USPTO Proposes To Require Form For IDS PTA Safe Harbor

19 July 2022 PharmaPatents Blog
Author(s): Courtenay C. Brinckerhoff

The USPTO Patent Term Adjustment (PTA) rules include a “safe harbor” that avoids a PTA deduction for “Applicant delay” for Information Disclosure Statements that are accompanied by a certain statement averring that the items being submitted only were recently cited in another application. Under current rules, the statement can be provided in any paper submitted with the IDS, including USPTO form PTO/SB/133. The USPTO is now proposing to require use of USPTO form PTO/SB/133 in order to invoke the safe harbor.

 

IDS-Related PTA Deductions

As discussed in this article, there is a mismatch between the timing requirements of the Information Disclosure Statement (IDS) rules and the PTA rules. An IDS that is timely under the IDS rules can lead to a PTA deduction for “Applicant delay” under certain circumstances, such as when an IDS is filed after a reply to an Office Action has been filed, or after a Request for Continued Examination (RCE) has been filed. Such PTA deductions may be taken under PTA rules 37 CFR § 1.704(c)(6), (8), (9), or (10).

The safe harbor of 37 CFR § 1.704(d)(1) provides limited exceptions to those PTA deductions, and holds that a paper containing only an IDS will not be considered a “failure to engage in reasonable efforts to conclude prosecution” under 37 CFR § 1.704(c)(6), (8), (9), or (10) if it is accompanied by one or both of two specific statements regarding the items cited in the IDS. The same rule includes a similar provision for an RCE filed with only such an IDS.

The safe harbor statements are one or both of:

Each item of information contained in the information disclosure statement was first cited in any communication from a patent office in a counterpart foreign or international application or from the Office, and this communication was not received by any individual designated in 37 CFR 1.56(c) more than thirty days prior to the filing of the information disclosure statement.

Each item of information contained in the information disclosure statement is a communication that was issued by a patent office in a counterpart foreign or international application or by the Office, and this communication was not received by any individual designated in 37 CFR 1.56(c) more than thirty days prior to the filing of the information disclosure statement.

In a Federal Register Notice published July 12, 2022, the USPTO proposes to revise 37 CFR § 1.704(d) to require the use of PTO/SB/133 in order to invoke the safe harbor. In particular, the USPTO proposes to add subsection (3):

(3) The statement under paragraph (d)(1) of this section must be submitted on the Office form (PTO/SB/133) provided for such a patent term adjustment statement. Otherwise, the paper or request for continued examination will be treated as not accompanied by a statement under paragraph (d)(1) of this section. No changes to statements on this Office form may be made. The presentation to the Office (whether by signing, filing, submitting, or later advocating) of this form, whether by a practitioner or non-practitioner, constitutes a certification under § 11.18(b) of this chapter that the existing text and any certification statements on this form have not been altered.

Comments on the proposed rule change must be submitted via the Federal eRulemaking Portal at www.regulations.gov under docket number PTO-P-2022-0008, and received by September 12, 2022 to ensure consideration.

Use Of PTO/SB/133 Will Lead To More Accurate PTA Calculations (Eventually)

When the USPTO first rolled out form PTO/SB/133 in 2018, it indicated that its PTA calculator would be updated to identify when an IDS had been filed with that form, and would not charge a PTA deduction for a submission that included only an IDS (or RCE and IDS) with that form.

As stated in a November 2, 2018 Federal Register Notice:

The USPTO is planning to update the patent term adjustment computer program to recognize when form PTO/SB/133 has been filed. Once updated, the patent term adjustment computer program will perform the patent term calculation by taking into account that applicant filed a compliant safe harbor statement under 37 CFR 1.704(d) when it performs the patent term adjustment calculation.

The July 12, 2022 Federal Register Notice renews that promise:

[T]he USPTO's patent term adjustment algorithm is being modified to detect when a patent term adjustment statement under 37 CFR 1.704(d)(1) is filed using the Office form. The Office has created a particular document code for the filing of this patent term adjustment statement form under 37 CFR 1.704(d). Once modified, the patent term adjustment algorithm will recognize that the Office form (PTO/SB/133) has been filed concurrently with (i.e., on the same date as) the information disclosure statement and, accordingly, will not assess a reduction in patent term adjustment under the applicable applicant delay sections of 37 CFR 1.704(c) for the patent.

The July 12, 2022 Federal Register Notice also explains that requiring use of form PTO/SB/133 will “eliminate” deficient safe harbor statements that do not use the exact words of 37 CFR § 1.704(d)(1).

Requiring PTO/SB/133 May Lead To Loss Of PTA

Although I have been using form PTO/SB/133 to make IDS safe harbor statements since 2018, and look forward to the day the USPTO’s PTA calculator finally stops erroneously charging PTA deductions for IDSs filed with safe harbor statements, I have concerns about requiring the use of a specific form to be entitled to a statutory right to additional patent term, especially when use of the form has been “voluntary” for nearly four years.

A more flexible approach would continue the current practice of permitting applicants to make the required safe harbor statement(s) in any paper filed on the same date as the IDS, but require a request for reconsideration of patent term adjustment under 37 CFR § 1.705(b) (and the associated fee) to invoke the safe harbor if form PTO/SB/133 was not used.

(Under the “interim” procedures implemented in 2018, the USPTO currently permits applicants to file a request for recalculation of patent term adjustment without a fee if the only alleged PTA error pertains to an IDS filed with a safe harbor statement. While not mentioned in the July 12, 2022 Federal Register Notice, the November 2, 2018 Federal Register Notice advised that the “interim procedure will remain in effect until the USPTO can update the patent term adjustment computer program and provide notice to the public that the computer program has been updated.” Thus, once the USPTO's patent term adjustment algorithm is updated to account for form PTO/SB/133, the request for recalculation procedures may be eliminated.)

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