request’s examination.18 A flow chart summarizing Supplemental Examination procedure can be found here.
A. Who May File
Only patent owners who can establish the entirety of the ownership interest may file a Supplemental Examination request. Third parties are barred from participating in the Supplemental Examination proceeding “in any manner.”19
B. “Items of Information”
An item of information is not limited to patents and printed publications as the information submitted may raise issues of patentability under 35 U.S.C. §§ 101 and 112.20 Up to ten (10) items of information may be included with each request.21 Should the patent owner wish to submit more than ten items of information, the patent owner may file multiple requests for Supplemental Examination of the same patent at the same time22. Each item of information must include a supporting document and must be in writing.23
35 U.S.C. § 257 does not define what type of information may be submitted. According to the USPTO, examples include a journal article, a patent, an affidavit or declaration, or a transcript of an audio or video recording.24 Other possible types of information might be an Office Action from a co-pending or foreign application, incorrect arguments of a declaration, incorrect interpretations of prior art, public sale before the critical date, litigation-related papers, small entity status wrongly claimed, and corrected experimental results.
Additionally, submitting a request without a supporting document will not allow the patent owner to avoid counting an item of information. The USPTO has made clear that if the information to be considered, reconsidered, or corrected is not contained in a supporting document, “the discussion within the body of the request relative to the information will be considered as the item of information.”25 As another example of how the counting of information will be enforced, the USPTO explained that if the patent owner presents an argument regarding a public use or sale of the claimed invention under 35 U.S.C. § 103 and also submits a supporting document with the request as possible evidence of the public use or sale (or lack thereof), the supporting document containing the possible evidence will be counted as an item of information.26
It also appears that one item of information may raise multiple issues of patentability without being counted twice.27 However, if an item of information must be combined with one or more additional items of information, for example under 35. U.S.C. § 103(a), each item of information may be counted separately.28
The fee for a Supplemental Examination request is $5,180 in addition to the $16,120 fee for ex parte reexamination and any applicable document size fees.29 Although the office will return $16,120 if ex parte reexamination is not ordered,30 the Supplemental Examination request fee, the ex parte examination fee, and any applicable document size fees must accompany the request at the time of filing.31 Thus, the minimum cost of filing a Supplemental Examination request is $21,300.32
D. Materials Included in the Request
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.d33
In addition to the filing fees, specific materials required are listed in Proposed Rules §§ 1.610(b)(1)-(12).34 Due to the numerous proposed requirements for a complete request, each requirement is listed numerically here.
- A cover sheet itemizing each component submitted as part of the request. Proposed Rule § 1.610 (b)(1).
- A table of contents. Proposed Rule § 1.610(b)(2).
- An identification of the number, the date of issue, and the first named inventor of the patent for which supplemental examination is requested. Proposed Rule § 1.610(b)(3).
- 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. Proposed Rule § 1.610(b)(4).
- A list identifying any other prior or concurrent post grant proceeding(e.g., inter partes reexamination or review) involving the patent for which Supplemental Examination is requested, the identifying number, and filing date. Proposed Rule § 1.610(b)(5).
- An identification of each “aspect of the patent.” The USPTO defines an “aspect of the patent” as including the abstract, any drawing, specification, patent claims, or benefit claims.35 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. Proposed Rule § 1.610(b)(6).
- An identification of each issue of patentability raised by the item of information. An item of information can raise multiple issues of patentability. Proposed Rule § 1.610(b)(7).
- 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. Proposed Rule § 1.610(b)(8). Note: Two subsections refine the requirements for the detailed explanation. Subsection (i) requires that the explanation must discuss the support in the specification for each limitation of each claim identified for examination with respect to issues involving 35 U.S.C. § 101 (other than double patenting) or 35 U.S.C. § 112. Proposed Rule § 1.610(b)(8)(i). Subsection (ii) requires that an explanation of how each limitation of each claim identified for examination is met or is not met with respect to issues involving 35 U.S.C. §§ 102, 103, or double patenting. Proposed Rule § 1.610(b)(8)(ii). According to the USPTO, this explanation would “preferably” contain a claim chart..36
- 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. Proposed Rule § 1.610(b)(9).
- 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. Proposed Rule § 1.610(b)(10).
- 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. Proposed Rule § 1.610(b)(11).
- 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. Proposed Rule § 1.610(b)(12).
E. USPTO Procedure Following the Filing of a Request for Supplemental Examination
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.37 If the patent owner remedies the defect such that the request complies with the requirements set forth in Proposed Rules §§ 1.605, 1.615 and 1.610(a) and (b), the filing date for the Supplemental Examination request will be the receipt date of the corrected reques.t38
Within three months of the filing date, the USPTO will determine whether a substantial new question of patentability (“SNQ”) exists.39 The standard for determining whether an SNQ exists will be the standard set forth in the Manual of Patent Examining Procedure (“MPEP”), which states that an SNQ exists when there is a substantial likelihood that a reasonable examiner would consider the item of information important in determining patentability.40 The USPTO will not permit interviews in a Supplemental Examination proceeding.41 Furthermore, no amendment to any aspect of the patent is permitted in a Supplemental Examination proceeding, however, the USPTO acknowledges that a subsequently ordered ex parte reexamination proceeding will allow a patent owner to amend.42
A Supplemental Examination proceeding will conclude when the Supplemental Examination certificate is electronically issued.43 The certificate will indicate whether any of the items of information presented in the request raise an SNQ and will be viewable by the public in the USPTO’s Public Patent Application Information Retrieval (“PAIR”) site.44 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.45 If the request does raise an SNQ, ex parte reexamination of the patent will be ordered.46
F. Ex Parte Reexamination Resulting from a Request for Supplemental Examination
The ex parte reexamination ordered under 35 U.S.C. § 257 will be 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.47
- 77 Fed. Reg. 3666 (January 25, 2012).
- Except, where the failure only concerns an omission of the cover sheet requirement in proposed rule § 1.615(b)(1) and/or the cover sheet requirement in proposed rule § 1.610(b)(2). 77 Fed. Reg. at 3671; Proposed Rule § 1.610(d).
- See Id.
- See 112 Cong. Rec. S5319 (daily ed. September 6, 2011)(Senator Kyl Remarks)(“The authorization of supplemental examination will result in path-breaking inventions being developed and brought to market that otherwise would have lingered on the shelf because of legal uncertainty over the patent.”). Available at http://www.uspto.gov/aia_implementation/20110906-kyl_rmrks_s5319.pdf (last visited May 31, 2012).
- See Public Law 112-29, Stat. 284 (2011).
- See 35 U.S.C. § 257 (2011).
- 35 U.S.C. § 257(a) (2011).
- Therasense, Inc. v. Becton, Dickinson & Co., 649 F.3d 1276, 1289 (Fed. Cir. 2011) (quoting Burlington Indus., Inc. v. Dayco Corp., 849 F.2d 1418, 1422 (Fed. Cir. 1988) (“[T]he habit of charging inequitable conduct in almost every major patent case has become an absolute plague. Reputable lawyers seem to feel compelled to make the charge against other reputable lawyers on the slenderest grounds, to represent their client’s interests adequately, perhaps.”))
- The “inequitable conduct” defense allows the defendant accused-infringer to allege that the plaintiff patent-holder would not have received a patent “but for” misrepresentations made to the USPTO. Therasense, 649 F.3d at 1295-1296.
- See Report on H.R. 1249, Background and Need for Legislation at 50, House Judiciary Committee, (June 29, 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”). Available at http://www.uspto.gov/aia_implementation/crpt-112hrpt98-pt1.pdf (last visited May 31, 2012).
- 35 U.S.C. § 257 (a) (2011).
- 35 U.S.C. § 257 (b) (2011).
- The two exceptions are: (1) The patent owner does not have a right to file a statement pursuant to 35 U.S.C. § 304; and (2) the basis of the ex parte reexamination is not limited to patents and printed publications. 35 U.S.C § 257(a) and (b); 77 Fed. Reg. 3666 (January 25, 2012).
- 35 U.S.C. § 257 (c)(1).
- i.e. 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) (2011).
- 35 U.S.C. § 257(a) (2011). Thus, to receive protection against an allegation in a civil action or an Abbreviated New Drug Act paragraph IV certification of unenforceability, the patent owner must have filed his request prior to the allegation or paragraph IV certification. To receive protection in a § 337 investigation, the Supplemental Examination and any subsequently ordered reexamination must have concluded prior to the date on which the action is brought.
- 77 Fed. Reg. at 3666.
- Proposed Rules §§ 1.601(a) and (c).
- 77 Fed. Reg. at 3668. The USPTO stated “[F]or example, transcripts of audio or video recordings.”
- Proposed Rule § 1.605(a).
- 77 Fed. Reg. at 3669.
- Proposed Rules §§ 1.605(b) and (c). Thus, for example, if an item of information is an audio recording, the patent owner must also submit a transcript of the recording. See also 77 Fed. Reg. at 3670.
- 77 Fed. Reg. at 3669.
- Id. “For example, if the patent owner raises an issue under 35 U.S.C. § 101, and the issue is wholly contained in a discussion within the body of the request and is not based . . . on any supporting document, the discussion in the request will be considered an item of information.”
- Id. at 3669-70.
- Id. at 3668. (emphasis added). In explaining why the number of items of information is limited to ten, the USPTO stated that “[T]he variety of information that is permitted to be submitted . . . is more extensive than the information permitted to be submitted in an ex parte reexamination proceeding. . . the patent owner may present one item of information that raises multiple issues in addition to those permitted to be raised in ex parte examination.”
- Proposed Rule § 1.605(d)
- 77 Fed. Reg. at 3667-68; Proposed Rules §§ 1.20(k)(1)-(3)
- 77 Fed. Reg. at 3668; Proposed Rule § 1.26(c).
- 77 Fed. Reg. at 3667; Proposed Rule § 1.610(a).
- Provided that none of the documents submitted are over 20 pages in length. See Proposed Rule § 1.20(k)(3).
- Supra at FN 2.
- 77 Fed. Reg. at 3670-71; Proposed Rule § 1.610(d) provides that the filing date of a request for supplemental examination will not be granted if the request is not in compliance with Proposed Rules §§ 1.605, 1.615, and 1.610(a) and (b). The USPTO may still grant a filing date to a defective Supplemental Examination request if the defect is limited to the omission of the cover page and/or the table of contents.
- 77 Fed. Reg. at 3570.
- 77 Fed. Reg. at 3671
- Proposed Rule § 1.610(e).
- Proposed Rule § 1.620(a).
- 77 Fed. Reg. at 3672 (citing MPEP § 2242 (8th ed. 2001) (Rev. 8, July 2010)).
- Proposed Rule § 1.620(e).
- 77 Fed Reg. at 3672; Proposed Rule § 1.620(f).
- Proposed Rule § 1.625(a).
- Proposed Rule § 1.625(c).
- Proposed Rule § 1.625(b).
- 77 Fed. Reg. at 3673; Proposed Rule § 1.625(d).