SMEDs: A Practitioner’s Best Tool for § 101?

Director Squires issued a memorandum late September on Subject Matter Eligibility Declarations (SMEDs) that continues a series of memos on the subject. Two flowcharts on when and how examiners should consider SMEDs were issued alongside the memo. The memo begins by summarizing the previous changes Direction Squires has made to USPTO policies on § 101 and then provides five points of “best Practices for Submitting a SMED.”

The two flowcharts are meant to be cohesive with the first flowchart essentially being a list of requirements that must be satisfied before an examiner should consider the merits of a filed SMED. A novel point on this flowchart is that a SMED can still be timely when filed “after final rejection, but before or on the same date of filing an appeal” if there is “a showing of good and sufficient reasons.” But no further details or examples are provided on what “a showing of good and sufficient reasons” should look like, and this can pose a challenge to both the practitioner trying to provide reasons and to the examiner trying to decide whether to consider an after-final SMED. With the USPTO providing minimal “other time” for training, a majority of examiners likely have no guidance on when to consider SMEDs beyond what is stated on the flowchart, and this means that there may be inconsistencies between examiners as to what a “good and sufficient reason” looks like. But this change in policy might still provide a new opportunity to file  a SMED when a § 101 rejection is persistent.

The second flowchart explains how an examiner should weigh the “probative value” of evidence provided in a SMED and is consistent with previous MPEP guidance on the matter. While the information may not be new, the flowchart may be useful when arguing that an examiner has not provided sufficient reason or a correct analysis on why a SMED was unpersuasive.

The memo itself provides five points of “best practices” for practitioners to follow when submitting a SMED: (1) Submit a SMED separately from other declarations (e.g. enablement, non-obviousness). (2) “Submitting the SMED as early as possible in prosecution may be advantageous.” (3) “Evidence from disinterested parties may be more persuasive.” (4) Explain which prong of the subject matter eligibility flowchart is being addressed by the SMED. And (5), “Interviews may be helpful to advance prosecution” which addresses general prosecution more than it does SMEDs.

Among these points, the one that might be not always be “best practice” is “Submitting the SMED as early as possible in prosecution may be advantageous.” This point is followed in the memo by an explanation that an applicant can even file a SMED “prior to first action on the merits.” The memo goes on to explain that “this may avoid complications in submitting one later in prosecution and allows the examiner to consider the SMED while initially evaluating subject matter eligibility.” But is submitting a SMED before the first office action really best practice?

Filing a SMED before an application has even been reviewed by an examiner may be inviting a § 101 rejection that may not have been coming. And if there is no § 101 rejection after filing the SMED, the SMED is now on the record and there to be used as proof of invalidity in future litigation. And as anyone familiar with § 101 prosecution will know, the best approach to overcoming a § 101 rejection can vary by the technology center, the art unit, and even by the examiner. Oftentimes, an amendment that only slightly narrows the scope is all that’s needed to overcome a § 101 rejection. Whereas SMEDs can often add time and costs to the prosecution of an application. This all goes to show that there are still plenty of reasons to not file a SMED early.

Director Squires has been focusing on providing ways to overcome § 101 since he took office. This coincides with the current administrations focus on removing barriers to the development of AI technology. As the memo explains, Director Squires authored the appeals review panel decision for Ex Parte Desjardins shortly after taking office in an effort to encourage the allowance of AI-related applications. SMEDs appear to be another tool that the director wants to provide practitioners with to help overcome § 101 rejections as this is the third memo on SMEDs after one in December 2025 and one in April 2026.

While the leadership at the USPTO is placing a clear emphasis on SMEDs, it remains to be seen how effective they will actually be in application. Many examiners and judges may not appreciate SMEDs as much as leadership does. And a recent study by Dennis Crouch shows that this is likely the case with SMEDs failing to overcome § 101 rejections 66% of the time. When working with an examiner that you are already familiar with, it is probably best to rely on approaches that worked previously to overcome the § 101 rejection. But when a § 101 rejection becomes persistent, then SMEDs may be a useful tool to fall back on. While there is limited clarity on what “a showing of good and sufficient reasons” may entail, this new standard might provide an opportunity for practitioners to file a SMED, after a final rejection, once it becomes clear that arguments and amendments will be insufficient. And so while the benefit of SMEDs may be limited, they can be useful for tougher § 101 rejections. And because leadership at the USPTO is taking a friendly stance towards § 101 adverse technologies, this may be an opportune time for applicants to file for such technologies as more tools for overcoming § 101 may be on there way.


USPTO Announces new PIER Pilot Program

The USPTO announced a new PCT Informed Examination Request (PIER) pilot program for 371 national stage applications.

Under this pilot PIER program, the USPTO will issue a requirement for information (PIER RFI) in selected 371 applications. The USPTO will not accept requests to opt out of the PIER pilot program.

The PIER RFI will require the applicant to respond by requesting one of: (1) proceeding with examination; (2) a 12-month delay in examination; or (3) the express abandonment of the application. The response to the PIER RFI must be filed using a new USPTO form: the PTO/SB/478.

The USPTO considers the PIER RFI to be an Office action under 35 U.S.C. § 132, meaning that it satisfies the 14-month patent term adjustment (PTA) time frame. While not stated, this also means that the applicant’s response to a PIER RFI is a reply for purposes of the first 4-month PTA time frame.

Proceeding with Examination: The request to proceed with examination may be accompanied by a preliminary amendment. A preliminary amendment may be desirable in view of the PCT International Search Report (ISR), Written Opinion, and any Supplemental International Search (SIS) or International Preliminary Examination Report (IPER).

A 12-month Delay: The request for a 12-month delay will result in a “non-terminable” delay in examination. The 12-month period will be measured from the USPTO’s receipt of the applicant’s response requesting the delay. This response will be considered an applicant delay for PTA purposes.

Express Abandonment: There is also an option to request express abandonment. The benefit of filing this response appears to be questionable since (1) any 371 application is likely to have been published during the PCT international stage, (2) the USPTO indicates that it will not refund any search or examination fees for an application expressly abandoned in response to the PIER RFI, and (3) the USPTO indicates that simply not responding to a PIER RFI will result in abandonment of the application.

The notice was published in the Federal Register at 91 Fed. Reg. 17949-52.


Maier & Maier Secures Victory in Competitor Litigation

Maier & Maier PLLC is pleased to report that it has obtained victory for its client Mayflower Auto Equipments Inc. in a case involving automotive repair equipment. The case was originally filed by Demax USA Inc. in the Eastern District of Texas on February 18, 2026 (case number 4:26-cv-00177-SDJ). Demax subsequently filed a motion for preliminary injunction on April 2, 2026, seeking to enjoin Mayflower from making, using, selling, offering for sale, importing, or distributing the accused products. Demax alleged that as a competitor in the automotive repair equipment market, it was irreparably harmed by Mayflower.

We responded to the preliminary injunction motion, pointing out numerous flaws in Demax’s position. Instead of filing a reply or continuing to litigate the case, Demax voluntarily dismissed the case. This case represents another victory for the Maier & Maier team in the area of competitor patent litigation.

About Maier & Maier PLLC

Maier & Maier’s litigation team has been hard at work delivering positive results for clients. The Maier & Maier Team continues to advocate on behalf of clients in federal courts, before the Patent Trial and Appeal Board, Trademark Trial and Appeal Board, and the International Trade Commission.


USPTO Announces new PIER Pilot Program

The USPTO announced a new PCT Informed Examination Request (PIER) pilot program for 371 national stage applications.

Under this pilot PIER program, the USPTO will issue a requirement for information (PIER RFI) in selected 371 applications. The USPTO will not accept requests to opt out of the PIER pilot program.

The PIER RFI will require the applicant to respond by requesting one of: (1) proceeding with examination; (2) a 12-month delay in examination; or (3) the express abandonment of the application. The response to the PIER RFI must be filed using a new USPTO form: the PTO/SB/478.

The USPTO considers the PIER RFI to be an Office action under 35 U.S.C. § 132, meaning that it satisfies the 14-month patent term adjustment (PTA) time frame. While not stated, this also means that the applicant’s response to a PIER RFI is a reply for purposes of the first 4-month PTA time frame.

Proceeding with Examination: The request to proceed with examination may be accompanied by a preliminary amendment. A preliminary amendment may be desirable in view of the PCT International Search Report (ISR), Written Opinion, and any Supplemental International Search (SIS) or International Preliminary Examination Report (IPER).

A 12-month Delay: The request for a 12-month delay will result in a “non-terminable” delay in examination. The 12-month period will be measured from the USPTO’s receipt of the applicant’s response requesting the delay. This response will be considered an applicant delay for PTA purposes.

Express Abandonment: There is also an option to request express abandonment. The benefit of filing this response appears to be questionable since (1) any 371 application is likely to have been published during the PCT international stage, (2) the USPTO indicates that it will not refund any search or examination fees for an application expressly abandoned in response to the PIER RFI, and (3) the USPTO indicates that simply not responding to a PIER RFI will result in abandonment of the application.

The notice was published in today’s Federal Register at 91 Fed. Reg. 17949-52.

 


Adriene Lepiane Hanlon joins Maier & Maier

Maier & Maier PLLC is proud to announce its newest addition to the firm, Adriene Hanlon. Ms. Hanlon enjoyed a long and distinguished career at the USPTO, starting as an Examiner and ending with a long tenor as an Administrative Patent Judge (APJ) at the Patent Trial and Appeal Board (PTAB).

During her time as an APJ Ms. Hanlon authored over 1,700 decisions in ex parte appeals and wrote interlocutory and final decisions in numerous interferences. Ms. Hanlon provides unparalleled experience and expertise to patent matters and operations at the USPTO and PTAB allowing Maier & Maier to better serve our valued clients.

Maier & Maier is excited for a bright future with the addition of Ms. Hanlon to our team. To inquire about Ms. Hanlon’s services, please reach out to us at info@maierandmaier.com or 703-740-8322 for a consultation.


Maier & Maier Secures Victory on Appeal at the Federal Circuit

Maier & Maier is pleased to report that we secured a victory for our client Firstbeat Technologies OY in a case involving a heart rate measuring apparatus incorporated into wearable technology. The case was originally filed by Polar Electro OY in the District of Delaware on November 7, 2011, but was eventually transferred to the District of Utah where we obtained a grant of summary judgement of invalidity on the basis of §101.

The Plaintiff then appealed the decision to the Federal Circuit where a three-judge panel upheld in full the District Courts grant of summary judgement, issuing a rule 36 affirmance in record time. See 2024-1801, Dkt. 38.

Maier & Maier continues to enjoy consistent and favorable results in its litigation matters. The firm has obtained favorable results when defending clients accused of infringement by competitors as well as cases brought by patent assertion entities.

About Maier & Maier PLLC

Maier & Maier’s litigation team has been hard at work delivering positive results for clients. The Maier & Maier Team continues to advocate on behalf of clients in federal courts, before the Patent Trial and Appeal Board, Trademark Trial and Appeal Board, and the International Trade Commission.


Note on Revision to Rules of Practice before the Patent Trial and Appeal Board

On October 17, 2025, the United States Patent and Trademark Office posted proposed revisions to the rules of practice before the Patent Trial and Appeal Board. See  https://www.govinfo.gov/app/details/FR-2025-10-17/2025-19580. Time for comment closes November 17, 2025.

The Proposed Rules would change which patents are subject to inter partes review and limit the ability of patent challengers to invalidate patents. The USPTO states that the goals of the Proposed Rules are to:

  • Curb serial and parallel patent validity challenges.
  • Focus IPRs on patents not previously tested in court or other USPTO proceedings.
  • Enhance fairness, efficiency, and predictability in the patent system.

The USPTO believes that multiple or duplicative challenges erode confidence in patent reliability, increase costs, and discourage investment, especially by small and medium-sized innovators. The idea is that IPRs were designed as a substitute for litigation, not an additional layer. The Proposed Rules aim to reduce redundant reviews, increase finality of patent rights, and allocate PTAB resources toward ex parte appeals and initial examination quality.

The below is a brief summary of the changes introduced by the Proposed Rules.

Key Proposed Rule Changes (37 CFR §42.108)

  1. Required Stipulation (§42.108(d))
    • IPRs will not be instituted unless the petitioner stipulates that it (and any party in interest or privy) will not pursue invalidity challenges under §§102 or 103 in district court or the ITC regarding the same patent.
    • The stipulation must be filed in all relevant venues.
  2. Claims Found Valid in Prior Proceedings (§42.108(e))
    • IPR will not be instituted for claims previously upheld as valid (or “not unpatentable”) by:
      • A district court (after trial or summary judgment);
      • The ITC;
      • The PTAB (in prior IPRs or ex parte reexaminations); or
      • Affirmed by the Federal Circuit after reversal of an invalidity finding.
  3. Parallel Litigation (§42.108(f))
    • No IPR will be instituted if a district court trial, ITC determination, or PTAB final written decision on the same claims is likely before the PTAB’s final written decision deadline.
  4. Extraordinary Circumstances (§42.108(g))
    • The Director may personally authorize IPR institution despite the above restrictions only in extraordinary cases, e.g.:
      • Prior challenges brought in bad faith, or
      • Major statutory or Supreme Court changes affecting validity law.
    • “Extraordinary” does not include new prior art, new expert testimony, or failure to appeal prior decisions.

Takeaway

The Proposed Rules indicate that the USPTO will continue to strengthen patent rights under the direction of new director John A. Squires. Combined with the rise in discretionary denials, the Proposed Rules would further limit defendants’ abilities to invalidate asserted patents. If the Proposed Rules take effect, defendants will need to better coordinate their invalidity strategies, as patents could become “IPR proof” if a prior validity challenge fails.


Upcoming Webinar – Cutting USPTO Pendency at the Source – Front-End AI for Faster, Stronger Filings

On Tuesday October 7, 2025, at 12 PM ET Maier & Maier Partner and former Deputy Commissioner for Patent Examination Policy at the USPTO Bob Bahr will be a commentator on a Webinar hosted by Gene Quinn of IPWatchDog to discuss pendency at the USPTO.

Patent pendency at the United States Patent and Trademark Office (USPTO) is a problem. As of January, the number of unexamined applications reached a staggering and historic high, with 837,928 applications unexamined and nearly 1.2 million applications pending overall. As of August, the USPTO has been able to reduce the number of unexamined applications to 800,559, which is a great improvement, but much work remains to be done.

USPTO pendency isn’t just a back-end prosecution problem—it starts at the very first touchpoints of the innovation process. Small, AI-assisted changes to invention capture, prior-art triage, and claim strategy can help, and are becoming a necessity as the USPTO continues to implement AI solutions themselves.

Tune in on Tuesday, October 7, at 12 PM ET, for a conversation about how effective use of AI tools can reduce Office actions, avoid §101/§102/§103/§112 pitfalls, and accelerate filing paths. Find more info at Webinar: Cutting USPTO Pendency at the Source – Front-End AI for Faster, Stronger Filings – IPWatchdog.com | Patents & Intellectual Property Law


Kathleen Cooney-Porter returns to USPTO as Senior Trademark Advisor

            Kathleen Cooney-Porter has announced her return to the USPTO to serve as a senior trademark advisor Under Secretary and Director of The United States Patent and Trademark Office. Ms. Cooney-Porter is an expert in trademark matters having previously worked both at the USPTO as a trademark examiner and senior law advisor as well as in private practice at both law firms and as a consultant. Maier & Maier thanks her for her time as a partner and wishes her well at her new role.


Maier & Maier recognized by Chambers USA in 2025 List

We are pleased to announce that Maier & Maier has been recognized by Chambers USA, the premier legal guide known for ranking top law firms and attorneys nationwide.  
 
In the 2025 edition, Maier & Maier was recognized for our work in the Intellectual Property field. Our inclusion in Chambers USA is an honor to Maier & Maier and is a testament to our commitment to delivering superior legal counsel in intellectual property matters.
 
Chambers USA rankings are based on independent research and interviews with clients and peers, evaluating firms on their technical legal ability, client service, depth of team, and market reputation.