Pre-Issuance Patent Submissions- A New Way to Participate in Patent Prosecution
Pre-issuance patent submissions, also sometimes referred to as third-party submissions, provide a means for a third party to submit potentially relevant prior art or other documents to the United States Patent Office (USPTO) to be considered during the prosecution of a pending patent application. This procedure is believed to be a means to improve patent quality by allowing third parties who may have expertise in technology fields to assist the USPTO examiners in locating relevant prior art early in prosecution. Since becoming effective on September 16, 2012, there were approximately 90 submissions, and as of December 15, 2012, over 250 submissions have been made. These statistics indicate that the process is actually being used. Submissions have been made within a variety of classifications; however, the highest number of submissions has been made in TC 3700, which is a software-specific classification within the USPTO.
Overview of the Pre-Issuance Patent Submission Process
In order to evaluate the pros and cons of and best practices for making pre-issuance submissions, one must first understand how the process works, particularly what submissions may be made, when they may be made, and how to make a submission in compliance with the statute. Section 8 of the America Invents Act authorizes any member of the public, including private individuals and corporate entities, to submit potentially relevant publications with respect to any application filed after September 16, 2012, as well as for applications already on file with the USPTO that are pending as of that date. This process may be employed with respect to examination of any non-provisional utility, design or plant application, as well as any continuation-type application. The process may still be employed even if the application to which the submission is directed has been abandoned or has not been published.
A. Types of Submissions
The statute does not restrict the types of publications that may be submitted. Of course, patents and other traditional printed publications may be submitted. Submissions also may include patents or printed publications that were already of record. Such a case would arise where, for example, the patent or printed publication was a part of the examination of the parent application and was submitted for consideration in the examination of a continuation application as part of an Information Disclosure Statement (“IDS”). These particular pre-issuance submissions can be particularly helpful to third parties if it is believed that the examiner is likely to miss a relevant feature of the reference or if a key issue in the reference was left unaddressed in an earlier filed application. It also may be possible to submit emails or other internal correspondence under this Section.
The statute calls for the submission of any printed publication “of potential relevance to the examination of the application.” As such, pre-issuance submissions are not restricted to just issues of novelty and non-obviousness. For example, a dictionary definition may be submitted to address a definiteness issue; a related parent patent application may be submitted to address a new matter issue; or a court decision may be submitted to address a patentable subject matter issue. Some have even questioned whether an expert could prepare a report to submit to the USPTO to address an enablement question or whether third-party postings on its own website(s) may constitute a proper publication that may be submitted to the USPTO. While it remains to be seen the reach of third-party submissions, the USPTO has defined some parameters in the interim. In particular, the USPTO has suggested that it will not accept materials created and published for the sole purpose of challenging a pending patent application.
B. Concise Description Requirement
Any items that are submitted as part of a pre-issuance submission must be accompanied by a concise description of the asserted relevance of each item that is identified in the submission. The most likely reason for a pre-issuance submission being found to not comply with the statutory requirements relates to the concise description requirement. As such, the USPTO has provided guidelines/tips for ensuring compliance. A concise description of relevance should set forth facts explaining how a particular printed publication is of potential relevance to the examination of the application in which the submission has been filed. This is done, most effectively, by (i) pointing out relevant pages or lines of the respective printed publication where the relevant issues raised by the text are located; and (ii) providing a focused description of the import of the cited text to draw the examiner’s attention to the issues. The concise description may be presented in narrative or claim chart form.
A compliant concise description in narrative form may state the following:
Publication X and Publication Y both disclose machines that perform the same function as the machine recited in claim 1. The machine set forth in Publication X includes many of the same parts discussed in the specification of this application. In the first embodiment depicted in Figure 2 and discussed on page 5, Publication X expressly teaches a machine that includes element A of claim 1. See lines 7-14 on page 5 of Publication X. Publication Y teaches a machine having element B of claim 1. See lines 1-3 on page 6 of Publication Y. Publication Y further teaches the benefits of using element B in this type of a machine.
Alternatively, a concise description in claim chart form may map various portions of a submitted document to different claim elements. When a pre-issuance submission is filed electronically via the EFS-Web system, a concise description of relevance may be entered as text in the provided text box on the “Application Data” screen. Alternatively, the concise description of relevance may be uploaded as a separate document on the “Attach Documents” screen. When entering a concise description of relevance in the provided text box, up to 250 characters may be entered. A concise description of relevance that exceeds 250 characters must be uploaded as a separate document on the “Attach Documents” screen. When filed as a separate paper, the concise description of relevance should clearly identify the printed publication to which it pertains. While a concise description of relevance does not have to be provided as a separate paper, the USPTO highly recommends this practice to ensure that the screener and the examiner may readily identify and consider it.
A concise description of relevance does not permit third parties to submit arguments against patentability or set forth conclusions regarding whether one or more claims are patentable. A concise description of relevance likewise is not an invitation for a third party to propose rejections of the claims or set forth arguments relating to an Office Action in the application or to an applicant’s reply to an Office Action in the application. Further, merely annotating or highlighting the copy of a particular printed publication will not be deemed a proper concise description of relevance. Additional information on the concise description of relevance requirement can be found in the listing of Frequently Asked Questions available at http://www.uspto.gov/aia_implementation/faq.jsp#heading-12.
C. When to Make Submission
Pre-issuance submissions must be filed in a patent application before the date a Notice of Allowance under 35 U.S.C. § 151 is mailed. The USPTO will not consider submissions made after the Notice of Allowance is mailed. Furthermore, pre-issuance submissions must be filed before the date the first office action rejection is mailed in the application or within six (6) months from the publication of the application. The timing standard related to the publication of the application is set to allow for pre-issuance submissions to be made in examinations in which there may be a first action allowance or other quick action by the USPTO. It is important for patent applicants to keep in mind that the filing of a request for continued examination (“RCE”) cannot prevent pre-issuance submissions from being made, if the filing would otherwise could be made within these set time periods.
D. Costs Associated With Submission
A third party must submit a fee of $180 for every ten items or fractions thereof identified in the submission. Accordingly, a third party that files a pre-issuance submission identifying ten (10) items would be required to submit a fee of $180, while a third party that files a pre-issuance submission identifying eleven (11) items would be required to submit a fee of $360. The appropriate required fee must be paid when the pre-issuance submission is filed. However, a third party filing a submission containing three (3) or less items is exempt from paying a fee, provided it is the party’s first pre-issuance submission for that particular application and the party files a “first and only” statement. A third party who files a pre-issuance submission identifying not more than three items and takes advantage of the fee exemption may file a subsequent pre-issuance submission if the need for the subsequent submission was not known at the time of the earlier submission. Nevertheless, the subsequent submission will not qualify for the fee exemption. As indicated by the fee schedule, the relative costs associated with pre-issuance submissions are minimal for fewer items and thus, are designed to encourage the submission of the most relevant documents that are the most likely to assist in the examination process. While the higher costs assessed against pre-issuance submissions identifying greater numbers of items most probably will not deter many, as is usually the case, third parties may be cautioned against filing submissions containing large numbers of irrelevant art as their credibility and reputation with the USPTO could be called into question.
E. How to File and Anonymity of Process
Pre-issuance submissions may be made either electronically or via paper, and they may be submitted anonymously. This is true even if the pre-issuance submission is made electronically. Thus, this may be advantageous for third-party competitors in that they do not have to reveal their interest in the prosecution to either the USPTO or the applicant. The third party also has no requirement to serve the applicant with its pre-issuance submission. Rather, a compliant pre-issuance submission will be made available via the submission’s entry in the image file wrapper record of the application. Additionally, the USPTO will provide direct notification to the applicant if the applicant participates in the USPTO’s e-Office Action program. When an applicant is provided with notice that a third-party submission has been made, the USPTO is including the following statement:
A third-party submission under 37 CFR 1.290 has been filed on [DATE], and is being entered in the above-referenced application. Please allow a few days for the submission to be visible in the Patent Application Information Retrieval (PAIR) system. Note that the submission will be identified using the “Information Disclosure Statement Filed” Document Description. This Document Description is being used for the internal purposes only. The Office does not consider the submission to be an Information Disclosure Statement under 37 CFR 1.97 and 1.98.
Based on this statement, it is unclear whether the USPTO is actually requiring an applicant to formally submit an information disclosure statement identifying the references included in the third-party submission or if the examiner is considering the references but just wants to make clear that it is not truly an information disclosure statement.
Making a Compliant Pre-Issuance Submission
Under 35 USC § 122(e), pre-issuance submissions must comply with several requirements for entry in the record of a pending patent application. The submission must:
Identify the publication(s), or portion(s) of the publication(s) submitted.
Provide a concise description of the asserted relevance of each item identified in the submission.
Include a legible copy of each item identified in the submission, other than U.S. patents and U.S. patent application publications.
Provide an English language translation of any non-English language item identified in the submission.
Include a statement by the party making the submission that:
The party is not an individual who has a duty to disclose information with respect to the application under 37 CFR § 1.56; and
The submission complies with 35 U.S.C. § 122(e) and 37 CFR § 1.290.
Submit any required fee, or a statement that the fee exemption applies to the submission.
Pre-issuance submissions found to be non-compliant under the requirements set forth in 35 U.S.C. § 122(e) and 37 CFR § 1.290, will not be entered into the image file wrapper record of the application, nor will such submissions be considered by the examiner. Rather, non-compliant submissions will be discarded prior to substantive review. No amendments to correct non-compliant submissions will be accepted. Perhaps more importantly, non-compliant submissions will not toll the statutory time period for making a third-party submission. The USPTO will accept new complete submissions, assuming the new filing is compliant and the statutory time period for filing a submission is not closed. It also is important to keep in mind that the USPTO will notify a third party if its pre-issuance submission is found to be non-compliant, if and only if, the third party provided the USPTO with its e-mail address when the pre-issuance submission was filed, whether filed electronically or in paper. The USPTO will notify the third party of the submission’s non-compliance, along with the reason(s) for non-compliance. As an added incentive to ensure the compliance of one’s pre-issuance submission, a third party whose pre-issuance submission is found to be non-compliant must re-submit any required fees when re-submitting the pre-issuance submission. As any fee exemption is applicable only to the third party’s first pre-issuance submission, a party having been exempt from the required fee during the first non-compliant filing must submit the required fee during the re-submission of the filing even if the art being submitted is the same.
As previously mentioned, while most of the submissions made thus far have been found to be compliant with statutory requirements, and accordingly entered into the prosecution record, the most common reason for non-compliance has been an improper concise description of relevance. Further, to lessen the likelihood of making non-compliant submissions, the USPTO encourages third parties to file pre-issuance submissions electronically using the USPTO’s dedicated web-based interface, which walks third parties through the submission process, as opposed to filing in paper form.
Pros and Cons of Making Pre-Issuance Submissions
Pre-issuance submissions may be an inexpensive helpful tool for concerned third parties to actively watch and participate in a competitor’s patent prosecution, to a degree not previously permitted in the USPTO. Through effective use of this process, it may be possible to limit the patent scope of a competitor’s pending patent application by introducing prior art. Although arguments cannot be presented as to why claims should be rejected, comments may be made directing the examiner to key portions of submitted items, along with their relevance to the application. While a double-edged sword (discussed below), compliant pre-issuance submissions will be listed on the face of the patent, if the patent later issues. This fact could be helpful with respect to claim construction, if the issued patent is later the subject of patent litigation. The pre-issuance submission mechanism is not meant to create estoppel. A third party that files a pre-issuance submission identifying certain prior art is not precluded from presenting other prior art. In fact, the same third party may even strategically reserve other prior art for post-grant challenges. Other possible advantages to filing a pre-issuance submission include, an early determination of risk, a lower burden of proof than if presented at trial, and even possible avoidance of patent litigation all together.
A possible drawback to making pre-issuance submissions is that a broad patent might still issue, despite the filing of a pre-issuance submission(s). Strategically then, when determining whether or not a pre-issuance submission should be filed, it is important to at least consider the implications of: (1) having the relevant printed publication(s) listed on the face of the patent, but not cited by the examiner in an Office Action; or (2) having the relevant printed publication(s) listed on the face of the patent and cited by the examiner in an Office Action, but where the reference is overcome by the applicant’s arguments. It may be more difficult to challenge the patent in later proceedings with the same art, as presumption is the patent issued in spite of the examiner’s consideration of the prior art. Furthermore, once the pre-issuance submission is filed, there is no process whereby the third party can readdress the references if not cited by or not fully applied by the examiner, or rebut any arguments or claim amendments presented by the applicant. The third party’s next opportunity to tackle the issue would be during a post-grant challenge, during which time attempting to invalidate the patent based on the same art used in the prosecution still may be difficult. Additionally, it is possible that the applicant may prosecute the patent application more vigorously knowing that third parties are watching and have a vested interest in the prosecution. This may result in the applicant amending the scope of claims to get an allowance and filing and prosecuting divisional, continuation and continuation-in-part applications. Other possible disadvantages of filing pre-issuance submissions include, the risk of retaliatory competitor action and the time, effort and costs required to monitor competitive patent filings.
Examples of Disadvantages of Filing Pre-Issuance Submissions
While it is not possible to discuss the actions taken in each of the many different applications where third-party submissions have been made, several examples provide some guidance as to how the USPTO is handling these third-party submissions.
U.S. Patent Application No. 12/829,968 is an application filed by Alcon related to an implantable remote monitoring sensor that first published on January 5, 2012. On September 17, 2012 (the first day after third-party submissions were first permitted to be filed), a third-party submission was made identifying a German patent publication and a U.S. patent and alleging that these references anticipated the invention. As the third-party submission complied with the statutes, the USPTO provided the applicant with notice of the third-party submission on September 25, 2012 (approximately 8 days after the third-party submission was made). Then, on November 15, 2012, the USPTO issued a non-final office action rejecting the applicant’s claims for anticipation based on the German patent publication identified in the third-party submission. While there is some symmetry between the third-party submission and the rejection made in the non-final office action, it is interesting to note that the analysis constituting the rejection did not match up with the claim chart contained in the third-party submission. The applicant’s deadline to respond to the outstanding office action has not yet so it is unclear how the applicant will respond to the rejection or whether the application will ultimately be allowed.
U.S. Patent Application No. 13/460,635 is a continuation application related to an indoor greenhouse where a non-final office action issued (August 13, 2012) before the application published (August 23, 2012); however, both of these activities occurred before third-party submissions were permitted. On October 5, 2012, a third-party submission was made identifying 8 publications, and the third party submitted a document setting forth a paragraph-long concise description of relevance as well as an identification of the claim elements allegedly taught with respect to each of the publications. The applicant was notified of the third-party submission on October 17, 2012. The applicant conducted an interview with the examiner, and the application was allowed following the interview. As a non-final office action was pending at the time of the third-party submission, it is unclear the extent to which the references identified in the third-party submission affected the examiner’s evaluation of the application.
U.S. Patent Application No. 13/465,789 presents a somewhat unique way where an applicant has handled a third-party submission. On September 27, 2012, a third-party submission was filed identifying a single patent and providing a claim chart, and the applicant was notified of the submission on October 9, 2012. The applicant then elected to file a preliminary amendment amending the claims and arguing against the reference identified in the third-party submission. More specifically, while the applicant alleged that the reference did not disclose all limitations of the pending claims, the applicant elected to make a claim amendment allegedly “in an abundance of caution.” Unfortunately for the applicant, the non-final office action issued close in time to when the preliminary amendment was submitted. Thus, the preliminary amendment was not considered in the non-final office action, and the non-final office action did not apply the reference submitted by the third party. Although the preliminary amendment was not considered, this raises a question as to whether the applicant should feel compelled to consider the items submitted in a third-party submission before the examiner issues any office action considering the items. It may be advantageous to do so in order to potentially expedite prosecution; however, it is the examiner’s burden to consider the third-party submission and make any rejection based on what is submitted.
U.S. Application No. 13/493,787 addresses the issue of what happens when a non-final office action issues before a third-party submission is filed. In this instance, a non-final office action issued before the application even published, but the deadline to respond to the non-final office action occurred after the third-party submission (identifying a single publication and providing a claim chart) was made. The applicant responded to the non-final office action but did not make explicit reference to having considered the third-party submission (and was not required to do so). Then, several weeks after filing the response, the examiner issued another non-final office action including an anticipation rejection based on the reference included in the third-party submission. It is helpful to note that this later rejection following consideration of the third-party submission was made non-final, and this appears to indicate that the examiner may have appreciated the timing of when the third-party submission was made and did not hold this against the applicant.
Best Practice Considerations for Pre-Issuance Submissions
Third parties wishing to take advantage of the pre-issuance submission process should plan to timely review competitive patent filings. For example, this review may take the form of a quarterly patent review as the time periods set forth under the statute cannot be tolled. A third party also may consider contracting this periodic review out to a search firm. In some instances, the third party may opt to train its employees to perform relevant searches involving keywords and/or subject matter codes. However, there may be some risk of inviting willful infringement allegations, particularly if searches are being done but no third-party submissions are made based on the search results.
Next, it is important to remember that a pre-issuance submission should identify and address quality or on-point prior art, as opposed to overburdening the examiner with voluminous submissions of irrelevant items. Such filings could affect the third party’s credibility, not just for that particular application, but rather the third party’s reputation before the USPTO in general particularly if filings are made in an art group where the third party may find its own patent applications being examined. Moreover, regardless what prior art is submitted as part of a pre-issuance submission, the explanation of relevance should be prima facie credible, well drafted, and should quickly lead the examiner to make a rejection.
While it may be preferable to present highly relevant prior art, one should appreciate that there is no requirement that the third party submit the “best” prior art known as part of using the pre-issuance submission process. References may be reserved for other proceedings in which the third party has more of an opportunity to participate in its analysis. Consequently, it is possible for a third party to supply prior art in a pre-issuance submission, while reserving better prior art for a post-issuance litigation-based challenge.
Keep in mind that the applicant may still receive a patent despite the third-party submission. The pre-issuance submission process may be more useful in limiting and defining the patent scope of an application. The record may reflect that the patent should not cover certain elements. Even if no claims are amended in view of a third-party submission, the applicant may end up defining a claim term in order to overcome the prior art, which may in itself be helpful to the third-party challenger to clear a path for its own current and potential technology usage.
Finally, as the cost of engaging in post-grant proceedings under the America Invents Act or making challenges through the courts may be quite high, it will be increasingly likely that pre-issuance submissions will be a preferred method of challenge over time.
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