Supplemental Examination (SE) was created by 35 U.S.C. § 257 of the America Invents Act and is now over 12 years old. SE provides a patent owner with a mechanism to request that the Patent Office (Office) consider, reconsider, or correct information that may be relevant to patentability, and in some situations to cleanse the patent from inequitable conduct issues so long as they had not yet be raised in district court. But SE offers so much more to patent owners. Yet for many practitioners and patent owners, SE remains an unknown, misunderstood, or overlooked procedure.
Briefly, any patent owner may file a request for SE with up to 12 items of information for the Office to consider. The Office’s Central Reexamination Unit (CRU) decides whether or not one or more of the submitted items raises a substantial new question of patentability (SNQ) to one or more of the patent’s claims and issues a SE Certificate communicating their findings. When an SNQ is raised, the Office orders a § 257 Reexamination (SE-Rx), which is examined by a team of CRU examiners. An expanded reexamination of the patent ensues, ultimately culminating in a Reexamination Certificate summarizing the SE-Rx outcomes.
For this article, we reviewed almost all SE requests and the submitted items of information from 2019-2024. Focusing on cases where SE-Rx’s were instituted, we considered the resultant SE-Rx’s to understand how the CRU handled those proceedings. We included Patent Trial and Appeal Board (PTAB) outcomes to get a full picture of strategic risks and benefits of filing a SE request and the potential subsequent § 257 Reexamination.
In the first four sections of this article we provide four important takeaways that emerged from our findings: a gain in acceptance by patent owners, prevalent errors for non-compliant requests, a wide variety of “items of information” are raising SNQs, and once SNQ is found, how the CRU and PTAB examine SE-Rx with a broader scope of examination as compared to traditional Rx.
Based on these findings, we end by providing some strategic considerations for choosing between SE, RE, and RX.
1. SE has gained acceptance by the patent community
To determine acceptance, we looked at the overall number of SE requests filed from the procedure’s first full year, 2013, to the last full year of available data, 2023. We then looked at the speed of the procedures.
First, as illustrated in Chart 1, initially PO’s use of SE was low with only 30 requests for SE considered by the CRU during the procedure’s first full year. The volume of SE requests steadily increased until 2017 when the CRU considered 161 SE requests. Beginning in 2018, SE request volume has remained relatively steady with 80-100 each year. We note 2021 as somewhat of a lower outlier, with 68 SE requests, and we suggest that this slight dip as likely related to Covid-19 impacts, noting that Office fiscal year 2021 numbers included October – December 2020 filings.
Office statistics separately report the number of total SE requests with an SNQ found separately from the number of SE-Rx’s ordered, with most years having slightly less SE-Rx’s ordered than SE requests with an SNQ found. We speculate this difference is caused by SE requests that raise an SNQ being determined in one Office fiscal year and then proceed to an SE-Rx Order in the subsequent fiscal year. This speculation would also account for 2021, where 54 SE-Rx’s were ordered and only 51 SEs raised an SNQ. To discount our speculation, we considered the percentage of SE-Rxs ordered in relation to the total number of SE requests filed, illustrated in Chart 2.
Consistently between 60 and 80% of SE requests result in an SE-Rx order, with three outlier years: 2019 at 54%, 2020 at 56%, and 2023 with 33%. (We also note that through the first three quarters of fiscal year 2024, only 31% of SE requests have resulted in an SE-Rx order, but it is too early to call this reduction in outcomes a “trend”).
Second, timing is often an important consideration to those practitioners and owners considering SE as an alternative to Reissue (RE) or Ex Parte Reexamination (RX). SE is very fast – on average less than 2 months – when no SNQ is raised. This speed can be very attractive to certain owners with items of information that need to be considered, but are believed unlikely to raise an SNQ against patent claims. Moreover, as Chart 3 illustrates, SE-Rx proceedings proceed slightly faster through CRU prosecution than regular RX proceedings. We believe this may be due to a number of factors including 1) patent owner’s willingness to cancel or amend claims in an SE-Rx (necessarily owner filed) contrasted with patent owner’s fighting for patentability based on claim construction arguments usually found in third-party requested RXs, and 2) the relatively low number of SE-Rx appeals compared to the number of RX appeals, probably also based on amending versus arguing, given that a PTAB appeals adds, on average, 8-12 months to proceeding time.
2. Noncompliant SE requests remain a problem
With any new proceeding, a certain number of mistakes on initial filings are to be expected as practitioners seek boundaries and learn new rules. Yet even 10 years in for the review proceedings filed over the last five years a significant number of SE requests continue to be rejected by the CRU as noncompliant with one or more requirements of 37 C.F.R. §§ 1.605, 1.610 and/or 1.615.
A non-compliant request is not given a filing date and the owner is required, via a Notice of Noncompliant Supple-mental Examination Request (NNSER) (37 C.F.R. § 1.610(d)), to correct the request within a specified time. The patent owner must submit a complete, corrected request because the Office expunges the entire originally-filed request once a corrected request is received. For this reason, a corrected request must contain all of the required information with-out reliance on any defective originally-filed request. If the patent owner does not cure the issues in the corrected filing, the SE is terminated and only the advance paid reexamination fee is refunded.
There appear to be two flavors of issues that result in non-compliance: insufficient application of each item of information to the patent claims and procedural errors, e.g., improper counting of items, excessive number of items, and improper fee calculations.
a) Insufficient application of each item of information to the patent claims
MPEP § 2802(a) notes that the “patent owner may request supplemental examination of a patent in the Office to consider, reconsider, or correct information believed to be relevant to the patent.” A patent owner must provide this information in their list of items of items of information submitted to the Office. MPEP § 2809(a) states that “[e] ach request for supplemental examination may include no more than twelve items of information believed to be relevant to the patent” (emphasis added). A patent owner must, among other requirements, identify the one or more claims to which each item is relevant to and have a “separate, detailed explanation of the relevance and manner of applying” each item to the one or more claims. (emphasis added). See MPEP § 2811(b)(5).
In our analysis of supplemental examination requests since 2019, 33 out of approximately 150 supplemental examination requests, or 22% of all initial filings, were not compliant with Office regulations. Nearly every noncompliant request failed to provide a “separate, detailed explanation of relevance and manner of applying” the item of information to at least one claim of the patent. The Office regularly noted that such noncompliant requests simply provided a general statement of relevance and had no direct citations to the relevant portions of the item. Another common scenario involved the submission of prior art and an expert declaration espousing opinion about the operation of the prior art. While the request may or may not have applied the prior art to the claims of the patent, commonly the declaration was applied to the prior art and not applied to the claims at issue in the request. Such expert declarations, and their incorporated background materials, are generally inappropriate for inclusion as an item of information in an SE request and should be reserved for submission and consideration of their probative weight after an SE-Rx has been granted and prior art actually applied to reject the claims.
b) Procedural issues: Improper counting of items, excessive number of items, and improper fee calculations
Some patent owners inadvertently cited to more than 12 items of information in their original and supplemental examination requests. While the requests themselves listed 12 or fewer items of information, many of the items and their corresponding descriptions contained references to additional materials outside of the listed items. In these instances, the Office classifies such items and any references to outside materials as separate items. For example, a declaration from a company sales executive attesting to facts surrounding a potential offer of sale of the claimed article may be entirely appropriate for submission as an item of information. However, if that declaration refers to multiple exhibits such as email communications and references sales contracts or receipts, each of those referenced exhibit materials must be separately submitted and each will separately count as one of the 12 total items of information. Similarly, the patent owner may not avoid the 12 item limit by not submitting something that is fully described within the body of the request.
Additionally, a handful of requests were noncompliant based on adding items of information which were illegible, too cumulative, and required translations.
Some requests failed to properly include appropriate fees or improperly calculate document size fees as set forth in 37 C.F.R. § 1.20(k)(3). Each item of information may be subject to document size fees, and blank pages are counted.
A summary of all these issues is found in Charts 4 and 5. Chart 4 illustrates our analysis of noncompliant requests over the past 5 years and Chart 5 illustrates the total number of noncompliant requests and the reasons for noncompliance.
As Chart 5 indicates, there has been a noticeable increase in noncompliant requests since 2019, with the Office becoming more focused on highlighting insufficient detailed explanations. The Office has emphasized that it does not want to be inundated with too many items of information in a single supplemental examination request. Nor does the Office want to guess on how the item is specifically related to the one or more claims of a patent.
Patent owners who avoid these common pitfalls can put themselves in the best position to receive a filing date for their supplemental examination request and avoiding excess legal fees in an already expensive post-issue legal procedure.
3. A wide variety of “items of information” are raising SNQs
a) Patents and printed publications
Patents and printed patent publications are perhaps the most common form in which items of information are presented. Our analysis analyzed how many times such references raised an SNQ and where the items originated from. Of course, many patent owners referred to U.S. patents and publications in their list of items of information. Additionally, patent owners also included patents and publications from outside the United States. Such patents often originated from European governing bodies and procedures, such as the EPO and Germany, potentially from prosecution, opposition, litigation, and now Unified Patent Court (UPC) proceedings. Asia also played an important role in the supplemental examination landscape, as many items were patents originating from Korea, Japan, and China and their respective proceedings.
Our analysis shows that there were 63 instances of one or more U.S. patents and patent publications cited in an owner’s list of items of information. Out of these instances, U.S. patents and printed patent publications raised an SNQ 46 times. Further, one or more non-U.S. patents and publications were cited in 49 supplemental examination requests. We noted 29 SNQs followed these requests.
b) Non-Patent Literature (NPL) and “other information”
Non-patent literature (NPL) encompasses a wide variety of materials. It can range from PTAB decisions, research articles, technical standards, declarations, and “other information.” There has been an increased focus on “other information” including declarations, internal corporate documents, adjudicative decisions, on sale bar information, etc. The Office has grouped this kind of information into the NPL landscape, despite taking an untraditional form. Nonetheless, both forms of NPL can present a significant obstacle towards patentability and, in turn, has serious implications as to whether a supplemental examination request raises an SNQ.
Our analysis shows that one or more NPL documents, in the traditional sense, were cited 43 times in a patent owner’s list of items of information. Out of these instances, traditional NPL was involved in generating a SNQ 25 times. Further, “other” forms of NPL were cited one or more times in 27 supplemental examination requests. 14 SNQs were associated with such requests.
Chart 6 below compares the number of instances in which one or more forms of prior art were presented in supplemental examination requests with the number of times SNQs resulted from the request. While our analytical process focused on the raw numbers of the types of art cited, each type of art appeared to be cited a consistent amount over the past 5 years.
4. Once an SNQ is found, the CRU and PTAB examine SE-Rx with a broader scope of examination as compared to traditional Rx
Reexamination proceedings have existed for more than 40 years. Requests for Reexamination and subsequent RX proceedings under 35 U.S.C. §§ 301-305 are limited to prior art consisting of patents or printed publications. This limitation therefore limits questions of patentability to those raised under 35 U.S.C. §§ 102 and 103. As prescribed in 37 C.F.R. § 1.552(a), “claims in an ex parte reexamination proceeding will be examined on the basis of patents or printed publications and, with respect to subject matter added or deleted in the reexamination proceeding, on the basis of the requirements of 35 U.S.C. 112.”
In contrast, SE-Rx proceedings ordered under 35 U.S.C. § 257 as a result of a SE request are not so limited. SE’s “other information” is much broader than “patent and printed publications.” If the SE-Rx is ordered, and rejections under all statutory requirements of patentability are available to CRU examiners. Another distinction is that for SE-Rx, a new prior art search is performed by CRU examiners whereas in RX, a new prior art search is generally not performed. Thus, the subsequent SE-Rx proceeding’s broader scope and implications must be considered when deciding to file an SE request as compared to a reissue or patent owner ex parte reexamination.
In our look at SE-Rx proceedings over the last five years, we noted the statutory basis of rejections entered by the CRU and took a look at appeals of SE-Rx rejections to assist patent owners considering filing SE requests.
a. Statutory basis for rejections entered by CRU
Our review indicates that the CRU examiners are extremely thorough in their examination during SE-Rx proceedings. All proceedings contained new prior art searches performed by the CRU examiner. We observed many instances of the CRU examiner supplementing the “other information” with additional prior art discovered during these new searches. We also observed at least two instances of the CRU examiner not utilizing any “other information” that was found to raise an SNQ in the SE determination, and instead relied wholly on new prior art discovered by their search.
From an in-depth analysis of over 100 SE-Rx proceedings, we found the following distribution of rejections illustrated in Chart 7.
While a few SE-Rx proceedings contained only one statutory type of rejection, most contained two types and some contained as many as six different statutory types of rejections. Unsurprisingly, 35 U.S.C § 103 rejections were the most common, followed closely by 35 U.S.C § 102 rejections and 35 U.S.C § 112(b) rejections. We noted a surprising number of 35 U.S.C. § 112(a) (written description/enablement) rejections were applied, particularly upon claim amendment. For example, in attempting to narrow the claims in response to other rejections, applicant’s often utilized language that was deemed outside the boundaries or scope of possession demonstrated by the original disclosure. Here, we noted that patent owners should pay careful attention to the terms and phrases utilized in the disclosure and amend claims precisely to avoid these rejections.
We were surprised to see 35 U.S.C. § 112(d) rejections applied on multiple occasions, indicating that the CRU Examiners pay close attention to the format and language of dependent claims. Also surprising were newly applied double patenting rejections, indicating the CRU Examiner’s thorough review of related files of the underlying patent’s extended patent family. And we noted that in at least nine proceedings, 35 U.S.C. § 112(f) (means plus function) analysis was applied during claim interpretation.
b. A quick look at SE-Rx PTAB and CAFC Appeals
As part of our analysis, we looked at all SE-Rx PTAB and Court of Appeals for the Federal Circuit (CAFC) appeals filed and decided since the inception of the proceeding.
The numbers show that the PTAB judges find little fault in the CRU’s work product and determinations. For 24 appeals, 16 were fully affirmed or affirmed-in-part. Only five appeals resulted in the Examiner’s rejection(s) being fully reversed. In three additional reversals, the PTAB entered new grounds of rejection at their own initiative.
There are few CAFC appeals, so they may not show much new information. In one appeal, the CAFC vacated the prior PTAB affirmance of an obviousness rejection comprising more than five references and remanded the SE-Rx proceeding to the PTAB for reconsideration. Upon reconsideration, the PTAB reversed the prior § 103 rejections and entered new § 103 rejections based upon applicant’s admissions from the oral hearing, and new § 112(b) rejections, before returning the file to the CRU for further prosecution. Ultimately, in that file, the Reexamination Certificate shows numerous cancelled claims, narrowing amended claims, and new narrow claim were found patentable.
We summarize some of our finding in Charts 8, 9, and 10.
Chart 8 illustrates common types of rejections being appealed from SE-Rx rejections included § 112(a) (both enablement and written description bases), § 112(b); § 102, and § 103. We also saw § 101 rejections, § 305 rejections (improper broadening), § 112(d) (improper dependent claim) rejections affirmed by the PTAB. In several instances, a decision on one or more appealed rejections was not reached as the PTAB fully affirmed the rejections of all claims based upon § 112(a) or § 112(b).
Charts 9 and 10 illustrate what technologies are being appealed and the success of these appeals. Applicants have been most dissatisfied with the examinations in CRU Art Unit 3992, which handles all electrical technologies. With 18 appeals decided, the PTAB has affirmed one or more AU 3992 Examiner rejections in 15 proceedings, or 83% of the time. The mechanical technology art unit 3993 has been affirmed in three of four appeals (75%). Only two applicants have appealed AU 3991 Examiner’s rejections. In both cases, the rejections were fully affirmed (100% affirmance rate).
5. Strategic consideration for choosing between SE, RE, and RX
Patent owners have three distinct procedures available for corrective action post-patent grant: reissue, reexamination, and supplemental examination. Each procedure has distinct requirements, timelines, advantages, and risks. Each can be used to have additional prior art or “other information” considered by the Office. Careful consideration must be given to each by assessing the risks and advantages of each procedure.
A reissue application is the only post-grant proceeding that potentially allows claim broadening when applied for within two years of patent grant. Reissue applications can be controlled by a patent owner – that is they may be abandoned and they may support the filing of a continuation or a continued examination reissues. Additional prior art or “other information” may be filed on an information disclosure statement during reissue prosecution. However, for a reissue to be proper, the patent owner must correct an “error” in the original patent and admit that the error is one that renders the patent “wholly or partly inoperative or invalid.” This may be a difficult statement for some patent owners. Reissues may not recapture subject matter surrendered during the original prosecution, including during prosecution of related applications (the patent family). Reissue may be lengthy, and the patent claims are subject to a wholly new prosecution, including a new prior art search. Reissues cannot cure inequitable conduct.
A patent owner may request a reexamination of their patent, if there is a “patent or printed publication” that raises an SNQ against at least one claim of the patent. In the request, the patent owner must detail how the patent or printed publication raises an SNQ of patentability against at least one of the patent’s claims, and usually provide narrowing amendments to overcome the SNQs. And while an SNQ of patentability is a lower threshold than a rejection’s preponderance of evidence standard, some patent owners may have discomfort admitting to patentability questions and proving proposed rejections of their claims. RX proceedings, when granted, are generally limited to the issues of the reexamination request and not subjected to additional prior art search. Potential rejections are limited to those based solely in prior art, unless the claims are amended. And like Reissues, additional prior art or “other information” may be filed on an IDS during the RX proceeding. However, once an RX proceeding is ordered, the RX proceeding must conclude with the issuance of a reexamination certificate. That is, a patent owner cannot stop the RX proceeding from going forward without giving up all the claims present in the proceedings. And like reissues, RX proceedings may be lengthy. Claims can only be narrowed during RX proceedings, and the patent owner has no right of continuation.
SE requests provide patent owners with a path for having “other information” reviewed by the Office without admission of an underlying error in the patent or assertion that the information raises an SNQ of patentability. And SEs are the only proceeding that can cleanse the patent from inequitable conduct. Because “other information” is broad, the patent owner is not restricted as to the type of information that may be cited to the Office in an SE request. This alone offers advantages over RX proceedings as it allows consideration of information that is not restricted to prior art. Another clear advantage of an SE request is speed. The Office must render a decision on an SE request within three months. When the goal is simply to have the information considered by the Office, and when the patent owner is reasonably confident that the information does not raise an SNQ of patentability or rise to the level of supporting a rejection against the claims, SE is highly advantageous. Even when SE-Rx is ordered, these proceedings move through the CRU at a slightly faster rate than RX proceedings. The patent owner must balance these advantages against the risk of an SE-Rx being ordered by the Office, because an SE-Rx has a broader scope of rejections that can be applied compared to regular RX. For the right fact pattern, SE clearly has advantages that must be acknowledged.
This article appeared in the 2024 PTAB Year in Review: Analysis & Trends report.
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