USPTO Notices: Three IP Requests Published in Federal Register
More notices coming
On November 19, 2025, the United States Patent and Trademark Office (USPTO) published a trio of formal notices in the Federal Register, quietly reaffirming the substantial administrative scaffolding that supports—and sometimes constrains—innovation. Specifically, the agency is soliciting public comments on the extension and revision of existing information collections regarding the deposit of biological materials, the issuance of secrecy orders and foreign filing licenses, and the calculation of patent term extensions and adjustments.
While the headlines in the Federal Register—”Agency Information Collection Activities”—may appear mundane, they signal a critical administrative checkpoint for intellectual property professionals. The USPTO is not proposing new substantive laws in these notices; rather, it is seeking to validate the administrative burdens it places on applicants to comply with existing statutes.
These “information collections” are the gears that keep the patent system running. By renewing them, the Office is effectively stating that the current time and cost estimates for these procedures—ranging from shipping frozen biological samples to navigating national security reviews—are accurate. For practitioners, this is the moment to scrutinize the “fine print” of patent practice.
Here is what the USPTO is effectively maintaining across three key areas of practice:
1. The High Cost of “Enablement” for Biotech (Biological Materials)
For the biotechnology sector, satisfying 35 U.S.C. § 112 often requires more than just a written description. The USPTO is renewing the requirements for depositing biological materials, explicitly acknowledging that “words and figures may not sufficiently describe how to make and use the invention in a reproducible manner” (Bio, p. 2).
The proposal reaffirms the logistical reality of these filings. It is not merely a digital transaction; it involves the physical transport of sensitive material.
The Proposal: The Office estimates that 1,500 respondents per year will need to ship biological deposits to an International Depository Authority (IDA).
The Real Cost: The Office maintains that the “average cost of frozen infectious shipments is estimated to be $170 per package of four” (Bio, p. 3). Furthermore, the Office recognizes that “depositories charge fees to depositors,” estimating the “depository fee is $2,500 per deposit” (Bio, p. 3).
Key Quote: The collection ensures that “the inventive biological material must be known and readily available to the public or be capable to be made or isolated without undue experimentation” (Bio, p. 2).
2. National Security and the “Error” of Foreign Filing (Secrecy Orders)
The second notice reinforces the USPTO’s gatekeeping role in national security under 35 U.S.C. §§ 181-186. The Office is soliciting comments on the collection of information related to Secrecy Orders and Foreign Filing Licenses (FFL).
The “real” proposal here is the continued stringent oversight of technology exports. The Office notes that if a secrecy order is applied, “the application will not be forwarded to the International Bureau as long as the secrecy order is in effect” (FFL, p. 1).
The Proposal: The Office is renewing the mechanisms for applicants to petition for licenses, including the high-stakes “Petition for Retroactive License” when a filing error has occurred.
The Risk: The Office anticipates 131 petitions annually for retroactive licenses from “undiscounted entities” (FFL, p. 3). This implies that over a hundred applicants each year face the potential invalidity of their patents due to inadvertent foreign filings.
Key Quote: A secrecy order is issued whenever the publication of an invention is “determined to be detrimental to national security” (FFL, p. 1). The collection includes petitions to “permit the widest utilization of the technical data... while still controlling any publication or disclosure that would result in an unlawful exportation” (FFL, p. 1).
3. The Calculus of Time (Patent Term Extension and Adjustment)
The third notice addresses the complex accounting of patent term. The USPTO is renewing the information collection for both Patent Term Extension (PTE) (for regulatory delays) and Patent Term Adjustment (PTA) (for examination delays).
This collection highlights the strict “reasonable efforts” standard imposed on applicants. It serves as a reminder that the Office expects diligent prosecution and will deduct term for delays.
The Proposal: The Office estimates that “responses in this information collection will take the public approximately 1 to 25 hours to complete” (PTA, p. 2), covering everything from simple adjustments to complex regulatory extensions.
The Warning: The notice explicitly reiterates that term adjustment “shall be reduced by a period equal to the period of time during which the applicant failed to engage in reasonable efforts to conclude prosecution” (PTA, p. 2).
Key Quote: For pharmaceutical patents, the stakes are defined clearly: “The maximum length that a patent may be extended under 35 U.S.C. 156 is 5 years” (PTA, p. 2).
What This Actually Means
At first glance, the renewal of these burdensome “information collections” might seem at odds with the agenda of USPTO Director John Squires, who has spent his early tenure championing a “pro-patent” philosophy focused on reducing barriers to entry and streamlining subject matter eligibility. Why would an administration focused on efficiency and promoting American innovation maintain such costly red tape?
The answer likely lies in the distinction between “deregulation” and “robustness.”
Quality Over Convenience (Bio Deposits): By maintaining strict requirements for biological deposits, the Office is signaling that a “pro-patent” environment is not a “loose” one. Director Squires has emphasized that strong patents must be defensible. A biotech patent that lacks a verified physical deposit is a litigation target waiting to happen. Renewing this collection ensures that the “quid pro quo” of the patent system remains intact—supporting the validity of the assets the Director wants to promote.
National Security as IP Strategy (Secrecy Orders): The continued rigor around Secrecy Orders aligns perfectly with the Director’s testimony regarding intellectual property as a tool of national defense (and the White House’s leverage for dismantling the examiner union). The renewal of the “Retroactive License” petition (FFL, p. 2) is particularly notable. It suggests that while the Office will be hawkish on security, it acknowledges the reality of global commerce and provides a necessary safety valve for inadvertent errors, preventing invalidity for minor procedural foot-faults.
Accountability for Delay (PTA): Perhaps the most “pro-patent” signal is the renewal of the Patent Term Adjustment collection. While it imposes a paperwork burden, it is the primary mechanism by which applicants hold the USPTO accountable for its own delays. By validating the process to challenge term calculations (PTA, p. 3), the administration is preserving the applicant’s statutory right to maximize the lifespan of their monopoly—a core tenet of a strong property rights regime.
Analysis and Final Thoughts
These renewals aim to provide certainty. They appear to confirm that the established pathways for handling complex filings—whether they involve live cells, classified tech, or FDA delays—remain open and operational. For example, the “Petition for Expedited Handling of License” (FFL, p. 3) provides a necessary release valve for businesses needing to move quickly in global markets.
The burden estimates may be optimistic. While the Office estimates “1 to 25 hours” for PTA-related responses (PTA, p. 2), complex challenges to a term adjustment calculation often require significantly more legal analysis.
Similarly, the “non-hourly cost burden” for biological deposits is estimated at over $4.3 million (Bio, p. 3), a significant collective tax on the biotech industry.
There is still plenty of bureaucracy at the USPTO, and red tape increases costs for everyone. Still, the primary risk remains the “strict liability” nature of these administrative hurdles.
Administrative Traps: A failure to properly document the “viability” of a biological deposit (Bio, p. 2) or a failure to respond to a USPTO communication “within three months” (PTA, p. 2) can result in an irrevocable loss of rights or patent term. For most folks, this is not just a quick check.
Security vs. Disclosure: The tension in the FFL collection is palpable. Applicants must navigate the fine line between “widest utilization” of data and “unlawful exportation” (FFL, p. 1), a risk that is arguably heightened in an era of collaborative, cloud-based drafting tools. The USPTO’s talk of “national security” concerns has been mocked recently, but the potential for losing rights should cause folks to double check these rules.
Overall, the bottom line is that too much red tape and expense can have a chilling effect on patent filings and IP strategy.
These burdens and the associated fees cost companies and firms resources, can affect the budgets, and rising expenses may influence IP owners on protection strategies.
If the estimates and statements made by the USPTO in these Federal Register notices do not corroborate your point of view as a practitioner, you are the intended subject of these requests for feedback. Now is the time to go on the record.
Practitioners have until January 20, 2026, to submit comments (PTA, p. 1; FFL, p. 2; Bio, p. 2).
Disclaimer: This is provided for informational purposes only and does not constitute legal or financial advice. To the extent there are any opinions in this article, they are the author’s alone and do not represent the beliefs of his firm or clients. The strategies expressed are purely speculation based on publicly available information. The information expressed is subject to change at any time and should be checked for completeness, accuracy and current applicability. For advice, consult a suitably licensed attorney and/or patent professional.