USPTO Mandates Official Form for PTA Information Disclosure Statements to Automate Assessments of Patent Term Adjustments

Today, the U.S. Patent and Trademark Office (USPTO) published a notice of proposed rulemaking (NPRM) in the Federal Register announcing that the agency would be revising its rules of practice to require that information disclosure statements related to patent term adjustments (PTAs) be submitted on Form PTO/SB/133. The use of this document is expected to streamline communications between the USPTO and patent applicants regarding delays in patent prosecution and also save agency resources by reducing manual review of PTA statements and leveraging information technology (IT) resources at the agency for automatically detecting and reviewing such statements.

PTAs for Office Delay Reduced by Applicant Failure to Conclude Prosecution

Established by the American Inventors Protection Act of 1999, PTAs are available to patent applicants to extend the period of time in which a patent is in force to account for prosecution delays attributable to agency inaction. Adjustments extending the life of a patent from its original filing date can be obtained when the agency fails to meet what are known as the 14-4-4-4-36 timeframes: issuance of a first office action within 14 months of the filing of a patent application; response to a reply or appeal within four months of the reply’s filing or when the appeal was taken; issuance of an office action within four months of a decision by the Patent Trial and Appeal Board (PTAB) or a federal court; issuance of a patent within four months of the issue fee’s payment; or issuance of a patent within 36 months of the filing of a patent application. Provisions governing PTAs and the types of USPTO delay triggering those adjustments are codified at 35 U.S.C. § 154(b).

The recent NPRM issued by the USPTO is mainly concerned with the showing that must be made by patent applicants that they have engaged in reasonable efforts to conclude prosecution, processing or examination of a patent application. A failure to engage in such reasonable efforts usually leads to a reduction of the total PTA issued for a particular patent, and a list of such circumstances that will reduce PTAs has been outlined within agency rulemaking at 37 CFR § 1.704(c)(1)-(14). These circumstances include failure to file a petition to revive a patent application within two months after a notice of abandonment was mailed, submission of a reply to a notice of abandonment that has an omission, or the submission of certain amendments less than one month prior to the mailing of an office action or a notice of allowance.

Information Disclosure Statements Within 30-Day Window Meet Safe Harbor Provision

In some circumstances, material prior art and other information material to patentability and required to be disclosed to the USPTO is discovered later in the prosecution process, sometimes as a result of examination processes in foreign patent offices. To ensure that patent applicants do not have their PTA shortened by such late disclosures of new information, Section 1.704(d)(1) includes a safe harbor provision allowing patent applicants to file an information disclosure statement regarding information material to patentability. Such disclosures can be filed to avoid PTA reductions in the following circumstances: submission of a preliminary amendment less than one month before an office action or notice of allowance has been mailed; submission of a supplemental reply after a reply has been filed; submission of an amendment after a PTAB decision; or submission of an amendment or a request for continued examination after a notice of allowance has been mailed.

If such a statement is filed within 30 days of the disclosure of the material information to inventors named in the patent application, attorneys or agents prosecuting the application or any other person substantively involved in the application’s preparation or prosecution, the statement will ensure that the circumstances surrounding the late submission will not be considered a failure to engage in reasonable efforts to conclude prosecution that would result in a PTA reduction. Section 1.704(d)(2) provides that the 30-day period for submitting such a statement cannot be extended. If the proposed rule is adopted as drafted, it would add new Section 1.704(d)(3) to the USPTO’s rules governing PTA reductions, which would require that Section 1.704(d)(1) information disclosure statements be submitted on Form PTO/SB/133. The agency expects that the use of this form will reduce the number of requests for PTA reconsideration available under 37 CFR § 1.705(b).

Mandating Electronic Form Will Improve Algorithmic Assessment of PTAs

The USPTO’s modernization efforts have increasingly turned to electronic documentation in recent months, including the agency’s goals to transition to electronic trademark certificates and electronic patent issuance. As the USPTO’s recent NPRM on PTA statements notes, the agency’s PTA algorithm, which assesses PTA reductions based on applicant delay, is currently being modified to automatically detect when Form PTO/SB/133, which certifies that information material to patentability was received within the 30-day window, is submitted concurrently with an information disclosure statement containing the material information. The agency’s decision to mandate use of Form PTO/SB/133 for PTA statements follows a sampling of PTA statements submitted independent of the official form, which revealed a portion of statements that were deficient for failing to meet the language of Section 1.704(d).

While PTAs and information disclosure statements aren’t often the subject of major case law, the Federal Circuit recently clarified the law surrounding circumstances in which applicant delay will lead to a PTA reduction in Supernus Pharmaceuticals v. Iancu (2019). In that decision, the Federal Circuit restored 546 days to a PTA granted to Supernus Pharmaceuticals after finding that the patent owner could not have engaged in reasonable efforts to conclude prosecution until it was notified by the European Patent Office (EPO) that the EU counterpart to Supernus’ U.S. patent application was facing an opposition filed by Swiss-based pharmaceutical firm Sandoz. In response to that decision, the USPTO issued a final rule on PTAs in June 2020 clarifying that PTAs would not be reduced by a period of time during which there was no identifiable action that the patent applicant could take to conclude prosecution.

Although the USPTO’s NPRM notes that the proposed rulemaking involves interpretive rules or rules of agency procedure that under 5 U.S.C. § 553(b)(A) do not require notice and comment rulemaking, the agency is still seeking public input prior to implementing the proposed rule. Public comments must be received by the agency by September 12 to ensure consideration.

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Author stuartmiles
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