USPTO Issues Final Rule in View of Novartis v. Lee

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USPTO SealEarlier this year, the U.S. Patent and Trademark Office published a final rule in the Federal Register (80 Fed. Reg. 1346) to revise the rules of practice to implement the Federal Circuit's decision in Novartis AG v. Lee.  In Novartis, the Federal Circuit agreed with the USPTO that "no [patent term] adjustment time is available for any time in continued examination, even if the continued examination was initiated more than three calendar years after the application's filing" (i.e., the filing of an RCE tolls the B Delay clock even if the RCE was filed more than three years after the application was filed).  However, the Federal Circuit agreed with Novartis "that the 'time consumed by continued examination' should be limited to the time before allowance, as long as no later examination actually occurs."

The final rule indicates that the rules of practice have been revised "to provide that the time consumed by continued examination does not include the time after the mailing date of a notice of allowance, unless the applicant files a request for continued examination under 35 U.S.C. 132(b) after such allowance," stating that "the submission of a request for continued examination after any notice of allowance has been mailed will constitute a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application and thus result in a reduction of any period of patent term adjustment."  The final rule points out that an RCE filed after a notice of allowance has been mailed will not constitute a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application when the RCE is "filed solely to submit information cited in a patent office communication in a counterpart application that is submitted to the Office within thirty days of receipt of the patent office communication."

The final rule follows the Office's publication of a notice of proposed rulemaking last July, in which the Office sought comments from the public regarding proposed changes to the rules of practice.  In response to its request for comments, the Office received eight written submissions from the public.  The final rule addresses sixteen discrete comments culled from these submissions (see pages 1349-55 of the final rule notice).

In explaining why RCEs filed after allowance are treated differently than RCEs filed prior to allowance in response to one comment, the Office notes that "the filing of a request for continued examination after the mailing of a notice of allowance removes the application from the issue process and prevents the Office from issuing the patent, which adds to the pendency of the application as well as the pendency of other applications since examination resources must be diverted from other applications to the application in which the request for continued examination was filed after a notice of allowance was filed."  In response to another comment suggesting that applicants should not be penalized for filing an RCE to request correction of an error in the claims or the failure of the Office to provide an initialed copy of an information disclosure statement, or to respond to an amendment under § 1.312, the Office reminds applicants that:

A request for continued examination should never be filed simply to obtain correction of a notice of allowability or a response to an amendment under § 1.312.  An applicant may simply call the examiner to obtain the correction (such as a supplemental notice of allowability correctly indicating the allowed claims or an initialed copy of an information disclosure statement) or a response to the amendment under § 1.312 (or call the supervisory patent examiner or technology center director if the call to the examiner is unavailing).

In addressing the last comment, the Office provided some important clarification regarding the types of papers that may -- or may not -- be submitted after a notice of allowance without the applicant being considered to have failed to engage in reasonable efforts to conclude processing or examination of the application.  In particular, the final rule states that:

[T]he submission of the following papers after a notice of allowance will not be considered a failure to engage in reasonable efforts to conclude processing of examination of the application under § 1.704(c)(10): (1) An Issue Fee(s) Transmittal (PTOL–85B); (2) a power of attorney; (3) a power to inspect; (4) a change of address; (5) a change of entity status (micro, small, non-small); (6) a response to the examiner's reasons for allowance or a request to correct an error or omission in the ''Notice of Allowance'' or ''Notice of Allowability''; (7) status letters; (8) requests for a refund; (9) an inventor's oath or declaration; (10) an information disclosure statement with a statement in compliance with § 1.704(d); (11) the resubmission by applicant of unlocatable paper(s) previously filed in the application (§ 1.251); (12) a request for acknowledgment of an information disclosure statement in compliance with §§ 1.97 and 1.98, provided that the applicant had requested that the examiner acknowledge the information disclosure statement prior to the notice of allowance, or the request for acknowledgement was applicant's first opportunity to request that the examiner acknowledge the information disclosure statement; (13) comments on the substance of an interview where the applicant-initiated interview resulted in a notice of allowance; and (14) letters related to government interests (e.g., those between NASA and the Office).

The final rule notes that three of the above papers (i.e., written status inquiries, requests for refund, an inventor's oath or declaration) had been previously considered as a failure to engage in reasonable efforts to conclude processing and examination of the application, but that such papers would no longer be considered as such "due to the changes that have been brought about by the electronic filing and processing of patent applications."  The final rule also provides a list of papers that when submitted after a notice of allowance has been mailed will constitute a failure to engage in reasonable efforts to conclude processing or examination of an application.  In particular, the final rules states that:

An exemplary listing of such papers includes: (1) An amendment under § 1.312; (2) a paper containing a claim for priority or benefit or request to correct priority or benefit information (e.g., a new or supplemental application data sheet filed to correct foreign or domestic benefit information); (3) a request for a corrected filing receipt; (4) a certified copy of a priority document; (5) drawings; (6) a letter relating to biologic deposits; (7) a request to change or correct inventorship; and (8) an information disclosure statement not accompanied by a statement in compliance with § 1.704(d).

A listing of the specific rules changes can be found on pages 1356-57 of the final rule.  The final rule indicates that the changes to 37 C.F.R. § 1.703 set forth in the final rule took effect on January 9, 2015, and that the changes to 37 C.F.R. § 1.704 set forth in the final rule took effect on March 10, 2015.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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