On January 9, 2015, the Federal Register published final rules implementing changes to patent term adjustment (PTA) in view of Novartis v. Lee, which the Federal Circuit decided last January.  The new rules affect patents where a request for continued examination (RCE) was filed during prosecution.  In general, the first new rule, effective January 9, 2015, provides that applicants are entitled to B-Delay between allowance and issuance, and the second new rule, effective March 10, 2015, creates a new type of applicant delay when an RCE is filed after allowance.

As previously discussed by Global IP Matters, Novartis focuses on B-Delay, which occurs, per 35 U.S.C. § 154(b)(1)(B), when the U.S. Patent and Trademark Office (USPTO) fails to issue a patent within three years of an application’s actual filing date.  Novartis held that the filing of an RCE tolls the running of the B-Delay clock whether or not the RCE was filed within three years of the application’s actual filing date.  Accordingly, the Federal Circuit concluded that once an RCE is filed, no B-Delay is available for any time in continued examination.  The Federal Circuit also held that, for cases where an RCE was filed during prosecution, applicants could be entitled to B-Delay for the time period between allowance and issuance.  The new rules reflect these holdings.

The first new rule changes section (b)(1) of 37 CFR 1.703 to read (with relevant language emphasized):

(b) The period of adjustment under § 1.702(b) is the number of days, if any, in the period beginning on the day after the date that is three years after the date on which the application was filed under 35 U.S.C. 111(a) or the national stage commenced under 35 U.S.C. 371(b) or (f) in an international application and ending on the date a patent was issued, but not including the sum of the following periods:

(1) The number of days, if any, in the period beginning on the date on which a request for continued examination of the application under 35 U.S.C. 132(b) was filed and ending on the date of mailing of a notice of allowance under 35 U.S.C. 151;

In other words, time consumed after an RCE filing does not, for PTA purposes, include the time after a notice of allowance is mailed.

The second new rule changes section (c)(12) of 37 CFR 1.704 to read:

(12) Submission of a request for continued examination under 35 U.S.C. 132(b) after any notice of allowance under 35 U.S.C. 151 has been mailed, in which case the period of adjustment set forth in § 1.703 shall be reduced by the number of days, if any, beginning on the day after the date of mailing of the notice of allowance under 35 U.S.C. 151 and ending on the date the request for continued examination under 35 U.S.C. 132(b) was filed.

In other words, filing an RCE in reply to a Notice of Allowance tolls the running of the B-Delay clock and creates applicant delay, resulting in PTA loss, between the date of the notice of allowance and the date of the RCE filing.

Applicants should remember to consider these new PTA rules for pending applications when presented with the USPTO-calculated PTA in Issue Notifications mailed on or after January 9, 2015.  Additionally, it may be prudent for patentees to evaluate whether the new rules apply to their patents because an RCE was filed during prosecution and, if so, whether to file a request for PTA reconsideration for the patent pursuant to 37 CFR 1.705 within seven months of the patent’s issue date.